Genfit Files for $132 Million Nasdaq IPO to Advance Elafibranor in NASH

VCBeat (WeChat ID: vcbeat) has learned that biopharmaceutical company Genfit has decided to conduct its initial public offering (IPO) on the Nasdaq Stock Market at a valuation of $132 million. The company will issue 5 million shares at a price of $26.33 per share. The funds raised will be used to support Phase III clinical trials of its candidate drug, Elafibranor, and to strengthen commercial infrastructure in preparation for the drug’s market launch.

Genfit, a biopharmaceutical company based in France, is dedicated to developing therapies for the treatment and prevention of cardiometabolic and neurodegenerative diseases. The company focuses on a range of conditions, including diabetes, atherosclerosis, dyslipidemia, obesity, and Alzheimer’s disease, with elafibranor being one of its lead drug candidates.

Elafibranor is a dual agonist of PPAR-α and PPAR-δ (proteins that play a role in cellular metabolism) for the treatment of NASH (non-alcoholic steatohepatitis). Studies have found that Elafibranor is safe and well-tolerated while effectively treating NASH, without causing side effects such as weight gain, edema, or fluid retention. Elafibranor can also be used to treat primary biliary cholangitis (PBC).

Genfit has committed $50 million to advance the Elafibranor research program for FDA and EMA approval. The company will also invest $15 million to strengthen its commercial infrastructure, $35 million in Phase III trials of Elafibranor, $6 million in research on combination therapies including Elafibranor, and $6 million in in vitro diagnostic tests for NASH.

NASH is a common chronic liver disease affecting millions of people, with a global prevalence of approximately 3%, and there is currently no standard treatment regimen. The development of NASH results from the interplay of multiple factors, including environmental, genetic, dietary, and metabolic influences. Its histopathological changes are driven by diverse mechanisms, such as fatty acid accumulation, mitochondrial dysfunction, free radical generation, oxidative stress, lipid peroxidation, and endotoxin-mediated cytokine release. If left untreated, it can cause liver damage and ultimately lead to liver failure.

Furthermore, with the rising prevalence of childhood obesity, NASH has become a significant health concern in the pediatric population. In January 2018, Genfit officially launched its pediatric NASH program. Elafibranor is currently the only adult medication proven to be effective for pediatric patients with NASH.

It is understood that NASH will become the leading indication for liver transplantation over the next 30 years, representing a multi-billion-dollar market. Some analysts even project that this market could reach $35 billion, driven by the rising prevalence of obesity and diabetes. In recent years, the development of NASH therapeutics has become a key focus for major pharmaceutical companies. Although Genfit currently holds a leading position in this field, the collaboration between pharmaceutical giants Novartis and Pfizer to develop NASH treatments still poses a significant threat to Genfit.

(Compiled by Jiao Yanli)