While Lyft is rightfully getting most of the IPO attention
this week ahead of its debut on Friday, another company is making its IPO debut
today with some success: Genfit (GNFT), which priced its upsized 6.15 mln share
IPO (from 5 mln shares) at $20.32. It opened for trading this morning on the
Nasdaq at $22.00.
Genfit is a France-based late-stage clinical biopharma company developing drug candidates that target metabolic and liver-related diseases. Its stock already trades on Euronext Paris, and its ADS is now making its debut in the US.
Genfit is a leader in the field of nuclear receptor-based drug discovery. Its most advanced drug candidate, elafibranor, is in Phase 3 trials as a potential treatment for non-alcoholic steatohepatitis, or NASH. It's also in a Phase 2 trial as a treatment for primary biliary cholangitis, or PBC.
A key differentiator of Genfit's development strategy is its NASH biomarker-based diagnostic program, in which Genfit is developing a new in vitro diagnostic, or IVD, test to identify patients with NASH who may be appropriate candidates for drug therapy. In January 2019, Genfit entered into a license agreement with LabCorp to allow them to deploy Genfit's IVD test in the clinical research space.
NASH is a liver disease characterized by an accumulation of fat, inflammation, and degeneration of hepatocytes that may ultimately lead to life-threatening conditions like cirrhosis, liver failure, or liver cancer requiring liver transplant. The global market for the treatment of NASH, which affects millions of people and for which there are no approved therapies, is growing rapidly and is projected to reach $20 bln by 2025.
NASH, notes Genfit, is a silent disease. Patients often have no symptoms until the first signs of liver failure, and the lack of an accurate, non-invasive diagnosis tool contributes to under-diagnosis. Currently, liver biopsy is the standard for diagnosis. Genfit's blood-based IVD test is a diagnostic that can identify NASH patients who may be appropriate candidates for drug intervention, thereby decreasing the need for liver biopsy. Genfit expects to market its IVD test first as a laboratory developed test, or LDT, in 2019, and then to submit it for FDA marketing authorization in 2020.
PBC is a chronic, progressive liver disease that leads to inflammation and scarring of the small bile ducts in the liver. Although a relatively rare disease mainly affecting women, PBC can develop into cirrhosis and other serious liver complications. There is currently no cure for PBC, and the two drugs approved for the treatment of PBC are limited by drug intolerance, lack of patient response, and safety issues. The hope is that elafibranor's unique mechanism of action can provide benefits for patients with PBC without significant side effects. In December 2018, Genfit announced positive preliminary results from its Phase 2 trial for PBC, and it plans to advance its PBC program into Phase 3 development.
Genfit believes that elafibranor, if approved, has the potential to become a first-line treatment as a monotherapy and the backbone of combination regimens. In its Phase 2b trial, elafibranor achieved resolution of NASH without worsening of fibrosis, which is the primary endpoint of its ongoing Phase 3 trial. However, elafibranor did not achieve statistical significance on the pre-specified primary endpoint of its Phase 2b clinical trial, which Genfit says was based on an outdated definition of resolution of NASH.
In sum, the main positive to the Genfit story is that while it is a clinical stage biopharma, it is a late-stage biopharma. The time frame for potential approval would be of a shorter time period than the years and years that still remain ahead for many debuting biopharmaceutical companies. While there is no guarantee that approvals will ever happen, Genfit's IVD test and drug candidates do look promising in combating NASH and PBC.
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