Inventiva (IVA) Q4 2024 earnings summary

Executive summary

• Significant progress in the NATiV3 Phase III trial of lanifibranor for MASH, with last patient screened in January 2025 and enrollment completion targeted for H1 2025; positive DMC reviews confirmed safety and protocol continuity.

• LEGEND Phase 2 trial showed positive results for lanifibranor alone and with empagliflozin in MASH and T2D patients, meeting primary and secondary endpoints.

• Strategic focus shifted entirely to lanifibranor, halting all unrelated preclinical activities and reducing workforce by 50%.

• Secured structured multi-tranche equity financing of up to €348 million, with €116 million gross proceeds from the first tranche.

• Strengthened governance with new board members, including a new chairman with MASH and financial expertise.

Financial highlights

• Year-end 2024 cash position was €96.6 million, up from €26.9 million at end-2023, mainly due to €170 million ($184 million) raised through various financing operations.

• 2024 revenues were €9.2 million, down from €17.5 million in 2023, primarily from CTTQ milestone payments.

• R&D expenses decreased 17% to €90.9 million due to operational delays and trial completion.

• Net financial loss was €86 million, mainly due to non-cash IFRS adjustments and interest expenses.

• Net loss for 2024 was €184.2 million, compared to €110.4 million in 2023.

Outlook and guidance

• Cash runway extends to mid-Q3 2025 without the second financing tranche; with the tranche and CTTQ milestone, runway extends to end-Q3 2026.

• Completion of NATiV3 recruitment expected in H1 2025, with topline results in H2 2026.

• NDA filing for lanifibranor planned for H1 2027, with an outcome study underway at the time of filing as per FDA guidance.

• R&D expenses expected to increase 10–20% in 2025 as commercial and NDA preparations ramp up.

• Material uncertainty remains regarding going concern and sufficiency of net working capital for 12 months.