0001493152-20-015639.txt : 20200814 0001493152-20-015639.hdr.sgml : 20200814 20200814061205 ACCESSION NUMBER: 0001493152-20-015639 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 48 CONFORMED PERIOD OF REPORT: 20200630 FILED AS OF DATE: 20200814 DATE AS OF CHANGE: 20200814 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CYTRX CORP CENTRAL INDEX KEY: 0000799698 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 581642750 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-15327 FILM NUMBER: 201101211 BUSINESS ADDRESS: STREET 1: 11726 SAN VICENTE BOULEVARD STREET 2: SUITE 650 CITY: LOS ANGELES STATE: CA ZIP: 90049 BUSINESS PHONE: 310-826-5648 MAIL ADDRESS: STREET 1: 11726 SAN VICENTE BOULEVARD STREET 2: SUITE 650 CITY: LOS ANGELES STATE: CA ZIP: 90049 10-Q 1 form10-q.htm

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

[X]QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2020

OR

 

[  ]TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from __________ to __________

 

Commission file number 0-15327

 

CytRx Corporation

(Exact name of Registrant as specified in its charter)

 

Delaware   58-1642740
(State or other jurisdiction of
incorporation or organization)		   (I.R.S. Employer
Identification No.)

 

11726 San Vicente Blvd., Suite 650

Los Angeles, CA

   90049
(Address of principal executive offices)   (Zip Code)

 

(310) 826-5648

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.001 per share   CYTR   OTC Market

 

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 (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [  ]

 

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

 

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

 

Large accelerated filer [  ] Accelerated filer Non-accelerated filer [X] Smaller reporting company [X]
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 is a shell company (as defined in Rule 12(b)-2 of the Exchange Act). Yes [  ] No [X]

 

Number of shares of CytRx Corporation common stock, $0.001 par value, outstanding as of August 14, 2020: 33,637,501 shares.

 

 

 

 
 

 

CYTRX CORPORATION

 

FORM 10-Q

 

TABLE OF CONTENTS

 

  Page
PART I. — FINANCIAL INFORMATION 3
Item 1. Consolidated Financial Statements (unaudited) 3
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 15
Item 3. Quantitative and Qualitative Disclosures About Market Risk 20
Item 4. Controls and Procedures 20
   
PART II. — OTHER INFORMATION 20
Item 1. Legal Proceedings 20
Item 1A Risk Factors 20
Item 2 Unregistered Sales of Equity Securities and Use of Proceeds 20
Item 5. Other Information 20
Item 6. Exhibits 20
   
SIGNATURES 21
   
INDEX TO EXHIBITS 22

 

2
 

 

PART I — FINANCIAL INFORMATION

 

Item 1. — Consolidated Financial Statements

 

CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS

   June 30, 2020   December 31, 2019 
    (Unaudited)      
ASSETS         
Current assets:          
Cash and cash equivalents  $14,587,401   $16,130,410 
Receivables   12,065    7,628 
Prepaid expenses and other current assets   285,801    1,066,497 
Total current assets   14,885,267    17,204,535 
Equipment and furnishings, net   54,783    42,893 
Other assets   19,366    7,590 
Operating lease right-of-use assets   669,666    — 
Total assets  $15,629,082   $17,255,018 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $952,411   $887,835 
Accrued expenses and other current liabilities   1,131,130    1,092,895 
Current portion of operating lease liabilities   174,772    69,576 
Total current liabilities   2,258,313    2,050,306 
           
Operating lease liabilities, net of current portion   507,012    — 
           
Total liabilities   2,765,325    2,050,306 
           
Commitments and contingencies          
           
Stockholders’ equity:          
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   —    — 
Common stock, $0.001 par value, 41,666,666 shares authorized; 33,637,501 shares issued and outstanding at June 30, 2020 and December 31, 2019   33,637    33,637 
Additional paid-in capital   479,371,170    479,197,849 
Accumulated deficit   (466,541,050)   (464,026,774)
Total stockholders’ equity   12,863,757    15,204,712 
Total liabilities and stockholders’ equity  $15,629,082   $17,255,018 

 

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

 

3
 

 

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

  

Three Months Ended

June 30,

  

Six Months Ended

June 30,

 
   2020   2019   2020   2019 
Revenue:                    
Licensing revenue  $—   $—   $—   $— 
                     
Expenses:                    
Research and development   —    580    —    1,056 
General and administrative   1,379,426    1,531,073    2,605,730    3,268,223 
    1,379,426    1,531,653    2,605,730    3,269,279 
                     
Loss before other income (expense)   (1,379,426)   (1,531,653)   (2,605,730)   (3,269,279)
                     
Other income (loss):                    
Interest income   35,893    104,095    90,714    192,405 
Interest expense   —    —    —    — 
Other income (loss), net   2,043    14,968    740    (2,321)
Gain on warrant derivative liabilities   —    —    —    — 
                     
Net loss from continuing operations   (1,341,490)   (1,412,590)   (2,514,276)   (3,079,195)
                     
Income from discontinued operations   —    138,095    —    378,712 
                     
Net loss  $(1,341,490)  $(1,274,495)  $(2,514,276)  $(2,700,483)
                     
Basic and diluted loss per share                    
Continuing operations  $(0.04)  $(0.04)  $(0.08)  $(0.09)
Discontinued operations  $—   $—   $—   $0.01 
Total basic and diluted loss per share  $(0.04)  $(0.04)  $(0.08)  $(0.08)
                     
Basic and diluted weighted-average shares outstanding   33,508,302    33,249,904    33,508,302    33,249,904 

 

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

 

4
 

 

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Six Months Ended June 30, 
   2020   2019 
Cash flows from operating activities:          
Net loss  $(2,514,276)  $(2,700,483)
Income from discontinued operations   —    378,712 
Loss from continuing operations   (2,514,276)  $(3,079,195)
Adjustments to reconcile net loss from continuing operations to net cash used in operating activities:          
Depreciation and amortization   14,012    10,828 
Loss on retirement of fixed assets   —    5,432 
Stock-based compensation expense   173,321    427,880 
Changes in assets and liabilities:          
Receivable   (4,437)   139,144 
Prepaid expenses and other current assets   714,425    448,143 
Other assets   (11,776)   27,993 
Amortization of right-of-use asset   111,915    — 
Accounts payable   64,576    (339,027)
Decrease in lease liabilities   (103,102)   — 
Accrued expenses and other current liabilities   20,862    211,549 
Net cash used in operating activities from continuing operations   (1,534,480)   (2,147,253)
Net cash used in operating activities from discontinued operations   —    (348,338)
Net cash used in operating activities   (1,534,480)   (2,495,591)
           
Cash flows from investing activities:          
Purchase of fixed assets   (8,529)   — 
Sale of fixed assets held for sale   —    500,142 
Net cash used in investing activities   (8,529)   500,142 
           
Net decrease in cash and cash equivalents   (1,543,009)   (1,995,449)
Cash and cash equivalents at beginning of period   16,130,410    21,373,273 
Cash and cash equivalents at end of period  $14,587,401   $19,377,824 
           
Supplemental disclosure of Cash Flow Information:          
Recognition of operating lease right-of-use assets and obligations under ASC Topic 842  $715,310   $— 
           
Reclassification of right-of-use asset, from prepaid expenses  $66,271   $— 
           
Acquisition of equipment included in accrued expenses  $17,374   $— 

 

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

 

5
 

 

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY

(Unaudited)

 

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

Additional

Paid-in

Capital

   Accumulated Deficit   Total 
Balance at January 1, 2020   —    33,637,501        $33,637   $479,197,849   $(464,026,774)  $15,204,712 
Issuance of stock options/restricted stock and warrants for compensation and services                       86,662         86,662 
Net loss                            (1,172,786)   (1,172,786)
Balance at March 31, 2020        33,637,501         33,637    479,284,511    (465,199,560)   14,118,588 
Issuance of stock options/restricted stock and warrants for compensation and services   —    —    —    —    86,659    —    86,659 
Net loss                            (1,341,490)   (1,341,490)
                                    
Balance at June 30, 2020   —    33,637,501        $33,637   $479,371,170   $(466,541,050)  $12,863,757 
                                    
Balance at January 1, 2019   —    33,637,501        $33,637   $477,192,747   $(456,864,085)  $20,362,299 
Issuance of stock options/warrants for compensation and services   —    —    —    —    210,502    —    210,502 
Net loss                            (1,425,988)   (1,425,988)
Balance at March 31, 2019   —    33,637,501        $33,637   $477,403,249   $(458,290,073)  $19,146,813 
Issuance of stock options/restricted stock for compensation and services                       214,706         214,706 
Net loss                            (1,274,495)   (1,274,905)
Balance at June 30, 2019        33,637,501        $33,637   $477,617,955   $(459,564,568)  $18,087,024 

 

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

 

6
 

 

CYTRX CORPORATION

NOTES TO CONDENSED FINANCIAL STATEMENTS

For the Six-Months Period Ended June 30, 2020 and 2019
(Unaudited)

 

1. Description of Company and Basis of Presentation

 

CytRx Corporation (“CytRx”) is a biopharmaceutical research and development company specializing in oncology and neurodegenerative diseases. The Company’s focus has been on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel linker technologies to enhance the accumulation and release of cytotoxic anti-cancer agents at the tumor. During 2017, CytRx’s discovery laboratory, located in Freiburg, Germany, synthesized and tested over 75 rationally designed drug conjugates with highly potent 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 preclinical studies, stability, and manufacturing feasibility. In 2018, additional animal efficacy and toxicology testing of these lead candidates was conducted. In addition, a novel albumin 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, CytRx 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. The Management Services Agreement may be terminated by either party at any time. Centurion is focused on the development of personalized medicine for solid tumor treatment. On December 21, 2018, CytRx 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 would no longer be needed and, accordingly, the lab was closed at the end of January 2019.

 

LADR Drug Discovery Platform and Centurion

 

Centurion’s LADR™ (Linker Activated Drug Release) technology platform is a discovery engine combining our expertise in linker chemistry and albumin biology to create a pipeline of anti-cancer molecules that will avoid unacceptable systemic toxicity while delivering highly potent agents directly to the tumor. Centurion has created a “toolbox” of linker technologies that are designed to significantly increase the therapeutic index of ultra-high potency drugs (10-1,000 times more potent than traditional cytotoxins) by controlling the release of the drug payloads and improving drug-like properties.

 

Centurion’s efforts were focused on two classes of ultra-high potency albumin-binding drug conjugates. These drug conjugates combine the proprietary LADR™ linkers with novel derivatives of the auristatin and maytansinoid drug classes. These payloads historically have required a targeting antibody for successful administration to humans. These drug conjugates eliminate the need for a targeting antibody and provide a small molecule therapeutic option with potential broader applicability.

 

Centurion’s postulated mechanism of action for the albumin-binding drug conjugates 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 at the tumors, bypassing concentration in other non-tumor sites, including the heart, liver and gastrointestinal tract due to a mechanism called “Enhanced Permeability and Retention”;

 

once localized at the tumor, the acid-sensitive linker is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and

 

free active drug is then released.

 

Centurion’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.

 

7
 

 

CytRx and Centurion have been working on identifying partnership opportunities for LADR™ ultra-high potency drug conjugates and its albumin companion diagnostic. However no partnership or any source of financing has become available after over two years of effort. Management continues to seek out potential partnerships or sources of capital for Centurion.

 

Aldoxorubicin

 

Until July 2017, the Company was focused on the research and clinical development of aldoxorubicin, its modified version of the widely-used cytotoxin agent, doxorubicin. Aldoxorubicin combines the agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of higher amounts of doxorubicin (3½ to 4 times) without several of the major dose-limiting toxicities seen with administration of doxorubicin alone.

 

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 our company is no longer directly working on development of aldoxorubicin. As part of the license, ImmunityBio made a strategic investment of $13 million in CytRx 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. 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 has initiated a Phase 2, randomized, two-cohort, open-label registrational-intent study for first-line and second-line treatment of locally advanced or metastatic pancreatic cancer, which includes aldoxorubicin.

 

Molecular Chaperone Assets

 

In 2011, CytRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme A/S (formerly Orphazyme ApS) in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million (USD) 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. Orphazyme is testing arimoclomol in three additional indications beyond ALS, including Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). Orphazyme has highlighted positive Phase2/3 clinical trial data in patients with NPC and have submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), and plans on submitting a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the second half of 2020. Orphazyme has also received FDA Breakthrough Therapy Designation for arimoclomol for NPC and their Early Access Program is now operational. CytRx will be entitled to a milestone payment of $6 million upon FDA approval, $4 million upon EMA approval and $2 million upon approval in Japan, along with royalties and potential additional milestone payments. There can be no assurance that Orphazyme will achieve such approvals.

 

Current Business Strategy

 

Currently, the Company and Centurion are working on identifying partnership opportunities for LADR™ ultra-high potency drug conjugates and their albumin companion diagnostic, although no partnerships or other sources of financing have become available after over two years of effort We have concluded all research and development on LADR and its companion diagnostic and continue to focus on identifying these partnership and financing opportunities. In addition, the Company is investigating new lines of business.

 

Basis of Presentation

 

The accompanying condensed consolidated financial statements at June 30, 2020 and for the three-month and six-month periods ended June 30, 2020 and 2019, respectively, are unaudited, but include all adjustments, consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2019 have been derived from our audited financial statements as of that date.

 

8
 

 

The consolidated financial statements included herein have been prepared by us pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations. The consolidated financial statements should be read in conjunction with our audited financial statements contained in its Annual Report on Form 10-K for the year ended December 31, 2019.

 

Liquidity and Capital Resources

 

At June 30, 2020, we had cash and cash equivalents and short-term investments of approximately $14.6 million. Management believes that our current cash and cash equivalents and short-term investments will be sufficient to fund its operations for the foreseeable future. This estimate is based, in part, upon our currently projected expenditures for the remainder of 2020 and the first seven months of 2021 of approximately $5.9 million (unaudited) to fund operating activities. These projected expenditures and payments are also based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these projections.

 

While these projections represent the Company’s current expected expenditures, the Company has the ability to reduce the amounts as needed to manage its liquidity needs while still advancing its corporate objectives. The Company will ultimately be required to obtain additional funding in order to execute its long-term business plans, although it does not currently have commitments from any third parties to provide it with long term debt, capital or non-dilutive up-front payments from a potential strategic partner. The Company cannot assure that additional funding will be available on favorable terms, or at all. If the Company fails to obtain additional funding when needed, it may not be able to execute its business plans and its business may suffer, which would have a material adverse effect on its financial position, results of operations and cash flows.

 

2. Summary of Significant Accounting Policies

 

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, 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.

 

Stock 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.

 

Foreign Currency Remeasurement

 

The U.S. dollar has been determined to be the functional currency for the net assets of our 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 gain (loss) of approximately ($5,400) and $100, respectively, for the three-month and six-month periods ended June 30, 2020 and a gain of approximately $8,200 and $6,500, respectively, for the three and six-month periods ended June 30, 2019, respectively.

 

9
 

 

Basic and Diluted Net Loss Per Common Share

 

Basic and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding. Common share equivalents that could potentially dilute net loss per share in the future, and which were excluded from the computation of diluted loss per share, totaled 7.9 million shares for each of the three-month and six-month periods ended June 30, 2020, and 2.6 million shares for each of the three-month and six-month periods ended June 30, 2019.

 

Fair Value Measurements

 

Assets and liabilities recorded at fair value on the 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.

 

We consider carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments. Our non-financial assets are measured at fair value when there is an indicator of impairment and recorded at fair value only when an impairment charge is recognized.

 

Recently 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 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. Discontinued Operations

 

On December 21, 2018, the Company announced that its pre-clinical lab operations had successfully completed its objectives – namely, it has developed four lead compounds, LADR 7, LADR-8, LADR-9 and LADR 10 along with a companion diagnostic (ACDx). Accordingly, the Company terminated the contracts of all its employees at this location.

 

The Company terminated its lease in Freiburg Germany on April 30, 2019 with no penalty. The Company sold its analytical equipment in March 2019 and accordingly has classified these assets as current assets held for sale and has written down these assets by $7,000. On April 30, 2019 the Company also sold its German office furniture and German leasehold improvements for $0.3 million. The net book value of the assets held for sale is $0 at June 30, 2019 and $0.4 million at December 31, 2018. The value of the assets sold in April 2019 are greater than their net book value and so no write-down has been recorded in the period. The results of these discontinued operations are presented separately on the Company’s Consolidated Statement of Operations.

 

   Three Months Ended June 30,   Six Months Ended June 30, 
   2020   2019   2020   2019 
Research and development  $—   $(1,940)  $—   $(172,272)
Loss on impairment of equipment and furnishings   —    —    —    7,100 
Employee stock option expense   —    —    —    (2,672)
Gain on sale of assets held for sale   —    (138,976)   —    (193,791)
Other (income) loss   —    2,821    —    (17,077)
Depreciation expense   —    —    —    — 
Income from discontinued operations  $—   $(138,095)  $—   $(378,712)

 

10
 

 

4. Leases

 

We lease office space and office copiers related primarily to the 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 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 $13,855, 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 $1,370, 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 June 30, 2020, the balance of right-of-use assets was approximately $670,000, and the balance of total lease liabilities was approximately $682,000.

 

Future minimum lease payments under non-cancelable operating leases under ASC 842 as of June 30, 2020 are as follows:

 

   Operating
Lease Payments		 
     
July 2020 – June 2021  $196,156 
July 2021 – June 2022   199,618 
July 2022 – June 2023   197,600 
July 2023 – June 2024   134,690 
Total future minimum lease payments   728,064 
      
Less: present value adjustment   46,280 
Operating lease liabilities at June 30, 2020   681,784 
Less: current portion of operating lease liabilities   174,772 
Operating lease liabilities, net of current portion  $507,012 

  

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

 

   Period Ended
June 30, 2020 		 
Lease Cost     
      
Operating lease cost (included in General and administrative expenses in the Company’s condensed Consolidated Statements of Operations)  $80,443 
      
Other information     
      
Cash paid for amounts included in the measurement of lease liabilities for the period ended June 30, 2020  $88,227 
      
Weighted average remaining lease term – operating leases (in years)   3. 6 
      
Average discount rate   3.6%

  

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5. Stock Based Compensation

 

The Company has a 2000 Long-Term Incentive Plan, which expired on August 6, 2010. As of June 30, 2020, there were 1,521 shares subject to outstanding stock options under this plan. No further shares are available for future grant under this plan.

 

The Company also has a 2008 Stock Incentive Plan under which 5 million shares of common stock are reserved for issuance. As of June 30, 2020, there were approximately 2.3 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 2019, the Company adopted a 2019 Stock Incentive Plan under which 5.4 million shares of common stock are reserved for issuance. As of June 30, 2020, there were 5.4 million shares subject to outstanding stock options. This Plan expires on November 14, 2029.

 

The following table sets forth the total stock-based compensation expense resulting from stock options, restricted stock and warrants included in our Condensed Consolidated Statements of Operations:

 

   Three Months Ended June 30,   Six Months Ended June 30, 
   2020   2019   2020   2019 
Research and development  $—   $—   $    $(2,672)
General and administrative — employee   86,659    214,706    173,321    427,880 
Total employee stock-based compensation  $86,659   $214,706   $173,321   $425,208 

 

Options

 

There were no options granted in either periods ended June 30, 2020 and June 30, 2019.

 

Presented below is our stock option activity:

 

   Six Months Ended June 30, 2020 
   Number of Options (Employees)   Number of Options (Non-Employees)   Total Number of Options   Weighted-Average Exercise Price 
Outstanding at January 1, 2020   7,126,340    615,000    7,741,340   $3.32 
Granted   —    —    —    — 
Forfeited or expired   (3,570)   —    (3,570)  $32.76 
Outstanding at June 30, 2020   7,122,770    615,000    7,737,770   $3.31 
Exercisable at June 30, 2020   7,075,104    615,000    7,690,104   $3.32 

 

The following table summarizes significant ranges of outstanding stock options under our plans at June 30, 2020:

 

 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    5,400,000    9.46   $0.26    5,400,000    9.46   $0.26 
$1.01 – $3.00    1,050,673    7.11   $2.04    1,003,007    7.00   $2.04 
$3.01 – $15.00    852,360    4.47   $12.56    852,360    4.47   $12.56 
$15.01 –$42.42    434,737    3.44   $26.13    434,737    3.44   $26.13 
      7,737,770    8.25   $3.32    7,690,104    8.24   $3.32 

 

The Company recorded stock compensation costs related to vesting of options during the period of $30,392 and $60,787, respectively, for the three and six-month periods ended June 30, 2020, as compared to $75,410 and $148,146, respectively, for the three and six-month periods ended June 30, 2019. As of June 30, 2020, there remained approximately $0.1 million of unrecognized compensation expense related to unvested stock options granted to current employees, which we expect will be recognized over a weighted-average period of 0.31 years. The aggregate intrinsic value of the outstanding options and options vested as of June 30, 2020 was $2.3 million.

 

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At June 30, 2020 and December 31, 2019, there were warrants outstanding to purchase 193,196, at a weighted-average exercise price of $8.60, in each period.

 

Restricted Stock

 

In December 2017, the Company granted to Steven Kriegsman, Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years. 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 $679,000. In December 2016, the Company granted to Steven Kriegsman, Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years. 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 $1,000,000. The Company recorded an employee stock-based compensation expense for restricted stock of $56,267 and $112,534 respectively, for the three and six-month periods ended June 30, 2020 as compared to $139,296 and $277,062 respectively, for the three and six-month periods ended June 30, 2019. As of June 30,2020, there remained approximately $110,000 of unrecognized compensation expense related to the vesting of these shares.

 

6. Income Taxes

 

At December 31, 2019, we had federal and state net operating loss carryforwards of $321.8 million and $246.7 million, respectively, available to offset against future taxable income, which expire in 2024 through 2037, of which $249.1 million and $235.6 million, respectively, are not subject to limitation under Section 382 of the Internal Revenue Code.

 

7. Commitments and Contingencies

 

Commitments

 

Aldoxorubicin

 

We have an agreement with Vergell Medical (formerly with KTB) (“Vergell”) for the exclusive license of patent rights held by Vergell for the worldwide development and commercialization of aldoxorubicin. Under the agreement, we must make payments to Vergell in the aggregate of $7.5 million upon meeting clinical and regulatory milestones up to and including the product’s second final marketing approval. We also have agreed to pay:

 

●commercially reasonable royalties based on a percentage of net sales (as defined in the agreement);

 

●a percentage of 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.

 

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.

 

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.

 

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Contingencies

 

We apply the disclosure provisions of ASC 460, Guarantees (“ASC 460”) to its agreements that contain guarantees or indemnities by the Company. We provide (i) indemnifications of varying scope and size to certain investors and other parties for certain losses suffered or incurred by the indemnified party in connection with various types of third-party claims; and (ii) indemnifications of varying scope and size to officers and directors against third party claims arising from the services they provide to the Company.

 

The Company evaluates developments in legal proceedings and other matters on a quarterly basis. The Company records accruals for loss contingencies to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated.

 

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 and will return to their offices at a yet to be determined date.

 

8. Subsequent Event

 

In August 2020, the Company’s Chief Executive Officer, certain Board members and an outside consultant exercised 4.4 million of their 2019 stock options on a cashless exercise basis, and were issued a total of approximately 2.7 million common shares of the Company.

 

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Item 2. — Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Forward Looking Statements

 

All statements in this Quarterly Report, including statements in this section, other than statements of historical fact are forward-looking statements, including statements of our current views with respect to the recent developments regarding our business strategy, business plan and research and development activities, our future financial results, and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology industry, in general. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential” or “could” or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements.

 

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, the factors discussed in this section and under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019, which should be reviewed carefully. If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. Please consider our forward-looking statements in light of those risks as you read this Quarterly 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.

 

Overview

 

CytRx Corporation (“CytRx”) is a biopharmaceutical research and development company specializing in oncology and neurodegenenerative diseases. The Company’s focus has been on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel linker technologies to enhance the accumulation and release of cytotoxic anti-cancer agents at the tumor. During 2017, CytRx’s discovery laboratory, located in Freiburg, Germany, synthesized and tested over 75 rationally designed drug conjugates with highly potent 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 preclinical studies, stability, and manufacturing feasibility. In 2018, additional animal efficacy and toxicology testing of these lead candidates was conducted. In addition, a novel albumin companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates.

 

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On June 1, 2018, CytRx 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. The Management Services Agreement may be terminated by either party at any time. Centurion is focused on the development of personalized medicine for solid tumor treatment. On December 21, 2018, CytRx 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 would no longer be needed and, accordingly, the lab was closed at the end of January 2019.

 

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. Although te hCompany’s current operations have not been impacted, 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 and will return to their offices at a yet to be determined date.

 

LADR Drug Discovery Platform and Centurion

 

Centurion’s LADR™ (Linker Activated Drug Release) technology platform is a discovery engine combining our expertise in linker chemistry and albumin biology to create a pipeline of anti-cancer molecules that will avoid unacceptable systemic toxicity while delivering highly potent agents directly to the tumor. Centurion has created a “toolbox” of linker technologies that are designed to significantly increase the therapeutic index of ultra-high potency drugs (10-1,000 times more potent than traditional cytotoxins) by controlling the release of the drug payloads and improving drug-like properties.

 

Centurion’s efforts were focused on two classes of ultra-high potency albumin-binding drug conjugates. These drug conjugates combine the proprietary LADR™ linkers with novel derivatives of the auristatin and maytansinoid drug classes. These payloads historically have required a targeting antibody for successful administration to humans. These drug conjugates eliminate the need for a targeting antibody and provide a small molecule therapeutic option with potential broader applicability.

 

Centurion’s postulated mechanism of action for the albumin-binding drug conjugates 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 at the tumors, bypassing concentration in other non-tumor sites, including the heart, liver and gastrointestinal tract due to a mechanism called “Enhanced Permeability and Retention”;

 

once localized at the tumor, the acid-sensitive linker is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and

 

free active drug is then released.

 

Centurion’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.

 

CytRx and Centurion have been working on identifying partnership opportunities for LADR™ ultra-high potency drug conjugates and its albumin companion diagnostic. However no partnership or any source of financing has become available after over two years of effort. Management continues to seek out potential partnerships or sources of capital for Centurion.

 

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Aldoxorubicin

 

Until July 2017, the Company was focused on the research and clinical development of aldoxorubicin, its modified version of the widely-used cytotoxin agent, doxorubicin. Aldoxorubicin combines the agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of higher amounts of doxorubicin (3½ to 4 times) without several of the major dose-limiting toxicities seen with administration of doxorubicin alone.

 

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 our company is no longer directly working on development of aldoxorubicin. As part of the license, ImmunityBio made a strategic investment of $13 million in CytRx 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. 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 has initiated a Phase 2, randomized, two-cohort, open-label registrational-intent study for first-line and second-line treatment of locally advanced or metastatic pancreatic cancer, which includes aldoxorubicin.

 

Molecular Chaperone Assets

 

In 2011, CytRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme A/S (formerly Orphazyme ApS) in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million (USD) 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. Orphazyme is testing arimoclomol in three additional indications beyond ALS, including Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). CytRx received a milestone payment of $250,000 in September 2018. Orphazyme has highlighted positive Phase2/3 clinical trial data in patients with NPC and have announced they submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), and and plans on submitting a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the second half of 2020. Orphazyme has also received FDA Breakthrough Therapy Designation for arimoclomol for NPC and their Early Access Program is now operational. CytRx will be entitled to a milestone payment of $6 million upon FDA approval, $4 million upon EMA approval and $2 million upon approval in Japan, along with royalties and potential additional milestone payments. There can be no assurance that Orphazyme will achieve such approvals.

 

Current Business Strategy

 

Currently, the Company and Centurion are working on identifying partnership opportunities for LADR™ ultra-high potency drug conjugates and their albumin companion diagnostic, although no partnerships or other sources of financing have become available after over two years of effort. We have concluded all research and development on LADR and its companion diagnostic and continue to focus on identifying these partnership and financing opportunities In addition, the Company is investigating new lines of business.

 

Critical Accounting Policies and Estimates

 

Management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, impairment of long-lived assets, including finite-lived intangible assets, research and development expenses and clinical trial expenses and stock-based compensation expense.

 

17
 

 

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 to our financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2019. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements.

 

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.

 

Use of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free interest rate. The Company estimates volatility using a blend of its own historical stock price volatility as well as that of market comparable entities since the Company’s common stock has limited trading history and limited observable volatility of its own. The expected term of the options is estimated by using the Securities and Exchange Commission Staff Bulletin No. 107’s Simplified Method for Estimate Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.

 

Net Income (Loss) per Share

 

Basic and diluted net loss per common share is computed using the weighted-average number of common shares outstanding. Potentially dilutive stock options and warrants to purchase 7.9 million shares for each of the three-month and six-month periods ended June 30, 2020, and 2.6 million shares for each of the three-month and six-month periods ended June 30, 2019, were excluded from the computation of diluted net loss per share, because the effect would be anti-dilutive.

 

Liquidity and Capital Resources

 

We have relied primarily upon proceeds from sales of our equity securities and the exercise of options and warrants, and to a much lesser extent upon payments from our strategic partners and licensees, to generate funds needed to finance our business and operations.

 

At June 30, 2020, we had cash and cash equivalents and short-term investments of approximately $14.6 million. Management believes that our current cash and cash equivalents and short-term investments will be sufficient to fund the Company’s operations for the foreseeable future. This estimate is based, in part, upon our currently projected expenditures for the remainder of 2020 and the first seven months of 2021 of approximately $5.9 million (unaudited) to fund operating activities. These projected expenditures and payments are also based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these projections. While these projections represent our current expected expenditures, CytRx has the ability to reduce the amounts and alter the timing of certain expenditures as needed to manage its liquidity needs while still advancing its corporate objectives. 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 it with long term debt or capital. CytRx 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 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 recorded a net loss of approximately $2.5 million for the six-month period ended June 30, 2020, as compared to a net loss from continuing operations in the six-month period ended June 30, 2019 of $2.7 million. In 2019, we had closed our drug development operations in Freiburg Germany and sold most of the Company’s fixed assets, resulting in a gain from discontinued operations of $0.5 million in the six-month period ended June 30, 2019. Consequently, our net loss from continuing operations were approximately $0.6 million lower on a comparative basis, primarily due to a reduction in head count.

 

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We purchased a minimal amount of fixed assets in the period ended June 30, 2020 as compared to the realization of $0.5 million from the sale of fixed assets from discontinued operations in the six-month period ended June 30, 2019 and do not expect any significant capital spending during the next 12 months.

 

There were no financing transactions in either six month-periods ended June 30, 2020 or June 30, 2019.

 

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.

 

Results of Operations

 

We recorded a net loss of approximately $1.3 and $2.5 million for the three-month and six-month periods ended June 30, 2020, as compared to a net loss of approximately $1.3 million and $2.7 million for the three-month and six-month periods ended June 30, 2019, respectively. In 2019, we had closed our drug development operations in Freiburg Germany and sold most of the Company’s fixed assets, resulting in a gain from discontinued operations of $0.4 million in the six-month period ended June 30, 2019. Consequently, our net loss from continuing operations were approximately $0.6 million lower on a comparative basis, primarily due to a reduction in head count.

 

We recognized no licensing revenue in the six-month periods ended June 30, 2020 and 2019. All future licensing fees under our current licensing agreements are dependent upon successful development milestones being achieved by the licensor. During the remainder of 2020, we do not foresee receiving any significant licensing fees.

 

General and Administrative Expenses

 

   Three-Month Period Ended
June 30,		  

Six-Month Period Ended

June 30,

 
   2020   2019   2020   2019 
   (In thousands)   (In thousands) 
General and administrative expenses  $1,284   $1,311   $2,419   $2,830 
Amortization of stock awards   87    215    173    428 
Depreciation and amortization   8    5    14    11 
   $1,379   $1,531   $2,606   $3,269 

 

General and administrative expenses include all administrative salaries and general corporate expenses, including legal expenses. Our general and administrative expenses, excluding stock expense, non-cash expenses and depreciation and amortization, were $1.3 million and $2.4 million for the three and six-month periods ended June 30, 2020, respectively, and $1.3 million and $2.8 million, respectively, for the same periods in 2019. Our general and administrative expenses in the comparative six-month periods excluding amortization of stock awards, non-cash expenses and depreciation and amortization, decreased by approximately $0.4 million, primarily due to a reduction in head count.

 

Depreciation and Amortization

 

Depreciation expense reflects the depreciation of our equipment and furnishings.

 

Interest Income

 

Interest income was approximately $36,000 and $91,000 for the three-month and six-month periods ended June 30, 2020, respectively, as compared to $104,000 and $192,000, respectively, for the same periods in 2019.

 

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Item 3. — Quantitative and Qualitative Disclosures About Market Risk

 

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 nature of our short-term investments, we believe that we are not subject to any material market risk exposure. We do not have any speculative or hedging derivative financial instruments or foreign currency instruments. If interest rates had varied by 10% in the three-month period ended June 30, 2020, it would not have had a material effect on our results of operations or cash flows for that period.

 

Item 4. — Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our Chief Executive Officer and our Chief 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 the end of the quarterly period covered by this Quarterly Report. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.

 

Changes in Controls over Financial Reporting

 

There was no change in our internal control over financial reporting that occurred during the quarter ended June 30, 2020 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We continually seek to assure that all of our controls and procedures are adequate and effective. Any failure to implement and maintain improvements in the controls over our financial reporting could cause us to fail to meet our reporting obligations under the SEC’s rules and regulations. Any failure to improve our internal controls to address the weaknesses we have identified could also cause investors to lose confidence in our reported financial information, which could have a negative impact on the trading price of our common stock.

 

PART II — OTHER INFORMATION

Item 1. — Legal Proceedings

 

None.

 

Item 1A. — Risk Factors

 

You should carefully consider and evaluate the information in this Quarterly Report and the risk factors set forth under the caption “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (the “Form 10-K”), which was filed with the SEC on March 26, 2020. The risk factors associated with our business have not materially changed compared to the risk factors disclosed in the Form 10-K.

 

Item 2. — Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 5. — Other Information

 

On or about August 12, 2020, CytRx authorized the issuance of an aggregate of 2,692,537 shares of Common Stock that were not registered under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the cashless exercise provisions of stock options that were issued by CytRx under the 2019 Stock Incentive Plan.  These issuances were exempt from registration under the Securities Act in reliance on Section 4(a)(2) thereof as transactions by an issuer not involving a public offering.

 

Item 6. — Exhibits

 

The exhibits listed in the accompanying Index to Exhibits are filed as part of this Quarterly Report and incorporated herein by reference.

 

20
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  CytRx Corporation
     
Date: August 14, 2020 By: /s/ JOHN Y. CALOZ
    John Y. Caloz
    Chief Financial Officer

 

21
 

 

INDEX TO EXHIBITS

 

Exhibit

Number

   Description
31.1   Certification of Chief Executive Officer Pursuant to Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
31.2   Certification of Chief Financial Officer Pursuant to Item 601(b)(31) of Regulation S-K, 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   XBRL Instance Document
     
101.SCH   XBRL Schema Document
     
101.CAL   XBRL Calculation Linkbase Document
     
101.DEF   XBRL Definition Linkbase Document
     
101.LAB   XBRL Label Linkbase Document
     
101.PRE   XBRL Presentation Linkbase Document

 

22

 

 EX-31.1 2 ex31-1.htm

 

Exhibit 31.1

 

CERTIFICATIONS

 

I, Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx Corporation, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of CytRx Corporation;

 

2. Based on my knowledge, this quarterly 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 quarterly report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly 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 Rules713a-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, including its subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly 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 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: August 14, 2020 By: /s/ STEVEN A. KRIEGSMAN
    Steven A. Kriegsman
    Chairman and Chief Executive Officer

 

 
 EX-31.2 3 ex31-2.htm

 

Exhibit 31.2

 

CERTIFICATIONS

 

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

 

1. I have reviewed this quarterly report on Form 10-Q of CytRx Corporation;

 

2. Based on my knowledge, this quarterly 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 quarterly report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly 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, including its subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly 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 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: August 14, 2020 By: /s/ JOHN Y. CALOZ
    John Y. Caloz
    Chief Financial Officer

 

 
 EX-32.1 4 ex32-1.htm

 

Exhibit 32.1

 

Certification of Chief Executive Officer

 

Pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of CytRx Corporation (the “Company”) hereby certifies based on his knowledge that:

 

(i) the accompanying Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2020 as filed with the Securities and Exchange Commission on the date hereof (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 as of and for the periods covered in the Report.

 

Date: August 14, 2020 By: /s/ STEVEN A. KRIEGSMAN
    Steven A. Kriegsman
    Chairman and 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-Q and shall not be considered filed as part of the Form 10-Q.

 

 
 EX-32.2 5 ex32-2.htm

 

Exhibit 32.2

 

Certification of Chief Financial Officer

 

Pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of CytRx Corporation (the “Company”) hereby certifies based on his knowledge that:

 

(i) the accompanying Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2020 as filed with the Securities and Exchange Commission on the date hereof (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 as of and for the periods covered in the Report.

 

Date: August 14, 2020 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 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-Q and shall not be considered filed as part of the Form 10-Q.

 

 

 

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Document and Entity Information - shares
 6 Months Ended
Jun. 30, 2020
Aug. 14, 2020
Cover [Abstract]    
Entity Registrant Name CYTRX CORP  
Entity Central Index Key 0000799698  
Document Type 10-Q  
Document Period End Date Jun. 30, 2020  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity's Reporting Status Current Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business Flag true  
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Entity Shell Company false  
Entity Common Stock, Shares Outstanding   33,637,501
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2020  
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Condensed Consolidated Balance Sheets - USD ($)
Jun. 30, 2020
Dec. 31, 2019
Current assets:    
Cash and cash equivalents $ 14,587,401 $ 16,130,410
Receivables 12,065 7,628
Prepaid expenses and other current assets 285,801 1,066,497
Total current assets 14,885,267 17,204,535
Equipment and furnishings, net 54,783 42,893
Other assets 19,366 7,590
Operating lease right-of-use assets 669,666
Total assets 15,629,082 17,255,018
Current liabilities:    
Accounts payable 952,411 887,835
Accrued expenses and other current liabilities 1,131,130 1,092,895
Current portion of operating lease liabilities 174,772 69,576
Total current liabilities 2,258,313 2,050,306
Operating lease liabilities, net of current portion 507,012
Total liabilities 2,765,325 2,050,306
Commitments and contingencies
Stockholders' equity:    
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
Common stock, $0.001 par value, 41,666,666 shares authorized; 33,637,501 shares issued and outstanding at June 30, 2020 and December 31, 2019 33,637 33,637
Additional paid-in capital 479,371,170 479,197,849
Accumulated deficit (466,541,050) (464,026,774)
Total stockholders' equity 12,863,757 15,204,712
Total liabilities and stockholders' equity $ 15,629,082 $ 17,255,018
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Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Jun. 30, 2020
Dec. 31, 2019
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 41,666,666 41,666,666
Common stock, shares issued 33,637,501 33,637,501
Common stock, shares outstanding 33,637,501 33,637,501
Series B Junior Participating Preferred Stock [Member]    
Preferred stock, shares authorized 50,000 50,000
Preferred stock, shares issued
Preferred stock, shares outstanding
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Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
 3 Months Ended 6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Revenue:        
Licensing revenue
Expenses:        
Research and development 580 1,056
General and administrative 1,379,426 1,531,073 2,605,730 3,268,223
Total operating expenses 1,379,426 1,531,653 2,605,730 3,269,279
Loss before other income (expense) (1,379,426) (1,531,653) (2,605,730) (3,269,279)
Other income (loss):        
Interest income 35,893 104,095 90,714 192,405
Interest expense
Other income (loss), net 2,043 14,968 740 (2,321)
Gain on warrant derivative liabilities
Net loss from continuing operations (1,341,490) (1,412,590) (2,514,276) (3,079,195)
Income from discontinued operations 138,095 378,712
Net loss $ (1,341,490) $ (1,274,495) $ (2,514,276) $ (2,700,483)
Basic and diluted loss per share        
Continuing operations $ (0.04) $ (0.04) $ (0.08) $ (0.09)
Discontinued operations 0.01
Total basic and diluted loss per share $ (0.04) $ (0.04) $ (0.08) $ (0.08)
Basic and diluted weighted-average shares outstanding 33,508,302 33,249,904 33,508,302 33,249,904
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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
 6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Cash flows from operating activities:    
Net loss $ (2,514,276) $ (2,700,483)
Income from discontinued operations 378,712
Loss from continuing operations (2,514,276) (3,079,195)
Adjustments to reconcile net loss from continuing operations to net cash used in operating activities:    
Depreciation and amortization 14,012 10,828
Loss on retirement of fixed assets 5,432
Stock-based compensation expense 173,321 427,880
Changes in assets and liabilities:    
Receivable (4,437) 139,144
Prepaid expenses and other current assets 714,425 448,143
Other assets (11,776) 27,993
Amortization of right-of-use asset 111,915
Accounts payable 64,576 (339,027)
Decrease in lease liabilities (103,102)
Accrued expenses and other current liabilities 20,862 211,549
Net cash used in operating activities from continuing operations (1,534,480) (2,147,253)
Net cash used in operating activities from discontinued operations (348,338)
Net cash used in operating activities (1,534,480) (2,495,591)
Cash flows from investing activities:    
Purchase of fixed assets (8,529)
Sale of fixed assets held for sale 500,142
Net cash used in investing activities (8,529) 500,142
Net decrease in cash and cash equivalents (1,543,009) (1,995,449)
Cash and cash equivalents at beginning of period 16,130,410 21,373,273
Cash and cash equivalents at end of period 14,587,401 19,377,824
Supplemental disclosure of Cash Flow Information:    
Recognition of operating lease right-of-use assets and obligations under ASC Topic 842 715,310
Reclassification of right-of-use asset, from prepaid expenses 66,271
Acquisition of equipment included in accrued expenses $ 17,374
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Condensed Consolidated Statements of Stockholders Equity (Unaudited) - USD ($)
Series B Preferred Shares [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Deficit [Member]
Total
Balance at Dec. 31, 2018 $ 33,637 $ 477,192,747 $ (456,864,085) $ 20,362,299
Balance, shares at Dec. 31, 2018 33,637,501      
Issuance of stock options/restricted stock and warrants for compensation and services 210,502 210,502
Net loss (1,425,988) (1,425,988)
Balance at Mar. 31, 2019 $ 33,637 477,403,249 (458,290,073) 19,146,813
Balance, shares at Mar. 31, 2019 33,637,501      
Balance at Dec. 31, 2018 $ 33,637 477,192,747 (456,864,085) 20,362,299
Balance, shares at Dec. 31, 2018 33,637,501      
Net loss         (2,700,483)
Balance at Jun. 30, 2019 $ 33,637 477,617,955 (459,564,568) 18,087,024
Balance, shares at Jun. 30, 2019 33,637,501      
Balance at Mar. 31, 2019 $ 33,637 477,403,249 (458,290,073) 19,146,813
Balance, shares at Mar. 31, 2019 33,637,501      
Issuance of stock options/restricted stock and warrants for compensation and services 214,706 214,706
Net loss (1,274,495) (1,274,495)
Balance at Jun. 30, 2019 $ 33,637 477,617,955 (459,564,568) 18,087,024
Balance, shares at Jun. 30, 2019 33,637,501      
Balance at Dec. 31, 2019 $ 33,637 479,197,849 (464,026,774) 15,204,712
Balance, shares at Dec. 31, 2019 33,637,501      
Issuance of stock options/restricted stock and warrants for compensation and services 86,662 86,662
Net loss (1,172,786) (1,172,786)
Balance at Mar. 31, 2020 $ 33,637 479,284,511 (465,199,560) 14,118,588
Balance, shares at Mar. 31, 2020 33,637,501      
Balance at Dec. 31, 2019 $ 33,637 479,197,849 (464,026,774) 15,204,712
Balance, shares at Dec. 31, 2019 33,637,501      
Net loss         (2,514,276)
Balance at Jun. 30, 2020 $ 33,637 479,371,170 (466,541,050) 12,863,757
Balance, shares at Jun. 30, 2020 33,637,501      
Balance at Mar. 31, 2020 $ 33,637 479,284,511 (465,199,560) 14,118,588
Balance, shares at Mar. 31, 2020 33,637,501      
Issuance of stock options/restricted stock and warrants for compensation and services 86,659 86,659
Net loss (1,341,490) (1,341,490)
Balance at Jun. 30, 2020 $ 33,637 $ 479,371,170 $ (466,541,050) $ 12,863,757
Balance, shares at Jun. 30, 2020 33,637,501      
XML 18 R7.htm IDEA: XBRL DOCUMENT v3.20.2
Description of Company and Basis of Presentation
 6 Months Ended
Jun. 30, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Description of Company and Basis of Presentation

1. Description of Company and Basis of Presentation

 

CytRx Corporation (“CytRx”) is a biopharmaceutical research and development company specializing in oncology and neurodegenerative diseases. The Company’s focus has been on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel linker technologies to enhance the accumulation and release of cytotoxic anti-cancer agents at the tumor. During 2017, CytRx’s discovery laboratory, located in Freiburg, Germany, synthesized and tested over 75 rationally designed drug conjugates with highly potent 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 preclinical studies, stability, and manufacturing feasibility. In 2018, additional animal efficacy and toxicology testing of these lead candidates was conducted. In addition, a novel albumin 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, CytRx 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. The Management Services Agreement may be terminated by either party at any time. Centurion is focused on the development of personalized medicine for solid tumor treatment. On December 21, 2018, CytRx 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 would no longer be needed and, accordingly, the lab was closed at the end of January 2019.

 

LADR Drug Discovery Platform and Centurion

 

Centurion’s LADR™ (Linker Activated Drug Release) technology platform is a discovery engine combining our expertise in linker chemistry and albumin biology to create a pipeline of anti-cancer molecules that will avoid unacceptable systemic toxicity while delivering highly potent agents directly to the tumor. Centurion has created a “toolbox” of linker technologies that are designed to significantly increase the therapeutic index of ultra-high potency drugs (10-1,000 times more potent than traditional cytotoxins) by controlling the release of the drug payloads and improving drug-like properties.

 

Centurion’s efforts were focused on two classes of ultra-high potency albumin-binding drug conjugates. These drug conjugates combine the proprietary LADR™ linkers with novel derivatives of the auristatin and maytansinoid drug classes. These payloads historically have required a targeting antibody for successful administration to humans. These drug conjugates eliminate the need for a targeting antibody and provide a small molecule therapeutic option with potential broader applicability.

 

Centurion’s postulated mechanism of action for the albumin-binding drug conjugates 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 at the tumors, bypassing concentration in other non-tumor sites, including the heart, liver and gastrointestinal tract due to a mechanism called “Enhanced Permeability and Retention”;

 

once localized at the tumor, the acid-sensitive linker is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and

 

free active drug is then released.

 

Centurion’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.

 

CytRx and Centurion have been working on identifying partnership opportunities for LADR™ ultra-high potency drug conjugates and its albumin companion diagnostic. However no partnership or any source of financing has become available after over two years of effort. Management continues to seek out potential partnerships or sources of capital for Centurion.

 

Aldoxorubicin

 

Until July 2017, the Company was focused on the research and clinical development of aldoxorubicin, its modified version of the widely-used cytotoxin agent, doxorubicin. Aldoxorubicin combines the agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of higher amounts of doxorubicin (3½ to 4 times) without several of the major dose-limiting toxicities seen with administration of doxorubicin alone.

 

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 our company is no longer directly working on development of aldoxorubicin. As part of the license, ImmunityBio made a strategic investment of $13 million in CytRx 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. 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 has initiated a Phase 2, randomized, two-cohort, open-label registrational-intent study for first-line and second-line treatment of locally advanced or metastatic pancreatic cancer, which includes aldoxorubicin.

 

Molecular Chaperone Assets

 

In 2011, CytRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme A/S (formerly Orphazyme ApS) in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million (USD) 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. Orphazyme is testing arimoclomol in three additional indications beyond ALS, including Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). Orphazyme has highlighted positive Phase2/3 clinical trial data in patients with NPC and have submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), and plans on submitting a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the second half of 2020. Orphazyme has also received FDA Breakthrough Therapy Designation for arimoclomol for NPC and their Early Access Program is now operational. CytRx will be entitled to a milestone payment of $6 million upon FDA approval, $4 million upon EMA approval and $2 million upon approval in Japan, along with royalties and potential additional milestone payments. There can be no assurance that Orphazyme will achieve such approvals.

 

Current Business Strategy

 

Currently, the Company and Centurion are working on identifying partnership opportunities for LADR™ ultra-high potency drug conjugates and their albumin companion diagnostic, although no partnerships or other sources of financing have become available after over two years of effort We have concluded all research and development on LADR and its companion diagnostic and continue to focus on identifying these partnership and financing opportunities. In addition, the Company is investigating new lines of business.

 

Basis of Presentation

 

The accompanying condensed consolidated financial statements at June 30, 2020 and for the three-month and six-month periods ended June 30, 2020 and 2019, respectively, are unaudited, but include all adjustments, consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2019 have been derived from our audited financial statements as of that date.

  

The consolidated financial statements included herein have been prepared by us pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations. The consolidated financial statements should be read in conjunction with our audited financial statements contained in its Annual Report on Form 10-K for the year ended December 31, 2019.

 

Liquidity and Capital Resources

 

At June 30, 2020, we had cash and cash equivalents and short-term investments of approximately $14.6 million. Management believes that our current cash and cash equivalents and short-term investments will be sufficient to fund its operations for the foreseeable future. This estimate is based, in part, upon our currently projected expenditures for the remainder of 2020 and the first seven months of 2021 of approximately $5.9 million (unaudited) to fund operating activities. These projected expenditures and payments are also based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these projections.

 

While these projections represent the Company’s current expected expenditures, the Company has the ability to reduce the amounts as needed to manage its liquidity needs while still advancing its corporate objectives. The Company will ultimately be required to obtain additional funding in order to execute its long-term business plans, although it does not currently have commitments from any third parties to provide it with long term debt, capital or non-dilutive up-front payments from a potential strategic partner. The Company cannot assure that additional funding will be available on favorable terms, or at all. If the Company fails to obtain additional funding when needed, it may not be able to execute its business plans and its business may suffer, which would have a material adverse effect on its financial position, results of operations and cash flows.
XML 19 R8.htm IDEA: XBRL DOCUMENT v3.20.2
Summary of Significant Accounting Policies
 6 Months Ended
Jun. 30, 2020
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

 

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, 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.

 

Stock 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.

 

Foreign Currency Remeasurement

 

The U.S. dollar has been determined to be the functional currency for the net assets of our 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 gain (loss) of approximately ($5,400) and $100, respectively, for the three-month and six-month periods ended June 30, 2020 and a gain of approximately $8,200 and $6,500, respectively, for the three and six-month periods ended June 30, 2019, respectively.

 

Basic and Diluted Net Loss Per Common Share

 

Basic and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding. Common share equivalents that could potentially dilute net loss per share in the future, and which were excluded from the computation of diluted loss per share, totaled 7.9 million shares for each of the three-month and six-month periods ended June 30, 2020, and 2.6 million shares for each of the three-month and six-month periods ended June 30, 2019.

 

Fair Value Measurements

 

Assets and liabilities recorded at fair value on the 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.

 

We consider carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments. Our non-financial assets are measured at fair value when there is an indicator of impairment and recorded at fair value only when an impairment charge is recognized.

 

Recently 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 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 20 R9.htm IDEA: XBRL DOCUMENT v3.20.2
Discontinued Operations
 6 Months Ended
Jun. 30, 2020
Discontinued Operations and Disposal Groups [Abstract]  
Discontinued Operations

3. Discontinued Operations

 

On December 21, 2018, the Company announced that its pre-clinical lab operations had successfully completed its objectives – namely, it has developed four lead compounds, LADR 7, LADR-8, LADR-9 and LADR 10 along with a companion diagnostic (ACDx). Accordingly, the Company terminated the contracts of all its employees at this location.

 

The Company terminated its lease in Freiburg Germany on April 30, 2019 with no penalty. The Company sold its analytical equipment in March 2019 and accordingly has classified these assets as current assets held for sale and has written down these assets by $7,000. On April 30, 2019 the Company also sold its German office furniture and German leasehold improvements for $0.3 million. The net book value of the assets held for sale is $0 at June 30, 2019 and $0.4 million at December 31, 2018. The value of the assets sold in April 2019 are greater than their net book value and so no write-down has been recorded in the period. The results of these discontinued operations are presented separately on the Company’s Consolidated Statement of Operations.

 

    Three Months Ended June 30,     Six Months Ended June 30,  
    2020     2019     2020     2019  
Research and development   $ —     $ (1,940 )   $ —     $ (172,272 )
Loss on impairment of equipment and furnishings     —       —       —       7,100  
Employee stock option expense     —       —       —       (2,672 )
Gain on sale of assets held for sale     —       (138,976 )     —       (193,791 )
Other (income) loss     —       2,821       —       (17,077 )
Depreciation expense     —       —       —       —  
Income from discontinued operations   $ —     $ (138,095 )   $ —     $ (378,712 )
XML 21 R10.htm IDEA: XBRL DOCUMENT v3.20.2
Leases
 6 Months Ended
Jun. 30, 2020
Leases [Abstract]  
Leases

4. Leases

 

We lease office space and office copiers related primarily to the 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 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 $13,855, 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 $1,370, 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 June 30, 2020, the balance of right-of-use assets was approximately $670,000, and the balance of total lease liabilities was approximately $682,000.

 

Future minimum lease payments under non-cancelable operating leases under ASC 842 as of June 30, 2020 are as follows:

 

    Operating
Lease Payments		  
       
July 2020 – June 2021   $ 196,156  
July 2021 – June 2022     199,618  
July 2022 – June 2023     197,600  
July 2023 – June 2024     134,690  
Total future minimum lease payments     728,064  
         
Less: present value adjustment     46,280  
Operating lease liabilities at June 30, 2020     681,784  
Less: current portion of operating lease liabilities     174,772  
Operating lease liabilities, net of current portion   $ 507,012  

  

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

 

    Period Ended
June 30, 2020		  
Lease Cost        
         
Operating lease cost (included in General and administrative expenses in the Company’s condensed Consolidated Statements of Operations)   $ 80,443  
         
Other information        
         
Cash paid for amounts included in the measurement of lease liabilities for the period ended June 30, 2020   $ 88,227  
         
Weighted average remaining lease term – operating leases (in years)     3. 6  
         
Average discount rate     3.6 %
XML 22 R11.htm IDEA: XBRL DOCUMENT v3.20.2
Stock Based Compensation
 6 Months Ended
Jun. 30, 2020
Share-based Payment Arrangement [Abstract]  
Stock Based Compensation

5. Stock Based Compensation

 

The Company has a 2000 Long-Term Incentive Plan, which expired on August 6, 2010. As of June 30, 2020, there were 1,521 shares subject to outstanding stock options under this plan. No further shares are available for future grant under this plan.

 

The Company also has a 2008 Stock Incentive Plan under which 5 million shares of common stock are reserved for issuance. As of June 30, 2020, there were approximately 2.3 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 2019, the Company adopted a 2019 Stock Incentive Plan under which 5.4 million shares of common stock are reserved for issuance. As of June 30, 2020, there were 5.4 million shares subject to outstanding stock options. This Plan expires on November 14, 2029.

 

The following table sets forth the total stock-based compensation expense resulting from stock options, restricted stock and warrants included in our Condensed Consolidated Statements of Operations:

 

    Three Months Ended June 30,     Six Months Ended June 30,  
    2020     2019     2020     2019  
Research and development   $ —     $ —     $       $ (2,672 )
General and administrative — employee     86,659       214,706       173,321       427,880  
Total employee stock-based compensation   $ 86,659     $ 214,706     $ 173,321     $ 425,208  

 

Options

 

There were no options granted in either periods ended June 30, 2020 and June 30, 2019.

 

Presented below is our stock option activity:

 

    Six Months Ended June 30, 2020  
    Number of Options (Employees)     Number of Options (Non-Employees)     Total Number of Options     Weighted-Average Exercise Price  
Outstanding at January 1, 2020     7,126,340       615,000       7,741,340     $ 3.32  
Granted     —       —       —       —  
Forfeited or expired     (3,570 )     —       (3,570 )   $ 32.76  
Outstanding at June 30, 2020     7,122,770       615,000       7,737,770     $ 3.31  
Exercisable at June 30, 2020     7,075,104       615,000       7,690,104     $ 3.32  

 

The following table summarizes significant ranges of outstanding stock options under our plans at June 30, 2020:

 

 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       5,400,000       9.46     $ 0.26       5,400,000       9.46     $ 0.26  
$ 1.01 – $3.00       1,050,673       7.11     $ 2.04       1,003,007       7.00     $ 2.04  
$ 3.01 – $15.00       852,360       4.47     $ 12.56       852,360       4.47     $ 12.56  
$ 15.01 –$42.42       434,737       3.44     $ 26.13       434,737       3.44     $ 26.13  
          7,737,770       8.25     $ 3.32       7,690,104       8.24     $ 3.32  

 

The Company recorded stock compensation costs related to vesting of options during the period of $30,392 and $60,787, respectively, for the three and six-month periods ended June 30, 2020, as compared to $75,410 and $148,146, respectively, for the three and six-month periods ended June 30, 2019. As of June 30, 2020, there remained approximately $0.1 million of unrecognized compensation expense related to unvested stock options granted to current employees, which we expect will be recognized over a weighted-average period of 0.31 years. The aggregate intrinsic value of the outstanding options and options vested as of June 30, 2020 was $2.3 million.

 

At June 30, 2020 and December 31, 2019, there were warrants outstanding to purchase 193,196, at a weighted-average exercise price of $8.60, in each period.

 

Restricted Stock

 

In December 2017, the Company granted to Steven Kriegsman, Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years. 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 $679,000. In December 2016, the Company granted to Steven Kriegsman, Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years. 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 $1,000,000. The Company recorded an employee stock-based compensation expense for restricted stock of $56,267 and $112,534 respectively, for the three and six-month periods ended June 30, 2020 as compared to $139,296 and $277,062 respectively, for the three and six-month periods ended June 30, 2019. As of June 30,2020, there remained approximately $110,000 of unrecognized compensation expense related to the vesting of these shares.
XML 23 R12.htm IDEA: XBRL DOCUMENT v3.20.2
Income Taxes
 6 Months Ended
Jun. 30, 2020
Income Tax Disclosure [Abstract]  
Income Taxes

6. Income Taxes

 

At December 31, 2019, we had federal and state net operating loss carryforwards of $321.8 million and $246.7 million, respectively, available to offset against future taxable income, which expire in 2024 through 2037, of which $249.1 million and $235.6 million, respectively, are not subject to limitation under Section 382 of the Internal Revenue Code.
XML 24 R13.htm IDEA: XBRL DOCUMENT v3.20.2
Commitments and Contingencies
 6 Months Ended
Jun. 30, 2020
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

7. Commitments and Contingencies

 

Commitments

 

Aldoxorubicin

 

We have an agreement with Vergell Medical (formerly with KTB) (“Vergell”) for the exclusive license of patent rights held by Vergell for the worldwide development and commercialization of aldoxorubicin. Under the agreement, we must make payments to Vergell in the aggregate of $7.5 million upon meeting clinical and regulatory milestones up to and including the product’s second final marketing approval. We also have agreed to pay:

 

  ● commercially reasonable royalties based on a percentage of net sales (as defined in the agreement);

 

  ● a percentage of 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.

 

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.

 

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.

 

Contingencies

 

We apply the disclosure provisions of ASC 460, Guarantees (“ASC 460”) to its agreements that contain guarantees or indemnities by the Company. We provide (i) indemnifications of varying scope and size to certain investors and other parties for certain losses suffered or incurred by the indemnified party in connection with various types of third-party claims; and (ii) indemnifications of varying scope and size to officers and directors against third party claims arising from the services they provide to the Company.

 

The Company evaluates developments in legal proceedings and other matters on a quarterly basis. The Company records accruals for loss contingencies to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated.

 

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 and will return to their offices at a yet to be determined date.
XML 25 R14.htm IDEA: XBRL DOCUMENT v3.20.2
Subsequent Event
 6 Months Ended
Jun. 30, 2020
Subsequent Events [Abstract]  
Subsequent Event

8. Subsequent Event

 

In August 2020, the Company’s Chief Executive Officer, certain Board members and an outside consultant exercised 4.4 million of their 2019 stock options on a cashless exercise basis, and were issued a total of approximately 2.7 million common shares of the Company.
XML 26 R15.htm IDEA: XBRL DOCUMENT v3.20.2
Summary of Significant Accounting Policies (Policies)
 6 Months Ended
Jun. 30, 2020
Accounting Policies [Abstract]  
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, 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.
Stock Compensation

Stock 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.
Foreign Currency Remeasurement

Foreign Currency Remeasurement

 

The U.S. dollar has been determined to be the functional currency for the net assets of our 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 gain (loss) of approximately ($5,400) and $100, respectively, for the three-month and six-month periods ended June 30, 2020 and a gain of approximately $8,200 and $6,500, respectively, for the three and six-month periods ended June 30, 2019, respectively.
Basic and Diluted Net Loss Per Common Share

Basic and Diluted Net Loss Per Common Share

 

Basic and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding. Common share equivalents that could potentially dilute net loss per share in the future, and which were excluded from the computation of diluted loss per share, totaled 7.9 million shares for each of the three-month and six-month periods ended June 30, 2020, and 2.6 million shares for each of the three-month and six-month periods ended June 30, 2019.
Fair Value Measurements

Fair Value Measurements

 

Assets and liabilities recorded at fair value on the 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.

 

We consider carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments. Our non-financial assets are measured at fair value when there is an indicator of impairment and recorded at fair value only when an impairment charge is recognized.
Recently Accounting Pronouncements

Recently 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 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 27 R16.htm IDEA: XBRL DOCUMENT v3.20.2
Discontinued Operations (Tables)
 6 Months Ended
Jun. 30, 2020
Discontinued Operations and Disposal Groups [Abstract]  
Schedule of Discontinued Operations

The results of these discontinued operations are presented separately on the Company’s Consolidated Statement of Operations.

 

    Three Months Ended June 30,     Six Months Ended June 30,  
    2020     2019     2020     2019  
Research and development   $ —     $ (1,940 )   $ —     $ (172,272 )
Loss on impairment of equipment and furnishings     —       —       —       7,100  
Employee stock option expense     —       —       —       (2,672 )
Gain on sale of assets held for sale     —       (138,976 )     —       (193,791 )
Other (income) loss     —       2,821       —       (17,077 )
Depreciation expense     —       —       —       —  
Income from discontinued operations   $ —     $ (138,095 )   $ —     $ (378,712 )
XML 28 R17.htm IDEA: XBRL DOCUMENT v3.20.2
Leases (Tables)
 6 Months Ended
Jun. 30, 2020
Leases [Abstract]  
Schedule of Future Minimum Lease Payments

Future minimum lease payments under non-cancelable operating leases under ASC 842 as of June 30, 2020 are as follows:

 

    Operating
Lease Payments		  
       
July 2020 – June 2021   $ 196,156  
July 2021 – June 2022     199,618  
July 2022 – June 2023     197,600  
July 2023 – June 2024     134,690  
Total future minimum lease payments     728,064  
         
Less: present value adjustment     46,280  
Operating lease liabilities at June 30, 2020     681,784  
Less: current portion of operating lease liabilities     174,772  
Operating lease liabilities, net of current portion   $ 507,012  
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:

 

    Period Ended
June 30, 2020		  
Lease Cost        
         
Operating lease cost (included in General and administrative expenses in the Company’s condensed Consolidated Statements of Operations)   $ 80,443  
         
Other information        
         
Cash paid for amounts included in the measurement of lease liabilities for the period ended June 30, 2020   $ 88,227  
         
Weighted average remaining lease term – operating leases (in years)     3. 6  
         
Average discount rate     3.6 %
XML 29 R18.htm IDEA: XBRL DOCUMENT v3.20.2
Stock Based Compensation (Tables)
 6 Months Ended
Jun. 30, 2020
Share-based Payment Arrangement [Abstract]  
Schedule of Stock-based Compensation Expense

The following table sets forth the total stock-based compensation expense resulting from stock options, restricted stock and warrants included in our Condensed Consolidated Statements of Operations:

 

    Three Months Ended June 30,     Six Months Ended June 30,  
    2020     2019     2020     2019  
Research and development   $ —     $ —     $       $ (2,672 )
General and administrative — employee     86,659       214,706       173,321       427,880  
Total employee stock-based compensation   $ 86,659     $ 214,706     $ 173,321     $ 425,208  
Schedule of Share-based Compensation, Stock Options, Activity

Presented below is our stock option activity:

 

    Six Months Ended June 30, 2020  
    Number of Options (Employees)     Number of Options (Non-Employees)     Total Number of Options     Weighted-Average Exercise Price  
Outstanding at January 1, 2020     7,126,340       615,000       7,741,340     $ 3.32  
Granted     —       —       —       —  
Forfeited or expired     (3,570 )     —       (3,570 )   $ 32.76  
Outstanding at June 30, 2020     7,122,770       615,000       7,737,770     $ 3.31  
Exercisable at June 30, 2020     7,075,104       615,000       7,690,104     $ 3.32  
Schedule of Ranges of Stock Options

The following table summarizes significant ranges of outstanding stock options under our plans at June 30, 2020:

 

 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       5,400,000       9.46     $ 0.26       5,400,000       9.46     $ 0.26  
$ 1.01 – $3.00       1,050,673       7.11     $ 2.04       1,003,007       7.00     $ 2.04  
$ 3.01 – $15.00       852,360       4.47     $ 12.56       852,360       4.47     $ 12.56  
$ 15.01 –$42.42       434,737       3.44     $ 26.13       434,737       3.44     $ 26.13  
          7,737,770       8.25     $ 3.32       7,690,104       8.24     $ 3.32  
XML 30 R19.htm IDEA: XBRL DOCUMENT v3.20.2
Description of Company and Basis of Presentation (Details Narrative) - USD ($)
 6 Months Ended 12 Months Ended
Jul. 27, 2017
Jun. 30, 2020
Dec. 31, 2011
Dec. 31, 2019
Jun. 01, 2018
Percentage of service charge         5.00%
Cash investment $ 13,000,000        
Investment in common stock per share $ 6.60        
Common stock market price premium percentage 92.00%        
Number of warrants issued to purchase shares of common stock 500,000 193,196   193,196  
Warrants exercise price per share $ 6.60 $ 8.60   $ 8.60  
Warrant expiration Jan. 26, 2019        
Fee contingent payments entitled to be received under license agreement $ 343,000,000        
Cash and cash equivalents   $ 14,587,401   $ 16,130,410  
Reminder 2020 and First Seven Months of 2021 [Member]          
Currently projected expenditures   5,900,000      
Japan [Member]          
Payments for milestone   2,000,000      
FDA [Member]          
Payments for milestone   6,000,000      
EMA [Member]          
Payments for milestone   $ 4,000,000      
Orphazyme A/S [Member]          
Fee contingent payments entitled to be received under license agreement     $ 120,000,000    
XML 31 R20.htm IDEA: XBRL DOCUMENT v3.20.2
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
 3 Months Ended 6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Accounting Policies [Abstract]        
Foreign currency remeasurement gain (loss) $ (5,400) $ 8,200 $ 100 $ 6,500
Potentially dilutive shares excluded from computation of diluted net income (loss) 7,900,000 2,600,000 7,900,000 2,600,000
XML 32 R21.htm IDEA: XBRL DOCUMENT v3.20.2
Discontinued Operations (Details Narrative) - USD ($)
 1 Months Ended
Jun. 30, 2019
Apr. 30, 2019
Dec. 31, 2018
Analytical Equipment [Member]      
Assets written down value $ 7,000    
Office Furniture and Leasehold Improvements [Member]      
Proceeds from sale of analytical equipment   $ 300,000  
Net book value $ 0   $ 400,000
XML 33 R22.htm IDEA: XBRL DOCUMENT v3.20.2
Discontinued Operations - Schedule of Discontinued Operations (Details) - USD ($)
 3 Months Ended 6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Discontinued Operations and Disposal Groups [Abstract]        
Research and development $ (1,940) $ (172,272)
Loss on impairment of equipment and furnishings 7,100
Employee stock option expense (2,672)
Gain on sale of assets held for sale (138,976) (193,791)
Other income 2,821 (17,077)
Depreciation expense
Income from discontinued operations $ (138,095) $ (378,712)
XML 34 R23.htm IDEA: XBRL DOCUMENT v3.20.2
Leases (Details Narrative)
 1 Months Ended
Feb. 29, 2020
USD ($)
Jan. 31, 2020
USD ($)
ft²
Jun. 30, 2020
USD ($)
Dec. 31, 2019
USD ($)
Leases [Abstract]        
Area of land | ft²   2,771    
Lease term   4 years    
Lease expiration date   Feb. 29, 2024    
Lease extend description   Right to extend the term for an additional five-year period, subject to the terms and conditions set forth in the lease agreement    
Payments of rent $ 1,370 $ 13,855    
Annual percentage increased in monthly rent 2.50% 3.50%    
Right of use asset upon inception of leases     $ 715,310  
Lease liability upon inception of leases     715,310  
Previous existing right-of-use asset     66,271  
Right of use asset     669,666
Lease liability     $ 681,784  
XML 35 R24.htm IDEA: XBRL DOCUMENT v3.20.2
Leases - Schedule of Future Minimum Lease Payments (Details) - USD ($)
Jun. 30, 2020
Dec. 31, 2019
Leases [Abstract]    
July 2020 - June 2021 $ 196,156  
July 2021 - June 2022 199,618  
July 2022 - June 2023 197,600  
July 2023 - June 2024 134,690  
Total future minimum lease payments 728,064  
Less: present value adjustment 46,280  
Operating lease liabilities at June 30, 2020 681,784  
Less: current portion of operating lease liabilities 174,772 $ 69,576
Operating lease liabilities, net of current portion $ 507,012
XML 36 R25.htm IDEA: XBRL DOCUMENT v3.20.2
Leases - Schedule of Rent Expense and Supplemental Cash Flow Information Related to Leases (Details)
 6 Months Ended
Jun. 30, 2020
USD ($)
Leases [Abstract]  
Operating lease cost (included in General and administrative expenses in the Company's condensed Consolidated Statements of Operations) $ 80,443
Cash paid for amounts included in the measurement of lease liabilities for the period ended June 30, 2020 $ 88,227
Weighted average remaining lease term - operating leases (in years) 3 years 7 months 6 days
Average discount rate 3.60%
XML 37 R26.htm IDEA: XBRL DOCUMENT v3.20.2
Stock Based Compensation (Details Narrative) - USD ($)
 1 Months Ended 3 Months Ended 6 Months Ended 12 Months Ended
Dec. 31, 2017
Dec. 31, 2016
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Dec. 31, 2019
Jul. 27, 2017
Stock option issuance expense     $ 30,392 $ 75,410 $ 60,787 $ 148,146    
Unrecognized compensation expense related to unvested stock options, granted     100,000   $ 100,000      
Unrecognized compensation cost, recognized as expense over a weighted-average period         3 months 22 days      
Aggregate intrinsic value of outstanding options and vested options     $ 2,300,000   $ 2,300,000      
Warrants to purchase shares     193,196   193,196   193,196 500,000
Warrants exercise price per share     $ 8.60   $ 8.60   $ 8.60 $ 6.60
Restricted Stock [Member]                
Stock option issuance expense     $ 56,267 $ 139,296 $ 112,534 $ 277,062    
Unrecognized compensation expense related to unvested stock options, granted     $ 110,000   $ 110,000      
Restricted Stock [Member] | Steven Kriegsman [Member]                
Number of restricted shares granted 387,597 387,597            
Vested period 3 years 3 years            
Fair value of restricted stock $ 679,000 $ 1,000,000            
2000 Long Term Incentive Plan [Member]                
Share-based compensation, outstanding stock options     1,521   1,521      
2008 Stock Incentive Plan [Member]                
Number of common stock reserved for future issuance     5,000,000   5,000,000      
Share-based compensation, shares subject to stock options     2,300,000   2,300,000      
Expiration date         Nov. 20, 2018      
2008 Stock Incentive Plan [Member] | Restricted Stock [Member]                
Share-based compensation, shares subject to stock options     800,000   800,000      
2019 Stock Incentive Plan [Member]                
Number of common stock reserved for future issuance             5,400,000  
Share-based compensation, shares subject to stock options     5,400,000   5,400,000      
Expiration date             Nov. 14, 2029  
XML 38 R27.htm IDEA: XBRL DOCUMENT v3.20.2
Stock Based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($)
 3 Months Ended 6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Allocated employee and non-employee stock-based compensation expense, Total $ 86,659 $ 214,706 $ 173,321 $ 425,208
Research and Development [Member]        
Allocated employee and non-employee stock-based compensation expense, Total (2,672)
General and Administrative Expense [Member]        
Allocated employee and non-employee stock-based compensation expense, Total $ 86,659 $ 214,706 $ 173,321 $ 427,880
XML 39 R28.htm IDEA: XBRL DOCUMENT v3.20.2
Stock Based Compensation - Schedule of Share-based Compensation, Stock Options, Activity (Details) - Stock Options [Member]
 6 Months Ended
Jun. 30, 2020
$ / shares
shares
Number of Options, Outstanding at beginning of period 7,741,340
Number of Options, Granted
Number of Options, Forfeited or expired (3,570)
Number of Options, Outstanding at end of period 7,737,770
Number of Options, Exercisable at end of period 7,690,104
Weighted-Average Exercise Price Options, Outstanding at beginning of period | $ / shares $ 3.32
Weighted-Average Exercise Price Options, Granted | $ / shares
Weighted-Average Exercise Price Options, Forfeited or expired | $ / shares 32.76
Weighted-Average Exercise Price Options, Outstanding at end of period | $ / shares 3.31
Weighted-Average Exercise Price Options, Exercisable at end of period | $ / shares $ 3.32
Employees [Member]  
Number of Options, Outstanding at beginning of period 7,126,340
Number of Options, Granted
Number of Options, Forfeited or expired (3,570)
Number of Options, Outstanding at end of period 7,122,770
Number of Options, Exercisable at end of period 7,075,104
Non Employees [Member]  
Number of Options, Outstanding at beginning of period 615,000
Number of Options, Granted
Number of Options, Forfeited or expired
Number of Options, Outstanding at end of period 615,000
Number of Options, Exercisable at end of period 615,000
XML 40 R29.htm IDEA: XBRL DOCUMENT v3.20.2
Stock Based Compensation - Schedule of Ranges of Stock Options (Details)
 6 Months Ended
Jun. 30, 2020
$ / shares
shares
Number of Options Outstanding | shares 7,737,770
Weighted-Average Remaining Contractual Life (years) 8 years 2 months 30 days
Weighted-Average Exercise Price $ 3.32
Number of Options Exercisable | shares 7,690,104
Weighted-Average Remaining Contractual Life (years) 8 years 2 months 27 days
Weighted-Average Exercise Price, Options Exercisable $ 3.32
Stock Options [Member] | Exercise Price Range One [Member]  
Range of Exercise Prices, Lower Range 0.26
Range of Exercise Prices, Upper Range $ 1.00
Number of Options Outstanding | shares 5,400,000
Weighted-Average Remaining Contractual Life (years) 9 years 5 months 16 days
Weighted-Average Exercise Price $ 0.26
Number of Options Exercisable | shares 5,400,000
Weighted-Average Remaining Contractual Life (years) 9 years 5 months 16 days
Weighted-Average Exercise Price, Options Exercisable $ 0.26
Stock Options [Member] | Exercise Price Range Two [Member]  
Range of Exercise Prices, Lower Range 1.01
Range of Exercise Prices, Upper Range $ 3.00
Number of Options Outstanding | shares 1,050,673
Weighted-Average Remaining Contractual Life (years) 7 years 1 month 9 days
Weighted-Average Exercise Price $ 2.04
Number of Options Exercisable | shares 1,003,007
Weighted-Average Remaining Contractual Life (years) 7 years
Weighted-Average Exercise Price, Options Exercisable $ 2.04
Stock Options [Member] | Exercise Price Range Three [Member]  
Range of Exercise Prices, Lower Range 3.01
Range of Exercise Prices, Upper Range $ 15.00
Number of Options Outstanding | shares 852,360
Weighted-Average Remaining Contractual Life (years) 4 years 5 months 20 days
Weighted-Average Exercise Price $ 12.56
Number of Options Exercisable | shares 852,360
Weighted-Average Remaining Contractual Life (years) 4 years 5 months 20 days
Weighted-Average Exercise Price, Options Exercisable $ 12.56
Stock Options [Member] | Exercise Price Range Four [Member]  
Range of Exercise Prices, Lower Range 15.01
Range of Exercise Prices, Upper Range $ 42.42
Number of Options Outstanding | shares 434,737
Weighted-Average Remaining Contractual Life (years) 3 years 5 months 9 days
Weighted-Average Exercise Price $ 26.13
Number of Options Exercisable | shares 434,737
Weighted-Average Remaining Contractual Life (years) 3 years 5 months 9 days
Weighted-Average Exercise Price, Options Exercisable $ 26.13
XML 41 R30.htm IDEA: XBRL DOCUMENT v3.20.2
Income Taxes (Details Narrative)
 12 Months Ended
Dec. 31, 2019
USD ($)
Earliest Tax Year [Member]  
Expiration date Dec. 31, 2024
Latest Tax Year [Member]  
Expiration date Dec. 31, 2037
Federal [Member]  
Operating loss carryforwards $ 321,800,000
Operating loss carryforwards, not subject to limitation 249,100,000
State [Member]  
Operating loss carryforwards 246,700,000
Operating loss carryforwards, not subject to limitation $ 235,600,000
XML 42 R31.htm IDEA: XBRL DOCUMENT v3.20.2
Commitments and Contingencies (Details Narrative) - USD ($)
Jun. 30, 2020
Dec. 31, 2019
Issuance of common stock value $ 33,637 $ 33,637
Aldoxorubicin [Member]    
Amount of milestone payment payable 7,500,000  
Potential future milestone payments on each additional final marketing approval 1,000,000  
Arimoclomol [Member]    
Amount of milestone payment payable 3,650,000  
Innovivel [Member]    
Issuance of common stock value $ 18,300,000  
XML 43 R32.htm IDEA: XBRL DOCUMENT v3.20.2
Subsequent Event (Details Narrative) - Subsequent Event [Member] - 2019 Stock Options [Member]
 1 Months Ended
Aug. 31, 2020
shares
Number of stock options exercised 4,400,000
Issuance of common shares stock option exercised 2,700,000
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