Inventiva (IVA) investor relations material

Strategic recapitalization and leadership transformation

• Secured €348 million in PIPE financing in October 2024, delivered in three tranches, with the final tranche contingent on clinical data.

• Refocused exclusively on lanifibranor, divesting all other assets as per investor requirements.

• Appointed experienced leadership, including a new Board Chair, CMO, Chief Regulatory Officer, CFO, and other key executives with proven track records in scaling organizations from phase III to commercialization.

• Strengthened balance sheet through multiple financings and extended debt maturity, ensuring a cash runway through Q1 2028.

Clinical development and market positioning

• Lanifibranor targets F2 and F3 MASH patients, a rapidly growing segment expected to expand significantly by 2028.

• Anticipates being the second oral entrant in the MASH market, competing primarily with Rezdiffra for F2/F3 patients, especially those with type 2 diabetes.

• Phase IIb trial showed 18% fibrosis reduction at six months and 24% on the dual endpoint of fibrosis improvement and MASH resolution.

• Phase III trial enrolled 1,000 patients (F2/F3 only), with top-line data expected in Q4 2024; primary endpoint is MASH resolution and one-stage fibrosis improvement.

• Phase III includes patients on GLP-1 and SGLT2 therapies, reflecting evolving real-world treatment patterns.

Product profile and differentiation

• Lanifibranor is a rationally designed, balanced pan-PPAR agonist, aiming to minimize side effects seen in previous PPARs.

• Demonstrated clean preclinical toxicity profile and broad metabolic benefits, including improved liver and cardiovascular biomarkers.

• Phase IIb safety profile consistent with moderated PPAR gamma effects; weight gain observed in some patients but not correlated with efficacy.

• Expected to be particularly competitive in F3 diabetic and F2 diabetic segments due to dual efficacy in fibrosis and diabetes control.