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

Table of Contents

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 September 30, 20092010

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

750 Battery Street, Suite 330, San Francisco, CA 94111
(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
(Former Name, Former Address of principal executive offices)

Registrant's telephone number, including area code: (650) 583-3774and Former Fiscal Year, if Changed Since the Last Report)

        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 October 30, 2009, 34,961,497November 2, 2010, 48,326,678 shares of the registrant's common stock, $0.02 par value per share, were outstanding.


Table of Contents


TABLE OF CONTENTS

QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 20092010

 
  
 PAGE

PART I

 

FINANCIAL INFORMATION

  

Item 1.

 

Financial Statements:

  

 

Condensed Consolidated Balance Sheets as of September 30, 20092010 (Unaudited) and December 31, 20082009 (Note 1)

 
3

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 20092010 and 20082009 (Unaudited)

 
4

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 20092010 and 20082009 (Unaudited)

 
5

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

 
6

Item 2.

 

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

 
1822

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 
2531

Item 4.

 

Controls and Procedures

 
2531

PART II

 

OTHER INFORMATION

  

Item 1A.

 

Risk Factors

 
2633

Item 6.

 

Exhibits

 
2634

Signatures

 
2735

Exhibit Index

 
2836

Table of Contents


PART I. FINANCIAL INFORMATION

Item 1.    Financial Statements

        


PONIARD PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)



 September 30, 2009 December 31, 2008 
 September 30,
2010
 December 31,
2009
 


 (Unaudited) (Note 1) 
 (Unaudited)
 (Note 1)
 

ASSETS

ASSETS

 

ASSETS

 

Current assets:

Current assets:

 

Current assets:

 

Cash and cash equivalents

 $19,040 $44,144 

Cash and cash equivalents

 $11,018 $15,938 

Cash—restricted

 281 281 

Cash—restricted

 158 281 

Investment securities

 21,074 28,611 

Investment securities

 12,327 27,451 

Prepaid expenses and other current assets

 918 977 

Prepaid expenses and other current assets

 855 826 
           
 

Total current assets

 41,313 74,013  

Total current assets

 24,358 44,496 

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

 277 1,123 

Facilities and equipment, net of depreciation of $1,156 and $1,199 at September 30, 2010 and December 31, 2009, respectively

 73 219 

Other assets

 154 289 

Other assets

 32 135 

Licensed products, net

 7,896 8,807 

Licensed products, net

 6,681 7,592 
           
 

Total assets

 $49,640 $84,232  

Total assets

 $31,144 $52,442 
           

LIABILITIES AND SHAREHOLDERS' EQUITY

LIABILITIES AND SHAREHOLDERS' EQUITY

 

LIABILITIES AND SHAREHOLDERS' EQUITY

 

Current liabilities:

Current liabilities:

 

Current liabilities:

 

Accounts payable

 $825 $604 

Accounts payable

 $1,579 $849 

Accrued liabilities

 8,188 10,688 

Accrued liabilities

 2,960 7,679 

Current portion of note payable

 8,561 7,886 

Current portion of note payable and capital lease obligations

 7,886 8,599 
           
 

Total current liabilities

 17,574 19,178  

Total current liabilities

 12,425 17,127 

Long-term liabilities:

Long-term liabilities:

 

Long-term liabilities:

 
 

Note payable obligation, noncurrent portion, net

 11,848 17,407 

Note payable, noncurrent portion, net of debt discounts

 5,034 10,186 

Commitments and contingencies (Note 13)

 

Capital lease obligations, noncurrent portion

 1,551 1,485 
     
 

Total long-term liabilities

 6,585 11,671 

Commitments and contingencies

Commitments and contingencies

 

Shareholders' equity:

Shareholders' equity:

 

Shareholders' equity:

 
 

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

 

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  

Convertible preferred stock, Series 1, 78,768 and 205,340 shares issued and outstanding as of September 30, 2010 and December 31, 2009, respectively (entitled in liquidation to $2,033 and $5,175, respectively)

 2 4 
 

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

 

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

 
 

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

 696 694  

48,326,678 and 42,079,468 shares issued and outstanding as of September 30, 2010 and December 31, 2009, respectively

 966 842 
 

Additional paid-in capital

 414,361 409,244 

Additional paid-in capital

 444,878 430,971 
 

Other comprehensive income/(loss)

 23 (354)

Other comprehensive gain/(loss)

 16 (17)
 

Accumulated deficit

 (394,866) (361,941)

Accumulated deficit

 (433,728) (408,156)
           
 

Total shareholders' equity

 20,218 47,647  

Total shareholders' equity

 12,134 23,644 
           
 

Total liabilities and shareholders' equity

 $49,640 $84,232  

Total liabilities and shareholders' equity

 $31,144 $52,442 
           

See notes to the condensed consolidated financial statements.


Table of Contents


PONIARD PHARMACEUTICALS, INC.

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 
          
 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2010 2009 2010 2009 

Operating expenses:

             
 

Research and development

 $891 $5,056 $7,870 $18,545 
 

General and administrative

  5,060  4,142  13,747  10,929 
 

Restructuring

      1,626  468 
 

Asset impairment loss

        588 
          
  

Total operating expenses

  5,951  9,198  23,243  30,530 
          
   

Loss from operations

  (5,951) (9,198) (23,243) (30,530)

Other (expense) income:

             
 

Interest expense

  (516) (750) (1,744) (2,413)
 

Interest income and other, net

  18  71  103  396 
          
  

Total other (expense) income, net

  (498) (679) (1,641) (2,017)
          
   

Net loss

  (6,449) (9,877) (24,884) (32,547)

Preferred stock dividends

  
(48

)
 
(125

)
 
(118

)
 
(375

)

Preferred stock dividends, in-kind

      (570)  
          
   

Net loss applicable to common shareholders

 $(6,497)$(10,002)$(25,572)$(32,922)
          

Net loss per share applicable to common shareholders—basic and diluted

 $(0.13)$(0.29)$(0.55)$(0.95)
          

Weighted average common shares outstanding—basic and diluted

  48,237  34,769  46,357  34,723 
          

See notes to the condensed consolidated financial statements.


Table of Contents


PONIARD PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)



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


 2009 2008 
 2010 2009 

Cash flows from operating activities:

Cash flows from operating activities:

 

Cash flows from operating activities:

 

Net loss

Net loss

 $(32,547)$(34,623)

Net loss

 $(24,884)$(32,547)

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

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

 

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

 

Depreciation and amortization

Depreciation and amortization

 989 1,126 

Amortization of discount on notes payable

Amortization of discount on notes payable

 820 1,088 

Accretion of premium on investment securities

Accretion of premium on investment securities

 390 322 

Loss/(gain) on disposal of facilities and equipment

Loss/(gain) on disposal of facilities and equipment

 58 (43)

Asset impairment loss

Asset impairment loss

  588 

Restructuring

Restructuring

 321 32 

Interest accrued on capital lease obligation

Interest accrued on capital lease obligation

 66  

Share-based compensation issued for services

Share-based compensation issued for services

 369 387 

Share-based employee compensation

Share-based employee compensation

 6,998 4,325 

Change in operating assets and liabilities:

Change in operating assets and liabilities:

 

Depreciation and amortization

 1,126 1,193 

Prepaid expenses and other assets

 (25) 131 

Amortization of discount on notes payable

 1,088 440 

Accounts payable

 730 221 

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

 322 (392)

Accrued liabilities

 (5,062) (2,639)

Gain on disposal of facilities and equipment

 (43)        

Asset impairment loss

 588   

Net cash used in operating activities

 (19,230) (27,009)

Restructuring

 32        

Cash flows from investing activities:

Cash flows from investing activities:

 

Proceeds from sales and maturities of investment securities

Proceeds from sales and maturities of investment securities

 22,089 39,150 

Purchases of investment securities

Purchases of investment securities

 (7,322) (31,561)

Facilities and equipment purchases

Facilities and equipment purchases

 (7) (18)

Proceeds from disposals of facilities and equipment

Proceeds from disposals of facilities and equipment

 58 97 
     
 

Net cash provided by investing activities

 14,818 7,668 
     

Cash flows from financing activities:

Cash flows from financing activities:

 

Repayment of principal on note payable

Repayment of principal on note payable

 (6,589) (5,914)

Repayment of capital lease obligation

Repayment of capital lease obligation

 (38)  

Decrease in restricted cash

Decrease in restricted cash

 123  

Proceeds from stock options exercised

Proceeds from stock options exercised

  401 

Net proceeds from issuance of common stock

Net proceeds from issuance of common stock

 6,092  

Payment of preferred dividends

Payment of preferred dividends

 (96) (250)

Stock-based compensation issued for services

 387 95       

Stock-based employee compensation

 4,325 5,519  

Net cash used in financing activities

 (508) (5,763)

Change in operating assets and liabilities:

       
 

Prepaid expenses and other assets

 131 (415) 

Net decrease in cash and cash equivalents

 (4,920) (25,104)
 

Accounts payable

 221 215       

Cash and cash equivalents:

Cash and cash equivalents:

 

Beginning of period

Beginning of period

 15,938 44,144 
 

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 

End of period

End of period

 $11,018 $19,040 
           

Supplemental disclosure of non-cash financing activities:

Supplemental disclosure of non-cash financing activities:

 

Supplemental disclosure of non-cash financing activities:

 

Accrual of preferred dividend

 $125 $125 

Accrual of preferred dividends

Accrual of preferred dividends

 $118 $375 

Preferred stock dividends, in-kind

Preferred stock dividends, in-kind

 570  

Supplemental disclosure of cash paid during the period for:

Supplemental disclosure of cash paid during the period for:

 

Supplemental disclosure of cash paid during the period for:

 

Interest

Interest

 $1,369 $529 

Interest

 $897 $1,369 

See notes to the condensed consolidated financial statements.


Table of Contents


PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

Note 1. BasisBusiness Overview and Summary of PresentationSignificant Accounting Policies

Overview

        Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of cancer therapeutics. The accompanying unaudited condensed consolidated financial statements include the accounts of Poniard Pharmaceuticals, Inc. and its wholly-owned subsidiary, NeoRx Manufacturing Group, Inc. (the "Company"). All intercompany balances and transactions have been eliminated in consolidation.eliminated.

Basis of Presentation

        The accompanying condensed consolidated financial statements contained herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). As permitted under those rules, certain footnotes or other financial information that are normally required by accounting principles generally accepted in the United States have been condensed or omitted pursuant to such rules and regulations. In the opinion of the Company's management, the accompanying interim unaudited condensed consolidated 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, the2010, results of operations for the three and nine months ended September 30, 20092010 and 20082009, and cash flows for the nine months ended September 30, 20092010 and 2008.2009.

        The results of operations for the periodperiods ended September 30, 20092010 are not necessarily indicative of the expected operating results for the full year.

        The balance sheet as of December 31, 20082009 has been derived from the audited financial statements at that date. The balance sheet does not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. For further information, refer to the financial statements and footnotes thereto included in the Company's annual reportAnnual Report on Form 10-K for the year ended December 31, 20082009 filed with the SEC on March 16, 2009,2010, and available on the SEC's website,www.sec.gov.

        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.

Use of Estimates: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:Reclassifications    Management has reviewed

        Certain balances and evaluated material subsequent events, if any, occurring afterresults from the balance sheet dateprior year have been reclassified to conform to the Company's current year presentation. In particular, certain legal expenses related to intellectual property and patents have been reclassified from research and development expense to general and administrative expense in the condensed consolidated statements of operations to conform to the current year's presentation. The amounts reclassified for these patent-related legal expenses for the three and nine months ended 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:    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 assetsare $340,000 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 September 30, 2009, the Company had working capital of $23,739,000, an accumulated deficit of $394,866,000 and total shareholders' equity of $20,218,000.

$608,000, respectively. 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 (seereclassifications had no effect on total operating expenses, net loss or shareholders' equity.


Table of Contents


PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 1. BasisBusiness Overview and Summary of PresentationSignificant Accounting Policies (Continued)

Significant Risks and Uncertainties

        The Company has historically suffered recurring operating losses and negative cash flows from operations. As of September 30, 2010, the Company had net working capital of $11,933,000, an accumulated deficit of $433,728,000 and total shareholders' equity of $12,134,000. The Company's total cash, cash equivalents and investment securities balances, net of restricted cash of $158,000, was $23,345,000 at September 30, 2010. The Company has financed its operations to date primarily through the sale of equity securities, borrowings under debt instruments, technology licensing and collaborative agreements. The Company invests excess cash in investment securities that will be used to fund future operating costs. Cash used for operating activities for the nine months ended September 30, 2010 totaled $19,230,000. The Company is focusing its resources on the continued development of its primary product candidate, picoplatin. Based on the Company's activities to date for the development of registration strategies for picoplatin and its evaluation of strategic alternatives, the Company does not anticipate that its picoplatin product will be commercially available before 2014, if at all. As a result, the Company does not have a predictable source of revenue or other cash flows and does not expect to generate cash from operations for the foreseeable future. Thus, the Company is dependent upon its ability to sell equity instruments, borrow, or enter into licensing agreements or other strategic relationships to provide capital to sustain its operations. In March 2010, in connection with the adoption of an initiative to develop registration strategies for picoplatin in multiple indications, the Company engaged an investment banker to conduct a comprehensive review of strategic alternatives, including raising additional capital, a merger or sale of the Company or partnering with another company. The Company may not be able to obtain required additional capital or enter into relationships with corporate partners or other third parties on a timely basis, on terms ultimately favorable to the Company, or at all. Conditions in the capital markets in general, and in the life science capital markets specifically, may affect the Company's potential financing sources and opportunities for partnering or other strategic relationships. If the Company is unable to secure additional capital to fund its working capital and capital expenditure requirements, it may be forced to explore liquidation alternatives, including seeking protection from creditors through the application of bankruptcy laws.

        On July 20, 2010, the Company received a letter from The Nasdaq Stock Market stating that the minimum bid price of its common stock has been below $1.00 per share for 30 consecutive business days and that the Company therefore is not in compliance with the minimum bid price requirements of The Nasdaq Global Market. The Company has 180 calendar days, or until January 18, 2011, to regain compliance with the minimum bid price requirement, which would consist of the closing bid price of its common stock meeting or exceeding $1.00 per share for at least ten consecutive business days during the 180-day grace period. If the Company does not regain compliance by January 18, 2011, it may, at that time, appeal any delisting determination to a Nasdaq Hearings Panel. Alternatively, if at that time the Company satisfies all of the initial listing standards, with the exception of the minimum bid price, for The Nasdaq Capital Market, it could apply to transfer the listing of its common stock to The Nasdaq Capital Market and thereby receive an additional 180 calendar days to regain compliance with the minimum bid price requirement. The notification of noncompliance has no immediate effect on the listing or trading of the Company's common stock on The Nasdaq Global Market. There can be no assurance the Company will be able to regain and/or maintain compliance with the minimum bid price or other Nasdaq continued listing requirements. For further information, see "Item 1A, Risk Factors," in Part II of this Form 10-Q.


Table of Contents


PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 1. Business Overview and Summary of Significant Accounting Policies (Continued)

        The Company's loan facility with GE Business Financial Services and Silicon Valley Bank, described in Note 5 for further details).below, requires that the Company maintain a minimum amount of cash, cash equivalents and investments ("unrestricted cash") during the term of the loan equal to the lesser of (i) $17,940,000 or (ii) the outstanding aggregate principal balance of the term loans plus $4,000,000. At September 30, 2010, the outstanding aggregate principal balance of the term loans plus $4,000,000 was $15,829,000. Taking into account the minimum unrestricted cash requirement under the loan agreement and the Company's projected operating results, the Company believes that its current cash, cash equivalents and investment securities balances will provide adequate resources to fund operations at least intothrough the first quarterend of 2010. However, givenThereafter, unless the uncertainties of outcomesCompany raises additional funds, or enters into a partnering or other strategic relationship, it will be in default of the Company's clinical trials, there is no assurance thatminimum unrestricted cash requirement and potentially other provisions of the Company can achieve its projected operating results.loan agreements. The Company has 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. These factors, among others, raise substantial doubt aboutThe 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. If an event of default were to occur, the Company would not have sufficient funds to repay the loan and to fund its continuing operations beyond December 31, 2010. Provisions of the loan agreement limit the Company's ability to continuedispose of certain assets, engage in certain mergers, incur certain indebtedness, make certain distributions, and engage in certain investment activities without the prior consent of the lenders.

Recent Accounting Standards

        In October 2009, the Financial Accounting Standards Board ("FASB") issued new standards for revenue recognition with multiple deliverables. These new standards impact the determination of when the individual deliverables included in a multiple-element arrangement may be treated as separate units of accounting. Additionally, these new standards modify the manner in which the transaction consideration is allocated across the separately identified deliverables by no longer permitting the residual method of allocating arrangement consideration. These new standards are required to be adopted in the first quarter of 2011; however, early adoption is permitted. The Company believes that these new standards would have an impact on its consolidated financial statements in the future were it to enter into an arrangement with multiple deliverables.

        In April 2010, the FASB issued updated guidance on defining milestones and determining when it may be appropriate to apply the milestone method of revenue recognition for research and development transactions involving arrangements with deliverables in which one or more payments are contingent upon achieving uncertain future events or circumstances. The updates are effective on a going concern. Management is developing plansprospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010, with early adoption permitted. The Company believes that this new guidance would have an impact on its consolidated financial statements if it were to addressenter into any milestone-based revenue agreements in the Company's liquidity needs, including raising additional capital through the public or private salefuture.


Table 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 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.Contents


PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 2. Fair Value Measurements

        We categorizeThe Company categorizes assets and liabilities recorded at fair value in ourits condensed consolidated balance sheetsheets based upon the level of judgment associated with inputs used to measure their value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. We useThe Company uses valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs when determining fair value and then we rankranks 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").FASB. The three levels of the FASB fair 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 following tables present a summary of the Company's assets that are measured at fair value on a recurring basis (in thousands):

 
 Fair Value Measurements as of
September 30, 2010
 
 
 Total Level 1 Level 2 Level 3 

Cash equivalents

 $9,503 $9,503 $ $ 

Investment securities

  12,327    12,327   
          

 $21,830 $9,503 $12,327 $ 
          


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

Cash equivalents

 $15,447 $15,447 $ $ 

Investment securities

  27,451    27,451   
          

 $42,898 $15,447 $27,451 $ 
          

        As of September 30, 2010 and December 31, 2009, 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, 2010, the cash equivalents balance consists of $9,503,000 in


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 2. Fair Value Measurements (Continued)


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

 
 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.funds. Investment securities are comprised of corporate debt securities and federal government and agency securities (see Note 3 below for further details on investment securities).

        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, 2009.2010.

Note 3. Investment Securities

        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 gain/(loss). on the condensed consolidated balance sheets. 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.net, in the condensed consolidated statements of operations.

        Investment securities consisted of the following at September 30, 2010 (in thousands):

 
  
 Gross Unrealized  
 
 
 Amortized
Cost
 Estimated
Fair Value
 
 
 Gains (Losses) 

Type of security:

             
 

Corporate debt securities, with unrealized gains

 $4,068 $12 $ $4,080 
 

Corporate debt securities, with unrealized losses

  1,002      1,002 
 

Federal government and agency securities, with unrealized gains

  7,241  4    7,245 
 

Federal government and agency securities, with unrealized losses

         
          

 $12,311 $16 $ $12,327 
          
  

Net unrealized gain

       $16    
             

Maturity:

             
 

Less than one year

 $12,311       $12,327 
 

Due in 1 - 2 years

           
            

 $12,311       $12,327 
            

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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 3. Investment Securities (Continued)

        Investment securities consisted of the following at September 30,December 31, 2009 (in thousands):



  
 Gross Unrealized  
 
  
 Gross Unrealized  
 


 Amortized
Cost
 Estimated
Fair Value
 
 Amortized
Cost
 Estimated
Fair Value
 


 Gains (Losses) 
 Gains (Losses) 

Type of security:

Type of security:

 

Type of security:

 

Corporate debt securities, with unrealized gains

 $12,081 $15 $ $12,096 

Corporate debt securities, with unrealized gains

 $12,608 $8 $ $12,616 

Federal government and agency securities

 8,970 8  8,978 

Corporate debt securities, with unrealized losses

 5,565  (13) 5,552 
         

Federal government and agency securities, with unrealized gains

 1,509 1  1,510 

 $21,051 $23 $ $21,074 

Federal government and agency securities, with unrealized losses

 7,786  (13) 7,773 
                   
 

Net unrealized gain

   $23     

 $27,468 $9 $(26)$27,451 
               
 

Net unrealized loss

     $(17)   
     

Maturity:

Maturity:

 

Maturity:

 

Less than one year

 $21,051     $21,074 

Less than one year

 $23,199     $23,198 
       

Due in 1 - 2 years

 4,269     4,253 
       

 $27,468     $27,451 
       

        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, 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 
            

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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
  September 30,
2010
 December 31,
2009
 

Clinical trials

 $5,671 $8,266  $961 $6,550 

Accrued expenses

 869 689  993 803 

Compensation

 1,307 1,164  685 326 

Severance

  285  321  

Other

 341 284 
          

 $8,188 $10,688  $2,960 $7,679 
          

Note 5. Note Payable

        On September 2, 2008, the Company entered into an Amended and Restated Loan and Security 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"), with Merrill Lynch Capital and Silicon Valley Bank,the lenders, pursuant to which the Company obtained a $15,000,000 capital loan that was to mature on April 1, 2010.


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 5. Note Payable (Continued)

        The loan agreement provides for a $27,600,000 senior secured term 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"), 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 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.2010. All final payment amounts are 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. At September 30, 2010, the outstanding principal balance under the loan facility was $12,920,000, net of discount of $879,000.

        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 areis being amortized to interest expense using an effective interest rate of 13.8%. At September 30,The warrants became exercisable upon issuance and are exercisable anytime during their term. In October 2009, Silicon Valley Bank exercised its warrants held in connection with the 2006 and 2008 loan agreements to purchase an aggregate of 197,169 common shares, net of equivalent shares at market to cover the total exercise price. In November 2009, the outstanding principal balance underCompany amended the warrants held by GE Business Financial Services in connection with the 2006 and 2008 loan facility was $20,409,000, netagreements to purchase an aggregate of discount197,169 common shares to change the exercise price to $2.00 per share resulting in an increase in shareholders' equity and a charge to interest expense of $1,951,000.$33,000 in 2009.

        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. At September 30, 2010, the outstanding aggregate principal balance of the term loans plus $4,000,000 was $15,829,000. 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,


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 5. Note Payable (Continued)


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, 2009.2010.

Note 6. Committed Equity Line of CreditCommon Stock Purchase Agreement

        On August, 19, 2009,February 23, 2010, the Company entered into an equity line of credit arrangementfacility with Azimuth OpportunityCommerce Court Small Cap Value Fund, Ltd. ("Azimuth"Commerce Court") pursuant to a Common Stock Purchase Agreement ("Purchase Agreement"), which. The facility provides that, upon the terms and subject to the price and share amount parameters and other conditions set forth therein, Azimuththereof, Commerce Court is committed to purchase up to $60 million$20,000,000 worth of shares of the Company's registered common stock over approximately 18 months; provided, however, that in no event may the 18-month termCompany issue to Commerce Court more than 8,423,431 shares of common stock, which is equal to one share less than 20% of the Purchase Agreement. From time to time overCompany's outstanding common shares on the termclosing date of the Purchase Agreement,facility, less 121,183 shares issued to Commerce Court as a commitment fee. The purchase price of the Company may, at its sole discretion and upon presentation of a draw down notice, require Azimuthshares will be equal to purchase its common stockthe daily volume weighted average price over teneight consecutive trading days or such other draw down period mutually agreed upon by the Company and Azimuth ("Draw Down Period"). Each draw down is subjectparties, less a discount ranging from 3.125% to limitations5.0%, based on the trading price of the Company's common stock and a limit of 2.5%stock. In addition, Commerce Court may not at any time acquire shares if, after giving effect to such purchase, Commerce Court would beneficially own 9.9% or more of the Company's market capitalizationoutstanding common stock. Unless otherwise mutually agreed between the parties, Commerce Court is not obligated to purchase shares at the time of the draw down. The Purchase Agreement requires a minimum price of $3.00that is less than $1.00 per share (before taking into account the discount). Given the Company's current stock price, which was $0.54 as of November 2, 2010, it has no assurance that Commerce Court will agree to allowpurchase additional shares under the facility. On March 15, 2010, the Company to issue shares to Azimuth. Under the Purchase Agreement, the Company may sell to Azimuth up to 6,955,606completed a draw down and sale of 4,229,000 shares of its common stock. The Company may present Azimuth with upstock, at a price of approximately $1.49 per share, 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 soldCommerce Court under the Purchase Agreement.equity line of credit facility. Net proceeds of approximately $6,092,000 were received, after deducting offering costs of approximately $228,000.

Note 7. Restructuring and Asset Impairment

        EffectiveApril 2010 Restructuring

        On March 24, 2010, the Company announced a restructuring plan in connection with its decision to suspend efforts to pursue a New Drug Application for its drug candidate, picoplatin, in small cell lung cancer. This restructuring plan resulted in a decrease in the number of employees by approximately 45%, to a total of 12 employees, effective April 30, 2010. In connection with this plan, the Company recorded a restructuring charge of approximately $543,000 for the period ended March 31, 2009,2010, consisting of one-time employee termination benefits, which will be paid in their entirety by January 31, 2011. As a consequence of the Company implementedrestructuring, approximately 965,000 restricted stock units ("RSUs"), which were awarded in February 2010 pursuant to the Amended and Restated 2004 Incentive Compensation Plan (the "2004 Plan"), became fully vested in accordance with the terms of the underlying RSU agreements (see Note 10 below for additional information). These RSUs converted to common stock on a strategic restructuring plan to refocus its cash resources on clinical and commercial development of picoplatin, resultingone-for-one basis in the discontinuationsecond quarter of the Company's preclinical research operations and reducing its workforce by approximately 12%, or eight employees.2010. The Company incurred severance charges totaling $296,000 related torecognized approximately $1,486,000 in share-based compensation expense during the reduction in staff. All severance charges related to the restructuring have been paid as of September 30, 2009. Thefirst two quarters


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 7. Restructuring and Asset Impairment (Continued)


of 2010 for terminated employees related to the accelerated vesting of these RSUs as a result of the restructuring.

        The following table summarizes the impact of the restructuring charges reported in the condensed consolidated statement of operations for the nine months ended September 30, 2010 and in accrued liabilities in the condensed consolidated balance sheet as of September 30, 2010 related to the April 2010 restructuring (in thousands):

Description
 Initial
Restructuring
Charge
March 2010
 Payment of
Restructuring
Obligations
 Accrued
Restructuring
Charge as of
September 30,
2010
 

Employee termination benefits

 $543 $(432)$111 
        

February 2010 Restructuring

        On February 5, 2010, the Company implemented a restructuring plan to conserve its capital resources, resulting in a reduction in the Company's workforce by approximately 57%, to 22 employees. The Company incurred restructuring charges of approximately $1,083,000, primarily consisting of one-time employee termination benefits. As a consequence of the restructuring, approximately 130,000 RSUs, which were awarded in July 2009 pursuant to the 2004 Plan, became fully vested in accordance with the terms of the underlying RSU agreements (see Note 10 below for additional information). These RSUs converted to common stock on a one-for-one basis in February 2010. The Company recognized approximately $174,000 in share-based compensation expense in the first quarter of 2010 related to the accelerated vesting of these RSUs as a result of the restructuring.

        The following table summarizes the impact of the restructuring charges reported in the condensed consolidated statement of operations for the nine months ended September 30, 2010 and in accrued liabilities in the condensed consolidated balance sheet as of September 30, 2010 related to the February 2010 restructuring (in thousands):

Description
 Initial
Restructuring
Charge
February 2010
 Payment of
Restructuring
Obligations
 Accrued
Restructuring
Charge as of
September 30,
2010
 

Employee termination benefits

 $1,061 $(851)$210 

Other termination costs

  22  (22)  
        

Total

 $1,083 $(873)$210 
        

March 2009 Restructuring

        On March 31, 2009, the Company implemented a strategic restructuring plan to refocus its cash resources on clinical and commercial development of picoplatin, which resulted in the discontinuation of the Company's preclinical research operations and in the reduction of its workforce by approximately 12%, to a total of 57 employees. The Company incurred severance charges totaling $296,000 related to


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 7. Restructuring and Asset Impairment (Continued)


the reduction in staff. All severance charges related to the restructuring were paid in 2009. The Company incurred additional charges totaling approximately $172,000 related to the closure of its lab facilities in South San Francisco, California. Of this amount, $6,000 was incurred as share-based 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 unpaidAll outstanding liabilities for contract and is payable within one year.termination costs were paid in 2009.

        The following table summarizes the impact of the restructuring charges throughreported in the condensed consolidated statements of operations for the periods ended September 30, 2009 and 2010 and in accrued liabilities in condensed consolidated balance sheets as of December 31, 2009 and September 30, 2010 related to the March 2009 restructuring (in thousands):

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

Employee termination benefits

Employee termination benefits

 $296 $(296)$ 

Employee termination benefits

 $296 $(296)$ 
               

Contract termination costs

Contract termination costs

 125 (125)  

Contract termination costs

 125 (125)  

Other termination costs

Other termination costs

 47 (33) 14 

Other termination costs

 47 (47)  
               

Subtotal

 172 (158) 14 

Subtotal

 172 (172)  
               

Total

Total

 $468 $(454)$14 

Total

 $468 $(468)$ 
               

        In conjunction with the decision to discontinue the Company's preclinical research operations during the quarter ended March 31, 2009, the Company recognized an asset impairment loss of $588,000 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 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.condensed consolidated balance sheets. All remaining impaired assets held for sale were sold in January 2010.

        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 Upon Restructuring (March 31, 2009)

 $57 

Disposals of Assets

  (50)
    

Post Impairment Carrying Value as of September 30, 2009

 $7 
    
 
 Lab Equipment &
Leasehold
Improvements
 

Impairment loss

 $588 
    

Impaired carrying value upon restructuring March 31, 2009

 $57 

Disposals of assets

  (52)
    

Post impairment carrying value as of December 31, 2009

  5 

Disposals of assets

  (5)
    

Post impairment carrying value as of September 30, 2010

 $ 
    

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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 8. Picoplatin License and Amendment

        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 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") 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 II2 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, 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 twelve12 years remaining for the primary patent term was the appropriate useful life for the picoplatin intangible asset, in accordance with the FASB's guidance for intangibles, and is amortizing the initial $2,000,000 license payment over this twelve12 year useful life beginning in April 2004. The Company concluded that no change in the twelve-year12 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 twelve12 year useful life and is amortizing the license amendment payment of $10,000,000 over the remainder of the twelve12 year useful life of the picoplatin intangible asset.

        Licensed products consistThe Company reviews its long-lived assets for possible impairment whenever significant events indicate such impairment may have occurred. In November 2009, the Company announced that its pivotal Phase 3 SPEAR trial of picoplatin in the picoplatin amortizable intangible assetsecond-line treatment of patients with a gross amountsmall cell lung cancer did not meet its primary endpoint of $12,000,000, net of accumulated amortization of $4,104,000 and $3,193,000 at September 30, 2009 and December 31, 2008, respectively.overall survival. The Company considers this event to be a


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 8. Picoplatin License and Amendment (Continued)


trigger for testing its picoplatin intangible asset for possible impairment; however, upon review of the expected future undiscounted net cash flows identifiable to the picoplatin license, the Company determined that the picoplatin intangible asset is recoverable and that no impairment occurred.

        Licensed products consists of the picoplatin amortizable intangible asset with a gross amount of $12,000,000, net of accumulated amortization of $5,319,000 and $4,408,000 at September 30, 2010 and December 31, 2009, respectively.

Note 9. Net Loss 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
September 30,
 Nine Months Ended
September 30,
  Three Months Ended
September 30,
 Nine Months Ended
September 30,
 

 2009 2008 2009 2008  2010 2009 2010 2009 

Common stock options

 5,722,570 5,397,071 5,722,570 5,397,071  5,683,497 5,722,570 5,683,497 5,722,570 

Performance-based restricted stock units

 514,668  514,668  

Restricted stock units

 2,765,654 514,668 2,765,654 514,668 

Common stock warrants

 5,496,651 6,165,129 5,496,651 6,165,129  4,765,026 5,496,651 4,765,026 5,496,651 

        In addition, 14,966 and 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 September 30, 20092010 and 2008,2009, respectively, because the effect of including such shares would not be dilutive.

Note 10. Stock-basedShare-based Compensation

        A summary of the Company's 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 September 30, 2009

  3,232 $7.10  6.6 $5,377 
 
 Number of
Shares
 Weighted
Average
Exercise
Price
 Weighted
Average
Remaining
Contractual
Term in
Years
 Aggregate Intrinsic Value 

Options exercisable at September 30, 2010

  4,255 $6.39  5.49 $ 

        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
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 nine months ended 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-basedShare-based Compensation (Continued)


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

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2010 2009 2010 2009 

Research and development expense

 $136 $493 $2,139 $1,097 

General and administrative expense

  1,433  1,113  4,859  3,228 
          
 

Total

 $1,569 $1,606 $6,998 $4,325 
          

        The share-based compensation expense for the nine months ended September 30, 2009 includes a stock option granted during the first quarter of 2009 to a Company officer to purchase an aggregate of 200,000 shares of common stock.stock that vests over a four year period. The officer's employment was terminated in August 2010, at which time unvested options were cancelled in accordance with the 2004 Plan. The share-based compensation expense for the nine months ended September 30, 2010 includes a stock option granted during the first quarter of 2010 to a Company officer to purchase an aggregate of 500,000 shares of common stock that vests over a four year period. There were no options granted during the three month period ended September 30, 2010.

        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,
 
 
 2010 2009 2010 2009 

Expected term (in years)

 NA  2.3  5.0  5.8 

Risk-free interest rate

 NA  1.19% 2.22% 2.30%

Expected stock price volatility

 NA  95% 95% 95%

Expected dividend rate

 NA  0% 0% 0%

        Certain options that were granted to officers of the Company during 2006 and 2007 vest 50% in equal monthly installments over four years from the date of grant and vest 50% on the seven-yearseven 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 management 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 20072009, the equity awards subcommittee accelerated vesting with respect to 20%25% of the shares subject to the seven-yearseven year vesting schedule in the first quarter of 2008.2010. As of September 30, 2009,2010, the cumulative accelerated vesting for options subject to the seven year vesting schedule equals 60%85% of the shares subjectgranted in 2006 and 65% of the shares granted in 2007.


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 10. Share-based Compensation (Continued)

        The Company's share-based compensation expense also includes RSUs awarded to the seven-year vesting schedule.

        Estimated fair valuesemployees and non-employee consultants. The table below summarizes RSU awards outstanding as of stock options granted have been determined using the Black-Scholes option pricing model with the following assumptions for the periods presented:September 30, 2010 (RSUs in thousands):

 
 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%
Award Date
 RSUs
Awarded
 RSUs
Vested
 RSUs
Forfeited
 Unvested
RSUs as of
September30,
2010
 Weighted
Average
Grant Date
Fair Value
per RSU
 

06/09/2010

  961      961 $0.83 

04/20/2010

  15  (15)     1.20 

04/09/2010

  587    (37) 550  1.14 

02/04/2010

  2,354  (1,153) (131) 1,070  1.54(A)

12/08/2009

  15    (15)   2.30(B)

10/06/2009

  100      100  7.27 

07/23/2009

  290  (263) (27)   7.34(C)

07/11/2009

  170  (85)   85  6.60(B)

10/31/2008

  96  (89) (7)   3.13 
             

Total RSUs

  4,588  (1,605) (217) 2,766    
             

        During 2008


(A)
On February 4, 2010, the Company awarded 92,000 restricted stock units ("RSUs") under the 2004 Incentive Compensation Plan, as amendedapproximately 2,354,000 RSUs to certain employees and restated (the "2004 Plan"), to non-officer employeesofficers as an incentive for future performance. The RSUs become fully vested on December 31, 2010, subject to earlier acceleration upon termination of employment by the Company without cause. Due to the Company's restructuring that was effective April 30, 2010 (see Note 7 above for further discussion), approximately 965,000 of these RSUs became fully vested on April 30, 2010. An additional 4,000188,000 RSUs were awardedvested in 2009 for this incentive program. Upon vesting, each RSU is payable with one sharethe third quarter of the Company's common stock. The average fair value of the RSUs was $3.13 per unit, or approximately $299,000 in total, based2010 upon the closingtermination of employment of a Company officer. The Company determined the expense for these awards on a straight-line basis from grant date through the respective accelerated vesting dates.

(B)
RSUs awarded to non-employee consultants. For share-based compensation expense, these awards are revalued to the underlying 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. Asas 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.

or $0.58 per unit.

(C)
On July 23, 2009, the Company awarded an additional 290,400approximately 290,000 RSUs under the 2004 Plan to non-officer employees as an incentive for future performance. The fair value of the RSUsvesting schedule for these awards 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, subject to acceleration upon termination of employment by the Company without cause. Due to the Company's February 2010 restructuring (see Note 7 above for further discussion), approximately 157,000 of these RSUs became fully vested on February 5, 2010.

        No income tax benefit has been recorded for share-based compensation expense as the Company has a full valuation allowance and management has concluded that it is more likely than not that the Company's net deferred tax assets will not be realized. As of September 30, 2009, the Company determined that milestones are probable of being achieved and2010, total unrecognized costs related to employee share-based compensation is therefore recognizing the related stock-basedapproximately $5,131,000. Unrecognized share-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 grantfrom outstanding stock options is approximately $2,802,000 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-basedShare-based Compensation (Continued)


expected to be recognized over a weighted average period of 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-based1.9 years. Unrecognized share-based compensation expense as the Company has a full valuation allowancefrom outstanding RSUs is approximately $2,329,000 and management has concluded it is more likely than not that the Company's net deferred tax assets will not be realized. As of September 30, 2009, total unrecognized costs related to employee stock-based compensation was $11,074,000, which is expected to be recognized over a weighted average period of approximately 2.3 years.1.2 years subject to acceleration with the occurrence of certain qualifying events.

Note 11. Comprehensive Loss

        The Company's comprehensive loss for the three and nine months ended September 30, 20092010 and 20082009 is summarized as follows (in thousands):


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

 2009 2008 2009 2008  2010 2009 2010 2009 

Net loss

 $9,877 $12,237 $32,547 $34,623  $6,449 $9,877 $24,884 $32,547 

Net unrealized (gain) loss on investment securities

 (39) 531 (377) 651 

Net unrealized gain on investment securities

 (13) (39) (33) (377)
                  

Comprehensive loss

 $9,838 $12,768 $32,170 $35,274  $6,436 $9,838 $24,851 $32,170 
                  

Note 12. Recent Accounting Pronouncements

        In June 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 ASU 2009-05, "Fair Value Measurements and Disclosures (Topic 820)—Measuring Liabilities at Fair Value" ("ASU 2009-05," currently within the scope 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 1 fair value measurements. The ASU is effective for the first reporting


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 12. Recent Accounting Pronouncements (Continued)


period, including interim periods, beginning after issuance. Adoption of ASU 2009-05 did not have a material effect on the Company's condensed consolidated financial statements.

Note 13.12. Commitments and Contingencies

        The Company entered into a picoplatin active pharmaceutical ingredient ("API") commercial supply agreement with W.C. Heraeus GmbH ("Heraeus") in March 2008. Under this agreement Heraeus will produce the 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 $1,800,000 (including interest charges of approximately $336,000) will be repaid 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 September 30,December 31, 2009, Heraeus had completed partial construction of the dedicated equipment at a total cost of approximately $1,722,000 (including interest). Because$1,485,000. The Company determined that the Company is not underequipment should be accounted for as a presentcapital lease and accordingly recognized an asset and long-term obligation to pay this amount andfor the agreement is not under any potential circumstanceequipment 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$1,485,000 on the condensedits consolidated balance sheet as of that date.December 31, 2009. The Company anticipates thatwill reflect the surcharge payments as reductions to the capital lease balance outstanding, and will accrete a finance charge to interest expense as specified under the agreement. The balance of the obligation at September 30, 2010 was $1,551,000, including accreted interest of approximately $66,000. The Company does not anticipate beginning production of commercial supplies of picoplatin API, thereby utilizing the dedicated equipment, will be readywithin the next 12 months and has, therefore, classified the obligation as long-term. Due to the delay in the Company's plans for usethe commercialization of picoplatin, the Company determined that its capital lease asset for equipment under the Heraeus agreement was impaired as of December 31, 2009 and, therefore, recognized an asset impairment charge of $1,485,000 in the consolidated statement of operations during the fourth quarter ended December 31, 2009.


Table of 2009, after which it expectsContents


PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 13. Exchange of Preferred Stock

        On February 6, 2010, the Company issued 379,956 shares of its common stock to accountan institutional shareholder in exchange for the equipmentshareholder's delivery to the Company of 126,572 shares of the Company's outstanding $2.4375 convertible exchangeable preferred stock, Series 1 ("Series 1 shares"). The shareholder approached the Company with the proposed exchange transaction and related surcharge paymentsthe final terms of the exchange were determined by arms-length negotiation between the parties. A portion of the common stock issued by the Company in the exchange was in addition to the number of shares that were calculable under the exchange provisions of the Series 1 preferred stock designation of rights in the Company's articles of incorporation. This portion was accounted for by the Company as a capital lease.an in-kind dividend, the fair value of which is $570,000. The Series 1 shares received by the Company in the exchange constitute authorized but unissued shares of preferred stock of the Company.


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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 Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and in reliance upon the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. TheseForward-looking statements relate toare those that predict or describe future events or future financial performancetrends and are subjectthat do not relate solely to change based on various important factors, many of which are beyond our control.historical matters. In some cases, you can identify forward-looking statements by terminology such as "currently," "may," "will," "could," "should," "expect," "plan," "intend," "anticipate," "believe," "target," "estimate," "predict," "project," "potential," "propose" or"propose," "continue," the negative of these terms"assume" or other terminology. Thesesimilar expressions, or the negatives of those expressions. All statements contained in this Form 10-Q regarding our corporate objectives and strategies, future operations, potential partnering and other strategic transactions, projected financial position, planned product development activities, proposed registration strategies and product indications, future regulatory approvals, proposed product commercialization, adequacy of current cash resources, projected costs, potential sources and availability of capital, ability to regain and maintain compliance with Nasdaq continued listing requirements, future prospects, the future of our industry, and results that might be obtained by pursuing management's current plans and objectives are forward-looking statements.

        You should not place undue reliance on our forward-looking statements because 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 theOur forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. You should not place undue reliancebased on our forward-looking statements, whichthe information currently available to us and speak only as of the date of this report. Wereport or, in the case of forward-looking statements incorporated herein by reference, the date of the filing that includes the statement. Over time, our actual results, performance or achievements may differ from those expressed or implied by our forward-looking statements, and such difference might be significant and materially adverse to our security holders. Except as required by law, 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.

        We have identified some of the important factors that could cause future events to differ from our current expectations and they are described in our Annual Report on Form 10-K for the year ended December 31, 2009, filed with the SEC on March 16, 2010 and available on the SEC's website,www.sec.gov, including under the heading "Risk Factors" in the Form 10-K, and in this Form 10-Q, including in this "Management's Discussion and Analysis of Financial Condition and Results of Operation" and in the section entitled "Risk Factors" in Part II of this report. Please consider our forward-looking statements in light of these risks as you read this report.

Background and Corporate Update

        During the first quarter of 2010, we completed a management restructuring and reduced our workforce as we refocused our clinical and regulatory goals. On March 24, 2010, we announced that we were suspending our effort to file a New Drug Application, or NDA, seeking approval of picoplatin as a second-line treatment for patients with small cell lung cancer. We made this decision following a detailed analysis of primary and updated data from our Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) study and an evaluation of the NDA process with the U.S. Food and Drug Administration, or FDA. We now are focusing our efforts on developing registration strategies for picoplatin in colorectal, prostate, ovarian and small cell lung cancers and are continuing to evaluate partnering and other arrangements to fund these strategies. In April 2010, we restructured our operations to conserve resources and support our registration and partnering strategies. This followed an earlier reduction in workforce headcount in February 2010. Through these two restructuring steps, our headcount was reduced from 50 to 12 employees. Concurrent with these events, we engaged


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Leerink Swann LLC to conduct a comprehensive review of strategic alternatives aimed at supporting and optimizing the value of our picoplatin program to our shareholders. These alternatives may include a potential cash raise, merger, sale or partnership. As of September 30, 2010, we had approximately $23.3 million in cash, cash equivalents and investment securities balances, net of restricted cash of $158,000, which we believe will provide adequate resources to fund our operations at least through the end of 2010. Thereafter, we will need to raise additional funds or enter into a partnering or other strategic relationship to avoid a default under our current credit facility and sustain our current operations. Our ability to continue to evaluate strategic alternatives and potentially resume development activities with respect to picoplatin is dependent on our ability to obtain substantial additional funding. We may seek to raise necessary additional funds through public or private equity, debt financings, collaborative arrangements with corporate partners or other sources. We can provide no assurance that any particular alternative will be pursued or that any transaction will occur, or on what terms. We do not plan to release additional information about the status of the review of alternatives unless and until a definitive agreement is entered into or the process is otherwise completed. If we are unable to secure additional funds, we may be forced to explore liquidation alternatives, including seeking protection from creditors through the application of bankruptcy laws.

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, 20082009 filed with the SEC on March 16, 2009.2010. For a more complete description, please refer to our Annual Report on Form 10-K.

Results of Operations

Three and Nine Months Ended September 30, 20092010 Compared to the Three and Nine Months Ended September 30, 20082009

Research and Development

        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 have completed a Phase I study of an oral formulation of picoplatin in advanced solid tumors.


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Research and development expenses decreased 40%82% to $5.4 million from $9.0approximately $0.9 million during the third quarter of 20092010 and decreased 22%58% to $19.2 million from $24.5approximately $7.9 million in the first nine months of 2010 from the comparable periods in 2009. The significant decrease in our research and development expenses during the three and nine months ended September 30, 2009 compared to the comparable periods in 2008.2010, is primarily a result of our picoplatin trials winding down. Our research and development expenses are summarized as follows:



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


 2009 2008 % Change 2009 2008 % Change 
 2010 2009 % Change 2010 2009 % Change 


 ($ in thousands)
  
 ($ in thousands)
  
 
 ($ in thousands)
  
 ($ in thousands)
  
 

Research

Research

 $ $1,043 (100)%$764 $2,614 (71)%

Research

 $ $  $ $764 (100)%

Contract manufacturing

Contract manufacturing

 717 1,149 (38)% 2,524 3,270 (23)%

Contract manufacturing

 167 717 (77)% 1,024 2,524 (59)%

Clinical

Clinical

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

Clinical

 586 3,815 (85)% 4,309 14,064 (69)%

Share-based compensation

Share-based compensation

 524 472 11% 1,193 1,289 (7)%

Share-based compensation

 138 524 (74)% 2,537 1,193 113%
                           

Total

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

Total

 $891 $5,056 (82)%$7,870 $18,545 (58)%
                           

        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 2010 or 2009 due to the discontinuation of our strategic restructuring implementedresearch operations effective March 31, 2009. Contract manufacturing costs decreased 38%77% to $0.7approximately $0.2 million in the third quarter of 20092010 and decreased 23%59% to $2.5approximately $1.0 million in the first nine months of 20092010 from the comparable periods in 2008.2009. These decreases reflect reduced clinicalthe absence of drug production activity resulting fromin the current year due to the completion of our trials nearing completion.and reduced drug product stability testing and analysis activity. Clinical costs decreased 35%85% to $4.2approximately $0.6 million in the third quarter of 20092010 and decreased 15%69% to $14.7approximately


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$4.3 million in the first nine months of 20092010 from the comparable periods in 2008. These decreases reflect2009. This decrease resulted primarily from reduced clinical activity in connection with our current picoplatin studies, all of which are fully enrolled and two of which areeither completed or in a follow-up or extended follow-up stage. Share-based compensation expense increased 11%decreased 74% to $0.5approximately $0.1 million in the third quarter of 20092010 from the comparable period in 2008,2009, due primarily to an employee incentive program introduced duringexpense recognized for restricted stock units, or RSUs, awarded in 2009 for which there was no expense recognized in the third quarter of 2009.2010 and to lower expense recognized for options resulting from the reduction in our headcount during 2010. Share-based compensation expense decreased 7%increased 113% to $1.2approximately $2.5 million for the nine months ended September 30, 20092010 from the comparable period in 2008,2009, primarily due to the effectsrecognition of the acceleration ofexpense for accelerated vesting of certain stock options held by certain officers based on the overall achievement of corporate goals in 2009, accelerated vesting of RSUs held by employees terminated in connection with our February 2010 and April 2010 restructuring activities, and awards of RSUs granted in February 2010 and July 2009 as incentives for future performance.

        Recap of Development and Clinical Program Costs.    Our research and development administrative overhead costs, consisting of rent, utilities, consulting fees and other various overhead costs, are included in total research and development expense for each period, but are not allocated to our picoplatin project. Also, our total research and development costs include the costs of various research efforts that support our trial activities and may also be directed toward the identification and evaluation of future product candidates. These other research projects are preclinical and not considered major projects. We implemented a restructuring on March 31, 2009, which resulted in the first quarterdiscontinuation of 2008.

        The following table shows expenses incurred forour preclinical study support, contract manufacturing for clinical suppliesresearch operations. Our total research and clinical trial services provided by third parties, as well as other associateddevelopment 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:are summarized below:



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


 2009 2008 % Change 2009 2008 % Change 
 2010 2009 % Change 2010 2009 % Change 


 ($ in thousands)
  
 ($ in thousands)
  
 
 ($ in thousands)
  
 ($ in thousands)
  
 

Picoplatin

Picoplatin

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

Picoplatin

 $587 $3,487 (83)%$3,838 $13,506 (72)%

Other unallocated costs and overhead

Other unallocated costs and overhead

 1,131 2,014 (44)% 3,674 5,845 (37)%

Other unallocated costs and overhead

 166 1,045 (84)% 1,495 3,846 (61)%

Share-based compensation

Share-based compensation

 524 472 11% 1,193 1,289 (7)%

Share-based compensation

 138 524 (74)% 2,537 1,193 113%
                           

Total research and development costs

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

Total

 $891 $5,056 (82)%$7,870 $18,545 (58)%
                           

        Our external costs for picoplatin for the three and nine month periods ended September 30, 20092010 and for the comparable periods in 2008,2009, reflect costs associated with our various picoplatin clinical studies and the manufacture and development of drug product to support our clinical trials. We expect our external costs for picoplatin to increase slightly during the balance of 2009, comparedcontinue to early 2009, as we prepare for submission of our rolling NDA, offset bydecrease in 2010, reflecting lower costs for clinical trials upon completion of our Phase III pivotal trial of picoplatin incompleted small cell lung, cancer.


Tablecolorectal and prostate cancer trials and our completed oral picoplatin study, partially offset by clinical, consulting and other development costs associated with our efforts to identify a strategic partner and explore other alternatives to support the continued development of Contentspicoplatin.

        As of September 30, 2009,2010, we have incurred external costs of approximately $68.6$77.2 million in connection with our entire picoplatin clinical program. TotalWe expect total estimated future costs through the end of 2010 for our picoplatin Phase III trial incompleted small cell lung, colorectal and prostate cancer is in the range of $20.0 million to $25.0 million through 2010, including the cost of drug supply. Total estimated future costs of our picoplatin Phase II trial in colorectal cancertrials and our Phase II trial in castration-resistant prostate cancer are in the ranges of $3.5 millioncompleted oral picoplatin study to $4.0 million and $1.0 million to $1.5 million, respectively, through 2010, including the cost of drug supply. Total remaining estimated future costs of our Phase I trial of an oral formulation of picoplatin are in the range of $50,000 to $100,000 through 2010. These costs could be substantially higher if we have to repeat, revise or expand the scope of any of our trials.minimal. Material cash inflows relating to ourthe commercialization of picoplatin development will not commence unless and until we complete required clinical trialsstudies and obtain FDA and foreign marketing approvals, and then only if picoplatin finds acceptance in the marketplace. To date, we have not received any revenues from product sales of picoplatin.


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        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 in our Annual Report on Form 10-K for the year ended December 31, 2008:2009:

        If we fail to obtain marketing approvals for picoplatin, are unable to secure adequate commercial supplies of picoplatin active pharmaceutical ingredient, or API, 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,
 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 


 2009 2008 % Change 2009 2008 % Change 
 2010 2009 % Change 2010 2009 % Change 


 ($ in thousands)
  
 ($ in thousands)
  
 
 ($ in thousands)
  
 ($ in thousands)
  
 

General and administrative

General and administrative

 $2,398 $2,245 7%$6,802 $6,964 (2)%

General and administrative

 $3,633 $2,738 33%$8,917 $7,410 20%

Share-based compensation

Share-based compensation

 1,404 1,138 23% 3,519 4,325 (19)%

Share-based compensation

 1,427 1,404 2% 4,830 3,519 37%
                           

Total

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

Total

 $5,060 $4,142 22%$13,747 $10,929 26%
                           

        The increase inTotal general and administrative expense of 7%expenses costs increased 22% to $2.4approximately $5.1 million forin the third quarter of 2010 and increased 26% to approximately $13.7 million in the first nine months of 2010 from the comparable periods in 2009. Excluding share-based compensation expense, general and administrative expenses increased 33% to approximately $3.6 million in the third quarter of 2010 from the comparable period in 2009, isprimarily due to increased accounting and legal fees of approximately $1.2 million associated with our evaluation of potential strategic alternatives and increased 20% to approximately $8.9 million in the first nine months of 2010 from the comparable period in 2009, primarily due to increased accounting and legal fees of approximately $1.2 million associated with our evaluation of potential strategic alternatives, a one-time credit of approximately $0.5 million for reimbursement of patent related legal costs in the first quarter of 2009 and higher facilities and consulting costs of approximately $0.7 million, offset by decreased personnel costs in 2010. While we expect the increase in accounting and legal costs to continue in the fourth quarter of 2010, we anticipate that such rate of increase will be less than that experienced in the third quarter of 2010. Share-based compensation costs and,expense increased 2% to approximately $1.4 million in the third quarter of 2010 from the comparable period in 2009. Share-based compensation expense increased 37% to approximately $4.8 million for the nine months ended September 30, 2010 from the comparable period in 2009, primarily due to the decreaserecognition 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 millionfor accelerated vesting of stock options held by


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certain officers based on the overall achievement of corporate goals in 2009, accelerated vesting of RSUs held by employees terminated in connection with our February 2010 and April 2010 restructuring activities, and awards of RSUs granted in February 2010 and July 2009 as incentives for the third quarterfuture performance.

Restructuring and Asset Impairments

        On March 24, 2010, we announced a restructuring plan in connection with our decision to suspend efforts to pursue an NDA for our drug candidate, picoplatin, in small cell lung cancer, resulting in a reduction of 2009, over the comparable periodour workforce by approximately 45%, to a total of 2008, due primarily12 employees, effective April 30, 2010. In connection with this plan, we recorded a restructuring charge of approximately $0.5 million upon our commitment to the effects of restricted stock units awarded during the third quarter of 2009 to non-officer employees and a consultant. Share-based compensation expense decreased 19% to $3.5 million for the first nine months of 2009 from the comparable period in 2008 primarily due to the effects of the acceleration of vesting of certain stock optionsrestructuring plan in the first quarter of 2008.2010, consisting of one-time employee termination benefits, which will be paid in their entirety by January 31, 2011. As a consequence of the restructuring, approximately 965,000 RSUs, which were awarded in February 2010 and held by the terminated employees, became fully vested in accordance with the terms of the underlying RSU agreements. These RSUs converted to common stock on a one-for-one basis in the second quarter of 2010. We recognized approximately $1.5 million in share-based compensation expense for the terminated employees during the six month period ended June 30, 2010 related to the accelerated vesting of these RSUs as a result of the restructuring.

        On February 5, 2010, we implemented a restructuring plan to conserve our capital resources, resulting in a reduction of our workforce by approximately 57%, to a total of 22 employees. We recorded restructuring charges of approximately $1.1 million in the first quarter of 2010, primarily consisting of one-time employee termination benefits. As a consequence of the restructuring, approximately 130,000 RSUs, which were awarded in July 2009 and held by the employees who were terminated, became fully vested in accordance with the terms of the underlying RSU agreements. These RSUs converted to common stock on a one-for-one basis in February 2010. We recognized approximately $0.2 million in share-based compensation expense in the first quarter of 2010 related to the accelerated vesting of these RSUs as a result of the restructuring.

        EffectiveOn March 31, 2009, we implemented a strategic restructuring plan to refocus our cash resources on clinical and commercial development of picoplatin, resultingwhich resulted in the discontinuation of our preclinical research operations and reducingin the reduction of our workforce by approximately 12%, or eightto a total of 57 employees. This restructuring resulted in charges of $0.5 million in the first quarter of 2009, 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 during the quarter ended March 31, 2009, 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 the impaired assets, which are included in assets held for sale and reported in the prepaid expenses and other assets lineon our consolidated balance sheet as of December 31, 2009. Additionally, during the quarter ended December 31, 2009, we recognized an impairment charge of approximately $1.5 million for our dedicated manufacturing equipment asset. The impairment charge was determined based on the accompanying Condensed Consolidated Balance Sheets.delay in our plans for the commercialization of picoplatin, which we do not anticipate will occur before 2014, if at all.


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Other Income and Expense



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


 2009 2008 % Change 2009 2008 % Change 
 2010 2009 % Change 2010 2009 % Change 


 ($ in thousands)
  
 ($ in thousands)
  
 
 ($ in thousands)
  
 ($ in thousands)
  
 

Interest expense

Interest expense

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

Interest expense

 $(516)$(750) (31)%$(1,744)$(2,413) (28)%

Interest income and other, net

Interest income and other, net

 71 499 (86)% 396 2,198 (82)%

Interest income and other, net

 18 71 (75)% 103 396 (74)%
                           

Total

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

Total

 $(498)$(679) (27)%$(1,641)$(2,017) (19)%
                           

        Interest expense increased 128%decreased 31% and 136%28% for the three and nine months ended September 30, 20092010 to $0.8approximately $0.5 million and $2.4$1.7 million, respectively, from the comparable periods in 2008.2009. The increasedecrease in interest expense was primarily due to increased interest costs resulting from additionalreduced borrowings in September 2008 under our loan facility.between periods. Interest income and other, net decreased 86%75% to $0.1 million$18,000 during the third quarter of 20092010 and decreased 82%74% to $0.4$0.1 million for the first nine months of 20092010 from the comparable periods in 2008.2009. The decreases were primarily due to decreased balances in and lower average yields from our investment securities portfolio.

Liquidity and Capital Resources



 September 30,
2009
 December 31,
2008
  September 30,
2010
 December 31,
2009
 


 ($ in thousands)
  ($ in thousands)
 

Cash, cash equivalents and

 $40,114 $72,755 

investment securities

 

Cash, cash equivalents and investment securities

 $23,345 $43,389 

Working capital

Working capital

 23,739 54,835  11,933 27,369 

Shareholders' equity

Shareholders' equity

 20,218 47,647  12,134 23,644 

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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 
 
 Nine Months Ended
September 30,
 
 
 2010 2009 
 
 ($ in thousands)
 

Cash provided by (used in):

       
 

Operating activities

 $(19,230)$(27,009)
 

Investing activities

  14,818  7,668 
 

Financing activities

  (508) (5,763)

        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,$158,000, totaled $40.1$23.3 million at September 30, 2009 compared to $72.8 million at December 31, 2008.2010. As of September 30, 2009,2010, we had net working capital of $23.7$11.9 million, an accumulated deficit total of $394.9$433.7 million and total shareholders' equity of $20.2$12.1 million.

        We have financedhistorically maintained our operations to date primarilyfinancial position through strategic management of our resources, including, the sale of equity securities, borrowings under 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 nine months ended September 30, 20092010 totaled $27.0$19.2 million.

Capital Resources

        Equity Financing.    On February 23, 2010, we entered into an equity line of credit facility with Commerce Court Small Cap Value Fund, Ltd., or Commerce Court. On March 15, 2010, we completed a draw down and sale of an aggregate of approximately 4.2 million shares of our common stock, at a price of approximately $1.49 per share, to Commerce Court under the equity line of credit facility. Net proceeds of approximately $6.1 million were received, after deducting offering expenses of


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approximately $0.2 million. We are using the proceeds of this draw down to fund our efforts to develop registrational strategies and explore partnering and other strategic relationships to support the continued development of picoplatin in small cell lung, colorectal, prostate and ovarian cancers. The equity line of credit facility provides that, unless otherwise mutually agreed between the parties, Commerce Court is not obligated to purchase common shares at a price that is less than $1.00 per share (before discount). Given our current stock price, which was $0.54 as of November 2, 2010, we have no assurance that Commerce Court will agree to purchase additional shares under the facility. See Note 6 under the section entitled "Notes to Condensed Consolidated Financial Statements" for additional information.

        During 2009, we sold an aggregate of approximately 7.0 million shares of our common stock to Azimuth Opportunity Ltd., or Azimuth, pursuant to two draw downs under an equity line of credit facility with Azimuth. In the first draw down on November 23, 2009, we sold approximately 3.5 million common shares to Azimuth at a purchase price of approximately $2.15 per share. We sold Azimuth approximately 3.5 million common shares for approximately $1.87 per share in the second draw down on December 22, 2009. The equity facility terminated by its terms on December 22, 2009. We received aggregate net proceeds from the draw downs of approximately $13.7 million. The proceeds of the draw downs under the Azimuth facility are being used for general corporate purposes, including working capital.

        Secured Loan Facility.    On September 2, 2008, we entered into an amended and restated loan and security agreement ("loan agreement") with GE HealthcareBusiness 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").2010. 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 HealthcareBusiness Financial Services on the earlier of March 31, 2010 or the date of repayment of the loan facility.2010. 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. In October 2009, Silicon Valley Bank exercised its warrants. In November 2009, we amended the warrants held by GE Business Financial Services to change the exercise price to $2.00 per share. At September 30, 2009,2010, the net loan balanceoutstanding principal amount under the loan facility was $20.4$12.9 million, net of discount of approximately $0.9 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. At September 30, 2010, the outstanding aggregate principal balance of the term loans plus $4.0 million was $15.8 million. The loan agreement contains events of default that include nonpayment of principal, interest or fees, breaches of covenants, material adverse changes, bankruptcy and


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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. We were in compliance with all loan covenants as of September 30, 2009.2010.

        Taking into account the minimum unrestricted cash requirement under the loan agreement and our projected operating results, we believe that our current cash, cash equivalentequivalents and investment securities balances will provide adequate resources to fund operations at least intothrough the first quarterend of 2010. However, given the uncertainties of outcomes of our clinical trials,strategies to support the continued development of picoplatin, there is no assurance that we can achieve our 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 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 distresseddifficult 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.

        DuringIf an event of default were to occur, we would not have sufficient funds to repay the nine months ended September 30, 2009,loan and to fund our continuing operations beyond December 31, 2010. Provisions of the loan agreement limit our ability to dispose of certain assets, engage in certain mergers, incur certain indebtedness, make certain distributions and engage in certain investment activities without the prior consent of the lenders. We have no assurance that we paid total rent (base rent andcan obtain financing or otherwise raise additional rent basedfunds, if at all, on terms acceptable to us or to our sharelenders.

        Operating Agreements.    On February 12, 2010, we entered into a sublease agreement with Veracyte, Inc., pursuant to which Veracyte is subleasing, effective March 1, 2010, approximately 11,000 square feet of facility common operating expenses)our 17,045 square feet of $1.1 million under the operating leases for our former executive office space located at 7000 Shoreline Court, South San Francisco, headquartersCalifornia. Base sublease rental income for this space was $17,600 per month. In September 2010, the subleased space expanded to encompass the entire 17,045 square feet of our former executive office space. Base sublease rental income on this space is $28,124 per month until expiration of the sublease on July 10, 2011, at which time Veracyte will lease the entire space directly from the landlord. Additional rent under the sublease will be payable monthly to us by Veracyte, based on Veracyte's share of operating expenses attributable to the subleased space. We expect to save approximately $700,000 in aggregate rental and our Seattle facility. Of this amount, $0.9 million represents total aggregate minimum lease payments under these leases.operating expenses over the term of the sublease.

        We have entered into clinical supply agreements with W. C. Heraeus GmbH, or Heraeus, and Baxter Oncology GmbH, or Baxter, pursuant to which they produce picoplatin active pharmaceutical ingredient ("API")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 forhad an initial term ending December 31, 2009, and isin December 2009, we exercised our first renewal option, extending the term to December 31, 2010, after which it will terminate. This agreement remains subject to renewal, at our option, for twoan additional one-year terms, at our option.term. The total aggregate cost ofduring the three and nine months ended September 30, 2010 attributable to follow-on activities for clinical supplies of picoplatin API and finished drug product for the three and nine months ended September 30, 2009produced in prior periods was $0.3approximately $0.1 million and $1.3$0.3 million, respectively. We believe that we presentlydo not have adequate supplies of picoplatin API and finished drug product to complete our current clinical trials.any purchase commitments under these agreements.

        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 API commercial supply agreement continues for an initial term ending December 31, 2013, and the finished drug product commercial supply agreement continues for an initial term ending November 22, 2013, in


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each case subject to extension. The costs to Heraeus for the purchase and set-up of dedicated manufacturing equipment estimated to becosting approximately $1.8$1.5 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 atas of December 31, 2009. We determined that the equipment should be accounted for as a costcapital lease and, accordingly, recognized an asset and long term obligation for the equipment of approximately $1.7$1.5 million, (including interest). Becauserespectively. We will reflect the surcharge payments as reductions in the capital lease balance outstanding and will accrete a finance charge to interest expense as specified under the agreement. The balance of the obligation at September 30, 2010 was approximately $1.5 million, including accreted interest of approximately $66,000. Due to the delay in our plans for the commercialization of picoplatin, which we aredo not anticipate will occur before 2014, if at all, we determined that our capital lease asset for equipment under a present obligation to paythe Heraeus agreement was impaired as of December 31, 2009 and therefore recognized an impairment charge of $1.5 million. We do not have any purchase commitments under these agreements.

        During the nine months ended September 30, 2010, we paid total rent (base rent and additional rent based on our share of facility common operating expenses) of $1.2 million under the operating leases for our former South San Francisco, current San Francisco and Seattle facilities. Of this amount, and the agreement is not$0.9 million represents total aggregate minimum lease payments under any potential circumstance of default or termination, it is not probable that a financial liability exists for this amountthese leases. As discussed above, we have sublet, as of September 30, 20091, 2010, all of our former executive office space in South San Francisco. On September 15, 2010, we relocated our executive offices to 1,554 square feet of leased space at 750 Battery Street, Suite 330, San Francisco. Monthly costs and therefore no such liability was recorded on the condensed consolidated balance sheet as of that date. We anticipate that the dedicated equipmentshared expenses payable by us under this lease will be ready for use during$5,214. Our Seattle office lease expires December 2010. We are currently finalizing plans to lease space at another location in the fourth quarter of 2009, after which we expect to account for the equipmentSeattle area.

        Potential Milestone and related surcharge payments as a capital lease.

Royalty Obligations.    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.picoplatin related products.

        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.

        Additional Capital Requirements.    We will require substantial additional fundingcapital to develop and commercializepursue our strategies to support the continued development of picoplatin and to fund our future operations. Management is continuously exploring financing alternatives, including:

        IfThe amount of additional financing 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 sellwill require in 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.

        Our actual capital requirementsfuture will depend upon numerouson a number of factors, including:


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        We may not be able to obtain required additional capital or enter into relationships with potential corporate partners on a timely basis, on terms that ultimately prove favorable terms,to us, 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 inIf we are unable to secure additional capital to fund our working capital and capital expenditure requirements, we may be forced to explore liquidation alternatives, including seeking protection from creditors through the United States, assuming that we will continue as a going concern and do not include any adjustments that might result from the outcomeapplication of this uncertainty. The report of 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.bankruptcy laws.

Item 3.    Quantitative and Qualitative Disclosures About Market Risk

        Our market rate risks at September 30, 20092010 have not changed materially from those discussed in Item 7A of our Form 10-K for the year ended December 31, 2008.2009 filed with the SEC on March 16, 2010.

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 the Interim Chief Financial Officer, the Company has evaluated the effectiveness and design of its disclosure controls and procedures (as such term is defined inpursuant to Exchange Act Rules 13a-15(e) and 15d-15(e))Rule 13a-15(b) as of 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.2010. Based on thisthat evaluation, the Chief Executive Officer and the Interim Chief Financial Officer have concluded that as of September 30, 2009, these disclosure controls and procedures were effective.effective as of September 30, 2010.

        There were no changes in the Company's internal control over financial reporting that occurred during the fiscal quarter ended September 30, 2010 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 Interim 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


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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, 20082009 filed with the SEC on March 16, 2009,2010, 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, 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. Other than the updated risk factors set forth below, there have not been any material changes to the risk factors set forth in our annual report on 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.

Our common stock may be delisted from The Nasdaq Global Market if we are unable to maintain compliance with Nasdaq Global Market continued listing requirements.

        On July 20, 2010, we received a letter from The Nasdaq Stock Market stating that the minimum bid price of our common stock has been below $1.00 per share for 30 consecutive business days and that we therefore are not in compliance with the minimum bid price requirement for continued listing set forth in Marketplace Rule 5450(a)(1). The notification of noncompliance has no immediate effect on the listing or trading of our common stock on The Nasdaq Global Market.

        We have been provided 180 calendar days, or until January 18, 2011, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this 180-day grace period. Nasdaq may, in its discretion, require our common stock to maintain a closing bid price of at least $1.00 for a period in excess of ten consecutive trading days, but generally no more than 20 consecutive business days, before determining that we have demonstrated an ability to maintain long-term compliance. If we do not regain compliance by January 18, 2011, we will receive written notification from Nasdaq that our common stock is subject to delisting. We may, at that time, appeal the delisting determination to a Nasdaq Hearings Panel. Such an appeal, if granted, would stay delisting until a Panel ruling. Alternatively, if at that time we satisfy all of the initial listing standards, with the exception of the minimum bid price, for The Nasdaq Capital Market, we could apply to transfer the listing of our common stock to The Nasdaq Capital Market and thereby receive an additional 180 calendar days to regain compliance with the minimum bid price requirement.

        There can be no assurance that we will be able to regain or maintain compliance with the minimum bid price rule or other listing criteria. In addition to a minimum bid price of $1.00 per share, The Nasdaq Global Market continued listing standards require us to maintain either (A) stockholders' equity of at least $10 million and market value of shares beneficially owned by persons who are not officers, directors or greater than 10% shareholders ("unaffiliated shares") of at least $5 million or (B) market value of listed securities of at least $50 million and market value of unaffiliated shares of at least $15 million. At September 30, 2010, the market value of our listed securities was approximately $28.0 million, the market value of our unaffiliated shares was approximately $21.5 million and our stockholders' equity was approximately $12.1 million. If we do not maintain sufficient stockholders' equity and/or increase the market value of our common stock, we may not be able to sustain compliance with these requirements in the future. In such case, we would be required, separate from the minimum bid price deficiency, to demonstrate a short or near-term plan to cure such noncompliance.

        If we are unable to cure any events of noncompliance in a timely or effective manner, our common stock could be delisted from The Nasdaq Global Market. If our common stock were threatened with delisting from The Nasdaq Global Market, we may, depending on the circumstances,


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seek to extend the period for regaining compliance with Nasdaq listing requirements by moving our common stock to The Nasdaq Capital Market. Failing that, we may seek quotation on a regional stock exchange, if available. Any such change in listing could reduce the market liquidity for our common stock. If our common stock is not eligible for quotation on another market or exchange, trading of our common stock could be conducted in the over-the-counter market on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. As a result, an investor would find it more difficult to dispose of, or obtain accurate quotations for the price of, our common stock.

        If our common stock were to be delisted from The Nasdaq Stock Market, and our trading price remained below $5.00 per share, trading in our common stock might also become subject to the requirements of certain rules promulgated under the Securities Exchange Act of 1934, as amended, or the Exchange Act, which require additional disclosure by broker-dealers in connection with any trade involving a stock defined as a "penny stock" (generally, any equity security not listed on a national securities exchange or quoted on Nasdaq that has a market price of less than $5.00 per share, subject to certain exceptions). Many brokerage firms are reluctant to recommend low-priced stocks to their clients. Moreover, various regulations and policies restrict the ability of shareholders to borrow against or "margin" low-priced stocks, and declines in the stock price below certain levels may trigger unexpected margin calls. Additionally, because brokers' commissions on low-priced stocks generally represent a higher percentage of the stock price than commissions on higher priced stocks, the current price of the common stock can result in an individual shareholder paying transaction costs that represent a higher percentage of total share value than would be the case if our share price were higher. This factor may also limit the willingness of institutions to purchase our common stock. The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from facilitating trades in our common stock, which could severely limit the market liquidity of the stock and the ability of investors to trade our common stock.

        Further, if our common stock were to be delisted, we may no longer qualify for exemptions from state securities registration requirements. Without an exemption from registration, we may need to file time-consuming and costly registration statements for future securities transactions and issuances and to amend our stock incentive plans. Furthermore, if our common stock is delisted, we would be required to utilize the long-form registration statement on SEC Form S-1 in order to register any future securities under the Securities Act of 1933, as amended, or the Securities Act, either for sale by us or for resale by investors who previously acquired securities from us in a private placement. The SEC Form S-1 requires more information than SEC Form S-3 and would take longer and be more expensive to prepare and keep current than SEC Form S-3.

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:    November 6, 20099, 2010

 

By:

 

/s/ GREGORY L. WEAVERMICHAEL K. JACKSON

Gregory L. WeaverMichael K. Jackson
Interim Chief Financial Officer
(Principal Financial Officer and
Principal Accounting Officer)

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EXHIBIT INDEX

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


10.1


IndemnificationCost Sharing and Confidentiality Agreement dated July 7, 2009,August 20, 2010, between VIA Pharmaceuticals, Inc. and 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)Company(B)

 

31.1

 

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


(C)Officer(A)

 

31.2

 

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


(C)Officer(A)

 

32.1

 

Section 1350 Certification of Chief Executive Officer


(C)Officer(A)

 

32.2

 

Section 1350 Certification of Interim Chief Financial Officer


(C)Officer(A)

(A)
Filed as an exhibitherewith.

(B)
Incorporated by reference herein to Exhibit 10.1 to the Company's Current Report on Form 8-K filed with the Commission 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.September 14, 2010