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IVA

InventivaD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-07-30
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Investor releaseQuarter not tagged2026-07-30

Correction: Inventiva Announces Preliminary Financial Results for the First Half of 2026¹

GlobeNewswire
Cash and cash equivalents at €166.1 million and €67.8 million in short-term deposits2 as at June 30, 2026 Daix (France), New York City (New York, United States), July 30, 2026 – Update to Press Release Dated July 29, 2026. The Company wishes to correct an error in the press release issued on July 29, 2026. On page 2, the potential proceeds for the Tranche C of the Debt Financing Transaction was mistakenly stated as €20 million. The correct figure is €55 million. All other information in the press release remains unchanged. As a result, the corrected version shall read as follows: Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported certain preliminary financial results for the first half of 2026, including its cash, cash equivalents and revenues. Preliminary Financial Results As at June 30, 2026, the Company’s cash and cash equivalents amounted to €166.1 million and €67.8 million in short-term deposits2, compared to cash and cash equivalents at €99.3 million and €131.6 million in short-term deposits as at December 31, 2025. Net cash used in operating activities amounted to (€48.7) million for the first half of 2026, compared to (€53.7) million for the same period in 2025. The lower cash consumption mainly reflects the working capital change of €8.8 million between the two periods. This lower cash consumption is partially offset by the increase in operating expenses relating to the continued advancement of the NATiV3 Phase 3 clinical trial and preparation of pre commercial activities. R&D expenses amounted to (€50.1) million in the first half of 2026 compared to (€44.9) for the same period in 2025. Net cash generated from investing activities for the first half of 2026 amounted to €63.9 million, compared to (€24.8) million for the first half of 2025. The increase is mostly due to new short-term deposit subscriptions following the June combined financing operations announced on June 2, 20263. Net cash generated from financing activities for the first half of 2026 amounted to €50.9 million, compared to €104.8 million in the first half of 2025. The net cash generated from financing activities in the first half of 2026 reflects the comprehensive capital structu…Read full document

Cash and cash equivalents at €166.1 million and €67.8 million in short-term deposits2 as at June 30, 2026 Daix (France), New York City (New York, United States), July 30, 2026 – Update to Press Release Dated July 29, 2026. The Company wishes to correct an error in the press release issued on July 29, 2026. On page 2, the potential proceeds for the Tranche C of the Debt Financing Transaction was mistakenly stated as €20 million. The correct figure is €55 million. All other information in the press release remains unchanged. As a result, the corrected version shall read as follows: Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported certain preliminary financial results for the first half of 2026, including its cash, cash equivalents and revenues. Preliminary Financial Results As at June 30, 2026, the Company’s cash and cash equivalents amounted to €166.1 million and €67.8 million in short-term deposits2, compared to cash and cash equivalents at €99.3 million and €131.6 million in short-term deposits as at December 31, 2025. Net cash used in operating activities amounted to (€48.7) million for the first half of 2026, compared to (€53.7) million for the same period in 2025. The lower cash consumption mainly reflects the working capital change of €8.8 million between the two periods. This lower cash consumption is partially offset by the increase in operating expenses relating to the continued advancement of the NATiV3 Phase 3 clinical trial and preparation of pre commercial activities. R&D expenses amounted to (€50.1) million in the first half of 2026 compared to (€44.9) for the same period in 2025. Net cash generated from investing activities for the first half of 2026 amounted to €63.9 million, compared to (€24.8) million for the first half of 2025. The increase is mostly due to new short-term deposit subscriptions following the June combined financing operations announced on June 2, 20263. Net cash generated from financing activities for the first half of 2026 amounted to €50.9 million, compared to €104.8 million in the first half of 2025. The net cash generated from financing activities in the first half of 2026 reflects the comprehensive capital structure optimization announced on June 2, 2026, including the Equity Offering of €103 million and the Debt Financing Transaction of €75 million4. These cash inflows were partially offset by the repayment in full of the existing EIB loan for an aggregate amount of €62 million, and the repurchase of the Legacy EIB Tranche A Warrants and 700,000 of the Legacy EIB Tranche B Warrants for an aggregate repurchase price of €50 million. For further information regarding these transactions, please refer to the Company’s press releases dated June 2, 2026 and June 12, 2026. The net cash generated from financing activities in the first half of 2025 came from the gross proceeds of €115.6 million (net proceeds of €108.0 million) from the second tranche of the Structured Financing announced in October 20245. Based on the Company’s existing cash and cash equivalents and short-term deposits, together with the net proceeds from the completed Equity Offering, the completed EIB Transactions and the issuance of Tranches A and B under the Debt Financing Transaction6, the Company expects to be able to finance its operations as currently planned until the end of the second quarter of 2027. At the date of this communication, the Company's current cash and cash equivalents are not sufficient to cover operating needs as currently planned for the next 12 months. Based on the Company’s existing cash and cash equivalents and short-term deposits, together with the net proceeds from the completed Equity Offering, the completed EIB Transactions and the issuance of Tranches A and B under the Debt Financing Transaction, and assuming the successful completion of Tranche C of the Debt Financing Transaction for potential proceeds of up to €55.0 million and the exercise in full of the Tranche 3 warrants previously issued by the Company in the Structured Financing4 for potential proceeds of up to €116.0 million, the Company expects to be able to finance its operations as currently planned until the start of the first quarter of 20287. Over the first half of 2026, the Company recorded a positive foreign exchange effect on cash and cash equivalents of €0.7 million, compared with a negative effect of (€0.7) million for the first half of 2025, primarily due to the changes in the EUR/USD exchange rate. Revenues No revenues recorded for the first half of 2026, compared to €4.5 million generated for the same period in 2025. Next financial results publication Financial results for the first half of 2026: Wednesday September 25, 2026 (after U.S. market close) About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. 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. 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). https://www.inventivapharma.com Contacts Forward-Looking Statements 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, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, preliminary unaudited financial results for Inventiva’s six months ended June 30, 2026, forecasts and estimates with respect to Inventiva’s cash resources and expenses, including expectations and assumptions in connection with Inventiva’s estimated cash runway and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including design, duration, timing, costs, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, and Inventiva’s pipeline development plans, future activities, expectations, plans, growth and prospects. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such 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 future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including the completion of financial closing procedures, final adjustments and other developments that may arise that could cause the preliminary financial results for the first half of 2026 to differ from the financial results that will be reflected in Inventiva’s reviewed consolidated financial statements for the first half of 2026, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, 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 be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not support Inventiva’s and its partners’ product candidate claims, Inventiva’s expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including the timing, potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s and its partners’ control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s and its partners’ business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in law and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil, and natural catastrophes, 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. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2025 filed with the Autorité des Marchés Financiers on April 8, 2026, and the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on April 8, 2026 for other risks and uncertainties affecting Inventiva, including those described under the caption "Risk Factors", and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events 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 has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. 1 Preliminary, non-audited financial information2 Short-term deposits were included in the category “other current assets” in the IFRS consolidated statement of financial position and were considered by the Company as liquid and easily available.3 Cf press release of June 2, 20264 Capitalized terms used herein and not otherwise defined have the meanings given to them in the Company's press release dated June 2, 2026.5 Cf press release of October 13, 20246 Cf press release of June 2, 2026 (In particular the description of the financial covenants pertaining to the Debt Financing)7 These estimates are based on the Company’s current business plan and exclude any potential milestones payable to or by the Company and any additional expenditures related to the product candidate or resulting from any potential in licensing or acquisition of additional product candidates or technologies, or any associated product development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, the Company may amend its business plan in the future and the Company may have to use its resources sooner than anticipated. These estimates may be shortened in the event of an increase, in expenditure relating to the development programs beyond the Company's expectations, or if the development program progresses more quickly than expected. There can be no assurance whether, and to what extent, the Tranche 3 warrants will be exercised, if at all. Attachment Inventiva - PR - Preliminary Financial Results H1 2026 - EN - 07 30 2026

Investor releaseQuarter not tagged2026-07-29

Inventiva Announces Preliminary Financial Results for the First Half of 2026¹

GlobeNewswire
Cash and cash equivalents at €166.1 million and €67.8 million in short-term deposits2 as at June 30, 2026 Daix (France), New York City (New York, United States), July 29, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported certain preliminary financial results for the first half of 2026, including its cash, cash equivalents and revenues. Preliminary Financial Results As at June 30, 2026, the Company’s cash and cash equivalents amounted to €166.1 million and €67.8 million in short-term deposits2, compared to cash and cash equivalents at €99.3 million and €131.6 million in short-term deposits as at December 31, 2025. Net cash used in operating activities amounted to (€48.7) million for the first half of 2026, compared to (€53.7) million for the same period in 2025. The lower cash consumption mainly reflects the working capital change of €8.8 million between the two periods. This lower cash consumption is partially offset by the increase in operating expenses relating to the continued advancement of the NATiV3 Phase 3 clinical trial and preparation of pre commercial activities. R&D expenses amounted to (€50.1) million in the first half of 2026 compared to (€44.9) for the same period in 2025. Net cash generated from investing activities for the first half of 2026 amounted to €63.9 million, compared to (€24.8) million for the first half of 2025. The increase is mostly due to new short term deposit subscriptions following the June combined financing operations announced on June 2, 20263. Net cash generated from financing activities for the first half of 2026 amounted to €50.9 million, compared to €104.8 million in the first half of 2025. The net cash generated from financing activities in the first half of 2026 reflects the comprehensive capital structure optimization announced on June 2, 2026, including the Equity Offering of €103 million and the Debt Financing Transaction of €75 million4. These cash inflows were partially offset by the repayment in full of the existing EIB loan for an aggregate amount of €62 million, and the repurchase of the Legacy EIB Tranche A Warrants and 700,000 of the Legacy EIB Tranche B Warrants for an aggregate repurchase pric…Read full document

Cash and cash equivalents at €166.1 million and €67.8 million in short-term deposits2 as at June 30, 2026 Daix (France), New York City (New York, United States), July 29, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported certain preliminary financial results for the first half of 2026, including its cash, cash equivalents and revenues. Preliminary Financial Results As at June 30, 2026, the Company’s cash and cash equivalents amounted to €166.1 million and €67.8 million in short-term deposits2, compared to cash and cash equivalents at €99.3 million and €131.6 million in short-term deposits as at December 31, 2025. Net cash used in operating activities amounted to (€48.7) million for the first half of 2026, compared to (€53.7) million for the same period in 2025. The lower cash consumption mainly reflects the working capital change of €8.8 million between the two periods. This lower cash consumption is partially offset by the increase in operating expenses relating to the continued advancement of the NATiV3 Phase 3 clinical trial and preparation of pre commercial activities. R&D expenses amounted to (€50.1) million in the first half of 2026 compared to (€44.9) for the same period in 2025. Net cash generated from investing activities for the first half of 2026 amounted to €63.9 million, compared to (€24.8) million for the first half of 2025. The increase is mostly due to new short term deposit subscriptions following the June combined financing operations announced on June 2, 20263. Net cash generated from financing activities for the first half of 2026 amounted to €50.9 million, compared to €104.8 million in the first half of 2025. The net cash generated from financing activities in the first half of 2026 reflects the comprehensive capital structure optimization announced on June 2, 2026, including the Equity Offering of €103 million and the Debt Financing Transaction of €75 million4. These cash inflows were partially offset by the repayment in full of the existing EIB loan for an aggregate amount of €62 million, and the repurchase of the Legacy EIB Tranche A Warrants and 700,000 of the Legacy EIB Tranche B Warrants for an aggregate repurchase price of €50 million. For further information regarding these transactions, please refer to the Company’s press releases dated June 2, 2026 and June 12, 2026. The net cash generated from financing activities in the first half of 2025 came from the gross proceeds of €115.6 million (net proceeds of €108.0 million) from the second tranche of the Structured Financing announced in October 20245. Based on the Company’s existing cash and cash equivalents and short-term deposits, together with the net proceeds from the completed Equity Offering, the completed EIB Transactions and the issuance of Tranches A and B under the Debt Financing Transaction6, the Company expects to be able to finance its operations as currently planned until the end of the second quarter of 2027. At the date of this communication, the Company's current cash and cash equivalents are not sufficient to cover operating needs as currently planned for the next 12 months. Based on the Company’s existing cash and cash equivalents and short-term deposits, together with the net proceeds from the completed Equity Offering, the completed EIB Transactions and the issuance of Tranches A and B under the Debt Financing Transaction, and assuming the successful completion of Tranche C of the Debt Financing Transaction for potential proceeds of up to €20.0 million and the exercise in full of the Tranche 3 warrants previously issued by the Company in the Structured Financing4 for potential proceeds of up to €116.0 million, the Company expects to be able to finance its operations as currently planned until the start of the first quarter of 20287. Over the first half of 2026, the Company recorded a positive foreign exchange effect on cash and cash equivalents of €0.7 million, compared with a negative effect of (€0.7) million for the first half of 2025, primarily due to the changes in the EUR/USD exchange rate. Revenues No revenues recorded for the first half of 2026, compared to €4.5 million generated for the same period in 2025. Next financial results publication Financial results for the first half of 2026: Wednesday September 25, 2026 (after U.S. market close) About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. 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. 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). https://www.inventivapharma.com Contacts Forward-Looking Statements 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, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, preliminary unaudited financial results for Inventiva’s six months ended June 30, 2026, forecasts and estimates with respect to Inventiva’s cash resources and expenses, including expectations and assumptions in connection with Inventiva’s estimated cash runway and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including design, duration, timing, costs, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, and Inventiva’s pipeline development plans, future activities, expectations, plans, growth and prospects. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such 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 future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including the completion of financial closing procedures, final adjustments and other developments that may arise that could cause the preliminary financial results for the first half of 2026 to differ from the financial results that will be reflected in Inventiva’s reviewed consolidated financial statements for the first half of 2026, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, 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 be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not support Inventiva’s and its partners’ product candidate claims, Inventiva’s expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including the timing, potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s and its partners’ control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s and its partners’ business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in law and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil, and natural catastrophes, 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. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2025 filed with the Autorité des Marchés Financiers on April 8, 2026, and the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on April 8, 2026 for other risks and uncertainties affecting Inventiva, including those described under the caption "Risk Factors", and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events 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 has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. 1 Preliminary, non-audited financial information2 Short-term deposits were included in the category “other current assets” in the IFRS consolidated statement of financial position and were considered by the Company as liquid and easily available.3 Cf press release of June 2, 20264 Capitalized terms used herein and not otherwise defined have the meanings given to them in the Company's press release dated June 2, 2026.5 Cf press release of October 13, 20246 Cf press release of June 2, 2026 (In particular the description of the financial covenants pertaining to the Debt Financing)7 These estimates are based on the Company’s current business plan and exclude any potential milestones payable to or by the Company and any additional expenditures related to the product candidate or resulting from any potential in licensing or acquisition of additional product candidates or technologies, or any associated product development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, the Company may amend its business plan in the future and the Company may have to use its resources sooner than anticipated. These estimates may be shortened in the event of an increase, in expenditure relating to the development programs beyond the Company's expectations, or if the development program progresses more quickly than expected. There can be no assurance whether, and to what extent, the Tranche 3 warrants will be exercised, if at all. Attachment Inventiva - PR - Preliminary Financial Results H1 2026 - EN - 07 29 2026

Investor releaseQuarter not tagged2026-07-02

Results of the Votes of the Combined Shareholders’ General Meeting of June 30, 2026

GlobeNewswire
Daix (France), New York City (New York, United States), July 2, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the results of the votes of its Combined Shareholders’ Meeting. The Combined Shareholders' Meeting was held on Tuesday June 30, 2026, at 2 p.m. at Hôtel Villa M, 24-30 Bd Pasteur, 75015 Paris (France), under the chairmanship of Mr. Andrew Obenshain, Chief Executive Officer of Inventiva. Mr. Andrew Obenshain proceeded to the usual formalities of the opening of the meeting, in particular to the constitution of the Bureau by appointing Mrs Susan Coles and Mr. Jean Volatier, as tellers, as well as Mr. Abel Colomb, as secretary of the general meeting. All the resolutions submitted to vote have been adopted by the shareholders, with the exception of the 31st resolution, which had been the subject of a negative recommendation by the Board of Directors. The 31st resolution would have empowered the Board of Directors to decide on share capital increases reserved for members of a company savings plan to be set up by the Company. Pursuant to Article R. 22-10-14 IV. of the French Commercial Code, the Combined Shareholders’ Meeting approved, without modification, the compensation policy for corporate officers as presented in the 2025 Universal Registration Document (section 3.5.1, pages 134 et seq.) and, with respect specifically to the chairman of the board of directors, in the notice of meeting (brochure de convocation) for the Combined General Meeting, made available on the Company’s website under the “General Meetings” section. The results of the vote are presented below: Total number of shares composing the share capital: 236 280 202 Total number of shares with voting rights: 236 280 202 VOTE RESULTS: Ordinary Resolutions VOTE RESULTS: Extraordinary Resolutions About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. 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 progressiv…Read full document

Daix (France), New York City (New York, United States), July 2, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the results of the votes of its Combined Shareholders’ Meeting. The Combined Shareholders' Meeting was held on Tuesday June 30, 2026, at 2 p.m. at Hôtel Villa M, 24-30 Bd Pasteur, 75015 Paris (France), under the chairmanship of Mr. Andrew Obenshain, Chief Executive Officer of Inventiva. Mr. Andrew Obenshain proceeded to the usual formalities of the opening of the meeting, in particular to the constitution of the Bureau by appointing Mrs Susan Coles and Mr. Jean Volatier, as tellers, as well as Mr. Abel Colomb, as secretary of the general meeting. All the resolutions submitted to vote have been adopted by the shareholders, with the exception of the 31st resolution, which had been the subject of a negative recommendation by the Board of Directors. The 31st resolution would have empowered the Board of Directors to decide on share capital increases reserved for members of a company savings plan to be set up by the Company. Pursuant to Article R. 22-10-14 IV. of the French Commercial Code, the Combined Shareholders’ Meeting approved, without modification, the compensation policy for corporate officers as presented in the 2025 Universal Registration Document (section 3.5.1, pages 134 et seq.) and, with respect specifically to the chairman of the board of directors, in the notice of meeting (brochure de convocation) for the Combined General Meeting, made available on the Company’s website under the “General Meetings” section. The results of the vote are presented below: Total number of shares composing the share capital: 236 280 202 Total number of shares with voting rights: 236 280 202 VOTE RESULTS: Ordinary Resolutions VOTE RESULTS: Extraordinary Resolutions About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. 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. 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). https://www.inventivapharma.com Contacts Forward-Looking Statements 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, other than statements of historical fact, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates regarding Inventiva's cash resources and expenses, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including the quality of trial results, design, duration, timing, costs, and funding, timing of clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, Inventiva’s pipeline and development plans, and Inventiva's future activities, expectations, plans, growth and prospects. Some of these statements, forecasts, and estimates may be identified by the use of words such as, without limitation, “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “estimate,” “may,” “will,” “could,” “should,” “designed,” “hope,” “target,” “potential,” “opportunity,” “possible,” “aim,” and “continue” and other similar expressions. These statements are not historical facts, but rather statements of future expectations and other forward-looking statements based on management's beliefs. These statements reflect the opinions 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 in such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva's control. There can be no guarantee, with respect to product candidates, that clinical trial results will be available on schedule, that future clinical trials will be initiated as planned, that product candidates will receive the necessary regulatory approvals, or that the milestones planned by Inventiva or its partners will be achieved on schedule, or even at all. Future results may differ materially from the anticipated future results, performance, or achievements expressed or implied by these statements, forecasts, and estimates due to a number of factors, including the fact that interim data or data from any interim analysis of ongoing clinical trials do not predict the future results of clinical trials, the fact that the DMC's recommendation does not prejudge any eventual marketing authorization, that Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on recruitment or the final impact on the results or timing of the NATiV3 trial or related regulatory issues, Inventiva is a clinical-stage company with no approved products and no historical revenue, Inventiva has incurred significant losses since its inception, Inventiva has never generated revenue from product sales, Inventiva will need additional capital to fund its operations, without which Inventiva may be required to significantly reduce its activities, delay or discontinue one or more of its research or development programs, expand its activities or capitalize on its business opportunities, and may not be able to continue as a going concern. Inventiva's ability to obtain financing and complete potential transactions on a timely basis, as well as whether, when, and to what extent dilutive instruments may be exercised and by which holders, Inventiva's future success depends on the successful clinical development, regulatory approvals, and subsequent commercialization of lanifibranor, preclinical studies or previous clinical trials are not necessarily predictive of future results, and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' claims regarding product candidates, Inventiva's expectations regarding its clinical trials may prove to be incorrect, and regulatory authorities may require additional stops and/or modifications to Inventiva's clinical trials. Inventiva's expectations regarding the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to implement its commercialization, marketing, and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with its existing partners or enter into new partnerships, and to fulfil its obligations under any agreements entered into in connection with such partnerships, the benefits of its current and future partnerships on the clinical development, regulatory approvals, and, if applicable, commercialization of its product candidates, as well as the achievement of milestones and timelines anticipated in connection with such partnerships, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of the applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, the recruitment and retention of patients in clinical trials is a costly and time-consuming process that could be made more difficult or impossible by multiple factors beyond the control of Inventiva and its partners, Inventiva's product candidates may cause adverse reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and Inventiva's activities, preclinical studies, and clinical development programs, as well as timelines, Inventiva's financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, adverse conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and the resulting sanctions, the conflict in the Middle East and the related risk of a wider conflict and ongoing conflicts, epidemics, and macroeconomic conditions, including changes in international trade policies, global inflation, fluctuations in financial and credit markets, customs duties and other trade barriers, political unrest and natural disasters, uncertain financial markets, and disruptions in banking systems. In light of these risks and uncertainties, no representation is made as to the accuracy or completeness of these forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts, and estimates are only valid as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Veuillez vous référer au Document d'Enregistrement Universel pour l'exercice clos le 31 décembre 2025 déposé auprès de l'Autorité des Marchés Financiers le 8 avril 2026, au Rapport Annuel sur le Formulaire 20-F pour l'exercice clos le 31 décembre 2025 déposé auprès de la Securities and Exchange Commission (la « SEC ») le 8 avril 2026 pour d'autres risques et incertitudes affectant Inventiva, y compris ceux susceptibles de mettre en cause la continuité d'exploitation, et ceux décrits sous la rubrique « Facteurs de risques », et dans les futurs dépôts auprès de la SEC. D'autres risques et incertitudes dont Inventiva n'est pas actuellement consciente peuvent également affecter ses déclarations prospectives et peuvent faire en sorte que les résultats réels et le calendrier des événements diffèrent matériellement de ceux anticipés. Toutes les informations contenues dans ce communiqué de presse sont à jour à la date du communiqué. Sauf obligation légale, Inventiva n'a ni l'intention ni l'obligation de mettre à jour ou de réviser les déclarations prospectives mentionnées ci-dessus. Par conséquent, Inventiva n'accepte aucune responsabilité pour les conséquences découlant de l'utilisation de l'une des déclarations susmentionnées. Attachment Inventiva - EN - Results of the votes of the shareholder meeting - PR - 06 30 2026

Investor releaseQuarter not tagged2026-05-26

Inventiva Reports 2026 First Quarter Financial Information¹

GlobeNewswire
Cash and cash equivalents at €75.0 million, and €121.5 million in short-term deposits2 Daix (France), New York City (New York, United States), May 26, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its financial information for the first quarter of 2026, including its cash, cash equivalents and revenues. Key Financial Results Cash, Cash Equivalents and Deposits As of March 31, 2026, the Company's cash and cash equivalents amounted to €75.0 million and its short-term deposits2 to €121.5 million, compared to cash and cash equivalents of €99.3 million and short-term deposits of €131.6 million as of December 31, 2025. The net cash used was mainly the result of the Company’s planned operating activities related to its lanifibranor development program. Considering its current cost structure and projected expenses, the Company estimates that its cash, cash equivalents, and short-term deposits should enable it to finance its operations until the middle of the first quarter of 20273. If the Tranche 3 warrants issued in the structured financing announced by the Company in October 2024 (the “Structured Financing”) are exercised in full for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 20273. There is no guarantee that the Tranche 3 warrants will be exercised in full, if at all. Revenues The Company did not recognize revenues for the first quarter of 2026, in line with the first quarter of 2025. Anticipated Potential Key Milestones Topline results of NATiV3 – expected in the fourth quarter of 2026 Upcoming Conference Participation EASL Congress, Barcelona, May 27-30 2026 Jefferies Global Healthcare Conference, New York, June 2-4, 2026 Portzamparc BNP Paribas group mid & small caps conference 2026, Paris, June 25, 2026 Next Financial Results Publication Revenues and cash and cash equivalents for the first half of 2026: Wednesday, July 29, 2026 (after U.S. market close) About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the…Read full document

Cash and cash equivalents at €75.0 million, and €121.5 million in short-term deposits2 Daix (France), New York City (New York, United States), May 26, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its financial information for the first quarter of 2026, including its cash, cash equivalents and revenues. Key Financial Results Cash, Cash Equivalents and Deposits As of March 31, 2026, the Company's cash and cash equivalents amounted to €75.0 million and its short-term deposits2 to €121.5 million, compared to cash and cash equivalents of €99.3 million and short-term deposits of €131.6 million as of December 31, 2025. The net cash used was mainly the result of the Company’s planned operating activities related to its lanifibranor development program. Considering its current cost structure and projected expenses, the Company estimates that its cash, cash equivalents, and short-term deposits should enable it to finance its operations until the middle of the first quarter of 20273. If the Tranche 3 warrants issued in the structured financing announced by the Company in October 2024 (the “Structured Financing”) are exercised in full for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 20273. There is no guarantee that the Tranche 3 warrants will be exercised in full, if at all. Revenues The Company did not recognize revenues for the first quarter of 2026, in line with the first quarter of 2025. Anticipated Potential Key Milestones Topline results of NATiV3 – expected in the fourth quarter of 2026 Upcoming Conference Participation EASL Congress, Barcelona, May 27-30 2026 Jefferies Global Healthcare Conference, New York, June 2-4, 2026 Portzamparc BNP Paribas group mid & small caps conference 2026, Paris, June 25, 2026 Next Financial Results Publication Revenues and cash and cash equivalents for the first half of 2026: Wednesday, July 29, 2026 (after U.S. market close) About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. 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. 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). https://www.inventivapharma.com Contacts Forward-Looking Statements 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, other than statements of historical fact, included in this press release are forward-looking statements. These statements include, but are not limited to, unaudited financial results for Inventiva’s three months ended March 31, 2026, forecasts and estimates regarding Inventiva's cash resources and expenses, including expectations with respect to EIB mattersand assumptions in connection with Inventiva’s estimated cash runway, the potential exercise by investors of warrants and pre-funded warrants, including warrants and pre-funded warrants issued in connection with the Structured Financing, potential milestone and royalty payments the Company may receive under its agreement with Biossil with respect to odiparcil, including the timing thereof, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including the quality of trial results, design, duration, timing, costs, and funding,timing of clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, Inventiva’s pipeline and development plans, and Inventiva's future activities, expectations, plans, growth and prospects. Some of these statements, forecasts, and estimates may be identified by the use of words such as, without limitation, “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “estimate,” “may,” “will,” “could,” “should,” “designed,” “hope,” “target,” “potential,” “opportunity,” “possible,” “aim,” and “continue” and other similar expressions. These statements are not historical facts, but rather statements of future expectations and other forward-looking statements based on management's beliefs. These statements reflect the opinions 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 in such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva's control. There can be no guarantee, with respect to product candidates, that clinical trial results will be available on schedule, that future clinical trials will be initiated as planned, that product candidates will receive the necessary regulatory approvals, or that the milestones planned by Inventiva or its partners will be achieved on schedule, or even at all. Future results may differ materially from the anticipated future results, performance, or achievements expressed or implied by these statements, forecasts, and estimates due to a number of factors, including the fact that interim data or data from any interim analysis of ongoing clinical trials do not predict the future results of clinical trials, the fact that the DMC's recommendation does not prejudge any eventual marketing authorization, that Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on recruitment or the final impact on the results or timing of the NATiV3 trial or related regulatory issues, Inventiva is a clinical-stage company with no approved products and no historical revenue, Inventiva has incurred significant losses since its inception, Inventiva has never generated revenue from product sales, Inventiva will need additional capital to fund its operations, without which Inventiva may be required to significantly reduce its activities, delay or discontinue one or more of its research or development programs, expand its activities or capitalize on its business opportunities, and may not be able to continue as a going concern. Inventiva's ability to obtain financing and complete potential transactions on a timely basis, as well as whether, when, and to what extent dilutive instruments may be exercised and by which holders, Inventiva's future success depends on the successful clinical development, regulatory approvals, and subsequent commercialization of lanifibranor, preclinical studies or previous clinical trials are not necessarily predictive of future results, and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' claims regarding product candidates, Inventiva's expectations regarding its clinical trials may prove to be incorrect, and regulatory authorities may require additional stops and/or modifications to Inventiva's clinical trials. Inventiva's expectations regarding the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to implement its commercialization, marketing, and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with its existing partners or enter into new partnerships, and to fulfil its obligations under any agreements entered into in connection with such partnerships, the benefits of its current and future partnerships on the clinical development, regulatory approvals, and, if applicable, commercialization of its product candidates, as well as the achievement of milestones and timelines anticipated in connection with such partnerships, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of the applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, the recruitment and retention of patients in clinical trials is a costly and time-consuming process that could be made more difficult or impossible by multiple factors beyond the control of Inventiva and its partners, Inventiva's product candidates may cause adverse reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and Inventiva's activities, preclinical studies, and clinical development programs, as well as timelines, Inventiva's financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, adverse conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and the resulting sanctions, the conflict in the Middle East and the related risk of a wider conflict and ongoing conflicts, epidemics, and macroeconomic conditions, including changes in international trade policies, global inflation, fluctuations in financial and credit markets, customs duties and other trade barriers, political unrest and natural disasters, uncertain financial markets, and disruptions in banking systems. In light of these risks and uncertainties, no representation is made as to the accuracy or completeness of these forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts, and estimates are only valid as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Please refer to the Universal Registration Document for the fiscal year ended December 31, 20242025, filed with the Autorité des Marchés Financiers on April 158, 2025, the semi-annual financial report as of June 30, 2025, published on September 29, 20252026, and the Annual Report on Form 20-F for the fiscal year ended December 31, 20242025 filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2025 and the Half-Year Report for the six months ended June 30, 2025 on Form 6-K filed with the SEC on October 15, 20258, 2026 for other risks and uncertainties affecting Inventiva, including those described under the heading “Risk Factors,” and in future filings with the SEC. Other risks and uncertainties that Inventiva is not currently aware of may also affect its forward-looking statements and may cause actual results and timing of events to differ materially from those anticipated. All information contained in this press release is current as of the date of this release. Except as required by law, Inventiva has no intention or obligation to update or revise the forward-looking statements mentioned above. Therefore, Inventiva accepts no responsibility for the consequences arising from the use of any of the above statements. Non-audited financial information. Short-term deposits were classified as “other current assets” in the consolidated statement of financial position in accordance with IFRS and were considered by the Company to be liquid and readily available. This estimate is based on the Company's current business plan, but excludes potential milestone payments to be paid or received by the Company, any potential proceeds from the exercise of Tranche 3 warrants issued as part of the Structured Financing (unless specifically stated), as well as any additional expenses related to other product candidates or resulting from the licensing or acquisition of additional product candidates or technologies, or any related developments that the Company may pursue. The Company may have based these estimates on assumptions that are incorrect or may amend its business plan in the future, and the Company may end up using its resources sooner than anticipated. These estimates may be shortened in the event of an increase, beyond the Company's expectations, in expenditure relating to the development program, or if the development program of the Company progresses more quickly than expected. Attachment Inventiva - PR - Q1 2026 Financial Report - EN - 05 26 2026

Investor releaseQuarter not tagged2026-04-02

Inventiva SA (IVA) (Q4 2025) Earnings Call Highlights: Strategic Milestones and Financial ...

GuruFocus.com
This article first appeared on GuruFocus. Cash and Cash Equivalents: EUR230.9 million as of December 31, 2025. Net Proceeds from Financing: EUR108 million from structured financing in May 2025; EUR139.4 million from U.S.-registered public offering in November 2025. Cash Runway: Estimated to extend to mid-Q1 2027, potentially to mid-Q3 2027 with full exercise of Tranche 3 warrants. R&D Expenses: EUR87 million for the full year 2025. Marketing and Business Development Expenses: EUR5 million for pre-commercial investment. G&A Expenses: EUR47.9 million, including EUR20.3 million of non-cash share-based compensation. Warning! GuruFocus has detected 7 Warning Signs with IVA. Is IVA fairly valued? Test your thesis with our free DCF calculator. Release Date: March 31, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Inventiva SA (NASDAQ:IVA) completed enrollment for its global Phase III clinical trial, NATIV-3, marking a significant operational milestone. The company is well-funded, with EUR230.9 million in cash equivalents and short-term deposits, ensuring financial stability beyond the anticipated NATIV-3 readout. Inventiva SA (NASDAQ:IVA) strategically sold global rights to OdaParcel, potentially receiving up to $90 million in milestone payments and royalties, allowing focus on lanifibranor. Lanifibranor has received both breakthrough therapy and fast-track designations from the FDA, highlighting its potential as a treatment for MASH. The leadership team has been strengthened with key appointments to align with the company's strategic focus on lanifibranor and MASH. The top-line readout for the NATIV-3 trial has been delayed to Q4 2026, which may impact investor expectations. Despite improvements, only around 10% of the estimated 18 million people in the US with MASH have been diagnosed, indicating a significant gap in market penetration. The company faces competition from Madrigal, which has seen strong market uptake in the US, posing a challenge for lanifibranor's market entry. There are concerns about weight gain associated with lanifibranor, which could affect its tolerability and acceptance among patients. The company is reliant on the success of the NATIV-3 trial for future funding, as the third tranche of financing is contingent on positive trial results. Q: Can you update us on the trial's dropout r…Read full document

This article first appeared on GuruFocus. Cash and Cash Equivalents: EUR230.9 million as of December 31, 2025. Net Proceeds from Financing: EUR108 million from structured financing in May 2025; EUR139.4 million from U.S.-registered public offering in November 2025. Cash Runway: Estimated to extend to mid-Q1 2027, potentially to mid-Q3 2027 with full exercise of Tranche 3 warrants. R&D Expenses: EUR87 million for the full year 2025. Marketing and Business Development Expenses: EUR5 million for pre-commercial investment. G&A Expenses: EUR47.9 million, including EUR20.3 million of non-cash share-based compensation. Warning! GuruFocus has detected 7 Warning Signs with IVA. Is IVA fairly valued? Test your thesis with our free DCF calculator. Release Date: March 31, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Inventiva SA (NASDAQ:IVA) completed enrollment for its global Phase III clinical trial, NATIV-3, marking a significant operational milestone. The company is well-funded, with EUR230.9 million in cash equivalents and short-term deposits, ensuring financial stability beyond the anticipated NATIV-3 readout. Inventiva SA (NASDAQ:IVA) strategically sold global rights to OdaParcel, potentially receiving up to $90 million in milestone payments and royalties, allowing focus on lanifibranor. Lanifibranor has received both breakthrough therapy and fast-track designations from the FDA, highlighting its potential as a treatment for MASH. The leadership team has been strengthened with key appointments to align with the company's strategic focus on lanifibranor and MASH. The top-line readout for the NATIV-3 trial has been delayed to Q4 2026, which may impact investor expectations. Despite improvements, only around 10% of the estimated 18 million people in the US with MASH have been diagnosed, indicating a significant gap in market penetration. The company faces competition from Madrigal, which has seen strong market uptake in the US, posing a challenge for lanifibranor's market entry. There are concerns about weight gain associated with lanifibranor, which could affect its tolerability and acceptance among patients. The company is reliant on the success of the NATIV-3 trial for future funding, as the third tranche of financing is contingent on positive trial results. Q: Can you update us on the trial's dropout rate and the performance of the 800 vs. 1,200-milligram dose in terms of weight gain and fibrosis? Also, how do you view the opportunity to compete with Madrigal? A: The dropout rate is below 30%, ensuring the trial is well-powered. The 800-milligram dose may catch up to the 1,200-milligram dose over time, with potential differences in tolerability. We believe an 18% fibrosis improvement would position lanifibranor well in the market, especially for F3 diabetic patients. (Andrew Obenshain, CEO; Jason Campagna, CMO) Q: What quality control measures are in place for analyzing biopsy samples in the NATIV-3 trial? A: Quality control involves ensuring proper biopsy procedures, assessing the quality of biopsy samples, and maintaining consistency in slide preparation and reading. Our experienced team is focused on maintaining high standards throughout the process. (Jason Campagna, CMO) Q: What is the effect size for the primary endpoint in NATIV-3, and how does it compare to placebo response? A: We are powered to over 90% for the primary endpoint, with a smaller effect size than seen in Phase II. The composite endpoint is less prone to placebo response, which was 7% in Phase II. We expect a low placebo response in NATIV-3 as well. (Jason Campagna, CMO) Q: How do you view the F3 diabetic population in terms of market opportunity and diagnosis rates? A: The F3 diabetic population is significant, with about 375,000 patients under treated care. Diagnosis rates are improving, and this segment is growing proportionately with the overall market. (Andrew Obenshain, CEO) Q: Can you discuss the potential impact of background GLP-1 use on lanifibranor's effect size and the use of the AIMMASH tool for histological assessments? A: Background GLP-1 use is not expected to significantly impact treatment response, as patients entering the trial have active MASH. The AIMMASH tool is interesting but not anticipated for use in NATIV-3; it may be considered for future trials. (Jason Campagna, CMO) For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-03-31

Inventiva reports 2025 full year results and provides a business update

GlobeNewswire
Revenues of €4.5 million for the full year of 2025 Cash and cash equivalents at €99.3 million, and €131.6 million in short-term deposits1 as at December 31, 2025 Completed a U.S. registered public offering for gross proceeds of approximately $172.5 million (€149 million2) Cash runway expected until the middle of the first quarter of 20273 Completed the sale of odiparcil with potential milestone payments of up to $90 million and potential royalties on future net sales, if approved Topline results of NATiV3 Phase 3 clinical trial expected for the fourth quarter of 2026 The Company will host a conference call on March 31, 2026, at 8 a.m. EDT / 2 p.m. CEST Daix (France), New York City (New York, United States), March 30, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its financial results for the full year ended December 31, 2025 and also provided a business update. Andrew Obenshain, CEO of Inventiva, stated: “Inventiva closes the 2025 financial year with the resources expected to fund our operations through the anticipated top-line readout of NATiV3 later this year. In alignment with the careful sequencing of our clinical and operational milestones, we are refining our expected data readout to the fourth quarter of 2026. Our regulatory and commercial infrastructure is advancing in lockstep, to position us to act with speed and conviction once we have the trial data. Lanifibranor has the potential to deliver transformative outcomes for patients with MASH and to generate enduring value for the physicians who treat them and the shareholders who have placed their trust in us. We believe the foundation is sound and the path is clear. And we are fully prepared to deliver.” Key financial results for the full year of 2025 As of December 31, 2025, the Company's cash and cash equivalents amounted to €99.3 million and its short-term deposits1 to €131.6 million, compared to cash and cash equivalents of €96.6 million as of December 31, 2024. Net cash used in operating activities amounted to (€104.9) million in 2025, compared to (€85.9) million in 2024, representing an increase of 22%. R&D expenses, mainly related to the development of lanifibranor in MASH, amounted to €87.0…Read full document

Revenues of €4.5 million for the full year of 2025 Cash and cash equivalents at €99.3 million, and €131.6 million in short-term deposits1 as at December 31, 2025 Completed a U.S. registered public offering for gross proceeds of approximately $172.5 million (€149 million2) Cash runway expected until the middle of the first quarter of 20273 Completed the sale of odiparcil with potential milestone payments of up to $90 million and potential royalties on future net sales, if approved Topline results of NATiV3 Phase 3 clinical trial expected for the fourth quarter of 2026 The Company will host a conference call on March 31, 2026, at 8 a.m. EDT / 2 p.m. CEST Daix (France), New York City (New York, United States), March 30, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its financial results for the full year ended December 31, 2025 and also provided a business update. Andrew Obenshain, CEO of Inventiva, stated: “Inventiva closes the 2025 financial year with the resources expected to fund our operations through the anticipated top-line readout of NATiV3 later this year. In alignment with the careful sequencing of our clinical and operational milestones, we are refining our expected data readout to the fourth quarter of 2026. Our regulatory and commercial infrastructure is advancing in lockstep, to position us to act with speed and conviction once we have the trial data. Lanifibranor has the potential to deliver transformative outcomes for patients with MASH and to generate enduring value for the physicians who treat them and the shareholders who have placed their trust in us. We believe the foundation is sound and the path is clear. And we are fully prepared to deliver.” Key financial results for the full year of 2025 As of December 31, 2025, the Company's cash and cash equivalents amounted to €99.3 million and its short-term deposits1 to €131.6 million, compared to cash and cash equivalents of €96.6 million as of December 31, 2024. Net cash used in operating activities amounted to (€104.9) million in 2025, compared to (€85.9) million in 2024, representing an increase of 22%. R&D expenses, mainly related to the development of lanifibranor in MASH, amounted to €87.0 million in 2025, down by 4% from €90.9 million in 2024. The increase in net cash used in operating activities was mainly related to the net cash impact of the strategic pipeline prioritization plan for the Company's activities implemented in 2025, lower revenues under the licensing agreement with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), and an increase in general and administrative expenses. Net cash used in investing activities amounted to (€133.2) million in 2025, mainly related to the subscription of new short-term deposits during the period, compared with €8.7 million generated in 2024. Net cash generated by financing activities amounted to €241.3 million in 2025, compared to €145.6 million in 2024. This positive cash flow was mainly due to the receipt of (i) gross proceeds of €115.6 million (net proceeds of €108.0 million) from the second tranche in May 2025 of the structured financing announced by the Company in October 2024 (the “Structured Financing”), and (ii) gross proceeds of $172.5 million (net proceeds of €139.4 million) from the public offering in the United States in November 2025. In 2025, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€0.5) million, compared to a positive effect of €1.2 million in 2024, due to changes in the EUR/USD exchange rate. Given its current cost structure and projected expenses, the Company estimates that its cash, cash equivalents, and short-term deposits should enable it to finance its operations until the middle of the first quarter of 20273. If the Tranche 3 warrants issued in the Structured Financing are exercised in full for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 20273. There is no guarantee that the Tranche 3 warrants will be exercised in full, if at all. The audit procedures on the consolidated financial statements have been carried out. The statutory audit report will include a section on the material uncertainty related to going concern and will be issued after verification of the management report. The Company's Board of Directors met on March 27, 2026 and approved the consolidated financial statements for the year ended December 31, 2025. Revenues in 2025 amounted to €4.5 million, compared to €9.2 million generated in 2024. They consisted mainly of the $10 million gross proceeds (net proceeds of €8.5 million) milestone payment invoiced to CTTQ and the $5 million (€4.4 million) credit notes recognized under the license agreement with CTTQ following the closing of the second tranche of the Structured Financing in May 2025. The milestone payment from CTTQ was received in July 2025. Other income amounted to €3.4 million for the full year 2025, as compared to €5.5 million for 2024. Other income mainly consisted of French research tax credit (credit d’impôt recherche) for 2025 and 2024 in the amounts of €2.3 million and €4.9 million recorded in 2025 and 2024, respectively. R&D expenses for the fiscal year ended December 31, 2025, amounted to (€87.0) million compared to (€90.9) million in 2024. This 4% decrease was primarily due to the focus on the development of lanifibranor in MASH, in connection with the pipeline prioritization plan that was implemented in 2025 and, to a lesser extent, to the completion of patient enrollment in its NATiV3 trial in April 2025. Marketing and business development expenses was (€5.0) million for the fiscal year ended December 31, 2025, compared to (€2.0) million in 2024, primarily due to a €2.4 million increase in expenses related to the preparation for the potential commercial development of lanifibranor, if approved. The increase was consistent with the Company's planned pre-commercialization investment plan ahead of the potential NATiV3 data readout. General and administrative expenses (G&A) amounted to (€47.9) million for the fiscal year ended December 31, 2025, an increase of €32.1 million compared to (€15.8) million in 2024, of which €20.3 million related to share-based compensation expenses driven by the changes in governance, management and organization, including the accelerated vesting of equity awards. Other operating income (expenses) amounted to (€9.0) million for the fiscal year ended December 31, 2025, an increase of €5.4 million compared to (€3.6) million in 2024. The 2025 expenses are related to the pipeline prioritization plan implemented in 2025, and its related expenses. Net financial loss was (€212.8) million for the fiscal year ended December 31, 2025, compared to (€86.0) million in 2024. The net financial loss in 2025 was mainly due to (i) non-cash IFRS treatment of the accounting at the fair value, including (€84.7) million related to derivative instruments in connection with the second tranche of the Structured Financing and (€95.1) million from warrants previously issued to the European Investment Bank (“EIB”) and (ii) (€28.9) million, mainly non-cash, in loans and royalty certificates interests expenses. Share of net loss – Equity method was (€0.4) million for the fiscal year ended December 31, 2025, compared to (€0.3) million for the same period in 2024. Income tax amounted to (€0.0) million for the 2025 fiscal year, compared to (€0.3) million for 2024. The Company’s net loss for the full year 2025 was (€354.1), compared to (€184.2) million for 2024. The following table presents Inventiva’s income statement, prepared in accordance with IFRS, for the 2025 financial year, with comparatives for the 2024 financial year. Main areas of progress in the R&D portfolio Lanifibranor in MASH Publication in the peer-reviewed scientific journal Journal of Hepatology of the results from the investigator-initiated proof-of-concept clinical trial evaluating lanifibranor in patients with T2D and MASLD – January 2025 Initiation by Hepalys Pharma, Inc of the clinical development program of lanifibranor in Japan - February 2025 Publication in the peer-reviewed scientific journal Biomedicine & Pharmacotherapy of the results from a preclinical study showing improvement of portal hypertension with lanifibranor treatment – February 2025 Completion of enrollment in the Phase 3 NATiV3 clinical trial evaluating lanifibranor in patients with MASH and advanced fibrosis – April 2025 Publication in the peer-reviewed scientific journal Clinical Gastroenterology and Hepatology of the results of its analysis of new and specific non-invasive signature predictive of histological response in patients with MASH treated with lanifibranor – April 2025 Publication in the peer-reviewed scientific journal Journal of Hepatology Reports on results of lanifibranor treatment on liver sinusoidal endothelial cells in patients with MASLD/MASH and in preclinical models of the disease – July 2025 Other milestones Appointment of Renee Aguiar-Lucander to the Board of Directors – June 2025 Appointment of Jason Campagna, MD, PhD, as President of Research and Development and Chief Medical Officer – July 2025 Appointment of Martine Zimmermann, PharmD, as Executive Vice President of Regulatory Affairs and Quality Assurance – August 2025 Appointment of Andrew Obenshain as CEO of Inventiva – October 2025 Appointment of Nazira Arma as Chief Commercial Strategy Officer – December 2025 Sale of Odiparcil In 2025, the Company completed the sale of its global rights to odiparcil to Biossil, Inc., including without limitation, Inventiva’s preclinical data and results from the positive Phase 2a clinical trial for odiparcil in mucopolysaccharidosis type IV (MPS IV). Under the terms of the agreement, the Company received an upfront payment of $600,000 and may be eligible to receive up to $90 million in potential regulatory and commercial milestones and high single-digit royalties on future net sales, if approved. The Company’s ability to generate revenue from this arrangement will depend on Biossil’s abilities and efforts to successfully develop and seek marketing approval for odiparcil. Because of the numerous risks and uncertainties associated with product development and regulatory approval, there is no assurance that the Company will receive any future payments under this agreement. Termination of the Liquidity Contract The Company announces the termination of the liquidity contract entered into on February 1, 2018, with Kepler Cheuvreux, effective February 27, 2026. At the time the contract was established, the following resources appeared on the liquidity account: Cash: €163,510.42 Number of shares: 34,063 Inventiva shares As of the contract termination date, the following resources appeared on the liquidity account: Cash: €826,388.92 Number of shares: 0 Inventiva shares *** Upcoming key milestones Topline results of NATiV3 – expected in fourth quarter of 2026 Upcoming scientific conference participation EASL Congress, Barcelona, May 27-30 Conference call A conference call in English will be held tomorrow, Tuesday, March 31, 2026, at 8:00 am (New York)/2:00 pm (Paris) to discuss 2025 financial results and business updates. The live webcast may be accessed at the Investors Presentations section of the Inventiva website. In order to receive the conference access information necessary to join the conference call, it is required to register in advance here. Participants will need to use the conference access information provided in the e-mail received at the point of registering (dial-in number and access code). A replay of the conference call and the presentation will be available after the event one the Company’s website. Next financial results publication Revenues and cash, cash equivalents and deposits for the first quarter of 2026: Tuesday, May 26, 2026 (before U.S. market open) About Inventiva 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. 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. 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). Contacts Avertissement 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, other than statements of historical fact, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates regarding Inventiva's cash resources and expenses, expectations with respect to EIB matters, the potential exercise by investors of warrants and pre-funded warrants, including warrants and pre-funded warrants issued in connection with the Structured Financing, potential milestone and royalty payments the Company may receive under its agreement with Biossil with respect to odiparcil, including the timing thereof, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including the quality of trial results, design, duration, timing, costs, and funding, clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, Inventiva’s pipeline and development plans, and Inventiva's future activities, expectations, plans, growth and prospects. Some of these statements, forecasts, and estimates may be identified by the use of words such as, without limitation, “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “estimate,” “may,” “will,” “could,” “should,” “designed,” “hope,” “target,” “potential,” “opportunity,” “possible,” “aim,” and “continue” and other similar expressions. These statements are not historical facts, but rather statements of future expectations and other forward-looking statements based on management's beliefs. These statements reflect the opinions 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 in such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva's control. There can be no guarantee, with respect to product candidates, that clinical trial results will be available on schedule, that future clinical trials will be initiated as planned, that product candidates will receive the necessary regulatory approvals, or that the milestones planned by Inventiva or its partners will be achieved on schedule, or even at all. Future results may differ materially from the anticipated future results, performance, or achievements expressed or implied by these statements, forecasts, and estimates due to a number of factors, including the fact that interim data or data from any interim analysis of ongoing clinical trials do not predict the future results of clinical trials, the fact that the DMC's recommendation does not prejudge any eventual marketing authorization, that Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on recruitment or the final impact on the results or timing of the NATiV3 trial or related regulatory issues, Inventiva is a clinical-stage company with no approved products and no historical revenue, Inventiva has incurred significant losses since its inception, Inventiva has never generated revenue from product sales, Inventiva will need additional capital to fund its operations, without which Inventiva may be required to significantly reduce its activities, delay or discontinue one or more of its research or development programs, expand its activities or capitalize on its business opportunities, and may not be able to continue as a going concern. Inventiva's ability to obtain financing and complete potential transactions on a timely basis, as well as whether, when, and to what extent dilutive instruments may be exercised and by which holders, Inventiva's future success depends on the successful clinical development, regulatory approvals, and subsequent commercialization of lanifibranor, preclinical studies or previous clinical trials are not necessarily predictive of future results, and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' claims regarding product candidates, Inventiva's expectations regarding its clinical trials may prove to be incorrect, and regulatory authorities may require additional stops and/or modifications to Inventiva's clinical trials. Inventiva's expectations regarding the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to implement its commercialization, marketing, and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with its existing partners or enter into new partnerships, and to fulfil its obligations under any agreements entered into in connection with such partnerships, the benefits of its current and future partnerships on the clinical development, regulatory approvals, and, if applicable, commercialization of its product candidates, as well as the achievement of milestones and timelines anticipated in connection with such partnerships, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of the applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, the recruitment and retention of patients in clinical trials is a costly and time-consuming process that could be made more difficult or impossible by multiple factors beyond the control of Inventiva and its partners, Inventiva's product candidates may cause adverse reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and Inventiva's activities, preclinical studies, and clinical development programs, as well as timelines, Inventiva's financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, adverse conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and the resulting sanctions, the conflict in the Middle East and the related risk of a wider conflict, epidemics, and macroeconomic conditions, including changes in international trade policies, global inflation, fluctuations in financial and credit markets, customs duties and other trade barriers, political unrest and natural disasters, uncertain financial markets, and disruptions in banking systems. In light of these risks and uncertainties, no representation is made as to the accuracy or completeness of these forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts, and estimates are only valid as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Please refer to the Universal Registration Document for the fiscal year ended December 31, 2024, filed with the Autorité des Marchés Financiers on April 15, 2025, the semi-annual financial report as of June 30, 2025, published on September 29, 2025, and the Annual Report on Form 20-F for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2025 and the Half-Year Report for the six months ended June 30, 2025 on Form 6-K filed with the SEC on October 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the heading “Risk Factors,” and in future filings with the SEC. Other risks and uncertainties that Inventiva is not currently aware of may also affect its forward-looking statements and may cause actual results and timing of events to differ materially from those anticipated. All information contained in this press release is current as of the date of this release. Except as required by law, Inventiva has no intention or obligation to update or revise the forward-looking statements mentioned above. Therefore, Inventiva accepts no responsibility for the consequences arising from the use of any of the above statements. 1 Short-term deposits were classified as “other current assets” in the consolidated statement of financial position in accordance with IFRS and were considered by the Company to be liquid and readily available. 2 Based on the exchange rate of €1.00 = $1.1576 as published by the European Central Bank on November 12, 2025. See press release of November 17, 2025. 3 This estimate is based on the Company's current business plan , but excludes potential milestone payments to be paid or received by the Company, any potential proceeds from the exercise of Tranche 3 warrants issued as part of the Structured Financing, as well as any additional expenses related to other product candidates or resulting from the licensing or acquisition of additional product candidates or technologies, or any related developments that the Company may pursue. The Company may have based these estimates on assumptions that are incorrect or may amend its business plan in the future, and the Company may end up using its resources sooner than anticipated. These estimates may be shortened in the event of an increase, beyond the Company's expectations, in expenditure relating to the development program, or if the development program of the Company progresses more quickly than expected. Attachment Inventiva - PR - Full Year results 2025 - EN - 03 30 2026

Investor releaseQuarter not tagged2026-03-31

Inventiva Q4 Earnings Call Highlights

MarketBeat
Inventiva has centralized its strategy around lead candidate lanifibranor and the global Phase 3 NATiV3 trial, which completed enrollment in April 2025, but there is ambiguity on the expected top-line readout timing—management formally updated it to Q4 2026 while several executives repeatedly referred to “Q4 of this calendar year.” NATiV3 is a large randomized, double-blind, placebo-controlled study with over 1,000 patients in the main F2–F3 cohort plus ~410 in an exploratory F1–F4 cohort (including ~75 with cirrhosis), includes a meaningful diabetic population and background GLP‑1/SGLT2 use, and uses two Phase 3 doses (800 mg and 1,200 mg) with dropout rates confirmed below the 30% covenant threshold. As of Dec. 31, 2025 Inventiva held EUR 230.9 million in cash and short-term deposits, which management says funds the company beyond the NATiV3 readout with runway to the middle of Q1 2027 (extendable to mid‑Q3 2027 if tranche‑three warrants generate up to an additional EUR 116 million), and the company sold odiparcil rights with up to $90 million in potential milestones plus royalties. Interested in Inventiva S.A. Sponsored ADR? Here are five stocks we like better. Inventiva (NASDAQ:IVA) used its full-year 2025 results call to outline a company-wide focus on advancing its lead candidate lanifibranor toward a potential approval in metabolic dysfunction-associated steatohepatitis (MASH), while also detailing a strengthened cash position and several strategic organizational changes. Chief Executive Officer Andrew Obenshain said that since joining the company about six months ago, he has aligned “every resource, every decision, and every member of this team” behind advancing lanifibranor in MASH. → Coursera's Options Anomaly: A Big Bet on What's Next? Obenshain highlighted Inventiva’s global Phase 3 NATiV3 trial as the company’s central priority, calling completion of enrollment in April 2025 a “landmark operational milestone.” He also said the company is “updating the expected timing of our top-line readout to Q4 2026,” describing the change as reflecting “disciplined sequencing of our clinical and biostatistical milestones.” However, during the call, executives also repeatedly referred to a top-line readout expected in the fourth quarter of “this calendar year,” including Chief Medical Officer and President of R&D Jason Campagna, who said the company anticipate…Read full document

Inventiva has centralized its strategy around lead candidate lanifibranor and the global Phase 3 NATiV3 trial, which completed enrollment in April 2025, but there is ambiguity on the expected top-line readout timing—management formally updated it to Q4 2026 while several executives repeatedly referred to “Q4 of this calendar year.” NATiV3 is a large randomized, double-blind, placebo-controlled study with over 1,000 patients in the main F2–F3 cohort plus ~410 in an exploratory F1–F4 cohort (including ~75 with cirrhosis), includes a meaningful diabetic population and background GLP‑1/SGLT2 use, and uses two Phase 3 doses (800 mg and 1,200 mg) with dropout rates confirmed below the 30% covenant threshold. As of Dec. 31, 2025 Inventiva held EUR 230.9 million in cash and short-term deposits, which management says funds the company beyond the NATiV3 readout with runway to the middle of Q1 2027 (extendable to mid‑Q3 2027 if tranche‑three warrants generate up to an additional EUR 116 million), and the company sold odiparcil rights with up to $90 million in potential milestones plus royalties. Interested in Inventiva S.A. Sponsored ADR? Here are five stocks we like better. Inventiva (NASDAQ:IVA) used its full-year 2025 results call to outline a company-wide focus on advancing its lead candidate lanifibranor toward a potential approval in metabolic dysfunction-associated steatohepatitis (MASH), while also detailing a strengthened cash position and several strategic organizational changes. Chief Executive Officer Andrew Obenshain said that since joining the company about six months ago, he has aligned “every resource, every decision, and every member of this team” behind advancing lanifibranor in MASH. → Coursera's Options Anomaly: A Big Bet on What's Next? Obenshain highlighted Inventiva’s global Phase 3 NATiV3 trial as the company’s central priority, calling completion of enrollment in April 2025 a “landmark operational milestone.” He also said the company is “updating the expected timing of our top-line readout to Q4 2026,” describing the change as reflecting “disciplined sequencing of our clinical and biostatistical milestones.” However, during the call, executives also repeatedly referred to a top-line readout expected in the fourth quarter of “this calendar year,” including Chief Medical Officer and President of R&D Jason Campagna, who said the company anticipates sharing top-line results in “Q4 of this calendar year.” Obenshain similarly reiterated that the “anticipated top-line readout in the fourth quarter of this year” is an inflection point for the company. → HP Inc. Stock Is Historically Cheap, but Can AI Change the Story? Campagna described lanifibranor as a small-molecule therapy designed to activate all three PPAR isoforms—alpha, delta and gamma—in a “balanced manner,” with the goal of inducing antifibrotic, anti-inflammatory, and metabolic effects in a single oral therapy. He said lanifibranor was the first asset in Inventiva’s Phase 2b NATIVE trial to achieve statistical significance on a composite endpoint combining fibrosis improvement and MASH resolution after 24 weeks, with a “favorable safety and tolerability profile.” Based on the Phase 2b results, Campagna said the FDA granted the drug breakthrough therapy and fast track designations. → MercadoLibre Stock Is in Deep Pullback Territory: Time to Buy? NATiV3 is a randomized, double-blind, placebo-controlled study in biopsy-confirmed MASH patients with F2 or F3 fibrosis. Campagna said Inventiva deliberately designed the study to reflect both the Phase 2b population and “the real world,” including a meaningful proportion of patients with type 2 diabetes and other metabolic comorbidities and some patients using background GLP-1 and/or SGLT2 inhibitors. Enrollment surpassed original targets, he said, with “over 1,000 patients in the main cohort” and an additional “410 patients” in an exploratory cohort spanning fibrosis stages F1 through F4. In Q&A, Guggenheim’s Seamus Fernandez asked about trial dropouts. Campagna said Inventiva’s 2024 structured financing included covenants tied to early termination rates, with the trial needing to remain below a 30% threshold. He said the company previously disclosed it was below that threshold at the time follow-on tranches were released and added that Inventiva can “confirm we are well within that range” and that management remains confident the trial is “well powered to detect the primary endpoint” given the observed early terminations. Fernandez also asked about the two Phase 3 doses (800 mg and 1,200 mg). Campagna said it is “very reasonable” to think the 800 mg dose could show a deeper effect over a longer treatment period because PPARs are transcriptional modulators and “six months is relatively thin for a PPAR.” He added that fluid-retention-related weight gain is traditionally associated with PPAR gamma agonism and is “highly likely to be dose dependent,” which could make a lower dose meaningful from a tolerability perspective if efficacy remains strong. Piper Sandler’s Dominic Pannarale asked about biopsy quality control and safety monitoring. Campagna outlined multiple quality checkpoints for biopsies, including bedside procedures, assessments of biopsy length and core quality, slide preparation checks prior to central reading, and ongoing tracking of whether readers remain on time with paired-biopsy review per protocol and analysis plan. On safety monitoring committees, Obenshain said meetings occur every six months and noted that “you would know if they had said anything,” adding that the company could not provide additional details beyond that. UBS’s Michael Yee asked about weight gain and cardiovascular risk. Campagna said Inventiva has previously disclosed, based on a blinded look at NATiV3 in September 2024 and from the one-year FASST trial in systemic scleroderma, that fluid-retention weight gain “does appear to plateau.” He also said it is possible weight could come down in some patients, pointing to the LEGEND study and stating that when patients received SGLT2 inhibition alongside lanifibranor, there was “almost no weight gain at all.” On cardiac concerns, Campagna said the company has not been seeing congestive heart failure as a clinical issue in its program, while emphasizing that the company continues to monitor for it and expects ongoing dialogue with the FDA. Obenshain framed MASH as underdiagnosed and undertreated but improving in awareness and screening. He cited an estimate of “18 million people in the U.S. living with MASH,” adding that “only around 10% have been diagnosed,” which he said is up 25% versus 2024 estimates. He also said that among diagnosed patients with clinically actionable F2 or F3 disease, “only around 40% are currently under the care of a treating physician.” When asked about commercial opportunity and competition, Obenshain said that if Inventiva can replicate the Phase 2 fibrosis effect—an “18% effect on the fibrosis”—the company believes it will have “an excellent drug” and “clearing efficacy” needed for an attractive market opportunity. He added that Inventiva sees a potential entry point in the “F3 diabetic patient population,” citing the combination of fibrosis effect and HbA1c lowering. In response to questions about the size of the treated population, Obenshain said Inventiva’s market research indicates “about 375,000 patients total F2, F3, in treatment or care right now.” He also said “55%–65% of the patients are diabetic,” and that the distribution splits roughly 50/50 between F2 and F3. On background GLP-1 use in NATiV3, Campagna said about “14% or so” of the population across cohorts were on GLP-1 therapy at randomization. He suggested the impact on treatment response should be minimal because patients still entered the trial with active disease, and he added that doses used in this setting are “the diabetic doses.” Several analysts asked about the exploratory F4 cohort and potential outcomes trial planning. Campagna said the company expects the exploratory cirrhotic population to inform safety and pharmacology questions and help Inventiva understand disease progression and event rates for planning a future outcomes-driven trial the company is referring to as “NATiV4.” He also said there are “approximately 75 patients” with cirrhosis in that exploratory cohort, and that the patients are compensated by definition, with a spectrum of portal hypertension severity. Campagna also addressed questions on regulatory requirements for a confirmatory trial in the context of conditional approval. He said the detailed expectations are discussed with FDA during pre-NDA and review interactions, but characterized the general framework as requiring a confirmatory trial to be “meaningfully underway” at the time of filing, with continued progress evaluated at mid-cycle review. Chief Financial Officer Jean Volatier said that as of Dec. 31, 2025, Inventiva held “EUR 230.9 million” in combined cash equivalents and short-term deposits, supported by two financings in 2025: the second tranche of a 2024 structured financing in May (about “EUR 108 million” net proceeds) and a U.S. registered public offering in November (about “EUR 139.4 million” net proceeds). Volatier said the company estimates it is funded “beyond our anticipated NATiV3 readout.” Based on the current operating plan and cost structure, he said cash runway extends to “the middle of Q1 2027,” and to “the middle of Q3 2027” assuming full exercise of tranche three warrants that could generate up to “an additional EUR 116 million.” On expenses, Volatier reported: R&D expenses: EUR 87 million for the full year, reflecting pipeline prioritization and completion of NATiV3 enrollment in April 2025. Marketing and business development: EUR 5 million, driven by planned pre-commercial investment in anticipation of a potential lanifibranor launch. G&A expenses: EUR 47.9 million, including about EUR 20.3 million in non-cash share-based compensation tied to governance and organizational transition. Obenshain also noted that Inventiva sold global rights to odiparcil to Biosil in Q4 2025 as part of its strategic focus, and said the company may receive up to $90 million in potential regulatory and commercial milestone payments, plus potential “high single-digit royalties” on future net sales if approved. Looking ahead, management said it is building regulatory and commercial readiness in a “lean and targeted way.” Obenshain said the regulatory and quality functions are fully staffed, while the commercial team is focused on strategic planning—such as market access, market research and medical affairs—without a major commercialization headcount build prior to data. Inventiva (NASDAQ: IVA) is a clinical‐stage biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies for the treatment of metabolic, inflammatory, and fibrotic diseases. The company's core expertise lies in the modulation of nuclear receptors and signaling pathways that regulate fibrosis, inflammation and metabolic dysfunction. Inventiva's scientific platform integrates medicinal chemistry, in vitro and in vivo pharmacology, and translational sciences to advance a diversified pipeline of therapeutic candidates. The company's lead asset, lanifibranor (IVA337), is a pan-PPAR agonist in Phase III development for nonalcoholic steatohepatitis (NASH) and has demonstrated anti-inflammatory and anti-fibrotic effects in preclinical and clinical studies. The article "Inventiva Q4 Earnings Call Highlights" was originally published by MarketBeat.

TranscriptFY2025 Q42026-03-31

FY2025 Q4 earnings call transcript

Earnings source - 116 paragraphs
Operator

Good day, and thank you for standing by. Welcome to the Inventiva Full Year 2025 Financial Report webcast and conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to speakers today, David Nikodem, Head of Investor Relations. Please go ahead.

David Nikodem

Good morning. Good afternoon, everyone, and thank you for joining Inventiva's full year 2025 financial results and business update. Our press release was issued yesterday evening, and this webcast and slides will be available in the investor section on our website following the call. Joining us on the call today are Andrew Obenshain, Chief Executive Officer, Jean Volatier, Chief Financial Officer, and Dr. Jason Campagna, Chief Medical Officer and President of R&D. I would like to remind everyone that statements made during today's conference call and during the Q&A session may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Please refer to slide two of the slides and our SEC and AMF filings for a discussion of associated risks.

David Nikodem

These statements reflect our views as of today and should not be relied upon as representing our views at any later date. With that, I will now turn it over to Andrew, starting on slide three. Andrew?

Andrew Obenshain

Thank you, David. Good morning, good afternoon to everyone, and thank you for joining us. Since joining Inventiva six months ago, I've been struck by the depth of scientific conviction behind lanifibranor and the dedication of this team. Today, every resource, every decision, and every member of this team is now aligned behind a single objective: advancing lanifibranor towards approval for patients with MASH. Let me start with our main focus, our global phase III clinical trial, NATiV3. Enrollment was completed in April 2025 and represented a landmark operational milestone for this company. Today, we are updating the expected timing of our top-line readout to Q4 2026, reflecting the disciplined sequencing of our clinical and biostatistical milestones. We believe that the data from the NATiV3 trial, if positive, has the potential to carry weight with regulators, physicians, and most importantly, with patients.

Andrew Obenshain

We believe we are running this program with the rigor and precision all stakeholders deserve. On our pipeline and organizational focus, in the first half of 2025, we made the strategic decision to concentrate all of Inventiva's resources on lanifibranor and MASH. As part of this plan, in Q4 2025, we sold our global rights to odiparcil to Biosil, and we may receive up to $90 million in potential regulatory and commercial milestone payments, as well as potential high single-digit royalties on future net sales if approved. While this transaction frees up our internal resources to fully focus on lanifibranor, we are pleased that odiparcil has found a new home where its development can continue, potentially offering patients with MPS VI an opportunity for treatment. At the same time, we strengthened our leadership team to align with the level this opportunity demands.

Andrew Obenshain

Jason Campagna joined as CMO and President of R&D. Martine Zimmermann joined as a new EVP and Head of Quality and Regulatory Affairs. Nazira Amra joined as our Chief Commercial Strategy Officer. We are building towards launch in a lean and targeted way, advancing our readout and NDA preparations while laying the early groundwork for commercialization in anticipation of potential approval of lanifibranor. The opportunity is real. MASH has been underdiagnosed and undertreated for too long, but that is changing. More patients are being identified, more are being diagnosed and entering care. Awareness is growing, screening is improving, and metabolic disease is finally getting the attention it deserves. The numbers tell that story clearly.

Andrew Obenshain

There are an estimated 18 million people in the U.S. living with MASH, but only around 10% have been diagnosed, and that number has grown by 25% compared to 2024 estimates. Among those diagnosed with clinically actionable F2 or F3 disease, only around 40% are currently under the care of a treating physician. While diagnosis rates are improving and the market is evolving, far too many patients with significant fibrosis remain without the care they need and face a real risk of progression to cirrhosis and liver failure. If our NATiV3 trial can replicate the 18% fibrosis improvement seen in phase II, we believe lanifibranor could be well-positioned as a potential best-in-disease oral therapy with significant commercial impact. Ultimately, our goal is to make a meaningful difference for patients, and that is what drives everything we are doing.

Andrew Obenshain

I will now turn the floor over to Jason, who will give a brief update on lanifibranor, our differentiated oral antifibrotic and a potential new treatment option that we believe addresses the remaining unmet medical needs in MASH.

Jason Campagna

Thank you, Andrew. Good morning and good afternoon, everyone. Let me start by reminding you of the mechanism of action and the development pathway of lanifibranor. Lanifibranor is a small molecule designed to induce antifibrotic, anti-inflammatory, and beneficial vascular and metabolic changes by activating all three PPAR isoforms, alpha, delta, and gamma, in a balanced manner. This broad mechanism of action is designed to target the hepatic and extrahepatic drivers of MASH simultaneously and in one oral therapy.

Jason Campagna

Lanifibranor was the first asset to achieve statistically significant improvement in the composite endpoint of both fibrosis improvement and MASH resolution in our phase II-B NATIVE trial after just 24 weeks of treatment with a favorable safety and tolerability profile. On the basis of these results from our phase II-B, the FDA granted lanifibranor both breakthrough therapy and fast track designations. NATiV3, our pivotal phase III clinical trial, was designed to confirm and extend those findings in a larger, more diverse global population over 72 weeks, and is intended to provide the data to enable successful marketing authorization in the United States and Europe.

Jason Campagna

NATiV3 is a randomized, double-blind, placebo-controlled trial in patients with biopsy-confirmed MASH and stages F2 or F3 fibrosis, the core of the MASH treatment population, those with significant disease burden and a high risk of progression to cirrhosis, liver failure, and liver-related mortality. We specifically chose a clinically meaningful primary endpoint for NATiV3, fibrosis improvement and MASH resolution. At six months in our phase II-B, the 1,200 mg dose of lanifibranor showed a 24% treatment effect. NATiV3 was also deliberately designed to mirror the patient population of our positive phase II-B and the real world as it exists today.

Jason Campagna

A meaningful proportion of our patients have type 2 diabetes and other metabolic comorbidities, and a number are on background GLP-1 and/or SGLT2 inhibitor therapies, mirroring the patients physicians actually see in their clinics, which we believe will ensure that we generate clinically meaningful data to support both NDA and MAA submission. In April 2025, we completed enrollment, exceeding our original targets with over 1,000 patients in the main cohort and additional 410 patients with MASH and fibrosis stages F1 through F4 in an exploratory cohort. We anticipate sharing the top-line results of our pivotal phase III trial in Q4 of this calendar year, a moment I believe will be significant for this field and for the patients who need new treatment options. I will now turn the floor over to Jean for our financial review.

Jean Volatier

Thank you, Jason. Good morning and good afternoon, everyone. Yesterday evening, we issued our press release with our full financial results for the year ending December 31, 2025. I will focus on the highlights. As of December 31, 2025, we held EUR 230.9 million, close to EUR 231 million in combined cash equivalents, and short-term deposits. This position was built by two significant financing events in 2025. First, the execution of the second tranche of our 2024 structured financing in May, generating approximately EUR 108 million in net proceeds. Second, our U.S. registered public offering in November, generating approximately EUR 139.4 million in net proceeds. We estimate that we are funded beyond our anticipated NATiV3 readout.

Jean Volatier

Based on our current operating plan and cost structure, we estimate that our cash runway extends to the middle of Q1 2027 and to the middle of Q3 2027, assuming the full exercise of our tranche three warrants, which could generate up to an additional EUR 116 million. We confirm this way the cash guidance provided earlier. Our R&D expenses for the full year were EUR 87 million, primarily reflecting our pipeline prioritization and, to a lesser extent, the completion of NATiV3 enrollment in April 2025. Marketing and business development spend increased to EUR 5 million, primarily due to expenses related to a planned pre-commercial investment as we prepare for potential launch of lanifibranor, if approved.

Jean Volatier

G&A expenses of EUR 47.9 million include approximately EUR 20.3 million of non-cash share-based compensation tied to the governance and organizational transition we implemented this past year. I will now turn the floor back to Andrew for closing remarks.

Andrew Obenshain

Thank you, Jean. Inventiva enters 2026 well-funded, operationally focused, and ready for a consequential chapter in this company's history. NATiV3 is fully enrolled. We've built a leadership team with deep medical, regulatory, and commercial expertise, and our regulatory and commercial readiness work is progressing in parallel. Our anticipated top-line readout in the fourth quarter of this year represents a genuine inflection point, not just for Inventiva, but for the millions of patients living with MASH who still have no adequate treatment options. We are truly executing with the discipline and urgency this moment demands. Thank you for joining us today, and we will now open the floor for questions. Operators, please go ahead and provide instructions for the Q&A session.

Operator

Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Please, may we ask you that you limit yourself to one question each. We will now take our first question. Our first question for today comes from the line of Seamus Fernandez from Guggenheim. Please go ahead.

Seamus Fernandez

Great. Thanks, guys. Just a few quick questions. First, can you update us on how the performance of the trial has been in terms of dropouts? I know that there were some requirements from the tranches that were coming in that were successfully completed, but just wanted to get a sense of where the dropout rate was, you know, as you were kind of wrapping up enrollment. Second question is, can you help us understand how you're thinking about the performance of the 800 versus the 1200 milligram dose, in terms of both weight gain and then ultimately on fibrosis?

Seamus Fernandez

Is the sort of change from a you know more typical 12-month endpoint to the 18-month endpoint geared to kind of have the 800 mg dose catch up to the 1200 but also manage the you know potential tolerability or weight gain issues? The last question is just you know what you're seeing in terms of the overall market interest. You know, Madrigal continues to see very strong uptake you know in the U.S. How are you thinking about the opportunity to you know compete with Madrigal? What do you think is the threshold necessary? Andrew, you mentioned 18%.

Seamus Fernandez

Just interested to know if you think 18% is the threshold where the impact is going to be substantial or is that more reference to the powering of the study? Thanks.

Andrew Obenshain

Morning, Seamus. Thanks for the questions. I'm actually gonna take your third one first and then hand the first two over to Jason. Yes, just to be really direct, we think that if we replicate the phase II trial and have an 18% effect on the fibrosis, we have an excellent drug. That is the clearing efficacy that we need for in order to have a very attractive market opportunity. We continue to see a lot of market growth thanks to the entry of, you know, the two approvals and a lot of awareness around MASH. And there still continues to be unmet need, especially we see in that F3 diabetic patient population, where we think there'll be a very good entry point for lanifibranor.

Andrew Obenshain

At 18% of fibrosis effect with our HbA1c lowering, we have a very good profile for that. Let me then turn the question over to Jason first on the drop-offs and what we've last discussed publicly there, and then the second question about the 800 catching up to the 1200 dose.

Jason Campagna

Hey, Seamus. Let's take the first one. You are correct. As part of the structured financing from 2024, there were covenants in there around the release of follow-on tranches that the early termination rate for the trial needed to be below 30%. That number was selected because the original powering analysis when the trial was built allowed for up to a 30% dropout rate. That was the metric that was used, and we had disclosed publicly at the time of both the first and the second tranche release, which would have been in April 2025, that we were below that threshold.

Jason Campagna

I think now that we're tightening the guidance to Q4 of this calendar year, I think we are able to confirm we are well within that range and feeling quite good about where we've landed and are reaffirming that the trial is well powered to detect the primary endpoint with the size of the trial that we have and the early terminations that we've seen. The second question you asked about the two doses, I think you're landing sort of in the right mixture of elements that are important to us. We agree with you that in theory, with additional time, just because of the way PPARs work and the biology of the liver, that 800 mg dose will have time to sort of catch up to the 1200. It was already quite a good dose back in NATIVE, as you recall.

Jason Campagna

Six months is relatively thin for a PPAR, which is a transcriptional modulator to sort of do its work. The idea that you could see a deeper effect with that 800 dose at 18 months is very reasonable. I think where you're landing around the potential dose responsiveness of the tolerability concerns, that is also very important to us. Take weight gain, which you mentioned. Weight gain is a traditional PPAR gamma mediated fluid retention event, and we know that fluid retention is highly likely to be dose dependent just from what's been shown with other PPAR agonists and our own data from NATIVE.

Jason Campagna

We think that potential to have really strong efficacy with both doses, which we were able to show in NATIVE, but may have a different tolerability profile at the lower dose, could be meaningful for patients. It's our hope that both will be positive, and we'll have that opportunity to discuss that with regulators.

Seamus Fernandez

Great. Thanks so much.

Operator

Thank you. Our next question comes from the line of Yasmeen Rahimi from Piper Sandler. Please go ahead.

Dominic Pannarale

Hi, this is Dominic on for Yas. Congrats on the great quarter, and thank you for taking our questions. The first one, we know that NATiV3 is a very large dataset. As we're getting closer to top-line data in Q4, what are some of the quality control, I guess, protocols going on in the background to analyze the biopsy samples? And what procedures are in place to ensure timely and thoughtful assessment of these biopsies? And then our second question is, can you just talk or help us understand, I guess, how, if you had any recent safety monitoring committee, and are you seeing anything on a blinded basis on the safety profile? Any color there would be helpful. Thank you.

Andrew Obenshain

Good morning, Dominic. Two questions. Let me actually take the second one first. I'm gonna hand the first one over to Jason. Just on safety monitoring, there are periodic monitoring committee meetings every six months. You would know if they had said anything. Other than that, we really can't say anything about those meetings. Go ahead, Jason, on the biopsy.

Jason Campagna

Yeah. Thanks, Andrew. Dominic, quality control and biopsy. Let me start by saying that the team we have here is outstanding. The clinical operation, the clinical development team have been immersed in the world of NASH clinical trials for the better part of a decade. This is something that they know well, and we carry that expertise forward. You could think of quality control of biopsy around three issues. Are we hurting the patient? Meaning at the bedside, are we doing the right things? Second, are we capturing the biopsy according to standard practice? That's the length of the biopsy, the overall quality of the core, if you will. There's measurements and things that sort of go in to say check or not check.

Jason Campagna

We have reviewed all of those and continued to do so right up until when we get to last patient, last visit later this year. Lastly, finally, when the slides are sectioned prior to going off and being read, there's a quality control step there that looks at what actually gets made onto the slide. Afterwards, at that point, we are obviously blinded to all of that information, but there is a quality check in terms of are the reviewers, the readers staying on time and on track reading biopsies in the paired manner that's specified both in the protocol and the analysis plan. I like the teams that we have in front of it, and more importantly, I think that they're doing exactly the right work to keep us on track.

Dominic Pannarale

Great. Thank you.

Operator

Thank you. Our next question for today comes from the line of Ritu Baral from TD Cowen. Please go ahead.

Ritu Baral

Good morning, guys. Thanks for taking the question. I want to drill down a little bit more upon final powering. You guys disclosed the over 1000 final patient number. I think it's 1009, and the 90% powering. What's the effect size that that powering is for on the primary combined endpoint? And what are your expectations for potential movement around placebo of that, I think it was 7% at the six-month, you know, the final primary endpoint? And then I have a follow-up on market expectations around that F3 diabetic population that was mentioned.

Andrew Obenshain

Great. Thank you, Ritu. Jason, why don't you go ahead and answer that question?

Jason Campagna

Hi, Ritu. Good morning. On the first one, you know, we are not guiding to the actual effect size, but I can reiterate for you and for everyone what we have been saying. First, we are with a sample size of over 1,000 patients. We are powered to over 90% on a primary endpoint of the composite fibrosis improvement one stage or more MASH resolution. That one has a higher placebo response than we showed in NATIVE, which as you know, was 7%. Two, a smaller treatment effect than we showed in NATIVE at the 1,200 milligram dose. That means the overall effect size that we are powered to is smaller. A much more conservative view than the actual data that we showed in the phase II program.

Jason Campagna

I think we just talked earlier with Seamus that alongside our comfort with the early termination rates we have, we feel very good that the trial is structurally sound and that will give us an answer to the question one way or the other. You know, did lanifibranor work first at the 1,200 mg dose? The testing is hierarchical. We can't get to the 800 unless you went on the 1,200. But that is the core question. We think the trial is well set up to deliver an answer to that question that is well powered and highly confident. I think to your second question around placebo response, the individual endpoints of fibrosis alone, I think everybody on the call knows this, fibrosis alone improvement or MASH resolution alone can be quite noisy.

Jason Campagna

It's not clear after all these years of study why that is, but we do know that they're noisy. On the other hand, the composite endpoint, the primary endpoint of NATiV3, are with us and other sponsors, have shown that that endpoint is much less prone to placebo response. That makes sense, Ritu, biologically, right? You have in one patient, they may, on a placebo response, move their fibrosis stage by one point or more. The idea that they can also resolve their MASH spontaneously, what that 7% tells you is that in the wild, in the real world, that's incredibly uncommon, and that makes total sense with the actual way that patients walk in. It is unusual if you leave them sort of sitting alone without treatment, that both of those things will get better on their own.

Jason Campagna

The placebo response there actually reflects, we believe, the underlying biology, and it should remain very low. We've seen it by precedent, and it's our expectation for the trial that we're running.

Ritu Baral

Very helpful. Andrew, question on how you guys in your own market research is viewing that F3 diabetic population. Do you have an approximate patient number? How is the diagnosis rate in that population changing versus the overall MASH population given the ADA focus on MASH and its messaging to diabetologists?

Andrew Obenshain

Yeah. Thanks for the question, Ritu. In terms of size, there's about 375,000 patients total F2, F3, in treatment or care right now, the largest segment is. Or one of the largest segments is that F3 diabetic patient population, being 55%-65% of the patients are diabetic, and about it splits roughly 50/50 in our market research between F2, F3. That patient population is quite a large patient population overall. In terms of growth, we don't have the granularity down to that segment. However, I would just note anecdotally that F4 is one of the fastest-growing segments.

Andrew Obenshain

I think the diagnosis rates are increasing quite a bit, overall for F2, F3, F4, just due to the number of entrants into the market. They are growing at minimally proportionate with the market, in that segment.

Ritu Baral

To that point, Andrew, can you tell us of the 410 expansion cohort patients, how many are F4? Do you know at this point?

Andrew Obenshain

I'll pass that question.

Jason Campagna

Yeah. Confirming you're talking about the exploratory cohort, correct? Yeah.

Ritu Baral

Exploratory cohort, yes.

Jason Campagna

We do have F4s in that cohort. They would have screen failed in that case by histology, potentially other lab values for the actual main cohort in NATIVE. They represent a sort of range of F4 from. They're all compensated by definition, meaning they've had no clinical outcome events, decompensation events. Their range of severity with portal hypertension can be from none to evidence of clinically significant. That data set is going to be quite interesting to us. We're not yet guiding on when we'll have an opportunity to get those data out. It's unclear right now if we'll have them at topline per se, or in the weeks that follow it in one way or another. I think as we get closer to topline data, we should be guiding on that more tightly.

Ritu Baral

Got it. Looking forward to that. Thanks for taking all the questions.

Andrew Obenshain

Okay. Thank you.

Operator

Thank you. Our next question today comes from the line of Thomas Smith from Leerink Partners. Please go ahead.

Thomas Smith

Hey, guys. Good morning. Thanks for taking the questions, and congrats on all the progress. Just wanted to follow up on that F4 population. I know you're capturing some of those patients in the exploratory cohort. Can you just expand a little bit on what you hope to learn from that exploratory cohort and how you're thinking about planning for the outcome study in F4 pending the NATiV3 data and perhaps how you're thinking about perhaps how some of those plans could change. We know we're going to get F4 outcomes data for Rezdiffra also in 2027. Some interesting timing around that data set relative to when you're planning on starting this F4 outcome study. Thanks so much.

Andrew Obenshain

Thanks for the question, Tom. Jason, go ahead.

Jason Campagna

Tom, good morning. There's a lot there. Let me make sure I get it all for you. One, just in general, what are we expecting to learn from that cirrhotic population in the exploratory cohort? First, above all else, safety of lanifibranor in that population. Clearly, right, if you're going to bring in a new therapeutic into a more, let's say, just sicker population, you want to obviously have safety headroom to do that. The approximately 75 patients we have in that cohort, safety above all else. Second, it's not that, as you know, that cohort is not tracked systematically for efficacy. That being said, we do anticipate having data of things on like LFTs, transaminases, and other things that would point directionally towards whether the drug is biologically active.

Jason Campagna

Really a pharmacology question, very important. We have done ad hoc impairment studies with the drug, but looking at it in the real world in a clinical trial would be incredibly helpful. I think lastly, it will give us a sense in our own hands of how those patients progress over time to later-stage disease. You can read about it, you can model it, you can look at other people's trial, but in your own trial, we will see how many of those patients go on to actually have liver-related or other events. That will be incredibly helpful as we think about powering and sizing of an outcome-driven trial, which is what we're, you know, right now calling NATiV4, for lack of a better term. Make sure that that gets your question, Tom, on the value of that cohort to us.

Thomas Smith

Yep, that's helpful.

Jason Campagna

Great. Look, you note the Madrigal data coming, and then yet we acknowledge that. We agree. I think our view is that positive data, if Madrigal were to show it, would only be helpful for the field, period, full stop. The idea that we have now finally shown that the surrogate endpoint does correlate with clinical outcomes would be an enormous win for the field. Look no further than what happened in the cardio renal division with proteinuria in the last six years. You know, proteinuria was issued as a surrogate in 2019. Now you have five or coming six approved therapeutics for IgAN. That's an enormous win for patients. We expect something like that would, I hope, happen here.

Jason Campagna

Clearly, that would influence our thinking about how we think about populations and the ones that are most likely to develop liver-related outcomes because we'd want to get more of them since we know that the sort of door is open to show that the histology will map to clinical outcomes.

Thomas Smith

Very helpful. Thanks for taking the questions.

Operator

Thank you. We are now going to take our next question, and our next question comes from the line of Michael Yee from UBS. Please go ahead.

Michael Yee

Thanks. Good morning. I have 32 questions myself. First question is on weight gain. Can you remind or confirm the view that, based on the phase II also, I think what you've sort of said in the ongoing phase III, that there is some initial weight gain, but that it plateaus and that you don't really see anything beyond a modest increase in some patients, at least in the phase II, and that that plateaus, and that was initially seen in the phase III and therefore no concerns. The second question is there any view that either because of other drugs or because of longer time duration of 18 months versus six months here that that could actually come down in some of those patients or at least come back down to baseline? Is that possible?

Michael Yee

The third question is around getting the regulators comfortable with that what I guess fluid retention effect in some patients, and that there would be presumably no at least initial cardiac imbalance in any of the arms that you see and would you be able to talk about no imbalance in any cardiovascular events numerically or any SAEs of that nature in when you disclose the data in the fourth quarter? Thanks, guys.

Andrew Obenshain

Thank you for the question, Mike. You were a little soft, so I'm just gonna repeat some of it. There's a question about does weight gain indeed plateau, and number one, if in the phase II. Number two, is there a chance that that weight gain would actually go down in the phase III, either due to concomitant medications or longer treatment? Number three, some of the weight gain is if the weight gain is due to fluid, is there any concerns about a cardiac imbalance in the trial? For those three questions, I'll hand it over to Jason.

Jason Campagna

Yeah. Mike, good to talk to you again. Good morning. We have previously said, and we'll reaffirm it here, that the data that we have previously shown from the blinded look at NATiV3 back in September 2024, and that we also disclosed at that time the FASST clinical trial in systemic scleroderma, which was a one-year trial with treatment of lanifibranor, same doses in NATiV3, 800, 1200 milligrams, that the weight, the fluid retention weight gain does appear to plateau. I think we don't have any additional information to guide on that publicly, but I think that's what we've seen in both of the clinical trials so far. I think second, do we expect the weight to come down? Well, it's well possible.

Jason Campagna

I think there are a couple of factors at play. Take the LEGEND study, for example. We show that when patients are given SGLT2 inhibition in parallel with lanifibranor, that there's almost no weight gain at all. There are many patients in the trial that are on SGLT2 inhibition. I do not have the number for you off the top of my head. We know that patients can be started on those therapeutics for management of diabetes or any other reason. It is entirely possible and reasonable to believe that if patients are getting SGLT2 inhibitors or other diuretics to manage blood pressure, et cetera, that the fluid retention could be blunted or resolved so that the final landing spot, if you will, for any patient might be lower than the peak weight gain that they had in the trial.

Jason Campagna

I think we'll see what the data show. Last thing in terms of regulators, I think, I can't speak for the FDA, but I can only speak to what I've read, of everything they've put out. The fluid retention is a known phenomenon with PPAR gamma agonism. The thing about lanifibranor is it was designed to be different than other PPAR gammas, and we'll see what the data show. Our view is that it is a very different type of PPAR agonist. But that being said, the PPAR gamma is a known effect. It is on target. It is not idiosyncratic in any way. FDA has shown with labeling and other work that they are comfortable with fluid retention.

Jason Campagna

I think you're hitting on the right point, the cardiac, and as we've talked about and guided publicly, over the years, we are not seeing congestive heart failure as a clinical issue in our program. It doesn't mean that we don't follow it, and it doesn't mean that you're thinking about how fluid retention may lead to that. That's certainly in the PPAR labels today, the gamma agonist. It is just not something that we are generally seeing in our program, but we will be paying careful attention to it, and it's a dialogue we'll have with FDA.

Michael Yee

Super helpful. Thank you, guys. Very good.

Operator

Thank you. As a reminder, to ask a question, you will need to press star one and one on your telephone. In the interest of time, we kindly ask to limit yourself to one question each. Our next question comes from the line of Ellie Merle from Barclays. Please go ahead.

Jasmine Kaur

Hi, this is Jasmine on for Ellie. Thank you for taking our question. Just kind of a follow-up to Ritu's question. You talked about the overlap of MASH and type 2 diabetes as a segment where lanifibranor can be particularly attractive.

Jason Campagna

Mm-hmm.

Jasmine Kaur

Do you have a specific bar for what competitive data would look like in this population? And then specifically, how many type 2 diabetes patients do you think have undiagnosed MASH? And how do you plan to work to increase the diagnosis in this population and unlock that segment? Thank you.

Andrew Obenshain

Hi. Hi, Jasmine. I'll take those two questions. First of all, just the diabetes and overlap with MASH, it is enormous, right? I think there's about 18 million patients in the U.S. with undiagnosed MASH. At least half of those or more have diabetes. That is obviously way more than that 375 under the treat or care. The way we see the market evolving is we've seen since about 2004, that market's grown about 20%. It's really quite robust growth, and we do anticipate that to grow nicely. We, as a company, probably will not be pushing diagnosis, at least initially.

Andrew Obenshain

There are enough patients coming in that we can focus on the existing patients being diagnosed. That would obviously. Maybe a later marketing strategy would be to actually increase diagnosis. Your first question. I'm sorry, I forgot your first question already. What was that first question?

Jasmine Kaur

Just if you have like a specific bar in that population for what competitive data looks like?

Andrew Obenshain

Yeah. In terms of competitive data, the way we look at this is that the differentiated profile that we have is we work both on the liver and we're extrahepatic. We work on the body, and we work on the liver. We have direct anti-fibrotic effects. Again, as I said that, you know, an 18% effect size, if we duplicated that in the phase III trial, we feel like a very competitive drug. The other thing we'll be looking at is HbA1c lowering, which was on average across the whole patient population, diabetic and nondiabetic in the phase II, was just over half a point. That would be an approvable diabetes medication years ago.

Andrew Obenshain

That combination of HbA1c lowering, combined with triglyceride lowering, HDL raising, and the fibrosis effect, we think has an extremely attractive profile for that diabetic F3 patient.

Jasmine Kaur

Okay. Awesome. Thank you.

Operator

Thank you. Our next question comes from the line of One second. Lucy Codrington from Jefferies. Please go ahead.

Lucy Codrington

Hi there. Thank you for taking my question. Just one left, please. Regarding the confirmatory trial, just wanted to confirm, do you have an understanding with the FDA in terms of what underway means when it comes to granting accelerated approval? Is it enough just to have started that trial? Does this need to be by the time you file or by the time you get to approval? Related to that, is starting that trial included in that mid-3Q cash runway with the third tranche of warrants? Thank you.

Andrew Obenshain

Yes, it is included. Starting that trial is included in the cash runway of that mid-Q3 runway. Jason, you wanna talk about what's necessary.

Jason Campagna

Yeah.

Andrew Obenshain

For the trial?

Jason Campagna

Lucy, I think you have the broad brushstrokes of it right, but just something on the language. Accelerated approval is only at the time of the review. What we're looking to get is conditional approval under Subpart H, which is you get marketing authorization, and then the trial, as you note, confirms your surrogate, and then you get full approval. Whether accelerated is only a question of how long it takes the FDA to actually review the file. With that, just trying to make sure that we're all clear on that. You have the broad brushstrokes, right? The individual rules are discussed with each sponsor at the time of the pre-NDA meeting and then during the mid-cycle review.

Jason Campagna

The general framework is you need to have most of the trial structurally in place, protocol approved, at the time you are filing the drug, and it needs to be moving on. The definition of moving is going to be something FDA will define for us. We will be prepared. We'll have our CROs selected, the protocol is approved. May even have sites open. All of that is in the future, but at the time we file, we will meet the FDA position of trial meaningfully underway. At the mid-cycle review, you need to show continued progress on that, so they will check again. That may be a much more detailed look around enrollment curves, site activation curves, et cetera.

Jason Campagna

Again, each sponsor has their own detailed agreement with FDA on that, and it is our plan, of course, not only to have those conversations, but to make sure that we're meeting those requirements so that when we are offered, if we're fortunate enough to make it there, and we are offered, the conditional approval, that trial will be well underway at that point.

Lucy Codrington

Got it. Thank you, and thank you for clarifying on the terminology.

Operator

Thank you. Our next question for today comes from the line of Annabel Samimy from Stifel. Please go ahead.

Jayed Momin

Hi, this is Jayed on for Annabel. Congrats on the progress and thank you for taking my questions. Just two from me. The first one is around the use of background GLP-1 in the trial. What are your expectations on the potential impact of having that background GLP-1 use on lanifibranor effect size for those patients? My second question is around the AIM-MASH tool that was newly FDA qualified as a supportive tool to help with histological assessment. Do you have any plans to maybe leverage that to control or minimize variability? Thank you.

Andrew Obenshain

Yeah. Thanks for the questions on the impact on the lanifibranor effect size based on background GLP-1 and then the trial. Go ahead, Jason.

Jason Campagna

Yeah. In confirming, we do have, and we've previously shared that we have about 14% or so of the population in NATiV3, that's across both cohorts, that have background GLP-1 use at the time of randomization. That could be semaglutide, older drugs, liraglutide, dulaglutide, et cetera, so it's not only limited to the modern GLP-1. I think its effect on treatment response should be minimal and that should. It will sound tongue in cheek, it's not intended to be. It's because when you enter the clinical trial, independent of what drugs you're on, whether you've lost weight by any other measure independent of a GLP-1, you're entering the trial because you have F2, F3 disease with active MASH. So whatever it is, one, those drugs are not doing it for you or your lifestyle modifications.

Jason Campagna

Second, that the doses that we're using are really the diabetic doses. They are not anticipated to have much of an effect at all. We've certainly seen that in the clinical trial data. I think to the second question about the tools, are you talking about PathAI specifically or just more general non-invasives?

Jayed Momin

Yeah, no, it's the PathAI tool.

Jason Campagna

Yeah. It's an interesting idea, right? Looking at it really simply, what PathAI lets you do is substitute one human pathologist for a digital pathologist, and then you need a second pathologist to read. It's still the same idea, two plus one consensus. In this case, one of the two is PathAI. It's interesting. It's not something that in NATiV3 we anticipate taking much advantage of, but it is something we're thinking very closely about for NATiV4, potentially even using that as the in the exploratory cohort presently for NATiV3, to see how we may be able to pull more data out of those patients that happen to have a biopsy.

Jayed Momin

Got it. Thank you so much for the answers.

Operator

Thank you. Our next question for today comes from the line of Rami Katkhuda from LifeSci Capital. Please go ahead.

Rami Katkhuda

Hi, guys. Thanks for taking my questions as well. I guess, can you remind us of lanifibranor's FC and F2 versus F3 patients in the phase II study and how those differences may impact the expectations for NATiV3, just given the higher proportion of F3 patients enrolled?

Andrew Obenshain

Good morning, Rami. Go ahead, Jason.

Jason Campagna

Rami, just to qualify, you want the proportion of patients in NATIVE2 or the responses of the F2, F3?

Rami Katkhuda

The responses, please, between the phase II's and phase III's.

Jason Campagna

The sample sizes are simply too small to break out. What we have done, we think the analysis that's more helpful, it's in our corporate materials, is that when you strip away the F1s in that trial, you get down to about 188 F2, F3 across all three arms. You can see that the effect size actually slightly goes up. What we guide to is that it remains unchanged. The drug seems to work equally well in more advanced fibrosis than patients with earlier disease. You're not getting much of a free ride on those F1s if you will. Second, when we look at NATiV3, as Andrew talked about earlier, this is a contemporary MASH market. The majority of patients showing up in clinics today that have F3 disease will have diabetes.

Jason Campagna

We think that aligns pretty well with the outside world, and we're pretty comfortable with what we've seen from our Nature publication back in 2024, that the drug not only works equally well in earlier and late stage disease, but the adiponectin levels actually go up equally well across all cohorts. It's that adiponectin that's really driving, we think, well correlated with the clinical response. We like where we're landing with NATiV3 and the likelihood of efficacy in both those F2 and F3 patients. As a reminder, we're stratified by fibrosis stage and diabetes in NATiV3. We have to cut those data a number of different ways to sort of get where you're headed with your question.

Rami Katkhuda

Makes a lot of sense. Thank you.

Operator

Thank you. Our next question comes from the line of Srikripa Devarakonda from Truist Securities. Please go ahead.

Anna Chien

Hi, this is Anna on for Srikripa. Thanks so much for taking our questions. Two questions from us. First, looking ahead a little bit in terms of the MASH guidelines, would you expect an update on the MASH guidelines this year, and how are you thinking about getting Lani into the MASH guidelines? Then second question, in terms of cash, what kind of needs to happen for you to have access to that third tranche? Is it based on kind of phase III success only? And are you looking at any other non-dilutive sources of funding, such as partnerships? Thank you.

Andrew Obenshain

Morning, Anna. Thanks for the questions. On the MASH guidelines, I think we wanna wait. We need to get data first before we have any conversations about putting lanifibranor into the MASH guidelines. On cash, the tranche three is a positive endpoint. We hit a positive endpoint in our trial, and then those 77 million shares at EUR 50 become exercisable, and the investors have 45 days to exercise them. That's how that mechanically works. Positive trial equals quickly cash coming in, so long as the stock price stays above EUR 50. We are always looking for ways to increase our cash runway. We're obviously in a very strong cash position right now.

Andrew Obenshain

In terms of partnerships, right now our plan is to commercialize lanifibranor ourselves. Going forward, we think that there's plenty of access to capital either in the equity markets, or other kind of capital sources that we don't necessarily need to partner lanifibranor.

Anna Chien

Great. Thank you so much.

Operator

Thank you. We are going to take our next question, and our next question comes from the line of Sushila Hernandez from Van Lanschot Kempen. Please go ahead.

Sushila Hernandez

Yes, thank you for taking my question. Could you elaborate on your regulatory and commercial infrastructure? What steps are you taking to act with speed once the data is here, also considering your cash runway? Thank you.

Andrew Obenshain

Yes. Sushila Hernandez, good question, and morning. Yeah, we are being very careful stewards of our capital right now before data. The regulatory team is fully staffed, and I would include the quality team in that too, because that's necessary to make a really good filing with the FDA. We've invested. We've increased the size of that team and the talent on that team in the course of this year. From a commercial standpoint, really focused on strategic commercial execution. Being led by Nazira Amra, really focused on market access and market research. I'm gonna include in the broad commercialization medical affairs there. The strategic roles that will really set us up for success in the future.

Andrew Obenshain

We will not staff up aggressively in commercial until we have positive data.

Sushila Hernandez

That's clear. Thank you.

Operator

Thank you. This concludes today's question and answer session. I will now hand the call back to Andrew Obenshain, CEO of Inventiva, for closing remarks.

Andrew Obenshain

Thank you so much. Thank you everyone for joining the call this morning. We certainly have an exciting remainder of the year coming up from, for Inventiva, and we look forward to engaging with you all as we go forward. Thank you.

Operator

This concludes today's conference call. Thank you for participating. You may now all disconnect.

Investor releaseQuarter not tagged2026-03-24

Inventiva Schedules the Publication and Presentation of its 2025 Full-Year Financial Results

GlobeNewswire

Daix (France), New York (United States), March 23, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced that it will release its 2025 full-year financial results on Monday, March 30, 2026, after market close in the United States. Inventiva’s management will hold a conference call in English, followed by a Q&A session, on Tuesday, March 31, 2026, at 8:00 am (New York), 2:00 pm (Paris). Participants wishing to join the conference call by phone and ask questions must register in advance here. Upon registration, participants will receive dial-in details by email. The live webcast may be accessed at the Investors Presentations section of the Inventiva website. A replay of the conference call will be available after the event on the Company’s website. About Inventiva 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. 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). http://www.inventivapharma.com Contacts Attachment Inventiva - PR - FY 2025 Results Webcast - EN - 03 23 2026

Investor releaseQuarter not tagged2026-02-17

Inventiva reports preliminary 2025¹ fiscal year financial results

GlobeNewswire
Cash and cash equivalents at €99.3 million, and €131.6 million in short-term deposits2 as of December 31, 2025 Revenues of €4.5 million in 2025 Completed a U.S. registered public offering for gross proceeds of approximately $172.5 million (€149 million3) Cash runway expected until the middle of the first quarter of 20274 Daix (France), New York City (New York, United States), February 17, 2026 – Inventiva (Euronext Paris and Nasdaq: IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), today reported its certain preliminary unaudited financial results for the full year ending December 31, 2025, including cash, cash equivalents, and revenues. Cash and cash equivalents As of December 31, 2025, the Company's cash and cash equivalents amounted to €99.3 million and its short-term deposits2 to €131.6 million, compared to cash and cash equivalents of €96.6 million as of December 31, 2024. Net cash used in operating activities amounted to (€104.6) million in 2025, compared to (€85.9) million in 2024, representing an increase of 22%. R&D expenses, mainly related to the development of lanifibranor in MASH, amounted to €86.9 million in 2025, down 4% from €90.9 million in 2024. The increase in net cash used in operating activities is mainly related to the net cash impact of the strategic pipeline prioritization plan for the Company's activities implemented in the first half of 2025, lower revenues under the licensing agreement with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), and an increase in general and administrative expenses. Net cash used in investing activities amounted to (€133.2) million in 2025, mainly related to the subscription of new short-term deposits2 during the period, compared with €8.7 million generated in 2024. Net cash generated by financing activities amounted to €241.1 million in 2025, compared to €145.6 million in 2024. This positive cash flow is mainly due to the receipt of (i) gross proceeds of €115.6 million (net proceeds of €108.0 million) from the second tranche5 in May 2025 of the structured financing announced by the Company in October 2024 (the “Structured Financing”), and (ii) gross proceeds of $172.5 million (net proceeds of €139.3 million) from the public offering in the Un…Read full document

Cash and cash equivalents at €99.3 million, and €131.6 million in short-term deposits2 as of December 31, 2025 Revenues of €4.5 million in 2025 Completed a U.S. registered public offering for gross proceeds of approximately $172.5 million (€149 million3) Cash runway expected until the middle of the first quarter of 20274 Daix (France), New York City (New York, United States), February 17, 2026 – Inventiva (Euronext Paris and Nasdaq: IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), today reported its certain preliminary unaudited financial results for the full year ending December 31, 2025, including cash, cash equivalents, and revenues. Cash and cash equivalents As of December 31, 2025, the Company's cash and cash equivalents amounted to €99.3 million and its short-term deposits2 to €131.6 million, compared to cash and cash equivalents of €96.6 million as of December 31, 2024. Net cash used in operating activities amounted to (€104.6) million in 2025, compared to (€85.9) million in 2024, representing an increase of 22%. R&D expenses, mainly related to the development of lanifibranor in MASH, amounted to €86.9 million in 2025, down 4% from €90.9 million in 2024. The increase in net cash used in operating activities is mainly related to the net cash impact of the strategic pipeline prioritization plan for the Company's activities implemented in the first half of 2025, lower revenues under the licensing agreement with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), and an increase in general and administrative expenses. Net cash used in investing activities amounted to (€133.2) million in 2025, mainly related to the subscription of new short-term deposits2 during the period, compared with €8.7 million generated in 2024. Net cash generated by financing activities amounted to €241.1 million in 2025, compared to €145.6 million in 2024. This positive cash flow is mainly due to the receipt of (i) gross proceeds of €115.6 million (net proceeds of €108.0 million) from the second tranche5 in May 2025 of the structured financing announced by the Company in October 2024 (the “Structured Financing”), and (ii) gross proceeds of $172.5 million (net proceeds of €139.3 million) from the public offering in the United States in November 2025. In 2025, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€0.5) million, compared to a positive effect of €1.2 million in 2024, due to changes in the EUR/USD exchange rate. Given its current cost structure and projected expenses, the Company estimates that its cash, cash equivalents, and short-term deposits, should enable it to finance its operations until the middle of the first quarter of 2027. Assuming the potential exercise in full of the Tranche 3 warrants issued in the Structured Financing for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 20276. Revenues The Company's revenues in 2025 amounted to €4.5 million, compared to €9.2 million generated in 2024. Revenues recorded by the Company in 2025 consist mainly of the $10 million gross proceeds (net proceeds of €8.6 million) milestone payment invoiced to CTTQ and the $5 million (€4.3 million) credit notes recognized under the license agreement with CTTQ following the closing of the second tranche of the Structured Financing in May 2025. The milestone payment from CTTQ was received in July 2025. *** Next financial results publication Financial audited results for the full fiscal year 2025: March 30, 2026 (after U.S. market close). About Inventiva 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. 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. 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). http://www.inventivapharma.com Contacts Avertissement 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, other than statements of historical fact, included in this press release are forward-looking statements. These statements include, but are not limited to, preliminary unaudited financial information, forecasts and estimates regarding Inventiva's cash resources and expenses, the potential exercise by investors of warrants and pre-funded warrants, including warrants and pre-funded warrants issued in connection with the Structured Financing, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including design, duration, timing, costs, and funding, clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, Inventiva’s pipeline and development plans, and Inventiva's future activities, expectations, plans, growth and prospects. Some of these statements, forecasts, and estimates may be identified by the use of words such as, without limitation, “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “estimate,” “may,” “will,” “could,” “should,” “designed,” “hope,” “target,” “potential,” “opportunity,” “possible,” “aim,” and “continue” and other similar expressions. These statements are not historical facts, but rather statements of future expectations and other forward-looking statements based on management's beliefs. These statements reflect the opinions 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 in such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva's control. There can be no guarantee, with respect to product candidates, that clinical trial results will be available on schedule, that future clinical trials will be initiated as planned, that product candidates will receive the necessary regulatory approvals, or that the milestones planned by Inventiva or its partners will be achieved on schedule, or even at all. Future results may differ materially from the anticipated future results, performance, or achievements expressed or implied by these statements, forecasts, and estimates due to a number of factors, including the completion of financial closing procedures, final audit adjustments and other developments that may arise that could cause the preliminary financial results for 2025 to differ from the financial results that will be reflected in Inventiva’s audited consolidated financial statements for the fiscal year ended December 31, 2025, the fact that interim data or data from any interim analysis of ongoing clinical trials do not predict the future results of clinical trials, the fact that the DMC's recommendation does not prejudge any eventual marketing authorization, that Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on recruitment or the final impact on the results or timing of the NATiV3 trial or related regulatory issues, Inventiva is a clinical-stage company with no approved products and no historical revenue, Inventiva has incurred significant losses since its inception, Inventiva has never generated revenue from product sales, Inventiva will need additional capital to fund its operations, without which Inventiva may be required to significantly reduce its activities, delay or discontinue one or more of its research or development programs, expand its activities or capitalize on its business opportunities, and may not be able to continue as a going concern. Inventiva's ability to obtain financing and complete potential transactions on a timely basis, as well as whether, when, and to what extent dilutive instruments may be exercised and by which holders, Inventiva's future success depends on the successful clinical development, regulatory approvals, and subsequent commercialization of lanifibranor, preclinical studies or previous clinical trials are not necessarily predictive of future results, and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' claims regarding product candidates, Inventiva's expectations regarding its clinical trials may prove to be incorrect, and regulatory authorities may require additional stops and/or modifications to Inventiva's clinical trials. Inventiva's expectations regarding the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to identify other products or product candidates with significant commercial potential, Inventiva's expectations regarding its strategic reorganization plan and the resulting reduction in headcount, including the potential benefits, expenses, and consequences thereof, Inventiva's ability to implement its commercialization, marketing, and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with its existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its current and future partnerships on the clinical development, regulatory approvals, and, if applicable, commercialization of its product candidates, as well as the achievement of milestones and timelines anticipated in connection with such partnerships, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of the applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, the recruitment and retention of patients in clinical trials is a costly and time-consuming process that could be made more difficult or impossible by multiple factors beyond the control of Inventiva and its partners, Inventiva's product candidates may cause adverse reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and Inventiva's activities, preclinical studies, and clinical development programs, as well as timelines, Inventiva's financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, adverse conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and the resulting sanctions, the conflict in the Middle East and the related risk of a wider conflict, epidemics, and macroeconomic conditions, including changes in international trade policies, global inflation, fluctuations in financial and credit markets, customs duties and other trade barriers, political unrest and natural disasters, uncertain financial markets, and disruptions in banking systems. In light of these risks and uncertainties, no representation is made as to the accuracy or completeness of these forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts, and estimates are only valid as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Please refer to the Universal Registration Document for the fiscal year ended December 31, 2024, filed with the Autorité des Marchés Financiers on April 15, 2025, the semi-annual financial report as of June 30, 2025, published on September 29, 2025, and the Annual Report on Form 20-F for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the heading “Risk Factors,” and in future filings with the SEC. Other risks and uncertainties that Inventiva is not currently aware of may also affect its forward-looking statements and may cause actual results and timing of events to differ materially from those anticipated. All information contained in this press release is current as of the date of this release. Except as required by law, Inventiva has no intention or obligation to update or revise the forward-looking statements mentioned above. Therefore, Inventiva accepts no responsibility for the consequences arising from the use of any of the above statements. 1 Preliminary non audited financial information. 2 Short-term deposits were classified as “other current assets” in the consolidated statement of financial position in accordance with IFRS and were considered by the Company to be liquid and readily available. 3 Based on the exchange rate of €1.00 = $1.1576 as published by the European Central Bank on November 12, 2025. See press release of November 17, 2025. 4 This estimate is based on the Company's current business plan and excludes potential milestone payments to be paid or received by the Company, any potential additional proceeds from the exercise of Tranche 3 share purchase warrants issued as part of the Structured Financing, as well as any additional expenses related to other product candidates or resulting from the licensing or acquisition of additional product candidates or technologies, or any related developments that the Company may pursue. The Company may have based this estimate on incorrect assumptions and may end up using its resources more quickly than anticipated. 5 Press release 5 May 2025 6 These estimates are based on the Company's current business plan and exclude any milestone payments that may be made by or to the Company, as well as any additional expenses related to other product candidates or resulting from a potential license agreement or acquisition of additional product candidates or technologies, or any associated development that the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources more quickly than anticipated. There is no guarantee that the warrants in Tranche 3 will be exercised, if at all. Attachment Inventiva - PR - Preliminary FY 2025 - EN - 02 17 2026

Investor releaseQuarter not tagged2025-11-28

Results of the Votes of the Combined Shareholders’ General Meeting of November 27, 2025

GlobeNewswire
Daix (France), New York City (New York, United States), November 28, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the results of the votes of its Combined Shareholders’ Meeting. The Combined Shareholders' Meeting was held on Thursday November 27, 2025, at 9 a.m. at Hôtel Villa M, 24-30 Bd Pasteur, 75015 Paris (France), under the chairmanship of Mr. Pierre Broqua. Mr. Pierre Broqua proceeded to the usual formalities of the opening of the meeting, in particular to the constitution of the Bureau by appointing Mr. Eric Duranson, as secretary of the general meeting. All the resolutions submitted to vote have been adopted by the shareholders, with the exception of the 5th resolution, which had been the subject of a negative recommendation by the Board of Directors. The 5th resolution would have empowered the Board of Directors to decide on share capital increases reserved for members of a company savings plan to be set up by the Company. Pursuant to Article R. 22-10-14 IV. of the French Commercial Code, the Combined Shareholders’ Meeting approved, without modification, the compensation policy for the Chief Executive Officer as described in the Combined Shareholders' Meeting notice brochure available on the Company's website under the heading “Shareholders' Meeting”. Total number of shares composing the share capital: 191 077 498 Total number of shares with voting rights: 191 027 885 About Inventiva 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. 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). http://www.inventivapharma.com Contacts Important Notice This press release contains certain “forward-looking statements” within the mean…Read full document

Daix (France), New York City (New York, United States), November 28, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the results of the votes of its Combined Shareholders’ Meeting. The Combined Shareholders' Meeting was held on Thursday November 27, 2025, at 9 a.m. at Hôtel Villa M, 24-30 Bd Pasteur, 75015 Paris (France), under the chairmanship of Mr. Pierre Broqua. Mr. Pierre Broqua proceeded to the usual formalities of the opening of the meeting, in particular to the constitution of the Bureau by appointing Mr. Eric Duranson, as secretary of the general meeting. All the resolutions submitted to vote have been adopted by the shareholders, with the exception of the 5th resolution, which had been the subject of a negative recommendation by the Board of Directors. The 5th resolution would have empowered the Board of Directors to decide on share capital increases reserved for members of a company savings plan to be set up by the Company. Pursuant to Article R. 22-10-14 IV. of the French Commercial Code, the Combined Shareholders’ Meeting approved, without modification, the compensation policy for the Chief Executive Officer as described in the Combined Shareholders' Meeting notice brochure available on the Company's website under the heading “Shareholders' Meeting”. Total number of shares composing the share capital: 191 077 498 Total number of shares with voting rights: 191 027 885 About Inventiva 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. 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). http://www.inventivapharma.com Contacts Important Notice This press release contains certain “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates with respect to Inventiva’s cash resources, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial of lanifibranor in MASH , including duration, timing and costs, and the results and timing thereof and regulatory matters with respect thereto, clinical trial data releases and publications, the potential therapeutic benefits of lanifibranor, and future activities, expectations, plans, growth and prospects of Inventiva, and the absence of material adverse events. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “opportunity”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such 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 future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, 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 be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of its lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's and its partners’ clinical trials may not support Inventiva's and its partners’ product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or additional amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including whether the plan will be implemented and the timing, potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's and its partners’ control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, international trade relations, political turmoil, and natural catastrophes, 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. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2024 filed with the Autorité des Marchés Financiers on April 15, 2025 and the Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption “Risk Factors”, and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events 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 has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. Attachment Inventiva - PR - Results General Meeting November 2025 - EN - 11 28 2025

Investor releaseQuarter not tagged2025-11-22

Inventiva reports 2025 Third Quarter Financial Information¹

GlobeNewswire
Cash and cash equivalents at €97.6 million, and €24.7 million in short-term deposits2 as of September 30, 2025. Revenues of €4.5 million for the first nine months of 2025. Cash runway expected until the end of the first quarter of 20273, including net proceeds from the November 2025 public offering. Daix (France), New York City, (New York, United States), November 21, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), today reported its cash position as of September 30, 2025 and its revenues for the first nine months of 2025. Cash and cash equivalents As of September 30, 2025, the Company’s cash and cash equivalents amounted to €97.6 million, compared to cash and cash equivalents at €96.6 million as of December 31, 2024. Net cash used in operating activities amounted to (€76.3) million in the first nine months of 2025, compared to (€63.7) million for the same period in 2024, up by 20%, while R&D expenses for the first nine months of 2025 were slightly lower by 11% at (€64.6) million, compared to the same period of 2024. The increase in net cash used in operating activities is due to working capital evolution and, to a lesser extent, the net cash impact of the implementation of the Company’s previously disclosed pipeline prioritization plan initiated in the first half of 2025. Net cash used in investing activities for the first nine months of 2025 amounted to (€25.0) million, compared to €8.9 million generated for the same period in 2024. The change is mostly due to the variation in short-term2 deposits during the period. Net cash generated from financing activities for the first nine months of 2025 amounted to €103.4 million, compared to €41.9 million in the same period in 2024. Net cash generated from financing activities during the first nine months of 2025 primarily comes from the receipt of gross proceeds of €115.6 million (net proceeds of €108.0 million) from the settlement in May 2025 of the second tranche4 of the structured financing announced by the Company in October 2024 (the “Structured Financing”). Net cash generated from financing activities during the first nine months of 2024 was mainly comprised of (i) the second tranche of €25 million drawn in Ja…Read full document

Cash and cash equivalents at €97.6 million, and €24.7 million in short-term deposits2 as of September 30, 2025. Revenues of €4.5 million for the first nine months of 2025. Cash runway expected until the end of the first quarter of 20273, including net proceeds from the November 2025 public offering. Daix (France), New York City, (New York, United States), November 21, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), today reported its cash position as of September 30, 2025 and its revenues for the first nine months of 2025. Cash and cash equivalents As of September 30, 2025, the Company’s cash and cash equivalents amounted to €97.6 million, compared to cash and cash equivalents at €96.6 million as of December 31, 2024. Net cash used in operating activities amounted to (€76.3) million in the first nine months of 2025, compared to (€63.7) million for the same period in 2024, up by 20%, while R&D expenses for the first nine months of 2025 were slightly lower by 11% at (€64.6) million, compared to the same period of 2024. The increase in net cash used in operating activities is due to working capital evolution and, to a lesser extent, the net cash impact of the implementation of the Company’s previously disclosed pipeline prioritization plan initiated in the first half of 2025. Net cash used in investing activities for the first nine months of 2025 amounted to (€25.0) million, compared to €8.9 million generated for the same period in 2024. The change is mostly due to the variation in short-term2 deposits during the period. Net cash generated from financing activities for the first nine months of 2025 amounted to €103.4 million, compared to €41.9 million in the same period in 2024. Net cash generated from financing activities during the first nine months of 2025 primarily comes from the receipt of gross proceeds of €115.6 million (net proceeds of €108.0 million) from the settlement in May 2025 of the second tranche4 of the structured financing announced by the Company in October 2024 (the “Structured Financing”). Net cash generated from financing activities during the first nine months of 2024 was mainly comprised of (i) the second tranche of €25 million drawn in January 2024 under the unsecured loan agreement granted by the European Investment Bank, and (ii) the issuance of royalty certificates in July 2024 for €20.1 million. Over the first nine months of 2025, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€1.0) million, compared to none for the same period in 2024, due to the evolution of the EUR/USD exchange rate. Financial information after closing the accounts In November 2025, the Company completed a public offering in the United States of 44,805,193 American Depositary Shares (“ADSs”) for aggregate gross proceeds of approximately €149 million (€139.3 million net proceeds)5, including the exercise in full of the underwriters’ option to purchase additional ADSs. Considering its current cost structure and forecasted expenditures, the Company estimates that its cash, cash equivalents and short-term deposits, including the net proceeds from the public offering, should enable it to finance its operations until the end of the first quarter of 2027. Assuming the potential exercise in full of the Tranche 3 warrants issued in the Structured Financing for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 20276. Revenues Revenues for the first nine months of 2025 amounted to €4.5 million, compared to none generated for the same period in 2024. Revenues recorded by the Company in the first nine months of 2025 consist mainly of the $10 million gross proceeds (net proceeds of €8.6 million) milestone payment invoiced to Chia Tai Tianqing Pharmaceutical Group (“CTTQ”) and the $5 million (€4.3 million) credit notes recognized under the license agreement with CTTQ following the closing of the second tranche of the Structured Financing in May 2025. The milestone payment from CTTQ was received in July 2025. *** Next key milestones expected Topline results of NATiV3 – expected in the second half of 2026 Upcoming shareholders meeting Combined General Meeting of Shareholders – November 27, 2025 Upcoming investor conference participation Euronext Tech Leaders Forum – November 26, 2025 – Paris Piper Sandler 37th Annual Healthcare Conference – December 2-4, 2025 – New York Upcoming scientific conference participation MASH-TAG – January 7-11, 2026 – Park City Next financial results publication Full-Year 2025 Revenues and cash and cash equivalents: Thursday, February 16, 2026 (after U.S. market close) About Inventiva 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. 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. 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). http://www.inventivapharma.com Contacts Important Notice This press release contains certain "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, unaudited financial information, forecasts and estimates with respect to Inventiva’s cash resources, the potential exercise by investors of warrants and pre-funded warrants, including the warrants and pre-funded warrants issued in connection with the Structured Financing, the potential benefit of the pipeline prioritization plan and related workforce reduction, and Inventiva’s future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "would", "could", "might", "should", "designed", "hopefully", "target", "potential", "opportunity", "possible", "aim", and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such 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 future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, that the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, 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 be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, on the expected timing or at all, and whether, when and to what extent dilutive instruments may be exercised, and by which holders, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's and its partners’ clinical trials may not support Inventiva's and its partners’ product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or additional amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's and its partners’ control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil, and natural catastrophes, 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. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2024 filed with the Autorité des Marchés Financiers on April 15, 2025, the interim financial report for the six months ended June 30, 2025 published on September 29, 2025 and the Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission (the "SEC") on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption "Risk Factors", and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events 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 has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. 1 Non-audited financial information. 2 Short-term deposits were included in the category “other current assets” in the IFRS unaudited interim condensed consolidated statement of financial position and were considered by the Company as liquid and easily available. 3 This estimate is based on the Company’s current business plan and excludes any potential milestones payable to or by the Company, any proceeds from the potential exercise of the Tranche 3 warrants issued in the Structured Financing 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. 4 Press release of May 5, 2025 5 Based on the exchange rate of €1.00 = $1.1576 as published by the European Central Bank on November 12, 2025 6 These estimates are based on the Company’s current business plan and exclude 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 these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated. There can be no assurance whether, and to which extent, the Tranche 3 warrants will be exercised, if at all. Attachment Inventiva - PR - Q3 2025 CA Cash - EN - 11 21 2025

As of 2026-08-01 • Updated weeklySource: Earnings sourceIngestion runbook