With one product awaiting FDA review and another in late-stage trials, Neurochem Inc. ensured access to up to $60 million over the next two years with an equity credit facility.
The Laval, Quebec-based firm promised to draw down at least $25 million over the term of the agreement, but is not obligated to access the remaining $35 million. The credit facility is intended to provide the company with some fund-raising flexibility, as "we stand on the threshold of important developments in the near future," Francesco Bellini, Neurochem's chairman, president and CEO said, though the company is not precluded from conducting other types of financing.
Neurochem, which also released its second-quarter earnings, posted a net loss of C$20.4 million (US$18.1 million), or C53 cents per share for the three months ending June 30. Its cash, cash equivalents and marketable securities totaled C$41.9 million. While the company said existing funds should adequately cover operations for the coming year, the $60 million facility would serve as a safety net in case of unexpected regulatory or clinical setbacks.
In April, Neurochem completed a rolling new drug application begun last August for Fibrillex (eprodisate), an oral compound for amyloid A amyloidosis, based on results from a Phase II/III trial. Despite missing the primary endpoint, results demonstrated positive trends in that patient population, and a subsequent open-label extension study showed a reduction in the risk of renal decline or all-cause mortality to 41 percent relative to patients on placebo. (See BioWorld Today, Aug. 23, 2005.)
The FDA granted the product a priority six-month review process, and Fibrillex's estimated review date is set for the middle of this month.
Fibrillex, a member of the glycosaminoglycan mimetic class of drugs, was given orphan drug and fast-track status in the U.S. It's partnered with Malvern, Pa.-based Centocor Inc., which has exclusive, worldwide distribution rights, except Canada, Switzerland, Japan, China, South Korea and Taiwan.
The company expects a marketing authorization application for Fibrillex to be submitted in Europe this fall.
In the meantime, Neurochem's Alzheimer's disease drug, Alzhemed (tramiprosate) is well under way in two large-scale Phase III trials involving a total of about 2,000 Alzheimer's patients. The North American trial is expected to be completed in January, and patient enrollment in the European study should conclude by the end of this year.
Under the credit facility terms, the company can draw down funds at its discretion and, in exchange, would issue common shares at a discount of 3 percent to market price. Rodman & Renshaw, of New York, acted as placement agent for the transaction.
Shares of Neurochem (NASDAQ:NRMX) lost 54 cents Thursday to close at $9.88.
In other financings news:
• Cytori Therapeutics Inc., of San Diego, entered agreements to raise about $16.8 million through the sale of 2.9 million shares of common stock priced at $5.75 each. About 1.9 million of those shares will be purchased by Tokyo-based Olympus Corp., which has an ongoing joint venture agreement, signed in November 2005, with Cytori focusing on adult stem cell-based therapies for cardiac disease. Olympus continues to hold an option to purchase up to 2.2 million shares of Cytori stock through December, as part of a separate equity agreement from May 2005. Shares of Cytori (NASDAQ:CYTX) closed at $5.69 Thursday, down 6 cents. (See BioWorld Today, Nov. 7, 2005.)
• Logical Therapeutics Inc., of Pittsburgh, completed an undisclosed seed round of financing in partnership with PA Early Stage Partners, of Wayne, Pa. Established as an early stage firm developing therapies for inflammation, Logical expects to use the funding to initiate operations, secure intellectual property rights and begin work on its clinical development strategy. Logical was founded by Carolyn Green, of the University of Pittsburgh, who assumed the position of executive vice president and chief operating officer, and Mitchell Fink, who previously founded Cambridge, Mass.-based Critical Therapeutics Inc.
• The Immune Response Corp., of Carlsbad, Calif., raised $9.9 million in gross proceeds from investors exercising 495.6 million warrants from the first-tranche warrants issued in the company's March 2006 private placement financing, in which company issued $8 million of secured notes convertible into 400 million shares of common stock priced at 2 cents per share. At that time, investors also received warrants to purchase an aggregate of 1.2 billion shares of stock at 2 cents per share. Warrants were divided into two 600 million warrant tranches, each generating a potential $12 million in proceeds. The second tranche will be exercisable Oct. 16, 2006. Funds will be used to advance clinical development in multiple sclerosis and HIV.
• Vical Inc., of San Diego, completed a $9.8 million registered direct offering, in which it sold about 2.1 million common shares priced at $4.77 each to a single institutional investor. Proceeds are expected to fund the company's ongoing programs, as well as for general corporate purposes. Vical focuses on developing products based on its DNA delivery technologies, including DNA vaccines for infectious diseases and cancer, immunotherapeutics for cancer and cardiovascular therapies. Shares of Vical (NASDAQ:VICL) closed at $4.97 Thursday, up 24 cents.