Lev Pharmaceuticals Inc. is expecting to raise $35 million from a registered direct offering to advance Cinryze, its C1 inhibitor for hereditary angioedema.
The New York-based firm plans to sell about 23.3 million units priced at $1.50 each to a select group of institutional investors. Each unit consists of one share of common stock and warrants to purchase an additional 0.2 shares of common stock. The exercise price for the warrants is set at $1.86 per share.
At closing, expected to take place Aug. 17, the biopharmaceutical maker plans to issue about 23.3 million shares of common stock and warrants to purchase about 4.7 million shares of common stock to the investors.
As of June 30, the 4-year-old company had about $8.4 million in cash and cash equivalents, according to the firm's prospectus.
Chief Executive Officer Joshua D. Schein told BioWorld Today the funds will be used as working capital to conclude the development of Lev's C1 inhibitor Cinryze.
The firm submitted a biological license application to the FDA July 31 seeking approval for the product to treat hereditary angioedema, a genetic disorder that causes episodes of swelling in the hands, feet, face, gastrointestinal tract and airway passages. (See BioWorld Today, Aug. 1, 2007.)
Lev was the first company to seek U.S. approval of a treatment for the condition. The FDA granted Cinryze orphan drug status, a provision that provides sponsors certain benefits, such as tax credits and market exclusivity, from the government in exchange for developing products for rare diseases. The designation generally results in shorter approval times for products.
Schein said Cinryze also received fast-track status, which expedites the review of products. He said he expects Cinryze to receive approval for the HAE indication in the next six months. The firm plans to launch the product in the first quarter of 2008, he added.
Lev also is evaluating the development of the C1 inhibitor for the treatment of acute myocardial infarction and selective other diseases and disorders in which inflammation is known or believed to play an underlying role.
Schein said the $35 million, which does not include placement agent fees and estimated offering expenses, will put the company "in a very good financial position."
Jefferies & Co. Inc. acted as lead placement agent, CIBC World Markets Corp. served as co-lead placement agent and Morgan Joseph & Co. Inc. acted as co-placement agent for the transaction.
In other financing news:
• Alseres Pharmaceuticals Inc., of Hopkinton, Mass., amended a convertible promissory note purchase agreement from May, a change that allows it to borrow up to $10 million from Ingalls & Snyder Value Partners LP, a new purchaser. Alseres recently changed its name from Boston Life Sciences Inc. It is developing Altropane, a Phase III-stage molecular imaging agent for diagnosing Parkinson's disease, and Cethrin, a recombinant protein-based drug in Phase I/IIa development for promoting nerve repair after acute spinal cord injury. It also has products in the research and preclinical stages.
• Celsense Inc., Glucose Sensing Technologies LLC and Falcon Genomics Inc., all of Pittsburgh, received a total of $350,000 from a public-private partnership known as the Pittsburgh Life Sciences Greenhouse. The investment will support Falcon Genomics' validation of its Cancer BioChip System, the development and testing of Glucose Sensing Technologies' catheter for measuring blood glucose levels in intensive care settings and Celsense's commercialization of its MRI tracer agent product Cell Sense.
• Neurobiological Technologies Inc., of Emeryville, Calif., filed a registration statement with the SEC seeking to raise up to $65 million in a proposed public offering of common stock. Proceeds from the offering will be used primarily to fund the ongoing clinical development of Viprinex (ancrod), a novel reperfusion agent that is in pivotal Phase III trials for the treatment of acute ischemic stroke.
• SyntheMed Inc., of Iselin, N.J., completed an initial, $2.8 million closing of a private placement. It sold 2.8 million shares at $1 per share, and authorized the sale of an additional 3.2 million shares on the same terms. Funds will be used to support the launch later this year of its Repel-CV Adhesion Barrier products. SyntheMed is a biomaterials company developing anti-adhesion and drug-delivery products based on its bioresorbable polymer technology.