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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-K

 

(Mark One)

 

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
   
  For the fiscal year ended December 31, 2022
   
or
   
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934
   
  For the transition period from _________ to _________

 

Commission file number 000-15327

 

LadRx Corporation

(Exact name of Registrant as specified in its charter)

 

Delaware   58-1642740
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification No.)
     
11726 San Vicente Blvd, Suite 650,    
Los Angeles, California   90049
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (310) 826-5648

 

CytRx Corporation

(Former name, former address and former fiscal year, if changed since last report)

 

Securities Registered Pursuant to Section 12(b) of the Act:

None

 

Securities Registered Pursuant to Section 12(g) of the Act:

 

Title of each class   Trading Symbol(s)   Name of exchange on which registered
Common Stock, $0.001 par value per share   LADX   OTC Markets
Series B Junior Participating Preferred Stock Purchase Rights        

 

Indicate by check mark if the Registrant is a well-known seasoned issuer (as defined in Securities Act Rule 405). Yes ☐ No ☒

 

Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934. Yes ☐ No ☒

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer ☐

    

Accelerated filer ☐

       
Non-accelerated filer ☒     Smaller reporting company ☒
       
      Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

 

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

 

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

 

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

 

Based on the closing price of the Registrant’s common stock as reported on the OTC Markets, the aggregate market value of the Registrant’s common stock held by non-affiliates on June 30, 2022 (the last business day of the Registrant’s most recently completed second fiscal quarter) was approximately $4.0 million. Shares of common stock held by directors and executive officers and any ten percent or greater stockholders and their respective affiliates have been excluded from this calculation, because such stockholders may be deemed to be “affiliates” of the Registrant. This is not necessarily determinative of affiliate status for other purposes. The number of outstanding shares of the Registrant’s common stock as of March 20, 2023 was 46,587,391.

 

 

 

 
 

 

LADRX CORPORATION

2022 ANNUAL REPORT ON FORM 10-K

 

TABLE OF CONTENTS

 

    Page
     
NOTE ON FORWARD-LOOKING STATEMENTS   3
PART I   4
Item 1. BUSINESS   4
Item 1A. RISK FACTORS   20
Item 1B. UNRESOLVED STAFF COMMENTS   43
Item 2. PROPERTIES   44
Item 3. LEGAL PROCEEDINGS   44
Item 4. MINE SAFETY DISCLOSURES   44
PART II   44
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES   44
Item 6. [RESERVED]   45
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS   45
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK   54
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA   54
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE   54
Item 9A. CONTROLS AND PROCEDURES   54
Item 9B. OTHER INFORMATION   55
Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS   55
PART III   55
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE   55
Item 11. EXECUTIVE COMPENSATION  

58

Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS   64
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE   65
Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES   66
PART IV   67
Item 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES   67
Item 16. FORM 10-K SUMMARY   72
     
SIGNATURES   73

 

2

 

 

NOTE ON FORWARD-LOOKING STATEMENTS

 

References throughout this Annual Report on Form 10-K, the “Company,” “LadRx,” “we,” “us,” and “our,” except where the context requires otherwise, refer to LadRx Corporation.

 

Some of the information contained in this Annual Report may include forward-looking statements that reflect our current views with respect to our research and development activities, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise.

 

All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth in the sections entitled “Business,” “Risk Factors,” “Legal Proceedings,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Quantitative and Qualitative Disclosures About Market Risk” and “Controls and Procedures” in this Annual Report, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this Annual Report. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

 

If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note.

 

INDUSTRY DATA

 

Unless otherwise indicated, information contained in this Annual Report concerning our industry, including our general expectations and market opportunity, is based on information from our own management estimates and research, as well as from industry and general publications and research, surveys and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which we believe to be reasonable. In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described below in the “Risk Factors” section of this Annual Report. These and other factors could cause our future performance to differ materially from our assumptions and estimates.

 

TRADEMARKS

 

LadRx, LADR and ACDx are some of our trademarks used in this Annual Report. This Annual Report also includes trademarks, trade names and service marks that are the property of other organizations. Solely for convenience, trademarks and trade names referred to in this Annual Report sometimes appear without the ® and ™ symbols, but those references are not intended to indicate that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and trade names.

 

3

 

 

PART I

 

Item 1. BUSINESS

 

COMPANY OVERVIEW

 

LadRx Corporation (“LadRx” or the Company) is a biopharmaceutical research and development company specializing in oncology. The Company’s focus is on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel technologies that target chemotherapeutic drugs to solid tumors and reduce off-target toxicities. During 2017, the Company’s discovery laboratory in Freiburg, Germany synthesized and tested over 75 rationally designed drug candidates with highly potent anti-cancer payloads, culminating in the creation of two distinct classes of compounds. Four lead candidates (LADR-7 through LADR-10) were selected based on in vitro and animal studies in several different cancer models, and based on stability and manufacturing feasibility. In addition, a novel companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates. However, the Company’s research and development activities have been curtailed as they seek additional financing.

 

On June 1, 2018, the Company launched Centurion BioPharma Corporation (“Centurion”), a private subsidiary, and transferred all of its assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection with said transfer, the Company and Centurion entered into a Management Services Agreement whereby the Company agreed to render advisory, consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the Company for the cost of such services plus a 5% service charge. On December 21, 2018, LadRx announced that Centurion had concluded the pre-clinical phase of development for its four LADR™ drug candidates, and for its albumin companion diagnostic (ACDx™). As a result of completing this work, operations taking place at the pre-clinical laboratory in Freiburg, Germany were no longer needed and, accordingly, the lab was closed at the end of January 2019.

 

On March 9, 2022, Centurion merged with and into LadRx, with LadRx absorbing all of Centurion’s assets and continuing after the merger as the surviving entity (the “Merger”). The Merger was implemented through an agreement and plan of merger pursuant to Section 253 of the General Corporation Law of the State of Delaware (the “DGCL”) and did not require approval from either our or Centurion’s stockholders. The Certificate of Ownership merging Centurion into LadRx was filed with the Secretary of State of Delaware on March 9, 2022.

 

Effective September 26, 2022, the Company changed its name from CytRx Corporation to LadRx Corporation pursuant to a Certificate of Amendment to our Restated Certificate of Incorporation (the “Certificate of Incorporation”) filed with the Secretary of State of Delaware. In accordance with the DGCL, its board of directors (the “Board”) approved the name change and the Certificate of Amendment. Pursuant to Section 242(b)(1) of the DGCL, stockholder approval was not required for the name change or the Certificate of Amendment.

 

LadRx is a Delaware corporation, incorporated in 1985. Our corporate offices are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles, California 90049, and our telephone number is (310) 826-5648. Our web site is located at http://www.ladrxcorp.com. We do not incorporate by reference into this Annual Report the information on, or accessible through, our website, and you should not consider it as part of this Annual Report.

 

LADR Drug Discovery Platform

 

The LADR Technology offers the opportunity for multiple pipeline drugs. The Company’s LADR™ (Linker Activated Drug Release) technology platform consists of an organic backbone that is attached to a chemotoxic agent. The purpose of the LADR™ backbone is to first target and deliver the chemotoxic agent to the tumor environment, and then to release the chemotoxic agent within the tumor. By delivering, concentrating, and releasing the chemotoxic agent within the tumor, one expects to reduce the off-target side-effects of the chemotherapeutic, which in turn allows for several-fold higher dosing of the chemotherapeutic to the patient. Being small organic molecules, the Company expects LADR-based drugs to offer the benefits of targeting the tumor without the complexity, side effects, and expense inherent in macromolecules such as antibodies and nanoparticles.

 

The Company’s LADR-based drugs use circulating albumin as the binding target and as the trojan horse to deliver the LADR™ drugs to the tumor. Albumin is the most abundant protein in plasma and accumulates inside tumors due to the aberrant vascular structure that exists within solid tumors. Tumors use albumin as a nutritional source and for transport of signaling and other molecules that are important to the maintenance and growth of the tumor, which makes albumin an excellent target for drugs that are intended for solid tumors.

 

4

 

 

The Company’s LADR™ development efforts are focused on two classes of ultra-high potency albumin-binding drugs. These LADR-based drugs, LADR7, 8, 9, and 10, combine the proprietary LADR™ backbone with novel derivatives of the auristatin and maytansinoid drug classes. Auristatin and maytansinoid are highly potent chemotoxins, and require targeting to the tumor for safe administration to humans, as is the case for the U.S. Food and Drug Administration (“FDA”)-approved drugs Adcetris (auristatin antibody-drug-conjugate by Seagen) and Kadcyla (maytansine antibody-drug-conjugate by Genentech). We believe that LADR-based drugs offer the benefits of tumor targeting without the disadvantages of antibodies and other macromolecules, which include expense, complexity, and negative side effects. Additionally, albumin is a very well-characterized drug target, which we believe will reduce clinical and regulatory costs and risks.

 

The Company’s postulated mechanism of action for LADR-based drugs is as follows:

 

●after administration, the linker portion of the drug conjugate forms a rapid and specific covalent bond to the cysteine-34 position of circulating albumin;
   
●circulating albumin preferentially accumulates in tumors due to a mechanism called “Enhanced Permeability and Retention”, which results in lower exposure to the drug in noncancerous tissues of the heart, liver, and other organs;
   
●once localized at the tumor, the acid-sensitive linker of the LADR™ backbone is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and
   
●free active drug is then released within the tumor, causing tumor cell death.

 

The first-generation LADR-based drug is called aldoxorubicin. Aldoxorubicin is the drug doxorubicin attached to the first generation LADR™ backbone (LADRs 7-10 employ a next generation LADR™ backbone). Aldoxorubicin has been administered to over 600 human subjects in human clinical trials and has proven the concept of LADR™ in that several-fold more doxorubicin can be safely administered to patients when the doxorubicin is attached to LADR™ than when administered as native doxorubicin. Aldoxorubicin has been licensed to ImmunityBio, Inc. (formerly known as NantCell, Inc.) (“ImmunityBio”), and is currently in a Phase II registrational intent trial for pancreatic cancer. Aldoxorubicin is expected to enter a Phase I/II trial for glioblastoma in 2023.

 

The next generation LADR™ drugs are termed LADR7, 8, 9, and 10. A great deal of Investigational New Drug (“IND”) enabling work has already been accomplished on LADR7-10, including in-silico modeling, in-vitro efficacy testing in several different cancer models, in-vivo dosing, safety, and efficacy testing in several different cancer models in animals. We have also developed and proven manufacturability, an important step prior to beginning human clinical trials.

 

The IND-enabling work that remains prior to applying to the FDA for first-in-human studies for LADR7-10 is limited due to the extensive experimentation already completed. For example, in the case of LADR7, a manufacturing run under Good Manufacturing Practices (GMP) must be completed and some toxicology studies completed using the GMP material must be completed in animals. Toxicology studies with LADR7 have already been completed with non-GMP manufactured drug. Management estimates that these final IND-enabling activities for LADR7 would take approximately 12 months to complete, once funded and initiated, and that first-in-human dosing would be achieved within approximately 6-9 months after completion of the IND-enabling studies. Management further estimates that the cost to manufacture GMP material for one LADR™ drug, for example LADR7, complete all pre-IND studies, and to obtain an IND could be approximately $2 million in direct costs, based on current estimates, representing a capital-efficient path to clinical entry.

 

Because the LADR™ backbone in future products would be the same as the LADR™ backbone in current product candidates, (i.e. the chemotoxin can be changed without changing the LADR™ backbone), management anticipates that future product candidates beyond LADR7-10 may enjoy abbreviated pre-clinical pathways to first-in-human. Such abbreviated pathways would be subject to FDA review and agreement.

 

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The Company’s novel companion diagnostic, ACDx™ (albumin companion diagnostic) was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR™ lead assets. We have not yet determined whether the use of a companion diagnostic will be necessary or helpful, and plan to continue to investigate this question in parallel to the pre-clinical and clinical development of LADRs 7-10.

 

The LADR™ backbone and drugs that employ LADR™ are protected by domestic and international patents, and additional patents are pending.

 

Business Strategy for LADR™ Platform

 

Throughout 2022, with the assistance of oncology drug development experts, the Company has inventoried the IND-enabling data for LADRs 7-10, developed a strategy to complete the IND-enabling studies necessary for at least one LADR™ drug, and worked with vendors on establishing approximate time lines and costs to reach first-in-human dosing, inclusive of manufacturing, and completion of pre-IND studies and FDA filings, With this important groundwork completed, we believe that management is well situated to rapidly advance our next-generation LADR™ assets as soon as funding or partnering is achieved, and is working diligently to obtain funding and/or partnering of the LADR™ assets. Management will continue to explore in parallel both partnered and non-partnered funding and development strategies for LADR™ with a goal of obtaining the least costly capital possible to enable value inflection milestones.

 

Partnering of Aldoxorubicin

 

On July 27, 2017, the Company entered into an exclusive worldwide license agreement with ImmunityBio, Inc, granting to ImmunityBio the exclusive rights to develop, manufacture and commercialize aldoxorubicin in all indications, and the Company is no longer directly working on the development of aldoxorubicin. As part of the license agreement, ImmunityBio made a strategic investment of $13 million in LadRx common stock at $6.60 per share (adjusted to reflect the Company’s 2017 reverse stock split), a premium of 92% to the market price on that date. In connection therewith, the Company also issued ImmunityBio a warrant to purchase up to 500,000 shares of common stock at $6.60, which expired on January 26, 2019. The Company is entitled to receive up to an aggregate of $343 million in potential milestone payments, contingent upon achievement of certain regulatory approvals and commercial milestones. The Company is also entitled to receive ascending double-digit royalties for net sales for soft tissue sarcomas and mid to high single digit royalties for other indications. There can be no assurance that ImmunityBio will achieve such milestones, approvals or sales with respect to aldoxorubicin.

 

ImmunityBio is conducting an open-label, randomized, Phase 2 study of a combination of immunotherapy, aldoxorubicin and standard-of-care chemotherapy versus standard-of-care chemotherapy alone for the treatment of locally advanced or metastatic pancreatic cancer in patients who have had 1 or 2 lines of treatment (Cohorts A and B) or 3 or greater lines of treatment (Cohort C).

 

In December 2022, Immunity Bio held a Type B meeting with the FDA to discuss the path for approval for this combination therapy for pancreatic cancer. The FDA advised ImmunityBio to conduct a randomized trial. This Phase 2, randomized, three-cohort, open-label study plans to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus low-dose chemotherapy in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and C, respectively, with Cohorts A and B having independent experimental and control arms. The primary objective of Cohorts A and B is progression-free survival (PFS) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS)

 

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In January 2023, ImmunityBio announced positive results in its non-randomized fully-enrolled metastatic pancreatic cancer study in third-line or greater subjects (QUILT 88) showing that the overall survival rate for patients continues to be double compared to historical survival rates after two or more prior lines of therapy. The results were presented at the American Society of Clinical Oncology Gastrointestinal (ASCO GI) conference in San Francisco January 19-21, 2023. The median OS in this highly advanced group of patients, up to seven lines (N=83) of treatment, was 5.8 months (95% CI: 4.9, 6.4 months), exceeding the approximately 2- to 3-month historical median OS. In the third-line setting (N=41), the median OS in this group was 6.3 months (95% CI: 5.0, 7.2 months), more than doubling the historical OS. The baseline median CA 19-9 level (a marker of metastatic pancreatic disease) of the enrolled subjects (N=83) was very high at 4120 IU/ml, a significant increase from normal levels of 40 IU/ml. In subjects with CA 19-9 levels less than 4120 IU/ml (N=40), the median OS was 6.9 months (95% CI: 5.7,10.9).

 

Aldoxorubicin has received Orphan Drug Designation (ODD) by the FDA for the treatment of soft tissue sarcoma (“STS”). ODD provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other benefits.

 

ImmunityBio also lists ongoing clinical studies in glioblastoma; it is currently reviewing its options in STS.

 

Molecular Chaperone Assets (Orphayzme)

 

In 2011, LadRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme A/S (“Orphazyme”, formerly Orphazyme ApS) in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million in milestone payments upon the achievement of certain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any net sales of products derived from arimoclomol (the “2011 Arimoclomol Agreement”). Orphazyme transferred its rights and obligations under the 2011 Arimoclomol Agreement to KemPharm Denmark A/S (“KemPharm”), a wholly owned subsidiary of KemPharm Inc., in May 2022 (the “KemPharm Transaction”).

 

In May 2021, Orphazyme announced that the pivotal phase 3 clinical trial for arimoclomol in Amyotrophic Lateral Sclerosis did not meet its primary and secondary endpoints, reducing the maximum amount that LadRx currently has the right to receive under the 2011 Arimoclomol Agreement to approximately $100 million. Orphazyme also tested arimoclomol in Niemann-Pick disease Type C (“NPC”) and Gaucher disease, and following a Phase II/III trial submitted to the FDA a New Drug Application (‘NDA”) for the treatment of NPC with arimoclomol. On June 18, 2021, Orphazyme announced it had received a complete response letter (the “Complete Response Letter”) from the FDA indicating the need for additional data. In late October 2021, Orphazyme announced it held a Type A meeting with the FDA, at which the FDA recommended that Orphazyme submit additional data, information and analyses to address certain topics in the Complete Response Letter and engage in further interactions with the FDA to identify a pathway to resubmission. The FDA concurred with Orphazyme’s proposal to remove the cognition domain from the NPC Clinical Severity Scale (“NPCCSS”) endpoint, with the result that the primary endpoint is permitted to be recalculated using the 4- domain NPCCSS, subject to the submission of additional requested information which Orphazyme had publicly indicated that it intended to provide. To bolster the confirmatory evidence already submitted, the FDA affirmed that it would require additional in vivo or pharmacodynamic (PD)/pharmacokinetic (PK) data. Orphazyme planned to request a Type C Meeting with the FDA in the second quarter of 2022. Subject to discussions with the regulatory body, Orphazyme had publicly indicated that it planned to resubmit the NDA for arimoclomol in the second half of 2022.

 

Orphazyme had also submitted a Marketing Authorization Application (“MAA”) with the European Medicines Agency (the “EMA”). In February 2022, Orphazyme announced that although they had received positive feedback from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA, they were notified by the CHMP of a negative trend vote on the MAA for arimoclomol for NPC following an oral explanation. In March 2022 Orphazyme removed its application with the EMA. Orphazyme had publicly indicated that it will assess its strategic options and provide an update to the market at the applicable time.

 

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On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately $5.2 million to KemPharm, a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (“CNS”) diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties on sales, were assumed by KemPharm. KemPharm is expected to continue the early access programs with arimoclomol, and to continue to pursue the potential approval of arimoclomol as a treatment option for NPC. KemPharm has indicated it plans on resubmitting the NDA for arimoclomol to the FDA in the third quarter of 2023. In February, 2023, KemPharm published positive data based on the recent completion of their four-year open-label safety trial that indicated arimoclomol may reduce the long-term progression of NPC. They plan on including these data as part of the updated NDA resubmission. It is also identifying a regulatory path forward with the EMA. KemPharm has recently re-branded to Zevra Therapeutics, Inc.

 

Innovive Acquisition Agreement

 

On September 19, 2008, we completed our merger acquisition of Innovive Pharmaceuticals, Inc. (“Innovive”), and its clinical-stage cancer product candidates, including aldoxorubicin and tamibarotene. Under the merger agreement by which we acquired Innovive, we agreed to pay the former Innovive stockholders up to approximately $18.3 million of future earnout merger consideration, subject to our achievement of specified net sales under the Innovive license agreements. The earnout merger consideration, if any, will be payable in shares of our common stock, subject to specified conditions, or, at our election, in cash or by a combination of shares of our common stock and cash. Our common stock will be valued for purposes of any future earnout merger consideration based upon the trading price of our common stock at the time the earnout merger consideration is paid. The earnout will be accrued if and when earned. As of December 31, 2022 and 2021, no amounts were due under this agreement.

 

Commercialization and Marketing

 

We currently have no sales, marketing or commercial product distribution capabilities or experience in marketing products.

 

We are searching for a development and commercialization partner or a financing for our LADR drug candidates and do not currently plan on commercializing them ourselves. Over the past two years, we have been unable to attract either a development and commercial partner or a financing for this endeavor; however, we are continuing to pursue all possibilities.

 

Patents and Proprietary Technology

 

We actively seek patent protection for our technologies, processes, uses, and ongoing improvements and consider our patents and other intellectual property to be critical to our business. We regularly evaluate the patentability of new inventions and improvements developed by us or our collaborators, and, whenever appropriate, will endeavor to file U.S. and international patent applications to protect these new inventions and improvements. We cannot be certain that any of the current pending patent applications we have filed or licensed, or any new patent applications we may file or license, will ever be issued in the U.S. or any other country. There also is no assurance that any issued patents will be effective to prevent others from using our products or processes. It is also possible that any patents issued to us, as well as those we have licensed or may license in the future, may be held invalid or unenforceable by a court, or third parties could obtain patents that we would need to either license or to design around, which we may be unable to do. Current and future competitors may have licensed or filed patent applications or received patents and may acquire additional patents and proprietary rights relating to compounds, products or processes that may be competitive with ours.

 

In addition to patent protection, we attempt to protect our proprietary products, processes and other information by relying on trade secrets and non-disclosure agreements with our employees, consultants and certain other persons who have access to such products, processes and information. Under the agreements, all inventions conceived by employees are our exclusive property, but there is no assurance that these agreements will afford significant protection against misappropriation or unauthorized disclosure of our trade secrets and confidential information.

 

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As of December 31, 2022, we have three granted U.S. patents and twenty-five granted foreign patents, and two pending U.S. patent applications and thirty-eight pending foreign patent applications covering our LADRTM-related technology including LADR-7, LADR-8, LADR-9 and LADR-10. The un-extended patent term of patents that issue covering our LADRTM-related technology is between June 2036 and November 2038. We also have one pending US patent application and fourteen pending foreign patent applications covering our albumin companion diagnostic (ACDxTM). The un-extended patent term of patents that issue covering our ACDxTM is July 2039. The patents and patent applications covering our LADRTM-related technology, and ACDxTM are assigned to LadRx Corporation. In conjunction with our July 27, 2017, ImmunityBio licensing agreement, we granted ImmunityBio an exclusive license to all our aldoxorubicin-related patents, including the rights in three granted U.S. patents, twenty granted foreign patents and three pending foreign patent applications covering aldoxorubicin and related technologies. Our intellectual property holdings relating to aldoxorubicin, and related technologies include an exclusive license from Vergell Medical, S.A (“Vergell”). Patents and applications that cover pharmaceutical compositions comprising aldoxorubicin and their use in treating cancer (including glioblastoma) have un-extended patent terms expiring between December 2033 and June 2034.

 

LICENSE AGREEMENTS

 

Aldoxorubicin

 

We are the licensee of patent rights held by KTB Tumorforschungs GmbH (“KTB”) for the worldwide development and commercialization of aldoxorubicin under a license agreement dated April 17, 2006. In February 2017, we received notice that KTB had transferred and assigned its rights and obligations under the license to Vergell. The license is exclusive and applies to all products that may be subject to the licensed intellectual property in all fields of use. We may sublicense the intellectual property in our sole discretion. Pursuant to an amendment to the license agreement entered into in March 2014, we also have a non-exclusive worldwide license to any additional technology that is claimed or disclosed in the licensed patents and patent applications for use in the field of oncology.

 

Under the agreement, we must make payments to Vergell in the aggregate of up to $7.5 million upon meeting certain clinical and regulatory milestones, and up to and including the product’s second final marketing approval. We also agreed to pay:

 

  ● commercially reasonable royalties based on a percentage of net sales (as defined in the agreement);
     
  ● a percentage of any non-royalty sub-licensing income (as defined in the agreement); and
     
  ● milestones of $1 million for each additional final marketing approval that we obtain.

 

In the event that we must pay a third party in order to exercise our rights to the intellectual property under the agreement, we are entitled to deduct a percentage of those payments from the royalties due Vergell, up to an agreed upon cap.

 

Under the agreement with Vergell, we must use commercially reasonable efforts to conduct the research and development activities we determine are necessary to obtain regulatory approval to market aldoxorubicin in those countries that we determine are commercially feasible. Under the agreement, Vergell is to use its commercially reasonable efforts to provide us with access to suppliers of the active pharmaceutical ingredient, or API, of aldoxorubicin, on the same terms and conditions as may be provided to Vergell by those suppliers.

 

The agreement will expire on a product-by-product basis upon the expiration of the subject patent rights. We have the right to terminate the agreement on 30 days’ notice, provided we pay a cash penalty to Vergell. Vergell may terminate the agreement if we are in breach and the breach is not cured within a specified cure period, or if we fail to use diligent and commercial efforts to meet specified clinical milestones.

 

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Molecular Chaperone Assets

 

The agreement relating to our worldwide rights to arimoclomol provides for our payment up to an aggregate of $3.65 million upon receipt of milestone payments from KemPharm.

 

Competition

 

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. While we believe that our LADR™ technology platform and ultra-high potency albumin-bind drug conjugates provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions. Any drug candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

 

Many competitors and potential competitors have substantially greater scientific, research and product development capabilities, as well as greater financial, marketing and human resources than we do. In addition, many specialized biotechnology firms have formed collaborations with large, established companies to support the research, development and commercialization of products that may be competitive with ours.

 

There are many companies developing antibody-drug conjugates (ADC) for the treatment of cancer and some that use the same classes of cytotoxic payloads as we are currently using. These include Takeda Pharmaceutical Co. Ltd. and Seattle Genetics Inc. who market Adcetris®, and F. Hoffmann-LaRoche Ltd./Genentech who market Kadcyla®. According to www.clinicaltrials.gov, many other major pharmaceutical companies, including Celgene and GlaxoSmithKline are testing an ADC in either on-going or currently enrolling clinical trials. Other companies have created or have programs to create cell-killing agents for attachment to antibodies or other targeting agents. These companies may compete with us for technology out-license arrangements.

 

In addition to ADCs, we face competition from other nanomedicine platforms developing targeted therapies, including platforms focused on nanoparticles and liposomes. Non-ADC therapies may be in development for the cancer types we or our partners elect to pursue. Further, these companies may also compete with us for technology out-license arrangements.

 

Continuing development of conventional and targeted cytotoxins by large pharmaceutical companies and biotechnology companies may result in new compounds that may compete with our product candidates. More recently, immuno-oncology therapies that stimulate the body’s own defense system to attack cancers are being developed by certain of these companies and some have been approved for use as cancer therapeutics. In the future, immuno-oncology agents including cell therapies, targeted therapies or cytotoxic treatments may compete with our product candidates. Other companies have created or have programs to create potent cell-killing agents for attachment to tumor targeting agents. These companies may compete with us for technology out-license arrangements.

 

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we obtain approval for ours. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic products. If our drug candidates achieve marketing approval, we expect that they will be priced at a significant premium over competitive generic products.

 

Many companies, including large pharmaceutical and biotechnology firms with financial resources, research and development staffs, and facilities that may be substantially greater than those of ours or our strategic partners or licensees, are engaged in the research and development of pharmaceutical products that could compete with our potential products. To the extent that we seek to acquire, through license or otherwise, existing or potential new products, we will be competing with numerous other companies, many of which will have substantially greater financial resources, large acquisition and research and development staffs that may give those companies a competitive advantage over us in identifying and evaluating these drug acquisition opportunities. Any products that we acquire will be competing with products marketed by companies that in many cases will have substantially greater marketing resources than we have. The industry is characterized by rapid technological advances and competitors may develop their products more rapidly and such products may be more effective than those currently under development or that may be developed in the future by our strategic partners or licensees. Competitive products for a number of the disease indications that we have targeted are currently being marketed by other parties, and additional competitive products are under development and may also include products currently under development that we are not aware of or products that may be developed in the future.

 

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Government Regulation

 

Regulation of Pharmaceuticals in the United States

 

The U.S. and other developed countries extensively regulate the preclinical and clinical testing, manufacturing, labeling, storage, record-keeping, advertising, promotion, export, marketing and distribution of drugs and biologic products. In the United States, the FDA, under the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service (“PHS”) Act and other federal statutes and regulations, regulates pharmaceutical and biologic products and product candidates, and the parties engaged in the development, testing, manufacture, distribution, storage, marketing, labeling, advertising, and/or commercialization thereof (in addition to any other related activities) are subject to rigorous pre- and post-market requirements.

 

To obtain FDA approval for a new drug candidate, we must, among other requirements, submit data supporting the candidate’s safety and efficacy for the intended indication(s), as well as detailed information on the manufacture and composition of the product candidate. In most cases, this will require extensive laboratory tests and preclinical and clinical trials. The collection of these data, as well as the preparation of applications for review by the FDA involve significant time and expense and are inherently complex and uncertain. The FDA may not act quickly or favorably in reviewing these applications, and we (and/or any current or future partners in development) may encounter significant difficulties or costs in our (and/or their) efforts to obtain FDA approvals that could delay or preclude the U.S. commercialization of one or more of our product candidates.

 

The process required by the FDA before a new drug may be marketed in the U.S. generally involves some or all of the following key steps:

 

  ● completion of nonclinical studies, such as laboratory tests, animal studies, and formulation studies, performed in compliance with FDA regulations for good laboratory practices (“GLPs”) and other applicable regulations;
     
  ● design of a clinical protocol and its submission to the FDA as part of an Investigational New Drug application (“IND”), which must become effective before human clinical trials may begin;
     
  ● performance of adequate and well-controlled human clinical trials according to good clinical practices (“GCPs”) to establish the safety and efficacy of the product candidate for its intended use;
     
  ● submission of an NDA to the FDA along with payment of the application user fee and FDA acceptance of that NDA as a complete submission eligible for substantive review;
     
  ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the active pharmaceutical ingredient, or API, and finished drug product are produced and tested to assess readiness for commercial manufacturing and conformance to the manufacturing-related elements of the application, to conduct a data integrity audit, and to assess compliance with current good manufacturing practices (“cGMPs”), in order to assure that the facilities, methods and controls are adequate to preserve the drug candidate’s identity, strength, quality and purity;
     
  ● possible inspection of selected clinical study sites to confirm compliance with GCP requirements and data integrity; and
     
  ● FDA substantive review and approval of the NDA, including satisfactory completion of an FDA advisory committee review of the product candidate, if applicable, which must occur prior to any commercial marketing or sale of the drug product in the United States.

 

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Preclinical Studies

 

After a therapeutic candidate is identified for development, it enters the preclinical or nonclinical testing stage. Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy. Preclinical tests intended for submission to the FDA to support the safety of a product candidate must be conducted in compliance with GLP regulations and the United States Department of Agriculture’s Animal Welfare Act, if applicable. A drug sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND. Some nonclinical testing may continue after the IND is submitted. In addition to including the results of the nonclinical studies, the IND will include one or more clinical protocols detailing, among other things, the objectives of the clinical trial and the safety and effectiveness criteria to be evaluated.

 

An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence. A clinical hold may occur at any time during the life of an IND and may affect one or more specific studies or all studies conducted under the IND. Occasionally, clinical holds are imposed due to manufacturing issues that may present safety issues for the clinical study subjects.

 

Human Clinical Trials in Support of an NDA

 

The clinical investigation of an investigational new drug is divided into three phases that typically are conducted sequentially but may overlap or be combined. The three phases are as follows:

 

  ● Phase 1. Phase 1 includes initial clinical trials introducing an investigational new drug into humans and may be conducted in subjects with the target disease or healthy volunteers. These trials are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
     
  ● Phase 2. Phase 2 includes the controlled clinical trials conducted to evaluate the effectiveness of the drug candidate for a particular indication or indications in subjects with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 trials are typically well controlled, closely monitored, and conducted in a relatively small number of subjects.
     
  ● Phase 3. Phase 3 trials are typically large trials performed after preliminary evidence suggesting effectiveness of the drug candidate has been obtained. They are intended to gather additional information about the effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling and product marketing approval. Phase 3 trials usually are conducted at geographically dispersed clinical study sites.

 

A clinical trial may combine the elements of more than one phase and the FDA often requires more than one Phase 3 trial to support marketing approval of a product candidate. A company’s designation of a clinical trial as being of a particular phase is not necessarily indicative that the study will be sufficient to satisfy the FDA requirements of that phase because this determination cannot be made until the protocol and data have been submitted to and reviewed by the FDA. Human clinical trials are inherently uncertain and Phase 1, Phase 2 and Phase 3 testing may not be successfully completed.

 

A pivotal trial is a clinical trial that is believed to satisfy FDA requirements for the evaluation of a product candidate’s safety and efficacy such that it can be used, alone or with other pivotal or non-pivotal trials, to support regulatory approval. Generally, pivotal trials are Phase 3 trials, but they may be Phase 2 trials if the design provides a well-controlled and reliable assessment of clinical benefit, particularly in an area of unmet medical need.

 

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Clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with the FDA’s GCP requirements. They must be conducted under protocols detailing the objectives of the trial, dosing procedures, research subject selection and exclusion criteria and the safety and effectiveness criteria to be evaluated. Each protocol, and any subsequent material amendment to the protocol, must be submitted to the FDA as part of the IND, and progress reports detailing the status of the clinical trials must be submitted to the FDA annually. Sponsors also must report to the FDA serious and unexpected adverse reactions in a timely manner, any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigation brochure or any findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the product or therapeutic candidate. The FDA may order the temporary or permanent discontinuation of a clinical trial at any time, via a clinical hold, or impose other sanctions if it believes that the clinical trial is not being conducted in accordance with FDA requirements or that the subjects are being exposed to an unacceptable health risk. An institutional review board (“IRB”), is responsible for ensuring that human subjects in clinical studies are protected from inappropriate study risks. An IRB at each institution participating in the clinical trial must review and approve the protocol before a clinical trial commences at that institution and must also approve the information regarding the trial and the consent form that must be provided to each research subject or the subject’s legal representative, monitor the trial until completed and otherwise comply with IRB regulations. The IRB also may halt a study, either temporarily or permanently, for failure to comply with GCP or the IRB’s requirements, or if the investigational new drug has been associated with unexpected serious harm to patients.

 

During the development of a new drug product candidate, sponsors are given opportunities to meet with the FDA at certain points; specifically, prior to the submission of an IND, at the end of Phase 2 and before an NDA is submitted. Meetings at other times may be requested. These meetings can provide an opportunity for the sponsor to share information about the data gathered to date and for the FDA to provide advice on the next phase of development. Sponsors typically use the meeting at the end of Phase 2 to discuss their Phase 2 clinical results and present their plans for the pivotal Phase 3 clinical trial that they believe will support the approval of the new therapeutic.

 

Post-approval trials, sometimes referred to as “Phase 4” clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, FDA may mandate the performance of “Phase 4” clinical trials.

 

Concurrent with clinical trials, sponsors usually complete additional animal safety studies, develop additional information about the chemistry and physical characteristics of the product candidate and finalize a process for manufacturing commercial quantities of the product candidate in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other criteria, the sponsor must develop methods for testing the identity, strength, quality, and purity of the finished drug product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

 

Marketing Application Submission and FDA Review

 

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, detailed information on the product candidate is submitted to the FDA in the form of an NDA requesting approval to market the drug for one or more indications. An NDA includes all relevant data available from pertinent nonclinical studies and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information on the product candidate’s chemistry, manufacturing, and controls, or CMC, and proposed labeling, among other things. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the product candidate for its intended use to the satisfaction of the FDA.

 

Under the Prescription Drug User Fee Act (“PDUFA”), each NDA must be accompanied by a significant user fee. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual program fee for prescription drug products. Fee waivers or reductions are available in certain circumstances, such as where a waiver is necessary to protect the public health, where the fee would present a significant barrier to innovation, or where the applicant is a small business submitting its first human therapeutic application for review.

 

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Under the goals and policies agreed to by the FDA under PDUFA, the FDA has ten months from receipt in which to complete its initial review of a standard NDA for a drug that is not a new molecular entity, and six months from the receipt date for an application with priority review. The FDA does not always meet its PDUFA goal dates, and the review process is often significantly extended by FDA requests for additional information or clarification and a sponsor’s process to respond to such inquiries. As a result, the NDA review process can be very lengthy. Most innovative drug products (other than biological products) obtain FDA marketing approval pursuant to an NDA submitted under Section 505(b)(1) of the FDCA, commonly referred to as a traditional (or full) NDA.

 

The FDA conducts a preliminary review of all NDAs it receives to ensure that they are sufficiently complete for substantive review before it accepts them for filing. The FDA may refuse to file any NDA that it deems incomplete or not properly reviewable at the time of submission, and may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. The FDA has 60 days after submission of an NDA to conduct an initial review to determine whether it is sufficient to accept for filing. If the submission is accepted for filing, the FDA begins an in-depth substantive review of the NDA. The FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for its intended use, whether it has an acceptable purity profile and whether the product is being manufactured in accordance with cGMPs. During its review of an NDA, the FDA may refer the application to an advisory committee of independent experts for a recommendation as to whether the application should be approved. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it typically follows such recommendations. Data from clinical trials are not always conclusive, and the FDA or its advisory committee may interpret data differently than the NDA sponsor interprets the same data. The FDA may also re-analyze the clinical trial data, which could result in extensive discussions between the FDA and the applicant during the review process.

 

Before approving an NDA, the FDA will typically inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving the NDA, the FDA will typically inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements and GCP requirements and to assure the integrity of the clinical data submitted to the FDA. To ensure cGMP and GCP compliance by its employees and third-party contractors, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production and quality control.

 

The FDA may also require the submission of a risk evaluation and mitigation strategy, or “REMS,” if it determines that a REMS is necessary to ensure that the benefits of the drug outweigh its risks and to assure the safe use of the product. A REMS could include medication guides, physician communication plans, assessment plans and/or elements to assure safe use, such as restricted distribution methods, patient registries or other risk minimization tools. The FDA determines the requirement for a REMS, as well as the specific REMS provisions, on a case-by-case basis. If the FDA concludes a REMS is needed, the sponsor must include a proposed REMS within its NDA submission.

 

After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities where the drug product or its API will be produced and the clinical trial sites, the FDA will either issue an approval letter or, in some cases, a complete response letter (“CRL”) that describes all of the specific deficiencies that the FDA has identified in the NDA. A CRL indicates that the review cycle of the application is complete but that the application will not be approved in its present form. The deficiencies identified may be minor (e.g., requiring labeling changes) or major (e.g., requiring additional clinical trials and/or other time-consuming and expensive measures to generate the requisite safety and/or efficacy data). After receiving a CRL, an applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter or withdraw the application. FDA will issue a letter within 30 days of an NDA resubmission acknowledging receipt and informing the applicant as follows. For resubmissions deemed to be complete responses to all deficiencies identified in the CRL, such letter will contain FDA’s designation of the resubmission as Class 1 or Class 2 (based on the nature of information received therein) and the corresponding due date by which it will take action (2 months for Class 1 resubmissions and 6 months for Class 2). If FDA does not find the resubmission to be a complete response to all CRL deficiencies, the FDA will inform the applicant, and the FDA’s “review clock” will not start until a complete response is received.

 

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Even if a drug product receives NDA approval, the approval may be significantly limited to specific indications and dosages and/or subject to limitations, specific labeling requirements, and/or other conditions that must be met to lawfully market the product in the United States, any or all of which could restrict the commercial value of the product. For example, the FDA may require that certain contraindications, warnings, and/or precautions be included in the product’s labeling. The FDA may also impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a REMS, or otherwise limit the scope of any approval. In addition, the FDA may require post marketing clinical trials, sometimes referred to as “Phase 4” clinical trials, designed to further assess a product’s safety and effectiveness, and/or testing and surveillance programs to monitor the safety of approved products that have been commercialized.

 

Post-Approval Requirements for Prescription Drugs

 

Following approval of a new drug product, the manufacturer and the approved drug are subject to pervasive and continuing regulation by the FDA, including, among other things, monitoring and recordkeeping activities, reporting of adverse experiences with the product, product sampling and distribution restrictions, and promotion and advertising requirements.

 

Promotional communications must be carefully crafted to ensure compliance with all applicable FDA regulations pertaining to prescription-drug marketing and labeling. In particular, prescription-drug advertisements must generally (1) not be false or misleading, (2) present a “fair balance” of information describing both the risks and benefits associated with the drug, (3) include facts that are “material” to the product’s advertised uses, and (4) include a “brief summary” that mentions every risk described in the product’s labeling. Further, where the intended use of a prescription drug differs from the intended use approved by FDA, as listed in the product’s approved NDA, FDA has asserted that the product is an unapproved “new drug” and taken enforcement action against sponsors for introducing such unapproved new drugs into interstate commerce in violation of the FDCA. This prohibited practice is also called “off-label” promotion. Although physicians may prescribe legally available products for off-label uses, sponsors may not legally market or promote such uses. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

 

To market an approved drug product for a new indication (i.e., beyond and/or differing from that set forth in the approved NDA), the sponsor must submit a new NDA (or NDA supplement), which, in many cases, will require the completion of adequate and well-controlled clinical trials to demonstrate the product’s safety and efficacy in the new indication. There is no guarantee that FDA will approve an NDA seeking an expansion of an approved drug’s labeling and/or indications for use more quickly than an NDA involving a novel product (i.e., that has never been approved for any indication) or ever. Relatedly, if the sponsor (or a contractor, partner, or other affiliated party) makes any post-market modifications to an approved drug or the production thereof, including changes in labeling or manufacturing processes or facilities, among other things, it may be required to submit and obtain FDA approval of a new NDA or an NDA supplement.

 

In addition, FDA regulations require that products be manufactured in specific approved facilities and in accordance with cGMPs. The cGMP regulations include requirements relating to organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and some state agencies, and are subject to periodic unannounced inspections by the FDA for compliance with cGMPs and other requirements. Changes to the manufacturing process, specifications or container closure system for an approved drug product are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require, among other things, the investigation and correction of any deviations from cGMPs and the imposition of reporting and documentation requirements upon the NDA sponsor and any third-party manufacturers involved in producing the approved drug product. Accordingly, both sponsors and manufacturers must continue to expend time, money, and effort on systems relating to production and quality control to maintain cGMP compliance and other aspects of quality control and quality assurance, and to ensure ongoing compliance with other statutory requirements of the FDCA. We anticipate that the products we may commercialize in the United States (if any) will be manufactured by our strategic partners (including licensees) or contractors (including any third parties who may be engaged by us or one of our partners to conduct any commercialization activities, as well as downstream subcontractors, as applicable) and we may, thus, be subject to enforcement action for any such third parties’ failures to comply with the applicable postmarket regulations or otherwise be adversely affected by any of our partners’ or contractors’ compliance issues.

 

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The FDA may withdraw its approval for a drug product if compliance with regulatory requirements is not maintained or unexpected problems occur after the product reaches the market. Later discovery of previously unknown problems with a drug, including serious and/or unexpected adverse experiences, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies to assess new safety risks; or the imposition of distribution or other restrictions under a REMS.

 

We and/or our present or future suppliers, contract manufacturers, and/or other affiliates involved in one or more of our current or future U.S. development and/or commercialization activities (if applicable) may not be able to comply with all FDA regulatory requirements. For example, we may believe that all clinical studies are being conducted in accordance with the FDA’s IND regulations and that none of our investigational products are being promoted with claims of safety and/or effectiveness for the intended use(s) for which they are under investigation, but the FDA may determine otherwise, which could subject us to enforcement action and/or delay or prevent the ultimate approval of our applicable product candidate(s). From a postmarket perspective, with regard to any products we may commercialize in the United States in the future, we may believe our manufacturing operations (including that of our partners and/or contractors, as applicable) are fully compliant with cGMPs and that all promotional communications disseminated by or on behalf of us are consistent with FDA’s prescription-drug marketing requirements, but the FDA may disagree and take enforcement action against us. Accordingly, we could be subject to a number of adverse enforcement actions and/or penalties in connection with any failure(s) to comply with the FDCA and/or its implementing regulations at any stage in development and/or commercialization (if applicable), including, but not limited to, the following:

 

  ● fines, warning letters, untitled letters, public warnings, consumer advisories, “dear doctor” letters, and other similar publications or issuances;
     
  ● refusal of the FDA to approve pending NDAs or supplements to approved NDAs;
     
  ● seizure, detention, import alerts;
     
  ● injunctions or the imposition of civil or criminal penalties;
     
  ● consent decrees, corporate integrity agreements, debarment, or exclusion from federal healthcare programs; or
     
  ● mandated modification of promotional materials and labeling and the issuance of corrective information.

 

We and our manufacturers and other partners in development and/or (future) commercialization, as applicable, also will be subject to regulation under the Occupational Safety and Health Act, the National Environmental Policy Act, the Nuclear Energy and Radiation Control Act, the Toxic Substance Control Act and the Resource Conservation and Recovery Act. We will also be subject to a variety of federal, state and local regulations relating to the use, handling, storage and disposal of hazardous materials, including chemicals and radioactive and biological materials.

 

We will also be subject to a variety of regulations governing clinical trials and sales of our products outside the U.S. Whether or not FDA approval has been obtained, approval of a product candidate by the comparable regulatory authorities of foreign countries and regions must be obtained prior to the commencement of marketing the product in those countries. The approval process varies from one regulatory authority to another and the time may be longer or shorter than that required for FDA approval. In the European Union, Canada and Australia, regulatory requirements and approval processes are similar, in principle, to those in the U.S.

 

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Other U.S. Healthcare Laws and Regulations

 

Healthcare Reform Measures

 

On March 23, 2010, former President Obama signed the “Patient Protection and Affordable Care Act” (P.L. 111-148) (the “ACA”) and on March 30, 2010, he signed the “Health Care and Education Reconciliation Act” (P.L. 111-152), collectively commonly referred to as the “Healthcare Reform Law.” The Healthcare Reform Law included a number of new rules regarding health insurance, the provision of healthcare, conditions to reimbursement for healthcare services provided to Medicare and Medicaid patients, and other healthcare policy reforms. Through the law-making process, substantial changes have been and continue to be made to the current system for paying for healthcare in the U.S., including changes made to extend medical benefits to certain Americans who lacked insurance coverage and to contain or reduce healthcare costs (such as by reducing or conditioning reimbursement amounts for healthcare services and drugs, and imposing additional taxes, fees, and rebate obligations on pharmaceutical and medical device companies). This legislation was one of the most comprehensive and significant reforms ever experienced by the U.S. in the healthcare industry and has significantly changed the way healthcare is financed by both governmental and private insurers. This legislation has impacted the scope of healthcare insurance and incentives for consumers and insurance companies, among others. Additionally, the Healthcare Reform Law’s provisions were designed to encourage providers to find cost savings in their clinical operations. Pharmaceuticals represent a significant portion of the cost of providing care. This environment has caused changes in the purchasing habits of consumers and providers and resulted in specific attention to the pricing negotiation, product selection and utilization review surrounding pharmaceuticals. This attention may result in our current commercial products, products we may commercialize or promote in the future, and our therapeutic candidates, being chosen less frequently or the pricing being substantially lowered. At this stage, it is difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on us.

 

These structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid, and the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some combination of both, as well as other changes. Restructuring the coverage of medical care in the U.S. could impact the reimbursement for prescribed drugs and pharmaceuticals, including our current commercial products, those we and our development or commercialization partners are currently developing or those that we may commercialize or promote in the future. If reimbursement for the products we currently commercialize or promote, any product we may commercialize or promote, or approved therapeutic candidates is substantially reduced or otherwise adversely affected in the future, or rebate obligations associated with them are substantially increased, it could have a material adverse effect on our reputation, business, financial condition or results of operations.

 

Extending medical benefits to those who currently lack coverage will likely result in substantial costs to the U.S. federal government, which may force significant additional changes to the healthcare system in the U.S. Much of the funding for expanded healthcare coverage may be sought through cost savings. While some of these savings may come from realizing greater efficiencies in delivering care, improving the effectiveness of preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost of care and increased enforcement activities. Cost of care could be reduced further by decreasing the level of reimbursement for medical services or products (including our current commercial products, our development or commercialization partners or any product we may commercialize or promote, or those therapeutic candidates currently being developed by us), or by restricting coverage (and, thereby, utilization) of medical services or products. In either case, a reduction in the utilization of, or reimbursement for our current commercial products, any product we may commercialize or promote, or any therapeutic candidate, or for which we receive marketing approval in the future, could have a material adverse effect on our reputation, business, financial condition or results of operations.

 

Several states and private entities initially mounted legal challenges to the Healthcare Reform Law, in particular, the ACA, and they continue to litigate various aspects of the legislation. On July 26, 2012, the U.S. Supreme Court generally upheld the provisions of the ACA at issue as constitutional. However, the U.S. Supreme Court held that the legislation improperly required the states to expand their Medicaid programs to cover more individuals. As a result, states have a choice as to whether they will expand the number of individuals covered by their respective state Medicaid programs. Some states have not expanded their Medicaid programs and have chosen to develop other cost-saving and coverage measures to provide care to currently uninsured individuals. Many of these efforts to date have included the institution of Medicaid-managed care programs. The manner in which these cost-saving and coverage measures are implemented could have a material adverse effect on our reputation, business, financial condition or results of operations, particularly once we and/or any of our partners have products on the U.S. market, if ever.

 

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Further, the healthcare regulatory environment has seen significant changes in recent years and is still in flux. Legislative initiatives to modify, limit, replace, or repeal the ACA and judicial challenges have continued. We cannot predict the extent to which our business may be impacted by legal challenges to the ACA or other aspects of the Healthcare Reform Law or other changes to the current laws and regulations. The financial impact of U.S. healthcare reform legislation over the next few years will depend on a number of factors, including the policies reflected in implementing regulations and guidance and changes in sales volumes for therapeutics affected by the legislation. From time to time, legislation is drafted, introduced and passed in the U.S. Congress that could significantly change the statutory provisions governing coverage, reimbursement, and marketing of pharmaceutical products. In addition, third-party payor coverage and reimbursement policies are often revised or interpreted in ways that may significantly affect our business and any products we or our partners may commercialize in the future, as well as the prospects and/or viability of our product candidates.

 

During his time in office, former President Trump supported the repeal of all or portions of the ACA. President Trump also issued an executive order in which he stated that it is his administration’s policy to seek the prompt repeal of the ACA and in which he directed executive departments and federal agencies to waive, defer, grant exemptions from, or delay the implementation of the provisions of the ACA to the maximum extent permitted by law. Congress has enacted legislation that repeals certain portions of the ACA, including but not limited to the Tax Cuts and Jobs Act, passed in December 2017, which included a provision that eliminates the penalty under the ACA’s individual mandate, effective January 1, 2019, as well as the Bipartisan Budget Act of 2018, passed in February 2018, which, among other things, repealed the Independent Payment Advisory Board (which was established by the ACA and was intended to reduce the rate of growth in Medicare spending).

 

Additionally, in December 2018, a district court in Texas held that the individual mandate is unconstitutional and that the rest of the ACA is, therefore, invalid. On appeal, the Fifth Circuit Court of Appeals affirmed the holding on the individual mandate but remanded the case back to the lower court to reassess whether and how such holding affects the validity of the rest of the ACA. The Fifth Circuit’s decision on the individual mandate was appealed to the U.S. Supreme Court. On June 17, 2021, the Supreme Court held that the plaintiffs (comprised of the state of Texas, as well as numerous other states and certain individuals) did not have standing to challenge the constitutionality of the ACA’s individual mandate and, accordingly, vacated the Fifth Circuit’s decision and instructed the district court to dismiss the case. As a result, the ACA will remain in-effect in its current form for the foreseeable future; however, we cannot predict what additional challenges may arise in the future, the outcome thereof, or the impact any such actions may have on our business.

 

The Biden administration also introduced various measures in 2021 focusing on healthcare and drug pricing, in particular. For example, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, which began on February 15, 2021, and remained open through August 15, 2021. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source drugs and innovator multiple source drugs, beginning January 1, 2024. And, in July 2021, the Biden administration released an executive order entitled, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response, on September 9, 2021, HHS released a “Comprehensive Plan for Addressing High Drug Prices” that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. And, in November 2021, President Biden announced the “Prescription Drug Pricing Plan” as part of the Build Back Better Act (H.R. 5376) passed by the House of Representatives on November 19, 2021, which aims to lower prescription drug pricing by, among other things, allowing Medicare to negotiate prices for certain high-cost prescription drugs covered under Medicare Part D and Part B after the drugs have been on the market for a certain number of years and imposing tax penalties on drug manufacturers that refuse to negotiate pricing with Medicare or increase drug prices “faster than inflation.” If enacted, this bill could have a substantial impact on our business. In the coming years, additional legislative and regulatory changes could be made to governmental health programs that could significantly impact pharmaceutical companies and the success of our product candidates. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

 

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There is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the U.S. or the effect of any future legislation or regulation. Furthermore, we cannot predict what actions the Biden administration will implement in connection with the Health Reform Law. However, it is possible that such initiatives could have an adverse effect on our or our partners’ ability to obtain approval for and/or successfully commercialize products in the U.S. in the future.

 

Fraud and Abuse, Transparency, and Privacy

 

In the United States, we may be subject to various federal and state laws and regulations regarding fraud and abuse in the healthcare industry, as well as industry standards and guidance, such as the codes issued by the Pharmaceutical Research and Manufacturers of America (or “PhRMA Codes”), which some states reference or incorporate in their statutes and regulations. These laws, regulations, standards, and guidance may impact, among other things, our sales and marketing activities and our relationships with healthcare providers and patients. In addition, we may be subject to patient privacy regulations by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include but are not limited to:

 

  ● the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order, or recommendation of, an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;
     
  ● federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claim Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from the federal government, including Medicare, Medicaid, or other third-party payors, that are false or fraudulent;

 

  ◌ The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which imposes federal criminal and civil liability for executing, or attempting to execute, a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;

 

  ● the federal transparency laws, including the Physician Payments Sunshine Act, which requires applicable manufacturers of covered drugs to disclose payments and other transfers of value provided to physicians and teaching hospitals and physician ownership and investment interests;
     
  ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and its implementing regulations, also imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information; and
     
  ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines, state laws that require pharmaceutical manufacturers to report certain pricing or payment information, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and are not preempted by HIPAA, thus complicating compliance efforts.

 

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Because of the breadth of these laws and the narrow scope of the statutory or regulatory exceptions and safe harbors available, our current or future activities, policies, and/or arrangements could be challenged under one or more of these laws. In addition, the federal government has identified relationships between drug companies (and other medical-product manufacturers) and healthcare providers as particularly susceptible to fraud and abuse and, thus, our relationships may be subject to heightened regulatory scrutiny, particularly once we have one or more products on the U.S. market, if ever. Further, many of the applicable healthcare laws and regulations are subject to varying and/or evolving interpretations, which makes achieving and maintaining consistent compliance more difficult. We may have to devote substantial costs, resources, and time to compliance efforts, particularly once one or more of our product candidates, or any other products to which we may obtain commercialization rights in the future, is marketed in the United States. If any of our past, current, or future operations and/or arrangements are found to be in violation of If our operations are found to be in violation of any healthcare laws or regulations that may apply to us, we may be subject to significant civil, criminal, and/or administrative penalties; damages; fines; personal imprisonment; exclusion from government-funded programs, such as Medicare and Medicaid; additional reporting requirements and oversight under a corporate integrity (or deferred prosecution or other similar) agreement with the applicable federal or state agency or agencies (such as the U.S. Office of Inspector General (“OIG”), the U.S. Department of Justice (“DOJ”), or state attorneys general); and/or the curtailment or restructuring of our operations. Any adverse enforcement action initiated against us based on actual or alleged violations of one or more of the healthcare laws and regulations could have a material adverse effect on our business, even if we are ultimately successful in defending against such claims.

 

Employees

 

As of March 20, 2023, we had three full-time employees.

 

Available Information

 

We maintain a website at www.ladrxcorp.com and make available there, free of charge, our periodic reports filed with the Securities and Exchange Commission ( the “SEC”), as soon as is reasonably practicable after filing. Among other things, we post on our website our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments and Code of Business Conduct and Ethics. The SEC maintains a website at http://www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers such as us that file electronically with the SEC.

 

Item 1A. RISK FACTORS

 

We are subject to various risks that may materially harm our business, prospects, financial condition and results of operations. An investment in our common stock is speculative and involves a high degree of risk. In evaluating an investment in our common stock, you should carefully consider the risks described below, together with the other information included in this Form 10-K, including the consolidated financial statements and related notes.

 

You should carefully consider the risks and uncertainties facing our business. The risks described below are not the only risks we face. If any of the events described in the following risk factors actually occurs, or if additional risks and uncertainties later materialize, that are not presently known to us or that we currently deem immaterial, then our business, prospects, results of operations and financial condition could be materially adversely affected. In that event, the trading price of our common stock could decline, and you may lose all or part of your investment in our shares. The risks discussed below include forward-looking statements, and our actual results may differ substantially from those discussed in these forward-looking statements. Our business is also subject to the risks that affect many other companies, such as employment relations, general economic conditions and geopolitical events. Further, additional risks not currently known to us or that we currently believe are immaterial may in the future materially and adversely affect our business, operations, liquidity and stock price.

 

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Risk Factor Summary

 

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Form 10-K and our other filings with the SEC, before making an investment decision regarding our common stock.

 

Risks Associated With Our Business:

 

  ● We have operated at a loss and will likely continue to operate at a loss for the foreseeable future.
  ● Our independent registered public accounting firm has included an explanatory paragraph in its report as of and for the year ended December 31, 2022 expressing substantial doubt in our ability to continue as a going concern based on our recurring and continuing losses from operations and our need for additional funding to continue operations.
  ● Because we have no source of significant recurring revenue, we must depend on capital raising to sustain our operations, and our ability to raise capital may be severely limited.
  ● If KemPharm fails to successfully develop and commercialize arimoclomol, our business prospects will be materially adversely affected.
  ● If ImmunityBio fails to successfully develop aldoxorubicin or our exclusive licensing arrangement with ImmunityBio is otherwise unsuccessful, our business prospects will be materially adversely affected.

 

Risks Associated With Drug Discovery and Development:

 

  ● If the projected development goals for our product candidates are not achieved in the expected time frames, the commercialization of our products may be delayed and our business prospects may suffer. Our financial projections also may prove to be materially inaccurate.
  ● The regulatory approval process is lengthy, time consuming and inherently unpredictable, and if our products or those we have sold or licensed are not successfully developed and approved by the FDA or foreign regulatory authorities, we may be forced to reduce or curtail our operations.
  ● Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
  ● We may be unable to protect our intellectual property rights, which could adversely affect our ability to compete effectively.
  ● If our product candidates infringe the rights of others, we could be subject to expensive litigation or be required to obtain licenses from others to develop or market them.
  ● The results of pre-clinical studies or early clinical trials are not necessarily predictive of future results, and our ultra-high potency albumin-binding drug conjugates may not have favorable results in later clinical trials or receive regulatory approval.
  ● Any products that we develop or are sold or licensed may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could have a material adverse effect on our business.
  ● Healthcare legislative reform measures could hinder or prevent the commercial success of our products and product candidates.
  ● We may also be subject to healthcare laws, regulation and enforcement and our failure to comply with those laws could adversely affect our business, operations and financial condition.
  ● We will be required to pay substantial milestone and other payments relating to the commercialization of our products.
  ● The COVID-19 pandemic and its ongoing effects could adversely impact our business and prospects, including active and planned clinical trials by ImmunityBio and KemPharm.
  ● In the event of a dispute regarding our international drug development, it may be necessary for us to resolve the dispute in the foreign country of dispute, where we would be faced with unfamiliar laws and procedures.
  ● Drug discovery is a complex, time-consuming and expensive process, and we may not succeed in creating new product candidates.
  ● We have a limited operating history in drug discovery, which is inherently risky, and we may not succeed in addressing these risks.

 

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General Risk Factors:

 

  ● We are subject to intense competition, and we may not compete successfully.
  ● We are subject to potential liabilities from clinical testing and future product liability claims.
  ● We may be unable to successfully acquire additional technologies or products. If we require additional technologies or products, our product development plans may change and the ownership interests of our shareholders could be diluted.
  ● The impact and results of our exploration of any strategic alternatives are uncertain and may not be successful.
  ● We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively.
  ● Our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  ● You may experience future dilution as a result of future equity offerings or other equity issuances.
  ● Our outstanding options and warrants and the availability for resale of the underlying shares may adversely affect the trading price of our common stock.
  ● We cannot assure investors that our internal controls will prevent future material weaknesses.
  ● We could be subject to legal actions that could adversely affect our financial condition.
  ● Our anti-takeover measures may make it more difficult to change our management, or may discourage others from acquiring us, and thereby adversely affect stockholder value.
  ● Our By-laws designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
  ● We may issue preferred stock in the future, and the terms of the preferred stock may reduce the value of our common stock.
  ● We do not expect to pay any cash dividends on our common stock.

 

Risks Associated With Our Business

 

We have operated at a loss and will likely continue to operate at a loss for the foreseeable future.

 

We have operated at a loss due to our ongoing expenditures for research and development of our product candidates and for general and administrative purposes, and lack of significant recurring revenues. We incurred a net loss of $4.2 million for the year ended December 31, 2022 and $13.2 million for the year ended December 31, 2021 and had an stockholder deficit as of December 31, 2022 of $1.3 million. We are likely to continue to incur losses unless and until we are able to earn milestones and royalties from our existing licensing and sale agreements and/or conclude a successful strategic partnership or financing for our LADR™ technology. These losses, among other things, have had and will continue to have an adverse effect on our stockholders’ equity and working capital. Because of the numerous risks and uncertainties associated with our product development efforts, we are unable to predict when we may become profitable, if at all. If we do not become profitable or are unable to maintain future profitability, the market value of our common stock will be adversely affected. These factors individually and collectively raise a substantial doubt about our ability to continue as a going concern.

 

Our independent registered public accounting firm has included an explanatory paragraph in its report as of and for the year ended December 31, 2022 expressing substantial doubt in our ability to continue as a going concern based on our recurring and continuing losses from operations and our need for additional funding to continue operations. Our consolidated financial statements do not include any adjustments that might result from the outcome of this going concern uncertainty and have been prepared under the assumption that we will continue to operate as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. If we are unable to continue as a going concern, we may be forced to liquidate our assets which would have an adverse impact on our business and developmental activities. In such a scenario, the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. The reaction of investors to the inclusion of a going concern statement by our independent registered public accounting firm and our potential inability to continue as a going concern may materially adversely affect our stock price and our ability to raise new capital or to enter into strategic alliances.

 

Because we have no source of significant recurring revenue, we must depend on capital raising to sustain our operations, and our ability to raise capital may be severely limited.

 

Developing products and conducting clinical trials require substantial amounts of capital. We need to raise additional capital to fund our general and administrative expenses and, if we determine to develop products based on our LADR™ technology platform, we will need to raise additional capital to fund development of product candidates, prepare, file, prosecute, maintain, enforce and defend patent and other proprietary rights, and develop and implement sales, marketing and distribution capabilities. However, capital raising has been significantly challenging.

 

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At December 31, 2022, we had cash and cash equivalents of approximately $1.4 million. The continuation of the Company as a going concern is dependent upon its ability to obtain necessary debt or equity financing to continue operations until it begins generating positive cash flow. No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to us. Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing or cause substantial dilution for our stockholders, in case of equity financing.

 

If we raise additional funds by issuing equity securities, dilution to stockholders may result and new investors could have rights superior to current equity holders. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available to us, we may have to liquidate some or all of our assets or delay or reduce the scope of or eliminate some portion or all of our development programs. We also may have to license to other companies our product candidates or technologies that we would prefer to develop and commercialize ourselves.

 

If KemPharm fails to successfully develop and commercialize arimoclomol, our business prospects will be materially adversely affected.

 

In 2011, LadRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million in milestone payments upon the achievement of certain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any net sales of products derived from the (“2011 Arimoclomol Agreement”). Orphazyme transferred its rights and obligations under the 2011 Arimoclomol Agreement to KemPharm in May 2022. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement including with regard to milestone payments and royalties on sales, were assumed by KemPharm. KemPharm is expected to continue the early access programs with arimoclomol, and to continue to pursue the potential approval of arimoclomol as a treatment option for NPC. KemPharm indicated it plans on resubmitting the NDA for arimoclomol in the third quarter of 2023. It is also identifying a regulatory path forward with the EMA.

 

In May 2021, Orphazyme announced that the pivotal phase 3 clinical trial for arimoclomol in Amyotrophic Lateral Sclerosis did not meet its primary and secondary endpoints, reducing the maximum amount that LadRx currently has the right to receive under the 2011 Arimoclomol Agreement to approximately $100 million. Orphazyme also tested arimoclomol in Niemann-Pick disease Type C (“NPC”) and Gaucher disease, and following a Phase II/III trial submitted to the FDA a New Drug Application for the treatment of NPC with arimoclomol. On June 18, 2021, Orphazyme announced it had received the Complete Response Letter from the FDA indicating the need for additional data. In late October 2021, Orphazyme announced it held a Type A meeting with the FDA, at which the FDA recommended that Orphazyme submit additional data, information and analyses to address certain topics in the Complete Response Letter and engage in further interactions with the FDA to identify a pathway to resubmission. The FDA concurred with Orphazyme’s proposal to remove the cognition domain from the NPC Clinical Severity Scale (“NPCCSS”) endpoint, with the result that the primary endpoint is permitted to be recalculated using the 4- domain NPCCSS, subject to the submission of additional requested information which Orphazyme had publicly indicated that it intended to provide. To bolster the confirmatory evidence already submitted, the FDA affirmed that it would require additional in vivo or pharmacodynamic (PD)/pharmacokinetic (PK) data. Orphazyme planned to request a Type C Meeting with the FDA in the second quarter of 2022. Subject to discussions with the regulatory body, Orphazyme had publicly indicated that it planned to resubmit the NDA for arimoclomol in the second half of 2022.

 

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Orphazyme had also submitted a Marketing Authorization Application (“MAA”) with the European Medicines Agency (the “EMA”). In February 2022, Orphazyme announced that although they had received positive feedback from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA, they were notified by the CHMP of a negative trend vote on the MAA for arimoclomol for NPC following an oral explanation. In March 2022 Orphazyme removed its application with the EMA. Orphazyme had publicly indicated that it will assess its strategic options and provide an update to the market at the applicable time.

 

The potential revenue from our arrangement with KemPharm is based on contingent payments, which will depend upon their ability to achieve regulatory approvals and successfully market and sell products derived from arimoclomol. Our ability to realize the maximum amount of aggregate milestone payments initially set forth in our agreement with Orphazyme has been reduced by approximately $20 million due to Orphazyme’s unsuccessful pivotal studies of arimoclomol for ALS and IBM and subsequent decision to cease arimoclomol’s development with regard such indications. While Orphazyme has progressed further in connection with its development of arimoclomol for NPC (than for ALS or IBM), its efforts to obtain the FDA and EMA approvals needed to lawfully market arimoclomol for NPC in the United States and the EU, respectively, have been unsuccessful thus far and may never succeed. We will not be involved in this process and will depend entirely on KemPharm, which may fail to develop or effectively commercialize products derived from arimoclomol for many reasons, including if they:

 

  ● decide not to devote the necessary resources due to internal constraints, such as limited personnel with the requisite scientific expertise, limited cash resources or specialized equipment limitations, or the belief that other drug development programs may have a higher likelihood of obtaining regulatory approval or may potentially generate a greater return on investment;
     
  ● do not have sufficient resources necessary to carry arimoclomol through clinical development, regulatory approval and commercialization;
     
  ● cannot obtain the necessary regulatory approvals for arimoclomol; or
     
  ● decide to pursue a competitive drug candidate.

 

If KemPharm does not obtain the regulatory approvals for arimoclomol that are necessary to trigger the corresponding milestone payments to us under our agreement, or if their research and development or commercialization efforts are, otherwise, unsuccessful, we will not realize the anticipated commercial benefits of the arrangement and our business prospects will be materially and adversely affected.

 

If ImmunityBio fails to successfully develop aldoxorubicin or our exclusive licensing arrangement with ImmunityBio is otherwise unsuccessful, our business prospects will be materially and adversely affected.

 

In July 2017, we entered into an exclusive licensing agreement with ImmunityBio to complete the clinical development of and commercialization of aldoxorubicin. Under this agreement, ImmunityBio has committed to provide substantial funding, as well as significant capabilities in clinical development, regulatory affairs, marketing and sales.

 

If, for any reason, ImmunityBio does not devote sufficient time and resources to the development and commercialization of aldoxorubicin, we will not realize the potential commercial benefits of the arrangement, and our results of operations will be adversely affected. In addition, if ImmunityBio were to breach or terminate its arrangement with us, the development and commercialization of aldoxorubicin could be delayed, curtailed or terminated, and we may not have sufficient financial resources or capabilities to continue development and commercialization of aldoxorubicin on our own.

 

Under our agreement with ImmunityBio, they may opt out of a project by giving us twelve months’ prior written notice. If ImmunityBio were to exercise its right to opt out of a program or to terminate the licensing agreement, the development and commercialization of aldoxorubicin would be adversely affected, our potential for generating revenue from this program would be adversely affected and attracting new partners would be made more difficult.

 

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Much of the potential revenue from our existing and future arrangement with ImmunityBio will consist of contingent payments, such as payments for achieving development and commercialization milestones and single- and double-digit royalties payable on commercial sales of successfully developed aldoxorubicin. The milestone, royalty and other revenue that we may receive under this arrangement will depend upon our, and ImmunityBio’s ability to successfully develop, introduce, market, commercialize and sell aldoxorubicin. We will not be directly involved in this process and will depend entirely on ImmunityBio, which may fail to develop or effectively commercialize aldoxorubicin for many reasons including if they:

 

  ● decide not to devote the necessary resources due to internal constraints, such as limited personnel with the requisite scientific expertise, limited cash resources or specialized equipment limitations, or the belief that other drug development programs may have a higher likelihood of obtaining regulatory approval or may potentially generate a greater return on investment;
     
  ● do not have sufficient resources necessary to carry aldoxorubicin through clinical development, regulatory approval and commercialization;
     
  ● cannot obtain the necessary regulatory approvals for aldoxorubicin; or
     
  ● decide to pursue a competitive drug candidate.

 

If ImmunityBio fails to develop or effectively commercialize aldoxorubicin or for any of the other reasons described above, we may not be able to develop and commercialize that drug independently or replace ImmunityBio with another suitable partner in a reasonable period of time and on commercially reasonable terms, if at all.

 

Risks Associated With Drug Discovery and Development

 

If the projected development goals for our product candidates are not achieved in the expected time frames, the commercialization of our products may be delayed and our business prospects may suffer. Our financial projections also may prove to be materially inaccurate.

 

From time to time, we estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings.

 

We also may disclose projected expenditures or other forecasts for future periods. These and other financial projections are based on management’s current expectations and do not contain any margin of error or cushion for any specific uncertainties, or for the uncertainties inherent in all financial forecasting.

 

The actual timing of milestones and actual expenditures or other financial results can vary dramatically compared to our estimates, in some cases for reasons beyond our control or the control of companies that have licensed or purchased our product candidates. If these milestones or financial projections are not met, the development and commercialization of our product candidates may be delayed and our business prospects may suffer. The assumptions management has used to produce these projections may significantly change or prove to be inaccurate. Accordingly, you should not unduly rely on any of these financial projections.

 

The regulatory approval process is lengthy, time consuming and inherently unpredictable, and if our products or those we have sold or licensed are not successfully developed and approved by the FDA or foreign regulatory authorities, we may be forced to reduce or curtail our operations.

 

All of our product candidates in development or those licensed or sold must be approved by the FDA or corresponding foreign governmental agencies before they can be marketed. The process for obtaining FDA and foreign government approvals is both time-consuming and costly, with no certainty of a successful outcome. This process typically includes the conduct of extensive pre-clinical and clinical testing, including post-approval testing, which may take longer or cost more than we or our licensees, if any, anticipate, and may prove unsuccessful due to numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. None of our product candidates in development or licensed or sold to third parties have received regulatory approval.

 

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Numerous factors could affect the timing, cost or outcome of product development efforts, including the following:

 

  ● difficulty in enrolling patients in conformity with required protocols or projected timelines;
     
  ● requirements for clinical trial design imposed by the FDA;
     
  ● unexpected adverse reactions by patients in trials;
     
  ● difficulty in obtaining clinical supplies of the product;
     
  ● changes in or our inability to comply with FDA or foreign governmental product testing, manufacturing or marketing requirements;
     
  ● regulatory inspections of clinical trials or manufacturing facilities, which may, among other things, require us or our manufacturers or licensees to undertake corrective action or suspend or terminate the affected clinical trials if investigators find them not to be in compliance with applicable regulatory requirements;
     
  ● inability to generate statistically significant data confirming the safety and efficacy of the product being tested;
     
  ● modification of the product during testing; and
     
  ● reallocation of our limited financial and other resources to other clinical programs.

 

It is possible that none of the product candidates we develop or have sold or licensed will obtain the regulatory approvals necessary for us to begin selling them or making us eligible to receive milestone or royalty payments. The time required to obtain FDA and foreign governmental approvals is unpredictable, but often can take years following the commencement of clinical trials, depending upon the complexity of the product candidate. Any analysis performed on data from clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. In addition, even if regulatory approval was obtained, regulatory authorities may approve any product candidates for fewer or more limited indications than requested, may not approve the intended price for such products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for the product candidates that we develop, have sold or licensed.

 

Furthermore, even if regulatory approvals are obtained, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, import, export, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with current good manufacturing practices (“cGMPs”), and good clinical practices(“cGCPs”), for any clinical trials that we conduct post-approval. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

 

  ● restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
     
  ● fines, warning letters or holds on clinical trials;
     
  ● refusal by the FDA to approve pending applications or supplements to approved applications filed by us or our strategic partners, or suspension or revocation of product license approvals;
     
  ● product seizure or detention, or refusal to permit the import or export of products; and
     
  ● injunctions or the imposition of civil or criminal penalties.

 

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The FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business. We will also be subject to periodic inspections and the potential for mandatory post- approval clinical trials required by the FDA and other U.S. and foreign regulatory authorities. Any delay or failure in obtaining required approvals or to comply with post-approval regulatory requirements could have a material adverse effect on our ability to generate revenue from the particular product candidate. The failure to comply with any post-approval regulatory requirements also could result in the rescission of the related regulatory approvals or the suspension of sales of the offending product.

 

Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

 

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical development may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or safety profiles, notwithstanding promising results in earlier trials. For example, aldoxorubicin has shown encouraging preliminary clinical results in our Phase 2b clinical trial as a treatment for STS. These conclusions may not be reproduced in future clinical trial results. For instance, the Phase 3 pivotal clinical trial testing aldoxorubicin as a treatment for STS narrowly missed statistical significance although it demonstrated a statistically significant improvement in PFS over investigator’s choice in 312 patients treated in North America and Australia. Accordingly, our development partner may ultimately be unable to provide the FDA and/or other U.S. and foreign regulatory authorities with satisfactory data on clinical safety and efficacy sufficient to obtain approval from the FDA of aldoxorubicin for any indication.

 

Further delays may occur in clinical trials of product candidates. We do not know whether ongoing clinical trials will be completed on schedule or at all, or whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including delays related to:

 

  ● obtaining regulatory approval to commence a trial;
     
  ● reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;
     
  ● obtaining institutional review board approval at each clinical trial site;
     
  ● recruiting suitable patients to participate in a trial;
     
  ● having patients complete a trial or return for post-treatment follow-up;
     
  ● clinical trial sites deviating from trial protocol or dropping out of a trial;
     
  ● adding new clinical trial sites; or
     
  ● manufacturing sufficient quantities of product candidate for use in clinical trials.

 

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We may be unable to protect our intellectual property rights, which could adversely affect our ability to compete effectively.

 

We will be able to protect our technologies from unauthorized use by third parties only to the extent that we have rights to valid and enforceable patents or other proprietary rights that cover them. Although we have rights to patents and patent applications directed to our product candidates, these patents and applications may not prevent third parties from developing or commercializing similar or identical technologies. In addition, our patents may be held to be invalid if challenged by third parties, and our patent applications may not result in the issuance of patents.

 

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged to date in the United States and in many foreign countries. The application and enforcement of patent laws and regulations in foreign countries is even more uncertain. Accordingly, we may not be able to effectively file, protect or defend our proprietary rights on a consistent basis. Many of the patents and patent applications on which we rely were issued or filed by third parties prior to the time we acquired rights to them. The validity, enforceability and ownership of those patents and patent applications may be challenged, and if a court decides that our patents are not valid, we will not have the right to stop others from using our inventions. There is also the risk that, even if the validity of our patents is upheld, a court may refuse to stop others on the ground that their activities do not infringe our patents.

 

Any litigation brought by us to protect our intellectual property rights could be costly and have a material adverse effect on our operating results or financial condition, make it more difficult for us to enter into strategic alliances with third parties to develop our products, or discourage our existing licensees from continuing their development work on our potential products. If our patent coverage is insufficient to prevent third parties from developing or commercializing similar or identical technologies, the value of our assets is likely to be materially and adversely affected.

 

Moreover, we may be subject to a third-party pre-issuance submission of prior art or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others. The costs of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the outcome can be uncertain. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

 

We have not pursued or maintained, and may not pursue or maintain in the future, patent protection for our product candidates in every country or territory in which we may sell our products, if approved. The laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from infringing our patents in all countries outside the United States, or from selling or importing products that infringe our patents in and into the United States or other jurisdictions.

 

Indeed, several companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of some countries do not favor the enforcement of patents and other intellectual property rights, which could make it difficult for us to stop the infringement, misappropriation or other violation of our intellectual property rights generally. Proceedings to enforce our intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

 

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Furthermore, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and product candidates. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

 

Moreover, the scope claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Changes in either the patent laws or interpretation of the patent laws may diminish the value of our or our collaborators’ patents or narrow the scope of such patent protection and could increase the uncertainties and costs surrounding the prosecution of our or any future collaborators’ patent applications and the enforcement or defense of any issued patents. Even if the patent applications we license or own do issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us or otherwise provide us with any competitive advantage. Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative products in a non-infringing manner.

 

Some of our technologies and processes do not fulfill the requirements for patent or trademark protection or are not protected by patent or trademark rights for other reasons, e.g., secrecy. We therefore also rely on certain proprietary trade secrets and know-how, especially where we believe patent protection is not appropriate or obtainable. Trade secrets and know-how are difficult to protect. Although we have taken measures to protect our unpatented trade secrets and know-how, including the use of confidentiality and invention assignment agreements with our employees, consultants and some of our contractors, it is possible that these persons may disclose our trade secrets or know-how or that our competitors may independently develop or otherwise discover our trade secrets and know-how.

 

There is no guarantee, however, that such agreements will not be breached, that they will provide sufficient protection for our business secrets and proprietary information or that adequate remedies will be available in the event of an unauthorized use or disclosure of such information. It cannot be excluded that we do not have, or cannot enforce, legal remedies that are effective at economically acceptable costs. Further, the violation of a non-disclosure agreement might be difficult to prove because business secrets and know- how may be developed independently by, or become otherwise known to, third parties. In addition, it may be difficult to quantify the damages which have occurred and to obtain legal remediation, or to undo the damages caused, by legal remedies. Our failure to effectively protect our business secrets and know-how could have material adverse effects on our business, prospects, financial condition and results of operations.

 

If our product candidates infringe or otherwise violate the rights of others, we could be subject to expensive litigation or be required to obtain licenses from others to develop or market them.

 

Our commercial success also depends upon our ability, and the ability of any third party with which we may partner, to develop, manufacture, market and sell our product candidates and/or products, if approved, and use our patent-protected technologies without infringing the patents of third parties. There is considerable patent litigation in the biotechnology and pharmaceutical industries. As the biopharmaceutical industry expands and more patents are issued, we face increased risks that there may be patents issued to third parties that relate to our product candidates and technology of which we are not aware or that we must challenge to continue our operations as currently contemplated.

 

Our competitors or others may have patent rights that they choose to assert against us or our licensees, suppliers, customers or potential collaborators. Moreover, we may not know about patents or patent applications that our products would infringe. For example, because patent applications do not publish for at least 18 months, if at all, and can take many years to issue, there may be currently pending applications unknown to us that may later result in issued patents that our product candidates would infringe. In addition, if third parties file patent applications or obtain patents claiming technology also claimed by us or our licensors in issued patents or pending applications, we may have to participate in interference proceedings in the U.S. Patent and Trademark Office to determine priority of invention. If third parties file oppositions in foreign countries, we may also have to participate in opposition proceedings in foreign tribunals to defend the patentability of our foreign patent applications.

 

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If a third-party claims that we are infringing on its proprietary rights, any of the following may occur:

 

  ● we may become involved in time-consuming and expensive litigation, even if the claim is without merit;
     
  ● we may become liable for substantial damages for past infringement if a court decides that our technology infringes a competitor’s patent;
     
  ● a court may prohibit us from selling or licensing our product without a license from the patent holder, which may not be available on commercially acceptable terms, if at all, or which may require us to pay substantial royalties or grant cross licenses to our patents; and
     
  ● we may have to redesign our product candidates or technology so that it does not infringe patent rights of others, which may not be possible or commercially feasible.

 

If any of these events occurs, our business and prospects will suffer and the market price of our common stock will likely decline substantially.

 

Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of non-compliance with these requirements.

 

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the relevant patent agencies in several stages over the lifetime of the patents and /or applications. The relevant patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent application process. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which the failure to comply with the relevant requirements can result in the abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to use our technologies and know-how which could have a material adverse effect on our business, prospects, financial condition and results of operation.

 

If we fail to comply with our obligations under our license agreements, we could lose the rights to intellectual property that is important to our business.

 

Our current license agreements impose on us various development obligations, payment of royalties and fees based on achieving certain milestones as well as other obligations. If we fail to comply with our obligations under these agreements, the licensor may have the right to terminate the license. In addition, if the licensor fails to enforce its intellectual property, the licensed rights may not be adequately maintained. The termination of any license agreements or failure to adequately protect such license agreements could prevent us from commercializing our product candidates or possible future products covered by the licensed intellectual property. Any of these events could materially adversely affect our business, prospects, financial condition and results of operation.

 

We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

 

Our employees may have been previously employed at other companies in the industry, including our competitors or potential competitors. Although we are not aware of any claims currently pending against us, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of the former employers of our employees. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. If we fail in defending such claims, in addition to paying money claims, we may lose valuable intellectual property rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize product(s), which would materially adversely affect our commercial development efforts.

 

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The results of pre-clinical studies or early clinical trials are not necessarily predictive of future results, and our ultra-high potency albumin-binding drug conjugates may not have favorable results in later clinical trials or receive regulatory approval.

 

Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will generate adequate data to demonstrate the efficacy and safety of our ultra-high potency albumin-binding drug conjugates. A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than we have, have suffered significant setbacks in clinical trials, even after seeing promising results in earlier clinical trials. We do not know whether the clinical trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market them in any particular jurisdiction. If our clinical trials do not produce favorable results, our ability to achieve regulatory approval for these drug candidates will be adversely impacted and the value of our stock may decline.

 

The successful commercialization of our product candidates that are approved for marketing in the United States, if any, and/or any other products that we or our partners may commercialize in the future will likely depend, in-part, on the coverage and reimbursement policies of third-party payors, which, if unfavorable, could have a material adverse effect on our business.

 

The commercial success of our product candidates that are approved for marketing in the United States, if any, as well as any other products that we may or our partners may commercialize in the future, may depend, in significant part, on the extent to such products will be covered and reimbursed by third-party payors, including government healthcare programs, such as Medicare and Medicaid, private insurers, and managed care organizations. Patients for whom prescription drugs are prescribed and prescribing practitioners generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Without adequate coverage and reimbursement, patients and providers are unlikely to use or prescribe any products that we or our partners may commercialize or from which we may, otherwise, generate revenue in connection with commercial sales.

 

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, there is no uniform policy of coverage and reimbursement. Accordingly, third-party payors, including private insurers and governmental payors, such as Medicare and Medicaid, play an important role in determining the extent to which new drugs and biologics will be covered and reimbursed. The Medicare program covers certain individuals aged 65 or older, as well as certain people under 65 with disabilities and individuals suffering from end-stage renal disease. The Medicaid program, which varies from state-to-state, covers eligible individuals and families who have limited financial means. The Medicare and Medicaid programs are increasingly used as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates and any other products we or our partners may commercialize or to which we may have commercialization rights or interests.

 

Third-party payors may deny coverage or reimbursement if they determine that a medical product was not used in accordance with cost-effective treatment methods, as determined by the third-party payor, and most, if not all, payors will deny coverage for products used or administered for an unapproved indication. Third-party payors also typically refuse to cover and reimburse for experimental procedures and devices. Furthermore, third-party payors are increasingly challenging the prices charged for medical products and services. And, the U.S. government and state legislatures have shown significant interest in implementing healthcare cost-containment programs, including price controls, restrictions on reimbursement, discount and rebate requirements, and requirements for substitution of generic products. Such measures, and the enactment of any more restrictive updates thereto and/or new measures could further limit our potential profitability and commercial success in connection with any products we or our partners may market in the United States. We cannot predict whether, or the extent to which, government and/or private payors will cover any products we or our partners may commercialize in the future, and there can be no assurances that such coverage and reimbursement levels, as applicable, will be sufficient to allow us to profit from the commercial sale of such product(s) in light of our costs from development and other related activities and any current or future arrangements with our development and/or commercialization partners.

 

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Any products that we develop or are sold or licensed may become subject to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, which could have a material adverse effect on our business.

 

Our product candidates are intended to be marketed primarily to hospitals, which generally receive reimbursement for the health care services they provide to their patients from third-party payors, such as Medicare, Medicaid and other domestic and international government programs, private insurance plans and managed care programs.

 

Such drugs will likely need to be administered under the supervision of a physician. Under currently applicable law, drugs that are not usually self-administered may be eligible for coverage by the Medicare program if:

 

  ● they are “incidental” to a physician’s services;
     
  ● they are “reasonable and necessary” for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standard of medical practice;
     
  ● they are not excluded as immunizations; and
     
  ● they have been approved by the FDA.

 

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered and reimbursed. The Medicare program covers certain individuals aged 65 or older, disabled or suffering from end-stage renal disease. The Medicaid program, which varies from state-to-state, covers certain individuals and families who have limited financial means. The Medicare and Medicaid programs increasingly are used as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.

 

Most third-party payors may deny coverage or reimbursement if they determine that a medical product was not used in accordance with cost-effective treatment methods, as determined by the third-party payor, or was used for an unapproved indication. Third-party payors also may refuse to cover and reimburse for experimental procedures and devices. Furthermore, because our programs are in the early stages of development, we are unable at this time to determine their cost-effectiveness and the level or method of reimbursement. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices, and are challenging the prices charged for medical products. If the price we are able to charge for any products we develop is inadequate in light of our development and other costs, our profitability could be adversely affected.

 

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Healthcare legislative reform measures could hinder or prevent the commercial success of our products and product candidates.

 

In the United States, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system that could affect our future revenues and profitability. Federal and state lawmakers regularly propose and, at times, enact legislation that results in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. For example, in March 2010, the Patient Protection and Affordable Care Act (the “ACA”), as amended by the Health Care and Education Reconciliation Act, or collectively, the “Healthcare Reform Law,” became law in the United States. It contains a number of provisions regarding health insurance, the provision of healthcare, conditions to reimbursement for healthcare services provided to Medicare and Medicaid patients, and other healthcare policy reforms. Through the law-making process, substantial changes have been and continue to be made to the current system for paying for healthcare in the United States, including changes made to extend medical benefits to certain Americans who lacked insurance coverage and to contain or reduce healthcare costs (such as by reducing or conditioning reimbursement amounts for healthcare services and drugs, and imposing additional taxes, fees, and rebate obligations on pharmaceutical and medical device companies). This legislation was one of the most comprehensive and significant reforms ever experienced by the United States in the healthcare industry and has significantly changed the way healthcare is financed by both governmental and private insurers. This legislation has impacted the scope of healthcare insurance and incentives for consumers and insurance companies, among others. Additionally, the Healthcare Reform Law’s provisions were designed to encourage providers to find cost savings in their clinical operations. Pharmaceuticals represent a significant portion of the cost of providing care. This environment has caused changes in the purchasing habits of consumers and providers and resulted in specific attention to the pricing negotiation, product selection and utilization review surrounding pharmaceuticals. This attention may result in any products we may commercialize or promote in the future, and/or our therapeutic candidates, as applicable, being chosen less frequently or subject to substantially lowered pricing.

 

These structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid, and the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some combination of both, as well as other changes. Restructuring the coverage of medical care in the U.S. could impact the reimbursement for prescribed drugs and pharmaceuticals, including our current commercial products, those we and our development or commercialization partners are currently developing or those that we may commercialize or promote in the future. If reimbursement for the products we currently commercialize or promote, any product we may commercialize or promote, or approved therapeutic candidates is substantially reduced or otherwise adversely affected in the future, or rebate obligations associated with them are substantially increased, it could have a material adverse effect on our reputation, business, financial condition or results of operations.

 

Further, there has been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their marketed products, which have resulted in several recent Congressional inquiries and proposed and enacted bills designed to, among other things, bring more transparency to prescription drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. In addition, the United States government, state legislatures, and foreign governments have shown significant interest in implementing drug cost containment programs, including price-controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs to limit the growth of government paid health care costs. For example, the United States government has passed legislation requiring pharmaceutical manufacturers to provide rebates and discounts to certain entities and governmental payors to participate in federal healthcare programs. Further, Congress and the current administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs, and the current administration recently released a “Blueprint”, or plan, to reduce the cost of drugs. The current administration’s Blueprint contains certain measures that the U.S. Department of Health and Human Services is already working to implement. Individual states in the United States have also been increasingly passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

 

We anticipate there will continue to be proposals by legislators at both the federal and state levels, regulators and commercial payers to reduce prescription drug costs while expanding individual healthcare benefits. Additional changes that may affect our business include those governing enrollment in federal healthcare programs, reimbursement changes, fraud and abuse enforcement, and expansion of new programs, such as Medicare payment for performance initiatives. The ultimate implementation of any healthcare reform legislation and any new laws and regulations, and its impact on us, is impossible to predict. Any significant reforms made to the healthcare system in the United States, or in other jurisdictions, may have an adverse effect on our business, financial condition, results of operations and prospects.

 

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We may also be subject to federal and state healthcare laws and regulations relating to our current and/or future operations, and our failure to comply with those laws could adversely affect our business, operations and financial condition.

 

If we obtain FDA approval for any of our product candidates and begin commercializing those products in the United States, our operations may be directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and physician sunshine laws and regulations. These laws may impact, among other things, our proposed sales, marketing, and education programs. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:

 

  ● the federal Anti-Kickback Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
     
  ● the federal False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false claims, or knowingly using false statements, to obtain payment from the federal government, and which may apply to entities that provide coding and billing advice to customers;
     
  ● federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
     
  ● the federal physician sunshine requirements under the Affordable Care Act, which requires manufacturers of drugs, devices, biologics, and medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value to physicians, other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members;

 

  ● the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; and
     
  ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. For instance, the California Consumer Privacy Act, or the CCPA, became effective on January 1, 2020. The CCPA gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing and receive detailed information about how their personal information is used by requiring covered companies to provide new disclosures to California consumers (as that term is broadly defined) and provide such consumers new ways to opt-out of certain sales of personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. Although there are limited exemptions for clinical trial data and the CCPA’s implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, the CCPA may increase our compliance costs and potential liability. Many similar privacy laws have been proposed at the federal level and in other states.

 

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Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, the federal government has identified relationships between drug companies (and other medical-product manufacturers) and healthcare providers as particularly susceptible to fraud and abuse and, thus, our relationships may be subject to heightened regulatory scrutiny, particularly once we have one or more products on the U.S. market, if ever. Further, many of the applicable healthcare laws and regulations are subject to varying and/or evolving interpretations, which makes achieving and maintaining consistent compliance more difficult.

 

Achieving and sustaining compliance with these laws may prove costly. In addition, any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, the exclusion from participation in federal and state healthcare programs, imprisonment, or the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.

 

We will be required to pay substantial milestone and other payments relating to the commercialization of our products.

 

Aldoxorubicin

 

The agreement relating to our worldwide rights to aldoxorubicin provides for our payment of up to an aggregate of $7.5 million upon meeting specified clinical and regulatory milestones up to and including the product’s second, final marketing approval. We also will be obliged to pay:

 

  ● commercially reasonable royalties based on a percentage of net sales (as defined in the agreement);
     
  ● a percentage of any non-royalty sub-licensing income (as defined in the agreement); and
     
  ● milestones of $1,000,000 for each additional final marketing approval that we might obtain.

 

Arimoclomol

 

The agreement relating to our worldwide rights to arimoclomol provides for our payment of up to an aggregate of $3.65 million upon receipt of milestone payments from Orphayzme A/S. On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately $5.2 million to KemPharm, a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare CNS diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties on sales, were assumed by KemPharm.

 

Innovive

 

Under the merger agreement by which we acquired Innovive, we agreed to pay the former Innovive stockholders a total of up to approximately $18.3 million of future earnout merger consideration, subject to our achievement of specified net sales under the Innovive license agreements. The earnout merger consideration, if any, will be payable in shares of our common stock, subject to specified conditions, or, at our election, in cash or by a combination of shares of our common stock and cash. Our common stock will be valued for purposes of any future earnout merger consideration based upon the trading price of our common stock at the time the earnout merger consideration is paid.

 

The COVID-19 pandemic and its ongoing effects could adversely impact our business and prospects, including active and planned clinical trials by ImmunityBio and KemPharm.

 

In December 2019, a novel strain of coronavirus, COVID-19, was first identified in China and has surfaced in several regions across the world. In March 2020, the disease was declared a pandemic by the World Health Organization. The COVID-19 pandemic has, from time to time, led to government-imposed quarantines, limitations on business activity and shelter-in-place mandates to mitigate or contain the virus, and has contributed to financial market volatility and uncertainty, significant disruptions in general commercial activity and the global economy.

 

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As the COVID-19 pandemic and its ongoing effects continue to evolve, the companies which we are working to develop and commercialize our products, ImmunityBio and KemPharm, could be materially and adversely affected by the risks, or the public perception of the risks, related to the COVID-19 pandemic and its ongoing effects, which could cause delays in our potential timing of receipts of milestones and royalties within the disclosed time periods and expected costs. The disruptions to ImmunityBio and KemPharm could include:

 

  ● delays or difficulties in recruiting and enrolling new patients in their clinical trials;
     
  ● delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
     
  ● diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as their clinical trial sites and hospital staff supporting the conduct of their clinical trials;
     
  ● interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others;
     
  ● limitations in employee resources that would otherwise be focused on the conduct of their clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
     
  ● interruption in global shipping that may affect the transport of clinical trial supplies and materials, such as investigational drug product used in their clinical trials;
     
  ● delays in receiving approval from the FDA and local regulatory authorities to initiate their planned clinical trials;
     
  ● changes in FDA and local regulation as part of a response to the COVID-19 coronavirus outbreak which may change the ways in which clinical trials are conducted of discontinue clinical trials altogether;
     
  ● delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;
     
  ● delay in the timing of other interactions with the FDA due to absenteeism by federal employees or by the diversion of their efforts and attention to approval of other therapeutics or other activities related to COVID-19; and
     
  ● refusal of the FDA to accept data from clinical trials in affected geographies outside the United States.

 

The extent to which the COVID-19 pandemic and its ongoing effects may impact our business and prospects will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the pandemic, new variants of the coronavirus, reinstatement of travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

 

In the event of a dispute regarding our international drug development, it may be necessary for us to resolve the dispute in the foreign country of dispute, where we would be faced with unfamiliar laws and procedures.

 

The resolution of disputes in foreign countries can be costly and time consuming, similar to the situation in the United States. In a foreign country, we face the additional burden of understanding unfamiliar laws and procedures. We may not be entitled to a jury trial, as we might be in the United States. Further, to litigate in any foreign country, we would be faced with the necessity of hiring lawyers and other professionals who are familiar with the foreign laws. For these reasons, we may incur unforeseen expenses if we are forced to resolve a dispute in a foreign country.

 

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Drug discovery is a complex, time-consuming and expensive process, and we may not succeed in creating new product candidates.

 

Conducting drug discovery and pre-clinical development of our albumin-binding technology is a complex and expensive process that will take many years. Accordingly, we cannot be sure whether or when our drug discovery and pre-clinical development activities will succeed in developing any new product candidates. In addition, any product candidates that we develop in pre-clinical testing may not demonstrate success in clinical trials required for marketing approval.

 

Any deficiency in the design, implementation or oversight of our drug discovery and pre-clinical testing programs could cause us to incur significant additional costs, experience significant delays, prevent us from obtaining marketing approval for any product candidate that may result from these programs or abandon development of certain product candidates. If any of these risks materializes, it could harm our business and cause our stock price to decline.

 

General Risk Factors

 

We are subject to intense competition, and we may not compete successfully.

 

Many companies, including large pharmaceutical and biotechnology firms with financial resources, research and development staffs, and facilities that may be substantially greater than those of ours or our strategic partners or licensees, are engaged in the research and development of pharmaceutical products that could compete with our potential products. To the extent that we seek to acquire, through license or otherwise, existing or potential new products, we will be competing with numerous other companies, many of which will have substantially greater financial resources and large acquisition staffs that may give those companies a competitive advantage over us in identifying and evaluating these drug acquisition opportunities. Any products that we acquire will be competing with products marketed by companies that in many cases will have substantially greater marketing resources than we have. The industry is characterized by rapid technological advances and competitors may develop their products more rapidly and such products may be more effective than those currently under development or that may be developed in the future by our strategic partners or licensees. Competitive products for a number of the disease indications that we have targeted are currently being marketed by other parties, and additional competitive products are under development and may also include products currently under development that we are not aware of or products that may be developed in the future.

 

As a result, these competitors may:

 

● succeed in developing competitive products sooner than us or our strategic partners or licensees;

 

● obtain FDA or foreign governmental approvals for their products before we can obtain approval of any of our products;

 

● obtain patents that block or otherwise inhibit the development and commercialization of our product candidate candidates;

 

● develop products that are safer or more effective than our products;

 

● devote greater resources than us to marketing or selling products;

 

● introduce or adapt more quickly than us to new technologies and other scientific advances;

 

● introduce products that render our products obsolete;

 

● withstand price competition more successfully than us or our strategic partners or licensees;

 

● negotiate third-party strategic alliances or licensing arrangements more effectively than us; and

 

● take better advantage than us of other opportunities.

 

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We are subject to potential liabilities from clinical testing and future product liability claims.

 

If any of our products are alleged to be defective, they may expose us to claims for personal injury by patients in clinical trials of our products or, if we obtain marketing approval and commercialize our products, by patients using our commercially marketed products. Even if one or more of our products is approved by the FDA, users may claim that such products caused unintended adverse effects. We maintain clinical trial insurance for our ongoing clinical trials, and we plan to seek to obtain similar insurance for any other clinical trials that we conduct. We also would seek to obtain product liability insurance covering the commercial marketing of our product candidates. We may not be able to obtain additional insurance, however, and any insurance obtained by us may prove inadequate in the event of a claim against us. Any claims asserted against us also may divert management’s attention from our operations, and we may have to incur substantial costs to defend such claims even if they are unsuccessful.

 

We may be unable to successfully acquire additional technologies or products. If we require additional technologies or products, our product development plans may change and the ownership interests of our shareholders could be diluted.

 

We may seek to acquire additional technologies by licensing or purchasing such technologies, or through a merger or acquisition of one or more companies that own such technologies. We have no current understanding or agreement to acquire any technologies, however, and we may not be able to identify or successfully acquire any additional technologies. We also may seek to acquire products from third parties that already are being marketed or have been approved for marketing, although we have not currently identified any of these products. We do not have any prior experience in acquiring or marketing products approved for marketing and may need to find third parties to market any products that we might acquire.

 

We have focused our product development efforts on our oncology and neurodegenerative drug candidates, which we believe have the greatest revenue potential. If we acquire additional technologies or product candidates, we may determine to make further changes to our product development plans and business strategy to capitalize on opportunities presented by the new technologies and product candidates.

 

We may determine to issue shares of our common stock to acquire additional technologies or products or in connection with a merger or acquisition of another company. To the extent we do so, the ownership interest of our stockholders will be diluted accordingly.

 

The impact and results of our exploration of any strategic alternatives are uncertain and may not be successful.

 

From time to time, we may consider strategic alternatives available to us to enhance shareholder value. Strategic alternatives could include acquisition transactions and/or strategic partnerships with one or more parties, the licensing of some of our proprietary technologies, or other possible transactions. Any strategic transaction that is completed ultimately may not deliver the anticipated benefits or enhance shareholder value. Further, we may devote a significant amount of our management resources to such a transaction, which could negatively impact our operations. We may incur significant costs in connection with seeking certain acquisitions or other strategic opportunities regardless of whether the transaction is completed, which could materially and adversely affect our liquidity and capital resources. In the event that we consummate an acquisition or strategic alternative in the future, there is no assurance that we would fully realize the potential benefits of such a transaction. Integration may be difficult and unpredictable, and acquisition-related integration costs, including certain non-recurring charges, could materially and adversely affect our results of operations. Moreover, integrating assets and businesses may significantly burden management and internal resources, including the potential loss or unavailability of key personnel. If we fail to successfully integrate any assets and businesses we acquire, we may not fully realize the potential benefits we expect, and our operating results could be adversely affected. If we pay for an acquisition in cash, it would reduce our cash available for operations or cause us to incur additional debt, and if we pay with our stock it could be dilutive to our stockholders.

 

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We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively.

 

We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively. We maintain sensitive data pertaining to our Company on our computer networks, including information about our development activities, our intellectual property and other proprietary business information. Our internal computer systems and those of third parties with which we contract may be vulnerable to damage from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures, despite the implementation of security measures. System failures, accidents or security breaches could cause interruptions to our operations, including material disruption of our development activities, result in significant data losses or theft of our intellectual property or proprietary business information, and could require substantial expenditures to remedy. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications or inappropriate disclosure of confidential or proprietary information, we could incur liability and our development programs could be delayed, any of which would harm our business and operations.

 

Our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

 

Natural disasters could severely disrupt our operations or the operations of manufacturing facilities and have a material adverse effect on our business, financial condition, results of operations and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as manufacturing facilities, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. The disaster recovery and business continuity plans we have in place currently are limited and may not prove adequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

 

Global, market and economic conditions may negatively impact our business, financial condition and share price.

 

Concerns over inflation, geopolitical issues, the U.S. financial markets, foreign exchange rates, capital and exchange controls, unstable global credit markets and financial conditions and the COVID-19 pandemic and its ongoing effects, have led to periods of significant economic instability, declines in consumer confidence and discretionary spending, diminished expectations for the global economy and expectations of slower global economic growth going forward, and increased unemployment rates. Our general business strategy may be adversely affected by any such economic downturns, volatile business environments and continued unstable or unpredictable economic and market conditions. If these conditions continue to deteriorate or do not improve, it may make any necessary debt or equity financing more difficult to complete, more costly, and more dilutive. In addition, there is a risk that one or more of our current or future service providers and other partners could be negatively affected by difficult economic times, which could adversely affect our ability to attain our operating goals on schedule and on budget or meet our business and financial objectives.

 

In addition, we face several risks associated with international business and are subject to global events beyond our control, including war, public health crises, such as pandemics and epidemics, trade disputes, economic sanctions, trade wars and their collateral impacts and other international events. Any of these changes could have a material adverse effect on our reputation, business, financial condition or results of operations. There may be changes to our business if there is instability, disruption or destruction in a significant geographic region, regardless of cause, including war, terrorism, riot, civil insurrection or social unrest; and natural or man-made disasters, including famine, flood, fire, earthquake, storm or disease. In February 2022, armed conflict escalated between Russia and Ukraine. The sanctions announced by the United States and other countries, following Russia’s invasion of Ukraine against Russia to date include restrictions on selling or importing goods, services or technology in or from affected regions and travel bans and asset freezes impacting connected individuals and political, military, business and financial organizations in Russia. The United States and other countries could impose wider sanctions and take other actions should the conflict further escalate. It is not possible to predict the broader consequences of this conflict, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, currency exchange rates and financial markets, all of which could impact our business, financial condition and results of operations.

 

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We may be subject to inflationary risk

 

The Company does not believe that inflation has had a material effect on its operations to date, other than the impact of inflation on the general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary pressures in the future, which would have the effect of increasing the Company’s operating costs, and which would put additional stress on the Company’s working capital resources.

 

We may not be successful in hiring and retaining key employees, which may harm our business.

 

Our business is highly dependent upon the continued services of our senior management and key personnel. As such, our future success depends on our ability to identify, attract, hire or engage, retain, and motivate well-qualified personnel. Our operations require qualified personnel with expertise in pharmaceutical development and clinical research We must compete for qualified individuals with numerous companies, universities, and other research institutions. Competition for such individuals is intense, and, when the need arises, we may not be able to hire the personnel necessary to support our efforts. There can be no assurance that these professionals will be available in the market, or that we will be able to retain existing professionals or to meet or to continue to meet their compensation requirements.

 

An overall tightening and increasingly competitive labor market in the U.S. employment market generally, especially in response to the COVID-19 pandemic, has been observed in the United States. Sustained labor shortage or increased turnover rates within our employee base, caused by the COVID-19 pandemic or as a result of general macroeconomic factors, could lead to increased costs, such as increased overtime to meet demand and increased wage rates to attract and retain employees, and could negatively affect our ability to efficiently operate and our overall business. If we are unable to hire and retain employees capable of performing at a high-level, or if mitigation measures we may take to respond to a decrease in labor availability, such as third-party outsourcing have unintended negative effects, our business could be adversely affected. An overall labor shortage, lack of skilled labor, increased turnover or labor inflation, caused by the COVID-19 pandemic or as a result of general macroeconomic factors, could have a material adverse impact on our operations, results of operations, liquidity or cash flows.

 

You may experience future dilution as a result of future equity offerings or other equity issuances.

 

To raise additional capital, we may in the future offer additional shares of our common stock, preferred stock or other securities convertible into or exchangeable for our common stock. We cannot assure you that we will be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the price per share that you may have paid for any of such securities that you currently hold. The price per share at which we sell additional shares of our common stock or other securities convertible into or exchangeable for our common stock in future transactions may be higher or lower than the price per share that you may have paid for previously for shares of our common stock. To the extent we raise additional capital by issuing equity securities or obtaining borrowings convertible into equity, ownership dilution to existing stockholders may result and future investors may be granted rights superior to those of existing stockholders.

 

Our outstanding options, warrants, convertible preferred shares, preferred investment option and the availability for resale of the underlying shares may adversely affect the trading price of our common stock.

 

As of December 31, 2022, we had outstanding stock options to purchase 1,765,108 shares of our common stock at a weighted-average exercise price of $6.83 per share and outstanding warrants to purchase 4,147 shares of common stock at a weighted-average exercise price of $33.60 per share. In addition, there are 2,752 shares of Series C 10% Convertible Preferred Stock outstanding that can be converted into 3,127,689 shares of common stock, as well as preferred investment options that can be exercised for up to 11,363,637 shares of common stock at an exercise price of $0.88 per share. These outstanding convertible instruments could adversely affect our ability to obtain future financing or engage in certain mergers or other transactions, since the holders of these outstanding securities can be expected to exercise or convert them (as applicable) at a time when we may be able to obtain additional capital through a new offering of securities on terms more favorable to us than the terms of these outstanding convertible instruments. For the life of these outstanding convertible instruments, the holders have the opportunity to profit from a rise in the market price of our common stock without assuming the risk of ownership. The issuance of shares upon the exercise or conversion (as applicable) of these outstanding convertible instruments will also dilute the ownership interests of our existing stockholders. Many of our outstanding warrants contain anti-dilution provisions pertaining to dividends with respect to our common stock. In the event that these anti-dilution provisions are triggered by us in the future, we would likewise be required to reduce the exercise price or conversion price (as applicable), and increase the number of shares underlying those convertible instruments, which would have a dilutive effect on our stockholders.

 

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We have registered with the SEC the resale by the holders of some of the shares of our common stock issuable upon exercise or conversion (as applicable) of our outstanding convertible instruments. The availability of these shares for public resale, as well as actual resales of these shares, could adversely affect the trading price of our common stock.

 

On July 27, 2022, at our 2022 Annual Meeting of Stockholders, the Company’s stockholders approved a proposal to authorize the Board, in its discretion but prior to July 26, 2023, to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of all of the outstanding shares of the Company’s Common Stock, at a ratio in the range of 1-for-2 to 1-for-100, with such ratio to be determined by the Board, and all outstanding shares of Series D Preferred Stock were automatically redeemed. As a result, no shares of Series D Preferred Stock remain outstanding. The stock split is not yet effective as of the date of this filing.

 

We cannot assure investors that our internal controls will prevent future material weaknesses.

 

Section 404 of the Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures. We are required to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. This assessment needs to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting.

 

There can be no assurance that we will not suffer from material weaknesses in the future. If we fail to remediate these material weaknesses or fail to otherwise maintain effective internal controls over financial reporting in the future, such failure could result in a material misstatement of our annual or quarterly consolidated financial statements that would not be prevented or detected on a timely basis and which could cause investors and other users to lose confidence in our consolidated financial statements, limit our ability to raise capital and have a negative effect on the trading price of our common stock. Additionally, failure to remediate the material weaknesses or otherwise failing to maintain effective internal controls over financial reporting may also negatively impact our operating results and financial condition, impair our ability to timely file our periodic and other reports with the SEC, subject us to additional litigation and regulatory actions and cause us to incur substantial additional costs in future periods relating to the implementation of remedial measures.

 

We are subject to legal actions that could adversely affect our financial condition.

 

From time to time, we may be involved in legal proceedings that arise in the ordinary course of business. Securities-related class action and derivative lawsuits have often been brought against companies, including many biotechnology companies, which experience volatility in the market price of their securities. This risk is especially relevant for biotechnology and biopharmaceutical companies such as ours, which often experience significant stock price volatility in connection with their product development programs.

 

We must pay the first legal fees and other litigation expenses incurred up to the application retention, or deductible, amounts under our insurance policies, including our director’s and officer’s and other liability insurance policies, and the insurance may not be sufficient to cover all of the liabilities that we may incur in connection with the pending or possible future legal actions. As a result, any future legal actions may adversely affect out financial condition.

 

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Our anti-takeover measures may make it more difficult to change our management, or may discourage others from acquiring us, and thereby adversely affect stockholder value.

 

We have a stockholder rights plan and provisions in our amended and restated by-laws (the “Bylaws”), as amended, that are intended to protect our stockholders’ interests by encouraging anyone seeking control of our company to negotiate with our Board. These provisions may discourage or prevent a person or group from acquiring us without the approval of our Board, even if the acquisition would be beneficial to our stockholders.

 

We have a classified Board, which means that at least two stockholder meetings, instead of one, will be required to effect a change in the majority control of our Board. This applies to every election of directors, not just an election occurring after a change in control. The classification of our board increases the amount of time it takes to change majority control of our Board and may cause potential acquirers to lose interest in a potential purchase of us, regardless of whether our purchase would be beneficial to us or our stockholders. The additional time and cost to change a majority of the members of our board of directors makes it more difficult and may discourage our existing stockholders from seeking to change our existing management in order to change the strategic direction or operational performance of our company.

 

At the 2022 Annual Meeting, a proposal (the “Declassification Proposal”) to declassify the structure of the Board was passed on a precatory basis, which advised the Board that a majority of our stockholders desired to end the classified Board structure in favor of the annual election of directors, in which each director standing for election will only be eligible to be elected for one-year terms. The Board plans to adopt a resolution approving and declaring the advisability of amending our governing documents to the extent necessary to remove provisions that provide for a classified Board, subject to approval by our stockholders at the 2023 annual meeting of the stockholders. If passed, such a proposal would provide for a rolling declassification of the Board to be completed by the 2026 annual meeting of the stockholders.

 

Our Bylaws provide that directors may only be removed for cause by the affirmative vote of the holders of at least a majority of the outstanding shares of our capital stock then entitled to vote at an election of directors. This provision prevents stockholders from removing any incumbent director without cause. Our Bylaws also provide that a stockholder must give us not fewer than 120 days but not more than 150 days’ notice of a proposal or director nomination that such stockholder desires to present at any annual meeting or special meeting of our stockholders. Such provision prevents a stockholder from making a proposal or director nomination at a stockholder meeting without us having advance notice of that proposal or director nomination. This could make a change in control more difficult by providing our directors with more time to prepare an opposition to a proposed change in control. By making it more difficult to remove or install new directors, these by-law provisions may also make our existing management less responsive to the views of our stockholders with respect to our operations and other issues such as management selection and management compensation.

 

We are subject to the anti-takeover provisions of Section 203 of the DGCL, which may also prevent or delay a takeover of us that may be beneficial to our stockholders.

 

Our Bylaws, as amended, designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.

 

Our Bylaws provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL, or (iv) any action asserting a claim that is governed by the internal affairs doctrine. Any person purchasing or otherwise acquiring any interest in any shares of our capital stock shall be deemed to have notice of and to have consented to this provision of our Bylaws. This choice-of-forum provision may limit our stockholders’ ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits. Alternatively, if a court were to find this provision of our amended and restated by-laws inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business and financial condition.

 

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The Series C Certificate of Designation contains covenants that could limit our financing options and liquidity position, which would limit our ability to grow our business.

 

Covenants in the Certificate of Designation for our Series C 10% Convertible Preferred Stock (the Series C Certificate of Designation”) impose operating and financial restrictions on us. These restrictions prohibit or limit our ability to, among other things:

 

  ● pay cash dividends to our stockholders, subject to certain limited exceptions;
     
  ● redeem or repurchase our common stock or other equity; or
     
  ● issue any classes of stock senior to the Series C Convertible Preferred Stock (the “Preferred Stock”) in right of dividends, redemption or distribution of assets upon certain liquidation events.

 

These restrictions may limit our ability to obtain additional financing, withstand downturns in our business or take advantage of business opportunities.

 

We may issue additional classes of preferred stock in the future, and the terms of the preferred stock may reduce the value of our common stock.

 

We are authorized to issue shares of preferred stock in one or more series. In the past, we have issued shares of preferred stock, including shares of our Preferred Stock issued in 2021. Our Board may determine the terms of future preferred stock offerings without further action by our stockholders. If we issue preferred stock, it could affect your rights or reduce the value of our outstanding common stock. In particular, specific rights granted to future holders of preferred stock may include voting rights, preferences as to dividends and liquidation, conversion and redemption rights, sinking fund provisions, and restrictions on our ability to merge with or sell our assets to a third party.

 

We do not expect to pay any cash dividends on our common stock.

 

We have not declared or paid any cash dividends on our common stock or other securities, and we currently do not anticipate paying any cash dividends in the foreseeable future. Because we do not anticipate paying cash dividends for the foreseeable future, our stockholders will not realize a return on their investment in our common stock except to the extent of any appreciation in the value of our common stock. Our common stock may not appreciate in value, or it may decline in value.

 

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

 

Under Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes (such as research and development tax credits) to offset its post-change income and taxes may be limited. In general, an “ownership change” occurs if there is a cumulative change in our ownership by “5% shareholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws. As a result of a previous ownership change, our annual utilization of approximately $67.6 million in federal net operating loss carryforwards became substantially limited. If we experience ownership changes as a result of future transactions in our stock, we may be further limited in our ability to use our net operating loss carryforwards and other tax assets to reduce taxes owed on the net taxable income that we earn. Any such limitations on the ability to use our net operating loss carryforwards and other tax assets could potentially result in increased future tax liability to us on any net income that we may earn in the future.

 

Item 1B. UNRESOLVED STAFF COMMENTS

 

None.

 

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Item 2. PROPERTIES

 

We lease our headquarters in Los Angeles, California. The lease covers approximately 2,771 square feet of office and storage space and expires in February 2024, with a right to extend the term for an additional five-year period, subject to the terms and conditions set forth in the lease agreement. Our monthly rent is $14,340, subject to an annual increase of 3.5 percent. We also lease additional storage space for approximately 540 square feet. This lease expires in February 2024, and requires us to make monthly payments of $1,405, subject to annual increases of 2.5 percent. In March 2022, we entered into a sub-lease for our office space that provides for a monthly rental income of $8,867, subject to an annual increase of 3.5 percent.

 

Item 3. LEGAL PROCEEDINGS

 

We are occasionally involved in legal proceedings and other matters arising from the normal course of business. On November 30, 2022, Jerald Hammann (“Hammann”) filed a complaint (the “Complaint”) against the Company, Mr. Caloz, and Mr. Kriegsman (together, “Defendants”) in the Court of Chancery of the State of Delaware, alleging various violations of a Cooperation Agreement, dated August 21, 2020, by and between the Company and Hammann. The Complaint alleges breaches of a provision limiting the Board’s ability to effect discretionary compensation and a non-disparagement provision. The Complaint further alleges a breach of a purported implied obligation that the Company disclose various internal records to Hammann. Defendants believe the Complaint is wholly without merit and have moved to dismiss the Complaint in its entirety. Defendants intend to litigate vigorously against Hammann’s claims.

 

We intend to vigorously defend against any complaint. We have directors’ and officers’ liability insurance, which will be utilized, after the deductible, in the defense of any matter involving our directors or officers.

 

We evaluate developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the period in which the outcome becomes probable and reasonably estimable.

 

Item 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

PART II

 

Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Market Information

 

Our common stock is traded on The OTC Market under the symbol “LADX.” The following table sets forth the high and low sale prices for our common stock for the periods indicated as reported by The OTC Market. The high and low prices reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions.

 

   High   Low 
Fiscal Year 2022:          
Fourth Quarter  $0.21   $0.08 
Third Quarter  $0.13   $0.08 
Second Quarter  $0.34   $0.09 
First Quarter  $0.67   $0.33 
           
Fiscal Year 2021          
Fourth Quarter  $0.83   $0.45 
Third Quarter  $1.00   $0.54 
Second Quarter  $3.21   $0.89 
First Quarter  $0.83   $0.45 

 

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Holders

 

On March 20, 2023, there were approximately 180 holders of record of our common stock. The number of record holders does not reflect the number of beneficial owners of our common stock for whom shares are held by brokerage firms and other nominees.

 

Dividends

 

We have not paid any cash dividends since our inception and do not contemplate paying any cash dividends in the foreseeable future.

 

Equity Compensation Plans

 

The following table sets forth certain information as of December 31, 2022, regarding securities authorized for issuance under our equity compensation plans:

 

 

 

Plan Category

 

(a)

Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights

  

(b)

Weighted-Average Exercise Price of Outstanding Options, Restricted Stock, Warrants and Rights

   Number of Securities Remaining Available for issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a) 
Equity compensation plans approved by our security holders:               
2008 Stock Incentive Plan   1,265,108   $9.42    — 
Equity compensation plans not approved by our security holders:               
2019 Stock Incentive Plan   500,000   $          0.26              — 
Outstanding warrants (1)   4,167   $33.60    — 
Total   1,769,275   $6.89    — 

 

(1) The warrants shown were issued in discrete transactions from time to time as compensation for services rendered by consultants, advisors or other third parties, and do not include warrants sold in capital-raising transactions. The material terms of such warrants were determined based upon arm’s-length negotiations with the service providers. The warrant exercise price approximates the market price of our common stock at or about the date of grant, and the warrants expire in March 2024. The warrants contain customary anti-dilution adjustments in the event of a stock split, reverse stock split, reclassification or combination of our outstanding common stock and similar events and certain of the warrants contain anti-dilution adjustments triggered by other corporate events, such as dividends.

 

For more information on the 2008 Stock Incentive Plan and the 2019 Stock Incentive Plan, see “Item 11. Executive Compensation—2008 Stock Incentive Plan and the 2019 Plan Descriptions”.

 

Recent Issuances of Unregistered Securities

 

There were no sales of unregistered securities during the year ended December 31, 2022.

 

Repurchase of Shares

 

We did not repurchase any of our shares during the year ended December 31, 2022.

 

Item 6. [RESERVED].

 

Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and analysis of our financial condition and results of operations should be read together with the discussion under “Selected Financial Data” and our consolidated financial statements included in this Annual Report. This discussion contains forward-looking statements, based on current expectations and related to future events and our future financial performance, that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many important factors, including those set forth under the caption “Risk Factors” and elsewhere in this Annual Report.

 

Overview

 

LadRx is a biopharmaceutical research and development company specializing in oncology. The Company’s focus is on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel technologies that target chemotherapeutic drugs to solid tumors and reduce off-target toxicities. During 2017, the Company’s discovery laboratory in Freiburg, Germany synthesized and tested over 75 rationally designed drug candidates with highly potent anti-cancer payloads, culminating in the creation of two distinct classes of compounds. Four lead candidates (LADR-7 through LADR-10) were selected based on in vitro and animal studies in several different cancer models, and based on stability and manufacturing feasibility. In addition, a novel companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates. However, the Company’s research and development activities have been curtailed as they seek additional financing.

 

On June 1, 2018, the Company launched Centurion and transferred all of its assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection with said transfer, the Company and Centurion entered into a Management Services Agreement whereby the Company agreed to render advisory, consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the Company for the cost of such services plus a 5% service charge. On December 21, 2018, LadRx announced that Centurion had concluded the pre-clinical phase of development for its four LADR™ drug candidates, and for its albumin companion diagnostic (ACDx™). As a result of completing this work, operations taking place at the pre-clinical laboratory in Freiburg, Germany were no longer needed and, accordingly, the lab was closed at the end of January 2019.

 

On March 9, 2022, Centurion merged with and into LadRx, with LadRx absorbing all of Centurion’s assets and continuing after the Merger. The Merger was implemented through an agreement and plan of merger pursuant to Section 253 of the General Corporation Law of the State of Delaware and did not require approval from either our or Centurion’s stockholders. The Certificate of Ownership merging Centurion into LadRx was filed with the Secretary of State of Delaware on March 9, 2022.

 

Effective September 26, 2022, the Company changed its name from CytRx Corporation to LadRx Corporation pursuant to a Certificate of Amendment to our Certificate of Incorporation filed with the Secretary of State of Delaware. In accordance with the General Corporation Law of the State of Delaware (the “DGCL”), its board of directors approved the name change and the Certificate of Amendment. Pursuant to Section 242(b)(1) of the DGCL, stockholder approval was not required for the name change or the Certificate of Amendment.

 

LadRx is a Delaware corporation, incorporated in 1985. Our corporate offices are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles, California 90049, and our telephone number is (310) 826-5648. Our web site is located at www.ladrxcorp.com. We do not incorporate by reference into this Annual Report the information on, or accessible through, our website, and you should not consider it as part of this Annual Report.

 

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LADR Drug Discovery Platform

 

The LADR Technology Offers the Opportunity for multiple pipeline drugs. The Company’s LADR™ (Linker Activated Drug Release) technology platform consists of an organic backbone that is attached to a chemotoxic agent. The purpose of the LADR™ backbone is to first target and deliver the chemotoxic agent to the tumor environment, and then to release the chemotoxic agent within the tumor. By delivering, concentrating, and releasing the chemotoxic agent within the tumor, one expects to reduce the off-target side-effects of the chemotherapeutic, which in turn allows for several-fold higher dosing of the chemotherapeutic to the patient. Being small organic molecules, the Company expects LADR-based drugs to offer the benefits of targeting the tumor without the complexity, side effects, and expense inherent in macromolecules such as antibodies and nanoparticles.

 

The Company’s LADR-based drugs use circulating albumin as the binding target and as the trojan horse to deliver the LADR™ drugs to the tumor. Albumin is the most abundant protein in plasma and accumulates inside tumors due to the aberrant vascular structure that exists within solid tumors. Tumors use albumin as a nutritional source and for transport of signaling and other molecules that are important to the maintenance and growth of the tumor, which makes albumin an excellent target for drugs that are intended for solid tumors.

 

The Company’s LADR™ development efforts are focused on two classes of ultra-high potency albumin-binding drugs. These LADR-based drugs, LADR7, 8, 9, and 10, combine the proprietary LADR™ backbone with novel derivatives of the auristatin and maytansinoid drug classes. Auristatin and maytansinoid are highly potent chemotoxins and require targeting to the tumor for safe administration to humans, as is the case for the FDA-approved drugs Adcetris (auristatin antibody-drug-conjugate by Seagen) and Kadcyla (maytansine antibody-drug-conjugate by Genentech). We believe that LADR-based drugs offer the benefits of tumor targeting without the disadvantages of antibodies and other macromolecules, which include expense, complexity, and negative side effects. Additionally, albumin is a very well-characterized drug target, which we believe will reduce clinical and regulatory costs and risks.

 

The Company’s postulated mechanism of action for LADR-based drugs is as follows:

 

  ● after administration, the linker portion of the drug conjugate forms a rapid and specific covalent bond to the cysteine-34 position of circulating albumin;
     
  ● circulating albumin preferentially accumulates in tumors due to a mechanism called “Enhanced Permeability and Retention”, which results in lower exposure to the drug in noncancerous tissues of the heart, liver, and other organs;
     
  ● once localized at the tumor, the acid-sensitive linker of the LADR™ backbone is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and
     
  ● free active drug is then released within the tumor, causing tumor cell death.

 

The first-generation LADR-based drug is called aldoxorubicin. Aldoxorubicin is the drug doxorubicin attached to the first generation LADR™ backbone (LADRs 7-10 employ a next generation LADR™ backbone). Aldoxorubicin has been administered to over 600 human subjects in human clinical trials and has proven the concept of LADR™ in that several-fold more doxorubicin can be safely administered to patients when the doxorubicin is attached to LADR™ than when administered as native doxorubicin. Aldoxorubicin has been licensed to ImmunityBio, and is currently in a Phase II registrational intent trial for pancreatic cancer. Aldoxorubicin is expected to enter a Phase I/II trial for glioblastoma in 2022 or 2023.

 

The next generation LADR™ drugs are termed LADR7, 8, 9, and 10. A great deal of Investigational New Drug (“IND”) enabling work has already been accomplished on LADR7-10, including in-silico modeling, in-vitro efficacy testing in several different cancer models, in-vivo dosing, safety, and efficacy testing in several different cancer models in animals. We have also developed and proven manufacturability, an important step prior to beginning human clinical trials.

 

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The IND-enabling work that remains prior to applying to the FDA for first-in-human studies for LADR7-10 is limited due to the extensive experimentation already completed. For example, in the case of LADR7, a manufacturing run under GMP must be completed and some toxicology studies completed using the GMP material must be completed in animals. Toxicology studies with LADR7 have already been completed with non-GMP manufactured drug. Management estimates that these final IND-enabling activities for LADR7 would take approximately 12 months to complete, once funded and initiated, and that first-in-human dosing would be achieved within approximately 6-9 months after completion of the IND-enabling studies. Management further estimates that the cost to manufacture GMP material for one LADR™ drug, for example LADR7, complete all pre-IND studies, and to obtain an IND could be approximately $2 million in direct costs, based on current estimates, representing a capital-efficient path to clinical entry.

 

Because the LADR™ backbone in future products would be the same as the LADR™ backbone in current product candidates, (i.e. the chemotoxin can be changed without changing the LADR™ backbone), management anticipates that future product candidates beyond LADR7-10 may enjoy abbreviated pre-clinical pathways to first-in-human. Such abbreviated pathways would be subject to FDA review and agreement.

 

The Company’s novel companion diagnostic, ACDx™ (albumin companion diagnostic) was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR™ lead assets. We have not yet determined whether the use of a companion diagnostic will be necessary or helpful, and plan to continue to investigate this question in parallel to the pre-clinical and clinical development of LADRs 7-10.

 

The LADR™ backbone and drugs that employ LADR™ are protected by domestic and international patents, and additional patents are pending.

 

Business Strategy for LADR™ Platform

 

Throughout 2022, with the assistance of oncology drug development experts, the Company has inventoried the IND-enabling data for LADRs 7-10, developed a strategy to complete the IND-enabling studies necessary for at least one LADR™ drug, and worked with vendors on establishing approximate time lines and costs to reach first-in-human dosing, inclusive of manufacturing, and completion of pre-IND studies and FDA filings, With this important groundwork completed, we believe that management is well situated to rapidly advance our next-generation LADR™ assets as soon as funding or partnering is achieved, and is working diligently to obtain funding and/or partnering of the LADR™ assets. Management will continue to explore in parallel both partnered and non-partnered funding and development strategies for LADR™ with a goal of obtaining the least costly capital possible to enable value inflection milestones.

 

Partnering of Aldoxorubicin

 

On July 27, 2017, the Company entered into an exclusive worldwide license with ImmunityBio, granting to ImmunityBio the exclusive rights to develop, manufacture and commercialize aldoxorubicin in all indications, and the Company is no longer directly working on the development of aldoxorubicin. As part of the license agreement, ImmunityBio made a strategic investment of $13 million in LadRx common stock at $6.60 per share (adjusted to reflect our 2017 reverse stock split), a premium of 92% to the market price on that date. In connection therewith, the Company also issued ImmunityBio a warrant to purchase up to 500,000 shares of common stock at $6.60, which expired on January 26, 2019. The Company is entitled to receive up to an aggregate of $343 million in potential milestone payments, contingent upon achievement of certain regulatory approvals and commercial milestones. The Company is also entitled to receive ascending double-digit royalties for net sales for soft tissue sarcomas and mid to high single digit royalties for other indications. There can be no assurance that ImmunityBio will achieve such milestones, approvals or sales with respect to aldoxorubicin.

 

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ImmunityBio is conducting an open-label, randomized, Phase 2 study of a combination of immunotherapy, aldoxorubicin and standard-of-care chemotherapy versus standard-of-care chemotherapy alone for the treatment of locally advanced or metastatic pancreatic cancer in patients who have had 1 or 2 lines of treatment (Cohorts A and B) or 3 or greater lines of treatment (Cohort C).

 

In January 2023, ImmunityBio announced positive results in its fully-enrolled metastatic pancreatic cancer study in third-line or greater subjects (QUILT 88) showing that the overall survival rate for patients continues to be double compared to historical survival rates after two or more prior lines of therapy. The results were presented at the American Society of Clinical Oncology Gastrointestinal (ASCO GI) conference in San Francisco on January 19-21, 2023. The median OS in this highly advanced group of patients, up to seven lines (N=83) of treatment, was 5.8 months (95% CI: 4.9, 6.4 months), exceeding the approximately 2- to 3-month historical median OS. In the third-line setting (N=41), the median OS in this group was 6.3 months (95% CI: 5.0, 7.2 months), more than doubling the historical OS. The baseline median CA 19-9 level (a marker of metastatic pancreatic disease) of the enrolled subjects (N=83) was very high at 4120 IU/ml, a significant increase from normal levels of 40 IU/ml. In subjects with CA 19-9 levels less than 4120 IU/ml (N=40), the median OS was 6.9 months (95% CI: 5.7,10.9).

 

In December 2022, Immunity Bio held a Type B meeting with the FDA to discuss the path for approval of this combination therapy for pancreatic cancer. The FDA advised ImmunityBio to conduct a randomized trial. This Phase 2, randomized, three-cohort, open-label study plans to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus low-dose chemotherapy in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and C, respectively, with Cohorts A and B having independent experimental and control arms. The primary objective of Cohorts A and B is progression-free survival (PFS) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS)

 

Aldoxorubicin has received ODD by the FDA for the treatment of STS. ODD provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other benefits.

 

ImmunityBio also lists ongoing clinical studies in glioblastoma; it is currently reviewing its options in STS.

 

Molecular Chaperone Assets (Orphayzme)

 

In 2011, LadRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million in milestone payments upon the achievement of certain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any net sales of products derived from the 2011 Arimoclomol Agreement. Orphazyme transferred its rights and obligations under the 2011 Arimoclomol Agreement to KemPharm in May 2022.

 

In May 2021, Orphazyme announced that the pivotal phase 3 clinical trial for arimoclomol in Amyotrophic Lateral Sclerosis did not meet its primary and secondary endpoints, reducing the maximum amount that LadRx currently has the right to receive under the 2011 Arimoclomol Agreement to approximately $100 million. Orphazyme also tested arimoclomol in NPC and Gaucher disease, and following a Phase II/III trial submitted to the FDA a NDA for the treatment of NPC with arimoclomol. On June 18, 2021, Orphazyme announced it had received a Complete Response Letter from the FDA indicating the need for additional data. In late October 2021, Orphazyme announced it held a Type A meeting with the FDA, at which the FDA recommended that Orphazyme submit additional data, information and analyses to address certain topics in the Complete Response Letter and engage in further interactions with the FDA to identify a pathway to resubmission. The FDA concurred with Orphazyme’s proposal to remove the cognition domain from the NPCCSS endpoint, with the result that the primary endpoint is permitted to be recalculated using the 4- domain NPCCSS, subject to the submission of additional requested information which Orphazyme had publicly indicated that it intended to provide. To bolster the confirmatory evidence already submitted, the FDA affirmed that it would require additional in vivo or pharmacodynamic (PD)/pharmacokinetic (PK) data. Orphazyme planned to request a Type C Meeting with the FDA in the second quarter of 2022. Subject to discussions with the regulatory body, Orphazyme had publicly indicated that it planned to resubmit the NDA for arimoclomol in the second half of 2022.

 

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Orphazyme had also submitted a MAA with the EMA. In February 2022, Orphazyme announced that although they had received positive feedback from the CHMP of the EMA, they were notified by the CHMP of a negative trend vote on the MAA for arimoclomol for NPC following an oral explanation. In March 2022 Orphazyme removed its application with the EMA. Orphazyme has publicly indicated that it will assess its strategic options and provide an update to the market at the applicable time.

 

On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately $5.2 million to KemPharm, a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare CNS diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties on sales, were assumed by KemPharm. KemPharm is expected to continue the early access programs with arimoclomol, and to continue to pursue the potential approval of arimoclomol as a treatment option for NPC. KemPharm indicated it plans on resubmitting the NDA for arimoclomol in the first quarter of 2023. It is also identifying a regulatory path forward with the EMA.

 

Research and Development

 

There were no expenditures for research and development activities related to continuing operations in 2022 or 2021.

 

We do not currently project incurring any material research and development expenditures in 2023. Should the Company be successful in raising capital to further develop its LADR compounds along with a companion diagnostic, only then would the Company incur research and development expenditures.

 

All of our product candidates in development must be approved by the FDA or corresponding foreign governmental agencies before they can be marketed. The process for obtaining FDA and foreign government approvals is both time-consuming and costly, with no certainty of a successful outcome. A discussion of these and other risks and uncertainties associated with our business is set forth in the “Risk Factors” section of this Annual Report.

 

Research and Development Expenses

 

Research and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology developed for use in our product candidates is expensed as incurred until technological feasibility has been established.

 

Critical Accounting Policies and Estimates

 

Management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to stock options, impairment of long-lived assets, including accrued liabilities and certain expenses. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

 

Our significant accounting policies are summarized in Note 2 of the Notes to Consolidated Financial Statements included in this Annual Report. We believe the following critical accounting policies are affected by our more significant judgments and estimates used in the preparation of our consolidated financial statements:

 

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Clinical Trial Expenses

 

Clinical trial expenses, which are included in research and development expenses, include obligations resulting from our contracts with various contract research organizations (“ CROs”), in connection with conducting clinical trials of our product candidates. We recognize expenses for these activities based on a variety of factors, including actual and estimated labor hours, clinical site initiation activities, patient enrollment rates, estimates of external costs and other activity-based factors. We believe that this method is the best measure of the efforts expended on a clinical trial with the expenses we record. We adjust our rate of clinical expense recognition if actual results differ from our estimates. If our estimates prove to be incorrect, clinical trial expenses recorded in any particular period could vary.

 

Stock-based Compensation

 

The fair value of the Company’s stock option and restricted stock grants is estimated using the Black-Scholes-Merton Option Pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the stock options or restricted stock, and future dividends. Compensation expense is recorded based upon the value derived from the Black-Scholes-Merton Option Pricing model and based on actual experience. The assumptions used in the Black-Scholes-Merton Option Pricing model could materially affect compensation expense recorded in future periods.

 

Basic and Diluted Net Loss Per Share of Common Stock

 

Basic and diluted net loss per share of common stock is computed based on the weighted-average number of shares of common stock outstanding. for the period. Diluted net income (loss) per share is computed by dividing the net income (loss) applicable to common stockholders by the weighted average number of shares of common stock outstanding plus the number of additional shares of common stock that would have been outstanding if all dilutive potential common stock had been issued using the treasury stock method. Potential shares of common stock are excluded from the computation when their effect is antidilutive. Common stock equivalents that could potentially dilute net loss per share in the future, and which were excluded from the computation of diluted loss per share, were as follows:

 

   As of December 31, 
   2022   2021 
     
Options to acquire common stock   1,765,108    2,827,829 
Warrants to acquire common stock   4,167    4,167 
Convertible preferred stock   3,127,689    9,363,637 
Preferred Investment option   11,363,637    11,363,637 
    16,260,601    23,559,270 

 

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Liquidity and Capital Resources

 

Going Concern

 

The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. During the year ended December 31, 2022, the Company incurred a net loss of $4.2 million, utilized cash in operations of $4.8 million, and the Company had a stockholders’ deficit of $1.3 million as of December 31, 2022. In addition, the Company has no recurring revenue. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

In order to fund our business and operations, we have relied primarily upon sales of our equity securities, including proceeds from the exercise of stock options and common stock purchase warrants and long-term loan financing. We also have received limited funding from our strategic partners and licensees. We will ultimately be required to obtain additional funding in order to execute our long-term business plans, although we do not currently have commitments from any third parties to provide us with long term debt or capital. We cannot assure that additional funding will be available on favorable terms, or at all. If we fail to obtain additional funding when needed, we may not be able to execute our business plans and our business may suffer, which would have a material adverse effect on our financial position, results of operations and cash flows. We have approximately $1.2 million of contractual obligations in 2023 and expect to pay these out of the Company’s balance sheet cash. We have a total of approximately $1.9 million of material contractual obligations beyond 2023.

 

If ImmunityBio obtains marketing approval and successfully commercializes aldoxorubicin, we anticipate it will take two years, and possibly longer, for us to generate significant recurring revenue, and we will be dependent on future financing until such time, if ever, as we can generate significant recurring revenue. There are also no certainties that KemPharm will be successful in obtaining FDA and EMA approval for arimoclomol or choose to commercialize arimoclomol. We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern. If we raise additional funds by issuing equity securities, dilution to stockholders may result and new investors could have rights superior to some or all of our existing equity holders. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available to us, we may have to liquidate some or all of our assets or to delay or reduce the scope of or eliminate some portion or all of our development programs or clinical trials.

 

Discussion of Operating, Investing and Financing Activities

 

Cash Flows from Operating Activities

 

Net cash used in operating activities for the year ended December 31, 2022 was $4.8 million, which was primarily the result of a net loss from operations of $4.2 million, plus $0.6 million in net cash outflows associated with changes in assets and liabilities. The net cash outflows associated with changes in assets and liabilities were primarily due to reductions of $1.0 million of accrued expenses, $0.5 million in accounts payable and $0.2 million in lease liabilities, offset by an increase in prepaid expenses and other current assets of $0.7 million, $0.2 million in accounts receivable and $0.2 million in amortization of right-of-use assets.

 

Net cash used in operating activities for the year ended December 31, 2021 was $12.3 million, which was primarily the result of a net loss from operations of $13.2 million, offset by $0.9 million in net cash inflows associated with changes in assets and liabilities. The net cash inflows associated with changes in assets and liabilities were primarily due to increases of $0.9 million of accrued expenses and other current liabilities, $0.2 million of amortization of right-of-use asset and $0.1 million of insurance receivable, offset by reductions of $0.2 million of prepaid expenses and other current assets and $0.2 million of decrease in lease liabilities.

 

Cash Flows from Investing Activities

 

We purchased $1,000 of fixed assets in the year ended December 31, 2022 and $7,000 of fixed assets in the year ended December 31, 2021, and do not expect any significant capital spending during the next 12 months.

 

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Cash Flows from Financing Activities

 

We paid dividends on the preferred shares of $0.6 million in the year ended December 31, 2022. Net cash provided by financing activities for the year ended December 31, 2021 was $9.1 million, $9.2 million of which was related to the sale of our common stock, Preferred Stock and preferred investment options described in Note 2 of our audited financial statements contained in this Annual Report and $0.1 million from the exercise of stock options, offset by $0.2 million paid in respect of preferred stock dividend.

 

We continue to evaluate potential future sources of capital, as we do not currently have commitments from any third parties to provide us with additional capital and we may not be able to obtain future financing on favorable terms, or at all. The results of our technology licensing efforts and the actual proceeds of any fund-raising activities will determine our ongoing ability to operate as a going concern. Our ability to obtain future financings through joint ventures, product licensing arrangements, royalty sales, equity financings, grants or otherwise is subject to market conditions and our ability to identify parties that are willing and able to enter into such arrangements on terms that are satisfactory to us. Depending upon the outcome of our fundraising efforts, the accompanying financial information may not necessarily be indicative of our future financial condition. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern.

 

There can be no assurance that we will be able to generate revenues from our product candidates and become profitable. Even if we become profitable, we may not be able to sustain that profitability.

 

We do not have any off-balance sheet arrangements.

 

Results of Operations

 

We incurred a net loss of $4.2 million and $13.2 million for the years ended December 31, 2022 and 2021, respectively.

 

During the years ended December 31, 2022 and 2021, we recognized no service revenue and earned an immaterial amount of license fees and grant revenue. All future licensing fees under our current licensing agreements are dependent upon the achievement of successful development milestones by our licensees.

 

General and Administrative

 

   Year Ended December 31, 
   2022   2021 
   (In thousands) 
General and administrative expenses  $4,534   $5,966 
Employee stock and stock option expense   11    — 
Total  $4,545   $5,966 

 

General and administrative expenses include all administrative salaries and general corporate expenses, including legal expenses associated with the prosecution of our intellectual property. Our general and administrative expenses, excluding employee stock and stock option exercises, were $4.5 million and $6.0 million in the years ended December 31, 2022 and 2021, respectively.

 

Depreciation and Amortization

 

Depreciation and amortization expenses for the years ended December 31, 2022 and 2021 were approximately $15,000 and $14,000, respectively. The depreciation expense reflects the depreciation of our equipment and furnishings.

 

Settlement with former Chief Executive Officer

 

On January 3, 2022, in connection with the Separation Agreement, Steven A. Kriegsman, who served as the Chairman and Chief Executive Officer of CytRx Corporation, departed from his roles as an officer of the Company and the Chairman of the Company’s board of directors, Mr. Kriegsman’s departure as Chairman of the Board was not in connection with any disagreement between Mr. Kriegsman and the Company, its management, the Board or any committee of the Board on any matter relating to the Company’s operations, policies or practices, or any other matter.

 

In connection with the execution of the Separation Agreement, Mr. Kriegsman’s existing executive employment agreement, as amended (the “Prior Employment Agreement”), was terminated; provided, however, that certain surviving customary confidentiality provisions and milestone and royalty payments as defined in the Prior Employment Agreement remain in full force and effect. Pursuant to the Prior Employment Agreement and the Separation Agreement, Mr. Kriegsman received a lump sum cash payment equal to approximately $6.0 million.

 

Liquidated Damages

 

On July 13, 2021, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional investor (the “Investor”) for aggregate gross proceeds of $10 million and net proceeds of approximately $9.2 million. The transaction closed on July 16, 2021. Under the Purchase Agreement, the Company sold and issued (i) 2 million shares of its common stock at a purchase price of $0.88 per share for total gross proceeds of approximately $1.76 million in a registered direct offering (the “Registered Direct Offering”) and (ii) 8,240 shares of Preferred Stock at a purchase price of $1,000 per share, for aggregate gross proceeds of approximately $8.24 million, in a concurrent private placement (the “Private Placement” and, together with the Registered Direct Offering, the “July 2021 Offerings”). The shares of the Preferred Stock are convertible, upon shareholder approval as described below, into an aggregate of up to 9,363,637 shares of common stock at a conversion price of $0.88 per share. The Company also issued to the Investor an unregistered preferred investment option (the “Preferred Investment Option”) that allows for the purchase of up to 11,363,637 shares of common stock for additional gross proceeds of approximately $10 million if the Preferred Investment Option is exercised in full. The Preferred Investment Option has a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval, which was increased on March 15, 2022, following approval by the stockholders at a special meeting held on March 15, 2022.

 

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In connection with the July 2021 Offerings, the Company entered into a registration rights agreement, dated as of July 13, 2021 (the “Registration Rights Agreement”), with the investor named therein, pursuant to which the Company will undertake to file, within five calendar days of the date of the filing of the proxy statement seeking the Stockholder Approval, a resale registration statement to register the shares of common stock issuable upon: (i) the conversion of the Preferred Stock sold in the Private Placement and (ii) the exercise of the Preferred Investment Option (collectively, the “Registrable Securities”); and to cause such registration statement to be declared effective under the Securities Act as promptly as possible after the filing thereof, but in any event no later than 75 days following the pricing date of this offering, or no later than 105 days following such date in the event of a “full review” by the SEC, and shall use its reasonable best efforts to keep such registration statement continuously effective under the Securities Act until the date that all Registrable Securities covered by such registration statement have been sold or are otherwise able to be sold pursuant to Rule 144.

 

The Registration Rights Agreement provides for liquidated damages to the extent that the Company does not file or maintain a registration statement in accordance with the terms thereof. The Registration Rights Agreement contains a triggering event which would require us to pay to any holder of the Preferred Stock an amount in cash, as partial liquidated damages and not as a penalty, on a monthly basis equal to the product of 2.0% multiplied by the aggregate subscription amount paid by such holder for shares of Preferred Stock pursuant to the Purchase Agreement; provided, however, that such partial liquidated damages shall not exceed 24% of the aggregate subscription amounts paid by such holders pursuant to the Purchase Agreement, or $1,977,600. If we fail to pay any partial liquidated damages within seven days after the date payable, we will be required to pay interest on any such amounts at a rate equal to the lesser of 18% per annum or the maximum rate permitted by applicable law.

 

The Company was required to hold a special shareholders meeting to approve an increase in authorized common shares to allow for conversion of preferred shares. At the first such meeting, held on September 23, 2021, the proposal was not approved by shareholders. On March 15, 2022,the Company held a special meeting of stockholders, which was originally opened and subsequently adjourned on September 23, 2021, at which meeting the Company’s stockholders, by an affirmative vote of the majority of the Company’s outstanding shares of capital stock, approved the amendment to the Company’s Certificate of Incorporation to effect an increase in the number of shares of authorized common stock, par value $0.001 per share, from 41,666,666 shares to 62,393,940 shares, and to make a corresponding change to the number of authorized shares of capital stock in order to comply with the Company’s contractual obligations under a securities purchase agreement entered into on July 13, 2021 (the “Authorized Share Increase Amendment”).

 

On March 15, 2022, the Company filed a Certificate of Amendment to Restated Certificate of Incorporation with the Secretary of State of Delaware to effect the Authorized Share Increase Amendment.

 

For the year ended December 31, 2021, the Company incurred $1.1 million of liquidated damages, which included an accrual for estimated 2022 payments.

 

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Interest Income

 

Interest income was $12,000 in the year ended December 31, 2022 and $17,000 in the year ended December 31, 2021. The variance between years is attributable primarily to the amount of funds available for investment each year and, to a lesser extent, changes in prevailing market interest rates.

 

Known Trends, Events and Uncertainties

 

The future events that would have the most material impact on the Company relate to the Securities Purchase Agreement in which we are required to pay, on a quarterly basis, a 10% dividend on the outstanding shares of Preferred Stock, with an outstanding balance of $28 million as of December 31, 2022.

 

Recently Adopted Accounting Pronouncements

 

In June 2016, the FASB issued ASU No. 2016-13, Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”). The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The standard is effective for interim and annual reporting periods beginning after December 15, 2019. The adoption of ASU 2016-13 is not expected to have a material impact on the Company’s financial position, results of operations, and cash flows.

 

Other recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the SEC did not, or are not expected to, have a material impact on the Company’s consolidated financial statements and related disclosures.

 

Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Historically, our exposure to market risk is limited primarily to interest income sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because a significant portion of our investments are in short-term debt securities issued by the U.S. government and institutional money market funds. The primary objective of our investment activities is to preserve principal. Due to the short-term nature of our investments, we believe that we are not exposed to any material market risk. We do not have any speculative or hedging derivative financial instruments or foreign currency instruments. If interest rates had varied by 10% in the year ended December 31, 2022, it would not have had a material effect on our results of operations or cash flows for that period.

 

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

Our consolidated financial statements and notes thereto as of December 31, 2022 and 2021, and for the years ended December 31, 2022 and 2021, together with the reports thereon of our independent registered public accounting firm, are set forth beginning on page F-1 of this Annual Report.

 

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 

None.

 

Item 9A. CONTROLS AND PROCEDURES

 

Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officer and principal financial officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Securities Exchange Act Rule 13a-15(e)) as of December 31, 2022, the end of the period covered by this Annual Report. Based on this evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective as of December 31, 2022, as described further below.

 

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Management’s Report on Internal Control Over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we assessed the effectiveness of our internal control over financial reporting as of December 31, 2022. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control-Integrated Framework (2013 Edition). Based upon management’s assessment using the criteria contained in COSO, management has concluded that our internal control over financial reporting was effective as of December 31, 2022.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the year ended December 31, 2022 that have materially affected, or are reasonably likely to have a material affect, on our internal control over financial reporting.

 

Item 9B. OTHER INFORMATION

 

None.

 

Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

 

Not applicable.

 

PART III

 

Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

 

The following table sets forth information concerning our directors and executive officers:

 

Name(1)   Age  

Class of

Director(2)

   Position
Jennifer K Simpson, Ph.D.   54   III   Chair of the Board(4)
Joel Caldwell   67   II   Director(3))
Cary Claiborne   62   I   Director(3) (4)
Stephen Snowdy, Ph.D.   54   —   Chief Executive Officer
John Y. Caloz   70   —   Chief Financial Officer and Senior Vice-President

 

(1) Dr. Simpson was appointed Chair of the Board on July 27, 2022.
   
(2) Our Class I director serves until the 2025 annual meeting of our stockholders; our Class II director serves until the 2023 annual meeting of our stockholders, and our Class III directors serve until the 2024 annual meeting of our stockholders.
   
(3) Members of our Audit Committee. Mr. Caldwell is Chairman of the Committee.
   
(4) Members of our Compensation Committee. Mr. Claiborne is Chairman of the Committee.

 

Joel Caldwell joined our Board on July 12, 2017. Mr. Caldwell brings more than 30 years of experience in tax matters, finance, and internal auditing. Mr. Caldwell retired from Southern California Edison, one of the nation’s largest public utilities, where he had been employed for 28 years in various executive-level accounting and finance positions covering Internal Audits, Executive Compensation, Long Term Finance, Employee Benefits and, most recently prior to his retirement, Sarbanes-Oxley Internal Controls Compliance. He also worked in public accounting at the firm of Arthur Andersen & Co. In 1980, Mr. Caldwell earned his MBA with a major in finance from the University of California at Berkeley. Prior to that, Mr. Caldwell received a Bachelor of Science degree in Accounting and Finance, also from the University of California at Berkeley. Mr. Caldwell has been a Certified Public Accountant in California since 1982 and a Certified Internal Auditor since 1986. Mr. Caldwell volunteers his business skills, serving as a financial advisor on the board of trustees of a charitable organization, and continues his involvement with track and field sports by volunteering as a meet official at Pacific Palisades Charter High School. Mr. Caldwell is a member of both the American Institute of Certified Public Accountants and the California Society of Certified Public Accountants. Mr. Caldwell was appointed Lead Director on January 3, 2022.

 

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Mr. Caldwell’s diverse background in accounting, auditing and finance, along with his accreditation as a member of both the American Institute of Certified Public Accountants and the California Society of Certified Public Accountants will provide the board with a balanced perspective to enhance its stewardship and fulfill his role as the named financial expert on our Audit Committee.

 

Jennifer Simpson, Ph.D. joined our Board in July 2021. She was appointed Chair of the Board on July 27, 2022. Dr. Simpson serves as President and Chief Executive Officer and as a member of the board of directors of Panbela Therapeutics since July 2020. She most recently served as President and Chief Executive Officer and as a member of the board of directors of Delcath Systems, Inc. from 2015 to June 2020. She had previously held various other leadership roles at Delcath since 2012. From 2011 to 2012, Dr. Simpson served as Vice President, Global Marketing, Oncology Brand Lead at ImClone Systems, Inc. (a wholly owned subsidiary of Eli Lilly and Company), where she was responsible for all product commercialization activities and launch preparation for one of the late-stage assets. From 2009 to 2011, Dr. Simpson served as Vice President, Product Champion and from 2008 to 2009 as the Associate Vice President, Product Champion for ImClone’s product Ramucirumab. From 2006 to 2008, Dr. Simpson served as Product Director, Oncology Therapeutics Marketing at Ortho Biotech (now Janssen Biotech), a Pennsylvania-based biotech company that focuses on innovative solutions in immunology, oncology and nephrology. Earlier in her career, Dr. Simpson spent over a decade as a hematology/oncology nurse practitioner and educator. Dr. Simpson has served on the board of directors and nominating and corporate governance committee of Eagle Pharmaceuticals, Inc. since August 2019. has been a director since July 2002 and has served as the Chairman of the Board’s Compensation Committee since December 2016. Dr. Simpson’s experience in the field of clinical development and oncology will be very helpful to the Board and the Company.

 

Cary Claiborne has served on the Board of Directors of NeuroSense Therapeutics since December 2021, where he also serves as chair of the audit committee. Mr. Claiborne has served as the Chief Executive Officer since August 18, 2022 and prior to that as Chief Operating officer since December 2021 and a director since November 2021 for Adial Pharmaceuticals Inc. a public biopharmaceutical company. Prior to joining Adial, Mr. Claiborne served as the CEO of Prosperity Capital Management, LLC, a US based Private Investment and Advisory firm that he founded. From 2014 until 2017, Mr. Claiborne served as the Chief Financial Officer and board member of Indivior PLC. a public global commercial stage pharmaceutical company. Mr. Claiborne was also a director on the Board of Directors of New Generation Biofuels Inc. and MedicAlert Foundation, where he also served as the chair of the audit and finance committees. From 2011 to 2014, Mr. Claiborne was the Chief Financial Officer of Sucampo Pharmaceuticals Inc., a public global biopharmaceutical company focused on drug discovery, development, and commercialization. Mr. Claiborne graduated from Rutgers University with a B.A. in Business Administration. He also holds an M.B.A from Villanova University and was previously a NACD Governance Fellow. His diverse background in the pharmaceutical industry and finance will provide the board with a balanced perspective and will be very helpful to the Board and the Company.

 

Stephen Snowdy, Ph.D. was appointed Chief Executive Officer on January 3, 2022, effective January 10, 2022. Dr. Snowdy is a scientist, serial entrepreneur and medical venture capitalist with two decades of experience in life science investing and executive management. Dr. Snowdy joins from Visioneering Technologies, Inc. (ASX: VTI), where he was Chief Executive Officer and Executive Director. Dr. Snowdy previously served as Chief Executive Officer at Abby Med LLC, a start-up pharmaceutical company dedicated to the development of a novel class of cancer drugs. Prior to that, Dr. Snowdy was Chairman and Chief Executive Officer of Calosyn Pharma, Inc., a Phase 2 osteoarthritis company, and was a partner for several years at a top-tier medical venture capital firm. Dr. Snowdy simultaneously earned a PhD in Neurobiology and an MBA from the University of North Carolina. Dr. Snowdy studied Chemical Engineering and Chemistry at the University of Florida, where he also completed two years of postbaccalaureate study in cardiopharmacology. His academic training followed service in the United States Navy Special Forces.

 

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John Y. Caloz joined us in October 2007 as our Chief Accounting Officer. In January 2009, Mr. Caloz was named Chief Financial Officer and in August of 2020 was appointed Senior Vice-President. Mr. Caloz has a history of providing senior financial leadership in the life sciences sector, as Chief Financial Officer of Occulogix, Inc, a NASDAQ listed, medical therapy company. Prior to that, Mr. Caloz served as Chief Financial Officer of IRIS International Inc., a Chatsworth, CA based medical device manufacturer. Mr. Caloz served as Chief Financial Officer of San Francisco-based Synarc, Inc., a medical imaging company, and from 1993 to 1999 he was Senior Vice President, Finance and Chief Financial Officer of Phoenix International Life Sciences Inc. of Montreal, Canada, which was acquired by MDS Inc. in 1999. Mr. Caloz was a partner at Rooney, Greig, Whitrod, Filion & Associates of Saint Laurent, Quebec, Canada, a firm of Chartered Accountants specializing in research and development and high-tech companies from 1983 to 1993, Mr. Caloz, a Chartered Professional Accountant and Chartered Accountant, holds a degree in Accounting from York University, Toronto, Canada.

 

Family Relationships

 

There are no family relationships among our directors and executive officers.

 

Diversity

 

Our Board is responsible for assembling for stockholder consideration director-nominees who, taken together, have appropriate experience, qualifications, attributes, and skills to function effectively as a board. The Board periodically reviews its composition in light of our changing requirements, its assessment of its performance, and the input of stockholders and other key constituencies. The Board looks for certain characteristics common to all board members, including integrity, strong professional reputation and record of achievement, constructive and collegial personal attributes, and the ability and commitment to devote sufficient time and energy to board service. In addition, they seek to include on the Board a complementary mix of individuals with diverse backgrounds and skills reflecting the broad set of challenges that the Board confronts. These individual qualities can include matters such as experience in our company’s industry, technical experience (i.e., medical or research expertise), experience gained in situations comparable to the company’s, leadership experience, and relevant geographical diversity.

 

Corporate Governance

 

Board Committees, Meetings and Attendance

 

Our business, property and affairs are managed by or under the direction of the board of directors. Members of the board are kept informed of our business through informal discussions with our chief executive and financial officers and other officers, by reviewing materials provided to them and by participating at meetings of the board and its committees.

 

Our Board currently has two committees, the Audit Committee, in accordance with section 3(a)(58)(A) of the Securities Exchange Act of 1934, as amended (the “Securities Act”), and the Compensation Committee. The Audit Committee consists of Mr. Caldwell and Mr. Claiborne. The Chairman of the Audit Committee is Mr. Caldwell. The Compensation Committee consists of Mr. Claiborne and Dr. Simpson. Mr. Claiborne is the Chairman of the Compensation Committee. The Audit Committee and the Compensation Committee operate under formal charters that govern their duties and conduct. Copies of the charters are available on our website at www.ladrx.com.

 

Our Board has determined that Mr. Caldwell, one of the independent directors serving on our Audit Committee, is an “audit committee financial expert” as defined by the SEC’s rules. Our Board has determined that Mr. Claiborne and Mr. Caldwell are “independent” under the current independence standards of both The OTC Market and the SEC.

 

In the year ended December 31, 2022, the Board met five times, the Audit Committee met four times and the Compensation Committee met twice.

 

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Section 16(a) Beneficial Ownership Reporting Compliance

 

Delinquent Section 16(a) Reports

 

Each of our executive officers and directors and persons who own more than 10% of our outstanding shares of common stock is required under Section 16(a) of the Exchange Act to file with the SEC initial reports of ownership and reports of changes in ownership of our common stock and to furnish us with copies of those reports. To our knowledge, based solely on our review of copies of reports we have received and written representations from certain reporting persons, we do not believe that there were any delinquent filers. We believe our directors and executive officers and greater than 10% shareholders for the year ended December 31, 2022 complied with all applicable Section 16(a) filing requirements.

 

Code of Ethics

 

We have adopted a Code of Ethics applicable to all employees, including our principal executive officer, principal financial officer and principal accounting officer, a copy of which is available on our website at www.ladrx.com. We will furnish, without charge, a copy of our Code of Ethics upon request. Such requests should be directed to Attention: Corporate Secretary, 11726 San Vicente Boulevard, Suite 650, Los Angeles, California, or by telephone at 310-826-5648.

 

Board Structure

 

Our Certificate of Incorporation and our Bylaws provide for the classification of our directors into three classes, which we refer to as Class I, Class II and Class III, with each class to consist as nearly as possible of an equal number of directors. Our Class I director serves until the 2025 annual meeting of our stockholders, our Class II director serves until the 2023 annual meeting of our stockholders, and our Class III director serves until the 2024 annual meeting of our stockholders.

 

On July 27, 2022, our Board appointed Dr. Simpson as Chair of the Board. The Chair of the Board presides at all meetings of our Board (but not at its executive sessions), and exercises and performs such other powers and duties as may be assigned to him or her from time to time by the Board or prescribed by our Bylaws. On March 8, 2022, Dr. Ignarro, our previous Chairman of the Board, tendered his resignation from the Board, effective immediately prior to the 2022 Annual Meeting.

 

At the 2022 Annual Meeting, the Declassification Proposal to declassify the structure of the Board was passed on a precatory basis, which advised the Board that a majority of our stockholders desired to end the classified Board structure in favor of the annual election of directors, in which each director standing for election will only be eligible to be elected for one-year terms. The Board plans to adopt a resolution approving and declaring the advisability of amending our governing documents to the extent necessary to remove provisions that provide for a classified Board, subject to approval by our stockholders at the 2023 annual meeting of the stockholders. If passed, such a proposal would provide for a rolling declassification of the Board to be completed by the 2026 annual meeting of the stockholders.

 

Board of Directors Role in Risk Oversight

 

In connection with its oversight responsibilities, our Board, including the Audit Committee, periodically assesses the significant risks that we face. These risks include, but are not limited to, financial, technological, competitive, and operational risks. Our Board administers its risk oversight responsibilities through our Chief Executive Officer and Chief Financial Officer who review and assess the operations of our business, as well as operating management’s identification, assessment and mitigation of the material risks affecting our operations.

 

Item 11. EXECUTIVE COMPENSATION

 

Summary Compensation Table

 

The following table presents summary information concerning all compensation paid or accrued by us for services rendered in all capacities during the years ended December 31, 2022 and 2021 by Stephen Snowdy, Steven A. Kriegsman and John Y. Caloz, who were considered our “Named Executive Officers” for the year ended December 31, 2022.

 

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Summary Compensation Table

 

Name and Principal Position  Year   Salary ($)  

Bonus

($) (2)

  

Option

Awards

($)

  

All Other

Compensation ($)

  

Total

($)

 
Stephen Snowdy, Ph.D.(1)                              
Chief Executive Officer   2022    488,063    75,000    —(5)   —    563,063 
    2021    —    —    —    —    — 
                               
Steven A. Kriegsman (1)                              
Former Chief Executive Officer   2022    —    —    —    —(3)   — 
    2021    850,000    150,000    —    6,013,700(4)   7,013,700 
                               
John Y. Caloz                              
Chief Financial Officer, Treasurer and Senior Vice-President   2022    400,000    100,000    —    —    500,000 
    2021    400,000    100,000    —    —    500,000 

 

(1) Mr. Kriegsman stepped down from his position as Chief Executive Officer as of January 3, 2022.
   
(2) Bonuses paid to Dr. Snowdy, the current Chief Executive Officer were paid on a quarterly basis, beginning April 10, 2022 and the bonus paid to Mr. Caloz was paid in full in December of each applicable year.
   
(3) Mr. Kriegsman received a settlement payment of $6 million pursuant to the General Release and Separation Agreement (the “Kriegsman Separation Agreement”), dated January 3, 2022, by and between the Company and Mr. Kriegsman. The settlement payment was remitted to the payroll service in December 2021 and paid to Mr. Kriegsman on January 3, 2022.
   
(4) $13,700 represents life insurance premiums.
   
(5) On January 10, 2022, Dr. Snowdy was granted Stock Appreciation Rights (“SARs”) relating to the appreciation of 300,000 shares of common stock of the Company at an exercise price of $0.64, the fair market value on the date of grant. These SARs vest equally over three years on the annual anniversary of the date of grant.

 

Outstanding Equity Awards at Fiscal Year-End

 

The following table sets forth outstanding equity awards held by our Named Executive Officers as of December 31, 2022 issued under our 2008 Plan and our 2019 Plan:

 

Name  Number of Securities Underlying Options Exercisable  

Number of

Securities

Underlying

Unexercised

Options

  

 

Option Exercise Price ($)

   Option Expiration Date
                
John Y. Caloz   350,000              0.26   12/12/29
Chief Financial Officer, Treasurer and Senior Vice-President   58,333        1.75   12/14/27
    58,333        2.58   12/14/26
    50,000        14.64   12/14/25
    33,334        12.90   12/14/24
    25,000(1)       27.96   12/09/23

 

(1) The options were re-priced from $14.34 to $27.96 on June 1, 2015, with no change to the expiration date of the options.

 

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2022 Grants of Plan-Based Awards

 

No stock options or restricted stock were granted in 2022.

 

2008 Stock Incentive Plan and the 2019 Stock Incentive Plan

 

The purpose of our 2008 Stock Incentive Plan, (the “2008 Plan”), and our 2019 Stock Incentive Plan, (the “2019 Plan”), and together with the 2008 Plan, (the “Plans”) is to promote our success and enhance our value by linking the personal interests of our employees, officers, consultants and directors to those of our stockholders. The 2008 Plan was adopted by our Board on November 21, 2008 and by our stockholders on July 1, 2009 with certain amendments to the 2008 Plan having been subsequently approved by our Board and stockholders. The 2019 Plan was adopted by our Board on November 15, 2019.

 

2008 Plan and the 2019 Plan Descriptions

 

The Plans are administered by the Compensation Committee of our Board. The Compensation Committee has the power, authority and discretion to:

 

  ● designate participants;
     
  ● determine the types of awards to grant to each participant and the number, terms and conditions of any award;
     
  ● establish, adopt or revise any rules and regulations as it may deem necessary or advisable to administer the Plans; and
     
  ● make all other decisions and determinations that may be required under, or as the Compensation Committee deems necessary or advisable to administer, the Plans.

 

Awards under the 2008 Plan

 

The 2008 Plan expired on November 20, 2018, and thus no shares are available for future grant under the 2008 Plan.

 

Awards under the 2019 Plan

 

The following is a summary description of financial instruments that may be granted to participants in our 2019 Plan by the Compensation Committee of our Board.

 

Stock Options. The Compensation Committee is authorized to grant non-qualified stock options. The terms of any incentive stock option must meet the requirements of Section 422 of the Internal Revenue Code. The exercise price of an option may not be less than the fair market value of the underlying stock on the date of grant, and no option may have a term of more than 10 years from the grant date.

 

Restricted Stock. The Compensation Committee may make awards of restricted stock, which will be subject to forfeiture to us and other restrictions as the Compensation Committee may impose.

 

Stock Bonus Awards. The Compensation Committee may make awards of stock bonus awards in consideration for past services actually rendered, which will be subject to repurchase by us and such other terms as the Compensation Committee may impose.

 

Limitations on Transfer; Beneficiaries. Stock Option awards under the 2019 Plan may generally not be transferred or assigned by participants other than by will or the laws of descent and distribution. Awards of Restricted Stock or Stock Bonus awards may be transferred or assigned only upon such terms and conditions as set forth in the award agreement or as determined by the Compensation Committee in its discretion.

 

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Acceleration Upon Certain Events. In the event of a “Corporate Transaction” as defined in the 2019 Plan, all outstanding options will become fully vested, subject to the holder’s consent with respect to incentive stock options, and exercisable and all restrictions on all outstanding awards will lapse. Unless the surviving or acquiring entity assumes the awards in the Corporate Transaction or the stock award agreement provides otherwise, the stock awards will terminate if not exercised at or prior to the Corporate Transaction.

 

Termination and Amendment

 

Our Board or the Compensation Committee may, at any time and from time to time, terminate or amend the 2019 Plan without stockholder approval; provided, however, that our Board or the Compensation Committee may condition any amendment on the approval of our stockholders if such approval is necessary or deemed advisable with respect to tax, securities or other applicable laws, policies or regulations. No termination or amendment of the Plans may adversely affect any award previously granted without the written consent of the participants affected. The Compensation Committee may amend any outstanding award without the approval of the participants affected, except that no such amendment may diminish or impair the value of an award.

 

Employment Agreements and Potential Payment upon Termination or Change in Control

 

Employment Agreements with Stephen Snowdy

 

2022 Snowdy Employment Agreement

 

On January 3, 2022, the Company entered into an employment agreement, effective January 10, 2022 (the “Effective Date”), with Dr. Stephen Snowdy, under which the Company agreed to employ Dr. Snowdy as its Chief Executive Officer through December 31, 2022 (the “Snowdy Employment Agreement”). Pursuant to the Snowdy Employment Agreement, Dr. Snowdy is entitled to a base annual salary of $500,000. Dr. Snowdy also is entitled to receive a signing bonus of $100,000, payable in four quarterly installments, with the first installment to be paid on the date that is 90 days following the Effective Date, and an annual bonus to be determined by the Board in its sole discretion, based on certain performance criteria as established by the Board, with such bonus payable no later than the last regular payroll in 2022. Dr. Snowdy is also eligible to receive a bonus of up to 3.0% of the amount of non-broker assisted funding raised to fund Centurion on terms acceptable to both the Board of Centurion and LadRx. The Snowdy Employment Agreement also entitles Dr. Snowdy to receive customary benefits and reimbursement for ordinary business expenses. In connection with Dr. Snowdy’s appointment and as a further inducement to enter into the Snowdy Employment Agreement, the Company granted Dr. Snowdy 300,000 cash-based stock appreciation rights with a base price equal to the closing price of the Company’s common stock on the date of grant, subject to the terms and conditions of the Company’s form of cash-based stock appreciation rights agreement, which terms shall include vesting in three substantially equal tranches on the first, second and third anniversary of the Effective Date.

 

Under the Snowdy Employment Agreement, Dr. Snowdy is also eligible to receive nonqualified stock options equal to 2% of the fully diluted common stock of Centurion with an exercise price equal to the fair market value of Centurion on the date of grant, subject to the terms and conditions of a grant agreement. In the event Dr. Snowdy’s employment is terminated without “cause” or due to “disability” (each term as defined in the Snowdy Employment Agreement) or death, the Company has agreed to (i) pay Dr. Snowdy or his heirs or personal representatives, as applicable, a lump-sum severance amount equal to six months’ base annual salary, or twelve months’ base annual salary if Dr. Snowdy’s employment is terminated without “cause” following a “change in control” (each term as defined in the Snowdy Employment Agreement), and (ii) continue the participation, at the Company’s cost, for a period of six months, or twelve months if the Snowdy Employment Agreement is terminated without “cause” following a “change in control”, of Dr. Snowdy and his dependents in the employee benefits plan in which Dr. Snowdy was participating. In the event Dr. Snowdy’s employment is terminated without “cause”, all of Dr. Snowdy’s vested stock options and any other vested equity awards will remain exercisable for their full term notwithstanding the termination of his employment. In the event Dr. Snowdy’s employment is terminated due to Dr. Snowdy’s “disability” or death, all of Dr. Snowdy’s unvested stock options and other equity awards based on the Company’s securities will immediately vest in full and all of Dr. Snowdy’s stock options and any other equity awards will remain exercisable for their full term notwithstanding the termination of his employment. Dr. Snowdy may also terminate the Employment Agreement for good reason.

 

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2023 Snowdy Employment Agreement

 

On December 30, 2022, the Company entered into a new employment agreement with Dr. Stephen Snowdy, effective as of January 1, 2023 (the “2023 Snowdy Employment Agreement”), pursuant to which the Company agreed to continue to employ Dr. Snowdy as its Chief Executive Officer through December 31, 2025, unless terminated sooner in accordance with the terms of the 2023 Snowdy Employment Agreement (the “Snowdy Term”). In the event that Dr. Snowdy’s employment has not been terminated and the Company has not offered to extend or renew Dr. Snowdy’s employment under the 2023 Snowdy Employment Agreement upon expiration of the Snowdy Term, in lieu of any other severance benefits as provided in the 2023 Snowdy Employment Agreement, the Company shall continue to pay Dr. Snowdy his salary commencing on the final date of the Snowdy Term and ending on (a) June 30, 2026, or (b) the date of Dr. Snowdy’s re-employment with another employer, whichever is earlier; provided that Dr. Snowdy shall have executed and delivered to the Company a General Release of All Claims. Pursuant to the 2023 Snowdy Employment Agreement, Dr. Snowdy is entitled to receive an annual salary of $520,000, less applicable payroll deductions and tax withholdings. Dr. Snowdy also is eligible for an annual target performance based bonus (the “Snowdy Target Bonus”), equal to 50% of Dr. Snowdy’s annual salary during the Snowdy Term, with such bonus dependent in part on the Company’s performance and the Compensation Committee’s discretion in assessing Dr. Snowdy’s individual performance in relation to his objectives as determined by the Company’s Board of Directors and the overall performance and status of the Company, payable no later than February 28th of the calendar year following the calendar year in which the Snowdy Target Bonus relates.

 

The 2023 Snowdy Employment Agreement also entitles Dr. Snowdy to receive customary benefits and reimbursement for ordinary business expenses. In the event Dr. Snowdy’s employment is terminated without cause, due to disability or death, or due to good reason by Dr. Snowdy (each term as defined in the 2023 Snowdy Employment Agreement), the Company has agreed to, among other things, (i) pay Dr. Snowdy or his heirs or personal representatives, as applicable, a lump-sum severance amount equal to twelve months’ base annual salary and an amount equal to the prorated portion of the Snowdy Target Bonus for the year in which the termination occurred based on the number of days Dr. Snowdy was employed, or an amount equal to eighteen months’ annual salary and the full Snowdy Target Bonus amount if such termination occurs within six months prior to or within twelve months following a change in control; and (ii) reimburse Dr. Snowdy and his dependents all premiums associated with Dr. Snowdy’s continuation of health insurance pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1986 (“COBRA”), subject to certain conditions. In the event Dr. Snowdy’s employment is terminated without cause or by Dr. Snowdy due to good reason, all of Dr. Snowdy’s vested stock options and any other vested equity awards will remain exercisable for their full term notwithstanding the termination of his employment. In the event Dr. Snowdy’s employment is terminated due to disability or death, all of Dr. Snowdy’s unvested stock options and other equity awards based on the Company’s securities will immediately vest in full and all of Dr. Snowdy’s stock options and any other equity awards will remain exercisable for their full term notwithstanding the termination of his employment.

 

Employment Agreements with John Y. Caloz

 

John Y. Caloz is employed as our Chief Financial Officer, Treasurer and Senior Vice-President pursuant to an employment agreement (the “Caloz Employment Agreement”) dated as of December 16, 2021 that expired on December 31, 2022. Mr. Caloz is paid an annual base salary of $400,000 and is eligible to receive an annual bonus as determined by our Board (or our Compensation Committee) in its sole discretion, but not to be less than $100,000. In the event we terminate Mr. Caloz’s employment without cause (as defined in the Caloz Employment Agreement), we have agreed to pay him a lump-sum equal to his accrued but unpaid salary and vacation, plus an amount equal to six months’ salary under his employment agreement.

 

Pursuant to the Caloz Employment Agreement, if the Company does not offer to renew or extend the Caloz Employment Agreement, and that Mr. Caloz’s employment had not theretofore been terminated, we will continue to pay him his annual salary thereunder during the period commencing upon expiration of the Caloz Employment Agreement and ending on June 30, 2023.

 

2023 Caloz Employment Agreement

 

On December 30, 2022, the Company entered into a new employment agreement with John Y. Caloz, effective January 1, 2023 (the “2023 Caloz Employment Agreement”), pursuant to which the Company agreed to continue to employ Mr. Caloz as its Chief Financial Officer and Senior Vice President through December 31, 2025, unless terminated sooner in accordance with the 2023 Caloz Employment Agreement (the “Caloz Term”). In the event that Mr. Caloz’s employment has not been terminated and the Company has not offered to extend or renew Mr. Caloz’s employment under the 2023 Caloz Employment Agreement upon expiration of the Caloz Term, in lieu of any other severance benefits as provided in the 2023 Caloz Employment Agreement, the Company shall continue to pay Mr. Caloz his salary commencing on the final date of the Caloz Term and ending on (a) June 30, 2026, or (b) the date of Mr. Caloz’s re-employment with another employer, whichever is earlier; provided that Mr. Caloz shall have executed and delivered to the Company a General Release of All Claims. Pursuant to the 2023 Caloz Employment Agreement, Mr. Caloz is entitled to receive an annual salary of $416,000, less applicable payroll deductions and tax withholdings. Mr. Caloz also is eligible for an annual target performance-based bonus (the “Caloz Target Bonus”), equal to 40% of Mr. Caloz’s annual salary during the Caloz Term, with such bonus dependent in part on the Company’s performance and the Compensation Committee’s discretion in assessing Mr. Caloz’s individual performance in relation to his objectives as determined by the Board and the overall performance and status of the Company, payable no later than February 28th of the calendar year following the calendar year in which the Caloz Target Bonus relates.

 

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The 2023 Caloz Employment Agreement also entitles Mr. Caloz to receive customary benefits and reimbursement for ordinary business expenses. In the event Mr. Caloz’s employment is terminated without cause, due to disability or death, or due to good reason by Mr. Caloz (each term as defined in the 2023 Caloz Employment Agreement), the Company has agreed to, among other things, (i) pay Mr. Caloz or his heirs or personal representatives, as applicable, a lump-sum severance amount equal to twelve months’ base annual salary and an amount equal to the prorated portion of the Caloz Target Bonus for the year in which the termination occurred based on the number of days Mr. Caloz was employed, or an amount equal to eighteen months’ annual salary and the full Caloz Target Bonus amount if such termination occurs within six months prior to or within twelve months following a change in control; and (ii) reimburse Mr. Caloz and his dependents for all Medicare premiums and premiums associated with Mr. Caloz continuation of health insurance pursuant to COBRA, subject to certain conditions. In the event Mr. Caloz’s employment is terminated without cause or by Mr. Caloz due to good reason, all of Mr. Caloz’s vested stock options and any other vested equity awards will remain exercisable for their full term notwithstanding the termination of his employment. In the event Mr. Caloz’s employment is terminated due to disability or death, all of Mr. Caloz’s unvested stock options and other equity awards based on the Company’s securities will immediately vest in full and all of Mr. Caloz’s stock options and any other equity awards will remain exercisable for their full term notwithstanding the termination of his employment.

 

Quantification of Termination Payments and Benefits

 

In January 2022, in connection with the Kriegsman Separation Agreement, Mr. Kriegsman’s executive employment agreement (the “Kriegsman Employment Agreement”), dated as of March 26, 2019 by, and between the Company and Mr. Kriegsman, was terminated; provided, however, that certain surviving customary confidentiality provisions and milestone and royalty payments as defined in the Kriegsman Employment Agreement remain in full force and effect. Pursuant to the Kriegsman Separation Agreement, Mr. Kriegsman received a lump sum cash payment equal to approximately $6.0 million. This amount was accrued in the Company’s financial results for the year ended December 31, 2021; however the payment was made in January 2022. In addition, Mr. Kriegsman was entitled to receive continuing health benefits and life insurance premiums for 2022 and 2023 at an approximate cost of $43,000 per year. These future payments were also accrued in the Company’s financial results for the year ended December 31, 2021.

 

Compensation of Directors

 

We use a combination of cash and stock-based compensation to attract and retain qualified candidates to serve on our Board. Directors who also are employees of our company currently receive no compensation for their service as directors or as members of board committees. In setting director compensation, we consider the significant amount of time that directors dedicate to the fulfillment of their director responsibilities, as well as the competency and skills required of members of our board. The directors’ annual compensation year begins with the annual election of directors at the annual meeting of stockholders. Periodically, our Board reviews our director compensation policies and, from time to time, makes changes to such policies based on various criteria the board deems relevant. For 2023, the Board implemented an increase of 4 percent in their compensation.

 

The non-employee director who serves as Chair of the Board receives a quarterly retainer of $6,250. Our non-employee directors receive a quarterly retainer of $6,000 (plus an additional $5,000 for the Chairmen of the Audit and Compensation Committees), a fee of $4,000 for each Board meeting attended ( or $750 for Board actions taken by unanimous written consent) and $3,000 for each meeting of the Audit Committee and $2,500 for each meeting of the Compensation Committee attended. Non-employee directors who serve as the chairman of a board committee receive an additional $3,000 for each Audit Committee meeting they chair and an additional $4,500 for each Compensation Committee meeting they chair and the non-employee director who serves as chairperson of the Board receives an additional $4,000 for each meeting attended. These fees will increase by 4 percent commencing January 2023.

 

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The following table sets forth the compensation paid to our directors other than our Chief Executive Officer for 2022:

 

Director Compensation Table

 

Name (1)  Fees Earned or Paid in Cash ($) (2)   Total ($) 
Louis Ignarro, Ph.D., Former Chairman of the Board   71,000    71,000 
Cary Claiborne, Director   31,000    31,000 
Joel Caldwell, Director   98,250    98,250 
Jennifer Simpson, Ph.D., Chair of the Board (3)   69,416    69,416 

 

(1) On January 3, 2022, Mr. Kriegsman stepped down as Chairman of the Board and Dr. Ignarro was appointed Chairman of the Board. On July 27, 2022, Dr. Simpson replaced Dr. Ignarro as Chair of the Board following Dr. (Ignarro’s resignation from the Board. Dr. Claiborne was appointed to the Board effective July 27, 2022. For information relating to Mr. Kriegsman’s compensation as Chief Executive Officer, see the Summary Compensation Table above. Mr. Kriegsman resigned from his position as director on March 8, 2022.
   
(2) The amounts in this column represent cash payments made to Non-Employee Directors for annual retainer fees, committee and/or chairmanship fees and meeting fees during the year.

 

(3) On December 15, 2021, Dr. Simpson was granted SARs relating to the appreciation of 50,000 shares of common stock of the Company at an exercise price of $0.45, the fair market value of the Company’s common stock on the date of grant. The SARs vested in full on December 15, 2022.

 

Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

 

Based solely upon information made available to us, the following table sets forth information with respect to the beneficial ownership of our common stock as of March [22], 2023 by (1) each person who is known by us to beneficially own more than five percent of our common stock; (2) each of our directors; (3) the Named Executive Officers listed in the Summary Compensation Table under Item 11 who were serving as Named Executive Officers as of March [22], 2023; and (4) all of our executive officers and directors as a group. Beneficial ownership is determined in accordance with the SEC rules. Shares of common stock subject to any warrants or options that are presently exercisable, or exercisable within 60 days of March [22], 2023 (which are indicated by footnote) are deemed outstanding for the purpose of computing the percentage ownership of the person holding the warrants or options, but are not treated as outstanding for the purpose of computing the percentage ownership of any other person. The percentage ownership reflected in the table is based on 46,587,391 shares of our common stock outstanding as of March [22], 2023. Except as otherwise indicated, the holders listed below have sole voting and investment power with respect to all shares of common stock shown, subject to applicable community property laws. An asterisk represents beneficial ownership of less than 1%.

 

Name and Address of Beneficial Owner (5)  Amount and Nature of Beneficial Ownership (Common Stock)   Percent of Class (Common Stock) 
Named Executive Officers and Directors          
Cary Claiborne   —    %
Joel Caldwell   335,373    *(1)
Jennifer Simpson, Ph.D.   25,000    * 
Stephen Snowdy, Ph.D.   —    0.0%
John Y. Caloz   575,758    1.2 %(2)
All executive officers and directors as a group (five persons)   5,194,932    2.0 %(3)
          
5% Beneficial Owners         
Armistice Capital, LLC   4,624,309    9.9 %(4)

 

(1) Includes 60,000 shares subject to options.

 

(2) Includes 575,001 shares subject to options.
   
(3) Includes 635,001 shares subject to options.
   
(4) Based on the Schedule 13(G/A) filed on February 14, 2023.
   
(5) The address of each of the below listed Named Executive Officers and directors is the Company’s business address located at 11726 San Vicente Blvd, Ste 650, Los Angeles, CA 90049.

 

64

 

 

Equity Compensation Plans

 

The information required is incorporated herein by reference to Item 5 of this Annual Report relating to our Equity Compensation Plans as set forth on page 38.

 

Item 13. CERTAIN RELATIONSHIPS, RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

 

Director Independence

 

Although the Company is no longer listed on The NASDAQ Capital Market, our Board has determined that Dr. Simpson, Mr. Caldwell and Mr. Claiborne are “independent” under the current independence standards of both The NASDAQ Capital Market and the SEC, and have no material relationships with us (either directly or as a partner, shareholder or officer of any entity) that are inconsistent with a finding of their independence as members of our Board. Our Board has determined that Mr. Claiborne and Mr. Caldwell also are “independent” for purposes of service as the members of our Audit Committee. In making these determinations, our Board has broadly considered all relevant facts and circumstances, recognizing that material relationships can include commercial, banking, consulting, legal, accounting, and familial relationships, among others.

 

Transactions with Related Persons

 

Our Audit Committee is responsible for reviewing and approving, as appropriate, all transactions with related persons, in accordance with its Charter.

 

Transactions between us and one or more related persons may present risks or conflicts of interest or the appearance of conflicts of interest. Our Code of Ethics requires all employees, officers and directors to avoid activities or relationships that conflict, or may be perceived to conflict, with our interests or adversely affect our reputation. It is understood, however, that certain relationships or transactions may arise that would be deemed acceptable and appropriate so long as there is full disclosure of the interest of the related parties in the transaction and review and approval by disinterested directors to ensure there is a legitimate business reason for the transaction and that the transaction is fair to us and our stockholders.

 

As a result, the procedures followed by the Audit Committee to evaluate transactions with related persons require:

 

  ● that all related person transactions, all material terms of the transactions, and all the material facts as to the related person’s direct or indirect interest in, or relationship to, the related person transaction must be communicated to the Audit Committee; and
     
  ● that all related person transactions, and any material amendment or modification to any related person transaction, be reviewed and approved or ratified by the Audit Committee, as required by OTC Market Rules.

 

65

 

 

Our Audit Committee will evaluate related person transactions based on:

 

  ● information provided by members of our Board in connection with the required annual evaluation of director independence;
     
  ● pertinent responses to the Directors’ and Officers’ Questionnaires submitted periodically by our officers and directors and provided to the Audit Committee by our management; and
     
  ● any other relevant information provided by any of our directors or officers.
     
  ● In connection with its review and approval or ratification, if appropriate, of any related person transaction, our Audit Committee is to consider whether the transaction will compromise standards included in our Code of Ethics. In the case of any related person transaction involving an outside director or nominee for director, the Audit Committee also is to consider whether the transaction will compromise the director’s status as an independent director as prescribed in the OTC Market Rules.

 

In connection with Mr. Kriegsman’s resignation as the Company’s Chief Executive Officer, the Company and Mr. Kriegsman entered into the Kriegsman Separation Agreement, which was approved by the Board in December 2021. Mr. Kriegsman received a settlement payment of $6 million pursuant to the Kriegsman Separation Agreement. The settlement payment was remitted to the payroll service in December 2021 and paid to Mr. Kriegsman on January 3, 2022.

 

Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

 

Audit Fees

 

Weinberg & Company (“Weinberg”), served as our independent registered public accounting firm and audited our consolidated financial statements for the years ended December 31, 2022 and 2021.

 

The fees for the year ended December 31, 2022 from Weinberg for professional services rendered in connection with the audit of our annual consolidated financial statements and reviews of our unaudited consolidated financial statements were approximately $125,000. The fees for the year ended December 31, 2021 from Weinberg for professional services rendered in connection with the audit of our annual consolidated financial statements and reviews of our unaudited consolidated financial statements and registration statements on Form S-3 were approximately $130,000.

 

Audit-Related Fees

 

None.

 

Tax Fees

 

The aggregate fees billed by Weinberg for professional services for tax compliance were approximately $26,000 for the year ended December 31, 2022.

 

All Other Fees

 

No other services were rendered by Weinberg in either year ended December 31, 2022 or 2021.

 

Pre-Approval Policies and Procedures

 

It is the policy of our Audit Committee that all services to be provided by our independent registered public accounting firm, including audit services and permitted audit-related and non-audit services, must be pre-approved by our Audit Committee. Our Audit Committee pre-approved all services, audit and non-audit, provided to us by Weinberg for the years ended December 31, 2022 and 2021.

 

66

 

 

PART IV

 

Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

 

(a) The following documents are filed as part of this 10-K:

 

(1) Financial Statements

 

Our consolidated financial statements and the related report of the independent registered public accounting firm thereon are set forth on pages F-1 to F-26 of this Annual Report. These consolidated financial statements are as follows:

 

Consolidated Balance Sheets as of December 31, 2022 and 2021

 

Consolidated Statements of Operations for the Years Ended December 31, 2022 and 2021

 

Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2022 and 2021

 

Consolidated Statements of Cash Flows for the Years Ended December 31, 2022 and 2021

 

Notes to Consolidated Financial Statements

 

Reports of Independent Registered Public Accounting Firm

 

(2) Financial Statement Schedules

 

All schedules are omitted because they are not required, not applicable, or the information is provided in the consolidated financial statements or notes thereto.

 

(3) Exhibits

 

See Exhibit Index to this Annual Report, which is incorporated herein by reference.

 

67

 

 

CytRx Corporation

Form 10-K Exhibit Index

 

        Incorporated By Reference to   Filed /

Exhibit

Number

   Description   Form   Exhibit   Filing Date  

Furnished

Herewith

2.1   Agreement and Plan of Merger, dated as of June 6, 2008, among CytRx Corporation, CytRx Merger Subsidiary, Inc., Innovive Pharmaceuticals, Inc., and Steven Kelly   8-K   2.1   6/9/2008    
3.1   Restated Certificate of Incorporation of CytRx Corporation, as amended   10-K   3.1   3/13/2012    
3.2   Certificate of Amendment of Restated Certificate of Incorporation   8-K   3.1   5/15/2012    
3.3   Certificate of Amendment of Restated Certificate of Incorporation   8-K   3.1   11/1/2017    
3.4   Certificate of Amendment of Restated Certificate of Incorporation   8-K   3.1   3/16/2022    
3.5   Certificate of Elimination of Designation of Series A Junior Participating Preferred Stock   8-K   3.2   12/19/2019    
3.6   Certificate of Elimination of Series B Convertible Preferred Stock   8-K   3.3   12/19/2019    
3.7   Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock   8-K   3.1   11/17/2020    
3.8   Amended and Restated By-Laws of CytRx Corporation, effective November 12, 2020 and Amendment No. 1 to the Amended and Restated Bylaws of dated May 19, 2022.   8-K   3.3   5/19/2022    
3.9   Certificate of the Designations, Powers, Preferences and Rights of Series C 10.00% Convertible Preferred Stock   8-K   3.1   7/15/2021    
3.10   Certificate of Amendment of Restated Certificate of Incorporation   8-K   3.1   3/16/2022    
3.11   Certificate of Correction to the Certificate of Amendment of Restated Certificate of Incorporation   8-K   3.3   5/19/2022    
3.12   Certificate of Designation of Series D Preferred Stock   8-K   3.1   5/19/2022    

 

68

 

 

        Incorporated By Reference to   Filed /

Exhibit

Number

   Description   Form   Exhibit   Filing Date  

Furnished

Herewith

3.13   Certificate of Amendment of Restated Certificate of Incorporation   8-K   3.1   9/23/2022    
4.1   Amended and Restated Rights Agreement, dated as of November 16, 2020, by and between CytRx Corporation and American Stock Transfer & Trust Company, LLC, as rights agent   8-K   4.1   11/17/2020    
4.3   Form of Preferred Investment Option   8-K   4.1   7/15/2021    
4.4   Description of Securities   10-K   4.4   3/23/2022    
10.1+   CytRx Corporation Amended and Restated 2008 Stock Incentive Plan   10-K   10.6   3/13/2012    
10.1.2+   Eighth Amendment to Amended and Restated CytRx Corporation 2008 Stock Incentive Plan   14A (proxy)   Annex B   5/20/2016    
10.1.3+   Form of Non-qualified Stock Option for grants to non-employee directors under Amended and Restated 2008 Stock Incentive Plan.   10-K   10.11   3/11/2016    
10.1.4+   Form of Non-qualified Stock Option for grants to executive officers under Amended and Restated 2008 Stock Incentive Plan.   10-K   10.12   3/11/2016    
10.1.5+   Form of Non-qualified Stock Option for grants to Steven A. Kriegsman and Daniel J. Levitt, M.D., Ph.D., under Amended and Restated 2008 Stock Incentive Plan.   10-K   10.13   3/11/2016    
10.1.6+   Amendment No. 1 to Stock Option Agreements of Daniel J. Levitt, M.D., Ph.D., dated December 31, 2015.   10-K   10.14   3/11/2016    
10.1.7+   Amendment No. 1 to Stock Option Agreements (2000 Long-Term Incentive Plan) of Steven A. Kriegsman, dated March 8, 2016.   10-K   10.15   3/11/2016    

 

69

 

 

        Incorporated By Reference to   Filed /

Exhibit

Number

   Description   Form   Exhibit   Filing Date  

Furnished

Herewith

10.1.8+   Amendment No. 1 to Stock Option Agreements (2008 Stock Incentive Plan) of Steven A. Kriegsman, dated March 8, 2016   10-K   10.16   3/11/2016    
10.2†   License Agreement, dated December 7, 2001, by and between CytRx Corporation and Vical Incorporated   8-K   99   12/21/2001    
10.3   Office Lease between The Kriegsman Capital Group, LLC and Douglas Emmett Joint Venture, dated April 13, 2000   10-K   10.63   5/14/2004    
10.3.1   Assignment, Assumption and Consent, effective July 1, 2003, by and among CytRx Corporation, The Kriegsman Capital Group, LLC and Douglas Emmett Joint Venture, concerning Office Lease dated April 13, 2000   10-K   10.64   5/14/2004    
10.3.2   Fifth Amendment to Office Lease dated January 13, 2020 by and between CytRx Corporation and Douglas Emmett 1993, LLC   10-K   10.3.2   3/24/2021    
10.4†   License Agreement dated April 17, 2006 between Innovive Pharmaceuticals, Inc. and KTB Tumorforschungs GmbH   10-Q   10.15   11/14/2006    
10.4.1   Amendment dated March 14, 2014 to License Agreement between CytRx Corporation and KTB Tumorforschungs GmbH   8-K   1.1   3/17/2014    
10.5   Asset Purchase Agreement dated May 13, 2011 between CytRx Corporation and Orphazyme ApS   10-Q   10.1   5/17/2011    
10.6   Exclusive License Agreement, dated as of July 27, 2017, by and between CytRx Corporation and NantCell, Inc.   8-K   10.1   8/1/2017    
10.7   Amended and Restated Employment Agreement, dated March 26, 2019, by and between CytRx Corporation and Steven A. Kriegsman   10-K   10.18   3/29/2019    

 

70

 

 

        Incorporated By Reference to   Filed /

Exhibit

Number

   Description   Form   Exhibit   Filing Date  

Furnished

Herewith

10.7.1   First Amendment, dated December 19, 2019, to Amended and Restated Employment Agreement, dated March 26, 2019, by and between CytRx Corporation and Steven A. Kriegsman   8-K   10.1   12/19/2019    
10.8+   Employment Agreement, dated December 16, 2021, by and between CytRx Corporation and John Y. Caloz   10-K   10.8   3/23/2022    
10.9   CytRx Corporation 2019 Stock Incentive Plan   8-K   10.1   11/15/2019    
10.10   Form of Securities Purchase Agreement, dated as of July 13, 2021, by and between the Company and the purchaser thereto   8-K   10.1   7/15/2021    
10.11   Form of Registration Rights Agreement, dated as of July 13, 2021, by and between the Company and the purchaser thereto   8-K   10.2   7/15/2021    
10.12   Amendment No. 1 to the Cooperation Agreement, dated September 2, 2021, by and between CytRx Corporation and Jerald A. Hammann   8-K   10.1   9/9/2021    
10.13+   Employment Agreement, dated January 3, 2022, by and between CytRx Corporation and Dr. Stephen Snowdy   8-K   10.1   1/4/2022    
10.14+   General Release and Separation Agreement, dated January 3, 2022, by and between CytRx Corporation and Steven A. Kriegsman.   8-K   10.2   1/4/2022    
10.15+   Employment Agreement, dated December 30, 2022, by and between LadRx Corporation and Dr. Stephen Snowdy.               **
10.16+   Employment Agreement, dated December 30, 2022, by and between LadRx Corporation and John Y. Caloz               ** 
23.1   Consent of Weinberg & Company               **

 

71

 

 

        Incorporated By Reference to    

Exhibit

Number

   Description   Form   Exhibit   Filing Date  

Filed / Furnished

Herewith

31.1   Certification of Chief Executive Officer Pursuant to 15 U.S.C. Section 7241, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002               **
31.2   Certification of Chief Financial Officer Pursuant to 15 U.S.C. Section 7241, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002               **
32.1   Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002               ***
32.2   Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002               ***
101.INS   Inline XBRL Instance Document.               **
101.SCH   Inline XBRL Taxonomy Extension Schema Document.               **
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document.               **
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document.               **
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document.               **
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document.               **
104   Cover Page Interactive Data File (formatted as Inline XBRL)                

 

* Indicates a management contract or compensatory plan or arrangement.
** Filed herewith.
*** Furnished herewith.
† Confidential treatment has been requested or granted for certain portions which have been blanked out in the copy of the exhibit filed with the SEC. The omitted information has been filed separately with the SEC.

 

Item 16. FORM 10-K SUMMARY

 

None.

 

72

 

 

SIGNATURES

 

In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  LADRX CORPORATION
     
Date: March 20, 2023 By: /s/ STEPHEN SNOWDY
   

Dr. Stephen Snowdy

Chief Executive Officer (Principal Executive Officer)

     
  By: /s/ JOHN Y. CALOZ
    John Y. Caloz
    Chief Financial Officer (Principal Financial and Accounting Officer)

 

In accordance with the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated.

 

Signature   Title   Date
         
/s/ STEPHEN SNOWDY   Chief Executive Officer   March 20, 2023
Stephen Snowdy, Ph.D.   (Principal Executive Officer)    
         
/s/ JOHN Y. CALOZ   Chief Financial Officer   March 20, 2023
John Y. Caloz   (Principal Financial and Accounting Officer)    
         

/s/ CARY CLAIBORNE

  

Director

  

March 20, 2023

Cary Claiborne, Ph.D.        
         
/s/ JENNIFER SIMPSON   Chair of the Board   March 20, 2023
Jennifer Simpson, Ph.D.        
         
/s/ JOEL CALDWELL   Director   March 20, 2023
Joel Caldwell        

 

73

 

 

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

 

LadRx Corporation  
Reports of Independent Registered Public Accounting Firm (PCAOB ID No. 572) F- 2
Consolidated Balance Sheets F- 3
Consolidated Statements of Operations F- 4
Consolidated Statements of Stockholders’ Equity (Deficit) F- 5
Consolidated Statements of Cash Flows F- 6
Notes to Consolidated Financial Statements F- 7

 

F-1

 

 

Report of Independent Registered Public Accounting Firm

 

Board of Directors and Stockholders

LadRx Corporation

Los Angeles, California

 

Opinion on the Consolidated Financial Statements

 

We have audited the accompanying consolidated balance sheets of LadRx Corporation (the “Company”) and subsidiary as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’ equity (deficit), and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company and its subsidiary as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

 

Going Concern

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has no recurring source of revenue, has incurred recurring operating losses and negative operating cash flows since inception and has an accumulated deficit at December 31, 2022. These matters raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1 to the consolidated financial statements. These consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Basis for Opinion

 

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

 

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

Critical Audit Matter

 

Critical audit matters are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.

 

We have served as the Company’s auditor since 2019.

 

/s/ Weinberg & Company

 

Los Angeles, California

 

March 20, 2023

 

F-2

 

 

LADRX CORPORATION

CONSOLIDATED BALANCE SHEETS

 

   2022   2021 
   December 31, 
   2022   2021 
         
ASSETS          
Current assets:          
Cash and cash equivalents  $1,374,992   $6,769,603 
Insurance claim receivable   —    200,000 
Prepaid expenses and other current assets   628,745    1,310,382 
Total current assets   2,003,737    8,279,985 
Equipment and furnishings, net   18,546    32,784 
Other assets   7,703    16,836 
Operating lease right-of-use assets   216,786    397,172 
Total assets  $2,246,772   $8,726,777 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)          
Current liabilities:          
Accounts payable  $975,944   $1,470,652 
Accrued expenses and other current liabilities   1,015,501    2,064,506 
Current portion of operating lease obligations   196,081    198,819 
Total current liabilities   2,187,526    3,733,977 
           
Operating lease liabilities, net of current portion   33,526    216,381 
           
Total liabilities   2,221,052    3,950,358 
           
Preferred Stock, Series C 10% Convertible, $1,000 par value, 2,752 and 8,240 shares issued and outstanding at December 31, 2022 and 2021, respectively   1,343,684    4,022,700 
           
Commitments and contingencies   -     -  
Stockholders’ equity (deficit):          
Preferred Stock, $0.01 par value, 833,333 shares authorized, including 50,000 shares of Series B Junior Participating Preferred Stock; no shares issued and outstanding at December 31, 2022 and 2021, respectively   —    — 
Common stock, $0.001 par value, 62,393,940 shares authorized; 45,037,391 and 38,780,038 shares issued and outstanding at December 31, 2022 and 2021, respectively   45,037    38,780 
Additional paid-in capital   487,474,664    484,790,650 
Accumulated deficit   (488,837,665)   (484,075,711)
Total stockholders’ equity (deficit)   (1,317,964)   753,719 
Total liabilities and stockholders’ equity (deficit)  $2,246,772   $8,726,777 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

F-3

 

 

LADRX CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

 

   2022   2021 
   Years Ended December 31, 
   2022   2021 
Revenue:          
Licensing revenue  $—   $— 
           
Expenses:          
General and administrative   4,545,884    5,966,415 
Settlement with former Chief Executive Officer   —    6,096,597 
Depreciation and amortization   15,004    13,978 
Total operating expenses   4,560,888    12,076,990 
Loss from operations   (4,560,888)   (12,076,990)
Other income (expense):          
Liquidated damages expense   —    (1,109,653)
Forgiveness of accounts payable   351,241    — 
Interest income   11,689    16,822 
Other income (expense), net   (2,615)   (6,842)
           
Net Loss   (4,200,573)   (13,176,663)
           
Dividends paid on preferred shares   (561,381)   (171,668)
           
Net loss attributable to common stockholders  $(4,761,954)   (13,348,331)
Basic and diluted loss per share  $(0.11)  $(0.35)
Basic and diluted weighted average shares outstanding   43,359,233    37,584,695 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

F-4

 

 

LADRX CORPORATION

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

 

   Series B Preferred Shares Issued   Shares of Common Stock Issued   Preferred Stock Amount   Common Stock Amount  

Additional

Paid-in

Capital

   Accumulated Deficit   Total 
Balance at January 1, 2021   —    36,480,038    —   $36,480    479,561,860   $(470,727,380)  $8,870,960 
Issuance of common stock and preferred investment options   —    2,000,000    —    2,000    5,151,090    —    5,153,090 
Exercise of stock options   —    300,000    —    300    77,700    —    78,000 
Preferred dividend   —    —    —    —    —    (171,668)   (171,668)
Net loss   —    —    —         —    (13,176,663)   (13,176,663)
Balance at December 31, 2021   —    38,780,038    —    38,780    484,790,650    (484,075,711)   753,719 
                                    
Issuance of common stock upon conversion of preferred shares   —    6,235,949         6,236    2,672,780    —    2,679,016 
Exercise of stock options   —    21,404    —    21    (21)   —    — 
Preferred dividend   —    —    —    —    —    (561,381)   (561,381)
Issuance of restricted stock from compensation and services   —    —    —    —    11,255    —    11,255 
Net loss   —    —    —    —    —    (4,200,573)   (4,200,573)
Balance at December 31, 2022   —    45,037,391        $45,037   $487,474,664   $(488,837,665)  $(1,317,964)

 

The accompanying notes are an integral part of these consolidated financial statements.

 

F-5

 

 

LADRX CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

    2022     2021  
    Years Ended December 31,  
    2022     2021  
Cash flows from operating activities:                
Net loss from operations   $ (4,200,573 )   $ (13,176,663 )
                 
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization     15,004       13,978  
Stock-based compensation expense     11,255       —  
Changes in assets and liabilities:                
Insurance receivable     200,000       125,105  
Prepaid expenses and other current assets     681,637       (215,707 )
Reduction of right of-use assets     180,386       183,306  
Accounts payable     (494,708)       68,598  
Other assets     9,133       —  
Decrease in lease liabilities     (185,593 )     (181,103 )
Accrued expenses and other current liabilities     (1,049,005)       873,596  
Net cash used in operating activities     (4,832,464 )     (12,308,890 )
                 
Cash flows from investing activities:                
Purchases of equipment and furnishings     (766 )     (7,004 )
Net cash used in investing activities     (766 )     (7,004 )
                 
Cash flows from financing activities:                
Net proceeds from Security Purchase Agreement     —       9,175,790  
Preferred stock dividend     (561,381 )     (171,668)  
Proceeds from the exercise of stock options     —       78,000  
Net cash (used in ) provided by financing activities     (561,381)       9,082,122  
                 
Net decrease in cash and cash equivalents     (5,394,611 )     (3,233,772 )
Cash and cash equivalents at beginning of year     6,769,603       10,003,375  
Cash and cash equivalents at end of year   $ 1,374,992     $ 6,769,603  
                 
Supplemental disclosures of Cash Flow Information:                
                 
Insurance claims to offset accounts payable   $ —     $ 200,000  

 

The accompanying notes are an integral part of these consolidated financial statements.

 

F-6

 

 

LADRX CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021

 

1. Nature of Business

 

LadRx Corporation (“LadRx” or the Company) is a biopharmaceutical research and development company specializing in oncology. The Company’s focus is on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel technologies that target chemotherapeutic drugs to solid tumors and reduce off-target toxicities. However, the Company’s research and development activities have been curtailed as they seek additional financing. During 2017, the Company’s discovery laboratory in Freiburg, Germany synthesized and tested over 75 rationally designed drug candidates with highly potent anti-cancer payloads, culminating in the creation of two distinct classes of compounds. Four lead candidates (LADR-7 through LADR-10) were selected based on in vitro and animal studies in several different cancer models, and based on stability and manufacturing feasibility. In addition, a novel companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates.

 

On June 1, 2018, the Company launched Centurion BioPharma Corporation (“Centurion”), a private subsidiary, and transferred all of its assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection with said transfer, the Company and Centurion entered into a Management Services Agreement whereby the Company agreed to render advisory, consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the Company for the cost of such services plus a 5% service charge. On December 21, 2018, LadRx announced that Centurion had concluded the pre-clinical phase of development for its four LADR™ drug candidates, and for its albumin companion diagnostic (ACDx™). As a result of completing this work, operations taking place at the pre-clinical laboratory in Freiburg, Germany were no longer needed and, accordingly, the lab was closed at the end of January 2019.

 

On March 9, 2022, Centurion merged with and into LadRx, with LadRx absorbing all of Centurion’s assets and continuing after the merger as the surviving entity (the “Merger”). The Merger was implemented through an agreement and plan of merger pursuant to Section 253 of the General Corporation Law of the State of Delaware and did not require approval from either our or Centurion’s stockholders. The Certificate of Ownership merging Centurion into LadRx was filed with the Secretary of State of Delaware on March 9, 2022.

 

Effective September 26, 2022, the Company changed its name from CytRx Corporation to LadRx Corporation pursuant to a Certificate of Amendment to our Certificate of Incorporation filed with the Secretary of State of Delaware. In accordance with the General Corporation Law of the State of Delaware (the “DGCL”), its board of directors approved the name change and the Certificate of Amendment. Pursuant to Section 242(b)(1) of the DGCL, stockholder approval was not required for the name change or the Certificate of Amendment.

 

We are a Delaware corporation, incorporated in 1985. Our corporate offices are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles, California 90049, and our telephone number is (310) 826-5648. Our web site is located at http://www.ladrxcorp.com. We do not incorporate by reference into this Annual Report the information on, or accessible through, our website, and you should not consider it as part of this Annual Report.

 

LADR Drug Discovery Platform and Centurion

 

The LADR Technology Offers the Opportunity for multiple pipeline drugs. The Company’s LADR™ (Linker Activated Drug Release) technology platform consists of an organic backbone that is attached to a chemotoxic agent. The purpose of the LADR™ backbone is to first target and deliver the chemotoxic agent to the tumor environment, and then to release the chemotoxic agent within the tumor. By delivering, concentrating, and releasing the chemotoxic agent within the tumor, one expects to reduce the off-target side-effects of the chemotherapeutic, which in turn allows for several-fold higher dosing of the chemotherapeutic to the patient. Being small organic molecules, the Company expects LADR-based drugs to offer the benefits of targeting the tumor without the complexity, side effects, and expense inherent in macromolecules such as antibodies and nanoparticles.

 

F-7

 

 

The Company’s LADR-based drugs use circulating albumin as the binding target and as the trojan horse to deliver the LADR™ drugs to the tumor. Albumin is the most abundant protein in plasma and accumulates inside tumors due to the aberrant vascular structure that exists within solid tumors. Tumors use albumin as a nutritional source and for transport of signaling and other molecules that are important to the maintenance and growth of the tumor, which makes albumin an excellent target for drugs that are intended for solid tumors.

 

The Company’s LADR™ development efforts are focused on two classes of ultra-high potency albumin-binding drugs. These LADR-based drugs, LADR7, 8, 9, and 10, combine the proprietary LADR™ backbone with novel derivatives of the auristatin and maytansinoid drug classes. Auristatin and maytansinoid are highly potent chemotoxins, and require targeting to the tumor for safe administration to humans, as is the case for the FDA-approved drugs Adcetris (auristatin antibody-drug-conjugate by Seagen) and Kadcyla (maytansine antibody-drug-conjugate by Genentech). We believe that LADR-based drugs offer the benefits of tumor targeting without the disadvantages of antibodies and other macromolecules, which include expense, complexity, and negative side effects. Additionally, albumin is a very well-characterized drug target, which we believe will reduce clinical and regulatory costs and risks.

 

The Company’s postulated mechanism of action for LADR-based drugs is as follows:

 

  ● after administration, the linker portion of the drug conjugate forms a rapid and specific covalent bond to the cysteine-34 position of circulating albumin;
  ● circulating albumin preferentially accumulates in tumors due to a mechanism called “Enhanced Permeability and Retention”, which results in lower exposure to the drug in noncancerous tissues of the heart, liver, and other organs;
  ● once localized at the tumor, the acid-sensitive linker of the LADR™ backbone is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and
  ● free active drug is then released within the tumor, causing tumor cell death.

 

The first-generation LADR-based drug is called aldoxorubicin. Aldoxorubicin is the drug doxorubicin attached to the first generation LADR™ backbone (LADRs 7-10 employ a next generation LADR™ backbone). Aldoxorubicin has been administered to over 600 human subjects in human clinical trials and has proven the concept of LADR™ in that several-fold more doxorubicin can be safely administered to patients when the doxorubicin is attached to LADR™ than when administered as native doxorubicin. Aldoxorubicin has been licensed to ImmunityBio, and is currently in a Phase II registrational intent trial for pancreatic cancer. Aldoxorubicin is expected to enter a Phase I/II trial for glioblastoma in 2022 or 2023.

 

The next generation LADR™ drugs are termed LADR7, 8, 9, and 10. A great deal of Investigational New Drug (“IND”) enabling work has already been accomplished on LADR7-10, including in-silico modeling, in-vitro efficacy testing in several different cancer models, in-vivo dosing, safety, and efficacy testing in several different cancer models in animals. We have also developed and proven manufacturability, an important step prior to beginning human clinical trials.

 

The IND-enabling work that remains prior to applying to the FDA for first-in-human studies for LADR7-10 is limited due to the extensive experimentation already completed. For example, in the case of LADR7, a manufacturing run under Good Manufacturing Practices (GMP) must be completed and some toxicology studies completed using the GMP material must be completed in animals. Toxicology studies with LADR7 have already been completed with non-GMP manufactured drug. Management estimates that these final IND-enabling activities for LADR7 would take approximately 12 months to complete, once funded and initiated, and that first-in-human dosing would be achieved within approximately 6-9 months after completion of the IND-enabling studies. Management further estimates that the cost to manufacture GMP material for one LADR™ drug, for example LADR7, complete all pre-IND studies, and to obtain an IND could be approximately $2M in direct costs, based on current estimates, representing a capital-efficient path to clinical entry.

 

F-8

 

 

Because the LADR™ backbone in future products would be the same as the LADR™ backbone in current product candidates, (i.e. the chemotoxin can be changed without changing the LADR™ backbone), management anticipates that future product candidates beyond LADR7-10 may enjoy abbreviated pre-clinical pathways to first-in-human. Such abbreviated pathways would be subject to FDA review and agreement.

 

The Company’s novel companion diagnostic, ACDx™ (albumin companion diagnostic) was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR™ lead assets. We have not yet determined whether the use of a companion diagnostic will be necessary or helpful, and plan to continue to investigate this question in parallel to the pre-clinical and clinical development of LADRs 7-10.

 

The LADR™ backbone and drugs that employ LADR™ are protected by domestic and international patents, and additional patents are pending.

 

Business Strategy for LADR™ Platform

 

Throughout 2022, with the assistance of oncology drug development experts, the Company has inventoried the IND-enabling data for LADRs 7-10, developed a strategy to complete the IND-enabling studies necessary for at least one LADR™ drug, and worked with vendors on establishing approximate time lines and costs to reach first-in-human dosing, inclusive of manufacturing, and completion of pre-IND studies and FDA filings, With this important groundwork completed, we believe that management is well situated to rapidly advance our next-generation LADR™ assets as soon as funding or partnering is achieved, and is working diligently to obtain funding and/or partnering of the LADR™ assets. Management will continue to explore in parallel both partnered and non-partnered funding and development strategies for LADR™ with a goal of obtaining the least costly capital possible to enable value inflection milestones.

 

Partnering of Aldoxorubicin

 

On July 27, 2017, the Company entered into an exclusive worldwide license with ImmunityBio, Inc. (formerly known as NantCell, Inc. (“ImmunityBio”)), granting to ImmunityBio the exclusive rights to develop, manufacture and commercialize aldoxorubicin in all indications, and the Company is no longer directly working on the development of aldoxorubicin. As part of the license agreement, ImmunityBio made a strategic investment of $13 million in LadRx common stock at $6.60 per share (adjusted to reflect our 2017 reverse stock split), a premium of 92% to the market price on that date. In connection therewith, the Company also issued ImmunityBio a warrant to purchase up to 500,000 shares of common stock at $6.60, which expired on January 26, 2019. The Company is entitled to receive up to an aggregate of $343 million in potential milestone payments, contingent upon achievement of certain regulatory approvals and commercial milestones. The Company is also entitled to receive ascending double-digit royalties for net sales for soft tissue sarcomas and mid to high single digit royalties for other indications. There can be no assurance that ImmunityBio will achieve such milestones, approvals or sales with respect to aldoxorubicin.

 

ImmunityBio is conducting an open-label, randomized, Phase 2 study of a combination of immunotherapy, aldoxorubicin and standard-of-care chemotherapy versus standard-of-care chemotherapy alone for the treatment of locally advanced or metastatic pancreatic cancer in patients who have had 1 or 2 lines of treatment (Cohorts A and B) or 3 or greater lines of treatment (Cohort C).

 

F-9

 

 

In January 2023, ImmunityBio announced positive results in its non-randomized fully-enrolled metastatic pancreatic cancer study in third-line or greater subjects (QUILT 88) showing that the overall survival rate for patients continues to be double compared to historical survival rates after two or more prior lines of therapy. The results were presented at the American Society of Clinical Oncology Gastrointestinal (ASCO GI) conference in San Francisco January 19-21, 2023. The median OS in this highly advanced group of patients, up to seven lines (N=83) of treatment, was 5.8 months (95% CI: 4.9, 6.4 months), exceeding the approximately 2- to 3-month historical median OS. In the third-line setting (N=41), the median OS in this group was 6.3 months (95% CI: 5.0, 7.2 months), more than doubling the historical OS. The baseline median CA 19-9 level (a marker of metastatic pancreatic disease) of the enrolled subjects (N=83) was very high at 4120 IU/ml, a significant increase from normal levels of 40 IU/ml. In subjects with CA 19-9 levels less than 4120 IU/ml (N=40), the median OS was 6.9 months (95% CI: 5.7,10.9).

 

In December 2022, Immunity Bio held a Type B meeting with the FDA to discuss the path for approval of this combination therapy for pancreatic cancer. The FDA advised ImmunityBio to conduct a randomized trial. This Phase 2, randomized, three-cohort, open-label study plans to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus low-dose chemotherapy in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and C, respectively, with Cohorts A and B having independent experimental and control arms. The primary objective of Cohorts A and B is progression-free survival (PFS) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS)

 

Aldoxorubicin has received Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (“FDA”) for the treatment of soft tissue sarcoma (“STS”). ODD provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other benefits.

 

ImmunityBio also lists ongoing clinical studies in glioblastoma; it is currently reviewing its options in STS.

 

Molecular Chaperone Assets (Orphayzme)

 

In 2011, LadRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme A/S (“Orphazyme”, formerly Orphazyme ApS) in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million in milestone payments upon the achievement of certain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any net sales of products derived from arimoclomol (the “2011 Arimoclomol Agreement”). Orphazyme transferred its rights and obligations under the 2011 Arimoclomol Agreement to KemPharm Denmark A/S (“KemPharm”), a wholly owned subsidiary of KemPharm Inc., in May 2022.

 

In May 2021, Orphazyme announced that the pivotal phase 3 clinical trial for arimoclomol in Amyotrophic Lateral Sclerosis did not meet its primary and secondary endpoints, reducing the maximum amount that LadRx currently has the right to receive under the 2011 Arimoclomol Agreement to approximately $100 million. Orphazyme also tested arimoclomol in Niemann-Pick disease Type C (“NPC”) and Gaucher disease, and following a Phase II/III trial submitted to the FDA a New Drug Application for the treatment of NPC with arimoclomol. On June 18, 2021, Orphazyme announced it had received a complete response letter (the “Complete Response Letter”) from the FDA indicating the need for additional data. In late October 2021, Orphazyme announced it held a Type A meeting with the FDA, at which the FDA recommended that Orphazyme submit additional data, information and analyses to address certain topics in the Complete Response Letter and engage in further interactions with the FDA to identify a pathway to resubmission. The FDA concurred with Orphazyme’s proposal to remove the cognition domain from the NPC Clinical Severity Scale (“NPCCSS”) endpoint, with the result that the primary endpoint is permitted to be recalculated using the 4- domain NPCCSS, subject to the submission of additional requested information which Orphazyme had publicly indicated that it intended to provide. To bolster the confirmatory evidence already submitted, the FDA affirmed that it would require additional in vivo or pharmacodynamic (PD)/pharmacokinetic (PK) data. Orphazyme planned to request a Type C Meeting with the FDA in the second quarter of 2022. Subject to discussions with the regulatory body, Orphazyme had publicly indicated that it planned to resubmit the NDA for arimoclomol in the second half of 2022.

 

F-10

 

 

Orphazyme had also submitted a Marketing Authorization Application (“MAA”) with the European Medicines Agency (the “EMA”). In February 2022, Orphazyme announced that although they had received positive feedback from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA, they were notified by the CHMP of a negative trend vote on the MAA for arimoclomol for NPC following an oral explanation. In March 2022 Orphazyme removed its application with the EMA. Orphazyme has publicly indicated that it will assess its strategic options and provide an update to the market at the applicable time.

 

On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately $5.2 million to KemPharm, a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (“CNS”) diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties on sales, were assumed by KemPharm. KemPharm is expected to continue the early access programs with arimoclomol, and to continue to pursue the potential approval of arimoclomol as a treatment option for NPC. KemPharm indicated it plans on resubmitting the NDA for arimoclomol in the first quarter of 2023. In February, 2023, KemPharm published positive data based on the recent completion of their four-year open-label safety trial that indicated arimoclomol may reduce the long-term progression of NPC. They plan on including these data as part of the updated NDA resubmission. It is also identifying a regulatory path forward with the EMA. KemPharm has recently re-branded to Zevra Therapeutics, Inc.

 

Going Concern

 

The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. During the year ended December 31, 2022, the Company incurred a net loss of $4.2 million, utilized cash in operations of $4.8 million, and the Company had a stockholders deficit of $1.3 million as of December 31, 2022. In addition, the Company has no recurring revenue. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

In order to fund our business and operations, we have relied primarily upon sales of our equity securities, including proceeds from the exercise of stock options and common stock purchase warrants and long-term loan financing. We also have received limited funding from our strategic partners and licensees. We will ultimately be required to obtain additional funding in order to execute our long-term business plans, although we do not currently have commitments from any third parties to provide us with long term debt or capital. We cannot assure that additional funding will be available on favorable terms, or at all. If we fail to obtain additional funding when needed, we may not be able to execute our business plans and our business may suffer, which would have a material adverse effect on our financial position, results of operations and cash flows. We have approximately $1.2 million of contractual obligations in 2023 and expect to pay these out of the Company’s balance sheet cash. We have a total of approximately $1.9 million of material contractual obligations beyond 2023.

 

If ImmunityBio obtains marketing approval and successfully commercializes aldoxorubicin, we anticipate it will take two years, and possibly longer, for us to generate significant recurring revenue, and we will be dependent on future financing until such time, if ever, as we can generate significant recurring revenue. There are also no certainties that KemPharm will be successful in obtaining FDA and EMA approval for arimoclomol or choose to commercialize arimoclomol. We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern. If we raise additional funds by issuing equity securities, dilution to stockholders may result and new investors could have rights superior to some or all of our existing equity holders. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available to us, we may have to liquidate some or all of our assets or to delay or reduce the scope of or eliminate some portion or all of our development programs or clinical trials.

 

Current Business Strategy

 

Currently, the Company is working on identifying partnership or financing opportunities for LADR™ ultra-high potency drug conjugates and their albumin companion diagnostic. We have concluded all research and development on LADR and its companion diagnostic and continue to focus on identifying these partnership or financing opportunities.

 

2. Summary of Significant Accounting Policies

 

Basis of Presentation and Principles of Consolidation — The accompanying Consolidated Financial Statements are prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and accounting principles generally accepted in the United States (“GAAP”). The Consolidated Financial Statements include the accounts of LadRx Corporation and its wholly-owned subsidiary. All intercompany accounts are eliminated.

 

F-11

 

 

Revenue Recognition — Revenue consists of license fees from strategic alliances with pharmaceutical companies. During the years ended December 31, 2022 and 2021, no revenue was earned from license fees.

 

Cash Equivalents — The Company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. Cash equivalents consist primarily of amounts invested in certificates of deposit and money market accounts.

 

Equipment and Furnishings — Equipment and furnishings are stated at cost and depreciated using the straight-line method based on the estimated useful lives (generally three to five years for equipment and furniture) of the related assets. Whenever there is a triggering event that might suggest impairment, management evaluates the realizability of recorded long-lived assets to determine whether their carrying values have been impaired. The Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that the assets might be impaired and the non-discounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Any impairment loss is measured by comparing the fair value of the asset to its carrying amount.

 

Insurance recoveries — The Company has several policies with insurance underwriters that provide for the recovery of certain costs incurred by the Company. The Company’s policy is to record any liability as incurred, and then to record the estimated recovery from the insurance company for that cost as a receivable in accordance with terms of its existing policies. As of December 31, 2021, there were $200,000 of insurance recoveries that were collected in 2022. As of December 31, 2022, there were no amounts recoverable from its insurance company carriers under the terms of its policies.

 

Fair Value Measurements — Assets and liabilities recorded at fair value on the consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure the fair value. Level inputs are as follows:

 

Level 1 – quoted prices in active markets for identical assets or liabilities.

 

Level 2 – other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.

 

Level 3 – significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.

 

The Company considers carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments.

 

Patents and Patent Application Costs — Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are therefore expensed as incurred.

 

Net Income (Loss) Per Share of Common Stock — Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted earnings per share is computed by dividing the net income applicable to common stockholders by the weighted average number of shares of common stock outstanding plus the number of additional shares of common stock that would have been outstanding if all dilutive potential shares of common stock had been issued using the treasury stock method. Potential shares of common stock are excluded from the computation when their effect is antidilutive. The dilutive effect of potentially dilutive securities is reflected in diluted net income per share if the exercise prices were lower than the average fair market value of common stock during the reporting period.

 

F-12

 

 

 

   2022   2021 
   As of December 31, 
   2022   2021 
     
Options to acquire common stock   1,765,108    2,827,820 
Warrants to acquire common stock   4,167    4,167 
Convertible preferred stock   3,127,689    9,363,637 
Preferred investment option   11,363,637    11,363,637 
Shares excluded from computation of diluted loss per share   16,260,601    23,559,261 

 

Potentially dilutive stock options, warrants and securities from the table above were excluded from the computation of diluted net income (loss) per share, because the effect would be anti-dilutive.

 

Stock-based Compensation — The Company accounts for share-based awards to employees and nonemployees directors and consultants in accordance with the provisions of ASC 718, Compensation—Stock Compensation., and under the recently issued guidance following FASB’s pronouncement, ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Under ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur.

 

Research and Development Expenses — Research and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including licenses and drugs, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology developed for use in its products is expensed as incurred until technological feasibility has been established.

 

Income Taxes — The Company accounts for income taxes in accordance with the provisions of FASB ASC 740-10, Income Taxes, (“ASC 740”) which requires the recognition of deferred tax assets and liabilities for taxable temporary differences and deferred tax assets for deductible temporary differences and operating loss carry-forwards using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit or expense is recognized as a result of changes in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all of any deferred tax assets will not be realized.

 

The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expenses.

 

Concentrations of Risks — Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and short-term investments. The Company maintains cash and cash equivalents in large well-capitalized financial institutions and the Company’s investment policy disallows investment in any debt securities rated less than “investment-grade” by national ratings services. The Company has not experienced any losses on its deposits of cash or cash equivalents or its short-term investments. Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances.

 

Use of Estimates — Preparation of the Company’s consolidated financial statements in conformance with U.S. GAAP requires the Company’s management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The significant estimates in the Company’s consolidated financial statements relate to the valuation of equity awards, recoverability of deferred tax assets, insurance claims and estimated useful lives of fixed assets. The Company bases estimates and assumptions on historical experience, when available, and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis, and its actual results may differ from estimates made under different assumptions or conditions.

 

F-13

 

 

New Accounting Pronouncements — In June 2016, the FASB issued ASU No. 2016-13, Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”). The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The standard is effective for interim and annual reporting periods beginning after December 15, 2022. The adoption of ASU 2016-13 is not expected to have a material impact on the Company’s financial position, results of operations, and cash flows.

 

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. Early adoption is permitted, including adoption in an interim period. If an entity elects to early adopt ASU 2021-04 in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The adoption of ASU 2021-04 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

Other recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission (“SEC”) did not, or are not expected to, have a material impact on the Company’s consolidated financial statements and related disclosures.

 

3. Foreign Currency Remeasurement

 

The U.S. dollar has been determined to be the functional currency for the net assets of the Company’s German operations. The transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and current exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). The Company recognized a loss of approximately $(2,889) and $(22,440) for the years ended December 31, 2022 and 2021, respectively.

 

As of December 31, 2022 and 2021, the Company’s cash balances consisted of the following:

 

   2022   2021 
U.S. Dollars  $1,374,992   $6,671,404 
Euros – in US $   —    98,199 
Cash Balance  $1,374,992   $6,769,603 

 

4. Equipment and Furnishings

 

Equipment and furnishings at December 31, 2022 and 2021 consist of the following:

 

   2022   2021 
Equipment and furnishings  $48,742   $59,728 
Less — accumulated depreciation   (30,196)   (26,944)
Equipment and furnishings, net  $18,546   $32,784 

 

Depreciation and amortization expense for the years ended December 31, 2022 and 2021 were $15,004 and $13,978, respectively. During the year ended December 31, 2022, fully depreciated equipment and furnishings of $11,752 were written off.

 

F-14

 

 

5. Accrued Expenses and Other Current Liabilities

 

Accrued expenses and other current liabilities at December 31, 2022 and 2021 are summarized below.

 

   2022   2021 
Professional fees  $77,785   $208,345 
Liquidated damages– see Note 7   —    615,253 
Payable to former CEO   50,191    256,115 
Wages, bonuses and employee benefits   152,990    261,375 
Royalties and milestones   716,155    716,155 
Other   18,380    7,263 
Total  $1,015,501   $2,064,506 

 

6. Leases

 

We lease office space and office copiers related primarily to the Company’s administrative activities. The Company accounts for leases under ASC 842, Leases, which requires an entity to recognize a right-of-use asset and a lease liability for virtually all leases.

 

In January 2020, the Company signed a new four-year office lease which covers approximately 2,771 square feet of office and storage space. This lease is effective March 1, 2020 and extends through February 29, 2024, with a right to extend the term for an additional five-year period, subject to the terms and conditions set forth in the lease agreement. The monthly rent is $14,340, subject to annual increases of 3.5 percent. In February 2020, the Company renewed its additional storage space lease, which requires us to make monthly payments of $1,405, subject to a 2.5 percent annual increase. The Company recorded a right of use asset and lease liability obligation of $715,310 upon inception of these leases. The Company also reclassified a previously existing right-of-use asset of $66,271 from other assets to right-of-use asset.

 

As of December 31, 2022, the balance of right-of-use assets was approximately $216,800, and the balance of total lease liabilities was approximately $229,600.

 

Future minimum lease payments under non-cancelable operating leases under ASC 842 as of December 31, 2022 are as follows:

 

  

Operating

Lease Payments

 
     
Jan 2023 – Dec 2023  $200,927 
Jan 2024 – Dec 2024   33,673 
Total future minimum lease payments   234,600 
      
Less: present value adjustment   (4,993)
Operating lease liabilities at December 31, 2022   229,607 
Less: current portion of operating lease liabilities   (196,081)
Operating lease liabilities, net of current portion  $33,526 

 

F-15

 

 

The components of rent expense and supplemental cash flow information related to leases for the period are as follows:

 

  

Year Ended

December 31, 2022

 
Lease Cost     
      
Operating lease cost (included in General and administrative expenses in the Company’s Consolidated Statements of Operations)  $197,154 
      
Other information     
      
Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2022  $180,786 
      
Weighted average remaining lease term – operating leases (in years)   1.2 
      
Average discount rate   3.5%

 

7. Financing Under Security Purchase Agreement

 

On July 13, 2021, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional investor (the “Investor”) for aggregate gross proceeds of $10 million and net proceeds of approximately $9.2 million. The transaction closed on July 16, 2021. Under the Purchase Agreement, the Company sold and issued (i) 2 million shares of its common stock at a purchase price of $0.88 per share for total gross proceeds of approximately $1.76 million in a registered direct offering (the “Registered Direct Offering”) and (ii) 8,240 shares of Series C 10.00% Convertible Preferred Stock (the “Preferred Stock”) at a purchase price of $1,000 per share, for aggregate gross proceeds of approximately $8.24 million, in a concurrent private placement (the “Private Placement” and, together with the Registered Direct Offering, the “July 2021 Offerings”). The shares of the Preferred Stock are convertible, upon shareholder approval as described below, into an aggregate of up to 9,363,637 shares of common stock at a conversion price of $0.88 per share. Holders of the Preferred Stock shall be entitled to receive, and the Company shall pay, cumulative dividends at the rate per share (as a percentage of the stated value per share) of 10.00% per annum, payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the date of issuance. The terms of the Preferred Stock include beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock. LadRx also issued to the Investor an unregistered preferred investment option (the “Preferred Investment Option”) that allows for the purchase of up to 11,363,637 shares of common stock for additional gross proceeds of approximately $10 million if the Preferred Investment Option is exercised in full. The exercise price for the Preferred Investment Option is $0.88 per share. The Preferred Investment Option has a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval.

 

The Company accounted for these transactions as a single transaction for accounting purposes and allocated total proceeds to the respective instruments based upon the relative fair value of each instrument. The Company determined that the relative fair value of (i) the 2,000,000 shares of the common stock issued was $859,218, (ii) the relative fair value of the 8,240 shares of Preferred Stock was $4,022,700, and (iii) the relative fair value of the Preferred Investment Option was $4,293,872 based upon a Black Scholes valuation model. As such, the Company recorded as Additional Paid in Capital the fair value of the common stock and Preferred Investment Option of $5,153,090, and the fair value of the Series C Preferred Stock was $4,022,700 which has been reflected as mezzanine (temporary equity) due to certain clauses of the Securities Purchase Agreement.

 

On October 1, 2021, the Company paid a quarterly 10% dividend to the Investor in the amount of $171,668. In 2022, the Company paid the following dividends: on January 1, 2022, $206,000, on April 1, 2022, $202,567, on July 1, 2022, $84,005 and on October 1, 2022, $68,809 for a total of $561,381.

 

On March 15, 2022, at a special meeting of its stockholders which was originally opened and subsequently adjourned on September 23, 2021, the Company’s stockholders, by an affirmative vote of the majority of the Company’s outstanding shares of capital stock, approved the amendment to the Company’s Restated Certificate of Incorporation to effect an increase in the number of shares of authorized common stock, par value $0.001 per share, from 41,666,666 shares to 62,393,940 shares, and to make a corresponding change to the number of authorized shares of capital stock in order to comply with the Company’s contractual obligations under the Purchase Agreement.

 

F-16

 

 

On March 28, 2022, the Investor converted 4,120 shares of the Series C Preferred Stock in accordance with the initial terms of the agreement and received 4,681,819 common shares. On May 15, 2022, the Investor converted a further 1,368 shares of the Series C Preferred Stock and received 1,554,130 common shares. As of December 31, 2022, there were 2,752 shares of Series C Preferred Stock outstanding, convertible into 3,127,689 shares of common stock.

 

Terms of Series C Preferred Stock

 

Under the Certificate of the Designations, Powers, Preferences and Rights of Series C 10.00% Convertible Preferred Stock (the “Certificate of Designations”), each share of Series C Preferred Stock will be convertible, subject to the Beneficial Ownership Limitation (as defined below), at either the holder’s option or at the Company’s option (a “Company Initiated Conversion”) at any time following stockholder approval having been obtained to amend our restated certificate of incorporation to increase the number of authorized shares of common stock above 41,666,666 (the “Stockholder Approval”), into common stock at a conversion rate equal to the quotient of (i) the Series C Stated Value of $1,000 (the “Series C Stated Value”) plus, in the case of a Company Initiated Conversion, all accrued and accumulated and unpaid dividends on such share of Series C Preferred Stock, divided by (ii) the initial conversion price of $0.88, subject to specified adjustments for stock splits, stock dividends, reclassifications or other similar events as set forth in the Certificate of Designations.

 

The Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of common stock upon conversion that would result in the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of common stock outstanding immediately after giving effect to the conversion (the “Beneficial Ownership Limitation”), except that upon notice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of common stock after converting the holder’s shares of Series C Preferred Stock, provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of outstanding shares of the common stock outstanding immediately after giving effect to the issuance of shares of common stock upon conversion of the shares of Series C Preferred Stock held by the holder and provided that any increase in the Beneficial Ownership Limitation shall not be effective until 61 days following notice to the Company

 

Each holder of shares of Preferred Stock is entitled to receive dividends, commencing from the date of issuance of the Preferred Stock. Such dividends may be paid only when, as and if declared by the Board of Directors of the Company (the “Board”), out of assets legally available therefore, quarterly in arrears on the first day of January, April, July and October in each year, commencing on the date of issuance, at the dividend rate of 10.00% per year. Such dividends are cumulative and continue to accrue on a daily basis whether or not declared and whether or not we have assets legally available therefore.

 

Under the Certificate of Designations, each share of Series C Preferred Stock carries a liquidation preference equal to the Series C Stated Value plus accrued and unpaid and accumulated dividends thereon. Such liquidation preference is payable upon certain change in control transactions and accordingly, this instrument is classified as mezzanine (temporary equity).

 

The holders of the Series C Preferred Stock may vote their shares of Preferred Stock on an as-converted basis, subject to the Beneficial Ownership Limitation (which Beneficial Ownership Limitation shall be calculated on a basis which includes the number of shares of common stock which are issuable upon conversion of the unconverted Series C Stated Value beneficially owned by a holder or any of its affiliates or attribution parties on all matters submitted to the holders of common stock for approval). The Company may not take the following actions without the prior consent of the holders of at least a majority of the Preferred Stock then outstanding: (a) alter or change adversely the powers, preferences or rights given to the Preferred Stock or alter or amend the Certificate of Designations, (b) authorize or create any class of stock ranking as to dividends, redemption or distribution of assets upon a Liquidation (as defined in the Certificate of Designations) senior to, or otherwise pari passu with, the Preferred Stock, (c) amend its Certificate of Incorporation or other charter documents in any manner that adversely affects any rights of the holders of the Preferred Stock, (d) increase the number of authorized shares of Preferred Stock, or (e) enter into any agreement with respect to any of the foregoing.

 

F-17

 

 

Terms of Preferred Investment Option

 

The Preferred Investment Option to purchase up to 11,363,637 shares of common stock is exercisable at a price of $0.88 per share. The Preferred Investment Option have a term of five and one-half years from the Authorized Share Increase Date. The holders of the Preferred Investment Option may exercise the Preferred Investment Option on a cashless basis, solely to the extent there is no effective registration statement registering, or the prospectus in such registration statement is not available for the resale of the shares of common stock issuable at the time of exercise. The Company is prohibited from effecting an exercise of any Preferred Investment Option to the extent that such exercise would result in the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of common stock outstanding immediately after giving effect to the exercise of the Preferred Investment Options by the holder (the “PIO Beneficial Ownership Limitation”), except that upon notice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of Common Stock after exercising the holder’s Preferred Investment Option, provided that the PIO Beneficial Ownership Limitation in no event exceeds 9.99% of the number of outstanding shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of common stock upon exercise of the Preferred Investment Option held by the holder and provided that any increase in the PIO Beneficial Ownership Limitation shall not be effective until 61 days following notice to the Company. The Preferred Investment Option provides for a Black-Scholes payout upon certain fundamental change transactions relating to the Company, as specified therein. If the fundamental change transaction is within the control of the Company, the payout will be in cash. Otherwise, the payout will be in the same form of consideration received by the common stockholders as a result of this transaction.

 

Registration Rights Agreement

 

In connection with the July 2021 Offerings, the Company entered into a registration rights agreement, dated as of July 13, 2021 (the “Registration Rights Agreement”), with the investor named therein, pursuant to which the Company will undertake to file, within five calendar days of the date of the filing of the proxy statement seeking the Stockholder Approval, a resale registration statement to register the shares of common stock issuable upon: (i) the conversion of the Preferred Stock sold in the Private Placement and (ii) the exercise of the Preferred Investment Option (the “Registrable Securities”); and to cause such registration statement to be declared effective under the Securities Act as promptly as possible after the filing thereof, but in any event no later than 75 days following the pricing date of this offering, or no later than 105 days following such date in the event of a “full review” by the SEC, and shall use its reasonable best efforts to keep such registration statement continuously effective under the Securities Act until the date that all Registrable Securities covered by such registration statement have been sold or are otherwise able to be sold pursuant to Rule 144. The Registration Rights Agreement provided for liquidated damages to the extent that the Company does not file or maintain a registration statement in accordance with the terms thereof. The registration rights agreement entered into between us and the Investor on July 13, 2021, contains a triggering event which would require us to pay to any holder of the Preferred Stock an amount in cash, as partial liquidated damages and not as a penalty, on a monthly basis equal to the product of 2.0% multiplied by the aggregate subscription amount paid by such holder for shares of Preferred Stock pursuant to the Purchase Agreement; provided, however, that such partial liquidated damages shall not exceed 24% of the aggregate subscription amounts paid by such holders pursuant to the Purchase Agreement, or $1,977,600. If we fail to pay any partial liquidated damages within seven days after the date payable, we will be required to pay interest on any such amounts at a rate equal to the lesser of 18% per annum or the maximum rate permitted by applicable law.

 

During the year ended December 31, 2021, the Company did not have enough authorized shares to issue the issuable shares under the Preferred Stock and Preferred Investment Option. The Company attempted, but was unsuccessful, to obtain stockholders’ approval for the increase in authorized shares, and accordingly, the Company was unable to meet its registration rights obligation as of December 31, 2021. As such, the Company recognized an aggregate of approximately $1.1 million in liquidated damages during the year ended December 31, 2021, of which includes a provision of $615,123 as an accrual for estimated damages until stockholders’ approval is achieved and the Registration Statement is filed. On March 15, 2022, the Company received its stockholders’ approval to increase its authorized shares and filed a certificate of amendment to its Certificate of Incorporation to increase the number of authorized shares from 41,666,666 shares to 63,227,273 shares on the same date. The Company filed its registration statement registering the shares underlying the Registrable Securities on March 23, 2022 and has provided for liquidated damages through that date. As of December 31, 2022, all liquidated damages had been paid and we no longer have any liabilities related to the Registration Rights Agreement.

 

F-18

 

 

8. Series D Preferred Stock

 

On May 19, 2022, the Board declared a dividend of one one-thousandth of a share of Series D Preferred Stock, par value $0.01 per share (“Series D Preferred Stock”), for each outstanding share of Company’s Common Stock to stockholders of record at 5:00 p.m. Eastern Time on May 20, 2022. The Certificate of Designation of Series D Preferred Stock (the “Series D Certificate of Designation”) provides that all shares of Series D Preferred Stock that are not present in person or by proxy at any meeting of stockholders held to vote on the Reverse Stock Split (as defined in the Series D Certificate of Designation) and the Adjournment Proposal (as defined in the Series D Certificate of Designation) as of immediately prior to the opening of the polls at such meeting (the “Initial Redemption Time”) will automatically be redeemed in whole, but not in part, by the Company at the Initial Redemption Time without further action on the part of the Company or the holder of shares of Series D Preferred Stock (the “Initial Redemption”). Any outstanding shares of Series D Preferred Stock that have not been redeemed pursuant to an Initial Redemption will be redeemed in whole, but not in part, (i) if such redemption is ordered by the Board in its sole discretion, automatically and effective on such time and date specified by the Board in its sole discretion or (ii) automatically upon the approval by the Company’s stockholders of the Reverse Stock Split at any meeting of the stockholders held for the purpose of voting on such proposal (the “Subsequent Redemption”).

 

On July 27, 2022, at the Company’s 2022 Annual Meeting of Stockholders, the Company’s stockholders approved a proposal to authorize the Board, in its discretion but prior to July 26, 2023, to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of all of the outstanding shares of the Company’s Common Stock, at a ratio in the range of 1-for-2 to 1-for-100, with such ratio to be determined by the Board, and all outstanding shares of Series D Preferred Stock were automatically redeemed. As a result, no shares of Series D Preferred Stock remain outstanding. The stock split is not yet effective as of the date of this filing.

 

9. Stock Compensation

 

Stock Options

 

The Company has a 2008 Stock Incentive Plan under which 5 million shares of common stock are reserved for issuance. As of December 31, 2022, there were approximately 1.3 million shares subject to outstanding stock options and approximately 0.8 million shares outstanding related to restricted stock grants issued from the 2008 Plan. This plan expired on November 20, 2018 and thus no further shares are available for future grant under this plan.

 

In November 2019, the Company adopted a 2019 Stock Incentive Plan under which 5.4 million shares of common stock are reserved for issuance. As of December 31, 2022, there were 0.5 million shares subject to outstanding stock options and 25,000 shares outstanding related to restricted stock grants from the 2019 Plan. This Plan expires on November 14, 2029.

 

All outstanding options issued to employees, directors and consultants were fully vested in 2020. As such, no further stock compensation expense was recognized during the year ended December 31, 2022 and 2021.

 

No stock options were issued to employees, directors and consultants in 2022 and 2021.

 

During the year ended December 31, 2022, options to acquire 50,000 shares of common stock were exercised on a cashless basis in exchange for 21,404 shares of common stock. During the year ended December 31, 2021, options to acquire 300,000 shares of common stock were exercised resulting in net proceeds of $78,000.

 

The following table sets forth the total stock-based compensation expense resulting from restricted stock included in our Consolidated Statements of Operations for the years ended December 31, 2022 and 2021:

 

   Years Ended December 31, 
   2022   2021 
General and administrative – employee  $11,255   $— 
Total employee stock-based compensation  $11,255   $— 

 

F-19

 

 

 

   Stock Options  

Weighted Average

Exercise Price

 
   2022   2021   2022   2021 
Outstanding — beginning of year   2,462,820    2,801,270   $7.68   $7.68 
Granted   —    —    —    — 
Exercised   (50,000)   (300,000)   0.26    0.26 
Forfeited   —    —    —    — 
Expired   (1,012,712)   (38,450)   10.67    14.62 
Outstanding — end of year   1,400,108    2,462,820    7.18    7.68 
Exercisable at end of year   1,400,108    2,462,820   $7.18   $7.68 
Weighted average fair value of stock options granted during the year:  $—   $—           

 

Presented below is the Company’s non-employee stock option activity:

 

   Stock Options  

Weighted Average

Exercise Price

 
   2022   2021   2022   2021 
Outstanding — beginning of year   365,000    365,000   $5.49   $5.49 
Granted   —    —    —    — 
Exercised   —    —   —    — 
Expired/Forfeited   —    —    —    — 
Outstanding — end of year   365,000    365,000    5.49    5.49 
Exercisable at end of year   365,000    365,000   $5.49   $5.49 
Weighted average fair value of stock options granted during the year:  $—   $—           

 

 

The following table summarizes significant ranges of outstanding stock options under the two plans at December 31, 2022:

 

Range of
Exercise
Prices		     Number of Options     Weighted-Average Remaining Contractual Life (years)     Weighted-Average Exercise Price     Number of Options Exercisable     Weighted-Average Remaining Contractual Life (years)     Weighted-Average Exercise Price  
$ 0.26 - $1.00       500,000       6.95     $ 0.26       500,000       6.95     $ 0.26  
$ 1.01 - $2.00       472,617       4.96     $ 1.75       472,617       4.96     $ 1.75  
$ 2.01 - $3.00       161,388             3.96     $ 2.58       161,388           3.96     $            2.58  
$ 3.01 - $41.46       631,103       2.16     $            16.93       631,103       2.16     $ 16.93  
          1,765,108       4.43     $ 6.83       1,765,108       4.43     $ 6.83  

 

There was no aggregate intrinsic value of the outstanding options and options vested as of December 31, 2022.

 

F-20

 

 

Restricted Stock

 

No restricted stock was granted in 2022. In December 2021, the Company granted to Jennifer Simpson, who serves on our Board of Directors, 25,000 shares of restricted common stock, pursuant to the 2019 Plan. This restricted stock vests on the first anniversary of the date of the grant. The fair value of the restricted stock is based on the market price of the Company’s shares on the grant date less the par value received as consideration. The fair value of the restricted stock on the grant date was $11,200. As of December 31, 2022, there is no unamortized stock compensation.

 

Equity-Classified Warrants

 

A summary of the Company’s warrant activity and related information for the years ended December 31, 2022 and 2021 are shown below.

 

   Warrants  

Weighted Average

Exercise Price

 
   2022   2021   2022   2021 
Outstanding — beginning of year   4,167    4,167   $33.60   $33.60 
Granted   —    —    —    — 
Exercised   —    —    —    — 
Forfeited   —    —    —    — 
Expired   —    —    —    — 
Outstanding — end of year   4,167    4,167    33.60    33.60 
Exercisable at end of year   4,167    4,167   $33.60   $33.60 
Weighted average fair value of warrants granted during the year:  $—   $—           

 

 

The outstanding warrants as of December 31, 2022 had no intrinsic value.

 

9. Stockholder Protection Rights Plan

 

On December 13, 2019, the Board of Directors of the Company, authorized and declared a dividend of one right (a “Right”) for each of the Company’s issued and outstanding shares of common stock, par value $0.001 per share. The dividend was paid to the stockholders of record at the close of business on December 23, 2019. Each Right entitled the registered holder, subject to the terms of the Original Rights Agreement (as defined below), to purchase from the Company one one-thousandth of a share of the Company’s Series B Junior Participating Preferred Stock, par value $0.01 per share (the “Preferred Stock”), at a price of $5.00 (the “Purchase Price”), subject to certain adjustments. The description and terms of the Rights were set forth in the Rights Agreement, dated as of December 13, 2019 (the “Original Rights Agreement”), by and between the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent (the “Rights Agent”).

 

On November 12, 2020, the Board approved an amendment and restatement of the Original Rights Agreement (as amended and restated, the “Amended and Restated Rights Agreement”) to effect certain changes to the Original Rights Agreement, including (i) reducing the duration to a term of three years, subject to certain earlier expiration as described in more detail below, and (ii) lowering the beneficial ownership threshold at which a person or group of persons becomes an Acquiring Person (as defined below) to 4.95% or more of the Company’s outstanding shares of Common Stock, subject to certain exceptions. The Amended and Restated Rights Agreement is designed to discourage (i) any person or group of persons from acquiring beneficial ownership of more than 4.95% of the Company’s shares of Common Stock and (ii) any existing stockholder currently beneficially holding 4.95% or more of the Company’s shares of Common Stock from acquiring additional shares of the Company’s Common Stock.

 

The purpose of the Amended and Restated Rights Agreement is to protect value by preserving the Company’s ability to utilize its net operating losses and certain other tax attributes (collectively, the “Tax Benefits”) to offset potential future income tax obligations. The Company’s ability to use its Tax Benefits would be substantially limited if it experiences an “ownership change,” as such term is defined in Section 382 of the Internal Revenue Code of 1986, as amended (the “Tax Code”). A corporation generally will experience an ownership change if the percentage of the corporation’s stock owned by its “5-percent shareholders,” as defined in Section 382 of the Tax Code, increases by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. The Amended and Restated Rights Agreement is intended to reduce the likelihood the Company would experience an ownership change under Section 382 of the Tax Code.

 

F-21

 

 

The Rights will not be exercisable until the earlier to occur of (i) the close of business on the tenth business day after a public announcement or filing that a person or group of affiliated or associated persons has become an “Acquiring Person,” which is defined as a person or group of affiliated or associated persons that, at any time after the date of the Amended and Restated Rights Agreement, has acquired, or obtained the right to acquire, beneficial ownership of 4.95% or more of the Company’s outstanding shares of Common Stock, subject to certain exceptions or (ii) the close of business on the tenth business day after the commencement of, or announcement of an intention to commence, a tender offer or exchange offer the consummation of which would result in any person becoming an Acquiring Person (the earlier of such dates being called the “Distribution Date”) (provided, however, that if such tender or exchange offer is terminated prior to the occurrence of the Distribution Date, then no Distribution Date shall occur as a result of such tender or exchange offer).

 

The Rights, which are not exercisable until the Distribution Date, will expire at or prior to the earliest of (i) the close of business on November 16, 2023; (ii) the time at which the Rights are redeemed pursuant to the Amended and Restated Rights Agreement; (iii) the time at which the Rights are exchanged pursuant to the Amended and Restated Rights Agreement; (iv) the time at which the Rights are terminated upon the occurrence of certain mergers or other transactions approved in advance by the Board; and (v) the close of business on the date set by the Board following a determination by the Board that (x) the Amended and Restated Rights Agreement is no longer necessary or desirable for the preservation of the Tax Benefits or (y) no Tax Benefits are available to be carried forward or are otherwise available (the earliest of (i), (ii), (iii), (iv) and (v) is referred to as the “Expiration Date”).

 

Each share of Preferred Stock will be entitled, when, as and if declared, to a preferential per share quarterly dividend payment equal to the greater of (i) $1.00 per share or (ii) an amount equal to 1,000 times the dividend declared per share of Common Stock. Each share of Preferred Stock will entitle the holder thereof to 1,000 votes on all matters submitted to a vote of the stockholders of the Company. In the event of any merger, consolidation or other transaction in which shares of Common Stock are converted or exchanged, each share of Preferred Stock will be entitled to receive 1,000 times the amount received per one share of Common Stock.

 

The Purchase Price payable, and the number of shares of Preferred Stock or other securities or property issuable, upon exercise of the Rights are each subject to adjustment from time to time to prevent dilution (i) in the event of a stock dividend on, or a subdivision, combination or reclassification of the Preferred Stock, (ii) upon the grant to holders of the Preferred Stock of certain rights or warrants to subscribe for or purchase Preferred Stock or convertible securities at less than the then-current market price of the Preferred Stock or (iii) upon the distribution to holders of the Preferred Stock of evidences of indebtedness or assets (excluding regular periodic cash dividends or dividends payable in Preferred Stock) or of subscription rights or warrants (other than those referred to above). The number of outstanding Rights and the number of one one-thousandths of a share of Preferred Stock issuable upon exercise of each Right are also subject to adjustment in the event of a stock split, reverse stock split, stock dividends and other similar transactions involving the Common Stock.

 

In the event that any person or group of affiliated or associated persons becomes an Acquiring Person, each holder of a Right, other than the Rights beneficially owned by the Acquiring Person, affiliates and associates of the Acquiring Person and certain transferees thereof (which will thereupon become null and void), will thereafter have the right to receive upon exercise of a Right that number of shares of Common Stock having a market value of two times the Purchase Price.

 

In the event that, after a person or a group of affiliated or associated persons has become an Acquiring Person, the Company is acquired in a merger or other business combination transaction, or 50% or more of the Company’s assets or earning power are sold, proper provision will be made so that each holder of a Right will thereafter have the right to receive, upon the exercise thereof at the then-current purchase price of the Right, that number of shares of common stock of the acquiring company having a market value at the time of that transaction equal to two times the Purchase Price.

 

F-22

 

 

With certain exceptions, no adjustment in the Purchase Price will be required unless such adjustment would require an increase or decrease of at least one percent (1%) in the Purchase Price. No fractional shares of Preferred Stock will be issued (other than fractions which are integral multiples of one one-thousandth of a share of Preferred Stock, which may, at the election of the Company, be evidenced by depositary receipts) and, in lieu thereof, an adjustment in cash will be made based on the market price of the Preferred Stock on the trading day immediately prior to the date of exercise.

 

At any time after any person or group of affiliated or associated persons becomes an Acquiring Person and prior to the acquisition of beneficial ownership by such Acquiring Person of 50% or more of the outstanding shares of Common Stock, the Board, at its option, may exchange each Right (other than Rights owned by such person or group of affiliated or associated persons which will have become void), in whole or in part, at an exchange ratio of one share of Common Stock per outstanding Right (subject to adjustment).

 

In connection with any exercise or exchange of the Rights, no holder of a Right will be entitled to receive shares of Common Stock if receipt of such shares would result in such holder, together with such holder’s affiliates and associates, beneficially owning more than 4.95% of the then-outstanding Common Stock (such shares, the “Excess Shares”) and the Board determines that such holder’s receipt of Excess Shares would jeopardize or endanger the value or availability of the Tax Benefits or the Board otherwise determines that such holder’s receipt of Excess Shares is not in the best interests of the Company. In lieu of such Excess Shares, such holder will only be entitled to receive cash or a note or other evidence of indebtedness with a principal amount equal to the then-current market price of the Common Stock multiplied by the number of Excess Shares that would otherwise have been issuable.

 

At any time before the Distribution Date, the Board may redeem the Rights in whole, but not in part, at a price of $0.001 per Right (subject to certain adjustments) (the “Redemption Price”). The redemption of the Rights may be made effective at such time, on such basis and with such conditions as the Board in its sole discretion may establish.

 

Immediately upon the action of the Board electing to redeem or exchange the Rights, the Company shall make a public announcement thereof, and upon such election, the right to exercise the Rights will terminate and the only right of the holders of Rights will be to receive the Redemption Price.

 

Until a Right is exercised or exchanged, the holder thereof, as such, will have no rights as a stockholder of the Company, including, without limitation, the right to vote or to receive dividends.

 

The Board may amend or supplement the Amended and Restated Rights Agreement without the approval of any holders of Rights, including, without limitation, in order to (a) cure any ambiguity, (b) correct inconsistent provisions, (c) alter time period provisions, including the Expiration Date, or (d) make additional changes to the Amended and Restated Rights Agreement that the Board deems necessary or desirable. However, from and after the date any person or group of affiliated or associated persons becomes an Acquiring Person, the Amended and Restated Rights Agreement may not be supplemented or amended in any manner that would adversely affect the interests of the holders of Rights.

 

10. Income Taxes

 

At December 31, 2022, the Company had federal and state net operating loss carryforwards (“NOLs”) of $338.3 million and $263.1 million, respectively, available to offset against future taxable income. Of this amount, $310.6 million of federal NOLs expire in 2024 through 2037. The federal operating losses after 2018 totaling $27.7 million carry forward indefinitely but are only able to offset 80% of taxable income in future years. The California NOLs expire in 2029 through 2042.

 

As a result of a change in-control that occurred in the LadRx shareholder base, approximately $66.1 million in federal net operating loss carryforwards became substantially limited in their annual availability. Management currently believes that the remaining $272.1 million in federal net operating loss carryforwards, and the $263.1 million in state net operating loss carryforwards, are unrestricted.

 

F-23

 

 

As of December 31, 2022, LadRx also had research and development tax credits for federal and state purposes of approximately $15.4 million and $22.0 million, respectively, available for offset against future income taxes, which expire in 2022 through 2036. The credits are subject to change-in-control limitations, which may affect their utilization in future years. Based on an assessment of all available evidence including, but not limited to, the Company’s limited operating history in its core business and lack of profitability, uncertainties of the commercial viability of its technology, the impact of government regulation and healthcare reform initiatives, and other risks normally associated with biotechnology companies, the Company has concluded that it is more likely than not that these net operating loss carryforwards and credits will not be realized and, as a result, a 100% deferred tax valuation allowance has been recorded against these assets.

 

Deferred income taxes reflect the net effect of temporary differences between the financial reporting carrying amounts of assets and liabilities and income tax carrying amounts of assets and liabilities. The components of the Company’s deferred tax assets and liabilities, all of which are long-term, are as follows (in thousands):

 

             
   December 31, 
   2022   2021 
Deferred tax assets:          
Net operating loss carryforwards  $74,903   $74,167 
Tax credit carryforwards   37,353    37,866 
Equipment, furnishings and other   19    4,174 
Total deferred tax assets   112,275    116,207 
Deferred tax liabilities   —    — 
Net deferred tax assets   112,275    116,207 
Valuation allowance   (112,275)   (116,207)
Deferred tax assets  $—   $— 

 

For all years presented, the Company did not recognize any deferred tax assets or liabilities. The net change in valuation allowance for the years ended December 31, 2022 and 2021 was $3.9 million and $1.6 million, respectively.

 

The provision for income taxes differs from the provision computed by applying the Federal statutory rate to net loss before income taxes as follows (in thousands):

 

         
   Years ended December 31, 
   2022   2021 
Federal benefit at statutory rate  $(1,000)  $(2,745)
State income taxes, net of Federal taxes   (333)   (913)
State credits   —    — 
Warrant liabilities   —    — 
Other permanent differences   261    1,685 
Provision related to change in valuation allowance   957    1,947 
Federal rate adjustment   —    — 
NQ Options   —    — 
Current year tax credit   —    — 
NOL Adjustments   —    — 
Termination/Cancellation of Equity Compensation Awards   —    — 
Return to provision   115    26 
Other, net   —    — 
Provision for Income taxes  $—   $— 

 

There have been no changes to the Company’s liability for unrecognized tax benefits during the year ended December 31, 2022.

 

The Company files income tax returns in the U.S. Federal jurisdiction and various state jurisdictions. As of the year ended December 31, 2022, the tax returns for 2019 through 2022 remain open to examination by the Internal Revenue Service and for 2017 to 2021 for various state tax authorities.

 

The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense. As of the date of adoption of ASC 740 and the years ended December 31, 2022 and 2021, the Company had accrued no interest or penalties related to uncertain tax positions.

 

F-24

 

 

11. Commitments and Contingencies

 

Commitments

 

Aldoxorubicin

 

The agreement relating to our worldwide rights to aldoxorubicin provides for our payment of up to an aggregate of $7.5 million upon meeting specified clinical and regulatory milestones up to and including the product’s second, final marketing approval. We also will be obliged to pay:

 

  ● commercially reasonable royalties based on a percentage of net sales (as defined in the agreement);
     
  ● a percentage of any non-royalty sub-licensing income (as defined in the agreement); and
     
  ● milestones of $1,000,000 for each additional final marketing approval that we might obtain.

 

Arimoclomol

 

The agreement relating to our worldwide rights to arimoclomol provides for our payment of up to an aggregate of $3.65 million upon receipt of milestone payments from KemPharm.

 

Innovive

 

Under the merger agreement by which we acquired Innovive, we agreed to pay the former Innovive stockholders a total of up to approximately $18.3 million of future earnout merger consideration, subject to our achievement of specified net sales under the Innovive license agreements. The earnout merger consideration, if any, will be payable in shares of our common stock, subject to specified conditions, or, at our election, in cash or by a combination of shares of our common stock and cash. Our common stock will be valued for purposes of any future earnout merger consideration based upon the trading price of our common stock at the time the earnout merger consideration is paid.

 

As of December 31, 2022, no amounts are due under the above agreements.

 

F-25

 

 

Contractual obligations

 

LadRx’s current contractual obligations that will require future cash payments for the following Employment Agreements as follows (in thousands):

 Schedule of Current Contractual Obligations

   Employment Agreements (1) 
2023        961 
2024   936 
2025   936 
2026   468 
Thereafter   — 
Total  $3,301 

 

(1) Employment agreements include management contracts which have been revised from time to time. The employment agreements for the Company’s executive officers provide for minimum salaries, which are adjusted annually at the discretion of the Company’s Compensation Committee, and in some cases provide for minimum annual bonuses and employee benefits, as well. New employment agreements for the Company’s other executive officers are usually entered into annually.

 

Contingencies

 

The Company is occasionally involved in legal proceedings and other matters arising from the normal course of business. On November 30, 2022, Jerald Hammann (“Hammann”) filed a complaint (the “Complaint”) against the Company, Mr. Caloz, and Mr. Kriegsman (together, “Defendants”) in the Court of Chancery of the State of Delaware, alleging various violations of a Cooperation Agreement, dated August 21, 2020, by and between the Company and Hammann.  The Complaint alleges breaches of a provision limiting the Board’s ability to effect discretionary compensation and a non-disparagement provision. The Complaint further alleges a breach of a purported implied obligation that the Company disclose various internal records to Hammann. Defendants believe the Complaint is wholly without merit and have moved to dismiss the Complaint in its entirety. Defendants intend to litigate vigorously against Hammann’s claims.

 

The Company intends to vigorously defend against any complaint. We have directors’ and officers’ liability insurance, which will be utilized, after the deductible, in the defense of any matter involving our directors or officers.

 

The Company evaluates developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the period in which the outcome becomes probable and reasonably estimable.

 

In December 2019, a novel strain of coronavirus, COVID-19, was first identified in China and has surfaced in several regions across the world. In March 2020, the disease was declared a pandemic by the World Health Organization. As the situation with Covid-19 continues to evolve, the companies which are working to further develop and commercialize our products, ImmunityBio and Orphazyme, could be materially and adversely affected by the risks, or the public perception of the risks, related to this pandemic. Among other things, the active and planned clinical trials by ImmunityBio and Orphazyme and their regulatory approvals, if any, may be delayed or interrupted, which could delay or adversely affect the Company’s potential receipt of milestone and royalty payments within the disclosed time periods and increase expected costs. As of the date of this filing, senior management and administrative staff are working primarily remotely.

 

12. Subsequent Events

 

On January 1, 2023, the Company paid a quarterly dividend to its holder of Series C Preferred Stock of $68,809.

 

On January 31, 2023, 1,342 Series C Preferred Stock was converted to 1,525,000 common shares.

 

 

F-26

 EX-10.15 2 ex10-15.htm

 

Exhibit 10.15

 

EMPLOYMENT AGREEMENT

 

This Employment Agreement (this “Agreement”) is made and entered into this 30th day of December, 2022, with an effective date of January 1, 2023 (the “Effective Date”) by and between LadRx Corporation, a Delaware corporation (the “Company”), and Stephen Snowdy (the “Executive”).

 

WHEREAS, the Company desires to continue to employ the Executive, and the Executive is willing to continue to be employed by the Company, on the terms set forth in this Agreement.

 

NOW, THEREFORE, upon the above premises, and in consideration of the mutual covenants and agreements hereinafter contained, the parties hereto agree as follows.

 

1. Employment. Effective as of the Effective Date, the Company shall continue to employ the Executive, and the Executive shall serve, as the Company’s Chief Executive Officer on the terms set forth herein.

 

2. Duties; Place of Employment. The Executive shall perform in a professional and business-like manner, and to the best of his ability, the duties as are customarily performed and exercised by a Chief Executive Officer of a public company and such other duties as are reasonably assigned to him from time to time by the Company’s Chair of the Board of Directors of the Company (the “Board”). The Executive’s services hereunder shall be rendered on a virtual basis, except for travel when and as required in the performance of the Executive’s duties hereunder.

 

3. Time and Efforts. The Executive shall devote all of his business time, efforts, attention and energies to the Company’s business and to discharge his duties hereunder.

 

4. Term. The term (the “Term”) of the Executive’s employment hereunder shall commence on the Effective Date and shall expire on December 31, 2025 unless sooner terminated in accordance with Section 6. Neither the Company nor the Executive shall have any obligation to extend or renew this Agreement. In the event that the Executive’s employment has not theretofore been terminated and the Company has not offered to extend or renew the Executive’s employment under this Agreement, upon expiration of the Term (and termination of the Executive’s employment) on December 31, 2025, in lieu of any other severance benefits provided by Section 6, the Company shall continue to pay the Executive his salary in accordance with the Company’s normal payroll practices as provided for in Section 5.1 during the period commencing on the final date of the Term and ending on (a) June 30, 2026, or (b) the date of the Executive’s re-employment with another employer, whichever is earlier; provided that, as a condition to the Company’s obligations under this sentence, the Executive shall have executed and delivered to the Company a General Release of All Claims in the form attached hereto as Exhibit A (the “Release”).

 

Snowdy, S Employment Agreement – 2023

 

 

5. Compensation. As the total consideration for the Executive’s services rendered hereunder, the Company shall pay or provide the Executive the following compensation and benefits:

 

5.1. Base Salary. The Executive shall be entitled to receive an annual salary of $520,000, less applicable payroll deductions and tax withholdings and payable in accordance with the Company’s normal payroll policies and procedures (the “Base Salary”).

 

5.2. Target Bonus. The Executive also shall be eligible for an annual target performance-based bonus for the Executive’s services equal to 50% of the Base Salary during the Term, less applicable payroll deductions and tax withholdings (the “Target Bonus”). Target Bonuses do not constitute a promise of payment and the Executive’s actual bonus, if any, will depend in part on the Company’s performance and the Compensation Committee’s discretion in assessing the Executive’s individual performance in relation to his objectives as determined by the Board and the overall performance and status of the Company. Any Target Bonus payable to the Executive shall be paid with respect to a performance period consistent with the Company’s standard timing for paying such bonuses and in any event no later than February 28th of the calendar year following the calendar year to which the Target Bonus relates.

 

5.3. Expense Reimbursement. The Company shall reimburse the Executive for reasonable and necessary business expenses incurred by the Executive in connection with the performance of the Executive’s duties in accordance with the Company’s usual practices and policies in effect from time to time.

 

5.4. Vacation. The Executive shall continue to accrue vacation days without loss of compensation in accordance with the Company’s usual policies applicable to all executives at a rate of four weeks’ vacation time for each 12-month period during the Term.

 

5.5. Benefits. The Executive shall be eligible to participate in all employee benefit plans and programs, fringe benefits and perquisites as in effect generally with respect to other senior officers of the Company.

 

5.6. Payroll Taxes. The Company shall have the right to deduct from the compensation and benefits due to the Executive hereunder any and all sums required for social security and withholding taxes and for any other federal, state, or local tax or charge which may be in effect or hereafter enacted or required as a charge on the compensation or benefits of the Executive.

 

6. Termination. This Agreement may be terminated as set forth in this Section 6.

 

6.1. Termination by the Company for Cause. The Company may terminate the Executive’s employment hereunder for “Cause” upon notice to the Executive. “Cause” for this purpose shall mean any of the following:

 

Snowdy, S Employment Agreement – 20232

 

 

(a) The Executive’s breach of any material term of this Agreement; provided that the first occasion of any particular breach shall not constitute such Cause unless the Executive shall have previously received written notice from the Company stating the nature of such breach and affording the Executive at least ten days to correct such breach;

 

(b) The Executive’s conviction of, or plea of guilty or nolo contendere to, any misdemeanor, felony or other crime of moral turpitude;

 

(c) The Executive’s act of fraud or dishonesty injurious to the Company or its reputation;

 

(d) The Executive’s continual failure or refusal to perform his material duties as required under this Agreement after written notice from the Company stating the nature of such failure or refusal and affording the Executive at least ten days to correct the same;

 

(e) The Executive’s act or omission that, in the reasonable determination of the Company’s Board of Directors (or a Committee of the Board), indicates alcohol or drug abuse by the Executive; or

 

(f) The Executive’s act or personal conduct that, in the judgment of the Company’s Board of Directors (or a Committee of the Board), gives rise to a material risk of liability of the Executive or the Company under federal or applicable state law for discrimination, or sexual or other forms of harassment, or other similar liabilities to subordinate employees.

 

Upon termination of the Executive’s employment by the Company for Cause, all compensation and benefits to the Executive hereunder shall cease and the Executive shall be entitled only to payment upon the effective date of termination of any accrued but unpaid Base Salary and unused vacation as provided in Sections 5.1 and 5.4 as of the date of such termination and any unpaid Target Bonus that may have been awarded the Executive as provided in Section 5.2 prior to such date.

 

Snowdy, S Employment Agreement – 20233

 

 

6.2. Termination by the Company without Cause or by the Executive for Good Reason. The Company may also terminate the Executive’s employment without Cause upon ten days’ notice to the Executive and the Executive may also terminate the Executive’s employment for Good Reason (as defined below) upon ten days’ written notice to the Company. Upon termination of the Executive’s employment by the Company without Cause or the Executive’s termination of the Executive’s employment for Good Reason, all compensation and benefits to the Executive hereunder shall cease and the Executive shall be entitled to, subject to Section 20, (1) any accrued but unpaid Base Salary and unused vacation as of the date of such termination as required by California law, which shall be due and payable upon the effective date of such termination, (2) any unpaid Target Bonus that may have been awarded to the Executive under Section 5.2 prior to such date, which shall be due and payable in accordance with the Company’s normal payroll policies and procedures or as otherwise required by California law, (3) all of the Executive’s vested stock options and other equity awards as of the date of termination of the Executive’s employment shall remain exercisable for their full term, subject to the terms of the applicable award agreements, (4) retain and have full ownership of all electronic devices provided to the Executive (including, without limitation, a computer, telephone, tablet and printer), provided that all the Company confidential information shall be deleted by the Company from such devices before releasing them to the Executive, (5) a lump sum amount, which shall be due and payable within ten days following the effective date of the Release (as defined above), equal to twelve months of the Executive’s Base Salary as provided in Section 5.1 and an amount equal to the prorated portion of the Target Bonus provided in Section 5.2 for the year in which the termination occurred based on the number of days the Executive was employed, provided, that if such termination occurs within six months prior to or within twelve months following a Change of Control (as hereinafter defined), then the amount described in this clause (5) shall be equal to eighteen months of the Executive’s Base Salary as provided in Section 5.1, and the full Target Bonus amount as provided in Section 5.2, and (6) reimbursement of the Executive and his dependents for a period of twelve months following such termination (eighteen months if such termination occurs within six months prior to or within twelve months following a Change of Control) of all the premiums associated with Executive’s continuation of health insurance pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1986 (“COBRA”), as applicable, provided, that the Executive timely elects and is eligible to continue to receive COBRA benefits (less all applicable tax withholdings), payable in accordance with the Company’s usual reimbursement practices and policies in effect from time to time. The Executive’s right to the compensation and benefits provided for in clauses (5) and (6) of this Section shall be conditioned upon the Executive having executed and delivered to the Company the Release, provided that the compensation and benefits shall be paid or commence, as applicable, after the time period for the Executive to execute, return and revoke the Release has expired (and if such time period begins in one taxable year and ends in a second taxable year, no payment shall be made until the first payroll period in the second taxable year). For purposes of this Section 6.2:

 

(a) “Change of Control” shall mean a “change in ownership or effective control of a corporation, or a change in the ownership of a substantial portion of the assets of a corporation,” as applied to the Company, within the meaning of Section 409A(a)(2)(A)(v) of the Internal Revenue Code of 1986, as amended (the “Code”) and Treas. Reg. §1.409A-3(i)(5).

 

(b) “Good Reason” shall mean any material breach by the Company of the terms hereof that is not corrected by the Company within five days after written notice by the Executive to the Company, including, without limitation, (i) the assignment to the Executive of any duties inconsistent in any respect with his position as the Chief Executive Officer (including status, offices, titles, reporting requirements, authority, duties or responsibilities); or (ii) any failure by the Company to comply with its compensation obligations under this Agreement. If the Executive terminates his employment for Good Reason, subject to the Company’s right to cure as set forth above, the termination shall take effect on the effective date of the written notice to the Company (determined under Section 15). Notwithstanding the foregoing, in the event the Executive does not terminate his employment for Good Reason within thirty days after the Company’s failure to cure as provided herein, such condition giving rise to a “Good Reason” shall no longer constitute Good Reason for the Executive to terminate his employment.

 

Snowdy, S Employment Agreement – 20234

 

 

6.3. Death or Disability. In the event of the Executive’s death or “Disability” (as defined below) during the Term, the Executive’s employment shall automatically cease and terminate as of the date of the Executive’s death or the effective date of the Company’s written notice to the Executive of its decision to terminate his employment by reason of his Disability, as the case may be, and the Executive or his heirs or personal representative shall be entitled to the same payments and benefits, at the same times, as described in Section 6.2 for a termination of employment by the Company without Cause and all of the Executive’s stock options and any other equity awards based on the Company securities held by the Executive at the time of his death or Disability shall immediately vest in full and shall remain exercisable thereafter for their full term. In addition, the Executive or his heirs or personal representative shall be entitled to retain and have full ownership of all electronic devices provided to the Executive (including, without limitation, a computer, telephone and tablet); provided that all the Company confidential information shall be deleted by the Company from such devices before releasing them to the Executive or such heirs or personal representatives. Notwithstanding the foregoing or any provision of Section 6.2, the Company’s obligation to pay the Executive the Base Salary provided in Section 6.2 for the severance period following termination of his employment by reason of his Disability shall be subject to offset and shall be reduced by any and all amounts paid to the Executive under any disability insurance policy paid or provided for by the Company as provided in Section 5.5 or otherwise. The Executive’s “Disability” shall have the meaning ascribed to such term in any policy of disability insurance maintained by the Company (or by the Executive, as the case may be) with respect to the Executive or, if no such policy is then in effect, shall mean the Executive’s inability to fully perform his duties hereunder for any period of at least 75 consecutive days or for a total of 90 days, whether or not consecutive.

 

7. Confidentiality. While this Agreement is in effect and for a period of five years thereafter, the Executive shall hold and keep secret and confidential all “trade secrets” (within the meaning of applicable law) and other confidential or proprietary information of the Company and shall use such information only in the course of performing the Executive’s duties hereunder; provided, however, that with respect to trade secrets, the Executive shall hold and keep secret and confidential such trade secrets for so long as they remain trade secrets under applicable law. The Executive shall maintain in trust all such trade secrets or other confidential or proprietary information, as the Company’s property, including, but not limited to, all documents concerning the Company’s business, including the Executive’s work papers, telephone directories, customer information and notes, and any and all copies thereof in the Executive’s possession or under the Executive’s control. Upon the expiration or earlier termination of the Executive’s employment with the Company, or upon request by the Company, the Executive shall deliver to the Company all such documents belonging to the Company, including any and all copies in the Executive’s possession or under the Executive’s control.

 

8. Equitable Remedies; Injunctive Relief. The Executive hereby acknowledges and agrees that monetary damages are inadequate to fully compensate the Company for the damages that would result from a breach or threatened breach of Section 7 of this Agreement and, accordingly, that the Company shall be entitled to equitable remedies, including, without limitation, specific performance, temporary restraining orders, and preliminary injunctions and permanent injunctions, to enforce such Section without the necessity of proving actual damages in connection therewith. This provision shall not, however, diminish the Company’s right to claim and recover damages or enforce any other of its legal or equitable rights or defenses.

 

Snowdy, S Employment Agreement – 20235

 

 

9. Indemnification; Insurance. The Company and the Executive acknowledge that, as the Chief Executive Officer of the Company, the Executive shall be a corporate officer of the Company and, as such, the Executive shall be entitled to indemnification to the full extent provided by the Company to its officers, directors and agents under the Company’s Certificate of Incorporation and Bylaws as in effect as of the date of this Agreement. the Company shall maintain the Executive as an additional insured under its current policy of directors and officers liability insurance and shall use commercially reasonable efforts to continue to insure the Executive thereunder, or under any replacement policies in effect from time to time, during the Term.

 

10. Severable Provisions. The provisions of this Agreement are severable and if any one or more provisions is determined to be illegal or otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provisions to the extent enforceable, shall nevertheless be binding and enforceable.

 

11. Successors and Assigns. This Agreement shall inure to the benefit of and shall be binding upon the Company, its successors and assigns and the Executive and his heirs and representatives; provided, that this Agreement may be assigned by the Company to a successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business or assets of the Company.

 

12. Entire Agreement. This Agreement contains the entire agreement of the parties relating to the subject matter hereof, and the parties hereto have made no agreements, representations or warranties relating to the subject matter of this Agreement that are not set forth otherwise herein. This Agreement supersedes any and all prior or contemporaneous agreements, written or oral, between the Executive and the Company relating to the subject matter hereof. Any such prior or contemporaneous agreements are hereby terminated and of no further effect, and the Executive, by the execution hereof, agrees that any compensation provided for under any such agreements is specifically superseded and replaced by the provisions of this Agreement.

 

13. Amendment. No modification of this Agreement shall be valid unless made in writing and signed by the parties hereto and unless such writing is made by an executive officer of the Company (other than the Executive). The parties hereto agree that in no event shall an oral modification of this Agreement be enforceable or valid.

 

14. Governing Law. This Agreement is and shall be governed and construed in accordance with the laws of the State of California without giving effect to California’s choice-of-law rules.

 

Snowdy, S Employment Agreement – 20236

 

 

15. Notice. All notices and other communications under this Agreement shall be in writing and mailed, telecopied (in case of notice to the Company only) or delivered by hand or by a nationally recognized courier service guaranteeing overnight delivery to a party at the following address (or to such other address as such party may have specified by notice given to the other party pursuant to this provision):

 

 

If to the Company:

 

LadRx Corporation

11726 San Vicente Boulevard, Suite 650

Los Angeles, California 90049

Facsimile: (310) 826-5529

Attention: Chair of the Board

 

 

Stephen Snowdy

1022 Reeder Circle NE

Atlanta, Georgia 30306

 

16. Survival. Sections 7 through 17 and 19 through 20 shall survive the expiration or termination of this Agreement.

 

17. Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same agreement. A counterpart executed and transmitted by facsimile shall have the same force and effect as an originally executed counterpart.

 

18. Attorney’s Fees. In any action or proceeding to construe or enforce any provision of this Agreement the prevailing party shall be entitled to recover its or his reasonable attorneys’ fees and other costs of suit (up to a maximum of $15,000) in addition to any other recoveries.

 

19. No Interpretation of Ambiguities Against Drafting Party. This Agreement has been negotiated at arm’s length between persons knowledgeable in the matters dealt with herein. In addition, each party has been represented by experienced and knowledgeable legal counsel. Accordingly, the parties agree that any rule of law, including, but not limited to, California Civil Code Section 1654 or any other statutes, legal decisions, or common law principles of similar effect, that would require interpretation of any ambiguities in this Agreement against the party that has drafted it, is of no application and is hereby expressly waived. The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intentions of the parties hereto.

 

Snowdy, S Employment Agreement – 20237

 

 

20. Code Section 409A.

 

20.1. To the extent (a) any payments to which the Executive becomes entitled under this Agreement, or any agreement or plan referenced herein, in connection with the Executive’s termination of employment with the Company constitute deferred compensation subject to Section 409A of the Code; (b) the Executive is deemed at the time of his separation from service to be a “specified employee” under Section 409A of the Code; and (c) at the time of the Executive’s separation from service the Company is publicly traded (as defined in Section 409A of Code), then such payments (other than any payments permitted by Section 409A of the Code to be paid within six months of the Executive’s separation from service) shall not be made until the earlier of (x) the first day of the seventh month following the Executive’s separation from service or (y) the date of the Executive’s death following such separation from service. Upon the expiration of the applicable deferral period described in the immediately preceding sentence, any payments which would have otherwise been made during that period (whether in a single sum or in installments) in the absence of this Section 20 shall be paid to the Executive or the Executive’s beneficiary in one lump sum, plus interest thereon at the Delayed Payment Interest Rate computed from the date on which each such delayed payment otherwise would have been made to the Executive until the date of payment. For purposes of the foregoing, the “Delayed Payment Interest Rate” shall mean the national average annual rate of interest payable on jumbo six-month bank certificates of deposit, as quoted in the business section of the most recently published Sunday edition of The New York Times preceding the Executive’s separation from service.

 

20.2. To the extent any benefits provided under Section 6.2 above are otherwise taxable to the Executive, such benefits shall, for purposes of Section 409A of the Code, be provided as separate in-kind payments of those benefits, and the provision of in-kind benefits during one calendar year shall not affect the in-kind benefits to be provided in any other calendar year.

 

20.3. In the case of any amounts payable to the Executive under this Agreement, or under any plan of the Company, that may be treated as payable in the form of “a series of installment payments,” as defined in Treas. Reg. §1.409A-2(b)(2)(iii), the Executive’s right to receive such payments shall be treated as a right to receive a series of separate payments for purposes of Treas. Reg. §1.409A-2(b)(2)(iii).

 

20.4. It is intended that this Agreement comply with or be exempt from the provisions of Section 409A of the Code and the Treasury Regulations and guidance of general applicability issued thereunder, and in furtherance of this intent, this Agreement shall be interpreted, operated, and administered in a manner consistent with such intent.

 

[Remainder of Page Intentionally Left Blank; Signature Page Follows.]

 

Snowdy, S Employment Agreement – 20238

 

 

IN WITNESS WHEREOF, this Agreement is executed as of the day and year first above written.

 

  “COMPANY”
     
  LadRx Corporation
     
  By:
    Jennifer Simpson
    Chair of the Board
     
     
  “EXECUTIVE”
     
   
    Stephen Snowdy

 

Snowdy, S Employment Agreement – 20239

 

 

EXHIBIT A

 

GENERAL RELEASE OF ALL CLAIMS

 

This General Release of All Claims is made as of December __, 2022 (this “General Release”), by and between Stephen Snowdy (the “Executive”) and LadRx Corporation, a Delaware corporation (the “Company”), with reference to the following facts:

 

WHEREAS, this General Release is provided for in, and is in furtherance of, the Employment Agreement, dated as of December __, 2022, between the Company and the Executive (the “Employment Agreement”);

 

WHEREAS, the Executive desires to execute and deliver to the Company this General Release in consideration of the Company’s providing the Executive with certain severance benefits pursuant to Section 4 or Section 6.2, as applicable, of the Employment Agreement; and

 

WHEREAS, the Executive and the Company intend that this General Release shall be in full satisfaction of any and all obligations described in this General Release owed to the Executive by the Company, except as expressly provided in this General Release.

 

NOW, THEREFORE, in consideration of the promises and the mutual covenants and agreements herein contained, the Executive and the Company agree as follows:

 

1. The Executive, for himself, his spouse, heirs, administrators, children, representatives, executors, successors, assigns, and all other persons claiming through the Executive, if any (collectively, “Releasers”), does hereby release, waive, and forever discharge the Company and each of its agents, subsidiaries, parents, affiliates, related organizations, executives, officers, directors, attorneys, successors, and assigns (collectively, the “Releasees”) from, and does fully waive any obligations of Releasees to Releasers for, any and all liability, actions, charges, causes of action, obligations, demands, damages, or claims for relief, remuneration, sums of money, accounts or expenses (including attorneys’ fees and costs) of any kind whatsoever, whether known or unknown or contingent or absolute, which heretofore has been or which hereafter may be suffered or sustained, directly or indirectly, by Releasers in consequence of, arising out of, or in any way relating to: (a) the Executive’s employment with and services to the Company or any of its affiliates; (b) the termination of the Executive’s employment with and services to the Company and any of its affiliates; or (c) any event whatsoever occurring on or prior to the date of this General Release. The foregoing release and discharge, waiver and covenant not to sue includes, but is not limited to, all claims and any obligations or causes of action arising from such claims, under common law including, but not limited to, wrongful or retaliatory discharge, breach of contract (including but not limited to any claims under any employment agreement between the Executive, on the one hand, and the Company or its affiliates, on the other hand) and any action arising in tort including, but not limited to, libel, slander, defamation or intentional infliction of emotional distress, and claims under any federal, state or local statute including the Age Discrimination in Employment Act (“ADEA”), Title VII of the Civil Rights Act of 1964, the Civil Rights Act of 1866 and 1871 (42 U.S.C. § 1981), the National Labor Relations Act, the Fair Labor Standards Act, the Employee Retirement Income Security Act, the Americans with Disabilities Act of 1990, the Rehabilitation Act of 1973, the California Fair Employment and Housing Act, the Family and Medical Leave Act, the California Family Rights Act or the discrimination or employment laws of any state or municipality, and any claims under any express or implied contract which Releasers may claim existed with Releasees. This also includes, but is not limited to, a release of any claims for wrongful discharge and all claims for alleged physical or personal injury, emotional distress relating to or arising out of the Executive’s employment with or services to the Company or any of its affiliates or the termination of that employment or those services; and any claims under the Worker Adjustment and Retraining Notification Act, California Labor Code Section 1400 et seq. or any similar law, which requires, among other things, that advance notice be given of certain work force reductions. This release and waiver does not apply to: (i) the Executive’s rights to receive the compensation and benefits provided for in clauses (1) through (2) of Section 6.2, as applicable, of the Employment Agreement; or (ii) the Executive’s rights under any stock option agreement between the Executive and the Company.

 

Snowdy, S Employment Agreement – 202310

 

 

2. The Executive understands and agrees that he is expressly waiving all rights afforded by Section 1542 of the Civil Code of the State of California (“Section 1542”) with respect to the Releasees. Section 1542 states as follows:

 

A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR.

 

Notwithstanding the provisions of Section 1542, and for the purpose of implementing a full and complete release, the Executive understands and agrees that this General Release is intended to include all claims, if any, which the Executive may have and which he does not now know or suspect to exist in his favor against the Releasees and the Executive understands and agrees that this Agreement extinguishes those claims.

 

3. Excluded from this General Release and waiver are any claims which cannot be waived by law, including but not limited to the right to participate in an investigation conducted by certain government agencies. The Executive, however, waives the Executive’s right to any monetary recovery should any agency (such as the Equal Employment Opportunity Commission or the California Department of Fair Employment and Housing) pursue any claims on the Executive’s behalf. The Executive represents and warrants that the Executive has not filed any complaint, charge or lawsuit against the Releasees with any government agency or any court.

 

4. The Executive agrees never to seek personal recovery from Releasees in any forum for any claim covered by the above waiver and release language, except that the Executive may bring a claim under the ADEA to challenge this General Release. Nothing in this General Release is intended to reflect any party’s belief that the Executive’s waiver of claims under ADEA is invalid or unenforceable, it being the intent of the parties that such claims are waived.

 

5. The Executive acknowledges and recites that:

 

(a) The Executive has executed this General Release knowingly and voluntarily;

 

(b) The Executive has read and understands this General Release in its entirety;

 

Snowdy, S Employment Agreement – 202311

 

 

(c) The Executive acknowledges that he has been advised by his own legal counsel and has sought such other advice as he wishes with respect to the terms of this General Release before executing it;

 

(d) The Executive’s execution of this General Release has not been forced by any the Executive or agent of the Company, and the Executive has had an opportunity to negotiate about the terms of this General Release; and

 

(e) The Executive has not sold, assigned, transferred or conveyed any claim, demand, right, action, suit, cause of action or other interest that is the subject matter of this General Release.

 

6. This General Release shall be governed by the internal laws (and not the choice of laws) of the State of California, except for the application of preemptive Federal law.

 

7. The Executive acknowledges that he is waiving his rights under the ADEA and the Older Worker’s Benefit Protection Act and therefore, in compliance with those statutes, acknowledges the following:

 

The Executive acknowledges that he has been provided a minimum of twenty-one calendar days after receipt of this Agreement to consider whether to sign it;

 

The Executive acknowledges that he shall have seven days from the date he executes this General Release to revoke his waiver and release of any ADEA claims only (but not his waiver or release hereunder of other claims) by providing written notice of the revocation to the Company, and that, in the event of such revocation, the provisions of Section 4 or clauses (4) through (6) of Section 6.2, as applicable, of the Employment Agreement shall thereupon become null and void and the Company shall be entitled to a return from the Executive of all payments to the Executive pursuant to such clauses;

 

The Executive acknowledges that this waiver and release does not apply to any rights or claims that may arise under ADEA after the effective date of this Agreement; and

 

The Executive acknowledges that the consideration given in exchange for this waiver and release Agreement is in addition to anything of value to which he was already entitled.

 

PLEASE READ THIS AGREEMENT CAREFULLY. IT CONTAINS A RELEASE OF ALL KNOWN AND UNKNOWN CLAIMS.

 

Dated: December __, 2022

  Stephen Snowdy

 

Snowdy, S Employment Agreement – 202312

 EX-10.16 3 ex10-16.htm

 

Exhibit 10.16

 

EMPLOYMENT AGREEMENT

 

This Employment Agreement (this “Agreement”) is made and entered into this 30th day of December, 2022, with an effective date of January 1, 2023 (the “Effective Date”) by and between LadRx Corporation, a Delaware corporation (the “Company”), and John Caloz (the “Executive”).

 

WHEREAS, the Company desires to continue to employ the Executive, and the Executive is willing to continue to be employed by the Company, on the terms set forth in this Agreement.

 

NOW, THEREFORE, upon the above premises, and in consideration of the mutual covenants and agreements hereinafter contained, the parties hereto agree as follows.

 

1. Employment. Effective as of the Effective Date, the Company shall continue to employ the Executive, and the Executive shall serve, as the Company’s Chief Financial Officer and Senior Vice President on the terms set forth herein.

 

2. Duties; Place of Employment. The Executive shall perform in a professional and business-like manner, and to the best of his ability, the duties as are customarily performed and exercised by a Chief Financial Officer and Senior Vice President of a public company and such other duties as are reasonably assigned to him from time to time by the Company’s Chair of the Board of Directors of the Company (the “Board”). The Executive understands and agrees that his duties, title and authority may be changed from time to time in the discretion of the Company’s Chair of the Board. The Executive’s services hereunder shall be rendered from his home office on a virtual basis, except for travel when and as required in the performance of the Executive’s duties hereunder.

 

3. Time and Efforts. The Executive shall devote all of his business time, efforts, attention and energies to the Company’s business and to discharge his duties hereunder.

 

4. Term. The term (the “Term”) of the Executive’s employment hereunder shall commence on the Effective Date and shall expire on December 31, 2025 unless sooner terminated in accordance with Section 6. Neither the Company nor the Executive shall have any obligation to extend or renew this Agreement. In the event that the Executive’s employment has not theretofore been terminated and the Company has not offered to extend or renew the Executive’s employment under this Agreement, upon expiration of the Term (and termination of the Executive’s employment) on December 31, 2025, in lieu of any other severance benefits provided by Section 6, the Company shall continue to pay the Executive his salary in accordance with the Company’s normal payroll practices as provided for in Section 5.1 during the period commencing on the final date of the Term and ending on (a) June 30, 2026, or (b) the date of the Executive’s re-employment with another employer, whichever is earlier; provided that, as a condition to the Company’s obligations under this sentence, the Executive shall have executed and delivered to the Company a General Release of All Claims in the form attached hereto as Exhibit A (the “Release”).

 

Caloz, J. Employment Agreement – 2023

 

 

5. Compensation. As the total consideration for the Executive’s services rendered hereunder, the Company shall pay or provide the Executive the following compensation and benefits:

 

5.1. Base Salary. The Executive shall be entitled to receive an annual salary of $416,000, less applicable payroll deductions and tax withholdings and payable in accordance with the Company’s normal payroll policies and procedures (the “Base Salary”).

 

5.2. Target Bonus. The Executive also shall be eligible for an annual target performance-based bonus for the Executive’s services equal to 40% of the Base Salary during the Term, less applicable payroll deductions and tax withholdings (the “Target Bonus”). Target Bonuses do not constitute a promise of payment and the Executive’s actual bonus, if any, will depend in part on the Company’s performance and the Compensation Committee’s discretion in assessing the Executive’s individual performance in relation to his objectives as determined by the Board and the overall performance and status of the Company. Any Target Bonus payable to the Executive shall be paid with respect to a performance period consistent with the Company’s standard timing for paying such bonuses and in any event no later than February 28th of the calendar year following the calendar year to which the Target Bonus relates.

 

5.3. Expense Reimbursement. The Company shall reimburse the Executive for reasonable and necessary business expenses incurred by the Executive in connection with the performance of the Executive’s duties in accordance with the Company’s usual practices and policies in effect from time to time.

 

5.4. Vacation. The Executive shall continue to accrue vacation days without loss of compensation in accordance with the Company’s usual policies applicable to all executives at a rate of four weeks’ vacation time for each 12-month period during the Term.

 

5.5. Benefits. The Executive shall be eligible to participate in all employee benefit plans and programs (including reimbursement of all Medicare premiums), fringe benefits and perquisites as in effect generally with respect to other senior officers of the Company.

 

5.6. Payroll Taxes. The Company shall have the right to deduct from the compensation and benefits due to the Executive hereunder any and all sums required for social security and withholding taxes and for any other federal, state, or local tax or charge which may be in effect or hereafter enacted or required as a charge on the compensation or benefits of the Executive.

 

6. Termination. This Agreement may be terminated as set forth in this Section 6.

 

6.1. Termination by the Company for Cause. The Company may terminate the Executive’s employment hereunder for “Cause” upon notice to the Executive. “Cause” for this purpose shall mean any of the following:

 

Caloz, J. Employment Agreement – 20232

 

 

(a) The Executive’s breach of any material term of this Agreement; provided that the first occasion of any particular breach shall not constitute such Cause unless the Executive shall have previously received written notice from the Company stating the nature of such breach and affording the Executive at least ten days to correct such breach;

 

(b) The Executive’s conviction of, or plea of guilty or nolo contendere to, any misdemeanor, felony or other crime of moral turpitude;

 

(c) The Executive’s act of fraud or dishonesty injurious to the Company or its reputation;

 

(d) The Executive’s continual failure or refusal to perform his material duties as required under this Agreement after written notice from the Company stating the nature of such failure or refusal and affording the Executive at least ten days to correct the same;

 

(e) The Executive’s act or omission that, in the reasonable determination of the Company’s Board of Directors (or a Committee of the Board), indicates alcohol or drug abuse by the Executive; or

 

(f) The Executive’s act or personal conduct that, in the judgment of the Company’s Board of Directors (or a Committee of the Board), gives rise to a material risk of liability of the Executive or the Company under federal or applicable state law for discrimination, or sexual or other forms of harassment, or other similar liabilities to subordinate employees.

 

Upon termination of the Executive’s employment by the Company for Cause, all compensation and benefits to the Executive hereunder shall cease and the Executive shall be entitled only to payment upon the effective date of termination of any accrued but unpaid Base Salary and unused vacation as provided in Sections 5.1 and 5.4 as of the date of such termination and any unpaid Target Bonus that may have been awarded the Executive as provided in Section 5.2 prior to such date.

 

Caloz, J. Employment Agreement – 20233

 

 

6.2. Termination by the Company without Cause or by the Executive for Good Reason. The Company may also terminate the Executive’s employment without Cause upon ten days’ notice to the Executive and the Executive may also terminate the Executive’s employment for Good Reason (as defined below) upon ten days’ written notice to the Company. Upon termination of the Executive’s employment by the Company without Cause or the Executive’s termination of the Executive’s employment for Good Reason, all compensation and benefits to the Executive hereunder shall cease and the Executive shall be entitled to, subject to Section 20, (1) any accrued but unpaid Base Salary and unused vacation as of the date of such termination as required by California law, which shall be due and payable upon the effective date of such termination, (2) any unpaid Target Bonus that may have been awarded to the Executive under Section 5.2 prior to such date, which shall be due and payable in accordance with the Company’s normal payroll policies and procedures or as otherwise required by California law, (3) all of the Executive’s vested stock options and other equity awards as of the date of termination of the Executive’s employment shall remain exercisable for their full term, subject to the terms of the applicable award agreements, (4) retain and have full ownership of all electronic devices provided to the Executive (including, without limitation, a computer, telephone, tablet and printer), provided that all the Company confidential information shall be deleted by the Company from such devices before releasing them to the Executive, (5) a lump sum amount, which shall be due and payable within ten days following the effective date of the Release (as defined above), equal to twelve months of the Executive’s Base Salary as provided in Section 5.1 and an amount equal to the prorated portion of the Target Bonus provided in Section 5.2 for the year in which the termination occurred based on the number of days the Executive was employed, provided, that if such termination occurs within six months prior to or within twelve months following a Change of Control (as hereinafter defined), then the amount described in this clause (5) shall be equal to eighteen months of the Executive’s Base Salary as provided in Section 5.1, and the full Target Bonus amount as provided in Section 5.2, and (6) reimbursement of the Executive and his dependents for a period of twelve months following such termination (eighteen months if such termination occurs within six months prior to or within twelve months following a Change of Control) of all Medicare premiums and the premiums associated with Executive’s continuation of health insurance pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1986 (“COBRA”), as applicable, provided, that the Executive timely elects and is eligible to continue to receive COBRA benefits (less all applicable tax withholdings), payable in accordance with the Company’s usual reimbursement practices and policies in effect from time to time. The Executive’s right to the compensation and benefits provided for in clauses (5) and (6) of this Section shall be conditioned upon the Executive having executed and delivered to the Company the Release, provided that the compensation and benefits shall be paid or commence, as applicable, after the time period for the Executive to execute, return and revoke the Release has expired (and if such time period begins in one taxable year and ends in a second taxable year, no payment shall be made until the first payroll period in the second taxable year). For purposes of this Section 6.2:

 

(a) “Change of Control” shall mean a “change in ownership or effective control of a corporation, or a change in the ownership of a substantial portion of the assets of a corporation,” as applied to the Company, within the meaning of Section 409A(a)(2)(A)(v) of the Internal Revenue Code of 1986, as amended (the “Code”) and Treas. Reg. §1.409A-3(i)(5).

 

(b) “Good Reason” shall mean any material breach by the Company of the terms hereof that is not corrected by the Company within five days after written notice by the Executive to the Company, including, without limitation, (i) the assignment to the Executive of any duties inconsistent in any respect with his position as the Chief Financial Officer and Senior Vice President (including status, offices, titles, reporting requirements, authority, duties or responsibilities); or (ii) any failure by the Company to comply with its compensation obligations under this Agreement. If the Executive terminates his employment for Good Reason, subject to the Company’s right to cure as set forth above, the termination shall take effect on the effective date of the written notice to the Company (determined under Section 15). Notwithstanding the foregoing, in the event the Executive does not terminate his employment for Good Reason within thirty days after the Company’s failure to cure as provided herein, such condition giving rise to a “Good Reason” shall no longer constitute Good Reason for the Executive to terminate his employment.

 

Caloz, J. Employment Agreement – 20234

 

 

6.3. Death or Disability. In the event of the Executive’s death or “Disability” (as defined below) during the Term, the Executive’s employment shall automatically cease and terminate as of the date of the Executive’s death or the effective date of the Company’s written notice to the Executive of its decision to terminate his employment by reason of his Disability, as the case may be, and the Executive or his heirs or personal representative shall be entitled to the same payments and benefits, at the same times, as described in Section 6.2 for a termination of employment by the Company without Cause and all of the Executive’s stock options and any other equity awards based on the Company securities held by the Executive at the time of his death or Disability shall immediately vest in full and shall remain exercisable thereafter for their full term. In addition, the Executive or his heirs or personal representative shall be entitled to retain and have full ownership of all electronic devices provided to the Executive (including, without limitation, a computer, telephone and tablet); provided that all the Company confidential information shall be deleted by the Company from such devices before releasing them to the Executive or such heirs or personal representatives. Notwithstanding the foregoing or any provision of Section 6.2, the Company’s obligation to pay the Executive the Base Salary provided in Section 6.2 for the severance period following termination of his employment by reason of his Disability shall be subject to offset and shall be reduced by any and all amounts paid to the Executive under any disability insurance policy paid or provided for by the Company as provided in Section 5.5 or otherwise. The Executive’s “Disability” shall have the meaning ascribed to such term in any policy of disability insurance maintained by the Company (or by the Executive, as the case may be) with respect to the Executive or, if no such policy is then in effect, shall mean the Executive’s inability to fully perform his duties hereunder for any period of at least 75 consecutive days or for a total of 90 days, whether or not consecutive.

 

7. Confidentiality. While this Agreement is in effect and for a period of five years thereafter, the Executive shall hold and keep secret and confidential all “trade secrets” (within the meaning of applicable law) and other confidential or proprietary information of the Company and shall use such information only in the course of performing the Executive’s duties hereunder; provided, however, that with respect to trade secrets, the Executive shall hold and keep secret and confidential such trade secrets for so long as they remain trade secrets under applicable law. The Executive shall maintain in trust all such trade secrets or other confidential or proprietary information, as the Company’s property, including, but not limited to, all documents concerning the Company’s business, including the Executive’s work papers, telephone directories, customer information and notes, and any and all copies thereof in the Executive’s possession or under the Executive’s control. Upon the expiration or earlier termination of the Executive’s employment with the Company, or upon request by the Company, the Executive shall deliver to the Company all such documents belonging to the Company, including any and all copies in the Executive’s possession or under the Executive’s control.

 

8. Equitable Remedies; Injunctive Relief. The Executive hereby acknowledges and agrees that monetary damages are inadequate to fully compensate the Company for the damages that would result from a breach or threatened breach of Section 7 of this Agreement and, accordingly, that the Company shall be entitled to equitable remedies, including, without limitation, specific performance, temporary restraining orders, and preliminary injunctions and permanent injunctions, to enforce such Section without the necessity of proving actual damages in connection therewith. This provision shall not, however, diminish the Company’s right to claim and recover damages or enforce any other of its legal or equitable rights or defenses.

 

Caloz, J. Employment Agreement – 20235

 

 

9. Indemnification; Insurance. The Company and the Executive acknowledge that, as the Chief Financial Officer of the Company, the Executive shall be a corporate officer of the Company and, as such, the Executive shall be entitled to indemnification to the full extent provided by the Company to its officers, directors and agents under the Company’s Certificate of Incorporation and Bylaws as in effect as of the date of this Agreement. the Company shall maintain the Executive as an additional insured under its current policy of directors and officers liability insurance and shall use commercially reasonable efforts to continue to insure the Executive thereunder, or under any replacement policies in effect from time to time, during the Term.

 

10. Severable Provisions. The provisions of this Agreement are severable and if any one or more provisions is determined to be illegal or otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provisions to the extent enforceable, shall nevertheless be binding and enforceable.

 

11. Successors and Assigns. This Agreement shall inure to the benefit of and shall be binding upon the Company, its successors and assigns and the Executive and his heirs and representatives; provided, that this Agreement may be assigned by the Company to a successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business or assets of the Company.

 

12. Entire Agreement. This Agreement contains the entire agreement of the parties relating to the subject matter hereof, and the parties hereto have made no agreements, representations or warranties relating to the subject matter of this Agreement that are not set forth otherwise herein. This Agreement supersedes any and all prior or contemporaneous agreements, written or oral, between the Executive and the Company relating to the subject matter hereof. Any such prior or contemporaneous agreements are hereby terminated and of no further effect, and the Executive, by the execution hereof, agrees that any compensation provided for under any such agreements is specifically superseded and replaced by the provisions of this Agreement.

 

13. Amendment. No modification of this Agreement shall be valid unless made in writing and signed by the parties hereto and unless such writing is made by an executive officer of the Company (other than the Executive). The parties hereto agree that in no event shall an oral modification of this Agreement be enforceable or valid.

 

14. Governing Law. This Agreement is and shall be governed and construed in accordance with the laws of the State of California without giving effect to California’s choice-of-law rules.

 

Caloz, J. Employment Agreement – 20236

 

 

15. Notice. All notices and other communications under this Agreement shall be in writing and mailed, telecopied (in case of notice to the Company only) or delivered by hand or by a nationally recognized courier service guaranteeing overnight delivery to a party at the following address (or to such other address as such party may have specified by notice given to the other party pursuant to this provision):

 

 

If to the Company:

 

LadRx Corporation

11726 San Vicente Boulevard, Suite 650

Los Angeles, California 90049

Facsimile: (310) 826-5529

Attention: Chief Executive Officer

 

 

If to the Executive:

 

John Caloz

604 NW 9th Avenue

Camas, Washington 98607

 

16. Survival. Sections 7 through 17 and 19 through 20 shall survive the expiration or termination of this Agreement.

 

17. Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same agreement. A counterpart executed and transmitted by facsimile shall have the same force and effect as an originally executed counterpart.

 

18. Attorney’s Fees. In any action or proceeding to construe or enforce any provision of this Agreement the prevailing party shall be entitled to recover its or his reasonable attorneys’ fees and other costs of suit (up to a maximum of $15,000) in addition to any other recoveries.

 

19. No Interpretation of Ambiguities Against Drafting Party. This Agreement has been negotiated at arm’s length between persons knowledgeable in the matters dealt with herein. In addition, each party has been represented by experienced and knowledgeable legal counsel. Accordingly, the parties agree that any rule of law, including, but not limited to, California Civil Code Section 1654 or any other statutes, legal decisions, or common law principles of similar effect, that would require interpretation of any ambiguities in this Agreement against the party that has drafted it, is of no application and is hereby expressly waived. The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intentions of the parties hereto.

 

Caloz, J. Employment Agreement – 20237

 

 

20. Code Section 409A.

 

20.1. To the extent (a) any payments to which the Executive becomes entitled under this Agreement, or any agreement or plan referenced herein, in connection with the Executive’s termination of employment with the Company constitute deferred compensation subject to Section 409A of the Code; (b) the Executive is deemed at the time of his separation from service to be a “specified employee” under Section 409A of the Code; and (c) at the time of the Executive’s separation from service the Company is publicly traded (as defined in Section 409A of Code), then such payments (other than any payments permitted by Section 409A of the Code to be paid within six months of the Executive’s separation from service) shall not be made until the earlier of (x) the first day of the seventh month following the Executive’s separation from service or (y) the date of the Executive’s death following such separation from service. Upon the expiration of the applicable deferral period described in the immediately preceding sentence, any payments which would have otherwise been made during that period (whether in a single sum or in installments) in the absence of this Section 20 shall be paid to the Executive or the Executive’s beneficiary in one lump sum, plus interest thereon at the Delayed Payment Interest Rate computed from the date on which each such delayed payment otherwise would have been made to the Executive until the date of payment. For purposes of the foregoing, the “Delayed Payment Interest Rate” shall mean the national average annual rate of interest payable on jumbo six-month bank certificates of deposit, as quoted in the business section of the most recently published Sunday edition of The New York Times preceding the Executive’s separation from service.

 

20.2. To the extent any benefits provided under Section 6.2 above are otherwise taxable to the Executive, such benefits shall, for purposes of Section 409A of the Code, be provided as separate in-kind payments of those benefits, and the provision of in-kind benefits during one calendar year shall not affect the in-kind benefits to be provided in any other calendar year.

 

20.3. In the case of any amounts payable to the Executive under this Agreement, or under any plan of the Company, that may be treated as payable in the form of “a series of installment payments,” as defined in Treas. Reg. §1.409A-2(b)(2)(iii), the Executive’s right to receive such payments shall be treated as a right to receive a series of separate payments for purposes of Treas. Reg. §1.409A-2(b)(2)(iii).

 

20.4. It is intended that this Agreement comply with or be exempt from the provisions of Section 409A of the Code and the Treasury Regulations and guidance of general applicability issued thereunder, and in furtherance of this intent, this Agreement shall be interpreted, operated, and administered in a manner consistent with such intent.

 

[Remainder of Page Intentionally Left Blank; Signature Page Follows.]

 

Caloz, J. Employment Agreement – 20238

 

 

IN WITNESS WHEREOF, this Agreement is executed as of the day and year first above written.

 

  “COMPANY”
     
  LadRx Corporation
     
  By:
    Jennifer Simpson
    Chair of the Board
     
     
  “EXECUTIVE”
     
   
    John Caloz

 

Caloz, J. Employment Agreement – 20239

 

 

EXHIBIT A

 

GENERAL RELEASE OF ALL CLAIMS

 

This General Release of All Claims is made as of December __, 2022 (this “General Release”), by and between John Caloz (the “Executive”) and LadRx Corporation, a Delaware corporation (the “Company”), with reference to the following facts:

 

WHEREAS, this General Release is provided for in, and is in furtherance of, the Employment Agreement, dated as of December __, 2022, between the Company and the Executive (the “Employment Agreement”);

 

WHEREAS, the Executive desires to execute and deliver to the Company this General Release in consideration of the Company’s providing the Executive with certain severance benefits pursuant to Section 4 or Section 6.2, as applicable, of the Employment Agreement; and

 

WHEREAS, the Executive and the Company intend that this General Release shall be in full satisfaction of any and all obligations described in this General Release owed to the Executive by the Company, except as expressly provided in this General Release.

 

NOW, THEREFORE, in consideration of the promises and the mutual covenants and agreements herein contained, the Executive and the Company agree as follows:

 

1. The Executive, for himself, his spouse, heirs, administrators, children, representatives, executors, successors, assigns, and all other persons claiming through the Executive, if any (collectively, “Releasers”), does hereby release, waive, and forever discharge the Company and each of its agents, subsidiaries, parents, affiliates, related organizations, executives, officers, directors, attorneys, successors, and assigns (collectively, the “Releasees”) from, and does fully waive any obligations of Releasees to Releasers for, any and all liability, actions, charges, causes of action, obligations, demands, damages, or claims for relief, remuneration, sums of money, accounts or expenses (including attorneys’ fees and costs) of any kind whatsoever, whether known or unknown or contingent or absolute, which heretofore has been or which hereafter may be suffered or sustained, directly or indirectly, by Releasers in consequence of, arising out of, or in any way relating to: (a) the Executive’s employment with and services to the Company or any of its affiliates; (b) the termination of the Executive’s employment with and services to the Company and any of its affiliates; or (c) any event whatsoever occurring on or prior to the date of this General Release. The foregoing release and discharge, waiver and covenant not to sue includes, but is not limited to, all claims and any obligations or causes of action arising from such claims, under common law including, but not limited to, wrongful or retaliatory discharge, breach of contract (including but not limited to any claims under any employment agreement between the Executive, on the one hand, and the Company or its affiliates, on the other hand) and any action arising in tort including, but not limited to, libel, slander, defamation or intentional infliction of emotional distress, and claims under any federal, state or local statute including the Age Discrimination in Employment Act (“ADEA”), Title VII of the Civil Rights Act of 1964, the Civil Rights Act of 1866 and 1871 (42 U.S.C. § 1981), the National Labor Relations Act, the Fair Labor Standards Act, the Employee Retirement Income Security Act, the Americans with Disabilities Act of 1990, the Rehabilitation Act of 1973, the California Fair Employment and Housing Act, the Family and Medical Leave Act, the California Family Rights Act or the discrimination or employment laws of any state or municipality, and any claims under any express or implied contract which Releasers may claim existed with Releasees. This also includes, but is not limited to, a release of any claims for wrongful discharge and all claims for alleged physical or personal injury, emotional distress relating to or arising out of the Executive’s employment with or services to the Company or any of its affiliates or the termination of that employment or those services; and any claims under the Worker Adjustment and Retraining Notification Act, California Labor Code Section 1400 et seq. or any similar law, which requires, among other things, that advance notice be given of certain work force reductions. This release and waiver does not apply to: (i) the Executive’s rights to receive the compensation and benefits provided for in clauses (1) through (2) of Section 6.2, as applicable, of the Employment Agreement; or (ii) the Executive’s rights under any stock option agreement between the Executive and the Company.

 

Caloz, J. Employment Agreement – 202310

 

 

2. The Executive understands and agrees that he is expressly waiving all rights afforded by Section 1542 of the Civil Code of the State of California (“Section 1542”) with respect to the Releasees. Section 1542 states as follows:

 

A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR.

 

Notwithstanding the provisions of Section 1542, and for the purpose of implementing a full and complete release, the Executive understands and agrees that this General Release is intended to include all claims, if any, which the Executive may have and which he does not now know or suspect to exist in his favor against the Releasees and the Executive understands and agrees that this Agreement extinguishes those claims.

 

3. Excluded from this General Release and waiver are any claims which cannot be waived by law, including but not limited to the right to participate in an investigation conducted by certain government agencies. The Executive, however, waives the Executive’s right to any monetary recovery should any agency (such as the Equal Employment Opportunity Commission or the California Department of Fair Employment and Housing) pursue any claims on the Executive’s behalf. The Executive represents and warrants that the Executive has not filed any complaint, charge or lawsuit against the Releasees with any government agency or any court.

 

4. The Executive agrees never to seek personal recovery from Releasees in any forum for any claim covered by the above waiver and release language, except that the Executive may bring a claim under the ADEA to challenge this General Release. Nothing in this General Release is intended to reflect any party’s belief that the Executive’s waiver of claims under ADEA is invalid or unenforceable, it being the intent of the parties that such claims are waived.

 

5. The Executive acknowledges and recites that:

 

(a) The Executive has executed this General Release knowingly and voluntarily;

 

(b) The Executive has read and understands this General Release in its entirety;

 

Caloz, J. Employment Agreement – 202311

 

 

(c) The Executive acknowledges that he has been advised by his own legal counsel and has sought such other advice as he wishes with respect to the terms of this General Release before executing it;

 

(d) The Executive’s execution of this General Release has not been forced by any the Executive or agent of the Company, and the Executive has had an opportunity to negotiate about the terms of this General Release; and

 

(e) The Executive has not sold, assigned, transferred or conveyed any claim, demand, right, action, suit, cause of action or other interest that is the subject matter of this General Release.

 

6. This General Release shall be governed by the internal laws (and not the choice of laws) of the State of California, except for the application of preemptive Federal law.

 

7. The Executive acknowledges that he is waiving his rights under the ADEA and the Older Worker’s Benefit Protection Act and therefore, in compliance with those statutes, acknowledges the following:

 

The Executive acknowledges that he has been provided a minimum of twenty-one calendar days after receipt of this Agreement to consider whether to sign it;

 

The Executive acknowledges that he shall have seven days from the date he executes this General Release to revoke his waiver and release of any ADEA claims only (but not his waiver or release hereunder of other claims) by providing written notice of the revocation to the Company, and that, in the event of such revocation, the provisions of Section 4 or clauses (4) through (6) of Section 6.2, as applicable, of the Employment Agreement shall thereupon become null and void and the Company shall be entitled to a return from the Executive of all payments to the Executive pursuant to such clauses;

 

The Executive acknowledges that this waiver and release does not apply to any rights or claims that may arise under ADEA after the effective date of this Agreement; and

 

The Executive acknowledges that the consideration given in exchange for this waiver and release Agreement is in addition to anything of value to which he was already entitled.

 

PLEASE READ THIS AGREEMENT CAREFULLY. IT CONTAINS A RELEASE OF ALL KNOWN AND UNKNOWN CLAIMS.

 

 

Dated: December __, 2022

  John Caloz

 

Caloz, J. Employment Agreement – 202312

 EX-21.1 4 ex21-1.htm

 

EXHIBIT 21.1

 

LadRx Corporation

 

Subsidiaries (all 100% owned)

 

Subsidiaries of the Registrant   State or Other Jurisdiction of Incorporation
Centurion BioPharma Corporation   Delaware

 

 

 EX-23.1 5 ex23-1.htm

 

EXHIBIT 23.1

 

Consent of Independent Registered Public Accounting Firm

 

LadRx Corporation

Los Angeles, California

 

We hereby consent to the incorporation by reference in the Registration Statements on Form S-1 (File No. 333-258453), Form S-3 (File Nos. 333-255431, 333-223808, 333-208803 and 333-215252) and Form S-8 (File Nos. 333-249624, 333-68200, 333-93305, 333-123339, 333-163212 and 333-212934) of LadRx Corporation of our report dated March 20, 2023, relating to the consolidated financial statements for the years ended December 31, 2022 and 2021 (modified for a going concern uncertainty), which appears in this Form 10-K.

 

/s/ Weinberg & Company

 

Los Angeles, California

March 20, 2023

 

 

 EX-31.1 6 ex31-1.htm

 

Exhibit 31.1

 

CERTIFICATIONS

 

I, Stephen Snowdy, Chief Executive Officer of LadRx Corporation, certify that:

 

1. I have reviewed this annual report on Form 10-K of LadRx Corporation;

 

2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the periods covered by this annual report;

 

3. Based on my knowledge, the consolidated financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the periods covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: March 20, 2023 By: /s/ STEPHEN.SNOWDY
    Dr. Stephen Snowdy
    Chief Executive Officer

 

 

 EX-31.2 7 ex31-2.htm

 

Exhibit 31.2

 

CERTIFICATIONS

 

I, John Y. Caloz, Chief Financial Officer of LadRx Corporation, certify that:

 

1. I have reviewed this annual report on Form 10-K of LadRx Corporation;

 

2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the periods covered by this annual report;

 

3. Based on my knowledge, the consolidated financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the periods covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: March 20, 2023 By: /s/ JOHN Y. CALOZ
    John Y. Caloz
    Chief Financial Officer

 

 

 EX-32.1 8 ex32-1.htm

 

Exhibit 32.1

 

Certification of Chief Executive Officer

 

Pursuant to 18 U.S.C. 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of LadRx Corporation (the “Company”) hereby certifies that:

 

(i) the accompanying Annual Report on Form 10-K of the Company for the year ended December 31, 2022 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: March 20, 2023 By: /s/ STEPHEN SNOWDY
    Dr. Stephen Snowdy
    Chief Executive Officer

 

A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 (Section 906), or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to CytRx Corporation and will be retained by CytRx Corporation and furnished to the Securities and Exchange Commission or its staff upon request.

 

The foregoing certification is being furnished to the Securities and Exchange Commission as an Exhibit to the Form 10-K and shall not be considered filed as part of the Form 10-K.

 

 

 EX-32.2 9 ex32-2.htm

 

 

Exhibit 32.2

 

Certification of Chief Financial Officer

 

Pursuant to 18 U.S.C. 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of LadRx Corporation (the “Company”) hereby certifies that:

 

(i) the accompanying Annual Report on Form 10-K of the Company for the year ended December 31, 2022 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: March 20, 2023 By: /s/ JOHN Y. CALOZ
    John Y. Caloz
    Chief Financial Officer

 

A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 (Section 906), or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to LadRx Corporation and will be retained by LadRx Corporation and furnished to the Securities and Exchange Commission or its staff upon request.

 

The foregoing certification is being furnished to the Securities and Exchange Commission as an Exhibit to the Form 10-K and shall not be considered filed as part of the Form 10-K.

 

 

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Percentage of service charge Cash investments Investment in common stock per share Common stock market price premium percentage Number of warrants issued to purchase shares of common stock Warrrants exercise price per share Warrant expiration Fee contingent payments Cash consideration from sale of assets Net loss Cash in operations Stockholders equity Contractual obligation Contractual obligation Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table] Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] Shares excluded from computation of diluted loss per share Insurance recoveries Schedule of Share-Based Compensation Arrangements by Share-Based Payment Award [Table] Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] Cash Balance Foreign currency transaction gain (loss), recognized Equipment and furnishings Less — accumulated depreciation Equipment and furnishings, net Property, Plant and 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expiration date Extended term Annual percentage increased in monthly rent Payments for rent Right of use asset Lease liability obligation Gross proceeds from issuance of equity Number of shares issued, value Number of shares issued Purchase price per share Proceeds from issuance of common stock Proceeds from issuance of private placement Shares issued upon conversion Conversion price Preferred stock, contract terms Option to purchase common stock Option indexed to issuers equity shares value Option exercisable price Other liabilities fair value Additional piaid in capital Dividend paid Number of shares converted Stated value per share Option Indexed to Issuer's Equity, Settlement Alternatives Percentage of liquidated damages Liquidated damages Percentage of interest payable on liquidated damages Loss contingency, damages sought, value Loss contingency accrual provision Schedule of Stock by Class [Table] Class of Stock [Line Items] Dividend description Dividend rate per share Description of stock split ratio Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table] Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] Total employee stock-based compensation Stock Options, Outstanding at beginning of year Weighted-Average Exercise Price, Outstanding at beginning of year Stock Options, Granted Weighted-Average Exercise Price, Granted Stock Options, Exercised Weighted-Average Exercise Price, Exercised Stock Options, Expired/Forfeited Weighted-Average Exercise Price, Expired/Forfeited Stock Options, Outstanding at end of year Weighted-Average Exercise Price, Outstanding at end of year Stock Options, Exercisable at end of year Weighted average fair value of stock options granted Range of Exercise Prices, Lower Range Range of Exercise Prices, Upper Range Number of Options Outstanding Weighted-Average Remaining Contractual Life (years) Weighted-Average Exercise Price Number of Options Exercisable Weighted-Average Remaining 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Expired Weighted-Average Exercise Price, Expired Weighted-Average Exercise Price, Exercisable at end of year Stock Options, Weighted average fair value of stock options granted Shares issued, shares Warrants intrinsic value Common Stock, stated value per share Stockholders rights description Preferred stock, redemption price per share Net operating loss carryforwards Tax credit carryforwards Equipment, furnishings and other Total deferred tax assets Deferred tax liabilities Net deferred tax assets Valuation allowance Deferred tax assets Federal benefit at statutory rate State income taxes, net of Federal taxes State credits Warrant liabilities Other permanent differences Provision related to change in valuation allowance Federal rate adjustment NQ Options Current year tax credit NOL Adjustments Termination/Cancellation of Equity Compensation Awards Return to provision Other, net Provision for Income taxes Operating Loss Carryforwards [Table] Operating Loss Carryforwards [Line Items] 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Innovivel [Member] Increase decrease in reduction of right of use assets. Common stock market price premium percentage. 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Cover - USD ($)
$ in Millions
 12 Months Ended
Dec. 31, 2022
Mar. 20, 2023
Jun. 30, 2022
Document Type 10-K    
Amendment Flag false    
Document Annual Report true    
Document Transition Report false    
Document Period End Date Dec. 31, 2022    
Document Fiscal Period Focus FY    
Document Fiscal Year Focus 2022    
Current Fiscal Year End Date --12-31    
Entity File Number 000-15327    
Entity Registrant Name LadRx Corporation    
Entity Central Index Key 0000799698    
Entity Tax Identification Number 58-1642740    
Entity Incorporation, State or Country Code DE    
Entity Address, Address Line One 11726 San Vicente Blvd    
Entity Address, Address Line Two Suite 650    
Entity Address, City or Town Los Angeles    
Entity Address, State or Province CA    
Entity Address, Postal Zip Code 90049    
City Area Code (310)    
Local Phone Number 826-5648    
Entity Well-known Seasoned Issuer No    
Entity Voluntary Filers No    
Entity Current Reporting Status Yes    
Entity Interactive Data Current Yes    
Entity Filer Category Non-accelerated Filer    
Entity Small Business true    
Entity Emerging Growth Company false    
Entity Shell Company false    
Entity Public Float     $ 4.0
Entity Common Stock, Shares Outstanding   46,587,391  
ICFR Auditor Attestation Flag false    
Auditor Firm ID 572    
Auditor Name Weinberg & Company    
Auditor Location Los Angeles, California    
Common Stock, $0.001 par value per share      
Title of 12(b) Security Common Stock, $0.001 par value per share    
Trading Symbol LADX    
Series B Junior Participating Preferred Stock Purchase Rights [Member]      
Title of 12(b) Security Series B Junior Participating Preferred Stock Purchase Rights    
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Consolidated Balance Sheets - USD ($)
Dec. 31, 2022
Dec. 31, 2021
Current assets:    
Cash and cash equivalents $ 1,374,992 $ 6,769,603
Insurance claim receivable 200,000
Prepaid expenses and other current assets 628,745 1,310,382
Total current assets 2,003,737 8,279,985
Equipment and furnishings, net 18,546 32,784
Other assets 7,703 16,836
Operating lease right-of-use assets 216,786 397,172
Total assets 2,246,772 8,726,777
Current liabilities:    
Accounts payable 975,944 1,470,652
Accrued expenses and other current liabilities 1,015,501 2,064,506
Current portion of operating lease obligations 196,081 198,819
Total current liabilities 2,187,526 3,733,977
Operating lease liabilities, net of current portion 33,526 216,381
Total liabilities 2,221,052 3,950,358
Preferred Stock, Series C 10% Convertible, $1,000 par value, 2,752 and 8,240 shares issued and outstanding at December 31, 2022 and 2021, respectively 1,343,684 4,022,700
Commitments and contingencies
Stockholders’ equity (deficit):    
Preferred Stock, $0.01 par value, 833,333 shares authorized, including 50,000 shares of Series B Junior Participating Preferred Stock; no shares issued and outstanding at December 31, 2022 and 2021, respectively
Common stock, $0.001 par value, 62,393,940 shares authorized; 45,037,391 and 38,780,038 shares issued and outstanding at December 31, 2022 and 2021, respectively 45,037 38,780
Additional paid-in capital 487,474,664 484,790,650
Accumulated deficit (488,837,665) (484,075,711)
Total stockholders’ equity (deficit) (1,317,964) 753,719
Total liabilities and stockholders’ equity (deficit) $ 2,246,772 $ 8,726,777
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Consolidated Balance Sheets (Parenthetical) - $ / shares
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Temporary equity, par value $ 1,000 $ 1,000
Temporary equity, shares issued 2,752 8,240
Temporary equity, shares outstanding 2,752 8,240
Preferred stock, par value $ 0.01 $ 0.01
Preferred stock, shares authorized 833,333 833,333
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 62,393,940 62,393,940
Common stock, shares issued 45,037,391 38,780,038
Common stock, shares outstanding 45,037,391 38,780,038
Series C Convertible Preferred Stock [Member]    
Preferred stock, dividend rate, percentage 10.00% 10.00%
Series B Junior Participating Preferred Stock [Member]    
Preferred stock, shares authorized 50,000 50,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
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Consolidated Statements of Operations - USD ($)
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Revenue:    
Licensing revenue
Expenses:    
General and administrative 4,545,884 5,966,415
Settlement with former Chief Executive Officer 6,096,597
Depreciation and amortization 15,004 13,978
Total operating expenses 4,560,888 12,076,990
Loss from operations (4,560,888) (12,076,990)
Other income (expense):    
Liquidated damages expense (1,109,653)
Forgiveness of accounts payable 351,241
Interest income 11,689 16,822
Other income (expense), net (2,615) (6,842)
Net Loss (4,200,573) (13,176,663)
Dividends paid on preferred shares (561,381) (171,668)
Net loss attributable to common stockholders $ (4,761,954) $ (13,348,331)
Basic and diluted loss per share $ (0.11) $ (0.35)
Basic and diluted weighted average shares outstanding 43,359,233 37,584,695
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Consolidated Statements of Stockholders' Equity (deficit) - USD ($)
Preferred Stock [Member]
Series B Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Total
Beginning balance, value at Dec. 31, 2020 $ 36,480 $ 479,561,860 $ (470,727,380) $ 8,870,960
Beginning Balance, shares at Dec. 31, 2020 36,480,038      
Issuance of common stock and preferred investment options $ 2,000 5,151,090 5,153,090
Issuance of common stock and preferred investment options, shares   2,000,000      
Exercise of stock options $ 300 77,700 78,000
Exercise of stock options, shares   300,000      
Preferred dividend (171,668) (171,668)
Net loss   (13,176,663) (13,176,663)
Ending balance, value at Dec. 31, 2021 $ 38,780 484,790,650 (484,075,711) 753,719
Ending balance, shares at Dec. 31, 2021 38,780,038      
Exercise of stock options $ 21 (21)
Exercise of stock options, shares   21,404      
Preferred dividend (561,381) (561,381)
Net loss (4,200,573) (4,200,573)
Issuance of common stock upon conversion of preferred shares   $ 6,236 2,672,780 2,679,016
Issuance of common stock upon conversion of preferred shares, shares   6,235,949      
Issuance of restricted stock from compensation and services 11,255 11,255
Ending balance, value at Dec. 31, 2022   $ 45,037 $ 487,474,664 $ (488,837,665) $ (1,317,964)
Ending balance, shares at Dec. 31, 2022 45,037,391      
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Consolidated Statements of Cash Flows - USD ($)
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Cash flows from operating activities:    
Net loss from operations $ (4,200,573) $ (13,176,663)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 15,004 13,978
Stock-based compensation expense 11,255
Changes in assets and liabilities:    
Insurance receivable 200,000 125,105
Prepaid expenses and other current assets 681,637 (215,707)
Reduction of right of-use assets 180,386 183,306
Accounts payable (494,708) 68,598
Other assets 9,133
Decrease in lease liabilities (185,593) (181,103)
Accrued expenses and other current liabilities (1,049,005) 873,596
Net cash used in operating activities (4,832,464) (12,308,890)
Cash flows from investing activities:    
Purchases of equipment and furnishings (766) (7,004)
Net cash used in investing activities (766) (7,004)
Cash flows from financing activities:    
Net proceeds from Security Purchase Agreement 9,175,790
Preferred stock dividend (561,381) (171,668)
Proceeds from the exercise of stock options 78,000
Net cash (used in ) provided by financing activities (561,381) 9,082,122
Net decrease in cash and cash equivalents (5,394,611) (3,233,772)
Cash and cash equivalents at beginning of year 6,769,603 10,003,375
Cash and cash equivalents at end of year 1,374,992 6,769,603
Supplemental disclosures of Cash Flow Information:    
Insurance claims to offset accounts payable $ 200,000
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Nature of Business
 12 Months Ended
Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Nature of Business

1. Nature of Business

 

LadRx Corporation (“LadRx” or the Company) is a biopharmaceutical research and development company specializing in oncology. The Company’s focus is on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel technologies that target chemotherapeutic drugs to solid tumors and reduce off-target toxicities. However, the Company’s research and development activities have been curtailed as they seek additional financing. During 2017, the Company’s discovery laboratory in Freiburg, Germany synthesized and tested over 75 rationally designed drug candidates with highly potent anti-cancer payloads, culminating in the creation of two distinct classes of compounds. Four lead candidates (LADR-7 through LADR-10) were selected based on in vitro and animal studies in several different cancer models, and based on stability and manufacturing feasibility. In addition, a novel companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates.

 

On June 1, 2018, the Company launched Centurion BioPharma Corporation (“Centurion”), a private subsidiary, and transferred all of its assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection with said transfer, the Company and Centurion entered into a Management Services Agreement whereby the Company agreed to render advisory, consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the Company for the cost of such services plus a 5% service charge. On December 21, 2018, LadRx announced that Centurion had concluded the pre-clinical phase of development for its four LADR™ drug candidates, and for its albumin companion diagnostic (ACDx™). As a result of completing this work, operations taking place at the pre-clinical laboratory in Freiburg, Germany were no longer needed and, accordingly, the lab was closed at the end of January 2019.

 

On March 9, 2022, Centurion merged with and into LadRx, with LadRx absorbing all of Centurion’s assets and continuing after the merger as the surviving entity (the “Merger”). The Merger was implemented through an agreement and plan of merger pursuant to Section 253 of the General Corporation Law of the State of Delaware and did not require approval from either our or Centurion’s stockholders. The Certificate of Ownership merging Centurion into LadRx was filed with the Secretary of State of Delaware on March 9, 2022.

 

Effective September 26, 2022, the Company changed its name from CytRx Corporation to LadRx Corporation pursuant to a Certificate of Amendment to our Certificate of Incorporation filed with the Secretary of State of Delaware. In accordance with the General Corporation Law of the State of Delaware (the “DGCL”), its board of directors approved the name change and the Certificate of Amendment. Pursuant to Section 242(b)(1) of the DGCL, stockholder approval was not required for the name change or the Certificate of Amendment.

 

We are a Delaware corporation, incorporated in 1985. Our corporate offices are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles, California 90049, and our telephone number is (310) 826-5648. Our web site is located at http://www.ladrxcorp.com. We do not incorporate by reference into this Annual Report the information on, or accessible through, our website, and you should not consider it as part of this Annual Report.

 

LADR Drug Discovery Platform and Centurion

 

The LADR Technology Offers the Opportunity for multiple pipeline drugs. The Company’s LADR™ (Linker Activated Drug Release) technology platform consists of an organic backbone that is attached to a chemotoxic agent. The purpose of the LADR™ backbone is to first target and deliver the chemotoxic agent to the tumor environment, and then to release the chemotoxic agent within the tumor. By delivering, concentrating, and releasing the chemotoxic agent within the tumor, one expects to reduce the off-target side-effects of the chemotherapeutic, which in turn allows for several-fold higher dosing of the chemotherapeutic to the patient. Being small organic molecules, the Company expects LADR-based drugs to offer the benefits of targeting the tumor without the complexity, side effects, and expense inherent in macromolecules such as antibodies and nanoparticles.

 

 

The Company’s LADR-based drugs use circulating albumin as the binding target and as the trojan horse to deliver the LADR™ drugs to the tumor. Albumin is the most abundant protein in plasma and accumulates inside tumors due to the aberrant vascular structure that exists within solid tumors. Tumors use albumin as a nutritional source and for transport of signaling and other molecules that are important to the maintenance and growth of the tumor, which makes albumin an excellent target for drugs that are intended for solid tumors.

 

The Company’s LADR™ development efforts are focused on two classes of ultra-high potency albumin-binding drugs. These LADR-based drugs, LADR7, 8, 9, and 10, combine the proprietary LADR™ backbone with novel derivatives of the auristatin and maytansinoid drug classes. Auristatin and maytansinoid are highly potent chemotoxins, and require targeting to the tumor for safe administration to humans, as is the case for the FDA-approved drugs Adcetris (auristatin antibody-drug-conjugate by Seagen) and Kadcyla (maytansine antibody-drug-conjugate by Genentech). We believe that LADR-based drugs offer the benefits of tumor targeting without the disadvantages of antibodies and other macromolecules, which include expense, complexity, and negative side effects. Additionally, albumin is a very well-characterized drug target, which we believe will reduce clinical and regulatory costs and risks.

 

The Company’s postulated mechanism of action for LADR-based drugs is as follows:

 

  ● after administration, the linker portion of the drug conjugate forms a rapid and specific covalent bond to the cysteine-34 position of circulating albumin;
  ● circulating albumin preferentially accumulates in tumors due to a mechanism called “Enhanced Permeability and Retention”, which results in lower exposure to the drug in noncancerous tissues of the heart, liver, and other organs;
  ● once localized at the tumor, the acid-sensitive linker of the LADR™ backbone is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and
  ● free active drug is then released within the tumor, causing tumor cell death.

 

The first-generation LADR-based drug is called aldoxorubicin. Aldoxorubicin is the drug doxorubicin attached to the first generation LADR™ backbone (LADRs 7-10 employ a next generation LADR™ backbone). Aldoxorubicin has been administered to over 600 human subjects in human clinical trials and has proven the concept of LADR™ in that several-fold more doxorubicin can be safely administered to patients when the doxorubicin is attached to LADR™ than when administered as native doxorubicin. Aldoxorubicin has been licensed to ImmunityBio, and is currently in a Phase II registrational intent trial for pancreatic cancer. Aldoxorubicin is expected to enter a Phase I/II trial for glioblastoma in 2022 or 2023.

 

The next generation LADR™ drugs are termed LADR7, 8, 9, and 10. A great deal of Investigational New Drug (“IND”) enabling work has already been accomplished on LADR7-10, including in-silico modeling, in-vitro efficacy testing in several different cancer models, in-vivo dosing, safety, and efficacy testing in several different cancer models in animals. We have also developed and proven manufacturability, an important step prior to beginning human clinical trials.

 

The IND-enabling work that remains prior to applying to the FDA for first-in-human studies for LADR7-10 is limited due to the extensive experimentation already completed. For example, in the case of LADR7, a manufacturing run under Good Manufacturing Practices (GMP) must be completed and some toxicology studies completed using the GMP material must be completed in animals. Toxicology studies with LADR7 have already been completed with non-GMP manufactured drug. Management estimates that these final IND-enabling activities for LADR7 would take approximately 12 months to complete, once funded and initiated, and that first-in-human dosing would be achieved within approximately 6-9 months after completion of the IND-enabling studies. Management further estimates that the cost to manufacture GMP material for one LADR™ drug, for example LADR7, complete all pre-IND studies, and to obtain an IND could be approximately $2M in direct costs, based on current estimates, representing a capital-efficient path to clinical entry.

 

 

Because the LADR™ backbone in future products would be the same as the LADR™ backbone in current product candidates, (i.e. the chemotoxin can be changed without changing the LADR™ backbone), management anticipates that future product candidates beyond LADR7-10 may enjoy abbreviated pre-clinical pathways to first-in-human. Such abbreviated pathways would be subject to FDA review and agreement.

 

The Company’s novel companion diagnostic, ACDx™ (albumin companion diagnostic) was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR™ lead assets. We have not yet determined whether the use of a companion diagnostic will be necessary or helpful, and plan to continue to investigate this question in parallel to the pre-clinical and clinical development of LADRs 7-10.

 

The LADR™ backbone and drugs that employ LADR™ are protected by domestic and international patents, and additional patents are pending.

 

Business Strategy for LADR™ Platform

 

Throughout 2022, with the assistance of oncology drug development experts, the Company has inventoried the IND-enabling data for LADRs 7-10, developed a strategy to complete the IND-enabling studies necessary for at least one LADR™ drug, and worked with vendors on establishing approximate time lines and costs to reach first-in-human dosing, inclusive of manufacturing, and completion of pre-IND studies and FDA filings, With this important groundwork completed, we believe that management is well situated to rapidly advance our next-generation LADR™ assets as soon as funding or partnering is achieved, and is working diligently to obtain funding and/or partnering of the LADR™ assets. Management will continue to explore in parallel both partnered and non-partnered funding and development strategies for LADR™ with a goal of obtaining the least costly capital possible to enable value inflection milestones.

 

Partnering of Aldoxorubicin

 

On July 27, 2017, the Company entered into an exclusive worldwide license with ImmunityBio, Inc. (formerly known as NantCell, Inc. (“ImmunityBio”)), granting to ImmunityBio the exclusive rights to develop, manufacture and commercialize aldoxorubicin in all indications, and the Company is no longer directly working on the development of aldoxorubicin. As part of the license agreement, ImmunityBio made a strategic investment of $13 million in LadRx common stock at $6.60 per share (adjusted to reflect our 2017 reverse stock split), a premium of 92% to the market price on that date. In connection therewith, the Company also issued ImmunityBio a warrant to purchase up to 500,000 shares of common stock at $6.60, which expired on January 26, 2019. The Company is entitled to receive up to an aggregate of $343 million in potential milestone payments, contingent upon achievement of certain regulatory approvals and commercial milestones. The Company is also entitled to receive ascending double-digit royalties for net sales for soft tissue sarcomas and mid to high single digit royalties for other indications. There can be no assurance that ImmunityBio will achieve such milestones, approvals or sales with respect to aldoxorubicin.

 

ImmunityBio is conducting an open-label, randomized, Phase 2 study of a combination of immunotherapy, aldoxorubicin and standard-of-care chemotherapy versus standard-of-care chemotherapy alone for the treatment of locally advanced or metastatic pancreatic cancer in patients who have had 1 or 2 lines of treatment (Cohorts A and B) or 3 or greater lines of treatment (Cohort C).

 

 

In January 2023, ImmunityBio announced positive results in its non-randomized fully-enrolled metastatic pancreatic cancer study in third-line or greater subjects (QUILT 88) showing that the overall survival rate for patients continues to be double compared to historical survival rates after two or more prior lines of therapy. The results were presented at the American Society of Clinical Oncology Gastrointestinal (ASCO GI) conference in San Francisco January 19-21, 2023. The median OS in this highly advanced group of patients, up to seven lines (N=83) of treatment, was 5.8 months (95% CI: 4.9, 6.4 months), exceeding the approximately 2- to 3-month historical median OS. In the third-line setting (N=41), the median OS in this group was 6.3 months (95% CI: 5.0, 7.2 months), more than doubling the historical OS. The baseline median CA 19-9 level (a marker of metastatic pancreatic disease) of the enrolled subjects (N=83) was very high at 4120 IU/ml, a significant increase from normal levels of 40 IU/ml. In subjects with CA 19-9 levels less than 4120 IU/ml (N=40), the median OS was 6.9 months (95% CI: 5.7,10.9).

 

In December 2022, Immunity Bio held a Type B meeting with the FDA to discuss the path for approval of this combination therapy for pancreatic cancer. The FDA advised ImmunityBio to conduct a randomized trial. This Phase 2, randomized, three-cohort, open-label study plans to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus low-dose chemotherapy in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and C, respectively, with Cohorts A and B having independent experimental and control arms. The primary objective of Cohorts A and B is progression-free survival (PFS) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS)

 

Aldoxorubicin has received Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (“FDA”) for the treatment of soft tissue sarcoma (“STS”). ODD provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other benefits.

 

ImmunityBio also lists ongoing clinical studies in glioblastoma; it is currently reviewing its options in STS.

 

Molecular Chaperone Assets (Orphayzme)

 

In 2011, LadRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme A/S (“Orphazyme”, formerly Orphazyme ApS) in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million in milestone payments upon the achievement of certain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any net sales of products derived from arimoclomol (the “2011 Arimoclomol Agreement”). Orphazyme transferred its rights and obligations under the 2011 Arimoclomol Agreement to KemPharm Denmark A/S (“KemPharm”), a wholly owned subsidiary of KemPharm Inc., in May 2022.

 

In May 2021, Orphazyme announced that the pivotal phase 3 clinical trial for arimoclomol in Amyotrophic Lateral Sclerosis did not meet its primary and secondary endpoints, reducing the maximum amount that LadRx currently has the right to receive under the 2011 Arimoclomol Agreement to approximately $100 million. Orphazyme also tested arimoclomol in Niemann-Pick disease Type C (“NPC”) and Gaucher disease, and following a Phase II/III trial submitted to the FDA a New Drug Application for the treatment of NPC with arimoclomol. On June 18, 2021, Orphazyme announced it had received a complete response letter (the “Complete Response Letter”) from the FDA indicating the need for additional data. In late October 2021, Orphazyme announced it held a Type A meeting with the FDA, at which the FDA recommended that Orphazyme submit additional data, information and analyses to address certain topics in the Complete Response Letter and engage in further interactions with the FDA to identify a pathway to resubmission. The FDA concurred with Orphazyme’s proposal to remove the cognition domain from the NPC Clinical Severity Scale (“NPCCSS”) endpoint, with the result that the primary endpoint is permitted to be recalculated using the 4- domain NPCCSS, subject to the submission of additional requested information which Orphazyme had publicly indicated that it intended to provide. To bolster the confirmatory evidence already submitted, the FDA affirmed that it would require additional in vivo or pharmacodynamic (PD)/pharmacokinetic (PK) data. Orphazyme planned to request a Type C Meeting with the FDA in the second quarter of 2022. Subject to discussions with the regulatory body, Orphazyme had publicly indicated that it planned to resubmit the NDA for arimoclomol in the second half of 2022.

 

 

Orphazyme had also submitted a Marketing Authorization Application (“MAA”) with the European Medicines Agency (the “EMA”). In February 2022, Orphazyme announced that although they had received positive feedback from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA, they were notified by the CHMP of a negative trend vote on the MAA for arimoclomol for NPC following an oral explanation. In March 2022 Orphazyme removed its application with the EMA. Orphazyme has publicly indicated that it will assess its strategic options and provide an update to the market at the applicable time.

 

On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately $5.2 million to KemPharm, a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (“CNS”) diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties on sales, were assumed by KemPharm. KemPharm is expected to continue the early access programs with arimoclomol, and to continue to pursue the potential approval of arimoclomol as a treatment option for NPC. KemPharm indicated it plans on resubmitting the NDA for arimoclomol in the first quarter of 2023. In February, 2023, KemPharm published positive data based on the recent completion of their four-year open-label safety trial that indicated arimoclomol may reduce the long-term progression of NPC. They plan on including these data as part of the updated NDA resubmission. It is also identifying a regulatory path forward with the EMA. KemPharm has recently re-branded to Zevra Therapeutics, Inc.

 

Going Concern

 

The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. During the year ended December 31, 2022, the Company incurred a net loss of $4.2 million, utilized cash in operations of $4.8 million, and the Company had a stockholders deficit of $1.3 million as of December 31, 2022. In addition, the Company has no recurring revenue. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

In order to fund our business and operations, we have relied primarily upon sales of our equity securities, including proceeds from the exercise of stock options and common stock purchase warrants and long-term loan financing. We also have received limited funding from our strategic partners and licensees. We will ultimately be required to obtain additional funding in order to execute our long-term business plans, although we do not currently have commitments from any third parties to provide us with long term debt or capital. We cannot assure that additional funding will be available on favorable terms, or at all. If we fail to obtain additional funding when needed, we may not be able to execute our business plans and our business may suffer, which would have a material adverse effect on our financial position, results of operations and cash flows. We have approximately $1.2 million of contractual obligations in 2023 and expect to pay these out of the Company’s balance sheet cash. We have a total of approximately $1.9 million of material contractual obligations beyond 2023.

 

If ImmunityBio obtains marketing approval and successfully commercializes aldoxorubicin, we anticipate it will take two years, and possibly longer, for us to generate significant recurring revenue, and we will be dependent on future financing until such time, if ever, as we can generate significant recurring revenue. There are also no certainties that KemPharm will be successful in obtaining FDA and EMA approval for arimoclomol or choose to commercialize arimoclomol. We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern. If we raise additional funds by issuing equity securities, dilution to stockholders may result and new investors could have rights superior to some or all of our existing equity holders. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available to us, we may have to liquidate some or all of our assets or to delay or reduce the scope of or eliminate some portion or all of our development programs or clinical trials.

 

Current Business Strategy

 

Currently, the Company is working on identifying partnership or financing opportunities for LADR™ ultra-high potency drug conjugates and their albumin companion diagnostic. We have concluded all research and development on LADR and its companion diagnostic and continue to focus on identifying these partnership or financing opportunities.

 
XML 22 R8.htm IDEA: XBRL DOCUMENT v3.23.1
Summary of Significant Accounting Policies
 12 Months Ended
Dec. 31, 2022
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

 

Basis of Presentation and Principles of Consolidation — The accompanying Consolidated Financial Statements are prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and accounting principles generally accepted in the United States (“GAAP”). The Consolidated Financial Statements include the accounts of LadRx Corporation and its wholly-owned subsidiary. All intercompany accounts are eliminated.

 

 

Revenue Recognition — Revenue consists of license fees from strategic alliances with pharmaceutical companies. During the years ended December 31, 2022 and 2021, no revenue was earned from license fees.

 

Cash Equivalents — The Company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. Cash equivalents consist primarily of amounts invested in certificates of deposit and money market accounts.

 

Equipment and Furnishings — Equipment and furnishings are stated at cost and depreciated using the straight-line method based on the estimated useful lives (generally three to five years for equipment and furniture) of the related assets. Whenever there is a triggering event that might suggest impairment, management evaluates the realizability of recorded long-lived assets to determine whether their carrying values have been impaired. The Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that the assets might be impaired and the non-discounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Any impairment loss is measured by comparing the fair value of the asset to its carrying amount.

 

Insurance recoveries — The Company has several policies with insurance underwriters that provide for the recovery of certain costs incurred by the Company. The Company’s policy is to record any liability as incurred, and then to record the estimated recovery from the insurance company for that cost as a receivable in accordance with terms of its existing policies. As of December 31, 2021, there were $200,000 of insurance recoveries that were collected in 2022. As of December 31, 2022, there were no amounts recoverable from its insurance company carriers under the terms of its policies.

 

Fair Value Measurements — Assets and liabilities recorded at fair value on the consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure the fair value. Level inputs are as follows:

 

Level 1 – quoted prices in active markets for identical assets or liabilities.

 

Level 2 – other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.

 

Level 3 – significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.

 

The Company considers carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments.

 

Patents and Patent Application Costs — Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are therefore expensed as incurred.

 

Net Income (Loss) Per Share of Common Stock — Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted earnings per share is computed by dividing the net income applicable to common stockholders by the weighted average number of shares of common stock outstanding plus the number of additional shares of common stock that would have been outstanding if all dilutive potential shares of common stock had been issued using the treasury stock method. Potential shares of common stock are excluded from the computation when their effect is antidilutive. The dilutive effect of potentially dilutive securities is reflected in diluted net income per share if the exercise prices were lower than the average fair market value of common stock during the reporting period.

 

 

 

   2022   2021 
   As of December 31, 
   2022   2021 
     
Options to acquire common stock   1,765,108    2,827,820 
Warrants to acquire common stock   4,167    4,167 
Convertible preferred stock   3,127,689    9,363,637 
Preferred investment option   11,363,637    11,363,637 
Shares excluded from computation of diluted loss per share   16,260,601    23,559,261 

 

Potentially dilutive stock options, warrants and securities from the table above were excluded from the computation of diluted net income (loss) per share, because the effect would be anti-dilutive.

 

Stock-based Compensation — The Company accounts for share-based awards to employees and nonemployees directors and consultants in accordance with the provisions of ASC 718, Compensation—Stock Compensation., and under the recently issued guidance following FASB’s pronouncement, ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Under ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur.

 

Research and Development Expenses — Research and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including licenses and drugs, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology developed for use in its products is expensed as incurred until technological feasibility has been established.

 

Income Taxes — The Company accounts for income taxes in accordance with the provisions of FASB ASC 740-10, Income Taxes, (“ASC 740”) which requires the recognition of deferred tax assets and liabilities for taxable temporary differences and deferred tax assets for deductible temporary differences and operating loss carry-forwards using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit or expense is recognized as a result of changes in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all of any deferred tax assets will not be realized.

 

The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expenses.

 

Concentrations of Risks — Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and short-term investments. The Company maintains cash and cash equivalents in large well-capitalized financial institutions and the Company’s investment policy disallows investment in any debt securities rated less than “investment-grade” by national ratings services. The Company has not experienced any losses on its deposits of cash or cash equivalents or its short-term investments. Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances.

 

Use of Estimates — Preparation of the Company’s consolidated financial statements in conformance with U.S. GAAP requires the Company’s management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The significant estimates in the Company’s consolidated financial statements relate to the valuation of equity awards, recoverability of deferred tax assets, insurance claims and estimated useful lives of fixed assets. The Company bases estimates and assumptions on historical experience, when available, and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis, and its actual results may differ from estimates made under different assumptions or conditions.

 

 

New Accounting Pronouncements — In June 2016, the FASB issued ASU No. 2016-13, Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”). The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The standard is effective for interim and annual reporting periods beginning after December 15, 2022. The adoption of ASU 2016-13 is not expected to have a material impact on the Company’s financial position, results of operations, and cash flows.

 

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. Early adoption is permitted, including adoption in an interim period. If an entity elects to early adopt ASU 2021-04 in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The adoption of ASU 2021-04 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

Other recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission (“SEC”) did not, or are not expected to, have a material impact on the Company’s consolidated financial statements and related disclosures.

 
XML 23 R9.htm IDEA: XBRL DOCUMENT v3.23.1
Foreign Currency Remeasurement
 12 Months Ended
Dec. 31, 2022
Foreign Currency [Abstract]  
Foreign Currency Remeasurement

3. Foreign Currency Remeasurement

 

The U.S. dollar has been determined to be the functional currency for the net assets of the Company’s German operations. The transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and current exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). The Company recognized a loss of approximately $(2,889) and $(22,440) for the years ended December 31, 2022 and 2021, respectively.

 

As of December 31, 2022 and 2021, the Company’s cash balances consisted of the following:

 

   2022   2021 
U.S. Dollars  $1,374,992   $6,671,404 
Euros – in US $   —    98,199 
Cash Balance  $1,374,992   $6,769,603 

 
XML 24 R10.htm IDEA: XBRL DOCUMENT v3.23.1
Equipment and Furnishings
 12 Months Ended
Dec. 31, 2022
Property, Plant and Equipment [Abstract]  
Equipment and Furnishings

4. Equipment and Furnishings

 

Equipment and furnishings at December 31, 2022 and 2021 consist of the following:

 

   2022   2021 
Equipment and furnishings  $48,742   $59,728 
Less — accumulated depreciation   (30,196)   (26,944)
Equipment and furnishings, net  $18,546   $32,784 

 

Depreciation and amortization expense for the years ended December 31, 2022 and 2021 were $15,004 and $13,978, respectively. During the year ended December 31, 2022, fully depreciated equipment and furnishings of $11,752 were written off.

 

 
XML 25 R11.htm IDEA: XBRL DOCUMENT v3.23.1
Accrued Expenses and Other Current Liabilities
 12 Months Ended
Dec. 31, 2022
Payables and Accruals [Abstract]  
Accrued Expenses and Other Current Liabilities

5. Accrued Expenses and Other Current Liabilities

 

Accrued expenses and other current liabilities at December 31, 2022 and 2021 are summarized below.

 

   2022   2021 
Professional fees  $77,785   $208,345 
Liquidated damages– see Note 7   —    615,253 
Payable to former CEO   50,191    256,115 
Wages, bonuses and employee benefits   152,990    261,375 
Royalties and milestones   716,155    716,155 
Other   18,380    7,263 
Total  $1,015,501   $2,064,506 

 
XML 26 R12.htm IDEA: XBRL DOCUMENT v3.23.1
Leases
 12 Months Ended
Dec. 31, 2022
Leases  
Leases

6. Leases

 

We lease office space and office copiers related primarily to the Company’s administrative activities. The Company accounts for leases under ASC 842, Leases, which requires an entity to recognize a right-of-use asset and a lease liability for virtually all leases.

 

In January 2020, the Company signed a new four-year office lease which covers approximately 2,771 square feet of office and storage space. This lease is effective March 1, 2020 and extends through February 29, 2024, with a right to extend the term for an additional five-year period, subject to the terms and conditions set forth in the lease agreement. The monthly rent is $14,340, subject to annual increases of 3.5 percent. In February 2020, the Company renewed its additional storage space lease, which requires us to make monthly payments of $1,405, subject to a 2.5 percent annual increase. The Company recorded a right of use asset and lease liability obligation of $715,310 upon inception of these leases. The Company also reclassified a previously existing right-of-use asset of $66,271 from other assets to right-of-use asset.

 

As of December 31, 2022, the balance of right-of-use assets was approximately $216,800, and the balance of total lease liabilities was approximately $229,600.

 

Future minimum lease payments under non-cancelable operating leases under ASC 842 as of December 31, 2022 are as follows:

 

  

Operating

Lease Payments

 
     
Jan 2023 – Dec 2023  $200,927 
Jan 2024 – Dec 2024   33,673 
Total future minimum lease payments   234,600 
      
Less: present value adjustment   (4,993)
Operating lease liabilities at December 31, 2022   229,607 
Less: current portion of operating lease liabilities   (196,081)
Operating lease liabilities, net of current portion  $33,526 

 

 

The components of rent expense and supplemental cash flow information related to leases for the period are as follows:

 

  

Year Ended

December 31, 2022

 
Lease Cost     
      
Operating lease cost (included in General and administrative expenses in the Company’s Consolidated Statements of Operations)  $197,154 
      
Other information     
      
Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2022  $180,786 
      
Weighted average remaining lease term – operating leases (in years)   1.2 
      
Average discount rate   3.5%

 
XML 27 R13.htm IDEA: XBRL DOCUMENT v3.23.1
Financing Under Security Purchase Agreement
 12 Months Ended
Dec. 31, 2022
Equity Method Investments and Joint Ventures [Abstract]  
Financing Under Security Purchase Agreement

7. Financing Under Security Purchase Agreement

 

On July 13, 2021, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional investor (the “Investor”) for aggregate gross proceeds of $10 million and net proceeds of approximately $9.2 million. The transaction closed on July 16, 2021. Under the Purchase Agreement, the Company sold and issued (i) 2 million shares of its common stock at a purchase price of $0.88 per share for total gross proceeds of approximately $1.76 million in a registered direct offering (the “Registered Direct Offering”) and (ii) 8,240 shares of Series C 10.00% Convertible Preferred Stock (the “Preferred Stock”) at a purchase price of $1,000 per share, for aggregate gross proceeds of approximately $8.24 million, in a concurrent private placement (the “Private Placement” and, together with the Registered Direct Offering, the “July 2021 Offerings”). The shares of the Preferred Stock are convertible, upon shareholder approval as described below, into an aggregate of up to 9,363,637 shares of common stock at a conversion price of $0.88 per share. Holders of the Preferred Stock shall be entitled to receive, and the Company shall pay, cumulative dividends at the rate per share (as a percentage of the stated value per share) of 10.00% per annum, payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the date of issuance. The terms of the Preferred Stock include beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock. LadRx also issued to the Investor an unregistered preferred investment option (the “Preferred Investment Option”) that allows for the purchase of up to 11,363,637 shares of common stock for additional gross proceeds of approximately $10 million if the Preferred Investment Option is exercised in full. The exercise price for the Preferred Investment Option is $0.88 per share. The Preferred Investment Option has a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval.

 

The Company accounted for these transactions as a single transaction for accounting purposes and allocated total proceeds to the respective instruments based upon the relative fair value of each instrument. The Company determined that the relative fair value of (i) the 2,000,000 shares of the common stock issued was $859,218, (ii) the relative fair value of the 8,240 shares of Preferred Stock was $4,022,700, and (iii) the relative fair value of the Preferred Investment Option was $4,293,872 based upon a Black Scholes valuation model. As such, the Company recorded as Additional Paid in Capital the fair value of the common stock and Preferred Investment Option of $5,153,090, and the fair value of the Series C Preferred Stock was $4,022,700 which has been reflected as mezzanine (temporary equity) due to certain clauses of the Securities Purchase Agreement.

 

On October 1, 2021, the Company paid a quarterly 10% dividend to the Investor in the amount of $171,668. In 2022, the Company paid the following dividends: on January 1, 2022, $206,000, on April 1, 2022, $202,567, on July 1, 2022, $84,005 and on October 1, 2022, $68,809 for a total of $561,381.

 

On March 15, 2022, at a special meeting of its stockholders which was originally opened and subsequently adjourned on September 23, 2021, the Company’s stockholders, by an affirmative vote of the majority of the Company’s outstanding shares of capital stock, approved the amendment to the Company’s Restated Certificate of Incorporation to effect an increase in the number of shares of authorized common stock, par value $0.001 per share, from 41,666,666 shares to 62,393,940 shares, and to make a corresponding change to the number of authorized shares of capital stock in order to comply with the Company’s contractual obligations under the Purchase Agreement.

 

 

On March 28, 2022, the Investor converted 4,120 shares of the Series C Preferred Stock in accordance with the initial terms of the agreement and received 4,681,819 common shares. On May 15, 2022, the Investor converted a further 1,368 shares of the Series C Preferred Stock and received 1,554,130 common shares. As of December 31, 2022, there were 2,752 shares of Series C Preferred Stock outstanding, convertible into 3,127,689 shares of common stock.

 

Terms of Series C Preferred Stock

 

Under the Certificate of the Designations, Powers, Preferences and Rights of Series C 10.00% Convertible Preferred Stock (the “Certificate of Designations”), each share of Series C Preferred Stock will be convertible, subject to the Beneficial Ownership Limitation (as defined below), at either the holder’s option or at the Company’s option (a “Company Initiated Conversion”) at any time following stockholder approval having been obtained to amend our restated certificate of incorporation to increase the number of authorized shares of common stock above 41,666,666 (the “Stockholder Approval”), into common stock at a conversion rate equal to the quotient of (i) the Series C Stated Value of $1,000 (the “Series C Stated Value”) plus, in the case of a Company Initiated Conversion, all accrued and accumulated and unpaid dividends on such share of Series C Preferred Stock, divided by (ii) the initial conversion price of $0.88, subject to specified adjustments for stock splits, stock dividends, reclassifications or other similar events as set forth in the Certificate of Designations.

 

The Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of common stock upon conversion that would result in the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of common stock outstanding immediately after giving effect to the conversion (the “Beneficial Ownership Limitation”), except that upon notice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of common stock after converting the holder’s shares of Series C Preferred Stock, provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of outstanding shares of the common stock outstanding immediately after giving effect to the issuance of shares of common stock upon conversion of the shares of Series C Preferred Stock held by the holder and provided that any increase in the Beneficial Ownership Limitation shall not be effective until 61 days following notice to the Company

 

Each holder of shares of Preferred Stock is entitled to receive dividends, commencing from the date of issuance of the Preferred Stock. Such dividends may be paid only when, as and if declared by the Board of Directors of the Company (the “Board”), out of assets legally available therefore, quarterly in arrears on the first day of January, April, July and October in each year, commencing on the date of issuance, at the dividend rate of 10.00% per year. Such dividends are cumulative and continue to accrue on a daily basis whether or not declared and whether or not we have assets legally available therefore.

 

Under the Certificate of Designations, each share of Series C Preferred Stock carries a liquidation preference equal to the Series C Stated Value plus accrued and unpaid and accumulated dividends thereon. Such liquidation preference is payable upon certain change in control transactions and accordingly, this instrument is classified as mezzanine (temporary equity).

 

The holders of the Series C Preferred Stock may vote their shares of Preferred Stock on an as-converted basis, subject to the Beneficial Ownership Limitation (which Beneficial Ownership Limitation shall be calculated on a basis which includes the number of shares of common stock which are issuable upon conversion of the unconverted Series C Stated Value beneficially owned by a holder or any of its affiliates or attribution parties on all matters submitted to the holders of common stock for approval). The Company may not take the following actions without the prior consent of the holders of at least a majority of the Preferred Stock then outstanding: (a) alter or change adversely the powers, preferences or rights given to the Preferred Stock or alter or amend the Certificate of Designations, (b) authorize or create any class of stock ranking as to dividends, redemption or distribution of assets upon a Liquidation (as defined in the Certificate of Designations) senior to, or otherwise pari passu with, the Preferred Stock, (c) amend its Certificate of Incorporation or other charter documents in any manner that adversely affects any rights of the holders of the Preferred Stock, (d) increase the number of authorized shares of Preferred Stock, or (e) enter into any agreement with respect to any of the foregoing.

 

 

Terms of Preferred Investment Option

 

The Preferred Investment Option to purchase up to 11,363,637 shares of common stock is exercisable at a price of $0.88 per share. The Preferred Investment Option have a term of five and one-half years from the Authorized Share Increase Date. The holders of the Preferred Investment Option may exercise the Preferred Investment Option on a cashless basis, solely to the extent there is no effective registration statement registering, or the prospectus in such registration statement is not available for the resale of the shares of common stock issuable at the time of exercise. The Company is prohibited from effecting an exercise of any Preferred Investment Option to the extent that such exercise would result in the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of common stock outstanding immediately after giving effect to the exercise of the Preferred Investment Options by the holder (the “PIO Beneficial Ownership Limitation”), except that upon notice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of Common Stock after exercising the holder’s Preferred Investment Option, provided that the PIO Beneficial Ownership Limitation in no event exceeds 9.99% of the number of outstanding shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of common stock upon exercise of the Preferred Investment Option held by the holder and provided that any increase in the PIO Beneficial Ownership Limitation shall not be effective until 61 days following notice to the Company. The Preferred Investment Option provides for a Black-Scholes payout upon certain fundamental change transactions relating to the Company, as specified therein. If the fundamental change transaction is within the control of the Company, the payout will be in cash. Otherwise, the payout will be in the same form of consideration received by the common stockholders as a result of this transaction.

 

Registration Rights Agreement

 

In connection with the July 2021 Offerings, the Company entered into a registration rights agreement, dated as of July 13, 2021 (the “Registration Rights Agreement”), with the investor named therein, pursuant to which the Company will undertake to file, within five calendar days of the date of the filing of the proxy statement seeking the Stockholder Approval, a resale registration statement to register the shares of common stock issuable upon: (i) the conversion of the Preferred Stock sold in the Private Placement and (ii) the exercise of the Preferred Investment Option (the “Registrable Securities”); and to cause such registration statement to be declared effective under the Securities Act as promptly as possible after the filing thereof, but in any event no later than 75 days following the pricing date of this offering, or no later than 105 days following such date in the event of a “full review” by the SEC, and shall use its reasonable best efforts to keep such registration statement continuously effective under the Securities Act until the date that all Registrable Securities covered by such registration statement have been sold or are otherwise able to be sold pursuant to Rule 144. The Registration Rights Agreement provided for liquidated damages to the extent that the Company does not file or maintain a registration statement in accordance with the terms thereof. The registration rights agreement entered into between us and the Investor on July 13, 2021, contains a triggering event which would require us to pay to any holder of the Preferred Stock an amount in cash, as partial liquidated damages and not as a penalty, on a monthly basis equal to the product of 2.0% multiplied by the aggregate subscription amount paid by such holder for shares of Preferred Stock pursuant to the Purchase Agreement; provided, however, that such partial liquidated damages shall not exceed 24% of the aggregate subscription amounts paid by such holders pursuant to the Purchase Agreement, or $1,977,600. If we fail to pay any partial liquidated damages within seven days after the date payable, we will be required to pay interest on any such amounts at a rate equal to the lesser of 18% per annum or the maximum rate permitted by applicable law.

 

During the year ended December 31, 2021, the Company did not have enough authorized shares to issue the issuable shares under the Preferred Stock and Preferred Investment Option. The Company attempted, but was unsuccessful, to obtain stockholders’ approval for the increase in authorized shares, and accordingly, the Company was unable to meet its registration rights obligation as of December 31, 2021. As such, the Company recognized an aggregate of approximately $1.1 million in liquidated damages during the year ended December 31, 2021, of which includes a provision of $615,123 as an accrual for estimated damages until stockholders’ approval is achieved and the Registration Statement is filed. On March 15, 2022, the Company received its stockholders’ approval to increase its authorized shares and filed a certificate of amendment to its Certificate of Incorporation to increase the number of authorized shares from 41,666,666 shares to 63,227,273 shares on the same date. The Company filed its registration statement registering the shares underlying the Registrable Securities on March 23, 2022 and has provided for liquidated damages through that date. As of December 31, 2022, all liquidated damages had been paid and we no longer have any liabilities related to the Registration Rights Agreement.

 

 
XML 28 R14.htm IDEA: XBRL DOCUMENT v3.23.1
Series D Preferred Stock
 12 Months Ended
Dec. 31, 2022
Equity [Abstract]  
Series D Preferred Stock

8. Series D Preferred Stock

 

On May 19, 2022, the Board declared a dividend of one one-thousandth of a share of Series D Preferred Stock, par value $0.01 per share (“Series D Preferred Stock”), for each outstanding share of Company’s Common Stock to stockholders of record at 5:00 p.m. Eastern Time on May 20, 2022. The Certificate of Designation of Series D Preferred Stock (the “Series D Certificate of Designation”) provides that all shares of Series D Preferred Stock that are not present in person or by proxy at any meeting of stockholders held to vote on the Reverse Stock Split (as defined in the Series D Certificate of Designation) and the Adjournment Proposal (as defined in the Series D Certificate of Designation) as of immediately prior to the opening of the polls at such meeting (the “Initial Redemption Time”) will automatically be redeemed in whole, but not in part, by the Company at the Initial Redemption Time without further action on the part of the Company or the holder of shares of Series D Preferred Stock (the “Initial Redemption”). Any outstanding shares of Series D Preferred Stock that have not been redeemed pursuant to an Initial Redemption will be redeemed in whole, but not in part, (i) if such redemption is ordered by the Board in its sole discretion, automatically and effective on such time and date specified by the Board in its sole discretion or (ii) automatically upon the approval by the Company’s stockholders of the Reverse Stock Split at any meeting of the stockholders held for the purpose of voting on such proposal (the “Subsequent Redemption”).

 

On July 27, 2022, at the Company’s 2022 Annual Meeting of Stockholders, the Company’s stockholders approved a proposal to authorize the Board, in its discretion but prior to July 26, 2023, to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of all of the outstanding shares of the Company’s Common Stock, at a ratio in the range of 1-for-2 to 1-for-100, with such ratio to be determined by the Board, and all outstanding shares of Series D Preferred Stock were automatically redeemed. As a result, no shares of Series D Preferred Stock remain outstanding. The stock split is not yet effective as of the date of this filing.

 
XML 29 R15.htm IDEA: XBRL DOCUMENT v3.23.1
Stock Compensation
 12 Months Ended
Dec. 31, 2022
Share-Based Payment Arrangement [Abstract]  
Stock Compensation

9. Stock Compensation

 

Stock Options

 

The Company has a 2008 Stock Incentive Plan under which 5 million shares of common stock are reserved for issuance. As of December 31, 2022, there were approximately 1.3 million shares subject to outstanding stock options and approximately 0.8 million shares outstanding related to restricted stock grants issued from the 2008 Plan. This plan expired on November 20, 2018 and thus no further shares are available for future grant under this plan.

 

In November 2019, the Company adopted a 2019 Stock Incentive Plan under which 5.4 million shares of common stock are reserved for issuance. As of December 31, 2022, there were 0.5 million shares subject to outstanding stock options and 25,000 shares outstanding related to restricted stock grants from the 2019 Plan. This Plan expires on November 14, 2029.

 

All outstanding options issued to employees, directors and consultants were fully vested in 2020. As such, no further stock compensation expense was recognized during the year ended December 31, 2022 and 2021.

 

No stock options were issued to employees, directors and consultants in 2022 and 2021.

 

During the year ended December 31, 2022, options to acquire 50,000 shares of common stock were exercised on a cashless basis in exchange for 21,404 shares of common stock. During the year ended December 31, 2021, options to acquire 300,000 shares of common stock were exercised resulting in net proceeds of $78,000.

 

The following table sets forth the total stock-based compensation expense resulting from restricted stock included in our Consolidated Statements of Operations for the years ended December 31, 2022 and 2021:

 

   Years Ended December 31, 
   2022   2021 
General and administrative – employee  $11,255   $— 
Total employee stock-based compensation  $11,255   $— 

 

 

 

   Stock Options  

Weighted Average

Exercise Price

 
   2022   2021   2022   2021 
Outstanding — beginning of year   2,462,820    2,801,270   $7.68   $7.68 
Granted   —    —    —    — 
Exercised   (50,000)   (300,000)   0.26    0.26 
Forfeited   —    —    —    — 
Expired   (1,012,712)   (38,450)   10.67    14.62 
Outstanding — end of year   1,400,108    2,462,820    7.18    7.68 
Exercisable at end of year   1,400,108    2,462,820   $7.18   $7.68 
Weighted average fair value of stock options granted during the year:  $—   $—           

 

Presented below is the Company’s non-employee stock option activity:

 

   Stock Options  

Weighted Average

Exercise Price

 
   2022   2021   2022   2021 
Outstanding — beginning of year   365,000    365,000   $5.49   $5.49 
Granted   —    —    —    — 
Exercised   —    —   —    — 
Expired/Forfeited   —    —    —    — 
Outstanding — end of year   365,000    365,000    5.49    5.49 
Exercisable at end of year   365,000    365,000   $5.49   $5.49 
Weighted average fair value of stock options granted during the year:  $—   $—           

 

 

The following table summarizes significant ranges of outstanding stock options under the two plans at December 31, 2022:

 

Range of
Exercise
Prices		     Number of Options     Weighted-Average Remaining Contractual Life (years)     Weighted-Average Exercise Price     Number of Options Exercisable     Weighted-Average Remaining Contractual Life (years)     Weighted-Average Exercise Price  
$ 0.26 - $1.00       500,000       6.95     $ 0.26       500,000       6.95     $ 0.26  
$ 1.01 - $2.00       472,617       4.96     $ 1.75       472,617       4.96     $ 1.75  
$ 2.01 - $3.00       161,388             3.96     $ 2.58       161,388           3.96     $            2.58  
$ 3.01 - $41.46       631,103       2.16     $            16.93       631,103       2.16     $ 16.93  
          1,765,108       4.43     $ 6.83       1,765,108       4.43     $ 6.83  

 

There was no aggregate intrinsic value of the outstanding options and options vested as of December 31, 2022.

 

 

Restricted Stock

 

No restricted stock was granted in 2022. In December 2021, the Company granted to Jennifer Simpson, who serves on our Board of Directors, 25,000 shares of restricted common stock, pursuant to the 2019 Plan. This restricted stock vests on the first anniversary of the date of the grant. The fair value of the restricted stock is based on the market price of the Company’s shares on the grant date less the par value received as consideration. The fair value of the restricted stock on the grant date was $11,200. As of December 31, 2022, there is no unamortized stock compensation.

 

Equity-Classified Warrants

 

A summary of the Company’s warrant activity and related information for the years ended December 31, 2022 and 2021 are shown below.

 

   Warrants  

Weighted Average

Exercise Price

 
   2022   2021   2022   2021 
Outstanding — beginning of year   4,167    4,167   $33.60   $33.60 
Granted   —    —    —    — 
Exercised   —    —    —    — 
Forfeited   —    —    —    — 
Expired   —    —    —    — 
Outstanding — end of year   4,167    4,167    33.60    33.60 
Exercisable at end of year   4,167    4,167   $33.60   $33.60 
Weighted average fair value of warrants granted during the year:  $—   $—           

 

 

The outstanding warrants as of December 31, 2022 had no intrinsic value.

 
XML 30 R16.htm IDEA: XBRL DOCUMENT v3.23.1
Stockholder Protection Rights Plan
 12 Months Ended
Dec. 31, 2022
Stockholder Protection Rights Plan  
Stockholder Protection Rights Plan

9. Stockholder Protection Rights Plan

 

On December 13, 2019, the Board of Directors of the Company, authorized and declared a dividend of one right (a “Right”) for each of the Company’s issued and outstanding shares of common stock, par value $0.001 per share. The dividend was paid to the stockholders of record at the close of business on December 23, 2019. Each Right entitled the registered holder, subject to the terms of the Original Rights Agreement (as defined below), to purchase from the Company one one-thousandth of a share of the Company’s Series B Junior Participating Preferred Stock, par value $0.01 per share (the “Preferred Stock”), at a price of $5.00 (the “Purchase Price”), subject to certain adjustments. The description and terms of the Rights were set forth in the Rights Agreement, dated as of December 13, 2019 (the “Original Rights Agreement”), by and between the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent (the “Rights Agent”).

 

On November 12, 2020, the Board approved an amendment and restatement of the Original Rights Agreement (as amended and restated, the “Amended and Restated Rights Agreement”) to effect certain changes to the Original Rights Agreement, including (i) reducing the duration to a term of three years, subject to certain earlier expiration as described in more detail below, and (ii) lowering the beneficial ownership threshold at which a person or group of persons becomes an Acquiring Person (as defined below) to 4.95% or more of the Company’s outstanding shares of Common Stock, subject to certain exceptions. The Amended and Restated Rights Agreement is designed to discourage (i) any person or group of persons from acquiring beneficial ownership of more than 4.95% of the Company’s shares of Common Stock and (ii) any existing stockholder currently beneficially holding 4.95% or more of the Company’s shares of Common Stock from acquiring additional shares of the Company’s Common Stock.

 

The purpose of the Amended and Restated Rights Agreement is to protect value by preserving the Company’s ability to utilize its net operating losses and certain other tax attributes (collectively, the “Tax Benefits”) to offset potential future income tax obligations. The Company’s ability to use its Tax Benefits would be substantially limited if it experiences an “ownership change,” as such term is defined in Section 382 of the Internal Revenue Code of 1986, as amended (the “Tax Code”). A corporation generally will experience an ownership change if the percentage of the corporation’s stock owned by its “5-percent shareholders,” as defined in Section 382 of the Tax Code, increases by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. The Amended and Restated Rights Agreement is intended to reduce the likelihood the Company would experience an ownership change under Section 382 of the Tax Code.

 

 

The Rights will not be exercisable until the earlier to occur of (i) the close of business on the tenth business day after a public announcement or filing that a person or group of affiliated or associated persons has become an “Acquiring Person,” which is defined as a person or group of affiliated or associated persons that, at any time after the date of the Amended and Restated Rights Agreement, has acquired, or obtained the right to acquire, beneficial ownership of 4.95% or more of the Company’s outstanding shares of Common Stock, subject to certain exceptions or (ii) the close of business on the tenth business day after the commencement of, or announcement of an intention to commence, a tender offer or exchange offer the consummation of which would result in any person becoming an Acquiring Person (the earlier of such dates being called the “Distribution Date”) (provided, however, that if such tender or exchange offer is terminated prior to the occurrence of the Distribution Date, then no Distribution Date shall occur as a result of such tender or exchange offer).

 

The Rights, which are not exercisable until the Distribution Date, will expire at or prior to the earliest of (i) the close of business on November 16, 2023; (ii) the time at which the Rights are redeemed pursuant to the Amended and Restated Rights Agreement; (iii) the time at which the Rights are exchanged pursuant to the Amended and Restated Rights Agreement; (iv) the time at which the Rights are terminated upon the occurrence of certain mergers or other transactions approved in advance by the Board; and (v) the close of business on the date set by the Board following a determination by the Board that (x) the Amended and Restated Rights Agreement is no longer necessary or desirable for the preservation of the Tax Benefits or (y) no Tax Benefits are available to be carried forward or are otherwise available (the earliest of (i), (ii), (iii), (iv) and (v) is referred to as the “Expiration Date”).

 

Each share of Preferred Stock will be entitled, when, as and if declared, to a preferential per share quarterly dividend payment equal to the greater of (i) $1.00 per share or (ii) an amount equal to 1,000 times the dividend declared per share of Common Stock. Each share of Preferred Stock will entitle the holder thereof to 1,000 votes on all matters submitted to a vote of the stockholders of the Company. In the event of any merger, consolidation or other transaction in which shares of Common Stock are converted or exchanged, each share of Preferred Stock will be entitled to receive 1,000 times the amount received per one share of Common Stock.

 

The Purchase Price payable, and the number of shares of Preferred Stock or other securities or property issuable, upon exercise of the Rights are each subject to adjustment from time to time to prevent dilution (i) in the event of a stock dividend on, or a subdivision, combination or reclassification of the Preferred Stock, (ii) upon the grant to holders of the Preferred Stock of certain rights or warrants to subscribe for or purchase Preferred Stock or convertible securities at less than the then-current market price of the Preferred Stock or (iii) upon the distribution to holders of the Preferred Stock of evidences of indebtedness or assets (excluding regular periodic cash dividends or dividends payable in Preferred Stock) or of subscription rights or warrants (other than those referred to above). The number of outstanding Rights and the number of one one-thousandths of a share of Preferred Stock issuable upon exercise of each Right are also subject to adjustment in the event of a stock split, reverse stock split, stock dividends and other similar transactions involving the Common Stock.

 

In the event that any person or group of affiliated or associated persons becomes an Acquiring Person, each holder of a Right, other than the Rights beneficially owned by the Acquiring Person, affiliates and associates of the Acquiring Person and certain transferees thereof (which will thereupon become null and void), will thereafter have the right to receive upon exercise of a Right that number of shares of Common Stock having a market value of two times the Purchase Price.

 

In the event that, after a person or a group of affiliated or associated persons has become an Acquiring Person, the Company is acquired in a merger or other business combination transaction, or 50% or more of the Company’s assets or earning power are sold, proper provision will be made so that each holder of a Right will thereafter have the right to receive, upon the exercise thereof at the then-current purchase price of the Right, that number of shares of common stock of the acquiring company having a market value at the time of that transaction equal to two times the Purchase Price.

 

 

With certain exceptions, no adjustment in the Purchase Price will be required unless such adjustment would require an increase or decrease of at least one percent (1%) in the Purchase Price. No fractional shares of Preferred Stock will be issued (other than fractions which are integral multiples of one one-thousandth of a share of Preferred Stock, which may, at the election of the Company, be evidenced by depositary receipts) and, in lieu thereof, an adjustment in cash will be made based on the market price of the Preferred Stock on the trading day immediately prior to the date of exercise.

 

At any time after any person or group of affiliated or associated persons becomes an Acquiring Person and prior to the acquisition of beneficial ownership by such Acquiring Person of 50% or more of the outstanding shares of Common Stock, the Board, at its option, may exchange each Right (other than Rights owned by such person or group of affiliated or associated persons which will have become void), in whole or in part, at an exchange ratio of one share of Common Stock per outstanding Right (subject to adjustment).

 

In connection with any exercise or exchange of the Rights, no holder of a Right will be entitled to receive shares of Common Stock if receipt of such shares would result in such holder, together with such holder’s affiliates and associates, beneficially owning more than 4.95% of the then-outstanding Common Stock (such shares, the “Excess Shares”) and the Board determines that such holder’s receipt of Excess Shares would jeopardize or endanger the value or availability of the Tax Benefits or the Board otherwise determines that such holder’s receipt of Excess Shares is not in the best interests of the Company. In lieu of such Excess Shares, such holder will only be entitled to receive cash or a note or other evidence of indebtedness with a principal amount equal to the then-current market price of the Common Stock multiplied by the number of Excess Shares that would otherwise have been issuable.

 

At any time before the Distribution Date, the Board may redeem the Rights in whole, but not in part, at a price of $0.001 per Right (subject to certain adjustments) (the “Redemption Price”). The redemption of the Rights may be made effective at such time, on such basis and with such conditions as the Board in its sole discretion may establish.

 

Immediately upon the action of the Board electing to redeem or exchange the Rights, the Company shall make a public announcement thereof, and upon such election, the right to exercise the Rights will terminate and the only right of the holders of Rights will be to receive the Redemption Price.

 

Until a Right is exercised or exchanged, the holder thereof, as such, will have no rights as a stockholder of the Company, including, without limitation, the right to vote or to receive dividends.

 

The Board may amend or supplement the Amended and Restated Rights Agreement without the approval of any holders of Rights, including, without limitation, in order to (a) cure any ambiguity, (b) correct inconsistent provisions, (c) alter time period provisions, including the Expiration Date, or (d) make additional changes to the Amended and Restated Rights Agreement that the Board deems necessary or desirable. However, from and after the date any person or group of affiliated or associated persons becomes an Acquiring Person, the Amended and Restated Rights Agreement may not be supplemented or amended in any manner that would adversely affect the interests of the holders of Rights.

 
XML 31 R17.htm IDEA: XBRL DOCUMENT v3.23.1
Income Taxes
 12 Months Ended
Dec. 31, 2022
Income Tax Disclosure [Abstract]  
Income Taxes

10. Income Taxes

 

At December 31, 2022, the Company had federal and state net operating loss carryforwards (“NOLs”) of $338.3 million and $263.1 million, respectively, available to offset against future taxable income. Of this amount, $310.6 million of federal NOLs expire in 2024 through 2037. The federal operating losses after 2018 totaling $27.7 million carry forward indefinitely but are only able to offset 80% of taxable income in future years. The California NOLs expire in 2029 through 2042.

 

As a result of a change in-control that occurred in the LadRx shareholder base, approximately $66.1 million in federal net operating loss carryforwards became substantially limited in their annual availability. Management currently believes that the remaining $272.1 million in federal net operating loss carryforwards, and the $263.1 million in state net operating loss carryforwards, are unrestricted.

 

 

As of December 31, 2022, LadRx also had research and development tax credits for federal and state purposes of approximately $15.4 million and $22.0 million, respectively, available for offset against future income taxes, which expire in 2022 through 2036. The credits are subject to change-in-control limitations, which may affect their utilization in future years. Based on an assessment of all available evidence including, but not limited to, the Company’s limited operating history in its core business and lack of profitability, uncertainties of the commercial viability of its technology, the impact of government regulation and healthcare reform initiatives, and other risks normally associated with biotechnology companies, the Company has concluded that it is more likely than not that these net operating loss carryforwards and credits will not be realized and, as a result, a 100% deferred tax valuation allowance has been recorded against these assets.

 

Deferred income taxes reflect the net effect of temporary differences between the financial reporting carrying amounts of assets and liabilities and income tax carrying amounts of assets and liabilities. The components of the Company’s deferred tax assets and liabilities, all of which are long-term, are as follows (in thousands):

 

             
   December 31, 
   2022   2021 
Deferred tax assets:          
Net operating loss carryforwards  $74,903   $74,167 
Tax credit carryforwards   37,353    37,866 
Equipment, furnishings and other   19    4,174 
Total deferred tax assets   112,275    116,207 
Deferred tax liabilities   —    — 
Net deferred tax assets   112,275    116,207 
Valuation allowance   (112,275)   (116,207)
Deferred tax assets  $—   $— 

 

For all years presented, the Company did not recognize any deferred tax assets or liabilities. The net change in valuation allowance for the years ended December 31, 2022 and 2021 was $3.9 million and $1.6 million, respectively.

 

The provision for income taxes differs from the provision computed by applying the Federal statutory rate to net loss before income taxes as follows (in thousands):

 

         
   Years ended December 31, 
   2022   2021 
Federal benefit at statutory rate  $(1,000)  $(2,745)
State income taxes, net of Federal taxes   (333)   (913)
State credits   —    — 
Warrant liabilities   —    — 
Other permanent differences   261    1,685 
Provision related to change in valuation allowance   957    1,947 
Federal rate adjustment   —    — 
NQ Options   —    — 
Current year tax credit   —    — 
NOL Adjustments   —    — 
Termination/Cancellation of Equity Compensation Awards   —    — 
Return to provision   115    26 
Other, net   —    — 
Provision for Income taxes  $—   $— 

 

There have been no changes to the Company’s liability for unrecognized tax benefits during the year ended December 31, 2022.

 

The Company files income tax returns in the U.S. Federal jurisdiction and various state jurisdictions. As of the year ended December 31, 2022, the tax returns for 2019 through 2022 remain open to examination by the Internal Revenue Service and for 2017 to 2021 for various state tax authorities.

 

The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense. As of the date of adoption of ASC 740 and the years ended December 31, 2022 and 2021, the Company had accrued no interest or penalties related to uncertain tax positions.

 

 
XML 32 R18.htm IDEA: XBRL DOCUMENT v3.23.1
Commitments and Contingencies
 12 Months Ended
Dec. 31, 2022
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

11. Commitments and Contingencies

 

Commitments

 

Aldoxorubicin

 

The agreement relating to our worldwide rights to aldoxorubicin provides for our payment of up to an aggregate of $7.5 million upon meeting specified clinical and regulatory milestones up to and including the product’s second, final marketing approval. We also will be obliged to pay:

 

  ● commercially reasonable royalties based on a percentage of net sales (as defined in the agreement);
     
  ● a percentage of any non-royalty sub-licensing income (as defined in the agreement); and
     
  ● milestones of $1,000,000 for each additional final marketing approval that we might obtain.

 

Arimoclomol

 

The agreement relating to our worldwide rights to arimoclomol provides for our payment of up to an aggregate of $3.65 million upon receipt of milestone payments from KemPharm.

 

Innovive

 

Under the merger agreement by which we acquired Innovive, we agreed to pay the former Innovive stockholders a total of up to approximately $18.3 million of future earnout merger consideration, subject to our achievement of specified net sales under the Innovive license agreements. The earnout merger consideration, if any, will be payable in shares of our common stock, subject to specified conditions, or, at our election, in cash or by a combination of shares of our common stock and cash. Our common stock will be valued for purposes of any future earnout merger consideration based upon the trading price of our common stock at the time the earnout merger consideration is paid.

 

As of December 31, 2022, no amounts are due under the above agreements.

 

 

Contractual obligations

 

LadRx’s current contractual obligations that will require future cash payments for the following Employment Agreements as follows (in thousands):

 Schedule of Current Contractual Obligations

   Employment Agreements (1) 
2023        961 
2024   936 
2025   936 
2026   468 
Thereafter   — 
Total  $3,301 

 

(1) Employment agreements include management contracts which have been revised from time to time. The employment agreements for the Company’s executive officers provide for minimum salaries, which are adjusted annually at the discretion of the Company’s Compensation Committee, and in some cases provide for minimum annual bonuses and employee benefits, as well. New employment agreements for the Company’s other executive officers are usually entered into annually.

 

Contingencies

 

The Company is occasionally involved in legal proceedings and other matters arising from the normal course of business. On November 30, 2022, Jerald Hammann (“Hammann”) filed a complaint (the “Complaint”) against the Company, Mr. Caloz, and Mr. Kriegsman (together, “Defendants”) in the Court of Chancery of the State of Delaware, alleging various violations of a Cooperation Agreement, dated August 21, 2020, by and between the Company and Hammann.  The Complaint alleges breaches of a provision limiting the Board’s ability to effect discretionary compensation and a non-disparagement provision. The Complaint further alleges a breach of a purported implied obligation that the Company disclose various internal records to Hammann. Defendants believe the Complaint is wholly without merit and have moved to dismiss the Complaint in its entirety. Defendants intend to litigate vigorously against Hammann’s claims.

 

The Company intends to vigorously defend against any complaint. We have directors’ and officers’ liability insurance, which will be utilized, after the deductible, in the defense of any matter involving our directors or officers.

 

The Company evaluates developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the period in which the outcome becomes probable and reasonably estimable.

 

In December 2019, a novel strain of coronavirus, COVID-19, was first identified in China and has surfaced in several regions across the world. In March 2020, the disease was declared a pandemic by the World Health Organization. As the situation with Covid-19 continues to evolve, the companies which are working to further develop and commercialize our products, ImmunityBio and Orphazyme, could be materially and adversely affected by the risks, or the public perception of the risks, related to this pandemic. Among other things, the active and planned clinical trials by ImmunityBio and Orphazyme and their regulatory approvals, if any, may be delayed or interrupted, which could delay or adversely affect the Company’s potential receipt of milestone and royalty payments within the disclosed time periods and increase expected costs. As of the date of this filing, senior management and administrative staff are working primarily remotely.

 
XML 33 R19.htm IDEA: XBRL DOCUMENT v3.23.1
Subsequent Events
 12 Months Ended
Dec. 31, 2022
Subsequent Events [Abstract]  
Subsequent Events

12. Subsequent Events

 

On January 1, 2023, the Company paid a quarterly dividend to its holder of Series C Preferred Stock of $68,809.

 

On January 31, 2023, 1,342 Series C Preferred Stock was converted to 1,525,000 common shares.

 
XML 34 R20.htm IDEA: XBRL DOCUMENT v3.23.1
Summary of Significant Accounting Policies (Policies)
 12 Months Ended
Dec. 31, 2022
Accounting Policies [Abstract]  
Basis of Presentation and Principles of Consolidation

Basis of Presentation and Principles of Consolidation — The accompanying Consolidated Financial Statements are prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and accounting principles generally accepted in the United States (“GAAP”). The Consolidated Financial Statements include the accounts of LadRx Corporation and its wholly-owned subsidiary. All intercompany accounts are eliminated.

 

 
Revenue Recognition

Revenue Recognition — Revenue consists of license fees from strategic alliances with pharmaceutical companies. During the years ended December 31, 2022 and 2021, no revenue was earned from license fees.

 
Cash Equivalents

Cash Equivalents — The Company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. Cash equivalents consist primarily of amounts invested in certificates of deposit and money market accounts.

 
Equipment and Furnishings

Equipment and Furnishings — Equipment and furnishings are stated at cost and depreciated using the straight-line method based on the estimated useful lives (generally three to five years for equipment and furniture) of the related assets. Whenever there is a triggering event that might suggest impairment, management evaluates the realizability of recorded long-lived assets to determine whether their carrying values have been impaired. The Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that the assets might be impaired and the non-discounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Any impairment loss is measured by comparing the fair value of the asset to its carrying amount.

 
Insurance recoveries

Insurance recoveries — The Company has several policies with insurance underwriters that provide for the recovery of certain costs incurred by the Company. The Company’s policy is to record any liability as incurred, and then to record the estimated recovery from the insurance company for that cost as a receivable in accordance with terms of its existing policies. As of December 31, 2021, there were $200,000 of insurance recoveries that were collected in 2022. As of December 31, 2022, there were no amounts recoverable from its insurance company carriers under the terms of its policies.

 
Fair Value Measurements

Fair Value Measurements — Assets and liabilities recorded at fair value on the consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure the fair value. Level inputs are as follows:

 

Level 1 – quoted prices in active markets for identical assets or liabilities.

 

Level 2 – other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.

 

Level 3 – significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.

 

The Company considers carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments.

 
Patents and Patent Application Costs

Patents and Patent Application Costs — Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are therefore expensed as incurred.

 
Net Income (Loss) Per Share of Common Stock

Net Income (Loss) Per Share of Common Stock — Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted earnings per share is computed by dividing the net income applicable to common stockholders by the weighted average number of shares of common stock outstanding plus the number of additional shares of common stock that would have been outstanding if all dilutive potential shares of common stock had been issued using the treasury stock method. Potential shares of common stock are excluded from the computation when their effect is antidilutive. The dilutive effect of potentially dilutive securities is reflected in diluted net income per share if the exercise prices were lower than the average fair market value of common stock during the reporting period.

 

 

 

   2022   2021 
   As of December 31, 
   2022   2021 
     
Options to acquire common stock   1,765,108    2,827,820 
Warrants to acquire common stock   4,167    4,167 
Convertible preferred stock   3,127,689    9,363,637 
Preferred investment option   11,363,637    11,363,637 
Shares excluded from computation of diluted loss per share   16,260,601    23,559,261 

 

Potentially dilutive stock options, warrants and securities from the table above were excluded from the computation of diluted net income (loss) per share, because the effect would be anti-dilutive.

 
Stock-based Compensation

Stock-based Compensation — The Company accounts for share-based awards to employees and nonemployees directors and consultants in accordance with the provisions of ASC 718, Compensation—Stock Compensation., and under the recently issued guidance following FASB’s pronouncement, ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Under ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur.

 
Research and Development Expenses

Research and Development Expenses — Research and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including licenses and drugs, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology developed for use in its products is expensed as incurred until technological feasibility has been established.

 
Income Taxes

Income Taxes — The Company accounts for income taxes in accordance with the provisions of FASB ASC 740-10, Income Taxes, (“ASC 740”) which requires the recognition of deferred tax assets and liabilities for taxable temporary differences and deferred tax assets for deductible temporary differences and operating loss carry-forwards using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit or expense is recognized as a result of changes in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all of any deferred tax assets will not be realized.

 

The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expenses.

 
Concentrations of Risks

Concentrations of Risks — Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and short-term investments. The Company maintains cash and cash equivalents in large well-capitalized financial institutions and the Company’s investment policy disallows investment in any debt securities rated less than “investment-grade” by national ratings services. The Company has not experienced any losses on its deposits of cash or cash equivalents or its short-term investments. Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances.

 
Use of Estimates

Use of Estimates — Preparation of the Company’s consolidated financial statements in conformance with U.S. GAAP requires the Company’s management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The significant estimates in the Company’s consolidated financial statements relate to the valuation of equity awards, recoverability of deferred tax assets, insurance claims and estimated useful lives of fixed assets. The Company bases estimates and assumptions on historical experience, when available, and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis, and its actual results may differ from estimates made under different assumptions or conditions.

 

 
New Accounting Pronouncements

New Accounting Pronouncements — In June 2016, the FASB issued ASU No. 2016-13, Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”). The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The standard is effective for interim and annual reporting periods beginning after December 15, 2022. The adoption of ASU 2016-13 is not expected to have a material impact on the Company’s financial position, results of operations, and cash flows.

 

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. Early adoption is permitted, including adoption in an interim period. If an entity elects to early adopt ASU 2021-04 in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The adoption of ASU 2021-04 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

Other recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission (“SEC”) did not, or are not expected to, have a material impact on the Company’s consolidated financial statements and related disclosures.
XML 35 R21.htm IDEA: XBRL DOCUMENT v3.23.1
Summary of Significant Accounting Policies (Tables)
 12 Months Ended
Dec. 31, 2022
Accounting Policies [Abstract]  
Schedule of Shares Excluded from Computation of Diluted Loss Per Share

 

   2022   2021 
   As of December 31, 
   2022   2021 
     
Options to acquire common stock   1,765,108    2,827,820 
Warrants to acquire common stock   4,167    4,167 
Convertible preferred stock   3,127,689    9,363,637 
Preferred investment option   11,363,637    11,363,637 
Shares excluded from computation of diluted loss per share   16,260,601    23,559,261 
XML 36 R22.htm IDEA: XBRL DOCUMENT v3.23.1
Foreign Currency Remeasurement (Tables)
 12 Months Ended
Dec. 31, 2022
Foreign Currency [Abstract]  
Schedule of Company’s Cash Balance

As of December 31, 2022 and 2021, the Company’s cash balances consisted of the following:

 

   2022   2021 
U.S. Dollars  $1,374,992   $6,671,404 
Euros – in US $   —    98,199 
Cash Balance  $1,374,992   $6,769,603 
XML 37 R23.htm IDEA: XBRL DOCUMENT v3.23.1
Equipment and Furnishings (Tables)
 12 Months Ended
Dec. 31, 2022
Property, Plant and Equipment [Abstract]  
Schedule of Equipment and Furnishings

Equipment and furnishings at December 31, 2022 and 2021 consist of the following:

 

   2022   2021 
Equipment and furnishings  $48,742   $59,728 
Less — accumulated depreciation   (30,196)   (26,944)
Equipment and furnishings, net  $18,546   $32,784 
XML 38 R24.htm IDEA: XBRL DOCUMENT v3.23.1
Accrued Expenses and Other Current Liabilities (Tables)
 12 Months Ended
Dec. 31, 2022
Payables and Accruals [Abstract]  
Schedule of Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities at December 31, 2022 and 2021 are summarized below.

 

   2022   2021 
Professional fees  $77,785   $208,345 
Liquidated damages– see Note 7   —    615,253 
Payable to former CEO   50,191    256,115 
Wages, bonuses and employee benefits   152,990    261,375 
Royalties and milestones   716,155    716,155 
Other   18,380    7,263 
Total  $1,015,501   $2,064,506 
XML 39 R25.htm IDEA: XBRL DOCUMENT v3.23.1
Leases (Tables)
 12 Months Ended
Dec. 31, 2022
Leases  
Schedule of Future Minimum Lease Payments

Future minimum lease payments under non-cancelable operating leases under ASC 842 as of December 31, 2022 are as follows:

 

  

Operating

Lease Payments

 
     
Jan 2023 – Dec 2023  $200,927 
Jan 2024 – Dec 2024   33,673 
Total future minimum lease payments   234,600 
      
Less: present value adjustment   (4,993)
Operating lease liabilities at December 31, 2022   229,607 
Less: current portion of operating lease liabilities   (196,081)
Operating lease liabilities, net of current portion  $33,526 
Schedule of Rent Expense and Supplemental Cash Flow Information Related to Leases

The components of rent expense and supplemental cash flow information related to leases for the period are as follows:

 

  

Year Ended

December 31, 2022

 
Lease Cost     
      
Operating lease cost (included in General and administrative expenses in the Company’s Consolidated Statements of Operations)  $197,154 
      
Other information     
      
Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2022  $180,786 
      
Weighted average remaining lease term – operating leases (in years)   1.2 
      
Average discount rate   3.5%
XML 40 R26.htm IDEA: XBRL DOCUMENT v3.23.1
Stock Compensation (Tables)
 12 Months Ended
Dec. 31, 2022
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items]  
Schedule of Stock-based Compensation Expense

The following table sets forth the total stock-based compensation expense resulting from restricted stock included in our Consolidated Statements of Operations for the years ended December 31, 2022 and 2021:

 

   Years Ended December 31, 
   2022   2021 
General and administrative – employee  $11,255   $— 
Total employee stock-based compensation  $11,255   $— 
Schedule of Ranges of Stock options

The following table summarizes significant ranges of outstanding stock options under the two plans at December 31, 2022:

 

Range of
Exercise
Prices		     Number of Options     Weighted-Average Remaining Contractual Life (years)     Weighted-Average Exercise Price     Number of Options Exercisable     Weighted-Average Remaining Contractual Life (years)     Weighted-Average Exercise Price  
$ 0.26 - $1.00       500,000       6.95     $ 0.26       500,000       6.95     $ 0.26  
$ 1.01 - $2.00       472,617       4.96     $ 1.75       472,617       4.96     $ 1.75  
$ 2.01 - $3.00       161,388             3.96     $ 2.58       161,388           3.96     $            2.58  
$ 3.01 - $41.46       631,103       2.16     $            16.93       631,103       2.16     $ 16.93  
          1,765,108       4.43     $ 6.83       1,765,108       4.43     $ 6.83  
Schedule of Warrants Activity and Related Information

A summary of the Company’s warrant activity and related information for the years ended December 31, 2022 and 2021 are shown below.

 

   Warrants  

Weighted Average

Exercise Price

 
   2022   2021   2022   2021 
Outstanding — beginning of year   4,167    4,167   $33.60   $33.60 
Granted   —    —    —    — 
Exercised   —    —    —    — 
Forfeited   —    —    —    — 
Expired   —    —    —    — 
Outstanding — end of year   4,167    4,167    33.60    33.60 
Exercisable at end of year   4,167    4,167   $33.60   $33.60 
Weighted average fair value of warrants granted during the year:  $—   $—           

 
Non Employees [Member]  
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items]  
Schedule of Stock Option Activity

Presented below is the Company’s non-employee stock option activity:

 

   Stock Options  

Weighted Average

Exercise Price

 
   2022   2021   2022   2021 
Outstanding — beginning of year   365,000    365,000   $5.49   $5.49 
Granted   —    —    —    — 
Exercised   —    —   —    — 
Expired/Forfeited   —    —    —    — 
Outstanding — end of year   365,000    365,000    5.49    5.49 
Exercisable at end of year   365,000    365,000   $5.49   $5.49 
Weighted average fair value of stock options granted during the year:  $—   $—           

 
XML 41 R27.htm IDEA: XBRL DOCUMENT v3.23.1
Income Taxes (Tables)
 12 Months Ended
Dec. 31, 2022
Income Tax Disclosure [Abstract]  
Schedule of Deferred Tax Assets and Liabilities

Deferred income taxes reflect the net effect of temporary differences between the financial reporting carrying amounts of assets and liabilities and income tax carrying amounts of assets and liabilities. The components of the Company’s deferred tax assets and liabilities, all of which are long-term, are as follows (in thousands):

 

             
   December 31, 
   2022   2021 
Deferred tax assets:          
Net operating loss carryforwards  $74,903   $74,167 
Tax credit carryforwards   37,353    37,866 
Equipment, furnishings and other   19    4,174 
Total deferred tax assets   112,275    116,207 
Deferred tax liabilities   —    — 
Net deferred tax assets   112,275    116,207 
Valuation allowance   (112,275)   (116,207)
Deferred tax assets  $—   $— 
Schedule of Effective Income Tax Rate Reconciliation

The provision for income taxes differs from the provision computed by applying the Federal statutory rate to net loss before income taxes as follows (in thousands):

 

         
   Years ended December 31, 
   2022   2021 
Federal benefit at statutory rate  $(1,000)  $(2,745)
State income taxes, net of Federal taxes   (333)   (913)
State credits   —    — 
Warrant liabilities   —    — 
Other permanent differences   261    1,685 
Provision related to change in valuation allowance   957    1,947 
Federal rate adjustment   —    — 
NQ Options   —    — 
Current year tax credit   —    — 
NOL Adjustments   —    — 
Termination/Cancellation of Equity Compensation Awards   —    — 
Return to provision   115    26 
Other, net   —    — 
Provision for Income taxes  $—   $— 
XML 42 R28.htm IDEA: XBRL DOCUMENT v3.23.1
Commitments and Contingencies (Tables)
 12 Months Ended
Dec. 31, 2022
Commitments and Contingencies Disclosure [Abstract]  
Schedule of Current Contractual Obligations

LadRx’s current contractual obligations that will require future cash payments for the following Employment Agreements as follows (in thousands):

 Schedule of Current Contractual Obligations

   Employment Agreements (1) 
2023        961 
2024   936 
2025   936 
2026   468 
Thereafter   — 
Total  $3,301 

 

(1) Employment agreements include management contracts which have been revised from time to time. The employment agreements for the Company’s executive officers provide for minimum salaries, which are adjusted annually at the discretion of the Company’s Compensation Committee, and in some cases provide for minimum annual bonuses and employee benefits, as well. New employment agreements for the Company’s other executive officers are usually entered into annually.
XML 43 R29.htm IDEA: XBRL DOCUMENT v3.23.1
Nature of Business (Details Narrative) - USD ($)
 12 Months Ended
May 31, 2022
Dec. 31, 2022
Dec. 31, 2021
May 01, 2021
Dec. 31, 2020
Dec. 13, 2019
Jun. 01, 2018
Jul. 27, 2017
Dec. 31, 2011
Percentage of service charge             5.00%    
Cash investments               $ 13,000,000  
Investment in common stock per share           $ 5.00   $ 6.60  
Common stock market price premium percentage               92.00%  
Number of warrants issued to purchase shares of common stock               500,000  
Warrrants exercise price per share               $ 6.60  
Warrant expiration               Jan. 26, 2019  
Fee contingent payments               $ 343,000,000  
Net loss   $ 4,200,573 $ 13,176,663            
Cash in operations   4,832,464 12,308,890            
Stockholders equity   1,317,964 $ (753,719)   $ (8,870,960)        
Contractual obligation [1]   3,301,000              
Two Thousand Twenty Three [Member]                  
Contractual obligation   1,200,000              
Contractual obligation   $ 1,900,000              
Kem Pharm [Member]                  
Cash consideration from sale of assets $ 12,800,000                
Orphazyme [Member]                  
Fee contingent payments                 $ 120,000,000
Arimoclomol [Member]                  
Fee contingent payments $ 5,200,000     $ 100,000,000          
[1] Employment agreements include management contracts which have been revised from time to time. The employment agreements for the Company’s executive officers provide for minimum salaries, which are adjusted annually at the discretion of the Company’s Compensation Committee, and in some cases provide for minimum annual bonuses and employee benefits, as well. New employment agreements for the Company’s other executive officers are usually entered into annually.
XML 44 R30.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Shares Excluded from Computation of Diluted Loss Per Share (Details) - shares
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Shares excluded from computation of diluted loss per share 16,260,601 23,559,261
Share-Based Payment Arrangement, Option [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Shares excluded from computation of diluted loss per share 1,765,108 2,827,820
Warrant [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Shares excluded from computation of diluted loss per share 4,167 4,167
Convertible Preferred Stock [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Shares excluded from computation of diluted loss per share 3,127,689 9,363,637
Investment Option [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Shares excluded from computation of diluted loss per share 11,363,637 11,363,637
XML 45 R31.htm IDEA: XBRL DOCUMENT v3.23.1
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Accounting Policies [Abstract]    
Insurance recoveries $ 0 $ 200,000
XML 46 R32.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Company’s Cash Balance (Details) - USD ($)
Dec. 31, 2022
Dec. 31, 2021
Dec. 31, 2020
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]      
Cash Balance $ 1,374,992 $ 6,769,603 $ 10,003,375
US Dollar [Member]      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]      
Cash Balance 1,374,992 6,671,404  
Euros [Member]      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]      
Cash Balance $ 98,199  
XML 47 R33.htm IDEA: XBRL DOCUMENT v3.23.1
Foreign Currency Remeasurement (Details Narrative) - USD ($)
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Foreign Currency [Abstract]    
Foreign currency transaction gain (loss), recognized $ (2,889) $ (22,440)
XML 48 R34.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Equipment and Furnishings (Details) - USD ($)
Dec. 31, 2022
Dec. 31, 2021
Property, Plant and Equipment [Abstract]    
Equipment and furnishings $ 48,742 $ 59,728
Less — accumulated depreciation (30,196) (26,944)
Equipment and furnishings, net $ 18,546 $ 32,784
XML 49 R35.htm IDEA: XBRL DOCUMENT v3.23.1
Equipment and Furnishings (Details Narrative) - USD ($)
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Property, Plant and Equipment [Line Items]    
Depreciation and amortization expense $ 15,004 $ 13,978
Depreciation and amortization expense 15,004 $ 13,978
Equipment and Furnishing [Member]    
Property, Plant and Equipment [Line Items]    
Depreciation $ 11,752  
XML 50 R36.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($)
Dec. 31, 2022
Dec. 31, 2021
Payables and Accruals [Abstract]    
Professional fees $ 77,785 $ 208,345
Liquidated damages– see Note 7 615,253
Payable to former CEO 50,191 256,115
Wages, bonuses and employee benefits 152,990 261,375
Royalties and milestones 716,155 716,155
Other 18,380 7,263
Total $ 1,015,501 $ 2,064,506
XML 51 R37.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Future Minimum Lease Payments (Details) - USD ($)
Dec. 31, 2022
Dec. 31, 2021
Feb. 29, 2020
Leases      
Jan 2023 – Dec 2023 $ 200,927    
Jan 2024 – Dec 2024 33,673    
Total future minimum lease payments 234,600    
Less: present value adjustment (4,993)    
Operating lease liabilities at December 31, 2022 229,607   $ 715,310
Less: current portion of operating lease liabilities (196,081) $ (198,819)  
Operating lease liabilities, net of current portion $ 33,526 $ 216,381  
XML 52 R38.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Rent Expense and Supplemental Cash Flow Information Related to Leases (Details)
 12 Months Ended
Dec. 31, 2022
USD ($)
Leases  
Operating lease cost (included in General and administrative expenses in the Company's condensed Consolidated Statements of Operations) $ 197,154
Cash paid for amounts included in the measurement of lease liabilities for the period ended September 30, 2022 $ 180,786
Weighted average remaining lease term - operating leases (in years) 1 year 2 months 12 days
Average discount rate 3.50%
XML 53 R39.htm IDEA: XBRL DOCUMENT v3.23.1
Leases (Details Narrative)
 1 Months Ended
Feb. 29, 2020
USD ($)
Jan. 31, 2020
ft²
Dec. 31, 2022
USD ($)
Dec. 31, 2021
USD ($)
Lease term   4 years    
Area of land | ft²   2,771    
Lease expiration date   Feb. 29, 2024    
Extended term   5 years    
Annual percentage increased in monthly rent 2.50% 3.50%    
Payments for rent $ 1,405      
Right of use asset 715,310   $ 216,786 $ 397,172
Lease liability obligation 715,310   $ 229,607  
Revision of Prior Period, Reclassification, Adjustment [Member]        
Right of use asset $ 66,271      
XML 54 R40.htm IDEA: XBRL DOCUMENT v3.23.1
Financing Under Security Purchase Agreement (Details Narrative) - USD ($)
 12 Months Ended
Oct. 01, 2022
Jul. 01, 2022
Apr. 01, 2022
Jan. 02, 2022
Oct. 01, 2021
Jul. 13, 2021
Dec. 31, 2022
Dec. 31, 2021
May 15, 2022
Mar. 28, 2022
Mar. 15, 2022
Mar. 14, 2022
Sep. 23, 2021
Sep. 22, 2021
Dec. 13, 2019
Jul. 27, 2017
Purchase price per share                             $ 5.00 $ 6.60
Dividend paid $ 561,381                              
Common stock, par value             $ 0.001 $ 0.001     $ 0.001       $ 0.001  
Common stock, shares authorized             62,393,940 62,393,940     63,227,273 41,666,666 62,393,940 41,666,666    
Stated value per share             $ 1,000 $ 1,000                
Liquidated damages             $ 615,253                
Loss contingency, damages sought, value               $ 1,100,000                
Loss contingency accrual provision             $ 615,123                  
Preferred Investment Option [Member]                                
Option to purchase common stock           11,363,637                    
Option exercisable price           $ 0.88                    
Option Indexed to Issuer's Equity, Settlement Alternatives           The holders of the Preferred Investment Option may exercise the Preferred Investment Option on a cashless basis, solely to the extent there is no effective registration statement registering, or the prospectus in such registration statement is not available for the resale of the shares of common stock issuable at the time of exercise. The Company is prohibited from effecting an exercise of any Preferred Investment Option to the extent that such exercise would result in the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of common stock outstanding immediately after giving effect to the exercise of the Preferred Investment Options by the holder (the “PIO Beneficial Ownership Limitation”), except that upon notice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of Common Stock after exercising the holder’s Preferred Investment Option, provided that the PIO Beneficial Ownership Limitation in no event exceeds 9.99% of the number of outstanding shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of common stock upon exercise of the Preferred Investment Option held by the holder and provided that any increase in the PIO Beneficial Ownership Limitation shall not be effective until 61 days following notice to the Company                    
Series C Convertible Preferred Stock [Member]                                
Preferred stock, dividend rate, percentage           10.00% 10.00% 10.00%                
Conversion price           $ 0.88                    
Preferred stock, contract terms           The Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of common stock upon conversion that would result in the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of common stock outstanding immediately after giving effect to the conversion (the “Beneficial Ownership Limitation”), except that upon notice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of common stock after converting the holder’s shares of Series C Preferred Stock, provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of outstanding shares of the common stock outstanding immediately after giving effect to the issuance of shares of common stock upon conversion of the shares of Series C Preferred Stock held by the holder and provided that any increase in the Beneficial Ownership Limitation shall not be effective until 61 days following notice to the Company                    
Common stock, shares authorized           41,666,666                    
Stated value per share           $ 1,000                    
Investor [Member]                                
Shares issued upon conversion             3,127,689   1,554,130 4,681,819            
Number of shares converted             2,752   1,368 4,120            
Securities Purchase Agreement [Member] | Common Stock [Member]                                
Number of shares issued, value           $ 859,218                    
Number of shares issued           2,000,000                    
Securities Purchase Agreement [Member] | Series C Convertible Preferred Stock [Member]                                
Number of shares issued, value           $ 4,022,700                    
Number of shares issued           8,240                    
Additional piaid in capital           $ 4,022,700                    
Securities Purchase Agreement [Member] | Preferred Investment Option [Member]                                
Other liabilities fair value           4,293,872                    
Additional piaid in capital           5,153,090                    
Securities Purchase Agreement [Member] | Investor [Member]                                
Gross proceeds from issuance of equity           10,000,000                    
Number of shares issued, value           $ 9,200,000                    
Number of shares issued           2,000,000                    
Purchase price per share           $ 0.88                    
Proceeds from issuance of common stock           $ 1,760,000                    
Securities Purchase Agreement [Member] | Investor [Member] | Preferred Investment Option [Member]                                
Option to purchase common stock           11,363,637                    
Option indexed to issuers equity shares value           $ 10,000,000                    
Option exercisable price           $ 0.88                    
Securities Purchase Agreement [Member] | Investor [Member] | Series C Convertible Preferred Stock [Member]                                
Number of shares issued           8,240                    
Purchase price per share           $ 1,000                    
Preferred stock, dividend rate, percentage         10.00% 10.00%                    
Proceeds from issuance of private placement           $ 8,240,000                    
Shares issued upon conversion           9,363,637                    
Conversion price           $ 0.88                    
Preferred stock, contract terms           The terms of the Preferred Stock include beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock                    
Dividend paid $ 68,809 $ 84,005 $ 202,567 $ 206,000 $ 171,668                      
Registration Rights Agreement [Member]                                
Percentage of liquidated damages           2.00%                    
Liquidated damages           $ 1,977,600                    
Percentage of interest payable on liquidated damages           18.00%                    
Registration Rights Agreement [Member] | Maximum [Member]                                
Percentage of liquidated damages           24.00%                    
XML 55 R41.htm IDEA: XBRL DOCUMENT v3.23.1
Series D Preferred Stock (Details Narrative) - $ / shares
Jul. 27, 2022
May 19, 2022
Nov. 12, 2020
Class of Stock [Line Items]      
Dividend description     Each share of Preferred Stock will be entitled, when, as and if declared, to a preferential per share quarterly dividend payment equal to the greater of (i) $1.00 per share or (ii) an amount equal to 1,000 times the dividend declared per share of Common Stock. Each share of Preferred Stock will entitle the holder thereof to 1,000 votes on all matters submitted to a vote of the stockholders of the Company. In the event of any merger, consolidation or other transaction in which shares of Common Stock are converted or exchanged, each share of Preferred Stock will be entitled to receive 1,000 times the amount received per one share of Common Stock
Series D Preferred Stock [Member]      
Class of Stock [Line Items]      
Dividend description   On May 19, 2022, the Board declared a dividend of one one-thousandth of a share of Series D Preferred Stock, par value $0.01 per share (“Series D Preferred Stock”), for each outstanding share of Company’s Common Stock to stockholders of record at 5:00 p.m. Eastern Time on May 20, 2022  
Dividend rate per share   $ 0.01  
Description of stock split ratio On July 27, 2022, at the Company’s 2022 Annual Meeting of Stockholders, the Company’s stockholders approved a proposal to authorize the Board, in its discretion but prior to July 26, 2023, to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of all of the outstanding shares of the Company’s Common Stock, at a ratio in the range of 1-for-2 to 1-for-100, with such ratio to be determined by the Board, and all outstanding shares of Series D Preferred Stock were automatically redeemed    
Preferred stock, shares outstanding 0    
XML 56 R42.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Stock-based Compensation Expense (Details) - USD ($)
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Total employee stock-based compensation $ 11,255
Share-Based Payment Arrangement, Employee [Member]    
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Total employee stock-based compensation 11,255
General and Administrative Expense [Member] | Share-Based Payment Arrangement, Employee [Member]    
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Total employee stock-based compensation $ 11,255
XML 57 R43.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Stock Option Activity (Details) - Non Employees [Member] - $ / shares
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items]    
Stock Options, Outstanding at beginning of year 365,000 365,000
Weighted-Average Exercise Price, Outstanding at beginning of year $ 5.49 $ 5.49
Stock Options, Granted
Weighted-Average Exercise Price, Granted
Stock Options, Exercised
Weighted-Average Exercise Price, Exercised
Stock Options, Expired/Forfeited
Weighted-Average Exercise Price, Expired/Forfeited
Stock Options, Outstanding at end of year 365,000 365,000
Weighted-Average Exercise Price, Outstanding at end of year $ 5.49 $ 5.49
Stock Options, Exercisable at end of year 365,000 365,000
Weighted average fair value of stock options granted
XML 58 R44.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Ranges of Stock options (Details) - Share-Based Payment Arrangement, Option [Member]
 12 Months Ended
Dec. 31, 2022
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Number of Options Outstanding | shares 1,765,108
Weighted-Average Remaining Contractual Life (years) 4 years 5 months 4 days
Weighted-Average Exercise Price $ 6.83
Number of Options Exercisable | shares 1,765,108
Weighted-Average Remaining Contractual Life (years) 4 years 5 months 4 days
Weighted-Average Exercise Price, Options Exercisable $ 6.83
Exercise Price Range One [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Range of Exercise Prices, Lower Range 0.26
Range of Exercise Prices, Upper Range $ 1.00
Number of Options Outstanding | shares 500,000
Weighted-Average Remaining Contractual Life (years) 6 years 11 months 12 days
Weighted-Average Exercise Price $ 0.26
Number of Options Exercisable | shares 500,000
Weighted-Average Remaining Contractual Life (years) 6 years 11 months 12 days
Weighted-Average Exercise Price, Options Exercisable $ 0.26
Exercise Price Range Two [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Range of Exercise Prices, Lower Range 1.01
Range of Exercise Prices, Upper Range $ 2.00
Number of Options Outstanding | shares 472,617
Weighted-Average Remaining Contractual Life (years) 4 years 11 months 15 days
Weighted-Average Exercise Price $ 1.75
Number of Options Exercisable | shares 472,617
Weighted-Average Remaining Contractual Life (years) 4 years 11 months 15 days
Weighted-Average Exercise Price, Options Exercisable $ 1.75
Exercise Price Range Three [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Range of Exercise Prices, Lower Range 2.01
Range of Exercise Prices, Upper Range $ 3.00
Number of Options Outstanding | shares 161,388
Weighted-Average Remaining Contractual Life (years) 3 years 11 months 15 days
Weighted-Average Exercise Price $ 2.58
Number of Options Exercisable | shares 161,388
Weighted-Average Remaining Contractual Life (years) 3 years 11 months 15 days
Weighted-Average Exercise Price, Options Exercisable $ 2.58
Exercise Price Range Four [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Range of Exercise Prices, Lower Range 3.01
Range of Exercise Prices, Upper Range $ 41.46
Number of Options Outstanding | shares 631,103
Weighted-Average Remaining Contractual Life (years) 2 years 1 month 28 days
Weighted-Average Exercise Price $ 16.93
Number of Options Exercisable | shares 631,103
Weighted-Average Remaining Contractual Life (years) 2 years 1 month 28 days
Weighted-Average Exercise Price, Options Exercisable $ 16.93
XML 59 R45.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Warrants Activity and Related Information (Details) - $ / shares
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Share-Based Payment Arrangement [Abstract]    
Warrants, Outstanding at beginning of period 4,167 4,167
Weighted-Average Exercise Price, Outstanding at beginning of period $ 33.60 $ 33.60
Warrants, Granted
Weighted-Average Exercise Price, Granted
Warrants, Exercised
Weighted-Average Exercise Price, Exercised
Warrants, Forfeited
Weighted-Average Exercise Price, Forfeited
Warrants, Expired
Weighted-Average Exercise Price, Expired
Warrants, Outstanding at end of period 4,167 4,167
Weighted-Average Exercise Price, Outstanding at end of period $ 33.60 $ 33.60
Warrants, Exercisable at end of period 4,167 4,167
Weighted-Average Exercise Price, Exercisable at end of period $ 33.60 $ 33.60
Weighted average fair value of warrants granted
XML 60 R46.htm IDEA: XBRL DOCUMENT v3.23.1
Stock Compensation (Details Narrative) - USD ($)
 12 Months Ended
Dec. 15, 2021
Dec. 31, 2022
Dec. 31, 2021
Nov. 30, 2019
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Proceeds from stock options exercised   $ 78,000  
Warrants intrinsic value   $ 0    
Employees and Directors [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Share-based compensation, outstanding stock options   1,400,108 2,462,820  
Number of stock option exercised   50,000 300,000  
Stock Options, Outstanding at beginning of year   2,462,820 2,801,270  
Weighted-Average Exercise Price, Outstanding at beginning of year   $ 7.68 $ 7.68  
Stock Options, Granted    
Weighted-Average Exercise Price, Granted    
Stock Options, Exercised   (50,000) (300,000)  
Weighted-Average Exercise Price, Exercised   $ 0.26 $ 0.26  
Stock Options, Forfeited    
Weighted-Average Exercise Price, Forfeited    
Stock Options, Expired   (1,012,712) (38,450)  
Weighted-Average Exercise Price, Expired   $ 10.67 $ 14.62  
Stock Options, Outstanding at end of year   1,400,108 2,462,820  
Weighted-Average Exercise Price, Outstanding at end of year   $ 7.18 $ 7.68  
Stock Options, Exercisable at end of year   1,400,108 2,462,820  
Weighted-Average Exercise Price, Exercisable at end of year   $ 7.18 $ 7.68  
Stock Options, Weighted average fair value of stock options granted    
Jennifer Simpson [Member] | Restricted Stock [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Shares granted 25,000      
Shares issued, shares   11,200    
Equity Option [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Number of stock option exercised   50,000 300,000  
Proceeds from stock options exercised     $ 78,000  
Stock Options, Exercised   (50,000) (300,000)  
Equity Option [Member] | Holders [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Conversion of stock   21,404    
2008 Stock Incentive Plan [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Number of common stock reserved for future issuance   5,000,000    
Share-based compensation, outstanding stock options   1,300,000    
Shares granted   800,000    
Expiration date   Nov. 20, 2018    
Stock Options, Outstanding at end of year   1,300,000    
2019 Stock Incentive Plan [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Number of common stock reserved for future issuance       5,400,000
Share-based compensation, outstanding stock options   500,000    
Shares granted   25,000    
Expiration date   Nov. 14, 2029    
Stock Options, Outstanding at end of year   500,000    
XML 61 R47.htm IDEA: XBRL DOCUMENT v3.23.1
Stockholder Protection Rights Plan (Details Narrative) - $ / shares
Nov. 12, 2020
Dec. 31, 2022
Mar. 15, 2022
Dec. 31, 2021
Nov. 21, 2021
Dec. 13, 2019
Jul. 27, 2017
Stockholder Protection Rights Plan              
Common Stock, stated value per share   $ 0.001 $ 0.001 $ 0.001   $ 0.001  
Preferred stock, par value   $ 0.01   $ 0.01   0.01  
Purchase price per share           $ 5.00 $ 6.60
Stockholders rights description the Board approved an amendment and restatement of the Original Rights Agreement (as amended and restated, the “Amended and Restated Rights Agreement”) to effect certain changes to the Original Rights Agreement, including (i) reducing the duration to a term of three years, subject to certain earlier expiration as described in more detail below, and (ii) lowering the beneficial ownership threshold at which a person or group of persons becomes an Acquiring Person (as defined below) to 4.95% or more of the Company’s outstanding shares of Common Stock, subject to certain exceptions. The Amended and Restated Rights Agreement is designed to discourage (i) any person or group of persons from acquiring beneficial ownership of more than 4.95% of the Company’s shares of Common Stock and (ii) any existing stockholder currently beneficially holding 4.95% or more of the Company’s shares of Common Stock from acquiring additional shares of the Company’s Common Stock            
Dividend description Each share of Preferred Stock will be entitled, when, as and if declared, to a preferential per share quarterly dividend payment equal to the greater of (i) $1.00 per share or (ii) an amount equal to 1,000 times the dividend declared per share of Common Stock. Each share of Preferred Stock will entitle the holder thereof to 1,000 votes on all matters submitted to a vote of the stockholders of the Company. In the event of any merger, consolidation or other transaction in which shares of Common Stock are converted or exchanged, each share of Preferred Stock will be entitled to receive 1,000 times the amount received per one share of Common Stock            
Preferred stock, redemption price per share         $ 0.001    
XML 62 R48.htm IDEA: XBRL DOCUMENT v3.23.1
Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($)
$ in Thousands
Dec. 31, 2022
Dec. 31, 2021
Income Tax Disclosure [Abstract]    
Net operating loss carryforwards $ 74,903 $ 74,167
Tax credit carryforwards 37,353 37,866
Equipment, furnishings and other 19 4,174
Total deferred tax assets 112,275 116,207
Deferred tax liabilities
Net deferred tax assets 112,275 116,207
Valuation allowance (112,275) (116,207)
Deferred tax assets
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Schedule of Effective Income Tax Rate Reconciliation (Details) - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Income Tax Disclosure [Abstract]    
Federal benefit at statutory rate $ (1,000) $ (2,745)
State income taxes, net of Federal taxes (333) (913)
State credits
Warrant liabilities
Other permanent differences 261 1,685
Provision related to change in valuation allowance 957 1,947
Federal rate adjustment
NQ Options
Current year tax credit
NOL Adjustments
Termination/Cancellation of Equity Compensation Awards
Return to provision 115 26
Other, net
Provision for Income taxes
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Income Taxes (Details Narrative) - USD ($)
$ in Millions
 12 Months Ended
Dec. 31, 2022
Dec. 31, 2021
Operating Loss Carryforwards [Line Items]    
Tax credit expiration date, description expire in 2022 through 2036  
Deferred tax valuation allowance, percentage 100.00%  
Deferred tax valuation allowance $ 3.9 $ 1.6
Domestic Tax Authority [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards 338.3  
Operating loss carryforwards, not subject to limitation 27.7  
Tax credit research and development 15.4  
Domestic Tax Authority [Member] | Shareholders [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards 66.1  
Domestic Tax Authority [Member] | Expire in 2024 Through 2037 [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards 310.6  
Domestic Tax Authority [Member] | Unrestricted [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards 272.1  
State and Local Jurisdiction [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards 263.1  
Tax credit research and development 22.0  
State and Local Jurisdiction [Member] | Unrestricted [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards $ 263.1  
California [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards, expiration date expire in 2029 through 2042  
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Schedule of Current Contractual Obligations (Details)
$ in Thousands
Dec. 31, 2022
USD ($)
 [1]
Commitments and Contingencies Disclosure [Abstract]  
2023 $ 961
2024 936
2025 936
2026 468
Thereafter
Total $ 3,301
[1] Employment agreements include management contracts which have been revised from time to time. The employment agreements for the Company’s executive officers provide for minimum salaries, which are adjusted annually at the discretion of the Company’s Compensation Committee, and in some cases provide for minimum annual bonuses and employee benefits, as well. New employment agreements for the Company’s other executive officers are usually entered into annually.
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Commitments and Contingencies (Details Narrative)
Dec. 31, 2022
USD ($)
Aldoxorubicin [Member]  
Product Liability Contingency [Line Items]  
Amount of milestone payment payable $ 1,000,000
Aldoxorubicin [Member] | Maximum [Member]  
Product Liability Contingency [Line Items]  
Amount of milestone payment payable 7,500,000
Arimoclomol [Member]  
Product Liability Contingency [Line Items]  
Amount of milestone payment payable 3,650,000
Innovivel [Member]  
Product Liability Contingency [Line Items]  
Future earnout merger consideration $ 18,300,000
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Subsequent Events (Details Narrative) - USD ($)
Jan. 31, 2023
Jan. 01, 2023
Oct. 01, 2022
Subsequent Event [Line Items]      
Dividend paid     $ 561,381
Series C Convertible Preferred Stock [Member] | Subsequent Event [Member]      
Subsequent Event [Line Items]      
Dividend paid   $ 68,809  
Conversion of stock, shares converted 1,525,000    
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company specializing in oncology. The Company’s focus is on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel technologies that target chemotherapeutic drugs to solid tumors and reduce off-target toxicities. However, the Company’s research and development activities have been curtailed as they seek additional financing. During 2017, the Company’s discovery laboratory in Freiburg, Germany synthesized and tested over 75 rationally designed drug candidates with highly potent anti-cancer payloads, culminating in the creation of two distinct classes of compounds. Four lead candidates (LADR-7 through LADR-10) were selected based on <i>in vitro </i>and animal studies in several different cancer models, and based on stability and manufacturing feasibility. In addition, a novel companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On June 1, 2018, the Company launched Centurion BioPharma Corporation (“Centurion”), a private subsidiary, and transferred all of its assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection with said transfer, the Company and Centurion entered into a Management Services Agreement whereby the Company agreed to render advisory, consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the Company for the cost of such services plus a <span id="xdx_902_ecustom--PercentageOfServiceCharge_iI_pid_dp_uPure_c20180601_z777XnkU4W0l" title="Percentage of service charge">5</span>% service charge. On December 21, 2018, LadRx announced that Centurion had concluded the pre-clinical phase of development for its four LADR™ drug candidates, and for its albumin companion diagnostic (ACDx™). As a result of completing this work, operations taking place at the pre-clinical laboratory in Freiburg, Germany were no longer needed and, accordingly, the lab was closed at the end of January 2019.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On March 9, 2022, Centurion merged with and into LadRx, with LadRx absorbing all of Centurion’s assets and continuing after the merger as the surviving entity (the “Merger”). The Merger was implemented through an agreement and plan of merger pursuant to Section 253 of the General Corporation Law of the State of Delaware and did not require approval from either our or Centurion’s stockholders. The Certificate of Ownership merging Centurion into LadRx was filed with the Secretary of State of Delaware on March 9, 2022.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Effective September 26, 2022, the Company changed its name from CytRx Corporation to LadRx Corporation pursuant to a Certificate of Amendment to our Certificate of Incorporation filed with the Secretary of State of Delaware. In accordance with the General Corporation Law of the State of Delaware (the “DGCL”), its board of directors approved the name change and the Certificate of Amendment. Pursuant to Section 242(b)(1) of the DGCL, stockholder approval was not required for the name change or the Certificate of Amendment.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We are a Delaware corporation, incorporated in 1985. Our corporate offices are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles, California 90049, and our telephone number is (310) 826-5648. Our web site is located at http://www.ladrxcorp.com. We do not incorporate by reference into this Annual Report the information on, or accessible through, our website, and you should not consider it as part of this Annual Report.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>LADR Drug Discovery Platform and Centurion</i></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The LADR Technology Offers the Opportunity for multiple pipeline drugs. The Company’s LADR™ (Linker Activated Drug Release) technology platform consists of an organic backbone that is attached to a chemotoxic agent. The purpose of the LADR™ backbone is to first target and deliver the chemotoxic agent to the tumor environment, and then to release the chemotoxic agent within the tumor. By delivering, concentrating, and releasing the chemotoxic agent within the tumor, one expects to reduce the off-target side-effects of the chemotherapeutic, which in turn allows for several-fold higher dosing of the chemotherapeutic to the patient. Being small organic molecules, the Company expects LADR-based drugs to offer the benefits of targeting the tumor without the complexity, side effects, and expense inherent in macromolecules such as antibodies and nanoparticles.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company’s LADR-based drugs use circulating albumin as the binding target and as the trojan horse to deliver the LADR™ drugs to the tumor. Albumin is the most abundant protein in plasma and accumulates inside tumors due to the aberrant vascular structure that exists within solid tumors. Tumors use albumin as a nutritional source and for transport of signaling and other molecules that are important to the maintenance and growth of the tumor, which makes albumin an excellent target for drugs that are intended for solid tumors.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company’s LADR™ development efforts are focused on two classes of ultra-high potency albumin-binding drugs. These LADR-based drugs, LADR7, 8, 9, and 10, combine the proprietary LADR™ backbone with novel derivatives of the auristatin and maytansinoid drug classes. Auristatin and maytansinoid are highly potent chemotoxins, and require targeting to the tumor for safe administration to humans, as is the case for the FDA-approved drugs Adcetris (auristatin antibody-drug-conjugate by Seagen) and Kadcyla (maytansine antibody-drug-conjugate by Genentech). We believe that LADR-based drugs offer the benefits of tumor targeting without the disadvantages of antibodies and other macromolecules, which include expense, complexity, and negative side effects. Additionally, albumin is a very well-characterized drug target, which we believe will reduce clinical and regulatory costs and risks.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company’s postulated mechanism of action for LADR-based drugs is as follows:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="width: 0.75in"> </td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">after administration, the linker portion of the drug conjugate forms a rapid and specific covalent bond to the cysteine-34 position of circulating albumin;</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td> </td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">circulating albumin preferentially accumulates in tumors due to a mechanism called “Enhanced Permeability and Retention”, which results in lower exposure to the drug in noncancerous tissues of the heart, liver, and other organs;</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td> </td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">once localized at the tumor, the acid-sensitive linker of the LADR™ backbone is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td> </td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">free active drug is then released within the tumor, causing tumor cell death.</span></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The first-generation LADR-based drug is called aldoxorubicin. Aldoxorubicin is the drug doxorubicin attached to the first generation LADR™ backbone (LADRs 7-10 employ a next generation LADR™ backbone). Aldoxorubicin has been administered to over 600 human subjects in human clinical trials and has proven the concept of LADR™ in that several-fold more doxorubicin can be safely administered to patients when the doxorubicin is attached to LADR™ than when administered as native doxorubicin. Aldoxorubicin has been licensed to ImmunityBio, and is currently in a Phase II registrational intent trial for pancreatic cancer. Aldoxorubicin is expected to enter a Phase I/II trial for glioblastoma in 2022 or 2023.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The next generation LADR™ drugs are termed LADR7, 8, 9, and 10. A great deal of Investigational New Drug (“IND”) enabling work has already been accomplished on LADR7-10, including in-silico modeling, in-vitro efficacy testing in several different cancer models, in-vivo dosing, safety, and efficacy testing in several different cancer models in animals. We have also developed and proven manufacturability, an important step prior to beginning human clinical trials.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The IND-enabling work that remains prior to applying to the FDA for first-in-human studies for LADR7-10 is limited due to the extensive experimentation already completed. For example, in the case of LADR7, a manufacturing run under Good Manufacturing Practices (GMP) must be completed and some toxicology studies completed using the GMP material must be completed in animals. Toxicology studies with LADR7 have already been completed with non-GMP manufactured drug. Management estimates that these final IND-enabling activities for LADR7 would take approximately 12 months to complete, once funded and initiated, and that first-in-human dosing would be achieved within approximately 6-9 months after completion of the IND-enabling studies. Management further estimates that the cost to manufacture GMP material for one LADR™ drug, for example LADR7, complete all pre-IND studies, and to obtain an IND could be approximately $2M in direct costs, based on current estimates, representing a capital-efficient path to clinical entry.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Because the LADR™ backbone in future products would be the same as the LADR™ backbone in current product candidates, (i.e. the chemotoxin can be changed without changing the LADR™ backbone), management anticipates that future product candidates beyond LADR7-10 may enjoy abbreviated pre-clinical pathways to first-in-human. Such abbreviated pathways would be subject to FDA review and agreement.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company’s novel companion diagnostic, ACDx™ (albumin companion diagnostic) was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR™ lead assets. We have not yet determined whether the use of a companion diagnostic will be necessary or helpful, and plan to continue to investigate this question in parallel to the pre-clinical and clinical development of LADRs 7-10.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The LADR™ backbone and drugs that employ LADR™ are protected by domestic and international patents, and additional patents are pending.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Business Strategy for LADR™ Platform</i></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Throughout 2022, with the assistance of oncology drug development experts, the Company has inventoried the IND-enabling data for LADRs 7-10, developed a strategy to complete the IND-enabling studies necessary for at least one LADR™ drug, and worked with vendors on establishing approximate time lines and costs to reach first-in-human dosing, inclusive of manufacturing, and completion of pre-IND studies and FDA filings, With this important groundwork completed, we believe that management is well situated to rapidly advance our next-generation LADR™ assets as soon as funding or partnering is achieved, and is working diligently to obtain funding and/or partnering of the LADR™ assets. Management will continue to explore in parallel both partnered and non-partnered funding and development strategies for LADR™ with a goal of obtaining the least costly capital possible to enable value inflection milestones.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Partnering of Aldoxorubicin</i></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On July 27, 2017, the Company entered into an exclusive worldwide license with ImmunityBio, Inc. (formerly known as NantCell, Inc. (“ImmunityBio”)), granting to ImmunityBio the exclusive rights to develop, manufacture and commercialize aldoxorubicin in all indications, and the Company is no longer directly working on the development of aldoxorubicin. As part of the license agreement, ImmunityBio made a strategic investment of $<span id="xdx_90D_eus-gaap--Investments_iI_pn5n6_c20170727_zButHuWXo0o8" title="Cash investments">13</span> million in LadRx common stock at $<span id="xdx_90A_eus-gaap--SharesIssuedPricePerShare_iI_c20170727_zaTvQX2VPrRg" title="Investment in common stock per share">6.60</span> per share (adjusted to reflect our 2017 reverse stock split), a premium of <span id="xdx_905_ecustom--CommonStockMarketPricePremiumPercentage_iI_dp_uPure_c20170727_zmZRMJ1WiQwf" title="Common stock market price premium percentage">92</span>% to the market price on that date. In connection therewith, the Company also issued ImmunityBio a warrant to purchase up to <span id="xdx_908_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20170727_zj7ut1DmwWIb" title="Number of warrants issued to purchase shares of common stock">500,000</span> shares of common stock at $<span id="xdx_904_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_c20170727_z0XSKn7VvsTi" title="Warrrants exercise price per share">6.60</span>, which expired on <span id="xdx_909_eus-gaap--WarrantsAndRightsOutstandingMaturityDate_iI_c20170727_zP6rUdzJa1n4" title="Warrant expiration">January 26, 2019</span>. The Company is entitled to receive up to an aggregate of $<span id="xdx_902_ecustom--FutureMilestonePaymentReceivableUnderLicenseAgreement_pn5n6_c20170727_zuDPfyzGzm8d" title="Fee contingent payments">343</span> million in potential milestone payments, contingent upon achievement of certain regulatory approvals and commercial milestones. The Company is also entitled to receive ascending double-digit royalties for net sales for soft tissue sarcomas and mid to high single digit royalties for other indications. There can be no assurance that ImmunityBio will achieve such milestones, approvals or sales with respect to aldoxorubicin.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">ImmunityBio is conducting an open-label, randomized, Phase 2 study of a combination of immunotherapy, aldoxorubicin and standard-of-care chemotherapy versus standard-of-care chemotherapy alone for the treatment of locally advanced or metastatic pancreatic cancer in patients who have had 1 or 2 lines of treatment (Cohorts A and B) or 3 or greater lines of treatment (Cohort C).</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 0.5in; background-color: white; color: #1D2228"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In January 2023, ImmunityBio announced positive results in its non-randomized fully-enrolled metastatic pancreatic cancer study in third-line or greater subjects (QUILT 88) showing that the overall survival rate for patients continues to be double compared to historical survival rates after two or more prior lines of therapy. The results were presented at the American Society of Clinical Oncology Gastrointestinal (ASCO GI) conference in San Francisco January 19-21, 2023. The median OS in this highly advanced group of patients, up to seven lines (N=83) of treatment, was 5.8 months (95% CI: 4.9, 6.4 months), exceeding the approximately 2- to 3-month historical median OS. In the third-line setting (N=41), the median OS in this group was 6.3 months (95% CI: 5.0, 7.2 months), more than doubling the historical OS. The baseline median CA 19-9 level (a marker of metastatic pancreatic disease) of the enrolled subjects (N=83) was very high at 4120 IU/ml, a significant increase from normal levels of 40 IU/ml. In subjects with CA 19-9 levels less than 4120 IU/ml (N=40), the median OS was 6.9 months (95% CI: 5.7,10.9).</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In December 2022, Immunity Bio held a Type B meeting with the FDA to discuss the path for approval of this combination therapy for pancreatic cancer. The FDA advised ImmunityBio to conduct a randomized trial. This Phase 2, randomized, three-cohort, open-label study plans to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus low-dose chemotherapy in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and C, respectively, with Cohorts A and B having independent experimental and control arms. The primary objective of Cohorts A and B is progression-free survival (PFS) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS)</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Aldoxorubicin has received Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (“FDA”) for the treatment of soft tissue sarcoma (“STS”). ODD provides several benefits including seven years of market exclusivity after approval, certain R&amp;D related tax credits, and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other benefits.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">ImmunityBio also lists ongoing clinical studies in glioblastoma; it is currently reviewing its options in STS.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Molecular Chaperone Assets (Orphayzme)</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In 2011, LadRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme A/S (“Orphazyme”, formerly Orphazyme ApS) in exchange for a one-time, upfront payment and the right to receive up to a total of $<span id="xdx_901_ecustom--FutureMilestonePaymentReceivableUnderLicenseAgreement_iI_pn5n6_c20111231__dei--LegalEntityAxis__custom--OrphazymeMember_zkgFVxU4Gmwl" title="Fee contingent payments">120</span> million in milestone payments upon the achievement of certain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any net sales of products derived from arimoclomol (the “2011 Arimoclomol Agreement”). Orphazyme transferred its rights and obligations under the 2011 Arimoclomol Agreement to KemPharm Denmark A/S (“KemPharm”), a wholly owned subsidiary of KemPharm Inc., in May 2022.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In May 2021, Orphazyme announced that the pivotal phase 3 clinical trial for arimoclomol in Amyotrophic Lateral Sclerosis did not meet its primary and secondary endpoints, reducing the maximum amount that LadRx currently has the right to receive under the 2011 Arimoclomol Agreement to approximately $<span id="xdx_901_ecustom--FutureMilestonePaymentReceivableUnderLicenseAgreement_iI_pn5n6_c20210501__dei--LegalEntityAxis__custom--ArimoclomolMember_zADm4QE6pm9b" title="Fee contingent payments">100</span> million. Orphazyme also tested arimoclomol in Niemann-Pick disease Type C (“NPC”) and Gaucher disease, and following a Phase II/III trial submitted to the FDA a New Drug Application for the treatment of NPC with arimoclomol. On June 18, 2021, Orphazyme announced it had received a complete response letter (the “Complete Response Letter”) from the FDA indicating the need for additional data. In late October 2021, Orphazyme announced it held a Type A meeting with the FDA, at which the FDA recommended that Orphazyme submit additional data, information and analyses to address certain topics in the Complete Response Letter and engage in further interactions with the FDA to identify a pathway to resubmission. The FDA concurred with Orphazyme’s proposal to remove the cognition domain from the NPC Clinical Severity Scale (“NPCCSS”) endpoint, with the result that the primary endpoint is permitted to be recalculated using the 4- domain NPCCSS, subject to the submission of additional requested information which Orphazyme had publicly indicated that it intended to provide. To bolster the confirmatory evidence already submitted, the FDA affirmed that it would require additional in vivo or pharmacodynamic (PD)/pharmacokinetic (PK) data. Orphazyme planned to request a Type C Meeting with the FDA in the second quarter of 2022. Subject to discussions with the regulatory body, Orphazyme had publicly indicated that it planned to resubmit the NDA for arimoclomol in the second half of 2022.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Orphazyme had also submitted a Marketing Authorization Application (“MAA”) with the European Medicines Agency (the “EMA”). In February 2022, Orphazyme announced that although they had received positive feedback from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA, they were notified by the CHMP of a negative trend vote on the MAA for arimoclomol for NPC following an oral explanation. In March 2022 Orphazyme removed its application with the EMA. Orphazyme has publicly indicated that it will assess its strategic options and provide an update to the market at the applicable time.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and business activities for cash consideration of $<span id="xdx_906_eus-gaap--ProceedsFromDivestitureOfBusinessesNetOfCashDivested_pn5n6_c20220531__20220531__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__custom--KemPharmMember_zigPWT5R6Dse" title="Cash consideration from sale of assets">12.8</span> million and assumption of liabilities estimated to equal approximately $<span id="xdx_90F_ecustom--FutureMilestonePaymentReceivableUnderLicenseAgreement_iI_pn5n6_c20220531__dei--LegalEntityAxis__custom--ArimoclomolMember_zwLgWoJNI9I" title="Fee contingent payments">5.2</span> million to KemPharm, a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (“CNS”) diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties on sales, were assumed by KemPharm. KemPharm is expected to continue the early access programs with arimoclomol, and to continue to pursue the potential approval of arimoclomol as a treatment option for NPC. KemPharm indicated it plans on resubmitting the NDA for arimoclomol in the first quarter of 2023. In February, 2023, KemPharm published positive data based on the recent completion of their four-year open-label safety trial that indicated arimoclomol may reduce the long-term progression of NPC. They plan on including these data as part of the updated NDA resubmission. It is also identifying a regulatory path forward with the EMA. KemPharm has recently re-branded to Zevra Therapeutics, Inc.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Going Concern</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. During the year ended December 31, 2022, the Company incurred a net loss of $<span id="xdx_90B_eus-gaap--NetIncomeLoss_iN_pn5n6_di_c20220101__20221231_zLwixMXuY6Bi" title="Net loss">4.2</span> million, utilized cash in operations of $<span id="xdx_904_eus-gaap--NetCashProvidedByUsedInOperatingActivities_iN_pn5n6_di_c20220101__20221231_zMJiwJqDcmqe" title="Cash in operations">4.8</span> million, and the Company had a stockholders deficit of $<span id="xdx_90F_eus-gaap--StockholdersEquity_iNI_pn5n6_di_c20221231_zLeTStxMtfOl" title="Stockholders equity">1.3</span> million as of December 31, 2022. In addition, the Company has no recurring revenue. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in">In order to fund our business and operations, we have relied primarily upon sales of our equity securities, including proceeds from the exercise of stock options and common stock purchase warrants and long-term loan financing. We also have received limited funding from our strategic partners and licensees. We will ultimately be required to obtain additional funding in order to execute our long-term business plans, although we do not currently have commitments from any third parties to provide us with long term debt or capital. We cannot assure that additional funding will be available on favorable terms, or at all. If we fail to obtain additional funding when needed, we may not be able to execute our business plans and our business may suffer, which would have a material adverse effect on our financial position, results of operations and cash flows. We have approximately $<span id="xdx_90E_eus-gaap--ContractualObligation_iI_pn5n6_c20221231__us-gaap--AwardDateAxis__custom--TwoThousandTwentyThreeMember_zNRZksXbg6C" title="Contractual obligation">1.2</span> million of contractual obligations in 2023 and expect to pay these out of the Company’s balance sheet cash. We have a total of approximately $<span id="xdx_906_ecustom--MaterialContractualObligation_iI_pn5n6_c20221231__us-gaap--AwardDateAxis__custom--TwoThousandTwentyThreeMember_zcGlV8uh28A3" title="Contractual obligation">1.9</span> million of material contractual obligations beyond 2023.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.2in"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in">If ImmunityBio obtains marketing approval and successfully commercializes aldoxorubicin, we anticipate it will take two years, and possibly longer, for us to generate significant recurring revenue, and we will be dependent on future financing until such time, if ever, as we can generate significant recurring revenue. There are also no certainties that KemPharm will be successful in obtaining FDA and EMA approval for arimoclomol or choose to commercialize arimoclomol. We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern. If we raise additional funds by issuing equity securities, dilution to stockholders may result and new investors could have rights superior to some or all of our existing equity holders. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available to us, we may have to liquidate some or all of our assets or to delay or reduce the scope of or eliminate some portion or all of our development programs or clinical trials.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Current Business Strategy</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Currently, the Company is working on identifying partnership or financing opportunities for LADR™ ultra-high potency drug conjugates and their albumin companion diagnostic. We have concluded all research and development on LADR and its companion diagnostic and continue to focus on identifying these partnership or financing opportunities.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 0.05 13000000 6.60 0.92 500000 6.60 2019-01-26 343000000 120000000 100000000 12800000 5200000 -4200000 -4800000 -1300000 1200000 1900000 <p id="xdx_808_eus-gaap--BasisOfPresentationAndSignificantAccountingPoliciesTextBlock_z85qPB95hUd2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>2. <span id="xdx_82B_zs4nPaTotes2">Summary of Significant Accounting Policies</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_84E_eus-gaap--BasisOfAccountingPolicyPolicyTextBlock_zOfG8wxpTPK9" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_862_zVu6CBYxnNKk">Basis of Presentation and Principles of Consolidation</span></i> — The accompanying Consolidated Financial Statements are prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and accounting principles generally accepted in the United States (“GAAP”). The Consolidated Financial Statements include the accounts of LadRx Corporation and its wholly-owned subsidiary. All intercompany accounts are eliminated.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_849_eus-gaap--RevenueFromContractWithCustomerPolicyTextBlock_zvQbF5FYMId2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_863_z82jX3eUdoOb">Revenue Recognition</span> </i>— Revenue consists of license fees from strategic alliances with pharmaceutical companies. During the years ended December 31, 2022 and 2021, no revenue was earned from license fees.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_847_eus-gaap--CashAndCashEquivalentsPolicyTextBlock_zkJJQnels294" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_864_zdds1UKQzr9k">Cash Equivalents</span> </i>— The Company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. Cash equivalents consist primarily of amounts invested in certificates of deposit and money market accounts.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_841_eus-gaap--PropertyPlantAndEquipmentPolicyTextBlock_zjiGgTXjKMQ8" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86D_zsn7gSC0ywjk">Equipment and Furnishings</span> </i>— Equipment and furnishings are stated at cost and depreciated using the straight-line method based on the estimated useful lives (generally three to five years for equipment and furniture) of the related assets. Whenever there is a triggering event that might suggest impairment, management evaluates the realizability of recorded long-lived assets to determine whether their carrying values have been impaired. The Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that the assets might be impaired and the non-discounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Any impairment loss is measured by comparing the fair value of the asset to its carrying amount.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_847_ecustom--InsuranceRecoveriesPolicyTextBlock_zdaPM2qWMtu5" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 13.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_863_zgcFbGAvOF3e">Insurance recoveries</span></i> — The Company has several policies with insurance underwriters that provide for the recovery of certain costs incurred by the Company. The Company’s policy is to record any liability as incurred, and then to record the estimated recovery from the insurance company for that cost as a receivable in accordance with terms of its existing policies. As of December 31, 2021, there were $<span id="xdx_905_eus-gaap--InsuranceRecoveries_c20210101__20211231_zNRjtRXxCFUe" title="Insurance recoveries">200,000</span> of insurance recoveries that were collected in 2022. As of December 31, 2022, there were <span id="xdx_90D_eus-gaap--InsuranceRecoveries_do_c20220101__20221231_zYuBsxN1Uahk" title="Insurance recoveries">no</span> amounts recoverable from its insurance company carriers under the terms of its policies.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_848_eus-gaap--FairValueMeasurementPolicyPolicyTextBlock_zIz7zXLrC1u3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86E_zgai6hHUhS37">Fair Value Measurements</span> </i>— Assets and liabilities recorded at fair value on the consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure the fair value. Level inputs are as follows:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-indent: 0.5in; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Level 1 – quoted prices in active markets for identical assets or liabilities.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Level 2 – other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Level 3 – significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company considers carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_849_ecustom--PatentsAndPatentApplicationCostsPolicyTextBlock_zAhZfnERDig7" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86F_z7Sweql4iBn3">Patents and Patent Application Costs</span> </i>— Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are therefore expensed as incurred.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_84D_eus-gaap--EarningsPerSharePolicyTextBlock_zWh3jCwMJGFk" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_865_zwu1tpsA27T6">Net Income (Loss) Per Share of Common Stock</span> </i>— Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted earnings per share is computed by dividing the net income applicable to common stockholders by the weighted average number of shares of common stock outstanding plus the number of additional shares of common stock that would have been outstanding if all dilutive potential shares of common stock had been issued using the treasury stock method. Potential shares of common stock are excluded from the computation when their effect is antidilutive. The dilutive effect of potentially dilutive securities is reflected in diluted net income per share if the exercise prices were lower than the average fair market value of common stock during the reporting period.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_897_eus-gaap--ScheduleOfAntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareTextBlock_zJAn6opI9yT2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B3_zPpmm2nTZKx3" style="display: none">Schedule of Shares Excluded from Computation of Diluted Loss Per Share</span> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 90%; margin-right: auto"> <tr style="display: none; vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_499_20220101__20221231_z8WpY67uXLA4" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_496_20210101__20211231_zlmeSxmoEtog" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">As of December 31,</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold"> </td> <td colspan="6" style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold"> </td></tr> <tr id="xdx_406_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--EmployeeStockOptionMember_zArx7Ut0H615" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Options to acquire common stock</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">1,765,108</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">2,827,820</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_400_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--WarrantMember_zTN5LGP1XUdk" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Warrants to acquire common stock</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">4,167</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">4,167</td><td style="text-align: left"> </td></tr> <tr id="xdx_400_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--ConvertiblePreferredStockMember_zRMKxseJxFHe" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Convertible preferred stock</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">3,127,689</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">9,363,637</td><td style="text-align: left"> </td></tr> <tr id="xdx_409_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__custom--InvestmentOptionMember_zD2xx5OUz18d" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Preferred investment option</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">11,363,637</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">11,363,637</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40B_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_zd4v4TbHuWU2" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 1.5pt"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Shares excluded from computation of diluted loss per share</span></td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">16,260,601</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">23,559,261</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8A4_zwf0sQmijgk4" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Potentially dilutive stock options, warrants and securities from the table above were excluded from the computation of diluted net income (loss) per share, because the effect would be anti-dilutive.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_842_eus-gaap--CompensationRelatedCostsPolicyTextBlock_zGgUvMaYyo6k" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86F_zEUj6y9nofMi">Stock-based Compensation</span> </i>— The Company accounts for share-based awards to employees and nonemployees directors and consultants in accordance with the provisions of ASC 718, <i>Compensation—Stock Compensation.</i>, and under the recently issued guidance following FASB’s pronouncement, ASU 2018-07, <i>Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting</i>. Under ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_84E_eus-gaap--ResearchAndDevelopmentExpensePolicy_zy2KTCGE79re" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_866_zqX87pUTjkv1">Research and Development Expenses</span> </i>— Research and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including licenses and drugs, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology developed for use in its products is expensed as incurred until technological feasibility has been established.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_84D_eus-gaap--IncomeTaxPolicyTextBlock_zclHOPyxhAO8" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_869_znxL6V18x5n6">Income Taxes</span> </i>— The Company accounts for income taxes in accordance with the provisions of FASB ASC 740-10, <i>Income Taxes, (“ASC 740”</i>) which requires the recognition of deferred tax assets and liabilities for taxable temporary differences and deferred tax assets for deductible temporary differences and operating loss carry-forwards using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit or expense is recognized as a result of changes in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all of any deferred tax assets will not be realized.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expenses.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_846_eus-gaap--ConcentrationRiskCreditRisk_zMLhZ5hULASg" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86F_zb5qU4N7hija">Concentrations of Risks</span> </i>— Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and short-term investments. The Company maintains cash and cash equivalents in large well-capitalized financial institutions and the Company’s investment policy disallows investment in any debt securities rated less than “investment-grade” by national ratings services. The Company has not experienced any losses on its deposits of cash or cash equivalents or its short-term investments. Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_845_eus-gaap--UseOfEstimates_zGLJe01aGSi9" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86D_zH1KSr6qKtYh">Use of Estimates</span> </i>— Preparation of the Company’s consolidated financial statements in conformance with U.S. GAAP requires the Company’s management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The significant estimates in the Company’s consolidated financial statements relate to the valuation of equity awards, recoverability of deferred tax assets, insurance claims and estimated useful lives of fixed assets. The Company bases estimates and assumptions on historical experience, when available, and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis, and its actual results may differ from estimates made under different assumptions or conditions.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_840_eus-gaap--NewAccountingPronouncementsPolicyPolicyTextBlock_zgd3FMIUzhVb" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_860_zisEeMtBjD2b">New Accounting Pronouncements</span> — In June 2016, the FASB issued ASU No. 2016-13,</i> Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”). The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The standard is effective for interim and annual reporting periods beginning after December 15, 2022. The adoption of ASU 2016-13 is not expected to have a material impact on the Company’s financial position, results of operations, and cash flows.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. Early adoption is permitted, including adoption in an interim period. If an entity elects to early adopt ASU 2021-04 in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The adoption of ASU 2021-04 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission (“SEC”) did not, or are not expected to, have a material impact on the Company’s consolidated financial statements and related disclosures.</span></p> <p id="xdx_857_zN5w5rn25Pba" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_84E_eus-gaap--BasisOfAccountingPolicyPolicyTextBlock_zOfG8wxpTPK9" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_862_zVu6CBYxnNKk">Basis of Presentation and Principles of Consolidation</span></i> — The accompanying Consolidated Financial Statements are prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and accounting principles generally accepted in the United States (“GAAP”). The Consolidated Financial Statements include the accounts of LadRx Corporation and its wholly-owned subsidiary. All intercompany accounts are eliminated.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_849_eus-gaap--RevenueFromContractWithCustomerPolicyTextBlock_zvQbF5FYMId2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_863_z82jX3eUdoOb">Revenue Recognition</span> </i>— Revenue consists of license fees from strategic alliances with pharmaceutical companies. During the years ended December 31, 2022 and 2021, no revenue was earned from license fees.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_847_eus-gaap--CashAndCashEquivalentsPolicyTextBlock_zkJJQnels294" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_864_zdds1UKQzr9k">Cash Equivalents</span> </i>— The Company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. Cash equivalents consist primarily of amounts invested in certificates of deposit and money market accounts.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_841_eus-gaap--PropertyPlantAndEquipmentPolicyTextBlock_zjiGgTXjKMQ8" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86D_zsn7gSC0ywjk">Equipment and Furnishings</span> </i>— Equipment and furnishings are stated at cost and depreciated using the straight-line method based on the estimated useful lives (generally three to five years for equipment and furniture) of the related assets. Whenever there is a triggering event that might suggest impairment, management evaluates the realizability of recorded long-lived assets to determine whether their carrying values have been impaired. The Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that the assets might be impaired and the non-discounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Any impairment loss is measured by comparing the fair value of the asset to its carrying amount.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_847_ecustom--InsuranceRecoveriesPolicyTextBlock_zdaPM2qWMtu5" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 13.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_863_zgcFbGAvOF3e">Insurance recoveries</span></i> — The Company has several policies with insurance underwriters that provide for the recovery of certain costs incurred by the Company. The Company’s policy is to record any liability as incurred, and then to record the estimated recovery from the insurance company for that cost as a receivable in accordance with terms of its existing policies. As of December 31, 2021, there were $<span id="xdx_905_eus-gaap--InsuranceRecoveries_c20210101__20211231_zNRjtRXxCFUe" title="Insurance recoveries">200,000</span> of insurance recoveries that were collected in 2022. As of December 31, 2022, there were <span id="xdx_90D_eus-gaap--InsuranceRecoveries_do_c20220101__20221231_zYuBsxN1Uahk" title="Insurance recoveries">no</span> amounts recoverable from its insurance company carriers under the terms of its policies.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 200000 0 <p id="xdx_848_eus-gaap--FairValueMeasurementPolicyPolicyTextBlock_zIz7zXLrC1u3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86E_zgai6hHUhS37">Fair Value Measurements</span> </i>— Assets and liabilities recorded at fair value on the consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure the fair value. Level inputs are as follows:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-indent: 0.5in; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Level 1 – quoted prices in active markets for identical assets or liabilities.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Level 2 – other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Level 3 – significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company considers carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_849_ecustom--PatentsAndPatentApplicationCostsPolicyTextBlock_zAhZfnERDig7" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86F_z7Sweql4iBn3">Patents and Patent Application Costs</span> </i>— Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are therefore expensed as incurred.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_84D_eus-gaap--EarningsPerSharePolicyTextBlock_zWh3jCwMJGFk" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_865_zwu1tpsA27T6">Net Income (Loss) Per Share of Common Stock</span> </i>— Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted earnings per share is computed by dividing the net income applicable to common stockholders by the weighted average number of shares of common stock outstanding plus the number of additional shares of common stock that would have been outstanding if all dilutive potential shares of common stock had been issued using the treasury stock method. Potential shares of common stock are excluded from the computation when their effect is antidilutive. The dilutive effect of potentially dilutive securities is reflected in diluted net income per share if the exercise prices were lower than the average fair market value of common stock during the reporting period.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_897_eus-gaap--ScheduleOfAntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareTextBlock_zJAn6opI9yT2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B3_zPpmm2nTZKx3" style="display: none">Schedule of Shares Excluded from Computation of Diluted Loss Per Share</span> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 90%; margin-right: auto"> <tr style="display: none; vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_499_20220101__20221231_z8WpY67uXLA4" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_496_20210101__20211231_zlmeSxmoEtog" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">As of December 31,</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold"> </td> <td colspan="6" style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold"> </td></tr> <tr id="xdx_406_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--EmployeeStockOptionMember_zArx7Ut0H615" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Options to acquire common stock</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">1,765,108</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">2,827,820</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_400_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--WarrantMember_zTN5LGP1XUdk" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Warrants to acquire common stock</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">4,167</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">4,167</td><td style="text-align: left"> </td></tr> <tr id="xdx_400_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--ConvertiblePreferredStockMember_zRMKxseJxFHe" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Convertible preferred stock</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">3,127,689</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">9,363,637</td><td style="text-align: left"> </td></tr> <tr id="xdx_409_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__custom--InvestmentOptionMember_zD2xx5OUz18d" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Preferred investment option</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">11,363,637</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">11,363,637</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40B_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_zd4v4TbHuWU2" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 1.5pt"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Shares excluded from computation of diluted loss per share</span></td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">16,260,601</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">23,559,261</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8A4_zwf0sQmijgk4" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Potentially dilutive stock options, warrants and securities from the table above were excluded from the computation of diluted net income (loss) per share, because the effect would be anti-dilutive.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_897_eus-gaap--ScheduleOfAntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareTextBlock_zJAn6opI9yT2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B3_zPpmm2nTZKx3" style="display: none">Schedule of Shares Excluded from Computation of Diluted Loss Per Share</span> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 90%; margin-right: auto"> <tr style="display: none; vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_499_20220101__20221231_z8WpY67uXLA4" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_496_20210101__20211231_zlmeSxmoEtog" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">As of December 31,</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold"> </td> <td colspan="6" style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold"> </td></tr> <tr id="xdx_406_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--EmployeeStockOptionMember_zArx7Ut0H615" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Options to acquire common stock</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">1,765,108</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">2,827,820</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_400_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--WarrantMember_zTN5LGP1XUdk" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Warrants to acquire common stock</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">4,167</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">4,167</td><td style="text-align: left"> </td></tr> <tr id="xdx_400_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--ConvertiblePreferredStockMember_zRMKxseJxFHe" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Convertible preferred stock</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">3,127,689</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">9,363,637</td><td style="text-align: left"> </td></tr> <tr id="xdx_409_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__custom--InvestmentOptionMember_zD2xx5OUz18d" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Preferred investment option</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">11,363,637</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">11,363,637</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40B_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_zd4v4TbHuWU2" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 1.5pt"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Shares excluded from computation of diluted loss per share</span></td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">16,260,601</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">23,559,261</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> </table> 1765108 2827820 4167 4167 3127689 9363637 11363637 11363637 16260601 23559261 <p id="xdx_842_eus-gaap--CompensationRelatedCostsPolicyTextBlock_zGgUvMaYyo6k" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86F_zEUj6y9nofMi">Stock-based Compensation</span> </i>— The Company accounts for share-based awards to employees and nonemployees directors and consultants in accordance with the provisions of ASC 718, <i>Compensation—Stock Compensation.</i>, and under the recently issued guidance following FASB’s pronouncement, ASU 2018-07, <i>Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting</i>. Under ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_84E_eus-gaap--ResearchAndDevelopmentExpensePolicy_zy2KTCGE79re" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_866_zqX87pUTjkv1">Research and Development Expenses</span> </i>— Research and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including licenses and drugs, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology developed for use in its products is expensed as incurred until technological feasibility has been established.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_84D_eus-gaap--IncomeTaxPolicyTextBlock_zclHOPyxhAO8" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_869_znxL6V18x5n6">Income Taxes</span> </i>— The Company accounts for income taxes in accordance with the provisions of FASB ASC 740-10, <i>Income Taxes, (“ASC 740”</i>) which requires the recognition of deferred tax assets and liabilities for taxable temporary differences and deferred tax assets for deductible temporary differences and operating loss carry-forwards using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit or expense is recognized as a result of changes in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all of any deferred tax assets will not be realized.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expenses.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_846_eus-gaap--ConcentrationRiskCreditRisk_zMLhZ5hULASg" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86F_zb5qU4N7hija">Concentrations of Risks</span> </i>— Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and short-term investments. The Company maintains cash and cash equivalents in large well-capitalized financial institutions and the Company’s investment policy disallows investment in any debt securities rated less than “investment-grade” by national ratings services. The Company has not experienced any losses on its deposits of cash or cash equivalents or its short-term investments. Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_845_eus-gaap--UseOfEstimates_zGLJe01aGSi9" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86D_zH1KSr6qKtYh">Use of Estimates</span> </i>— Preparation of the Company’s consolidated financial statements in conformance with U.S. GAAP requires the Company’s management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The significant estimates in the Company’s consolidated financial statements relate to the valuation of equity awards, recoverability of deferred tax assets, insurance claims and estimated useful lives of fixed assets. The Company bases estimates and assumptions on historical experience, when available, and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis, and its actual results may differ from estimates made under different assumptions or conditions.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_840_eus-gaap--NewAccountingPronouncementsPolicyPolicyTextBlock_zgd3FMIUzhVb" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_860_zisEeMtBjD2b">New Accounting Pronouncements</span> — In June 2016, the FASB issued ASU No. 2016-13,</i> Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”). The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The standard is effective for interim and annual reporting periods beginning after December 15, 2022. The adoption of ASU 2016-13 is not expected to have a material impact on the Company’s financial position, results of operations, and cash flows.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. Early adoption is permitted, including adoption in an interim period. If an entity elects to early adopt ASU 2021-04 in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The adoption of ASU 2021-04 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission (“SEC”) did not, or are not expected to, have a material impact on the Company’s consolidated financial statements and related disclosures.</span></p> <p id="xdx_803_eus-gaap--ForeignCurrencyDisclosureTextBlock_zOl4ZyAKxXc" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>3. <span id="xdx_82F_zX2ii4d1fNp9">Foreign Currency Remeasurement</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The U.S. dollar has been determined to be the functional currency for the net assets of the Company’s German operations. The transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and current exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). The Company recognized a loss of approximately $<span id="xdx_907_eus-gaap--ForeignCurrencyTransactionGainLossBeforeTax_c20220101__20221231_zXV3TCqlpzRd" title="Foreign currency transaction gain (loss), recognized">(2,889)</span> and $<span id="xdx_90B_eus-gaap--ForeignCurrencyTransactionGainLossBeforeTax_c20210101__20211231_zCMqeB0hKAd2" title="Foreign currency transaction gain (loss), recognized">(22,440)</span> for the years ended December 31, 2022 and 2021, respectively.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_895_eus-gaap--ScheduleOfCashAndCashEquivalentsTableTextBlock_z7gVUDa8PEc8" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of December 31, 2022 and 2021, the Company’s cash balances consisted of the following:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8BE_zBEdzqJBR4kc" style="display: none">Schedule of Company’s Cash Balance</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 90%; margin-right: auto"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_49B_20221231_zRNuRloCYU51" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_490_20211231_zx92oMvmevf7" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_407_eus-gaap--CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations_iI_hus-gaap--AwardTypeAxis__custom--USDollarMember_zKeIfPmdjRX1" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">U.S. Dollars</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">1,374,992</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">6,671,404</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40C_eus-gaap--CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations_iI_hus-gaap--AwardTypeAxis__custom--EurosMember_zScPVTm5tqz4" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Euros – in US $</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0505">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">98,199</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40E_eus-gaap--CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations_iI_zcpmKYqvtCx" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 1.5pt">Cash Balance</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td style="border-bottom: Black 1.5pt solid; text-align: right">1,374,992</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td style="border-bottom: Black 1.5pt solid; text-align: right">6,769,603</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8A0_zSRAQ0PfXYX2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> -2889 -22440 <p id="xdx_895_eus-gaap--ScheduleOfCashAndCashEquivalentsTableTextBlock_z7gVUDa8PEc8" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of December 31, 2022 and 2021, the Company’s cash balances consisted of the following:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8BE_zBEdzqJBR4kc" style="display: none">Schedule of Company’s Cash Balance</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 90%; margin-right: auto"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_49B_20221231_zRNuRloCYU51" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_490_20211231_zx92oMvmevf7" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_407_eus-gaap--CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations_iI_hus-gaap--AwardTypeAxis__custom--USDollarMember_zKeIfPmdjRX1" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">U.S. Dollars</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">1,374,992</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">6,671,404</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40C_eus-gaap--CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations_iI_hus-gaap--AwardTypeAxis__custom--EurosMember_zScPVTm5tqz4" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Euros – in US $</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0505">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">98,199</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40E_eus-gaap--CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations_iI_zcpmKYqvtCx" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 1.5pt">Cash Balance</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td style="border-bottom: Black 1.5pt solid; text-align: right">1,374,992</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td style="border-bottom: Black 1.5pt solid; text-align: right">6,769,603</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> </table> 1374992 6671404 98199 1374992 6769603 <p id="xdx_80D_eus-gaap--PropertyPlantAndEquipmentDisclosureTextBlock_zoAuyb88qup4" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>4. <span id="xdx_828_zle7wv22GGZ">Equipment and Furnishings</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_898_eus-gaap--PropertyPlantAndEquipmentTextBlock_zYG1qxbUvYU" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Equipment and furnishings at December 31, 2022 and 2021 consist of the following:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8B5_zLOXKMy7rXd" style="display: none">Schedule of Equipment and Furnishings</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 90%; margin-right: auto"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_491_20221231_zOFnXYoUcKQa" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_490_20211231_zjQJ2cfKTsPd" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_408_eus-gaap--PropertyPlantAndEquipmentGross_iI_maPPAENzwaO_zkEtuoLsdiji" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Equipment and furnishings</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">48,742</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">59,728</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment_iNI_di_msPPAENzwaO_z0ePWSUiFKz8" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Less — accumulated depreciation</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(30,196</td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(26,944</td><td style="padding-bottom: 1.5pt; text-align: left">)</td></tr> <tr id="xdx_40D_eus-gaap--PropertyPlantAndEquipmentNet_iTI_mtPPAENzwaO_zTxJppVoMjC4" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 2.5pt">Equipment and furnishings, net</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">18,546</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">32,784</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8A7_zEtpKKFg9M43" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Depreciation and amortization expense for the years ended December 31, 2022 and 2021 were $<span id="xdx_90D_eus-gaap--DepreciationDepletionAndAmortization_c20220101__20221231_zOvncWLoFBel" title="Depreciation and amortization expense">15,004</span> and $<span id="xdx_906_eus-gaap--DepreciationAndAmortization_c20210101__20211231_zzt6nZI7Di17" title="Depreciation and amortization expense">13,978</span>, respectively. During the year ended December 31, 2022, fully depreciated equipment and furnishings of $<span id="xdx_909_eus-gaap--Depreciation_c20220101__20221231__us-gaap--PropertyPlantAndEquipmentByTypeAxis__custom--EquipmentAndFurnishingMember_zdEGNPq0Kizi" title="Depreciation">11,752</span> were written off.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_898_eus-gaap--PropertyPlantAndEquipmentTextBlock_zYG1qxbUvYU" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Equipment and furnishings at December 31, 2022 and 2021 consist of the following:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8B5_zLOXKMy7rXd" style="display: none">Schedule of Equipment and Furnishings</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 90%; margin-right: auto"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_491_20221231_zOFnXYoUcKQa" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_490_20211231_zjQJ2cfKTsPd" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_408_eus-gaap--PropertyPlantAndEquipmentGross_iI_maPPAENzwaO_zkEtuoLsdiji" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Equipment and furnishings</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">48,742</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">59,728</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment_iNI_di_msPPAENzwaO_z0ePWSUiFKz8" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Less — accumulated depreciation</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(30,196</td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(26,944</td><td style="padding-bottom: 1.5pt; text-align: left">)</td></tr> <tr id="xdx_40D_eus-gaap--PropertyPlantAndEquipmentNet_iTI_mtPPAENzwaO_zTxJppVoMjC4" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 2.5pt">Equipment and furnishings, net</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">18,546</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">32,784</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> 48742 59728 30196 26944 18546 32784 15004 13978 11752 <p id="xdx_803_eus-gaap--AccountsPayableAccruedLiabilitiesAndOtherLiabilitiesDisclosureCurrentTextBlock_z43JP7216Lp3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>5. <span id="xdx_82B_zRIXoBuNWW27">Accrued Expenses and Other Current Liabilities</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_89E_eus-gaap--ScheduleOfAccountsPayableAndAccruedLiabilitiesTableTextBlock_zh6BBcOrP1li" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accrued expenses and other current liabilities at December 31, 2022 and 2021 are summarized below.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8B5_zo7gYJNixmse" style="display: none">Schedule of Accrued Expenses and Other Current Liabilities</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 90%; margin-right: auto"> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_496_20221231_zOveUGGJ6KI1" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_493_20211231_zz5QZNUHNdmg" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_404_eus-gaap--AccruedProfessionalFeesCurrent_iI_pp0p0_maAPAOAzCBq_zlzo47NudPRd" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: justify">Professional fees</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">77,785</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">208,345</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_400_ecustom--LiquidatedDamages_iI_pp0p0_maAPAOAzCBq_zlKaANqiMdz6" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Liquidated damages– see Note 7</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0537">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">615,253</td><td style="text-align: left"> </td></tr> <tr id="xdx_400_eus-gaap--AccountsPayableOtherCurrent_iI_pp0p0_maAPAOAzCBq_zvncTqkOnqv1" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Payable to former CEO</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">50,191</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">256,115</td><td style="text-align: left"> </td></tr> <tr id="xdx_401_eus-gaap--EmployeeRelatedLiabilitiesCurrent_iI_pp0p0_maAPAOAzCBq_zM6cblgzu9f" style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Wages, bonuses and employee benefits</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">152,990</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">261,375</td><td style="text-align: left"> </td></tr> <tr id="xdx_409_eus-gaap--AccruedRoyaltiesCurrent_iI_pp0p0_maAPAOAzCBq_z4znZeCKfW12" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Royalties and milestones</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">716,155</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">716,155</td><td style="text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--OtherAccruedLiabilitiesCurrent_iI_pp0p0_maAPAOAzCBq_zo9l8ErZKntk" style="vertical-align: bottom; background-color: White"> <td style="text-align: justify; padding-bottom: 1.5pt">Other</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">18,380</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">7,263</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_402_eus-gaap--AccountsPayableAndOtherAccruedLiabilitiesCurrent_iTI_pp0p0_mtAPAOAzCBq_zct50iHQlxJk" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify; padding-bottom: 2.5pt; padding-left: 10pt">Total</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">1,015,501</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">2,064,506</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8A4_z3slQDUCchS2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_89E_eus-gaap--ScheduleOfAccountsPayableAndAccruedLiabilitiesTableTextBlock_zh6BBcOrP1li" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accrued expenses and other current liabilities at December 31, 2022 and 2021 are summarized below.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8B5_zo7gYJNixmse" style="display: none">Schedule of Accrued Expenses and Other Current Liabilities</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 90%; margin-right: auto"> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_496_20221231_zOveUGGJ6KI1" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_493_20211231_zz5QZNUHNdmg" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_404_eus-gaap--AccruedProfessionalFeesCurrent_iI_pp0p0_maAPAOAzCBq_zlzo47NudPRd" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: justify">Professional fees</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">77,785</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">208,345</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_400_ecustom--LiquidatedDamages_iI_pp0p0_maAPAOAzCBq_zlKaANqiMdz6" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Liquidated damages– see Note 7</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0537">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">615,253</td><td style="text-align: left"> </td></tr> <tr id="xdx_400_eus-gaap--AccountsPayableOtherCurrent_iI_pp0p0_maAPAOAzCBq_zvncTqkOnqv1" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Payable to former CEO</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">50,191</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">256,115</td><td style="text-align: left"> </td></tr> <tr id="xdx_401_eus-gaap--EmployeeRelatedLiabilitiesCurrent_iI_pp0p0_maAPAOAzCBq_zM6cblgzu9f" style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Wages, bonuses and employee benefits</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">152,990</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">261,375</td><td style="text-align: left"> </td></tr> <tr id="xdx_409_eus-gaap--AccruedRoyaltiesCurrent_iI_pp0p0_maAPAOAzCBq_z4znZeCKfW12" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Royalties and milestones</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">716,155</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">716,155</td><td style="text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--OtherAccruedLiabilitiesCurrent_iI_pp0p0_maAPAOAzCBq_zo9l8ErZKntk" style="vertical-align: bottom; background-color: White"> <td style="text-align: justify; padding-bottom: 1.5pt">Other</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">18,380</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">7,263</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_402_eus-gaap--AccountsPayableAndOtherAccruedLiabilitiesCurrent_iTI_pp0p0_mtAPAOAzCBq_zct50iHQlxJk" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify; padding-bottom: 2.5pt; padding-left: 10pt">Total</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">1,015,501</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">2,064,506</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> 77785 208345 615253 50191 256115 152990 261375 716155 716155 18380 7263 1015501 2064506 <p id="xdx_80E_eus-gaap--LesseeOperatingLeasesTextBlock_zSKRHuxjuuYa" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>6. <span id="xdx_82A_zcABoeUbev69">Leases</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We lease office space and office copiers related primarily to the Company’s administrative activities. The Company accounts for leases under ASC 842, <i>Leases,</i> which requires an entity to recognize a right-of-use asset and a lease liability for virtually all leases.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In January 2020, the Company signed a new <span id="xdx_906_eus-gaap--LesseeOperatingLeaseTermOfContract_iI_pid_dxL_c20200131_zQUfTpkVIMn6" title="Lease term::XDX::P4Y"><span style="-sec-ix-hidden: xdx2ixbrl0557">four-year</span></span> office lease which covers approximately <span id="xdx_902_eus-gaap--AreaOfLand_iI_pid_usqft_c20200131_z0ocYXX3axF5" title="Area of land">2,771</span> square feet of office and storage space. This lease is effective March 1, 2020 and extends through <span id="xdx_906_eus-gaap--LeaseExpirationDate1_dd_c20200101__20200131_zKShzNi9BnLj" title="Lease expiration date">February 29, 2024</span>, with a right to extend the term for an additional <span id="xdx_903_eus-gaap--LesseeOperatingLeaseRenewalTerm_iI_dxL_c20200131_zlghdwaXvH4" title="Extended term::XDX::P5Y"><span style="-sec-ix-hidden: xdx2ixbrl0563">five</span></span>-year period, subject to the terms and conditions set forth in the lease agreement. The monthly rent is $14,340, subject to annual increases of <span id="xdx_909_ecustom--AnnualPercentageIncreasedInMonthlyRent_pid_dp_uPure_c20200101__20200131_zS9SNkOaers4" title="Annual percentage increased in monthly rent">3.5</span> percent. In February 2020, the Company renewed its additional storage space lease, which requires us to make monthly payments of $<span id="xdx_902_eus-gaap--PaymentsForRent_pp0p0_c20200201__20200229_z4MmwQq1pcQf" title="Payments for rent">1,405</span>, subject to a <span id="xdx_906_ecustom--AnnualPercentageIncreasedInMonthlyRent_pid_dp_uPure_c20200201__20200229_zT7HJOpXyMC8" title="Annual percentage increased in monthly rent">2.5</span> percent annual increase. The Company recorded a right of use asset and lease liability obligation of $<span id="xdx_90A_eus-gaap--OperatingLeaseRightOfUseAsset_iI_pp0p0_c20200229_z7YKknCpSvHj" title="Lease liability obligation"><span id="xdx_90D_eus-gaap--OperatingLeaseLiability_iI_pp0p0_c20200229_zsWc6R7rMSxk" title="Lease liability obligation">715,310</span></span> upon inception of these leases. The Company also reclassified a previously existing right-of-use asset of $<span id="xdx_902_eus-gaap--OperatingLeaseRightOfUseAsset_iI_c20200229__srt--RestatementAxis__srt--RevisionOfPriorPeriodReclassificationAdjustmentMember_zQtPDsitYfa" title="Right of use asset">66,271</span> from other assets to right-of-use asset.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of December 31, 2022, the balance of right-of-use assets was approximately $<span id="xdx_90B_eus-gaap--OperatingLeaseRightOfUseAsset_iI_pn2d_c20221231_z6or7mvolOHg" title="Right of use asset">216,800</span>, and the balance of total lease liabilities was approximately $<span id="xdx_906_eus-gaap--OperatingLeaseLiability_iI_dxL_c20221231_zQ6THQjff3c6" title="Lease liability obligation::XDX::229607"><span style="-sec-ix-hidden: xdx2ixbrl0579">229,600</span></span>.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_891_eus-gaap--LesseeOperatingLeaseLiabilityMaturityTableTextBlock_ziJLkiRA4Ctf" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Future minimum lease payments under non-cancelable operating leases under ASC 842 as of December 31, 2022 are as follows:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8B3_zNgdBukWtH68" style="display: none">Schedule of Future Minimum Lease Payments</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_495_20221231_ziiywYeTSmUk" style="border-bottom: Black 1.5pt solid; text-align: center"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Operating </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Lease Payments</b></span></p></td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td> </td> <td colspan="2" style="text-align: right"> </td><td> </td></tr> <tr id="xdx_408_eus-gaap--LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths_iI_pp0p0_maLOLLPzi79_ztqxTHr3UpQl" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 78%">Jan 2023 – Dec 2023</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 18%; text-align: right">200,927</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40C_eus-gaap--LesseeOperatingLeaseLiabilityPaymentsDueYearTwo_iI_pp0p0_maLOLLPzi79_z9SAP59zRm94" style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt">Jan 2024 – Dec 2024</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">33,673</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_402_eus-gaap--LesseeOperatingLeaseLiabilityPaymentsDue_iTI_pp0p0_mtLOLLPzi79_z6b8ECQBLmn7" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Total future minimum lease payments</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">234,600</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--LesseeOperatingLeaseLiabilityUndiscountedExcessAmount_iNI_pp0p0_di_zAE3kMxPL5b5" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 1.5pt">Less: present value adjustment</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(4,993</td><td style="padding-bottom: 1.5pt; text-align: left">)</td></tr> <tr id="xdx_40A_eus-gaap--OperatingLeaseLiability_iTI_zr08XKE3jYk4" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Operating lease liabilities at December 31, 2022</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">229,607</td><td style="text-align: left"> </td></tr> <tr id="xdx_40B_eus-gaap--OperatingLeaseLiabilityCurrent_iNI_pp0p0_di_zSgRd7RVwLJb" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 1.5pt">Less: current portion of operating lease liabilities</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(196,081</td><td style="padding-bottom: 1.5pt; text-align: left">)</td></tr> <tr id="xdx_40C_eus-gaap--OperatingLeaseLiabilityNoncurrent_iI_pp0p0" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Operating lease liabilities, net of current portion</td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">$</td><td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: right">33,526</td><td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left"> </td></tr> </table> <p id="xdx_8A4_zFXl7G0s9YYj" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_898_eus-gaap--LeaseCostTableTextBlock_zbCtnJjD5Ox1" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The components of rent expense and supplemental cash flow information related to leases for the period are as follows:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8B3_zzbHY2LHzv8b" style="display: none">Schedule of Rent Expense and Supplemental Cash Flow Information Related to Leases</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Year Ended </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>December 31, 2022</b></span></p></td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-decoration: underline; font-weight: bold; text-align: left">Lease Cost</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 78%; text-align: justify">Operating lease cost (included in General and administrative expenses in the Company’s Consolidated Statements of Operations)</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_982_eus-gaap--OperatingLeaseCost_pp0p0_c20220101__20221231_zb6MSFYEBKEh" style="width: 18%; text-align: right" title="Operating lease cost (included in General and administrative expenses in the Company's condensed Consolidated Statements of Operations)">197,154</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-decoration: underline; font-weight: bold; text-align: left">Other information</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2022</td><td> </td> <td style="text-align: left">$</td><td id="xdx_981_eus-gaap--RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability_pp0p0_c20220101__20221231_zVHz8OHVuJke" style="text-align: right" title="Cash paid for amounts included in the measurement of lease liabilities for the period ended September 30, 2022">180,786</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Weighted average remaining lease term – operating leases (in years)</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span id="xdx_90E_eus-gaap--OperatingLeaseWeightedAverageRemainingLeaseTerm1_iI_dtY_c20221231_zFf9QBMV3di4" title="Weighted average remaining lease term - operating leases (in years)">1.2</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Average discount rate</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98C_eus-gaap--OperatingLeaseWeightedAverageDiscountRatePercent_iI_pid_dp_c20221231_zKa4V5tQUDAe" style="text-align: right" title="Average discount rate">3.5</td><td style="text-align: left">%</td></tr> </table> <p id="xdx_8A4_zcILc8gJmXS3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 2771 2024-02-29 0.035 1405 0.025 715310 715310 66271 216800 <p id="xdx_891_eus-gaap--LesseeOperatingLeaseLiabilityMaturityTableTextBlock_ziJLkiRA4Ctf" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Future minimum lease payments under non-cancelable operating leases under ASC 842 as of December 31, 2022 are as follows:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8B3_zNgdBukWtH68" style="display: none">Schedule of Future Minimum Lease Payments</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_495_20221231_ziiywYeTSmUk" style="border-bottom: Black 1.5pt solid; text-align: center"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Operating </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Lease Payments</b></span></p></td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td> </td> <td colspan="2" style="text-align: right"> </td><td> </td></tr> <tr id="xdx_408_eus-gaap--LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths_iI_pp0p0_maLOLLPzi79_ztqxTHr3UpQl" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 78%">Jan 2023 – Dec 2023</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 18%; text-align: right">200,927</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40C_eus-gaap--LesseeOperatingLeaseLiabilityPaymentsDueYearTwo_iI_pp0p0_maLOLLPzi79_z9SAP59zRm94" style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt">Jan 2024 – Dec 2024</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">33,673</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_402_eus-gaap--LesseeOperatingLeaseLiabilityPaymentsDue_iTI_pp0p0_mtLOLLPzi79_z6b8ECQBLmn7" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Total future minimum lease payments</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">234,600</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--LesseeOperatingLeaseLiabilityUndiscountedExcessAmount_iNI_pp0p0_di_zAE3kMxPL5b5" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 1.5pt">Less: present value adjustment</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(4,993</td><td style="padding-bottom: 1.5pt; text-align: left">)</td></tr> <tr id="xdx_40A_eus-gaap--OperatingLeaseLiability_iTI_zr08XKE3jYk4" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Operating lease liabilities at December 31, 2022</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">229,607</td><td style="text-align: left"> </td></tr> <tr id="xdx_40B_eus-gaap--OperatingLeaseLiabilityCurrent_iNI_pp0p0_di_zSgRd7RVwLJb" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 1.5pt">Less: current portion of operating lease liabilities</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(196,081</td><td style="padding-bottom: 1.5pt; text-align: left">)</td></tr> <tr id="xdx_40C_eus-gaap--OperatingLeaseLiabilityNoncurrent_iI_pp0p0" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Operating lease liabilities, net of current portion</td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">$</td><td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: right">33,526</td><td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left"> </td></tr> </table> 200927 33673 234600 4993 229607 196081 33526 <p id="xdx_898_eus-gaap--LeaseCostTableTextBlock_zbCtnJjD5Ox1" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The components of rent expense and supplemental cash flow information related to leases for the period are as follows:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8B3_zzbHY2LHzv8b" style="display: none">Schedule of Rent Expense and Supplemental Cash Flow Information Related to Leases</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Year Ended </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>December 31, 2022</b></span></p></td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-decoration: underline; font-weight: bold; text-align: left">Lease Cost</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 78%; text-align: justify">Operating lease cost (included in General and administrative expenses in the Company’s Consolidated Statements of Operations)</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_982_eus-gaap--OperatingLeaseCost_pp0p0_c20220101__20221231_zb6MSFYEBKEh" style="width: 18%; text-align: right" title="Operating lease cost (included in General and administrative expenses in the Company's condensed Consolidated Statements of Operations)">197,154</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-decoration: underline; font-weight: bold; text-align: left">Other information</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2022</td><td> </td> <td style="text-align: left">$</td><td id="xdx_981_eus-gaap--RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability_pp0p0_c20220101__20221231_zVHz8OHVuJke" style="text-align: right" title="Cash paid for amounts included in the measurement of lease liabilities for the period ended September 30, 2022">180,786</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Weighted average remaining lease term – operating leases (in years)</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span id="xdx_90E_eus-gaap--OperatingLeaseWeightedAverageRemainingLeaseTerm1_iI_dtY_c20221231_zFf9QBMV3di4" title="Weighted average remaining lease term - operating leases (in years)">1.2</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Average discount rate</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98C_eus-gaap--OperatingLeaseWeightedAverageDiscountRatePercent_iI_pid_dp_c20221231_zKa4V5tQUDAe" style="text-align: right" title="Average discount rate">3.5</td><td style="text-align: left">%</td></tr> </table> 197154 180786 P1Y2M12D 0.035 <p id="xdx_80B_eus-gaap--EquityMethodInvestmentsTextBlock_zRDXWkv0FVsg" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>7. <span id="xdx_828_z6CLy29SSnp2">Financing Under Security Purchase Agreement</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On July 13, 2021, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional investor (the “Investor”) for aggregate gross proceeds of $<span id="xdx_90D_eus-gaap--ProceedsFromIssuanceOrSaleOfEquity_pn6n6_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_zADOvYZKcaE" title="Gross proceeds from issuance of equity">10</span> million and net proceeds of approximately $<span id="xdx_907_eus-gaap--StockIssuedDuringPeriodValueNewIssues_pn5n6_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_zaddHdZWmSog" title="Net proceeds from issuance of equity">9.2</span> million. The transaction closed on July 16, 2021. Under the Purchase Agreement, the Company sold and issued (i) <span id="xdx_90B_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_pn6n6_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_zIN6K4cNXmkh" title="Stock issued during period, shares, new issues">2</span> million shares of its common stock at a purchase price of $<span id="xdx_902_eus-gaap--SharesIssuedPricePerShare_iI_pid_c20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_z7Yit6WjeO3j" title="Purchase price per share">0.88</span> per share for total gross proceeds of approximately $<span id="xdx_901_eus-gaap--ProceedsFromIssuanceOfCommonStock_pn4n6_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_zDP34hYlcdF5" title="Proceeds from issuance of common stock">1.76</span> million in a registered direct offering (the “Registered Direct Offering”) and (ii) <span id="xdx_908_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zjRXwcUSiO4l" title="Stock issued during period, shares, new issues">8,240</span> shares of Series C <span id="xdx_907_eus-gaap--PreferredStockDividendRatePercentage_pid_dp_uPure_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zYzjhvqGMVwb" title="Preferred stock dividend rate percentage">10.00</span>% Convertible Preferred Stock (the “Preferred Stock”) at a purchase price of $<span id="xdx_904_eus-gaap--SharesIssuedPricePerShare_iI_c20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zMBzEjz9wI9i" title="Purchase price per share">1,000</span> per share, for aggregate gross proceeds of approximately $<span id="xdx_905_eus-gaap--ProceedsFromIssuanceOfPrivatePlacement_pn4n6_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zLNmN23TB2mg" title="Proceeds from issuance of private placement">8.24</span> million, in a concurrent private placement (the “Private Placement” and, together with the Registered Direct Offering, the “July 2021 Offerings”). The shares of the Preferred Stock are convertible, upon shareholder approval as described below, into an aggregate of up to <span id="xdx_90A_eus-gaap--PreferredStockConvertibleSharesIssuable_iI_c20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zmj9nSfZoyPb" title="Preferred Stock, Convertible, Shares Issuable">9,363,637</span> shares of common stock at a conversion price of $<span id="xdx_901_eus-gaap--PreferredStockConvertibleConversionPrice_iI_c20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zj5B1TkpL0Z5" title="Preferred stock, convertible, conversion price">0.88</span> per share. Holders of the Preferred Stock shall be entitled to receive, and the Company shall pay, cumulative dividends at the rate per share (as a percentage of the stated value per share) of <span id="xdx_90D_eus-gaap--PreferredStockDividendRatePercentage_pid_dp_uPure_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_z1WxjAK0U14g" title="Dividend percentage">10.00</span>% per annum, payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the date of issuance. <span id="xdx_907_eus-gaap--PreferredStockContractTerms_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_z9WYWRRhqdVh" title="Preferred stock, contract terms">The terms of the Preferred Stock include beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock</span>. LadRx also issued to the Investor an unregistered preferred investment option (the “Preferred Investment Option”) that allows for the purchase of up to <span id="xdx_903_eus-gaap--OptionIndexedToIssuersEquityShares_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--OptionIndexedToIssuersEquityTypeAxis__custom--PreferredInvestmentOptionMember_zHrj5p0VmIZc" title="Option to purchase common stock">11,363,637</span> shares of common stock for additional gross proceeds of approximately $<span id="xdx_905_ecustom--OptionIndexedToIssuersEquitySharesValue_pn6n6_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--OptionIndexedToIssuersEquityTypeAxis__custom--PreferredInvestmentOptionMember_zxbO3kRaix1d" title="Option indexed to issuers equity shares value">10</span> million if the Preferred Investment Option is exercised in full. The exercise price for the Preferred Investment Option is $<span id="xdx_90D_eus-gaap--OptionIndexedToIssuersEquityStrikePrice1_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--OptionIndexedToIssuersEquityTypeAxis__custom--PreferredInvestmentOptionMember_z61c0mFGoHwe" title="Option exercisable price">0.88</span> per share. The Preferred Investment Option has a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company accounted for these transactions as a single transaction for accounting purposes and allocated total proceeds to the respective instruments based upon the relative fair value of each instrument. The Company determined that the relative fair value of (i) the <span id="xdx_904_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_pid_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zpoqwhZYq39c" title="Shares issued during period">2,000,000</span> shares of the common stock issued was $<span id="xdx_90D_eus-gaap--StockIssuedDuringPeriodValueNewIssues_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_z52zrBLKq8Dj" title="Fair value of shares issued">859,218</span>, (ii) the relative fair value of the <span id="xdx_907_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_pdd" title="Number of shares issued">8,240</span> shares of Preferred Stock was $<span id="xdx_90D_eus-gaap--StockIssuedDuringPeriodValueNewIssues_pp0p0_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zS4Q5kGGmzF6" title="Number of shares issued, value">4,022,700</span>, and (iii) the relative fair value of the Preferred Investment Option was $<span id="xdx_905_eus-gaap--OtherLiabilitiesFairValueDisclosure_iI_c20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--StatementClassOfStockAxis__custom--PreferredInvestmentOptionMember_zCTlQHtT7jJ8" title="Other liabilities fair value">4,293,872</span> based upon a Black Scholes valuation model. As such, the Company recorded as Additional Paid in Capital the fair value of the common stock and Preferred Investment Option of $<span id="xdx_90B_eus-gaap--AdjustmentsToAdditionalPaidInCapitalMarkToMarket_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--StatementClassOfStockAxis__custom--PreferredInvestmentOptionMember_z3GvSXUjiSHg" title="Fair value of the common stock and Preferred Investment Option">5,153,090</span>, and the fair value of the Series C Preferred Stock was $<span id="xdx_908_eus-gaap--AdjustmentsToAdditionalPaidInCapitalMarkToMarket_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zUE91Q0ws295" title="Additional piaid in capital">4,022,700</span> which has been reflected as mezzanine (temporary equity) due to certain clauses of the Securities Purchase Agreement.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On October 1, 2021, the Company paid a quarterly <span id="xdx_909_eus-gaap--PreferredStockDividendRatePercentage_dp_uPure_c20210925__20211001__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_z87yFEarSf83" title="Preferred stock dividend rate percentage">10</span>% dividend to the Investor in the amount of $<span id="xdx_904_eus-gaap--PaymentsOfDividends_c20210925__20211001__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zPvwJADF2bUb" title="Dividend paid">171,668</span>. In 2022, the Company paid the following dividends: on January 1, 2022, $<span id="xdx_90A_eus-gaap--PaymentsOfDividends_c20211230__20220102__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zhMQdmGrbb18" title="Dividend paid">206,000</span>, on April 1, 2022, $<span id="xdx_902_eus-gaap--PaymentsOfDividends_c20220401__20220401__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zEdjWnApmV14" title="Dividend paid">202,567</span>, on July 1, 2022, $<span id="xdx_902_eus-gaap--PaymentsOfDividends_c20220701__20220701__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zEO1qKR2yTN4" title="Dividend paid">84,005</span> and on October 1, 2022, $<span id="xdx_906_eus-gaap--PaymentsOfDividends_c20221001__20221001__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zGgInr5WwsZi" title="Dividend paid">68,809</span> for a total of $<span id="xdx_909_eus-gaap--PaymentsOfDividends_c20221001__20221001_zYLnltke6Yof" title="Dividend paid">561,381</span>.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On March 15, 2022, at a special meeting of its stockholders which was originally opened and subsequently adjourned on September 23, 2021, the Company’s stockholders, by an affirmative vote of the majority of the Company’s outstanding shares of capital stock, approved the amendment to the Company’s Restated Certificate of Incorporation to effect an increase in the number of shares of authorized common stock, par value $<span id="xdx_906_eus-gaap--CommonStockParOrStatedValuePerShare_iI_pid_c20220315_zWfDGg8ysK44" title="Common stock, par value">0.001</span> per share, from <span id="xdx_903_eus-gaap--CommonStockSharesAuthorized_c20210922_pdd" title="Common stock, shares authorized">41,666,666</span> shares to <span id="xdx_904_eus-gaap--CommonStockSharesAuthorized_c20210923_pdd" title="Common stock, shares authorized">62,393,940</span> shares, and to make a corresponding change to the number of authorized shares of capital stock in order to comply with the Company’s contractual obligations under the Purchase Agreement.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On March 28, 2022, the Investor converted <span id="xdx_904_eus-gaap--ConvertiblePreferredStockSharesIssuedUponConversion_iI_c20220328__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_z1z9KbZENpwj" title="Number of shares converted">4,120</span> shares of the Series C Preferred Stock in accordance with the initial terms of the agreement and received <span id="xdx_900_eus-gaap--PreferredStockConvertibleSharesIssuable_iI_c20220328__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_zn4F3kfp45Ma" title="Shares issued upon conversion">4,681,819</span> common shares. On May 15, 2022, the Investor converted a further <span id="xdx_905_eus-gaap--ConvertiblePreferredStockSharesIssuedUponConversion_iI_c20220515__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_zwTuEq7IKdl6" title="Number of shares converted">1,368</span> shares of the Series C Preferred Stock and received <span id="xdx_908_eus-gaap--PreferredStockConvertibleSharesIssuable_iI_pid_c20220515__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_zxX0lOaGhpXj" title="Shares issued upon conversion">1,554,130</span> common shares. As of December 31, 2022, there were <span id="xdx_905_eus-gaap--ConvertiblePreferredStockSharesIssuedUponConversion_iI_c20221231__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_zIWClewTxuge" title="Number of shares converted">2,752</span> shares of Series C Preferred Stock outstanding, convertible into <span id="xdx_901_eus-gaap--PreferredStockConvertibleSharesIssuable_iI_c20221231__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__us-gaap--InvestorMember_zNmmEhs1gPab" title="Shares issued upon conversion">3,127,689</span> shares of common stock.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Terms of Series C Preferred Stock</i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under the Certificate of the Designations, Powers, Preferences and Rights of Series C <span id="xdx_90F_eus-gaap--PreferredStockDividendRatePercentage_dp_uPure_c20210712__20210713__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zbmOpebtPAd" title="Preferred stock dividend rate percentage">10.00</span>% Convertible Preferred Stock (the “<b><i>Certificate of Designations</i></b>”), each share of Series C Preferred Stock will be convertible, subject to the Beneficial Ownership Limitation (as defined below), at either the holder’s option or at the Company’s option (a “<b><i>Company Initiated Conversion</i></b>”) at any time following stockholder approval having been obtained to amend our restated certificate of incorporation to increase the number of authorized shares of common stock above <span id="xdx_902_eus-gaap--CommonStockSharesAuthorized_iI_c20210713__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zyYhn3DC6q58" title="Common stock, shares authorized">41,666,666</span> (the “Stockholder Approval”), into common stock at a conversion rate equal to the quotient of (i) the Series C Stated Value of $<span id="xdx_90E_eus-gaap--TemporaryEquityParOrStatedValuePerShare_iI_c20210713__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zI4FN2PwmQlb" title="Stated value per share">1,000</span> (the “<b><i>Series C Stated Value</i></b>”) plus, in the case of a Company Initiated Conversion, all accrued and accumulated and unpaid dividends on such share of Series C Preferred Stock, divided by (ii) the initial conversion price of $<span id="xdx_90A_eus-gaap--PreferredStockConvertibleConversionPrice_iI_c20210713__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_z5CCONEFVGh4" title="Conversion price">0.88</span>, subject to specified adjustments for stock splits, stock dividends, reclassifications or other similar events as set forth in the Certificate of Designations.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span id="xdx_90F_eus-gaap--PreferredStockContractTerms_c20210712__20210713__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zTSEQJER1BTd" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of common stock upon conversion that would result in the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of common stock outstanding immediately after giving effect to the conversion (the “<b><i>Beneficial Ownership Limitation</i></b>”), except that upon notice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of common stock after converting the holder’s shares of Series C Preferred Stock, provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of outstanding shares of the common stock outstanding immediately after giving effect to the issuance of shares of common stock upon conversion of the shares of Series C Preferred Stock held by the holder and provided that any increase in the Beneficial Ownership Limitation shall not be effective until 61 days following notice to the Company</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Each holder of shares of Preferred Stock is entitled to receive dividends, commencing from the date of issuance of the Preferred Stock. Such dividends may be paid only when, as and if declared by the Board of Directors of the Company (the “<b><i>Board</i></b>”), out of assets legally available therefore, quarterly in arrears on the first day of January, April, July and October in each year, commencing on the date of issuance, at the dividend rate of <span id="xdx_90C_eus-gaap--PreferredStockDividendRatePercentage_dp_uPure_c20210712__20210713__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zTg9nGimazS4" title="Preferred stock, dividend rate, percentage">10.00</span>% per year. Such dividends are cumulative and continue to accrue on a daily basis whether or not declared and whether or not we have assets legally available therefore.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under the Certificate of Designations, each share of Series C Preferred Stock carries a liquidation preference equal to the Series C Stated Value plus accrued and unpaid and accumulated dividends thereon. Such liquidation preference is payable upon certain change in control transactions and accordingly, this instrument is classified as mezzanine (temporary equity).</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The holders of the Series C Preferred Stock may vote their shares of Preferred Stock on an as-converted basis, subject to the Beneficial Ownership Limitation (which Beneficial Ownership Limitation shall be calculated on a basis which includes the number of shares of common stock which are issuable upon conversion of the unconverted Series C Stated Value beneficially owned by a holder or any of its affiliates or attribution parties on all matters submitted to the holders of common stock for approval). The Company may not take the following actions without the prior consent of the holders of at least a majority of the Preferred Stock then outstanding: (a) alter or change adversely the powers, preferences or rights given to the Preferred Stock or alter or amend the Certificate of Designations, (b) authorize or create any class of stock ranking as to dividends, redemption or distribution of assets upon a Liquidation (as defined in the Certificate of Designations) senior to, or otherwise <i><span style="text-decoration: underline">pari</span> passu</i> with, the Preferred Stock, (c) amend its Certificate of Incorporation or other charter documents in any manner that adversely affects any rights of the holders of the Preferred Stock, (d) increase the number of authorized shares of Preferred Stock, or (e) enter into any agreement with respect to any of the foregoing.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Terms of Preferred Investment Option</i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Preferred Investment Option to purchase up to <span id="xdx_902_eus-gaap--OptionIndexedToIssuersEquityShares_pid_c20210712__20210713__us-gaap--OptionIndexedToIssuersEquityTypeAxis__custom--PreferredInvestmentOptionMember_zq5yoP0yZ4o3">11,363,637 </span></span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of common stock is exercisable at a price of $<span id="xdx_900_eus-gaap--OptionIndexedToIssuersEquityStrikePrice1_pid_c20210712__20210713__us-gaap--OptionIndexedToIssuersEquityTypeAxis__custom--PreferredInvestmentOptionMember_zBuIRLHfCXM5">0.88 </span></span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">per share. The Preferred Investment Option have a term of five and one-half years from the Authorized Share Increase Date. <span id="xdx_90E_eus-gaap--OptionIndexedToIssuersEquitySettlementAlternatives_c20210712__20210713__us-gaap--OptionIndexedToIssuersEquityTypeAxis__custom--PreferredInvestmentOptionMember_zdtvy3E9Khfb">The holders of the Preferred Investment Option may exercise the Preferred Investment Option on a cashless basis, solely to the extent there is no effective registration statement registering, or the prospectus in such registration statement is not available for the resale of the shares of common stock issuable at the time of exercise. The Company is prohibited from effecting an exercise of any Preferred Investment Option to the extent that such exercise would result in the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of common stock outstanding immediately after giving effect to the exercise of the Preferred Investment Options by the holder (the “<b><i>PIO Beneficial Ownership Limitation</i></b>”), except that upon notice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of Common Stock after exercising the holder’s Preferred Investment Option, provided that the PIO Beneficial Ownership Limitation in no event exceeds 9.99% of the number of outstanding shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of common stock upon exercise of the Preferred Investment Option held by the holder and provided that any increase in the PIO Beneficial Ownership Limitation shall not be effective until 61 days following notice to the Company</span></span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">. The Preferred Investment Option provides for a Black-Scholes payout upon certain fundamental change transactions relating to the Company, as specified therein. If the fundamental change transaction is within the control of the Company, the payout will be in cash. Otherwise, the payout will be in the same form of consideration received by the common stockholders as a result of this transaction.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Registration Rights Agreement</i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In connection with the July 2021 Offerings, the Company entered into a registration rights agreement, dated as of July 13, 2021 (the “Registration Rights Agreement”), with the investor named therein, pursuant to which the Company will undertake to file, within five calendar days of the date of the filing of the proxy statement seeking the Stockholder Approval, a resale registration statement to register the shares of common stock issuable upon: (i) the conversion of the Preferred Stock sold in the Private Placement and (ii) the exercise of the Preferred Investment Option (the “<b><i>Registrable Securities</i></b>”); and to cause such registration statement to be declared effective under the Securities Act as promptly as possible after the filing thereof, but in any event no later than 75 days following the pricing date of this offering, or no later than 105 days following such date in the event of a “full review” by the SEC, and shall use its reasonable best efforts to keep such registration statement continuously effective under the Securities Act until the date that all Registrable Securities covered by such registration statement have been sold or are otherwise able to be sold pursuant to Rule 144. The Registration Rights Agreement provided for liquidated damages to the extent that the Company does not file or maintain a registration statement in accordance with the terms thereof. The registration rights agreement entered into between us and the Investor on July 13, 2021, contains a triggering event which would require us to pay to any holder of the Preferred Stock an amount in cash, as partial liquidated damages and not as a penalty, on a monthly basis equal to the product of <span id="xdx_901_ecustom--PercentageOfLiquidatedDamages_pid_dp_uPure_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--RegistrationRightsAgreementMember_zurnNAl8gTo4" title="Percentage of liquidated damages">2.0</span>% multiplied by the aggregate subscription amount paid by such holder for shares of Preferred Stock pursuant to the Purchase Agreement; provided, however, that such partial liquidated damages shall not exceed <span id="xdx_900_ecustom--PercentageOfLiquidatedDamages_pid_dp_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--RegistrationRightsAgreementMember__srt--RangeAxis__srt--MaximumMember_z68zf6MgeCW7" title="Percentage of liquidated damages">24</span>% of the aggregate subscription amounts paid by such holders pursuant to the Purchase Agreement, or $<span id="xdx_90D_ecustom--LiquidatedDamages_iI_c20210713__us-gaap--TypeOfArrangementAxis__custom--RegistrationRightsAgreementMember_zOEVaRVZGIS5" title="Liquidated damages">1,977,600</span>. If we fail to pay any partial liquidated damages within seven days after the date payable, we will be required to pay interest on any such amounts at a rate equal to the lesser of <span id="xdx_902_ecustom--PercentageOfIntresetPayableOnLiquidatedDamages_pid_dp_c20210712__20210713__us-gaap--TypeOfArrangementAxis__custom--RegistrationRightsAgreementMember_zqRSnhBgSvad" title="Percentage of interest payable on liquidated damages">18</span>% per annum or the maximum rate permitted by applicable law.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">During the year ended December 31, 2021, the Company did not have enough authorized shares to issue the issuable shares under the Preferred Stock and Preferred Investment Option. The Company attempted, but was unsuccessful, to obtain stockholders’ approval for the increase in authorized shares, and accordingly, the Company was unable to meet its registration rights obligation as of December 31, 2021. As such, the Company recognized an aggregate of approximately $<span id="xdx_909_eus-gaap--LossContingencyDamagesSoughtValue_pn5n6_c20210101__20211231_zJ8oQQd5jMG6" title="Loss contingency, damages sought, value">1.1</span> million in liquidated damages during the year ended December 31, 2021, of which includes a provision of $<span id="xdx_90F_eus-gaap--LossContingencyAccrualProvision_pp0p0_c20220101__20221231_zkTyxIkxcQm5" title="Loss contingency accrual provision">615,123</span> as an accrual for estimated damages until stockholders’ approval is achieved and the Registration Statement is filed. On March 15, 2022, the Company received its stockholders’ approval to increase its authorized shares and filed a certificate of amendment to its Certificate of Incorporation to increase the number of authorized shares from <span id="xdx_908_eus-gaap--CommonStockSharesAuthorized_c20220314_pdd" title="Common stock, shares authorized">41,666,666</span> shares to <span id="xdx_900_eus-gaap--CommonStockSharesAuthorized_c20220315_pdd" title="Common stock, shares authorized">63,227,273</span> shares on the same date. The Company filed its registration statement registering the shares underlying the Registrable Securities on March 23, 2022 and has provided for liquidated damages through that date. As of December 31, 2022, all liquidated damages had been paid and we no longer have any liabilities related to the Registration Rights Agreement.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 10000000 9200000 2000000 0.88 1760000 8240 0.1000 1000 8240000 9363637 0.88 0.1000 The terms of the Preferred Stock include beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock 11363637 10000000 0.88 2000000 859218 8240 4022700 4293872 5153090 4022700 0.10 171668 206000 202567 84005 68809 561381 0.001 41666666 62393940 4120 4681819 1368 1554130 2752 3127689 0.1000 41666666 1000 0.88 The Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of common stock upon conversion that would result in the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of common stock outstanding immediately after giving effect to the conversion (the “Beneficial Ownership Limitation”), except that upon notice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of common stock after converting the holder’s shares of Series C Preferred Stock, provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of outstanding shares of the common stock outstanding immediately after giving effect to the issuance of shares of common stock upon conversion of the shares of Series C Preferred Stock held by the holder and provided that any increase in the Beneficial Ownership Limitation shall not be effective until 61 days following notice to the Company 0.1000 11363637 0.88 The holders of the Preferred Investment Option may exercise the Preferred Investment Option on a cashless basis, solely to the extent there is no effective registration statement registering, or the prospectus in such registration statement is not available for the resale of the shares of common stock issuable at the time of exercise. The Company is prohibited from effecting an exercise of any Preferred Investment Option to the extent that such exercise would result in the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of common stock outstanding immediately after giving effect to the exercise of the Preferred Investment Options by the holder (the “PIO Beneficial Ownership Limitation”), except that upon notice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of Common Stock after exercising the holder’s Preferred Investment Option, provided that the PIO Beneficial Ownership Limitation in no event exceeds 9.99% of the number of outstanding shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of common stock upon exercise of the Preferred Investment Option held by the holder and provided that any increase in the PIO Beneficial Ownership Limitation shall not be effective until 61 days following notice to the Company 0.020 0.24 1977600 0.18 1100000 615123 41666666 63227273 <p id="xdx_80F_eus-gaap--PreferredStockTextBlock_zLwC8JmxMueh" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>8. <span id="xdx_826_zrZRfaHJ8Lpf">Series D Preferred Stock</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 27.75pt; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_904_eus-gaap--PreferredStockDividendPaymentTerms_c20220519__20220519__us-gaap--StatementClassOfStockAxis__us-gaap--SeriesDPreferredStockMember_zR8JXws0PD81" title="Dividend description">On May 19, 2022, the Board declared a dividend of one one-thousandth of a share of Series D Preferred Stock, par value $<span id="xdx_906_eus-gaap--PreferredStockDividendRatePerDollarAmount_pid_c20220519__20220519__us-gaap--StatementClassOfStockAxis__us-gaap--SeriesDPreferredStockMember_z7AgQhP0iaCi" title="Dividend rate per share">0.01</span> per share (“Series D Preferred Stock”), for each outstanding share of Company’s Common Stock to stockholders of record at 5:00 p.m. Eastern Time on May 20, 2022</span>. The Certificate of Designation of Series D Preferred Stock (the “Series D Certificate of Designation”) provides that all shares of Series D Preferred Stock that are not present in person or by proxy at any meeting of stockholders held to vote on the Reverse Stock Split (as defined in the Series D Certificate of Designation) and the Adjournment Proposal (as defined in the Series D Certificate of Designation) as of immediately prior to the opening of the polls at such meeting (the “Initial Redemption Time”) will automatically be redeemed in whole, but not in part, by the Company at the Initial Redemption Time without further action on the part of the Company or the holder of shares of Series D Preferred Stock (the “Initial Redemption”). Any outstanding shares of Series D Preferred Stock that have not been redeemed pursuant to an Initial Redemption will be redeemed in whole, but not in part, (i) if such redemption is ordered by the Board in its sole discretion, automatically and effective on such time and date specified by the Board in its sole discretion or (ii) automatically upon the approval by the Company’s stockholders of the Reverse Stock Split at any meeting of the stockholders held for the purpose of voting on such proposal (the “Subsequent Redemption”).</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 27.75pt; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt; text-indent: 27.75pt; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_908_eus-gaap--StockholdersEquityNoteStockSplit_c20220725__20220727__us-gaap--StatementClassOfStockAxis__us-gaap--SeriesDPreferredStockMember_z4ON8Fxserxb" title="Description of stock split ratio">On July 27, 2022, at the Company’s 2022 Annual Meeting of Stockholders, the Company’s stockholders approved a proposal to authorize the Board, in its discretion but prior to July 26, 2023, to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of all of the outstanding shares of the Company’s Common Stock, at a ratio in the range of 1-for-2 to 1-for-100, with such ratio to be determined by the Board, and all outstanding shares of Series D Preferred Stock were automatically redeemed</span>. As a result, <span id="xdx_903_eus-gaap--PreferredStockSharesOutstanding_iI_pid_do_c20220727__us-gaap--StatementClassOfStockAxis__us-gaap--SeriesDPreferredStockMember_zRhGMuTcFOt5" title="Preferred stock, shares outstanding">no</span> shares of Series D Preferred Stock remain outstanding. The stock split is not yet effective as of the date of this filing.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> On May 19, 2022, the Board declared a dividend of one one-thousandth of a share of Series D Preferred Stock, par value $0.01 per share (“Series D Preferred Stock”), for each outstanding share of Company’s Common Stock to stockholders of record at 5:00 p.m. Eastern Time on May 20, 2022 0.01 On July 27, 2022, at the Company’s 2022 Annual Meeting of Stockholders, the Company’s stockholders approved a proposal to authorize the Board, in its discretion but prior to July 26, 2023, to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of all of the outstanding shares of the Company’s Common Stock, at a ratio in the range of 1-for-2 to 1-for-100, with such ratio to be determined by the Board, and all outstanding shares of Series D Preferred Stock were automatically redeemed 0 <p id="xdx_807_eus-gaap--DisclosureOfCompensationRelatedCostsShareBasedPaymentsTextBlock_zoxe2mpYyJrj" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>9. <span id="xdx_823_zgfDDJ3MFNOb">Stock Compensation</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Stock Options</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company has a 2008 Stock Incentive Plan under which <span id="xdx_906_eus-gaap--CommonStockCapitalSharesReservedForFutureIssuance_iI_pn6n6_c20221231__us-gaap--PlanNameAxis__custom--StockIncentivePlanMember_zMsp8VezpXbk" title="Number of common stock reserved for future issuance">5</span> million shares of common stock are reserved for issuance. As of December 31, 2022, there were approximately <span id="xdx_90A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iI_pn5n6_c20221231__us-gaap--PlanNameAxis__custom--StockIncentivePlanMember_z1OW8IwTr1Ad" title="Share-based compensation, outstanding stock options">1.3</span> million shares subject to outstanding stock options and approximately <span id="xdx_90D_eus-gaap--StockIssuedDuringPeriodSharesRestrictedStockAwardGross_pn5n6_c20220101__20221231__us-gaap--PlanNameAxis__custom--StockIncentivePlanMember_zeubMl3ys318" title="Number of restricted stock grants">0.8</span> million shares outstanding related to restricted stock grants issued from the 2008 Plan. This plan expired on <span id="xdx_90F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardExpirationDate_dd_c20220101__20221231__us-gaap--PlanNameAxis__custom--StockIncentivePlanMember_zyDLXBHv3ezd" title="Expiration date">November 20, 2018</span> and thus no further shares are available for future grant under this plan.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In November 2019, the Company adopted a 2019 Stock Incentive Plan under which <span id="xdx_90D_eus-gaap--CommonStockCapitalSharesReservedForFutureIssuance_iI_pn5n6_c20191130__us-gaap--PlanNameAxis__custom--TwoThousandNineteenStockIncentivePlanMember_zobUNI5UPIE1" title="Number of common stock reserved for future issuance">5.4</span> million shares of common stock are reserved for issuance. As of December 31, 2022, there were <span id="xdx_903_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iI_pn5n6_c20221231__us-gaap--PlanNameAxis__custom--TwoThousandNineteenStockIncentivePlanMember_zzRnnevGgswg" title="Share-based compensation, outstanding stock options">0.5</span> million shares subject to outstanding stock options and <span id="xdx_906_eus-gaap--StockIssuedDuringPeriodSharesRestrictedStockAwardGross_c20220101__20221231__us-gaap--PlanNameAxis__custom--TwoThousandNineteenStockIncentivePlanMember_z0mLeo4Ndbd2" title="Number of restricted stock grants">25,000</span> shares outstanding related to restricted stock grants from the 2019 Plan. This Plan expires on <span id="xdx_904_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardExpirationDate_dd_c20220101__20221231__us-gaap--PlanNameAxis__custom--TwoThousandNineteenStockIncentivePlanMember_z0E46MAZx4bh" title="Expiration date">November 14, 2029</span>.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">All outstanding options issued to employees, directors and consultants were fully vested in 2020. As such, no further stock compensation expense was recognized during the year ended December 31, 2022 and 2021.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">No stock options were issued to employees, directors and consultants in 2022 and 2021.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">During the year ended December 31, 2022, options to acquire <span id="xdx_903_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_c20220101__20221231__us-gaap--DerivativeInstrumentRiskAxis__us-gaap--StockOptionMember_z1uHK3ZOU9kl" title="Number of stock option exercised">50,000</span> shares of common stock were exercised on a cashless basis in exchange for <span id="xdx_903_eus-gaap--ConversionOfStockSharesConverted1_pid_c20220101__20221231__us-gaap--DerivativeInstrumentRiskAxis__us-gaap--StockOptionMember__srt--TitleOfIndividualAxis__custom--HoldersMember_zalcbCVOXOrk" title="Conversion of stock">21,404</span> shares of common stock. During the year ended December 31, 2021, options to acquire <span id="xdx_90D_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_c20210101__20211231__us-gaap--DerivativeInstrumentRiskAxis__us-gaap--StockOptionMember_z1eNnzvB9k4b" title="Number of stock option exercised">300,000</span> shares of common stock were exercised resulting in net proceeds of $<span id="xdx_90A_eus-gaap--ProceedsFromStockOptionsExercised_c20210101__20211231__us-gaap--DerivativeInstrumentRiskAxis__us-gaap--StockOptionMember_zZbDnAoMypX3" title="Proceeds from stock options exercised">78,000</span>.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_898_eus-gaap--ScheduleOfShareBasedCompensationActivityTableTextBlock_z2lfC5CGAink" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The following table sets forth the total stock-based compensation expense resulting from restricted stock included in our Consolidated Statements of Operations for the years ended December 31, 2022 and 2021:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span id="xdx_8BB_zBFm5FcqSQji" style="display: none">Schedule of Stock-based Compensation Expense</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Years Ended December 31,</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left; padding-bottom: 1.5pt">General and administrative – employee</td><td style="width: 2%; padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; width: 1%; text-align: left">$</td><td id="xdx_98E_eus-gaap--ShareBasedCompensation_pdp0_c20220101__20221231__us-gaap--IncomeStatementLocationAxis__us-gaap--GeneralAndAdministrativeExpenseMember__us-gaap--GranteeStatusAxis__us-gaap--ShareBasedPaymentArrangementEmployeeMember_zma7WjjyNcRi" style="border-bottom: Black 1.5pt solid; width: 16%; text-align: right" title="General and administrative - employee">11,255</td><td style="width: 1%; padding-bottom: 1.5pt; text-align: left"> </td><td style="width: 2%; padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; width: 1%; text-align: left">$</td><td id="xdx_980_eus-gaap--ShareBasedCompensation_pdp0_c20210101__20211231__us-gaap--IncomeStatementLocationAxis__us-gaap--GeneralAndAdministrativeExpenseMember__us-gaap--GranteeStatusAxis__us-gaap--ShareBasedPaymentArrangementEmployeeMember_zZoY26EgW8Kg" style="border-bottom: Black 1.5pt solid; width: 16%; text-align: right" title="General and administrative - employee"><span style="-sec-ix-hidden: xdx2ixbrl0757">—</span></td><td style="width: 1%; padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify; padding-bottom: 2.5pt">Total employee stock-based compensation</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_981_eus-gaap--ShareBasedCompensation_pdp0_c20220101__20221231__us-gaap--GranteeStatusAxis__us-gaap--ShareBasedPaymentArrangementEmployeeMember_z47B0VnJ7vI8" style="border-bottom: Black 2.5pt double; text-align: right" title="Total employee stock-based compensation">11,255</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_981_eus-gaap--ShareBasedCompensation_pdp0_c20210101__20211231__us-gaap--GranteeStatusAxis__us-gaap--ShareBasedPaymentArrangementEmployeeMember_zn5iU6kgmEgh" style="border-bottom: Black 2.5pt double; text-align: right" title="Total employee stock-based compensation"><span style="-sec-ix-hidden: xdx2ixbrl0761">—</span></td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8AD_zHQRiFxR27bi" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"/> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B3_zQtG48qd9Ya6" style="display: none">Schedule of Stock Option Activity</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Stock Options</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; text-align: center"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted Average</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Exercise Price</b></span></p></td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 36%; text-align: left">Outstanding — beginning of year</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_98F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iS_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zPBHrW4Dbivh" style="width: 12%; text-align: right" title="Stock Options, Outstanding at beginning of year">2,462,820</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iS_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_z4B38rvRSce1" style="width: 12%; text-align: right" title="Stock Options, Outstanding at beginning of year">2,801,270</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_98F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iS_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zNOckaBsS8jd" style="width: 12%; text-align: right" title="Weighted-Average Exercise Price, Outstanding at beginning of year">7.68</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iS_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zbPPQC99Yfye" style="width: 12%; text-align: right" title="Weighted-Average Exercise Price, Outstanding at beginning of year">7.68</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Granted</td><td> </td> <td style="text-align: left"> </td><td id="xdx_980_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_z1NwzenEuNv5" style="text-align: right" title="Stock Options, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0771">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_981_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zkBLvJXrBRel" style="text-align: right" title="Stock Options, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0773">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98C_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zIBHwPEShfGg" style="text-align: right" title="Weighted-Average Exercise Price, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0775">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zH4wCjsQ4tJ8" style="text-align: right" title="Weighted-Average Exercise Price, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0777">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Exercised</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98C_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_iN_di_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zGrx9Xri23Lc" style="text-align: right" title="Stock Options, Exercised">(50,000</td><td style="text-align: left">)</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98B_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_iN_di_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_z3GiHrQkJq8f" style="text-align: right" title="Stock Options, Exercised">(300,000</td><td style="text-align: left">)</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98E_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zR0FsymE8CV6" style="text-align: right" title="Weighted-Average Exercise Price, Exercised">0.26</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_989_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zJRLFSvNceq9" style="text-align: right" title="Weighted-Average Exercise Price, Exercised">0.26</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Forfeited</td><td> </td> <td style="text-align: left"> </td><td id="xdx_980_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zIc28jhaUDGa" style="text-align: right" title="Stock Options, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0787">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_986_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zBRPDYs3d1Mc" style="text-align: right" title="Stock Options, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0789">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98A_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zc34v5ZIIKu7" style="text-align: right" title="Weighted-Average Exercise Price, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0791">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zOGcnO5RR0x" style="text-align: right" title="Weighted-Average Exercise Price, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0793">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 1.5pt">Expired</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_989_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExpirationsInPeriod_iN_di_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zo3WWTVMTmh2" style="border-bottom: Black 1.5pt solid; text-align: right" title="Stock Options, Expired">(1,012,712</td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98C_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExpirationsInPeriod_iN_di_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zr2MM2jvbLQc" style="border-bottom: Black 1.5pt solid; text-align: right" title="Stock Options, Expired">(38,450</td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExpirationsInPeriodWeightedAverageExercisePrice_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zzoRz5YsMVEb" style="border-bottom: Black 1.5pt solid; text-align: right" title="Weighted-Average Exercise Price, Expired">10.67</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExpirationsInPeriodWeightedAverageExercisePrice_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_z5VZJYtKy3w2" style="border-bottom: Black 1.5pt solid; text-align: right" title="Weighted-Average Exercise Price, Expired">14.62</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 2.5pt">Outstanding — end of year</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_z4ym5bVXTZX1" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Outstanding at end of year">1,400,108</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_z1u0CnlHKyod" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Outstanding at end of year">2,462,820</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_98F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zAni7vXIPTw6" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of year">7.18</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_980_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zxlxJ1PMsj6k" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of year">7.68</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 2.5pt">Exercisable at end of year</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zFz9epWufsk2" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Exercisable at end of year">1,400,108</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_98A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zhBTWiNP1Skb" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Exercisable at end of year">2,462,820</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_980_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_znyLLzwmcNw2" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Exercisable at end of year">7.18</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zamHyXMEWJQ6" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Exercisable at end of year">7.68</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Weighted average fair value of stock options granted during the year:</td><td> </td> <td style="text-align: left">$</td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20220101__20221231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zg6TnwUUauw" style="text-align: right" title="Stock Options, Weighted average fair value of stock options granted"><span style="-sec-ix-hidden: xdx2ixbrl0819">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20210101__20211231__srt--TitleOfIndividualAxis__custom--EmployeesAndDirectorsMember_zc24Lwr56v7" style="text-align: right" title="Stock Options, Weighted average fair value of stock options granted"><span style="-sec-ix-hidden: xdx2ixbrl0821">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"/><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p> <p id="xdx_8A5_zLIRrQE7QxJ1" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p> <p id="xdx_89D_eus-gaap--ScheduleOfShareBasedCompensationStockOptionsActivityTableTextBlock_hsrt--TitleOfIndividualAxis__custom--NonEmployeesMember_z7TYpxlN29Yc" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Presented below is the Company’s non-employee stock option activity:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"/> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"/> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B7_zh7Y8LMsnmvf" style="display: none">Schedule of Stock Option Activity</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Stock Options</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; text-align: center"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted Average</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Exercise Price</b></span></p></td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 36%; text-align: left">Outstanding — beginning of year</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_98E_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iS_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zZvLkrktRVnb" style="width: 12%; text-align: right" title="Stock Options, Outstanding at beginning of year">365,000</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_984_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iS_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zt6t00gQm8pf" style="width: 12%; text-align: right" title="Stock Options, Outstanding at beginning of year">365,000</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iS_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_z32bXz4L6EI4" style="width: 12%; text-align: right" title="Weighted-Average Exercise Price, Outstanding at beginning of year">5.49</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iS_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_ztvhtTZHwkAg" style="width: 12%; text-align: right" title="Weighted-Average Exercise Price, Outstanding at beginning of year">5.49</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Granted</td><td> </td> <td style="text-align: left"> </td><td id="xdx_989_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zuAoH2tneOS" style="text-align: right" title="Stock Options, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0833">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zW2iN8cNlkI1" style="text-align: right" title="Stock Options, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0835">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zhX4IjskCvi6" style="text-align: right" title="Weighted-Average Exercise Price, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0837">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zy6hGg5EUNu5" style="text-align: right" title="Weighted-Average Exercise Price, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0839">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Exercised</td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_iN_di_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zVi1JFIDkhA2" style="text-align: right" title="Stock Options, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0841">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_iN_di_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zMntrzIyzTsc" style="text-align: right" title="Stock Options, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0843">—</span></td><td style="text-align: left"/><td> </td> <td style="text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zQxuOSOhXyUa" style="text-align: right" title="Weighted-Average Exercise Price, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0845">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_z2QtBZYSyuJe" style="text-align: right" title="Weighted-Average Exercise Price, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0847">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt">Expired/Forfeited</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriod_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zokn5InkCO75" style="border-bottom: Black 1.5pt solid; text-align: right" title="Stock Options, Expired/Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0849">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriod_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zp7hwrpIJWQk" style="border-bottom: Black 1.5pt solid; text-align: right" title="Stock Options, Expired/Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0851">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98B_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriodWeightedAverageExercisePrice_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zKOhfZUBiuAf" style="border-bottom: Black 1.5pt solid; text-align: right" title="Weighted-Average Exercise Price, Expired/Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0853">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98E_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriodWeightedAverageExercisePrice_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zaxFPyLp4nel" style="border-bottom: Black 1.5pt solid; text-align: right" title="Weighted-Average Exercise Price, Expired/Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0855">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 2.5pt">Outstanding — end of year</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_989_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zm2nP5eYzoIe" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Outstanding at end of year">365,000</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zx81P6e9V4U9" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Outstanding at end of year">365,000</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zzbqQ4nqDgVd" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of year">5.49</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_98F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zsitWjjroWW8" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of year">5.49</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 2.5pt">Exercisable at end of year</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_981_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zWnO7wKB9GE8" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Exercisable at end of year">365,000</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_98F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_z9XFoSETflmc" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Exercisable at end of year">365,000</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zfnjRraMq9Ml" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of year">5.49</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zL1k28s3nwt1" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of year">5.49</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Weighted average fair value of stock options granted during the year:</td><td> </td> <td style="text-align: left">$</td><td id="xdx_984_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_z9efRPGZTu3j" style="text-align: right" title="Weighted average fair value of stock options granted"><span style="-sec-ix-hidden: xdx2ixbrl0873">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_z5664PlUyPzk" style="text-align: right" title="Weighted average fair value of stock options granted"><span style="-sec-ix-hidden: xdx2ixbrl0875">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_8A5_z4OVGQZcon8k" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"> </p> <p id="xdx_896_eus-gaap--ScheduleOfShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeTextBlock_zoYMwolcRmUg" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The following table summarizes significant ranges of outstanding stock options under the two plans at December 31, 2022:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8B4_za1vF2udAjI2" style="display: none">Schedule of Ranges of Stock options</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Range of<br/> Exercise<br/> Prices</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Number of Options</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted-Average Remaining Contractual Life (years)</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted-Average Exercise Price</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Number of Options Exercisable</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted-Average Remaining Contractual Life (years)</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted-Average Exercise Price</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 26%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_904_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeLowerRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zjsRHU1FgHRj" title="Range of Exercise Prices, Lower Range">0.26</span> - $<span id="xdx_901_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeUpperRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zh0vorFB7Kq3" title="Range of Exercise Prices, Upper Range">1.00</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_983_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zI4n7JtVZJwb" style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right" title="Number of Options Outstanding"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">500,000</span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_907_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zhdSUsVb6E8f" title="Weighted-Average Remaining Contractual Life (years)">6.95</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_987_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zttZJE7TCCUa" style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right" title="Weighted-Average Exercise Price"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">0.26</span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_988_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zUou8ggxorH4" style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right" title="Number of Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">500,000</span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_90D_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zFfij4mSdn27" title="Weighted-Average Remaining Contractual Life (years)">6.95</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_985_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageExercisePrice1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zr0SQKbX0NLe" style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right" title="Weighted-Average Exercise Price, Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">0.26</span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White"> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_907_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeLowerRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zI1Su8tE8dXc" title="Range of Exercise Prices, Lower Range">1.01</span> - $<span id="xdx_906_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeUpperRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zGXNviT1JgL8" title="Range of Exercise Prices, Upper Range">2.00</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_984_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zY3wycRRvz7h" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Outstanding"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">472,617</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_903_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zcrjy0jSewui" title="Weighted-Average Remaining Contractual Life (years)">4.96</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_988_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zXBBqJPgZSId" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.75</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_98E_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zoucGQ0IbeO" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">472,617</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_90D_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zCeL6Jbkvztf" title="Weighted-Average Remaining Contractual Life (years)">4.96</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_981_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageExercisePrice1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_z4NdJ7rxpCnc" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price, Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.75</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_902_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeLowerRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zLMdPOlNAbD7" title="Range of Exercise Prices, Lower Range">2.01</span> - $<span id="xdx_901_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeUpperRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zIbOtv4sglv6" title="Range of Exercise Prices, Upper Range">3.00</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_98C_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zYRq2sinkoee" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Outstanding"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">161,388</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right">      <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_905_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zJ8QXKGcj6qe" title="Weighted-Average Remaining Contractual Life (years)">3.96</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_980_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zhiN24yXTN12" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.58</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_98F_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zZxNERoMTMWb" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">161,388</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right">    <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_909_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_znVL5i79dcU" title="Weighted-Average Remaining Contractual Life (years)">3.96</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_981_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageExercisePrice1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zvOiSq75vqy4" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price, Options Exercisable">           <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.58</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White"> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_907_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeLowerRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zTJEBK0GJyK3" title="Range of Exercise Prices, Lower Range">3.01</span> - $<span id="xdx_90E_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeUpperRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zG60XiaXiYrg" title="Range of Exercise Prices, Upper Range">41.46</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_987_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zeKd4oEoHfwh" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Outstanding"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">631,103</span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_908_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zuXD5VtQGfXl" title="Weighted-Average Remaining Contractual Life (years)">2.16</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_984_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zvdLOFYsriB1" style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right" title="Weighted-Average Exercise Price">           <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">16.93</span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_98C_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zlJLw69jVbX4" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">631,103</span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_90D_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zd40qymZs0Mb" title="Weighted-Average Remaining Contractual Life (years)">2.16</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_983_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageExercisePrice1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zsBoihpJJW8b" style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right" title="Weighted-Average Exercise Price, Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">16.93</span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="border-bottom: black 2.25pt double; font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_98D_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zUhVSvH9FLG" style="border-bottom: black 2.25pt double; font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Outstanding"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1,765,108</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_906_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zhShkd5V2Mp2" title="Weighted-Average Remaining Contractual Life (years)">4.43</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_98A_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zYIS2zt9D0nk" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">6.83</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="border-bottom: black 2.25pt double; font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_987_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zWowGcqH9Kak" style="border-bottom: black 2.25pt double; font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1,765,108</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_907_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zn8rsAiBdIS3" title="Weighted-Average Remaining Contractual Life (years)">4.43</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_98D_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageExercisePrice1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zKXFbJyL9TX9" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price, Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">6.83</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> </table> <p id="xdx_8A7_zeytU8UClFch" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There was no aggregate intrinsic value of the outstanding options and options vested as of December 31, 2022.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Restricted Stock</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">No restricted stock was granted in 2022. In December 2021, the Company granted to Jennifer Simpson, who serves on our Board of Directors, <span id="xdx_90E_eus-gaap--StockIssuedDuringPeriodSharesRestrictedStockAwardGross_pid_c20211201__20211215__srt--TitleOfIndividualAxis__custom--JenniferSimpsonMember__us-gaap--AwardTypeAxis__us-gaap--RestrictedStockMember_zXaI9nMVeAM2" title="Shares granted">25,000</span> shares of restricted common stock, pursuant to the 2019 Plan. This restricted stock vests on the first anniversary of the date of the grant. The fair value of the restricted stock is based on the market price of the Company’s shares on the grant date less the par value received as consideration. The fair value of the restricted stock on the grant date was $<span id="xdx_90D_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20220101__20221231__srt--TitleOfIndividualAxis__custom--JenniferSimpsonMember__us-gaap--AwardTypeAxis__us-gaap--RestrictedStockMember_z0a0ZJWDPAp" title="Shares issued, shares">11,200</span>. As of December 31, 2022, there is no unamortized stock compensation.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Equity-Classified Warrants</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_893_eus-gaap--ScheduleOfStockholdersEquityNoteWarrantsOrRightsTextBlock_zmNLVHC2A9g" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A summary of the Company’s warrant activity and related information for the years ended December 31, 2022 and 2021 are shown below.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B7_zfFE8BTGOVT7" style="display: none">Schedule of Warrants Activity and Related Information</span> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Warrants</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; text-align: center"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted Average</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Exercise Price</b></span></p></td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 36%; text-align: left">Outstanding — beginning of year</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_986_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsOutstandingNumber_iS_c20220101__20221231_zujJ20Ygsae7" style="width: 12%; text-align: right" title="Warrants, Outstanding at beginning of period">4,167</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsOutstandingNumber_iS_c20210101__20211231_zl8zGOHpBHR3" style="width: 12%; text-align: right" title="Warrants, Outstanding at beginning of period">4,167</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_987_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsOutstandingWeightedAverageExercisePrice_iS_c20220101__20221231_zjss2BMjs42k" style="width: 12%; text-align: right" title="Weighted-Average Exercise Price, Outstanding at beginning of period">33.60</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_983_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsOutstandingWeightedAverageExercisePrice_iS_c20210101__20211231_zfNP83OQ0sW3" style="width: 12%; text-align: right" title="Weighted-Average Exercise Price, Outstanding at beginning of period">33.60</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Granted</td><td> </td> <td style="text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsGranted_c20220101__20221231_zOZkYFBCLMUg" style="text-align: right" title=" Warrants, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0969">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsGranted_c20210101__20211231_zboLXl3VT2G9" style="text-align: right" title="Warrants, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0971">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98F_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsGrantsInPeriodWeightedAverageExercisePrice_c20220101__20221231_zUkiayGADpl3" style="text-align: right" title="Weighted-Average Exercise Price, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0973">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_981_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsGrantsInPeriodWeightedAverageExercisePrice_c20210101__20211231_zn0o55AAw83h" style="text-align: right" title="Weighted-Average Exercise Price, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0975">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Exercised</td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExercised_c20220101__20221231_zwKgdb6vxB1i" style="text-align: right" title="Warrants, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0977">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98B_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExercised_c20210101__20211231_zgBhT13ph00g" style="text-align: right" title="Warrants, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0979">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_984_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsExercisesInPeriodWeightedAverageExercisePrice_c20220101__20221231_zuDvx3wV3SW9" style="text-align: right" title="Weighted-Average Exercise Price, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0981">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98D_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsExercisesInPeriodWeightedAverageExercisePrice_c20210101__20211231_z3niHIafs2Le" style="text-align: right" title="Weighted-Average Exercise Price, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0983">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Forfeited</td><td> </td> <td style="text-align: left"> </td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsForfeitures_c20220101__20221231_zjpqYqDk5pqh" style="text-align: right" title=" Warrants, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0985">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsForfeitures_c20210101__20211231_zze59qZCLRPi" style="text-align: right" title="Warrants, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0987">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_980_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsForfeituresInPeriodWeightedAverageExercisePrice_c20220101__20221231_zrDnc8PXfIm6" style="text-align: right" title="Weighted-Average Exercise Price, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0989">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98B_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsForfeituresInPeriodWeightedAverageExercisePrice_c20210101__20211231_zMwxYSX1oj15" style="text-align: right" title="Weighted-Average Exercise Price, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0991">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 1.5pt">Expired</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98E_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExpirations_iN_di_c20220101__20221231_zqS33dPpcAsj" style="border-bottom: Black 1.5pt solid; text-align: right" title="Warrants, Expired"><span style="-sec-ix-hidden: xdx2ixbrl0993">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExpirations_iN_di_c20210101__20211231_zbqz4wLbk7S7" style="border-bottom: Black 1.5pt solid; text-align: right" title="Warrants, Expired"><span style="-sec-ix-hidden: xdx2ixbrl0995">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_983_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsExpirationsInPeriodWeightedAverageExercisePrice_c20220101__20221231_zfOSnjb5btY5" style="border-bottom: Black 1.5pt solid; text-align: right" title="Weighted-Average Exercise Price, Expired"><span style="-sec-ix-hidden: xdx2ixbrl0997">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_988_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsExpirationsInPeriodWeightedAverageExercisePrice_c20210101__20211231_zOmYPReUDOd2" style="border-bottom: Black 1.5pt solid; text-align: right" title="Weighted-Average Exercise Price, Expired"><span style="-sec-ix-hidden: xdx2ixbrl0999">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 2.5pt">Outstanding — end of year</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsOutstandingNumber_iE_c20220101__20221231_zOtH8lKXX7ph" style="border-bottom: Black 2.5pt double; text-align: right" title=" Warrants, Outstanding at end of period">4,167</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_980_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsOutstandingNumber_iE_c20210101__20211231_zfR06Mkx1Zi" style="border-bottom: Black 2.5pt double; text-align: right" title="Warrants, Outstanding at end of period">4,167</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_98F_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsOutstandingWeightedAverageExercisePrice_iE_c20220101__20221231_zfHhoMXDENo6" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of period">33.60</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_982_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsOutstandingWeightedAverageExercisePrice_iE_c20210101__20211231_zdKo3jQoypj8" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of period">33.60</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 2.5pt">Exercisable at end of year</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_985_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExercisableNumber_iE_c20220101__20221231_zFEF6OL1fu1d" style="border-bottom: Black 2.5pt double; text-align: right" title=" Warrants, Exercisable at end of period">4,167</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_980_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExercisableNumber_iE_c20210101__20211231_zdcnApnh6V12" style="border-bottom: Black 2.5pt double; text-align: right" title="Warrants, Exercisable at end of period">4,167</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_986_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsExercisableWeightedAverageExercisePrice_iE_c20220101__20221231_zqCln349IZF9" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Exercisable at end of period">33.60</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_984_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsExercisableWeightedAverageExercisePrice_iE_c20210101__20211231_zu5yoSmI6fw" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Exercisable at end of period">33.60</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Weighted average fair value of warrants granted during the year:</td><td> </td> <td style="text-align: left">$</td><td id="xdx_985_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20220101__20221231_zN9btzkc5I83" style="text-align: right" title="Weighted average fair value of warrants granted"><span style="-sec-ix-hidden: xdx2ixbrl1017">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_983_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20210101__20211231_zkzoDJtbZfA" style="text-align: right" title="Weighted average fair value of warrants granted"><span style="-sec-ix-hidden: xdx2ixbrl1019">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_8A9_zcdZIYzikJI4" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The outstanding warrants as of December 31, 2022 had <span id="xdx_906_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsNonvestedIntrinsicValue_iI_do_c20221231_zQetc1xJi8u8" title="Warrants intrinsic value">no</span> intrinsic value.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 5000000 1300000 800000 2018-11-20 5400000 500000 25000 2029-11-14 50000 21404 300000 78000 <p id="xdx_898_eus-gaap--ScheduleOfShareBasedCompensationActivityTableTextBlock_z2lfC5CGAink" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The following table sets forth the total stock-based compensation expense resulting from restricted stock included in our Consolidated Statements of Operations for the years ended December 31, 2022 and 2021:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span id="xdx_8BB_zBFm5FcqSQji" style="display: none">Schedule of Stock-based Compensation Expense</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Years Ended December 31,</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left; padding-bottom: 1.5pt">General and administrative – employee</td><td style="width: 2%; padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; width: 1%; text-align: left">$</td><td id="xdx_98E_eus-gaap--ShareBasedCompensation_pdp0_c20220101__20221231__us-gaap--IncomeStatementLocationAxis__us-gaap--GeneralAndAdministrativeExpenseMember__us-gaap--GranteeStatusAxis__us-gaap--ShareBasedPaymentArrangementEmployeeMember_zma7WjjyNcRi" style="border-bottom: Black 1.5pt solid; width: 16%; text-align: right" title="General and administrative - employee">11,255</td><td style="width: 1%; padding-bottom: 1.5pt; text-align: left"> </td><td style="width: 2%; padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; width: 1%; text-align: left">$</td><td id="xdx_980_eus-gaap--ShareBasedCompensation_pdp0_c20210101__20211231__us-gaap--IncomeStatementLocationAxis__us-gaap--GeneralAndAdministrativeExpenseMember__us-gaap--GranteeStatusAxis__us-gaap--ShareBasedPaymentArrangementEmployeeMember_zZoY26EgW8Kg" style="border-bottom: Black 1.5pt solid; width: 16%; text-align: right" title="General and administrative - employee"><span style="-sec-ix-hidden: xdx2ixbrl0757">—</span></td><td style="width: 1%; padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify; padding-bottom: 2.5pt">Total employee stock-based compensation</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_981_eus-gaap--ShareBasedCompensation_pdp0_c20220101__20221231__us-gaap--GranteeStatusAxis__us-gaap--ShareBasedPaymentArrangementEmployeeMember_z47B0VnJ7vI8" style="border-bottom: Black 2.5pt double; text-align: right" title="Total employee stock-based compensation">11,255</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_981_eus-gaap--ShareBasedCompensation_pdp0_c20210101__20211231__us-gaap--GranteeStatusAxis__us-gaap--ShareBasedPaymentArrangementEmployeeMember_zn5iU6kgmEgh" style="border-bottom: Black 2.5pt double; text-align: right" title="Total employee stock-based compensation"><span style="-sec-ix-hidden: xdx2ixbrl0761">—</span></td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> 11255 11255 2462820 2801270 7.68 7.68 50000 300000 0.26 0.26 1012712 38450 10.67 14.62 1400108 2462820 7.18 7.68 1400108 2462820 7.18 7.68 <p id="xdx_89D_eus-gaap--ScheduleOfShareBasedCompensationStockOptionsActivityTableTextBlock_hsrt--TitleOfIndividualAxis__custom--NonEmployeesMember_z7TYpxlN29Yc" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Presented below is the Company’s non-employee stock option activity:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"/> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"/> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B7_zh7Y8LMsnmvf" style="display: none">Schedule of Stock Option Activity</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Stock Options</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; text-align: center"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted Average</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Exercise Price</b></span></p></td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 36%; text-align: left">Outstanding — beginning of year</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_98E_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iS_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zZvLkrktRVnb" style="width: 12%; text-align: right" title="Stock Options, Outstanding at beginning of year">365,000</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_984_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iS_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zt6t00gQm8pf" style="width: 12%; text-align: right" title="Stock Options, Outstanding at beginning of year">365,000</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iS_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_z32bXz4L6EI4" style="width: 12%; text-align: right" title="Weighted-Average Exercise Price, Outstanding at beginning of year">5.49</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iS_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_ztvhtTZHwkAg" style="width: 12%; text-align: right" title="Weighted-Average Exercise Price, Outstanding at beginning of year">5.49</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Granted</td><td> </td> <td style="text-align: left"> </td><td id="xdx_989_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zuAoH2tneOS" style="text-align: right" title="Stock Options, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0833">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zW2iN8cNlkI1" style="text-align: right" title="Stock Options, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0835">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zhX4IjskCvi6" style="text-align: right" title="Weighted-Average Exercise Price, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0837">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zy6hGg5EUNu5" style="text-align: right" title="Weighted-Average Exercise Price, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0839">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Exercised</td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_iN_di_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zVi1JFIDkhA2" style="text-align: right" title="Stock Options, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0841">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_iN_di_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zMntrzIyzTsc" style="text-align: right" title="Stock Options, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0843">—</span></td><td style="text-align: left"/><td> </td> <td style="text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zQxuOSOhXyUa" style="text-align: right" title="Weighted-Average Exercise Price, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0845">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_z2QtBZYSyuJe" style="text-align: right" title="Weighted-Average Exercise Price, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0847">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt">Expired/Forfeited</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriod_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zokn5InkCO75" style="border-bottom: Black 1.5pt solid; text-align: right" title="Stock Options, Expired/Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0849">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriod_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zp7hwrpIJWQk" style="border-bottom: Black 1.5pt solid; text-align: right" title="Stock Options, Expired/Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0851">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98B_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriodWeightedAverageExercisePrice_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zKOhfZUBiuAf" style="border-bottom: Black 1.5pt solid; text-align: right" title="Weighted-Average Exercise Price, Expired/Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0853">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98E_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriodWeightedAverageExercisePrice_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zaxFPyLp4nel" style="border-bottom: Black 1.5pt solid; text-align: right" title="Weighted-Average Exercise Price, Expired/Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0855">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 2.5pt">Outstanding — end of year</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_989_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zm2nP5eYzoIe" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Outstanding at end of year">365,000</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zx81P6e9V4U9" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Outstanding at end of year">365,000</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zzbqQ4nqDgVd" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of year">5.49</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_98F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zsitWjjroWW8" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of year">5.49</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 2.5pt">Exercisable at end of year</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_981_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zWnO7wKB9GE8" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Exercisable at end of year">365,000</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_98F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_z9XFoSETflmc" style="border-bottom: Black 2.5pt double; text-align: right" title="Stock Options, Exercisable at end of year">365,000</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zfnjRraMq9Ml" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of year">5.49</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_zL1k28s3nwt1" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of year">5.49</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Weighted average fair value of stock options granted during the year:</td><td> </td> <td style="text-align: left">$</td><td id="xdx_984_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20220101__20221231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_z9efRPGZTu3j" style="text-align: right" title="Weighted average fair value of stock options granted"><span style="-sec-ix-hidden: xdx2ixbrl0873">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20210101__20211231__srt--TitleOfIndividualAxis__custom--NonEmployeesMember_z5664PlUyPzk" style="text-align: right" title="Weighted average fair value of stock options granted"><span style="-sec-ix-hidden: xdx2ixbrl0875">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 365000 365000 5.49 5.49 365000 365000 5.49 5.49 365000 365000 5.49 5.49 <p id="xdx_896_eus-gaap--ScheduleOfShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeTextBlock_zoYMwolcRmUg" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The following table summarizes significant ranges of outstanding stock options under the two plans at December 31, 2022:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span id="xdx_8B4_za1vF2udAjI2" style="display: none">Schedule of Ranges of Stock options</span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Range of<br/> Exercise<br/> Prices</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Number of Options</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted-Average Remaining Contractual Life (years)</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted-Average Exercise Price</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Number of Options Exercisable</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted-Average Remaining Contractual Life (years)</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted-Average Exercise Price</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 26%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_904_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeLowerRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zjsRHU1FgHRj" title="Range of Exercise Prices, Lower Range">0.26</span> - $<span id="xdx_901_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeUpperRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zh0vorFB7Kq3" title="Range of Exercise Prices, Upper Range">1.00</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_983_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zI4n7JtVZJwb" style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right" title="Number of Options Outstanding"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">500,000</span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_907_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zhdSUsVb6E8f" title="Weighted-Average Remaining Contractual Life (years)">6.95</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_987_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zttZJE7TCCUa" style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right" title="Weighted-Average Exercise Price"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">0.26</span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_988_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zUou8ggxorH4" style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right" title="Number of Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">500,000</span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_90D_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zFfij4mSdn27" title="Weighted-Average Remaining Contractual Life (years)">6.95</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_985_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageExercisePrice1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeOneMember_zr0SQKbX0NLe" style="font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: right" title="Weighted-Average Exercise Price, Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">0.26</span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White"> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_907_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeLowerRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zI1Su8tE8dXc" title="Range of Exercise Prices, Lower Range">1.01</span> - $<span id="xdx_906_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeUpperRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zGXNviT1JgL8" title="Range of Exercise Prices, Upper Range">2.00</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_984_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zY3wycRRvz7h" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Outstanding"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">472,617</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_903_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zcrjy0jSewui" title="Weighted-Average Remaining Contractual Life (years)">4.96</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_988_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zXBBqJPgZSId" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.75</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_98E_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zoucGQ0IbeO" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">472,617</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_90D_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_zCeL6Jbkvztf" title="Weighted-Average Remaining Contractual Life (years)">4.96</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_981_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageExercisePrice1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeTwoMember_z4NdJ7rxpCnc" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price, Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.75</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_902_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeLowerRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zLMdPOlNAbD7" title="Range of Exercise Prices, Lower Range">2.01</span> - $<span id="xdx_901_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeUpperRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zIbOtv4sglv6" title="Range of Exercise Prices, Upper Range">3.00</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_98C_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zYRq2sinkoee" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Outstanding"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">161,388</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right">      <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_905_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zJ8QXKGcj6qe" title="Weighted-Average Remaining Contractual Life (years)">3.96</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_980_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zhiN24yXTN12" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.58</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_98F_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zZxNERoMTMWb" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">161,388</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right">    <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_909_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_znVL5i79dcU" title="Weighted-Average Remaining Contractual Life (years)">3.96</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_981_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageExercisePrice1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeThreeMember_zvOiSq75vqy4" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price, Options Exercisable">           <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.58</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White"> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_907_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeLowerRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zTJEBK0GJyK3" title="Range of Exercise Prices, Lower Range">3.01</span> - $<span id="xdx_90E_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeUpperRangeLimit_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zG60XiaXiYrg" title="Range of Exercise Prices, Upper Range">41.46</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_987_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zeKd4oEoHfwh" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Outstanding"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">631,103</span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_908_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zuXD5VtQGfXl" title="Weighted-Average Remaining Contractual Life (years)">2.16</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_984_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zvdLOFYsriB1" style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right" title="Weighted-Average Exercise Price">           <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">16.93</span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_98C_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zlJLw69jVbX4" style="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">631,103</span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_90D_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zd40qymZs0Mb" title="Weighted-Average Remaining Contractual Life (years)">2.16</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_983_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageExercisePrice1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--ExercisePriceRangeFourMember_zsBoihpJJW8b" style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right" title="Weighted-Average Exercise Price, Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">16.93</span></td> <td style="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="border-bottom: black 2.25pt double; font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_98D_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zUhVSvH9FLG" style="border-bottom: black 2.25pt double; font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Outstanding"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1,765,108</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_906_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zhShkd5V2Mp2" title="Weighted-Average Remaining Contractual Life (years)">4.43</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_98A_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zYIS2zt9D0nk" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">6.83</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="border-bottom: black 2.25pt double; font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td id="xdx_987_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zWowGcqH9Kak" style="border-bottom: black 2.25pt double; font: 10pt Times New Roman, Times, Serif; text-align: right" title="Number of Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1,765,108</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_907_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zn8rsAiBdIS3" title="Weighted-Average Remaining Contractual Life (years)">4.43</span></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</span></td> <td id="xdx_98D_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageExercisePrice1_iI_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zKXFbJyL9TX9" style="font: 10pt Times New Roman, Times, Serif; text-align: right" title="Weighted-Average Exercise Price, Options Exercisable"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">6.83</span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> </table> 0.26 1.00 500000 P6Y11M12D 0.26 500000 P6Y11M12D 0.26 1.01 2.00 472617 P4Y11M15D 1.75 472617 P4Y11M15D 1.75 2.01 3.00 161388 P3Y11M15D 2.58 161388 P3Y11M15D 2.58 3.01 41.46 631103 P2Y1M28D 16.93 631103 P2Y1M28D 16.93 1765108 P4Y5M4D 6.83 1765108 P4Y5M4D 6.83 25000 11200 <p id="xdx_893_eus-gaap--ScheduleOfStockholdersEquityNoteWarrantsOrRightsTextBlock_zmNLVHC2A9g" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A summary of the Company’s warrant activity and related information for the years ended December 31, 2022 and 2021 are shown below.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B7_zfFE8BTGOVT7" style="display: none">Schedule of Warrants Activity and Related Information</span> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Warrants</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; text-align: center"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Weighted Average</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Exercise Price</b></span></p></td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 36%; text-align: left">Outstanding — beginning of year</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_986_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsOutstandingNumber_iS_c20220101__20221231_zujJ20Ygsae7" style="width: 12%; text-align: right" title="Warrants, Outstanding at beginning of period">4,167</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsOutstandingNumber_iS_c20210101__20211231_zl8zGOHpBHR3" style="width: 12%; text-align: right" title="Warrants, Outstanding at beginning of period">4,167</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_987_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsOutstandingWeightedAverageExercisePrice_iS_c20220101__20221231_zjss2BMjs42k" style="width: 12%; text-align: right" title="Weighted-Average Exercise Price, Outstanding at beginning of period">33.60</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_983_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsOutstandingWeightedAverageExercisePrice_iS_c20210101__20211231_zfNP83OQ0sW3" style="width: 12%; text-align: right" title="Weighted-Average Exercise Price, Outstanding at beginning of period">33.60</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Granted</td><td> </td> <td style="text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsGranted_c20220101__20221231_zOZkYFBCLMUg" style="text-align: right" title=" Warrants, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0969">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsGranted_c20210101__20211231_zboLXl3VT2G9" style="text-align: right" title="Warrants, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0971">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98F_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsGrantsInPeriodWeightedAverageExercisePrice_c20220101__20221231_zUkiayGADpl3" style="text-align: right" title="Weighted-Average Exercise Price, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0973">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_981_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsGrantsInPeriodWeightedAverageExercisePrice_c20210101__20211231_zn0o55AAw83h" style="text-align: right" title="Weighted-Average Exercise Price, Granted"><span style="-sec-ix-hidden: xdx2ixbrl0975">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td>Exercised</td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExercised_c20220101__20221231_zwKgdb6vxB1i" style="text-align: right" title="Warrants, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0977">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98B_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExercised_c20210101__20211231_zgBhT13ph00g" style="text-align: right" title="Warrants, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0979">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_984_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsExercisesInPeriodWeightedAverageExercisePrice_c20220101__20221231_zuDvx3wV3SW9" style="text-align: right" title="Weighted-Average Exercise Price, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0981">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98D_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsExercisesInPeriodWeightedAverageExercisePrice_c20210101__20211231_z3niHIafs2Le" style="text-align: right" title="Weighted-Average Exercise Price, Exercised"><span style="-sec-ix-hidden: xdx2ixbrl0983">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Forfeited</td><td> </td> <td style="text-align: left"> </td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsForfeitures_c20220101__20221231_zjpqYqDk5pqh" style="text-align: right" title=" Warrants, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0985">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsForfeitures_c20210101__20211231_zze59qZCLRPi" style="text-align: right" title="Warrants, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0987">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_980_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsForfeituresInPeriodWeightedAverageExercisePrice_c20220101__20221231_zrDnc8PXfIm6" style="text-align: right" title="Weighted-Average Exercise Price, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0989">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98B_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsForfeituresInPeriodWeightedAverageExercisePrice_c20210101__20211231_zMwxYSX1oj15" style="text-align: right" title="Weighted-Average Exercise Price, Forfeited"><span style="-sec-ix-hidden: xdx2ixbrl0991">—</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 1.5pt">Expired</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98E_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExpirations_iN_di_c20220101__20221231_zqS33dPpcAsj" style="border-bottom: Black 1.5pt solid; text-align: right" title="Warrants, Expired"><span style="-sec-ix-hidden: xdx2ixbrl0993">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExpirations_iN_di_c20210101__20211231_zbqz4wLbk7S7" style="border-bottom: Black 1.5pt solid; text-align: right" title="Warrants, Expired"><span style="-sec-ix-hidden: xdx2ixbrl0995">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_983_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsExpirationsInPeriodWeightedAverageExercisePrice_c20220101__20221231_zfOSnjb5btY5" style="border-bottom: Black 1.5pt solid; text-align: right" title="Weighted-Average Exercise Price, Expired"><span style="-sec-ix-hidden: xdx2ixbrl0997">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_988_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardNonOptionsExpirationsInPeriodWeightedAverageExercisePrice_c20210101__20211231_zOmYPReUDOd2" style="border-bottom: Black 1.5pt solid; text-align: right" title="Weighted-Average Exercise Price, Expired"><span style="-sec-ix-hidden: xdx2ixbrl0999">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 2.5pt">Outstanding — end of year</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsOutstandingNumber_iE_c20220101__20221231_zOtH8lKXX7ph" style="border-bottom: Black 2.5pt double; text-align: right" title=" Warrants, Outstanding at end of period">4,167</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_980_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsOutstandingNumber_iE_c20210101__20211231_zfR06Mkx1Zi" style="border-bottom: Black 2.5pt double; text-align: right" title="Warrants, Outstanding at end of period">4,167</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_98F_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsOutstandingWeightedAverageExercisePrice_iE_c20220101__20221231_zfHhoMXDENo6" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of period">33.60</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_982_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsOutstandingWeightedAverageExercisePrice_iE_c20210101__20211231_zdKo3jQoypj8" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Outstanding at end of period">33.60</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 2.5pt">Exercisable at end of year</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_985_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExercisableNumber_iE_c20220101__20221231_zFEF6OL1fu1d" style="border-bottom: Black 2.5pt double; text-align: right" title=" Warrants, Exercisable at end of period">4,167</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td id="xdx_980_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityInstrumentsExercisableNumber_iE_c20210101__20211231_zdcnApnh6V12" style="border-bottom: Black 2.5pt double; text-align: right" title="Warrants, Exercisable at end of period">4,167</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_986_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsExercisableWeightedAverageExercisePrice_iE_c20220101__20221231_zqCln349IZF9" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Exercisable at end of period">33.60</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_984_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsExercisableWeightedAverageExercisePrice_iE_c20210101__20211231_zu5yoSmI6fw" style="border-bottom: Black 2.5pt double; text-align: right" title="Weighted-Average Exercise Price, Exercisable at end of period">33.60</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Weighted average fair value of warrants granted during the year:</td><td> </td> <td style="text-align: left">$</td><td id="xdx_985_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20220101__20221231_zN9btzkc5I83" style="text-align: right" title="Weighted average fair value of warrants granted"><span style="-sec-ix-hidden: xdx2ixbrl1017">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_983_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20210101__20211231_zkzoDJtbZfA" style="text-align: right" title="Weighted average fair value of warrants granted"><span style="-sec-ix-hidden: xdx2ixbrl1019">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 4167 4167 33.60 33.60 4167 4167 33.60 33.60 4167 4167 33.60 33.60 0 <p id="xdx_801_ecustom--StockholderProtectionRightsPlanTextBlock_zoRCR1Y1SVT4" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>9. <span id="xdx_821_zdWOBYdAtBYh">Stockholder Protection Rights Plan</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On December 13, 2019, the Board of Directors of the Company, authorized and declared a dividend of one right (a “Right”) for each of the Company’s issued and outstanding shares of common stock, par value $<span id="xdx_906_eus-gaap--CommonStockParOrStatedValuePerShare_iI_c20191213_zVAP6s4hDirl" title="Common Stock, stated value per share">0.001</span> per share. The dividend was paid to the stockholders of record at the close of business on December 23, 2019. Each Right entitled the registered holder, subject to the terms of the Original Rights Agreement (as defined below), to purchase from the Company one one-thousandth of a share of the Company’s Series B Junior Participating Preferred Stock, par value $<span id="xdx_908_eus-gaap--PreferredStockParOrStatedValuePerShare_iI_pid_c20191213_z0dn9X5qfPse" title="Preferred stock, par value">0.01</span> per share (the “Preferred Stock”), at a price of $<span id="xdx_907_eus-gaap--SharesIssuedPricePerShare_iI_pid_c20191213_zZRyZ8rjfK4j" title="Purchase price per share">5.00</span> (the “Purchase Price”), subject to certain adjustments. The description and terms of the Rights were set forth in the Rights Agreement, dated as of December 13, 2019 (the “Original Rights Agreement”), by and between the Company and American Stock Transfer &amp; Trust Company, LLC, as Rights Agent (the “Rights Agent”).</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On November 12, 2020, <span id="xdx_90C_ecustom--StockholdersRightsDescription_c20201111__20201112_zjHa9HHr3WC3" title="Stockholders rights description">the Board approved an amendment and restatement of the Original Rights Agreement (as amended and restated, the “Amended and Restated Rights Agreement”) to effect certain changes to the Original Rights Agreement, including (i) reducing the duration to a term of three years, subject to certain earlier expiration as described in more detail below, and (ii) lowering the beneficial ownership threshold at which a person or group of persons becomes an Acquiring Person (as defined below) to 4.95% or more of the Company’s outstanding shares of Common Stock, subject to certain exceptions. The Amended and Restated Rights Agreement is designed to discourage (i) any person or group of persons from acquiring beneficial ownership of more than 4.95% of the Company’s shares of Common Stock and (ii) any existing stockholder currently beneficially holding 4.95% or more of the Company’s shares of Common Stock from acquiring additional shares of the Company’s Common Stock</span>.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The purpose of the Amended and Restated Rights Agreement is to protect value by preserving the Company’s ability to utilize its net operating losses and certain other tax attributes (collectively, the “Tax Benefits”) to offset potential future income tax obligations. The Company’s ability to use its Tax Benefits would be substantially limited if it experiences an “ownership change,” as such term is defined in Section 382 of the Internal Revenue Code of 1986, as amended (the “Tax Code”). A corporation generally will experience an ownership change if the percentage of the corporation’s stock owned by its “5-percent shareholders,” as defined in Section 382 of the Tax Code, increases by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. The Amended and Restated Rights Agreement is intended to reduce the likelihood the Company would experience an ownership change under Section 382 of the Tax Code.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Rights will not be exercisable until the earlier to occur of (i) the close of business on the tenth business day after a public announcement or filing that a person or group of affiliated or associated persons has become an “Acquiring Person,” which is defined as a person or group of affiliated or associated persons that, at any time after the date of the Amended and Restated Rights Agreement, has acquired, or obtained the right to acquire, beneficial ownership of 4.95% or more of the Company’s outstanding shares of Common Stock, subject to certain exceptions or (ii) the close of business on the tenth business day after the commencement of, or announcement of an intention to commence, a tender offer or exchange offer the consummation of which would result in any person becoming an Acquiring Person (the earlier of such dates being called the “Distribution Date”) (<span style="text-decoration: underline">provided</span>, <span style="text-decoration: underline">however</span>, that if such tender or exchange offer is terminated prior to the occurrence of the Distribution Date, then no Distribution Date shall occur as a result of such tender or exchange offer).</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Rights, which are not exercisable until the Distribution Date, will expire at or prior to the earliest of (i) the close of business on November 16, 2023; (ii) the time at which the Rights are redeemed pursuant to the Amended and Restated Rights Agreement; (iii) the time at which the Rights are exchanged pursuant to the Amended and Restated Rights Agreement; (iv) the time at which the Rights are terminated upon the occurrence of certain mergers or other transactions approved in advance by the Board; and (v) the close of business on the date set by the Board following a determination by the Board that (x) the Amended and Restated Rights Agreement is no longer necessary or desirable for the preservation of the Tax Benefits or (y) no Tax Benefits are available to be carried forward or are otherwise available (the earliest of (i), (ii), (iii), (iv) and (v) is referred to as the “<b><span style="text-decoration: underline">Expiration Date</span></b>”).</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_909_eus-gaap--PreferredStockDividendPaymentTerms_c20201111__20201112_z4shQWdWjfoh" title="Dividend description">Each share of Preferred Stock will be entitled, when, as and if declared, to a preferential per share quarterly dividend payment equal to the greater of (i) $1.00 per share or (ii) an amount equal to 1,000 times the dividend declared per share of Common Stock. Each share of Preferred Stock will entitle the holder thereof to 1,000 votes on all matters submitted to a vote of the stockholders of the Company. In the event of any merger, consolidation or other transaction in which shares of Common Stock are converted or exchanged, each share of Preferred Stock will be entitled to receive 1,000 times the amount received per one share of Common Stock</span>.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Purchase Price payable, and the number of shares of Preferred Stock or other securities or property issuable, upon exercise of the Rights are each subject to adjustment from time to time to prevent dilution (i) in the event of a stock dividend on, or a subdivision, combination or reclassification of the Preferred Stock, (ii) upon the grant to holders of the Preferred Stock of certain rights or warrants to subscribe for or purchase Preferred Stock or convertible securities at less than the then-current market price of the Preferred Stock or (iii) upon the distribution to holders of the Preferred Stock of evidences of indebtedness or assets (excluding regular periodic cash dividends or dividends payable in Preferred Stock) or of subscription rights or warrants (other than those referred to above). The number of outstanding Rights and the number of one one-thousandths of a share of Preferred Stock issuable upon exercise of each Right are also subject to adjustment in the event of a stock split, reverse stock split, stock dividends and other similar transactions involving the Common Stock.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In the event that any person or group of affiliated or associated persons becomes an Acquiring Person, each holder of a Right, other than the Rights beneficially owned by the Acquiring Person, affiliates and associates of the Acquiring Person and certain transferees thereof (which will thereupon become null and void), will thereafter have the right to receive upon exercise of a Right that number of shares of Common Stock having a market value of two times the Purchase Price.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In the event that, after a person or a group of affiliated or associated persons has become an Acquiring Person, the Company is acquired in a merger or other business combination transaction, or 50% or more of the Company’s assets or earning power are sold, proper provision will be made so that each holder of a Right will thereafter have the right to receive, upon the exercise thereof at the then-current purchase price of the Right, that number of shares of common stock of the acquiring company having a market value at the time of that transaction equal to two times the Purchase Price.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">With certain exceptions, no adjustment in the Purchase Price will be required unless such adjustment would require an increase or decrease of at least one percent (1%) in the Purchase Price. No fractional shares of Preferred Stock will be issued (other than fractions which are integral multiples of one one-thousandth of a share of Preferred Stock, which may, at the election of the Company, be evidenced by depositary receipts) and, in lieu thereof, an adjustment in cash will be made based on the market price of the Preferred Stock on the trading day immediately prior to the date of exercise.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">At any time after any person or group of affiliated or associated persons becomes an Acquiring Person and prior to the acquisition of beneficial ownership by such Acquiring Person of 50% or more of the outstanding shares of Common Stock, the Board, at its option, may exchange each Right (other than Rights owned by such person or group of affiliated or associated persons which will have become void), in whole or in part, at an exchange ratio of one share of Common Stock per outstanding Right (subject to adjustment).</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In connection with any exercise or exchange of the Rights, no holder of a Right will be entitled to receive shares of Common Stock if receipt of such shares would result in such holder, together with such holder’s affiliates and associates, beneficially owning more than 4.95% of the then-outstanding Common Stock (such shares, the “Excess Shares”) and the Board determines that such holder’s receipt of Excess Shares would jeopardize or endanger the value or availability of the Tax Benefits or the Board otherwise determines that such holder’s receipt of Excess Shares is not in the best interests of the Company. In lieu of such Excess Shares, such holder will only be entitled to receive cash or a note or other evidence of indebtedness with a principal amount equal to the then-current market price of the Common Stock multiplied by the number of Excess Shares that would otherwise have been issuable.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">At any time before the Distribution Date, the Board may redeem the Rights in whole, but not in part, at a price of $<span id="xdx_903_eus-gaap--PreferredStockRedemptionPricePerShare_iI_c20211121_zyg70B6yB1gk" title="Preferred stock, redemption price per share">0.001</span> per Right (subject to certain adjustments) (the “Redemption Price”). The redemption of the Rights may be made effective at such time, on such basis and with such conditions as the Board in its sole discretion may establish.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Immediately upon the action of the Board electing to redeem or exchange the Rights, the Company shall make a public announcement thereof, and upon such election, the right to exercise the Rights will terminate and the only right of the holders of Rights will be to receive the Redemption Price.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Until a Right is exercised or exchanged, the holder thereof, as such, will have no rights as a stockholder of the Company, including, without limitation, the right to vote or to receive dividends.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Board may amend or supplement the Amended and Restated Rights Agreement without the approval of any holders of Rights, including, without limitation, in order to (a) cure any ambiguity, (b) correct inconsistent provisions, (c) alter time period provisions, including the Expiration Date, or (d) make additional changes to the Amended and Restated Rights Agreement that the Board deems necessary or desirable. However, from and after the date any person or group of affiliated or associated persons becomes an Acquiring Person, the Amended and Restated Rights Agreement may not be supplemented or amended in any manner that would adversely affect the interests of the holders of Rights.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 0.001 0.01 5.00 the Board approved an amendment and restatement of the Original Rights Agreement (as amended and restated, the “Amended and Restated Rights Agreement”) to effect certain changes to the Original Rights Agreement, including (i) reducing the duration to a term of three years, subject to certain earlier expiration as described in more detail below, and (ii) lowering the beneficial ownership threshold at which a person or group of persons becomes an Acquiring Person (as defined below) to 4.95% or more of the Company’s outstanding shares of Common Stock, subject to certain exceptions. The Amended and Restated Rights Agreement is designed to discourage (i) any person or group of persons from acquiring beneficial ownership of more than 4.95% of the Company’s shares of Common Stock and (ii) any existing stockholder currently beneficially holding 4.95% or more of the Company’s shares of Common Stock from acquiring additional shares of the Company’s Common Stock Each share of Preferred Stock will be entitled, when, as and if declared, to a preferential per share quarterly dividend payment equal to the greater of (i) $1.00 per share or (ii) an amount equal to 1,000 times the dividend declared per share of Common Stock. Each share of Preferred Stock will entitle the holder thereof to 1,000 votes on all matters submitted to a vote of the stockholders of the Company. In the event of any merger, consolidation or other transaction in which shares of Common Stock are converted or exchanged, each share of Preferred Stock will be entitled to receive 1,000 times the amount received per one share of Common Stock 0.001 <p id="xdx_803_eus-gaap--IncomeTaxDisclosureTextBlock_zI5oOWWr77m9" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>10. <span id="xdx_828_zXH7FfnL6708">Income Taxes</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">At December 31, 2022, the Company had federal and state net operating loss carryforwards (“NOLs”) of $<span id="xdx_90C_eus-gaap--OperatingLossCarryforwards_iI_pn5n6_c20221231__us-gaap--IncomeTaxAuthorityAxis__us-gaap--DomesticCountryMember_ztMOQ0FmVj26">338.3</span> </span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">million and $<span id="xdx_908_eus-gaap--OperatingLossCarryforwards_iI_pn5n6_c20221231__us-gaap--IncomeTaxAuthorityAxis__us-gaap--StateAndLocalJurisdictionMember_zfJ1LbaW1ZK6">263.1</span> </span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">million, respectively, available to offset against future taxable income. Of this amount, $<span id="xdx_905_eus-gaap--OperatingLossCarryforwards_iI_pn5n6_c20221231__us-gaap--IncomeTaxAuthorityAxis__us-gaap--DomesticCountryMember__srt--StatementScenarioAxis__custom--ExpireBetweenTwoThousandTwentyFourAndTwoThousandThirtySevenMember_zya51NU2MjSd">310.6</span> </span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">million of federal NOLs expire in 2024 through 2037. The federal operating losses after 2018 totaling $<span id="xdx_900_ecustom--OperatingLossCarryforwardsNotSubjectToLimitation_iI_pn5n6_c20221231__us-gaap--IncomeTaxAuthorityAxis__us-gaap--DomesticCountryMember_zK3auG72udJd">27.7</span> </span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">million carry forward indefinitely but are only able to offset 80% of taxable income in future years. The California NOLs <span id="xdx_90F_ecustom--OperatingLossCarryforwardsExpirationDateDescription_c20220101__20221231__us-gaap--IncomeTaxAuthorityAxis__custom--CaliforniaNOLMember_zim3XnItTL1j">expire in 2029 through 2042</span></span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As a result of a change in-control that occurred in the LadRx shareholder base, approximately $<span id="xdx_903_eus-gaap--OperatingLossCarryforwards_iI_pn5n6_c20221231__us-gaap--IncomeTaxAuthorityAxis__us-gaap--DomesticCountryMember__srt--TitleOfIndividualAxis__custom--ShareHoldersMember_zk3X2AjdLAZ9" title="Operating loss carryforwards">66.1</span> million in federal net operating loss carryforwards became substantially limited in their annual availability. Management currently believes that the remaining $<span id="xdx_90D_eus-gaap--OperatingLossCarryforwards_iI_pn5n6_c20221231__us-gaap--IncomeTaxAuthorityAxis__us-gaap--DomesticCountryMember__srt--StatementScenarioAxis__custom--UnrestrictedMember_zWPwjqkTeP3b" title="Operating loss carryforwards">272.1</span> million in federal net operating loss carryforwards, and the $<span id="xdx_901_eus-gaap--OperatingLossCarryforwards_iI_pn5n6_c20221231__us-gaap--IncomeTaxAuthorityAxis__us-gaap--StateAndLocalJurisdictionMember__srt--StatementScenarioAxis__custom--UnrestrictedMember_zRO7o72cFwI7" title="Operating loss carryforwards">263.1</span> million in state net operating loss carryforwards, are unrestricted.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of December 31, 2022, LadRx also had research and development tax credits for federal and state purposes of approximately $<span id="xdx_90B_eus-gaap--DeferredTaxAssetsTaxCreditCarryforwardsResearch_iI_pn5n6_c20221231__us-gaap--IncomeTaxAuthorityAxis__us-gaap--DomesticCountryMember_z1OoBcAJjuy6" title="Tax credit research and development">15.4</span> million and $<span id="xdx_90E_eus-gaap--DeferredTaxAssetsTaxCreditCarryforwardsResearch_iI_pn5n6_c20221231__us-gaap--IncomeTaxAuthorityAxis__us-gaap--StateAndLocalJurisdictionMember_zi4r7hicH1yh" title="Tax credit research and development">22.0</span> million, respectively, available for offset against future income taxes, which <span id="xdx_90C_eus-gaap--TaxCreditCarryforwardDescription_c20220101__20221231_zGkKhqg5rTVi" title="Tax credit expiration date, description">expire in 2022 through 2036</span>. The credits are subject to change-in-control limitations, which may affect their utilization in future years. Based on an assessment of all available evidence including, but not limited to, the Company’s limited operating history in its core business and lack of profitability, uncertainties of the commercial viability of its technology, the impact of government regulation and healthcare reform initiatives, and other risks normally associated with biotechnology companies, the Company has concluded that it is more likely than not that these net operating loss carryforwards and credits will not be realized and, as a result, a <span id="xdx_908_ecustom--DeferredTaxValuationAllowancePercentage_dp_c20220101__20221231_zBl93UhTxtR6" title="Deferred tax valuation allowance, percentage">100</span>% deferred tax valuation allowance has been recorded against these assets.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_89B_eus-gaap--ScheduleOfDeferredTaxAssetsAndLiabilitiesTableTextBlock_zdk5pNKCcL0d" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Deferred income taxes reflect the net effect of temporary differences between the financial reporting carrying amounts of assets and liabilities and income tax carrying amounts of assets and liabilities. The components of the Company’s deferred tax assets and liabilities, all of which are long-term, are as follows (in thousands):</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span id="xdx_8BA_ztUsfSg9t8D5" style="display: none">Schedule of Deferred Tax Assets and Liabilities</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="display: none; vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td> <td id="xdx_49B_20221231_zNnwqJNG2b0i" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td> <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td> <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td> <td colspan="2" id="xdx_49A_20211231_zl1IJAhcYU67" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">December 31,</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Deferred tax assets:</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr id="xdx_402_eus-gaap--DeferredTaxAssetsOperatingLossCarryforwards_iI_pn3n3_maDTAGzEjC_zqNYjRr0WOcc" style="vertical-align: bottom; background-color: White"> <td style="padding-left: 10pt; width: 60%; text-align: left">Net operating loss carryforwards</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">74,903</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">74,167</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40D_eus-gaap--DeferredTaxAssetsTaxCreditCarryforwards_iI_pn3n3_maDTAGzEjC_z8IhStzoPjEg" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-left: 10pt; text-align: left">Tax credit carryforwards</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">37,353</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">37,866</td><td style="text-align: left"> </td></tr> <tr id="xdx_407_eus-gaap--DeferredTaxAssetsPropertyPlantAndEquipment_iI_pn3n3_maDTAGzEjC_zhbkL99HMNua" style="vertical-align: bottom; background-color: White"> <td style="padding-left: 10pt; text-align: left; padding-bottom: 1.5pt">Equipment, furnishings and other</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">19</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">4,174</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_400_eus-gaap--DeferredTaxAssetsGross_iTI_pn3n3_mtDTAGzEjC_maDTANzJS2_zkXn6YDC8S6c" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Total deferred tax assets</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">112,275</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">116,207</td><td style="text-align: left"> </td></tr> <tr id="xdx_40D_eus-gaap--DeferredIncomeTaxLiabilities_iI_pn3n3_msDTANzJS2_zlualcUj6DWk" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Deferred tax liabilities</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1072">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1073">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--DeferredTaxAssetsNet_iTI_pn3n3_mtDTANzJS2_maDTALNzsix_znkYTocE6kd3" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Net deferred tax assets</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">112,275</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">116,207</td><td style="text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--DeferredTaxAssetsValuationAllowance_iNI_pn3n3_di_msDTALNzsix_z1Ebnhb0zMAc" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Valuation allowance</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(112,275</td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(116,207</td><td style="padding-bottom: 1.5pt; text-align: left">)</td></tr> <tr id="xdx_406_eus-gaap--DeferredTaxAssetsLiabilitiesNet_iTI_pn3n3_mtDTALNzsix_zwzdzBlERpWk" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="display: none; padding-bottom: 2.5pt">Deferred tax assets</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1081">—</span></td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1082">—</span></td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8A4_zTcBdNnXQyd4" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For all years presented, the Company did not recognize any deferred tax assets or liabilities. The net change in valuation allowance for the years ended December 31, 2022 and 2021 was $<span id="xdx_902_eus-gaap--ValuationAllowanceDeferredTaxAssetChangeInAmount_pn5n6_c20220101__20221231_zHA2iJmz8jMg" title="Deferred tax valuation allowance">3.9</span> million and $<span id="xdx_904_eus-gaap--ValuationAllowanceDeferredTaxAssetChangeInAmount_pn5n6_c20210101__20211231_zZWz9EaU1Kdl" title="Deferred tax valuation allowance">1.6</span> million, respectively.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_899_eus-gaap--ScheduleOfEffectiveIncomeTaxRateReconciliationTableTextBlock_zIXlZz11w4nj" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The provision for income taxes differs from the provision computed by applying the Federal statutory rate to net loss before income taxes as follows (in thousands):</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B0_zsOMyoabqTmj" style="display: none">Schedule of Effective Income Tax Rate Reconciliation</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="display: none; vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_491_20220101__20221231_zWDhnWKaGGkl" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_492_20210101__20211231_zB6mFOzc8EYf" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Years ended December 31,</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_404_eus-gaap--IncomeTaxReconciliationIncomeTaxExpenseBenefitAtFederalStatutoryIncomeTaxRate_iN_pn3n3_di_maITEBz7jf_zwp8emZ7H4th" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Federal benefit at statutory rate</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">(1,000</td><td style="width: 1%; text-align: left">)</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">(2,745</td><td style="width: 1%; text-align: left">)</td></tr> <tr id="xdx_40B_eus-gaap--IncomeTaxReconciliationStateAndLocalIncomeTaxes_iN_pn3n3_di_maITEBz7jf_zqrUaj1WMsPg" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">State income taxes, net of Federal taxes</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">(333</td><td style="text-align: left">)</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">(913</td><td style="text-align: left">)</td></tr> <tr id="xdx_403_ecustom--IncomeTaxReconciliationTaxStateCredits_pn3n3_maITEBz7jf_zm78RuxHohb7" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">State credits</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1096">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1097">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_404_ecustom--IncomeTaxReconciliationWarrantLiabilities_pn3n3_maITEBz7jf_zjv7KSM4QwGh" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Warrant liabilities</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1099">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1100">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_406_ecustom--IncomeTaxReconciliationOtherPermanentDifferences_pn3n3_maITEBz7jf_zFIdvMq7dvck" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Other permanent differences</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">261</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">1,685</td><td style="text-align: left"> </td></tr> <tr id="xdx_401_eus-gaap--IncomeTaxReconciliationChangeInDeferredTaxAssetsValuationAllowance_pn3n3_maITEBz7jf_zZWmELqc1i8c" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Provision related to change in valuation allowance</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">957</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">1,947</td><td style="text-align: left"> </td></tr> <tr id="xdx_406_eus-gaap--IncomeTaxReconciliationChangeInEnactedTaxRate_pn3n3_maITEBz7jf_zQiqgioyBLWl" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Federal rate adjustment</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1108">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1109">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_408_ecustom--IncomeTaxReconciliationNonQualifiedOptions_pn3n3_maITEBz7jf_zrMQNnswREd6" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">NQ Options</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1111">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1112">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_404_eus-gaap--IncomeTaxReconciliationTaxCredits_iN_pn3n3_di_msITEBz7jf_z9qLnEq7YTS2" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Current year tax credit</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1114">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1115">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_407_ecustom--IncomeTaxReconciliationNetOperatinglossAdjustments_pn3n3_maITEBz7jf_zXsHtrlmcPL9" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">NOL Adjustments</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1117">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1118">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_40B_eus-gaap--IncomeTaxReconciliationNondeductibleExpenseShareBasedCompensationCost_pn3n3_maITEBz7jf_zbwhERBxWy0d" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Termination/Cancellation of Equity Compensation Awards</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1120">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1121">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_40D_ecustom--IncomeTaxReconciliationReturnToProvision_iN_pn3n3_di_maITEBz7jf_zATFFu2bO58b" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Return to provision</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">115</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">26</td><td style="text-align: left"> </td></tr> <tr id="xdx_408_eus-gaap--IncomeTaxReconciliationOtherAdjustments_pn3n3_maITEBz7jf_zn7jTMzPOgg" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 1.5pt">Other, net</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1126">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1127">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--IncomeTaxReconciliationOtherReconcilingItems_iT_pn3n3_mtITEBz7jf_zIuQ9NiK44e5" style="vertical-align: bottom; background-color: White"> <td style="display: none; text-align: justify; padding-bottom: 2.5pt">Provision for Income taxes</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1129">—</span></td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1130">—</span></td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8A8_zpIVwAx2Ng6l" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There have been no changes to the Company’s liability for unrecognized tax benefits during the year ended December 31, 2022.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company files income tax returns in the U.S. Federal jurisdiction and various state jurisdictions. As of the year ended December 31, 2022, the tax returns for 2019 through 2022 remain open to examination by the Internal Revenue Service and for 2017 to 2021 for various state tax authorities.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense. As of the date of adoption of ASC 740 and the years ended December 31, 2022 and 2021, the Company had accrued no interest or penalties related to uncertain tax positions.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"/> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 338300000 263100000 310600000 27700000 expire in 2029 through 2042 66100000 272100000 263100000 15400000 22000000.0 expire in 2022 through 2036 1 <p id="xdx_89B_eus-gaap--ScheduleOfDeferredTaxAssetsAndLiabilitiesTableTextBlock_zdk5pNKCcL0d" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Deferred income taxes reflect the net effect of temporary differences between the financial reporting carrying amounts of assets and liabilities and income tax carrying amounts of assets and liabilities. The components of the Company’s deferred tax assets and liabilities, all of which are long-term, are as follows (in thousands):</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span id="xdx_8BA_ztUsfSg9t8D5" style="display: none">Schedule of Deferred Tax Assets and Liabilities</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="display: none; vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td> <td id="xdx_49B_20221231_zNnwqJNG2b0i" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td> <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td> <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td> <td colspan="2" id="xdx_49A_20211231_zl1IJAhcYU67" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">December 31,</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Deferred tax assets:</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr id="xdx_402_eus-gaap--DeferredTaxAssetsOperatingLossCarryforwards_iI_pn3n3_maDTAGzEjC_zqNYjRr0WOcc" style="vertical-align: bottom; background-color: White"> <td style="padding-left: 10pt; width: 60%; text-align: left">Net operating loss carryforwards</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">74,903</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">74,167</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40D_eus-gaap--DeferredTaxAssetsTaxCreditCarryforwards_iI_pn3n3_maDTAGzEjC_z8IhStzoPjEg" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-left: 10pt; text-align: left">Tax credit carryforwards</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">37,353</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">37,866</td><td style="text-align: left"> </td></tr> <tr id="xdx_407_eus-gaap--DeferredTaxAssetsPropertyPlantAndEquipment_iI_pn3n3_maDTAGzEjC_zhbkL99HMNua" style="vertical-align: bottom; background-color: White"> <td style="padding-left: 10pt; text-align: left; padding-bottom: 1.5pt">Equipment, furnishings and other</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">19</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">4,174</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_400_eus-gaap--DeferredTaxAssetsGross_iTI_pn3n3_mtDTAGzEjC_maDTANzJS2_zkXn6YDC8S6c" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Total deferred tax assets</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">112,275</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">116,207</td><td style="text-align: left"> </td></tr> <tr id="xdx_40D_eus-gaap--DeferredIncomeTaxLiabilities_iI_pn3n3_msDTANzJS2_zlualcUj6DWk" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Deferred tax liabilities</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1072">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1073">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--DeferredTaxAssetsNet_iTI_pn3n3_mtDTANzJS2_maDTALNzsix_znkYTocE6kd3" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Net deferred tax assets</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">112,275</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">116,207</td><td style="text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--DeferredTaxAssetsValuationAllowance_iNI_pn3n3_di_msDTALNzsix_z1Ebnhb0zMAc" style="vertical-align: bottom; background-color: White"> <td style="text-align: left; padding-bottom: 1.5pt">Valuation allowance</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(112,275</td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">(116,207</td><td style="padding-bottom: 1.5pt; text-align: left">)</td></tr> <tr id="xdx_406_eus-gaap--DeferredTaxAssetsLiabilitiesNet_iTI_pn3n3_mtDTALNzsix_zwzdzBlERpWk" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="display: none; padding-bottom: 2.5pt">Deferred tax assets</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1081">—</span></td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1082">—</span></td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> 74903000 74167000 37353000 37866000 19000 4174000 112275000 116207000 112275000 116207000 112275000 116207000 3900000 1600000 <p id="xdx_899_eus-gaap--ScheduleOfEffectiveIncomeTaxRateReconciliationTableTextBlock_zIXlZz11w4nj" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The provision for income taxes differs from the provision computed by applying the Federal statutory rate to net loss before income taxes as follows (in thousands):</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B0_zsOMyoabqTmj" style="display: none">Schedule of Effective Income Tax Rate Reconciliation</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="display: none; vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_491_20220101__20221231_zWDhnWKaGGkl" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_492_20210101__20211231_zB6mFOzc8EYf" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"> </td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Years ended December 31,</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_404_eus-gaap--IncomeTaxReconciliationIncomeTaxExpenseBenefitAtFederalStatutoryIncomeTaxRate_iN_pn3n3_di_maITEBz7jf_zwp8emZ7H4th" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Federal benefit at statutory rate</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">(1,000</td><td style="width: 1%; text-align: left">)</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">(2,745</td><td style="width: 1%; text-align: left">)</td></tr> <tr id="xdx_40B_eus-gaap--IncomeTaxReconciliationStateAndLocalIncomeTaxes_iN_pn3n3_di_maITEBz7jf_zqrUaj1WMsPg" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">State income taxes, net of Federal taxes</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">(333</td><td style="text-align: left">)</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">(913</td><td style="text-align: left">)</td></tr> <tr id="xdx_403_ecustom--IncomeTaxReconciliationTaxStateCredits_pn3n3_maITEBz7jf_zm78RuxHohb7" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">State credits</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1096">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1097">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_404_ecustom--IncomeTaxReconciliationWarrantLiabilities_pn3n3_maITEBz7jf_zjv7KSM4QwGh" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Warrant liabilities</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1099">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1100">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_406_ecustom--IncomeTaxReconciliationOtherPermanentDifferences_pn3n3_maITEBz7jf_zFIdvMq7dvck" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Other permanent differences</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">261</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">1,685</td><td style="text-align: left"> </td></tr> <tr id="xdx_401_eus-gaap--IncomeTaxReconciliationChangeInDeferredTaxAssetsValuationAllowance_pn3n3_maITEBz7jf_zZWmELqc1i8c" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Provision related to change in valuation allowance</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">957</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">1,947</td><td style="text-align: left"> </td></tr> <tr id="xdx_406_eus-gaap--IncomeTaxReconciliationChangeInEnactedTaxRate_pn3n3_maITEBz7jf_zQiqgioyBLWl" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Federal rate adjustment</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1108">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1109">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_408_ecustom--IncomeTaxReconciliationNonQualifiedOptions_pn3n3_maITEBz7jf_zrMQNnswREd6" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">NQ Options</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1111">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1112">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_404_eus-gaap--IncomeTaxReconciliationTaxCredits_iN_pn3n3_di_msITEBz7jf_z9qLnEq7YTS2" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Current year tax credit</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1114">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1115">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_407_ecustom--IncomeTaxReconciliationNetOperatinglossAdjustments_pn3n3_maITEBz7jf_zXsHtrlmcPL9" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">NOL Adjustments</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1117">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1118">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_40B_eus-gaap--IncomeTaxReconciliationNondeductibleExpenseShareBasedCompensationCost_pn3n3_maITEBz7jf_zbwhERBxWy0d" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Termination/Cancellation of Equity Compensation Awards</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1120">—</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1121">—</span></td><td style="text-align: left"> </td></tr> <tr id="xdx_40D_ecustom--IncomeTaxReconciliationReturnToProvision_iN_pn3n3_di_maITEBz7jf_zATFFu2bO58b" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Return to provision</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">115</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">26</td><td style="text-align: left"> </td></tr> <tr id="xdx_408_eus-gaap--IncomeTaxReconciliationOtherAdjustments_pn3n3_maITEBz7jf_zn7jTMzPOgg" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 1.5pt">Other, net</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1126">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1127">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--IncomeTaxReconciliationOtherReconcilingItems_iT_pn3n3_mtITEBz7jf_zIuQ9NiK44e5" style="vertical-align: bottom; background-color: White"> <td style="display: none; text-align: justify; padding-bottom: 2.5pt">Provision for Income taxes</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1129">—</span></td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1130">—</span></td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> 1000000 2745000 333000 913000 261000 1685000 957000 1947000 -115000 -26000 <p id="xdx_806_eus-gaap--CommitmentsAndContingenciesDisclosureTextBlock_zsK0lXemSaK9" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>11. <span id="xdx_823_zEYDCp7Myii">Commitments and Contingencies</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Commitments</i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Aldoxorubicin</span></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The agreement relating to our worldwide rights to aldoxorubicin provides for our payment of up to an aggregate of $<span id="xdx_902_ecustom--AmountOfMilestonePaymentPayable_iI_pn5n6_c20221231__srt--ProductOrServiceAxis__custom--AldoxorubicinMember__srt--RangeAxis__srt--MaximumMember_zTTjeOlAjL0a" title="Amount of milestone payment payable">7.5</span> million upon meeting specified clinical and regulatory milestones up to and including the product’s second, final marketing approval. We also will be obliged to pay:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">commercially reasonable royalties based on a percentage of net sales (as defined in the agreement);</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a percentage of any non-royalty sub-licensing income (as defined in the agreement); and</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">milestones of $<span id="xdx_90B_ecustom--AmountOfMilestonePaymentPayable_iI_pp0p0_c20221231__srt--ProductOrServiceAxis__custom--AldoxorubicinMember_zQNuSFSDBlqg" title="Amount of milestone payment payable">1,000,000</span> for each additional final marketing approval that we might obtain.</span></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Arimoclomol</span></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The agreement relating to our worldwide rights to arimoclomol provides for our payment of up to an aggregate of $<span id="xdx_902_ecustom--AmountOfMilestonePaymentPayable_iI_pn4n6_c20221231__srt--ProductOrServiceAxis__custom--ArimoclomolMember_zn9SEq9Fnj9c" title="Amount of milestone payment payable">3.65</span> million upon receipt of milestone payments from KemPharm.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Innovive</span></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under the merger agreement by which we acquired Innovive, we agreed to pay the former Innovive stockholders a total of up to approximately $<span id="xdx_903_ecustom--FutureEarnoutMergerConsideration_iI_pn5n6_c20221231__srt--ProductOrServiceAxis__custom--InnoviveMember_zvsXW658qUU9" title="Future earnout merger consideration">18.3</span> million of future earnout merger consideration, subject to our achievement of specified net sales under the Innovive license agreements. The earnout merger consideration, if any, will be payable in shares of our common stock, subject to specified conditions, or, at our election, in cash or by a combination of shares of our common stock and cash. Our common stock will be valued for purposes of any future earnout merger consideration based upon the trading price of our common stock at the time the earnout merger consideration is paid.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of December 31, 2022, no amounts are due under the above agreements.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Contractual obligations</i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_89C_esrt--ContractualObligationFiscalYearMaturityScheduleTableTextBlock_zEDA0FLl6Nmj" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">LadRx’s current contractual obligations that will require future cash payments for the following Employment Agreements as follows (in thousands):</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span style="display: none"><span id="xdx_8B0_zq4wrH6TLJU8">Schedule of Current Contractual Obligations</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 70%; margin-right: auto"> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_49C_20221231_zPoPGMAFskx1" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Employment Agreements <span id="xdx_F5F_zmnQnECegjH8">(1)</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_400_eus-gaap--ContractualObligationDueInNextTwelveMonths_iI_pn3n3_maCOze5q_zZc6tpEPc8N" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 74%; text-align: justify">2023</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 22%; text-align: right">     961</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40D_eus-gaap--ContractualObligationDueInSecondYear_iI_pn3n3_maCOze5q_zUNpAzcmCgx7" style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">2024</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">936</td><td style="text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--ContractualObligationDueInThirdYear_iI_pn3n3_maCOze5q_z7FY52NzNP37" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">2025</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">936</td><td style="text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--ContractualObligationDueInFourthYear_iI_pn3n3_maCOze5q_z3wfNYVy7ij7" style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">2026</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">468</td><td style="text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--ContractualObligationDueInFifthYear_iI_pn3n3_maCOze5q_ziYi5b3debHf" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify; padding-bottom: 1.5pt">Thereafter</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1152">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--ContractualObligation_iTI_pn3n3_mtCOze5q_zytfD1pMei45" style="vertical-align: bottom; background-color: White"> <td style="text-align: justify; padding-bottom: 2.5pt">Total</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">3,301</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.25in"><span id="xdx_F00_zSAdrtrSB85b" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span id="xdx_F10_zcMZ7I29xIW" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Employment agreements include management contracts which have been revised from time to time. The employment agreements for the Company’s executive officers provide for minimum salaries, which are adjusted annually at the discretion of the Company’s Compensation Committee, and in some cases provide for minimum annual bonuses and employee benefits, as well. New employment agreements for the Company’s other executive officers are usually entered into annually.</span></td></tr> </table> <p id="xdx_8A9_z1zqArJeQwMc" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Contingencies</i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in">The Company is occasionally involved in legal proceedings and other matters arising from the normal course of business. On November 30, 2022, Jerald Hammann (“Hammann”) filed a complaint (the “Complaint”) against the Company, Mr. Caloz, and Mr. Kriegsman (together, “Defendants”) in the Court of Chancery of the State of Delaware, alleging various violations of a Cooperation Agreement, dated August 21, 2020, by and between the Company and Hammann.  The Complaint alleges breaches of a provision limiting the Board’s ability to effect discretionary compensation and a non-disparagement provision. The Complaint further alleges a breach of a purported implied obligation that the Company disclose various internal records to Hammann. Defendants believe the Complaint is wholly without merit and have moved to dismiss the Complaint in its entirety. Defendants intend to litigate vigorously against Hammann’s claims.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in">The Company intends to vigorously defend against any complaint. We have directors’ and officers’ liability insurance, which will be utilized, after the deductible, in the defense of any matter involving our directors or officers.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company evaluates developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the period in which the outcome becomes probable and reasonably estimable.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In December 2019, a novel strain of coronavirus, COVID-19, was first identified in China and has surfaced in several regions across the world. In March 2020, the disease was declared a pandemic by the World Health Organization. As the situation with Covid-19 continues to evolve, the companies which are working to further develop and commercialize our products, ImmunityBio and Orphazyme, could be materially and adversely affected by the risks, or the public perception of the risks, related to this pandemic. Among other things, the active and planned clinical trials by ImmunityBio and Orphazyme and their regulatory approvals, if any, may be delayed or interrupted, which could delay or adversely affect the Company’s potential receipt of milestone and royalty payments within the disclosed time periods and increase expected costs. As of the date of this filing, senior management and administrative staff are working primarily remotely.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 7500000 1000000 3650000 18300000 <p id="xdx_89C_esrt--ContractualObligationFiscalYearMaturityScheduleTableTextBlock_zEDA0FLl6Nmj" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">LadRx’s current contractual obligations that will require future cash payments for the following Employment Agreements as follows (in thousands):</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span><span style="display: none"><span id="xdx_8B0_zq4wrH6TLJU8">Schedule of Current Contractual Obligations</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 70%; margin-right: auto"> <tr style="vertical-align: bottom"> <td style="font-weight: bold; text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" id="xdx_49C_20221231_zPoPGMAFskx1" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Employment Agreements <span id="xdx_F5F_zmnQnECegjH8">(1)</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_400_eus-gaap--ContractualObligationDueInNextTwelveMonths_iI_pn3n3_maCOze5q_zZc6tpEPc8N" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 74%; text-align: justify">2023</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 22%; text-align: right">     961</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40D_eus-gaap--ContractualObligationDueInSecondYear_iI_pn3n3_maCOze5q_zUNpAzcmCgx7" style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">2024</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">936</td><td style="text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--ContractualObligationDueInThirdYear_iI_pn3n3_maCOze5q_z7FY52NzNP37" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">2025</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">936</td><td style="text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--ContractualObligationDueInFourthYear_iI_pn3n3_maCOze5q_z3wfNYVy7ij7" style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">2026</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">468</td><td style="text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--ContractualObligationDueInFifthYear_iI_pn3n3_maCOze5q_ziYi5b3debHf" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify; padding-bottom: 1.5pt">Thereafter</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl1152">—</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--ContractualObligation_iTI_pn3n3_mtCOze5q_zytfD1pMei45" style="vertical-align: bottom; background-color: White"> <td style="text-align: justify; padding-bottom: 2.5pt">Total</td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">3,301</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.25in"><span id="xdx_F00_zSAdrtrSB85b" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span id="xdx_F10_zcMZ7I29xIW" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Employment agreements include management contracts which have been revised from time to time. The employment agreements for the Company’s executive officers provide for minimum salaries, which are adjusted annually at the discretion of the Company’s Compensation Committee, and in some cases provide for minimum annual bonuses and employee benefits, as well. New employment agreements for the Company’s other executive officers are usually entered into annually.</span></td></tr> </table> 961000 936000 936000 468000 3301000 <p id="xdx_800_eus-gaap--SubsequentEventsTextBlock_zBJkuv3ut8Gf" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>12. <span id="xdx_826_zH2IX2b3Pjx3">Subsequent Events</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; margin-left: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On January 1, 2023, the Company paid a quarterly dividend to its holder of Series C Preferred Stock of $<span id="xdx_904_eus-gaap--PaymentsOfDividends_c20230101__20230101__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember_zghBmRTSK6H8" title="Dividend paid">68,809</span>.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; margin-left: 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; margin-left: 0pt; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On January 31, 2023, 1,342 Series C Preferred Stock was converted to <span id="xdx_906_eus-gaap--ConversionOfStockSharesConverted1_c20230130__20230131__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember_z9fhwMfJvBd6" title="Conversion of stock, shares converted">1,525,000</span> common shares.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"> </p> 68809 1525000 Employment agreements include management contracts which have been revised from time to time. 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