Attempting a second try at the public markets, BioNumerik Pharmaceuticals Inc. set out to raise $86.25 million in an initial public offering more than three years after it filed the first time.

The San Antonio-based company said in its SEC filing that it plans to use proceeds for the clinical development, manufacturing and marketing of its most advanced cancer products, Tavocept and BNP1350, as well as for other research and development activities, and for general corporate purposes.

BioNumerik, which is in an SEC-imposed quiet period, did not specify the number of shares to be offered or the expected price range. It plans to list its stock on the Nasdaq National Market under the symbol "BNPI." New York-based UBS Investment Bank will serve as lead underwriter, with Needham & Co. Inc., Leerink Swann & Co. and Punk, Ziegel & Co., all of New York, acting as co-managers.

As of March 31, BioNumerik had cash, cash equivalents and short-term investments of $33.24 million. With the IPO proceeds, BioNumerik would have enough money to carry it through 24 months of operations.

The company's lead product, Tavocept, is designed to prevent neuropathy, or nerve damage, often caused by the taxane and platinum classes of chemotherapy drugs (paclitaxel and cisplatin), without impairing their antitumor benefits. The FDA granted Tavocept fast-track status, as there are no FDA-approved treatments to prevent or reduce neuropathy caused by chemotherapy. The compound is being studied in three Phase III trials in the U.S., Europe and Japan in patients with metastatic breast cancer and advanced non-small-cell lung cancer. Under a best-case scenario, the company expects to file for regulatory approval in the U.S. and Europe sometime in 2006.

BioNumerik's second product, BNP1350, is an antitumor drug in the camptothecin class that appears to have fewer side effects and an improved safety profile. It could provide a lower incidence of diarrhea than can be caused by irinotecan, as well as a lower incidence of reduced red and white blood cell counts that can be caused by topotecan. The company has completed one Phase II trial and is conducting another three evaluating the product administered intravenously in patients with advanced non-small-cell lung cancer, brain tumors, metastatic melanoma and advanced ovarian cancer. BNP1350 also is being studied in Phase I trials as an orally administered product. BioNumerik plans on starting a Phase III trial in the first half of 2005. Combined worldwide sales of camptothecins were about $940 million in 2003, BioNumerik said in its filing.

Baxter Healthcare SA holds the rights to exclusively develop, market, distribute and sell Tavocept in all markets other than the U.S., Canada and Japan. Grelan Pharmaceutical Co. Ltd., of Tokyo, holds exclusive rights to both Tavocept and BNP1350 in Japan.

Founded in May 1992, BioNumerik has a strategy to get its two most advanced products on the market for initial indications, and then to expand their development into additional indications.

Aside from those products, the company intends to use its mechanism-based approach to design and develop new drugs. The approach integrates chemistry, biology and physics-based molecular simulations using high-performance computing. It allows BioNumerik to conduct laboratory evaluations on a reduced number of compounds, making the process more cost-effective and efficient.

The company also has one other early clinical product, MDAM, a non-polyglutamylatable antifolate, to treat solid tumors, rheumatoid arthritis, psoriasis and asthma. MDAM has demonstrated in preclinical studies superior safety and antitumor activity relative to methotrexate.

BioNumerik attempted an IPO in March 2001, when it filed to raise $50 million. Officials withdrew the filing in November of that year due to unfavorable market conditions. (See BioWorld Today, March 6, 2001.)

The company last raised $29 million in a private placement with existing investors toward the end of last year. (See BioWorld Today, Dec. 18, 2003.)

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