Genfit Updates Market on Clinical Progress; Phase 3 on Track for Chronic Liver Disease (PBC)

Edward Kim  |

Genfit ( GNFT) announced full year 2021 results on Thursday, providing a complete update on its clinical program.

Critically, the French-US biotech confirmed that its Phase 3 study of its lead candidate, elafibrinor for the treatment of primary biliary cholangitis (PBC) — a chronic disease in which the bile ducts in the liver are slowly destroyed — is back on track after a delay at the end of last year due to the massive spread of the omicron variant of COVID-19.

Genfit stated in its press release that its "recruitment numbers rebounded significantly in the first quarter 2022" as omicron normalized.

The company said that screening of patients will stop next week, and it expects to have topline data in the second quarter of 2023, in line with its previous guidance.

The company ended 2021 with €258.8 million (US$280.8 million) in cash and equivalents.

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Investment thesis

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Genfit ordinary shares have been trading on Euronext since 2006, and its ADSs have been listed on Nasdaq since March 2019.

Investors have had few reasons to cheer in the past two years, but we find reasons to be optimistic, especially at current levels.

  • Thursday's close of $3.92 per ADS gives Genfit a market cap of just $199 million.
  • With cash levels at $281 million at the end of 2021, investors in Genfit are essentially getting a free call option on a company with a promising Phase 3 asset in PBC.
  • 90,000 patients in the US in EU are indicated for second line treatment in PBC, representing a market potential of $1 billion.
  • In December 2021, Genfit and Ipsen ( IPSEY), the $10 billion French multinational pharmaceutical concern, entered into a strategic licensing deal for Genfit's elafibranor for PBC.
  • Genfit got €120 million (US$130 million) upfront and is eligible to receive up to €360 million (US$390 million) in additional milestone payments plus tiered royalties of up to 20%.
  • Ipsen also became an 8% shareholder of Genfit via an equity investment of €28 million (US$30 million).

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Source: Equities News

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