IVEVF - Inventiva reports its 2023 first-half financial results and provides a corporate update | Benzinga

• Cash and cash equivalents at €31.2 million, short-term deposits at €0.05 million¹, and long-term deposit at €9.3 million², as of June 30, 2023, compared to €86.7 million, €1.0 million and €0.7 million as of December 31, 2022, respectivel
• Revenues amounted to €1.9 million for the first half of 2023
• In August 2023, Inventiva received a financing of approximately €35.7 million from new and existing investors consisting of €30.6 million from a capital increase and €5.1 million issuance of royalty certificates
• In September 2023, Inventiva announced an exclusive licensing agreement with Hepalys Pharma, Inc., to develop and commercialize lanifibranor for the treatment of NASH and potentially other metabolic diseases in Japan and South Korea. Under this agreement, Inventiva will receive a $10 million upfront payment and is eligible to receive up to $231 million in milestone payments
• With the financial raise of €35.7 million, the expected upfront payment of $10 million from Hepalys Pharma, Inc. and milestone payment from CTTQ, Inventiva will meet the financial condition for the disbursement of the second tranche of €25 million of the European Investment Bank ("EIB")³, which is expected to extend Inventiva's estimated cash runway until the beginning of the third quarter of 2024
• Implementation of a new ATM program replacing the existing program
• In July 2023, Inventiva announced positive topline results of the Phase II clinical trial conducted by Dr. Kenneth Cusi, evaluating lanifibranor in patients with NAFLD and T2D, and confirming its favorable safety and tolerability profile
• First visit of the last patient for NATiV3 is targeted by the end of the second half of 2023
• Topline results of the LEGEND study with lanifibranor and empagliflozin in patients with NASH and T2D expected for the end of the first quarter of  2024

Daix (France), Long Island City (New York, United States), September 28, 2023 – 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 its financial results for the six months ended June 30, 2023, and provided a corporate update.

Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: "The first half of the year has been rich in progress for Inventiva. One of the major milestones achieved in recent months has been the positive topline results of the Phase II clinical trial initiated by Prof. Kenneth Cusi, evaluating lanifibranor in patients with T2D and NAFLD. These results further confirm the robustness of lanifibranor's mechanism of action. On the clinical front, we have received confirmation from our partner Sino Biopharm, that it is eligible to start clinical development of lanifibranor in China, the second largest country in the world in terms of NASH population. Finally, we have made advancements in our pivotal Phase III clinical trial following the implementation of the new study design announced this past January. We are continuing to recruit patients in this trial and look forward to the months ahead, with the first visit of the last patient targeted for the end of the year. We have started the second half of this year with two major financial milestones as we have obtained a financing of approximately 36 million euros from new and existing investors and recently entered into an exclusive licensing agreement with Hepalys Pharma, Inc., to develop and commercialize lanifibranor for the treatment of NASH in Japan and South Korea. We are delighted with this partnership, which enables us to extend our international footprint to two countries where the prevalence of NASH is high and enables us to receive in addition to the 10 million dollars upfront, up to approximately 231 million dollars in milestone payments, subject to achievement of specified milestones. We are looking to the months ahead with great optimism."

Key financial results for the first half of 2023

The Company's revenues for the first half of 2023 amounted to €1.9 million, as compared to €0.1 million for the same period in 2022. The increase is mainly due to the receipt of the first regulatory milestone payment from CTTQ, Sino Biopharm's subsidiary, which was received in July 2023. The milestone payment was triggered in May 2023 after CTTQ received the Investigational New Drug ("IND") approval from the Chinese National Medical Products Administration ("NMPA") to initiate the clinical development in mainland China of lanifibranor in NASH.  

Other income amounted to €4.7 million for the first half of 2023, as compared to €3.3 million for the first half of 2022, increased 42% mainly driven by the French R&D tax credit based on the increasing eligible expenses, by the U.S. R&D tax credit and to a lesser extent by the commencement of invoicing CTTQ, Sino Biopharm's subsidiary for their clinical development expenses in Great China incurred by Inventiva.

R&D expenses for the first half of 2023 amounted to €54.1 million, mainly driven by the development of lanifibranor in NASH, and were up 81% compared to the €29.9 million for the first half of 2022. This increase reflects the 2023 planned acceleration of the clinical development activities 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").

Marketing and business development expenses stood at (€0.7) million for the first half of 2023 compared to (€0.3) million for the same period in 2022 mainly related to the increasing market access activities to prepare for the potential commercial development of lanifibranor.

General and administrative expenses (G&A) amounted to €6.8 million in the first half of 2023, stable compared to the first half of 2022.

Net financial income (loss) amounted to (€0.3) million in the first half of 2023, compared to €4.0 million mainly related to less favourable foreign exchange rates in 2023 due to the depreciation of the U.S. dollar against the euro during the period, and the full effect of the interest expenses related to the EIB and state loans contracted in 2022.

The Company's net loss stood at (€55.3) million as of June 30, 2023 compared to (€29.5) million as of June 30, 2022.

As of June 30, 2023, the Company's cash and cash equivalents amounted to €31.2 million, short-term deposits amounted to 0.05 million², and long-term deposit amounted to €9.3 million³, compared to €86.7 million, €1.0 million and €0.7 million as of December 31, 2022, respectively.

The €48.0 million decrease in cash and cash equivalents between June 30, 2023 and December 31, 2022 is mainly due to increased cash used in operating activities and reflects the ...

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