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 September 30, 20192020

 

OR

 

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

 

For the transition period fromfrom__________ to __________

 

Commission file number 0-15327

 

CytRx Corporation

(Exact name of Registrant as specified in its charter)

 

Delaware58-1642740

(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: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:Act. (Check one):

 

Large accelerated filer [  ]Accelerated filer [  ]Non-accelerated filer [X]Smaller reporting company [X]
Emerging growth company [  ](Do not check if a smaller reporting 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 November 2, 2019: 33,637,50113, 2020: 36,480,038 shares.

 

 

 

 

 

CYTRX CORPORATION

 

FORM 10-Q

 

TABLE OF CONTENTS

 

 Page
PART I. — FINANCIAL INFORMATION3
Item 1.Condensed Consolidated Financial Statements (unaudited)3
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations15
Item 3.Quantitative and Qualitative Disclosures About Market Risk20
Item 4.Controls and Procedures20
  
PART II. — OTHER INFORMATION20
Item 1.Legal Proceedings20
Item 1A.1ARisk Factors20
Item 2Unregistered Sales of Equity Securities and Use of Proceeds20
Item 6.Exhibits20
  
SIGNATURES21
  
INDEX TO EXHIBITS22

PART I — FINANCIAL INFORMATION

 

Item 1. — CondensedConsolidated Financial Statements

 

CYTRX CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 September 30, 2019  December 31, 2018  September 30, 2020 December 31, 2019 
 (Unaudited)      (Unaudited)     
ASSETS                
Current assets:                
Cash and cash equivalents $8,491,265  $21,373,273  $12,601,878  $16,130,410 
Short-term investments  10,023,850    
Receivables  4,789   148,527 
Insurance claims receivable  613,905   7,628 
Prepaid expenses and other current assets  1,410,277   913,162   1,464,289   1,066,497 
Current assets held for sale     81,182 
Total current assets  19,930,181   22,516,144   14,680,072   17,204,535 
Equipment and furnishings, net  23,071   44,326   47,270   42,893 
Other assets  10,119   40,642   16,836   7,590 
Non-current assets held for sale     324,853 
Operating lease right-of-use assets  625,302    
Total assets $19,963,371  $22,925,965  $15,369,480  $17,255,018 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                
Current liabilities:                
Accounts payable $2,194,276  $1,234,762  $3,136,376  $887,835 
Accrued expenses and other current liabilities  936,105   726,191   1,378,349   1,162,471 
Current liabilities of discontinued operations  1,272   602,713 
Current portion of operating lease liabilities  174,772    
Total current liabilities  4,689,497   2,050,306 
        
Operating lease liabilities, net of current portion  464,505    
        
Total liabilities  3,131,653   2,563,666   5,154,002   2,050,306 
                
Commitments and contingencies                
                
Stockholders’ equity:                
Preferred Stock, $0.01 par value, 833,334 shares authorized, including 4,167 shares of Series A Junior Participating Preferred Stock; no shares issued and outstanding      
Preferred Stock, $1,000 stated value, 650 shares authorized, no shares issued and outstanding      
Common stock, $0.001 par value, 41,666,667 shares authorized; 33,637,501 shares issued and outstanding at September 30, 2019 and December 31, 2018  33,637   33,637 
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 and 33,637,501 shares issued and outstanding, respectively, at September 30, 2020 and December 31, 2019  36,480   33,637 
Additional paid-in capital  477,834,188   477,192,747   479,494,604   479,197,849 
Accumulated deficit  (461,036,107)  (456,864,085)  (469,315,606)  (464,026,774)
Total stockholders’ equity  16,831,718   20,362,299   10,215,478   15,204,712 
Total liabilities and stockholders’ equity $19,963,371  $22,925,965  $15,369,480  $17,255,018 

 

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

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 Three Months Ended
September 30,
  Nine Months Ended
September 30,
  

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 
 2019  2018  2019  2018  2020 2019 2020 2019 
Revenue:                         
Licensing revenue $  $250,000  $  $250,000  $  $  $  $ 
                                
Expenses:                                
Research and development  374   (485)  1,430   577,843   592,768   374   819,950   1,430 
General and administrative  1,546,213   2,360,996   4,814,436   6,514,107   2,207,874   1,546,213   4,586,422   4,814,436 
  1,546,587   2,360,511   4,815,866   7,091,950   2,800,642   1,546,587   5,406,372   4,815,866 
                                
Loss before other income (expense)  (1,546,587)  (2,110,511)  (4,815,866)  (6,841,950)  (2,800,642)  (1,546,587)  (5,406,372)  (4,815,866)
                                
Other income (loss):                                
Interest income  91,403   93,391   283,808   269,299   21,302   91,403   112,016   283,808 
Interest expense     (363,086)     (1,715,733)
Other income (loss), net  (35,598)  (1,502)  (37,919)  (13,230)  4,782   (35,598)  5,522   (37,919)
Gain on warrant derivative liabilities           527,025 
                                
Net loss from continuing operations  (1,490,782)  (2,381,708)  (4,569,977)  (7,774,589)  (2,774,558)  (1,490,782)  (5,288,834)  (4,569,977)
                                
Gain (loss) from discontinued operations  19,243   (909,336)  397,955   (2,601,614)
Income from discontinued operations     19,243      397,955 
                                
Net loss $(1,471,539) $(3,291,044) $(4,172,022) $(10,376,203) $(2,774,558) $(1,471,539) $(5,288,834) $(4,172,022)
                                
Basic and diluted loss per share                                
Continuing operations $(0.04) $(0.07) $(0.14) $(0.26) $(0.08) $(0.04) $(0.16) $(0.14)
Discontinued operations $  $(0.03) $0.01  $(0.08) $  $  $  $0.01 
Total basic and diluted loss per share $(0.04) $(0.10) $(0.13) $(0.34) $(0.08) $(0.04) $(0.16) $(0.13)
                                
Basic and diluted weighted-average shares outstanding  33,249,904   32,991,506   33,249,904   30,242,788   35,195,082   33,249,904   34,070,562   33,249,904 

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

4

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

  Nine Months Ended September 30, 
  2020  2019 
Cash flows from operating activities:        
Net loss $(5,288,834) $(4,172,022)
Income from discontinued operations     397,955 
Loss from continuing operations  (5,288,834)  (4,569,977)
Adjustments to reconcile net loss from continuing operations to net cash used in operating activities:        
Depreciation and amortization  21,524   15,824 
Loss on retirement of fixed assets     5,432 
Stock-based compensation expense  260,598   644,113 
Changes in assets and liabilities:        
Receivable  7,628   143,738 
Prepaid expenses and other current assets  (464,063)  (497,040)
Other assets  (9,246)  30,523 
Amortization of right-of-use asset  156,279    
Accounts payable  1,634,946   959,514 
Decrease in lease liabilities  (145,609)   
Accrued expenses and other current liabilities  285,145   209,914 
Net cash used in operating activities from continuing operations  (3,541,631)  (3,057,959)
Net cash used in operating activities from discontinued operations     (300,341)
Net cash used in operating activities  (3,541,631)  (3,358,300)
         
Cash flows from investing activities:        
Purchase of short-term investments     (10,023,850)
Purchase of equipment and furnishings  (25,902)   
Sale of fixed assets held for sale     500,142 
Net cash used in investing activities  (25,902)  (9,523,708)
         
Cash flows from financing activities        
Proceeds from exercise of stock options  39,000    
Net cash used in financing activities  39,000    
         
Net decrease in cash and cash equivalents  (3,528,532)  (12,882,008)
Cash and cash equivalents at beginning of period  16,130,410   21,373,273 
Cash and cash equivalents at end of period $12,601,878  $8,491,265 
         
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  $ 
Insurance claims to offset accounts payable $613,905  $ 

 

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

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSSTOCKHOLDERS EQUITY

(Unaudited)

 

  Nine Months Ended September 30, 
  2019  2018 
Cash flows from operating activities:        
Net loss $(4,172,022) $(10,376,203)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  15,824   23,819 
Stock-based compensation expense  644,113   1,278,105 
Fair value adjustment on warrant liabilities     (527,025)
Amortization of loan cost and discount     1,157,817 
Loss on retirement of fixed assets  5,432    
Gain on disposal from discontinued operations  (186,691)   
Stock compensation from discontinued operations  (2,672)  89,105 
Depreciation from discontinued operations     384,051 
Changes in assets and liabilities:        
Receivables  143,738   1,557,584 
Prepaid expenses and other current assets  (497,040)  665,323 
Other assets  30,523    
Current assets held for sale  92,508   88,941 
Accounts payable  959,514   (1,464,496)
Current liabilities held for sale  (601,441)  195,042 
Accrued expenses and other current liabilities  209,914   (688,224)
Net cash used in operations  (3,358,300)  (7,616,161)
         
Cash flows from investing activities:        
Purchase of short-term investments  (10,023,850)   
Sale of fixed assets held for sale  500,142     
Purchases of equipment and furnishings     (11,478)
Net cash used in investing activities  (9,523,708)  (11,478)
         
Cash flows from financing activities:        
Proceeds from public offering     6,512,151 
Loan end fee payment     (1,771,250)
Payment of principal on term loan     (9,986,362)
Net cash provided by (used in) financing activities     (5,245,461)
         
Net decrease in cash and cash equivalents  (12,882,008)  (12,873,100)
Cash and cash equivalents at beginning of period  21,373,273   37,497,691 
Cash and cash equivalents at end of period $8,491,265  $24,624,591 
         
Supplemental disclosure of cash flow information:        
         
Cash paid during the period for interest $  $647,308 
         
Cash paid for income taxes $800  $800 
  Series B Preferred Shares Issued  Common Shares Issued  Preferred Stock Amount  Common Stock Amount  

Additional

Paid-in

Capital

  Accumulated Deficit  Total 
Balance at January 1, 2020     33,637,501      $33,637  $479,197,849  $(464,026,774) $15,204,712 
Issuance of stock options/restricted stock and warrants for compensation and services                  86,662       86,662 
Net loss                      (1,172,786)  (1,172,786)
Balance at March 31, 2020      33,637,501       33,637   479,284,511   (465,199,560)  14,118,588 
Issuance of stock options/restricted stock and warrants for compensation and services                86,659      86,659 
Net loss                      (1,341,490)  (1,341,490)
                             
Balance at June 30, 2020     33,637,501      $33,637  $479,371,170  $(466,541,050) $12,863,757 
Exercise of stock options      2,842,537       2,843   36,157       39,000 
Issuance of stock options/restricted stock for compensation and services               87,277      87,277 
Net loss                      (2,774,558)  (2,774,558)
                             
Balance at September 30, 2020     36,480,038      $36,480  $479,494,604  $(469,315,606) $10,215,478 
                             
Balance at January 1, 2019     33,637,501      $33,637  $477,192,747  $(456,864,085) $20,362,299 
Issuance of stock options/warrants for compensation and services              210,502      210,502 
Net loss                     (1,425,988)  (1,425,988)
Balance at March 31, 2019     33,637,501      $33,637  $477,403,249  $(458,290,073) $19,146,813 
Issuance of stock options/restricted stock for compensation and services                  214,706       214,706 
Net loss                      (1,274,495)  (1,274,495)
Balance at June 30, 2019      33,637,501      $33,637  $477,617,955  $(459,564,568) $18,087,024 
Issuance of stock options/restricted stock for compensation and services              216,233      216,233 
Net loss                     (1,471,539)  (1,471,539)
Balance at September 30, 2019      33,637,501      $33,637  $477,834,188  $(461,036,107) $16,831,718 

 

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

CYTRX CORPORATION

NOTES TO CONDENSED CONSOLIDATEDFINANCIAL STATEMENTS OF STOCKHOLDERS EQUITY

For the Nine-Month Periods Ended September 30, 2020 and 2019

(Unaudited)

 

For the Three Month Periods Ended March 31, June 30 and September 30, 2018

  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, 2018     28,037,501      $28,037  $468,969,445  $(450,852,427) $18,145,055 
Cumulative affect of adopting ASC 606 Adoption                 6,701,950   6,701,950 
Issuance of stock options/restricted stock and warrants for compensation and services                  481,311       481,311 
Net loss                      (4,075,574)  (4,075,574)
Balance at March 31, 2018     28,037,501       28,037   469,450,756   (448,226,051)  21,252,742 
Stock issued in connection with a public offering      5,600,000       5,600   6,506,551       6,512,151 
Issuance of stock options/restricted stock and warrants for compensation and services                  453,199      453,199 
Net loss                      (3,009,588)  (3,009,588)
                             
Balance at June 30, 2018     33,637,501      $33,637  $476,410,506  $(451,235,639) $25,208,504 
Issuance of stock options/restricted stock and warrants for compensation and services                  432,700      432,700 
Net loss                      (3,291,041)  (3,291,041)
Balance at September 30, 2018     33,637,501      $33,637  $476,843,206  $(454,526,680) $22,350,163 
                             
For the Three Month Periods Ended March 31, June 30 and September 30, 2019 
  
Balance at January 1, 2019     33,637,501      $33,637  $477,192,747  $(456,864,085) $20,362,299 
Issuance of stock options/warrants for compensation and services              210,502      210,502 
Net loss                      (1,425,988)  (1,425,988)
Balance at March 31, 2019     33,637,501      $33,637  $477,403,249  $(458,290,073) $19,146,813 
Issuance of stock options/restricted stock for compensation and services                  214,706       214,706 
Net loss                      (1,274,495)  (1,274,495)
Balance at June 30, 2019     33,637,501      $33,637  $477,617,955  $(459,564,568) $18,087,024 
Issuance of stock options/warrants for compensation and services                  216,233       216,233 
Net loss                      (1,471,539)  (1,471,539)
Balance at September 30, 2019     33,637,501      $33,637  $477,834,188  $(461,036,107) $16,831,718 

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

CYTRX CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

For the Nine Months Ended September 30, 2019 and 2018
(Unaudited)

1.Description of Company and Basis of Presentation

 

CytRx Corporation (“CytRx”) is a biopharmaceutical research and development company specializing in oncology and rareneurodegenerative 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 onin 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 to it 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 chemotherapies)cytotoxins) by controlling the release of the drug payloads and improving drug-like properties.

 

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

 

Centurion’s postulated mechanism of action for the albumin-binding drug conjugates is as follows:

after administration, the linker portion of the drug conjugate forms a rapid and specific covalent bond to the cysteine-34 position of circulating albumin;

circulating albumin preferentially accumulates at the tumors, bypassing concentration in other non-tumor sites, including the heart, liver and gastrointestinal tract due to a mechanism called “Enhanced Permeability and Retention”;

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

free active drug is then released.

Centurion’s novel companion diagnostic, ACDx™ (albumin companion diagnostic), was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR lead assets.

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

Aldoxorubicin

 

Until July 2017, the Company was focused on the research and clinical development of aldoxorubicin, theirits modified version of the widely-used chemotherapeuticcytotoxin agent, doxorubicin. Aldoxorubicin combines the chemotherapeutic 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, andindications. As a result, our company is no longer directly working on development of aldoxorubicin. As part of the license, ImmunityBio made a strategic investment of $13 million in CytRx common stock at $6.60 per share (adjusted to reflect our 2017 reverse stock split), a premium of 92% to the market price on that date. The Company also issued ImmunityBio a warrant to purchase up to 500,000 shares of common stock at $6.60, which expired on January 26, 2019. The Company is entitled to receive up to an aggregate of $343 million in potential milestone payments, contingent upon achievement of certain regulatory approvals and commercial milestones. The Company is also entitled to receive ascending double-digit royalties for net sales for orphan indications such as soft tissue sarcomas and mid to high single digit royalties for other indications. There can be no assurance that ImmunityBio will achieve such milestones, approvals or sales with respect to aldoxorubicin. ImmunityBio has initiated a Phase 2, randomized, two-cohort, open-label registrational-intent study for first-line and second-line treatment of locally advanced or metastatic pancreatic cancer, which includes aldoxorubicin.

 

Molecular Chaperone Assets

 

In 2011, CytRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme A/S (formerly Orphazyme ApS) in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million (USD) in milestone payments upon the achievement of certain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any net sales of products derived from arimoclomol. Orphazyme is testing arimoclomol in three additional indications beyond ALS, including Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). CytRx received a milestone payment of $250,000 in September 2018. Orphazyme has highlighted positive Phase2/Phase 2/3 clinical trial data in patients with NPC and has announced they remain on track to submithave submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), which is currently under Priority Review by the U.S. Food and Drug Administration (“FDA”) with a target action date of March 17, 2021. It also recently submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA). Orphazyme has also received FDA Breakthrough Therapy Designation for arimoclomol for NPC and their Early Access Program is now operational. Orphazyme expects to obtain results from its registration trials for both sIBM and ALS in the first half of 2020. In such event,2021. CytRx will be entitled to a milestone payment of $6 million upon FDA approval, $4 million upon EMA approval and $6$2 million upon FDA approval in Japan, along with royalties and potential additional milestones.milestone payments. There can be no assurance that Orphazyme will achieve such approvals or that CytRx will receive any milestone or royalty payments.

Current Business Strategy

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

8

Basis of Presentation

 

The accompanying condensed consolidated financial statements at September 30, 20192020 and for the three-month and nine-month periods ended September 30, 20192020 and 2018,2019, respectively, are unaudited, but include all adjustments, consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 20182019 have been derived from our audited financial statements as of that date.

 

The condensed 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 condensed consolidated financial statements should be read in conjunction with the Company’sour audited financial statements contained in its Annual Report on Form 10-K for the year ended December 31, 2018.2019.

 

2. Foreign Currency Remeasurement

The U.S. dollar has been determined to be the functional currency for the net assets of our German operations. The transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and current exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). The Company recognized a loss of approximately $16,800 and $8,400, respectively, for the three-month and nine-month periods ended September 30, 2019 and a loss of approximately $1,300 and $7,600, respectively, for the three and nine-month periods ended September 30, 2018, respectively. The Company does not engage in currency hedging transactions.

3. Recently Adopted Accounting Pronouncement

On January 1, 2019, CytRx adopted Accounting Standards Update (“ASU”) No. 2016-02, “Leases (Topic 842),” which requires the recognition of right-of-use (“ROU”) assets and lease liabilities on the consolidated balance sheet. This ASU retains a distinction between finance leases and operating leases, and the classification criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria for distinguishing between capital leases and operating leases in the current accounting literature. Under the standard, disclosures are required to meet the objective of enabling users of financial statements to assess the amount , timing, and uncertainty of cash flows arising from leases. We elected the available practical expedients on adoption. Adoption of the new standard resulted in total lease liabilities of $310,000 and ROU assets of $290,000 as of January 1, 2019. At September 30, 2019, the total lease liabilities were $140,000 and the ROU assets were $131,000.

On January 1, 2018 CytRx adopted Accounting Standards Update 2014-09,Revenue from Contracts with Customers (“ASC 606”) using the modified retrospective method for contracts that were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under the new standard, while prior period amounts are not adjusted and continue to be reported under the accounting standards in effect for the prior period. The cumulative effect of initially applying ASC 606 was an adjustment to decrease the opening balance of Accumulated Deficit by $6.7 million as of January 1, 2018.

The guidance provides for a five-step analysis of transactions to determine when and how revenue is recognized. Other major provisions include capitalization of certain contract costs, consideration of the time value of money in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The guidance also requires enhanced disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from an entity’s contracts with customers.

Under the new standard the ImmunityBio Licensing Agreement, which was determined to be a functional license agreement, as the underlying intellectual property had standalone functionality, was recognizable in 2017 when ImmunityBio obtained the right to use the intellectual property. The subsequent Reimbursement Agreement was determined to be a contract modification that introduced variable contra revenue for the Company’s reimbursement obligations. In accordance with ASC 606, management estimated its obligations under the Reimbursement Agreement to be $3.2 million which is recognized as a contract liability at the time of revenue recognition. These costs were previously recognized as research and development expense in 2017 in accordance with prior accounting standards. This contract liability was reduced to $50,000 and $9,000, respectively, as of December 31, 2018 and September 30, 2019 as a result of costs incurred under the Reimbursement Agreement and is included within accrued expenses and other current liabilities on the condensed balance sheet as of September 30, 2019. Under prior revenue recognition standards, no revenue was recognized in 2017 under the ImmunityBio Licensing Agreement as a result of revenue recognition criteria not being met, resulting in a deferred revenue balance of $6.9 million as of December 31, 2017.

4. Discontinued Operations

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

The Company terminated its lease in Freiburg Germany on April 30, 2019 with no penalty. The Company sold its analytical equipment in March 2019 and wrote down these assets by $7,000. On April 30, 2019 the Company also sold its German office furniture and German leasehold improvements for $0.3 million, realizing a gain on sale of $0.2 million. The net book value of the assets held for sale is $0 at September 30, 2019 and $0.4 million at December 31, 2018. The results of these discontinued operations are presented separately on the Company’s Consolidated Statement of Operations.

  As of 
  September 30, 2019  December 31, 2018 
Current assets held for sale $  $81,182 
Equipment and furnishings, net    $313,425 
Deposit     11,401 
Non-current assets held for sale $  $324,826 
         
Accounts payable $1,272  $323,736 
Accrued expenses and other current liabilities     278,977 
Current liabilities of discontinued operations $1,272  $602,713 
  Three Months Ended September 30,  Nine Months Ended September 30, 
  2019  2018  2019  2018 
Research and development $(58) $753,174  $(171,432) $2,135,840 
Loss on impairment of equipment and furnishings        7,100    
Employee stock option expense     28,683   (2,672)  89,105 
Gain on sale of assets held for sale         (192,791)   
Other (income) loss  (19,185)  (861)  (38,160)  (7,382)
Depreciation expense     128,340      384,051 
Loss (gain) from discontinued operations $(19,243) $909,336  $(397,955) $2,601,614 

5. 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 and warrants) 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 2.6 million shares for each of the three-month and nine-month periods ended September 30, 2019, and 3.5 million shares for each of the three-month and nine-month periods ended September 30, 2018.

6. Warrant Liabilities

Liabilities measured at fair value on a recurring basis include warrant liabilities resulting from our equity financings. In accordance with ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity (“ASC 815-40”), the warrant liabilities are recorded at fair value until they are completely settled. The warrants are valued using the Black-Scholes method, using assumptions consistent with the Company’s application of ASC 505-50,Equity-Based Payments to Non-Employees (“ASC 505-50”). The gain or loss resulting from the change in fair value is shown on the Condensed Statements of Operations as gain (loss) on warrant derivative liability. On July 20, 2018, 2,834,246 warrants classified as liabilities expired and consequently, no gain or loss was recorded in the current period ended September 30, 2019. We recognized a gain of $0 and $0.5 million for the three-month and nine-months periods ended September 30, 2018, respectively. The following reflects the weighted-average assumptions for each of the nine-month periods indicated:

  Nine Months Ended September 30, 
  2019  2018 
       
Risk-free interest rate     1.77%
Expected dividend yield     0%
Expected lives     0.05 
Expected volatility     50.2%
Warrants classified as liabilities (in shares)     2,834,246 

Our computation of expected volatility is based on the historical daily volatility of our publicly traded stock. The dividend yield assumption of zero is based upon the fact that we have never paid cash dividends and presently have no intention to do so. The risk-free interest rate used for each warrant classified as a derivative is equal to the U.S. Treasury rates in effect at September 30 of each year presented. The expected lives are based on the remaining contractual lives of the related warrants at the valuation date.

7. Leases

The Company determines whether an arrangement is, or contains, a lease at inception. Prior to 2019, the company generally accounted for operating lease payments by charging them to expense as incurred. Beginning in 2019, operating leases that have commenced are included in other assets, other accrued expenses and other long-term liabilities in the consolidated balance sheet. Classification of operating lease liabilities as either current or noncurrent is based on the expected timing of payments due under the company’s obligations.

Because most of the company’s leases do not provide an implicit rate, the company estimates incremental borrowing rates based on the information available at the commencement date in determining the present value of lease payments. The company uses the implicit rate when readily determinable. Lease terms may include the effect of options to extend or terminate the lease when it is reasonably certain that the company will exercise that option.

We lease office space related primarily to the administrative activities and at September 30, 2019, the remaining term of these leases are less than 12 months. See Note 3.

Leases with lease terms of twelve-months or less are expensed on a straight-line basis over the lease term and are not recorded in the Condensed Consolidated Balance Sheet.

In addition, we elected the hindsight practical expedient to determine the lease term for existing leases. In our application of hindsight, we evaluated the Freiburg lease and determined the term would be less than 12 months.

As of September 30, 2019, balance of the right-of-use assets was approximately $131,000, and balance of the total lease liabilities was approximately $140,000. The remaining term of the leases were less than 12 months and as such, balances of the right-of-use assets and lease liabilities were included in prepaid expenses and other current assets, and accrued expenses and other current liabilities, respectively, on the accompanying condensed consolidated balance sheet.

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

  

Nine Months Ended
September 30, 2019

 
Lease Cost    
Operating lease cost (included in General and Administrative expenses in the Company’s unaudited condensed consolidated statements of operations) $205,520 
Other information    
Cash paid for amounts included in the measurement of lease liabilities for nine months ended September 30, 2019 $211,749 
Weighted average remaining lease term – operating leases (in years)  0.88 
Average discount rate  5.5%

8.Stock Based Compensation

We have a 2000 Long-Term Incentive Plan, which expired on August 6, 2010. As of September 30, 2019, there were 10,452 shares subject to outstanding stock options under this plan. No further shares are available for future grant under this plan.

We also have a 2008 Stock Incentive Plan. As of September 30, 2019, there were approximately 2.4 million shares subject to outstanding stock options and approximately 0.8 million shares outstanding related to restricted stock grants. This plan expired on November 20, 2018 and thus no further shares are available for future grant under this plan.

We follow ASC 718,Compensation-Stock Compensation,which requires the measurement and recognition of compensation expense for all stock-based awards made to employees.

For stock options and stock warrants paid in consideration of services rendered by non-employees, we recognize compensation expense in accordance with the requirements of ASC 505-50.

Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period, the value of these options, as calculated using the Black-Scholes option-pricing model, is determined, and compensation expense recognized or recovered during the period is adjusted accordingly. As a result, the amount of the future compensation expense is subject to adjustment until the common stock options are fully vested.

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

  Three Months Ended September 30,  Nine Months Ended September 30, 
  2019  2018  2019  2018 
Research and development — employee $  $28,683  $(2,672) $89,105 
General and administrative — employee  216,234   243,673   644,113   799,832 
Total employee stock-based compensation $216,234  $272,356  $641,441  $888,937 
                 
Research and development — non-employee $  $  $  $ 
General and administrative — non-employee $   19,517      60,384 
Total non-employee stock-based compensation $  $19,517  $  $60,384 

No options were granted during the nine-month period ended September 30, 2019 as compared to 1,667 stock options at an exercise price of $1.89 during the comparative September 30, 2018 period. The fair value of the stock options was estimated using the Black-Scholes option-pricing model, based on the following assumptions:

Nine Months Ended September 30, 2019Nine Months Ended September 30, 2018
Risk-free interest rate2.42%
Expected volatility91.6%
Expected lives (years)6
Expected dividend yield0.00%

Our computation of expected volatility is based on the historical daily volatility of our publicly traded stock. We use historical information to compute expected lives. In the nine-month period ended September 30, 2018, the contractual term of the options granted was ten years. The dividend yield assumption of zero is based upon the fact we have never paid cash dividends and presently have no intention to do so. The risk-free interest rate used for each grant and issuance is equal to the U.S. Treasury rates in effect at the time of the grant and issuance for instruments with a similar expected life. On January 1, 2017, the Company adopted ASU 2016-09 and made a policy election to recognize forfeitures as they occur. The adoption of ASU 2016-09 did not have a material impact to the Company’s financial condition or results of operations. No amounts relating to stock-based compensation have been capitalized.

The Company recorded stock compensation expense on vested options of $75,407 and $226,225, respectively, for the three and nine-month periods ended September 30, 2019, as compared to $272,356 and $888,937, respectively, for the three and nine-month periods ended September 30, 2018.

As of September 30, 2019, there remained approximately $0.2 million of unrecognized compensation expense related to unvested stock options granted to current and former employees, directors, to be recognized as expense over a weighted-average period of 0.51 years. Presented below is our stock option activity:

  Nine Months Ended September 30, 2019 
  

Number of Options (Employees)

  Number of Options (Non-Employees)  Total Number
of Options
  Weighted-Average Exercise Price 
Outstanding at January 1, 2019  2,190,835   365,000   2,555,835  $10.69 
Granted          $ 
Exercised, Forfeited or Expired  (181,837)     (181,837) $10.66 
Outstanding at September 30, 2019  2,008,998   365,000   2,373,998  $10.69 
Options exercisable at September 30, 2019  1,857,291   365,000   2,222,291  $11.29 

The following table summarizes significant ranges of outstanding stock options under our plans at September 30, 2019:

Range of
Exercise Prices
  Total Number of Options  Weighted-Average Remaining Contractual Life (years)  Weighted-Average Exercise Price  Total Number of Options Exercisable  Weighted-Average Remaining Contractual Life (years)  Weighted-Average Exercise Price 
$0.77 - $5.00   1,123,449   7.84  $2.13   971,743   7.81  $2.16 
$5.01 – $11.00   165,834   3.19  $10.98   165,834   3.19  $10.98 
$11.01 – $15.00   623,193   5.54  $13.89   623,193   5.54  $13.89 
$15.01 – $98.28   461,523   3.96  $27.09   461,523   3.96  $27.09 
     2,373,998   6.16  $10.69   2,222,291   6.03  $11.29 

There was no aggregate intrinsic value to the outstanding options and vested options as of September 30, 2019.

There were 193,196 and 693,196 warrants outstanding at September 30, 2019 and December 31, 2018, respectively at a weighted-average exercise price of $8.60 and $7.16, respectively.

Restricted Stock

No restricted stock was granted in 2019 and 2018. In December 2017, the Company granted to our Chairman and 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 our Chairman and Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years. The fair value of the restricted stock is based on the market price of the Company’s shares on the grant date less the par value received as consideration. The fair value of the restricted stock on the grant date was $1,000,000 The Company recorded an employee stock-based compensation expense for restricted stock of $140,827 and $417,889 respectively, for the three and nine-month periods ended September 30, 2019 as compared to $140,827 and $417,889 respectively, for the three and nine-month periods ended September 30, 2018.

9. 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.

The following table summarizes fair value measurements by level at September 30, 2019 for assets and liabilities measured at fair value on a recurring basis:

(In thousands) Level I  Level II  Level III  Total 
Cash equivalents $6,519  $  $  $6,519 
Short-term investments  10,024        $10,024 

The following table summarizes fair value measurements by level at December 31, 2018 for assets and liabilities measured at fair value on a recurring basis:

(In thousands) Level I  Level II  Level III  Total 
Cash equivalents $19,731  $  $  $19,731 

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.

10.Liquidity and Capital Resources

 

At September 30, 2019, the Company2020, we had cash and cash equivalents and short-term investments of approximately $18.5$12.6 million. Management believes that our current cash and cash equivalents and short-term investments will be sufficient to fund ourits operations for the foreseeable future. TheThis estimate is based, in part, upon our currently projected expenditures for the remainder of 20192020 and the first ten months of 20202021 of approximately $5.0 million.$5.5 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.

 

11.2. Summary of Significant Accounting Policies

Use of Estimates

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

Stock Compensation

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

Foreign Currency Remeasurement

The U.S. dollar has been determined to be the functional currency for the net assets of our German operations. The transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and current exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). The Company recognized a gain of approximately $13,300 and $100, respectively, for the three-month and nine-month periods ended September 30, 2020 and a loss of approximately ($16,800) and ($8,400), respectively, for the three and nine-month periods ended September 30, 2019, respectively.

Insurance recoveries

The Company has several policies with insurance underwriters that provide for the recovery of certain costs incurred by the Company. The Company’s policy is to record any liability as incurred, and then to record the estimated recovery from the insurance company for that cost as a receivable in accordance with terms of its existing policies. As of September 30, 2020, management has estimated that $613,905 is recoverable from its insurance carriers under the terms of its policies.

Basic and Diluted Net Loss Per Common Share

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

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 3.4 million for the nine-month period ended September 30, 2020, and 2.6 million shares for the nine-month period ended September 30, 2019.

Fair Value Measurements

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

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

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

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

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

Recently Accounting Pronouncements

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

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

3. Discontinued Operations

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

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

  Three Months Ended September 30,  Nine Months Ended September 30, 
  2020  2019  2020  2019 
Research and development $  $(58) $  $(171,432)
Loss on impairment of equipment and furnishings           7,100 
Employee stock option expense           (2,672)
Gain on sale of assets held for sale           (192,791)
Other (income) loss     (19,185)     (38,160)
Depreciation expense            
Income from discontinued operations $  $(19,243) $  $(397,955)

4. Leases

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

In January 2020, the Company signed a new four-year office lease which covers approximately 2,771 square feet of office and storage space. This lease is effective March 1, 2020 and extends through February 29, 2024, with a right to extend the term for an additional five-year period, subject to the terms and conditions set forth in the lease agreement. The monthly rent is $13,855, subject to annual increases of 3.5 percent. In February 2020, the Company renewed its additional storage space lease, which requires us to make monthly payments of $1,370, subject to a 2.5 percent annual increase. The Company recorded a right of use asset and lease liability obligation of $715,310 upon inception of these leases. The Company also reclassified a previously existing right-of-use asset of $66,271 from other assets to right-of-use asset.

As of September 30, 2020, the balance of right-of-use assets was approximately $625,000, and the balance of total lease liabilities was approximately $639,000.

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

  Operating Lease Payments 
    
Oct 2020 – Sept 2021 $197,716 
Oct 2021 – Sept 2022  198,385 
Oct 2022 – Sept 2023  199,263 
Oct 2023 – Sept 2024  84,181 
Total future minimum lease payments  679,545 
     
Less: present value adjustment  40,268 
Operating lease liabilities at September 30, 2020  639,277 
Less: current portion of operating lease liabilities  174,772 
Operating lease liabilities, net of current portion $464,505 

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

  Period Ended
September 30, 2020
 
Lease Cost    
     
Operating lease cost (included in General and administrative expenses in the Company’s condensed Consolidated Statements of Operations) $128,962 
     
Other information    
     
Cash paid for amounts included in the measurement of lease liabilities for the period ended September 30, 2020 $136,746 
     
Weighted average remaining lease term – operating leases (in years)  3. 4 
     
Average discount rate  3.4%

5. Stock Based Compensation

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

The Company also has a 2008 Stock Incentive Plan under which 5 million shares of common stock are reserved for issuance. As of September 30, 2020, there were approximately 2.3 million shares subject to outstanding stock options and approximately 0.8 million shares outstanding related to restricted stock grants issued from the 2008 Plan. This plan expired on November 20, 2018 and thus no further shares are available for future grant under this plan.

In November 2019, the Company adopted the 2019 Stock Incentive Plan under which 5.4 million shares of common stock were reserved for issuance. As of September 30, 2020, there remained outstanding stock options to purchase 0.9 million shares issued under this Plan. No other options are available for issuance under this Plan, which expires on November 14, 2029.

During the period ended September 30, 2020, the Company issued an aggregate of approximately 2.8 million shares of its common stock upon the exercise of 4.55 million options. Of the 4.55 million option shares, holders of 4.4 million options exercised their shares on a cashless basis into approximately 2.69 million shares of the Company’s common stock. The Company received $39,000 for the exercise of the remaining 150,000 options shares in exchange for 150,000 shares of its common stock.

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 September 30,  Nine Months Ended September, 30, 
  2020  2019  2020  2019 
Research and development $  $  $   $(2,672)
General and administrative — employee  87,277   216,234   260,598   644,113 
Total employee stock-based compensation $87,277  $216,234  $260,598  $641,441 

Options

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

Presented below is our stock option activity:

  Nine Months Ended September 30, 2020 
  

Number of Options

(Employees)

  Number of Options (Non-Employees)  Total Number of Options  Weighted-Average Exercise Price 
Outstanding at January 1, 2020  7,126,340   615,000   7,741,340  $3.32 
Granted            
Exercised  (4,300,000)  (250,000)  (4,550,000) $0.26 
Forfeited or expired  (3,570)     (3,570) $32.76 
Outstanding at September 30, 2020  2,822,770   365,000   3,187,770  $7.67 
Exercisable at September 30, 2020  2,432,320   365,000   3,162,320  $7.71 

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


Range of Exercise Prices
  Number of Options  Weighted-Average Remaining Contractual Life (years)  Weighted-Average Exercise Price  Number of Options Exercisable  Weighted-Average Remaining Contractual Life (years)  Weighted-Average Exercise Price 
$0.26 - $1.00   850,000   9.21  $0.26   850,000   9.21  $0.26 
$1.01 – $3.00   1,050,673   6.86  $2.04   1,025,223   6.75  $2.05 
$3.01 – $15.00   852,360   4.22  $12.56   852,360   4.22  $12.56 
$15.01 –$42.42   434,737   3.19  $26.13   434,737   3.19  $26.13 
     3,187,770   6.28  $7.67   3,162,320   8.24  $7.71 

The Company recorded stock compensation costs related to vesting of options during the period of $30,392 and $91,179, respectively, for the three and nine-month periods ended September 30, 2020, as compared to $75,406 and $226,224, respectively, for the three and nine-month periods ended September 30, 2019. As of September 30, 2020, there remained approximately $20,000 of unrecognized compensation expense related to unvested stock options granted to current employees, which we expect will be recognized over a weighted-average period of 0.16 years. The aggregate intrinsic value of the outstanding options and options vested as of September 30, 2020 was $0.3 million.

At September 30, 2020 and December 31, 2019, there were warrants outstanding to purchase 193,196 shares, at a weighted-average exercise price of $8.60, in each period. Outstanding warrants at September 30, 2020 had no intrinsic value as of the period then ended.

Restricted Stock

In December 2017, the Company granted to Steven Kriegsman, Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years. The fair value of the restricted stock is based on the market price of the Company’s shares on the grant date less the par value received as consideration. The fair value of the restricted stock on the grant date was $679,000. In December 2016, the Company granted to Steven Kriegsman, Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years. The fair value of the restricted stock is based on the market price of the Company’s shares on the grant date less the par value received as consideration. The fair value of the restricted stock on the grant date was $1,000,000. The Company recorded an employee stock-based compensation expense for restricted stock of $56,885 and $169,419 respectively, for the three and nine-month periods ended September 30, 2020 as compared to $140,827 and $417,889 respectively, for the three and nine-month periods ended September 30, 2019. As of September 30,2020, there remained approximately $56,000 of unrecognized compensation expense related to the vesting of these shares.

6. Income Taxes

 

At December 31, 2018,2019, we had federal and state net operating loss carryforwards as of $310.6$321.8 million and $235.6$246.7 million, respectively, available to offset against future taxable income, which expire in 20192024 through 2038,2037, of which $237.9$249.1 million and $235.6 million, respectively, are not subject to limitation under Section 382 of the Internal Revenue Code.

12.7. Commitments and contingenciesContingencies

 

Commitments

CommitmentsAldoxorubicin

We have an agreement with Vergell Medical (formerly KTB Tumorforschungs GmbH, orwith KTB) (“Vergell”) for the Company’s 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 rightrights to the intellectual property under the agreement, we willare entitled to deduct a percentage of those payments from the royalties due Vergell, up to an agreed upon cap.

 

ContingenciesArimoclomol

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 appliedapply the disclosure provisions of ASC 460,Guarantees(“ASC 460”) to ourits agreements that contain guarantees or indemnities by us.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 us.the Company.

 

During 2018, the Company successfully resolved various shareholder derivative actions and a class action lawsuit that were pending against it. The Company has directors’ and officers’ liability insurance, which would be utilized in the defense of any such matters.

The Company may from time to time be subject to third-party claims or proceedings, include those claiming that we are infringing the proprietary rights of others or that we owe royalty, milestone or other payments to third parties. 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. The Company has made claims for reimbursements under its Directors & Officers insurance coverage. These claims are subject to inherent uncertainties, and management’s view of these matters may change in the future Until the claims are processed and finalized, there is no guarantee the amounts will be fully recoverable.

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

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

 

Forward Looking Statements

 

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

 

All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, the factors discussed in this section and under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2018,2019, which should be reviewed carefully. If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. Please consider our forward-looking statements in light of those risks as you read this Quarterly Report. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

 

Overview

 

CytRx Corporation (“CytRx”) is a biopharmaceutical research and development company specializing in oncology and rareneurodegenenerative 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 onin 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 to it all of its assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection with said transfer, the Company and Centurion entered into a Management Services Agreement whereby the Company agreed to render advisory, consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the Company for the cost of such services plus a 5% service charge. The Management Services Agreement may be terminated by either party at any time. Centurion is focused on the development of personalized medicine for solid tumor treatment. On December 21, 2018, CytRx announced that Centurion had concluded the pre-clinical phase of development for its four LADR drug candidates, and for its albumin companion diagnostic (ACDx™). As a result of completing this work, operations taking place at the pre-clinical laboratory in Freiburg, Germany would no longer be needed and, accordingly, the lab was closed at the end of January 2019.

 

In December 2019, a novel strain of coronavirus, COVID-19, was first identified in China and has surfaced in several regions across the world. In March 2020, the disease was declared a pandemic by the World Health Organization. Although te hCompany’s current operations have not been impacted, as the situation with Covid-19 continues to evolve, the companies which are working to further develop and commercialize our products, ImmunityBio and Orphazyme, could be materially and adversely affected by the risks, or the public perception of the risks, related to this pandemic. Among other things, the active and planned clinical trials by ImmunityBio and Orphazyme and their regulatory approvals, if any, may be delayed or interrupted, which could delay or adversely affect the Company’s potential receipt of milestone and royalty payments within the disclosed time periods and increase expected costs. As of the date of this filing, senior management and administrative staff are working primarily remotely and will return to their offices at a yet to be determined date.

15

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 chemotherapies)cytotoxins) by controlling the release of the drug payloads and improving drug-like properties.

 

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

 

Centurion’s postulated mechanism of action for the albumin-binding drug conjugates is as follows:

after administration, the linker portion of the drug conjugate forms a rapid and specific covalent bond to the cysteine-34 position of circulating albumin;

circulating albumin preferentially accumulates at the tumors, bypassing concentration in other non-tumor sites, including the heart, liver and gastrointestinal tract due to a mechanism called “Enhanced Permeability and Retention”;

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

free active drug is then released.

Centurion’s novel companion diagnostic, ACDx™ (albumin companion diagnostic), was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR lead assets.

 

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

Aldoxorubicin

 

Until July 2017, the Company was focused on the research and clinical development of aldoxorubicin, theirits modified version of the widely-used chemotherapeuticcytotoxin agent, doxorubicin. Aldoxorubicin combines the chemotherapeutic 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, andindications. As a result, our company is no longer directly working on development of aldoxorubicin. As part of the license, ImmunityBio made a strategic investment of $13 million in CytRx common stock at $6.60 per share (adjusted to reflect our 2017 reverse stock split), a premium of 92% to the market price on that date. The Company also issued ImmunityBio a warrant to purchase up to 500,000 shares of common stock at $6.60, which expired on January 26, 2019. The Company is entitled to receive up to an aggregate of $343 million in potential milestone payments, contingent upon achievement of certain regulatory approvals and commercial milestones. The Company is also entitled to receive ascending double-digit royalties for net sales for soft tissue sarcomas and mid to high single digit royalties for other indications.

There can be no assurance that ImmunityBio will achieve such milestones, approvals or sales with respect to aldoxorubicin. ImmunityBio has initiated a Phase 2, randomized, two-cohort, open-label registrational-intent study for first-line and second-line treatment of locally advanced or metastatic pancreatic cancer, which includes aldoxorubicin.

Molecular Chaperone Assets

 

In 2011, CytRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme A/S (formerly Orphazyme ApS) in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million (USD) in milestone payments upon the achievement of certain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any net sales of products derived from arimoclomol. Orphazyme is testing arimoclomol in three additional indications beyond ALS, including Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). CytRx received a milestone payment of $250,000 in September 2018. Orphazyme has highlighted positive Phase2/3 clinical trial data in patients with NPC and has announced they remain on track to submithave submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), which is currently under Priority Review by the U.S. Food and Drug Administration (“FDA”) with a target action date of March 17, 2021. It also recently submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA). Orphazyme has also received FDA Breakthrough Therapy Designation for arimoclomol for NPC and their Early Access Program is now operational. Orphazyme expects to obtain results from its registration trials for both sIBM and ALS in the first half of 2020. In such event,2021. CytRx will be entitled to a milestone payment of $6 million upon FDA approval, $4 million upon EMA approval and $6$2 million upon FDA approval in Japan, along with royalties and potential additional milestones.milestone payments. There can be no assurance that Orphazyme will achieve such approvals or that CytRx will receive any milestone or royalty payments.

 

Current Business Strategy

 

TheCurrently, the Company and Centurion are working on identifying partnership opportunities for LADR™ ultra-high potency drug conjugates and their albumin companion diagnostic, although no partnerships or other sources of financing have become available after over two years of effort. We have concluded all research and development on LADR and its companion diagnostic and continue to focus on identifying these partnership and financing opportunities. In addition, the Company is investigating new opportunities and lines of business. For this reason and others, including the closure of the lab, its operating expenses are expectedThere can be no assurances that any such opportunities will come to be significantly lower in the near future. Therefore, period to period comparisons should not be relied upon as predictive of the results in future periods.fruition.

 

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, 2018.2019. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements.

 

Revenue RecognitionStock-Based Compensation

 

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

Use of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free interest rate. The Company estimates volatility using a blend of its own historical stock price volatility as well as grant revenues. Grant revenues consistthat of governmentmarket comparable entities since the Company’s common stock has limited trading history and private grants.

On January 1, 2018 CytRx adopted Accounting Standards Update 2014-09,Revenue from Contracts with Customers (“ASC 606”)limited observable volatility of its own. The expected term of the options is estimated by using the modified retrospective methodSecurities and Exchange Commission Staff Bulletin No. 107’s Simplified Method for contracts that were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under the new standard, while prior period amounts are not adjusted and continue to be reported under the accounting standards in effect for the prior period.Estimate Expected Term. The cumulative effect of initially applying ASC 606 was an adjustment to decrease the opening balance of Accumulated Deficit by $6.7 million as of January 1, 2018.risk-free interest rate is estimated using comparable published federal funds rates.

 

Net Income (Loss) per Share

Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period. Diluted earnings per share is computed by dividing the net income applicable to common stockholders by the weighted average number of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential common shares had been issued using the treasury stock method. Potential common shares are excluded from the computation when their effect is antidilutive. The guidance provides for a five-step analysisdilutive effect of transactions to determine when and how revenuepotentially dilutive securities is recognized. Other major provisions include capitalization of certain contract costs, consideration ofreflected in diluted net income per share if the timeexercise prices were lower than the average fair market value of moneycommon shares during the reporting period.

Common share equivalents that could potentially dilute net loss per share in the transaction price,future, and allowing estimateswhich were excluded from the computation of variable consideration to be recognized before contingencies are resolved in certain circumstances. The guidance also requires enhanced disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from an entity’s contracts with customers.

Under the new standard the ImmunityBio Licensing Agreement, which was determined to be a functional license agreement, as the underlying intellectual property had standalone functionality, was recognizable in 2017 when ImmunityBio obtained the right to use the intellectual property. The subsequent Reimbursement Agreement was determined to be a contract modification that introduced variable contra revenuediluted loss per share, totaled 3.4 million for the Company’s reimbursement obligations. In accordance with ASC 606, management estimated its obligations undernine-month period ended September 30, 2020, and 2.6 million shares for the Reimbursement Agreement to be $3.2 million which is recognized as a contract liability at the time of revenue recognition. These costs were previously recognized as research and development expense in 2017 in accordance with prior accounting standards. This contract liability was reduced to $0.3 million as of January 1, 2018 as a result of costs incurred under the Reimbursement Agreement. This amount was further reduced to $50,000 as of December 31, 2018 and $9,000 as ofnine-month period ended September 30, 2019.

 

Additionally,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 September 30, 2020, we had cash and cash equivalents and short-term investments of approximately $12.6 million. Management believes that our current cash and cash equivalents and short-term investments will be sufficient to fund the Company’s operations for the foreseeable future. This estimate is based, in part, upon our currently projected expenditures for the remainder of 2020 and the first ten months of 2021 of approximately $5.5 million (unaudited) to fund operating activities. These projected expenditures and payments are also based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these projections. While these projections represent our current expected expenditures, CytRx is eligiblehas the ability to receive tiered high singlereduce the amounts and alter the timing of certain expenditures as needed to low double-digit royaltiesmanage its liquidity needs while still advancing its corporate objectives. We will ultimately be required to obtain additional funding in order to execute our long-term business plans, although we do not currently have commitments from any third parties to provide it with long term debt or capital. CytRx cannot assure that additional funding will be available on product sales. The royalty term is determinedfavorable terms, or at all. If we fail to obtain additional funding when needed, we may have to liquidate some or all of our assets or delay or reduce the scope of or eliminate some portion or all of our development programs.

We recorded a net loss from continuing operations of approximately $5.3 million for the nine-month period ended September 30, 2020, as compared to a net loss from continuing operations in the nine-month period ended September 30, 2019 of $4.6 million. This net loss from continuing operations was approximately $0.7 million higher on a licensed-product-by-licensed-productcomparative basis, due to increased consulting expenditures related to establishment of a regulatory plan for the Company’s Centurion Biopharma assets, a substantial increase in professional fees and country-by-country basisrelated costs associated with a proxy contest related to our 2020 annual meeting of stockholders, as compared to no research and begins ondevelopment expenses in the first commercial2019 period and a reduction in head count as well as other cost reduction initiatives in 2019 .. In 2019, we had closed our drug development operations in Freiburg, Germany and sold substantially all of the Company’s fixed assets, resulting in a gain from discontinued operations of $0.4 million in the nine-month period ended September 30, 2019.

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

One of the Company’s Board members exercised a licensed productportion of his stock options resulting in a countrycash infusion of $39,000 in the nine month period ended September 30, 2020, as compared to no financing transactions in the comparative 2019 period.

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 endswe may not be able to obtain future financing on favorable terms, or at all. The results of our technology licensing efforts and the expirationactual 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 $2.8 and $5.3 million for the three-month and nine-month periods ended September 30, 2020, as compared to a net loss of approximately $1.5 million and $4.2 million for the three-month and nine-month periods ended September 30, 2019, respectively. Our net loss from continuing operations for the nine-month period was approximately $0.7 million higher on a comparative basis, primarily due to increased consulting expenditures related to establishment of a regulatory plan for the Company’s Centurion Biopharma assets and an increase in professional fees and related costs associated with a proxy contest related to our 2020 annual meeting of stockholders. In 2019, we had closed our drug development operations in Freiburg Germany and sold most of the lastCompany’s fixed assets, resulting in a gain from discontinued operations of $0.4 million in the nine-month period ended September 30, 2019.

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

General and Administrative Expenses

  Three-Month Period Ended September 30,  

Nine-Month Period Ended

September 30,

 
  2020  2019  2020  2019 
  (In thousands)  (In thousands) 
General and administrative expenses $2,113  $1,325  $4,303  $4,154 
Amortization of stock awards  87   216   261   644 
Depreciation and amortization  8   5   22   16 
  $2,208  $1,546  $4,586  $4,814 

General and administrative expenses include all administrative salaries and general corporate expenses, including legal and consulting expenses. Our general and administrative expenses, excluding stock expense, non-cash expenses and depreciation and amortization, were $2.1 million and $4.3 million for the three and nine-month periods ended September 30, 2020, respectively, and $1.3 million and $4.2 million, respectively, for the same periods in 2019. Our general and administrative expenses in the comparative three-month period excluding amortization of stock awards, non-cash expenses and depreciation and amortization, increased by approximately $0.8 million, primarily due to expire of specified patents or regulatory exclusivity covering such licensed producta substantial increase in such country or,professional fees and related costs associated with a customary royaltyproxy contest related to our 2020 annual meeting of stockholders. For the nine-month period ended September 30, 2020, these increased professional fees and related costs were somewhat offset on a comparative period by a reduction ten years after the first commercial sale if there is no such exclusivity. These revenues will be recognized when earned.in head count as well as other cost reduction initiatives.

 

ResearchGeneral and DevelopmentAdministrative Expenses

 

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

  Three-Month Period Ended September 30,  

Nine-Month Period Ended

September 30,

 
  2020  2019  2020  2019 
  (In thousands)  (In thousands) 
General and administrative expenses $2,113  $1,325  $4,303  $4,154 
Amortization of stock awards  87   216   261   644 
Depreciation and amortization  8   5   22   16 
  $2,208  $1,546  $4,586  $4,814 

 

Stock-Based Compensation

Our stock-based employee compensation plans are described in Note 8 of the Notes to Condensed Financial Statements included in this Quarterly Report. We follow ASC 718,Compensation-Stock Compensation(“ASC 718”), which requires the measurementGeneral and recognition of compensation expense foradministrative expenses include all stock-based awards made to employees.

For stock optionsadministrative salaries and warrants paid in consideration of services rendered by non-employees, we recognize compensation expense in accordance with the requirements of ASC 505-50,Equity-Based Payments to Non-Employees(“ASC 505-50”).

Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period prior to performance, the value of these options is determined using the Black-Scholes option-pricing model,general corporate expenses, including legal and compensation expense recognized or recovered during the period is adjusted accordingly. Since the fair market value of options granted or issued to non-employees is subject to change in the future, the amount of the future compensation expense is subject to adjustment until the common stock options or warrants are fully vested.

The fair value of each stock option and warrant is estimated using the Black-Scholes option-pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the stock options and future dividends. Compensation expense is recorded based upon the value derived from the Black-Scholes option-pricing model, based on an expected forfeiture rate that is adjusted for our actual experience. If our Black-Scholes option-pricing model assumptions or our actual or estimated forfeiture rate are different in the future, it could materially affect our compensation expense recorded in future periods.

Net Income (Loss) per Share

Basic and diluted net loss per common share is computed using the weighted-average number of common shares outstanding. Potentially dilutive stock options and warrants to purchase 2.6 million shares for each of the three-month and nine-month periods ended September 30, 2019, and 3.5 million shares for each of the three-month and nine-month periods ended September 30, 2018, were excluded from the computation of diluted net loss per share, because the effect would be anti-dilutive.

Liquidity and Capital Resources

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

At September 30, 2019, the Company had cash and cash equivalents and short-term investments of approximately $18.5 million. We believe that our current cash and cash equivalents will be sufficient to fund our operations for the foreseeable future. The estimate is based, in part, upon our currently projected expenditures for the remainder of 2019 and the first ten months of 2020 of approximately $5.0 million. These projected expenditures are also based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these projections.

We recorded a net loss in the nine-months ended September 30, 2019 of $4.2 million as compared to a net loss in the nine-months ended September 30, 2018 of $10.4 million, or a decrease of $6.2 million. CytRx closed its drug development operations in Freiburg Germany in December 2018, resulting in a comparative decrease of approximately $3.0 million in these discontinued operations. There were also reductions in research and development expenditures of $0.6 million, a decrease of $1.7 million inconsulting expenses. Our general and administrative expendituresexpenses, excluding stock expense, non-cash expenses and a reduction in interest expense of $1.7 million, offset by the gain on warrant derivative liabilities of $0.5 million in 2018 as compared to none in 2019 We also received no milestone revenues in 2019 as compared to $0.3 million in the comparative 2018 period.

We purchased $10 million of short-term investments in the current nine-month period,depreciation and realized $0.5 million from the sale of fixed assets from the discontinued operations in the nine-month period ended September 30, 2019, as compared to capital expenditures of $11,000 in the nine-month period ended September 30, 2018. We do not expect any significant capital spending during the next 12 months.

Thereamortization, were no financing transactions in the nine-month period ended September 30, 2019. In the comparative 2018 period, we made principal term loan and loan end-fee payments on our now expired term loan of $11.8 million, partially offset by the receipt of a net amount of $6.5 million from the proceeds of a public offering in May 2018.

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. 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, the ability of our partner to commercialize aldoxorubicin and our ability to identify parties that are willing and able to enter into such arrangements related to our drug development efforts in our German lab 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.

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 $1.5$2.1 million and $4.2$4.3 million for the three-month and nine-month periods ended September 30, 2019, respectively, as compared to a net loss of approximately $3.3 million and $10.4 million for the three-month and nine-month periods ended September 30, 2018, respectively. The closure of our drug development operations in Freiburg Germany resulted in a comparative decrease of approximately $0.9 million and $3.0 million in expenditures for these discontinued operations for the three-month and nine-month 2019 periods. There were no research and development expenditures in the 2019 periods as compared to $0.6 million for the nine-month period ended September 30, 2018, since our aldoxorubicin program had been licensed to ImmunityBio.

We did not recognize any licensing revenue in 2019 as compared to $250,000 of licensing revenue in the three and nine-month periods ended September 30, 2018. All future licensing fees under our current licensing agreements are dependent upon successful development milestones being achieved by2020, respectively, and $1.3 million and $4.2 million, respectively, for the licensors. During the remainder of 2019, we do not anticipate receiving any significant licensing fees.

Researchsame periods in 2019. Our general and Development

  Three-Month Period Ended September 30,  

Nine-Month Period Ended

September 30,

 
  2019  2018  2019  2018 
  (In thousands)  (In thousands) 
Research and development expenses $  $(3) $1  $570 
Employee stock option expense            
Depreciation and amortization     3      8 
  $  $  $1  $578 

Researchadministrative expenses are incurred by us in the discoverycomparative three-month period excluding amortization of new information that will assist usstock awards, non-cash expenses and depreciation and amortization, increased by approximately $0.8 million, primarily due to a substantial increase in professional fees and related costs associated with a proxy contest related to our 2020 annual meeting of stockholders. For the creation and the development of new drugs or treatments. Development expenses are incurred by us in our efforts to commercialize the findings generated through our research efforts. Research and development expenses incurred during the three-month and nine-month periodsperiod ended September 30, 20182020, these increased professional fees and related primarily to our aldoxorubicin program which is licensed to ImmunityBio.costs were somewhat offset on a comparative period by a reduction in head count as well as other cost reduction initiatives.

 

General and Administrative Expenses

 

 Three-Month Period Ended September 30,  

Nine-Month Period Ended

September 30,

  Three-Month Period Ended September 30,  

Nine-Month Period Ended

September 30,

 
 2019 2018 2019 2018  2020  2019  2020  2019 
 (In thousands) (In thousands)  (In thousands) (In thousands) 
General and administrative expenses $1,325  $1,952  $4,154  $5,220  $2,113  $1,325  $4,303  $4,154 
Non-cash general and administrative expenses     20      60 
Employee stock option expense  216   384   644   1,218 
Amortization of stock awards  87   216   261   644 
Depreciation and amortization  5   5   16   16   8   5   22   16 
 $1,546  $2,361  $4,814  $6,514  $2,208  $1,546  $4,586  $4,814 

 

General and administrative expenses include all administrative salaries and general corporate expenses, including legal and consulting expenses. Our general and administrative expenses, excluding stock option expense, non-cash expenses and depreciation and amortization, were $1.3$2.1 million and $4.2$4.3 million for the three and nine-month periods ended September 30, 2019,2020, respectively, and $2.0$1.3 million and 5.2$4.2 million, respectively, for the same periods in 2018.2019. Our general and administrative expenses in the comparative nine-month periodsthree-month period excluding amortization of stock option expense,awards, non-cash expenses and depreciation and amortization, decreasedincreased by approximately $0.6$0.8 million, primarily due to a decreasesubstantial increase in legalprofessional fees and related costs associated with a proxy contest related to our 2020 annual meeting of stockholders. For the nine-month period ended September 30, 2020, these increased professional fees and related costs were somewhat offset on a comparative period by a reduction in head count as well as other cost reduction initiatives.

 

Employee stock option expense relatesResearch and Development Expenses

Research and development expenses consist of direct and overhead-related research expenses and are expensed as incurred. Costs to options granted to retainacquire technologies, including licenses, that are utilized in research and compensate directors, officersdevelopment and other employees. We recorded,that have no alternative future use are expensed when incurred. Costs of technology developed for use in total, approximately $0.2 millionour products are expensed as incurred until technological feasibility has been established. Our research and 0.6 million of employee stock option expense indevelopment expenses for the three-monththree and nine-month periods ended September 30, 2019,2020, respectively, were $0.6 million and $0.8 million as compared to $0.4 million and $1.2 million, respectively,a minimal amount in the comparative 2019 periods. The expenses in the current periods relate primarily to consulting fees for the same periods in 2018. We recorded no non-employee stock option expense in the three-month and nine-month periods, ended September 30, 2019, respectively, as compared to $20,000 and $60,000establishment of a regulatory plan for the comparative 2018 periods.Company’s Centurion BioPharma assets as we continue to focus on identifying a partnership.

 

Depreciation and Amortization

 

Depreciation expense reflects the depreciation of our equipment and furnishings.

Interest Income and Expense

 

Interest income was approximately $91,000$21,000 and $284,000$112,000 for the three-month and nine-month periods ended September 30, 2019,2020, respectively, as compared to $93,000$91,000 and $269,000,$284,000, respectively, for the same periods in 2018.2019, primarily due to a significant drop in interest rates.

 

There was no interest expense in 2019 as compared to $0.4 million and $1.7 million for the comparative 2018 periods

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 September 30, 2019,2020, it would not have had a material effect on our results of operations or cash flows for that period.

 

Item 4. — Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Securities Exchange Act Rule 13a-15(e)) as of the end of the quarterly period covered by this Quarterly Report. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.

 

Changes in Controls over Financial Reporting

 

There was no change in our internal control over financial reporting that occurred during the quarter ended September 30, 20192020 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 weaknessweaknesses 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, 20182019 (the “Form 10-K”), which was filed with the SEC on March 29, 2019.26, 2020. The risk factors associated with our business have not materially changed compared to the risk factors disclosed in the Form 10-K.

 

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

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

Item 6. — Exhibits

 

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

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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: November 14, 201913, 2020By:/s/ JOHN Y. CALOZ
  John Y. Caloz
  Chief Financial Officer

INDEX TO EXHIBITS

 

Exhibit

Number

 

Description

10.1Cooperation Agreement, dated August 21, 2020, by and between CytRx Corporation and Jerald A. Hammann (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 24, 2020).
31.1 Certification of Chief Executive Officer Pursuant to 17 CFR 240.13a-14(a)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 17 CFR 240.13a-14(a)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

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