Genfit, a French biotech with a phase 3 NASH program, has set its terms for its Nasdaq IPO. It will offer 5 million shares at $26.33 apiece in the hopes of raising up to $132 million in its U.S. debut, according to an SEC form filed Thursday. With the proceeds, the company hopes to complete the phase 3 trial for its lead asset elafibranor and build out its commercial organization in preparation for a potential launch.
Loos, France-based Genfit is developing elafibranor for both NASH (nonalcoholic steatohepatitis) and primary biliary cholangitis (PBC), an autoimmune disease of the liver. Elafibranor is a dual agonist of the PPAR-alpha and PPAR-delta, which are nuclear receptors, a type of protein found inside cells that play a role in, among other things, cellular metabolism.
The company has earmarked $50 million of its IPO proceeds for the completion of its elafibranor program in NASH, “through to, at least, the submission of an NDA to the FDA and EMA and the launch of a Phase 4 [postmarket] clinical trial,” it said in the form F-1/A. Genfit also plans to spend $15 million on boosting its commercial infrastructure and $35 million on a planned phase 3 trial of elafibranor in PBC. That leaves another $6 million for research on combination therapies involving elafibranor and another $6 million for the development of Genfit’s in-vitro diagnostic test for NASH.
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The most recent clinical data out of Genfit were phase 2 results for PBC. The trial involved 45 patients with PBC who had been treated with ursodeoxycholic acid without success. It met its primary endpoint, beating placebo at lowering levels of serum alkaline phosphatase (ALP), an enzyme whose levels can indicate how well a person’s liver or gallbladder are working. ALP levels dropped 48% in patients on an 80-g dose of elafibranor and 41% in patients receiving the 120-mg dose. ALP increased in patients taking placebo.
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One of many players trying to get a NASH drug to market, Genfit is among a handful with drugs in late-stage trials. In February, Intercept Pharmaceuticals looked to have pulled ahead—the New York-based biotech announced that its obeticholic acid (OCA) hit the mark in a pivotal trial, improving liver fibrosis without any worsening of NASH after 18 months of treatment. Intercept plans to file for approval in the U.S. and European Union by the end of the year.
Genfit’s compatriot, Inventiva suffered a blow the same week, with its pan-PPAR activator missing its primary endpoint in a phase 2 trial in systemic sclerosis, an autoimmune disease characterized by a buildup of scar tissue that affects the skin and internal organs. Inventiva, which had been developing the drug, lanifibranor for both NASH and systemic sclerosis, decided to drop the latter program, saying the setback would not affect its other work.