Salute e Benessere
Inventiva reports preliminary 2024 fiscal year financial results¹ and provides a business update
– 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 metabolic dysfunction-associated steatohepatitis (“MASH”), and other diseases with significant unmet medical needs, today reported certain preliminary unaudited financial results for the full year ended December 31, 2024, including cash, cash equivalents, and revenues, and also provided a business update.
As of December 31, 2024, the Company's amounted to €96.6 million compared to cash and cash equivalents at €26.9 million, short-term deposits at €0.01 million , and long-term deposit at €9.0 million as of December 31, 2023, respectively.
amounted to (€85.9) million in 2024, compared to (€81.6) million in 2023, an increase of 5.3%. R&D expenses, mainly driven by the development of lanifibranor in MASH, amounted to €90.9 million in 2024 and were down 17% compared to the €110.0 million in 2023. The decrease in R&D expenses over the period is primarily due to the temporary voluntary pause in the recruitment of patients in the NATiV3 Phase 3 clinical trial of lanifibranor in MASH (“NATiV3") following the Suspected Unexpected Serious Adverse Reaction (“SUSAR”) reported in the first quarter of 2024 and, to a lesser extent, due to the completion of the LEGEND Phase 2, a combination trial with lanifibranor and empagliflozin in patients with MASH and type 2 diabetes (“T2D”). For the second half of 2024, R&D expenses started to increase again following the restart of patient recruitment in NATiV3 and the planned clinical development activities and related costs associated with NATiV3.
The operating cash flow for 2024 also includes the gross proceeds of $10 million (net proceeds of €9.2 million ), received as a milestone payment under the amendment to the licensing agreement with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”) in connection with the closing of the first tranche of the Structured Financing (as defined below) in October 2024, compared to an operating cash flow for 2023, which included i) €4.6 million, recognized under the license agreement with CTTQ following the receipt of two regulatory milestone payments from CTTQ in connection with the approval of the Investigational New Drug (“IND”) by the Chinese National Medical Products Administration (the “NMPA”) to initiate the clinical development in mainland China of lanifibranor in MASH, and the randomization of the first patient and ii) €12.8 million, recognized under Hepalys License Agreement, (see also Revenues below).
amounted to €8.7 million in 2024, compared to (€7.7) million in 2023. The change is mostly due to the variation in term deposits between both periods.
for 2024 amounted to €145.6 million, compared to €29.1 million in 2023. The change is due to the receipt of:
In 2024, the Company recorded €1.2 million positive exchange rate effect on cash and cash equivalents, compared to €0.4 million for the same period in 2023, due almost exclusively to the evolution of the EUR/USD exchange rate.
Considering its current cost structure and expected expenses, the Company estimates that its cash and cash equivalents would enable it to finance its operations until the middle of the third quarter 2025. Accordingly, the Company does not have sufficient net working capital to meet its current obligations over the next 12 months from the date of this press release.
Subject to the satisfaction of the applicable conditions precedent, the Company expects to receive, in the second quarter of 2025 (i) gross proceeds of approximately €116 million from the second tranche of the Structured Financing and (ii) a second milestone payment of $10 million from CTTQ under the licensing agreement with CTTQ. Taking into account its current cost structure and expected expenses, including the pipeline prioritization described below, the Company estimates that its existing cash position and these expected potential additional sources of funding would enable it to finance its activities until the end of the third quarter of 2026.
There can be no guarantee that the conditions precedent for this second tranche of the Structured Financing and the second milestone from CTTQ will be satisfied with respect to the expected timing or at all.
The Company's revenues for 2024 amounted to €9.2 million, compared to €17.5 million in 2023.
Revenues for 2024 consist mainly of the $10 million (net proceeds of €9.2 million) milestone payment received from CTTQ, recognized under the license agreement with CTTQ following the receipt of the payment connection with the closing of the first part of the first tranche of the Structured Financing in October 2024, compared to i) €4.6 million, recognized under the license agreement with CTTQ following the receipt of two regulatory milestone payments from CTTQ in connection with the IND approval from the NMPA to initiate the clinical development in mainland China of lanifibranor in MASH, and the randomization of the first patient and ii) €12.8 million, recognized under Hepalys License Agreement.
Screening of patients in the ongoing NATiV3 trial was completed in early January 2025. More than 95% of the target number of patients have been randomized and completion of enrollment is expected within the first half of 2025.
The Company has informed the representatives of its workers council of its plan to focus exclusively on the development of lanifibranor. The plan includes stopping all preclinical research activities except those required to support the lanifibranor program, together with expanding the program team to prepare for potential filings for marketing approval and subsequent commercialization of lanifibranor for patients with MASH.
The plan presented includes reducing the Company's current workforce by approximately 50%. The plan is expected to be implemented in the course of the second quarter of 2025 and all work on the Company's pre-clinical programs (YAP-TEAD and NR4A1) will be terminated.
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease.
The Company has a scientific team of approximately 90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly owned research and development facility.
Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the NASDAQ Global Market in the United States (ticker: IVA). www.inventivapharma.com
Unaudited
Short-term deposits were included in the category “other current assets” in the IFRS consolidated statement of financial position as of December 31, 2023, and were considered by the Company as liquid and easily available.
The long-term deposit had a two-year term accessible prior to the expiration of the term with a notice period of 31 days and was considered as liquid by the Company.
Press release of July 18, 2024
Press release dated October 14, 2024
This estimate is based on the Company's current business plan for lanifibranor and excludes potential proceeds from subsequent tranches of the Structured Financing, any potential milestones payable to or by the Company and any additional expenditures related to other product candidates or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based this estimate on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
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