GenFit gets $135M Nasdaq IPO for NASH, PBC hopes

Paris Rooftops
Paris-based GenFit already trades in Europe and has now moved into the lucrative U.S. market. (Richard Nahem)

Already on the Euronext stock exchange, liver disease biotech GenFit has made the jump to the more lucrative Nasdaq with a $135 million IPO.

The French biotech, seen as one of a host of leading NASH players with phase 3 assets designed to help hit fatty livers caused by obesity, got a few million dollars more than it had first aimed for and will now trade as $GNFT in the U.S.

Genfit is developing lead drug 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 cellular metabolism, among other things.

Virtual Roundtable

ESMO Post Show: Highlights From the Virtual Conference

Cancer experts and pharma execs will break down the headline-making data from ESMO, sharing their insights and analysis around the conference’s most closely watched studies. This discussion will examine how groundbreaking research unveiled over the weekend will change clinical practice and prime drugs for key new indications, and panelists will fill you in on the need-to-know takeaways from oncology’s hottest fields.

Other players in this space, including Intercept, Gilead, Shire, Bristol-Myers Squibb and NGM Bio, are going after several different targets to hit liver fat; many have suffered setbacks and challenges in testing, but all are hopeful of getting in on a market talked up as being worth tens of billions of dollars at peak.

RELATED: Genfit’s elafibranor hits goal in phase 2 PBC trial

Specifically, GenFit 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 a recent SEC filing.

And $15 million is also on the table for boosting its commercial infrastructure, while $35 million is for a planned phase 3 trial of elafibranor in PBC, which it hopes can compete with rival Intercept’s drug Ocaliva, which is also gunning for a NASH approval.

That leaves $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.

Data from its NASH phase 3 are slated for the end of the year. Meanwhile, big biotech rival Gilead announced Wednesday that it will be sharing a host of NASH data from across its shots on goal at the EASL liver disease conference in Vienna in mid-April.

Suggested Articles

Novartis is forging ahead with the development of spartalizumab in "many, many other indications" despite the setback.

Chi-Med has detailed plans to seek approval from the FDA later this year in part on the strength of data from Chinese phase 3 trial.

Takeda tapped Roche’s Foundation Medicine to develop tissue- and blood-based companion diagnostic tests for its portfolio of lung cancer therapies.