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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549



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FORM 10-Q



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



For the quarterly period ended June 30, 2004



or



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



For the transition period from  to
.



Commission File Number: 000-31275



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LARGE SCALE BIOLOGY CORPORATION

(Exact name of registrant as specified in its charter)



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|                                                               |  |                                        
|-------------------------------------------------------------- |  | ---------------------------------------
|Delaware                                                       |  | 77-0154648                             
|(State or other jurisdiction of incorporation or organization) |  | (I.R.S. employer identification number)



3333 Vaca Valley
Parkway, Vacaville, CA 95688

(Address of principal executive offices and zip code)



(707) 446-5501

(Registrants telephone number, including area code)



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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 ̈



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



The number of shares outstanding of registrants common stock, $0.001 par value, as of August 5, 2004: 31,251,289



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Some of the statements contained in this report constitute forward-looking statements that involve
substantial risks and uncertainties. In some cases, you can identify these statements by forward-looking words such as may, will, expect, plan, anticipate, believe,
forecast, project, or continue and variations of these words or comparable words. In addition, any statements, which refer to expectations, projections or other characterizations of future events or circumstances
are forward-looking statements. Our Managements Discussion and Analysis of Financial Condition and Results of Operations contain many such forward-looking statements. These forward-looking statements involve known and unknown risks,
uncertainties and situations that may cause our or our industrys actual results, level of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or
implied by these statements. The risk factors contained in this report, under the heading Factors That May Affect Our Business, as well as any other cautionary language in this report, provide examples of risks, uncertainties and events that may
cause our actual results to differ from the expectations described or implied in our forward-looking statements.



Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of
activity, performance or achievements. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this report. Except as required by law, we do not undertake to update or revise any forward-looking
statement, whether as a result of new information, future events, or otherwise.



Large Scale Biology Corporation, LSBC, our logo, GENEWARE®, BAMF, GRAMMR and other
product and trade names are trademarks of or registered trademarks of Large Scale Biology Corporation in the United States and/or other countries. Other product and trade names mentioned herein may be trademarks and/or registered trademarks of their
respective companies. References in this report to the Company, our, we and us refer collectively to Large Scale Biology Corporation, a Delaware corporation, and its predecessors and subsidiaries.



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##### Table of Contents

Large Scale Biology Corporation

Form 10-Q

For the Quarter Ended June 30, 2004

Table of Contents



|                               |  |                                                                                                                       |  |   
|------------------------------ |  | --------------------------------------------------------------------------------------------------------------------- |  | --
|                               |  | Page                                                                                                                 
|                               | 
|PART I  FINANCIAL INFORMATION |  |                                                                                                                      
|                               |  |                                                                                                                      
|Item 1.                        |  | Financial Statements                                                                                                  |  |   
|                               |  |                                                                                                                      
|                               |  | Condensed Consolidated Balance Sheets as of June 30, 2004 and December 31, 2003 (Unaudited)                           |  | 1 
|                               |  |                                                                                                                      
|                               |  | Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2004 and 2003 (Unaudited) |  | 2 
|                               |  |                                                                                                                      
|                               |  | Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2004 and 2003 (Unaudited)           |  | 3 
|                               |  |                                                                                                                      
|                               |  | Notes to Condensed Consolidated Financial Statements (Unaudited)                                                      |  | 4 
|                               |  |                                                                                                                      
|Item 2.                        |  | Managements Discussion and Analysis of Financial Condition and Results of Operations                                 |  | 6 
|                               |  |                                                                                                                      
|Item 3.                        |  | Quantitative and Qualitative Disclosures About Market Risk                                                            |  | 18
|                               |  |                                                                                                                      
|Item 4.                        |  | Controls and Procedures                                                                                               |  | 18
|                               | 
|PART II  OTHER INFORMATION    |  |                                                                                                                      
|                               |  |                                                                                                                      
|Item 2.                        |  | Changes in Securities, Use of Proceeds and Issuer Purchases of Equity Securities                                      |  | 19
|                               |  |                                                                                                                      
|Item 6.                        |  | Exhibits and Reports on Form 8-K                                                                                      |  | 19
|                               | 
|SIGNATURE                      |  | 20                                                                                                                   



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##### Table of Contents

PART I  FINANCIAL INFORMATION



Item 1. Financial Statements



Large Scale Biology Corporation

Condensed Consolidated Balance Sheets

(Unaudited)



|                                                                                                               |  |               |              |   |                  |   |              |  
|-------------------------------------------------------------------------------------------------------------- |  | ------------- | ------------ | - | ---------------- | - | ------------ | -
|                                                                                                               |  | June 30, 2004 |              |   | December 31,2003 |  
|Assets                                                                                                         |  |               |              |   |                  |   |              |  
|Current assets:                                                                                                |  |               |              |   |                  |   |              |  
|Cash and cash equivalents                                                                                      |  | $             | 7,656,000    |   |                  | $ | 7,737,000    |  
|Accounts receivable, net                                                                                       |  |               | 240,000      |   |                  |   | 265,000      |  
|Prepaid expenses and other current assets                                                                      |  |               | 731,000      |   |                  |   | 706,000      |  
|                                                                                                               |  |               |              |   |                  |   |              |  
|Total current assets                                                                                           |  |               | 8,627,000    |   |                  |   | 8,708,000    |  
|Property, plant, and equipment, net                                                                            |  |               | 8,132,000    |   |                  |   | 8,628,000    |  
|Intangible assets, net                                                                                         |  |               | 2,821,000    |   |                  |   | 3,074,000    |  
|Other assets                                                                                                   |  |               | 671,000      |   |                  |   | 570,000      |  
|                                                                                                               |  |               |              |   |                  |   |              |  
|                                                                                                               |  | $             | 20,251,000   |   |                  | $ | 20,980,000   |  
|                                                                                                               |  |               |              |   |                  |   |              |  
|Liabilities and Stockholders Equity                                                                           |  |               |              |   |                  |   |              |  
|Current liabilities:                                                                                           |  |               |              |   |                  |   |              |  
|Accounts payable                                                                                               |  | $             | 584,000      |   |                  | $ | 592,000      |  
|Accrued expenses                                                                                               |  |               | 596,000      |   |                  |   | 953,000      |  
|Current portion of long-term debt                                                                              |  |               | 53,000       |   |                  |   | 52,000       |  
|Deferred revenue and customer advances                                                                         |  |               | 150,000      |   |                  |   | 147,000      |  
|                                                                                                               |  |               |              |   |                  |   |              |  
|Total current liabilities                                                                                      |  |               | 1,383,000    |   |                  |   | 1,744,000    |  
|Long-term debt                                                                                                 |  |               | 182,000      |   |                  |   | 209,000      |  
|Accrued stock compensation                                                                                     |  |               | 812,000      |   |                  |   | 708,000      |  
|                                                                                                               |  |               |              |   |                  |   |              |  
|Total liabilities                                                                                              |  |               | 2,377,000    |   |                  |   | 2,661,000    |  
|                                                                                                               |  |               |              |   |                  |   |              |  
|Stockholders equity:                                                                                          |  |               |              |   |                  |   |              |  
|Common stock; issued and outstanding: June 30, 2004  31,226,100 shares; December 31, 2003  25,901,273 shares |  |               | 200,487,000  |   |                  |   | 192,541,000  |  
|Stockholders notes receivable                                                                                 |  |               | (20,000      | ) |                  |   | (24,000      | )
|Accumulated deficit                                                                                            |  |               | (182,593,000 | ) |                  |   | (174,198,000 | )
|                                                                                                               |  |               |              |   |                  |   |              |  
|Total stockholders equity                                                                                     |  |               | 17,874,000   |   |                  |   | 18,319,000   |  
|                                                                                                               |  |               |              |   |                  |   |              |  
|                                                                                                               |  | $             | 20,251,000   |   |                  | $ | 20,980,000   |  
|                                                                                                               |  |               |              |   |                  |   |              |  



See accompanying notes
to condensed consolidated financial statements.



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Large Scale Biology Corporation

Condensed Consolidated Statements of Operations

(Unaudited)



|                                                        |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|------------------------------------------------------- |  | --------------------------- | ---------- | - | ------------------------- | - | ---------- | ---- |  | - | ---------- | - |  | - | ----------- | -
|                                                        |  | Three Months Ended June 30, |            |   | Six Months Ended June 30, |  
|                                                        |  | 2004                        |            |   | 2003                      |   |            | 2004 |  |   | 2003       |  
|Revenues                                                |  | $                           | 362,000    |   |                           | $ | 903,000    |      |  | $ | 681,000    |   |  | $ | 1,757,000   |  
|                                                        |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|Costs and expenses:                                     |  |                             |            |   |                          
|Development agreements                                  |  |                             | 535,000    |   |                           |   | 1,245,000  |      |  |   | 1,022,000  |   |  |   | 2,180,000   |  
|Research and development                                |  |                             | 2,280,000  |   |                           |   | 2,773,000  |      |  |   | 4,519,000  |   |  |   | 6,006,000   |  
|General and administrative                              |  |                             | 1,638,000  |   |                           |   | 3,140,000  |      |  |   | 3,564,000  |   |  |   | 5,781,000   |  
|Impairment of property                                  |  |                             |           |   |                           |   |           |      |  |   |           |   |  |   | 1,698,000   |  
|Amortization of purchased intangibles                   |  |                             |           |   |                           |   |           |      |  |   |           |   |  |   | 52,000      |  
|                                                        |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|Total costs and expenses                                |  |                             | 4,453,000  |   |                           |   | 7,158,000  |      |  |   | 9,105,000  |   |  |   | 15,717,000  |  
|                                                        |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|Loss from operations                                    |  |                             | (4,091,000 | ) |                           |   | (6,255,000 | )    |  |   | (8,424,000 | ) |  |   | (13,960,000 | )
|Interest income, net                                    |  |                             | 20,000     |   |                           |   | 48,000     |      |  |   | 29,000     |   |  |   | 118,000     |  
|                                                        |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|Net loss                                                |  | $                           | (4,071,000 | ) |                           | $ | (6,207,000 | )    |  | $ | (8,395,000 | ) |  | $ | (13,842,000 | )
|                                                        |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|Net loss per share - basic and diluted                  |  | $                           | (0.13      | ) |                           | $ | (0.24      | )    |  | $ | (0.29      | ) |  | $ | (0.54       | )
|                                                        |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|Weighted average shares outstanding - basic and diluted |  |                             | 31,186,663 |   |                           |   | 25,567,201 |      |  |   | 29,253,478 |   |  |   | 25,411,090  |  
|                                                        |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  



See accompanying notes
to condensed consolidated financial statements.



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Large Scale Biology Corporation

Condensed Consolidated Statements of Cash Flows

(Unaudited)



|                                                                            |  |                           |            |   |      |   |             |  
|--------------------------------------------------------------------------- |  | ------------------------- | ---------- | - | ---- | - | ----------- | -
|                                                                            |  | Six Months Ended June 30, |           
|                                                                            |  | 2004                      |            |   | 2003 |  
|Cash flows from operating activities:                                       |  |                           |            |   |      |   |             |  
|Net loss                                                                    |  | $                         | (8,395,000 | ) |      | $ | (13,842,000 | )
|Adjustments to reconcile net loss to net cash used in operating activities: |  |                           |            |   |      |   |             |  
|Depreciation of property, plant and equipment                               |  |                           | 686,000    |   |      |   | 1,443,000   |  
|Amortization of intangible assets                                           |  |                           | 265,000    |   |      |   | 503,000     |  
|Stock compensation expense                                                  |  |                           | 446,000    |   |      |   | 765,000     |  
|Impairment of property                                                      |  |                           |           |   |      |   | 1,698,000   |  
|Write-off of capitalized patent costs                                       |  |                           |           |   |      |   | 239,000     |  
|Loss on sale of equipment                                                   |  |                           |           |   |      |   | 156,000     |  
|Provision for doubtful accounts receivable                                  |  |                           |           |   |      |   | 154,000     |  
|Interest received in excess of interest accrued                             |  |                           |           |   |      |   | 141,000     |  
|Changes in assets and liabilities:                                          |  |                           |            |   |      |   |             |  
|Accounts receivable                                                         |  |                           | 160,000    |   |      |   | (305,000    | )
|Prepaid expenses and other current assets                                   |  |                           | (25,000    | ) |      |   | 540,000     |  
|Other assets                                                                |  |                           | (245,000   | ) |      |   | 50,000      |  
|Accounts payable                                                            |  |                           | (8,000     | ) |      |   | (153,000    | )
|Accrued expenses                                                            |  |                           | (357,000   | ) |      |   | 513,000     |  
|Deferred revenue and customer advances                                      |  |                           | 3,000      |   |      |   |            |  
|                                                                            |  |                           |            |   |      |   |             |  
|Net cash used in operating activities                                       |  |                           | (7,470,000 | ) |      |   | (8,098,000  | )
|                                                                            |  |                           |            |   |      |   |             |  
|Cash flows from investing activities:                                       |  |                           |            |   |      |   |             |  
|Purchases of marketable securities                                          |  |                           |           |   |      |   | (8,984,000  | )
|Proceeds from matured marketable securities                                 |  |                           |           |   |      |   | 12,687,000  |  
|Capital expenditures                                                        |  |                           | (325,000   | ) |      |   | (5,000      | )
|Increase in patents and intellectual property licenses                      |  |                           | (12,000    | ) |      |   |            |  
|                                                                            |  |                           |            |   |      |   |             |  
|Net cash provided by (used in) investing activities                         |  |                           | (337,000   | ) |      |   | 3,698,000   |  
|                                                                            |  |                           |            |   |      |   |             |  
|Cash flows from financing activities:                                       |  |                           |            |   |      |   |             |  
|Proceeds from issuance of common stock                                      |  |                           | 7,604,000  |   |      |   | 9,000       |  
|Proceeds from stockholder loan payments                                     |  |                           | 4,000      |   |      |   | 18,000      |  
|Change in restricted cash                                                   |  |                           | 144,000    |   |      |   | 143,000     |  
|Principal payments on long-term debt                                        |  |                           | (26,000    | ) |      |   | (25,000     | )
|                                                                            |  |                           |            |   |      |   |             |  
|Net cash provided by financing activities                                   |  |                           | 7,726,000  |   |      |   | 145,000     |  
|                                                                            |  |                           |            |   |      |   |             |  
|Net decrease in cash and cash equivalents                                   |  |                           | (81,000    | ) |      |   | (4,255,000  | )
|Cash and cash equivalents at beginning of period                            |  |                           | 7,737,000  |   |      |   | 8,238,000   |  
|                                                                            |  |                           |            |   |      |   |             |  
|Cash and cash equivalents at end of period                                  |  | $                         | 7,656,000  |   |      | $ | 3,983,000   |  
|                                                                            |  |                           |            |   |      |   |             |  



See accompanying notes
to condensed consolidated financial statements.



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Large Scale Biology Corporation

Notes to Condensed Consolidated Financial Statements

(Unaudited)



1. The Company and Summary of Significant Accounting Policies



Large Scale Biology Corporation and its subsidiaries (collectively, the Company, we or our) is an integrated
biotechnology company focusing on product development and biomanufacturing of vaccines, complex proteins and follow-on off-patent therapeutics. We are focusing our efforts on the following products:



| |  | Aprotinin, a protease inhibitor used in medical, research and manufacturing applications and other follow-on off-patent biologics, including interferon alpha 2a and 2b, and
granulocyte colony stimulating factor
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| |  | Alpha-galactosidase A for the treatment of Fabry disease, a lysosomal storage disorder
| | - | --------------------------------------------------------------------------------------



| |  | Vaccines for human and animal healthcare, including antiviral and anticancer applications
| | - | -----------------------------------------------------------------------------------------



| |  | Lysosomal acid lipase for the reduction of plaque in arteries
| | - | -------------------------------------------------------------



| |  | Diagnostic test based upon proprietary technology for detection of cancer and other diseases
| | - | --------------------------------------------------------------------------------------------



| |  | GRAMMR to shuffle and improve gene sequences
| | - | --------------------------------------------



The Companys proprietary systems are supported by patents and patent applications. The Companys corporate offices and research and development
are headquartered in Vacaville, California. The Companys biomanufacturing operation is located in Owensboro, Kentucky.



The Company incurred net losses of $8,395,000 and $25,293,000, and negative operating cash flows of $7,470,000 and $15,207,000 in the six months ended
June 30, 2004 and the year ended December 31, 2003, respectively. These negative cash flows were financed primarily by proceeds from the Companys IPO in 2000. The Companys history of negative cash flows and its cash and cash equivalent
balance of $7,656,000 at June 30, 2004, raise substantial doubt about the Companys ability to continue as a going concern, absent any new sources of significant cash flows. Towards mitigating this near-term concern, the Company is in the
process of securing non-dilutive loan financing as part of a broader investment initiative involving the Companys biomanufacturing operations in Owensboro, Kentucky. In addition, the Company is pursuing opportunities for significant revenue
growth and concurrent sources of working capital with other companies for the joint development and commercialization of recombinant Aprotinin and Interferon alpha 2a and 2b products. We are currently in discussions with pharmaceutical companies
capable of marketing these products. The commercialization of both products for therapeutic applications will require approval by the FDA and product scale-up at our biomanufacturing facility under FDA regulations. The financial statements do not
include any adjustments relating to the recoverability and classification of assets or the amounts and classification of recorded liabilities that might be necessary should the Company be unable to continue as a going concern.



Basis of Presentation  The unaudited condensed consolidated
financial statements have been prepared by the Company in accordance with the rules and regulations of the Securities and Exchange Commission regarding interim financial information. Accordingly, these financial statements and notes thereto do not
include certain disclosures normally associated with financial statements prepared in accordance with accounting principles generally accepted in the United States of America. This interim financial information should be read in conjunction with the
Companys audited consolidated financial statements and notes thereto for the year ended December 31, 2003 included in the Companys Annual Report on Form 10-K.



The unaudited condensed consolidated financial statements include the accounts of Large Scale Biology Corporation and its
subsidiaries. All intercompany balances and transactions have been eliminated. In the opinion of the Companys management, the unaudited condensed consolidated financial statements include all adjustments (consisting of only normal recurring
adjustments) and disclosures considered necessary for a fair presentation of the results of the interim periods presented. This interim financial information is not necessarily indicative of the results of any future interim periods or for the
Companys full year ending December 31, 2004.



Segment
Reporting  The Company operates in one reportable segment.



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Workforce Reductions  In connection with our 2003 restructuring plans and staff reductions,
we accrued $1,401,000 for severance payments and other related termination benefits provided to employees. Of this amount, $860,000 was paid during 2003 leaving $541,000 in accrued expenses at December 31, 2003. We accrue for these benefits in the
period when benefits are communicated to the terminated employees. Typically, terminated employees are not required to provide continued service to receive termination benefits. In general, we use a formula based on the number of years of service to
calculate the termination benefits to be provided to affected employees. During the six months ended June 30, 2004, former employees were paid $443,000 under the 2003 workforce reduction programs leaving $98,000 in accrued expenses at June 30, 2004.
Of this amount, we expect $82,000 to be paid during the remainder of 2004 and $16,000 to be paid during 2005.



Stock-Based Compensation  The Company adopted Statement of Financial Accounting Standards No. 123 (SFAS 123), Accounting
for Stock-Based Compensation effective as of January 1, 2003 for its stock-based employee compensation plans using the prospective recognition method under Statement of Financial Accounting Standards No. 148 (SFAS 148),
Accounting for Stock-Based Compensation-Transition and Disclosure, an amendment of SFAS 123. This method applies the recognition provisions of SFAS 123 to all employee stock awards granted, modified, or settled after January 1, 2003 and
accordingly, the Company recognized compensation expense for those issuances under our stock-based employee compensation plans. For stock awards granted prior to January 1, 2003, compensation expense has not been recognized under SFAS 123, unless
those stock awards were modified after January 1, 2003.



Prior
to January 1, 2003, the Company accounted for stock options granted to employees and directors and other stock-based employee compensation plans using the intrinsic value method of accounting in accordance with Accounting Principles Board Opinion
No. 25 (APB 25), Accounting for Stock Issued to Employees and related interpretations. As such, the Company recognized compensation expense for stock options only if the quoted market value of the Companys common stock
exceeded the exercise price of the option on the grant date. Any compensation expense realized using this intrinsic value method is being amortized over the vesting period of the option.



The following table presents the effect on net loss and net loss per share if we had applied the fair value recognition
provisions of SFAS 123 to all stock-based awards to employees:



|                                                                                                               |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|-------------------------------------------------------------------------------------------------------------- |  | --------------------------- | ---------- | - | ------------------------- | - | ---------- | ---- |  | - | ---------- | - |  | - | ----------- | -
|                                                                                                               |  | Three Months Ended June 30, |            |   | Six Months Ended June 30, |  
|                                                                                                               |  | 2004                        |            |   | 2003                      |   |            | 2004 |  |   | 2003       |  
|Net loss as reported                                                                                           |  | $                           | (4,071,000 | ) |                           | $ | (6,207,000 | )    |  | $ | (8,395,000 | ) |  | $ | (13,842,000 | )
|Stock-based employee compensation expense included in reported net loss for awards issued during 2004 and 2003 |  |                             | 215,000    |   |                           |   | 463,000    |      |  |   | 391,000    |   |  |   | 569,000     |  
|Stock-based employee compensation expense determined using the fair value method for all awards                |  |                             | (573,000   | ) |                           |   | (2,580,000 | )    |  |   | (1,119,000 | ) |  |   | (3,484,000  | )
|                                                                                                               |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|Pro forma net loss                                                                                             |  | $                           | (4,429,000 | ) |                           | $ | (8,324,000 | )    |  | $ | (9,123,000 | ) |  | $ | (16,757,000 | )
|                                                                                                               |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|Net loss per share:                                                                                            |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|Basic and diluted  as reported                                                                                |  | $                           | (0.13      | ) |                           | $ | (0.24      | )    |  | $ | (0.29      | ) |  | $ | (0.54       | )
|                                                                                                               |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  
|Basic and diluted  pro forma                                                                                  |  | $                           | (0.14      | ) |                           | $ | (0.33      | )    |  | $ | (0.31      | ) |  | $ | (0.66       | )
|                                                                                                               |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |             |  



The fair values of
stock options are estimated at the date of grant using the Black-Scholes option-pricing model and amortized over the vesting period of typically 3 or 4 years for the calculation of stock-based employee compensation in the above table. The Company
granted 539,000 and 1,246,500 stock options to employees and directors during the six months ended June 30, 2004 and 2003, respectively.



Stock options issued to non-employees as consideration for services provided to the Company have been and continue to be accounted for under the fair
value method in accordance with SFAS 123, which requires that compensation expense be recognized for all such options.



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##### Table of Contents

Net Loss Per Share  Basic net loss per share is computed by dividing the net loss for the
period by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of common shares outstanding during the period, plus
the potential dilutive effect of common shares issuable upon exercise or conversion of outstanding stock options and warrants during the period. The weighted average number of potentially dilutive common shares were 674,472 and 25,645 for the three
months ended June 30, 2004 and 2003, respectively, and 832,132 and 12,702 for the six months ended June 30, 2004 and 2003, respectively. These shares are excluded from diluted net loss per share because of their anti-dilutive effect.



2. Subsequent Event



During August 2004 the Company entered into a sublease of its entire Germantown, Maryland facility to the end of the lease
term in 2010 that will reduce the Companys operating lease commitments, with a sublet premium of $9,000 per month starting on March 11, 2005 and reduce associated facility operating expenses of approximately $16,000 per month starting during
August 2004. The sublease agreement is subject to the approval of the prime landlord. The following table presents future non-cancelable minimum payments under operating leases, the portion of sublease rental receipts that offset the Germantown,
Maryland facility lease obligation and the net rental expense obligation as of June 30, 2004:



|                  |  |                |           |                 |   |            |                    |  |   |          
|----------------- |  | -------------- | --------- | --------------- | - | ---------- | ------------------ |  | - | ---------
|                  |  | Minimum Rental |           | Sublease Rental |   |            | Net Rental Expense
|2004 (six months) |  | $              | 739,000   |                 | $ |           |                    |  | $ | 739,000  
|2005              |  |                | 1,525,000 |                 |   | (649,000   | )                  |  |   | 876,000  
|2006              |  |                | 1,578,000 |                 |   | (830,000   | )                  |  |   | 748,000  
|2007              |  |                | 1,633,000 |                 |   | (855,000   | )                  |  |   | 778,000  
|2008              |  |                | 1,690,000 |                 |   | (881,000   | )                  |  |   | 809,000  
|Thereafter        |  |                | 1,985,000 |                 |   | (1,842,000 | )                  |  |   | 143,000  
|                  |  |                |           |                 |   |            |                    |  |   |          
|                  |  | $              | 9,150,000 |                 | $ | (5,057,000 | )                  |  | $ | 4,093,000
|                  |  |                |           |                 |   |            |                    |  |   |          



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



The following discussion of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated
financial statements and related notes included in this Report and our audited consolidated financial statements and related notes for the year ended December 31, 2003 included in our Annual Report on Form 10-K.



Introduction



Our current efforts are focused on improving cash flows, manufacturing products and entering into relationships to market
and sell our products. Managements objective is to manufacture and sell products in order to generate sufficient cash flows to sustain the Companys operations. Our cash balance was $7.7 million at June 30, 2004. We have incurred negative
operating cash flows of $7.5 million during the first half of 2004 and $15.2 million during 2003. We expect that our operating cash usage will remain stable through 2004. The current rate of cash usage is not sustainable into 2005 without subsequent
funding through collaborations, or debt or equity financing. Towards mitigating this near-term concern, we are in the process of securing non-dilutive loan financing as part of a broader investment initiative involving our biomanufacturing
operations in Owensboro, Kentucky. In addition, we are pursuing opportunities for significant revenue growth and concurrent sources of working capital with other companies for the joint development and commercialization of recombinant Aprotinin and
Interferon alpha 2a and 2b products. We are currently in discussions with pharmaceutical companies capable of marketing these products. The commercialization of both products for therapeutic applications will require approval by the FDA and product
scale-up at our biomanufacturing facility under FDA regulations.



Recent
Developments



In late June, we shipped our first
plant-produced recombinant product, research-grade aprotinin, to Sigma-Aldrich Fine Chemicals Corporation, a division of Sigma-Aldrich Corporation. Aprotinin is a protease inhibitor commercially marketed for medical, research and biomanufacturing
applications. We believe that this is the initial step for meeting our objective to manufacture and sell products and generate sufficient cash flows to sustain the Companys operations. We expect limited 2004 results from our efforts to sell
research-grade aprotinin since the end-users of recombinant aprotinin require time for evaluating our product. Also, the market for non-pharmaceutical applications of aprotinin is significantly smaller than recombinant aprotinin for injection used
in surgical applications, which is our ultimate goal for commercializing aprotinin.



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##### Table of Contents

During the second quarter of 2004 we closed our Germantown, Maryland facility and equipment located at
Germantown, Maryland has been redeployed, disposed of or sold. Certain equipment being stored at Germantown, Maryland and Vacaville, California is being marketed for sale. Equipment with a net book value of $0.1 million and a gross book value of
$1.7 million, was disposed of or sold, generating $0.1 million of cash to be received in the third quarter of 2004. This amount was recorded in accounts receivable at June 30, 2004.



Results of Operations



Revenues The following tables presents the changes in revenues from 2003 to 2004:



|         |  |                             |         |      |                           |                      |  |   |          |   |      |     |                      |  |   |         |  |   |           |  |   |            |   |  |     |   
|-------- |  | --------------------------- | ------- | ---- | ------------------------- | -------------------- |  | - | -------- | - | ---- | --- | -------------------- |  | - | ------- |  | - | --------- |  | - | ---------- | - |  | --- | --
|         |  | Three Months ended June 30, |         |      | Six Months ended June 30, |                     
|         |  | 2004                        |         | 2003 |                           | (Decrease) from 2003 |  |   | 2004     |   | 2003 |     | (Decrease) from 2003 | 
|Revenues |  | $                           | 362,000 |      | $                         | 903,000              |  | $ | (541,000 | ) |      | (60 | )%                   |  | $ | 681,000 |  | $ | 1,757,000 |  | $ | (1,076,000 | ) |  | (61 | )%



The revenue decrease
is a result of exiting the fee-for-service proteomics business and winding down our contract with The National Institute of Environmental Health Services (NIEHS) that was completed on December 31, 2003. We expect, beginning in the third
quarter of 2004 and continuing through the first quarter of 2005, quarterly revenue increases with product sales of research grade aprotinin. However, we believe that the revenue increases from this source alone will not be sufficient to
significantly offset our current losses and negative cash flows.



Development agreementsandresearch and developmentcosts  The following tables presents the changes in total research activities from 2003 to 2004:



|                          |  |                             |           |      |                           |                      |  |   |            |   |      |     |                      |  |   |           |  |   |           |  |   |            |   |  |     |   
|------------------------- |  | --------------------------- | --------- | ---- | ------------------------- | -------------------- |  | - | ---------- | - | ---- | --- | -------------------- |  | - | --------- |  | - | --------- |  | - | ---------- | - |  | --- | --
|                          |  | Three Months ended June 30, |           |      | Six Months ended June 30, |                     
|                          |  | 2004                        |           | 2003 |                           | (Decrease) from 2003 |  |   | 2004       |   | 2003 |     | (Decrease) from 2003 | 
|Development agreements    |  | $                           | 535,000   |      | $                         | 1,245,000            |  | $ | (710,000   | ) |      | (57 | )%                   |  | $ | 1,022,000 |  | $ | 2,180,000 |  | $ | (1,158,000 | ) |  | (53 | )%
|Research & development    |  |                             | 2,280,000 |      |                           | 2,773,000            |  |   | (493,000   | ) |      | (18 | )%                   |  |   | 4,519,000 |  |   | 6,006,000 |  |   | (1,487,000 | ) |  | (25 | )%
|                          |  |                             |           |      |                           |                      |  |   |            |   |      |     |                      |  |   |           |  |   |           |  |   |            |   |  |     |   
|Total research activities |  | $                           | 2,815,000 |      | $                         | 4,018,000            |  | $ | (1,203,000 | ) |      | (30 | )%                   |  | $ | 5,541,000 |  | $ | 8,186,000 |  | $ | (2,645,000 | ) |  | (32 | )%
|                          |  |                             |           |      |                           |                      |  |   |            |   |      |     |                      |  |   |           |  |   |           |  |   |            |   |  |     |   



Development agreements
and research and development costs consist mainly of personnel expenses, outside research services, research materials and laboratory overhead costs. Development agreement costs, as they related to activities performed under revenue
generating research agreements and grants, have and are expected to fluctuate consistently with increases or decreases in revenues earned from research agreements and grants. The decrease in development agreement expense from 2003 to 2004 is
attributed to a $0.8 million and $1.4 million decrease in research activities during the three and six months ending June 30, respectively, related to the wind down of the NIEHS contract that was completed on December 31, 2003, partially offset by
increased efforts performed under other commercial contracts. We expect development agreement expense in the third quarter of 2004 to be materially consistent with the prior quarter.



The decrease in research and development expense from 2003 to 2004 is primarily attributable to our cost reduction
efforts that were implemented in June and December 2003. For the three months ending June 30, employee compensation and benefits expenses decreased by $0.3 million resulting from headcount reductions. In addition, non-cash depreciation and
amortization expenses for capital and other assets decreased by $0.2 million. For the six months ending June 30, cost reduction efforts resulted in employee compensation and benefit expense decreasing by $0.8 million and material purchases
decreasing by $0.1 million. In addition, non-cash depreciation and amortization expenses for capital and other assets decreased by $0.5 million. We expect research and development expense in the third quarter of 2004 to be materially consistent with
the prior quarter.



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##### Table of Contents

General and administrative The following table presents the changes in general and
administrative expenses from 2003 to 2004:



|                           |  |                             |           |      |                           |                      |  |   |            |   |      |     |                      |  |   |           |  |   |           |  |   |            |   |  |     |   
|-------------------------- |  | --------------------------- | --------- | ---- | ------------------------- | -------------------- |  | - | ---------- | - | ---- | --- | -------------------- |  | - | --------- |  | - | --------- |  | - | ---------- | - |  | --- | --
|                           |  | Three Months ended June 30, |           |      | Six Months ended June 30, |                     
|                           |  | 2004                        |           | 2003 |                           | (Decrease) from 2003 |  |   | 2004       |   | 2003 |     | (Decrease) from 2003 | 
|General and administrative |  | $                           | 1,638,000 |      | $                         | 3,140,000            |  | $ | (1,502,000 | ) |      | (48 | )%                   |  | $ | 3,564,000 |  | $ | 5,781,000 |  | $ | (2,217,000 | ) |  | (38 | )%



The decrease in
general and administrative expense is attributable to cost reduction efforts and certain charges incurred during 2003. The first quarter of 2003 included $0.2 million for the write-off of capitalized patent costs, $0.2 million for loss on sale of
equipment and $0.2 million for a provision for doubtful accounts receivable. The second quarter of 2003 included a charge of $1.1 million for severance benefits related to headcount reductions. The lower number of administrative personnel resulted
in $0.2 million of reduced salaries and benefit expense and $0.2 million of reduced employee non-cash compensation costs during the six months ended June 30, 2004. We expect general and administrative expense in the third quarter of 2004 to be
approximately the same as the prior quarter.



Impairment of
property During the first quarter of 2003, the carrying value of leasehold improvements at our Germantown, Maryland operations was written-down. We concluded that such property was impaired as of March 31, 2003 based upon a comparison of
the carrying value of the leasehold improvements with the fair market value of similarly improved office and laboratory space in the local area. We did not incur any impairment charges during the first half of 2004.



Liquidity and Capital Resources



Net cash used in operating activities  The following table
presents cash flows from operating activities for the first six months of 2004 and 2003:



|                                           |  |                          |            |   |      |   |            |  
|------------------------------------------ |  | ------------------------ | ---------- | - | ---- | - | ---------- | -
|                                           |  | Six Months Ended June 30 |           
|                                           |  | 2004                     |            |   | 2003 |  
|Cash paid to employees                     |  | $                        | (3,587,000 | ) |      | $ | (5,218,000 | )
|Cash paid to suppliers                     |  |                          | (4,756,000 | ) |      |   | (4,591,000 | )
|                                           |  |                          |            |   |      |   |            |  
|Total cash paid to employees and suppliers |  |                          | (8,343,000 | ) |      |   | (9,809,000 | )
|Cash received from customers               |  |                          | 844,000    |   |      |   | 1,452,000  |  
|Net interest received                      |  |                          | 29,000     |   |      |   | 259,000    |  
|                                           |  |                          |            |   |      |   |            |  
|Net cash used in operating activities      |  | $                        | (7,470,000 | ) |      | $ | (8,098,000 | )
|                                           |  |                          |            |   |      |   |            |  



The decrease innet
cash used in operating activities for the first six months of 2003 compared to 2004 is the result of the decrease in total cash paid to employees and suppliers.These savings exceeded the reduced cash received from customers
primarily attributable to the wind down of the NIEHS contract that was completed on December 31, 2003. The decrease in total cash paid to employees and suppliers is the result of our 2003 cost reduction program and reorganizations.
Specifically, workforce reductions decreasedcash paid to employees by $1.6 million. Partially offsetting these decreased expenditures were cash disbursements that resulted in fluctuations in certain asset and liability balances. Restricted
cash increased by $0.3 million related to our renewal of the Vacaville, California facility lease recorded in other assets and accrued severance benefits decreased by $0.4 million related to payments to former employees under the 2003 workforce
reduction program.



We expect the negative operating cash flows
to continue throughout 2004 at a similar rate as the first half of 2004 with improvements upon significant product sales. However, the current rate of cash usage is not sustainable into 2005 without subsequent funding through collaborations, or debt
or equity financing. Our ability to continue as a going concern and develop our products will depend on such funding. Towards mitigating this near-term concern, we are in the process of securing non-dilutive loan financing as part of a broader
investment initiative involving our biomanufacturing operations in Owensboro, Kentucky. In addition, we are pursuing opportunities for significant revenue growth and concurrent sources of working capital with other companies for the joint
development and commercialization of recombinant Aprotinin and Interferon alpha 2a and 2b products. We are currently in discussions with pharmaceutical companies capable of marketing these products. The commercialization of both products for
therapeutic applications will require approval by the FDA and product scale-up at our biomanufacturing facility under FDA regulations.



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Net cash used in investing activities We spent $0.3 million on capital expenditures during
the first half of 2004. Our commitments for capital expenditures at June 30, 2004 are $0.4 million and we anticipate that our biomanufacturing facility in Owensboro, Kentucky will require approximately $0.1 million of additional expenditures in 2004
to support our business objectives. We may fund these expenditures through an equipment financing arrangement or working capital. Additional capital expenditures may be required upon entering into new collaborative agreements. Such requirements will
be funded from the proceeds of corporate financing and/or partnering collaboration sources.



Net cash provided by financing activities In 2000, we received net proceeds of $88.8 million from our initial public offering, which has sustained the Companys operations since that time. On March
8, 2004, we received net proceeds of approximately $7.5 million from a private placement of our common stock. These funds combined with our existing resources and anticipated revenues and financings, are expected to sustain our operations into 2005.
We will require substantial additional working capital to continue our product development programs and to fund our future operations. We cannot assure you that additional equity or debt financing will be available on acceptable terms, if at all, to
sustain our operations.



Commitments



Our commitments for capital expenditures at June 30, 2004 are $0.4 million.
During August 2004, we entered into a sublease of our entire Germantown, Maryland facility to the end of the lease term in 2010 that will reduce the Companys operating lease commitments starting on March 11, 2005. The sublease agreement is
subject to the approval of the prime landlord. We are still legally obligated for lease payments if the subtenant should default upon its payments to us. The following table presents future non-cancelable minimum payments under operating leases, the
portion of sublease rental receipts that offset the Germantown, Maryland facility lease obligation and the net rental expense obligation as of June 30, 2004:



|                              |  |                 |  |               |   |  |               |   |  |            |   |  |            |  
|----------------------------- |  | --------------- |  | ------------- | - |  | ------------- | - |  | ---------- | - |  | ---------- | -
|                              |  | Payments Due    | 
|                              |  | 2004 (6 months) |  | 2005 and 2006 |   |  | 2007 and 2008 |   |  | Thereafter |   |  | Total      |  
|Minimum rental obligation     |  | 739,000         |  | 3,103,000     |   |  | 3,323,000     |   |  | 1,985,000  |   |  | 9,150,000  |  
|Sublease rental               |  |                |  | (1,479,000    | ) |  | (1,736,000    | ) |  | (1,842,000 | ) |  | (5,057,000 | )
|                              |  |                 |  |               |   |  |               |   |  |            |   |  |            |  
|Net rental expense obligation |  | 739,000         |  | 1,624,000     |   |  | 1,587,000     |   |  | 143,000    |   |  | 4,093,000  |  
|                              |  |                 |  |               |   |  |               |   |  |            |   |  |            |  



Critical Accounting Policies



We consider the following accounting policies to be
critical given they involve estimates and judgments made by management and are important for our investors understanding of our operating results and financial condition.



Long-Lived Assets  Our long-lived assets include capitalized costs of filing patent applications, capitalized
licenses and property and equipment. We evaluate our long-lived assets for impairment in accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets whenever events or changes in circumstances indicate
that the carrying amount of such assets may not be recoverable. Estimates of future cash flows and timing of events for evaluating long-lived assets for impairment are based upon managements judgment. If any of our intangible or long-lived
assets are considered to be impaired, the amount of impairment to be recognized is the excess of the carrying amount of the assets over its fair value.



All long-lived assets are amortized or depreciated over the shorter of their estimated useful lives, the estimated period that the assets will generate
revenue, or the statutory or contractual term in the case of patents and intellectual property licenses. Estimates of useful lives and periods of expected revenue generation are reviewed periodically for appropriateness and are based upon
managements judgment.



Stock-Based Compensation We adopted Statement of Financial Accounting Standards No. 123 (SFAS 123), Accounting for Stock-Based Compensation effective as of January 1, 2003 for its stock-based employee compensation plans using the
prospective recognition method under Statement of Financial Accounting Standards No. 148 (SFAS 148), Accounting for Stock-Based Compensation-Transition and Disclosure, an amendment of SFAS 123. This method applies the
recognition provisions of SFAS 123 to all employee stock awards granted, modified, or settled after January 1, 2003 and accordingly, the Company recognized compensation expense for those issuances under our stock-based employee compensation plans.
Methodologies used for calculations such as the Black-Scholes option-pricing model and variables such as volatility and expected life are based upon managements judgment. Such methodologies and variables are reviewed and updated periodically
for appropriateness and affect the amount of recorded charges.



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Factors That May Affect Our Business



Risks Related To Our Business



We have a history of significant net losses and negative cash flows. We recently have raised additional working capital. However, our working capital
may not be sufficient to fund all of our product development initiatives.



We have realized significant net losses and negative operating cash flows in recent years and in the six months ended June 30, 2004. Our working capital balance at June 30, 2004 was $7.2 million. Based upon our
current working capital balance, our current rate of negative operating cash flows and the expected cost to complete the development of our products, we cannot assure you that the Company will be able to continue as a going concern. Towards
mitigating this near-term concern, we are in the process of securing non-dilutive loan financing as part of a broader investment initiative involving our biomanufacturing operations in Owensboro, Kentucky. In addition, we are pursuing opportunities
for significant revenue growth and concurrent sources of working capital with other companies for the joint development and commercialization of recombinant Aprotinin and Interferon alpha 2a and 2b products. We are currently in discussions with
pharmaceutical companies capable of marketing these products. The commercialization of both products for therapeutic applications will require approval by the FDA and product scale-up at our biomanufacturing facility under FDA regulations.



Our recent operating results and our current stock price may
limit our ability to issue additional equity securities and existing stockholders could experience significant dilution upon such an issuance.



Our revenues for the six months ended June 30, 2004 and for the year ended December 31, 2003 were not significant. We may be required to further reduce
our operating costs by further restructuring our operations or reducing the scope of our development programs. These actions would adversely affect our ability to generate new sources of revenue. If we are unable to significantly increase our
revenues and cash received from customers, we will not be able to achieve profitability or positive operating cash flows, our working capital will continue to erode, and our business will suffer.



We need to continue funding our product development programs. Our recombinant
Aprotinin and Alpha-galactosidase A, and Interferon alpha 2a and 2b products require clinical trials to prove their efficacy and safety for pharmaceutical applications. We do not have sufficient working capital to complete all phases of clinical
trials. If we are unable to raise sufficient financing or collaborative funding, we may delay or abandon some of our product development initiatives, which would likely harm our business.



We require additional capital.



We require substantial working capital to continue our product development programs and to fund our operations. In addition,
the risks inherent in developing innovative products or platforms, such as recombinant Aprotinin and Alpha-galactosidase A, and Interferon alpha 2a and 2b and our BAMF technology-based diagnostic tests make it difficult to forecast with certainty
the capital required to commercialize our products. We may raise this capital through public or private equity financings or through collaborations or strategic partnerships. We cannot assure you that we will be able to obtain additional financing
on commercially reasonable terms, if at all. If additional funds are raised through the issuance of equity securities or convertible debt securities, the percentage ownership of our then-current stockholders would be reduced and the value of their
investments might decline. In addition, any new securities issued might have rights, preferences or privileges senior to those securities held by our existing stockholders. If we raise additional funds through the issuance of debt, we might become
subject to restrictive covenants or high rates of interest, and our assets could become encumbered, which would limit our ability to borrow in the future. We may be unsuccessful in entering into any new collaboration or strategic partnership that
results in significant working capital or revenue. If we are unable to raise sufficient additional capital, we may have to curtail or cease operations.



We may not be able to enter into collaborations necessary to fully develop and commercialize our products and technologies, and we will be dependent on
our collaborators if we do.



We are independently pursuing
some therapeutic product applications into the development stage. However, we expect to develop and commercialize most of our future products in collaboration with pharmaceutical, biotechnology and other companies. For example, our strategy
concerning our recombinant Aprotinin and Alpha-galactosidase A, and Interferon alpha 2a and 2b A involves seeking partners to complete the development of these products. We cannot assure you that such collaborative arrangements will be available to
us on acceptable terms, or at all. If our cash flows continue to deteriorate or we take significant steps to reduce our expenses, potential partners may question our ability to perform and choose not to do business with us, which would make it
harder for us to find a partner and would harm our ability to commercialize our products. Our success will depend in large part on our ability to enter into future collaborations with other companies for the financing of development and/or
regulatory approval and commercialization of our products. Our reliance upon these companies for these capabilities will reduce our control



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over such activities and could make us dependent upon them. Furthermore, obtaining funds through arrangements with
collaborative partners or others may require us to relinquish rights to certain of our technologies, product candidates or products that we would otherwise seek to develop or commercialize on our own, or to sell or license the rights to certain of
our products or technologies on terms that are worse than we might have been able to obtain in a different environment. To date, we have entered into only a limited number of collaborations. Generally, the scope of these collaborations has been to
demonstrate the function of plant genes and the feasibility of using viral vectors to create proteins in plants and to identify marker proteins for drug development and diagnostics. Some of our existing agreements provide us with rights to
participate financially in the commercial development of products resulting from the use of our technologies. We may be unable to obtain such rights in future collaborations. In addition, unforeseen delays or complications could arise and result in
the breach of our contractual obligations with our collaborators and others, or render our technologies unable to perform at the quality and capacity levels required for success.



We may be unable to recruit and retain senior management and other key scientific personnel on whom we are dependent.



The loss of a number of our senior management or other
key scientific personnel could significantly harm our business, cause collaborators to cease doing business with us or potential collaborators to decline to do business with us, and could otherwise inhibit our research and development and
commercialization efforts. None of our key personnel are subject to employment agreements that prevent them from leaving our employment. We face competition for research scientists and technical staff from other companies, academic institutions,
government entities, nonprofit laboratories and other organizations. We have implemented 10% cash salary reductions substituting non-cash stock compensation for our highest paid employees to conserve cash. Our compensation practices may be less
attractive compared to our competition. Failure to recruit and retain senior management and scientific personnel on acceptable terms may prevent us from achieving our business objectives.



Future workforce reductions and management restructurings may hurt the performance of our continuing personnel, and make
it more difficult to retain the services of key personnel.



We restructured our operations in both 2002 and 2003, resulting in substantial workforce reductions. These reductions affected all functional areas including a change in top management. Future changes and reductions may create concerns in
our employee base about job security, our direction or focus, and the continued viability of the Company. Such concerns could lower productivity, make it more likely that some of our key employees will seek new employment and require us to hire
replacements, and cause concerns among collaborators or potential collaborators about doing business with us. These factors also may make the management of our business more difficult and make it harder for us to attract employees in the future.



We are at an early or middle stage of product
commercialization, and we may not be able to successfully develop our products and technologies nor sustain commercial use of our technology.



We are in an early or middle stage of commercialization, and we are subject to all of the risks inherent in the development of a business enterprise,
including the need for substantial capital to support the development of our products and technologies. Our anticipated products most likely will require that we enter into new collaborations before we can manufacture and/or market them. For
instance, we believe that our NHL vaccine, which is ready for Phase II trials, cannot be further developed without collaboration. The prospects for development of our recombinant Aprotinin and Alpha-galactosidase A, and Interferon alpha 2a and 2b
products are limited without collaboration or partnering support. Because we are in new and developing fields such as diagnostic tests for disease, and our research focuses on new and unproven products, our therapeutic vaccines, proteins and other
therapeutics under development may not be effective for their intended purpose, or may not meet regulatory requirements for safety and efficacy. In addition, even if we successfully develop a product, there may not be a substantial commercial market
for that product at commercially viable prices.



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We are in new and developing fields and there may not be a market for our technologies.



Our technologies, including our GENEWARE and BAMF
technology, have limited commercial precedent. Much of our research is fundamentally unique and we cannot assure the acceptance of its scientific merit or the benefits of products produced by it, nor that the public will react favorably to it. The
usefulness of the information and products generated by our proteomics, functional genomics and bioinformatics technologies is unproven, and our collaborators and potential collaborators may determine that they are not useful, cost-effective, or
otherwise unacceptable to them. We generate large amounts of data from our research with genes and proteins and we may not be able to mine or integrate this data in a timely manner, or turn it into commercially viable information. In addition,
because our fields are characterized by rapid innovation, we must complete development of our technologies in time to meet market demand, if any. If we fail to do so, it is likely that other technologies and companies will predominate and we will
not be able to earn a sufficient return on our investment.



Alternative technologies may supersede our technologies or make them non-competitive.



Genomics, proteomics, biomanufacturing and bioinformatics are intensely competitive fields. They are characterized by extensive research efforts, which
result in rapid technological progress that can render existing technologies obsolete or economically noncompetitive. If our competitors succeed in developing more effective technologies or render our technologies obsolete or noncompetitive, our
business will suffer. Many universities, public agencies and established pharmaceutical, biotechnology, health care, chemical and other life sciences companies with substantially greater resources than we have are developing and using technologies
and are actively engaging in the development of products similar to or competitive with our products and technologies. Like us, our competitors are using proteomics and genomics technologies to identify potential drug targets, therapeutic proteins
and diagnostic marker proteins. To remain competitive, we must continue to invest in new technologies and improve existing technologies. If our revenues and cash flows do not improve significantly, we will not have the resources to continue such
investment.



Our competitors may devise faster, more complete
or more accurate methods to obtain proteomic and functional genomic information than our technologies and systems, including our GENEWARE systems and BAMF technology. There has been and continues to be substantial academic and commercial research
effort devoted to the development of such methods. If successful competitive methods were developed, it would undermine the commercial basis for the products and technologies we intend to provide.



General economic conditions may cause uncertainty with respect to other
companies and entities collaborating with us or otherwise dealing with us, and this can have an adverse effect on our revenues and cash flows.



To a large extent, decisions by businesses and other entities to collaborate or otherwise do business with us are discretionary, and the decision making
process typically takes many months to complete. We believe that the previous slowdown in the U.S. and global economies, and the biotechnology and pharmaceutical industries in particular, has caused potential collaborators and customers to defer
decisions to work with us or to access our technologies. As a result, revenues and cash flows have been uncertain. Future results are difficult to predict, as it is difficult to accurately assess and predict the future demand for our products,
technologies and services. General economic conditions are expected to improve as the economy grows. However, we cannot assure you that any such improvement will cause our results of operations to improve. If economic conditions decline or stagnate,
our revenues and operating results could be adversely affected.



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Conflicts with collaborators or licensees could harm our business.



Conflicts with collaborators could have a negative impact on our
relationships with them, including on our revenues to be derived from certain of these relationships, and impair our ability to enter into future collaborations, either of which could adversely affect our business. Collaborators could develop
competing products, preclude us from entering into collaborations with their competitors or terminate their agreements with us prematurely. Moreover, disagreements could arise with collaborators or licensees over rights to our intellectual property,
our rights to share in any of the future revenues from products or technologies resulting from use of our technologies, our rights to payments for achievement of milestones or our performance of research and development activities on behalf of
collaborators, or our activities in separate fields may conflict with other business plans of our collaborators or licensees.



We must enter into agreements with third parties to provide sales and marketing services, or develop these capabilities on our own, if we are to
successfully commercialize our products and technologies.



Although we plan to enter into sales and marketing arrangements with third parties, we may not be able to enter into these arrangements on favorable terms, if at all. We must also continue to develop a business development force with
sufficient technical expertise to generate demand for our products and technologies. Our possible inability to develop business development personnel, or contract for effective sales and marketing capabilities would significantly impair our ability
to develop and commercialize our products and technologies.



We may not be able to successfully manufacture products in commercial quantities or at acceptable costs.



The failure of our technologies to provide safe, effective, useful or commercially viable approaches to the discovery, development and/or production of
drug targets and proteins which can be used as therapeutics and diagnostic tests for diseases, such as cancer, would significantly limit our business plan and future growth.



Concentration of ownership among our existing executive officers, directors and principal stockholders may enable them to
collectively influence significant corporate transactions that require stockholder approval.



Our directors, our executive officers and principal stockholders affiliated with our directors and executive officers beneficially own, in the aggregate,
approximately 22% of our outstanding common stock as of August 5, 2004. The concentration of ownership in combination with other common stockholders may collectively influence significant corporate transactions such as mergers, changes in control,
consolidation or sale of some or all of our assets, and other significant corporate transactions requiring shareholder approval.



Our stockholder rights plan and provisions of our charter documents and Delaware law may inhibit a takeover, which could adversely affect our stock
price.



We have adopted a stockholder rights plan and
declared a dividend distribution of one right for each outstanding share of common stock to stockholders of record as of May 4, 2001. Subject to certain specified exceptions and limitations under the rights plan, we will continue to issue one right
for each share of common stock that becomes outstanding after May 4, 2001. Each right entitles the holder to purchase one unit consisting of one one-hundredth of a share of our Series A Junior Participating Preferred Stock for $45 per unit. Under
certain circumstances, if a person or group acquires 15% or more of our outstanding shares of common stock, holders of the rights (other than the person or group causing their exercisability) will be able to purchase, in exchange for the $45
exercise price, shares of our common stock or of any company into which we are merged having a value of $90. In addition, the board of directors has the option, under certain circumstances, to exchange each right (other than rights held by the
person or group triggering the board of directors option) for a share of common stock for no additional consideration on the part of the holder of the right. The rights expire on April 27, 2011. Our rights plan could make it more difficult for
a third party to acquire us (or a significant percentage of our outstanding capital stock) by causing substantial dilution of the stock ownership of a person or group attempting to acquire control of us. Our rights plan may have the effect of
discouraging takeover attempts because a potential acquirer would have to negotiate with our board of directors to avoid suffering dilution.



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Provisions in our charter and bylaws and applicable provisions of the Delaware General Corporation Law
may also make it more difficult for a third party to acquire control of us without the approval of our board of directors. These provisions may make it more difficult or expensive for a third party to acquire a majority of our common stock or delay,
prevent or deter a merger, acquisition, tender offer or proxy contest, which may adversely affect our stock price.



Risks Related to Our Industry



If companies in the pharmaceutical, biotechnology, healthcare, and life sciences industries do not succeed or their demand for our products and
technologies decreases, then our revenues could be reduced.



We expect to derive our revenues primarily from products and technologies provided to the pharmaceutical, biotechnology, healthcare and life sciences industries. Accordingly, our success will depend directly on the success of companies in
these industries and their demand for our products, services and technologies. Our operating results may fluctuate substantially due to reductions and delays in expenditures by companies in those industries, or their unwillingness or inability to
use our products and technologies. These reductions and delays may result from factors that are not within our control, such as:



| |  | changes in economic conditions generally;
| | - | -----------------------------------------



| |  | the extent to which companies in these industries conduct research and development involving diagnostics, proteomics and functional genomics in-house or through industry consortia;
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| |  | the extent to which genomic information is or is not made publicly available;
| | - | -----------------------------------------------------------------------------



| |  | consolidation within one or more of these industries;
| | - | -----------------------------------------------------



| |  | changes in the regulatory environment affecting these industries;
| | - | -----------------------------------------------------------------



| |  | pricing pressures;
| | - | ------------------



| |  | market-driven pressures on companies to consolidate and reduce costs; and/or
| | - | ----------------------------------------------------------------------------



| |  | other factors affecting spending in these industries.
| | - | -----------------------------------------------------



If competitive products are better than our products, then our business may fail.



Our human and veterinary therapeutics and vaccines are included in the highly competitive markets for protein development
and production. We face significant competition in our protein product development and production efforts from entities using alternative, and in some cases higher volume and larger scale, approaches for the same purpose. Competitors with
substantially greater resources are actively developing products similar to or competitive with our products and potential products. Our competitors may succeed in developing products or obtaining regulatory approval before we do or in developing
products that are more effective than those we develop or propose to develop. A large number of universities and other not-for-profit institutions, many of which are funded by the U.S. and foreign governments, are also conducting research to
discover genes and their functions. Any one or more of these entities may discover and establish a patent position in one or more of the genes or proteins that we wish to commercialize.



Several pharmaceutical, biotechnology, chemical and other life sciences companies engage in research and development in the
use of unique gene expression systems to produce therapeutic proteins. These competitors may develop products earlier or obtain regulatory approvals faster than we may be able to, or develop products that are more effective than ours. New
developments are expected to continue, and discoveries by others may render our products and technologies noncompetitive, which could lead to the failure of our business.



Diagnostics companies in the health care industry with more resources than us constitute varied competition for our
diagnostic technology, which is early stage. Competing diagnostic technologies may be developed and marketed that may be competitively superior to ours.



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Our collaborators and we may not obtain FDA and other approvals for our products in a timely manner,
or at all.



Drugs and certain diagnostic products and
tests are subject to an extensive and uncertain regulatory approval process by the FDA and comparable agencies in other countries. The regulation of new products and certain diagnostic products and tests is extensive, and the required process of
laboratory testing and human studies is lengthy, expensive and uncertain. The burden of these regulations will fall on us to the extent we are developing proprietary products. We may not be able to obtain the clearances and approvals necessary for
the clinical testing, field-testing, manufacturing or marketing of our products. If the products or diagnostic tests are the result of a collaborative effort, these burdens may fall on our collaborators or we may share these burdens with them. We
may not obtain FDA or other approvals for those products or tests in a timely manner, or at all. We may encounter significant delays or excessive costs in our efforts to secure necessary approvals or licenses. Even if we obtain FDA regulatory
approvals, the FDA extensively regulates manufacturing, labeling, marketing, promotion and advertising after product approval. Further, once a manufacturer obtains regulatory approval, a marketed product and its manufacturer are subject to continual
review, and discovery of previously unknown problems with a product, test or manufacturer may result in restrictions on the product, test, manufacturer or manufacturing facility, including withdrawal of the product or test from the market. In some
countries, regulatory agencies also set or approve the sale prices for drug and diagnostic products and tests. Additionally, several of our product development areas may involve relatively new technology that has not been the subject of extensive
product testing in humans. The regulatory requirements governing these products and diagnostic and tests and related clinical procedures remain uncertain and the products and tests themselves may be subject to substantial review by the FDA and
foreign governmental regulatory authorities that could prevent or delay approval. Regulatory requirements ultimately imposed on our products could limit our ability to test, manufacture and commercialize our products and tests.



USDA rules could adversely affect us or our collaborators.



We must comply with USDA regulations for outdoor releases of genetically
engineered organisms as well as other products designed for use on or with agricultural products. In addition, the USDA prohibits growing and transporting genetically modified plants except pursuant to an exemption or under special permits. We may
use genetically modified plants as screening or production hosts. Changes in USDA policy regarding the movement or field release of genetically modified plant hosts could adversely affect our business by increasing the cost of our products and
technologies or decreasing consumer demand for those products and technologies or causing the government to prohibit their sale or use. If we fail to comply with such rules or policies, we may be subject to financial loss or be liable for costs
incurred as a result of non-compliance.



If there is
negative public reaction to the use of genetically engineered products and technologies, then the market for certain products and technologies we develop will be adversely affected.



Future commercial success of some of our products and of the products of some of our collaborators will depend in part on
public acceptance of the use of genetically engineered products including drugs, plants and plant products. Claims that genetically engineered products are unsafe for consumption or pose a danger to the environment may influence public attitudes.
Negative public reaction to genetically modified organisms and products could result in greater government regulation of genetic research and resultant products, including stricter labeling requirements, and could cause a decrease in the demand for
our products, even if such products do not result from GMO organisms.



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We may be sued for product liability and our product liability insurance may not be adequate.



The testing, marketing and sale of our and our
collaborators products and diagnostic tests will entail a risk of allegations of product liability, and third parties may assert substantial product liability claims against us. While we have limited product liability insurance to protect
against this risk, adequate insurance coverage may not be available at an acceptable cost, if at all, in the future and a product liability claim or product recall could materially and adversely affect our business. Inability to obtain sufficient
insurance coverage at an acceptable cost or otherwise to protect against potential product liability claims could prevent or inhibit the commercialization of the products and diagnostic tests developed by our collaborators or us. If we are sued for
any injury allegedly caused by our products or our collaborators products, our liability could exceed our total assets and our ability to pay the liability.



If we use hazardous materials in our business in a manner that causes injury or violates laws, we may be liable for
substantial damages.



Our research and development
processes involve the use of hazardous materials, including chemicals and radioactive and biological materials. Our operations also produce hazardous waste products. The chemicals we use include, but are not limited to, flammable solvents such as
methanol and ethanol, ethidium dye which is a commonly used fluorescent dye for visualizing DNA, and buffer solutions used in the purification of DNA, and various organic solvents, acids and bases. We also use several radioisotopes including
phosphorous-32, carbon-14, sulfur-35, phosphorous-33, iodine-125 and hydrogen-3. We cannot eliminate the risk of accidental contamination or discharge and any resultant injury from these materials. Federal, state and local laws and regulations
govern the use, manufacture, storage, handling and disposal of these materials. We could be subject to civil damages and criminal penalties in the event of an improper or unauthorized release of, or exposure of individuals to, hazardous materials.
Further, it is possible that the materials we use could contaminate another partys property. In addition, claimants may sue us for injury or contamination that results from our use or the use by third parties of these materials, and our
liability may exceed our total assets and our ability to pay the liability. In addition, compliance with environmental laws and regulations is expensive, and current or future environmental regulations may impair our research and development and
production efforts. Although we have general liability insurance, these policies do not cover claims arising from pollution from chemical, radioactive or biological materials. Our collaborators may also be working with various types of hazardous
materials in connection with our collaborations. In the event of a lawsuit or investigation, we could be held responsible for any injury we or our collaborators cause to persons or property by exposure to, or release of, any hazardous materials.



Healthcare reform and restrictions on reimbursements may
limit the financial returns from our products and diagnostic tests.



Our ability and that of our collaborators to commercialize therapeutics and diagnostic products and tests may depend in part on the extent to which government health administration authorities, private health insurers
and other organizations will pay the cost of these products and tests. These third parties are increasingly challenging both the need for and the price of new medical products, tests and services. Significant uncertainty exists as to the
reimbursement status of newly approved therapeutics and diagnostics, and adequate third party reimbursement may not be available for any product to enable us to maintain price levels sufficient to realize an appropriate return on our investment in
research and product development.



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Risks Related to Our Intellectual Property



Patent protection in the biotechnology, pharmaceutical, and healthcare industries is uncertain, which may result in a
decrease in the value of our products and technologies.



We are involved in overlapping and rapidly evolving areas of biotechnology, pharmaceutical development, healthcare, and diagnostics and basic research involving viral vectors, plant transgenics, proteomics, functional genomics, protein
transformation, and immunotherapy. Each of these areas has been the subject of intense research and patenting activity throughout the world by our commercial competitors, actual and potential collaborators, academic institutions and government
researchers. We cannot determine whether or not there are patents currently pending that, if issued, would prevent us from practicing our core technologies, commercializing them or developing commercially viable products and diagnostic tests based
upon them.



The patent positions of biotechnology firms
generally are highly uncertain and involve complex legal and factual questions that will determine who has the right to develop a particular product. Changes in, or different interpretations of, patent laws in the United States and other countries
might allow others to use our discoveries or to develop and commercialize products and technologies similar to our products and technologies without any compensation to us. Our potential collaborators or customers may conclude that uncertainties
about patent protection decrease the value of our databases, products and services.



Throughout the world there are numerous issued patents, as well as published foreign patent applications which may be issued as patents, many of which relate to our current operations, our anticipated future
operations and the products we are likely to develop. The scope of these patents is a matter of legal interpretation and is subject to uncertainty. We have not obtained, but we may in the future obtain, opinions from our patent counsel that we have
freedom to conduct our commercial activities free of claims of patent infringement from third parties. From time to time, we receive letters from third parties that allege patent infringement on our part. Disagreements arising from these letters
could result in costly and time-consuming litigation and divert our financial and managerial resources. In addition, if we are ever determined to infringe the patent of any third party, we may be required to obtain a license to use this patent,
which would increase our cost of doing business.



Our patent
applications may not result in issued patents that are enforceable.



Our disclosures in our patent applications may not be sufficient to meet the statutory requirements for patentability in all cases. As a result, we do not know which of our patent applications will result in
enforceable patents. Our patent applications may not be issued as patents, and any patents that are issued to us may not provide commercially meaningful protection against competitors. Any issued patent may not provide us with competitive
advantages. Others may challenge our patents or independently develop similar products that could result in an interference proceeding in the U.S. Patent and Trademark Office. Others may be able to design around our issued patents or develop
products similar to our products. In addition, others may discover uses for genes or proteins other than those uses covered in our patents, and these other uses may be separately patentable.



Public disclosure and patents relating to genes and gene sequences and
diagnostic products and tests held by others may limit our proprietary rights.



The Human Genome Project and many companies and institutions have identified genes and deposited those sequences in public databases and are continuing to do so. These public disclosures might limit the scope of our
claims or make unpatentable subsequent patent applications on full-length gene sequences. We are aware of issued patents and patent applications containing subject matter such that we or our licensees or collaborators may require a license or rights
in order to research, develop or commercialize some of our products, diagnostic tests and technologies. We may find that licenses relating to such subject matter will not be available on acceptable terms, or at all.



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Patent infringement or enforcement litigation or interference proceedings could be costly and disrupt
our business and may prevent us from commercializing our products and diagnostic tests.



The technology that we use to develop our products, diagnostic tests and key resources, and those that we incorporate in our products, diagnostic tests and technologies, may be subject to claims by third parties,
including our collaborators, that they infringe the patents or proprietary rights of others. Technologies of our collaborators may also be subject to infringement or similar claims which could impair our collaborative product and diagnostic test
development and commercialization efforts. We also may need to enforce our patent rights in actions against others, which could be expensive. The risk of such events occurring will tend to increase as the fields of proteomics, genomics, health care
and the biotechnology industry expand, more patents are issued and other companies attempt to discover genes and proteins and engage in other proteomics, genomics, diagnostics and biotechnology-related businesses.



With respect to identifying proteins uniquely associated with disease states
or as targets for drug therapy, we are aware that companies have published patent applications relating to nucleic acids encoding specific proteins. We are also aware of issued and pending patent applications covering certain aspects of
bioinformatic-based diagnostic testing. The issued patents by the U.S. Patent and Trademark Office to these companies, may limit our ability and the ability of our collaborators to practice under any patents that may be issued to us. Also, even if
the U.S. Patent and Trademark office issues us a patent, the scope of coverage or protection afforded to the patent may be limited.



We may not be able to protect our know-how and trade secrets.



We generally control the disclosure and use of our know-how and trade secrets using confidentiality agreements. It is
possible, however, that:



| |  | Some or all confidentiality agreements will not be honored;
| | - | -----------------------------------------------------------



| |  | Third parties will independently develop equivalent technology;
| | - | ---------------------------------------------------------------



| |  | Disputes might arise with our consultants, collaborators or others concerning the ownership of intellectual property; and/or
| | - | ----------------------------------------------------------------------------------------------------------------------------



| |  | Unauthorized disclosure of our know-how or trade secrets will occur
| | - | -------------------------------------------------------------------



Item 3. Quantitative and Qualitative Disclosures About Market Risk



Information regarding our exposures to market risks is provided in Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2003. There
have been no material changes to our exposures to market risk since December 31, 2003.



Item 4. Controls and Procedures



(a) Disclosure controls and procedures. Our Chief Executive Officer and Chief Financial Officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in the Exchange Act Rules 13a-15(e)
and 15d-15(e)) as of the end of the period covered by this report on Form 10-Q, have concluded that as of the end of the period covered by this report, our disclosure controls and procedures were adequate and designed to ensure that material
information related to us and our consolidated subsidiaries would be made known to them by others within these entities.



(b) Changes in internal controls over financial reporting. During the second quarter of fiscal year 2004, there were no changes in our internal
controls over financial reporting identified in connection with the evaluation required by paragraph (d) of Exchange Act Rule 13a-15 or 15d-15 that have materially affected, or are reasonably likely to materially affect, our internal controls over
financial reporting.



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PART II  OTHER INFORMATION



Item 2. Changes in Securities, Use of Proceeds and Issuer Purchases of Equity Securities



(e) Issuer Purchases: None.



Item 6. Exhibits and Reports on Form 8-K



(a) List of Exhibits:



|              |  |                                                                                                                                                       
|------------- |  | ------------------------------------------------------------------------------------------------------------------------------------------------------
|ExhibitNumber |  | Exhibit Title or Description                                                                                                                          
|31.1          |  | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act.                                                   
|              | 
|31.2          |  | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act.                                                   
|              | 
|32.1          |  | Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|              | 
|32.2          |  | Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.



(b) Reports on Form
8-K:



None.



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SIGNATURE



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





|                      |  |                                                                           
|--------------------- |  | --------------------------------------------------------------------------
|                      |  | Large Scale Biology Corporation                                           
|                      | 
|Date: August 16, 2004 |  | By: /s/ Ronald J. Artale                                                  
|                      |  | Ronald J. Artale                                                          
|                      |  | Senior Vice President, Chief Operating Officer and Chief Financial Officer
|                      |  | (Principal Financial Officer)                                             



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Exhibit Index



|              |  |                                                                                                                                                       
|------------- |  | ------------------------------------------------------------------------------------------------------------------------------------------------------
|ExhibitNumber |  | Exhibit Title or Description                                                                                                                          
|31.1          |  | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act.                                                   
|              | 
|31.2          |  | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act.                                                   
|              | 
|32.1          |  | Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|              | 
|32.2          |  | Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.