XFRA:CX5N CytRx Corp Quarterly Report 10-Q Filing - 3/31/2012

Effective Date 3/31/2012

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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 March 31, 2012

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, $.001 par value, outstanding as of May 9, 2012: 148,427,069 shares exclusive of treasury shares.
 

 



 
 

 

CYTRX CORPORATION

FORM 10-Q

TABLE OF CONTENTS

 
 
Page
PART I. — FINANCIAL INFORMATION
 
Item 1.Financial Statements
2
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations
10
Item 3.Quantitative and Qualitative Disclosures About Market Risk
14
Item 4.Controls and Procedures
15
   
PART II. — OTHER INFORMATION
 
Item 1A.Risk Factors
15
Item 6.Exhibits
15
   
SIGNATURES
16
   
INDEX TO EXHIBITS
17


 
1

 
 
PART I — FINANCIAL INFORMATION

 
Item 1. — Financial Statements
 
CYTRX CORPORATION
CONDENSED BALANCE SHEETS
(Unaudited)

 
 
March 31, 2012
   
December 31, 2011
 
ASSETS
           
Current assets:
           
Cash and cash equivalents
  $ 16,916,696     $ 17,988,590  
Marketable securities
    15,067,770       18,057,672  
Receivable
    3,379       175,704  
Interest receivable
    11,555       41,275  
Prepaid expenses and other current assets
    800,481       1,017,799  
Total current assets
    32,799,881       37,281,040  
Equipment and furnishings, net
    267,432       266,335  
Goodwill
    183,780       183,780  
Other assets
    129,566       123,268  
Total assets
  $ 33,380,659     $ 37,854,423  
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
                 
Accounts payable
  $ 2,609,267     $ 2,074,463  
Accrued expenses and other current liabilities
    5,703,486       4,786,956  
Warrant liabilities
    10,627,100       6,738,934  
Total current liabilities
    18,939,853       13,600,353  
Commitment and contingencies
 
               
Stockholders’ equity:
               
Preferred Stock, $.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, $.001 par value, 250,000,000 shares authorized; 149,060,885 shares issued and outstanding at each of March 31, 2012 and December 31, 2011
    149,057       149,057  
Additional paid-in capital
    237,646,160       237,324,545  
Treasury stock, at cost (633,816 shares)
    (2,279,238 )     (2,279,238 )
Accumulated deficit
    (221,075,173 )     (210,940,294 )
Total stockholders’ equity
    14,440,806       24,254,070  
Total liabilities and stockholders’ equity
  $ 33,380,659     $ 37,854,423  



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

 
2

 


CYTRX CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)


   
Three Months Ended
March 31,
 
   
2012
   
2011
 
Revenue:
           
License revenue
  $     $  
 
Expenses:
               
Research and development
    4,401,515       4,820,708  
General and administrative
    1,914,715       2,049,463  
      6,316,230       6,870,171  
                 
Loss before other income
    (6,316,230 )     (6,870,171 )
Other income:
               
Interest income
    35,458       55,428  
Other income, net
    34,059       37,031  
Loss (gain) on warrant derivative liability
    (3,888,166 )     600,473  
Loss before provision for income taxes
    (10,134,879 )     (6,177,239 )
Provision for income taxes
          97,996  
Net loss
  $ (10,134,879 )   $ (6,275,235 )
                 
                 
Basic and diluted  net loss per share
  $ (0.07 )   $ (0.06 )
                 
Basic and diluted weighted-average shares outstanding
    148,427,069       109,213,838  


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

 
3

 


CYTRX CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)

   
 
Three Months Ended March 31,
 
 
 
2012
   
2011
 
Cash flows from operating activities:
           
Net loss
  $ (10,134,879 )   $ (6,275,235 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    26,184       22,581  
Retirement of fixed assets
    2,187       2,186  
Stock option and warrant expense
    321,614       348,328  
Fair value adjustment on warrant liability
    3,888,166       (600,473 )
Changes in assets and liabilities:
               
Receivable
    172,325       99,270  
Interest receivable
    29,720       49,495  
Prepaid expenses and other current assets
    211,020       (578,758 )
Income taxes recoverable
          97,996  
Accounts payable
    534,804       1,398,809  
Accrued expenses and other current liabilities
    916,530       1,692,156  
Net cash used in operating activities
    (4,032,329 )     (3,743,645 )
                 
Cash flows from investing activities:
               
Net proceeds from sale of marketable securities
    2,989,902       1,491,241  
Proceeds from sale of assets held for sale
           
Proceeds from sale of unconsolidated subsidiary shares
          6,938,603  
Purchases of equipment and furnishings
    (29,467 )     (8,214 )
Net cash provided by investing activities
    2,960,435       8,421,630  
                 
                 
Net increase (decrease) in cash
    (1,071,894 )     4,677,985  
Cash  at beginning of period
    17,988,590       6,324,430  
Cash  at end of period
  $ 16,916,696     $ 11,002,415  
                 
Supplemental disclosure of cash flow information:
               
Cash received during the period as interest income
  $ 65,178     $ 42,227  



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


 

 
4

 

NOTES TO CONDENSED FINANCIAL STATEMENTS
 
March 31, 2012
(Unaudited)

1.  Description of Company and Basis of Presentation
 
CytRx Corporation (“CytRx” or the “Company”) is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, specializing in oncology. CytRx’s oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, the Company has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, is completing an ongoing Phase 1b/2 clinical trial for primarily the same indication, and recently initiated a Phase 2 trial for advanced pancreatic ductual adenocarcinomas. The Company’s pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and which is in a clinical trial as a treatment for acute promyelocytic leukemia (APL). CytRx has evaluated bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib.
 
The accompanying condensed financial statements at March 31, 2012 and for the three-month periods ended March 31, 2012 and 2011 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. Prior period figures have been reclassified, wherever necessary, to conform to current presentation. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2011 have been derived from the Company’s audited financial statements as of that date.
 
The financial statements included herein have been prepared by the Company 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, 2011. The Company’s operating results will fluctuate for the foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.
 
2.  Recent Accounting Pronouncements
 
In June 2011, the Financial Accounting Standards Board (“FASB”) issued a final standard, requiring entities to present net income and other comprehensive income in either a single continuous statement or in two separate, but consecutive, statements of net income and other comprehensive income. The new standard eliminates the option to present items of other comprehensive income in the statement of changes in equity. The new requirements do not change which components of comprehensive income are recognized in net income or other comprehensive income, or when an item of other comprehensive income must be reclassified to net income. Also, earnings per share computations do not change. The new requirements are effective for interim and annual periods beginning after December 15, 2011, with early adoption permitted. Full retrospective application is required. The adoption of this accounting standard did not have an impact on the Company’s consolidated financial statements.
 
In May 2011, the FASB issued ASU 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and International Financial Reporting Standard (“IFRS”), to converge fair value measurement and disclosure guidance in U.S. GAAP with the guidance in the International Accounting Standards Board’s (“IASB”) concurrently issued IFRS 13, Fair Value Measurement. The amendments in ASU 2011-04 do not modify the requirements for when fair value measurements apply; rather, they generally represent clarifications on how to measure and disclose fair value under ASC 820, Fair Value Measurement. The amendments in the ASU 2011-04 are effective prospectively for interim and annual periods beginning after December 15, 2011. Early adoption is not permitted for public entities. Adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
 
3.  Marketable Securities
 
The Company held $15.1 million of marketable securities at March 31, 2012.  The Company has classified these investments as available for sale.  These investments are comprised of federally insured certificates of deposit as follows: $5.1 million with a maturity date of July 12, 2012; $7.0 million with a maturity date of October 4, 2012; and $3.0 million on March 28, 2013.
 

 
5

 

4.  Investment in ADVENTRX Pharmaceuticals
 
On April 8, 2011, ADVENTRX Pharmaceuticals completed its acquisition of SynthRx, Inc., in which the Company held a 19.1% interest. As a result of the transaction, the Company received approximately 126,000 shares of common stock of ADVENTRX, which it sold on October 11, 2011 for approximately $112,200.  In April 2012, the Company received an additional 38,000 shares of common stock of ADVENTRX that had been held in an escrow established in connection with the acquisition.  If all of the development milestones under the acquisition agreement were to be achieved, the Company also would be entitled to receive up to 2.9 million additional ADVENTRX shares. The Company’s ADVENTRX shares are “restricted” securities within the meaning of the federal securities laws and are subject to certain transfer and voting restrictions under a Stockholders' Voting and Transfer Restriction Agreement. The Company treats this investment as assets “available for sale”.
 
5. Basic and Diluted Net Loss Per Common Share
 
Basic and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding. Common share equivalents (which consist of options and warrants) are excluded from the computation of diluted net loss per common share where the effect would be anti-dilutive.  Common share equivalents that could potentially dilute basic earnings per share in the future, and which were excluded from the computation of diluted loss per share, totaled approximately 67.0 million shares at March 31, 2012 and 18.9 million shares at March 31, 2011.
 
6. Warrant Liabilities
 
Liabilities measured at market value on a recurring basis include warrant liabilities resulting from the Company’s past equity financing.  In accordance with ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity (“ASC 815-40”), the warrant liabilities are being marked to market until they are completely settled.  The warrants are valued using the Black-Scholes method, using assumptions consistent with our application of ASC 505-50, Equity-Based Payments to Non-Employees (“ASC 505-50”).  The gain or loss resulting from the marked to market calculation is shown on the Consolidated Statements of Operations as (Loss) Gain on warrant derivative liability. The Company recognized a (loss) gain of ($3.9 million) and $0.6 million for the three-month periods ended March 31, 2012 and 2011, respectively.
 
7.  Stock Based Compensation
 
The Company has a 2000 Long-Term Incentive Plan under which 10.0 million shares of common stock were originally reserved for issuance.  As of March 31, 2012, there were approximately 7.2 million shares subject to outstanding stock options. This plan expired on August 6, 2010, and thus no further shares are available for future grant under this plan.
 
The Company also has a 2008 Stock Incentive Plan under which 10.0 million shares of common stock were originally reserved for issuance.  As of March 31, 2012, there were 6.1 million shares subject to outstanding stock options and 3.9 million shares available for future grant under this plan.
 
The Company has adopted the provisions of 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, the Company recognizes 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. Since the fair market value of options granted 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 are fully vested.
 

 
6

 

The following table sets forth the total stock-based compensation expense resulting from stock options and warrants included in the Company’s unaudited interim statements of operations:
 
   
Three Months Ended March 31,
 
   
2012
   
2011
 
Research and development — employee
  $ 95,124     $ 83,431  
General and administrative — employee
    174,072       197,592  
Total employee stock-based compensation
  $ 269,196     $ 281,023  
                 
Research and development — non-employee
  $     $ 21,908  
General and administrative — non-employee
    52,418       45,397  
Total non-employee stock-based compensation
  $ 52,418     $ 67,305  

During the three-month period ended March 31, 2012, the Company issued stock options to purchase 30,000 shares of its common stock. The fair value of the stock options granted in the current three-month period was estimated using the Black-Scholes option-pricing model, based on the following assumptions:
 
   
Three Months Ended
March 31, 2012
 
Risk-free interest rate
    1.17 %
Expected volatility
    90.0 %
Expected lives (years)
    6  
Expected dividend yield
    0.00 %

The Company’s computation of expected volatility is based on the historical daily volatility of its publicly traded stock. For option grants issued during the three-month period ended March 31, 2012, the Company used a calculated volatility for each grant. The Company uses historical information to compute expected lives. In the three-month period ended March 31, 2012, the contractual term of the options granted was ten years and the Company used six years as the expected life. The dividend yield assumption of zero is based upon the fact the Company has never paid cash dividends and presently has no intention of paying cash dividends. The risk-free interest rate used for each grant is equal to the U.S. Treasury rates in effect at the time of the grant for instruments with a similar expected life. Based on historical experience, for the three-month period ended March 31, 2012, the Company has estimated an annualized forfeiture rate of 14% for options granted to its employees, 2% for options granted to senior management and 0% for options granted to directors and non-employees. Compensation costs will be adjusted for future changes in estimated forfeitures. The Company 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. No amounts relating to employee stock-based compensation have been capitalized.
 
As of March 31, 2012, there remained approximately $1.5 million of unrecognized compensation expense related to unvested stock options granted to current and former employees, directors and consultants, to be recognized as expense over a weighted-average period of 1.18 years. Presented below is the Company’s stock option activity:
 
 
 
Three Months Ended March 31, 2012
 
   
Number of Options(Employees)
   
Number of Options (Non-Employees)
   
Total Number of Options
   
Weighted-Average Exercise Price
 
Outstanding at January 1, 2012
    12,347,460       1,005,000       13,352,460     $ 0.86  
Granted
    30,000             30,000       0.31  
Exercised
                       
Forfeited or expired
    (110,833 )            (110,833 )   $ 0.51  
Outstanding at March 31, 2012
    12,266,627       1,005,000       13,271,627     $ 0.87  
Options exercisable at March 31, 2012
    8,004,601       880,000       8,884,601     $ 1.03  
                                 


 
7

 

A summary of the unvested stock options as of March 31, 2012, and changes during the three-month period then ended, is presented below:
 
   
Number of Options (Employees)
   
Number of Options (Non-Employees)
   
Total Number of Options
   
Weighted-Average Grant Date Fair Value per Share
 
Non-vested at January 1, 2012
    4,854,527       125,000       4,979,527     $ 0.47  
Granted
    30,000             30,000     $ 0.23  
Forfeited or expired
    (110,833 )           (110,833 )   $ 0.38  
Vested
    (511,668 )           (511,668 )   $ 0.71  
Non-vested at March 31, 2012
    4,262,026       125,000       4,387,026     $ 0.46  

The following table summarizes significant ranges of outstanding stock options under the Company’s plans at March 31, 2012:
Range of Exercise Prices
   
Number of Options
   
Weighted-Average Remaining Contractual Life (years)
   
Weighted-Average Exercise Price
   
Number of Options Exercisable
   
Weighted-Average Contractual Life
   
Weighted-Average Exercise Price
 
$ 0.30 - 1.00       5,656,477       8.25     $ 0.44       2,616,757       8.25     $ 0.57  
$ 1.01 –1.50       7,440,150       5.53     $ 1.14       6,092,844       5.53     $ 1.16  
$ 1.51 - 3.33       175,000       4.21     $ 3.05       175,000       4.21     $ 3.05  
          13,271,627       6.66     $ 0.87       8,884,601       6.66     $ 1.03  

The aggregate intrinsic value of outstanding options as of March 31, 2012 was $6.3 million, which represents the difference between the fair market value of the underlying shares based on the closing price of the Company’s common stock on March 30, 2012 of $0.40 and the aggregate exercise price of the options.
 
8. 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 March 31, 2012 for assets and liabilities measured at fair value on a recurring basis:

(In thousands)
 
Level I
   
Level II
   
Level III
   
Total
 
Cash equivalents
  $ 15,879     $     $     $ 15,879  
Marketable securities
    15,068                   15,068  
Warrant Liability
                10,627       10,627  

The following table summarizes fair value measurements by level at December 31, 2011 for assets and liabilities measured at fair value on a recurring basis:

(In thousands)
 
Level I
   
Level II
   
Level III
   
Total
 
Cash equivalents
  $ 17,073     $     $     $ 17,073  
Marketable securities
    18,058                   18,058  
Warrant Liability
                6,739       6,739  

Liabilities measured at market value on a recurring basis include warrant liabilities resulting from the Company’s July 2009 and August 2011 equity financings. In accordance with ASC 815-40, the warrant liabilities are being marked to market each quarter-end until they are completely settled. The warrants are valued using the Black-Scholes method, using assumptions consistent with the Company’s application of ASC 505-50. See Warrant Liabilities above.
 
The Company considers carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments.  
 
The Company’s 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.   The Company’s non-financial assets were not material at March 31, 2012 or March 31, 2011.
 

 
8

 

9. Sale of Assets
 
On May 13, 2011, the Company entered into an Asset Purchase Agreement with Orphazyme ApS (“Orphazyme”) pursuant to which it sold to Orphazyme certain pre-clinical and clinical data, intellectual property rights and other assets relating to its compounds associated with molecular chaperone regulation technology.  Under the Asset Purchase Agreement, the Company received a cash payment of $150,000 and is entitled to receive various future payments that will be contingent upon the achievement of specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any eventual net sales of products derived from the assets.  The Company also will be entitled to a percentage-based fee from any licensing agreement entered into by Orphazyme with respect to the assets within 18 months after entering into the Asset Purchase Agreement.
 
10.      Liquidity and Capital Resources
 
At March 31, 2012, the Company had cash and cash equivalents of approximately $16.9 million and marketable securities of approximately $15.1 million.  Management believes that the Company’s current cash on hand, together with its marketable securities, will be sufficient to fund its operations for the foreseeable future.  The estimate is based, in part, upon the Company’s currently projected expenditures for the remainder of 2012 and the first three months of 2013 of approximately $26.9 million, which includes approximately $10.0 million for its clinical programs for INNO-206, approximately $5.9 million for its clinical program for tamibarotene, approximately $0.3 million for its clinical programs for bafetinib, approximately $4.0 million for general operation of its clinical programs, and approximately $6.7 million for other general and administrative expenses. These projected expenditures are also based upon numerous other assumptions and subject to many uncertainties, and actual expenditures may be significantly different from these projections.
 
If the Company obtains marketing approval and successfully commercializes its product candidates, the Company anticipates it will take several years and possibly longer, for it to generate significant recurring revenue.  The Company will be dependent on future financing and possible asset sales until such time, if ever, as it can generate significant recurring revenue. The Company has no commitments from third parties to provide any additional financing, and it may not be able to obtain future financing on favorable terms, or at all. If the Company fails to obtain sufficient funding when needed, it may be forced to delay, scale back or eliminate all or a portion of its development programs or clinical trials, seek to license to other companies its product candidates or technologies that it would prefer to develop and commercialize itself, or seek to sell some or all of its assets or merge with or be acquired by another company. For example, the Company intends to assess periodically the costs and potential commercial value of its molecular chaperone programs, and depending on these assessments, the Company may determine to enter into one or more strategic partnerships to pursue the development of this technology or an outright sale of the assets.
 
11. Equity Transactions
 
On August 1, 2011, the Company undertook a $20.4 million underwritten public offering.  In the offering, the Company sold and issued 39.2 million shares of common stock at a price of $0.51 per share and warrants at a price of $0.01 per warrant to purchase up to approximately 45.1 million shares of common stock at an exercise price of $0.64 per share.  Net of underwriting discounts, legal, accounting and other offering expenses, the Company received proceeds of approximately $18.9 million.
 
On July 8, 2011, the Company effected an increase in the authorized shares of common stock from 175,000,000 shares to 250,000,000 shares and an increase in the designated number of shares of Series A Preferred Stock associated with the Company’s rights plan from 15,000 shares to 25,000 shares.
 
12. Income Taxes
 
Our utilization of net operating loss (“NOL”) carryforwards may be subject to a substantial annual limitation due to ownership change provisions of Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), as well as similar state and foreign provisions. These provisions limit the amount of NOL carryforwards that can be utilized annually to offset future taxable income and income tax following an “ownership change,” defined by Section 382 of the Code to mean a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the market value of a company by certain stockholders or public groups.  As a result of our underwritten public offering on August 1, 2011, we experienced an ownership change. The Company is performing a study to determine the extent of the limitation.  Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact its effective tax rate. Any carryforwards that expire prior to our utilization as a result of such limitations will be removed, if applicable, from deferred tax assets with a corresponding reduction of the valuation allowance.
 

 
9

 

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 recent developments regarding our business strategy, business plan and research and development activities, our future financial results, and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology industry, in general. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential” or “could” or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements.
 
All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those 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, 2011, all of which should be reviewed carefully. If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. Please consider our forward-looking statements in light of those risks as you read this Quarterly Report. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.
 
Overview
 
CytRx Corporation (“CytRx,” the “Company,” “we,” “us” or “our”) is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, specializing in oncology. Our oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With our tumor-targeted doxorubicin conjugate INNO-206, we have initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, are completing an ongoing Phase 1b/2 clinical trial for primarily the same indication, and recently initiated a Phase 2 trial for advanced pancreatic ductual adenocarcinomas. Our pipeline also includes tamibarotene, which we are testing in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer (NSCLC), and which is in a clinical trial as a treatment for acute promyelocytic leukemia (APL). We have evaluated bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plan to seek a partner for further development of bafetinib.
 
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 United States of America. 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, 2011. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements:
 

 
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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 costs incurred for 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. Technology developed for use in its products is expensed as incurred until technological feasibility has been established.
 
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 in connection with 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 are incorrect, clinical trial expenses recorded in any particular period could vary.
 
Stock-Based Compensation
 
Our stock-based employee compensation plans are described in Note 7 of the Notes to Condensed Financial Statements included in this Quarterly Report. We have adopted the provisions of 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 stock 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, as calculated using the Black-Scholes option-pricing model, is determined, and compensation expense recognized or recovered during the period is adjusted accordingly. Since the fair market value of options granted 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 grant 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 actual experience. If our Black-Scholes option-pricing model assumptions or our actual or estimated forfeiture rate are different in the future, that could materially affect compensation expense recorded in future periods.
 

 
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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 Loss per Share
 
Basic net loss per common share is computed using the weighted-average number of common shares outstanding. Diluted net loss per common share computed using the weighted-average number of common share and common share equivalents outstanding. Potentially dilutive stock options and warrants to purchase 67.0 million for the three-month period ended March 31, 2012, and 18.9 million shares for the three-month period ended March 31, 2011, were excluded from the computation of diluted net loss per share where the effect would be anti-dilutive.
 
Warrant Liabilities
 
Liabilities measured at market value on a recurring basis include warrant liabilities resulting from our July 2009 and August 2011 equity financings. 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 being 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 gain or loss resulting from the marked to market calculation is shown on the Statements of Operations as gain on warrant derivative liability.
 
Investment in Adventrx Pharmaceuticals
 
On April 8, 2011, ADVENTRX Pharmaceuticals completed its acquisition of SynthRx, Inc., in which we held a 19.1% interest. As a result of the transaction, we received approximately 126,000 shares of common stock of ADVENTRX, which we sold on October 11, 2011 for approximately $112,200.  In April 2012, we received an additional 37,000 shares of common stock of ADVENTRX that had been held in an escrow account established in connection with the acquisition.  If all of the development milestones under the acquisition agreement were to be achieved, we also would be entitled to receive up to 2.9 million additional ADVENTRX shares. Our ADVENTRX shares are “restricted” securities within the meaning of the federal securities laws and are subject to certain transfer and voting restrictions under a Stockholders' Voting and Transfer Restriction Agreement. This Investment is treated as assets “available for sale”.
 
Liquidity and Capital Resources
 
We have relied primarily upon proceeds from sales of our equity securities and the exercise of options and warrants, and to a much lesser extent upon payments from our strategic partners and licensees, to generate funds needed to finance our business and operations.
 
At March 31, 2012, we had cash and cash equivalents of approximately $16.9 million and marketable securities of approximately $15.1 million.  Management believes that our current cash on hand, together with our marketable securities, 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 2012 and the first three months of 2013 of approximately $26.9 million, which includes approximately $10.0 million for our clinical programs for INNO-206, approximately $5.9 million for our clinical program for tamibarotene, approximately $0.3 million for our clinical programs for bafetinib, approximately $4.0 million for general operation of our clinical programs, and approximately $6.7 million for other general and administrative expenses. These projected expenditures are also based upon numerous other assumptions and subject to many uncertainties, and actual expenditures may be significantly different from these projections.
 
If we obtain marketing approval and successfully commercialize one or more of our product candidates, we anticipate it will take several years and possibly longer, for us to generate significant recurring revenue. We will be dependent on future financing and possible asset sales 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.
 

 
12

 

We realized a net loss in the quarter ended March 31, 2012 of $10.1 million as compared to a $6.3 million net loss in the quarter ended March 31, 2011, or an increase of $3.8 million.  We recognized no revenues in either of the quarters ended March 31, 2012 or 2011. Our research and development expenditures were approximately $0.4 million lower in the current quarter as compared to the quarter ended March 31, 2011, due primarily to a $0.6 million milestone payment made in association with our tamibarotene development program. There was no appreciable change in our general and administrative expenditures in the current quarter as compared to the quarter ended March 31, 2011. In the current quarter, we recognized a loss of $3.9 million from the change in value of the warrant derivative liability, primarily resulting from the warrants issued in connection with the August 1, 2011 equity financing, as compared to a gain in the comparative period ended March 31, 2011.
 
In the three-month period ended March 31, 2012, we received $3.0 million of cash from investing activities, as compared to $8.4 million of cash from investing activities in the comparable 2011 period. In the three-month period ended March 31, 2011, we received proceeds from the sale of RXi shares for a total of $6.9 million; there were no such sales in the comparative 2012 period. We received net proceeds from the sale of marketable securities of $3.0 million in the three-month period ended March 31, 2012; in the comparable 2011 period, net proceeds from the sale of marketable securities were $1.5 million. We utilized approximately $29,000 for capital expenditures in the three-month period ended March 31, 2012 as compared to approximately $8,000 in the comparable 2011 period. We do not expect any significant capital spending during the next 12 months.
 
There was no cash provided by or used in financing activities in either of the three-month periods ended March 31, 2012 or 2011. 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 operating results or future financial condition.
 
As a development company that is primarily engaged in research and development activities, 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.
 
Results of Operations
 
We recorded a net loss of approximately $10.1 million for the three-month period ended March 31, 2012, as compared to a net loss of approximately $6.3 million for the comparative 2011 period. The increase in our net loss during the current three-month period resulted primarily from the loss we incurred from marking to market each quarter-end our warrant derivative liabilities, until they are completely settled.  This loss in the current quarter was $3.9 million as compared to a gain in the comparative quarter of $0.6 million.
 
We recognized no service revenue for either of the three-month periods ended March 31, 2012 and March 31, 2011. All future licensing fees under our current licensing agreements are dependent upon successful development milestones being achieved by the licensor. During 2012, we do not anticipate receiving any significant licensing fees.
 
Research and Development
 
   
Three-Month Period Ended March 31,
 
   
2012
   
2011
 
   
(In thousands)
 
Research and development expenses
  $ 4,303     $ 4,714  
Non-cash research and development expenses
          22  
Employee stock option expense
    95       83  
Depreciation and amortization
    4       2  
    $ 4,402     $ 4,821  

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, non-cash expenses, and depreciation expense, were $4.3 million for the three-month period ended March 31, 2012, and $4.7 million for the same period in 2011.

 
13

 

Research and development expenses incurred during the three-month period ended March 31, 2012 relate to our various development programs.  In the three-month period ended March 31, 2012, the development expenses of our program for INNO-206 were $2.7 million, the expenses of our program for tamibarotene were $0.8 million, and the expenses of our program for bafetinib were $0.1 million. The remainder of our research and development expenses primarily related to research and development support costs.
 
We sometimes issue equity securities as compensation to our consultants and in connection with the acquisition of technologies. For financial statement purposes, we record these transactions based on the fair value of the securities, or of the services received, whichever can be measured more reliably.  The value of non-employee options and warrants are marked to market using the Black-Scholes option-pricing model and most of the compensation expense recognized or recovered during the period is adjusted accordingly. We recorded $95,000 of employee stock option expense during the three-month period ended March 31, 2012, and $83,000 for the same period in 2011.
 
General and Administrative Expenses
 
   
Three-Month Period Ended March 31,
 
   
2012
   
2011
 
   
(In thousands)
 
General and administrative expenses
  $ 1,666     $ 1,786  
Non-cash general and administrative expenses
    52       45  
Employee stock option expense
    174       197  
Depreciation and amortization
    22       21  
    $ 1,914     $ 2,049  

General and administrative expenses include all administrative salaries and general corporate expenses, including legal expenses associated with the prosecution of our intellectual property. Our general and administrative expenses, excluding stock option expense, non-cash expenses and depreciation expense, were $1.7 million for the three-month period ended March 31, 2012, and $1.8 million for the same period in 2011.
 
Employee stock option expense relates to options granted to recruit and retain directors, officers and other employees.  We recorded approximately $174,000 of employee stock option expense in the three-month period ended March 31, 2012, as compared to $197,000 for the same period in 2011. We recorded approximately $52,000 of non-employee stock option expense in the three-month period ended March 31, 2012, as compared to $45,000 for the same period in 2011.
 
Depreciation and Amortization
 
Depreciation expense reflects the depreciation of our equipment and furnishings.
 
Interest Income
 
Interest income was $35,000 for the three-month period ended March 31, 2012, as compared to $55,000 for the same period in 2011.
 
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 derivative financial instruments or foreign currency instruments. If interest rates had varied by 10% in the three-month period ended March 31, 2012, it would not have had a material effect on our results of operations or cash flows for that period.
 

 
14

 
 
Item 4. — Controls and Procedures
 
Evaluation of Disclosure Controls and Procedures
 
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Securities Exchange Act Rule 13a-15(e)) as of the end of the quarterly period covered by this Quarterly Report. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
 
Changes in Controls over Financial Reporting
 
There was no change in our internal control over financial reporting that occurred during the quarter ended March 31, 2012 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We continually seek to assure that all of our controls and procedures are adequate and effective. Any failure to implement and maintain improvements in the controls over our financial reporting could cause us to fail to meet our reporting obligations under the SEC’s rules and regulations. Any failure to improve our internal controls to address the weaknesses we have identified could also cause investors to lose confidence in our reported financial information, which could have a negative impact on the trading price of our common stock.
 
PART II — OTHER INFORMATION

Item 1A. — Risk Factors

We are subject to a number of risks and uncertainties, including the risks and uncertainties discussed below, as well as those described in our Annual Report on Form 10-K for the year ended December 31, 2011 or reflected in any subsequent filings we make with the SEC. If any of these risks or uncertainties actually occur, our business, results of operations, financial condition and prospects could be materially and adversely affected. In that case, the trading price of our common stock could decline. These risks and uncertainties are not the only ones facing us. Additional risks and uncertainties not presently known to us, or that we currently perceive as immaterial, also may adversely affect us.

We intend to effect a reverse stock split of our outstanding shares, but it may not have the desired effect on our stock price.
 
In order to be eligible for continued listing on The NASDAQ Capital Market, our common stock must trade at a minimum bid price of $1.00 per share in accordance with Marketplace Rule 4310(c).  As of May 9, 2012, the closing price of our common stock was $0.41 per share.  Accordingly, in order to maintain our NASDAQ listing, we intend to effect a reverse split of our common stock, subject to the approval of a proposed amendment to our Restated Certificate of Incorporation to permit us to do so that is on the agenda for our upcoming Annual Meeting of stockholders to be held on May 14, 2012. The reverse stock split, by itself, is not expected to affect our market capitalization, although there can be no assurance that the market price per share of our common stock after the reverse stock split will rise or remain constant in proportion to the reduction in the number of shares of our common stock outstanding before the reverse stock split.  There also is no assurance that any initial increase in market price of our common stock resulting from the reverse stock split can be sustained or that the trading price of our common stock will not decline below the NASDAQ required minimum bid price in the future.

The market price of our common stock is based on our performance and other factors, some of which are unrelated to the number of shares outstanding. If the reverse stock split is effected and the market price of our common stock declines, the percentage decline as an absolute number and as a percentage of our overall market capitalization may be greater than would occur in the absence of a reverse stock split. In certain cases, both the total market capitalization of a company and the market price of a share of such company’s common stock following a reverse stock split are lower than they were before the reverse stock split. Furthermore, the liquidity of our common stock could be adversely affected by the reduced number of shares that would be outstanding after the reverse stock split.

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.

 
15

 

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
 
 
CytRx Corporation
 
       
Date: May 9, 2012
By:
/s/ JOHN Y. CALOZ
 
   
John Y. Caloz
 
   
Chief Financial Officer
 
       

 

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

 
17

 

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