Genfit has priced its initial public offering (IPO) in the US as it looks to raise $135m to help advance its drug for non-alcoholic steatohepatitis (NASH) – elafibranor – through late-stage development and onto the market.
The French biotech plans to use around $50m of the total to complete its phase 3 trials for elafibranor in NASH and file for US and European approvals, as well as fund a phase 4 post-marketing study in patients with the liver disease.
Another $35m earmarked for pivotal trials in primary biliary cirrhosis, a rare autoimmune disease of the liver, while $15m will go on developing Genfit’s commercial operations in anticipation of a launch and $6m apiece will be spent on a NASH diagnostic blood test and exploring combination use of elafibranor with other NASH drugs.
The company is offering 6.65 million American Depositary Shares (ADSs) at a price of $20.32 each, whilst simultaneously carrying out a private placement of a half-million shares in Europe and other ex-US territories.
NASH has been a big focus for the pharma industry for a few years now, with dozens of treatments coming through the pipeline. It causes fatty build-up and fibrosis in the liver, in serious cases leading to cirrhosis and the need for a liver transplant.
There are no approved therapies at the moment, but several candidates are coming through late-stage development, including Intercept’s obeticholic acid which is being prepared for a US filing later this year and currently looks most likely to reach the market first.
Another candidate – Gilead’s selonsertib – failed a phase 3 trial in patients with advanced disease last month, although the company says it is still confident the drug will work in less severe NASH cases. Market researchers have suggested sales of NASH drugs could go from a standing start to reach more than $20bn by 2025.
Elafibranor is a dual agonist of the peroxisome proliferator-activated receptor (PPAR) alpha and delta receptors, thought to play a key role in various metabolic processes that lead to the lipid changes, fibrosis and inflammation that characterise NASH, and showed promising activity in a phase 2b study.
A phase 3 trial of the drug is due to report results by the end of 2019, and “if positive, could support accelerated approval [in the US and Europe] as early as 2020”, according to the IPO prospectus.
NASH affects more than 10% of adults and is poised to become the number one cause of liver transplants in just a few years, with the incidence of cases seemingly rising quickly. The condition is mostly silent until late stages, and patients often find out about the disease when it is at its advanced stage, such as cirrhosis and liver cancer.
SVB Leerink and Barclays are acting as joint global coordinators for the private placement and joint bookrunners for the ADS offering.