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GEN News Highlights : Dec 31, 2013
Eleven Bio, Argos Ring Out 2013 with IPO Filings
Two drug developers yesterday began taxiing for takeoff on the proverbial runway for initial public offerings by filing plans to sell their first stock, helping ring out 2013 with a thunderous comeback for the industry on Wall Street after years of hype about revival.
Eleven Biotherapeutics, a clinical-stage biotech focused on engineering proteins into therapeutics for eye diseases, is looking to raise up to $69 million, according to a filing with the U.S. Securities and Exchange Commission (SEC).
Separately, Argos Therapeutics, a developer of immunotherapies for cancer and infectious and autoimmune diseases, told the SEC that it plans to raise up to $60 million through a revived IPO. The company’s latest filing followed up on a confidential IPO filing the company made on November 12—something made permissible for companies with annual revenue of less than $1 billion through the Jumpstarting Our Businesses (JOBS) Act enacted last year.
Eleven Bio and Argos became the 36th and 37th biopharma companies on the IPO runway with pending or postponed plans, according to data by Burrill and Co. Neither company disclosed exactly how many shares it plans to sell, the offering price of those shares, or the percentage stake of ownership that investors will hold upon completion of the IPO—details that companies typically furnish closer to when their offerings reach the market.
In its Form S-1 registration statement, Eleven Bio said it would use its IPO proceeds to fund a Phase III program for its lead product candidate, EBI-005, planned for 2014. The program would consist of two pivotal clinical trials—one evaluating the safety and efficacy of EBI-005 for moderate to severe dry eye disease, the other assessing the safety of treatment with EBI-005 for one year.
If the program is successful, Eleven Bio stated, it plans to submit a Biologics License Application to the FDA, seeking approval of EBI-005 for dry eye disease before the end of 2016. Eleven Bio also plans to launch a Phase II trial to evaluate EBI-005 in patients with allergic conjunctivitis in 2014.
EBI-005 is designed to treat elevated levels of the inflammatory cytokine interleukin-1 (IL-1) to fight inflammation and pain associated with dry eye disease, as well as redness and itching associated with allergic conjunctivitis. EBI-005 was developed through Eleven Bio’s AMP-Rx protein engineering platform to design and generate drug candidates that target cytokines.
Eleven Bio plans to trade its shares on NASDAQ under the symbol EBIO starting with the IPO, whose underwriters include Citigroup, Cowen & Co., and Leerink Swann.
Argos will use its IPO proceeds in developing its lead product candidate AGS-003 for metastatic renal cell carcinoma (mRCC) and other cancers. The company is enrolling patients in a Phase III trial of AGS-003 in combination with sunitinib (Sutent) for mRCC under a special protocol assessment with the FDA. The trial’s primary endpoint is overall survival.
AGS-003 showed promising results in a Phase II study where, in combination with sunitinib in mRCC patients, median overall survival was 30.2 months—compared with 14.7 months in 1,189 mRCC patients with similar risk factors treated with sunitinib or other targeted therapies, according to data from the International Metastatic Renal Cell Carcinoma Database Consortium, or the Consortium.
AGS-003 is among candidates developed through Argos’ Arcelis technology platform, designed to generate fully personalized immunotherapies by using biological components from a patient’s own cancer cells or virus. The immunotherapies use dendritic cells to activate an immune response specific to the patient’s own disease.
Also under development by Argos through Arcelis is AGS-004 for HIV. The company is conducting a phase IIb trial of AGS-004 that is being funded entirely by the NIH, under a $39.3 million contract.
Argos plans to trade under the symbol ARGS on NASDAQ. The company’s filing is its second proposed IPO in two years. The first was a $78.8 million initial offering filed in 2011, then withdrawn last year, with the company citing market conditions.
Underwriters for the revived filing include Piper Jaffray, Stifel Needham & Co., and JMP Securities. Only Needham carried over from the initial filing, which also listed as underwriters Canaccord Genuity, Lazard Capital markets, and BMO Capital Markets.
Argos is one of 15 companies to have filed and withdrawn IPO plans since 2010, according to Burrill, which lists a total 59 therapeutic, diagnostic, and industrial/agricultural biopharmas as having gone public this year as of December 30. Those companies raised more than a combined $6.359 billion, one-third of which came from the year’s single largest IPO, Zoetis, Pfizer’s animal-care spinout, with more than $2.2 billion raised.
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