{"success":true,"data":{"pressRelease":{"id":"134385","rtpr_id":"nGNX3tRL24","ticker":"IVAA","exchange":"Euronext Paris","all_tickers":["IVAA"],"title":"Inventiva Announces Last Patient Visit in NATiV3 Phase 3 Clinical Trial of Lanifibranor in MASH","author":"Globe Newswire","published_at":"2026-09-02T20:05:15.756Z","article_body":"* Last patient completed final 72-week visit in NATiV3, with 1,009 patients\nenrolled in the main cohort and 410 patients in the exploratory cohort\n* Topline results of NATiV3 expected in Q4 2026\n* September investor conference participation and timing of H1 2026 financial\nresults update\nDaix (France), New York (New York, United States), September 2(nd), 2026 –\nInventiva\n(https://www.globenewswire.com/Tracker?data=dzuZxuJI-HjdeHTCHjysFf5fdncupF8wylHPk03DVWS5Psszfjzx0PXUkGIJ8xetG9SLowNH2tFtSrKhXOfEo2sqTBPnA2TTme3CCddevFE=)\n(Euronext Paris and Nasdaq: IVA\n(https://www.globenewswire.com/Tracker?data=ihnzM5fvliQbtM8XYvJtvrvCW6H9YF6HPf-2r4V1rze4Jb6yMokvEXn7ftNoLeNqjIMBXl6sXck6jaz-W2EIc6Gk_eYwezaxZOCis_1REBdyTZewc9qeYqlhQXdNyVp8))\n(“Inventiva” or the “Company”), a clinical-stage biopharmaceutical\ncompany focused on the development of an oral small molecule therapy for the\ntreatment of metabolic dysfunction-associated steatohepatitis (“MASH”),\ntoday announced the last patient has completed their final 72-week visit in\nthe NATiV3 Phase 3 clinical trial evaluating lanifibranor for the treatment of\npatients with MASH with moderate and advanced fibrosis.\n\nNATiV3 enrolled 1,009 adults with biopsy-proven non-cirrhotic MASH and F2/F3\nfibrosis, with an additional 410 patients enrolled in an exploratory cohort.\nWith the last patient having completed their final visit, all patients have\ncompleted the 72-week treatment period.\n\nInventiva expects to report topline results from NATiV3 in the fourth quarter\nof 2026, as previously communicated. If the results are favorable, the Company\nanticipates regulatory submission in the first half of 2027 and is preparing\nfor a potential U.S. launch of lanifibranor in 2028, subject to FDA approval.\n\nAndrew Obenshain, Chief Executive Officer, Inventiva: “Our ambition is to\ndevelop a treatment that can make a meaningful difference for patients, and\nreaching last patient, last visit in NATiV3 is an important milestone for\nInventiva and for the development of lanifibranor in noncirrhotic MASH. We are\ndeeply grateful to the patients who participated in the study and to the\ninvestigators and clinical teams who led its execution alongside our dedicated\nInventiva team. We now look forward to topline results later this year.”\n\nProf. Arun Sanyal, M.D., Director of the Stravitz-Sanyal Institute for Liver\nDisease and Metabolic Health, Virginia Commonwealth University and\nco-principal investigator of NATiV3, stated: \"Having been involved in the\nclinical program of lanifibranor over the years, it is particularly meaningful\nto see the last patient complete their final visit in this important Phase 3\ntrial. Given the significant unmet need in MASH, where many patients continue\nto face limited treatment options and the burden of a progressive disease, and\nthe positive results observed in the NATIVE Phase 2b trial, I am looking\nforward to the topline read-out of the NATiV3 trial and the potential for\nlanifibranor to become a leading treatment for MASH.”\n\nProf. Sven Francque, M.D., Ph.D., Professor of Gastroenterology and Hepatology\nat the University of Antwerp and co-principal investigator of NATiV3, stated:\n“The completion of NATiV3 marks an important milestone for the MASH field\nand for the development of next-generation PPAR therapies. Lanifibranor’s\npan-PPAR mechanism has the potential to address the complexity of MASH\ndisease, by working on the interconnected pathways through both intrahepatic\nand extrahepatic effects. The NATIVE Phase 2b results provided compelling\nclinical evidence of the potential of this broad mechanism, with improvements\nin both MASH and fibrosis. I very much look forward to the NATiV3 topline\nresults.”\n\nNATiV3 is a randomized, double-blind, placebo-controlled clinical trial\ndesigned to evaluate the long-term efficacy and safety of lanifibranor\n(800mg/daily and 1200mg/daily) in 1009 adult patients with biopsy-proven\nnon-cirrhotic MASH and F2/F3 stage of liver fibrosis. The effect of\nlanifibranor will be assessed on several histological endpoints, including\nMASH resolution and improvement of fibrosis of at least one stage after 72\nweeks of treatment. An exploratory cohort has enrolled 410 patients with MASH\nand F1 through F4 stage of liver fibrosis. Following completion of the 72-week\ntreatment period, patients participating in NATiV3 had the option to continue\ninto a 48-week open-label extension period, during which all patients,\nincluding those originally randomized to placebo, receive active treatment\nwith lanifibranor. This extension will provide additional information on the\nlonger-term safety of lanifibranor.\n\nSeptember Investor Conference Participation\n\nInventiva leadership will be participating in the following healthcare\nconferences in September, presentation details are as follows:  \n\n Conference :  Morgan Stanley 24 (th)Annual Global Healthcare Conference Fireside Chat with Andrew Obenshain, CEO, and Jason Campagna, President of R&D and CMO  \n Date:         September 15, 2026                                                                                                                                \n Time:         4:50 – 5:25 pm ET                                                                                                                                 \n\n\n\n Conference :  Stifel 2026 Virtual Cardiometabolic Forum Fireside Chat with Andrew Obenshain, CEO, Jason Campagna, President of R&D and CMO and Axel-Sven Malkomes, CFO  \n Date:         Wednesday, September 30, 2026                                                                                                                             \n\n\n\n Conference :  Jefferies Healthcare C-Suite \"Back to School\" Series 2026 Fireside Chat with Andrew Obenshain, CEO, Jason Campagna, President of R&D and CMO and Axel-Sven Malkomes, CFO  \n Date:         Wednesday, September 30, 2026                                                                                                                                             \n Time:         10:00 – 11:00 am ET                                                                                                                                                       \n\nNext Financial Results Publication\n\nThe Company also provided updated timing for financial results for the first\nhalf of 2026: Monday September 28, 2026 revised from the previously disclosed\ndate of Friday, September 25, 2026.\n\nInventiva’s management will hold a conference call in English, followed by a\nQ&A session, on Monday, September 28, 2026, at 8:00 am (New York), 2:00 pm\n(Paris). Participants wishing to join the conference call by phone and ask\nquestions must register in advance here\n(https://www.globenewswire.com/Tracker?data=MeLIJhBGG2UctNzsIf9Z2eX2RgxGfPpCn3DuZW8s0IKWu4f_2pL3HvX3xqCFXCBVsk4WsTbcNaiaH7mlp7pYsveH4leGqz-UQgs6QUbl-2wzNh-XMOg5R6wqTpNl5VKj4ovpObdjHcW_5mzfEksEAUplR8JapkU9I5xkL_EyIoM=).\nUpon registration, participants will receive dial-in details by email. The\nlive webcast may be accessed on the Events\n(https://www.globenewswire.com/Tracker?data=Dvn8eh8Q4vu4Pog2RmUE_bTPALf3vCTf0DLgoiy-x_WyWFMRoteLqOWjZedjZ1iUevvV4prZBfnsl1NYNagEQT8K35Fb20wqGuSFcz2NnaBFmAzDR-tksDANLwJ0fQxw)\nsection of the Inventiva website. A replay of the conference call will be\navailable after the event on the Company’s website.\n\nAbout Lanifibranor\n\nLanifibranor, Inventiva’s lead product candidate, is an orally available\nsmall molecule that acts to induce antifibrotic, anti-inflammatory and\nbeneficial vascular and metabolic changes in the body by activating all three\nperoxisome proliferator-activated receptor (“PPAR”) isoforms, which are\nwell-characterized nuclear receptor proteins that regulate gene expression.\nLanifibranor is a PPAR agonist that is designed to target all three PPAR\nisoforms in a moderately potent manner, with a well-balanced activation of\nPPARα and PPARδ, and a partial activation of PPARγ. While there are other\nPPAR agonists that target only one or two PPAR isoforms for activation,\nlanifibranor is the only pan-PPAR agonist in clinical development for the\ntreatment of MASH. Inventiva believes that lanifibranor’s moderate and\nbalanced pan-PPAR binding profile contributes to the favorable tolerability\nprofile that has been observed in clinical trials and preclinical studies to\ndate. The FDA has granted Breakthrough Therapy and Fast Track designation to\nlanifibranor for the treatment of MASH. Lanifibranor is an investigational\nmedicine and has not been approved for use by any regulatory authority. Its\nsafety and efficacy have not been established.\n\nAbout Inventiva\n\nInventiva is a clinical-stage biopharmaceutical company focused on the\nresearch and development of an orally administered small molecule for the\ntreatment of patients with MASH. The Company is currently evaluating\nlanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical\ntrial for the treatment of adult patients with MASH, a common and progressive\nchronic liver disease.\n\nInventiva is a public company listed on compartment B of the regulated market\nof Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global\nMarket in the United States (ticker: IVA). https://www.inventivapharma.com\n\nContacts\n\n Media Relations  Lisa Buffington: media@inventivapharma.com  Investor Relations  David Nikodem: IR@inventivapharma.com  \n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” within the\nmeaning of the safe harbor provisions of the Private Securities Litigation\nReform Act of 1995. All statements, other than statements of historical fact,\nincluded in this press release are forward-looking statements. These\nstatements include, but are not limited to, forecasts and estimates with\nrespect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in\npatients with MASH, including the quality of trial results, design, duration,\ntiming, costs, and funding, timing of clinical trial data releases and\npublications, the information, insights and impacts that may be gathered from\nclinical trials, the potential therapeutic benefits of lanifibranor, potential\nregulatory submissions, approvals and commercialization, Inventiva’s\npipeline and development plans, and Inventiva's future activities,\nexpectations, plans, growth and prospects. Some of these statements,\nforecasts, and estimates may be identified by the use of words such as,\nwithout limitation, “believe,” “anticipate,” “expect,”\n“intend,” “plan,” “seek,” “estimate,” “may,” “will,”\n“could,” “should,” “designed,” “hope,” “target,”\n“potential,” “opportunity,” “possible,” “aim,” and\n“continue” and other similar expressions. These statements are not\nhistorical facts, but rather statements of future expectations and other\nforward-looking statements based on management's beliefs. These statements\nreflect the opinions and assumptions prevailing as of the date of the\nstatements and involve known and unknown risks and uncertainties that could\ncause future results, performance, or events to differ materially from those\nexpressed or implied in such statements. Actual events are difficult to\npredict and may depend on factors beyond Inventiva's control. There can be no\nguarantee, with respect to product candidates, that clinical trial results\nwill be available on schedule, that future clinical trials will be initiated\nas planned, that product candidates will receive the necessary regulatory\napprovals, or that the milestones planned by Inventiva or its partners will be\nachieved on schedule, or even at all. Future results may differ materially\nfrom the anticipated future results, performance, or achievements expressed or\nimplied by these statements, forecasts, and estimates due to a number of\nfactors, including the fact that interim data or data from any interim\nanalysis of ongoing clinical trials do not predict the future results of\nclinical trials, the fact that the DMC's recommendation does not prejudge any\neventual marketing authorization, that Inventiva cannot provide assurance on\nthe impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on\nrecruitment or the final impact on the results or timing of the NATiV3 trial\nor related regulatory issues, Inventiva is a clinical-stage company with no\napproved products and no historical revenue, Inventiva has incurred\nsignificant losses since its inception, Inventiva has never generated revenue\nfrom product sales, Inventiva will need additional capital to fund its\noperations, without which Inventiva may be required to significantly reduce\nits activities, delay or discontinue one or more of its research or\ndevelopment programs, expand its activities or capitalize on its business\nopportunities, and may not be able to continue as a going concern. Inventiva's\nability to obtain financing and complete potential transactions on a timely\nbasis, as well as whether, when, and to what extent dilutive instruments may\nbe exercised and by which holders, Inventiva's future success depends on the\nsuccessful clinical development, regulatory approvals, and subsequent\ncommercialization of lanifibranor, preclinical studies or previous clinical\ntrials are not necessarily predictive of future results, and the results of\nInventiva's and its partners' clinical trials may not support Inventiva's and\nits partners' claims regarding product candidates, Inventiva's expectations\nregarding its clinical trials may prove to be incorrect, and regulatory\nauthorities may require additional stops and/or modifications to Inventiva's\nclinical trials. Inventiva's expectations regarding the clinical development\nplan for lanifibranor for the treatment of MASH may not be realized and may\nnot support the approval of a New Drug Application, Inventiva's ability to\nimplement its commercialization, marketing, and manufacturing capabilities and\nstrategy, Inventiva's ability to successfully cooperate with its existing\npartners or enter into new partnerships, and to fulfil its obligations under\nany agreements entered into in connection with such partnerships, the benefits\nof its current and future partnerships on the clinical development, regulatory\napprovals, and, if applicable, commercialization of its product candidates, as\nwell as the achievement of milestones and timelines anticipated in connection\nwith such partnerships, Inventiva and its partners may encounter substantial\ndelays beyond expectations in their clinical trials or fail to demonstrate\nsafety and efficacy to the satisfaction of the applicable regulatory\nauthorities, the ability of Inventiva and its partners to recruit and retain\npatients in clinical studies, the recruitment and retention of patients in\nclinical trials is a costly and time-consuming process that could be made more\ndifficult or impossible by multiple factors beyond the control of Inventiva\nand its partners, Inventiva's product candidates may cause adverse reactions\nor have other properties that could delay or prevent their regulatory\napproval, or limit their commercial potential, Inventiva faces significant\ncompetition, and Inventiva's activities, preclinical studies, and clinical\ndevelopment programs, as well as timelines, Inventiva's financial condition\nand results of operations could be materially and adversely affected by\nchanges in laws and regulations, adverse conditions in its industry,\ngeopolitical events, such as the conflict between Russia and Ukraine and the\nresulting sanctions, the conflict in the Middle East and the related risk of a\nwider conflict and ongoing conflicts, epidemics, and macroeconomic conditions,\nincluding changes in international trade policies, global inflation,\nfluctuations in financial and credit markets, customs duties and other trade\nbarriers, political unrest and natural disasters, uncertain financial markets,\nand disruptions in banking systems. In light of these risks and uncertainties,\nno representation is made as to the accuracy or completeness of these\nforward-looking statements, forecasts, and estimates. Furthermore,\nforward-looking statements, forecasts, and estimates are only valid as of the\ndate of this press release. Readers are cautioned not to place undue reliance\non these forward-looking statements.\n\nPlease refer to the Universal Registration Document for the year ended\nDecember 31, 2025 filed with the Autorité des Marchés Financiers on April 8,\n2026, and the Annual Report on Form 20-F for the year ended December 31, 2025\nfiled with the SEC on April 8, 2026 for other risks and uncertainties\naffecting Inventiva, including those described under the caption \"Risk\nFactors\", and in future filings with the SEC. Other risks and uncertainties of\nwhich Inventiva is not currently aware may also affect its forward-looking\nstatements and may cause actual results and the timing of events to differ\nmaterially from those anticipated. All information in this press release is as\nof the date of the release. Except as required by law, Inventiva has no\nintention and is under no obligation to update or review the forward-looking\nstatements referred to above. Consequently, Inventiva accepts no liability for\nany consequences arising from the use of any of the above statements.\n\nAttachment\n*     Inventiva - PR - Inventiva LVLP - EN 09 02 2026\n(https://ml-eu.globenewswire.com/Resource/Download/9e3f8b7a-ca18-4e26-ae5f-31d7978c30ac)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/4e957060-eef5-4c1b-81e6-73683a4daa1e)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX3tRL24","title":"Inventiva Announces Last Patient Visit in NATiV3 Phase 3 Clinical Trial of Lanifibranor in MASH","author":"Globe Newswire","ticker":"IVAA","created":"2026-09-02T20:05:15.756Z","tickers":["IVAA"],"exchange":"Euronext Paris","article_body":"* Last patient completed final 72-week visit in NATiV3, with 1,009 patients\nenrolled in the main cohort and 410 patients in the exploratory cohort\n* Topline results of NATiV3 expected in Q4 2026\n* September investor conference participation and timing of H1 2026 financial\nresults update\nDaix (France), New York (New York, United States), September 2(nd), 2026 –\nInventiva\n(https://www.globenewswire.com/Tracker?data=dzuZxuJI-HjdeHTCHjysFf5fdncupF8wylHPk03DVWS5Psszfjzx0PXUkGIJ8xetG9SLowNH2tFtSrKhXOfEo2sqTBPnA2TTme3CCddevFE=)\n(Euronext Paris and Nasdaq: IVA\n(https://www.globenewswire.com/Tracker?data=ihnzM5fvliQbtM8XYvJtvrvCW6H9YF6HPf-2r4V1rze4Jb6yMokvEXn7ftNoLeNqjIMBXl6sXck6jaz-W2EIc6Gk_eYwezaxZOCis_1REBdyTZewc9qeYqlhQXdNyVp8))\n(“Inventiva” or the “Company”), a clinical-stage biopharmaceutical\ncompany focused on the development of an oral small molecule therapy for the\ntreatment of metabolic dysfunction-associated steatohepatitis (“MASH”),\ntoday announced the last patient has completed their final 72-week visit in\nthe NATiV3 Phase 3 clinical trial evaluating lanifibranor for the treatment of\npatients with MASH with moderate and advanced fibrosis.\n\nNATiV3 enrolled 1,009 adults with biopsy-proven non-cirrhotic MASH and F2/F3\nfibrosis, with an additional 410 patients enrolled in an exploratory cohort.\nWith the last patient having completed their final visit, all patients have\ncompleted the 72-week treatment period.\n\nInventiva expects to report topline results from NATiV3 in the fourth quarter\nof 2026, as previously communicated. If the results are favorable, the Company\nanticipates regulatory submission in the first half of 2027 and is preparing\nfor a potential U.S. launch of lanifibranor in 2028, subject to FDA approval.\n\nAndrew Obenshain, Chief Executive Officer, Inventiva: “Our ambition is to\ndevelop a treatment that can make a meaningful difference for patients, and\nreaching last patient, last visit in NATiV3 is an important milestone for\nInventiva and for the development of lanifibranor in noncirrhotic MASH. We are\ndeeply grateful to the patients who participated in the study and to the\ninvestigators and clinical teams who led its execution alongside our dedicated\nInventiva team. We now look forward to topline results later this year.”\n\nProf. Arun Sanyal, M.D., Director of the Stravitz-Sanyal Institute for Liver\nDisease and Metabolic Health, Virginia Commonwealth University and\nco-principal investigator of NATiV3, stated: \"Having been involved in the\nclinical program of lanifibranor over the years, it is particularly meaningful\nto see the last patient complete their final visit in this important Phase 3\ntrial. Given the significant unmet need in MASH, where many patients continue\nto face limited treatment options and the burden of a progressive disease, and\nthe positive results observed in the NATIVE Phase 2b trial, I am looking\nforward to the topline read-out of the NATiV3 trial and the potential for\nlanifibranor to become a leading treatment for MASH.”\n\nProf. Sven Francque, M.D., Ph.D., Professor of Gastroenterology and Hepatology\nat the University of Antwerp and co-principal investigator of NATiV3, stated:\n“The completion of NATiV3 marks an important milestone for the MASH field\nand for the development of next-generation PPAR therapies. Lanifibranor’s\npan-PPAR mechanism has the potential to address the complexity of MASH\ndisease, by working on the interconnected pathways through both intrahepatic\nand extrahepatic effects. The NATIVE Phase 2b results provided compelling\nclinical evidence of the potential of this broad mechanism, with improvements\nin both MASH and fibrosis. I very much look forward to the NATiV3 topline\nresults.”\n\nNATiV3 is a randomized, double-blind, placebo-controlled clinical trial\ndesigned to evaluate the long-term efficacy and safety of lanifibranor\n(800mg/daily and 1200mg/daily) in 1009 adult patients with biopsy-proven\nnon-cirrhotic MASH and F2/F3 stage of liver fibrosis. The effect of\nlanifibranor will be assessed on several histological endpoints, including\nMASH resolution and improvement of fibrosis of at least one stage after 72\nweeks of treatment. An exploratory cohort has enrolled 410 patients with MASH\nand F1 through F4 stage of liver fibrosis. Following completion of the 72-week\ntreatment period, patients participating in NATiV3 had the option to continue\ninto a 48-week open-label extension period, during which all patients,\nincluding those originally randomized to placebo, receive active treatment\nwith lanifibranor. This extension will provide additional information on the\nlonger-term safety of lanifibranor.\n\nSeptember Investor Conference Participation\n\nInventiva leadership will be participating in the following healthcare\nconferences in September, presentation details are as follows:  \n\n Conference :  Morgan Stanley 24 (th)Annual Global Healthcare Conference Fireside Chat with Andrew Obenshain, CEO, and Jason Campagna, President of R&D and CMO  \n Date:         September 15, 2026                                                                                                                                \n Time:         4:50 – 5:25 pm ET                                                                                                                                 \n\n\n\n Conference :  Stifel 2026 Virtual Cardiometabolic Forum Fireside Chat with Andrew Obenshain, CEO, Jason Campagna, President of R&D and CMO and Axel-Sven Malkomes, CFO  \n Date:         Wednesday, September 30, 2026                                                                                                                             \n\n\n\n Conference :  Jefferies Healthcare C-Suite \"Back to School\" Series 2026 Fireside Chat with Andrew Obenshain, CEO, Jason Campagna, President of R&D and CMO and Axel-Sven Malkomes, CFO  \n Date:         Wednesday, September 30, 2026                                                                                                                                             \n Time:         10:00 – 11:00 am ET                                                                                                                                                       \n\nNext Financial Results Publication\n\nThe Company also provided updated timing for financial results for the first\nhalf of 2026: Monday September 28, 2026 revised from the previously disclosed\ndate of Friday, September 25, 2026.\n\nInventiva’s management will hold a conference call in English, followed by a\nQ&A session, on Monday, September 28, 2026, at 8:00 am (New York), 2:00 pm\n(Paris). Participants wishing to join the conference call by phone and ask\nquestions must register in advance here\n(https://www.globenewswire.com/Tracker?data=MeLIJhBGG2UctNzsIf9Z2eX2RgxGfPpCn3DuZW8s0IKWu4f_2pL3HvX3xqCFXCBVsk4WsTbcNaiaH7mlp7pYsveH4leGqz-UQgs6QUbl-2wzNh-XMOg5R6wqTpNl5VKj4ovpObdjHcW_5mzfEksEAUplR8JapkU9I5xkL_EyIoM=).\nUpon registration, participants will receive dial-in details by email. The\nlive webcast may be accessed on the Events\n(https://www.globenewswire.com/Tracker?data=Dvn8eh8Q4vu4Pog2RmUE_bTPALf3vCTf0DLgoiy-x_WyWFMRoteLqOWjZedjZ1iUevvV4prZBfnsl1NYNagEQT8K35Fb20wqGuSFcz2NnaBFmAzDR-tksDANLwJ0fQxw)\nsection of the Inventiva website. A replay of the conference call will be\navailable after the event on the Company’s website.\n\nAbout Lanifibranor\n\nLanifibranor, Inventiva’s lead product candidate, is an orally available\nsmall molecule that acts to induce antifibrotic, anti-inflammatory and\nbeneficial vascular and metabolic changes in the body by activating all three\nperoxisome proliferator-activated receptor (“PPAR”) isoforms, which are\nwell-characterized nuclear receptor proteins that regulate gene expression.\nLanifibranor is a PPAR agonist that is designed to target all three PPAR\nisoforms in a moderately potent manner, with a well-balanced activation of\nPPARα and PPARδ, and a partial activation of PPARγ. While there are other\nPPAR agonists that target only one or two PPAR isoforms for activation,\nlanifibranor is the only pan-PPAR agonist in clinical development for the\ntreatment of MASH. Inventiva believes that lanifibranor’s moderate and\nbalanced pan-PPAR binding profile contributes to the favorable tolerability\nprofile that has been observed in clinical trials and preclinical studies to\ndate. The FDA has granted Breakthrough Therapy and Fast Track designation to\nlanifibranor for the treatment of MASH. Lanifibranor is an investigational\nmedicine and has not been approved for use by any regulatory authority. Its\nsafety and efficacy have not been established.\n\nAbout Inventiva\n\nInventiva is a clinical-stage biopharmaceutical company focused on the\nresearch and development of an orally administered small molecule for the\ntreatment of patients with MASH. The Company is currently evaluating\nlanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical\ntrial for the treatment of adult patients with MASH, a common and progressive\nchronic liver disease.\n\nInventiva is a public company listed on compartment B of the regulated market\nof Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global\nMarket in the United States (ticker: IVA). https://www.inventivapharma.com\n\nContacts\n\n Media Relations  Lisa Buffington: media@inventivapharma.com  Investor Relations  David Nikodem: IR@inventivapharma.com  \n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” within the\nmeaning of the safe harbor provisions of the Private Securities Litigation\nReform Act of 1995. All statements, other than statements of historical fact,\nincluded in this press release are forward-looking statements. These\nstatements include, but are not limited to, forecasts and estimates with\nrespect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in\npatients with MASH, including the quality of trial results, design, duration,\ntiming, costs, and funding, timing of clinical trial data releases and\npublications, the information, insights and impacts that may be gathered from\nclinical trials, the potential therapeutic benefits of lanifibranor, potential\nregulatory submissions, approvals and commercialization, Inventiva’s\npipeline and development plans, and Inventiva's future activities,\nexpectations, plans, growth and prospects. Some of these statements,\nforecasts, and estimates may be identified by the use of words such as,\nwithout limitation, “believe,” “anticipate,” “expect,”\n“intend,” “plan,” “seek,” “estimate,” “may,” “will,”\n“could,” “should,” “designed,” “hope,” “target,”\n“potential,” “opportunity,” “possible,” “aim,” and\n“continue” and other similar expressions. These statements are not\nhistorical facts, but rather statements of future expectations and other\nforward-looking statements based on management's beliefs. These statements\nreflect the opinions and assumptions prevailing as of the date of the\nstatements and involve known and unknown risks and uncertainties that could\ncause future results, performance, or events to differ materially from those\nexpressed or implied in such statements. Actual events are difficult to\npredict and may depend on factors beyond Inventiva's control. There can be no\nguarantee, with respect to product candidates, that clinical trial results\nwill be available on schedule, that future clinical trials will be initiated\nas planned, that product candidates will receive the necessary regulatory\napprovals, or that the milestones planned by Inventiva or its partners will be\nachieved on schedule, or even at all. Future results may differ materially\nfrom the anticipated future results, performance, or achievements expressed or\nimplied by these statements, forecasts, and estimates due to a number of\nfactors, including the fact that interim data or data from any interim\nanalysis of ongoing clinical trials do not predict the future results of\nclinical trials, the fact that the DMC's recommendation does not prejudge any\neventual marketing authorization, that Inventiva cannot provide assurance on\nthe impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on\nrecruitment or the final impact on the results or timing of the NATiV3 trial\nor related regulatory issues, Inventiva is a clinical-stage company with no\napproved products and no historical revenue, Inventiva has incurred\nsignificant losses since its inception, Inventiva has never generated revenue\nfrom product sales, Inventiva will need additional capital to fund its\noperations, without which Inventiva may be required to significantly reduce\nits activities, delay or discontinue one or more of its research or\ndevelopment programs, expand its activities or capitalize on its business\nopportunities, and may not be able to continue as a going concern. Inventiva's\nability to obtain financing and complete potential transactions on a timely\nbasis, as well as whether, when, and to what extent dilutive instruments may\nbe exercised and by which holders, Inventiva's future success depends on the\nsuccessful clinical development, regulatory approvals, and subsequent\ncommercialization of lanifibranor, preclinical studies or previous clinical\ntrials are not necessarily predictive of future results, and the results of\nInventiva's and its partners' clinical trials may not support Inventiva's and\nits partners' claims regarding product candidates, Inventiva's expectations\nregarding its clinical trials may prove to be incorrect, and regulatory\nauthorities may require additional stops and/or modifications to Inventiva's\nclinical trials. Inventiva's expectations regarding the clinical development\nplan for lanifibranor for the treatment of MASH may not be realized and may\nnot support the approval of a New Drug Application, Inventiva's ability to\nimplement its commercialization, marketing, and manufacturing capabilities and\nstrategy, Inventiva's ability to successfully cooperate with its existing\npartners or enter into new partnerships, and to fulfil its obligations under\nany agreements entered into in connection with such partnerships, the benefits\nof its current and future partnerships on the clinical development, regulatory\napprovals, and, if applicable, commercialization of its product candidates, as\nwell as the achievement of milestones and timelines anticipated in connection\nwith such partnerships, Inventiva and its partners may encounter substantial\ndelays beyond expectations in their clinical trials or fail to demonstrate\nsafety and efficacy to the satisfaction of the applicable regulatory\nauthorities, the ability of Inventiva and its partners to recruit and retain\npatients in clinical studies, the recruitment and retention of patients in\nclinical trials is a costly and time-consuming process that could be made more\ndifficult or impossible by multiple factors beyond the control of Inventiva\nand its partners, Inventiva's product candidates may cause adverse reactions\nor have other properties that could delay or prevent their regulatory\napproval, or limit their commercial potential, Inventiva faces significant\ncompetition, and Inventiva's activities, preclinical studies, and clinical\ndevelopment programs, as well as timelines, Inventiva's financial condition\nand results of operations could be materially and adversely affected by\nchanges in laws and regulations, adverse conditions in its industry,\ngeopolitical events, such as the conflict between Russia and Ukraine and the\nresulting sanctions, the conflict in the Middle East and the related risk of a\nwider conflict and ongoing conflicts, epidemics, and macroeconomic conditions,\nincluding changes in international trade policies, global inflation,\nfluctuations in financial and credit markets, customs duties and other trade\nbarriers, political unrest and natural disasters, uncertain financial markets,\nand disruptions in banking systems. In light of these risks and uncertainties,\nno representation is made as to the accuracy or completeness of these\nforward-looking statements, forecasts, and estimates. Furthermore,\nforward-looking statements, forecasts, and estimates are only valid as of the\ndate of this press release. Readers are cautioned not to place undue reliance\non these forward-looking statements.\n\nPlease refer to the Universal Registration Document for the year ended\nDecember 31, 2025 filed with the Autorité des Marchés Financiers on April 8,\n2026, and the Annual Report on Form 20-F for the year ended December 31, 2025\nfiled with the SEC on April 8, 2026 for other risks and uncertainties\naffecting Inventiva, including those described under the caption \"Risk\nFactors\", and in future filings with the SEC. Other risks and uncertainties of\nwhich Inventiva is not currently aware may also affect its forward-looking\nstatements and may cause actual results and the timing of events to differ\nmaterially from those anticipated. All information in this press release is as\nof the date of the release. Except as required by law, Inventiva has no\nintention and is under no obligation to update or review the forward-looking\nstatements referred to above. Consequently, Inventiva accepts no liability for\nany consequences arising from the use of any of the above statements.\n\nAttachment\n*     Inventiva - PR - Inventiva LVLP - EN 09 02 2026\n(https://ml-eu.globenewswire.com/Resource/Download/9e3f8b7a-ca18-4e26-ae5f-31d7978c30ac)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/4e957060-eef5-4c1b-81e6-73683a4daa1e)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-02T20:05:15.806948203Z","server_sent_at_ms":1788379515806},"received_at":"2026-09-02T20:05:16.040Z","source_url":"https://www.globenewswire.com/news-release/2026/09/02/3355510/0/en/inventiva-announces-last-patient-visit-in-nativ3-phase-3-clinical-trial-of-lanifibranor-in-mash.html"},"analysis":{"id":"123276","press_release_id":"134385","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["No efficacy data yet — Q4 2026 NATiV3 topline readout is a binary outcome risk","Forward-looking statements flag unresolved SUSAR with possible impact on NATiV3 results or timing","Clinical-stage company with no approved products or revenue; states it will need additional capital and may not continue as a going concern","Potential future dilution from outstanding dilutive instruments cited in risk language"],"eventType":"clinical_trial","narrative":"Inventiva's pivotal Phase 3 NATiV3 trial of lanifibranor in MASH has reached last patient, last visit, with all 1,009 main-cohort patients (biopsy-proven non-cirrhotic MASH, F2/F3 fibrosis) completing the 72-week treatment period.\n\nTopline results are expected in Q4 2026; if favorable, the company anticipates regulatory submission in the first half of 2027 and is preparing for a potential U.S. launch of lanifibranor in 2028, subject to FDA approval.\n\nAn exploratory cohort of 410 patients with F1-F4 fibrosis also completed treatment, with an optional 48-week open-label extension; lanifibranor is the only pan-PPAR agonist in clinical development for MASH and holds FDA Breakthrough Therapy and Fast Track designations.\n\nHousekeeping items: H1 2026 financial results are now due September 28, 2026 (revised from September 25), and management presents at Morgan Stanley, Stifel, and Jefferies healthcare conferences this month.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"LPLV achieved in NATiV3 locks the Q4 2026 topline readout — the binary catalyst that decides lanifibranor's MASH regulatory path."},"keyFigures":{"drugName":"lanifibranor","phaseOfTrial":"Phase 3","customDimensions":{"doses_tested":["800mg/daily","1200mg/daily"],"topline_timing":"Q4 2026","potential_us_launch":"2028","patients_main_cohort":1009,"treatment_duration_weeks":72,"open_label_extension_weeks":48,"patients_exploratory_cohort":410,"regulatory_submission_timing":"H1 2027"}},"quotedText":"We now look forward to topline results later this year.","namedEntities":{"people":[{"name":"Andrew Obenshain","role":"CEO, Inventiva"},{"name":"Jason Campagna","role":"President of R&D and CMO, Inventiva"},{"name":"Axel-Sven Malkomes","role":"CFO, Inventiva"},{"name":"Prof. Arun Sanyal, M.D.","role":"co-principal investigator of NATiV3; Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University"},{"name":"Prof. Sven Francque, M.D., Ph.D.","role":"co-principal investigator of NATiV3; Professor of Gastroenterology and Hepatology, University of Antwerp"}],"products":["lanifibranor","NATiV3","NATIVE Phase 2b"],"companies":[{"name":"Inventiva","ticker":"IVA","relationship":"filer (clinical-stage biopharma; listed Euronext Paris and Nasdaq as IVA)"},{"name":"Morgan Stanley","relationship":"conference host"},{"name":"Stifel","relationship":"conference host"},{"name":"Jefferies","relationship":"conference host"},{"name":"Virginia Commonwealth University","relationship":"investigator institution"},{"name":"University of Antwerp","relationship":"investigator institution"},{"name":"FDA","relationship":"regulator (Breakthrough Therapy and Fast Track designations granted)"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Last patient, last visit in the pivotal Phase 3 NATiV3 trial confirms the program stays on schedule for a Q4 2026 topline readout — the single binary catalyst that determines lanifibranor's regulatory path. No efficacy data was disclosed, so the impact is timeline de-risking rather than market-moving."},"tickerRelevance":{"others":[{"ticker":"IVA","relevance":"article-stated Nasdaq and Euronext Paris ticker for the same company (Inventiva)"}],"primary":"IVAA"},"globalImportance":28,"audienceRelevance":22,"eventTypeSecondary":["operations_update"],"importanceComponents":{"tickerTier":"small-cap clinical-stage biotech","eventGravity":"Phase 3 LPLV milestone (pre-readout)","sectorWeight":"biotech — catalyst-driven","binaryCatalyst":"Q4 2026 topline data","issuerAuthored":true,"dataReadoutPending":true}},"event_type":"clinical_trial","event_type_secondary":["operations_update"],"sentiment":"bullish","material_impact_score":3,"narrative":"Inventiva's pivotal Phase 3 NATiV3 trial of lanifibranor in MASH has reached last patient, last visit, with all 1,009 main-cohort patients (biopsy-proven non-cirrhotic MASH, F2/F3 fibrosis) completing the 72-week treatment period.\n\nTopline results are expected in Q4 2026; if favorable, the company anticipates regulatory submission in the first half of 2027 and is preparing for a potential U.S. launch of lanifibranor in 2028, subject to FDA approval.\n\nAn exploratory cohort of 410 patients with F1-F4 fibrosis also completed treatment, with an optional 48-week open-label extension; lanifibranor is the only pan-PPAR agonist in clinical development for MASH and holds FDA Breakthrough Therapy and Fast Track designations.\n\nHousekeeping items: H1 2026 financial results are now due September 28, 2026 (revised from September 25), and management presents at Morgan Stanley, Stifel, and Jefferies healthcare conferences this month.","key_figures":{"drugName":"lanifibranor","phaseOfTrial":"Phase 3","customDimensions":{"doses_tested":["800mg/daily","1200mg/daily"],"topline_timing":"Q4 2026","potential_us_launch":"2028","patients_main_cohort":1009,"treatment_duration_weeks":72,"open_label_extension_weeks":48,"patients_exploratory_cohort":410,"regulatory_submission_timing":"H1 2027"}},"named_entities":{"people":[{"name":"Andrew Obenshain","role":"CEO, Inventiva"},{"name":"Jason Campagna","role":"President of R&D and CMO, Inventiva"},{"name":"Axel-Sven Malkomes","role":"CFO, Inventiva"},{"name":"Prof. Arun Sanyal, M.D.","role":"co-principal investigator of NATiV3; Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University"},{"name":"Prof. Sven Francque, M.D., Ph.D.","role":"co-principal investigator of NATiV3; Professor of Gastroenterology and Hepatology, University of Antwerp"}],"products":["lanifibranor","NATiV3","NATIVE Phase 2b"],"companies":[{"name":"Inventiva","ticker":"IVA","relationship":"filer (clinical-stage biopharma; listed Euronext Paris and Nasdaq as IVA)"},{"name":"Morgan Stanley","relationship":"conference host"},{"name":"Stifel","relationship":"conference host"},{"name":"Jefferies","relationship":"conference host"},{"name":"Virginia Commonwealth University","relationship":"investigator institution"},{"name":"University of Antwerp","relationship":"investigator institution"},{"name":"FDA","relationship":"regulator (Breakthrough Therapy and Fast Track designations granted)"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-02T20:31:01.795Z","global_importance":28,"audience_relevance":22,"importance_components":{"tickerTier":"small-cap clinical-stage biotech","eventGravity":"Phase 3 LPLV milestone (pre-readout)","sectorWeight":"biotech — catalyst-driven","binaryCatalyst":"Q4 2026 topline data","issuerAuthored":true,"dataReadoutPending":true}},"durationMs":134133,"modelName":"glm-4.7"}}