GENFIT delivered on its promise to improve its financial situation in the year to December 31, 2021, posting an income of $40.8 million USD from a loss of $20.3 million in the year prior.
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GENFIT, the late-stage biopharmaceutical firm, delivered on its promise to improve its financial situation in the year to December 31, 2021, posting an income of $40.8 million USD from a loss of $20.3 million in the year prior. As of the year’s end, the company saw its cash and cash equivalents rise from $185.5 million in the previous year to $280.7 million.
Much of its recovery is attributable to the $130 million initial payment it received from its licensing deal with Ipsen in December, plus a $30.37 million equity investment. The company was also approved for two state-guaranteed loans and other loans subsidies amounting to a total of $16.5 million.
In the last year, GENFIT was also able to get a CIR reimbursement worth $8.6 million and gain $51.5 million for the partial repurchase of Oceane convertible bonds.
But what was particularly interesting about GENFIT’s bounce-back year was the apparent success in its attempt to change its direction in research and development to focus on cholestatic diseases and acute on chronic liver failure (ACLF) programs.
“We are pleased to have delivered on our key commitments which were to improve our financial situation, pursue our Phase 3 trial and strengthen our pipeline. We start 2022 having made great progress regarding ELATIVE, and our improved financial visibility will enable us to grow our pipeline and accelerate our existing programs, as we continue to seek therapeutic and diagnostic solutions that can improve the health and quality of life of patients affected by severe chronic liver diseases,” commented Pascal Prigent, CEO of GENFIT, in a statement.
The company is preparing to start its Phase I study of NTZ in patients with renal impairment by the fourth quarter of 2022 as part of its ACLF project. This initiative presents a potentially huge milestone for GENFIT. If successful and positive, it could lead to the launch of a proof-of-concept trial in patients with ACLF and acute decompensated cirrhosis.
Another highlight was an update on GENFIT’s Phase III ELATIVE clinical trial of elafibranor in patients diagnosed with primary biliary cholangitis (PBC) and an incomplete response to ursodeoxycholic acid (UDCA). Despite the COVID-19 restrictions and some disruptions to the company’s operations, participant enrollment progressed steadily, allowing GENFIT to still meet its timelines.
In addition, Elifibranor was able to meet the primary endpoint based on primary and composite biochemical evaluation guidelines, paving the way for possible accelerated approval. The company is expected to share topline data as scheduled by the second quarter of 2023.
“GENFIT will continue to grow and diversify its pipeline in 2022 by leveraging its expertise in bringing early-stage assets to late-development stages. To achieve this goal, we follow a dual-track approach based on repurposing of molecules approved in other indications and in-licensing of molecules developed by other companies,” said the announcement.
Details were shared in a conference call dated April 8, 2022.
