Significant Progress in Lanifibranor Clinical Development
Completed screening of Phase 3 NATiV3 trial in early January 2025, targeting recruitment completion in H1 2025. Three data monitoring committee meetings with positive recommendations for continuation without protocol modification.
Positive Results from LEGEND Trial
Statistically significant reduction in HBA1C with lanifibranor alone and in combination, improved insulin sensitivity, and significant improvement in markers of liver injury. Combination with empagliflozin mitigates weight gain.
Strong Financial Position
Raised approximately $184 million in gross proceeds from several financing operations, including a $125 million structured financing. Cash position at the end of 2024 was €96.6 million, a net positive variance of close to €61 million from the previous year.
Strategic Partnerships and Market Expansion
Partner Hepalys launched clinical development of lanifibranor in Japan. Licensing agreements in place in Japan, South Korea, and China position lanifibranor as a leading oral drug in MASH in these regions.
Strengthened Governance and Team
Reinforced Board of Directors with three new members, including Mark Pruzanski as Chairman. Reinforced development team to prepare for regulatory filing and potential commercial launch of lanifibranor.