Genfit heading toward Nasdaq IPO as PhIII NASH trial revs up

Genfit (EPA:GNFT) is working its way toward an IPO on Nasdaq. Listing in the U.S. would give Genfit's bank balance a boost at a time when it is facing the prospect of a €150 million ($160 million) bill for an upcoming Phase III trial of its nonalcoholic steatohepatitis (NASH) drug, elafibranor.

Jean-Francois Mouney, CEO of Genfit, told Reuters the company is "actively moving towards listing on the Nasdaq," although details of timing of the filing are yet to emerge. Genfit has long been seen as candidate for a listing on Nasdaq, in part because of the feverish levels of interest shown by U.S. investors in its rival for the NASH market, Intercept Pharmaceuticals ($ICPT). Mourney has already tapped into the hype around NASH by targeting U.S. institutional investors in last year's €50 million private placement. Listing on Nasdaq would mark an escalation of this U.S.-centric funding strategy.

Talk of a listing on Nasdaq comes as Genfit prepares for a make-or-break Phase III trial, for which the biotech plans to enrol 1,800 NASH patients at 200 sites. Genfit is specifically looking for people with NAFLD (nonalcoholic fatty liver disease) Activity Scores (NAS) of at least four and light to severe fibrosis, a focus that excludes patients with the earliest forms of NASH. An earlier Phase IIb trial was, in the view of Genfit, undermined by the resolution of NASH in patients with early forms of the disease who received the placebo and the use of a particular method for assessing responses.

Lille, France-based Genfit's stock tanked following the release of the Phase IIb data back in March. Management disclosed a more detailed breakdown of the data this week, in which it revealed the intention-to-treat (ITT) analysis of the primary endpoint. The placebo arm had a 17% response rate, compared to 21% among patients who received elafibranor. While the data suggest elafibranor is little better than placebo, by applying the new definition of NASH resolution and excluding patients with NAS of three or less, Genfit has sliced and diced its way to a positive reading of the results. 

When the new definition of NASH resolution is applied to the Phase IIb results, the response rates for the placebo and elafibranor are 12% and 19%, respectively. And when participants with NAS scores of three and below are excluded, the proportion in the placebo arm who responded falls further still to 9%. In this analysis, the response rate among patients who received elafibranor is unchanged at 19%. With the Phase III trial using the new definition of NASH resolution and focusing on patients with NAS scores of four or more and light to severe fibrosis, Genfit thinks the Phase IIb data bode well. 

Genfit's share price see-sawed as news trickled out through the week, with the 9% rise that followed the release of the Phase III trial plan being partly wiped out the following day. The initial uptick was underpinned by optimistic readings of the trial design, which could enable elafibranor to win FDA approval on the strength of an interim analysis of 900 patients after 72 weeks. If Genfit can show the Phase IIb flop was a blip by delivering impressive 72-week data, elafibranor could come to market in 2019.

With that timeline in mind, Genfit is starting to think more seriously about what will happen if it succeeds in bringing the drug to market. "It is important, before the authorization and commercial launch, to prepare marketing structures, especially alliances and collaborations to cover the whole of the global market," Mouney said. Talks with potential partners are ongoing, as are preparations for a Nasdaq IPO that could add to the €61 million in cash Genfit was sat on at the end June.

- read Reuters' article
- here's the release