On May 16, 2023 Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis ("NASH") and other diseases with significant unmet medical needs, reported financial information for the first quarter of 2023, including its cash, cash equivalents and revenues, and provided a corporate update (Press release, Inventiva Pharma, MAY 16, 2023, View Source [SID1234631776]).

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Financial Results

Cash Position

As of March 31, 2023, the Company’s cash and cash equivalents amounted to €56.3 million, short-term deposits to 0.7 million2, and long term deposit to €9.3 million3, compared to €86.7 million, €1.0 million and €0.7 million as of December 31, 2022, respectively.

Net cash used in operating activities amounted to (€20.4) million in the first quarter of 2023, compared to (€15.0) million for the same period in 2022. R&D expenses for the first quarter were up 38% compared to the first quarter of 2022. This increase is in line with the clinical development activities planned in 2023 and mostly driven by costs associated with the NATiV3 Phase III clinical trial of lanifibranor in NASH, and, to a lesser extent, with the LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes ("T2D").

Net cash used in investing activities for the first quarter of 2023 amounted to (€8.4) million, compared to (€0.1) million in the first quarter of 2022. The change is mostly due to the change in deposits between both periods.

Net cash used in financing activities for the first quarter of 2023 amounted to (€1.2) million, compared to (€0.1) million in the first quarter of 2022.

Over the first quarter of 2023, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€0.5) million, compared to a positive effect of €0.2 million for the first quarter of 2022, due to the evolution of EUR/USD exchange rate.

Considering its current R&D and clinical development programs, the Company estimates that its existing cash, cash equivalents and deposits should allow the Company to fund its operations until the end of the fourth quarter of 20234. This cash runway estimate does not include the conditional second tranche of €25.0 million of the EIB loan agreement5.

Revenues

The Company did not recognize revenues for the first quarter of 2023, in line with the first quarter of 2022.

Main areas of progress in the R&D portfolio

Implementation of the new design of the Phase III NATiV3 clinical trial evaluating lanifibranor in NASH announced in January 2023 is continuing. The new design has been cleared by regulatory authorities in key countries, including the United States. A total of 376 trial sites are activated in 23 countries and 218 trial sites are already operating under the new design of NATiV3.
Receipt of a positive recommendation, on May 3, 2023, following the second meeting of the Data Monitoring Committee of the Phase III NATIV3 clinical trial to continue the study without modification of the protocol, confirming the good safety profile of lanifibranor.
Positive conclusion of the Renal Impairment study required for regulatory submission, demonstrating that lanifibranor pharmacokinetics is not affected in patients with renal impairment.
Enrollment for the NATiV3 trial is on track and the first visit of the last patient is targeted for the second half of 2023.
Two lanifibranor abstracts have been accepted for presentation at the European Association for the Study of the Liver (« EASL ») International Liver CongressTM
– "Early aminotransferase improvement in the phase 2b NATIVE study is predictive of response pattern of liver histology as well as hepatic and cardiometabolic health markers at the end of treatment in patients with non-cirrhotic NASH" – Prof. Quentin Anstee – Poster

– "Correlation between severity of hepatic steatosis and markers of cardiometabolic health, and effect of lanifibranor therapy in patients with non-cirrhotic NASH" – Michael Cooreman, MD – Poster

After having finalized patient recruitment in September 2022, the data analysis of the investigator-initiated study with lanifibranor in patients with nonalcoholic fatty liver disease ("NAFLD") and T2D is ongoing. The topline results are expected to be published in the middle of the second quarter of 2023.
Anticipated potential key milestones

Publication of the topline results of the investigator-initiated study with lanifibranor in patients with NAFLD and T2D – anticipated in the middle of the second quarter of 2023
Publication of the topline results of the LEGEND Phase IIa combination trial of lanifibranor in combination with empagliflozin in patients with NASH and T2D – anticipated in the second half of 2023
Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating lanifibranor in NASH – anticipated in the second half of 2023
Upcoming investor conference participation

Jefferies Global Healthcare Conference – June 7-9 – New York City
KBC Life Sciences Metabolics Day – June 20 – Brussels
Upcoming scientific conferences

The EASL International Liver CongressTM – June 21-24 – Vienna, Austria
The American Diabetes Association 83rd Scientific Sessions – June 23-26 – San Diego
Next financial results publication

Financial results, cash position and revenues, for the first half of 2023: Thursday, July 27, 2023 (after U.S. market close)