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Biotech / Medical : Corixa [CRXA] - cancer vaccines

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To: Andreas Helke who started this subject10/26/2000 11:48:01 AM
From: nigel bates   of 222
 
BW HealthWire--Oct. 26, 2000--Corixa Corporation (Nasdaq:CRXA - news), a research- and development-based biotechnology company, today announced results for the third quarter ended September 30, 2000 and the first nine months of 2000.
For the third quarter of 2000, Corixa reported total revenue of $17.4 million compared with total revenue of $8.2 million for the third quarter of 1999. Net loss applicable to common stockholders for the third quarter of 2000 was $2.8 million compared with $1.3 million for the third quarter of 1999. Diluted net loss per common share for the third quarter of 2000 was $0.13 compared with diluted net loss per common share of $0.09 in for the third quarter of 1999.
For the first nine months of 2000, Corixa's total revenue was $33.6 million, compared to total revenue of $17.4 million for the first nine months of 1999. For the first nine months of 2000, net loss applicable to common stockholders was $21.2 million compared with $28.4 million for the first nine months of 1999. The net loss applicable to common stockholders for the nine month periods ended September 30, 2000 and 1999 include accrued dividends payable of $468,000 and $5.8 million, respectively, associated with Corixa's $50 million equity line of credit. Diluted net loss per common share for the first nine months of 2000 was $1.05 compared to diluted net loss per common share of $1.95 for the first nine months of 1999. The increase in revenue for the third quarter of 2000 and the first nine months of 2000 was due primarily to an upfront fee received as a result of a development, commercialization and license agreement related to the Company's PVAC(TM) treatment.
In 1999, the Securities and Exchange Commission (SEC) issued new guidelines regarding revenue recognition, which are required to be implemented by the fourth quarter of 2000. Corixa continues to recognize revenue in accordance with its historical revenue recognition policy while it evaluates the impact of the new guidelines. Depending on final implementation of the new guidelines, certain fees, and related expenses, if any, including the PVAC treatment upfront fee, may be required to be amortized over future periods. Net loss applicable to common stockholders for the third quarter of 2000 would have been $7.3 million (a net loss of $0.35 per share) if recognition of the upfront fee had been deferred.
At the end of the quarter, Corixa had more than $108.7 million in cash, cash equivalents and investments representing a net increase of $63.1 million as compared to December 31, 1999, due primarily to our public offering of Corixa common stock in April 2000.
Corixa expects its quarterly revenues to continue to vary as it enters into new agreements, reaches research milestones and receives license payments. Corixa also expects operating expenses to continue to increase as it adds to the number and scope of its research and development programs and as products currently under its control progress into, or through, clinical trials.
``Corixa enjoyed a third quarter filled with success, making demonstrable progress in both research and product development,'' stated Steven Gillis, chairman and chief executive officer of Corixa. ``We signed a major license agreement with Medicis regarding the development and marketing of PVAC, our potential product for the treatment of psoriasis in the United States and Canada, as well as another antibody partnership, in this case with Purdue Pharma, L.P. We visited with the FDA regarding the status of our Melacine® vaccine development and announced our intention to file a Biological License Application for the treatment of Stage II melanoma in the second quarter of 2001, and our tuberculosis vaccine program received additional external validation through the award of a Challenge Grant from the National Institutes of Allergy and Infectious Disease.''
Gillis added, ``On the financial front, we ended the quarter with over $100 million in cash and cash equivalents, representing the strongest financial position in our history. These developments serve as a strong foundation as we enter into our proposed merger with Coulter Pharmaceutical, Inc., based in South San Francisco. The merger with Coulter will add additional antibody and targeted oncologics technologies to our discovery platform, a major antibody therapeutic product candidate with the potential for significant near-term revenue -- Bexxar(TM) -- for treatment of low grade lymphoma, as well as a targeted sales and marketing capability. We look forward to closing the merger by year-end and to continued strong performance from the combined company.''
Recent Accomplishments
On October 16, 2000, Corixa announced its intent to merge with Coulter Pharmaceutical, a South San Francisco-based biopharmaceutical company. The merger will create a comprehensive immunotherapy company who's combined product portfolio will include two late-stage clinical products for which Biologics License Applications (BLAs) have been filed or are in preparation, 16 programs in clinical development, 22 preclinical programs and 16 corporate partnerships focusing on autoimmune diseases, cancer and infectious diseases. The combined product pipeline will include Bexxar (tositumomab, iodine I 131 tositumomab), Coulter's candidate cancer therapeutic comprised of a monoclonal antibody conjugated to a radioisotope; Melacine, Corixa's therapeutic cancer vaccine; MPL®, Corixa's widely used vaccine adjuvant; and PVAC, Corixa's development-stage treatment for psoriasis.
On September 29, 2000 -- Corixa was awarded a $2.3 million Challenge Grant from the National Institute of Allergy and Infectious Diseases (NIAID) to develop a new candidate vaccine for the treatment of tuberculosis. As a result, Corixa will conduct preclinical and clinical testing of a new vaccine produced using M. tuberculosis proteins, combined with formulations developed by SmithKline Beecham Biologicals containing components discovered and manufactured by Corixa. Corixa scientists will test these proteins in animals for their ability to stimulate an appropriate immune response, and then combine several of these proteins into a vaccine for further testing.
On September 27, Corixa announced its intent to file for U.S. regulatory approval its Melacine melanoma vaccine. The BLA will be based predominantly on data from the recently completed Phase III study of the use of Melacine vaccine for the treatment of Stage II melanoma that started enrollment in April 1992 and has followed patients through January 2000. The filing will also contain data following the same group of patients through January 2001.
On September 25, Corixa and Purdue Pharma L.P. announced a collaboration focused on tumor-antigen research and development. Under the terms of the agreement, Corixa and Purdue may develop up to four therapeutic antibodies directed against cell surface antigens chosen from selected Corixa tumor-antigen discovery programs. Corixa will provide Purdue with an opportunity to develop antibody-based therapeutics against four tumor antigens. Purdue will provide Corixa with guaranteed research funding, and based on the outcome of pre-clinical studies, Purdue may license the antibodies and targets from Corixa worldwide under currently defined terms that include up-front license fees, milestone payments and royalties.
On August 16, at its first annual analyst conference in Bellevue, Wash., Corixa provided updates on key company product developments, including the current clinical trial status of the company's PVAC treatment for psoriasis, Phase III clinical trial results for its Melacine melanoma vaccine clinical, and updates on additional programs in the company's preclinical and clinical pipeline.
On August 15, Corixa announced a multi-year license agreement with Medicis Pharmaceutical Corporation for the development and commercialization of Corixa's candidate psoriasis immunotherapeutic product, PVAC(TM) treatment. The agreement provides Medicis with exclusive rights to PVAC treatment in the United States and Canada. Under the terms of the agreement, Medicis has agreed to pay Corixa license fees, research funding and milestone payments of up to $107 million.
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