For San Diego’s Elcelyx Therapeutics, 2014 may someday be remembered as “the year of heavy lifting.”
Since the fall of 2013, when Elcelyx spun out NaZura BioHealth as a sister company with the same management (focused on commercializing a dietary ingredient called Lovidia), the company has crossed off a variety of accomplishments that include:
—Selling NaZura BioHealth about a year ago in a deal that has not been previously disclosed. Elcelyx CEO Alain Baron said Elcelyx pocketed some proceeds from the sale, although he declined to provide details.
—Completing mid-stage clinical trials of Elcelyx’s drug candidate, a proprietary oral compound for patients with type 2 diabetes who cannot tolerate metformin, the first-line drug of choice for most of them.
—Securing about $6 million in funding last month from existing investors Morganthaler Ventures, Kleiner Perkins Caufield & Byers, Technology Partners, and GSM Fund. Including the latest funding, Baron said Elcelyx has raised a total of roughly $57 million over the past five years.
—Concluding what Baron described as “a protracted, but ultimately very productive conversation with the FDA” that has positioned Elcelyx for a final push in the development of its drug candidate.
“We’ve agreed on a path forward, and agreed on the studies we need to do,” Baron told me this week. “We’re confident that this is something we can do.”
Now Elcelyx is developing specific protocols for carrying out three late-stage studies that would involve a total of 1,500 to 2,000 patients—and considering the best way to fund them. Baron estimated the cost of completing Phase 3 trials would be almost $100 million.
Baron is not yet sure how the company will fund the late-stage trials, but he sees three options for the company: raising capital through an IPO; selling Elcelyx and its drug program to a pharmaceutical company with the wherewithal to complete the trials, or remaining private and raising enough capital for Elcelyx to carry out the late-stage trials itself.
Elcelyx was founded in 2010 with initial support from Morgenthaler Ventures, where Baron was an entrepreneur-in-residence.
From the beginning, the company had a … Next Page »
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