French biotech Genfit has pressed the button on a public listing in the US, seeking to raise around $120m to help it fund development of lead liver disease drug elafibranor.
Genfit is offering five million shares at $26.33 on the Nasdaq Global Market to raise the cash, with the US listing sitting alongside the biotech’s current shares on the Euronext Paris exchange.
Around $50m of the proceeds will be used to complete a phase 3 trial of elafibranor in non-alcoholic steatohepatitis (NASH) – a hot therapeutic target in biopharma at the moment with no approved therapies – with another $15m earmarked to build the company’s commercial operations in anticipation of a launch.
$35m has been allocated to a phase 3 trial of elafibranor in primary biliary cholangitis (PBC), a rare autoimmune disease of the liver, and $6m will go towards developing a companion diagnostic for NASH to identify patients suitable for treatment with its drug, with another $6m set aside for testing the drug in combination regimens.
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.
In an SEC filing, the French company says that in a phase 2b trial elafibranor “achieved resolution of NASH without worsening of fibrosis, which is the primary endpoint of our ongoing global phase 3 clinical trial”.
It is expecting to have interim results from the pivotal trial before the end of the year and, if positive, thinks these will support accelerated approvals from the FDA and EMA. Elafibranor as already been granted a breakthrough designation from the US regulator in NASH, setting up a speedy review of the application if filed.
In December Genfit also