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SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 10-Q


(Mark one)

     
x
  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2005
 
   
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 NUMBER: 000-1029142

DYNAVAX TECHNOLOGIES CORPORATION

(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
     
DELAWARE
(State or Other Jurisdiction of
Incorporation or Organization
  33-0728374
(IRS Employer Identification No.)

2929 Seventh St., Suite 100
Berkeley, CA 94710-2753

(Address Of The Registrant’s Principal Executive Offices)

Registrant’s Telephone Number, Including Area Code: (510) 848-5100

      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 x No o

      Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act). Yes o No x

      The number of shares of the Registrant’s Common Stock outstanding as of April 30, 2005 was 24,747,207.

 
 

 


INDEX

DYNAVAX TECHNOLOGIES CORPORATION

             
        Page No.
PART I          
Item 1.       4  
        4  
        5  
        6  
        7  
Item 2.       13  
Item 3.       28  
Item 4.       28  
PART II       29  
Item 1.       29  
Item 2.       29  
Item 3.       29  
Item 4.       29  
Item 5.       29  
Item 6.       29  
SIGNATURES  
    30  
CERTIFICATIONS  
 
       
 EXHIBIT 31.1
 EXHIBIT 31.2
 EXHIBIT 32.1
 EXHIBIT 32.2

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FORWARD-LOOKING STATEMENTS

      This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements, including statements about our business strategy, our future research and development, our preclinical and clinical product development efforts, the timing of the introduction of our products, the effect of GAAP accounting pronouncements, uncertainty regarding our future operating results and our profitability, anticipated sources of funds and all plans, objectives, expectations and intentions. These statements appear in a number of places and can be identified by the use of forward-looking terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “future,” “intend,” or “certain” or the negative of these terms or other variations or comparable terminology, or by discussions of strategy.

      Actual results may vary materially from those in such forward-looking statements as a result of various factors that are identified in “Item 2 — Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this document. No assurance can be given that the risk factors described in this Quarterly Report on Form 10-Q are all of the factors that could cause actual results to vary materially from the forward-looking statements. All forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. Readers should not place undue reliance on these forward-looking statements and are cautioned that any such forward-looking statements are not guarantees of future performance. We assume no obligation to update any forward-looking statements.

      This Quarterly Report on Form 10-Q includes trademarks and registered trademarks of Dynavax Technologies Corporation. Products or service names of other companies mentioned in this Quarterly Report on Form 10-Q may be trademarks or registered trademarks of their respective owners.

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PART I. FINANCIAL STATEMENTS

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Dynavax Technologies Corporation
Condensed Consolidated Balance Sheets
(In thousands, except per share amounts)

                 
    March 31,     December 31,  
    2005     2004  
    (unaudited)     (Note 1)  
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 11,401     $ 16,590  
Marketable securities
    46,023       49,254  
Restricted cash
    408       408  
Accounts receivable
    8,957       3,131  
Prepaid expenses and other current assets
    2,117       1,396  
 
           
Total current assets
    68,906       70,779  
 
Property and equipment, net
    2,344       2,465  
Other assets
          402  
 
           
Total assets
  $ 71,250     $ 73,646  
 
           
 
Liabilities, minority interest, convertible preferred stock, and stockholders’ equity
               
Current liabilities:
               
Accounts payable
  $ 729     $ 1,391  
Accrued liabilities
    4,240       4,371  
Deferred revenues
          1,000  
 
           
Total current liabilities
    4,969       6,762  
 
Deferred revenues, noncurrent
    750       6,750  
Other long-term liabilities
    240       258  
 
Commitments and contingencies (Note 3)
               
 
Stockholders’ equity:
               
Preferred stock: $0.001 par value; 5,000 shares authorized and no shares issued and outstanding at March 31, 2005 and December 31, 2004
           
Common stock: $0.001 par value; 100,000 shares authorized at March 31, 2005 and December 31, 2004; 24,745 and 24,627 shares issued and outstanding at March 31, 2005 and December 31, 2004, respectively
    25       25  
Additional paid-in capital
    159,120       159,074  
Deferred stock compensation
    (3,029 )     (3,366 )
Notes receivable from stockholders
    (394 )     (419 )
Accumulated other comprehensive loss:
               
Unrealized loss on marketable securities available-for-sale
    (161 )     (102 )
Cumulative translation adjustment
    (4 )      
Accumulated deficit
    (90,266 )     (95,336 )
 
           
Total stockholders’ equity
    65,291       59,876  
 
           
Total liabilities and stockholders’ equity
  $ 71,250     $ 73,646  
 
           

See accompanying notes.

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Dynavax Technologies Corporation
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)

                 
    Three Months Ended  
    March 31,  
    2005     2004  
Revenues:
               
Collaboration revenue
  $ 12,199     $ 2,744  
Grant revenue
    499       461  
 
           
Total revenues
    12,698       3,205  
 
Operating expenses:
               
Research and development
    5,655       5,271  
General and administrative
    2,340       1,919  
 
           
Total operating expenses
    7,995       7,190  
 
           
 
Income (loss) from operations
    4,703       (3,985 )
Interest income, net
    367       119  
 
           
 
Net income (loss)
  $ 5,070     $ (3,866 )
 
           
 
Basic net income (loss) per share
  $ 0.21     $ (0.36 )
 
           
Shares used to compute basic net income (loss) per share
    24,722       10,847  
 
           
Diluted net income (loss) per share
  $ 0.20     $ (0.36 )
 
           
Shares used to compute diluted net income (loss) per share
    24,837       10,847  
 
           

See accompanying notes.

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Dynavax Technologies Corporation
Condensed Consolidated Statements Cash Flows
(In thousands)
(Unaudited)

                 
    Three Months Ended  
    March 31,  
    2005     2004  
Operating activities
               
Net income (loss)
  $ 5,070     $ (3,866 )
Adjustments to reconcile net income (loss) to net cash used in operating activities:
               
Depreciation and amortization
    184       119  
Loss on disposal of property and equipment
          17  
Accretion and amortization on marketable securities
    318       54  
Interest accrued on notes receivable from stockholders
    (7 )     (10 )
Amortization of stock-based compensation expense
    317       626  
Changes in operating assets and liabilities:
               
Accounts receivable
    (5,826 )     (2,560 )
Prepaid expenses and other current assets
    (721 )     231  
Other assets
    402       (417 )
Accounts payable
    (662 )     626  
Accrued liabilities
    (131 )     590  
Deferred revenues
    (7,000 )     7,750  
 
           
Net cash (used in) provided by operating activities
    (8,056 )     3,160  
 
           
Investing activities
               
Purchases of marketable securities
    (15,691 )      
Maturities and sales of marketable securities
    18,545       2,019  
Purchases of property and equipment
    (81 )     (42 )
 
           
Net cash provided by investing activities
    2,773       1,977  
 
           
Financing activities
               
Proceeds from issuance of common stock, net of issuance costs
          46,432  
Proceeds from employee stock purchase plan
    66        
Repayment of notes receivable from stockholders
    32       52  
Restricted cash
          (77 )
 
           
Net cash provided by financing activities
    98       46,407  
 
           
 
Effect of exchange rate on cash and cash equivalents
    (4 )      
 
           
 
Net (decrease) increase in cash and cash equivalents
    (5,189 )     51,544  
Cash and cash equivalents at beginning of period
    16,590       23,468  
 
           
Cash and cash equivalents at end of period
  $ 11,401     $ 75,012  
 
           
 
Supplemental disclosure of non-cash investing and financing activities
               
Net unrealized loss on marketable securities
  $ (59 )   $  
 
           
Change in cumulative translation adjustment
  $ (4 )   $  
 
           
Exercise of stock options
  $ 200     $  
 
           
Repurchase of common stock for exercise of stock options
  $ (200 )   $  
 
           
Conversion of preferred stock upon initial public offering
  $     $ 83,635  
 
           
Conversion of ordinary shares in Dynavax Asia upon initial public offering
  $     $ 14,733  
 
           

See accompanying notes.

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Dynavax Technologies Corporation
Notes to Condensed Consolidated Financial Statements
(Unaudited)

1. Organization

      Dynavax Technologies Corporation (“Dynavax”, the “Company”, “we” or “us”) is a biopharmaceutical company that discovers, develops, and intends to commercialize innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases. The Company was originally incorporated in California on August 29, 1996 and reincorporated in Delaware on March 26, 2001.

      In February 2004, the Company sold a total of 6,900,000 shares of its common stock, after adjusting for a one-for-three reverse stock split, in an underwritten initial public offering, raising net proceeds of approximately $46.5 million. The effect of the reverse stock split is reflected in the Condensed Consolidated Financial Statements for all periods presented.

Subsidiaries

      In October 2003, the Company formed Dynavax Asia Pte. Ltd. (Dynavax Asia), a 100% owned subsidiary in Singapore which focuses on the Company’s clinical and preclinical hepatitis B programs. In October 2003, the Company completed a sale of 15,200,000 ordinary shares in Dynavax Asia, which reduced the Company’s ownership in Dynavax Asia from 100% to 50%. The sale raised net proceeds of $14.7 million, which were recorded as a minority interest liability in the Consolidated Financial Statements as of December 31, 2003. In addition, the Company recorded a deemed dividend of $0.6 million for the year ended December 31, 2003 on the difference between the estimated fair value of the common stock at the issuance date and the conversion price of the ordinary shares. In connection with the February 2004 initial public offering, the ordinary shares in Dynavax Asia were converted to 2,111,111 shares of common stock and Dynavax Asia became a wholly owned subsidiary.

      In December 2004, the Company formed Ryden Therapeutics KK (Ryden), a 100% owned Japan subsidiary, to explore development and commercialization options for ISS-based immunotherapies for cedar tree allergy in Japan.

2. Summary of Significant Accounting Policies

Basis of Presentation

      Our accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with generally accepted accounting principles for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. In our opinion, these unaudited Condensed Consolidated Financial Statements include all adjustments, consisting only of normal recurring adjustments, which we consider necessary to fairly state our financial position and the results of our operations and cash flows. Interim-period results are not necessarily indicative of results of operations or cash flows for a full-year period. The balance sheet at December 31, 2004 has been derived from audited financial statements at that date, but does not include all disclosures required by U.S. generally accepted accounting principles for complete financial statements.

      These unaudited Condensed Consolidated Financial Statements and the notes accompanying them should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2004 as filed with the Securities and Exchange Commission (SEC) on March 18, 2005.

      The Condensed Consolidated Financial Statements include the accounts of Dynavax, Dynavax Asia and Ryden. All significant intercompany accounts and transactions have been eliminated. The Company operates in one business segment, which is the development of biopharmaceutical products.

      Certain reclassifications of prior year amounts related to legal costs have been made to conform with the current year presentation. These reclassifications, specifically from research and development to general and administrative expenses, did not have an impact on our financial position or results of operations.

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Use of Estimates

      The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the Condensed Consolidated Financial Statements and accompanying notes. Actual results may differ from these estimates.

Critical Accounting Policies

      The Company believes that there have been no significant changes in its critical accounting policies during the three months ended March 31, 2005 as compared with those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2004, except as described below.

      Revenue Recognition

      Certain of our contractual arrangements may involve multiple deliverables or elements. Under Emerging Issues Task Force (EITF) Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables,” multiple elements should be divided into separate units of accounting if certain criteria are met, including whether the delivered elements have stand alone value to the customer and whether there is objective reliable evidence of the fair value of the undelivered elements. Consideration should be allocated among the separate units of accounting based on their fair values, and each of the separate units of accounting should be evaluated for appropriate revenue recognition. We recognize revenue when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectibility is reasonably assured.

Recent Accounting Pronouncements

      On March 29, 2005, the SEC published Staff Accounting Bulletin (SAB) No. 107 regarding the interaction between Financial Accounting Standard (FAS) No. 123R (revised 2004), “Share-Based Payment” and certain SEC rules and regulations. The Financial Accounting Standards Board (FASB) issued FAS No. 123R on December 16, 2004, that requires all share-based payments to employees, including grants of employee stock options, to be recognized based on their fair values. Pro forma disclosure is no longer an alternative. FAS No. 123R supersedes Accounting Principles Board (APB) No. 25, “Accounting for Stock Issued to Employees,” and amends FAS No. 95, “Statement of Cash Flows.”

      Under FAS No. 123R, share-based payments result in a cost that will be measured at fair value on the awards’ grant date, based on the estimated number of awards that are expected to vest. Compensation cost for awards that vest would not be reversed if the awards expire without being exercised. When measuring fair value, companies can choose an option-pricing model (e.g., Black-Scholes or binomial models) that appropriately reflects their specific circumstances and the economics of their transactions. Public companies are allowed to select from three alternative transition methods, each having different reporting implications. FAS No. 123R is effective for the fiscal year beginning after June 15, 2005, and applies to all outstanding and unvested share-based payments as of the adoption date.

      We will adopt FAS No. 123R as of January 1, 2006. The adoption of FAS No. 123R’s fair value method will have a significant impact on our result of operations, although it will have no impact on our overall financial position. The impact of adoption of FAS No. 123R cannot be predicted at this time because we are in the process of reevaluating our methodology used to determine fair value, including consideration of an option-pricing model and related assumptions. In addition, the impact of adoption will depend on levels of share-based payments granted in the future.

Stock-Based Compensation

      As permitted under FAS No. 123, “Accounting for Stock-Based Compensation” as amended by FAS No. 148, “Accounting for Stock-Based Compensation – Transition and Disclosure,” we continue to recognize employee stock compensation under the intrinsic value method of accounting as prescribed by APB No. 25 and its interpretations. Under APB No. 25, compensation expense is based on the difference, if any, between the estimated fair value of our common stock and the option exercise price on the date of grant. We account for stock compensation to non-employees in accordance with FAS No. 123, as amended by FAS No. 148 and EITF Issue 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods or Services.”

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      The following table illustrates the pro forma effect on our net income (loss) and net income (loss) per share as if we had applied the fair value recognition provisions of FAS No. 123 to employee stock compensation (in thousands, except per share amounts):

                 
    Three months ended  
    March 31,  
    2005     2004  
Net income (loss) attributable to common stockholders, as reported
  $ 5,070     $ (3,866 )
Add: Stock-based employee compensation expense included in net income (loss)
    332       626  
Less: Stock-based employee compensation expense determined under the fair value based method
    (702 )     (762 )
 
           
Net income (loss) attributable to common stockholders, pro forma
  $ 4,700     $ (4,002 )
 
           
 
Net income (loss) per share attributable to common stockholders:
               
Basic net income (loss), as reported
  $ 0.21     $ (0.36 )
 
           
Diluted net income (loss), as reported
  $ 0.20     $ (0.36 )
 
           
 
Basic net income (loss), pro forma
  $ 0.19     $ (0.37 )
 
           
Diluted net income (loss), pro forma
  $ 0.19     $ (0.37 )
 
           

      Such pro forma disclosure may not be representative of future stock-based compensation expense because such options vest over several years and additional grants may be made each year.

      The estimated fair value of each option and employee purchase right is estimated on the date of grant using the Black-Scholes option-pricing model, assuming no expected dividends and the following weighted-average assumptions:

                 
            Employee Stock
    Employee Stock Options   Purchase Plan
    March 31,   March 31,
    2005   2004   2005   2004
Weighted-average fair value
  $4.17   $6.11   $6.25  
Risk-free interest rate
  3.5% to 3.6%   2.3% to 2.8%   3.0%  
Expected life (in years)
  4   4   0.5  
Volatility
  0.7   1.0   0.7  

3. Commitments and Contingencies

      The Company leases its facility under an operating lease that expires in September 2014. The lease can be terminated at no cost to the Company in September 2009 but otherwise extends automatically until September 2014.

      Our facility lease agreement provides for periods of escalating rent. The total cash payments over the life of the lease were divided by the total number of months in the lease period and the average rent is charged to expense each month during the lease period. In addition, our lease agreement provides a tenant improvement allowance of $0.4 million, which is considered a lease incentive and accordingly, has been included in accrued liabilities and other long-term liabilities in the Condensed Consolidated Balance Sheets as of March 31, 2005 and December 31, 2004. The lease incentive is amortized as an offset to rent expense over the estimated initial lease term, through September 2009. Total net rent expense related to this operating lease for the quarter ended March 31, 2005 was $0.3 million. Deferred rent was $0.1 million as of March 31, 2005.

      We have entered into a sublease agreement for a certain portion of the leased space with scheduled payments to the Company of $339,990 annually through 2007. This sublease agreement includes an option for early termination in August 2006 but otherwise extends automatically until August 2007.

      Future minimum payments under the non-cancelable portion of our operating lease at March 31, 2005, excluding payments from the sublease agreement, are as follows (in thousands):

         
Year ending December 31,        
2005
  $ 1,241  
2006
    1,698  
2007
    1,749  
2008
    1,802  
2009
    1,225  
 
     
 
  $ 7,715  
 
     

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      During the fourth quarter of 2004, we established a letter of credit with Silicon Valley Bank as security for our property lease in the amount of $0.4 million. The letter of credit remained outstanding as of March 31, 2005 and is collateralized by a certificate of deposit which has been included in restricted cash in the Condensed Consolidated Balance Sheets as of March 31, 2005 and December 31, 2004. Under the terms of the lease agreement, if the total amount of our cash, cash equivalents and marketable securities falls below $20.0 million for a period of more than 30 consecutive days during the lease term, the amount of the required security deposit will increase to $1.1 million, until such time as our projected cash and cash equivalents will exceed $20.0 million for the remainder of the lease term, or until our actual cash and cash equivalents remains above $20.0 million for a period of 12 consecutive months.

      We rely on research institutions and contract research organizations that conduct and manage clinical trials on our behalf. As of March 31, 2005, under the terms of an agreement with a contract research organization (CRO), we are obligated to make future payments as services are provided of up to $7.6 million through 2006. This agreement is terminable by us upon written notice to the CRO and we are only liable for actual effort expended by the CRO at any point in time during the contract, regardless of payment status.

      The Company, as permitted under Delaware law and in accordance with its bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officers or directors are or were serving at the Company’s request in such capacity. The term of the indemnification period is for each officer or director’s lifetime. The maximum amount of potential future indemnification is unlimited; however, the Company has a director and officer insurance policy that limits its exposure up to $10 million and may enable the Company to recover a portion of any future amounts paid. The Company believes the estimated fair value of these indemnification agreements is minimal. Accordingly, the Company has no liabilities recorded for these agreements as of March 31, 2005.

      The Company enters into indemnification provisions under its agreements with other companies in its ordinary course of business, typically with business partners, contractors, clinical sites and customers. Under these provisions, the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of the Company’s activities. These indemnification provisions generally survive termination of the underlying agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification provisions is unlimited. The Company has not incurred material costs to defend lawsuits or settle claims related to these indemnification agreements. As a result, the estimated fair value of these agreements is minimal. Accordingly, the Company has no liabilities recorded for these agreements as of March 31, 2005.

4. Collaborative Research, Development, and License Agreements

UCB Farchim, S.A.

      In February 2004, the Company entered into a development and commercialization collaboration with UCB Farchim, S.A. (UCB) in which the Company licensed the technology, know-how and preclinical and clinical data related to its AIC and grass allergy programs to UCB on an exclusive, worldwide basis. UCB was also granted an option to license the Company’s peanut allergy program. The Company received an $8.0 million upfront payment from UCB when the collaboration was established.

      In March 2005, the Company agreed to end its collaboration with UCB and regained full rights to its allergy program. This agreement provided for cash payment to the Company in satisfaction of outstanding receivables due from UCB and obligations owed by UCB under the collaboration. In addition, UCB assigned to the Company the rights and title to certain laboratory equipment and clinical materials used in undertaking specific development activities for AIC clinical trials. The Company was not obligated to make any cash payments to UCB in connection with the execution of the March 2005 agreement to end the collaboration.

      In accordance with the provisions of EITF 00-21, the Company accounted separately for each of the elements of consideration provided under the March 2005 agreement. During the quarter ended March 31, 2005, the Company accelerated the recognition of $7.0 million in deferred revenue from the upfront payment related to the collaboration, as the Company had no ongoing obligations under the collaboration. During the quarter ended March 31, 2005, the Company also recognized revenue associated with the agreed-upon cash payment which was received in April 2005. The equipment and clinical materials assigned were neither capitalized nor expensed as of the end of the period, due to the Company’s estimate of the useful life of those assets at less than one year and the Company’s estimate of a nominal fair value for those assets based on their potential resale value.

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University of California

      The Company entered into a series of exclusive license agreements with the Regents of the University of California (UC) in March 1997 and October 1998. These agreements provide the Company with certain technology and related patent rights and materials. Under the terms of the agreements, the Company pays annual license or maintenance fees and will be required to pay milestones and royalties on net sales of products originating from the licensed technologies. The agreements will expire on either the expiration date of the last-to-expire patent licensed under the agreements or the date upon which the last patent application licensed under the agreements is abandoned. In connection with these license agreements, the Company incurred license fees of $20,000 during the first quarters of 2005 and 2004 which was recorded as research and development expense, and the Company incurred patent expenses of $0.2 million and $42,000 during the first quarters of 2005 and 2004, respectively, which was recorded as general and administrative expense.

      The Company also incurred a $0.4 million one-time charge to UC due upon the closing of the Company’s initial public offering as partial consideration for the technology licenses, which was recorded as research and development expense in the first quarter of 2004. Additionally, as partial consideration for the technology licenses, the Company prepaid $0.2 million to UC related to the $8.0 million upfront payment from UCB and was amortizing the amount to research and development expense over the initial term of the UCB collaboration. During the quarter ended March 31, 2005, in conjunction with the termination of the UCB collaboration, the Company incurred $0.1 million in research and development expense from the accelerated amortization of the prepaid technology licenses fee.

BioSeek, Inc.

      In June 2003, the Company entered into a development collaboration agreement with BioSeek, Inc. to analyze and characterize the activity of certain compounds using BioSeek’s technology with the objective of advancing the development of such compounds. Under this agreement, the Company will make various payments to BioSeek based on the success and timing of the Company’s signing of a third party partnering agreement where the Company grants to the third party, directly or indirectly, any right or option to market, sell, distribute or otherwise commercialize a thiazolopyrimidine (TZP) product in any geographic territory. The agreement may be terminated by either party. During the quarter ended March 31, 2005, the Company paid BioSeek $0.3 million associated with the achievement of a contractual milestone.

Other Agreements

      In the third quarter of 2003, the Company was awarded government grants totaling $8.4 million to be received over as long as three and one-half years, assuming annual review criteria are met, to fund research and development of certain biodefense programs. Grant revenue associated with these awards is recognized as the related expenses are incurred. In the fourth quarter of 2004, the Company was awarded $0.5 million from the Alliance for Lupus Research to be received during 2005 and 2006 to fund research and development of new treatment approaches for lupus. For each of the quarters ended March 31, 2005 and 2004, the Company recognized grant revenue of approximately $0.5 million.

5. Net Income (Loss) Per Share

      Basic net income (loss) per share is calculated by dividing net income (loss) for the period by the weighted-average shares outstanding for that period. Diluted net income (loss) per share takes into account the effect of diluted instruments, such as stock options and warrants, and uses the average share price for the period in determining the number of incremental shares that are to be added to the weighted-average number of shares outstanding.

                 
    Three Months Ended  
    March 31,  
    2005     2004  
Shares used to compute basic net income (loss) per share
    24,721,829       10,846,894  
Shares used to compute diluted net income (loss) per share
    24,836,870       10,846,894  

      Certain potentially dilutive shares were excluded from the shares used to compute diluted net income (loss) per share since their inclusion would have been anti-dilutive, either because the options’ exercise prices exceeded the average fair market value of the stock during the period or due to the loss for the period.

6. Stockholders’ Equity

      At March 31, 2005, there were 24,745,201 shares of our common stock issued and outstanding.

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      Activity under stock option plans is set forth below:

                         
    Options              
    Available     Number of Options     Weighted-Average  
    for Grant     Outstanding     Price Per Share  
Balance at December 31, 2004 (1,527,989 exercisable at $2.55 weighted-average price per share)
    3,342,976       1,828,314     $ 3.17  
Options granted
    (615,000 )     615,000     $ 7.35  
Options exercised
          (133,498 )   $ 1.50  
Options canceled
    8,535       (8,535 )   $ 5.87  
Shares repurchased
    27,817           $ 7.19  
Shares retired
    (27,817 )         $ 7.19  
 
                   
Balance at March 31, 2005 (1,411,838 exercisable at $2.72 weighted-average price per share)
    2,736,511       2,301,281     $ 4.38  
 
                   

      During the three months ended March 31, 2005, the Company issued 133,498 shares of common stock resulting from option exercises, of which 27,817 shares were surrendered to the Company in lieu of cash payment for the option exercise.

      Employee and director stock-based compensation expense and non-employee stock-based compensation expense for the three months ended March 31, 2005 and 2004 were as follows (in thousands):

                 
    Three Months Ended  
    March 31,  
    2005     2004  
Employees and directors stock-based compensation expense
  $ 332     $ 626  
Non-employees stock-based compensation expense (recovery)
    (15 )      
 
           
Total
  $ 317     $ 626  
 
           

      During the quarter ended March 31, 2005, employees acquired 12,374 shares of our common stock under the 2004 Employee Stock Purchase Plan (the “Purchase Plan”). At March 31, 2005, 224,929 shares of our common stock remained available for future purchases under the Purchase Plan.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

      The following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements under federal securities laws. Forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties. Our actual results could differ materially from those indicated by forward-looking statements as a result of various factors, including but not limited to those set forth under this Item, as well as those discussed elsewhere in this document and those that may be identified from time to time in our reports and registration statements filed with the Securities and Exchange Commission.

      This discussion should be read in conjunction with the Condensed Consolidated Financial Statements and related Notes included in Item 1 of this quarterly report and the Consolidated Financial Statements and related Notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K as filed with the Securities and Exchange Commission on March 18, 2005.

Overview

      We discover, develop, and intend to commercialize innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. ISS are being developed in three initial indications: a ragweed allergy immunotherapeutic, a hepatitis B vaccine, and an asthma immunotherapeutic.

      We have developed a novel injectable product candidate to treat ragweed allergy that we call AIC. AIC has completed Phase II trials, and is currently completing a two-year Phase II/III clinical trial. At the end of 2004, we reported that the one-year interim analysis of this Phase II/III trial showed a clear positive trend relative to the trial’s major endpoint of nasal symptom scores, as well as other secondary endpoints, following the 2004 ragweed season. We intend to complete the Phase II/III clinical trial. We initiated a supportive Phase III clinical trial in ragweed allergic children. Pending the outcome of discussions with the US Food and Drug Administration (FDA) in 2005 and the results of the Phase II/III study, we plan to initiate a pivotal Phase III clinical program in early 2006.

      We have developed a product candidate for hepatitis B prophylaxis. A Phase II/III trial in subjects who are more difficult to immunize with conventional vaccines is currently underway in Singapore. Results from an interim analysis of the Phase II/III trial showed that our vaccine demonstrated statistically significant superiority in protective antibody response and robustness of protective effect after two vaccinations when compared to GlaxoSmithKline’s Engerix-B® vaccine. Results from a Phase II clinical trial in healthy adults conducted earlier in 2004 showed that our vaccine induced a more robust and durable antibody response than Engerix-B. We anticipate initiating a pivotal Phase III trial in the older, more difficult to immunize population in Asia by mid-year 2005, followed by a second pivotal trial in younger adults in Canada and Europe in early 2006. We believe that strategic opportunities for our vaccine exist in selected countries worldwide. Our initial commercialization strategies will likely target these markets and focus on high-value, underserved populations. These populations include pre-hemodialysis patients, HIV positive patients, other populations with compromised immune systems as well as professionals in healthcare and law enforcement for whom achieving seroprotection quickly is critical.

      We have an inhaled therapeutic product candidate for treatment of asthma, which has completed a Phase IIa trial in Canada. Results from a Phase IIa asthma challenge study confirmed the preliminary safety of inhaled immunostimulatory sequences in mild asthmatic patients, and showed substantial and statistically significant pharmacological activity, based upon the induction of genes associated with a reprogrammed immune response. Consistent with our decision to focus clinical and financial resources on our two lead programs in ragweed allergy and hepatitis B prophylaxis, anticipated additional clinical trials in asthma will be postponed. We will, however, perform additional preclinical work to optimize the route of administration and regimen for the asthma clinical program.

      For the quarter ended March 31, 2005, our net income was $5.1 million, compared to a net loss of $3.9 million in the first quarter of 2004. Our operating results for the first quarter of 2005 primarily reflect the financial impact resulting from the termination of our development and commercialization collaboration with UCB Farchim, S.A. (UCB) that occurred in March 2005. Total revenues for the quarter ended March 31, 2005 were $12.7 million, compared to $3.2 million for the first quarter of 2004. 96% of our first quarter

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2005 revenues were derived from our collaboration activities and the termination of the collaboration with UCB, while the remaining revenues were earned from government and private agency grants.

      As of March 31, 2005, we had an accumulated deficit of $90.3 million. We do not have any products that generate revenue. We expect to incur substantial and increasing losses as we continue the development of our lead product candidates and preclinical and research programs. If we were to receive regulatory approval for any of our product candidates, we would be required to invest significant capital to develop, or otherwise secure through collaborative relationships, commercial scale manufacturing, marketing and sales capabilities. Even if we are able to obtain approval for our product candidates, we are likely to incur increased operating losses until product sales grow sufficiently to support the organization.

      For the year ended December 31, 2005, excluding the potential impact of any business collaborations or other transactions that may be entered into, we anticipate that our operating expenses will increase as compared to prior year in connection with our clinical development activities and overall organizational growth.

Critical Accounting Policies and the Use of Estimates

      The Company believes that there have been no significant changes in its critical accounting policies during the three months ended March 31, 2005 as compared with those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2004, except as described below.

      Revenue Recognition

      Certain of our contractual arrangements may involve multiple deliverables or elements. Under Emerging Issues Task Force (EITF) Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables,” multiple elements should be divided into separate units of accounting if certain criteria are met, including whether the delivered elements have stand alone value to the customer and whether there is objective reliable evidence of the fair value of the undelivered elements. Consideration should be allocated among the separate units of accounting based on their fair values, and each of the separate units of accounting should be evaluated for appropriate revenue recognition. We recognize revenue when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectibility is reasonably assured.

Results of Operations

      The following table sets forth the results of operations for the quarters ended March 31, 2005 and 2004 (in thousands, except percentages):

                                   
      Three Months Ended     Increase (Decrease)  
      March 31,     from 2005 to 2004  
Results of Operations:     2005     2004     $     %