Elafibranor (GFT505) is GENFIT’s lead pipeline product for the treatment of NASH (Non-Alcoholic Steato-Hepatitis), a recognized unmet medical need.
Elafibranor has recently demonstrated therapeutic efficacy during Phase 2b study in NASH and is currently being evaluated in the Phase 3 study RESOLVE-IT.
The shares of Genfit have not been and are not being registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”) and neither Genfit, its shareholders or their affiliates intend to register its shares in the United States or to conduct a public offering of securities in the United States. Securities may not be offered or sold in the United States unless they are registered under the Securities Act, or exempt from registration.
Based on its historic and expected operations, composition of assets and market capitalization (which will fluctuate from time to time), Genfit does not expect that it will be a “passive foreign investment company” within the meaning of Section 1297 of the U.S. Internal Revenue Code of 1986, as amended, (a “PFIC”) for the current taxable year. However, the determination of whether Genfit is a PFIC is made annually, after the close of the relevant taxable year, and, therefore, it is possible that Genfit could be classified as a PFIC for the current taxable year or any future taxable year due to changes in the composition of its assets or income, as well as changes in its market capitalization.