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



FORM 10-Q




ý

 

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

For the quarterly period ended March 31,September 30, 2010

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.)

7000 Shoreline Court,750 Battery Street, Suite 270, South330, San Francisco, CA 9408094111

(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 and 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 April 30,November 2, 2010, 47,080,76248,326,678 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 MARCH 31,SEPTEMBER 30, 2010

 
  
 PAGE

PART I

 

FINANCIAL INFORMATION

  

Item 1.

 

Financial Statements:

  

 

Condensed Consolidated Balance Sheets as of March 31,September 30, 2010 (Unaudited) and December 31, 2009 (Note 1)

 
3

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended March 31,September 30, 2010 and 2009 (Unaudited)

 
4

 

Condensed Consolidated Statements of Cash Flows for the ThreeNine Months Ended March 31,September 30, 2010 and 2009 (Unaudited)

 
5

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

 
6

Item 2.

 

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

 
2122

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 
2931

Item 4.

 

Controls and Procedures

 
3031

PART II

 

OTHER INFORMATION

  

Item 1A.

 

Risk Factors

 
3133

Item 6.

 

Exhibits

 
3134

Signatures

 
3235

Exhibit Index

 
3336

Table of Contents


PART I. FINANCIAL INFORMATION

Item 1.    Financial Statements

        


PONIARD PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)



 March 31, 2010 December 31, 2009 
 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

 $12,573 $15,938 

Cash and cash equivalents

 $11,018 $15,938 

Cash—restricted

 281 281 

Cash—restricted

 158 281 

Investment securities

 25,775 27,451 

Investment securities

 12,327 27,451 

Prepaid expenses and other current assets

 820 826 

Prepaid expenses and other current assets

 855 826 
           
 

Total current assets

 39,449 44,496  

Total current assets

 24,358 44,496 

Facilities and equipment, net of depreciation of $1,135 and $1,199 at March 31, 2010 and December 31, 2009, respectively

 126 219 

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

 116 135 

Other assets

 32 135 

Licensed products, net

 7,288 7,592 

Licensed products, net

 6,681 7,592 
           
 

Total assets

 $46,979 $52,442  

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

 $1,230 $849 

Accounts payable

 $1,579 $849 

Accrued liabilities

 6,326 7,679 

Accrued liabilities

 2,960 7,679 

Current portion of note payable and capital lease obligations

 7,886 8,599 

Current portion of note payable and capital lease obligations

 7,886 8,599 
           
 

Total current liabilities

 15,442 17,127  

Total current liabilities

 12,425 17,127 

Long-term liabilities:

Long-term liabilities:

 

Long-term liabilities:

 

Note payable, noncurrent portion, net of debt discounts

 8,508 10,186 

Note payable, noncurrent portion, net of debt discounts

 5,034 10,186 

Capital lease obligations

 1,485 1,485 

Capital lease obligations, noncurrent portion

 1,551 1,485 
           
 

Total long-term liabilities

 9,993 11,671  

Total long-term liabilities

 6,585 11,671 

Commitments and contingencies

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, 78,768 and 205,340 shares issued and outstanding as of March 31, 2010 and December 31, 2009, respectively (entitled in liquidation to $2,033 and $5,175, respectively)

 2 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:

 
 

47,073,262 and 42,079,468 shares issued and outstanding as of March 31, 2010 and December 31, 2009, respectively

 941 842  

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

 441,249 430,971 

Additional paid-in capital

 444,878 430,971 

Other comprehensive loss

 (11) (17)

Other comprehensive gain/(loss)

 16 (17)

Accumulated deficit

 (420,637) (408,156)

Accumulated deficit

 (433,728) (408,156)
           
 

Total shareholders' equity

 21,544 23,644  

Total shareholders' equity

 12,134 23,644 
           
 

Total liabilities and shareholders' equity

 $46,979 $52,442  

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
March 31,
 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 


 2010 2009 
 2010 2009 2010 2009 

Operating expenses:

Operating expenses:

 

Operating expenses:

 

Research and development

 $4,891 $8,178 

Research and development

 $891 $5,056 $7,870 $18,545 

General and administrative

 4,799 3,010 

General and administrative

 5,060 4,142 13,747 10,929 

Restructuring

 1,626 468 

Restructuring

   1,626 468 

Asset impairment loss

  588 

Asset impairment loss

    588 
               
 

Total operating expenses

 11,316 12,244  

Total operating expenses

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

Loss from operations

 (11,316) (12,244) 

Loss from operations

 (5,951) (9,198) (23,243) (30,530)

Other (expense) income:

Other (expense) income:

 

Other (expense) income:

 

Interest expense

 (634) (867)

Interest expense

 (516) (750) (1,744) (2,413)

Interest income and other, net

 61 161 

Interest income and other, net

 18 71 103 396 
               
 

Total other (expense) income, net

 (573) (706) 

Total other (expense) income, net

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

Net loss

 (11,889) (12,950) 

Net loss

 (6,449) (9,877) (24,884) (32,547)

Preferred stock dividends

Preferred stock dividends

 (22) (125)

Preferred stock dividends

 
(48

)
 
(125

)
 
(118

)
 
(375

)

Preferred stock dividends, in-kind

Preferred stock dividends, in-kind

 (570)  

Preferred stock dividends, in-kind

   (570)  
               
 

Net loss applicable to common shareholders

 $(12,481)$(13,075) 

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

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

 $(0.29)$(0.38)

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

Weighted average common shares outstanding—basic and diluted

 43,254 34,688 

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)



 Three Months Ended
March 31,
 
 Nine Months Ended
September 30,
 


 2010 2009 
 2010 2009 

Cash flows from operating activities:

Cash flows from operating activities:

 

Cash flows from operating activities:

 

Net loss

Net loss

 $(11,889)$(12,950)

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

 334 408 

Depreciation and amortization

 989 1,126 

Amortization of discount on notes payable

Amortization of discount on notes payable

 312 386 

Amortization of discount on notes payable

 820 1,088 

Accretion of premium on investment securities

Accretion of premium on investment securities

 152 81 

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 

Asset impairment loss

  588 

Restructuring

Restructuring

 1,181 357 

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

 306 8 

Share-based compensation issued for services

 369 387 

Share-based employee compensation

Share-based employee compensation

 3,407 1,293 

Share-based employee compensation

 6,998 4,325 

Change in operating assets and liabilities:

Change in operating assets and liabilities:

 

Change in operating assets and liabilities:

 

Prepaid expenses and other assets

 28 (19)

Prepaid expenses and other assets

 (25) 131 

Accounts payable

 381 884 

Accounts payable

 730 221 

Accrued liabilities

 (2,556) (2,088)

Accrued liabilities

 (5,062) (2,639)
           
 

Net cash used in operating activities

 (8,344) (11,052) 

Net cash used in operating activities

 (19,230) (27,009)
           

Cash flows from investing activities:

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

 7,854 14,650 

Proceeds from sales and maturities of investment securities

 22,089 39,150 

Purchases of investment securities

Purchases of investment securities

 (6,324) (17,217)

Purchases of investment securities

 (7,322) (31,561)

Facilities and equipment purchases

Facilities and equipment purchases

  (13)

Facilities and equipment purchases

 (7) (18)

Proceeds from disposals of equipment and facilities

 41  

Proceeds from disposals of facilities and equipment

Proceeds from disposals of facilities and equipment

 58 97 
           
 

Net cash provided by (used in) investing activities

 1,571 (2,580) 

Net cash provided by investing activities

 14,818 7,668 
           

Cash flows from financing activities:

Cash flows from financing activities:

 

Cash flows from financing activities:

 

Repayment of principal on note payable

Repayment of principal on note payable

 (2,646) (1,971)

Repayment of principal on note payable

 (6,589) (5,914)

Repayment of capital lease obligation

Repayment of capital lease obligation

 (38)  

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  

Net proceeds from issuance of common stock

 6,092  

Payment of preferred dividends

Payment of preferred dividends

 (96) (250)
           
 

Net cash provided by (used in) financing activities

 3,408 (1,971) 

Net cash used in financing activities

 (508) (5,763)
           
 

Net decrease in cash and cash equivalents

 (3,365) (15,603) 

Net decrease in cash and cash equivalents

 (4,920) (25,104)
           

Cash and cash equivalents:

Cash and cash equivalents:

 

Cash and cash equivalents:

 

Beginning of period

Beginning of period

 15,938 44,144 

Beginning of period

 15,938 44,144 
           

End of period

End of period

 $12,573 $28,541 

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

 $22 $125 

Accrual of preferred dividends

Accrual of preferred dividends

 $118 $375 

Preferred stock dividends, in-kind

Preferred stock dividends, in-kind

 570  

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

 $334 $489 

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. Business Overview and Summary of Significant Accounting Policies

Overview

        Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of cancer therapeutics. The accompanying 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.

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 March 31,September 30, 2010, results of operations for the three and nine months ended March 31,September 30, 2010 and 2009, and cash flows for the threenine months ended March 31,September 30, 2010 and 2009.

        The results of operations for the periodperiods ended March 31,September 30, 2010 are not necessarily indicative of the expected operating results for the full year.

        The balance sheet as of December 31, 2009 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 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.

Use of Estimates

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

Reclassifications

        Certain balances and results from the prior 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 are $340,000 and $608,000, respectively. The Company's reclassifications 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. Business Overview and Summary of Significant Accounting Policies (Continued)

Significant Risks and Uncertainties

        The Company has historically suffered recurring operating losses and negative cash flows from operations. As of March 31,September 30, 2010, the Company had net working capital of $24,007,000,$11,933,000, an accumulated deficit of $420,637,000$433,728,000 and total shareholders' equity of $21,544,000.$12,134,000. The Company's total cash, cash equivalentequivalents and investment securities balances, net of restricted cash of $281,000,$158,000, was $38,348,000$23,345,000 at March 31,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 threenine months ended March 31,September 30, 2010 totaled $8,344,000.$19,230,000. The Company is focusing its resources on the continued development of its primary product candidate, picoplatin. TheBased 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 2011.2014, 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 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 Company's loan agreement and itsthe Company's projected operating results, the Company believes that its current cash, cash equivalentequivalents and investment securities balances will provide adequate resources to fund operations at least through the end of 2010. Thereafter, unless the Company raises additional funds, or enters into a partnering or other strategic relationship, it will be in default of the minimum unrestricted cash requirement and potentially other provisions of the 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. 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. If an event of default were to occur, the Company mightwould not have sufficient funds to repay the loan orand to fund its continuing operations.operations beyond December 31, 2010. Provisions of the loan agreement would limit the Company's 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.


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)

Subsequent Events Evaluation

        The Company has reviewed and evaluated material subsequent events through the date that the financial statements were available for issuance and all appropriate subsequent events disclosures, if any, have been made in the notes to the unaudited condensed consolidated financial statements.

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 JanuaryApril 2010, the FASB issued amended standards that require additional fair value disclosures. These amended standards require disclosures about inputsupdated guidance on defining milestones and valuation techniques useddetermining when it may be appropriate to measure fair value as well as disclosures about significant transfers,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 prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning in the first quarter of 2010. Additionally, these amended standards require presentation of disaggregated activity within the reconciliation for fair value measurements using significant unobservable inputs (Level 3), beginning in the first quarter of 2011.on or after June 15, 2010, with early adoption permitted. The Company does not believebelieves that thesethis new standards willguidance would have a material effectan impact on its consolidated financial statements.statements if it were to enter into any milestone-based revenue agreements in the future.


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 2. Fair Value Measurements

        The Company categorizes assets and liabilities recorded at fair value in its 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. The Company uses valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs when determining fair value and then ranks the estimated values based on the reliability of the inputs used following the fair value hierarchy set forth by the FASB. The three levels of the FASB fair value hierarchy are as follows:


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 2. Fair Value Measurements (Continued)

        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 March 31, 2010  Fair Value Measurements as of
September 30, 2010
 

 Total Level 1 Level 2 Level 3  Total Level 1 Level 2 Level 3 

Cash equivalents

 $11,154 $11,154 $ $  $9,503 $9,503 $ $ 

Investment securities

 25,775  25,775   12,327  12,327  
                  

 $36,929 $11,154 $25,775 $  $21,830 $9,503 $12,327 $ 
                  

 


 Fair Value Measurements as of December 31, 2009  Fair Value Measurements as of
December 31, 2009
 

 Total Level 1 Level 2 Level 3  Total Level 1 Level 2 Level 3 

Cash equivalents

 $15,447 $15,447 $ $  $15,447 $15,447 $ $ 

Investment securities

 27,451  27,451   27,451  27,451  
                  

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

        As of March 31,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 March 31,September 30, 2010, the cash equivalents balance consists of $11,154,000$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)


money market 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 March 31,September 30, 2010.


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

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 lossgain/(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, in the condensed consolidated statements of operations.

        Investment securities consisted of the following at March 31,September 30, 2010 (in thousands):

 
  
 Gross Unrealized  
 
 
 Amortized
Cost
 Estimated
Fair Value
 
 
 Gains (Losses) 

Type of security:

             
 

Corporate debt securities, with unrealized gains

 $10,519 $2 $ $10,521 
 

Corporate debt securities, with unrealized losses

  6,424    (7) 6,417 
 

Federal government and agency securities, with unrealized gains

  1,492  1    1,493 
 

Federal government and agency securities, with unrealized losses

  7,351    (7) 7,344 
          

 $25,786 $3 $(14)$25,775 
          
  

Net unrealized loss

       $(11)   
             

Maturity:

             
 

Less than one year

 $23,494       $23,487 
 

Due in 1 - 2 years

  2,292        2,288 
            

 $25,786       $25,775 
            

        Investment securities consisted of the following at 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

 $12,608 $8 $ $12,616 

Corporate debt securities, with unrealized gains

 $4,068 $12 $ $4,080 

Corporate debt securities, with unrealized losses

 5,565  (13) 5,552 

Corporate debt securities, with unrealized losses

 1,002   1,002 

Federal government and agency securities, with unrealized gains

 1,509 1  1,510 

Federal government and agency securities, with unrealized gains

 7,241 4  7,245 

Federal government and agency securities, with unrealized losses

 7,786  (13) 7,773 

Federal government and agency securities, with unrealized losses

     
                   

 $27,468 $9 $(26)$27,451 

 $12,311 $16 $ $12,327 
                   
 

Net unrealized loss

     $(17)    

Net unrealized gain

     $16   
           

Maturity:

Maturity:

 

Maturity:

 

Less than one year

 $23,199     $23,198 

Less than one year

 $12,311     $12,327 

Due in 1 - 2 years

 4,269     4,253 

Due in 1 - 2 years

       
               

 $27,468     $27,451 

 $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 December 31, 2009 (in thousands):

 
  
 Gross Unrealized  
 
 
 Amortized
Cost
 Estimated
Fair Value
 
 
 Gains (Losses) 

Type of security:

             
 

Corporate debt securities, with unrealized gains

 $12,608 $8 $ $12,616 
 

Corporate debt securities, with unrealized losses

  5,565    (13) 5,552 
 

Federal government and agency securities, with unrealized gains

  1,509  1    1,510 
 

Federal government and agency securities, with unrealized losses

  7,786    (13) 7,773 
          

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

Net unrealized loss

       $(17)   
             

Maturity:

             
 

Less than one year

 $23,199       $23,198 
 

Due in 1 - 2 years

  4,269        4,253 
            

 $27,468       $27,451 
            

Note 4. Accrued Liabilities

        Accrued liabilities consist of the following (in thousands):


 March 31,
2010
 December 31,
2009
  September 30,
2010
 December 31,
2009
 

Clinical trials

 $3,922 $6,550  $961 $6,550 

Accrued expenses

 778 803  993 803 

Compensation

 445 326  685 326 

Severance

 1,181   321  
          

 $6,326 $7,679  $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 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 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 paid $675,000 to GE Business Financial Services on March 31, 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 March 31,September 30, 2010, the outstanding principal balance under the loan facility was $16,394,000,$12,920,000, net of discount of $1,347,000.$879,000.

        In connection with the loan agreement, the Company issued 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 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


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 5. Note Payable (Continued)


warrants, which the Company recorded as discount to notes payable. The total of the final loan payments and the proceeds allocated to the warrants of approximately $4,051,000 is being amortized to interest expense using an effective interest rate of 13.8%. 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 Company amended the warrants held by GE Business Financial Services in connection with the 2006 and 2008 loan agreements to purchase an aggregate of 197,169 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 $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 March 31,September 30, 2010.

Note 6. Common Stock Purchase AgreementsAgreement

        On February 23, 2010, the Company entered into an equity line of credit facility with Commerce Court Small Cap Value Fund, Ltd. ("Commerce Court"). The facility provides that, upon the terms and subject to the price and share amount parameters and other conditions therein,thereof, Commerce Court is committed to purchase up to $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 Company issue to Commerce Court more than 8,423,431 shares of common stock, which is equal to one share less than 20% of the Company's outstanding common shares on the closing date of the facility, less 121,183 shares issued to Commerce Court as a commitment fee. The purchase price of the shares will be equal to the daily volume weighted average price over eight consecutive trading days or such other draw down period mutually agreed upon by the parties, less a discount ranging from 3.125% to 5.0%, based on the trading price of the Company's common 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 outstanding common stock. Unless otherwise mutually agreed between the parties, Commerce Court is not obligated to purchase shares at prices belowa price that is less than $1.00 per share.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 purchase additional shares under the facility. On March 15, 2010, the Company completed a draw down and sale of 4,229,000 shares of its 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 $6,092,000 were received, after deducting offering costs of approximately $228,000.


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 7. Restructuring and Asset Impairment

April 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 $542,000$543,000 for the period ended March 31, 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 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 one-for-one basis in the second quarter of 2010. The Company recognized approximately $962,000$1,486,000 in share-based compensation expense during the first 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 for the period ended March 31, 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 threenine months ended March 31,September 30, 2010 and in accrued liabilities in the condensed consolidated balance sheet as of March 31,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
March 31, 2010
  Initial
Restructuring
Charge
March 2010
 Payment of
Restructuring
Obligations
 Accrued
Restructuring
Charge as of
September 30,
2010
 

Employee termination benefits

 $542 $ $542  $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 for terminated employees forin the period ended March 31,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 threenine months ended March 31,September 30, 2010 and in accrued


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 7. Restructuring and Asset Impairment (Continued)


liabilities in the condensed consolidated balance sheet as of March 31,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
March 31, 2010
  Initial
Restructuring
Charge
February 2010
 Payment of
Restructuring
Obligations
 Accrued
Restructuring
Charge as of
September 30,
2010
 

Employee termination benefits

 $1,061 $(422)$639  $1,061 $(851)$210 

Other termination costs

 22 (22)   22 (22)  
              

Total

 $1,083 $(444)$639  $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. All outstanding liabilities for contract and termination costs were paid in 2009.

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

Description
Description
 Initial
Restructuring
Charge
March 2009
 Payment of
Restructuring
Obligations
 Accrued
Restructuring
Charge as of
March 31, 2009
 Payment of
Restructuring
Obligations
 Accrued
Restructuring
Charge as of
March 31, 2010
 
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 $(111)$185 $(185)$ 

Employee termination benefits

 $296 $(296)$ 
                   

Contract termination costs

Contract termination costs

 125  125 (125)  

Contract termination costs

 125 (125)  

Other termination costs

Other termination costs

 47 (18) 29 (29)  

Other termination costs

 47 (47)  
                   

Subtotal

 172 (18) 154 (154)  

Subtotal

 172 (172)  
                   

Total

Total

 $468 $(129)$339 $(339)$ 

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


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 7. Restructuring and Asset Impairment (Continued)


accompanying 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):


 Lab Equipment &
Leasehold
Improvements
  Lab Equipment &
Leasehold
Improvements
 

Impairment loss

 $588  $588 
      

Impaired carrying value upon restructuring March 31, 2009

 $57  $57 

Disposals of assets

 (52) (52)
      

Post impairment carrying value as of December 31, 2009

 5  5 

Disposals of assets

 (5) (5)
      

Post impairment carrying value as of March 31, 2010

 $ 

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,


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 8. Picoplatin License and Amendment (Continued)


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 12 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 12 year useful life beginning in April 2004. The Company concluded that no change in the 12 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 12 year useful life and is amortizing the license amendment payment of $10,000,000 over the remainder of the 12 year useful life of the picoplatin intangible asset.

        The 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 second-line treatment of patients with small cell lung cancer did not meet its primary endpoint of 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 $4,712,000$5,319,000 and $4,408,000 at March 31,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
March 31,
  Three Months Ended
September 30,
 Nine Months Ended
September 30,
 

 2010 2009  2010 2009 2010 2009 

Common stock options

 5,953,649 5,841,041  5,683,497 5,722,570 5,683,497 5,722,570 

Restricted stock units

 2,639,442 93,604  2,765,654 514,668 2,765,654 514,668 

Common stock warrants

 5,085,196 5,496,651  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 March 31,September 30, 2010 and 2009, respectively, because the effect of including such shares would not be dilutive.


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 10. Share-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 March 31, 2010

  3,752 $6.75  6.08 $ 
 
 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 $ 

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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 10. Share-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
March 31,
 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 


 2010 2009 
 2010 2009 2010 2009 

Research and development expense

Research and development expense

 $1,369 $320 

Research and development expense

 $136 $493 $2,139 $1,097 

General and administrative expense

General and administrative expense

 2,038 973 

General and administrative expense

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

Total

 $3,407 $1,293 

Total

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

        The share-based compensation expense for the threenine months ended March 31,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 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 threenine months ended March 31,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 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 2009, the equity awards subcommittee accelerated vesting with respect to 25% of the shares subject to the seven year vesting schedule in the first quarter of 2010. As of March 31,September 30, 2010, the cumulative accelerated vesting equals 85% of the sharesfor options subject to the seven year vesting schedule.

        On April 9, 2010, the Company awarded 587,200 RSUs to officers and employees. The fair valueschedule equals 85% of the RSUs was $1.14 per unit, or approximately $669,000shares granted in total, based upon the closing market price2006 and 65% of the Company's common stock on the award date. The RSUs vest 50% on each of the first two anniversaries of April 9, 2010, subject to forfeiture or acceleration of vesting upon the occurrence of certain events.

        On February 4, 2010, the Company awarded approximately 2,354,000 RSUs under the 2004 Plan to certain employees and officers as an incentive for future performance. The fair value of the RSUs was $1.54 per unit, or approximately $3,626,000shares granted in total, based upon the closing market price of the Company's common stock on the award date. The RSUs become fully vested on December 31, 2010,


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 10. Share-based Compensation (Continued)

subject to earlier acceleration upon termination of employment by the Company without cause. Due to the Company's restructuring in the first quarter of 2010 (see Note 7 for further discussion), approximately 965,000 of these RSUs became fully vested on April 30, 2010. The Company determined the expense for these awards on a straight-line basis from grant date through the accelerated vesting date. Share-based compensation expense for the period ended March 31, 2010 includes approximately $1,318,000 related to these awards.

        On October 6, 2009, the Company awarded 100,000 RSUs under the 2004 Plan to a Company officer as incentive compensation. The RSUs vest 25% on each of the first four anniversaries of the grant subject to continuous employment and further subject to accelerated vesting under specific conditions defined in the award agreement. The fair value of the award was $727,000 based upon the closing market price of the Company's common stock on the award date. As of March 31, 2010, the Company determined that it is probable that a portion of the award would be accelerated per the terms of the agreement and is recognizing share-based compensation expense for the award on a pro-rata basis through the estimated dates for vesting. Share-based compensation expense for the period ended March 31, 2010 includes approximately $65,000 for this award.

        On July 23, 2009, the Company awarded an additional 290,400 RSUs under the 2004 Plan to non-officer employees as an incentive for future performance. The fair value of the RSUs was $7.34 per unit, or approximately $2,132,000 in total, based upon the closing market price of the Company's common stock on the award date. The RSUs vest based on the achievement of certain performance milestones during 2010, subject to acceleration upon termination of employment by the Company without cause. Due to the Company's restructuring in the first quarter of 2010 (see Note 7 for further discussion), approximately 157,000 of these RSUs became fully vested on February 5, 2010. The Company determined share-based compensation expense for these awards on a straight-line basis from grant date through the accelerated vesting date. Share-based compensation expense for the period ended March 31, 2010 includes approximately $354,000 related to these awards.

        On July 11, 2009, a Company director was awarded 170,000 RSUs under the 2004 Plan as compensation for consulting services. The RSUs vest 50% on each of the first two anniversaries of the grant and are subject to 100% acceleration upon the achievement of a performance milestone defined in the agreement. The fair value of the award was approximately $196,000 at March 31, 2010, and will be re-measured at each reporting date as it is accounted for as a non-employee award. As of March 31, 2010, 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 from the grant date through the estimated date of achievement.

        In 2008, the Company awarded approximately 92,000 RSUs under the 2004 Plan to non-officer employees as an incentive for future performance. An additional 4,000 RSUs were awarded in 2009 for this incentive program. Upon vesting, each RSU is payable with one share of the Company's common stock. The average fair value of the RSUs was $3.13 per unit, or approximately $299,000 in total, based upon the closing market price of the Company's common stock on the award dates. The RSUs vest based on the achievement of certain performance milestones during 2009 and 2010. During 2009, all three milestones were achieved and the shares vested and were released. Share-based compensation for these awards was fully recognized during 2009.2007.


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 10. Share-based Compensation (Continued)

        Estimated fair valuesThe Company's share-based compensation expense also includes RSUs awarded to employees 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
March 31,
 
 
 2010 2009 

Expected term (in years)

  5.0  4.9 

Risk-free interest rate

  2.22% 1.86%

Expected stock price volatility

  95% 95%

Expected dividend rate

  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    
             

(A)
On February 4, 2010, the Company awarded approximately 2,354,000 RSUs to certain employees and officers 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 188,000 RSUs vested in the third quarter of 2010 upon the termination 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 as of September 30, 2010, or $0.58 per unit.

(C)
On July 23, 2009, the Company awarded approximately 290,000 RSUs to non-officer employees as an incentive for future performance. The vesting schedule for these awards was 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 March 31,September 30, 2010, total unrecognized costs related to employee share-based compensation is approximately $8,271,000.$5,131,000. Unrecognized share-based compensation expense from outstanding stock options is approximately $5,382,000$2,802,000 and is


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 10. Share-based Compensation (Continued)


expected to be recognized over a weighted average period of approximately 1.9 years. Unrecognized share-based compensation expense from outstanding RSUs is approximately $2,329,000 and is expected to be recognized over a weighted average period of approximately 2.1 years. Unrecognized share-based compensation expense from outstanding RSUs is approximately $2,889,000 and is expected to be recognized over a weighted average period of approximately 0.81.2 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 March 31,September 30, 2010 and 2009 is summarized as follows (in thousands):


 Three Months Ended
March 31,
  Three Months Ended
September 30,
 Nine Months Ended
September 30,
 

 2010 2009  2010 2009 2010 2009 

Net loss

 $11,889 $12,950  $6,449 $9,877 $24,884 $32,547 

Net unrealized gain on investment securities

 (6) (1) (13) (39) (33) (377)
              

Comprehensive loss

 $11,883 $12,949  $6,436 $9,838 $24,851 $32,170 
              

Note 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, 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 December 31, 2009, Heraeus


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PONIARD PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

Note 12. Commitments and Contingencies (Continued)


had completed construction of the dedicated equipment at a total cost of approximately $1,485,000. The Company determined that the equipment should be accounted for as a capital lease and accordingly recognized an asset and long termlong-term obligation for the equipment of $1,485,000 on its consolidated balance sheet as of December 31, 2009. The Company will 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, within the next 12 months and has, therefore, classified the obligation as long-term. Due to the delay in the Company's plans for the 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 quarter ended December 31, 2009.


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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 an institutional shareholder in exchange for the shareholder'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 the 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 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. Forward-looking statements are those that predict or describe future events or trends and that do not relate solely to historical matters. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "could," "should," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "project," "potential," "propose," "continue," "assume" or other similar 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. Our forward-looking statements are based on the information currently available to us and speak only as of the date of this report 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."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.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 exploreevaluate partnering and other arrangements to enable the execution offund these strategies. We haveIn 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.


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        WithSeptember 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 the review of strategic alternatives, wepicoplatin 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, 2009 filed with the SEC on March 16, 2010. For a more complete description, please refer to our Annual Report on Form 10-K.

Results of Operations

Three and Nine Months Ended March 31,September 30, 2010 Compared to the Three and Nine Months Ended September 30, 2009

        Research and development expenses decreased 40%82% to approximately $4.9$0.9 million during the third quarter of 2010 and decreased 58% to approximately $7.9 million in the first quarternine months of 2010 compared to approximately $8.2 millionfrom the comparable periods in 2009. The significant decrease in our research and development expenses during the first quarterthree and nine months ended September 30, 2010, is primarily a result of 2009.our picoplatin trials winding down. Our research and development expenses are summarized as follows:



 Three Months Ended March 31, 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 


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


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

Research

Research

 $ $749 -100%

Research

 $ $  $ $764 (100)%

Contract manufacturing

Contract manufacturing

 518 962 -46%

Contract manufacturing

 167 717 (77)% 1,024 2,524 (59)%

Clinical

Clinical

 2,714 6,139 -56%

Clinical

 586 3,815 (85)% 4,309 14,064 (69)%

Share-based compensation

Share-based compensation

 1,659 328 406%

Share-based compensation

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

Total

 $4,891 $8,178 -40%

Total

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

        Research and development expenses decreased significantly during the first quarter of 2010 from the comparable period in 2009 as a result of our picoplatin trials winding down.        We did not incur any research expenses during the firstthird quarter of 2010 or 2009 due to the discontinuation of our research operations effective March 31, 2009. Contract manufacturing costs decreased 46%77% to $0.5approximately $0.2 million in the third quarter of 2010 and decreased 59% to approximately $1.0 million in the first quarternine months of 2010 from the comparable periodperiods in 2009, reflecting no2009. These decreases reflect the absence of drug production in the current year due to the completion of our trials and reduced drug product stability testing and analysis activity. Clinical costs decreased 56%85% to $2.7approximately $0.6 million in the third quarter of 2010 and decreased 69% to approximately


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$4.3 million in the first quarternine months of 2010 from the comparable periodperiods in 2009. This decrease resulted primarily from reduced clinical activity in connection with our current picoplatin studies, all of which are either completed or in a follow-up or extended follow-up stage. Share-based compensation expense increased 406%decreased 74% to $1.7approximately $0.1 million in the firstthird quarter of 2010 from the comparable period in 2009, due primarily to expense recognized for restricted stock units, or RSUs, awarded in 2009 for which there was no expense recognized in the third quarter of 2010 and to lower expense recognized for options resulting from the reduction in our headcount during 2010. Share-based compensation expense increased 113% to approximately $2.5 million for the nine months ended September 30, 2010 from the comparable period in 2009, primarily due to the recognition of expense for accelerated vesting of 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 amongto our various projects. Ourpicoplatin 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


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March 31, 2009, which resulted in the discontinuation of our preclinical research operations. Our total research and development costs are summarized below:



 Three Months Ended March 31, 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 


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


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

Picoplatin

Picoplatin

 $2,379 $6,072 -61%

Picoplatin

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

Other unallocated costs and overhead

Other unallocated costs and overhead

 853 1,778 -52%

Other unallocated costs and overhead

 166 1,045 (84)% 1,495 3,846 (61)%

Share-based compensation

Share-based compensation

 1,659 328 406%

Share-based compensation

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

Total

 $4,891 $8,178 -40%

Total

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

        Our external costs for picoplatin infor the quartersthree and nine month periods ended March 31,September 30, 2010 and for the comparable periods in 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 continue to decrease in 2010, reflecting lower costs for our fully enrolledcompleted small cell lung, colorectal 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 picoplatin in multiple indications and two formulations.picoplatin.

        As of March 31,September 30, 2010, we have incurred external costs of approximately $75.7$77.2 million in connection with our entire picoplatin clinical program. TotalWe expect total estimated future costs of our picoplatin Phase 3 trial in small cell lung cancer is approximately $1.5 million through the end of 2010. Total estimated future costs of both2010 for our picoplatin Phase 2 trial incompleted small cell lung, colorectal and prostate cancer trials and our Phase 2 trial in castration-resistant prostate cancer are in the range of $0.6 millioncompleted oral picoplatin study to $0.8 million through the end of 2010. These future costs reflect activities to complete our trials through data analysis and data lock and 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 the commercialization of picoplatin will not commence unless and until we complete required clinical studies and obtain U.S. Food and Drug Administration, or FDA marketing approvals, and then only if picoplatin finds acceptance in the marketplace. To date, we have not received any revenues from 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, 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:


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        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.



 Three Months Ended March 31, 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 


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


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

General and administrative

General and administrative

 $2,745 $2,037 35%

General and administrative

 $3,633 $2,738 33%$8,917 $7,410 20%

Share-based compensation

Share-based compensation

 2,054 973 111%

Share-based compensation

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

Total

 $4,799 $3,010 59%

Total

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

        GeneralTotal general and administrative expenses costs increased 59%22% to approximately $4.8$5.1 million in the third quarter of 2010 and increased 26% to approximately $13.7 million in the first threenine months of 2010 compared to approximately $3.0 million forfrom the same periodcomparable periods in 2009. Excluding share-based compensation expense, general and administrative expenses increased 35%33% to approximately $2.7$3.6 million in the third quarter 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 and increased 20% to approximately $8.9 million in the first quarternine months of 2010 compared to approximately $2.0 million forfrom the samecomparable period in 2009. This increase was2009, primarily due primarily 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 generalfacilities and consulting costs of approximately $0.7 million, offset by decreased personnel costs in 2010. While we expect the increase in accounting and legal expensescosts 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 expense increased 2% to approximately $1.4 million in the third quarter of 2010 and 2009 reflects non-cash charges recognizedfrom the comparable period in accordance with the accounting rules for share-based compensation, under which the fair value of all employee and non-employee share-based payments is charged to expense over the vesting period of the share-based award.2009. Share-based compensation expense increased 111%37% to approximately $2.1 million in the first three months of 2010 compared to approximately $1.0$4.8 million for the samenine months ended September 30, 2010 from the comparable period in 2009, primarily due primarily to the recognition of expense for 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 future performance.