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TABLE OF CONTENTS QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED MARCH 31,SEPTEMBER 30, 2009

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



FORM 10-Q




ý

 

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

For the quarterly period ended March 31,September 30, 2009

or

o

 

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

For the transition period from                             to                              

Commission File No. 0-16614

PONIARD PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)

Washington
(State or other jurisdiction of
incorporation or organization)
 91-1261311
(IRS Employer Identification No.)

7000 Shoreline Court, Suite 270, South San Francisco, CA 94080
(Address of principal executive offices)

Registrant's telephone number, including area code: (650) 583-3774

7000 Shoreline Court, Suite 270, South San Francisco, CA 94080
(Address of principal executive offices)

Registrant's telephone number, including area code: (650) 583-3774

        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 ý    No o

        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 o    No o

        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 definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer o Accelerated filer ý Non-accelerated filer o
(Do not check if a smaller reporting company)
 Smaller reporting company o

        Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o    No ý

        As of May 1,October 30, 2009, 34,705,91134,961,497 shares of the registrant's common stock, $.02$0.02 par value per share, were outstanding.


Table of Contents


TABLE OF CONTENTS

QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED MARCH 31,SEPTEMBER 30, 2009

 
  
 PAGE

PART I

 

FINANCIAL INFORMATION

  

Item 1.

 

Financial Statements:

  

 

Condensed Consolidated Balance Sheets as of March 31,September 30, 2009 (Unaudited) and December 31, 2008 (unaudited)(Note 1)

 
3

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended March 31,September 30, 2009 and 2008 (unaudited)(Unaudited)

 
4

 

Condensed Consolidated Statements of Cash Flows for the ThreeNine Months Ended March 31,September 30, 2009 and 2008 (unaudited)(Unaudited)

 
5

 

Notes to Condensed Consolidated Financial Statements (unaudited)(Unaudited)

 
6

Item 2.

 

Management's Discussion and Analysis of Financial Condition and Results of Operations

 
1718

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 
2325

Item 4.

 

Controls and Procedures

 
2325

PART II

 

OTHER INFORMATION

  

Item 1A.

 

Risk Factors

 
24

Item 5

Other Information


2426

Item 6.

 

Exhibits

 
25

Signatures


26

Signatures


27

Exhibit Index

 


2728

Table of Contents


PART I. FINANCIAL INFORMATION

Item 1.    Financial Statements



PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)
(inIn thousands, except share data)

 
 March 31, 2009 December 31, 2008 

ASSETS

    

Current assets:

       
 

Cash and cash equivalents

 $28,541 $44,144 
 

Cash—restricted

  281  281 
 

Investment securities

  31,095  28,611 
 

Prepaid expenses and other current assets

  1,041  977 
      
   

Total current assets

  60,958  74,013 
 

Facilities and equipment, net of depreciation of $1,122 and $1,319

  387  1,123 
 

Other assets

  270  289 
 

Licensed products, net

  8,503  8,807 
      
     

Total assets

 $70,118 $84,232 
      

LIABILITIES AND SHAREHOLDERS' EQUITY

    

Current liabilities:

       
 

Accounts payable

 $1,499 $604 
 

Accrued liabilities

  9,110  10,688 
 

Current maturities of note payable

  8,561  7,886 
      
   

Total current liabilities

  19,170  19,178 
      

Long-term liabilities:

       
  

Note payable obligation, net of current portion and discount of $2,614 and $2,980

  15,128  17,407 
      
   

Total long-term liabilities

  15,128  17,407 
      

Shareholders' equity:

       
  

Preferred stock, $.02 par value, 2,998,425 shares authorized:

       
    

Convertible preferred stock, Series 1, 205,340 shares issued and outstanding (entitled in liquidation to $5,300 and $5,175)

  4  4 
  

Common stock, $.02 par value, 200,000,000 shares authorized:

       
    

34,687,724 shares issued and outstanding

  694  694 
  

Additional paid-in capital

  409,239  409,244 
  

Accumulated deficit, including other comprehensive loss of $353 and $354

  (374,117) (362,295)
      
    

Total shareholders' equity

  35,820  47,647 
      
     

Total liabilities and shareholders' equity

 $70,118 $84,232 
      

See notes to the condensed consolidated financial statements.


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share amounts)

 
 Three Months Ended March 31, 
 
 2009 2008 

Revenues

 $ $ 
      

Operating expenses:

       
 

Research and development

  8,104  6,336 
 

General and administrative

  3,084  4,183 
 

Restructuring

  468   
 

Asset impairment loss

  588   
      
 

Total operating expenses

  12,244  10,519 
      
  

Loss from operations

  (12,244) (10,519)

Other income (expense), net

  (706) 664 
      
  

Net loss

  (12,950) (9,855)

Preferred stock dividends

  (125) (125)
      
  

Net loss applicable to common shares

 $(13,075)$(9,980)
      

Net loss per share applicable to common shares - basic and diluted

 $(0.38)$(0.29)
      

Weighted average common shares outstanding - basic and diluted

  34,688  34,681 
      

See notes to the condensed consolidated financial statements.


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)

 
 Three Months Ended March 31, 
 
 2009 2008 

Cash flows from operating activities:

       

Net loss

 $(12,950)$(9,855)

Adjustments to reconcile net loss to net cash used in operating activities:

       

Depreciation and amortization

  408  393 

Amortization of discount on notes payable

  386  171 

(Amortization) accretion of (discount) premium on investment securities

  81  (213)

Asset impairment loss

  588   

Restructuring

  357   

Stock options and warrants issued for services

  8  (5)

Stock-based employee compensation

  1,293  2,358 

Change in operating assets and liabilities:

       
 

Prepaid expenses and other assets

  (19) (255)
 

Accounts payable

  884  (133)
 

Accrued liabilities

  (2,088) 406 
      

Net cash used in operating activities

  (11,052) (7,133)
      

Cash flows from investing activities:

       

Proceeds from sales and maturities of investment securities

  14,650  26,700 

Purchases of investment securities

  (17,217) (13,094)

Facilities and equipment purchases

  (13) (53)
      

Net cash provided by (used in) investing activities

  (2,580) 13,553 
      

Cash flows from financing activities:

       

Repayment of principal on notes payable

  (1,971) (1,032)

Proceeds from stock options and warrants exercised

    91 
      

Net cash used in financing activities

  (1,971) (941)
      

Net increase (decrease) in cash and cash equivalents

  (15,603) 5,479 
      

Cash and cash equivalents:

       

Beginning of period

  44,144  29,335 
      

End of period

 $28,541 $34,814 
      

Supplemental disclosure of non-cash financing activities:

       

Accrual of preferred dividend

 $125 $125 

Supplemental disclosure of cash paid during the period for:

       

Interest

 $489 $195 
 
 September 30, 2009 December 31, 2008 
 
 (Unaudited) (Note 1) 

ASSETS

       

Current assets:

       
 

Cash and cash equivalents

 $19,040 $44,144 
 

Cash—restricted

  281  281 
 

Investment securities

  21,074  28,611 
 

Prepaid expenses and other current assets

  918  977 
      
   

Total current assets

  41,313  74,013 
 

Facilities and equipment, net of depreciation of $1,202 and $1,319

  277  1,123 
 

Other assets

  154  289 
 

Licensed products, net

  7,896  8,807 
      
     

Total assets

 $49,640 $84,232 
      

LIABILITIES AND SHAREHOLDERS' EQUITY

       

Current liabilities:

       
 

Accounts payable

 $825 $604 
 

Accrued liabilities

  8,188  10,688 
 

Current portion of note payable

  8,561  7,886 
      
   

Total current liabilities

  17,574  19,178 

Long-term liabilities:

       
  

Note payable obligation, noncurrent portion, net

  11,848  17,407 

Commitments and contingencies (Note 13)

       

Shareholders' equity:

       
  

Preferred stock, $0.02 par value, 2,998,425 shares authorized:

       
    

Convertible preferred stock, Series 1, 205,340 shares issued and outstanding (entitled in liquidation to $5,300 and $5,175)

  4  4 
  

Common stock, $0.02 par value, 200,000,000 shares authorized:

       
    

34,820,603 and 34,687,724 shares issued and outstanding

  696  694 
  

Additional paid-in capital

  414,361  409,244 
  

Other comprehensive income/(loss)

  23  (354)
  

Accumulated deficit

  (394,866) (361,941)
      
    

Total shareholders' equity

  20,218  47,647 
      
     

Total liabilities and shareholders' equity

 $49,640 $84,232 
      

See notes to the condensed consolidated financial statements.


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Operating expenses:

             
 

Research and development

 $5,396 $9,024 $19,153 $24,511 
 

General and administrative

  3,802  3,383  10,321  11,289 
 

Restructuring

      468   
 

Asset impairment loss

      588   
          
  

Total operating expenses

  9,198  12,407  30,530  35,800 
          
   

Loss from operations

  (9,198) (12,407) (30,530) (35,800)

Other income (expense):

             
 

Interest expense

  (750) (329) (2,413) (1,021)
 

Interest income and other, net

  71  499  396  2,198 
          
  

Total other income (expense)

  (679) 170  (2,017) 1,177 
   

Net loss

  (9,877) (12,237) (32,547) (34,623)

Preferred stock dividends

  (125) (125) (375) (375)
          
  

Net loss applicable to common shares

 $(10,002)$(12,362)$(32,922)$(34,998)
          

Net loss per share applicable to common shares -

             
 

basic and diluted

 $(0.29)$(0.36)$(0.95)$(1.01)
          

Weighted average common shares outstanding -

             
 

basic and diluted

  34,769  34,688  34,723  34,685 
          

See notes to the condensed consolidated financial statements.


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PONIARD PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 
 Nine Months Ended
September 30,
 
 
 2009 2008 

Cash flows from operating activities:

       

Net loss

 $(32,547)$(34,623)

Adjustments to reconcile net loss to net cash used in operating activities:

       
 

Depreciation and amortization

  1,126  1,193 
 

Amortization of discount on notes payable

  1,088  440 
 

Accretion (amortization) of premium (discount) on investment securities

  322  (392)
 

Gain on disposal of facilities and equipment

  (43)  
 

Asset impairment loss

  588   
 

Restructuring

  32   
 

Stock-based compensation issued for services

  387  95 
 

Stock-based employee compensation

  4,325  5,519 
 

Change in operating assets and liabilities:

       
  

Prepaid expenses and other assets

  131  (415)
  

Accounts payable

  221  215 
  

Accrued liabilities

  (2,639) 3,729 
      

Net cash used in operating activities

  (27,009) (24,239)
      

Cash flows from investing activities:

       

Proceeds from maturities of investment securities

  39,150  65,800 

Purchases of investment securities

  (31,561) (41,288)

Facilities and equipment purchases

  (18) (344)

Proceeds from disposals of equipment and facilities

  97   
      

Net cash provided by investing activities

  7,668  24,168 
      

Cash flows from financing activities:

       

Net proceeds from bank note payable

    19,997 

Repayment of principal on note payable

  (5,914) (3,375)

Payment of debt issuance costs

    (200)

Proceeds from stock options exercised

  401  91 

Payment of preferred dividends

  (250) (250)
      

Net cash (used in) provided by financing activities

  (5,763) 16,263 
      

Net (decrease) increase in cash and cash equivalents

  (25,104) 16,192 

Cash and cash equivalents at beginning of period

  44,144  29,335 
      

Cash and cash equivalents at end of period

 $19,040 $45,527 
      

Supplemental disclosure of non-cash financing activities:

       

Accrual of preferred dividend

 $125 $125 

Supplemental disclosure of cash paid during the period for:

       

Interest

 $1,369 $529 

See notes to the condensed consolidated financial statements.


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(Unaudited)

Note 1. Basis of presentationPresentation

        The accompanying unaudited condensed consolidated financial statements include the accounts of Poniard Pharmaceuticals, Inc. and its subsidiary (the Company)"Company"). All intercompany balances and transactions have been eliminated in consolidation.

        The accompanying condensed consolidated financial statements contained herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (SEC)("SEC"). CertainAs permitted under those rules, certain footnotes or other financial information and note disclosuresthat are normally included in annual financial statements prepared in accordance withrequired by accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to thosesuch rules and regulations, althoughregulations. In the Company believesopinion of the Company's management, the accompanying interim unaudited condensed financial statements include all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of the Company's financial position as of September 30, 2009, the results of operations for the three and nine months ended September 30, 2009 and 2008 and cash flows for the nine months ended September 30, 2009 and 2008.

        The results of operations for the period ended September 30, 2009 are not necessarily indicative of the expected operating results for the full year.

        The balance sheet as of December 31, 2008 has been derived from the audited financial statements at that the disclosures made are adequate to makedate. The balance sheet does not include all of the information presented not misleading. Theseand footnotes required by accounting principles generally accepted in the United States for complete financial statements. For further information, refer to the financial statements should be readand footnotes thereto included in conjunction with the Company's Annual Reportannual report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 16, 2009, and available on the SEC's website,www.sec.gov.

        The accompanying condensed consolidated financial statements are unaudited. In the opinion of the Company's management, the condensed consolidated financial statements reflect all adjustments, consisting only of normal recurring accruals, necessary to present fairly the Company's financial position as of March 31, 2009 and the results of operations and cash flows for the three months ended March 31, 2009 and 2008.

        The results of operations for the periods ended March 31, 2009 and 2008 are not necessarily indicative of the expected operating results for the full year.

        Reclassifications:    Certain balances and results from prior years have been reclassified to conform to the Company's current year presentation. The Company's reclassifications had no effect on net earnings or shareholders' equity.

        Estimates and uncertainties:Use of Estimates:    The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

        Subsequent Events Evaluation:    Management has reviewed and evaluated material subsequent events, if any, occurring after the balance sheet date of September 30, 2009 through the financial statements issuance date of November 6, 2009. All appropriate subsequent event disclosures, if any, have been made in the notes to the unaudited condensed consolidated financial statements.

Going concern:Concern:    The accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business for a reasonable period of time. The Company has historically experienced recurring operating losses and negative cash flows from operations. As of March 31,September 30, 2009, the Company had net working capital of $41,788,000 and had$23,739,000, an accumulated deficit of $374,117,000 with$394,866,000 and total shareholders' equity of $35,820,000.$20,218,000.

        The Company's current loan facility contains covenants that restrict certain financing activities by the Company and require the Company to maintain a minimum amount of unrestricted cash (see


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 41. Basis of Presentation (Continued)


Note 5 for further details). Taking into account the minimum unrestricted cash requirement and the Company's projected operating results, the Company believes that its current cash, cash equivalents and investment securitysecurities balances will provide adequate resources to fund operations at least into the first quarter of 2010. However, given the uncertainties of outcomes of the Company's ongoing clinical trials, there is no assurance that the Company can achieve its projected operating results. The Company has no assurance that, especially in light of the current distressed economic environment, the lenders will


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (Continued)

Note 1. Basis of presentation (Continued)


be willing to waive or renegotiate the terms of the loan agreement to address or avoid financial or other defaults. These factors, among others, raise substantial doubt about the Company's ability to continue as a going concern. Management is developing plans to address the Company's liquidity needs, including raising additional capital through the public or private sale of equity or debt securities or through the establishment of credit or other funding facilities and entering into strategic collaborations, which may include joint ventures or partnerships for product development and commercialization, merger, sale of assets or other similar transactions, and taking other actions to limit the Company's expenditures. There can be no assurance that the Company can obtain financing or otherwise raise additional funds, if at all, on terms acceptable to the Company or to its lenders.

Note 2. Fair value measurementsValue Measurements

        The Company holds available-for-sale securities that are measuredWe categorize assets and liabilities recorded at fair value whichin our condensed consolidated balance sheet based upon the level of judgment associated with inputs used to measure their value. Fair value is determined on a recurring basis. These securities are classified within Level 2 ofdefined as the fair value hierarchy prescribed by Statement of Financial Accounting Standard (SFAS) No. 157, "Fair Value Measurements," because the value of the securities is based on quoted market prices or broker/dealer quotations for similar securities.

        The SFAS No. 157 framework requires fair value to be determined based on the exchange price that would be received forto sell an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants onat the measurement date. SFAS No. 157 establishes a fair value hierarchy which requires an entity toWe use valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs when measuringdetermining fair value.value and then we rank the estimated values based on the reliability of the inputs used following the fair value hierarchy set forth by the Financial Accounting Standards Board ("FASB"). The standard describes the following three levels of inputs that may be used to measurethe FASB fair value:value hierarchy are as follows:

        The determination of a financial instrument's level within the fair value hierarchy is based on an assessment of the lowest level of any input that is significant to the fair value measurement. The Company utilizes the market approach to measure fair value for its financial assets and liabilities. The market approach uses prices and other relevant information generated by market transactions involving identical or comparable assets or liabilities. The Company's investment securities, consisting of debt securities, are classified as available-for-sale. Unrealized holding gains or losses on these securities are included in other comprehensive income. Realized gains and losses and declines in value judged to be other-than-temporary (of which there have been none to date) on available-for-sale securities are included in interest income.


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (Continued)

(Unaudited)

Note 2. Fair value measurementsValue Measurements (Continued)

        The following tables presenttable presents a summary of the Company's assets and liabilitiesthat are measured at fair value on a recurring basis (in thousands):

 
 Fair Value Measurements as of March 31, 2009 
 
 Total Level 1 Level 2 Level 3 

Investment securities

 $31,095 $ $31,095 $ 
          

Total

 $31,095 $ $31,095 $ 
          

 
 Fair Value Measurements as of September 30, 2009 
 
 Total Level 1 Level 2 Level 3 

Cash equivalents

 $17,520 $16,216 $1,304 $ 

Investment securities

  21,074    21,074   
          

 $38,594 $16,216 $22,378 $ 
          

        
As of September 30, 2009 and December 31, 2008, the Company's cash equivalents and investment securities are recorded at fair value as determined through market prices and other observable and corroborated sources. At September 30, 2009 the cash equivalents balance consists of $16,216,000 in money market funds and $1,304,000 of corporate debt securities purchased with a maturity date less than 90 days from the purchase date. Investment securities are comprised of corporate debt securities and federal government and agency securities (see Note 3 below for further details on investment securities).

 
 Fair Value Measurements as of December 31, 2008 
 
 Total Level 1 Level 2 Level 3 

Investment securities

 $28,611 $ $28,611 $ 
          

Total

 $28,611 $ $28,611 $ 
          

        When the estimated fair value of a security is below its carrying value, the Company evaluates whether it is more likely than not that it will be required to sell the security before its anticipated recovery in market value and whether evidence indicating that the cost of the investment is recoverable within a reasonable period of time outweighs evidence to the contrary. The Company also evaluates whether or not it intends to sell the investment. If the impairment is considered to be other-than-temporary, the security is written down to its estimated fair value. In addition, the Company considers whether credit losses exist for any securities. A credit loss exists if the present value of cash flows expected to be collected is less than the amortized cost basis of the security. Other-than-temporary declines in estimated fair value and credit losses are charged to investment income. The Company has not deemed it necessary to record any charges related to impairments or other-than-temporary declines in the estimated fair values of its marketable debt securities or credit losses as of September 30, 2009.

Note 3. Investment securitiesSecurities

        InvestmentThe Company's investment securities, consistedconsisting of the following at March 31, 2009 (in thousands):debt securities, are classified as available-for-sale. Unrealized holding gains or losses on these securities are included in other comprehensive income (loss). Realized gains and losses and declines in value judged to be other-than-temporary (of which there have been none to date) on available-for-sale securities are included in interest income and other, net.

 
  
 Gross Unrealized  
 
 
 Amortized
Cost
 Estimated
Fair Value
 
 
 Gains (Losses) 

Type of security:

             
 

Corporate debt securities

 $20,916 $22 $(368)$20,570 
 

Federal government and agency securities

  10,532  2  (9) 10,525 
          

 $31,448 $24 $(377)$31,095 
          
  

Net unrealized loss

       $(353)   
             

Maturity:

             
 

Less than one year

 $31,448       $31,095 
            

 $31,448       $31,095 
            

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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (Continued)

(Unaudited)

Note 3. Investment securitiesSecurities (Continued)

        Investment securities consisted of the following at September 30, 2009 (in thousands):

 
  
 Gross Unrealized  
 
 
 Amortized
Cost
 Estimated
Fair Value
 
 
 Gains (Losses) 

Type of security:

             
 

Corporate debt securities, with unrealized gains

 $12,081 $15 $ $12,096 
 

Federal government and agency securities

  8,970  8    8,978 
          

 $21,051 $23 $ $21,074 
          
  

Net unrealized gain

    $23       
             

Maturity:

             
 

Less than one year

 $21,051       $21,074 
            

        Investment securities consisted of the following at December 31, 2008 (in thousands):

 
  
 Gross Unrealized  
 
 
 Amortized
Cost
 Estimated
Fair Value
 
 
 Gains (Losses) 

Type of security:

             
 

Corporate debt securities

 $23,967 $26 $(382)$23,611 
 

Federal government and agency securities

  4,998  2    5,000 
          

 $28,965 $28 $(382)$28,611 
          
  

Net unrealized loss

       $(354)   
             

Maturity:

             
 

Less than one year

 $27,912       $27,561 
 

Due in 1-2 years

  1,053        1,050 
            

 $28,965       $28,611 
            

 
  
 Gross Unrealized  
 
 
 Amortized
Cost
 Estimated
Fair Value
 
 
 Gains (Losses) 

Type of security:

             
 

Corporate debt securities, with unrealized gains

 $10,706 $26 $ $10,732 
 

Corporate debt securities, with unrealized losses

  13,261    (382) 12,879 
 

Federal government and agency securities

  4,998  2    5,000 
          

 $28,965 $28 $(382)$28,611 
          
  

Net unrealized loss

       $(354)   
             

Maturity:

             
 

Less than one year

 $27,912       $27,561 
 

Due in 1-2 years

  1,053        1,050 
            

 $28,965       $28,611 
            

        AsTable of March 31, 2009, the Company held a debt security issued by American General Finance Corporation (AGFC), a wholly-owned subsidiary of American International Group, Inc. (AIG), with a par value of $1,200,000, coupon rate of 3.875%, amortized cost of approximately $1,197,000 and maturity date of October 1, 2009. The market value for this security as of March 31, 2009, based on Level 2 inputs as described in SFAS No. 157, was approximately $849,000, resulting in an unrealized loss of approximately $348,000. This unrealized loss has resulted from downgrades from various ratings agencies since September 2008. The Company's management has concluded that the unrealized loss on the AGFC debt security, and the other debt securities that it holds, is temporary due to (a) the relatively short duration of the decline in value of the investments; (b) the assessment of the Company's management that it is probable that all contractual amounts under the debt securities will be received and (c) the Company's intent and ability to hold the securities until at least substantially all of the cost is recovered.Contents


PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 4. Accrued Liabilities

        Accrued liabilities consist of the following (in thousands):

 
 September 30,
2009
 December 31,
2008
 

Clinical trials

 $5,671 $8,266 

Accrued expenses

  869  689 

Compensation

  1,307  1,164 

Severance

    285 

Other

  341  284 
      

 $8,188 $10,688 
      

Note payable5. Note Payable

        On September 2, 2008, the Company entered into an Amended and Restated Loan and Security Agreement (loan agreement)("loan agreement"), with GE Business Financial Services Inc. (formerly known as Merrill Lynch Capital) and Silicon Valley Bank. The loan agreement amends and restates in its entirety the earlier Loan and Security Agreement dated as of October 25, 2006 (original loan)("original loan"), with Merrill Lynch Capital and Silicon Valley Bank, pursuant to which the Company obtained a $15,000,000 capital loan that was to mature on April 1, 2010.

        The loan agreement provides for a $27,600,000 senior secured term loan facility (loan facility)("loan facility") to be made available as follows: (i) an initial term loan advance in the amount of $17,600,000, which is comprised of (a) the outstanding principal balance of $7,600,000 remaining on the original loan and (b) an additional cash advance in the amount of $10,000,000 (cash portion)("cash portion"), which was fully funded on September 2, 2008; and (ii) a second term loan advance in the amount of $10,000,000, which was fully funded on September 30, 2008. The cash portion of the initial term loan advance and the proceeds of the second term loan advance will be used to fund the Company's clinical trials and for general


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (Continued)

Note 4. Note payable (Continued)


corporate purposes. The advances under the loan facility are repayable over 42 months, commencing on October 1, 2008. Interest on the advances is fixed at 7.80% per annum. Final loan payments in the amounts of $1,070,000 and $900,000 are due upon maturity or earlier repayment of the initial term loan advance and the second term loan advance, respectively. Additionally, as a condition to the amendment and restatement of the original loan, the Company agreed to modification of the final payment obligations under the original loan, pursuant to which the Company paid $600,000 to Silicon Valley Bank on September 2, 2008, the effective date of the loan facility, and will pay $675,000 to GE Business Financial Services on the earlier of March 31, 2010 or the date of repayment of the loan facility. All final payment amounts will beare being accreted to the note payable balance over the term of the loan facility using the effective interest rate method and reflected as additional interest expense. All interest payable under the loan agreement and the full amount of the final payments must be paid upon any prepayment of a term loan advance. The loan facility is secured by a first lien on all of the non-intellectual property assets of the Company.

        In connection with the loan agreement, the Company issued to the lenders ten-year warrants to purchase an aggregate of 219,920 shares of the Company's common stock at an exercise price of $4.297 per share. The fair value of the warrants using the Black-Scholes option-pricing model was approximately $928,000 based upon assumptions of expected volatility of 90%, a contractual term of ten


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 5. Note Payable (Continued)


years, an expected dividend rate of zero and a risk-free interest rate of 3.74%. The portion of the loan proceeds allocable to the warrants is approximately $806,000 based on the relative fair value of the warrants, which the Company recorded as additional discount to notes payable. The total of the final loan payments and the proceeds allocated to the warrants of approximately $4,051,000 will beare being amortized to interest expense using an effective interest rate of 13.8%. At September 30, 2009, the outstanding principal balance under the loan facility was $20,409,000, net of discount of $1,951,000.

        The loan agreement contains restrictions on the Company's ability to, among other things, dispose of certain assets, engage in certain mergers and acquisition transactions, incur indebtedness, create liens on assets, make investments, pay dividends and repurchase stock. The loan agreement also contains covenants requiring the Company to maintain unrestricted cash in an amount equal to the lesser of (i) $17,940,000 or (ii) the outstanding aggregate principal balance of the term loans plus $4,000,000. The loan agreement contains events of default that include nonpayment of principal, interest or fees, breaches of covenants, material adverse changes, bankruptcy and insolvency events, cross defaults to any other indebtedness, material judgments, inaccuracy of representations and warranties, and events constituting a change of control. The occurrence of an event of default would increase the applicable rate of interest by 5% and could result in the acceleration of the Company's payment obligations under the loan agreement. The Company was in compliance with all loan covenants as of September 30, 2009.

Note 6. Committed Equity Line of Credit

        On August, 19, 2009, the Company entered into an equity line of credit arrangement with Azimuth Opportunity Ltd. ("Azimuth") pursuant to a Common Stock Purchase Agreement ("Purchase Agreement"), which provides that, upon the terms and subject to the conditions set forth therein, Azimuth is committed to purchase up to $60 million worth of shares of the Company's common stock over the 18-month term of the Purchase Agreement. From time to time over the term of the Purchase Agreement, the Company may, at its sole discretion and upon presentation of a draw down notice, require Azimuth to purchase its common stock over ten consecutive trading days or such other period mutually agreed upon by the Company and Azimuth ("Draw Down Period"). Each draw down is subject to limitations based on the price of the Company's common stock and a limit of 2.5% of the Company's market capitalization at the time of the draw down. The Purchase Agreement requires a minimum price of $3.00 per share to allow the Company to issue shares to Azimuth. Under the Purchase Agreement, the Company may sell to Azimuth up to 6,955,606 shares of its common stock. The Company may present Azimuth with up to 24 draw down notices during the term of the Purchase Agreement with only one such draw down notice allowed per Draw Down Period and a minimum of five trading days required between each Draw Down Period. As of September 30, 2009, no shares have been sold under the Purchase Agreement.

Note 5.7. Restructuring and asset impairmentAsset Impairment

        Effective March 31, 2009, the Company implemented a strategic restructuring plan to refocus its cash resources on clinical and commercial development of picoplatin, resulting in the discontinuation of the Company's preclinical research operations and reducing its workforce by approximately 12%, or eight employees. The Company incurred severance charges totaling $296,000 related to the reduction in staff. Of this amount, $185,000 remained unpaidAll severance charges related to the restructuring have been paid as of March 31, 2009,September 30, 2009. The


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 7. Restructuring and is payable within one year. The Asset Impairment (Continued)


Company incurred additional charges totaling approximately $172,000 related to the closure of its lab facilities in South San Francisco, CA.California. Of this amount, $6,000 was incurred as share-based


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (Continued)

Note 5. Restructuring and asset impairment (Continued)


compensation expense, $12,000 was a write-off of prepaid expenses, and $154,000 was incurred for contract and other termination costs. As of September 30, 2009, $14,000 remained unpaid as of March 31, 2009, and is payable within one year.

        The following table summarizes the impact of the restructuring charges through March 31,September 30, 2009 (in thousands):

Description
 Initial
Restructuring
Charge
 Payment of
Restructuring
Obligations
 Accrued
Restructuring
Charge as of
March 31, 2009
 

Employee termination benefits

 $296 $(111)$185 
        

Contract termination costs

  125    125 

Other termination costs

  47  (18) 29 
        
 

Sub-total

  172  (18) 154 
        

Total

 $468 $(129)$339 
        

Description
 Initial
Restructuring
Charge
March 31, 2009
 Payment of
Restructuring
Obligations
 Accrued
Restructuring
Charge as of
September 30, 2009
 

Employee termination benefits

 $296 $(296)$ 
        

Contract termination costs

  125  (125)  

Other termination costs

  47  (33) 14 
        
 

Subtotal

  172  (158) 14 
        

Total

 $468 $(454)$14 
        

        In conjunction with the decision to discontinue the Company's preclinical research operations, the Company recognized an asset impairment loss of $588,000 on certain facilities and equipment related to the lab in South San Francisco, CA.California. The loss on the assets was determined based on estimates of potential sales values of used equipment. These impairment charges established new cost bases for the impaired assets, which are included in assets held for sale and reported in the prepaid expenses and other current assets line on the accompanying Condensed Consolidated Balance Sheets.

        The following table summarizes information related to the impairment charges (in thousands):

 
 So. San Francisco
Lab Equipment &
Leasehold
Improvements
 

Impairment Loss

 $588 
    

Impaired Carrying Value as of March 31, 2009

 $57 

Disposals of Assets

   
    

Post Impairment Carrying Value as of March 31, 2009

 $57 
    

 
 So. San Francisco
Lab Equipment &
Leasehold
Improvements
 

Impairment Loss

 $588 
    

Impaired Carrying Value Upon Restructuring (March 31, 2009)

 $57 

Disposals of Assets

  (50)
    

Post Impairment Carrying Value as of September 30, 2009

 $7 
    

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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 6.8. Picoplatin licenseLicense and amendmentAmendment

        The Company has entered into an exclusive worldwide license, as amended, with Genzyme Corporation (successor to AnorMED, Inc.) for the development and commercial sale of picoplatin. Under that license, the Company is solely responsible for the development and commercialization of picoplatin. Genzyme retains the right, at the Company's cost, to prosecute its patent applications and maintain all licensed patents. The parties executed the license agreement in April 2004, at which time the Company paid a one-time up-front payment of $1,000,000 in common stock and $1,000,000 in cash. The original agreement excluded Japan from the licensed territory and provided for $13,000,000 in development and commercialization milestones, payable in cash or a combination of cash and common stock, and a royalty rate of up to 15% on product net sales after regulatory approval. The parties


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (Continued)

Note 6. Picoplatin license and amendment (Continued)


amended the license agreement on September 18, 2006, modifying several key financial terms and expanding the licensed territory to include Japan, thereby providing the Company worldwide rights. In consideration of the amendment, the Company paid Genzyme $5,000,000 in cash on October 12, 2006 and an additional $5,000,000 in cash on March 30, 2007. The amendment eliminated all development milestone payments to Genzyme. Genzyme remains entitled to receive up to $5,000,000 in commercialization milestones upon the attainment of certain levels of annual net sales of picoplatin after regulatory approval. The amendment also reduced the royalty payable to Genzyme to a maximum of 9% of annual net product sales and eliminated the sharing of sublicense revenues with Genzyme.

        The Company accounted for all payments made in consideration of the picoplatin license, as amended, by capitalizing them as an intangible asset. The Company's capitalization of the total $12,000,000 of picoplatin license payments is based on the Company's reasonable expectation at the time of acquisition and through the date of the amendment that the intravenous formulation of picoplatin, as it existed at the time of the acquisition of the picoplatin license and the license amendment, would be used in research and development (R&D)("R&D") projects and therefore had alternative future uses in the treatment of different cancer indications. At the time of acquisition, the Company planned to use intravenous picoplatin in a Phase II clinical trial in patients with small cell lung cancer and reasonably expected that the intravenous formulation could be used in additional, currently identifiable R&D projects in the form of clinical trials for other solid tumor cancer indications, such as prostate and colorectal cancers.

        The Company, determined the original useful life of the picoplatin intangible asset in accordance with the requirements of the Financial Accounting Standards Board's (FASB) SFAS No. 142, "Goodwill and Other Intangible Assets." The Company, at the time of acquisition of the picoplatin license, reasonably anticipated using intravenous picoplatin in clinical trials that could be conducted during the remaining term of the primary patent, which is active through 2016. The Company concluded that the twelve years remaining for the primary patent term was the appropriate useful life for the picoplatin intangible asset, in satisfaction ofaccordance with the expected use and legal life provisions of SFAS No. 142,FASB's guidance for intangibles, and is amortizing the initial $2,000,000 license payment over this twelve year useful life beginning in April 2004. The Company concluded that no change in the twelve-year useful life of the picoplatin intangible asset occurred as a result of the 2006 license amendment and is, therefore, continuing to amortize the initial $2,000,000 license payment over the twelve year useful life and is amortizing the license amendment payment of $10,000,000 over the remainder of the twelve year useful life of the picoplatin intangible asset.

        Licensed products consistsconsist of the picoplatin amortizable intangible asset with a gross amount of $12,000,000, and net of accumulated amortization of $3,497,000$4,104,000 and $3,193,000 at March 31,September 30, 2009 and December 31, 2008, respectively.


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (Continued)

(Unaudited)

Note 7.9. Net loss per common shareLoss Per Common Share

        Basic and diluted loss per share are based on net loss applicable to common shares, which is comprised of net loss and preferred stock dividends in all periods presented. Shares used to calculate basic loss per share are based on the weighted average number of common shares outstanding during the period. Shares used to calculate diluted loss per share are based on the potential dilution that would occur upon the exercise or conversion of securities into common stock using the treasury stock method. The calculation of diluted loss per share excludes the effect of the following stock options and warrants to purchase additional shares of common stock because the share increments would not be dilutive.

 
 Three Months Ended
March 31,
 
 
 2009 2008 

Common stock options

  5,841,041  5,182,065 

Performance-based restricted stock units

  93,604   

Common stock warrants

  5,496,651  5,946,876 

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Common stock options

  5,722,570  5,397,071  5,722,570  5,397,071 

Performance-based restricted stock units

  514,668    514,668   

Common stock warrants

  5,496,651  6,165,129  5,496,651  6,165,129 

        In addition, 39,015 shares of common stock that would be issuable upon conversion of the Company's Series 1 preferred stock are not included in the calculation of diluted loss per share for the periods ended March 31,September 30, 2009 and 2008, respectively, because the effect of including such shares would not be dilutive.

Note 8.10. Stock-based compensationCompensation

        A summary of the fully vested stock options is presented below (shares and aggregate intrinsic value in thousands):

 
 Number of
Shares
 Weighted
Average
Exercise
Price
 Weighted Average
Remaining
Contractual Term
in Years
 Aggregate
Intrinsic
Value
 

Options exercisable at March 31, 2009

  2,706 $7.55  7.9 $15 

 
 Number of
Shares
 Weighted
Average
Exercise
Price
 Weighted Average
Remaining
Contractual Term
in Years
 Aggregate
Intrinsic
Value
 

Options exercisable at September 30, 2009

  3,232 $7.10  6.6 $5,377 

        The Company recorded the following amounts of stock-based compensation expense, not including expense for options granted to non-employee consultants, for the periods presented (in thousands):

 
 Three Months Ended
March 31,
 
 
 2009 2008 

Research and development expense

 $320 $433 

General and administrative expense

  973  1,925 
      
 

Total

 $1,293 $2,358 
      

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Research and development expense

 $493 $387 $1,097 $1,192 

General and administrative expense

  1,113  1,140  3,228  4,327 
          
 

Total

 $1,606 $1,527 $4,325 $5,519 
          

        The compensation expense for the threenine months ended March 31,September 30, 2008 includes the grant of stock options in the first quarter to Company officers to purchase an aggregate of 460,000 shares of


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 10. Stock-based Compensation (Continued)


common stock. Certain options that were granted to officers of the Company during 2006 and 2007 vest 50% in


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (Continued)

Note 8. Stock-based compensation (Continued)


equal monthly installments over four years from the date of grant and vest 50% on the seven-year anniversary of the date of grant, subject to accelerated vesting of up to 25% of such portion of the options, based on the Company's achievement of annual performance goals established under its annualmanagement incentive plan, at the discretion of the equity awards subcommittee of the compensation committee of the Company's board of directors. Based on the overall achievement of corporate goals in 2007 the equity awards subcommittee accelerated vesting with respect to 20% of the shares subject to the seven-year vesting schedule in the first quarter of 2008. As of March 31,September 30, 2009, the cumulative accelerated vesting equals 60% of the shares subject to the seven-year vesting schedule.

        Estimated fair values of stock options granted have been determined using the Black-Scholes option pricing model with the following assumptions for the periods presented:

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Expected term (in years)

  2.3  4.0  5.8  4.9 

Risk-free interest rate

  1.19% 2.95% 2.30% 3.05%

Expected stock price volatility

  95% 90% 95% 90%

Expected dividend rate

  0% 0% 0% 0%

        During 2008 the Company awarded 92,000 restricted stock units ("RSUs") under the 2004 Incentive Compensation Plan, as amended and restated (the "2004 Plan"), to non-officer employees as an incentive for future performance. An additional 4,000 RSUs were awarded in 2009 for this incentive program. Upon vesting, each RSU is payable with one share of the Company's common stock. The average fair value of the RSUs was $3.13 per unit, or approximately $299,000 in total, based upon the closing market price of the Company's common stock on the award dates. The RSUs vest based on the achievement of certain performance milestones during 2009 and 2010. As of September 30, 2009, the first two performance milestones were achieved and therefore 40% of the shares have vested and been released. The third performance milestone, if achieved no later than June 30, 2010, would result in the vesting of the remaining 60% upon the date of achievement. As of September 30, 2009, the Company determined that the third milestone is probable of being achieved and is therefore recognizing the related stock-based compensation expense on a pro-rata basis through the estimated date of achievement.

        On July 23, 2009 the Company awarded an additional 290,400 RSUs under the 2004 Plan to non-officer employees as an incentive for future performance. The fair value of the RSUs was $7.34 per unit, or approximately $2,132,000 in total, based upon the closing market price of the Company's common stock on the award date. The RSUs vest based on the achievement of certain performance milestones during 2010. As of September 30, 2009, the Company determined that milestones are probable of being achieved and is therefore recognizing the related stock-based compensation expense on a pro-rata basis through the estimated dates of achievement.

        On July 11, 2009, a Company director, was awarded 170,000 RSUs as compensation for consulting services. The RSUs vest 50% on each of the first two anniversaries of the grant and is subject to 100% acceleration upon the achievement of a performance milestone. The fair value of the award is


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 10. Stock-based Compensation (Continued)


approximately $1,272,000 at September 30, 2009, and will be re-measured at each reporting date because it is a non-employee award. As of September 30, 2009, the Company determined that the performance milestone is probable of being achieved in 2010 and is thus recognizing stock compensation for the fair value of the award on a pro-rata basis through the estimated date of achievement.

No income tax benefit has been recorded for stock optionstock-based compensation expense as the Company has a full valuation allowance and management has concluded it is more likely than not that the Company's net deferred tax assets will not be realized. As of March 31,September 30, 2009, total unrecognized costs related to employee stockstock-based compensation was $11,147,000,$11,074,000, which is expected to be recognized over a weighted average period of approximately three2.3 years.

        Estimated fair values of stock options granted have been determined using the Black-Scholes option pricing model with the following assumptions for the periods presented:

 
 Three Months Ended
March 31,
 
 
 2009 2008 

Expected term (in years)

  4.9  4.3 

Risk-free interest rate

  1.86% 2.91%

Expected stock price volatility

  95% 90%

Expected dividend rate

  0% 0%

Note 9.11. Comprehensive lossLoss

        The Company's comprehensive loss for the three and nine months ended March 31,September 30, 2009 and 2008 is summarized as follows (dollars in(in thousands):

 
 Three Months Ended
March 31,
 
 
 2009 2008 

Net loss

 $12,950 $9,855 

Net unrealized loss (gain) on investment securities

  (1) 13 
      

Comprehensive loss

 $12,949 $9,868 
      

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Net loss

 $9,877 $12,237 $32,547 $34,623 

Net unrealized (gain) loss on investment securities

  (39) 531  (377) 651 
          

Comprehensive loss

 $9,838 $12,768 $32,170 $35,274 
          

Note 10.12. Recent accounting pronouncementsAccounting Pronouncements

        In AprilJune 2009, the FASB established the FASB Accounting Standards Codification ("FASB ASC") as the source of authoritative accounting principles recognized by the FASB. The FASB will issue new standards in the form of Accounting Standards Updates ("ASUs"). FASB ASC is effective for financial statements issued for interim and annual periods ending after September 15, 2009 and therefore is effective for the Company in the third quarter of 2009. The issuance of FASB ASC does not change accounting principles generally accepted in the United States and therefore the adoption of FASB ASC only affects the specific references to accounting literature in the notes to the Company's consolidated financial statements.

        In August 2009, the FASB issued FASB Staff Position (FSP) No. SFAS 157-4, "DeterminingASU 2009-05, "Fair Value Measurements and Disclosures (Topic 820)—Measuring Liabilities at Fair Value WhenValue" ("ASU 2009-05," currently within the Volumescope of ASC Subtopic 820-10). ASU 2009-05 provides clarification regarding valuation techniques when a quoted price in an active market for an identical liability is not available in addition to treatment of the existence of restrictions that prevent the transfer of a liability. The ASU also clarifies that both a quoted price in an active market for an identical liability at the measurement date and the quoted price for an identical liability when traded as an asset in an active market (when no adjustments to the quoted price of the asset are required) are Level of Activity1 fair value measurements. The ASU is effective for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly" (FSP FAS 157-4). This FSP amends SFAS 157 and supersedes FSP No. FAS 157-3, "Determining the Fair Value of a Financial Asset When the Market for That Asset is Not Active" (FSP FAS 157-3). According to the FSP, an entity should consider several factors to determine whether there has been a significant decrease in the volume and level of activityfirst reporting


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (Continued)

(Unaudited)

Note 10.12. Recent accounting pronouncementsAccounting Pronouncements (Continued)


for the asset or liability when compared with normal market activity for the asset or liability. If an entity concludes, based on the weight of the evidence, there has been a significant decrease in volume and level of activity then transactions or quoted prices may not be determinative of fair value, thus requiring further analysis to determine whether the prices are based on orderly transactions. Based on the available evidence, an entity must determine whether or not a transaction is orderly. The weight placed on a transaction price when estimating fair value is based on this determination as well as the sufficiency of information available to make the determination. In addition to the accounting guidance, the FSP also amends FAS 157 disclosure requirements to require in interim periods the disclosure of the inputs and valuation techniques used to measure fair value and any changes in inputs and techniques during the period. The FSP also requires that the disclosures of FAS 157 be presented for debt and equity securities by major security type, based on the nature and risks of the security. The FSP will be effective forperiod, including interim periods, beginning April 1, 2009 and shall be applied prospectively. The Company is currently evaluating this FSP and its impact, if any,after issuance. Adoption of ASU 2009-05 did not have a material effect on the Company's condensed consolidated financial statements.

        In April 2009, the FASB issued FSP No. SFAS 107-1 and APB 28-1, "Interim Disclosures about Fair Value of Financial Instruments" (FSP FAS 107-1 and APB 28-1). This FSP relates to fair value disclosures for any financial instruments that are not reflected on the balance sheet of public companies at fair value. The FSP requires that for interim reporting periods, a company must (1) disclose the fair value of all financial instruments for which it is practicable to estimate that value, (2) present the fair value together with the related carrying amount reported on the balance sheet, and (3) describe the methods and significant assumptions used to estimate fair value and any changes in the methods and significant assumptions during the period. The FSP will be effective for interim periods beginning April 1, 2009. The Company is currently evaluating this FSP and its impact, if any, on the Company's consolidated financial statements.

        In April 2009, the FASB issued FSP No. SFAS 115-2 and SFAS 124-2, "Recognition and Presentation of Other-Than-Temporary Impairments" (FSP FAS 115-2 and FAS 124-2). This FSP amends the existing guidance regarding the recognition of other-than-temporary impairment (OTTI) for debt securities. If the fair value of a debt security is less than its amortized cost basis, an entity must assess whether the impairment is other than temporary. If an entity intends to sell or it is more likely than not the entity will be required to sell the debt security before its anticipated recovery of its amortized cost basis, an OTTI shall be considered to have occurred and the entire difference between the amortized cost basis and the fair value must be recognized in earnings. If the entity does not expect to sell the debt security, but the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss is deemed to exist and OTTI shall be considered to have occurred. However, in this case, the OTTI is separated into two components, the amount representing the credit loss which is recognized in earnings and the amount related to all other factors which is now recognized in other comprehensive income under the new guidance. In periods in which OTTI is determined, the total OTTI shall be presented in the statement of earnings as well as the offset for the amount that was recognized in other comprehensive income under the new FSP. Amounts recognized in accumulated other comprehensive income for which a portion of an OTTI has been recognized in earnings must also be presented separately. The FSP will be effective for the Company's existing and new investments as of April 1, 2009. The Company is currently evaluating this FSP and its impact, if any, on the Company's consolidated financial statements.


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PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (Continued)

Note 10. Recent accounting pronouncements (Continued)

        In June 2008, the FASB ratified the consensus opinion in EITF Issue No. 07-5, "Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity's Own Stock" (EITF 07-5). EITF 07-5 provides guidance for determining whether an equity-linked financial instrument or embedded feature is considered indexed to an entity's own stock. The consensus establishes a two-step approach as a framework for determining whether an instrument or embedded feature is indexed to an entity's own stock. The approach includes evaluating (1) the instrument's contingent exercise provisions, if any, and (2) the instrument's settlement provisions. Companies that issue financial instruments such as warrants or options on their own shares, convertible debt, convertible preferred stock, forward contracts on their own shares, or market-based employee stock option valuation instruments are affected by EITF Issue 07-5. If a financial instrument is shown not to be indexed solely to its issuing company's stock, it is required to be classified as a liability and re-measured at fair value at each reporting period, with changes in fair value recognized in operating results. EITF 07-5 is effective for financial statements issued for fiscal years beginning after December 15, 2008. In connection with a 2005 financing, the Company issued five-year warrants to purchase approximately 320,000 shares of common stock at an exercise price of $9.54 per share (2005 financing warrants). The warrants contain provisions requiring the adjustment of the exercise price and number of shares issuable if the Company sells shares of common stock at a price lower than the then-current exercise price of the warrants. Under the EITF, these warrants are not considered indexed to the Company's stock and are therefore subject to the liability and fair value re-measurement provisions of the EITF. The Company adopted EITF 07-5 on January 1, 2009, resulting in reductions in both additional paid in capital and accumulated deficit of approximately $1,255,000 to record the cumulative effect of adopting EITF 07-5 when applied to the 2005 financing warrants. The fair values of the liability recorded with respect to the 2005 financing warrants were $57,000 and $54,000 as of January 1, 2009 and March 31, 2009, respectively, resulting in a credit of $3,000 to other income for the three months ended March 31, 2009.

Note 11.13. Commitments and Contingencies

        The Company entered into a picoplatin active pharmaceutical ingredient (API)("API") commercial supply agreement with W.C. Heraeus (Heraeus)("Heraeus") in March 2008. Under this agreement Heraeus will produce picoplatin API to be used for preparing picoplatin finished drug product for commercial use. Manufacturing services are provided on a purchase order, fixed-fee basis, subject to certain purchase price adjustments and minimum quantity requirements. The costs to Heraeus for the purchase and set-up of dedicated equipment as required under the commercial supply agreement, estimated to be approximately $1,300,000,$1,800,000 (including interest charges of approximately $336,000) will be reimbursedrepaid by the Company in the form of a surcharge on an agreed upon amount of the picoplatin API ordered and delivered on or before December 31, 2013. If the Company orders and takes delivery of less than the agreed upon amount of picoplatin API through December 31, 2013, it will be obligated to pay the balance of the dedicated equipment cost as of that date. As of March 31,September 30, 2009, Heraeus had completed partial construction of the dedicated equipment that representedat a cost of approximately $912,000 of cost.$1,722,000 (including interest). Because the Company is not under a present obligation to pay this amount and the agreement is not under any potential circumstance of default or termination, it is not probable that a financial liability exists for this amount as of March 31, 2009.September 30, 2009 and therefore no such liability was recorded on the condensed consolidated balance sheet as of that date. The Company anticipates that the dedicated equipment will be ready for use during the fourth quarter of 2009, after which it expects to account for the equipment and related surcharge payments as a capital lease.


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

Important Information Regarding Forward-Looking Statements

        This Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance and are subject to change based on various important factors, many of which are beyond our control. In some cases, you can identify forward-looking statements by terminology such as "currently," "may," "will," "should," "expect," "plan," "intend," "anticipate," "believe," "target," "estimate," "predict," "potential," "propose" or "continue," the negative of these terms or other terminology. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties that are difficult to predict. In evaluating these statements, you should specifically consider various factors described below in the section entitled "Risk Factors." These and other factors may cause our actual results to differ materially from any forward-looking statements contained in this report or otherwise made by us.

        Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. You should not place undue reliance on our forward-looking statements, which speak only as of the date of this report. We undertake no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this report, or to reflect the occurrence of unanticipated events.

Critical Accounting Policies and Estimates

        Our critical accounting policies and estimates have not materially changed from those reported in our Annual Report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 16, 2009. For a more complete description, please refer to our Annual Report on Form 10-K.

Results of Operations

Three and Nine Months Ended March 31,September 30, 2009 Compared to the Three and Nine Months Ended March 31,September 30, 2008

        We had no revenue for the quarters ended March 31, 2009 and 2008.

        Research and development expenses increased 28% to $8.1 million during the first quarter of 2009. Our research and development expenses are summarized as follows:

 
 Three Months Ended March 31, 
 
 2009 2008 % Change 
 
 ($ in thousands)
  
 

Research

 $749 $677  11%

Contract manufacturing

  962  632  52%

Clinical

  6,065  4,598  32%

Share-based compensation

  328  429  (24)%
         
 

Total

 $8,104 $6,336  28%
         

        Research expenses include, among other things, personnel, occupancy and external laboratory expenses associated with the discovery and identification of new therapeutic agents for the treatment of cancer. Research expenses also include research activities associated with our product candidate, picoplatin, including formulation andin vitro andin vivo studies. Research expenses increased 11% to


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$0.7 million during the first quarter of 2009, primarily due to higher outside laboratory costs. We expect research expenses to decrease significantly during the balance of 2009 due to our strategic restructuring effective March 31, 2009, pursuant to which we discontinued our in-house research operations and reduced our workforce by approximately 12 percent.

        Contract manufacturing expenses include personnel and occupancy expenses and external contract manufacturing costs for the scale up and manufacturing of drug product for use in our clinical trials, in addition to drug product stability and toxicology studies. Contract manufacturing costs increased 52% to $1.0 million during the first quarter of 2009, due to increased costs resulting from increased drug production activity.

        Clinical expenses include personnel expenses, travel, occupancy costs and external clinical trial costs, including clinical research organization charges, principal investigator fees, clinical site expenses and regulatory activities associated with conducting human clinical trials. Clinical expenses also include quality control and assurance activities, such as storage and shipment services for our drug product candidates. Clinical costs increased 32% to $6.1 million during the first quarter of 2009, due primarily to expanded external clinical trial costs associated with our picoplatin trials and increased personnel and consulting costs.

        Share-based compensation expenses reflect the non-cash charge relating to the adoption of FAS 123R on January 1, 2006, under which the fair value of all employee share-based payments is charged to expense over the vesting period of the stock option. Share-based compensation expense decreased 24% to $0.3 million during the first quarter of 2009, due primarily to an acceleration of vesting for an option in the first quarter of 2008. This option, held by an officer, vests after seven years from the grant date, but is subject to limited accelerated vesting, based on company performance, at the discretion of the compensation committee of our board of directors. The vesting for this option was accelerated in the first quarter of 2008 for 2007 company performance and was accelerated in the fourth quarter of 2008 for 2008 company performance.

        Our major research and development program is picoplatin, a new generation platinum-based chemotherapeutic designed to overcome platinum resistance in the treatment of solid tumors. We completed patient enrollment in our Phase II clinical study of picoplatin in small cell lung cancer in August 2006 and, based on positive median overall survival data from that study, we initiated a Phase III pivotal trial of picoplatin in small cell lung cancer in April 2007. We completed enrollment in our Phase III trial in March 2009. In September 2009, we announced that 320 evaluable events (patient deaths) have occurred in our Phase III trial, enabling us to begin final analysis of data. We currently anticipate completing and reporting results of our preliminary analysis in November 2009 and, if positive, initiating a rolling submission of a new drug application ("NDA") with the U.S. Food and Drug Administration ("FDA") by year-end.

        In May 2006, we treated our first patients in two Phase I/II studies evaluating picoplatin as a first-line treatment of: (1) advanced colorectal cancer and (2) castration-resistant (or hormone-refractory) prostate cancer. We initiated enrollment in the Phase II component of our colorectal cancer study in November 2007 and completed enrollment in May 2008. We initiated the Phase II component of our prostate cancer study in July 2007 and completed enrollment in December 2007. We also initiatedhave completed a Phase I study of an oral formulation of picoplatin in advanced solid tumorstumors.


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        Research and development expenses decreased 40% to $5.4 million from $9.0 million during the third quarter of 2009 and decreased 22% to $19.2 million from $24.5 million in April 2007.the nine months ended September 30, 2009 compared to the comparable periods in 2008. Our research and development expenses are summarized as follows:

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 % Change 2009 2008 % Change 
 
 ($ in thousands)
  
 ($ in thousands)
  
 

Research

 $ $1,043  (100)%$764 $2,614  (71)%

Contract manufacturing

  717  1,149  (38)% 2,524  3,270  (23)%

Clinical

  4,155  6,360  (35)% 14,672  17,338  (15)%

Share-based compensation

  524  472  11% 1,193  1,289  (7)%
                
 

Total

 $5,396 $9,024  (40)%$19,153 $24,511  (22)%
                

        Research and development expenses decreased significantly during the third quarter of 2009 from the comparable period in 2008 as a result of our picoplatin trials entering their final stages. We did not incur any research expenses during the third quarter of 2009 due to our strategic restructuring implemented effective March 31, 2009. Contract manufacturing costs decreased 38% to $0.7 million in the third quarter of 2009 and decreased 23% to $2.5 million in the first nine months of 2009 from the comparable periods in 2008. These decreases reflect reduced clinical drug production activity resulting from our trials nearing completion. Clinical costs decreased 35% to $4.2 million in the third quarter of 2009 and decreased 15% to $14.7 million in the first nine months of 2009 from the comparable periods in 2008. These decreases reflect reduced clinical activity in connection with our current picoplatin studies, all of which are fully enrolled and two of which are in a follow-up or extended follow-up stage. Share-based compensation expense increased 11% to $0.5 million in the third quarter of 2009 from the comparable period in 2008, due primarily to an employee incentive program introduced during the third quarter of 2009. Share-based compensation expense decreased 7% to $1.2 million for the nine months ended September 30, 2009 from the comparable period in 2008, primarily due to the effects of the acceleration of vesting of certain stock options in the first quarter of 2008.

        The following table shows expenses incurred for preclinical study support, contract manufacturing for clinical supplies and clinical trial services provided by third parties, as well as other associated costs for our picoplatin product candidate. The table also presents unallocated costs which consist of facilities, consulting fees, patent costs and other costs not directly allocable to development programs:

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 % Change 2009 2008 % Change 
 
 ($ in thousands)
  
 ($ in thousands)
  
 

Picoplatin

 $3,741 $6,538  (43)%$14,286 $17,377  (18)%

Other unallocated costs and overhead

  1,131  2,014  (44)% 3,674  5,845  (37)%

Share-based compensation

  524  472  11% 1,193  1,289  (7)%
                
 

Total research and development costs

 $5,396 $9,024  (40)%$19,153 $24,511  (22)%
                

        Our external costs for picoplatin for the three and nine month periods ended September 30, 2009 and for the comparable periods in 2008, reflect costs associated with our various picoplatin clinical studies and the manufacture of drug product to support our clinical trials. We expect our external costs for picoplatin to increase slightly during the balance of 2009, compared to early 2009, as we prepare for submission of our rolling NDA, offset by lower costs for clinical trials upon completion of our Phase III pivotal trial of picoplatin in small cell lung cancer.


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        As of March 31,September 30, 2009, we have incurred external costs of approximately $60.7$68.6 million in connection with our entire picoplatin clinical program. Total estimated future costs of our picoplatin Phase II and Phase III trialstrial in small cell lung cancer areis in the rangesrange of $0.1$20.0 million to $0.2$25.0 million and $31.5 million to $37.5 million, respectively, through 2010, including the cost of drug supply. Total estimated future costs of our picoplatin Phase II trial in colorectal cancer and our Phase II trial in castration-resistant prostate cancer are in the ranges of $4.5$3.5 million to $7.0$4.0 million and $2.0$1.0 million to $4.5$1.5 million, respectively, through 2010, including the cost of drug supply. Total remaining estimated future costs of our Phase I trial inof an oral formulation of picoplatin are in the range of $0.1 million$50,000 to $0.3 million$100,000 through 2010, including the cost of drug supply.2010. These costs could be substantially higher if we have to repeat, revise or expand the scope of any of our trials. Material cash inflows relating to our picoplatin development will not commence unless and until we complete required clinical trials and obtain FDA and foreign marketing


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approvals, and then only if picoplatin finds acceptance in the marketplace. To date, we have not received any revenues from product sales of picoplatin.

        Recap of Development and Clinical Program Costs.    Our development administration overhead costs, consisting of rent, utilities, consulting fees, patent costs and other various overhead costs, are included in total research and development expense for each period, but are not allocated among our various projects. Our total research and development costs include the costs of various research efforts directed toward the identification and evaluation of future product candidates. These other research projects are preclinical and not considered major projects. Our total research and development costs are summarized below:

 
 Three Months Ended March 31, 
 
 2009 2008 % Change 
 
 ($ in thousands)
  
 

Picoplatin

 $6,374 $4,050  57%

Other unallocated costs and overhead

  1,402  1,857  (25)%

Share-based compensation

  328  429  (24)%
         
 

Total research and development costs

 $8,104 $6,336  28%
         

        Our external costs for picoplatin for the three months ended March 31, 2009 and 2008 reflect costs associated with our various picoplatin clinical studies and the manufacture of drug product to support our clinical trials. We expect our external costs for picoplatin to increase slightly during the balance of 2009 as we prepare for submission of our rolling NDA application, offset by lower costs for clinical trials upon completion.

        The risks and uncertainties associated with completing the development of picoplatin on schedule, or at all, include the following, as well as the other risks and uncertainties described in this report and our Annual Report on Form 10-K for the year ended December 31, 2008:

        If we fail to obtain marketing approvals for picoplatin, are unable to secure adequate commercial supplies of picoplatin active pharmaceutical ingredient and finished drug product, or do not complete development and obtain United States and foreign regulatory approvals on a timely basis, our operations, financial position and liquidity could be severely impaired, including as follows:

        Because of the many risks and uncertainties relating to completion of clinical trials, receipt of marketing approvals and acceptance in the marketplace, we cannot predict the period in which material cash inflows from our picoplatin program will commence, if ever.

General and Administrative

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 % Change 2009 2008 % Change 
 
 ($ in thousands)
  
 ($ in thousands)
  
 

General and administrative

 $2,398 $2,245  7%$6,802 $6,964  (2)%

Share-based compensation

  1,404  1,138  23% 3,519  4,325  (19)%
                
 

Total

 $3,802 $3,383  12%$10,321 $11,289  (9)%
                

        The increase in general and administrative expense of 7% to $2.4 million for the third quarter of 2009, is due primarily to higher compensation costs and, for the nine months ended September 30, 2009, the decrease of 2% to $6.8 million is due primarily to lower consulting costs. Share-based compensation expense included in general and administrative expenses increased 23% to $1.4 million


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 Three Months Ended March 31, 
 
 2009 2008 % Change 
 
 ($ in thousands)
  
 

General and administrative

 $2,111 $2,258  (7)%

Share-based compensation

  973  1,925  (49)%
         
 

Total

 $3,084 $4,183  (26)%
         

        General and administrative expenses decreased 26%for the third quarter of 2009, over the comparable period of 2008, due primarily to approximately $3.1 millionthe effects of restricted stock units awarded during the firstthird quarter of 2009. General2009 to non-officer employees and administrative expenses, excluding share-based compensation expense, decreased 7% during the first quarter of 2009. The decrease in general and administrative expense in 2009 was primarily attributable to lower travel costs and lower allocated facilities costs, offset by slightly increased consulting costs. Share-based compensation expense for the first quarters in 2009 and 2008 reflects charges related to the adoption of FAS 123R, under which the fair value of all employee share-based payments is charged to expense over the vesting period of the stock option.a consultant. Share-based compensation expense decreased 49% during19% to $3.5 million for the first quarternine months of 2009 from the comparable period in 2008 primarily due to anthe effects of the acceleration of vesting forof certain stock options in the first quarter of 2008. These specific options, held by certain officers, vest after seven years from

Restructuring and Asset Impairment Loss

        Effective March 31, 2009, we implemented a strategic restructuring plan to refocus our cash resources on clinical and commercial development of picoplatin, resulting in the grant date, but are subject to limited accelerated vesting, based on company performance, at the discretion of the compensation committeediscontinuation of our boardpreclinical research operations and reducing our workforce by approximately 12%, or eight employees. This restructuring resulted in charges of directors. The vesting for these options was accelerated$0.5 million in the first quarter of 20082009 consisting of $0.3 million in severance charges and $0.2 million in other expenses related to the closure of our lab facilities in South San Francisco, California.

        In conjunction with the decision to discontinue our preclinical research operations, we also recognized an asset impairment loss of $0.6 million on certain facilities and equipment related to the lab in South San Francisco, California. The loss on the assets was determined based on estimates of potential sales values of used equipment. These impairment charges established new cost bases for 2007 company performancethe impaired assets, which are included in assets held for sale and was acceleratedreported in the fourth quarter of 2008 for 2008 company performance.prepaid expenses and other assets line on the accompanying Condensed Consolidated Balance Sheets.

 
 Three Months Ended March 31, 
 
 2009 2008 % Change 
 
 ($ in thousands)
  
 

Other income (expense), net

 $(706)$664  (206)%
         

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 % Change 2009 2008 % Change 
 
 ($ in thousands)
  
 ($ in thousands)
  
 

Interest expense

 $(750)$(329) 128%$(2,413)$(1,021) 136%

Interest income and other, net

  71  499  (86)% 396  2,198  (82)%
                
 

Total

 $(679)$170  (499)%$(2,017)$1,177  (271)%
                

        Other incomeInterest expense increased 128% and expense decreased 206%136% for the three and nine months ended September 30, 2009 to an expense of approximately $0.7$0.8 million duringand $2.4 million, respectively, from the first quarter of 2009.comparable periods in 2008. The decreaseincrease was primarily due to decreased average yields from our investment securities portfolio and increased interest costs resulting from additional borrowings in September 2008 under our loan facility. Interest income and other, net decreased 86% to $0.1 million during the third quarter of 2009 and decreased 82% to $0.4 million for the first nine months of 2009 from the comparable periods in 2008. The decreases were primarily due to lower average yields from our investment securities portfolio.

Liquidity and Capital Resources

 
 March 31, 2009 December 31, 2008 
 
 ($ in thousands)
 

Cash, cash equivalents and investment securities

 $59,636 $72,755 

Working capital

  41,788  54,836 

Shareholders' equity

  35,820  47,647 


 
 Three Months Ended
March 31,
 
 
 2009 2008 
 
 ($ in thousands)
 

Cash provided by (used in):

       
 

Operating activities

 $(11,052)$(7,133)
 

Investing activities

  (2,580) 13,553 
 

Financing activities

  (1,971) (941)
 
 September 30,
2009
 December 31,
2008
 
 
 ($ in thousands)
 

Cash, cash equivalents and

 $40,114 $72,755 
 

investment securities

       

Working capital

  23,739  54,835 

Shareholders' equity

  20,218  47,647 

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 Nine Months Ended
September 30,
 
 
 2009 2008 
 
 ($ in thousands)
 

Cash provided by (used in):

       
 

Operating activities

 $(27,009)$(24,239)
 

Investing activities

  7,668  24,168 
 

Financing activities

  (5,763) 16,263 

        We have historically experienced recurring operating losses and negative cash flows from operations. Cash, cash equivalents and investment securities, net of restricted cash of $0.3 million, totaled $59.6$40.1 million at March 31,September 30, 2009 compared to $72.8 million at December 31, 2008. As of March 31,September 30, 2009, we had net working capital of $41.8$23.7 million, an accumulated deficit total of $374.1$394.9 million, and total shareholders' equity of $35.8$20.2 million.

        We have financed our operations to date primarily through the sale of equity securities, debt instruments, technology licensing and collaborative agreements. We invest excess cash in investment securities that will be used to fund future operating costs. Cash used for operating activities for the threenine months ended March 31,September 30, 2009 totaled $11.1$27.0 million. There were no revenues for the three months ended March 31, 2009.

        On September 2, 2008, we entered into an amended and restated loan and security agreement (loan agreement)("loan agreement") with GE Healthcare Financial Services Inc. (formerly known as Merrill Lynch Capital) and Silicon Valley Bank, establishing a $27.6 million senior secured loan facility. The loan agreement amends and restates our earlier loan and security agreement with Silicon Valley Bank and Merrill Lynch Capital dated as of October 25, 2006, pursuant to which we obtained a $15.0 million capital loan that was to mature on April 1, 2010 (original loan)("original loan"). Funds under the loan facility were made available as follows: (i) an initial term loan advance in the amount of $17.6 million, which was comprised of (a) the outstanding principal balance of $7.6 million remaining on the original loan and (b) an additional cash advance of approximately $10.0 million, which was fully funded on September 2, 2008; and (ii) a second term loan advance in the amount of $10.0 million, which was fully funded on September 30, 2008. The advances under the loan facility are repayable over 42 months, commencing on October 1, 2008. Interest on the advances is fixed at 7.80% per annum. Final payments in the amounts of $1.1 million and $0.9 million are due upon maturity or earlier repayment of the initial term loan advance and the second term loan advance, respectively. Additionally, as a condition to the amendment and restatement of the original loan, we agreed to modification of the final payment obligations under the original loan pursuant to which we paid $0.6 million to Silicon Valley Bank on September 2, 2008, the effective date of the loan facility, and will pay $0.7 million to GE Healthcare Financial Services on the earlier of March 31, 2010 or the date of repayment of the loan facility. The loan facility is secured by a first lien on all of our non-intellectual property assets. In connection with the loan agreement, we issued to the lenders ten-year warrants to purchase an aggregate of 219,920 shares of common stock at an exercise price of $4.297 per share. At September 30, 2009, the net loan balance under the loan facility was $20.4 million.

        The loan agreement contains restrictions on our ability to, among other things, dispose of certain assets, engage in certain mergers and acquisition transactions, incur indebtedness, create liens on assets, make investments, pay dividends and repurchase stock. The loan agreement also contains covenants requiring us to maintain a minimum amount of unrestricted cash during the term of the loan equal to the lesser of (i) $17.9 million or (ii) the outstanding aggregate principal balance of the term loans plus $4.0 million. The loan agreement contains events of default that include nonpayment of principal, interest or fees, breaches of covenants, material adverse changes, bankruptcy and insolvency events, cross defaults to any other indebtedness, material judgments, inaccuracy of representations and warranties and events constituting a change of control. The occurrence of an event of default would increase the applicable rate of interest by 5% and could result in the acceleration of our payment


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obligations under the loan agreement. In connectionWe were in compliance with theall loan agreement, we issued to the lenders ten-year warrants to purchase an aggregatecovenants as of 219,920 shares of common stock at an exercise price of $4.297 per share. At March 31, 2009, the net loan balance under the loan facility was $23.7 million.September 30, 2009.

        Taking into account the minimum unrestricted cash requirement under the loan agreement and our projected operating results, we believe that our current cash, cash equivalent and investment securities balances will provide adequate resources to fund operations at least into the first quarter of 2010. However, given the uncertainties of outcomes of the Company's ongoingour clinical trials, there is no assurance that the Companywe can achieve itsour projected operating results. Thereafter, unless we raise additional funds, we will be in default of the minimum unrestricted cash requirement and potentially other provisions of the loan agreement. The occurrence of an event of default would increase the


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applicable rate of interest by 5% and could result in the acceleration of our payment obligations under the loan agreement. We have no assurance that, especially in light of the current distressed economic environment, the lenders will be willing to waive or renegotiate the terms of the loan agreement to address or avoid financial or other defaults.

        During the threenine months ended March 31,September 30, 2009, we paid total rent (base rent and additional rent based on our share of facility common operating expenses) of $0.4$1.1 million under the operating leases for our South San Francisco headquarters facility and our Seattle facility. Of this amount, $0.3$0.9 million represents total aggregate minimum lease payments under these leases.

        We have entered into clinical supply agreements with Heraeus and Baxter, pursuant to which they produce picoplatin APIactive pharmaceutical ingredient ("API") and finished drug product, respectively, for our clinical trials. Manufacturing services under these clinical supply agreements are provided on a purchase order, fixed-fee basis. Our API clinical supply agreement continues in effect until it is terminated by mutual agreement of the parties or by either party in accordance with its terms. Our finished drug product clinical supply agreement runs for an initial term ending December 31, 2009, and is subject to renewal for two additional one-year terms, at our option. The total aggregate cost of clinical supplies of picoplatin API and finished drug product for the three and nine months ended March 31,September 30, 2009 was $0.6 million.$0.3 million and $1.3 million, respectively. We believe that we presently have adequate supplies of picoplatin API and finished drug product to complete our current clinical trials.

        We also have entered into a picoplatin API commercial supply agreement with Heraeus in March 2008 and a finished drug product commercial supply agreement with Baxter in November 2008. Under these agreements, Heraeus and Baxter will produce picoplatin API and finished drug product, respectively, for commercial use. Manufacturing services are provided on a purchase order, fixed-fee basis, subject to certain purchase price adjustments and minimum quantity requirements. The costs to Heraeus for the purchase and set-up of dedicated equipment, estimated to be approximately $1.3$1.8 million (including interest charges of approximately $0.3 million), will be repaid by us in the form of a surcharge on an agreed upon amount of the picoplatin API ordered and delivered on or before December 31, 2013. If we order and take delivery of less than the agreed upon amount of picoplatin API through December 31, 2013, we will be obligated to pay the balance of the dedicated equipment cost as of that date. As of September 30, 2009, Heraeus had completed partial construction of the dedicated equipment at a cost of approximately $1.7 million (including interest). Because we are not under a present obligation to pay this amount and the agreement is not under any potential circumstance of default or termination, it is not probable that a financial liability exists for this amount as of September 30, 2009 and therefore no such liability was recorded on the condensed consolidated balance sheet as of that date. We anticipate that the dedicated equipment will be ready for use during the fourth quarter of 2009, after which we expect to account for the equipment and related surcharge payments as a capital lease.

        If we are successful in our efforts to commercialize picoplatin, we would, under our amended license agreement with Genzyme, be required to pay Genzyme up to $5.0 million in commercialization


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milestones upon the attainment of certain levels of annual net sales of picoplatin. Genzyme also would be entitled to royalty payments of up to 9% of annual net sales of product.

        On August, 19, 2009, we entered into a common stock purchase agreement with Azimuth Opportunity Ltd. ("Azimuth"), pursuant to which we obtained a committed equity line of credit facility under which we may sell up to $60 million newly issued registered shares of our common stock to Azimuth at a pre-negotiated discount to market price. We will determine, at our sole discretion, the timing and amount of any sales of our common stock, subject to certain conditions, including limitations based on the price of our common stock (minimum price of $3.00 per share) and a limit of 2.5% of our market capitalization at the time of the stock issuance. In no event may we sell more than 6,955,606 shares of our common stock to Azimuth. The term of the purchase agreement is 18 months. We are not obligated to utilize the facility with Azimuth and remain free to enter into other financing transactions. As of September 30, 2009, no shares have been sold to Azimuth under the facility.

        We will require substantial additional funding to develop and commercialize picoplatin and to fund our operations. Management is continuously exploring financing alternatives, including:

        If we are unable to obtain sufficient additional cash when needed, we may be forced to delay, scale back or eliminate some or all of our picoplatin trials and commercialization efforts, reduce our workforce, license our picoplatin product candidates for development and commercialization by third parties, attempt to sell the company or, if these efforts fail, cease operations or declare bankruptcy. Provisions of the loan agreement would limit our ability to dispose of certain assets, engage in certain mergers, incur certain indebtedness, make certain distributions and engage in certain investment activities.


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        Our actual capital requirements will depend upon numerous factors, including:


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        We may not be able to obtain capital or enter into relationships with corporate partners on a timely basis, on favorable terms, or at all. Conditions in the capital markets in general, and in the life science capital market specifically, may affect our potential financing sources and opportunities for strategic partnering. Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. The report of our independent registered public accountants issued in connection with our annual report on Form 10-K for the year ended December 31, 2008 contains a statement expressing substantial doubt regarding our ability to continue as a going concern.

Item 3.    Quantitative and Qualitative Disclosures aboutAbout Market Risk

        Our market rate risks at March 31,September 30, 2009 have not changed materially from those discussed in Item 7A of our Form 10-K for the year ended December 31, 2008.

Item 4.    Controls and Procedures

        Under the supervision and with the participation of the Company's management, including the Company's Chief Executive Officer and Chief Financial Officer, the Company has evaluated the effectiveness and design of its disclosure controls and procedures (as such term is defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of March 31,September 30, 2009, to ensure that the information disclosed by the Company in the reports that the Company files or submits under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the rules and forms. Based on this evaluation, the Chief Executive Officer and the Chief Financial Officer have concluded that, as of March 31,September 30, 2009, these disclosure controls and procedures were effective.


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        There were no changes in the Company's internal control over financial reporting that occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the Company's control over financial reporting.

Limitations on the Effectiveness of Controls

        The Company's management, including its Chief Executive Officer and its Chief Financial Officer, does not expect that the Company's disclosure controls or internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of that control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of control must be considered relative to their costs. Because of the inherent limitation in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the reality that judgments in decision-making can be faulty, and breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more persons, or by management override of the control. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with the policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.


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PART II. OTHER INFORMATION

Item 1A.    Risk Factors

        Our Annual Report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 16, 2009, contains a detailed discussion of certain risk factors that could materially adversely affect our business, operating results and/or financial condition. In addition to other information contained in this report, specifically including the information set out in Part II, Item 5 below, you should carefully consider the potential risks or uncertainties that we have identified in Part I, "Item 1A, Risk Factors," in our Form 10-K. These risk factors are not the only ones affecting our company. Additional risks and uncertainties not currently deemed to be material also may materially or adversely affect our business, financial condition or results of operations.

Item 5.    Other Information

        The Company and its licensor are continually assessing and seeking to strengthen the intellectual property estate for picoplatin. On May 8, 2009, patent owners, Genzyme Corporation and The Institute of Cancer Research, together with the Company, filed with the U.S. Patent & Trademark Office (USPTO) an application to reissue U.S. Patent No. 5,665,771 ('771 patent) to the picoplatin compound. Like many composition of matter patents, the claims of the '771 patent include many compounds in addition to picoplatin. The reissue seeks to narrow certain claims by removing a number of compounds other than picoplatin from these claims. In the reissue proceeding, the USPTO will review the patent on its merits and an initial rejection is not unusual. We will have the opportunity to respond to any rejections and, if necessary, pursue appeals with the USPTO and the US federal courts. During this process the '771 patent stays in force and can be asserted in an infringement action. As we move closer to our goal of submitting a New Drug Application for the first marketing approval in the United States for picoplatin, we believe that filing the reissue to amend these claims and strengthen the intellectual


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property estate is a prudent course of action. Picoplatin is currently covered by additional issued process patents and other pending applications in the United States and abroad.

Item 6.    Exhibits


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SIGNATURES

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

  PONIARD PHARMACEUTICALS, INC.
(Registrant)

Date:    May 11,November 6, 2009

 

By:

 

/s/ GREGORY L. WEAVER

  Gregory L. Weaver
Chief Financial Officer

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EXHIBIT INDEX

Exhibit Description  
 31.13.2 Restated Bylaws, as amended June 23, 2009(A)


10.1


Indemnification Agreement dated July 7, 2009, between the Company and Gary A. Lyons


(B)


10.2


Consulting Agreement dated as of April 1, 2009, between the Company and Gary A. Lyons, as amended by Amendment One to Consulting Agreement effective July 11, 2009


(B)


10.3


Restricted Stock Unit Award Notice and Restricted Stock Unit Award Agreement, dated July 11, 2009, with Gary A. Lyons


(B)


31.1


Rule 13a-14(a)/15d-14(a) Certification of Chairman and Chief Executive Officer

 
(A)
(C)

 

31.2

 

Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer

 

(A)(C)

 

32.1

 

Section 1350 Certification of Chairman and Chief Executive Officer

 

(A)(C)

 

32.2

 

Section 1350 Certification of Chief Financial Officer

 

(A)(C)

(A)
Filed as an exhibit to the Company's Current Report on Form 8-K filed on June 25, 2009, and incorporated herein by reference.

(B)
Filed as an exhibit to the Company's Current Report on Form 8-K filed on July 13, 2009, and incorporated herein by reference.

(C)
Filed herewith.