0000799698-16-000046.txt : 20161109 0000799698-16-000046.hdr.sgml : 20161109 20161108193412 ACCESSION NUMBER: 0000799698-16-000046 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 55 CONFORMED PERIOD OF REPORT: 20160930 FILED AS OF DATE: 20161109 DATE AS OF CHANGE: 20161108 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: 161982517 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 form10q_q32016.htm QUARTERLY REPORT ON FORM 10-Q FOR QUARTER ENDING SEPTEMBER 30, 2016.




UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 10-Q

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

For the quarterly period ended September 30, 2016

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)

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 R     No £
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes R  No £
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer £
Accelerated filer R
Non-accelerated filer £
Smaller reporting company £
 
(Do not check if a smaller reporting company)

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12(b)-2 of the Exchange Act).  Yes £     No R
Number of shares of CytRx Corporation common stock, $0.001 par value, outstanding as of November 8, 2016: 96,943,072 shares.


CYTRX CORPORATION

FORM 10-Q

TABLE OF CONTENTS

 
Page
PART I. — FINANCIAL INFORMATION
 
Item 1. Financial Statements (unaudited)
 1
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
 12
Item 3. Quantitative and Qualitative Disclosures About Market Risk
 18
Item 4. Controls and Procedures
 19
   
PART II. — OTHER INFORMATION
 
Item 1. Legal Proceedings
 20
Item 1A.                  Risk Factors
 20
Item 6. Exhibits
 21
   
SIGNATURES
 22
   
INDEX TO EXHIBITS
 23



PART I — FINANCIAL INFORMATION
Item 1. — Financial Statements
CYTRX CORPORATION
CONDENSED BALANCE SHEETS
(Unaudited)
   
September 30, 2016
   
December 31, 2015
 
ASSETS
           
Current assets:
           
Cash and cash equivalents
 
$
58,875,925
   
$
22,261,372
 
Short-term investments
   
     
35,035,420
 
Receivables
   
108,345
     
4,621,605
 
Prepaid expenses and other current assets
   
2,618,919
     
2,373,708
 
Total current assets
   
61,603,189
     
64,292,105
 
Equipment and furnishings, net
   
2,066,392
     
1,467,681
 
Goodwill
   
183,780
     
183,780
 
Other assets
   
54,648
     
1,080,872
 
Total assets
 
$
63,908,009
   
$
67,024,438
 
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
Current liabilities:
Accounts payable
 
$
4,815,597
   
$
8,058,624
 
Accrued expenses and other current liabilities
   
5,049,006
     
9,693,359
 
Litigation settlement due in shares of common stock
   
     
4,500,000
 
Warrant liability
   
6,686,381
     
693,457
 
Term loan, net - current
   
3,562,578
     
 
Total current liabilities
   
20,113,562
     
22,945,440
 
                 
Long-term loan, net
   
20,197,992
     
 
Total liabilities
   
40,311,554
     
22,945,440
 
Commitments and contingencies
               
                 
Stockholders' equity:
               
Preferred stock, $0.01 par value, 5,000,000 shares authorized, including 25,000 shares of Series A Junior Participating Preferred Stock; no shares issued and outstanding
   
     
 
Common stock, $0.001 par value, 250,000,000 shares authorized;  96,943,072 shares issued and outstanding at September 30, 2016; 66,480,065 shares issued and outstanding at December 31, 2015
   
96,942
     
66,480
 
Additional paid-in capital
   
431,693,072
     
409,107,292
 
Accumulated deficit
   
(408,193,559
)
   
(365,094,774
)
Total stockholders' equity
   
23,596,455
     
44,078,998
 
Total liabilities and stockholders' equity
 
$
63,908,009
   
$
67,024,438
 

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

1

CYTRX CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)

   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
   
2016
   
2015
   
2016
   
2015
 
Revenue:
                       
License revenue
 
$
   
$
   
$
100,000
   
$
 
                                 
Expenses:
                               
Research and development
   
8,927,037
     
8,470,592
     
29,531,609
     
31,043,741
 
General and administrative
   
2,771,732
     
2,188,656
     
12,859,069
     
9,510,657
 
     
11,698,769
     
10,659,248
     
42,390,678
     
40,554,398
 
                                 
Loss before other income (loss)
   
(11,698,769
)
   
(10,659,248
)
   
(42,290,678
)
   
(40,554,398
)
                                 
Other income (loss):
                               
Interest income
   
68,635
     
68,678
     
195,809
     
171,707
 
Interest expense
   
(781,038
)
   
     
(1,939,186
)
   
 
Other income (loss), net
   
(10,489
)
   
2,040
     
(4,398
)
   
17,948
 
Gain on warrant derivative liability
   
246,211
     
3,515,178
     
939,668
     
4,079,748
 
                                 
Net loss
 
$
(12,175,450
)
 
$
(7,073,352
)
 
$
(43,098,785
)
 
$
(36,284,995
)
                                 
Basic and diluted net loss per share
 
$
(0.13
)
 
$
(0.11
)
 
$
(0.57
)
 
$
(0.62
)
                                 
Basic and diluted weighted-average shares outstanding
   
91,042,450
     
63,848,208
     
75,001,770
     
58,462,214
 
                                 
                                 

The accompanying notes are an integral part of these condensed financial statements
2


CYTRX CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)

   
Nine Months Ended September 30,
 
   
2016
   
2015
 
Cash flows from operating activities:
           
Net loss
 
$
(43,098,785
)
 
$
(36,284,995
)
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
   
364,548
     
240,391
 
Stock-based compensation expense
   
5,400,604
     
4,520,307
 
Fair value adjustment on warrant liability
   
(939,668
)
   
(4,079,748
)
Amortization of loan cost and discount
   
382,241
     
 
Loss on retirement of fixed assets
   
9,116
     
 
Changes in assets and liabilities:
               
Receivables
   
4,485,130
     
351,388
 
Interest receivable
   
28,130
     
97,873
 
Prepaid expenses and other assets
   
781,013
     
1,545,955
 
Accounts payable
   
(3,254,181
)
   
(447,430
)
Accrued expenses and other current liabilities
   
(4,644,353
)
   
(26,763
)
Net cash used in operating activities
   
(40,486,205
)
   
(34,083,022
)
                 
Cash flows from investing activities:
               
Purchase of short-term investments
   
     
(32,982,710
)
Proceeds from the sale of short-term investments
   
35,035,420
     
63,581,849
 
Purchases of equipment and furnishings
   
(961,221
)
   
(325,471
)
Net cash provided by investing activities
   
34,074,199
     
30,273,668
 
                 
Cash flows from financing activities:
               
Net proceeds from public offering
   
18,309,781
     
26,780,068
 
Net proceeds from term loan
   
24,012,078
     
 
Net proceeds from exercise of warrants and stock options
   
704,700
     
590,001
 
Net cash provided by financing activities
   
43,026,559
     
27,370,069
 
                 
Net increase in cash and cash equivalents
   
36,614,553
     
23,560,715
 
Cash and cash equivalents at beginning of period
   
22,261,372
     
32,218,905
 
Cash and cash equivalents at end of period
 
$
58,875,925
   
$
55,779,620
 
                 
Supplemental disclosure of cash flow information:
               
                 
Cash paid during the year for interest
 
$
1,359,028
   
$
 
                 
Cashless warrant exercises
 
$
   
$
3
 
                 
Cash paid for income taxes
 
$
800
   
$
800
 
 
Supplemental disclosure of non-cash activities:
           
             
Warrants issued in connection with term loan
 
$
633,749
   
$
 
                 
Equipment and furnishings purchased on credit
 
$
11,154
   
$
2,035
 
                 
Shares issued in connection with the class action settlement
 
$
4,500,000
   
$
 
 
Warrants issued in connection with public offering
 
$
6,932,592
   
$
 

The accompanying notes are an integral part of these condensed financial statements.
3

NOTES TO CONDENSED FINANCIAL STATEMENTS
September 30, 2016
(Unaudited)
1. Description of Company and Basis of Presentation
CytRx Corporation ("we," "us," "our" or the "Company") is a biopharmaceutical research and development company specializing in oncology. We currently are focused on the clinical development of aldoxorubicin (formerly known as INNO-206), our modified version of the widely-used chemotherapeutic agent, doxorubicin.  We are also developing new anti-cancer drug conjugates that utilize our Linker Activated Drug Release (LADRTM ) technology.
We previously announced the initial analysis of top-line data from our on-going global, randomized Phase 3 clinical trial of aldoxorubicin as a treatment for patients with relapsed or refractory soft tissue sarcomas, or STS. The trial enrolled 433 patients at 79 sites in 15 countries including the U.S. and Canada.
We also previously announced that we expected to conduct a second analysis which will include longer patient follow-up. In addition, we expect  to report the multiple sub-analyses of top-line data specified in the trial's statistical plan. We currently expect the second analysis to be completed in November or early December 2016.
We are currently evaluating aldoxorubicin in a global Phase 2b clinical trial in second-line small cell lung cancer in which we currently expect to announce top-line data in the first or second quarter of 2017, as the number of deaths and/or progressions needed for data analysis have not yet been reached. We are also evaluating aldoxorubicin in a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. We previously completed Phase 2 clinical trials of aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and HIV-related Kaposi's Sarcoma, a Phase 1b clinical trial of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial of aldoxorubicin in patients with metastatic solid tumors.
Although we have made progress on the pre-clinical development for DK049, a novel anti-cancer drug conjugate that utilizes our LADRTM  technology, we have suspended further development in order to devote our resources to the completion of the Phase 3 clinical trial of aldoxorubicin and preparations for our planned pre New Drug Application ("NDA") meeting with the FDA, which we believe could occur in the first quarter of 2017.  DK049 was created at our laboratory facility in Freiburg, Germany, and employs a proprietary linker that is both pH sensitive and requires a specific enzyme for the release of the cytotoxic payload.  We have now expanded our pipeline of oncology candidates utilizing our LADRTM technology to attach ultra-high potency drugs to albumin (10-1000 times more potent than traditional chemotherapies limited to antibodies only) to target tumors.
The accompanying condensed financial statements at September 30, 2016 and for the three-month and nine-month periods ended September 30, 2016 and 2015, 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, 2015 have been derived from the our audited financial statements as of that date.
The 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 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, 2015.
Following our announcement of the initial analysis of our on-going global Phase 3 clinical trial of aldoxorubicin, we took measures to reduce our "burn" rate, have decreased our head count and discontinued our pre-commercialization activities pending the results of our second analysis and of our planned pre-NDA meeting with the FDA.  For these reasons and others, our operating results may fluctuate from period to period, and the results of prior periods should not be relied upon as predictive of the results in future periods.
2. Recent Accounting Pronouncements
In August 2016, the Financial Accounting Standards Board issued ASU No. 2016-15 "Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force." The objective of ASU No. 2016-15 is to provide specific guidance on eight cash flow classification issues and how to reduce diversity in how certain cash receipts and cash payments are presented and classified in the statement of cash flows under Topic 230, Statement of Cash Flows, and other Topics. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years. We are still in the process of determining the impact that the implementation of ASU 2016-15 will have on the Company's financial statements.
4

In March 2016, the FASB issued Accounting Standards Update 2016-09, Compensation—Stock Compensation ("ASU 2016-09"). ASU 2016-09 includes several areas of simplification to stock compensation including simplifications to the accounting for income taxes, classification of excess tax benefits on the Statement of Cash Flows and forfeitures. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016. An entity that elects early adoption must adopt all of the amendments in the same period. We did not early adopt ASU 2016-09 as of and for the period ended September 30, 2016. We are still evaluating the effect of this update.
In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases ("ASU 2016-02"). ASU 2016-02 allows the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. 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 previous leases guidance. The Update 2016-02 is effective for annual reporting periods beginning after December 15, 2018 and early adoption is permitted. We are still evaluating the effect of this update.
In January 2016, the FASB issued Accounting Standards Update 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities ("ASU 2016-01"). ASU 2016-01 eliminates the requirement to disclose the methods and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet. The standard also clarifies the need to evaluate a valuation allowance on a deferred tax asset related to available-for-sale securities in combination with other deferred tax assets. ASU 2016-01 is effective for annual reporting periods beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact on our financial statements.
In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs ("ASU 2015-03"), which requires that debt issuance costs be reported in the balance sheet as a direct deduction from the face amount of the related liability, consistent with the presentation of debt discounts. Further, ASU 2015-03 requires the amortization of debt issuance costs to be reported as interest expense. Similarly, debt issuance costs and any discount or premium are considered in the aggregate when determining the effective interest rate on the debt. ASU 2015-03 is effective for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. ASU 2015-03 must be applied retrospectively. Entities may choose to adopt the new requirements as of an earlier date for financial statements that have not been previously issued. We adopted this Accounting Standard effective January 1, 2016.
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern ("Subtopic 205-40") ("ASU 2014-15"). The new guidance addresses management's responsibility to evaluate whether there is substantial doubt about an entity's ability to continue as a going concern and to provide related footnote disclosures. Management's evaluation should be based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued. The standard will be effective for the first interim period within annual reporting periods beginning after December 15, 2016. Early adoption is permitted. We do not expect to early adopt this guidance and do not believe that the adoption of this guidance will have a material impact on our financial statements.
3. Foreign Currency Remeasurement
The U.S. dollar has been determined to be the functional currency for the net assets of our laboratory facility in Germany. Transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). We recognized exchange rate losses of approximately $6,000 and $500, respectively, for the three-month and nine-month periods ended September 30, 2016 and an exchange rate gain of approximately $1,000 and an exchange rate loss of approximately $10,000 for the three and nine-month periods ended September 30, 2015, respectively.
4. Short-term Investments
We held no short-term investments at September 30, 2016, as compared to $35.0 million at December 31, 2015. We classified these investments as available for sale at December 31, 2015.
5


5. Litigation Settlement Due in Shares of Common Stock
The class-action settlement we announced in December 2015 was completed on May 25, 2016 with the issuance of 1,561,578 shares of our common stock valued at $4.5 million, or $2.88 a share, and payment of $4 million in cash, of which $3.5 million was paid by our insurance carriers and $500,000 was paid out of company funds.  In accordance with ASC 480, "Distinguishing Liabilities from Equity," we classified the $4.5 million worth of shares of the common stock as a non-cash liability due in shares of common stock on the December 31, 2015 balance sheet, due to the variable number of shares issuable under the settlement.
6. Term Loan
On February 5, 2016, we entered into a loan and security agreement with Hercules Technology Growth Capital, Inc. ("HTGC"), as administrative agent and lender, and Hercules Technology III, L.P., as lender, pursuant to which the lenders agreed to make long-term loans to us in an aggregate principal amount of up to $40 million, subject to certain conditions.  The lenders made an initial term loan to us on February 8, 2016 in the aggregate principal amount of $25 million.  The term loan bears interest at the daily variable rate per annum equal to 6.00% plus the prime rate, or 9.5%, whichever is greater.  We are required to make interest-only payments on the term loans through February 28, 2017, and beginning on March 1, 2017 we will be required to make amortizing payments of principal and accrued interest in equal monthly installments until the maturity date of the loan.  Under the terms of the loan, we are required to maintain a minimum cash balance equal to the greater of (i) $10 million or (ii) forward three months projected cash burn.  If we achieve certain milestones, we may request an additional term loan in an aggregate principal amount of up to $15 million no later than December 31, 2016, or such later date that HTGC otherwise determines in its sole discretion, but we do not expect to meet these milestones at this time.  In connection with the loan and security agreement, we issued to the lenders warrants to purchase a total of 634,146 shares of our common stock at an exercise price of $2.05. These warrants are classified on the September 30, 2016 balance sheet as equity warrants with a fair value of $633,749 as determined at the date of issuance. All outstanding principal and accrued interest on the term loans will be due and payable in full on the maturity date of February 1, 2020, subject to the lenders' right to accelerate the term loans if we were to experience a "material adverse event" (as defined in the loan and security agreement).
As security for our obligations under the loan and securities agreement, we granted HTGC, as administrative agent, a security interest in substantially all of our existing and after-acquired assets except for our intellectual property and certain other excluded assets.
The following sets forth information regarding the current and long-term portion of the term loan:
   
September 30, 2016
 
Term Loan Principal - Current
 
$
4,311,336
 
Issuance Cost - Current
   
(122,335
)
Loan Discount - Current
   
(626,423
)
Term Loan, Net - Current
 
$
3,562,578
 
         
Term Loan Principal
 
$
20,688,664
 
End Fee Payable
   
1,771,250
 
Long Term Issuance Cost
   
(353,919
)
Long Term Loan Discount
   
(1,908,003
)
Long Term Loan, Net
 
$
20,197,992
 
         
Interest expense on the term loan for the three-month and nine-month periods ended September 30, 2016 was $781,038 and $1,939,186, respectively. There was no interest expense in the 2015 comparative periods.
7. 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 44.0 million shares for each of the three-month and nine-month periods ended September 30, 2016, and 17.4 million shares for each of the three-month and nine-month periods ended September 30, 2015.
6


8. 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.  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. We recognized a gain of $0.2 million and $3.5 million for the three-month periods ended September 30, 2016 and 2015, respectively, and a gain of $0.9 million and $4.1 million for the nine-month periods ended September 30, 2016 and 2015, respectively. The following reflects the weighted-average assumptions for each of the nine-month periods indicated:
   
Nine Months Ended September 30,
 
   
2016
   
2015
 
             
Risk-free interest rate
   
0.52
%
   
0.21
%
Expected dividend yield
   
0
%
   
0
%
Expected lives
   
0.8
     
0.84
 
  Expected volatility
   
131.3
%
   
69.1
%
  Warrants classified as liabilities (in shares)
   
28,571,429
     
6,371,854
 
                 
Our computation of expected volatility is based on the historical daily volatility of its 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.
On August 1, 2016, 6,371,854 warrants expired. On July 20, 2016, we issued one-year warrants to purchase up to 28,571,429 shares of our common stock in the public offering described in Note 12.
9. Stock Based Compensation
Our 2000 Long-Term Incentive Plan expired on August 6, 2010 and no further shares are available for future grant under this plan.  As of September 30, 2016, there were approximately 0.6 million shares subject to outstanding stock options under this plan.
We also have a 2008 Stock Incentive Plan. As of September 30, 2016, there were 13.4 million shares subject to outstanding stock options and 16.4 million shares available for future grant.
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 Statements of Operations:
   
Three Months Ended September 30,
   
Nine Months Ended September 30,
 
   
2016
   
2015
   
2016
   
2015
 
Research and development — employee
 
$
455,341
   
$
402,292
   
$
1,443,347
   
$
1,131,072
 
General and administrative — employee
   
586,315
     
482,954
     
3,742,733
     
3,182,798
 
Total employee stock-based compensation
 
$
1,041,656
   
$
885,246
   
$
5,186,080
   
$
4,313,870
 
                                 
Research and development — non-employee
 
$
   
$
   
$
   
$
 
General and administrative — non-employee
   
(5,938
)
   
(27,647
)
   
214,524
     
206,437
 
Total non-employee stock-based compensation
 
$
(5,938
)
 
$
(27,647
)
 
$
214,524
   
$
206,437
 

7
During the nine-month period ended September 30, 2016, we granted stock options to purchase 475,000 shares of its common stock and warrants to purchase 500,000 shares of our common stock at a average weighted exercise price of $1.89. In the nine-month period ended September 30, 2016, we amended the terms of stock options of a former executive in respect of a Retirement Agreement, resulting in a one-time expense of approximately $1.9 million. During the nine-month period ended September 30, 2015, we granted stock options to purchase 550,000 shares of our common stock. 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, 2016
   
Nine Months Ended September 30, 2015
 
Risk-free interest rate
   
1.72
%
   
2.21
%
Expected volatility
   
74.9
%
   
78.2% - 84.4
%
Expected lives (years)
   
6
     
6 - 10
 
Expected dividend yield
   
0.00
%
   
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, 2016, 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. Based on historical experience, for the nine-month periods ended September 30, 2016 and 2015, we estimated annualized forfeiture rates of 10% for options granted to our employees, 2% for options granted to senior management and 0% for options granted to directors and non-employees and for warrants issued to non-employees  Compensation costs will be adjusted for future changes in estimated forfeitures.  We will record additional expense if the actual forfeitures are lower than estimated and will record a recovery of prior expense if the actual forfeiture rates are higher than estimated.
As of September 30, 2016, there remained approximately $4.1 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 0.96 years. Presented below is our stock option activity:
   
Nine Months Ended September 30, 2016
 
   
Number of Options (Employees)
   
Number of Options (Non-Employees)
   
Total Number of Options
   
Weighted-Average Exercise Price
 
Outstanding at January 1, 2016
   
13,583,862
     
635,714
     
14,219,576
   
$
3.10
 
Granted
   
475,000
     
     
475,000
   
$
2.05
 
Exercised, Forfeited or Expired
   
(1,221,040
)
   
(35,714
)
   
(1,256,754
)
 
$
3.30
 
Outstanding at September 30, 2016
   
12,837,822
     
600,000
     
13,437,822
   
$
3.04
 
Options exercisable at September 30, 2016
   
9,242,803
     
600,000
     
9,842,803
   
$
3.27
 


The following table summarizes significant ranges of outstanding stock options under our plans at September 30, 2016:

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
 
$
0.60 – $2.00
     
1,274,498
     
6.34
   
$
1.78
     
1,224,498
     
6.19
   
$
1.83
 
$
2.01 – $2.50
     
7,899,179
     
8.41
   
$
2.33
     
4,522,874
     
8.06
   
$
2.30
 
$
2.51 – $4.00
     
968,291
     
7.37
   
$
2.88
     
937,458
     
7.34
   
$
2.87
 
$
4.01 – $32.55
     
3,295,854
     
6.46
   
$
5.30
     
3,157,973
     
6.42
   
$
5.32
 
         
13,437,822
     
7.66
   
$
3.04
     
9,842,803
     
7.23
   
$
3.27
 

The aggregate intrinsic value of all outstanding options and vested options as of September 30, 2016 was $0 and $0, respectively, representing options with exercise prices of less than the closing fair market value of our common stock on September 30, 2016 of $0.59 per share.
There were 30,559,148 and 7,225,472 warrants outstanding at September 30, 2016 and December 31, 2015, respectively at a weighted-average exercise price of $0.80 and $4.28, respectively.
8


10. 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, 2016 for assets and liabilities measured at fair value on a recurring basis:
(In thousands)
 
Level I
   
Level II
   
Level III
   
Total
 
Cash equivalents
 
$
56,972
   
$
   
$
   
$
56,972
 
Warrant liability
   
     
     
(6,686
)
   
(6,686
)

The following table summarizes fair value measurements by level at December 31, 2015 for assets and liabilities measured at fair value on a recurring basis:
(In thousands)
 
Level I
   
Level II
   
Level III
   
Total
 
Cash equivalents
 
$
20,673
   
$
   
$
   
$
20,673
 
Short-term investments
   
35,035
     
     
     
35,035
 
Warrant liability
   
     
     
(693
)
   
(693
)

Liabilities measured at market value on a recurring basis include warrant liability resulting from our August 2011 equity financing. In accordance with ASC 815-40, the warrant liability are marked to market each quarter-end until they are completely settled. The warrants are valued using the Black-Scholes method, using assumptions consistent with our application of ASC 505-50. The $6.0 million increase in fair value of the warrant liability is due primarily to the warrants issued in connection with the July, 2016 public offering (see Note 8).
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.  Our non-financial assets were not material at September 30, 2016 or 2015.
11. Liquidity and Capital Resources
At September 30, 2016, we had cash and cash equivalents of approximately $58.9 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 2016 and the first ten months of 2017 of approximately $37.4 million, which includes approximately $15.6 million for our ongoing clinical programs for aldoxorubicin, approximately $2.7 million for our drug discovery operations at our Freiburg, Germany laboratory, approximately $3.4 million for general operation of our clinical programs, approximately $8.3 million for other general and administrative expenses, and approximately $7.4 million for interest and payments on our outstanding term loan.  These projected expenditures assume that we will not suffer a "material adverse event" which could trigger the lenders' acceleration of our outstanding term loan, and are based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these projections.
Following our announcement of the initial analysis of our on-going global Phase 3 clinical trial of aldoxorubicin, we took measures to reduce our "burn" rate, decreased our head count and discontinued our pre-commercialization activities pending the results of our second analysis and of our planned pre-NDA meeting with the FDA.  For these reasons and others, our operating results may fluctuate from period to period, and the results of prior periods should not be relied upon as predictive of the results in future periods.
If we obtain marketing approval and successfully commercialize aldoxorubicin or other product candidates, we anticipate it will take several years for us to generate significant recurring revenue. We will be dependent on future financing and possible strategic partnerships until such time, if ever, as it can generate significant recurring revenue. We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. If we fail to obtain sufficient funding when needed, we may be forced to delay, scale back or eliminate all or a portion of our development programs or clinical trials, seek to license to other companies our product candidates or technologies that we would prefer to develop and commercialize ourselves, or seek to sell some or all of our assets or merge with or be acquired by another company.
9

12. Equity Transactions
As of September 30, 2016, we have reserved approximately 16.4 million of our authorized but unissued shares of common stock for future issuance pursuant to our employee stock option plans issued to employees and consultants.
On July 20, 2016, we issued 28,579,421 shares of our common stock and one-year warrants to purchase an equal number of shares of our common stock in a public offering.
In the first quarter of 2016, we issued 100,000 common shares for $0.2 million resulting from the exercise of stock options and warrants to purchase 500,000 common shares at an exercise price of $1.74.
On October 26, 2015, we retired 199,275 shares of our treasury stock at cost ($2.6 million).
13. Income Taxes
At December 31, 2015, we had federal and state net operating loss carryforwards as of  $281.6 million and $173.7 million, respectively, available to offset against future taxable income, which expire in 2016 through 2034, of which $219.3 million and $173.7 million, respectively, are not subject to limitation under Section 382 of the Internal Revenue Code.
14. Commitments and contingencies
Commitments
We have an agreement with KTB for the Company's exclusive license of patent rights held by KTB for the worldwide development and commercialization of aldoxorubicin. Under the agreement, we must make payments to KTB 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 has 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 KTB, 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.
10


Shareholder Derivative Action in California.  On August 14, 2014, a shareholder derivative lawsuit, captioned Pankratz v. Kriegsman, et al., 2:14-cv-06414-PA-JPR, was filed in the United States District Court for the Central District of California purportedly on our behalf against certain of our officers and each of our directors. On August 15, 2014, a virtually identical complaint was filed, captioned Taylor v. Kriegsman, et al., 2:14-cv-06451.  Each of the complaints alleged breach of fiduciary duties, unjust enrichment, gross mismanagement, abuse of control, insider selling and misappropriation of information in connection with our alleged retention of DreamTeamGroup and MissionIR, as well as our December 9, 2013 grant of stock options to certain board members and officers. The complaint seeks unspecified damages, corporate governance and internal procedures reforms, restitution, disgorgement of all profits, benefits, and other compensation obtained by the individual defendants, and the costs and disbursements of the action. On October 8, 2014, the Court consolidated the Pankratz and Taylor cases and appointed lead plaintiffs and co-lead counsel. After a series of procedural events including an intervening stay of the action, on November 2, 2015, the Court granted the defendants' motion to dismiss the consolidated action on grounds of forum non conveniens, largely based on our by-law requiring derivative actions to be filed in the Delaware Court of Chancery.  On November 17, 2015, Plaintiffs filed an appeal with the Ninth Circuit Court of Appeals.  While the case was pending on appeal, on December 22, 2015, the parties executed a Memorandum of Understanding to settle the derivative action.  On April 4, 2016, the plaintiffs filed a Motion for Preliminary Approval of the Shareholder Derivative Settlement in the District Court.  On May 31, 2016, however, the Court denied without prejudice the Motion for Preliminary Approval of the Settlement on procedural grounds that included the Court's view that the settlement could not be considered until the Court's November 2 judgment dismissing the case was vacated.  The Court granted the parties the opportunity to file a motion to set aside the November 2 judgment.  However, on August 17, 2016, the Court denied the parties' motion to set aside the judgment.  No party took an appeal.  Accordingly, the derivative litigation in California has concluded.
Shareholder Derivative Actions in DelawareThere are two competing derivative complaints pending in the Delaware Court of Chancery alleging claims related to our alleged retention of DreamTeamGroup and MissionIR.  On December 14, 2015, a shareholder derivative complaint, captioned Niedermeyer et al. v. Kriegsman et al., C.A. No. 11800, was filed against certain of our officers and directors, for which a second amended complaint was filed on October 12, 2016.  On September 6, 2016, one of the plaintiffs in the California litigation (discussed above) effectively refiled his complaint in the Delaware Court of Chancery, with the case captioned Taylor v. Kriegsman, C.A. No. 12720.  Absent an agreement between the two plaintiffs and their respective counsel, competing motions for assignment as lead counsel and lead plaintiff will be necessary.  Following court appointment of lead counsel and lead plaintiff, a consolidated complaint will likely be filed or an operative complaint identified.  We and the defendant officers and defendants will then respond appropriately to the operative complaint.
Class Actions in California.  On July 25 and 29, 2016, nearly identical class action complaints were filed in the U.S. District Court for the Central District of California, titled Crihfield v. CytRx Corp., et al., Case No. 2:16-cv-05519 and Dorce v. CytRx Corp., Case No. 2:16-cv-05666 alleging that we and certain of our officers violated the Securities Exchange Act of 1934 by allegedly making materially false and/or misleading statements, and/or failing to disclose material adverse facts to the effect that the clinical hold placed on the Phase 3 trial of aldoxorubicin for STS would prevent sufficient follow-up for patients involved in the study, thus requiring further analysis, which could cause the trial's results and/or FDA approval to be materially adversely affected or delayed.  The plaintiffs allege that such wrongful acts and omissions caused significant losses and damages to a class of persons and entities that acquired our securities between November 18, 2014 and July 11, 2016, and seek an award of compensatory damages, costs and expenses, including counsel and expert fees, and such other and further relief as the Court may deem just and proper. On October 26, 2016, the Court entered an Order consolidating the actions titled In re: CytRx Corporation Securities Litigation, Master File No. 16-cv-05519-SJO and appointing a Lead Plantiff and Lead Counsel.
We intend to vigorously defend against the foregoing complaints. We have directors' and officers' liability insurance, which will be utilized in the defense of these matters. The liability insurance may not cover all of the future liabilities we may incur in connection with the foregoing matters. These claims are subject to inherent uncertainties, and management's view of these matters may change in the future.
We evaluate developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the period in which the outcome becomes probable and reasonably estimable.
11

Item 2. — Management's Discussion and Analysis of Financial Condition and Results of Operations
Forward Looking Statements
From time to time, we make oral and written statements that may constitute "forward-looking statements" (rather than historical facts) as defined in the Private Securities Litigation Reform Act of 1995 or by the SEC in its rules, regulations and releases, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We desire to take advantage of the "safe harbor" provisions in the Private Securities Litigation Reform Act of 1995 for forward-looking statements made from time to time, including, but not limited to, the forward-looking statements made in this Quarterly Report, as well as those made in our other filings with the SEC.
All statements in this Quarterly Report, including statements in this section, other than statements of historical fact are forward-looking statements for purposes of these provisions, including statements of our current views with respect to the timing of announcements of our clinical trial results and planned pre-NDA meeting with the FDA, the sufficiency of our current cash and cash equivalents to fund our operations for the foreseeable future, possible 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, 2015, 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.
12

Overview
We are a biopharmaceutical research and development company specializing in oncology. We currently are focused on the clinical development of aldoxorubicin (formerly known as INNO-206), our modified version of the widely-used chemotherapeutic agent, doxorubicin. We are also developing new anti-cancer drug conjugates that utilize our Linker Activated Drug Release  (LADRTM) technology.
We previously announced the initial analysis of top-line data from our on-going global, randomized Phase 3 clinical trial of aldoxorubicin as a treatment for patients with relapsed or refractory soft tissue sarcomas, or STS. The trial enrolled 433 patients at 79 sites in 15 countries including the U.S. and Canada. Since the initial analysis, we have continued to follow patients for overall survival (OS), a secondary endpoint of the trial.
We also previously announced that we expected to conduct a second analysis which will include longer patient follow-up. In addition, we expect to report the multiple sub-analyses of top-line date specified in the trial's statistical plan.  We currently expect the second analysis to be completed in November or early December 2016.
We are currently evaluating aldoxorubicin in a global Phase 2b clinical trial in second-line small cell lung cancer in which we currently expect to announce top-line data in the first or second quarter of 2017, as the number of deaths and/or progressions needed for data analysis have not yet been reached. We are also evaluating aldoxorubicin in a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. We previously completed Phase 2 clinical trials of aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and HIV-related Kaposi's Sarcoma, a Phase 1b clinical trial of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial of aldoxorubicin in patients with metastatic solid tumors.
Although we have made progress on the pre-clinical development for DK049, a novel anti-cancer drug conjugate that utilizes our LADRTM  technology, we have suspended further development in order to devote our resources to the completion of the Phase 3 clinical trial of aldoxorubicin and preparations for our planned pre NDA meeting with the FDA, which we believe could occur in the first quarter of 2017.  DK049 was created at our laboratory facility in Freiburg, Germany, and employs a proprietary linker that is both pH sensitive and requires a specific enzyme for the release of the cytotoxic payload.  We have now expanded our pipeline of oncology candidates utilizing our LADRTM technology to attach ultra-high potency drugs to albumin (10-1000 times more potent than traditional chemotherapies limited to antibodies only) to target tumors.
The accompanying condensed financial statements at September 30, 2016 and for the three-month and nine-month periods ended September 30, 2016 and 2015, 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, 2015 have been derived from the our audited financial statements as of that date.
The 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 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, 2015.
Following our announcement of the initial analysis of our on-going global Phase 3 clinical trial of aldoxorubicin, we took measures to reduce our "burn" rate, decreased our head count and discontinued our pre-commercialization activities pending the results of our second analysis and of our planned pre-NDA meeting with the U.S. food and Drug Administration, or FDA. For this reason and others, our operating results will fluctuate for the foreseeable future. Therefore, the results of prior periods should not be relied upon as predictive of the results in future periods.
13
Critical Accounting Policies and Estimates
Management's discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, impairment of long-lived assets, including finite-lived intangible assets, research and development expenses and clinical trial expenses and stock-based compensation expense.
We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.
Our significant accounting policies are summarized in Note 2 to our financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2015. 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 service and grant revenues. Service revenue consists of contract research and laboratory consulting. Grant revenues consist of government and private grants.
Monies received for license fees are deferred and recognized ratably over the performance period in accordance with  Financial Accounting Standards Board ("FASB") Accounting Codification Standards ("ASC") ASC 605-25, Revenue Recognition – Multiple-Element Arrangements ("ASC 605-25"). Milestone payments will be recognized upon achievement of the milestone as long as the milestone is deemed substantive and we have no other performance obligations related to the milestone and collectability is reasonably assured, which is generally upon receipt, or recognized upon termination of the agreement and all related obligations. Deferred revenue represents amounts received prior to revenue recognition.
Revenues from contract research, government grants, and consulting fees are recognized over the respective contract periods as the services are performed, provided there is persuasive evidence or an arrangement, the fee is fixed or determinable and collection of the related receivable is reasonably assured. Once all conditions of the grant are met and no contingencies remain outstanding, the revenue is recognized as grant fee revenue and an earned but unbilled revenue receivable is recorded.
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 product candidates are expensed as incurred until technological feasibility has been established.
14


Clinical Trial Expenses
Clinical trial expenses, which are included in research and development expenses, include obligations resulting from our contracts with various clinical research organizations conducting clinical trials for our product candidates. We recognize expenses for these activities based on a variety of factors, including actual and estimated labor hours, clinical site initiation activities, patient enrollment rates, estimates of external costs and other activity-based factors. We believe that this method best approximates the efforts expended on a clinical trial with the expenses we record. We adjust our rate of clinical expense recognition if actual results differ from our estimates. If our estimates prove incorrect, clinical trial expenses recorded in future periods could vary.
Stock-Based Compensation
Our stock-based employee compensation plans are described in Note 9 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.
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.
Impairment of Long-Lived Assets
We review long-lived assets, including finite-lived intangible assets, for impairment on an annual basis as of December 31, or on an interim basis if an event occurs that might reduce the fair value of such assets below their carrying values. An impairment loss would be recognized based on the difference between the carrying value of the asset and its estimated fair value, which would be determined based on either discounted future cash flows or other appropriate fair value methods. If our estimates used in the determination of either discounted future cash flows or other appropriate fair value methods are not accurate as compared to actual future results, we may be required to record an impairment charge.
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 44.0 million shares for each of the three-month and nine-month periods ended September 30, 2016, and 17.4 million  shares for each of the three-month and nine-month periods ended September 30, 2015, were excluded from the computation of diluted net loss per share, because the effect would be anti-dilutive.
Warrant Liabilities
Liabilities measured at fair value on a recurring basis include warrant liabilities resulting from our July 2016 equity financing. In accordance with ASC 815-40, Accounting for Derivative Financial Instruments Indexed to and Potentially Settled in a Company's Own Stock ("ASC 815-40"), the warrant liabilities are recorded at fair value each quarter-end until they are completely settled. The warrants are valued using the Black-Scholes method. The gain or loss resulting from the change in fair value is shown on the statements of operations as a gain or loss on warrant derivative liabilities.
15


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, 2016, we had cash and cash equivalents of approximately $58.9 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 2016 and the first ten months of 2017 of approximately $37.4 million, which includes approximately $15.6 million for our ongoing clinical programs for aldoxorubicin, approximately $2.7 million for our drug discovery operations at our Freiburg, Germany laboratory, approximately $3.4 million for general operation of our clinical programs, approximately $8.3 million for other general and administrative expenses, and approximately $7.4 million for interest and payments on our outstanding term loan.  These projected expenditures assume that we have not and will not suffer a "material adverse event" which could trigger the lenders' acceleration of our outstanding term loan, and are based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these projections.
If we obtain marketing approval and successfully commercialize aldoxorubicin or other product candidates, we anticipate it will take several years for us to generate significant recurring revenue. We will be dependent on future financing and possible strategic partnerships until such time, if ever, as we can generate significant recurring revenue. We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all.  If we fail to obtain sufficient funding when needed, we may be forced to delay, scale back or eliminate all or a portion of our development programs or clinical trials, seek to license to other companies our product candidates or technologies that we would prefer to develop and commercialize ourselves, or seek to sell some or all of our assets or merge with or be acquired by another company. Following our announcement of the initial analysis of our on-going global Phase 3 clinical trial of aldoxorubicin, we took measures to reduce our "burn" rate, decreased our head count and discontinued our pre-commercialization activities pending the results of our second analysis of the initial top-line data and preparation for our planned pre-NDA meeting with the FDA.  For these reasons and others, our operating results may fluctuate from period to period, and the results of prior periods should not be relied upon as predictive of the results in future periods.
We recorded a net loss in the nine-months ended September 30, 2016 of $43.1 million as compared to a net loss in the nine-months ended September 30, 2015 of $36.3 million, or an increase of $6.8 million.  This was due primarily to an increase in our general and administrative expenditures in the current nine-month period of $3.3 million as compared to comparative 2015 period, resulting primarily from an increase in legal fees, interest expense of $1.9 million related to our term loan, a reduction in the gain on warrant derivative liability of $3.1 million offset by a decrease of $1.5 million from a reduction in expenditures associated with our clinical program for aldoxorubicin.
We sold $35.0 million of short-term investments in the nine-month period ended September 30, 2016. We purchased $33.0 million and sold $63.6 million of short-term investments, for a net decrease of $30.6 million in the nine-month period ended September 30, 2015. We utilized approximately $1.0 million for capital expenditures in the nine-month period ended September 30, 2016 as compared to approximately $0.3 million in the comparable 2015 period. We do not expect any significant capital spending during the next 12 months.
We raised net proceeds of $18.3 million from a public offering in the nine-month period ended September 30, 2016, and we raised net proceeds of $26.8 million from a public offering in the nine-month period ended September 30, 2015. We received a net amount of $24.0 million from a long-term loan financing with Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. in the nine-month period ended September 30, 2016, as compared to no financing activites in the nine-month period ended September 30, 2015. We received $0.7 million from the exercise of options in the nine-month period ended September 30, 2016, as compared to $0.6 million in the comparative 2015 period.
We continue to evaluate potential future sources of capital, as we do not currently have commitments from any third parties to provide us with additional capital. The results of our technology licensing efforts and the actual proceeds of any fund-raising activities will determine our ongoing ability to operate as a going concern. Our ability to obtain future financings through joint ventures, product licensing arrangements, royalty sales, equity financings, grants or otherwise is subject to market conditions and our ability to identify parties that are willing and able to enter into such arrangements on terms that are satisfactory to us. Depending upon the outcome of our fundraising efforts, the accompanying financial information may not necessarily be indicative of our future financial condition
16


We expect to incur significant losses and negative cash flow from operating activities for the foreseeable future.  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.
Following our announcement of the initial analysis of our on-going global Phase 3 clinical trial of aldoxorubicin, we took measures to reduce our "burn" rate, decreased our head count and discontinued our pre-commercialization activities pending the results of our second analysis of the initial top-line data and of our planned pre-NDA meeting with the FDA.  For these reasons and others, our operating results may fluctuate from period to period, and the results of prior periods should not be relied upon as predictive of the results in future periods.
 We expect to complete the second analysis of the top line results of our pivotal Phase 3 trial of aldoxorubicin in STS in November or early December 2016.  Following that analysis, we plan to schedule a pre-NDA meeting with the FDA, seek marketing approval, and commercialize or partner aldoxorubicin. Pending the meeting with the FDA, which we believe could occur in the first quarter of 2017, we intend to review our product development and strategic alternatives, including a possible sale or merger of our company or possible acquisition or business combination, and may determine to change our business strategy.
Results of Operations
We recorded a net loss of approximately $12.2 million and $43.1 million for the three-month and nine-month periods ended September 30, 2016, respectively, as compared to a net loss of approximately $7.1 million and $36.3 million for the three-month and nine-month periods ended September 30, 2015, respectively. The increase of $5.1 million in our net loss during the current three-month period resulted from a reduction of $3.3 million in the gain on warrant derivative liability in the current quarter, an increase in our expenditures of $0.5 million in our aldodoxorubicin program, an increase in interest expense of $0.8 million as compared to $0 in the comparative period, and an increase in general and administrative expenses of $0.6 million, primarily legal fees.
We recognized $0.1 million of licensing revenue in the nine-month period ended September 30, 2016 as compared to $0 in the comparative 2015 periods. All future licensing fees under our current licensing agreements are dependent upon successful development milestones being achieved by the licensor. During the remainder of 2016, we do not anticipate receiving any significant licensing fees.
Research and Development
   
Three-Month Period Ended
September 30,
   
Nine-Month Period Ended
September 30,
 
   
2016
   
2015
   
2016
   
2015
 
   
(In thousands)
   
(In thousands)
 
Research and development expenses
 
$
8,331
   
$
8,002
   
$
27,756
   
$
29,709
 
Employee stock option expense
   
455
     
402
     
1,443
     
1,131
 
Depreciation and amortization
   
141
     
67
     
333
     
204
 
   
$
8,927
   
$
8,471
   
$
29,532
   
$
31,044
 
                                 

Research expenses are expenses 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 expenses incurred by us in our efforts to commercialize the findings generated through our research efforts.  Our research and development expenses, excluding stock option expense and depreciation and amortization, were $8.3 million and $27.8 million for the three-month and nine-month periods ended September 30, 2016, respectively, and $8.0 million and $29.7 million for the three-month and nine-month periods ended September 30, 2015, respectively.
Research and development expenses incurred during the three-month period ended September 30, 2016 related primarily to our aldoxorubicin clinical program.  In the three-month and nine-month periods ended September 30, 2016, the development expenses of our program for aldoxorubicin were $6.7 million and $22.9 million, respectively, as compared to $6.8 million and $25.9 million for the same periods in 2015, respectively. We incurred $0.7 million and $1.8 million, respectively, for the three-month and nine-month periods ended September 30, 2016, for our German lab operations, as compared to $0.4 million and $1.3 million in the 2015 comparative periods. The remainder of our research and development expenses primarily related to research and development support costs. We recorded approximately $0.5 million and $1.4 million of employee stock option expense in the three-month and nine-month periods ended September 30, 2016, as compared to $0.4 million and $1.1 million for the same periods in 2015, respectively.
17


General and Administrative Expenses
   
Three-Month Period Ended
September 30,
   
Nine-Month Period Ended
September 30,
 
   
2016
   
2015
   
2016
   
2015
 
   
(In thousands)
   
(In thousands)
 
General and administrative expenses
 
$
2,181
   
$
1,727
   
$
8,869
   
$
6,086
 
Non-employee warrant expenses
   
(6
)
   
(28
)
   
215
     
206
 
Employee stock option expense
   
587
     
483
     
3,743
     
3,183
 
Depreciation and amortization
   
10
     
7
     
32
     
36
 
   
$
2,772
   
$
2,189
   
$
12,859
   
$
9,511
 

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 $2.2 million and $8.9 million for the three and nine-month periods ended September 30, 2016, respectively, and $1.7 million and $6.1 million, respectively, for the same periods in 2015.
Employee stock option expense relates to options granted to retain and compensate directors, officers and other employees.  In the three-month period ended September 30, 2016, we amended the terms of stock options of a former executive in respect of a Retirement Agreement, resulting in a one-time expense of approximately $1.9 million. We recorded, in total, approximately $0.6 million and $3.7 million of employee stock option expense in the three-month and nine-month periods ended September 30, 2016, respectively, as compared $0.5 million and $3.2 million, respectively, for the same periods in 2015. We recorded approximately ($6,000) and $0.2 million of non-employee stock option expense in the three-month and nine-month periods, ended September 30, 2016, respectively, and ($28,000) and $0.2 million for the comparative 2015 periods.
Depreciation and Amortization
Depreciation expense reflects the depreciation of our equipment and furnishings.
Interest Income and Expense
Interest income was approximately $69,000 and $196,000 for the three-month and nine-month periods ended September 30, 2016, respectively, as compared to $69,000 and $172,000, respectively, for the same periods in 2015. This decrease was related to the reduction in cash and cash equivalents and short term investments.
Interest expenses was approximately $0.8 million and $1.9 million for the three-month and nine-month periods ended September 30, 2016, respectively. This expense resulted from the term loan of $25 million received on February 5, 2016. There was no interest expense in the comparative 2015 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, 2016, it would not have had a material effect on our results of operations or cash flows for that period.
18

Item 4. — Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As of September 30, 2016, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as that term is defined in Exchange Act Rules 13a-15(e) and 15d-15(e) as of the end of the period covered by this Quarterly Report on Form 10-Q.  Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of the end of the fiscal quarter covered by this Quarterly Report on Form 10-Q.
Changes in Controls over Financial Reporting
As previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 we identified a material weakness related to our internal control over a significant and unusual non-cash transaction.  The material weakness resulted in an inaccurate conclusion related to the accrual and presentation of an obligation incurred in connection with the litigation settlement referred to in Note 5 of the financial statements that was payable in a variable number of shares of our common stock.
During the quarter ended September 30, 2016, Management implemented new controls and strengthened existing controls over the identification and accounting for significant and unusual transactions. As of September 30, 2016, management has tested the remedial controls for a sufficient period of time and has concluded that these controls are operating effectively. Therefore, we have concluded that the material weakness in the Company's internal controls over financial reporting has been fully remediated.
Except as noted above, there has been no change in the Company's internal controls over financial reporting as of September 30, 2016, which has materially affected, or is reasonably likely to materially affect, the Company's internal controls 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.
19

PART II — OTHER INFORMATION
Item 1. — Legal Proceedings
The disclosure set forth in Note 14 to our financial statements is herein incorporated by reference.
Item 1A. — Risk Factors
We intend to review our drug development activities and strategic alternatives, and may determine to change our business strategy.
We expect to complete the second analysis of the top-line data from our pivotal Phase 3 trial of aldoxorubicin in STS in November or early December 2016. Following the analysis, we plan to schedule a pre-NDA meeting with the FDA,  seek marketing approval, and commercialize or partner aldoxorubicin.  Pending the meeting with the FDA, which we believe could occur in the first quarter of 2017, we may consider possible strategic transactions, including a possible sale or merger of our company or possible acquisition or business combination. There is no assurance that we will be able to obtain FDA approval of aldoxorubin. There also is no assurance that we would be successful in pursuing any strategic transaction.  If we complete a strategic transaction our future business could change, perhaps materially, from our current business, and we may not realize the anticipated benefits of a strategic transaction.
To finance strategic transactions, we may choose to issue shares of our common stock or preferred stock, which would dilute your ownership interest in us. Alternatively, it may be necessary for us to raise additional funds through public or private financings. Additional funds may not be available on terms that are favorable to us and, in the case of equity financings, may result in dilution to our stockholders.
Because we have no source of significant recurring revenue, we must depend on financing to sustain our operations.
Our revenue was $0.1 million respectively for the year ended December 31, 2015 and the nine months ended September 30, 2016. We will have no significant recurring revenue unless we are able to commercialize aldoxorubicin or one or more product candidates that we may develop or acquire, which commercialization may require us to first enter into license or other strategic arrangements with third parties.
We had cash and cash equivalents of approximately $58.9 million as of September 30, 2016, which includes the proceeds from a $25 million debt financing earlier this year.
We believe that our existing cash and cash equivalents, together with the net proceeds of this offering, will be sufficient to fund our operations for the foreseeable future.
Even if we obtain marketing approval and successfully commercialize aldoxorubicin or other product candidate, we anticipate it will take a minimum of two years, and likely longer, for us to generate significant recurring revenue, and we will be dependent on future financing until such time, if ever, as we can generate significant recurring revenue. We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern. If we raise additional funds by issuing equity securities, dilution to security holders may result and new investors could have rights superior to holders of the shares issued in this offering. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available to us, we may have to liquidate some or all of our assets or to delay or reduce the scope of or eliminate some portion or all of our development programs or clinical trials. We also may have to license to other companies our product candidates or technologies that we would prefer to develop and commercialize ourselves.
20

Our common stock may be delisted from The Nasdaq Capital Market.
On August 24, 2016, we received notice from The Nasdaq Stock Market ("Nasdaq") that the closing bid price for our common stock had been below $1.00 for the previous 30 consecutive business days, and that we are therefore not in compliance with the minimum bid price requirement for continued inclusion on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).  The notice indicates that we will have 180 calendar days, or until February 21, 2017, to regain compliance with this requirement.
We can regain compliance with the $1.00 minimum bid listing requirement if the closing bid price of our common stock is at least $1.00 for a minimum of ten consecutive business days during the 180-day compliance period.  If we do not regain compliance during the initial compliance period, we may be eligible for additional time to regain compliance.  To qualify, we will be required to meet the continued listing requirement for market value of our publicly held shares and all other Nasdaq initial listing standards, except the bid price requirement, and will need to provide written notice to Nasdaq of our intention to cure the deficiency during the second compliance period.  If we meet these requirements, we expect that Nasdaq will grant us an additional 180 calendar days to regain compliance with the minimum bid price requirement.  If it appears to Nasdaq that we will not be able to cure the deficiency, or if we are otherwise not eligible, we expect that Nasdaq will notify us that our common stock will be subject to delisting.
We have been, and in the future may be, subject to legal or administrative actions that could adversely affect our results of operations and our business.
In May 2016, we settled federal securities class actions lawsuits filed in 2014 against us and certain of our officers and directors, and two stockholder derivative claims are pending against us and certain of our officers and directors in the Delaware Chancery Court. 
In July, 2016, two class action complaints were filed against us and certain of our executive officers in the U.S. District Court of California. On October 26, 2016, the Court entered an order consolidating the actions.
Securities-related class action lawsuits and derivative litigation have often been brought against biotechnology and biopharmaceutical companies such as ours, which often experience significant stock price volatility in connection with their product development programs.
Although we carry director's and officer's and other liability insurance which will be utilized in the defense of these matters, the insurance may not be sufficient to cover future liabilities that we may incur in connection with pending or future legal or administrative actions.
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.
21

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 9, 2016
By:
/s/  JOHN Y. CALOZ  
    John Y. Caloz  
    Chief Financial Officer  
       

22

INDEX TO EXHIBITS
Exhibit
Number
 
 
Description
1.1
 
Engagement Letter, dated as of July 14, 2016, between CytRx Corporation and Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC (incorporated by reference to Exhibit 10.1 to Form 8-K filed on July 15, 2016)
4.1†
 
Amendment No. 3 to Shareholder Protection Rights Agreement
4.2
 
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to Form 8-K filed on July 15, 2016)
10.1
 
Form of Securities Purchase Agreement, dated as of July 15., 2016, among CytRx Corporation and the purchasers identified on the signature pages thereto (incorporated by reference to Exhibit 10.1 of Form 8‑K filed on July 15, 2016)
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
   
 Filed herewith.
* Furnished herewith.
 
23
EX-4.1 2 ex4-1.htm AMENDMENT NO. 3 TO SHAREHOLDER PROTECTION RIGHTS AGREEMENT

EXHIBIT 4.1
 
CYTRX CORPORATION
11726 San Vicente Boulevard, Suite 650
Los Angeles, California 90049
July 12, 2016
American Stock Transfer & Trust Company, LLC
40 Wall Street
New York, New York 10005
Attention: Corporate Trust Department
Re:  Amendment No. 3 to Shareholder Protection Rights Agreement dated as of April 16, 1997, as amended by Amendments Nos. 1 and 2 thereto dated February 11, 2002 and March 30, 2007, respectively (as so amended, the "Rights Agreement"), between CytRx Corporation ("CytRx") and American Stock Transfer & Trust Company, LLC
Ladies and Gentlemen:
Pursuant to Section 5.4 of the Rights Agreement, by resolution duly adopted on July 12, 2016 by the Board of Directors of CytRx, the Rights Agreement is hereby amended as follows:
1. The definition of "Expiration Time" in Section 1.1 of the Rights Agreement is hereby deleted and replaced in its entirely with the following:
                "'Expiration Time' shall mean the earliest of (i) the Exchange Time, (ii) April 16, 2022 and (iii) upon the merger of the Company into another corporation pursuant to an agreement entered  into prior to a "Flip-In Date."
2. Except as expressly amended hereby, the Rights Agreement shall remain in full force and effect.
3. Capitalized terms used herein and not otherwise defined herein shall have the meanings ascribed to them in the Rights Agreement.
4. This Amendment No. 3 shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to the conflicts of law principles thereof.
5. This Amendment No. 3 may be executed in counterparts. Each such counterpart shall be deemed to be an original, and such counterparts, together, shall be deemed to be one and the same agreement.
6. This Amendment No. 3 shall be effective as of the date hereof, and all references to the Rights Agreement shall, from and after such time, be deemed to be references to the Rights Agreement as           amended hereby.
Very truly yours,
         
       Accepted and agreed to as of the date first written above:  
       American Stock Transfer & Trust Company  
         
/s/ STEVEN A. KRIEGSMAN
   
/s/ MICHAEL A. NESPOLI
 
Name: Steven A. Kriegsman
   
Name: Michael A. Nespoli
 
Title: Chairman of the Board and Chief Executive Officer
   
Title: Executive Director
 
EX-31.1 3 exh31-1.htm CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO CFR 240.13A-14(A)

Exhibit 31.1

CERTIFICATIONS

I, Steven A. Kriegsman, 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 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.
 
  CytRx Corporation  
       
Date: November 9, 2016
By:
/s/ STEVEN A. KRIEGSMAN   
    Steven A. Kriegsman  
    Chief Executive Officer  
       
EX-31.2 4 exh31-2.htm CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO 17 CFR 240.13A-14(A)

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.
  CytRx Corporation  
       
Date: November 9, 2016
By:
/s/  JOHN Y. CALOZ  
    John Y. Caloz  
    Chief Financial Officer  
       
EX-32.1 5 exh32-1.htm 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

Exhibit 32.1

Certification of Chief Executive Officer
Pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of CytRx Corporation (the "Company") hereby certifies based on his knowledge that:
(i) the accompanying Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2016 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.
 
  Cytrx Corporation  
       
Date: November 9, 2016
By:
/s/ STEVEN A. KRIEGSMAN  
    Steven A. Kriegsman  
    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 6 exh32-2.htm 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

Exhibit 32.2

Certification of Chief Financial Officer
Pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of CytRx Corporation (the "Company") hereby certifies based on his knowledge that:
(i) the accompanying Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2016 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.
  CytRx Corporation  
       
Date: November 9, 2016
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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We currently are focused on the clinical development of aldoxorubicin (formerly known as INNO-206), our modified version of the widely-used chemotherapeutic agent, doxorubicin.&#160; We are also developing new anti-cancer drug conjugates that utilize our Linker Activated Drug Release (LADR<sup>TM</sup> ) technology.</div><div style="margin-bottom: 12pt; font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: normal; text-align: left; text-indent: 36pt;">We previously announced the initial analysis of top-line data from our on-going global, randomized Phase&#160;3 clinical trial of aldoxorubicin as a treatment for patients with relapsed or refractory soft tissue sarcomas, or STS. The trial enrolled 433 patients at 79 sites in 15 countries including the U.S. and Canada.</div><div style="margin-bottom: 12pt; font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: normal; text-align: left; text-indent: 36pt;">We also previously announced that we expected to conduct a second analysis which will include longer patient follow-up. In addition, we expect&#160; to report the multiple sub-analyses of top-line data specified in the trial's statistical plan.&#160;We currently expect the second analysis to be completed in November or early December 2016.</div><div style="margin-bottom: 12pt; font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: normal; text-align: left; text-indent: 36pt;">We are currently evaluating aldoxorubicin in a global Phase 2b clinical trial in second-line small cell lung cancer in which we currently expect to announce top-line data in the first or second quarter of 2017, as the number of deaths and/or progressions needed for data analysis have not yet been reached. We are also evaluating aldoxorubicin in a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. 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Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2015 have been derived from the our audited financial statements as of that date.</div><div style="margin-bottom: 12pt; font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: normal; text-align: left; text-indent: 36pt;">The 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. 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No. 12720.&#160; Absent an agreement between the two plaintiffs and their respective counsel, competing motions for assignment as lead counsel and lead plaintiff will be necessary.&#160; Following court appointment of lead counsel and lead plaintiff, a consolidated complaint will likely be filed or an operative complaint identified.&#160; We and the defendant officers and defendants will then respond appropriately to the operative complaint.</font></div><div style="margin-bottom: 12pt; font-size: 10pt; font-family: 'Times New Roman', Times, serif; text-align: left; text-indent: 36pt;"><font style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: bold;">Class Actions in California.&#160; </font><font style="font-weight: normal;">On July 25 and 29, 2016, nearly identical class action complaints were filed in the U.S. District Court for the Central District of California, titled <font style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-style: italic;">Crihfield v. CytRx Corp., et al.</font>, Case No. 2:16-cv-05519 and <font style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-style: italic;">Dorce v. CytRx Corp.</font>, Case No. 2:16-cv-05666 alleging that we and certain of our officers violated the Securities Exchange Act of 1934 by allegedly making materially false and/or misleading statements, and/or failing to disclose material adverse facts to the effect that the clinical hold placed on the Phase 3 trial of aldoxorubicin for STS would prevent sufficient follow-up for patients involved in the study, thus requiring further analysis, which could cause the trial's results and/or FDA approval to be materially adversely affected or delayed.&#160; The plaintiffs allege that such wrongful acts and omissions caused significant losses and damages to a class of persons and entities that acquired our securities between November 18, 2014 and July 11, 2016, and seek an award of compensatory damages, costs and expenses, including counsel and expert fees, and such other and further relief as the Court may deem just and proper. On October 26, 2016, the Court entered an Order consolidating the actions titled <font style="font-style: italic;">In re: CytRx Corporation Securities Litigation, Master File No. 16-cv-05519-SJO</font> and appointing a Lead Plantiff and Lead Counsel.</font></div><div style="margin-bottom: 12pt; font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: normal; text-align: left; text-indent: 36pt;">We intend to vigorously defend against the foregoing complaints. We have directors' and officers' liability insurance, which will be utilized in the defense of these matters. 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Based on historical experience, for the nine-month periods ended September 30, 2016 and 2015, we estimated annualized forfeiture rates of 10% for options granted to our employees, 2% for options granted to senior management and 0% for options granted to directors and non-employees and for warrants issued to non-employees&#160; Compensation costs will be adjusted for future changes in estimated forfeitures.&#160; We will record additional expense if the actual forfeitures are lower than estimated and will record a recovery of prior expense if the actual forfeiture rates are higher than estimated.</div><div style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: normal; text-align: left; text-indent: 36pt;">As of September 30, 2016, there remained approximately $4.1 million of unrecognized compensation expense related to unvested stock options granted to current and former employees, directors, to be recognized as expense over a weighted-average period of 0.96 years. 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font-family: 'Times New Roman', Times, serif;">$</div></td><td valign="bottom" style="vertical-align: bottom; padding-bottom: 4px; text-align: right; width: 9%; background-color: #cceeff;"><div style="font-size: 10pt; font-family: 'Times New Roman', Times, serif;">3.27</div></td><td nowrap="nowrap" valign="bottom" style="vertical-align: bottom; padding-bottom: 4px; text-align: left; width: 1%; background-color: #cceeff;">&#160;</td></tr></table><div><br /></div><div style="margin-bottom: 12pt; font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: normal; text-align: left; text-indent: 36pt;">The aggregate intrinsic value of all outstanding options and vested options as of September 30, 2016 was $0 and $0, respectively, representing options with exercise prices of less than the closing fair market value of our common stock on September 30, 2016 of $0.59 per share.</div><div style="margin-bottom: 12pt; font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: normal; text-align: left; text-indent: 36pt;">There were 30,559,148 and 7,225,472 warrants outstanding at September 30, 2016 and December 31, 2015, respectively at a weighted-average exercise price of $0.80 and $4.28, respectively.</div></div> -0.57 -0.13 -0.62 -0.11 <div style="font-family: 'Times New Roman'; font-size: 10pt;"><div style="margin-bottom: 12pt; text-align: left;"><font style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: bold;">7.</font><font style="font-size: 1px; display: inline-block; width: 36pt;">&#160;</font><font style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: bold;">Basic and Diluted Net Loss Per Common Share</font></div><div style="margin-bottom: 12pt; font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: normal; text-align: left; text-indent: 36pt;">Basic and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding. 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color: #000000; text-align: center;">Level II</div></td><td nowrap="nowrap" valign="bottom" style="vertical-align: bottom; padding-bottom: 2px; text-align: left;">&#160;</td><td valign="bottom" style="vertical-align: bottom; padding-bottom: 2px;">&#160;</td><td colspan="2" valign="bottom" style="vertical-align: top; border-bottom: #000000 2px solid;"><div style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: bold; color: #000000; text-align: center;">Level III</div></td><td nowrap="nowrap" valign="bottom" style="vertical-align: bottom; padding-bottom: 2px; text-align: left;">&#160;</td><td valign="bottom" style="vertical-align: bottom; padding-bottom: 2px;">&#160;</td><td colspan="2" valign="bottom" style="vertical-align: top; border-bottom: #000000 2px solid;"><div style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: bold; color: #000000; text-align: center;">Total</div></td><td nowrap="nowrap" valign="bottom" style="vertical-align: bottom; 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font-weight: normal; text-align: left; text-indent: 36pt;">The following sets forth information regarding the current and long-term portion of the term loan:</div><table cellpadding="0" cellspacing="0" style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; width: 100%;"><tr><td valign="bottom" style="vertical-align: top; font-weight: bold; padding-bottom: 2px;">&#160;</td><td valign="bottom" style="vertical-align: bottom; font-weight: normal; padding-bottom: 2px;">&#160;</td><td colspan="2" valign="bottom" style="vertical-align: top; border-bottom: #000000 2px solid; font-weight: normal;"><div style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; text-align: center;">September 30, 2016</div></td><td nowrap="nowrap" valign="bottom" style="vertical-align: bottom; font-weight: normal; padding-bottom: 2px; text-align: left;">&#160;</td></tr><tr><td valign="bottom" style="vertical-align: top; font-weight: normal; width: 88%; background-color: #cceeff;"><div style="font-size: 10pt; 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text-align: left;">Issuance Cost - Current</div></td><td valign="bottom" style="vertical-align: bottom; font-weight: normal; width: 1%; background-color: #ffffff;">&#160;</td><td valign="bottom" style="vertical-align: bottom; font-weight: normal; text-align: left; width: 1%; background-color: #ffffff;">&#160;</td><td valign="bottom" style="vertical-align: bottom; font-weight: normal; text-align: right; width: 9%; background-color: #ffffff;"><div style="font-size: 10pt; font-family: 'Times New Roman', Times, serif;">(122,335</div></td><td nowrap="nowrap" valign="bottom" style="vertical-align: bottom; font-weight: normal; text-align: left; width: 1%; background-color: #ffffff;"><div style="font-size: 10pt; font-family: 'Times New Roman', Times, serif;">)</div></td></tr><tr><td valign="bottom" style="vertical-align: top; font-weight: normal; padding-bottom: 2px; width: 88%; background-color: #cceeff;"><div style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; text-align: left;">Loan Discount - Current</div></td><td valign="bottom" style="vertical-align: bottom; 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background-color: #ffffff;">&#160;</td></tr><tr><td valign="bottom" style="vertical-align: top; font-weight: normal; width: 88%; background-color: #cceeff;">&#160;</td><td valign="bottom" style="vertical-align: bottom; font-weight: normal; width: 1%; background-color: #cceeff;">&#160;</td><td valign="bottom" style="vertical-align: bottom; font-weight: normal; text-align: left; width: 1%; background-color: #cceeff;">&#160;</td><td valign="bottom" style="vertical-align: bottom; font-weight: normal; text-align: right; width: 9%; background-color: #cceeff;">&#160;</td><td nowrap="nowrap" valign="bottom" style="vertical-align: bottom; font-weight: normal; text-align: left; width: 1%; background-color: #cceeff;">&#160;</td></tr></table></div> <div style="font-family: 'Times New Roman'; font-size: 10pt;"><div style="font-size: 10pt; font-family: 'Times New Roman', Times, serif; font-weight: normal; text-align: left; text-indent: 36pt;">The following table summarizes significant ranges of outstanding stock options under our plans at September 30, 2016:</div><div><br /></div><table cellpadding="0" cellspacing="0" style="font-size: 10pt; 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Stock Options And Warrants [Member] Stock Options and Warrants [Member] An arrangement whereby an employees stock-based compensation expense is classified. Employees [Member] An arrangement whereby an non-employees stock-based compensation expense is classified. Non employees [Member] Non-Employees [Member] Represents the number clinical sites. Number of Clinical Sites Number of clinical sites Represents the number of targeted patients enrolled. Number of Patients Enrolled Number of patients enrolled Represents the number of countries in which trial enrolled. Number of countries Number of countries Represents the number of progression events. Number of progression event Number of progression events Refers to currently projected expenditures for interest and payments on term loan. Interest and Term Loan Payment [Member] Schedule that describes that estimated projected expenditure by an entity. Estimated projected expenditures [Table] Estimated Projected Expenditures [Table] Line items represent the estimated projected expenditure. Estimated projected expenditure [Line Items] Estimated Projected Expenditure [Line Items] Refers to currently projected expenditures for clinical programs for other programs. Other Programs [Member] Refers to currently projected expenditures for clinical programs for other general and administrative expenses. Other general and administrative expenses [Member] Other General and Administrative Expenses [Member] Refers to currently projected expenditures for clinical programs for aldoxorubicin. Aldoxorubicin [Member] Refers to currently projected expenditures for clinical programs for general operation. General operation [Member] General Operation [Member] Monetary value refers to the entity estimate currently projected expenditures. Currently projected expenditures for clinical programs Currently projected expenditures for clinical programs Document and Entity Information [Abstract] 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. Range Four [Member] Range $4.01 - 32.55 [Member] Weighted-average price of equity instruments other than options outstanding, including both vested and non-vested instruments. Share Based Compensation Arrangement By Share Based Payment Award Non Option Equity Instruments Outstanding weighted average price Weighted-average exercise price of warrants outstanding (in dollars per share) 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. Range One [Member] Range $0.60 - $2.00 [Member] Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract] 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. Range Two [Member] Range $2.01 - 2.50 [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. Range Three [Member] Range $2.51 - 4.00 [Member] As a result of a change in-control that occurred in the CytRx shareholder base, federal net operating loss carryforwards became substantially limited in their annual availability. Unrestricted [Member] Refers to approval of the class action settlement, resulting in the issuance of common stock per share. Litigation Settlement Per Shares Issued Common stock issued for litigation settlement (in dollars per shares) Amount out of company funds used for settlement awarded to (against) the entity in respect of litigation. Litigation Settlement Amount Paid Out of Company Funds Payment made out of company funds Carrying amount of accrued term loan fee as on the balance sheet date that are expected to be paid after one year (or the normal operating cycle, if longer). Term Loan Fee Payable Noncurrent End Fee Payable Additional maximum borrowing capacity under the credit facility without consideration of any current restrictions on the amount that could be borrowed or the amounts currently outstanding under the facility. Additional Line Of Credit Facility Maximum Borrowing Capacity Additional maximum borrowing capacity under long-term loan agreement Represents the agent, with whom loan agreement is made. Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. [Member] Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. [Member] Refers to fair value of warrants classified as equity warrants. Warrants Classified as Equity Warrant, Fair Value Fair value of warrants classified as equity warrants Represents the amount of cash balance required to be maintained under the terms of a debt instrument. Debt Instrument, Minimum Cash Balance Required To Be Maintained Debt instrument, minimum cash balance required to be maintained Face (par) amount of debt instrument at time of issuance. Debt Instrument Face Amount Current Term Loan Principal - Current Face (par) amount of long term debt instrument at time of issuance. Debt Instrument Face Amount Noncurrent Term Loan Principal Refers to number of days to file a motion to set aside the judgment. Number Of Days To File A Motion to Set Aside Judgment Number of days motion to set aside the judgment Refers to number of competing derivative complaints against company. Number of Competing Derivative Complaints Number of competing derivative complaints Represents the amount of milestone payment payable under the agreement upon meeting clinical and regulatory milestones. Amount of milestone payment payable The potential future milestone payments on each additional final marketing approval as of the balance sheet date. Potential future milestone payments on each additional final marketing approval Potential future milestone payments on each additional final marketing approval Relating to the Corporation Stockholder Derivative Litigation. Corporation Stockholder Derivative Litigation [Member] Refers to number of days court afforded the plaintiffs to amend their complaint. Number of Days the Court Gave the Plaintiff to File an Amended Complaint Number of day's court afforded the plaintiffs to amend their complaint Refers to number of motions filed by company and the defendants with the Court of Chancery. Number of Motions Filed Number of motions filed by the company Share based compensation stock options activity [Abstract] Refers to share-based compensation arrangements by share-based payment award, options, exercised, forfeitures, expired in period. Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercised, Forfeitures, Expired in Period Exercised, forfeited or expired (in shares) A person serving on the board of directors (who collectively have responsibility for determining the overall policy of the entity and appointing officers) generally elected by the shareholders and an arrangement whereby an employee stock-based compensation expense is classified. Employees and Directors [Member] The 2008 stock incentive plan, reward system designed to improve employees' performance by providing rewards. 2008 Stock Incentive Plan [Member] Refers to share-based compensation arrangements by share-based payment award, options, exercised, forfeitures, expired in period, weighted average exercise price. Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercised, Forfeitures, Expired in Period, Weighted Average Exercise Price Exercised, forfeited or expired (in dollars per share) Former highest ranking executive officer, who has ultimate managerial responsibility for the entity and who reports to the board of directors. In addition, the chief executive officer (CEO) may also be the chairman of the board or president. Former Executive [Member] The 2000 Long-term incentive plan, reward system designed to improve employees' long term performance by providing rewards. 2000 Long Term Incentive Plan [Member] 2000 Long-Term Incentive Plan [Member] The estimated an annualized forfeiture rate for options granted to employees. Estimated annualized forfeiture rate Estimated annualized forfeiture rate EX-101.PRE 12 cytr-20160930_pre.xml XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE XML 13 R1.htm IDEA: XBRL DOCUMENT v3.5.0.2
Document and Entity Information - shares
9 Months Ended
Sep. 30, 2016
Nov. 08, 2016
Document and Entity Information [Abstract]    
Entity Registrant Name CYTRX CORP  
Entity Central Index Key 0000799698  
Current Fiscal Year End Date --12-31  
Entity Well-known Seasoned Issuer No  
Entity Voluntary Filers No  
Entity Current Reporting Status Yes  
Entity Filer Category Accelerated Filer  
Entity Common Stock, Shares Outstanding   96,943,072
Document Fiscal Year Focus 2016  
Document Fiscal Period Focus Q3  
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Sep. 30, 2016  
XML 14 R2.htm IDEA: XBRL DOCUMENT v3.5.0.2
CONDENSED BALANCE SHEETS (Unaudited) - USD ($)
Sep. 30, 2016
Dec. 31, 2015
Current assets:    
Cash and cash equivalents $ 58,875,925 $ 22,261,372
Short-term investments 0 35,035,420
Receivables 108,345 4,621,605
Prepaid expenses and other current assets 2,618,919 2,373,708
Total current assets 61,603,189 64,292,105
Equipment and furnishings, net 2,066,392 1,467,681
Goodwill 183,780 183,780
Other assets 54,648 1,080,872
Total assets 63,908,009 67,024,438
Current liabilities:    
Accounts payable 4,815,597 8,058,624
Accrued expenses and other current liabilities 5,049,006 9,693,359
Litigation settlement due in shares of common stock 0 4,500,000
Warrant liability 6,686,381 693,457
Term loan, net - current 3,562,578 0
Total current liabilities 20,113,562 22,945,440
Long term loan, net 20,197,992 0
Total liabilities 40,311,554 22,945,440
Commitments and contingencies
Stockholders' equity:    
Preferred Stock, $0.01 par value, 5,000,000 shares authorized, including 25,000 shares of Series A Junior Participating Preferred Stock; no shares issued and outstanding 0 0
Common stock, $0.001 par value, 250,000,000 shares authorized; 96,943,072 shares issued and outstanding at September 30, 2016; 66,480,065 shares issued and outstanding at December 31, 2015 96,942 66,480
Additional paid-in capital 431,693,072 409,107,292
Accumulated deficit (408,193,559) (365,094,774)
Total stockholders' equity 23,596,455 44,078,998
Total liabilities and stockholders' equity $ 63,908,009 $ 67,024,438
XML 15 R3.htm IDEA: XBRL DOCUMENT v3.5.0.2
CONDENSED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
Sep. 30, 2016
Dec. 31, 2015
Stockholders' equity:    
Preferred Stock, par value (in dollars per share) $ 0.01 $ 0.01
Preferred Stock, shares authorized (in shares) 5,000,000 5,000,000
Preferred Stock, shares issued (in shares) 0 0
Preferred Stock, shares outstanding (in shares) 0 0
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, shares authorized (in shares) 250,000,000 250,000,000
Common stock, shares issued (in shares) 96,943,072 66,480,065
Common stock, shares outstanding (in shares) 96,943,072 66,480,065
Series A Junior Participating Preferred Stock [Member]    
Stockholders' equity:    
Preferred Stock, shares authorized (in shares) 25,000 25,000
XML 16 R4.htm IDEA: XBRL DOCUMENT v3.5.0.2
CONDENSED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Revenue:        
License revenue $ 0 $ 0 $ 100,000 $ 0
Expenses:        
Research and development 8,927,037 8,470,592 29,531,609 31,043,741
General and administrative 2,771,732 2,188,656 12,859,069 9,510,657
Total expenses 11,698,769 10,659,248 42,390,678 40,554,398
Loss before other income (loss) (11,698,769) (10,659,248) (42,290,678) (40,554,398)
Other income (loss):        
Interest income 68,635 68,678 195,809 171,707
Interest expense (781,038) 0 (1,939,186) 0
Other income (loss), net (10,489) 2,040 (4,398) 17,948
Gain on warrant derivative liability 246,211 3,515,178 939,668 4,079,748
Net loss $ (12,175,450) $ (7,073,352) $ (43,098,785) $ (36,284,995)
Basic and diluted net loss per share (in dollars per share) $ (0.13) $ (0.11) $ (0.57) $ (0.62)
Basic and diluted weighted-average shares outstanding (in shares) 91,042,450 63,848,208 75,001,770 58,462,214
XML 17 R5.htm IDEA: XBRL DOCUMENT v3.5.0.2
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Cash flows from operating activities:    
Net loss $ (43,098,785) $ (36,284,995)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 364,548 240,391
Stock-based compensation expense 5,400,604 4,520,307
Fair value adjustment on warrant liability (939,668) (4,079,748)
Amortization of loan cost and discount 382,241 0
Loss on retirement of fixed assets 9,116 0
Changes in assets and liabilities:    
Receivables 4,485,130 351,388
Interest receivable 28,130 97,873
Prepaid expenses and other assets 781,013 1,545,955
Accounts payable (3,254,181) (447,430)
Accrued expenses and other current liabilities (4,644,353) (26,763)
Net cash used in operating activities (40,486,205) (34,083,022)
Cash flows from investing activities:    
Purchase of short-term investments 0 (32,982,710)
Proceeds from the sale of short-term investments 35,035,420 63,581,849
Purchases of equipment and furnishings (961,221) (325,471)
Net cash provided by investing activities 34,074,199 30,273,668
Cash flows from financing activities:    
Net proceeds from public offering 18,309,781 26,780,068
Net proceeds from term loan 24,012,078 0
Net proceeds from exercise of warrants and stock options 704,700 590,001
Net cash provided by financing activities 43,026,559 27,370,069
Net increase in cash and cash equivalents 36,614,553 23,560,715
Cash and cash equivalents at beginning of period 22,261,372 32,218,905
Cash and cash equivalents at end of period 58,875,925 55,779,620
Supplemental disclosure of cash flow information:    
Cash paid during the year for interest 1,359,028 0
Cashless warrant exercises 0 3
Cash paid for income taxes 800 800
Supplemental disclosure of non-cash activities:    
Warrants issued in connection with term loan 633,749 0
Equipment and furnishings purchased on credit 11,154 2,035
Shares issued in connection with the class action settlement 4,500,000 0
Warrants issued in connection with public offering $ 6,932,592 $ 0
XML 18 R6.htm IDEA: XBRL DOCUMENT v3.5.0.2
Description of Company and Basis of Presentation
9 Months Ended
Sep. 30, 2016
Description of Company and Basis of Presentation [Abstract]  
Description of Company and Basis of Presentation
1. Description of Company and Basis of Presentation
CytRx Corporation ("we," "us," "our" or the "Company") is a biopharmaceutical research and development company specializing in oncology. We currently are focused on the clinical development of aldoxorubicin (formerly known as INNO-206), our modified version of the widely-used chemotherapeutic agent, doxorubicin.  We are also developing new anti-cancer drug conjugates that utilize our Linker Activated Drug Release (LADRTM ) technology.
We previously announced the initial analysis of top-line data from our on-going global, randomized Phase 3 clinical trial of aldoxorubicin as a treatment for patients with relapsed or refractory soft tissue sarcomas, or STS. The trial enrolled 433 patients at 79 sites in 15 countries including the U.S. and Canada.
We also previously announced that we expected to conduct a second analysis which will include longer patient follow-up. In addition, we expect  to report the multiple sub-analyses of top-line data specified in the trial's statistical plan. We currently expect the second analysis to be completed in November or early December 2016.
We are currently evaluating aldoxorubicin in a global Phase 2b clinical trial in second-line small cell lung cancer in which we currently expect to announce top-line data in the first or second quarter of 2017, as the number of deaths and/or progressions needed for data analysis have not yet been reached. We are also evaluating aldoxorubicin in a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. We previously completed Phase 2 clinical trials of aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and HIV-related Kaposi's Sarcoma, a Phase 1b clinical trial of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial of aldoxorubicin in patients with metastatic solid tumors.
Although we have made progress on the pre-clinical development for DK049, a novel anti-cancer drug conjugate that utilizes our LADRTM  technology, we have suspended further development in order to devote our resources to the completion of the Phase 3 clinical trial of aldoxorubicin and preparations for our planned pre New Drug Application ("NDA") meeting with the FDA, which we believe could occur in the first quarter of 2017.  DK049 was created at our laboratory facility in Freiburg, Germany, and employs a proprietary linker that is both pH sensitive and requires a specific enzyme for the release of the cytotoxic payload.  We have now expanded our pipeline of oncology candidates utilizing our LADRTM technology to attach ultra-high potency drugs to albumin (10-1000 times more potent than traditional chemotherapies limited to antibodies only) to target tumors.
The accompanying condensed financial statements at September 30, 2016 and for the three-month and nine-month periods ended September 30, 2016 and 2015, 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, 2015 have been derived from the our audited financial statements as of that date.
The 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 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, 2015.
Following our announcement of the initial analysis of our on-going global Phase 3 clinical trial of aldoxorubicin, we took measures to reduce our "burn" rate, have decreased our head count and discontinued our pre-commercialization activities pending the results of our second analysis and of our planned pre-NDA meeting with the FDA.  For these reasons and others, our operating results may fluctuate from period to period, and the results of prior periods should not be relied upon as predictive of the results in future periods.
XML 19 R7.htm IDEA: XBRL DOCUMENT v3.5.0.2
Recent Accounting Pronouncements
9 Months Ended
Sep. 30, 2016
Recent Accounting Pronouncements [Abstract]  
Recent Accounting Pronouncements
2. Recent Accounting Pronouncements
In August 2016, the Financial Accounting Standards Board issued ASU No. 2016-15 "Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force." The objective of ASU No. 2016-15 is to provide specific guidance on eight cash flow classification issues and how to reduce diversity in how certain cash receipts and cash payments are presented and classified in the statement of cash flows under Topic 230, Statement of Cash Flows, and other Topics. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years. We are still in the process of determining the impact that the implementation of ASU 2016-15 will have on the Company's financial statements.
In March 2016, the FASB issued Accounting Standards Update 2016-09, Compensation—Stock Compensation ("ASU 2016-09"). ASU 2016-09 includes several areas of simplification to stock compensation including simplifications to the accounting for income taxes, classification of excess tax benefits on the Statement of Cash Flows and forfeitures. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016. An entity that elects early adoption must adopt all of the amendments in the same period. We did not early adopt ASU 2016-09 as of and for the period ended September 30, 2016. We are still evaluating the effect of this update.
In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases ("ASU 2016-02"). ASU 2016-02 allows the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. 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 previous leases guidance. The Update 2016-02 is effective for annual reporting periods beginning after December 15, 2018 and early adoption is permitted. We are still evaluating the effect of this update.
In January 2016, the FASB issued Accounting Standards Update 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities ("ASU 2016-01"). ASU 2016-01 eliminates the requirement to disclose the methods and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet. The standard also clarifies the need to evaluate a valuation allowance on a deferred tax asset related to available-for-sale securities in combination with other deferred tax assets. ASU 2016-01 is effective for annual reporting periods beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact on our financial statements.
In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs ("ASU 2015-03"), which requires that debt issuance costs be reported in the balance sheet as a direct deduction from the face amount of the related liability, consistent with the presentation of debt discounts. Further, ASU 2015-03 requires the amortization of debt issuance costs to be reported as interest expense. Similarly, debt issuance costs and any discount or premium are considered in the aggregate when determining the effective interest rate on the debt. ASU 2015-03 is effective for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. ASU 2015-03 must be applied retrospectively. Entities may choose to adopt the new requirements as of an earlier date for financial statements that have not been previously issued. We adopted this Accounting Standard effective January 1, 2016.
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern ("Subtopic 205-40") ("ASU 2014-15"). The new guidance addresses management's responsibility to evaluate whether there is substantial doubt about an entity's ability to continue as a going concern and to provide related footnote disclosures. Management's evaluation should be based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued. The standard will be effective for the first interim period within annual reporting periods beginning after December 15, 2016. Early adoption is permitted. We do not expect to early adopt this guidance and do not believe that the adoption of this guidance will have a material impact on our financial statements.
XML 20 R8.htm IDEA: XBRL DOCUMENT v3.5.0.2
Foreign Currency Remeasurement
9 Months Ended
Sep. 30, 2016
Foreign Currency Remeasurement [Abstract]  
Foreign Currency Remeasurement
3. Foreign Currency Remeasurement
The U.S. dollar has been determined to be the functional currency for the net assets of our laboratory facility in Germany. Transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). We recognized exchange rate losses of approximately $6,000 and $500, respectively, for the three-month and nine-month periods ended September 30, 2016 and an exchange rate gain of approximately $1,000 and an exchange rate loss of approximately $10,000 for the three and nine-month periods ended September 30, 2015, respectively.
XML 21 R9.htm IDEA: XBRL DOCUMENT v3.5.0.2
Short-term Investments
9 Months Ended
Sep. 30, 2016
Short-term Investments [Abstract]  
Short-term Investments
4. Short-term Investments
We held no short-term investments at September 30, 2016, as compared to $35.0 million at December 31, 2015. We classified these investments as available for sale at December 31, 2015.
XML 22 R10.htm IDEA: XBRL DOCUMENT v3.5.0.2
Litigation Settlement Due in Shares of Common Stock
9 Months Ended
Sep. 30, 2016
Litigation Settlement Due in Shares of Common Stock [Abstract]  
Litigation Settlement Due in Shares of Common Stock
5. Litigation Settlement Due in Shares of Common Stock
The class-action settlement we announced in December 2015 was completed on May 25, 2016 with the issuance of 1,561,578 shares of our common stock valued at $4.5 million, or $2.88 a share, and payment of $4 million in cash, of which $3.5 million was paid by our insurance carriers and $500,000 was paid out of company funds.  In accordance with ASC 480, "Distinguishing Liabilities from Equity," we classified the $4.5 million worth of shares of the common stock as a non-cash liability due in shares of common stock on the December 31, 2015 balance sheet, due to the variable number of shares issuable under the settlement.
XML 23 R11.htm IDEA: XBRL DOCUMENT v3.5.0.2
Term Loan
9 Months Ended
Sep. 30, 2016
Term Loan [Abstract]  
Term Loan
6. Term Loan
On February 5, 2016, we entered into a loan and security agreement with Hercules Technology Growth Capital, Inc. ("HTGC"), as administrative agent and lender, and Hercules Technology III, L.P., as lender, pursuant to which the lenders agreed to make long-term loans to us in an aggregate principal amount of up to $40 million, subject to certain conditions.  The lenders made an initial term loan to us on February 8, 2016 in the aggregate principal amount of $25 million.  The term loan bears interest at the daily variable rate per annum equal to 6.00% plus the prime rate, or 9.5%, whichever is greater.  We are required to make interest-only payments on the term loans through February 28, 2017, and beginning on March 1, 2017 we will be required to make amortizing payments of principal and accrued interest in equal monthly installments until the maturity date of the loan.  Under the terms of the loan, we are required to maintain a minimum cash balance equal to the greater of (i) $10 million or (ii) forward three months projected cash burn.  If we achieve certain milestones, we may request an additional term loan in an aggregate principal amount of up to $15 million no later than December 31, 2016, or such later date that HTGC otherwise determines in its sole discretion, but we do not expect to meet these milestones at this time.  In connection with the loan and security agreement, we issued to the lenders warrants to purchase a total of 634,146 shares of our common stock at an exercise price of $2.05. These warrants are classified on the September 30, 2016 balance sheet as equity warrants with a fair value of $633,749 as determined at the date of issuance. All outstanding principal and accrued interest on the term loans will be due and payable in full on the maturity date of February 1, 2020, subject to the lenders' right to accelerate the term loans if we were to experience a "material adverse event" (as defined in the loan and security agreement).
As security for our obligations under the loan and securities agreement, we granted HTGC, as administrative agent, a security interest in substantially all of our existing and after-acquired assets except for our intellectual property and certain other excluded assets.
The following sets forth information regarding the current and long-term portion of the term loan:
  
September 30, 2016
 
Term Loan Principal - Current
 
$
4,311,336
 
Issuance Cost - Current
  
(122,335
)
Loan Discount - Current
  
(626,423
)
Term Loan, Net - Current
 
$
3,562,578
 
     
Term Loan Principal
 
$
20,688,664
 
End Fee Payable
  
1,771,250
 
Long Term Issuance Cost
  
(353,919
)
Long Term Loan Discount
  
(1,908,003
)
Long Term Loan, Net
 
$
20,197,992
 
     
Interest expense on the term loan for the three-month and nine-month periods ended September 30, 2016 was $781,038 and $1,939,186, respectively. There was no interest expense in the 2015 comparative periods.
XML 24 R12.htm IDEA: XBRL DOCUMENT v3.5.0.2
Basic and Diluted Net Loss Per Common Share
9 Months Ended
Sep. 30, 2016
Basic and Diluted Net Loss Per Common Share [Abstract]  
Basic and Diluted Net Loss Per Common Share
7. 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 44.0 million shares for each of the three-month and nine-month periods ended September 30, 2016, and 17.4 million shares for each of the three-month and nine-month periods ended September 30, 2015.
XML 25 R13.htm IDEA: XBRL DOCUMENT v3.5.0.2
Warrant Liabilities
9 Months Ended
Sep. 30, 2016
Warrant Liabilities [Abstract]  
Warrant Liabilities
8. 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.  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. We recognized a gain of $0.2 million and $3.5 million for the three-month periods ended September 30, 2016 and 2015, respectively, and a gain of $0.9 million and $4.1 million for the nine-month periods ended September 30, 2016 and 2015, respectively. The following reflects the weighted-average assumptions for each of the nine-month periods indicated:
 
  
Nine Months Ended September 30,
 
  
2016
  
2015
 
       
Risk-free interest rate
  
0.52
%
  
0.21
%
Expected dividend yield
  
0
%
  
0
%
Expected lives
  
0.8
   
0.84
 
  Expected volatility
  
131.3
%
  
69.1
%
  Warrants classified as liabilities (in shares)
  
28,571,429
   
6,371,854
 
         
Our computation of expected volatility is based on the historical daily volatility of its 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.
On August 1, 2016, 6,371,854 warrants expired. On July 20, 2016, we issued one-year warrants to purchase up to 28,571,429 shares of our common stock in the public offering described in Note 12.
XML 26 R14.htm IDEA: XBRL DOCUMENT v3.5.0.2
Stock Based Compensation
9 Months Ended
Sep. 30, 2016
Stock Based Compensation [Abstract]  
Stock Based Compensation
9. Stock Based Compensation
Our 2000 Long-Term Incentive Plan expired on August 6, 2010 and no further shares are available for future grant under this plan.  As of September 30, 2016, there were approximately 0.6 million shares subject to outstanding stock options under this plan.
We also have a 2008 Stock Incentive Plan. As of September 30, 2016, there were 13.4 million shares subject to outstanding stock options and 16.4 million shares available for future grant.
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 Statements of Operations:
  
Three Months Ended September 30,
  
Nine Months Ended September 30,
 
  
2016
  
2015
  
2016
  
2015
 
Research and development — employee
 
$
455,341
  
$
402,292
  
$
1,443,347
  
$
1,131,072
 
General and administrative — employee
  
586,315
   
482,954
   
3,742,733
   
3,182,798
 
Total employee stock-based compensation
 
$
1,041,656
  
$
885,246
  
$
5,186,080
  
$
4,313,870
 
                 
Research and development — non-employee
 
$
  
$
  
$
  
$
 
General and administrative — non-employee
  
(5,938
)
  
(27,647
)
  
214,524
   
206,437
 
Total non-employee stock-based compensation
 
$
(5,938
)
 
$
(27,647
)
 
$
214,524
  
$
206,437
 
 
During the nine-month period ended September 30, 2016, we granted stock options to purchase 475,000 shares of its common stock and warrants to purchase 500,000 shares of our common stock at a average weighted exercise price of $1.89. In the nine-month period ended September 30, 2016, we amended the terms of stock options of a former executive in respect of a Retirement Agreement, resulting in a one-time expense of approximately $1.9 million. During the nine-month period ended September 30, 2015, we granted stock options to purchase 550,000 shares of our common stock. 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, 2016
  
Nine Months Ended September 30, 2015
 
Risk-free interest rate
  
1.72
%
  
2.21
%
Expected volatility
  
74.9
%
  
78.2% - 84.4
%
Expected lives (years)
  
6
   
6 - 10
 
Expected dividend yield
  
0.00
%
  
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, 2016, 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. Based on historical experience, for the nine-month periods ended September 30, 2016 and 2015, we estimated annualized forfeiture rates of 10% for options granted to our employees, 2% for options granted to senior management and 0% for options granted to directors and non-employees and for warrants issued to non-employees  Compensation costs will be adjusted for future changes in estimated forfeitures.  We will record additional expense if the actual forfeitures are lower than estimated and will record a recovery of prior expense if the actual forfeiture rates are higher than estimated.
As of September 30, 2016, there remained approximately $4.1 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 0.96 years. Presented below is our stock option activity:
 
  
Nine Months Ended September 30, 2016
 
  
Number of Options (Employees)
  
Number of Options (Non-Employees)
  
Total Number of Options
  
Weighted-Average Exercise Price
 
Outstanding at January 1, 2016
  
13,583,862
   
635,714
   
14,219,576
  
$
3.10
 
Granted
  
475,000
   
   
475,000
  
$
2.05
 
Exercised, Forfeited or Expired
  
(1,221,040
)
  
(35,714
)
  
(1,256,754
)
 
$
3.30
 
Outstanding at September 30, 2016
  
12,837,822
   
600,000
   
13,437,822
  
$
3.04
 
Options exercisable at September 30, 2016
  
9,242,803
   
600,000
   
9,842,803
  
$
3.27
 
 
The following table summarizes significant ranges of outstanding stock options under our plans at September 30, 2016:

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
 
$
0.60 – $2.00
   
1,274,498
   
6.34
  
$
1.78
   
1,224,498
   
6.19
  
$
1.83
 
$
2.01 – $2.50
   
7,899,179
   
8.41
  
$
2.33
   
4,522,874
   
8.06
  
$
2.30
 
$
2.51 – $4.00
   
968,291
   
7.37
  
$
2.88
   
937,458
   
7.34
  
$
2.87
 
$
4.01 – $32.55
   
3,295,854
   
6.46
  
$
5.30
   
3,157,973
   
6.42
  
$
5.32
 
     
13,437,822
   
7.66
  
$
3.04
   
9,842,803
   
7.23
  
$
3.27
 

The aggregate intrinsic value of all outstanding options and vested options as of September 30, 2016 was $0 and $0, respectively, representing options with exercise prices of less than the closing fair market value of our common stock on September 30, 2016 of $0.59 per share.
There were 30,559,148 and 7,225,472 warrants outstanding at September 30, 2016 and December 31, 2015, respectively at a weighted-average exercise price of $0.80 and $4.28, respectively.
XML 27 R15.htm IDEA: XBRL DOCUMENT v3.5.0.2
Fair Value Measurements
9 Months Ended
Sep. 30, 2016
Fair Value Measurements [Abstract]  
Fair Value Measurements
10. 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, 2016 for assets and liabilities measured at fair value on a recurring basis:
(In thousands)
 
Level I
  
Level II
  
Level III
  
Total
 
Cash equivalents
 
$
56,972
  
$
  
$
  
$
56,972
 
Warrant liability
  
   
   
(6,686
)
  
(6,686
)

The following table summarizes fair value measurements by level at December 31, 2015 for assets and liabilities measured at fair value on a recurring basis:
(In thousands)
 
Level I
  
Level II
  
Level III
  
Total
 
Cash equivalents
 
$
20,673
  
$
  
$
  
$
20,673
 
Short-term investments
  
35,035
   
   
   
35,035
 
Warrant liability
  
   
   
(693
)
  
(693
)

Liabilities measured at market value on a recurring basis include warrant liability resulting from our August 2011 equity financing. In accordance with ASC 815-40, the warrant liability are marked to market each quarter-end until they are completely settled. The warrants are valued using the Black-Scholes method, using assumptions consistent with our application of ASC 505-50. The $6.0 million increase in fair value of the warrant liability is due primarily to the warrants issued in connection with the July, 2016 public offering (see Note 8).
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.  Our non-financial assets were not material at September 30, 2016 or 2015.
XML 28 R16.htm IDEA: XBRL DOCUMENT v3.5.0.2
Liquidity and Capital Resources
9 Months Ended
Sep. 30, 2016
Liquidity and Capital Resources [Abstract]  
Liquidity and Capital Resources
11. Liquidity and Capital Resources
At September 30, 2016, we had cash and cash equivalents of approximately $58.9 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 2016 and the first ten months of 2017 of approximately $37.4 million, which includes approximately $15.6 million for our ongoing clinical programs for aldoxorubicin, approximately $2.7 million for our drug discovery operations at our Freiburg, Germany laboratory, approximately $3.4 million for general operation of our clinical programs, approximately $8.3 million for other general and administrative expenses, and approximately $7.4 million for interest and payments on our outstanding term loan.  These projected expenditures assume that we will not suffer a "material adverse event" which could trigger the lenders' acceleration of our outstanding term loan, and are based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these projections.
Following our announcement of the initial analysis of our on-going global Phase 3 clinical trial of aldoxorubicin, we took measures to reduce our "burn" rate, decreased our head count and discontinued our pre-commercialization activities pending the results of our second analysis and of our planned pre-NDA meeting with the FDA.  For these reasons and others, our operating results may fluctuate from period to period, and the results of prior periods should not be relied upon as predictive of the results in future periods.
If we obtain marketing approval and successfully commercialize aldoxorubicin or other product candidates, we anticipate it will take several years for us to generate significant recurring revenue. We will be dependent on future financing and possible strategic partnerships until such time, if ever, as it can generate significant recurring revenue. We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. If we fail to obtain sufficient funding when needed, we may be forced to delay, scale back or eliminate all or a portion of our development programs or clinical trials, seek to license to other companies our product candidates or technologies that we would prefer to develop and commercialize ourselves, or seek to sell some or all of our assets or merge with or be acquired by another company.
XML 29 R17.htm IDEA: XBRL DOCUMENT v3.5.0.2
Equity Transactions
9 Months Ended
Sep. 30, 2016
Equity Transactions [Abstract]  
Equity Transactions
12. Equity Transactions
As of September 30, 2016, we have reserved approximately 16.4 million of our authorized but unissued shares of common stock for future issuance pursuant to our employee stock option plans issued to employees and consultants.
On July 20, 2016, we issued 28,579,421 shares of our common stock and one-year warrants to purchase an equal number of shares of our common stock in a public offering.
In the first quarter of 2016, we issued 100,000 common shares for $0.2 million resulting from the exercise of stock options and warrants to purchase 500,000 common shares at an exercise price of $1.74.
On October 26, 2015, we retired 199,275 shares of our treasury stock at cost ($2.6 million).
XML 30 R18.htm IDEA: XBRL DOCUMENT v3.5.0.2
Income Taxes
9 Months Ended
Sep. 30, 2016
Income Taxes [Abstract]  
Income Taxes
13. Income Taxes
At December 31, 2015, we had federal and state net operating loss carryforwards as of  $281.6 million and $173.7 million, respectively, available to offset against future taxable income, which expire in 2016 through 2034, of which $219.3 million and $173.7 million, respectively, are not subject to limitation under Section 382 of the Internal Revenue Code.
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Commitments and contingencies
9 Months Ended
Sep. 30, 2016
Commitments and contingencies [Abstract]  
Commitments and contingencies
14. Commitments and contingencies
Commitments
We have an agreement with KTB for the Company's exclusive license of patent rights held by KTB for the worldwide development and commercialization of aldoxorubicin. Under the agreement, we must make payments to KTB 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 has 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 KTB, 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.
Shareholder Derivative Action in California.  On August 14, 2014, a shareholder derivative lawsuit, captioned Pankratz v. Kriegsman, et al., 2:14-cv-06414-PA-JPR, was filed in the United States District Court for the Central District of California purportedly on our behalf against certain of our officers and each of our directors. On August 15, 2014, a virtually identical complaint was filed, captioned Taylor v. Kriegsman, et al., 2:14-cv-06451.  Each of the complaints alleged breach of fiduciary duties, unjust enrichment, gross mismanagement, abuse of control, insider selling and misappropriation of information in connection with our alleged retention of DreamTeamGroup and MissionIR, as well as our December 9, 2013 grant of stock options to certain board members and officers. The complaint seeks unspecified damages, corporate governance and internal procedures reforms, restitution, disgorgement of all profits, benefits, and other compensation obtained by the individual defendants, and the costs and disbursements of the action. On October 8, 2014, the Court consolidated the Pankratz and Taylor cases and appointed lead plaintiffs and co-lead counsel. After a series of procedural events including an intervening stay of the action, on November 2, 2015, the Court granted the defendants' motion to dismiss the consolidated action on grounds of forum non conveniens, largely based on our by-law requiring derivative actions to be filed in the Delaware Court of Chancery.  On November 17, 2015, Plaintiffs filed an appeal with the Ninth Circuit Court of Appeals.  While the case was pending on appeal, on December 22, 2015, the parties executed a Memorandum of Understanding to settle the derivative action.  On April 4, 2016, the plaintiffs filed a Motion for Preliminary Approval of the Shareholder Derivative Settlement in the District Court.  On May 31, 2016, however, the Court denied without prejudice the Motion for Preliminary Approval of the Settlement on procedural grounds that included the Court's view that the settlement could not be considered until the Court's November 2 judgment dismissing the case was vacated.  The Court granted the parties the opportunity to file a motion to set aside the November 2 judgment.  However, on August 17, 2016, the Court denied the parties' motion to set aside the judgment.  No party took an appeal.  Accordingly, the derivative litigation in California has concluded.
Shareholder Derivative Actions in DelawareThere are two competing derivative complaints pending in the Delaware Court of Chancery alleging claims related to our alleged retention of DreamTeamGroup and MissionIR.  On December 14, 2015, a shareholder derivative complaint, captioned Niedermeyer et al. v. Kriegsman et al., C.A. No. 11800, was filed against certain of our officers and directors, for which a second amended complaint was filed on October 12, 2016.  On September 6, 2016, one of the plaintiffs in the California litigation (discussed above) effectively refiled his complaint in the Delaware Court of Chancery, with the case captioned Taylor v. Kriegsman, C.A. No. 12720.  Absent an agreement between the two plaintiffs and their respective counsel, competing motions for assignment as lead counsel and lead plaintiff will be necessary.  Following court appointment of lead counsel and lead plaintiff, a consolidated complaint will likely be filed or an operative complaint identified.  We and the defendant officers and defendants will then respond appropriately to the operative complaint.
Class Actions in California.  On July 25 and 29, 2016, nearly identical class action complaints were filed in the U.S. District Court for the Central District of California, titled Crihfield v. CytRx Corp., et al., Case No. 2:16-cv-05519 and Dorce v. CytRx Corp., Case No. 2:16-cv-05666 alleging that we and certain of our officers violated the Securities Exchange Act of 1934 by allegedly making materially false and/or misleading statements, and/or failing to disclose material adverse facts to the effect that the clinical hold placed on the Phase 3 trial of aldoxorubicin for STS would prevent sufficient follow-up for patients involved in the study, thus requiring further analysis, which could cause the trial's results and/or FDA approval to be materially adversely affected or delayed.  The plaintiffs allege that such wrongful acts and omissions caused significant losses and damages to a class of persons and entities that acquired our securities between November 18, 2014 and July 11, 2016, and seek an award of compensatory damages, costs and expenses, including counsel and expert fees, and such other and further relief as the Court may deem just and proper. On October 26, 2016, the Court entered an Order consolidating the actions titled In re: CytRx Corporation Securities Litigation, Master File No. 16-cv-05519-SJO and appointing a Lead Plantiff and Lead Counsel.
We intend to vigorously defend against the foregoing complaints. We have directors' and officers' liability insurance, which will be utilized in the defense of these matters. The liability insurance may not cover all of the future liabilities we may incur in connection with the foregoing matters. These claims are subject to inherent uncertainties, and management's view of these matters may change in the future.
We evaluate developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the period in which the outcome becomes probable and reasonably estimable.
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Term Loan (Tables)
9 Months Ended
Sep. 30, 2016
Term Loan [Abstract]  
Schedule of term loan
The following sets forth information regarding the current and long-term portion of the term loan:
  
September 30, 2016
 
Term Loan Principal - Current
 
$
4,311,336
 
Issuance Cost - Current
  
(122,335
)
Loan Discount - Current
  
(626,423
)
Term Loan, Net - Current
 
$
3,562,578
 
     
Term Loan Principal
 
$
20,688,664
 
End Fee Payable
  
1,771,250
 
Long Term Issuance Cost
  
(353,919
)
Long Term Loan Discount
  
(1,908,003
)
Long Term Loan, Net
 
$
20,197,992
 
     
XML 33 R21.htm IDEA: XBRL DOCUMENT v3.5.0.2
Warrant Liabilities (Tables)
9 Months Ended
Sep. 30, 2016
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,
 
  
2016
  
2015
 
       
Risk-free interest rate
  
0.52
%
  
0.21
%
Expected dividend yield
  
0
%
  
0
%
Expected lives
  
0.8
   
0.84
 
  Expected volatility
  
131.3
%
  
69.1
%
  Warrants classified as liabilities (in shares)
  
28,571,429
   
6,371,854
 
         
XML 34 R22.htm IDEA: XBRL DOCUMENT v3.5.0.2
Stock Based Compensation (Tables)
9 Months Ended
Sep. 30, 2016
Stock Based Compensation [Abstract]  
Schedule of total stock-based compensation expense from stock options and warrants
The following table sets forth the total stock-based compensation expense resulting from stock options and warrants included in our Condensed Statements of Operations:
  
Three Months Ended September 30,
  
Nine Months Ended September 30,
 
  
2016
  
2015
  
2016
  
2015
 
Research and development — employee
 
$
455,341
  
$
402,292
  
$
1,443,347
  
$
1,131,072
 
General and administrative — employee
  
586,315
   
482,954
   
3,742,733
   
3,182,798
 
Total employee stock-based compensation
 
$
1,041,656
  
$
885,246
  
$
5,186,080
  
$
4,313,870
 
                 
Research and development — non-employee
 
$
  
$
  
$
  
$
 
General and administrative — non-employee
  
(5,938
)
  
(27,647
)
  
214,524
   
206,437
 
Total non-employee stock-based compensation
 
$
(5,938
)
 
$
(27,647
)
 
$
214,524
  
$
206,437
 
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, 2016
  
Nine Months Ended September 30, 2015
 
Risk-free interest rate
  
1.72
%
  
2.21
%
Expected volatility
  
74.9
%
  
78.2% - 84.4
%
Expected lives (years)
  
6
   
6 - 10
 
Expected dividend yield
  
0.00
%
  
0.00
%
         
Schedule of share-based compensation, stock options, activity
Presented below is our stock option activity:
 
  
Nine Months Ended September 30, 2016
 
  
Number of Options (Employees)
  
Number of Options (Non-Employees)
  
Total Number of Options
  
Weighted-Average Exercise Price
 
Outstanding at January 1, 2016
  
13,583,862
   
635,714
   
14,219,576
  
$
3.10
 
Granted
  
475,000
   
   
475,000
  
$
2.05
 
Exercised, Forfeited or Expired
  
(1,221,040
)
  
(35,714
)
  
(1,256,754
)
 
$
3.30
 
Outstanding at September 30, 2016
  
12,837,822
   
600,000
   
13,437,822
  
$
3.04
 
Options exercisable at September 30, 2016
  
9,242,803
   
600,000
   
9,842,803
  
$
3.27
 
Schedule of share-based compensation, summarizes significant ranges of outstanding stock options
The following table summarizes significant ranges of outstanding stock options under our plans at September 30, 2016:

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
 
$
0.60 – $2.00
   
1,274,498
   
6.34
  
$
1.78
   
1,224,498
   
6.19
  
$
1.83
 
$
2.01 – $2.50
   
7,899,179
   
8.41
  
$
2.33
   
4,522,874
   
8.06
  
$
2.30
 
$
2.51 – $4.00
   
968,291
   
7.37
  
$
2.88
   
937,458
   
7.34
  
$
2.87
 
$
4.01 – $32.55
   
3,295,854
   
6.46
  
$
5.30
   
3,157,973
   
6.42
  
$
5.32
 
     
13,437,822
   
7.66
  
$
3.04
   
9,842,803
   
7.23
  
$
3.27
 
XML 35 R23.htm IDEA: XBRL DOCUMENT v3.5.0.2
Fair Value Measurements (Tables)
9 Months Ended
Sep. 30, 2016
Fair Value Measurements [Abstract]  
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, 2016 for assets and liabilities measured at fair value on a recurring basis:
(In thousands)
 
Level I
  
Level II
  
Level III
  
Total
 
Cash equivalents
 
$
56,972
  
$
  
$
  
$
56,972
 
Warrant liability
  
   
   
(6,686
)
  
(6,686
)

The following table summarizes fair value measurements by level at December 31, 2015 for assets and liabilities measured at fair value on a recurring basis:
(In thousands)
 
Level I
  
Level II
  
Level III
  
Total
 
Cash equivalents
 
$
20,673
  
$
  
$
  
$
20,673
 
Short-term investments
  
35,035
   
   
   
35,035
 
Warrant liability
  
   
   
(693
)
  
(693
)
XML 36 R24.htm IDEA: XBRL DOCUMENT v3.5.0.2
Description of Company and Basis of Presentation (Details)
3 Months Ended 9 Months Ended
Sep. 30, 2016
Patient
Mar. 31, 2016
Event
Sep. 30, 2016
ClinicalSite
Country
Description of Company and Basis of Presentation [Abstract]      
Number of patients enrolled | Patient 433    
Number of clinical sites | ClinicalSite     79
Number of countries | Country     15
Number of progression events | Event   191  
XML 37 R25.htm IDEA: XBRL DOCUMENT v3.5.0.2
Foreign Currency Remeasurement (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Foreign Currency Remeasurement [Abstract]        
Gain (loss) on foreign currency translation adjustment $ (6,000) $ 1,000 $ (500) $ (10,000)
XML 38 R26.htm IDEA: XBRL DOCUMENT v3.5.0.2
Short-term Investments (Details) - USD ($)
Sep. 30, 2016
Dec. 31, 2015
Short-term Investments [Abstract]    
Short-term investments $ 0 $ 35,035,420
XML 39 R27.htm IDEA: XBRL DOCUMENT v3.5.0.2
Litigation Settlement Due in Shares of Common Stock (Details) - USD ($)
May 25, 2016
Sep. 30, 2016
Jul. 20, 2016
Dec. 31, 2015
Loss Contingencies [Line Items]        
Litigation settlement due in shares $ 4,500,000 $ 0   $ 4,500,000
Common stock issued for litigation settlement (in dollars per shares) $ 2.88      
Litigation settlement, cash $ 4,000,000      
Payment paid by our insurance carriers 3,500,000      
Payment made out of company funds $ 500,000      
Common stock issued for litigation settlement (in shares) 1,561,578   28,579,421  
Litigation Settlement due in Shares of Common Stock [Member]        
Loss Contingencies [Line Items]        
Litigation settlement due in shares       $ 4,500,000
XML 40 R28.htm IDEA: XBRL DOCUMENT v3.5.0.2
Term Loan (Details) - USD ($)
3 Months Ended 9 Months Ended
Feb. 08, 2016
Feb. 05, 2016
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Mar. 31, 2016
Dec. 31, 2015
Debt Instrument [Line Items]                
Amount received under initial loan agreement         $ 24,012,078 $ 0    
Term Loan, Net - Current     $ 3,562,578   3,562,578     $ 0
Long Term Loan, Net     20,197,992   20,197,992     $ 0
Interest expense     $ 781,038 $ 0 $ 1,939,186 0    
Warrants [Member]                
Debt Instrument [Line Items]                
Number of warrants issued (in shares)     500,000   500,000   500,000  
Exercise price of warrant issued (in dollars per share)     $ 1.89   $ 1.89   $ 1.74  
Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. [Member]                
Debt Instrument [Line Items]                
Maximum borrowing capacity under long-term loan agreement   $ 40,000,000            
Amount received under initial loan agreement $ 25,000,000              
Additional maximum borrowing capacity under long-term loan agreement   $ 15,000,000            
Debt instrument, interest rate   9.50%            
Debt instrument, minimum cash balance required to be maintained   $ 10,000,000            
Debt instrument, maturity date     Feb. 01, 2020          
Term Loan Principal - Current     $ 4,311,336   $ 4,311,336      
Issuance Cost - Current     (122,335)   (122,335)      
Loan Discount - Current     (626,423)   (626,423)      
Term Loan, Net - Current     3,562,578   3,562,578      
Term Loan Principal     20,688,664   20,688,664      
End Fee Payable     1,771,250   1,771,250      
Loan Term Issuance Cost     (353,919)   (353,919)      
Long Term Loan Discount     (1,908,003)   (1,908,003)      
Long Term Loan, Net     20,197,992   20,197,992      
Interest expense     781,038 $ 0 1,939,186 $ 0    
Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. [Member] | Warrants [Member]                
Debt Instrument [Line Items]                
Number of warrants issued (in shares)   634,146            
Exercise price of warrant issued (in dollars per share)   $ 2.05            
Fair value of warrants classified as equity warrants     $ 633,749   $ 633,749      
Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. [Member] | Prime Rate [Member]                
Debt Instrument [Line Items]                
Debt instrument, basis spread on variable rate   6.00%            
XML 41 R29.htm IDEA: XBRL DOCUMENT v3.5.0.2
Basic and Diluted Net Loss Per Common Share (Details) - shares
shares in Millions
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Basic and Diluted Net Loss Per Common Share [Abstract]        
Antidilutive securities excluded from computation of earnings per share (in shares) 44.0 17.4 44.0 17.4
XML 42 R30.htm IDEA: XBRL DOCUMENT v3.5.0.2
Warrant Liabilities (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Derivative [Line Items]        
Gain on warrant liability $ 246,211 $ 3,515,178 $ 939,668 $ 4,079,748
Warrants [Member]        
Derivative [Line Items]        
Risk-free interest rate     0.52% 0.21%
Expected dividend yield     0.00% 0.00%
Expected lives     9 months 18 days 10 months 2 days
Expected volatility     131.30% 69.10%
Warrants classified as liabilities (in shares) 28,571,429 6,371,854 28,571,429 6,371,854
Gain on warrant liability $ 246,212 $ 3,515,178 $ 939,668 $ 4,079,748
Warrant expiration date     Aug. 01, 2016  
XML 43 R31.htm IDEA: XBRL DOCUMENT v3.5.0.2
Stock Based Compensation (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Mar. 31, 2016
Weighted-Average Exercise Price Options [Abstract]          
Share based compensation expense   $ 5,400,604 $ 4,520,307    
Employees [Member]          
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract]          
Estimated annualized forfeiture rate   10.00% 10.00%    
Non-Employees [Member]          
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract]          
Estimated annualized forfeiture rate   0.00% 0.00%    
Employees and Directors [Member]          
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract]          
Unrecognized compensation expense related to unvested stock options, granted       $ 4,100,000  
Unrecognized compensation cost, recognized as expense over a weighted-average period   11 months 16 days      
Senior Management [Member]          
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract]          
Estimated annualized forfeiture rate   2.00% 2.00%    
Directors [Member]          
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract]          
Estimated annualized forfeiture rate   0.00% 0.00%    
Former Executive [Member]          
Weighted-Average Exercise Price Options [Abstract]          
Share based compensation expense $ 1,900,000        
Stock Options [Member]          
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Share-based compensation, shares subject to stock options (in shares) 13,437,822 14,219,576   13,437,822  
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract]          
Contractual term and expected life   10 years      
Number of Options (Employees and Non-Employees) [Abstract]          
Outstanding at beginning of period (in shares)   14,219,576      
Granted (in shares)   475,000 550,000    
Exercised, forfeited or expired (in shares)   (1,256,754)      
Outstanding at end of period (in shares) 13,437,822 13,437,822      
Options exercisable at end of period (in shares) 9,842,803 9,842,803      
Weighted-Average Exercise Price Options [Abstract]          
Outstanding at beginning of period (in dollars per share)   $ 3.10      
Granted (in dollars per share)   2.05      
Exercised, forfeited or expired (in dollars per share)   3.30      
Outstanding at end of period (in dollars per share) $ 3.04 3.04      
Options exercisable at end of period (in dollars per share) $ 3.27 $ 3.27      
Stock Options [Member] | Employees [Member]          
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Share-based compensation, shares subject to stock options (in shares) 12,837,822 13,583,862   12,837,822  
Number of Options (Employees and Non-Employees) [Abstract]          
Outstanding at beginning of period (in shares)   13,583,862      
Granted (in shares)   475,000      
Exercised, forfeited or expired (in shares)   (1,221,040)      
Outstanding at end of period (in shares) 12,837,822 12,837,822      
Options exercisable at end of period (in shares) 9,242,803 9,242,803      
Stock Options [Member] | Non-Employees [Member]          
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Share-based compensation, shares subject to stock options (in shares) 600,000 635,714   600,000  
Number of Options (Employees and Non-Employees) [Abstract]          
Outstanding at beginning of period (in shares)   635,714      
Granted (in shares)   0      
Exercised, forfeited or expired (in shares)   (35,714)      
Outstanding at end of period (in shares) 600,000 600,000      
Options exercisable at end of period (in shares) 600,000 600,000      
Stock Options and Warrants [Member]          
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract]          
Risk-free interest rate   1.72% 2.21%    
Expected volatility   74.90%      
Expected lives   6 years      
Expected dividend yield   0.00% 0.00%    
Stock Options and Warrants [Member] | Minimum [Member]          
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract]          
Expected volatility     78.20%    
Expected lives     6 years    
Stock Options and Warrants [Member] | Maximum [Member]          
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract]          
Expected volatility     84.40%    
Expected lives     10 years    
Warrants [Member]          
Weighted-Average Exercise Price Options [Abstract]          
Number of warrants issued (in shares)       500,000 500,000
Exercise price of warrants (in dollars per share)       $ 1.89 $ 1.74
2000 Long-Term Incentive Plan [Member]          
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Share-based compensation, shares subject to stock options (in shares) 600,000 600,000   600,000  
Expiration date   Aug. 06, 2010      
Share-based compensation, shares available for future grant (in shares)       0  
Number of Options (Employees and Non-Employees) [Abstract]          
Outstanding at end of period (in shares) 600,000 600,000      
2008 Stock Incentive Plan [Member]          
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Share-based compensation, shares subject to stock options (in shares) 13,400,000 13,400,000   13,400,000  
Share-based compensation, shares available for future grant (in shares)       16,400,000  
Number of Options (Employees and Non-Employees) [Abstract]          
Outstanding at end of period (in shares) 13,400,000 13,400,000      
XML 44 R32.htm IDEA: XBRL DOCUMENT v3.5.0.2
Stock Based Compensation, Schedule of Employee and Non Employee Service Share Based Compensation (Details) - Stock Options and Warrants [Member] - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Employees [Member]        
Total stock-based compensation expense resulting from stock options and warrants [Abstract]        
Allocated employee and non-employee stock-based compensation expense, Total $ 1,041,656 $ 885,246 $ 5,186,080 $ 4,313,870
Non-Employees [Member]        
Total stock-based compensation expense resulting from stock options and warrants [Abstract]        
Allocated employee and non-employee stock-based compensation expense, Total (5,938) (27,647) 214,524 206,437
Research and Development Expense [Member] | Employees [Member]        
Total stock-based compensation expense resulting from stock options and warrants [Abstract]        
Allocated employee and non-employee stock-based compensation expense, Total 455,341 402,292 1,443,347 1,131,072
Research and Development Expense [Member] | Non-Employees [Member]        
Total stock-based compensation expense resulting from stock options and warrants [Abstract]        
Allocated employee and non-employee stock-based compensation expense, Total 0 0 0 0
General and Administrative Expense [Member] | Employees [Member]        
Total stock-based compensation expense resulting from stock options and warrants [Abstract]        
Allocated employee and non-employee stock-based compensation expense, Total 586,315 482,954 3,742,733 3,182,798
General and Administrative Expense [Member] | Non-Employees [Member]        
Total stock-based compensation expense resulting from stock options and warrants [Abstract]        
Allocated employee and non-employee stock-based compensation expense, Total $ (5,938) $ (27,647) $ 214,524 $ 206,437
XML 45 R33.htm IDEA: XBRL DOCUMENT v3.5.0.2
Stock Based Compensation, by Exercise Price Range (Details)
$ / shares in Units, $ in Millions
9 Months Ended
Sep. 30, 2016
USD ($)
$ / shares
shares
Dec. 31, 2015
$ / shares
shares
Stock Options [Member]    
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract]    
Number of Options (in shares) | shares 13,437,822  
Weighted-Average Remaining Contractual Life 7 years 7 months 28 days  
Weighted-Average Exercise Price (in dollars per share) $ 3.04  
Number of Options Exercisable (in shares) | shares 9,842,803  
Weighted-Average Remaining Contractual Life 7 years 2 months 23 days  
Weighted-Average Exercise Price, Options Exercisable (in dollars per share) $ 3.27  
The aggregate intrinsic value of outstanding options | $ $ 0  
Aggregate intrinsic value of options vested | $ $ 0  
Closing price of the common stock (in dollars per share) $ 0.59  
Warrants [Member]    
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract]    
Warrants outstanding (in shares) | shares 30,559,148 7,225,472
Weighted-average exercise price of warrants outstanding (in dollars per share) 0.80 4.28
Range $0.60 - $2.00 [Member] | Stock Options [Member]    
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract]    
Range of Exercise Prices, Lower Range (in dollars per share) $ 0.60  
Range of Exercise Prices, Upper Range (in dollars per share) $ 2.00  
Number of Options (in shares) | shares 1,274,498  
Weighted-Average Remaining Contractual Life 6 years 4 months 2 days  
Weighted-Average Exercise Price (in dollars per share) $ 1.78  
Number of Options Exercisable (in shares) | shares 1,224,498  
Weighted-Average Remaining Contractual Life 6 years 2 months 8 days  
Weighted-Average Exercise Price, Options Exercisable (in dollars per share) $ 1.83  
Range $2.01 - 2.50 [Member] | Stock Options [Member]    
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract]    
Range of Exercise Prices, Lower Range (in dollars per share) 2.01  
Range of Exercise Prices, Upper Range (in dollars per share) $ 2.50  
Number of Options (in shares) | shares 7,899,179  
Weighted-Average Remaining Contractual Life 8 years 4 months 28 days  
Weighted-Average Exercise Price (in dollars per share) $ 2.33  
Number of Options Exercisable (in shares) | shares 4,522,874  
Weighted-Average Remaining Contractual Life 8 years 22 days  
Weighted-Average Exercise Price, Options Exercisable (in dollars per share) $ 2.30  
Range $2.51 - 4.00 [Member] | Stock Options [Member]    
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract]    
Range of Exercise Prices, Lower Range (in dollars per share) 2.51  
Range of Exercise Prices, Upper Range (in dollars per share) $ 4.00  
Number of Options (in shares) | shares 968,291  
Weighted-Average Remaining Contractual Life 7 years 4 months 13 days  
Weighted-Average Exercise Price (in dollars per share) $ 2.88  
Number of Options Exercisable (in shares) | shares 937,458  
Weighted-Average Remaining Contractual Life 7 years 4 months 2 days  
Weighted-Average Exercise Price, Options Exercisable (in dollars per share) $ 2.87  
Range $4.01 - 32.55 [Member] | Stock Options [Member]    
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract]    
Range of Exercise Prices, Lower Range (in dollars per share) 4.01  
Range of Exercise Prices, Upper Range (in dollars per share) $ 32.55  
Number of Options (in shares) | shares 3,295,854  
Weighted-Average Remaining Contractual Life 6 years 5 months 16 days  
Weighted-Average Exercise Price (in dollars per share) $ 5.30  
Number of Options Exercisable (in shares) | shares 3,157,973  
Weighted-Average Remaining Contractual Life 6 years 5 months 1 day  
Weighted-Average Exercise Price, Options Exercisable (in dollars per share) $ 5.32  
XML 46 R34.htm IDEA: XBRL DOCUMENT v3.5.0.2
Fair Value Measurements (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2016
Dec. 31, 2015
Fair value measurements by level for assets and liabilities measured at fair value on a recurring basis [Abstract]    
Increase in fair value of warrant liability $ 6,000  
Recurring [Member]    
Fair value measurements by level for assets and liabilities measured at fair value on a recurring basis [Abstract]    
Cash equivalents 56,972 $ 20,673
Short-term investments   35,035
Warrant liability (6,686) (693)
Level I [Member] | Recurring [Member]    
Fair value measurements by level for assets and liabilities measured at fair value on a recurring basis [Abstract]    
Cash equivalents 56,972 20,673
Short-term investments   35,035
Warrant liability 0 0
Level II [Member] | Recurring [Member]    
Fair value measurements by level for assets and liabilities measured at fair value on a recurring basis [Abstract]    
Cash equivalents 0 0
Short-term investments   0
Warrant liability 0 0
Level III [Member] | Recurring [Member]    
Fair value measurements by level for assets and liabilities measured at fair value on a recurring basis [Abstract]    
Cash equivalents 0 0
Short-term investments   0
Warrant liability $ (6,686) $ (693)
XML 47 R35.htm IDEA: XBRL DOCUMENT v3.5.0.2
Liquidity and Capital Resources (Details) - USD ($)
9 Months Ended
Sep. 30, 2016
Dec. 31, 2015
Sep. 30, 2015
Dec. 31, 2014
Estimated Projected Expenditure [Line Items]        
Cash and cash equivalents $ 58,875,925 $ 22,261,372 $ 55,779,620 $ 32,218,905
Currently projected expenditures for clinical programs 37,400,000      
Aldoxorubicin [Member]        
Estimated Projected Expenditure [Line Items]        
Currently projected expenditures for clinical programs 15,600,000      
Other Programs [Member]        
Estimated Projected Expenditure [Line Items]        
Currently projected expenditures for clinical programs 2,700,000      
General Operation [Member]        
Estimated Projected Expenditure [Line Items]        
Currently projected expenditures for clinical programs 3,400,000      
Other General and Administrative Expenses [Member]        
Estimated Projected Expenditure [Line Items]        
Currently projected expenditures for clinical programs 8,300,000      
Interest and Term Loan Payment [Member]        
Estimated Projected Expenditure [Line Items]        
Currently projected expenditures for clinical programs $ 7,400,000      
XML 48 R36.htm IDEA: XBRL DOCUMENT v3.5.0.2
Equity Transactions (Details) - USD ($)
$ / shares in Units, $ in Millions
3 Months Ended
Jul. 20, 2016
Oct. 26, 2015
Mar. 31, 2016
Sep. 30, 2016
May 25, 2016
Class of Stock [Line Items]          
Common stock issued for litigation settlement (in shares) 28,579,421       1,561,578
Warrants exercised period 1 year        
Common shares issued from exercise of stock options (in shares)     100,000    
Authorized but unissued shares of common stock (in shares)       16,400,000  
Number of treasury stock retired (in shares)   199,275      
Number of treasury stock retired, value   $ (2.6)      
Net proceeds from the issuance of common stock     $ 0.2    
Warrants [Member]          
Class of Stock [Line Items]          
Number of warrants issued (in shares)     500,000 500,000  
Exercise price of warrants (in dollars per share)     $ 1.74 $ 1.89  
XML 49 R37.htm IDEA: XBRL DOCUMENT v3.5.0.2
Income Taxes (Details) - USD ($)
$ in Millions
9 Months Ended
Sep. 30, 2016
Dec. 31, 2015
Earliest Tax Year [Member]    
Operating Loss Carryforwards [Line Items]    
Expiration date Dec. 31, 2016  
Latest Tax Year [Member]    
Operating Loss Carryforwards [Line Items]    
Expiration date Dec. 31, 2034  
Federal [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards   $ 281.6
Federal [Member] | Unrestricted [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards   219.3
State [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards   173.7
State [Member] | Unrestricted [Member]    
Operating Loss Carryforwards [Line Items]    
Operating loss carryforwards   $ 173.7
XML 50 R38.htm IDEA: XBRL DOCUMENT v3.5.0.2
Commitments and contingencies (Details)
9 Months Ended
Sep. 30, 2016
USD ($)
Plaintiff
Complaint
shares
May 25, 2016
USD ($)
Feb. 26, 2016
Motion
Dec. 31, 2015
USD ($)
shares
Loss Contingencies [Line Items]        
Amount of milestone payment payable $ 7,500,000      
Potential future milestone payments on each additional final marketing approval $ 1,000,000      
Number of plaintiffs | Plaintiff 2      
Number of competing derivative complaints | Complaint 2      
Litigation settlement due in shares $ 0 $ 4,500,000   $ 4,500,000
Common stock issued (in shares) | shares 96,943,072     66,480,065
Number of motions filed by the company | Motion     2  
Litigation settlement due in shares of common [Member]        
Loss Contingencies [Line Items]        
Litigation settlement due in shares       $ 4,500,000
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