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PRESS RELEASES Biokeys Pharmaceuticals, Inc. Completes Private Placement of Common Stock and Warrants Additional Capital Provides Funds for Clinical Trial Programs San Diego May 28, 2003 Biokeys Pharmaceuticals, Inc. (OTCBB:BKYS - News), a biopharmaceutical company specializing in HIV/AIDS and Cancer therapeutics, today announced that it has completed a private placement of its common stock and warrants for gross proceeds of over $2 million. A select group of institutional and accredited investors participated in the private placement. The offering consisted of the sale of approximately 5,000,000 unregistered shares of the Company's common stock and the issuance of warrants to purchase an aggregate of just over 1,500,000 shares of the Company's common stock. The Company plans to use its current funds and the proceeds from this offering to finance its clinical trial programs. "This capital infusion, by such a respected group of investors, is a further endorsement that the successful results achieved by our scientific team represent significant progress in furthering the development of our drugs, " said Nicholas Virca, the Chief Executive Officer. "This new equity, combined with existing funds, gives us the ability to advance our two lead HIV therapies into the clinic and to also conduct further human testing, in a Phase II trial, of our key cancer drug for colorectal cancer." Biokeys Pharmaceuticals has set an aggressive agenda for 2003. During the third quarter, the Company plans to initiate a Phase Ib/IIa clinical trial for BlockAide/CR(TM). This new drug is a viral entry inhibitor that has demonstrated the ability to reduce HIV viral load by 100-fold in approximately two weeks of daily dosing, with no observable toxicity, in a primate model with acute infection. We anticipate filing an Investigational New Drug Application (the "IND") with the Food and Drug Administration (the "FDA ") in August 2003 with trials expected to begin in September 2003. Also during third quarter, the Company intends to begin a Phase II trial for CoFactor(TM) for first-line treatment of metastatic colorectal cancer patients. An IND to test this drug, in conjunction with 5-FU, has already been approved by the FDA. A previous Phase I/II trial of CoFactor treatment for gastrointestinal and breast cancers demonstrated dramatic improvement in the antitumor effects of 5-FU. Later in the year, the Company expects to initiate a Phase Ib/IIa clinical trial for EradicAide(TM), an HIV therapeutic vaccine that has demonstrated the ability to reduce HIV viral load to undetectable levels during non-human primate trials, which were designed to test the efficacy of this therapy. A single series of treatments was able to sustain viral inhibition for as long as three years, with no viral transmissibility, and no reported toxicities. About BKYS Biokeys Pharmaceuticals Inc. is a biopharmaceutical research and development company whose business strategy is to commercialize leading edge medical research through licensing agreements with prominent universities and research institutions. The Company is focusing its resources in anticancer and antiviral research to launch products that either extend the usefulness of current therapies or replace marginal therapies with new approaches to treatment. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are made based on management's current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the United States Food and Drug Administration. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof. CONTACT: Biokeys Pharmaceuticals Inc. Beth Marion, 858/271-9671 Fax: 8581/271-9678 beth@bkys.com |