0001493152-19-017120.txt : 20191114 0001493152-19-017120.hdr.sgml : 20191114 20191114061424 ACCESSION NUMBER: 0001493152-19-017120 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 58 CONFORMED PERIOD OF REPORT: 20190930 FILED AS OF DATE: 20191114 DATE AS OF CHANGE: 20191114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CYTRX CORP CENTRAL INDEX KEY: 0000799698 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 581642750 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-15327 FILM NUMBER: 191216196 BUSINESS ADDRESS: STREET 1: 11726 SAN VICENTE BOULEVARD STREET 2: SUITE 650 CITY: LOS ANGELES STATE: CA ZIP: 90049 BUSINESS PHONE: 310-826-5648 MAIL ADDRESS: STREET 1: 11726 SAN VICENTE BOULEVARD STREET 2: SUITE 650 CITY: LOS ANGELES STATE: CA ZIP: 90049 10-Q 1 form10-q.htm

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

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

 

For the quarterly period ended September 30, 2019

 

OR

 

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

 

For the transition period from            to           

 

Commission file number 0-15327

 

CytRx Corporation

(Exact name of Registrant as specified in its charter)

 

Delaware 58-1642740

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

11726 San Vicente Blvd., Suite 650

Los Angeles, CA

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

 

(310) 826-5648

(Registrant’s telephone number, including area code)

 

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

 

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

 

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [  ]

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 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:

 

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: 33,637,501 shares.

 

 

 

 
 

 

CYTRX CORPORATION

 

FORM 10-Q

 

TABLE OF CONTENTS

 

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

 

2
 

 

PART I — FINANCIAL INFORMATION

 

Item 1. — Condensed Financial Statements

 

CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS

 

   September 30, 2019   December 31, 2018 
   (Unaudited)     
ASSETS          
Current assets:          
Cash and cash equivalents  $8,491,265   $21,373,273 
Short-term investments   10,023,850     
Receivables   4,789    148,527 
Prepaid expenses and other current assets   1,410,277    913,162 
Current assets held for sale       81,182 
Total current assets   19,930,181    22,516,144 
Equipment and furnishings, net   23,071    44,326 
Other assets   10,119    40,642 
Non-current assets held for sale       324,853 
Total assets  $19,963,371   $22,925,965 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $2,194,276   $1,234,762 
Accrued expenses and other current liabilities   936,105    726,191 
Current liabilities of discontinued operations   1,272    602,713 
Total liabilities   3,131,653    2,563,666 
           
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 
Additional paid-in capital   477,834,188    477,192,747 
Accumulated deficit   (461,036,107)   (456,864,085)
Total stockholders’ equity   16,831,718    20,362,299 
Total liabilities and stockholders’ equity  $19,963,371   $22,925,965 

 

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

 

3
 

 

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

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

 

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, 
   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 

 

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

 

5
 

 

CYTRX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY

(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.

 

6
 

 

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 rare diseases. The Company’s focus has been on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel linker technologies to enhance the accumulation and release of cytotoxic anti-cancer agents at the tumor. During 2017, CytRx’s discovery laboratory, located in Freiburg, Germany, synthesized and tested over 75 rationally designed drug conjugates with highly potent payloads, culminating in the creation of two distinct classes of compounds. Four lead candidates (LADR-7 through LADR-10) were selected based on in vitro and animal preclinical studies, stability, and manufacturing feasibility. In 2018, additional animal efficacy and toxicology testing of these lead candidates was conducted. In addition, a novel albumin companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates.

 

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

 

LADR Drug Discovery Platform and Centurion

 

Centurion’s LADR™ (Linker Activated Drug Release) technology platform is a discovery engine combining 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) 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 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 partnerships or any source of financing has become available after twenty-one months of effort.

 

Aldoxorubicin

 

Until July 2017, the Company was focused on the research and clinical development of aldoxorubicin, their modified version of the widely-used chemotherapeutic 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.

 

7
 

 

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

 

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 submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first half of 2020. In such event, CytRx will be entitled to a milestone payment of $4 million upon EMA approval and $6 million upon FDA approval, along with royalties and potential additional milestones.

 

The accompanying condensed consolidated financial statements at September 30, 2019 and for the three-month and nine-month periods ended September 30, 2019 and 2018, 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, 2018 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’s audited financial statements contained in its Annual Report on Form 10-K for the year ended December 31, 2018.

 

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.

 

8
 

 

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 

 

9
 

 

   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.

 

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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.

 

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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, 2019   Nine Months Ended September 30, 2018 
Risk-free interest rate       2.42%
Expected volatility       91.6%
Expected lives (years)       6 
Expected dividend yield       0.00%

 

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.

 

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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 Company had cash and cash equivalents and short-term investments of approximately $18.5 million. Management believes 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.

 

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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. Income Taxes

 

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

 

12. Commitments and contingencies

 

Commitments

 

We have an agreement with Vergell Medical (formerly KTB Tumorforschungs GmbH, or 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 right to the intellectual property under the agreement, we will deduct a percentage of those payments from the royalties due Vergell, up to an agreed upon cap.

 

Contingencies

 

We applied the disclosure provisions of ASC 460, Guarantees (“ASC 460”) to our agreements that contain guarantees or indemnities by us. 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.

 

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.

 

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

 

Forward Looking Statements

 

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

 

All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, the factors discussed in this section and under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2018, 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 rare diseases. The Company’s focus has been on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel linker technologies to enhance the accumulation and release of cytotoxic anti-cancer agents at the tumor. During 2017, CytRx’s discovery laboratory, located in Freiburg, Germany, synthesized and tested over 75 rationally designed drug conjugates with highly potent payloads, culminating in the creation of two distinct classes of compounds. Four lead candidates (LADR-7 through LADR-10) were selected based on in vitro and animal preclinical studies, stability, and manufacturing feasibility. In 2018, additional animal efficacy and toxicology testing of these lead candidates was conducted. In addition, a novel albumin companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates.

 

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

 

LADR Drug Discovery Platform and Centurion

 

Centurion’s LADR™ (Linker Activated Drug Release) technology platform is a discovery engine combining 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) 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 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 partnerships or any source of financing has become available after twenty-one months of effort.

 

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Aldoxorubicin

 

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

 

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 submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first half of 2020. In such event, CytRx will be entitled to a milestone payment of $4 million upon EMA approval and $6 million upon FDA approval, along with royalties and potential additional milestones.

 

Current Business Strategy

 

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 expected 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.

 

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.

 

16
 

 

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

 

Revenue Recognition

 

Revenue consists of license fees from strategic alliances with pharmaceutical companies, as well as grant revenues. Grant revenues consist of government and private grants.

 

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 $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 of September 30, 2019.

 

Additionally, CytRx is eligible to receive tiered high single to low double-digit royalties on product sales. The royalty term is determined on a licensed-product-by-licensed-product and country-by-country basis and begins on the first commercial sale of a licensed product in a country and ends on the expiration of the last to expire of specified patents or regulatory exclusivity covering such licensed product in such country or, with a customary royalty reduction, ten years after the first commercial sale if there is no such exclusivity. These revenues will be recognized when earned.

 

Research and Development 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.

 

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 measurement and recognition of compensation expense for all stock-based awards made to employees.

 

For stock options 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, 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.

 

17
 

 

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 in general and administrative expenditures 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, 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.

 

There 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.

 

18
 

 

Results of Operations

 

We recorded 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, 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 by the licensors. During the remainder of 2019, we do not anticipate receiving any significant licensing fees.

 

Research 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 

 

Research expenses are incurred by us in the discovery of new information that will assist us in 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 periods ended September 30, 2018 related primarily to our aldoxorubicin program which is licensed to ImmunityBio.

 

General and Administrative Expenses

 

   Three-Month Period Ended September 30,  

Nine-Month Period Ended

September 30,

 
   2019   2018   2019   2018 
   (In thousands)   (In thousands) 
General and administrative expenses  $1,325   $1,952   $4,154   $5,220 
Non-cash general and administrative expenses       20        60 
Employee stock option expense   216    384    644    1,218 
Depreciation and amortization   5    5    16    16 
   $1,546   $2,361   $4,814   $6,514 

 

General and administrative expenses include all administrative salaries and general corporate expenses, including legal expenses. Our general and administrative expenses, excluding stock option expense, non-cash expenses and depreciation and amortization, were $1.3 million and $4.2 million for the three and nine-month periods ended September 30, 2019, respectively, and $2.0 million and 5.2 million, respectively, for the same periods in 2018. Our general and administrative expenses in the comparative nine-month periods excluding stock option expense, non-cash expenses and depreciation and amortization, decreased by approximately $0.6 million, primarily due to a decrease in legal fees and a reduction in head count

 

Employee stock option expense relates to options granted to retain and compensate directors, officers and other employees. We recorded, in total, approximately $0.2 million and 0.6 million of employee stock option expense in the three-month and nine-month periods ended September 30, 2019, respectively, as compared to $0.4 million and $1.2 million, respectively, 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 $60,000 for the comparative 2018 periods.

 

Depreciation and Amortization

 

Depreciation expense reflects the depreciation of our equipment and furnishings.

 

19
 

 

Interest Income and Expense

 

Interest income was approximately $91,000 and $284,000 for the three-month and nine-month periods ended September 30, 2019, respectively, as compared to $93,000 and $269,000, respectively, for the same periods in 2018.

 

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, 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, 2019 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 weakness 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, 2018 (the “Form 10-K”), which was filed with the SEC on March 29, 2019. The risk factors associated with our business have not materially changed compared to the risk factors disclosed in the Form 10-K.

 

Item 6. — Exhibits

 

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

 

20
 

 

SIGNATURES

 

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

 

  CytRx Corporation
     
Date: November 14, 2019 By: /s/ JOHN Y. CALOZ
    John Y. Caloz
    Chief Financial Officer

 

21
 

 

INDEX TO EXHIBITS

 

Exhibit Number

 

Description

31.1   Certification of Chief Executive Officer Pursuant to 17 CFR 240.13a-14(a)
31.2   Certification of Chief Financial Officer Pursuant to 17 CFR 240.13a-14(a)
32.1   Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2   Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS   XBRL Instance Document
101.SCH   XBRL Schema Document
101.CAL   XBRL Calculation Linkbase Document
101.DEF   XBRL Definition Linkbase Document
101.LAB   XBRL Label Linkbase Document
101.PRE   XBRL Presentation Linkbase Document

 

22
 

EX-31.1 2 ex31-1.htm

 

Exhibit 31.1

 

CERTIFICATIONS

 

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

 

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

 

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

 

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

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules713a-15(f) and 15d-15(f)) for the registrant and have:

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Date: November 14, 2019 By: /s/ STEVEN A. KRIEGSMAN
    Steven A. Kriegsman
    Chairman and Chief Executive Officer

 

 
 

EX-31.2 3 ex31-2.htm

 

Exhibit 31.2

 

CERTIFICATIONS

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Date: November 14, 2019 By: /s/ JOHN Y. CALOZ
    John Y. Caloz
    Chief Financial Officer

 

 
 

EX-32.1 4 ex32-1.htm

 

Exhibit 32.1

 

Certification of Chief Executive Officer

 

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

 

(i) the accompanying Quarterly Report on Form 10-Q of the Company for the period ended September 30, 2019 as filed with the Securities and Exchange Commission on the date hereof (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

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

 

Date: November 14, 2019 By: /s/ STEVEN A. KRIEGSMAN
    Steven A. Kriegsman
    Chairman and Chief Executive Officer

 

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

 

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

 

 
 

EX-32.2 5 ex32-2.htm

 

Exhibit 32.2

 

Certification of Chief Financial Officer

 

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

 

(i) the accompanying Quarterly Report on Form 10-Q of the Company for the period ended September 30, 2019 as filed with the Securities and Exchange Commission on the date hereof (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

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

 

Date: November 14, 2019 By: /s/ JOHN Y. CALOZ
    John Y. Caloz
    Chief Financial Officer

 

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

 

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

 

 
 

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Weighted-Average Remaining Contractual Life (years) Weighted-Average Exercise Price, Options Exercisable Cash equivalents Short-term investments Cash and cash equivalents and short-term investments Projected expenditures for preclinical programs Operating loss carryforwards Expiration date Amount of milestone payment payable Potential future milestone payments on each additional final marketing approval Aldoxorubicin [Member] Centurion Bio Pharma Corporation [Member] Common stock market price premium percentage. Consultants [Member] ContinuingOperation [Member] Refers to currently projected expenditures for clinical programs for contract liabilities. Current and Former Employees, Directors [Member] Current Employees and Directors [Member] DiscontinuingOperation [Member] Disposal group, including discontinued operation, employee stock option expense. Disposal group, including discontinued operation, loss on impairment of equipment and furnishings. Disposal group, including discontinued operation, research and development. EMA [Member] Employees and Consultants [Member] Employees And Directors [Member] Employees [Member] Employment Agreements [Member] Euro [Member] Type of estimate of range of exercise prices, one including, but not limited to, upper and lower bound amounts, maximum and minimum amounts, and point estimates. Type of estimate of range of exercise prices, one including, but not limited to, upper and lower bound amounts, maximum and minimum amounts, and point estimates. Type of estimate of range of exercise prices, one including, but not limited to, upper and lower bound amounts, maximum and minimum amounts, and point estimates. Type of estimate of range of exercise prices, one including, but not limited to, upper and lower bound amounts, maximum and minimum amounts, and point estimates. FDA [Member] Freiburg labFreiburg Lab [Member] Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. [Member] Lenders [Member] Licensing Agreement [Member] Loan Agreement [Member] Loan and Security Agreement [Member] The 2000 Long-term incentive plan, reward system designed to improve employees' long term performance by providing rewards. NantCell, Inc [Member] Non Employee [Member] Non Employees [Member] Operating Lease [Member] Orphazyme [Member] Refers to currently projected expenditures for clinical programs for other general and administrative expenses. Payments for milestone. Percentage of service charge. Aggregate par or stated value of issued nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable preferred shares, par value and other disclosure concepts are in another section within stockholders' equity. Reimbursement Agreement [Member] Tabular disclosure of the significant assumptions, including, but not limited to: (a) expected term of share options and similar instruments, (b) expected volatility of the entity's shares, (c) expected dividends, (d) risk-free rate(s), and (e) discount for post-vesting restrictions. Series A Junior Participating Preferred Stock [Member] Series B Convertible Preferred Stock [Member] Warrants classified as liabilities. Shareholders [Member] Steven Kriegsman [Member] The 2008 stock incentive plan, reward system designed to improve employees' performance by providing rewards. Incremental common shares attributable to stock options and warrants. A contract that gives the holder the right, but not the obligation, either to purchase or to sell a certain number of shares of stock at a predetermined price for a specified period of time. 2019 and First Quarter Of 2020 [Member] Unrestricted [Member] The entire disclosure of warrants or rights issued, specifically related to equity financing, and the accounting treatment of gain or loss prior to final settlement. Warrants [Member] Written down on assets held for sale. The entire disclosure of changes in accounting principles, including adoption of new accounting pronouncements, that describes the new methods, amount and effects on financial statement line items. The entire disclosure for liquidity and capital resources. Weighted-average price of equity instruments other than options outstanding, including both vested and non-vested instruments. Nant Cell Licensing Agreement [Member] April 30, 2019 [Member] Freiburg Germany [Member] Office Furniture [Member] Current Employees [Member] Stock Options, RestrictedStock and Warrants [Member] Monetary value refers to the entity estimate currently projected expenditures. The potential future milestone payments on each additional final marketing approval as of the balance sheet date. Milestone method revenue recognized. Accounting Standards Codification (ASC) 606 adoption. The number of shares increase in additional paid in capital (APIC) resulting from the issuance of warrants. Includes allocation of proceeds of debt securities issued with detachable stock purchase warrants. Tabular disclosure of total share-based compensation expense resulting from stock options, restricted stock and warrants included in the company's unaudited interim statements of operations. Management Services Agreement [Member] Issuance of stock options/restricted stock and warrants for compensation and services. (Purchase) Sale of fixed assets held for sale. Gain on sale of assets held for sale. Weighted average assumptions, expected lives. Warrants classified as liabilities (in shares). Preferred stock, additional shares authorized Current liabilities held for sale. Stock compensation from discontinued operations. 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Warrant Liabilities (Tables)
9 Months Ended
Sep. 30, 2019
Warrant Liabilities [Abstract]  
Schedule of Weighted-average Assumptions

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  

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Description of Company and Basis of Presentation (Details Narrative) - USD ($)
1 Months Ended 9 Months Ended 12 Months Ended
Jul. 27, 2017
Sep. 30, 2018
Sep. 30, 2019
Dec. 31, 2011
Jun. 01, 2018
Cash investment $ 13,000,000        
Investment in common stock per share $ 6.60        
Common stock market price premium percentage 92.00%        
Number of warrants issued to purchase shares of common stock 500,000        
Warrants exercise price per share $ 6.60        
Warrant expiration Jan. 26, 2019        
Milestone payments receivable $ 343,000,000 $ 250,000      
EMA [Member]          
Payments for milestone     $ 4,000,000    
FDA [Member]          
Payments for milestone     $ 6,000,000    
Management Services Agreement [Member]          
Service charge, percentage         5.00%
Orphazyme A/S [Member]          
Milestone payments receivable       $ 120,000,000  
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Discontinued Operations - Schedule of Discontinued Operations (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2019
Sep. 30, 2018
Sep. 30, 2019
Sep. 30, 2018
Dec. 31, 2018
Current assets held for sale     $ 81,182
Non-current assets held for sale     324,853
Current liabilities of discontinued operations 1,272   1,272   602,713
Loss (gain) from discontinued operations (19,243) $ 909,336 (397,955) $ 2,601,614  
Discontinued Operations [Member]          
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   1,272   323,736
Accrued expenses and other current liabilities     278,977
Current liabilities of discontinued operations 1,272   1,272   $ 602,713
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  
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Income Taxes (Details Narrative)
12 Months Ended
Dec. 31, 2018
USD ($)
Earliest Tax Year [Member]  
Expiration date Dec. 31, 2019
Latest Tax Year [Member]  
Expiration date Dec. 31, 2038
Federal [Member]  
Operating loss carryforwards $ 310,600,000
Federal [Member] | Earliest Tax Year [Member]  
Operating loss carryforwards 237,900,000
State [Member]  
Operating loss carryforwards 235,600,000
State [Member] | Latest Tax Year [Member]  
Operating loss carryforwards $ 235,600,000
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Condensed Consolidated Balance Sheets - USD ($)
Sep. 30, 2019
Dec. 31, 2018
Current assets:    
Cash and cash equivalents $ 8,491,265 $ 21,373,273
Short-term investments 10,023,850
Receivables 4,789 148,527
Prepaid expenses and other current assets 1,410,277 913,162
Current assets held for sale 81,182
Total current assets 19,930,181 22,516,144
Equipment and furnishings, net 23,071 44,326
Other assets 10,119 40,642
Non-current assets held for sale 324,853
Total assets 19,963,371 22,925,965
Current liabilities:    
Accounts payable 2,194,276 1,234,762
Accrued expenses and other current liabilities 936,105 726,191
Current liabilities of discontinued operations 1,272 602,713
Total liabilities 3,131,653 2,563,666
Commitments and contingencies
Stockholders' equity:    
Preferred Stock, value
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
Additional paid-in capital 477,834,188 477,192,747
Accumulated deficit (461,036,107) (456,864,085)
Total stockholders' equity 16,831,718 20,362,299
Total liabilities and stockholders' equity 19,963,371 22,925,965
Series A Junior Participating Preferred Stock [Member]    
Stockholders' equity:    
Preferred Stock, value
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Warrant Liabilities
9 Months Ended
Sep. 30, 2019
Warrant Liabilities [Abstract]  
Warrant Liabilities

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.

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Liquidity and Capital Resources
9 Months Ended
Sep. 30, 2019
Liquidity and Capital Resources [Abstract]  
Liquidity and Capital Resources

10Liquidity and Capital Resources

 

At September 30, 2019, the Company had cash and cash equivalents and short-term investments of approximately $18.5 million. Management believes 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.

 

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.

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Condensed Consolidated Statements of Stockholders Equity (Unaudited) - USD ($)
Series B Preferred Stock [Member]
Common Stock [Member]
Additional Paid-In Capital [Member]
Accumulated Deficit [Member]
Total
Balance at Dec. 31, 2017 $ 28,037 $ 468,969,445 $ (450,852,427) $ 18,145,055
Balance, shares at Dec. 31, 2017 28,037,501      
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 Mar. 31, 2018 $ 28,037 469,450,756 (448,226,051) 21,252,742
Balance, shares at Mar. 31, 2018 28,037,501      
Balance at Dec. 31, 2017 $ 28,037 468,969,445 (450,852,427) 18,145,055
Balance, shares at Dec. 31, 2017 28,037,501      
Net loss         (10,376,203)
Balance at Sep. 30, 2018   $ 33,637 476,843,206 (454,526,680) 22,350,163
Balance, shares at Sep. 30, 2018   33,637,501      
Balance at Mar. 31, 2018 $ 28,037 469,450,756 (448,226,051) 21,252,742
Balance, shares at Mar. 31, 2018 28,037,501      
Stock issued in connection with a public offering $ 5,600 6,506,551 $ 6,512,151
Stock issued in connection with a public offering, shares 5,600,000    
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 Jun. 30, 2018 $ 33,637 476,410,506 (451,235,639) 25,208,504
Balance, shares at Jun. 30, 2018 33,637,501      
Issuance of stock options/restricted stock and warrants for compensation and services   432,700 432,700
Net loss   (3,291,041) (3,291,044)
Balance at Sep. 30, 2018   $ 33,637 476,843,206 (454,526,680) 22,350,163
Balance, shares at Sep. 30, 2018   33,637,501      
Balance at Dec. 31, 2018 $ 33,637 477,192,747 (456,864,085) 20,362,299
Balance, shares at Dec. 31, 2018 33,637,501      
Issuance of stock options/warrants for compensation and services $ 210,502 $ 210,502
Issuance of stock options/warrants for compensation and services, shares
Net loss $ (1,425,988) $ (1,425,988)
Balance at Mar. 31, 2019 $ 33,637 477,403,249 (458,290,073) 19,146,813
Balance, shares at Mar. 31, 2019 33,637,501      
Balance at Dec. 31, 2018 $ 33,637 477,192,747 (456,864,085) 20,362,299
Balance, shares at Dec. 31, 2018 33,637,501      
Net loss         (4,172,022)
Balance at Sep. 30, 2019 $ 33,637 477,834,188 (461,036,107) 16,831,718
Balance, shares at Sep. 30, 2019 33,637,501      
Balance at Mar. 31, 2019 $ 33,637 477,403,249 (458,290,073) 19,146,813
Balance, shares at Mar. 31, 2019 33,637,501      
Issuance of stock options/restricted stock and warrants for compensation and services 214,706 214,706
Net loss (1,274,495) (1,274,495)
Balance at Jun. 30, 2019 $ 33,637 $ 477,617,955 $ (459,564,568) $ 18,087,024
Balance, shares at Jun. 30, 2019 33,637,501
Issuance of stock options/warrants for compensation and services $ 216,233 $ 216,233
Issuance of stock options/warrants for compensation and services, shares
Net loss $ (1,471,539) $ (1,471,539)
Balance at Sep. 30, 2019 $ 33,637 $ 477,834,188 $ (461,036,107) $ 16,831,718
Balance, shares at Sep. 30, 2019 33,637,501      
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Fair Value Measurements - Schedule of Fair Value Measurements by Level for Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($)
$ in Thousands
Sep. 30, 2019
Dec. 31, 2018
Cash equivalents $ 6,519 $ 19,731
Short-term investments 10,024  
Level 1 [Member] | Recurring [Member]    
Cash equivalents 6,519 19,731
Short-term investments 10,024  
Level 2 [Member] | Recurring [Member]    
Cash equivalents
Short-term investments  
Level 3 [Member] | Recurring [Member]    
Cash equivalents
Short-term investments  
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Stock Based Compensation - Schedule of Total Stock-based Compensation Expense from Stock Options, Restricted Stock and Warrants (Details) - Stock Options, Restricted Stock and Warrants [Member] - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2019
Sep. 30, 2018
Sep. 30, 2019
Sep. 30, 2018
Employees [Member]        
Allocated employee and non-employee stock-based compensation expense, Total $ 216,234 $ 272,356 $ 641,441 $ 888,937
Non Employees [Member]        
Allocated employee and non-employee stock-based compensation expense, Total 19,517 60,384
Research and Development Expense [Member] | Employees [Member]        
Allocated employee and non-employee stock-based compensation expense, Total 28,683 (2,672) 89,105
Research and Development Expense [Member] | Non Employees [Member]        
Allocated employee and non-employee stock-based compensation expense, Total
General and Administrative Expense [Member] | Employees [Member]        
Allocated employee and non-employee stock-based compensation expense, Total 216,234 243,673 644,113 799,832
General and Administrative Expense [Member] | Non Employees [Member]        
Allocated employee and non-employee stock-based compensation expense, Total $ 19,517 $ 60,384
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Warrant Liabilities - Schedule of Weighted-average Assumptions (Details) - Warrants [Member]
9 Months Ended
Sep. 30, 2019
shares
Sep. 30, 2018
shares
Weighted average assumptions, expected lives 0 years 18 days
Warrants classified as liabilities (in shares) 2,834,246
Risk Free Interest Rate [Member]    
Weighted average assumptions, input 0.00 1.77
Expected Dividend Yield [Member]    
Weighted average assumptions, input 0.00 0.00
Expected Volatility [Member]    
Weighted average assumptions, input 0.00 50.2
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Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)
Sep. 30, 2019
Dec. 31, 2018
Preferred stock, stated value $ 1,000 $ 1,000
Preferred stock, shares authorized 650 650
Preferred stock, shares issued
Preferred stock, shares outstanding
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 41,666,667 41,666,667
Common stock, shares issued 33,637,501 33,637,501
Common stock, shares outstanding 33,637,501 33,637,501
Series A Junior Participating Preferred Stock [Member]    
Preferred stock, par value $ 0.01 $ 0.01
Preferred stock, shares authorized 833,334  
Preferred stock, additional shares authorized 4,167  
Preferred stock, shares issued
Preferred stock, shares outstanding
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Leases
9 Months Ended
Sep. 30, 2019
Leases [Abstract]  
Leases

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 %

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Income Taxes
9 Months Ended
Sep. 30, 2019
Income Tax Disclosure [Abstract]  
Income Taxes

11. Income Taxes

 

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

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Description of Company and Basis of Presentation
9 Months Ended
Sep. 30, 2019
Accounting Policies [Abstract]  
Description of Company and Basis of Presentation

1. Description of Company and Basis of Presentation

 

CytRx Corporation (“CytRx”) is a biopharmaceutical research and development company specializing in oncology and rare diseases. The Company’s focus has been on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel linker technologies to enhance the accumulation and release of cytotoxic anti-cancer agents at the tumor. During 2017, CytRx’s discovery laboratory, located in Freiburg, Germany, synthesized and tested over 75 rationally designed drug conjugates with highly potent payloads, culminating in the creation of two distinct classes of compounds. Four lead candidates (LADR-7 through LADR-10) were selected based on in vitro and animal preclinical studies, stability, and manufacturing feasibility. In 2018, additional animal efficacy and toxicology testing of these lead candidates was conducted. In addition, a novel albumin companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates.

 

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

 

LADR Drug Discovery Platform and Centurion

 

Centurion’s LADR™ (Linker Activated Drug Release) technology platform is a discovery engine combining 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) 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 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 partnerships or any source of financing has become available after twenty-one months of effort.

 

Aldoxorubicin

 

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

 

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 submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first half of 2020. In such event, CytRx will be entitled to a milestone payment of $4 million upon EMA approval and $6 million upon FDA approval, along with royalties and potential additional milestones.

 

The accompanying condensed consolidated financial statements at September 30, 2019 and for the three-month and nine-month periods ended September 30, 2019 and 2018, 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, 2018 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’s audited financial statements contained in its Annual Report on Form 10-K for the year ended December 31, 2018.

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Stock Based Compensation (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Dec. 31, 2017
Dec. 31, 2016
Sep. 30, 2019
Sep. 30, 2018
Sep. 30, 2019
Sep. 30, 2018
Dec. 31, 2018
Share-based compensation, shares subject to stock options     2,373,998   2,373,998   2,555,835
Weighted average exercise price of stock options granted            
Expected dividend yield         0.00% 0.00%  
Stock compensation expense on vested options     $ 75,407 $ 272,356 $ 226,225 $ 888,937  
Warrants [Member]              
Warrants outstanding     193,196   193,196   693,196
Weighted-average exercise price of warrants outstanding     $ 8.60   $ 8.60   $ 7.16
Current Employees [Member]              
Unrecognized compensation expense related to unvested stock options, granted     $ 200,000   $ 200,000    
Unrecognized compensation cost, recognized as expense over a weighted-average period         6 months 3 days    
Restricted Stock [Member]              
Restricted stock expense     $ 140,827 $ 140,827 $ 417,889 $ 417,889  
Stock Options [Member]              
Number of stock options granted to purchase common stock           1,667  
Weighted average exercise price of stock options granted           $ 1.89  
Expected dividend yield           0.00%  
2000 Long Term Incentive Plan [Member]              
Expiration date         Aug. 06, 2010    
Share-based compensation, shares subject to stock options     10,452   10,452    
2008 Stock Incentive Plan [Member]              
Share-based compensation, shares subject to stock options     2,400,000   2,400,000    
2008 Stock Incentive Plan [Member] | Restricted Stock [Member]              
Share-based compensation, outstanding stock options     800,000   800,000    
2008 Stock Incentive Plan [Member] | Restricted Stock [Member] | Chairman and Chief Executive Officer [Member]              
Share based compensation arranged by share based payment award restricted stock granted 387,597 387,597          
Vesting period 3 years 3 years          
Share based compensation of fair value of restricted stock on grant $ 679,000 $ 1,000,000          
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Warrant Liabilities (Details Narrative) - USD ($)
3 Months Ended 9 Months Ended
Jul. 20, 2018
Sep. 30, 2019
Sep. 30, 2018
Sep. 30, 2019
Sep. 30, 2018
Gain loss on warrant liabilities   $ 527,025
Warrants [Member]          
Number of warrants classified as liabilities 2,834,246        
Gain loss on warrant liabilities     $ 0 $ 500,000
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Stock Based Compensation - Schedule of Outstanding Stock Options (Details)
9 Months Ended
Sep. 30, 2019
$ / shares
shares
Number of Options Outstanding | shares 2,373,998
Weighted-Average Remaining Contractual Life (years) 6 years 1 month 27 days
Weighted-Average Exercise Price $ 10.69
Number of Options Exercisable | shares 2,222,291
Weighted-Average Remaining Contractual Life (years) 6 years 11 days
Weighted-Average Exercise Price, Options Exercisable $ 11.29
Stock Options [Member] | Exercise Price Range One [Member]  
Range of Exercise Prices, Lower Range 0.77
Range of Exercise Prices, Upper Range $ 5.00
Number of Options Outstanding | shares 1,123,449
Weighted-Average Remaining Contractual Life (years) 7 years 10 months 3 days
Weighted-Average Exercise Price $ 2.13
Number of Options Exercisable | shares 971,743
Weighted-Average Remaining Contractual Life (years) 7 years 9 months 22 days
Weighted-Average Exercise Price, Options Exercisable $ 2.16
Stock Options [Member] | Exercise Price Range Two [Member]  
Range of Exercise Prices, Lower Range 5.01
Range of Exercise Prices, Upper Range $ 11.00
Number of Options Outstanding | shares 165,834
Weighted-Average Remaining Contractual Life (years) 3 years 2 months 8 days
Weighted-Average Exercise Price $ 10.98
Number of Options Exercisable | shares 165,834
Weighted-Average Remaining Contractual Life (years) 3 years 2 months 8 days
Weighted-Average Exercise Price, Options Exercisable $ 10.98
Stock Options [Member] | Exercise Price Range Three [Member]  
Range of Exercise Prices, Lower Range 11.01
Range of Exercise Prices, Upper Range $ 15.00
Number of Options Outstanding | shares 623,193
Weighted-Average Remaining Contractual Life (years) 5 years 6 months 14 days
Weighted-Average Exercise Price $ 13.89
Number of Options Exercisable | shares 623,193
Weighted-Average Remaining Contractual Life (years) 5 years 6 months 14 days
Weighted-Average Exercise Price, Options Exercisable $ 13.89
Stock Options [Member] | Exercise Price Range Four [Member]  
Range of Exercise Prices, Lower Range 15.01
Range of Exercise Prices, Upper Range $ 98.28
Number of Options Outstanding | shares 461,523
Weighted-Average Remaining Contractual Life (years) 3 years 11 months 15 days
Weighted-Average Exercise Price $ 27.09
Number of Options Exercisable | shares 461,523
Weighted-Average Remaining Contractual Life (years) 3 years 11 months 15 days
Weighted-Average Exercise Price, Options Exercisable $ 27.09
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Basic and Diluted Net Loss Per Common Share (Details Narrative) - shares
3 Months Ended 9 Months Ended
Sep. 30, 2019
Jun. 30, 2018
Sep. 30, 2019
Sep. 30, 2018
Earnings Per Share [Abstract]        
Antidilutive securities excluded from computation of earnings per share 2,600,000 3,500,000 2,600,000 3,500,000
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Leases (Tables)
9 Months Ended
Sep. 30, 2019
Leases [Abstract]  
Schedule of Rent Expense and Supplemental Cash Flow Information Related to Leases

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

 

    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 %

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Foreign Currency Remeasurement (Details Narrative) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2019
Sep. 30, 2018
Sep. 30, 2019
Sep. 30, 2018
Foreign Currency [Abstract]        
Foreign currency transaction loss, recognized $ 16,800 $ 1,300 $ 8,400 $ 7,600
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Liquidity and Capital Resources (Details Narrative)
9 Months Ended
Sep. 30, 2019
USD ($)
Liquidity and Capital Resources [Abstract]  
Cash and cash equivalents and short-term investments $ 18,500,000
Projected expenditures for preclinical programs $ 5,000,000
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Stock Based Compensation - Schedule of Share-based Payment Award, Fair Value of the Stock Options Granted, Assumptions (Details)
9 Months Ended
Sep. 30, 2019
Sep. 30, 2018
Share-based Payment Arrangement [Abstract]    
Risk-free interest rate 0.00% 2.42%
Expected volatility 0.00% 91.60%
Expected lives (years) 0 years 6 years
Expected dividend yield 0.00% 0.00%

XML 39 R32.htm IDEA: XBRL DOCUMENT v3.19.3
Leases (Details Narrative)
Sep. 30, 2019
USD ($)
Right-of-use assets $ 131,000
Lease liabilities $ 140,000
Maximum [Member]  
Operating lease, term of contract 12 months
XML 40 R1.htm IDEA: XBRL DOCUMENT v3.19.3
Document and Entity Information - shares
9 Months Ended
Sep. 30, 2019
Nov. 02, 2019
Document And Entity Information    
Entity Registrant Name CYTRX CORP  
Entity Central Index Key 0000799698  
Document Type 10-Q  
Document Period End Date Sep. 30, 2019  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity's Reporting Status Current Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business Flag true  
Entity Emerging Growth Company false  
Entity Ex Transition Period false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   33,637,501
Document Fiscal Period Focus Q3  
Document Fiscal Year Focus 2019  
XML 41 R11.htm IDEA: XBRL DOCUMENT v3.19.3
Basic and Diluted Net Loss Per Common Share
9 Months Ended
Sep. 30, 2019
Earnings Per Share [Abstract]  
Basic and Diluted Net Loss Per Common Share

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.

XML 42 R15.htm IDEA: XBRL DOCUMENT v3.19.3
Fair Value Measurements
9 Months Ended
Sep. 30, 2019
Fair Value Disclosures [Abstract]  
Fair Value Measurements

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.

XML 43 R5.htm IDEA: XBRL DOCUMENT v3.19.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
9 Months Ended
Sep. 30, 2019
Sep. 30, 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
XML 44 R9.htm IDEA: XBRL DOCUMENT v3.19.3
Recently Adopted Accounting Pronouncement
9 Months Ended
Sep. 30, 2019
New Accounting Pronouncements and Changes in Accounting Principles [Abstract]  
Recently Adopted Accounting Pronouncement

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.

XML 45 R19.htm IDEA: XBRL DOCUMENT v3.19.3
Discontinued Operations (Tables)
9 Months Ended
Sep. 30, 2019
Discontinued Operations and Disposal Groups [Abstract]  
Schedule of Discontinued Operations

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

 

    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
XML 46 R23.htm IDEA: XBRL DOCUMENT v3.19.3
Fair Value Measurements (Tables)
9 Months Ended
Sep. 30, 2019
Fair Value Disclosures [Abstract]  
Schedule of Fair Value Measurements by Level for Assets and Liabilities Measured at Fair Value on a Recurring Basis

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  

XML 47 R27.htm IDEA: XBRL DOCUMENT v3.19.3
Discontinued Operations (Details Narrative) - USD ($)
Apr. 30, 2019
Sep. 30, 2019
Dec. 31, 2018
Assets held for sale   $ 324,853
Freiburg Germany [Member]      
Written down on assets held for sale $ 7,000    
Assets held for sale   $ 0 $ 400,000
Freiburg Germany [Member] | Office Furniture and Leasehold Improvements [Member]      
Assets held for sale 300,000    
Gain on sale of property $ 200,000    
XML 48 Show.js IDEA: XBRL DOCUMENT // Edgar(tm) Renderer was created by staff of the U.S. Securities and Exchange Commission. Data and content created by government employees within the scope of their employment are not subject to domestic copyright protection. 17 U.S.C. 105. var Show={};Show.LastAR=null,Show.showAR=function(a,r,w){if(Show.LastAR)Show.hideAR();var e=a;while(e&&e.nodeName!='TABLE')e=e.nextSibling;if(!e||e.nodeName!='TABLE'){var ref=((window)?w.document:document).getElementById(r);if(ref){e=ref.cloneNode(!0); e.removeAttribute('id');a.parentNode.appendChild(e)}} if(e)e.style.display='block';Show.LastAR=e};Show.hideAR=function(){Show.LastAR.style.display='none'};Show.toggleNext=function(a){var e=a;while(e.nodeName!='DIV')e=e.nextSibling;if(!e.style){}else if(!e.style.display){}else{var d,p_;if(e.style.display=='none'){d='block';p='-'}else{d='none';p='+'} e.style.display=d;if(a.textContent){a.textContent=p+a.textContent.substring(1)}else{a.innerText=p+a.innerText.substring(1)}}} XML 49 R42.htm IDEA: XBRL DOCUMENT v3.19.3
Commitments and Contingencies (Details Narrative)
Sep. 30, 2019
USD ($)
Commitments and Contingencies Disclosure [Abstract]  
Amount of milestone payment payable $ 7,500,000
Potential future milestone payments on each additional final marketing approval $ 1,000,000
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Stock Based Compensation (Tables)
9 Months Ended
Sep. 30, 2019
Share-based Payment Arrangement [Abstract]  
Schedule of Total Stock-based Compensation Expense from Stock Options, Restricted Stock and Warrants

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  

Schedule of Share-based Payment Award, Fair Value of the Stock Options Granted, Assumptions

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, 2019     Nine Months Ended September 30, 2018  
Risk-free interest rate           2.42 %
Expected volatility           91.6 %
Expected lives (years)           6  
Expected dividend yield           0.00 %

Schedule of Share-based Compensation, Stock Options, Activity

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  

Schedule of Outstanding Stock Options

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  

XML 52 R26.htm IDEA: XBRL DOCUMENT v3.19.3
Recently Adopted Accounting Pronouncement (Details Narrative) - USD ($)
12 Months Ended
Dec. 31, 2017
Sep. 30, 2019
Jan. 02, 2019
Dec. 31, 2018
Jan. 02, 2018
Revenue, Initial Application Period Cumulative Effect Transition [Line Items]          
ROU assets   $ 131,000      
Nant Cell Licensing Agreement [Member]          
Revenue, Initial Application Period Cumulative Effect Transition [Line Items]          
Deferred revenue $ 6,900,000        
Difference Between Revenue Guidance In Effect Before and After Topic 606 [Member]          
Revenue, Initial Application Period Cumulative Effect Transition [Line Items]          
Contract liability   9,000   $ 50,000  
Accounting Standards Update 2016-02 [Member]          
Revenue, Initial Application Period Cumulative Effect Transition [Line Items]          
Total lease liabilities   140,000 $ 310,000    
ROU assets   $ 131,000 $ 290,000    
Accounting Standards Update 2014-09 [Member]          
Revenue, Initial Application Period Cumulative Effect Transition [Line Items]          
Contract with customer, liability, revenue recognized $ 3,200,000        
Accounting Standards Update 2014-09 [Member] | Accumulated Deficit [Member]          
Revenue, Initial Application Period Cumulative Effect Transition [Line Items]          
Cumulative effect adjustment         $ 6,700,000
XML 53 R37.htm IDEA: XBRL DOCUMENT v3.19.3
Stock Based Compensation - Schedule of Share-based Compensation, Stock Options, Activity (Details) - $ / shares
9 Months Ended
Sep. 30, 2019
Sep. 30, 2018
Number of Options Outstanding at beginning of period 2,555,835  
Number of Options Granted  
Number of Options Exercised, Forfeited or Expired (181,837)  
Number of Options Outstanding at end of period 2,373,998  
Number of Options exercisable at end of period 2,222,291  
Weighted-Average Exercise Price Options Outstanding at beginning of period $ 10.69  
Weighted-Average Exercise Price Options Granted  
Weighted-Average Exercise Price Options Exercised, Forfeited or Expired 10.66  
Weighted-Average Exercise Price Options Outstanding at end of period 10.69  
Weighted-Average Exercise Price Options exercisable at end of period $ 11.29  
Stock Options [Member]    
Weighted-Average Exercise Price Options Granted   $ 1.89
Stock Options [Member] | Employees [Member]    
Number of Options Outstanding at beginning of period 2,190,835  
Number of Options Granted  
Number of Options Exercised, Forfeited or Expired (181,837)  
Number of Options Outstanding at end of period 2,008,998  
Number of Options exercisable at end of period 1,857,291  
Stock Options [Member] | Non Employees [Member]    
Number of Options Outstanding at beginning of period 365,000  
Number of Options Granted  
Number of Options Exercised, Forfeited or Expired  
Number of Options Outstanding at end of period 365,000  
Number of Options exercisable at end of period 365,000  
XML 54 R33.htm IDEA: XBRL DOCUMENT v3.19.3
Leases - Schedule of Rent Expense and Supplemental Cash Flow Information Related to Leases (Details)
9 Months Ended
Sep. 30, 2019
USD ($)
Leases [Abstract]  
Operating lease cost (included in General and Administrative expenses in the Company's unaudited condensed consolidated statements of operations) $ 205,520
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 - perating leases (in years) 10 months 17 days
Average discount rate 5.50%
XML 55 R8.htm IDEA: XBRL DOCUMENT v3.19.3
Foreign Currency Remeasurement
9 Months Ended
Sep. 30, 2019
Foreign Currency [Abstract]  
Foreign Currency Remeasurement

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.

XML 56 R18.htm IDEA: XBRL DOCUMENT v3.19.3
Commitments and Contingencies
9 Months Ended
Sep. 30, 2019
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

12. Commitments and contingencies

 

Commitments

 

We have an agreement with Vergell Medical (formerly KTB Tumorforschungs GmbH, or 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 right to the intellectual property under the agreement, we will deduct a percentage of those payments from the royalties due Vergell, up to an agreed upon cap.

 

Contingencies

 

We applied the disclosure provisions of ASC 460, Guarantees (“ASC 460”) to our agreements that contain guarantees or indemnities by us. 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.

 

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.

XML 57 R10.htm IDEA: XBRL DOCUMENT v3.19.3
Discontinued Operations
9 Months Ended
Sep. 30, 2019
Discontinued Operations and Disposal Groups [Abstract]  
Discontinued Operations

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  

XML 58 R14.htm IDEA: XBRL DOCUMENT v3.19.3
Stock Based Compensation
9 Months Ended
Sep. 30, 2019
Share-based Payment Arrangement [Abstract]  
Stock Based Compensation

8Stock 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, 2019     Nine Months Ended September 30, 2018  
Risk-free interest rate           2.42 %
Expected volatility           91.6 %
Expected lives (years)           6  
Expected dividend yield           0.00 %

 

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.

XML 59 R4.htm IDEA: XBRL DOCUMENT v3.19.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2019
Sep. 30, 2018
Sep. 30, 2019
Sep. 30, 2018
Revenue:        
Licensing revenue $ 250,000 $ 250,000
Expenses:        
Research and development 374 (485) 1,430 577,843
General and administrative 1,546,213 2,360,996 4,814,436 6,514,107
Total operating expenses 1,546,587 2,360,511 4,815,866 7,091,950
Loss before other income (expense) (1,546,587) (2,110,511) (4,815,866) (6,841,950)
Other income (loss):        
Interest income 91,403 93,391 283,808 269,299
Interest expense (363,086) (1,715,733)
Other income (loss), net (35,598) (1,502) (37,919) (13,230)
Gain on warrant derivative liabilities 527,025
Net loss from continuing operations (1,490,782) (2,381,708) (4,569,977) (7,774,589)
Gain (loss) from discontinued operations 19,243 (909,336) 397,955 (2,601,614)
Net loss $ (1,471,539) $ (3,291,044) $ (4,172,022) $ (10,376,203)
Basic and diluted loss per share        
Continuing operations $ (0.04) $ (0.07) $ (0.14) $ (0.26)
Discontinued operations (0.03) 0.01 (0.08)
Total basic and diluted loss per share $ (0.04) $ (0.10) $ (0.13) $ (0.34)
Basic and diluted weighted-average shares outstanding 33,249,904 32,991,506 33,249,904 30,242,788