As Genfit hopes to get its liver drug on the market, founding CEO makes way for new blood

Genfit's CEO succession comes after its departing chief said he is leaving for "personal" reasons. (Genfit)

As Genfit hopes for phase 3 trial successes and future filings for its liver disease drug, its long-term CEO and co-founder Jean-François Mouney is stepping aside and promoting his executive vice president of marketing and commercial development to the top job.

The focus has been on R&D up until this point, but in the next few years the biotech hopes approvals will come for elafibranor, and Pascal Prigent, with his experience on the marketing side, seems to dovetail with its potential future.

Prigent, who only joined last May and was formerly VP of marketing of GSK’s vaccines division, becomes the new chief in two weeks, and Mouney stays on as chair.

Loos, France-based Genfit is developing elafibranor for both nonalcoholic steatohepatitis (NASH), or fatty liver disease, and primary biliary cholangitis (PBC), an autoimmune disease of the liver.

Rival biotech Intercept Pharmaceuticals already markets a drug for this second rare condition, known as Ocaliva (and is also, along with seemingly almost every other biopharma, gunning for NASH), but Genfit is hopeful its attempt could be better.

A recent phase 2 linked the two tested elafibranor doses to 67% and 79% responses rates against the composite endpoint used in the pivotal Ocaliva trial. Ocaliva, meanwhile, came to market in PBC with a 47% response rate.

RELATED: Genfit moves liver disease pill into mid-stage, hints at upcoming IPO

The bigger market opportunity is in NASH, which could yield billions annually for any company that gets it right, though nearly everyone in this area (and Genfit is one of the more advanced in terms of testing) has been hit by trial setbacks, Genfit included.

But sentiment has appeared to stay with the company; back in March, while already on the Euronext stock exchange, Genfit made the jump to the more lucrative Nasdaq with a healthy $135 million IPO.

Genfit 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.

A readout of its late-stage data is expected later this year, the success of which, or lack thereof, will have a big impact on the biotech.

Mouney said in a release that his leaving is a “personal decision taken after thoughtful consideration, following two decades of intensive work dedicated to developing Genfit.”

He continued: “I’ve asked Pascal to accept the CEO position because I’m convinced he is best positioned to oversee our future corporate growth. Pascal has the right experience, the right skills, the right mindset and the right personality to help build Genfit for success in the years to come. I look forward to continuing my leadership as Chairman of the Board, including potentially recruiting new board members with international and diverse experience to best prepare us for the exciting years ahead.”

Prigent added: “I am honored to take on the role of Genfit’s CEO and look forward to working with Jean-François and the Board, as well as Dean and the highly skilled teams at Genfit. In the coming months, our Phase 3 RESOLVE-IT trial will have an interim read-out, and elafibranor could potentially become the first and only therapy to address NASH resolution without worsening of fibrosis. With our recent expansion into the United States and a solid cash position, we are preparing the company’s future as a commercial organization, to create long term value for our employees and shareholders, and for the NASH field overall, especially the patients.”

Analysts at ODDO put out a note to clients saying that while the timing may “cause confusion” with investors, it doesn’t believe the upcoming RESOLVE-IT data and the company's CEO’s departure are linked.

“After a call with the company, we understand that this decision is unrelated to the future Phase 3 results of NASH (too early, results expected in Q4) and that this is a “personal decision taken with a great deal of objectivity and composure. … Our takeaway after contacting the company following this announcement is that the reorganization does not entail any changes to the group's strategy. The teams and the targets will remain the same. The choice of Pascal Prigent makes sense in our view given his commercial experience and the fact that the company is potentially just some months from its commercial phase.

“Although the timing might cause some confusion with key clinical results for the group due out at the end of this year, there is no connection.”

But investors didn’t seem to heed that call, sending Genfit's Nasdaq shares down more than 6% in premarket trading.