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Daix (France), Long Island City (New York, United States), February 15, 2024 – Inventiva (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, today reported certain preliminary unaudited financial results as of and for the full year ended December 31, 2023, including cash, cash equivalents, and revenues, and provided an update on its clinical trial NATiV3.
Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: "2023 has been an eventful year for the company. We achieved several key clinical milestones in our lanifibranor program, including a new partnership with Hepalys Pharma Inc. to develop and commercialize lanifibranor for the treatment of NASH in Japan and South Korea. During the year, we also raised approximately €36 million and received a $10 million upfront payment under our agreement with Hepalys. This allowed us to draw down the second tranche of €25 million of the €50 million EIB loan in January 2024.
We have advanced our pivotal NATiV3 Phase III clinical trial with lanifibranor in NASH after the implementation of the revised study design in early 2023, with 913 patients randomized to date. An adverse event of elevated aminotransferases has been reported in a patient enrolled in the trial following a scheduled visit. The patient has been asymptomatic and blood tests are improving. However, we have decided to temporarily suspend the screening and randomization of new patients to implement the exclusion criteria in line with the recommendations of the Data Monitoring Committee. All our teams are working diligently, and we are confident that recruitment will resume in around 4 to 6 weeks' time."
Preliminary Unaudited Financial Results
As of December 31, 2023, the Company's cash and cash equivalents amounted to €26.9 million, short-term deposits to €0.01 million2, and long-term deposit to €9.0 million3, compared to €86.7 million, €1.0 million, and €0.7 million as of December 31, 2022, respectively.
The decrease in cash and cash equivalents and short-term and long-term deposits between December 31, 2023, and December 31, 2022 was mainly caused by the increased use of cash in operating activities. This reflects the acceleration of clinical development activities in 2023, 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"). This decrease is partially offset by:
The above cash, cash equivalents and deposits do not include the disbursement of the second tranche of €25 million of the unsecured loan agreement executed with the European Investment Bank ("EIB"), which was received on January 18, 2024. Considering its current cost structure and forecasted expenditures, the Company estimates that, including the second tranche of the EIB loan, its cash, cash equivalents and deposits should allow the Company to fund its operations as currently planned until the beginning of the third quarter of 20245.
Net cash used in operating activities amounted to (€81.6) million for the full year 2023, compared to (€44.9) million in 2022. R&D expenses for 2023 were up 82% compared to 2022. This increase was primarily due to the clinical development activities planned for and executed in 2023, partially offset by the upfront and milestone payments received from our partners, CTTQ and Hepalys (see above).
Net cash used in investing activities for the full year 2023 amounted to (€7.7) million, compared to €8.9 million generated for the same period in 2022. The change was mostly due to the variations in deposits between both periods.
Net cash generated from financing activities for the full year 2023 amounted to €29.1 million, compared to €37.3 million for 2022. The increase was mainly due to the financing of €35.7 million (gross amount) in August 2023, consisting of a capital increase and the issuance of royalty certificates.
The net cash generated from financing activities in 2022 was mainly driven by the equity sold through the Company's At-The-Market Program for approximately €9.4 million (gross proceeds) in June 2022, three loan agreements with a syndicate of French banks for a total amount of €5.3 million entered into in the first half of 2022, and the receipt of the first tranche of €25 million of the unsecured loan agreement with the EIB. In 2023 and 2022, the net cash generated (see above) is partially offset by the repayments of medical imaging equipment lease liabilities and loans.
In 2023, the Company recorded a positive exchange rate effect on cash and cash equivalents of €0.4 million, compared to a negative effect of (€1.0) million for the same period in 2022, due to the evolution of EUR/USD exchange rate.
Revenues
The Company's revenues for 2023 amounted to €17.5 million, compared to €12.2 million for the same period in 2022.
Revenues for 2023 consist mainly of i) €4.6 million, recognized under the license agreement with CTTQ following the receipt of two regulatory milestone payments from CTTQ in connection with IND approval from the NMPA to initiate the clinical development in mainland China of lanifibranor in NASH, and the randomization of the first patient and ii) €12.8 million, recognized under Hepalys License Agreement7.
Update on NATiV3 clinical trial with lanifibranor
Following a routine visit during the course of the NATiV3 trial, an adverse event of liver tests was reported in a patient enrolled in the trial. This event has been assessed as a treatment-related Suspected Unexpected Serious Adverse Reaction ("SUSAR"). The study drug was discontinued for that patient and liver tests which are being closely followed at the clinical site are improving and the patient has been without clinical symptoms throughout the period of observation. Additional lab tests and a liver biopsy performed after study drug discontinuation provided results compatible with autoimmune hepatitis. This patient presented at baseline in September 2022 with a histological diagnosis of NASH with stage 2 fibrosis. An earlier diagnostic analysis had raised a suspicion of autoimmune hepatitis dating back to June 2022.
The SUSAR was duly reported to all regulatory authorities and reviewed by the DMC in conjunction with other milder cases of elevation of aminotransferases among trial participants. The DMC subsequently recommended that the NATiV3 trial can continue with the following modifications:
Following review of the data by the DMC, the Company made the decision to voluntarily pause screening and randomization to implement the DMC recommendations. Patients currently enrolled are continuing to receive treatment under the new liver monitoring schedule recommended by the DMC.
The Company is working diligently to make the appropriate amendments to the study protocol and the Informed Consent Form in line with the DMC recommendations and plans to resume screening and randomization in approximately four to six weeks once the operational implementation of the amendment is completed. Inventiva expects that the screening and randomization pause may extend the last patient first visit timeline for NATiV3 trial to the first half of 2024.
This SUSAR is the first reported in all clinical trials with lanifibranor. Prior to this voluntary pause, Inventiva was on track to complete screening by the end of the first quarter of 2024 with over 550 patients in screening and 913 patients randomized in the NATiV3 clinical trial, including 731 in the main cohort.
The pause in screening and randomization in NATiV3 is not impacting the publication of the topline results of the Phase IIa, LEGEND, evaluating lanifibranor in combination with empagliflozin and is expected for the first quarter of 2024.
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Next key milestones expected
Upcoming investor conference participation
Upcoming scientific conference participation
Next financial results publication
Posted In: IVA
