BioCryst Pharmaceuticals Inc., which plans to begin enrolling patients this quarter in a pivotal study of its oral cancer drug, Fodosine, in cutaneous T-cell lymphoma, padded its balance sheet with a $65.3 million private placement.
The Birmingham, Ala.-based firm agreed to place 8.3 million shares of stock and warrants, priced at $7.80 per share, to existing investors, including funds managed by Baker Brothers Investments, Kleiner Perkins Caulfield & Byers, EHS Holdings, OrbiMed Advisors, Texas Pacific Group Ventures and Stephens Investment Management.
It's a "great endorsement by some experienced investors," said BioCryst CEO Jon Stonehouse, and it "gives us the financial power" to execute the company's business plan, including clinical and preclinical development.
BioCryst updated investors in March of its plan to, at least temporarily, put off development of an intravenous formulation of its lead program, Fodosine, in T-cell acute lymphoblastic lymphoma/leukemia in favor of moving forward with an oral version of the purine nucleoside phosphorylase (PNP) inhibitor in cutaneous T-cell lymphoma (CTCL). Last month, the company reached an agreement with the FDA on a special protocol assessment for a pivotal trial in CTCL, and that trial, which is designed to measure objective response rate with a once-daily oral Fodosine regimen, is expected to start enrolling CTCL patients with Stage Ib through Stage IVa disease later this quarter. (See BioWorld Today, March, 28, 2007.)
Fodosine is partnered with Cambridge, UK-based Mundipharma International Holdings Ltd., which is responsible for overseas development.
Through partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland, BioCryst is moving another PNP inhibitor through clinical development for autoimmune disease. BCX-4208 started its first Phase II trial last month in psoriasis, "and we're really hopeful of that compound," since it's the first of the company's PNP inhibitors to be tested against autoimmune disease, Stonehouse told BioWorld Today. "If successful, there's a lot of value" for its potential use in other autoimmune disorders.
The firm also continues to advance its influenza drug, peramivir. A neuraminidase inhibitor, peramivir is in development for both seasonal and life-threatening forms of flu, and has demonstrated efficacy against a number of laboratory strains. Its ongoing development is augmented by a four-year $102.6 million contract awarded early this year by the Department of Health and Human Services. That money is earmarked for worldwide Phase II and Phase III studies, manufacturing and production process validation, as well as other regulatory requirements. (See BioWorld Today, Jan. 5, 2007.)
Most recently, the company started a Phase II trial in hospitalized patients with an intravenous version of peramivir. That study is testing BioCryst's drug against the orally administered Tamiflu (oseltamivir, Roche). A separate Phase III trial is ongoing using an intramuscular formulation in flu patients in an outpatient setting. Pivotal studies of peramivir are expected "in the near future," Stonehouse said.
In preclinical development, BioCryst is testing additional PNP inhibitors in indications such as HIV and gout, and is hoping to advance a group of antiviral compounds in hepatitis C and other diseases.
Overall, the recent financing should "give us a lot of runway," Stonehouse said. The company, which expects to report its second-quarter earnings later this week, posted a net loss of $8.8 million, or 30 cents per share, for the first three months of 2007 and ended that quarter with $42.8 million in cash.
Additional terms of the financing call for an exercise price for the warrants of $10.25. Investors agreed to pay an additional purchase price of 12.5 cents for each share underlying the warrants.
BioCryst's stock (NASDAQ:BCRX) closed at $8.72 Monday, up 84 cents.