INVENTIVA S.A.

A joint-stock company (société anonyme) with a share capital of 524,771.88 euros

Registered office: 50, rue de Dijon, 21121 Daix, France

Dijon Trade and Companies Register 537 530 255

INTERIM FINANCIAL REPORT

FOR THE SIX MONTHS ENDED JUNE 30, 2024

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Table of contents

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Definitions

In this half-yearly report (the “Interim Financial Report”), and unless otherwise specified, the terms Inventiva or the Company are taken to mean the company Inventiva S.A. with its registered office at 50, rue de Dijon, 21121 Daix, France, and which is listed with the Dijon Trade and Companies Register under number 537 530 255 and its subsidiary, 100% owned, Inventiva Inc. with its registered office at 10-34 44^th Dr, Long Island City, 11101 New York, USA, created in January 2021.

Certain terms used in this Interim Financial Report are defined in the Company’s annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission on April 3, 2024 (“the Annual Report”).

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management’s beliefs and assumptions and on information currently available to our management. All statements other than present and historical facts and conditions contained in this document, including statements regarding our future results of operations and financial positions, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this document, the words “anticipate,” “believe,” “can,” “continue”, “could,” “estimate,” “expect,” “goal”, “intend,” “is designed to,” “may,” “might,” “plan,” “will,” “would,” “potential,” “predict,” “objective,” “should,” “target”, or the negative of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements about:

We encourage you to read and carefully consider all of the risk factors disclosed in “Item 3.D—Risk Factors” of our Annual Report and Section 1.4 hereof, for a discussion of the risks and uncertainties material to our business, including important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this document will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. These forward-looking statements represent our plans, objectives, estimates, expectations and intentions only as of the date of this filing. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

You should read this document and the documents that we reference herein completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

Market and competitive position

This Interim Financial Report also contains information about the Company’s activities and the markets on which it operates. This information comes from studies or surveys carried out internally or externally. Other information contained in this Interim Financial Report is available to the general public. The Company considers that all of this information is reliable, but it has not been verified by an independent expert. The Company cannot guarantee that a third party using different methods to gather, analyze or calculate market data would obtain the same results.

Rounding of figures

Certain figures (including data expressed in thousands or millions of euros or dollars) and the percentages presented in this Interim Financial Report have been rounded up or down. Accordingly, totals given may vary slightly from those obtained by adding the exact (unrounded) values of those same figures.

Abbreviations

Certain figures are given in thousands or millions of euros and are indicated as € thousand or € million respectively in this Interim Financial Report.

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1.Interim Financial Report

1.1.    General overview of activities

Inventiva S.A. is a public limited company registered and domiciled in France. Its head office is located at 50 rue de Dijon, 21121 Daix. The consolidated financial statements of the company Inventiva include Inventiva S.A. and its subsidiary Inventiva Inc., created in January 2021.

Inventiva’s ordinary shares have been listed on compartment B of Euronext Paris regulated market since February 2017 and Inventiva’s American Depositary Shares (“ADSs”), each representing one ordinary share, have been listed on the Nasdaq Global Market since July 2020.

Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), also known as non-alcoholic steatohepatitis (“NASH”) and other diseases with significant unmet medical need.

Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing lanifibranor for the treatment of MASH/NASH, as well as a pipeline of earlier stage programs in oncology discovery.

Lanifibranor, its lead product candidate, is being developed for the treatment of patients with MASH/NASH, a chronic and progressive liver disease. In 2020, the Company announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with MASH/NASH and announced that the U.S. Food and Drug Administration ("FDA") had granted the Company the status of Breakthrough Therapy and Fast Track designation. The Company initiated the pivotal Phase III trial of lanifibranor in MASH/NASH (“NATiV3”) in the second half of 2021. In March 2024, the Company announced positive results from its Phase IIa combination trial with lanifibranor and empagliflozin in patients with MASH/NASH and Type 2 Diabetes (“DT2”) (“LEGEND”).

In the first half of 2022, the Company faced delays in its NATiV3 trial that were primarily due to a higher than originally projected screen failure rate resulting in slower than anticipated enrollment rate. In addition, the Company experienced slower than predicted site activation, screening and enrollment due to negative impacts from the COVID-19 pandemic, mainly during the years 2020 and 2021, and the Company was unable to conduct clinical trial activities at sites originally located in Ukraine due to the war between Ukraine and Russia and made the decision to put recruitment for its NATiV3 trial in Ukraine on hold and close all sites in Russia. Global geopolitical events that continue to impact the markets (including Russia's invasion of Ukraine or the state of war between Israel and Hamas) could affect the Company.

In January 2023, the Company amended the protocol for the NATiV3 trial in part to potentially accelerate enrollment and identified additional sites to help compensate for the inability to use sites in Ukraine and Russia. The revised study design limits the planned duration of the trial to 120 weeks instead of up to seven years, reduces the number of biopsies from three to two and included a 48-week active treatment extension study. The Company expects that the changes to the clinical development plan of lanifibranor, including plans for a new Phase III trial in patients with MASH/NASH and compensated cirrhosis, will be beneficial to the lanifibranor clinical program by reducing the number of biopsies and the trial duration, eventually offering all patients in the trial access to treatment and potentially expanding the addressable patient population beyond patients with F2 and F3 fibrosis to patients with NASH and compensated cirrhosis.

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In September 2022, the Company entered into a license and collaboration agreement with Chia Tai Tianqing Pharmaceutical (Guangzhou), Co., LTD (“CTTQ”), a Sino Biopharm group company, to develop and commercialize, subject to regulatory approval, lanifibranor for the treatment of MASH/NASH and other metabolic diseases in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan (“CTTQ Territory”). In May 2023, the Company announced that CTTQ had received the Investigational New Drug (“IND”) approval from the Chinese National Medicine Products Administration (“NMPA”) allowing CTTQ to initiate the clinical development of lanifibranor in MASH/NASH in mainland China. CTTQ is participating in the ongoing NATiV3 Phase III trial and is conducting a Phase I clinical pharmacology study. In the framework of its participation in the Company’s NATiV3 Phase III global clinical trials, pursuant to the terms of the agreement, CTTQ bears all costs associated with these trials conducted in the CTTQ Territory.

On September 20, 2023, the Company and Hepalys Pharma, Inc. (“Hepalys”) announced an exclusive licensing agreement to develop and commercialize lanifibranor in Japan and South Korea (the “Hepalys License Agreement”). Hepalys is a new company created by Catalys Pacific Fund II, LP (“Catalys”). Under the Hepalys License Agreement, the Company received a $10 million upfront payment (equal to €9.5 million) on October 18, 2023, and is eligible to receive up to $231 million if certain clinical, regulatory and commercial conditions are met; in addition to tiered royalties from mid double digits to low twenties based on net sales of lanifibranor in Japan and South Korea, subject to regulatory approval. In parallel with the Hepalys License Agreement, the Company entered into an option agreement with Catalys to acquire 30% of the shares of Hepalys (the “Catalys Option Agreement”). The Company exercised that option on September 26, 2023, with an effective date of October 11, 2023, at an aggregate exercise price of ¥300 (equal to €1.90). Also on September 20, 2023, the Company entered into a shareholders agreement with Catalys and Hepalys (the “Catalys Shareholders Agreement”). Pursuant to the Catalys Shareholders Agreement, the Company has the option to acquire all outstanding shares of Hepalys at a pre-agreed multiple of post-money valuation and the Company has a right of first refusal if Hepalys receives an offer for the license or rights related to lanifibranor.

In the first quarter of 2024, following a routine visit during Company’s NATiV3 clinical trial of lanifibranor in MASH/NASH, a Suspected Unexpected Serious Adverse Reaction (“SUSAR”) was reported in a patient. As a result of this SUSAR, the Company decided to voluntarily pause screening and randomization to implement changes to the enrollment criteria to exclude patients diagnosed or with a predisposition to autoimmune liver or thyroid disease and more frequent liver monitoring for patients enrolled in the trial as recommended by the Data Monitoring Committee¹ (“DMC”).

On March 7, 2024, the Company announced that screening activities had resumed in American sites under central Institutional Review Board (“IRB”). The impact of the pause on the overall timeline of the trial remains unclear, as new exclusion criteria were added, which may increase the screen failure rate, and the SUSAR, new exclusion criteria and increased liver monitoring may discourage potential trial participants.

On March 18, 2024, the Company announced positive results from its LEGEND proof-of-concept study combining lanifibranor with empagliflozin in patients with MASH /NASH and DT2.

The Company expects the first visit of the last patient to be in the fourth quarter of 2024 (versus the first quarter of 2024 as previously announced) and to complete randomization in the first half of 2025. Due to a delay of around 3 to 5 months in recruitment, the Company is currently targeting the topline results for the second half of 2026 (versus the beginning of the second half of 2026 as previously announced).

If the results of the trial confirm sufficient clinical benefit and a continued good safety profile, the Company plans to file an application for accelerated approval in the United States and conditional authorization in the European Union for the marketing of lanifibranor.

The Company’s pipeline also includes odiparcil, which it was previously developing for the treatment of patients with mucopolysaccharidosis type VI (“MPS VI”), a group of rare genetic diseases. As announced in 2020, the Company decided to focus its clinical efforts on the development of lanifibranor. Based on feedback from the FDA, the Company believes there is potential for an efficient development pathway for odiparcil for the treatment of MPS VI and it continues to review potential options to further develop odiparcil for the treatment of MPS VI, which may include pursuing or creating a partnership, license or other transaction.

¹ A DMC is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.

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1.2.    Significant events in the first half of 2024

1.2.1.Operations and product portfolio

Treatment-related Suspected Unexpected Serious Adverse Reaction in the first quarter of 2024

On February 15, 2024, the Company announced that an adverse event of elevated aminotransferases in liver tests was reported in a patient enrolled in the NATiV3 trial following a scheduled visit. The patient had been without clinical symptoms throughout the period of observation. This event has been assessed as a treatment-related SUSAR. Other milder cases of elevation of aminotransferases among trial participants have also been reported in the trial. The Company decided to voluntarily pause screening and randomization to implement changes to the enrollment criteria to exclude patients diagnosed or with a predisposition to autoimmune liver or thyroid disease and more frequent liver monitoring for patients enrolled in the trial as recommended by the DMC in the first quarter of 2024. Patients already enrolled in the Phase III NATiV3 trial continued to receive treatment under the new liver monitoring schedule recommended by the DMC. This SUSAR is the first reported in all clinical trials with lanifibranor.

On March 7, 2024, the Company received approval from the central IRB overseeing clinical research in the United States to resume screening activities in its sites. This was an important milestone as 152 sites of the NATiV3 clinical trial sites are operating under central IRB and have so far randomized over 60% of the patients in the main cohort.

Due to a delay of around 3 to 5 months in recruitment, the Company is currently targeting the first visit of the last patient for the fourth quarter of 2024, completion of randomization in the first half of 2025 and the main results are expected for the second half of 2026 (versus the beginning of the second half of 2026 as previously disclosed).

The Company presented the results of LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with MASH/NASH and T2D

On March 18, 2024, the Company announced positive results from its LEGEND proof-of-concept study combining lanifibranor with empagliflozin in patients with MASH/NASH and type 2 diabetes.

The LEGEND trial was designed as a multi-center, randomized, 24-week treatment, placebo-controlled Phase II Proof-of-Concept trial to assess the safety and efficacy of lanifibranor in combination with the SGLT2 inhibitor empagliflozin for the treatment of patients with non-cirrhotic MASH/NASH and T2D. The trial was double-blind for the placebo arm and lanifibranor (800mg daily) arm, and open-label for the combination of lanifibranor (800mg daily) and empagliflozin (10 mg daily) arm. The diagnosis of non-cirrhotic MASH/NASH was based on historic histology evaluation or a combination of non-invasive methods including diagnostic methods including imaging. As planned per protocol, the interim analysis was done once half of the 63 planned randomized patients with MASH completed the 24-week treatment period or prematurely discontinued from treatment.

The study achieved the primary efficacy endpoint with an absolute reduction in Hemoglobin A1c (HbA1c) of 1.14% and 1.59% in patients with MASH and T2D treated with lanifibranor (800mg daily) or in combination with empagliflozin (10mg daily) at week 24 compared to an increase of 0.26% observed in the placebo arm.

The study also demonstrated a statistically significant reduction in hepatic steatosis measured by MRI-PDFF, in patients treated with lanifibranor alone and in combination with empagliflozin, -47% and -38% respectively, compared to placebo (0%). 83% and 67% of patients treated with lanifibranor alone or in combination with empagliflozin respectively, showed a reduction greater or equal to 30% of their hepatic fat, compared to 0% in the placebo arm. In addition, the study demonstrated a statistically significant effect on several secondary and exploratory endpoints, including liver enzymes (alanine aminotransferase (“ALT”) and aspartate aminotransferase (“AST”)), insulin resistance (HOMA-IR), HDL, and adiponectin.  Markers of liver inflammation and fibrosis (corrected T1 relaxation time (cT1) assessed by LiverMultiScan®) were assessed for the first time with lanifibranor and showed a significant effect with lanifibranor alone and in combination with empagliflozin.

The study also demonstrated that patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that can be observed in some patients treated

with lanifibranor alone. Furthermore, these results demonstrated a significant relative reduction in the VAT/SAT ratio (visceral and subcutaneous adipose tissue) in patients treated with lanifibranor alone or in combination with empagliflozin, -5% and -17% respectively, compared to an increase of 11% in patients under placebo. This result reflects a shift from pro-inflammatory visceral fat towards metabolically healthy adipose tissue.

The treatment with lanifibranor 800mg/daily alone and in combination with empagliflozin 10mg/daily for 24 weeks appears to be well tolerated, with no safety concerns reported.

Given that the primary endpoint of LEGEND was met, and statistically significant results were achieved on several key additional markers, the Company has decided to stop the recruitment as defined per protocol. More details on these results are expected to be presented in upcoming scientific conferences and submitted for publication.

Additional results from NATIVE Phase IIb clinical trial

On May 13, 2024, the Company announced the publication in Nature Communications of additional results from NATIVE Phase IIb clinical trial demonstrating improvement of markers of cardiometabolic health in patients with MASH/NASH treated with lanifibranor.

Improvements were observed for insulin resistance (insulin levels, HOMA-IR), lipid metabolism (triglycerides, HDL-cholesterol, apolipoproteins), control of glycemia (HbA1c, fasting glucose (FG) levels), systemic inflammation (hs-CRP, ferritin), hepatic steatosis and diastolic blood pressure.

Recommendation of the fourth DMC of the NATiV3 Phase III clinical trial with lanifibranor in patients with MASH/NASH

On May 16, 2024, the Company announced the positive recommendation of the fourth DMC of the NATiV3 Phase III clinical trial with lanifibranor in patients with MASH/NASH.

The DMC recommended to continue the clinical trial without further modification of the protocol, as amended immediately after learning about the SUSAR based on the pre-planned review of safety data.

The recommendation was based on the unblinded review by the DMC of safety data from more than 900 patients randomized in the main and exploratory cohorts, including more than 360 and 80 patients that have been treated for more than 48 and 72 weeks, respectively.

The patient who experienced the adverse event of increased liver test results, which was reported as a SUSAR, had been without clinical symptoms throughout the period of observation and has fully recovered.

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1.2.2.Other events

The Company issued 3,144,654 warrants to EIB in connection with the drawdown of Tranche B

On January 4, 2024, the Company issued 3,144,654 additional warrants to the European Investment Bank (“EIB”) and such warrants (the “EIB Tranche B Warrants”), in accordance with the terms of the 6^th resolution of the combined general meeting of shareholders of January 25, 2023 and Article L.225-138 of the French Commercial Code, as a condition to the drawdown of the second tranche of €25.0 million (“Tranche B”) under the finance contract between the Company and EIB (“Finance Contract”). The 3,144,654 shares underlying the EIB Tranche B Warrants represented approximately 6.07% of the Company's then-outstanding share capital. If all the warrants issued to the EIB in connection with drawdown of the first tranche of €25.0 million (“Tranche A”) under the Finance Contract (the “EIB Tranche A Warrants” and, together with the EIB Tranche B Warrants, the “EIB Warrants”) and the EIB Tranche B Warrants were exercised, the EIB would hold approximately 11.3% of the Company's share capital as of June 30, 2024.

The exercise price of the EIB Tranche B Warrants is equal to €3.95 and corresponds to 95% of the volume-weighted average price of the Company's shares on the regulated market of Euronext Paris during the last trading session preceding the decision to issue the warrants (i.e. January 3, 2024).

The EIB Tranche B Warrants have a maturity of twelve years and shall be exercisable following the earliest to occur of (i) the maturity date of Tranche A (i.e., on December 8, 2026), (ii) a change of control event, (iii) an event of default under the Finance Contract, or (iv) a repayment demand by EIB under the Finance Contract. The EIB Warrants will automatically be deemed null and void if not exercised within the twelve-year period.

EIB has a put option which may require the Company to repurchase all or part of the unexercised EIB Tranche B Warrants then exercisable at their intrinsic value (subject to a cap equal to the amount drawn under the Finance Contract) under certain circumstances (for example, in the event of a change of control or on the maturity date of Tranche A or in the event of default). The Company (or a substitute third party) has a call option to require EIB to sell all shares and other securities of the Company, including the EIB Warrants, to the Company, subject to certain terms and conditions. In addition, the Company has a right of first refusal to buy-back all EIB Tranche B Warrants offered for sale to a third party, subject to certain terms and conditions.

On the basis of the 3,144,654 new shares of the Company issuable upon exercise of all the EIB Tranche B Warrants at a price of €3.95 per new share, the Company could potentially receive gross proceeds of up to €12,421,383. There is no assurance that EIB will exercise any or all of the EIB Warrants or that the Company will receive any proceeds from the exercise of the warrants.

The exercise ratio of EIB Tranche A Warrants has been adjusted following the issue of EIB Tranche B Warrants. As of the date of authorization of the issuance of these financial statements, one EIB Tranche A Warrant entitles its holder to subscribe for 1.27 ordinary shares in the Company.

The Company drew down Tranche B of €25 million under Finance Contract with EIB

On January 18, 2024, the Company drew down Tranche B under the Finance Contract for an amount of €25 million.

After the drawdown of Tranche A in December 2022, the Company had an option to access further €25 million tranche, Tranche B, subject to the achievement of certain conditions precedent. Following the achievement of those conditions, the Company decided to draw on Tranche B. The Company intends to use the proceeds to fund part of NATiV3.

Tranche B carries a 7% interest capitalized annually and repayment in fine. The repayment is due in January 2027, three years after its disbursement. The disbursement of Tranche B was subject to, among other conditions, (i) the full drawdown of Tranche A, (ii) the receipt by the Company from the date of the Finance Contract of an aggregate amount of at least €70 million (inclusive of the €18 million that was a condition for the disbursement of Tranche A), paid either in exchange for shares of the Company, or through upfront or milestone payments, (iii) an out-licensing, partnership or royalty transaction with an upfront payment of at least €10 million, (iv) operational criteria based on patient enrollment and number of sites activated in the Company’s NATiV3 Phase III clinical trial of lanifibranor in patients with MASH/NASH and (v) the Company issuing EIB Tranche B Warrants (see above - The Company issued 3,144,654 warrants to European Investment Bank in connection with the drawdown of Tranche B) in accordance with the terms and conditions of the warrant agreement entered into on July 1, 2022.

Tranche B of €25 million was recognized as financial debt at amortized cost, which takes into account the fair value of the derivative instrument (warrants) at inception and the borrowing costs.

On June 12, 2024, the Company and EIB amended the warrant to modify the rules for adjusting the exercise ratios of the EIB Warrants.

1.3.    Recent events and prospects

1.3.1.Operations and product portfolio

Update on NATiV3 clinical program evaluating lanifibranor in patients with MASH/NASH.

On July 5, 2024, the Company provided an update on its NATiV3 clinical program evaluating lanifibranor in patients with MASH/NASH. Recruitment in NATiV3 clinical trial continues in both cohorts with over 80% of the targeted number of patients enrolled in the main cohort and 100% in the exploratory cohort of NATiV3.

The first visit of the last patient of NATiV3 is anticipated to occur during the fourth quarter of 2024, and topline results are expected in the second half of 2026. The Company strengthened its patent portfolio with a new patent in Japan that provides intellectual property rights on the potential use of lanifibranor for the treatment of patients with cirrhosis until 2039, excluding any potential patent term adjustments or extensions that may provide additional protection until 2043.

1.3.2.Other events

Issuance of royalty certificates

On July 18, 2024, the Company announced the issuance of 201 royalty certificates (“2024 Royalty Certificates”) for aggregate gross proceeds of approximately €20.1 million. Royalties amount to 3% on future net sales of lanifibranor in the United States of America, the European Union and the United Kingdom over a 14-year term.

Approving of patent application

On July 25, 2024 the Company announces that the Japan Patent Office (“JPO”) approved Inventiva’s patent application No. JP 2019-203498, protecting the use of lanifibranor for the treatment of patients with cirrhosis. This new patent will be valid until November 8, 2039, excluding any potential patent term adjustments or extensions that may provide additional protection.

Financing in three tranches for a maximum amount of €348 million

The Company announced the following financing on 14 October 2024 structured in three tranches:

(i) the issuance , through a capital increase without preferential subscription rights reserved to a specific category of beneficiaries (“à catégorie de personnes”), of new ordinary shares at a gross value, including issuance premium, of €94.1 million through the issuance of 34,600,507 new ordinary shares, par value €0.01 per share (each, a “T1 New Shares”), and 35,399,481 prefunded warrants to subscribe for shares in the Company at a price outstanding of €0.01 per new ordinary share, each giving the right, in the event of exercise, to one new ordinary share (the “T1 BSAs”);

(ii) the issuance, in a second phase, as part of a new capital increase without preferential subscription rights reserved to certain identified investors (“à personne dénommée”), of new ordinary shares, par value €0.01 per share or of prefunded warrants to subscribe for ordinary shares of the Company (each, a “T1bis New Shares”), for a total amount of €21.4 million (excluding exercise of pre-funded warrants);

(iii) the issuance, in a third phase, as part of a new capital increase without preferential subscription rights reserved to certain identified investors (“à personne dénommée”) subject to operational conditions to be met and the adoption of the necessary resolutions by the Shareholders' Meeting to be held before December 16, 2024, (or prefunded warrants) to which share warrants (the “ABSAs”) are attached for a total amount of €116,000,000. Each ABSA will consist of a number of new ordinary shares with a par value of €0.01 (or pre-funded warrants) to be determined by the Company's Board of Directors (each, a “T2 New Share”) to which will be attached a number warrants exercisable at an exercise price of €1.50 (each, a “T3 BSA”) allowing the subscription of a number of new ordinary shares of the Company for a maximum total amount of €116,000,000.

The subscription agreements for the T1 New Shares and the T1 BSA were signed on October 11, 2024, and the settlement-delivery of the T1 New Shares and the T1 BSA is expected to take place on October 17, 2024, subject to the absence of any material adverse event between the signing of the agreements and the settlement-delivery of the T1 New Shares and the T1 BSA.

Amendment to the exclusive license and collaboration agreement with CTTQ

On October 11, 2024, the Company has entered into an amendment (the “Amendment”) to the exclusive license and collaboration agreement with Chia Tai Tianqing Pharmaceutical Group, Co., Ltd (“CTTQ”), dated September 21, 2022, as amended. Under the Amendment, if the Company receives subscription commitments, before December 31, 2024, from investors to subscribe to a fundraising, in two or three tranches, for a total gross amount of at least €180,000,000 (the “Fund Raising”), CTTQ shall pay to the Company (i) $10,000,000 within 30 days of settlement-delivery of the T1 New Shares and T1 Warrants in the event of the issuance of the first tranche of the Fund Raising to be paid by CTTQ, (ii) $10,000,000 in the event of the issuance of the second tranche of the Fund Raising, and (iii) $10,000,000 upon publication by the Company of the pivotal data announcing that the primary endpoint or one of the two key secondary endpoints of NATiV3, with one of the dosing regimens tested in the trial, have been met. Under the terms of the Amendment, the total amount of potential clinical, regulatory and commercial milestone payments remains unchanged, while the royalties that Inventiva is likely to receive have been reduced to a low figure.

1.4.Risk factors

The Company’s business faces significant risks. You should carefully consider all of the information set forth in this document and in the Company’s other filings with the United States Securities and Exchange Commission, or the SEC, including the risk factors which the Company faces and which are faced by the Company’s industry described in Chapter 2 of the Company’s 2023 Universal Registration Document Part I, Item 1A. “ Risk Factors” of the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, in addition to the following risk factors. Our business, financial condition or results of operations could be materially adversely affected by any of these risks.

Please refer to chapter 2.1 of the 2023 Universal Registration Document and as amended in Section 5 of the amendment to the universal document as filed with the AMF under number D.24-0227-A01 on October 14, 2024 (the "Amendment to the 2023 Universal Registration Document "), which are incorporated herein by reference.

The risk factor in the 2023 Universal Registration Document amended in the context of the Amendment to the 2023 Universal Registration Document is as follows:

Liquidity risk: the Company believes that it will be able to finance its activities until the end of the second half of 2025, and there is doubt regarding our ability to continue as a going concern.

As of 30 June 2024, the Company had cash and cash equivalents of €10.1 million, compared to €26.9 million, and €9.0 million of long-term deposit² as of December 31, 2023.

² The long-term deposit had a two year-term, were accessible prior to the expiration of the term with a notice period of 31 days and were considered as liquid by the Company.

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As of the date of this document, the Company believes, taking into account its current cost structure and forecast expenditure commitments, and the events after the reporting period presented in Note 6.4 – Events after the reporting period of the section 3.2 – Interim Condensed Consolidated financial statements as of June 30, 2024, mainly the issue of royalty certificates and the T1 capital increase, that it will have sufficient net working capital to meet its current obligations until the end of the second half of 2025.

Accordingly, our current cash position will not be sufficient to cover operating needs for at least the next 12 months.

This estimate is based on the Company’s current business plan and excludes (i) other expenses related to the potential development of odiparcil or resulting from any potential in-licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue, (ii) any potential milestone payments that may be received or paid by the Company or potential additional financing, including the issue of tranches 1bis and 2 as described in Note 6.4 – Events after the reporting period of the section 3.2 – Interim Condensed Consolidated financial statements as of June 30, 2024.

In order to finance its activities, the Company needs to raise additional funds, and is currently actively reviewing potential financing (including debt, equity and equity-linked or other instruments) and strategic options (for more on complementary financing, see section 2.3 of this document).

The Company may have based itself on incorrect assumptions and may have to use its resources sooner than expected. Although the Company is actively discussing financial and strategic options for financing its activities beyond its cash horizon, notably with its financial partners and financial advisors, the Company cannot guarantee that it will be able to obtain the necessary financing, through any of the foregoing measures or otherwise, to meet its needs or to obtain funds at acceptable terms and conditions, on a timely basis, or at all. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any approved product or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could impair our growth prospects. The perception that we may be unable to continue as a going concern may impede our ability to pursue any potential strategic opportunities or operate our business.

Ultimately, if we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements.

Risks associated with seeking and arranging financing and risks associated with uncertain additional financing

The development of the Company's programs has required, and will continue to require, significant financial investment, particularly for Phase III of lanifibranor, its YAP/TEAD program and the continued development of a portfolio of products at the preclinical stage. The Company will require additional funding as its clinical programs reach advanced stages of development, in particular to complete its clinical trials and, if successful, to manufacture and market the Company's drug candidates.

To meet this financing requirement, the Company needs to raise additional funds, and continues to actively explore financing options (including debt, equity-linked or other instruments) and strategic options.

However, taking on additional debt could lead to an increase in financial expenses and could also result in the Company having to comply with certain additional covenants, such as limitations on the Company's ability to take on additional debt or to carry out certain transactions.

Similarly, the conclusion of a financing agreement could be accompanied by undertakings limiting the Company's ability to acquire or grant intellectual property rights, particularly if it has to provide security and accept other operating restrictions that could have a negative impact on the Company's ability to continue its business.

It should be noted that additional financing, particularly in the form of equity instruments, could result in significant dilution. In addition, financing in the form of financial debt would worsen the Company's financial structure. The need for and pursuit of additional financing could also divert the Company's management from its day-to-day activities, which could affect the future development and marketing of its drug candidates.

The Company will also need additional funds to consider the pre-commercialisation and subsequent commercialisation of its drug candidate, or to make new investments that are unknown at this time or difficult to assess because they relate to projects in development. It is difficult to anticipate precisely all the costs associated with the preclinical and clinical development of the Company's products while some of its products are still at an early stage of development. The amount and timing of future additional funding requirements will depend in particular on the Company's ability to achieve milestones under its existing collaboration agreements, but also on the operating conditions associated with the Transaction and its ability to enter into new agreements, on market acceptance of any approved drug candidates, on the Company's need for and ability to recruit additional management and scientific personnel, and on the Company's ability to implement additional internal systems and infrastructure, including in its financial and IT management.

If the Company is unable to find such additional financing on acceptable terms or in a timely manner, particularly given the generally unfavorable environment for financing companies in the biotechnology sector, its business, organisation, results and development could be adversely affected, and it could be forced to delay or halt one or more of its research programs, the development or marketing of any approved products, not be able to expand its activities or take advantage of its commercial opportunities as desired. The Company may also have to implement a plan to reduce and manage its fixed costs or enter into new collaboration agreements that may be less favorable to it than those it could have obtained in a different context, which could harm its growth prospects or commercial activities, as set out in the liquidity risk factor above.

1.5.    Earnings analysis

1.5.1.Revenue and other income

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Revenue

The Company recorded minimal revenues in the first half of 2024, as compared to €1.9 million for the same period in 2023. The €1.9 million revenue as of June 30, 2023, was mainly related to the milestone payment the Company invoiced to CTTQ for $2.1 million on May 22, 2023, following the IND approval from the NMPA.

Other income

Other income decreased by €2.0 million, or 43%, compared to the first half of 2023.  Other income are mainly composed of research tax credits. The Research Tax Credit ("CIR") generated over the first six months of the fiscal year amounts to €2.7 million in 2024 as in 2023.

As of June 30, 2023, other operating income are composed of:

1.5.2.Operating expenses

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As of June 30, 2024, the decrease in operating expenses of €6.5 million, or 10%, compared to the first half of 2023 is mainly driven by the decrease in research and development expenses of €7.2 million.

1.5.2.1.Research and development expenses

Research and development expenses for the six months ended June 30, 2024 break down as follows:

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The decrease in R&D expenses is primarily due to the temporary pause in the recruitment of the patients in the NATiV3 Phase III clinical trial of lanifibranor in MASH/NASH following the SUSAR reported in the first quarter of 2024 and, to a lesser extent, due to the completion of the LEGEND trial with lanifibranor and empagliflozin in patients with MASH/NASH and DT2. R&D expenses are expected to increase in the second half of 2024 following the effective restart of patient recruitment in NATiV3, as well as the planned clinical development activities and related costs associated with NATiV3 for the second half of 2024 including costs related to the SUSAR protocol change and the reactivation of sites and patient recruitment. The €7.2 million (13%) decrease in research and development expenses as compared to the six months ended June 30, 2023, was primarily driven by:

The main expenses incurred in connection with the Company’s research and development activities in the six months ended June 30, 2024, are described below:

¡ Lanifibranor

Clinical trial-related expenses for lanifibranor development decreased by €7.1 million compared to the first half of 2023, totaling €34.8 million in the first half of 2024.

Costs relating to lanifibranor’s development in the first half of 2024 can be broken down into two main categories:

Costs linked to clinical trial activities included the following developments over the six months ended June 30, 2024:

Treatments for MASH/NASH​

LEGEND Phase IIa trial of lanifibranor in combination with empagliflozin in patients with MASH/NASH and T2D

Phase I studies

¡ YAP-TEAD

Trial-related expenses for the YAP-TEAD project increased by €0.2 million compared to the first half of 2023, totaling €0.6 million in the first half of 2024.

Costs incurred are mainly related to chemistry studies, biophysic and bio pharmaco study.

1.5.2.2.Marketing and business development expenses

Marketing and business development expenses break down as follows:

For the first six months ended June 30, 2024, and June 30, 2023

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Marketing and business development expenses for the first half of 2024 decreased by €0.1 million compared to the first half of 2023 mainly due to the decrease by €0.1 million of fees related to the business development.

1.5.2.3.General and administrative expenses

General and administrative expenses are mainly composed of administrative staff costs, support costs (mainly consisting of security costs, taxes and various rentals), non-scientific IT costs and consulting fees.

General and administrative expenses break down as follows:

For the first six months ended June 30, 2024, and June 30, 2023

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General and administrative expenses for the first half of 2024 increased by €0.9 million compared to the first half of 2023 mainly due to the increase in consulting fees by €0.8 million related to the double listing, personnel costs by €0.3 million and the decrease of insurances expenses by €0.2 million.

1.5.3.Other operating income and expenses

Other operating income and expenses break down as follows:

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For the first half of 2024, other operating income and expenses are mainly due to disposal of assets and transaction costs.

For the first half of 2023, other operating income and expenses are exclusively due to transaction costs.

1.5.4.Financial income and expenses

Financial income and expenses break down as follows:

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Net financial income for the first six months of 2024 increased by €3.8 million compared to the first half of 2023. This increase is mainly due to:

1.5.5.Income tax

In accordance with IAS 34, the income tax recognized in the financial statements for each interim period is adjusted based on a best estimate calculated by applying the expected weighted average tax rate for the entire year.

Current taxes

As the imputation of tax benefits on tax losses of Inventiva S.A., at short or mid-term, were considered unlikely due to the growth phase of the Company and regarding the nil projected tax rate as of December 31, 2024, no current taxes were recorded as of June 30, 2024, for Inventiva S.A. However, a €119 thousand tax expense was recorded related to Inventiva Inc (mainly due to the bonuses).

Deferred taxes

Inventiva S.A. recorded tax losses in the first half of 2024. As recovery of these losses in future periods is considered unlikely due to the uncertainty inherent to the Company’s activity, no deferred tax assets were recognized on this basis on June 30, 2024.

1.5.6.Net loss for the period

The Company recorded a net loss of €49.0 million in the first half of 2024 versus a net loss of €55.3 million in the first half of 2023, which was a decrease in net loss of €6.2 million year over year.

1.6.    Analysis of the financial situation

1.6.1.Non-current assets

Non-current assets mainly consist of:

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Non-current assets decreased by €10.6 million (49%) compared to December 31, 2023. This was mainly attributable to:

1.6.2.Current assets

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Current assets decreased by €19.6 million (41%) compared to December 31, 2023. This was mainly attributable to the €16.8 million (62%) decrease in cash and cash equivalents and the €3.0 million decrease in trade receivables, both related to the Company’s activity (see section 2 Cash flow and equity).

As of June 30, 2024, tax receivables are mainly composed of research tax credits receivable in the amount of €2.7 million corresponding to the 2024 CIR as of June 30, 2024.

The €2.9 million increase in other current assets is mainly due to:

1.6.3.Shareholders’ equity

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On June 30, 2024, shareholders’ equity decreased by €47.0 million, or 147%, compared to December 31, 2023. This change is mainly due to the net loss of the first six months of 2024.

Changes in shareholders’ equity during the first six months of 2024 are described in further detail in note 4.9 – Shareholders’ equity of the Unaudited interim condensed consolidated financial statements as of June 30, 2024, and in section 2 Cash flow and equity of this document.

1.6.4.Non-current liabilities

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The €18.9 million (37%) increase of non-current liabilities compared to December 31, 2023, is mainly due to the €14.7 million increase of long-term debt (the drawdown of Tranche B subscription), the €3.3 million increase of derivatives instruments (change in fair value) and the €0.9 million increase of 2023 Royalty Certificates liabilities related to the interests (see note 4.10 – Financial debt of the Unaudited interim condensed consolidated financial statements as of June 30, 2024).

1.6.5.Current liabilities

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Current liabilities decreased by €2.0 million (4%) for the six months ended June 30, 2024, compared to December 31, 2023. This change is mainly due to:

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2.Cash flow and equity

This section discusses the Company’s shareholders’ equity, cash position and sources of funding for the six months ended June 30, 2024, and the fiscal year ended December 31, 2023.

2.1.Cash and cash equivalents

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Since its inception, the Company has financed its growth through successive capital increases (see section 4.5. Cash flow and equity of the 2023 Universal Registration Document), debt, collaboration and license agreements and reimbursements of CIR receivables. The Company continues to pursue its research and development activities for its product candidates.

As of June 30, 2024, cash and cash equivalents amounted to €10.1 million compared to €26.9 million as of December 31, 2023, with a decrease of €16.8 million (62%), mainly related to the Company’s ongoing research activities, in particular the NATiV3 Phase III trial with lanifibranor for the treatment of MASH/NASH and, to a lesser extent, to the Phase IIa LEGEND trial.

Cash at hand and marketable securities held by the Company are generally invested in short-term deposit accounts that are readily convertible into known amounts of cash.

Cash at hand and marketable securities are used to finance the Company’s activities, in particular its R&D costs.

After deducting debt, the Company has a net cash deficit as of June 30, 2024, of €1.3 million due to bank overdrafts. Borrowings are set out in section 2.1.2 Financing from bank loans below.

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Net debt is a non-standard measure that includes cash and cash equivalents, long-term financial debt, long-term financial debt - derivative instruments, liabilities under royalty certificates, and short-term financial debt.

Here are no restrictions on the use of the Company’s cash and cash equivalents resources.

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2.1.1.Equity financing

As of June 30, 2024, the Company’s share capital increased by €3.6 thousand compared to December 31, 2023, and set at €524.8 thousand (see note 4.9 – Shareholders’ equity of the Unaudited interim condensed consolidated financial statements as of June 30, 2024).

2.1.2.Financing from bank loans

On May 16, 2022, the Company entered into the Finance Contract with EIB for up to €50 million, divided into two tranches of €25 million each. On January 18, 2024, the Company received the disbursement of Tranche B (see Note 1.2. – Significant events in the first half of 2024 of this document and note 4.10 – Financial debt of the Unaudited interim condensed consolidated financial statements as of June 30, 2024).

The Company’s loans and debt maturity profile as of June 30, 2024, is as follows:

2.1.3.Financing from Research Tax Credits

Due to its status as a European small and medium-sized enterprise (“SME”), the Company receives payment for research tax credits granted in the previous period. Consequently, cash proceeds from research tax credits in a given period correspond to the amount of credits calculated on eligible expenditure for the previous period.

As of June 30, 2024, Tax credits related to the 2024 CIR are set at €2.7 million. CIR tax credit amounted to €5.3 million for the year ended December 31, 2023.

Research tax credits during the six months ended June 30, 2024, and June 30, 2023 were as follows:

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The decrease of €1.0 million compared to the first half of 2023 is primarily attributable to the decrease in research and development expenses incurred by the Company.

2.2.Cash flow analysis

The following table sets forth the Company’s cash flow for the first half of 2024 and the first half of 2023:

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In the first six months of 2024 and 2023, the main financing needs of the Company related to its operating activities, including its working capital requirements.

2.2.1.Cash flow linked to operating activities

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Net cash used in operating activities amounted to €48.3 million in the first half of 2024, compared to €45.2 million for the first half of 2023, a decrease of 3.1 million euros due to changes in working capital requirements, and in particular linked to:

However, the operating expenses, excluding depreciation, amortization, provision, and IFRS 2 expenses for the first half of 2024 decreased by €7.3 million compared to the first half of 2023. The decrease mainly related to R&D expenses over the period is primarily due to the temporary pause in the recruitment of the patients in the NATiV3 Phase III clinical trial related to the SUSAR (see Note 1.2. – Significant events in the first half of 2024 of this document) and, to a lesser extent, due to the completion of the LEGEND Phase IIa trial.

2.2.2.Cash flow linked to investing activities

Cash flow used in investing activities over the periods presented was as follows:

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In the first half of 2024, net cash from investing activities amounted to €8.9 million, compared to €7.7 million used in the first half of 2023 the change is mainly related to the early closure of a €9 million two-year deposit forward contract (see note 4.5 – Other non-current assets of the Unaudited interim condensed consolidated financial statements as of June 30, 2024).

2.2.3.Cash flow linked to financing activities