0001493152-21-011185.txt : 20210513 0001493152-21-011185.hdr.sgml : 20210513 20210513061545 ACCESSION NUMBER: 0001493152-21-011185 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 42 CONFORMED PERIOD OF REPORT: 20210331 FILED AS OF DATE: 20210513 DATE AS OF CHANGE: 20210513 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: 21917077 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 March 31, 2021

 

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 May 13, 2021: 36,480,038 shares.

 

 

 

 
 

 

CYTRX CORPORATION

 

FORM 10-Q

 

TABLE OF CONTENTS

 

    Page
PART I. — FINANCIAL INFORMATION  
Item 1. Consolidated Financial Statements (unaudited) 4
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 15
Item 3. Quantitative and Qualitative Disclosures About Market Risk 19
Item 4. Controls and Procedures 19
   
PART II. — OTHER INFORMATION  
Item 1. Legal Proceedings 19
Item 1A Risk Factors 19
Item 2 Unregistered Sales of Equity Securities and Use of Proceeds 19
Item 6. Exhibits 19
   
SIGNATURES   20
     
INDEX TO EXHIBITS 21

 

2
 

 

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, 2020, 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.

 

Note Regarding Company References

 

References throughout this Quarterly Report on Form 10-Q, the “Company”, “CytRx”, “we”, “us”, and “our”, except where the context requires otherwise, refer to CytRx Corporation and its subsidiary.

 

3
 

 

PART I — FINANCIAL INFORMATION

 

Item 1. — Consolidated Financial Statements

 

CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS

   March 31, 2021   December 31, 2020 
   (Unaudited)      
ASSETS          
Current assets:          
Cash and cash equivalents  $9,322,529   $10,003,375 
Insurance claim receivable       325,105 
Prepaid expenses and other current assets   710,477    1,094,675 
Total current assets   10,033,006    11,423,155 
Equipment and furnishings, net   36,455    39,758 
Other assets   16,836    16,836 
Operating lease right-of-use assets   535,263    580,478 
Total assets  $10,621,560   $12,060,227 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $1,218,156   $1,402,054 
Accrued expenses and other current liabilities   1,259,328    1,190,910 
Current portion of operating lease liabilities   184,329    181,103 
Total current liabilities   2,661,813    2,774,067 
           
Operating lease liabilities, net of current portion   368,090    415,200 
           
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; 36,480,038 shares issued and outstanding at March 31, 2021 and December 31, 2020   36,480    36,480 
Additional paid-in capital   479,561,860    479,561,860 
Accumulated deficit   (472,006,683)   (470,727,380)
Total stockholders’ equity   7,591,657    8,870,960 
Total liabilities and stockholders’ equity  $10,621,560   $12,060,227 

 

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

 

4
 

 

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

  

Three Months Ended

March 31,

 
   2021   2020 
Revenue:          
License revenue  $   $ 
           
Expenses:          
General and administrative   1,279,848    1,226,305 
           
Loss from operations   (1,279,848)   (1,226,305)
           
Other income (expense):          
Interest income   4,836    54,821 
Other (expense), net   (4,291)   (1,302)
           
Net loss  $(1,279,303)  $(1,172,786)
           
Total basic and diluted loss per share  $(0.04)  $(0.03)
           
Basic and diluted weighted-average shares outstanding   36,480,038    33,508,302 

 

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

 

5
 

 

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Three Months Ended March 31, 
   2021   2020 
Cash flows from operating activities:          
Net loss from operations  $(1,279,303)  $(1,172,786)
Adjustments to reconcile net loss from operations to net cash used in operating activities:          
Depreciation and amortization   3,303    6,500 
Stock-based compensation expense       86,662 
Changes in assets and liabilities:          
Insurance claim Receivable   325,105    (95,774)
Prepaid expenses and other current assets   384,202    381,532 
Other assets       (14,125)
Amortization of right-of-use asset   45,215    62,443 
Accounts payable   (183,898)   (4,959)
Decrease in lease liabilities   (43,884)   (65,008)
Accrued expenses and other current liabilities   68,414    (9,471)
Net cash used in operating activities   (680,846)   (1,593,319)
           
Cash flows from investing activities:          
Purchase of fixed assets       (7,981)
Net cash used in investing activities       (7,981)
           
Net decrease in cash and cash equivalents   (680,846)   (832,967)
Cash and cash equivalents at beginning of period   10,003,375    16,130,410 
Cash and cash equivalents at end of period  $9,322,529   $15,297,442 
           
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 
           
Fixed assets acquired through issuance of notes payable  $   $17,374 

 

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

 

6
 

 

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY

(Unaudited)

 

   For the Three Month Period Ended March 31, 2021         
                             
   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, 2021       36,480,038             $36,480   $479,561,860   $(470,727,380)  $8,870,960 
Net loss                           (1,279,303)   (1,279,303)
Balance at March 31, 2021       36,480,038       $36,480   $479,561,860   $(472,006,683)  $7,591,657 

 

   For the Three Month Period Ended March 31, 2020         
   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 

 

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

 

7
 

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

 

For the Three-Months Period Ended March 31, 2021 and 2020
(Unaudited)

 

1. Basis of Presentation and Significant Accounting Policies

 

Basis of Presentation and Principles of Consolidation

 

The accompanying condensed consolidated financial statements at March 31, 2021 and for the three-month periods ended March 31, 2021 and 2020, 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, 2020 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, 2020.

 

Liquidity and Capital Resources

 

At March 31, 2021, we had cash and cash equivalents of approximately $9.3 million. Management believes that our current cash and cash equivalents 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 2021 and the first four months of 2022 of approximately $5.6 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.

 

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.

 

8
 

 

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). We recognized a loss of approximately ($13,070) and ($5,395) respectively, for the three-month periods ended March 31, 2021 and 2020.

 

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 (which consist of options, warrants and restricted stock) are excluded from the computation of diluted net loss per common share where the effect would be anti-dilutive. 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 3.2 million shares for the three-month period ended March 31, 2021 as compared to 7.9 million shares for the three-month period ended March 31, 2020.

 

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 Issued 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.

 

2. 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.

 

9
 

 

As of March 31, 2021, the balance of right-of-use assets was approximately $535,000, and the balance of total lease liabilities was approximately $552,000.

 

Future minimum lease payments under non-cancelable operating leases under ASC 842 as of March 31, 2021 are as follows:

 

   Operating
Lease Payments
 
      
April 2021 – March 2022  $200,852 
April 2022 – March 2023   195,936 
April 2023 – March 2024   185,200 
Total future minimum lease payments   581,988 
      
Less: present value adjustment   29,569 
Operating lease liabilities at March 31, 2021   552,419 
Less: current portion of operating lease liabilities   184,329 
Operating lease liabilities, net of current portion  $368,090

 

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

 

   Period Ended
March 31, 2021
 
Lease Cost     
      
Operating lease cost (included in General and administrative expenses in the Company’s condensed Consolidated Statements of Operations)  $49,039 
      
Other information     
      
Cash paid for amounts included in the measurement of lease liabilities for the period ended March 31, 2021  $47,061 
      
Weighted average remaining lease term – operating leases (in years)   2.9 
      
Average discount rate   3.6%

 

3. Stock Based Compensation

 

The Company has a 2008 Stock Incentive Plan under which 5 million shares of common stock are reserved for issuance. As of March 31, 2021, 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 November 2019, the Company adopted a 2019 Stock Incentive Plan under which 5.4 million shares of common stock are reserved for issuance. As of March 31, 2021, there were 0.9 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 March 31, 
   2021   2020 
General and administrative — employee       86,662 
Total employee stock-based compensation  $   $86,662 

 

10
 

 

Options

 

   Stock Options   Weighted Average Exercise Price 
   2021   2021 
Outstanding — beginning of year   3,166,270   $7.43 
Granted        
Exercised        
Forfeited        
Expired        
Outstanding — end of year   3,166,270    7.43 
Exercisable at end of year   3,166,270   $7.43 
Weighted average fair value of stock options granted during the year:  $      

 

The following table summarizes significant ranges of outstanding stock options under our plans at March 31, 2021:

 


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    850,000    8.71   $0.26    850,000    8.71   $0.26 
$1.01 – $3.00    1,050,673    6.36   $2.04    1,050,673    6.36   $2.04 
$3.01 – $15.00    852,360    3.72   $12.56    852,360    3.72   $12.56 
$15.01 –$42.42    413,237    2.85   $25.29    413,237    2.85   $25.29 
      3,166,270    5.82   $7.43    3,166,270    5.82   $7.43 

 

During the period ended March 31, 2021, the Company recognized no stock compensation cost as all options had previously vested and during the period ended March 31, 2020 the Company recognized $30,395 relating to the vesting of these options. At March 31, 2021, there was no unrecognized compensation expense related to unvested stock options.

 

The aggregate intrinsic value of the outstanding options and options vested as of March 31, 2021 was $3.1 million.

 

At December 31, 2020, the Company had 193,196 warrants outstanding at a weighted average exercise price of $8.60. During 2021, 189,029 warrants expired, and as such, there were 4,167 remaining warrants outstanding as of March 31, 2021 at a weighted average exercise price of $10.44. At March 31, 2021, the 4,167 warrants outstanding had no intrinsic value.

 

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 stock-based compensation expense for restricted stock of $56,267 for the quarter ended March 31, 2020. All shares had fully vested as of December 31, 2020. No restricted stock was granted in 2021 nor 2020.

 

4. Stockholder Protection Rights Plan

 

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

 

11
 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

12
 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

5. Income Taxes

 

At December 31, 2020, we had federal and state net operating loss carryforwards of $327.6 million and $252.6 million, respectively, available to offset against future taxable income. Of this amount, $310.3 million of federal NOLs expire in 2024 through 2037. The federal operating losses from 2018, 2019 and 2020 totaling $17.0 million carry forward indefinitely but are only able to offset 80% of taxable income in future years. The California NOLs expire in 2029 through 2039. Management currently believes that $258.3 million in federal net operating loss carryforwards and $252.6 million in state net operating loss carryforwards are unrestricted.

 

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6. Commitments and Contingencies

 

Commitments

 

Aldoxorubicin

 

We have an agreement with Vergell Medical (“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 remotely and will return to their offices at a yet to be determined date.

 

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

 

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.

 

On June 1, 2018, CytRx launched Centurion BioPharma Corporation (“Centurion”), a private wholly owned 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.

 

15
 

 

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 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 agreement with ImmunityBio, Inc. (formerly known as NantCell, Inc. (“ImmunityBio”)), granting to ImmunityBio the exclusive rights to develop, manufacture and commercialize aldoxorubicin in all indications. As a result, the Company is no longer directly working on the development of aldoxorubicin (ImmunityBio has recently merged with NantKwest, Inc.). As part of the license agreement, 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 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.

 

Aldoxorubicin is a conjugate of the commonly prescribed cytotoxin agent doxorubicin that binds to circulating albumin in the bloodstream and is believed to concentrate the drug at the site of the tumor. Aldoxorubicin has been tested in over 600 patients with various types of cancer. Specifically, it is comprised of (6-maleimidocaproyl) hydrazine, an acid-sensitive molecule that is conjugated to doxorubicin. The initial indication for aldoxorubicin is for patients with advanced soft tissue sarcomas (STS). ImmunityBio lists a randomized Phase 2 and a randomized Phase 3 study, as well as an aldoxorubicin and ifosfamide Phase 1/2 study in its solid tumor platform and is currently reviewing options in STS.

 

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

 

In addition to STS, ImmunityBio has expanded aldoxorubicin’s use by combining it with immunotherapies and cell-based treatments and is currently in late-stage clinical development in advanced and metastatic pancreatic cancer, in glioblastoma, and in triple negative breast cancer. ImmunityBio has initiated a phase 2 registrational-intent study in metastatic pancreatic cancer.

 

Molecular Chaperone Assets (Orphazyme)

 

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. As a result of Orphazyme’s disclosure that the pivotal phase 3 clinical trial for arimoclomol in Amyotrophic Lateral Sclerosis did not meet its primary and secondary endpoints, the maximum amount that CytRx has the right to receive is now approximately $100 million; however, there can be no assurance that said amount will be realized. Orphazyme is testing arimoclomol in Niemann-Pick disease Type C (NPC) and Gaucher disease. Orphazyme has highlighted positive Phase 2/3 clinical trial data in patients with NPC and has submitted a New Drug Application (NDA) with the FDA, which is currently under Priority Review by the FDA with a target action date of June 17, 2021. It also submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA). Orphazyme has established an Early Access Program in the U.S. as well as other select European countries. Orphazyme has also received FDA Breakthrough Therapy Designation for arimoclomol for NPC. Orphayzme recently announced its intention that arimoclomol will be marketed globally under the tradename MIPLYFFA™.

 

16
 

 

Current Business Strategy for LADRPlatform

 

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. The Company has no plans to conduct further research and development on LADR and its companion diagnostic, but continue to focus on identifying these partnership and financing opportunities

 

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.

 

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, 2020. 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.

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 (which consist of options, warrants and restricted stock) are excluded from the computation of diluted net loss per common share where the effect would be anti-dilutive. 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 3.2 million shares for the three-month period ended March 31, 2021 as compared to 7.9 million shares for the three-month period ended March 31, 2020.

 

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 March 31, 2021, we had cash and cash equivalents of approximately $9.3 million. Management believes that our current cash and cash equivalents 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 2021 and the first four months of 2022 of approximately $5.6 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, the Company 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.

 

17
 

 

recorded a net loss in the three-month period ended March 31, 2021 of $1.3 million as compared to a net loss in the comparative 2020 period from continuing operations of $1.2 million, or an increase of $0.1 million.

 

We purchased no fixed assets in the period ended March 31, 2021 and a minimal amount of fixed assets in the period ended March 31, 2020 and do not expect any significant capital spending during the next 12 months.

 

There were no financing transactions in either three month-periods ended March 31, 2021 or March 31, 2020.

 

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 million for the three-month period ended March 31, 2021, as compared to a net loss for the three-month period ended March 31, 2020 of $1.2 million.

 

We recognized no licensing revenue in the three-month periods ended March 31, 2021 and 2020. All future licensing fees under our current licensing agreements are dependent upon successful development milestones being achieved by the licensor.

 

General and Administrative Expenses

 

  

Three-Month Period Ended

March 31,

 
   2021   2020 
   (In thousands) 
General and administrative expenses  $1,277   $1,133 
Employee stock, and stock option expense       87 
Depreciation and amortization   3    6 
   $1,280   $1,226 

 

General and administrative expenses include all administrative salaries and general corporate expenses, including legal expenses. Our general and administrative expenses, excluding stock option expense, non-cash expenses and depreciation and amortization, were $1.3 million for the three-month period ended March 31, 2021, and $1.2 million for the same period in 2020. Our general and administrative expenses in the current three-month period, excluding stock option expense, non-cash expenses and depreciation and amortization, increased marginally by approximately $0.1 million, primarily due to an increase in professional fees and insurance, offset by a reduction in head count.

 

Depreciation and Amortization

 

Depreciation expense reflects the depreciation of our equipment and furnishings.

 

18
 

 

Interest Income and Expense

 

Interest income was approximately $5,000 for the three-month period ended March 31, 2021 as compared to approximately $55,000 for the same period in 2020.

 

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 March 31, 2021, 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 March 31, 2021 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, 2020 (the “Form 10-K”), which was filed with the SEC on March 24, 2021. 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 6. — Exhibits

 

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

 

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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: May 13, 2021 By: /s/ JOHN Y. CALOZ
    John Y. Caloz
    Chief Financial Officer

 

20
 

 

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

 

21

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: May 13, 2021 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: May 13, 2021 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 March 31, 2021 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: May 13, 2021 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 March 31, 2021 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: May 13, 2021 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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The standard will replace today&#8217;s &#8220;incurred loss&#8221; approach with an &#8220;expected loss&#8221; model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the standard&#8217;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. 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Document and Entity Information - shares
3 Months Ended
Mar. 31, 2021
May 13, 2021
Cover [Abstract]    
Entity Registrant Name CYTRX CORP  
Entity Central Index Key 0000799698  
Document Type 10-Q  
Document Period End Date Mar. 31, 2021  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Reporting Status Current Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business Flag true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   36,480,038
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2021  
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Condensed Consolidated Balance Sheets - USD ($)
Mar. 31, 2021
Dec. 31, 2020
Current assets:    
Cash and cash equivalents $ 9,322,529 $ 10,003,375
Insurance claim receivable 325,105
Prepaid expenses and other current assets 710,477 1,094,675
Total current assets 10,033,006 11,423,155
Equipment and furnishings, net 36,455 39,758
Other assets 16,836 16,836
Operating lease right-of-use assets 535,263 580,478
Total assets 10,621,560 12,060,227
Current liabilities:    
Accounts payable 1,218,156 1,402,054
Accrued expenses and other current liabilities 1,259,328 1,190,910
Current portion of operating lease liabilities 184,329 181,103
Total current liabilities 2,661,813 2,774,067
Operating lease liabilities, net of current portion 368,090 415,200
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; 36,480,038 shares issued and outstanding at March 31, 2021 and December 31, 2020 36,480 36,480
Additional paid-in capital 479,561,860 479,561,860
Accumulated deficit (472,006,683) (470,727,380)
Total stockholders' equity 7,591,657 8,870,960
Total liabilities and stockholders' equity $ 10,621,560 $ 12,060,227
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Mar. 31, 2021
Dec. 31, 2020
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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 36,480,038 36,480,038
Common stock, shares outstanding 36,480,038 36,480,038
Series B Junior Participating Preferred Stock [Member]    
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Preferred stock, shares issued
Preferred stock, shares outstanding
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Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Revenue:    
License revenue
Expenses:    
General and administrative 1,279,848 1,226,305
Loss from operations (1,279,848) (1,226,305)
Other income (expense):    
Interest income 4,836 54,821
Other (expense), net (4,291) (1,302)
Net loss $ (1,279,303) $ (1,172,786)
Total basic and diluted loss per share $ (0.04) $ (0.03)
Basic and diluted weighted-average shares outstanding 36,480,038 33,508,302
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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Cash flows from operating activities:    
Net loss from operations $ (1,279,303) $ (1,172,786)
Adjustments to reconcile net loss from operations to net cash used in operating activities:    
Depreciation and amortization 3,303 6,500
Stock-based compensation expense 86,662
Changes in assets and liabilities:    
Insurance claim Receivable 325,105 (95,774)
Prepaid expenses and other current assets 384,202 381,532
Other assets (14,125)
Amortization of right-of-use asset 45,215 62,443
Accounts payable (183,898) (4,959)
Decrease in lease liabilities (43,884) (65,008)
Accrued expenses and other current liabilities 68,414 (9,471)
Net cash used in operating activities (680,846) (1,593,319)
Cash flows from investing activities:    
Purchase of fixed assets (7,981)
Net cash used in investing activities (7,981)
Net decrease in cash and cash equivalents (680,846) (832,967)
Cash and cash equivalents at beginning of period 10,003,375 16,130,410
Cash and cash equivalents at end of period 9,322,529 15,297,442
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
Fixed assets acquired through issuance of notes payable $ 17,374
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Condensed Consolidated Statements of Stockholders Equity (Unaudited) - USD ($)
Series B Preferred Stock [Member]
Common Stock [Member]
Preferred Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Deficit [Member]
Total
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, 2020 $ 36,480 479,561,860 (470,727,380) 8,870,960
Balance, shares at Dec. 31, 2020 36,480,038      
Net loss (1,279,303) (1,279,303)
Balance at Mar. 31, 2021 $ 36,480 $ 479,561,860 $ (472,006,683) $ 7,591,657
Balance, shares at Mar. 31, 2021 36,480,038      
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Basis of Presentation and Significant Accounting Policies
3 Months Ended
Mar. 31, 2021
Accounting Policies [Abstract]  
Basis of Presentation and Significant Accounting Policies
1. Basis of Presentation and Significant Accounting Policies

 

Basis of Presentation and Principles of Consolidation

 

The accompanying condensed consolidated financial statements at March 31, 2021 and for the three-month periods ended March 31, 2021 and 2020, 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, 2020 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, 2020.

 

Liquidity and Capital Resources

 

At March 31, 2021, we had cash and cash equivalents of approximately $9.3 million. Management believes that our current cash and cash equivalents 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 2021 and the first four months of 2022 of approximately $5.6 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.

 

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). We recognized a loss of approximately ($13,070) and ($5,395) respectively, for the three-month periods ended March 31, 2021 and 2020.

 

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 (which consist of options, warrants and restricted stock) are excluded from the computation of diluted net loss per common share where the effect would be anti-dilutive. 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 3.2 million shares for the three-month period ended March 31, 2021 as compared to 7.9 million shares for the three-month period ended March 31, 2020.

 

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 Issued 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.

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Leases
3 Months Ended
Mar. 31, 2021
Leases [Abstract]  
Leases
2. 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.

  

As of March 31, 2021, the balance of right-of-use assets was approximately $535,000, and the balance of total lease liabilities was approximately $552,000.

 

Future minimum lease payments under non-cancelable operating leases under ASC 842 as of March 31, 2021 are as follows:

 

    Operating
Lease Payments
 
         
April 2021 – March 2022   $ 200,852  
April 2022 – March 2023     195,936  
April 2023 – March 2024     185,200  
Total future minimum lease payments     581,988  
         
Less: present value adjustment     29,569  
Operating lease liabilities at March 31, 2021     552,419  
Less: current portion of operating lease liabilities     184,329  
Operating lease liabilities, net of current portion   $ 368,090  

 

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

 

    Period Ended
March 31, 2021
 
Lease Cost        
         
Operating lease cost (included in General and administrative expenses in the Company’s condensed Consolidated Statements of Operations)   $ 49,039  
         
Other information        
         
Cash paid for amounts included in the measurement of lease liabilities for the period ended March 31, 2021   $ 47,061  
         
Weighted average remaining lease term – operating leases (in years)     2.9  
         
Average discount rate     3.6 %

XML 20 R9.htm IDEA: XBRL DOCUMENT v3.21.1
Stock Based Compensation
3 Months Ended
Mar. 31, 2021
Equity [Abstract]  
Stock Based Compensation
3. Stock Based Compensation

 

The Company has a 2008 Stock Incentive Plan under which 5 million shares of common stock are reserved for issuance. As of March 31, 2021, 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 November 2019, the Company adopted a 2019 Stock Incentive Plan under which 5.4 million shares of common stock are reserved for issuance. As of March 31, 2021, there were 0.9 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 March 31,  
    2021     2020  
General and administrative — employee           86,662  
Total employee stock-based compensation   $     $ 86,662  

  

Options

 

    Stock Options     Weighted Average Exercise Price  
    2021     2021  
Outstanding — beginning of year     3,166,270     $ 7.43  
Granted            
Exercised            
Forfeited            
Expired            
Outstanding — end of year     3,166,270       7.43  
Exercisable at end of year     3,166,270     $ 7.43  
Weighted average fair value of stock options granted during the year:   $          

 

The following table summarizes significant ranges of outstanding stock options under our plans at March 31, 2021:

 


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       850,000       8.71     $ 0.26       850,000       8.71     $ 0.26  
$ 1.01 – $3.00       1,050,673       6.36     $ 2.04       1,050,673       6.36     $ 2.04  
$ 3.01 – $15.00       852,360       3.72     $ 12.56       852,360       3.72     $ 12.56  
$ 15.01 –$42.42       413,237       2.85     $ 25.29       413,237       2.85     $ 25.29  
          3,166,270       5.82     $ 7.43       3,166,270       5.82     $ 7.43  

 

During the period ended March 31, 2021, the Company recognized no stock compensation cost as all options had previously vested and during the period ended March 31, 2020 the Company recognized $30,395 relating to the vesting of these options. At March 31, 2021, there was no unrecognized compensation expense related to unvested stock options.

 

The aggregate intrinsic value of the outstanding options and options vested as of March 31, 2021 was $3.1 million.

 

At December 31, 2020, the Company had 193,196 warrants outstanding at a weighted average exercise price of $8.60. During 2021, 189,029 warrants expired, and as such, there were 4,167 remaining warrants outstanding as of March 31, 2021 at a weighted average exercise price of $10.44. At March 31, 2021, the 4,167 warrants outstanding had no intrinsic value.

 

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 stock-based compensation expense for restricted stock of $56,267 for the quarter ended March 31, 2020. All shares had fully vested as of December 31, 2020. No restricted stock was granted in 2021 nor 2020.

XML 21 R10.htm IDEA: XBRL DOCUMENT v3.21.1
Stockholder Protection Rights Plan
3 Months Ended
Mar. 31, 2021
Equity [Abstract]  
Stockholder Protection Rights Plan
4. Stockholder Protection Rights Plan

 

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

  

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

 

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

 

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

 

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

 

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

 

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

 

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

  

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

XML 22 R11.htm IDEA: XBRL DOCUMENT v3.21.1
Income Taxes
3 Months Ended
Mar. 31, 2021
Income Tax Disclosure [Abstract]  
Income Taxes
5. Income Taxes

 

At December 31, 2020, we had federal and state net operating loss carryforwards of $327.6 million and $252.6 million, respectively, available to offset against future taxable income. Of this amount, $310.3 million of federal NOLs expire in 2024 through 2037. The federal operating losses from 2018, 2019 and 2020 totaling $17.0 million carry forward indefinitely but are only able to offset 80% of taxable income in future years. The California NOLs expire in 2029 through 2039. Management currently believes that $258.3 million in federal net operating loss carryforwards and $252.6 million in state net operating loss carryforwards are unrestricted.

XML 23 R12.htm IDEA: XBRL DOCUMENT v3.21.1
Commitments and Contingencies
3 Months Ended
Mar. 31, 2021
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies
6. Commitments and Contingencies

 

Commitments

 

Aldoxorubicin

 

We have an agreement with Vergell Medical (“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 remotely and will return to their offices at a yet to be determined date.

XML 24 R13.htm IDEA: XBRL DOCUMENT v3.21.1
Basis of Presentation and Significant Accounting Policies (Policies)
3 Months Ended
Mar. 31, 2021
Accounting Policies [Abstract]  
Basis of Presentation and Principles of Consolidation

Basis of Presentation and Principles of Consolidation

 

The accompanying condensed consolidated financial statements at March 31, 2021 and for the three-month periods ended March 31, 2021 and 2020, 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, 2020 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, 2020. 

Liquidity and Capital Resources

Liquidity and Capital Resources

 

At March 31, 2021, we had cash and cash equivalents of approximately $9.3 million. Management believes that our current cash and cash equivalents 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 2021 and the first four months of 2022 of approximately $5.6 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. 

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). We recognized a loss of approximately ($13,070) and ($5,395) respectively, for the three-month periods ended March 31, 2021 and 2020. 

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 (which consist of options, warrants and restricted stock) are excluded from the computation of diluted net loss per common share where the effect would be anti-dilutive. 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 3.2 million shares for the three-month period ended March 31, 2021 as compared to 7.9 million shares for the three-month period ended March 31, 2020.

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 Issued Accounting Pronouncements

Recently Issued 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 25 R14.htm IDEA: XBRL DOCUMENT v3.21.1
Leases (Tables)
3 Months Ended
Mar. 31, 2021
Leases [Abstract]  
Schedule of Future Minimum Lease Payments

Future minimum lease payments under non-cancelable operating leases under ASC 842 as of March 31, 2021 are as follows:

 

    Operating
Lease Payments
 
         
April 2021 – March 2022   $ 200,852  
April 2022 – March 2023     195,936  
April 2023 – March 2024     185,200  
Total future minimum lease payments     581,988  
         
Less: present value adjustment     29,569  
Operating lease liabilities at March 31, 2021     552,419  
Less: current portion of operating lease liabilities     184,329  
Operating lease liabilities, net of current portion   $ 368,090  

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
March 31, 2021
 
Lease Cost        
         
Operating lease cost (included in General and administrative expenses in the Company’s condensed Consolidated Statements of Operations)   $ 49,039  
         
Other information        
         
Cash paid for amounts included in the measurement of lease liabilities for the period ended March 31, 2021   $ 47,061  
         
Weighted average remaining lease term – operating leases (in years)     2.9  
         
Average discount rate     3.6 %

XML 26 R15.htm IDEA: XBRL DOCUMENT v3.21.1
Stock Based Compensation (Tables)
3 Months Ended
Mar. 31, 2021
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 March 31,  
    2021     2020  
General and administrative — employee           86,662  
Total employee stock-based compensation   $     $ 86,662  

Schedule of Stock Options Activity

Options

 

    Stock Options     Weighted Average Exercise Price  
    2021     2021  
Outstanding — beginning of year     3,166,270     $ 7.43  
Granted            
Exercised            
Forfeited            
Expired            
Outstanding — end of year     3,166,270       7.43  
Exercisable at end of year     3,166,270     $ 7.43  
Weighted average fair value of stock options granted during the year:   $          

Schedule of Ranges of Stock Options

The following table summarizes significant ranges of outstanding stock options under our plans at March 31, 2021:

 


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       850,000       8.71     $ 0.26       850,000       8.71     $ 0.26  
$ 1.01 – $3.00       1,050,673       6.36     $ 2.04       1,050,673       6.36     $ 2.04  
$ 3.01 – $15.00       852,360       3.72     $ 12.56       852,360       3.72     $ 12.56  
$ 15.01 –$42.42       413,237       2.85     $ 25.29       413,237       2.85     $ 25.29  
          3,166,270       5.82     $ 7.43       3,166,270       5.82     $ 7.43  

XML 27 R16.htm IDEA: XBRL DOCUMENT v3.21.1
Basis of Presentation and Significant Accounting Policies (Details Narrative) - USD ($)
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Dec. 31, 2020
Cash and cash equivalents $ 9,322,529   $ 10,003,375
Foreign currency remeasurement loss $ (13,070) $ (5,395)  
Potentially dilutive shares excluded from computation of diluted net income (loss) 3,200,000 7,900,000  
Reminder 2021 and First Four Months of 2022 [Member]      
Currently projected expenditures $ 5,600,000    
XML 28 R17.htm IDEA: XBRL DOCUMENT v3.21.1
Leases (Details Narrative)
1 Months Ended
Feb. 29, 2020
USD ($)
Jan. 31, 2020
USD ($)
ft²
Mar. 31, 2021
USD ($)
Dec. 31, 2020
USD ($)
Leases [Abstract]        
Lease term   4 years    
Area of land | ft²   2,771    
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   $ 715,310 $ 535,263 $ 580,478
Lease liability   $ 715,310 $ 552,419  
XML 29 R18.htm IDEA: XBRL DOCUMENT v3.21.1
Leases - Schedule of Future Minimum Lease Payments (Details) - USD ($)
Mar. 31, 2021
Dec. 31, 2020
Jan. 31, 2020
Leases [Abstract]      
April 2021 - March 2022 $ 200,852    
April 2022 - March 2023 195,936    
April 2023 - March 2024 185,200    
Total future minimum lease payments 581,988    
Less: present value adjustment 29,569    
Operating lease liabilities at March 31, 2021 552,419   $ 715,310
Less: current portion of operating lease liabilities 184,329 $ 181,103  
Operating lease liabilities, net of current portion $ 368,090 $ 415,200  
XML 30 R19.htm IDEA: XBRL DOCUMENT v3.21.1
Leases - Schedule of Rent Expense and Supplemental Cash Flow Information Related to Leases (Details)
3 Months Ended
Mar. 31, 2021
USD ($)
Leases [Abstract]  
Operating lease cost (included in General and administrative expenses in the Company's condensed Consolidated Statements of Operations) $ 49,039
Cash paid for amounts included in the measurement of lease liabilities for the period ended March 31, 2021 $ 47,061
Weighted average remaining lease term - operating leases (in years) 2 years 10 months 25 days
Average discount rate 3.60%
XML 31 R20.htm IDEA: XBRL DOCUMENT v3.21.1
Stock Based Compensation (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended
Dec. 31, 2017
Dec. 31, 2016
Mar. 31, 2021
Mar. 31, 2020
Dec. 31, 2020
Nov. 30, 2019
Share-based compensation, outstanding stock options     3,166,270   3,166,270  
Unrecognized compensation expense related to unvested stock options          
Aggregate intrinsic value of outstanding options and vested options     $ 3,100,000      
Number of warrants issued to purchase shares of common stock     4,167   193,196  
Warrants exercise price per share     $ 10.44   $ 8.60  
Number of warrant expired     189,029      
Intrinsic value of warrants          
Number of restricted shares granted          
Stock-based compensation expense     $ 86,662    
Stock Options [Member]            
Employee stock-based compensation expense       30,395    
Restricted Stock [Member]            
Stock-based compensation expense       $ 56,267    
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        
2008 Stock Incentive Plan [Member]            
Number of common stock reserved for future issuance     5,000,000      
Share-based compensation, outstanding stock options     2,300,000      
Expiration date     Nov. 20, 2018      
2008 Stock Incentive Plan [Member] | Restricted Stock [Member]            
Share-based compensation, outstanding restricted stock     800,000      
2019 Stock Incentive Plan [Member]            
Number of common stock reserved for future issuance           5,400,000
Share-based compensation, outstanding stock options     900,000      
Expiration date     Nov. 14, 2029      
XML 32 R21.htm IDEA: XBRL DOCUMENT v3.21.1
Stock Based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($)
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Total employee stock-based compensation $ 86,662
Employee [Member]    
Total employee stock-based compensation 86,662
General and Administrative Expense [Member] | Employee [Member]    
Total employee stock-based compensation $ 86,662
XML 33 R22.htm IDEA: XBRL DOCUMENT v3.21.1
Stock Based Compensation - Schedule of Stock Options Activity (Details)
3 Months Ended
Mar. 31, 2021
$ / shares
shares
Share-based Payment Arrangement [Abstract]  
Stock Options, Outstanding at beginning of year | shares 3,166,270
Stock Options, Granted | shares
Stock Options, Exercised | shares
Stock Options, Forfeited | shares
Stock Options, Expired | shares
Stock Options, Outstanding at end of year | shares 3,166,270
Stock Options, Exercisable at end of year | shares 3,166,270
Weighted average fair value of stock options granted during the year:
Weighted Average Exercise Price Options, Outstanding at beginning of year 7.43
Weighted Average Exercise Price Options, Granted
Weighted Average Exercise Price Options, Exercised
Weighted Average Exercise Price Options, Forfeited
Weighted Average Exercise Price Options, Expired
Weighted Average Exercise Price Options, Outstanding at end of year 7.43
Weighted Average Exercise Price Options, Exercisable at end of year $ 7.43
XML 34 R23.htm IDEA: XBRL DOCUMENT v3.21.1
Stock Based Compensation - Schedule of Ranges of Stock Options (Details)
3 Months Ended
Mar. 31, 2021
$ / shares
shares
Number of Options Outstanding | shares 3,166,270
Weighted-Average Remaining Contractual Life (years) 5 years 9 months 25 days
Weighted-Average Exercise Price $ 7.43
Number of Options Exercisable | shares 3,166,270
Weighted-Average Remaining Contractual Life (years) 5 years 9 months 25 days
Weighted-Average Exercise Price, Options Exercisable $ 7.43
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 850,000
Weighted-Average Remaining Contractual Life (years) 8 years 8 months 16 days
Weighted-Average Exercise Price $ 0.26
Number of Options Exercisable | shares 850,000
Weighted-Average Remaining Contractual Life (years) 8 years 8 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) 6 years 4 months 9 days
Weighted-Average Exercise Price $ 2.04
Number of Options Exercisable | shares 1,050,673
Weighted-Average Remaining Contractual Life (years) 6 years 4 months 9 days
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) 3 years 8 months 19 days
Weighted-Average Exercise Price $ 12.56
Number of Options Exercisable | shares 852,360
Weighted-Average Remaining Contractual Life (years) 3 years 8 months 19 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 413,237
Weighted-Average Remaining Contractual Life (years) 2 years 10 months 6 days
Weighted-Average Exercise Price $ 25.29
Number of Options Exercisable | shares 413,237
Weighted-Average Remaining Contractual Life (years) 2 years 10 months 6 days
Weighted-Average Exercise Price, Options Exercisable $ 25.29
XML 35 R24.htm IDEA: XBRL DOCUMENT v3.21.1
Stockholder Protection Rights Plan (Details Narrative) - $ / shares
Nov. 12, 2020
Mar. 31, 2021
Dec. 31, 2020
Dec. 13, 2019
Equity [Abstract]        
Common stock, par value   $ 0.001 $ 0.001 $ 0.001
Preferred stock, par value   $ 0.01 $ 0.01 0.01
Preferred stock purchase price per share       5.00
Stockholders rights, description The Board approved an amendment and restatement of the Original Rights Agreement (as amended and restated, the "Amended and Restated Rights Agreement") to effect certain changes to the Original Rights Agreement, including (i) reducing the duration to a term of three years, subject to certain earlier expiration as described in more detail below, and (ii) lowering the beneficial ownership threshold at which a person or group of persons becomes an Acquiring Person (as defined below) to 4.95% or more of the Company's outstanding shares of Common Stock, subject to certain exceptions. The Amended and Restated Rights Agreement is designed to discourage (i) any person or group of persons from acquiring beneficial ownership of more than 4.95% of the Company's shares of Common Stock and (ii) any existing stockholder currently beneficially holding 4.95% or more of the Company's shares of Common Stock from acquiring additional shares of the Company's Common Stock.      
Preferred stock dividend, description Each share of Preferred Stock will be entitled, when, as and if declared, to a preferential per share quarterly dividend payment equal to the greater of (i) $1.00 per share or (ii) an amount equal to 1,000 times the dividend declared per share of Common Stock. Each share of Preferred Stock will entitle the holder thereof to 1,000 votes on all matters submitted to a vote of the stockholders of the Company. In the event of any merger, consolidation or other transaction in which shares of Common Stock are converted or exchanged, each share of Preferred Stock will be entitled to receive 1,000 times the amount received per one share of Common Stock.      
Preferred stock, redemption price per share       $ 0.001
XML 36 R25.htm IDEA: XBRL DOCUMENT v3.21.1
Income Taxes (Details Narrative)
12 Months Ended
Dec. 31, 2020
USD ($)
Operating loss carryforwards, expiration date Expire in 2024 through 2037.
Federal [Member]  
Operating loss carryforwards $ 327,600,000
Operating loss carryforwards, not subject to limitation 17,000,000
Federal [Member] | Expire in 2024 Through 2037 [Member]  
Operating loss carryforwards 310,300,000
Federal [Member] | Unrestricted [Member]  
Operating loss carryforwards 258,300,000
State [Member]  
Operating loss carryforwards 252,600,000
State [Member] | Unrestricted [Member]  
Operating loss carryforwards $ 252,600,000
California [Member]  
Operating loss carryforwards, expiration date Expire in 2029 through 2039.
XML 37 R26.htm IDEA: XBRL DOCUMENT v3.21.1
Commitments and Contingencies (Details Narrative)
3 Months Ended
Mar. 31, 2021
USD ($)
Aldoxorubicin [Member]  
Amount of milestone payment payable $ 7,500,000
Milestone payment, description 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.
Arimoclomol [Member]  
Amount of milestone payment payable $ 3,650,000
Innovivel [Member]  
Future earnout merger consideration $ 18,300,000
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