As its lead product nears completion of a Phase III trial, Inhibitex Inc. entered into agreements to raise $41.3 million through a private placement.
The Alpharetta, Ga.-based company will issue 5 million shares of common stock at $8.25 each to a group of institutional investors. The financing is expected to close by Monday.
Inhibitex intends to use net proceeds to continue development of Veronate, and to advance its Aurexis clinical program. Remaining funds will support the company's preclinical and research programs, and cover general corporate purposes.
Since the shares in this financing were registered with the SEC as part of the PIPE (private investment in a public entity) financing, Inhibitex's management declined to comment.
According to the company's SEC filings, its lead product Veronate entered a Phase III trial in May 2004 to prevent hospital-associated infections in premature infants. A Phase II trial completed earlier this year showed favorable results in the primary composite endpoint of mortality, relapse rate and infection-related complications, as well as in a number of secondary endpoints, including the progression in the severity of sepsis and days in the intensive care unit.
About two weeks ago, the company said it had enrolled 1,500 of the 2,000 patients required for the Phase III trial. Enrollment should be complete by the end of November. Inhibitex expects top-line data in the second quarter of 2006. If positive, the company intends to submit a regulatory filing with the FDA. Veronate has fast-track and orphan drug status from the FDA.
Inhibitex's second product, Aurexis, just completed a Phase II trial in 60 patients with life-threatening Staphylococcus aureus bloodstream infections. The hospitalized patients were treated with Aurexis in combination with antibiotics. The company currently is designing a larger, follow-on, Phase II or Phase III trial that should begin around the end of this year. Aurexis also is being studied in a 30-patient Phase II trial to evaluate its impact on S. aureus bacterial load and pulmonary inflammation in cystic fibrosis patients. A humanized monoclonal antibody, Aurexis targets the same MSCRAMM protein as Veronate.
At the earlier stage of development, Inhibitex is working on a humanized monoclonal antibody to address enterococcus, another pathogen found in the hospital setting. That product is in preclinical studies with partner Dyax Corp., of Cambridge, Mass.
And, in addition to studying a monoclonal antibody against S. epidermidis, Inhibitex has outlicensed technology to Wyeth, of Madison, N.J., to develop an active vaccine against S. aureus.
Founded in May 1994, Inhibitex raised $39 million in its initial public offering conducted in June 2004. Later that year, it raised $50 million in a private placement to help fund the Phase III trial of Veronate. (See BioWorld Today, June 7, 2004, and Nov. 8, 2004.)
Neither of the company's clinical products is partnered.
Inhibitex's stock (NASDAQ:INHX) rose 24 cents on Thursday to close at $9.04.