With a marketing authorization application for the pain patch NGX-4010 under review by the European Medicines Agency, NeurogesX Inc. is raising $25 million in a private placement of stock and warrants.
The San Mateo, Calif.-based company agreed to sell about 4 million shares of common stock priced at $6.18 per share, along with five-year warrants to purchase an additional 1.2 million shares with an exercise price of $8.034 per share. The warrants were purchased at a price per underlying share of $0.125.
Although NeurogesX's stock (NASDAQ:NGSX) rose 11 cents to close at $6.15 Wednesday, it still is trading about 40 percent below its May initial public offering price of $11 per share. Positive data from the third Phase III trial of NGX-4010 gave the stock a boost in September, but the effect was short-lived. (See BioWorld Today, May 3, 2007, and Sept. 5, 2007.)
Despite its recent slump, NeurogesX's stock may benefit next year from several milestones expected with NGX-4010, a transdermal agonist of transient receptor potential vanilloid subfamily 1 (TRPV1) based on synthetic capsaicin.
The drug already met its endpoints in two Phase III trials for postherpetic neuralgia (PHN) and in one Phase III trial for HIV-associated distal sensory polyneuropathy (HIV-DSP).
In the first quarter, data are expected from a fourth Phase III trial of NGX-4010, the second to be conducted in HIV-DSP. Once that trial is completed, NeurogesX plans to pursue FDA approval for PHN and HIV-DSP, with a new drug application filing anticipated by the end of 2008. The company also is planning ahead for a label expansion into the lucrative diabetic neuropathy market and expects to begin a clinical program targeting that indication in the first half of 2008.
In Europe, NeurogesX is seeking approval of NGX-4010 in the broad indication of peripheral neuropathic pain, which includes painful diabetic neuropathy. The company's marketing authorization application, based on the three completed Phase III trials, was accepted for review in September.
NeurogesX also may sign a European marketing deal for NGX-4010 in 2008. Company spokespersons declined to comment Wednesday, but NeurogesX previously said it is in the process of seeking such a deal.
If previous TRPV deals are any indication, the company shouldn't have too much trouble attracting interest. Earlier this year, Glenmark Pharmaceuticals Ltd. licensed its Phase II TRPV1 antagonist pain treatment to Eli Lilly and Co. in a deal potentially worth more than $350 million, and Hydra Biosciences Inc. licensed pain applications for its TRPV3 antagonist program to Pfizer Inc. in a deal valued at up to $195 million. (See BioWorld Today, July 27, 2007, and Oct. 31, 2007.)
Although both Glenmark and Hydra's programs seek to block the activation of TRPV pain receptors, NGX-4010 attempts to knock the receptors out of commission through overstimulation.
NeurogesX also could have a non-NGX-4010 milestone to look forward to in 2008. The firm anticipates submitting an investigational new drug application for NGX-1998, a dermally delivered liquid formulation of synthetic capsaicin.
Pacific Growth Equities LLC served as exclusive placement agent for NeurogesX's financing, which will supplement the $39.3 million in cash, equivalents and short-term investments the company reported as of Nov. 30. Operating expenses during the quarter were $9.5 million, leading to a net loss of $9.2 million.
In other financing news:
• Anesiva Inc., of South San Francisco, said Friday that it closed its previously announced public offering of 11.1 million shares of common stock priced at $4.05 each. Net proceeds totaled $47.7 million, including the additional 1.2 million shares sold to cover overallotments, and will be used for clinical trials and for development of the company's pain products. Pacific Growth Equities LLC, Broadpoint Capital Inc. and Fortis Securities LLC served as underwriters for the offering. Shares of Anesiva (NASDAQ:ANSV) closed at $4.98 Wednesday, up 26 cents. (See BioWorld Today, Dec. 14, 2007.)
• AspenBio Pharma Inc., of Castle Rock, Colo., closed its previously announced private placement, raising gross proceeds of $18.2 million through the sale of 2.5 million shares of common stock. Oppenheimer & Co. Inc. acted as the placement agent for the financing. The money will be used to support development of the company's blood test for human appendicitis and several animal health products.
• Dyax Corp., of Cambridge, Mass., filed a universal shelf registration statement to allow the company to raise up to $100 million through the future sale of stock, debt and other securities. Specific terms will be determined at the time of any offering. Proceeds would be used for general corporate purposes, including clinical trials such as the ongoing Phase III study of recombinant plasma kallikrien inhibitor DX-88 (ecallantide) for hereditary angioedema (HAE).