GlobeNewsWire - Inventiva SA (VAT) Inventiva Reports First Quarter 2023 Financial Information¹ and Provides a Corporate Update (2023)

• Cash and cash equivalents at 56.3 million euros, short-term deposits at 0.7 million euros², and a long-term deposit of 9.3 million euros³as of March 31, 2023, compared to 86.7 million euros, 1.0 million euros and 0.7 million euros as of December 31, 2022, respectively
• Improvements in the phase III clinical trial of NATiV3 with lanifibranor in NASH with the implementation of the new design, advances in patient recruitment and recommendation, after the second meeting of the Data Monitoring Committee, to continue the trial without modifications
• Positive Conclusion of Renal Impairment Study Required for Lanifibranor Regulatory Submission in NASH
• Two Lanifibranor abstracts have been accepted for presentation at the EASL International Liver Congress^TM
• The first visit of the last patient for NATiV3 is planned for the second half of 2023
• Main results of the study with lanifibranor in patients with NAFLD and T2D expected by mid-Q2 2023

Daix (France),Long Island City (New York, United States),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 need, today reported financial information for the first quarter of 2023, including its cash, cash equivalents and revenue, and provided a corporate update.

Financial results

cash position

As of March 31, 2023, the CompanyCash and cash equivalentsamounts to 56.3 million euros, short-term deposits to 0.7 million², and a long-term deposit of 9.3 million euros³, compared to 86.7 million euros, 1.0 million euros and 0.7 million euros as of December 31, 2022, respectively.

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

Net cash used in investing activitiesfor the first quarter of 2023 it amounted to (€8.4) million, compared to (€0.1) million in the first quarter of 2022. The variation is mainly due to the variation in deposits between the two periods.

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

During the first quarter of 2023, the Company recorded anegative exchange rateeffectin 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 the EUR/USD exchange rate.

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

Income

The Company did not recognize revenue 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 continues. The new design has been approved by regulatory authorities in key countries, including the United States. A total of 376 test sites are activated in 23 countries and 218 test sites are already operating under the new NATiV3 design.
• Receipt of positive recommendation, on May 3, 2023, after 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 the pharmacokinetics of lanifibranor are not affected in patients with renal insufficiency.
• Enrollment for the NATiV3 trial is on track and the first visit of the last patient is planned for the second half of 2023.
• Two abstracts for lanifibranor have been accepted for presentation to the European Association for the Study of the Liver ("EASL») International Liver Congress^TM

- “Early aminotransferase improvement in the phase 2b NATIVE study predicts the response pattern of liver histology, as well as end-of-treatment liver and cardiometabolic health markers in non-cirrhotic NASH patients” – Prof. Quentin Anstee – Poster

- "Correlation Between Hepatic Steatosis Severity and Markers of Cardiometabolic Health and the Effect of Lanifibranor Therapy in Non-Cirrhotic NASH Patients" - Michael Cooreman, MD - Poster

• Following completion of patient enrollment in September 2022, data analysis from the investigator-initiated study with lanifibranor in patients with nonalcoholic fatty liver disease ("NAFLD") and T2D is ongoing. The main results are expected to be published in the middle of the second quarter of 2023.

Potential anticipated key milestones

• Publication of the main results of the investigator-initiated study with lanifibranor in patients with NAFLD and T2D –expected in the middle of the second quarter of 2023
• Publication of Main Results from the Phase IIa LEGEND Combination Trial of Lanifibranor in Combination with Empagliflozin in Patients With NASH and T2D –expected in the second half of 2023
• First visit of the last patient in the NATiV3 phase III clinical trial evaluating lanifibranor in NASH:expected in the second half of 2023

Next participation in the investor conference

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

Upcoming scientific congresses

• The EASL International Liver Congress^TM– June 21-24 – Vienna, Austria
• The American Diabetes Association 83^rdScientific Sessions – June 23-26 – San Diego

Next publication of financial results

• Financial results, cash position and income, for the first half of 2023:Thursday, July 27, 2023 (after US market close)

About Inventiveness

Inventiva is a clinical stage biopharmaceutical company focused on the research and development of small molecule oral therapies for the treatment of patients with NASH, mucopolysaccharidoses ("MPS") and other diseases with significant unmet medical needs. The company benefits from strong experience and expertise in the domain of nuclear receptor targeting compounds, transcription factors and epigenetic modulation. Inventiva is currently advancing a clinical candidate, has a pipeline of two preclinical programs, and continues to explore other development opportunities to add to its pipeline.

Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies.

Inventiva's pipeline also includes odiparcil, a drug candidate for the treatment of adult patients with MPS VI. As part of Inventiva's decision to focus clinical efforts on the development of lanifibranor, it has suspended its clinical efforts related to odiparcil and is reviewing available options regarding its potential future development. Inventiva is also in the process of selecting an oncology development candidate for its Hippo signaling pathway program.

The Company has a scientific team of approximately 90 people with extensive experience 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 Euronext Paris regulated market (ticker: VAT, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: VAT).

Contacts

Important news

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, except statements of historical fact, included in this press release are statements prospective. These statements include, but are not limited to, forecasts and estimates regarding Inventiva's preclinical programs and clinical trials, including the design, duration, timing, recruitment costs, selection, and enrollment for those trials, including the clinical trial Phase III NATiV3 in progress. with lanifibranor in NASH, the Phase IIa LEGEND combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes, andhe study with lanifibranor in patients with NAFLD and T2D, potential development and regulatory pathway for odiparcil, clinical trial data launches and publications, the information, insights, and impacts that can be gleaned from clinical trials, the potential therapeutic benefits of Inventiva product candidates, including lanifibranor, potential regulatory submissions and approvals, and Inventiveness Pipeline and preclinical and clinical development plans, future activities, expectations, plans, growth and prospects of Inventiva, the possible receipt of the second tranche under the EIB loan and any possible transaction or receipt of additional funds, future access to the two-year short-term deposit and the adequacy of the cash resources of Inventiva and the trail of estimated cash. Some of these statements, forecasts and estimates can be recognized by the use of words such as, but not limited to, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may ”, “will”, “would”, “could”, “could”, “should”, “designed”, “hopefully”, “target”, “target” and “continue” and similar expressions. Such statements are not historical facts, but statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect those views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or events to differ materially from those expressed or implied by such statements. . Actual events are difficult to predict and may depend on factors beyond Inventive's control. There can be no assurances with respect to product candidates under development that clinical trial results will be available on schedule, that future clinical trials will commence as planned, that product candidates will receive necessary regulatory approvals, or that any of Inventiva's or its partners' milestones will be reached on schedule, or not at all.Future results may be materially different from anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including the fact that Inventiva is a clinical stage company. no approved products and no historical product revenue Inventiva has incurred significant losses since inception Inventiva has limited operating history and has never generated any revenue from product sales Inventiva will require additional capital to finance its operations, in the absence of the which Inventiva may be forced to significantly reduce, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may not be able to continue as a going concern, Inventiva's future success depends on successful clinical development, regulatory approval, and subsequent marketing of current and future product candidates, prior preclinical studies or clinical trials are not necessarily predictive of future results, and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva's expectations regarding changes to the clinical development plan for lanifibranor for the treatment of NASH may not be realized and may not support approval of a new drug application, Inventiva may encounter substantial delays in its clinical trials or Inventiva may not demonstrate safety and efficacy to the satisfaction of applicable requirements. regulatory authorities, Inventiva's ability to recruit and retain patients in clinical trials, enrollment and retention of patients in clinical trials is a costly and time-consuming process and could be made difficult or impossible due to multiple factors outside of Inventiva's control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent regulatory approval, or limit its commercial potential, Inventiva faces considerable competition and Inventiva's business, preclinical studies, and clinical development schedules and schedules, its financial condition and results of operations could be materially and adversely affected by current geopolitical events, such as the conflict between Russia and Ukraine, related sanctions and related impacts, and potential startup impacts , enrollment and completion of Inventiva clinical trials on schedule, health epidemics, and macroeconomic conditions, including global inflation, rising interest rates, uncertain financial markets, and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. In addition, forward-looking statements, forecasts and estimates speak only as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

See the Universal Registration Document for the year ended December 31, 2022 filed with the Autorité des Marchés Financiers on March 30, 2023, and the Annual Report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission on March 30, 2023 for other risks and uncertainties affecting Inventiva, including those described from time to time under the heading “Risk Factors”. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and timing to differ materially from those anticipated.

All information in this press release is as of the date of the release. Except as required by law, Inventiva does not intend or have any obligation to update or revise any of the above forward-looking statements.

¹Unaudited financial information.
²Short-term deposits are included in the "other current assets" category in the consolidated statement of financial position under IFRS, and are considered by the Company to be liquid and readily available.
³The long-term deposit has a term of two years accessible before the expiration of the term with a notice of 31 days and is considered liquid by the Company.

⁴This estimate is based on the Company's current business plan and excludes any potential milestones payable to or by the Company and any additional expenses related to the possible continued development of the odiparcil program or resulting from the possible licensing or acquisition of candidates from additional products or technologies, or any associated developments that the Company may make. The Company may have based this estimate on assumptions that are incorrect and the Company may end up using its resources ahead of schedule.
⁵The disbursement of the second tranche of 25 million euros is subject, among other conditions, to (i) the Company issuing warrants to the EIB in accordance with the terms and conditions of the warrant agreements entered into on July 1, 2022, (ii ) the full drawdown of the first tranche, (iii) the receipt by the Company from the date of the EIB credit line of a total amount of at least 70.0 million euros (including the 18.0 million of euros that were a condition for the disbursement of the first tranche), paid in exchange for shares of the Company, or through advance payments or milestones, (iv) a licensing, partnership or royalty transaction with an advance payment of at least 10.0 million euros; and (v) operational criteria based on patient enrollment and number of sites activated in the NATiV3 Phase III clinical trial of lanifibranor in NASH patients.

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