CepTor Corp. Inc. entered a financing deal that could bring in up to $20 million over the next few years, as it prepares to move into Phase I/II trials with its lead product, Myodur, in Duchenne's muscular dystrophy.
The Hunt Valley, Md.-based company entered a common stock purchase agreement with Fusion Capital Fund II LLC, of Chicago, in which Fusion agreed to purchase stock over a 40-month period. According to the company's SEC filing, CepTor can sell $500,000 of its common stock per month to Fusion, based upon the market price the day of the sale. CepTor is responsible for controlling the timing and amount of the stock sales.
A spokeswoman for CepTor said Chairman and CEO William Pursley was in meetings Tuesday and could not be reached for comment. But Pursley stated in a press release that the financing arrangement will help "execute [CepTor's] development plan for Myodur in Duchenne's muscular dystrophy."
The company expects to file an investigational new drug application for Myodur to begin clinical testing early next year. CepTor also filed an application this week requesting the FDA to designate Myodur as an orphan drug product in the treatment of Duchenne's (DMD) and Becker's muscular dystrophy (BMD).
It is estimated that DMD affects about 25,000 people in the U.S. and European Union. That figure doubles when factoring in the world's remaining regions. Both DMD and BMD are forms of an X-linked genetic disease, generally affecting males, and are characterized by a weakening and degeneration of the skeletal muscles that control movement. The more severe of the two, DMD affects children, and patients suffering DMD rarely live past the age of 20. BMD is a less aggressive form that affects adults, and is estimated to comprise about 10 percent to 15 percent of the overall market.
The gene defect in muscular dystrophy is believed to lead to an inadequate amount of dystrophin, which causes poor muscle cell membrane integrity and allows for an up-regulation of calpain. Myodur was designed to include a leupeptin analogue, which has been shown to inhibit calpain. In preclinical studies, Myodur was shown to be as effective as leupeptin in preserving muscle tissue, though Myodur required much lower doses. The product also has a second component: a carnitine carrier molecule, which targets muscle cells. In a mouse model, the drug also showed statistically significant superiority to placebo in preserving muscle mass.
While its main focus is on advancing Myodur into clinical trials, CepTor also is developing several other programs to treat multiple sclerosis, retinal degeneration and epilepsy.
CepTor's stock (OTC BB:CEPO) dropped 10 cents Tuesday to close at $1.60.
In other financing news:
Cadence Pharmaceuticals Inc., of San Diego, completed a $25 million Series A round, led by Domain Associates, of Princeton, N.J. Proceeds will be used to complete the company's confirmatory Phase III study of omiganan 1 percent gel (CPI-226) for catheter-related infections, as well as to advance efforts in acquiring additional hospital-focused drugs and drug candidates. Princeton-based ProQuest Investments; Zurich, Switzerland-based BB Biotech Ventures; Taipei, Taiwan-based CDIB BioScience Venture Management and San Diego-based Windamere Venture Partners also participated in the financing.
Dynavax Technologies Corp., of Berkeley, Calif., is raising $31 million through the public offering of 5 million shares of its common stock priced at $6.25 each. That represents an increase of 1 million shares over the company's previously announced offering. Proceeds are expected to go toward general corporate purposes, including clinical trials, research and development. The company is in Phase IIb studies of Tolamba, a ragweed allergy immunotherapeutic. It has a hepatitis B vaccine, Heplisav, in a pivotal Phase III trial and a cancer therapy in Phase II studies. Dynavax also granted underwriters an option to purchase an additional 750,000 shares to cover any overallotments. New York-based Bear, Stearns & Co. Inc. is acting as lead manager, while CIBC World Markets Corp., also of New York, and Pacific Growth Equities LLC, of San Francisco, are acting as co-managers. The offering is expected to close Oct. 14. Shares of Dynavax (NASDAQ:DVAX) lost 2.5 cents Tuesday to close at $6.25.
GlycoFi Inc., of Lebanon, N.H., closed an $11 million financing. The round was oversubscribed and was an extension of the $10 million Series C financing closed in December 2003. Proceeds will be used to take the company's protein optimization technology platform to the next level of commercialization. Participating in the additional investment round were existing investors, including Boston firms Polaris Venture Partners, SV Life Sciences, Boston Millennia Partners, and Fletcher Spaght Ventures, along with Village Ventures, of Williamstown, Mass., and Borealis Ventures, of Hanover, N.H. New investors were London-based International Biotechnology Trust; Menlo Park, Calif.-based Peninsula Equity Partners; and Indianapolis-based Eli Lilly and Co. In conjunction with the financing, John Fletcher, of Fletcher Spaght Ventures, and Pat Fortune, of Boston Millennia Partners, joined GlycoFi's board. (See BioWorld Today, Dec. 11, 2003.)
GTx Inc., of Memphis, Tenn., filed a statement to sell 5 million shares of newly issued common stock, and will grant underwriters a 30-day option to purchase up to an additional 750,000 shares. The company said it expects to use proceeds to fund clinical development and other research and development activities, as well as for working capital and general corporate purposes. GTx anticipates the funding, along with its current cash resources and product revenue expected from the sale of Fareston, to sustain the company's operations through the first half of 2007. New York firms Lazard Capital Markets LLC and SG Cowen & Co. LLC are acting as joint book-running managers for the offering. Shares of GTx (NASDAQ:GTXI) closed at $7.80 Tuesday, down 33 cents.
Predicant Biosciences, of South San Francisco, received $7.5 million in debt financing from Hercules Technology Growth Capital Inc., of Palo Alto, Calif. Predicant, which develops minimally invasive technology for identifying and assaying protein biomarkers, plans to use the proceeds to fund ongoing work on tests for detecting, diagnosing and monitoring complex disease states.