As it gears up for the late-stage readout of its lead experimental NASH drug, France’s Genfit is vaulting onto the Nasdaq on Wednesday with a $135 million IPO under the symbol $GNFT.
The Lille-based company, which is already listed on Euronext Paris also as $GNFT, spelled out the terms of the offering on Tuesday.
The company decided it wanted a US listing to expand its base in Boston, access the US talent pool — considering the geography is going to be a large market for the drug (elafibranor) — as well a forge a closer connection with US investors, Genfit COO Dean Hum told Endpoints News.
NASH, which is typically associated with obesity and diabetes, is set to eclipse hepatitis C as the leading reason for liver transplants by 2020.
Genfit is offering 6.15 million American Depositary Shares priced $20.32 per ADS, and has concurrently secured a private placement of 500,000 ordinary shares in Europe at €18.00 per share. In total, the total offering is valued at roughly $135.1 million, before commissions and expenses.
Genfit’s future hinges on the regulatory fate of elafibranor for two main liver disorders: NASH and primary biliary cholangitis (PBC).
The bigger, more lucrative indication is NASH, an untreated fatty liver disease that has ravaged the developed world and sparked a flurry of drug development from biopharma firms big and small. It is characterized by a buildup of excess fat in the liver that induces chronic inflammation and eventually culminates in scarring that can lead to cirrhosis, liver failure, cancer and death.
While other major NASH contenders — Gilead $GILD (fail in Phase III) and Intercept $ICPT (mixed win in Phase III) — have disclosed the top line numbers of their late-stage trials, Genfit is expected to come out with its Phase III interim results by the end of 2019.
When compared to its main rival, Intercept, Hum asserted that elafibranor’s potential in NASH resolution and reducing CV risk along with a benign safety and tolerability profile set it apart.
Late-stage data on Intercept’s drug — obeticholic acid (OCA) — showed it induced a statistically significant improvement in fibrosis, but not NASH resolution, and a higher-than-expected number of patients dropped out due to the pesky side-effect of itching.
“If you think about another liver disease, like say viral hepatitis. The virus…drives the fibrosis forward in the liver. The way to treat viral hepatitis is you get rid of the virus, and the fibrosis gets better by itself. So NASH is not any different, what you want to is to treat the underlying cause of the onset of progression of fibrosis and that’s what elafibranor was able to demonstrate (in the phase IIb),” Hum said.
Upon the readout of OCA’s pivotal study last month, Intercept said it would apply for marketing approval based on the dataset. Although Genfit’s pivotal readout comes at the end of the year, which will mean that its marketing application (assuming the trial is positive) will certainly come after Intercept. But Hum is not worried.
“The drug is well positioned to become standard-of care,” he said, emphasizing that elafibranor has the ability to lower CV risk (the leading cause of mortality in NASH patients are CV events) and that its mechanism of action is such that it could treat the widest NASH patient population — from advanced late-stage patients to early-stage patients with less fibrosis.
Dubbed the silent disease, it is hard to diagnose in the early stages, making it difficult to estimate its prevalence, but studies show that it afflicts up to 12% of the adult population in developed countries. Although there are no approved drugs for the disease, the size of the NASH market is expected to cross $20 billion by 2025.
“NASH by and large is the liver manifestation of liver disease — it is a multifactorial disease with different facets to it…like other metabolic diseases — type II diabetes for example…NASH is very similar, I think NASH will probably be optimally managed clinically by combination therapy,” Hum said, adding that if approved, elafibranor could easily serve as the backbone therapy in future NASH combination regimens.
Genfit is currently working on getting its commercial operations ready in anticipation of the approval. The company plans to retain the commercial rights to elafibranor in the key European countries, and will likely pursue partnerships with a global pharma player in larger markets like North and South America, Hum said, adding that the company is in discussions with different groups about pricing.
“You’ve heard numbers of $10,000 per year, here in the United States — I think those numbers are reasonable,” he said.
Meanwhile, elafibranor is being tested for use in other liver indications. In the coming weeks, the company is recruiting patients for a study evaluating the drug in pediatric NASH patients. Positive mid-stage data on the use of the drug in PBC — a rare and progressive liver disease — were announced last December.
Another NASH hopeful, the Merck-partnered NGM Biopharma, on Monday broke out the terms of its IPO. The company, which plans to list on the Nasdaq under the symbol $NGM, is offering about 6.7 million shares priced between $14 to $16, according to the filing.
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