IVEVF - Inventiva reports 2024 First Quarter Financial Information¹ and provides a corporate update | Benzinga
- Cash and cash equivalents at €11.0 million, short-term2 deposits at €0.1million, and long-term deposit at €19.1 million3 as of March 31, 2024, compared to €26.9 million, €0.01 million and €9.0 million as of December 31, 2023, respectively.
- The fourth scheduled DMC meeting recommended to continue the NATiV3 Phase III clinical trial without modification of the current protocol, based on the pre-planned review of interim safety data of more than 900 patients randomized in the main and exploratory cohorts.
- 280 sites in 15 countries have restarted screening patients in NATiV3 Phase III clinical trial.
- First visit of the last patient of NATiV3 Phase III clinical trial with lanifibranor is targeted for first half of 2024.
Daix (France), Long Island City (New York, United States), May 21, 2024 – Inventiva (NASDAQ:IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), also known as non-alcoholic steatohepatitis ("NASH"), and other diseases with significant unmet medical needs, today reported financial information for the first quarter of 2024, including its cash, cash equivalents and revenues, and provided a corporate update.
Key Financial Results
Cash, cash equivalents and deposits
As of March 31, 2024, the Company's cash and cash equivalents amounted to €11.0 million, short-term deposits to 0.1 million, and long-term deposit to €19.0 million2, compared to €26.9 million, €0.01 million and €9.0 million as of December 31, 2023, respectively.
Net cash used in operating activities amounted to (€29.4) million in the first quarter of 2024, compared to (€20.4) million for the same period in 2023. R&D expenses for the first quarter of 2024 were up 82% compared to the first quarter of 2023. This increase is in line with the clinical development activities planned for 2024 and driven by costs associated with the NATiV3 Phase III clinical trial of lanifibranor in MASH/NASH, and, to a lesser extent, with the completion of the LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with MASH/NASH and type 2 diabetes ("T2D").
Net cash used in investing activities for the first quarter of 2024 amounted to (€10.3) million, compared to (€8.4) million in the first quarter of 2023. The change is mostly due to the change in deposits between both periods.
Net cash generated in financing activities for the first quarter of 2024 amounted to €23.7 million, compared to (€1.2) million in the first quarter of 2023. The change is due to the second tranche of €25 million drawn in January 2024 under the unsecured loan agreement granted by the European Investment Bank ("EIB"). As a condition to the drawdown, the Company issued 3,144,654 warrants to EIB.
Over the first quarter of 2024, the Company recorded a positive exchange rate effect on cash and cash equivalents of €0.1 million, compared to a negative effect of (€0.5) million for the first quarter of 2023, due to the evolution of EUR/USD exchange rate.
Considering its current cost structure and forecasted expenditures, the Company estimates that its cash, cash equivalents and deposits2,3 should allow the Company to fund its operations as currently planned until the beginning of the third quarter of 20244. Therefore, it indicates that a material uncertainty exists on the Company's ability to continue as a going concern. The Company is actively reviewing potential financing (including debt, equity and equity-linked or other instruments) and strategic options with potential counterparties and its financial advisors.
Revenues
The Company did not recognize revenues for the first quarter of 2024, in line with the first quarter of 2023.
Main areas of progress in the R&D portfolio and corporate update
- On March 28, 2024, the Company announced the nomination to its Board of Directors of Andre Turenne, President and CEO of the Boston-based biotech Matchpoint Therapeutics, and Advisor to Atlas Venture since 2021. Mr. Turenne's appointment will be submitted to the Company's shareholders for ratification at the next general shareholder meeting.
- On May 13, 2024, the Company announced the publication of additional results from its NATIVE Phase II clinical trial, which demonstrated improvement of markers of cardiometabolic health in patients with MASH/NASH treated with lanifibranor, regardless of the patients' diabetes and obesity status or weight change during treatment.
- On May 16, 2024, the Company announced that following the fourth scheduled meeting, the DMC recommended the NATiV3 Phase III clinical trial continue without modification of the current protocol. This recommendation was based on the pre-planned review of interim safety data of more than 900 patients randomized in the main and exploratory cohorts.
- To date 280 sites in 15 countries have resumed screening and randomization of new patients in the NATiV3 Phase III clinical trial, following the implementation of the additional screening criteria, previously disclosed, recommended by the DMC in response to the SUSAR.
Anticipated potential key milestones
- Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating lanifibranor in MASH/NASH - targeted for the first half of 2024.
Upcoming investor conference participation
- Portzamparc mid and small caps conference – June 11-12 - Paris
- Stifel European Healthcare Summit - June 25-27 - Lyon
- Canaccord Genuity's 44th Annual Growth Conference - August 13-15 - Boston
- H.C. Wainwright 26th Annual Global Investment Conference - September 9-11 - New York
- 7th edition of Forum Lyon Pôle Bourse – September 24 – Lyon
- KBC Securities life sciences conference - September 26 - Brussels
- Guggenheim Global Healthcare Conference - November 11-13 - ...