Preparing to begin a Phase III oncology program with its VEGF Trap product early next year, Regeneron Pharmaceuticals Inc. raised about $175.1 million in a public offering, pricing 7.6 million shares at $23.03 each.
The offering follows a month-long run-up on the company's stock on news of a substantial collaboration, some positive clinical data and a lower-than-expected loss in its third-quarter earnings report. Shares of Tarrytown, N.Y.-based Regeneron (NASDAQ:REGN) closed Monday at $23.85, up 20 cents.
The company was not available for comment but said in its prospectus that proceeds will be used to support preclinical and clinical development, research, continued development of its technology platforms, capital expenditures and to redeem, repay or purchase its 5.5 percent convertible senior subordinated notes due October 2008. Funds also will go toward general corporate purposes, including working capital, acquisitions and other opportunities.
Its lead product, VEGF (vascular endothelial growth factor) Trap, is expected to begin the first of three Phase III trials early in 2007. All three studies will evaluate the safety and efficacy of the VEGF Trap, an anti-angiogenesis compound, in combination with standard chemotherapy regimens in specific cancer types.
That product is partnered with Paris-based Sanofi-Aventis in a deal that could earn Regeneron up to $400 million in total milestones and allow the firm to share equally in worldwide profits, except for Japan. (See BioWorld Today, Dec. 23, 2005.)
Regeneron's product is designed to target the VEGF pathway, the same pathway targeted by South San Francisco-based Genentech Inc.'s blockbuster cancer drug, Avastin. It aims to work by "trapping" the VEGF that is made by the tumor and preventing it from stimulating the VEGF receptor and thereby preventing blood vessel growth.
The companies also are evaluating the VEGF Trap in Phase II as a single-agent therapy - on their own and in conjunction with the National Cancer Institute - in multiple cancer types.
Outside of cancer, Regeneron's VEGF Trap has shown promise in wet age-related macular degeneration, a condition characterized by the accumulation of blood vessels forming in the back of the eye. The company found a partner for that indication last month, signing a potential $320 million deal for VEGF Trap-Eye with Leverkusen, Germany-based Bayer Healthcare. (See BioWorld Today, Oct. 20, 2006.)
On its own, the company continues work on its IL-1 Trap and expects to submit a biologics license application in the second quarter of 2007 in CIAS1-associated periodic syndromes. Late last month, Regeneron reported positive data from its Phase III program and is completing a 24-week open-label extension study. IL-1 Trap has orphan drug and fast-track status for CAPS.
The company's earlier-stage research and development work stems from its VelociGene and VelocImmune technology for producing fully human monoclonal antibodies. Regeneron plans to move two antibody candidates into the clinic next year and anticipates adding two per year after that.
The firm posted a net loss of $27.4 million, or 48 cents per share, for the third quarter. As of Sept. 30, its cash and marketable securities totaled $289.6 million.
Following the offering, Regeneron has about 65 million shares outstanding.
Morgan Stanley & Co. Inc., of New York, served as underwriter.
In other financings news:
• Aegera Therapeutics Inc., of Montreal, closed its Series C round, raising $21 million, including more than $14 million in equity funding and a venture debt facility of up to $7 million. Proceeds are expected to support clinical advancement of Aegera's three apoptosis programs, including two clinical trials in cancer and neuropathic pain that are set to start next year. The financing was led by VenGrowth Advanced Life Sciences Fund Inc. and included investments from GrowthWorks, Business Development Bank of Canada, Desjardins Venture Capital, Multiple Capital and Solidarity Fund. The company is seeking additional investors for a second closing of the Series C round early in 2007.
• Alpha Biologics Sdn Bhd, of Cambridge, UK, raised $3 million to support ongoing commercial discussion and construction of the company's $18 million, 5,000-square-meter manufacturing facility in Penang, Malaysia. All the capital was provided by Westport, Conn.-based Pequot Capital Management Inc. The latest funding brings the company's 2006 fund raising total to $6 million.
• Dyadic International Inc., of Jupiter, Fla., entered an agreement to privately place 2.8 million shares at $4.68, plus warrants to purchase up to 557,400 shares of stock, for gross proceeds of $13 million. Part of that money will be used to expand the company's CI Host Technology development program and assist in development of large-scale enzyme production systems and manufacturing processes for production of low-cost fermentable sugars from biomass. Funds also will go toward Dyadic's enzyme pipeline, as well as for the commercial launch of products in pulp and paper, animal feed and other areas. Cowen and Co. LLC acted as the exclusive placement agent. Shares of Dyadic (AMEX:DIL) closed at $5.25 Monday, up 1 cent.
• Vivus Inc., of Mountain View, Calif., is raising proceeds of $33.6 million through a registered direct offering of 9.6 million shares priced at $3.50 each. The financing was led by Caxton Advantage Life Sciences Fund LP, with participation from Euclid SR Partners, OrbiMed Advisors LLC, Franklin Templeton Investments and Quogue Capital LLC. Vivus intends to use the proceeds for general corporate purposes and to fund clinical trials of its product candidates, including Qnexa, which is in development for obesity. Shares of Vivus (NASDAQ:VVUS) gained 37 cents Monday to close at $4.07.