Announcement • Jul 03

Inventiva Announces the Publication in 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

Inventiva announced the publication in Journal of Hepatology Reports, a peer-reviewed, scientific journal, of results from the Phase 2b NATIVE clinical trial and preclinical study evaluating the effects of lanifibranor on liver sinusoidal endothelial cells in Metabolic dysfunction-associated steatotic liver disease ("MASLD") and MASH. 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, the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected U 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, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of 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 product candidate, lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's 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. Inventiva's ability to identify additional products or product candidate claims, Inventiv's expectations with respect to its patients with MASLD/MASH may not be realized and will not support the approval of a new Drug Application, Inventiva' ability to identify additional products or products or product candidates with significant Commercial potential, Inventiva's plans with respect to the New Drug Application, Inventiv's ability to identify additional products and its partners' product candidates with significant commercial potential. Inventiva's expectations with regards to the clinical development plan forlanifibranor for thetreatment of MASH may not be realize and may not support the approval the approval of a New Drug application, Inventiva's ability of a New Drug Application, inventiva's ability to identify further identify additional products or product candidates With significant commercial potential, Inventiv's expectations With respect to the commercialization of its product candidate claims, Inventive's expectations with respect to its commercialization of its product candidates, Inventiva's clinical trials may require additional holds and/or/or additional amendments to In ventiva's clinical trials, In ventiva's expectations with respect to the clinical development plan of lanifibranor for The treatment of MASH may be realized and may be realized and may not support The approval of a New Drug Application. Inventiva's capabilities with a New Drug Application, in a New Drug Application, In ventiva's ability to identify additional product candidate, Inventiva's capabilities with significant commercial potential, In Ventiva's ability to detect additional products or product candidates with a New Drug Application, In Ventiva's capabilities with significant commercialization of a New Drug Application.

Announcement • Dec 21

Inventiva Announces the Randomization of the First Patient in China in the NATiV3 Clinical Trial and Provides an Update on Its Clinical Development Program

Inventiva announced that the first patient has been randomized in China in the global NATiV3 Phase III clinical trial and provided an update on its clinical development program. Following the randomization of the first patient in China, Inventiva is eligible to receive a $3 million milestone payment from Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ). This would be the second of the two short-term milestone payments following the $2 million milestone payment from CTTQ received on July 19, 2023, under the license and collaboration agreement with CTTQ. Upon the anticipated receipt in January 2024 of this $3 million milestone, Inventiva is expected to have met all financial and operational conditions precedent required to draw the second €25 million tranche under the finance contract with the European Investment Bank (EIB) dated May 16, 2022 (the Finance Contract). The Company expects to draw this second tranche in early 2024, following the issuance of warrants to the EIB as provided in the Finance Contract. Lanifibranor was granted Breakthrough Therapy Designation for NASH by China’s National Medical Products Administration (NMPA). Similar to the U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy Designation, this designation is intended to accelerate the development and review of drugs for serious or life-threatening conditions. The NMPA granted “Breakthrough Therapy Designation” based on the results of Inventiva's Phase IIb NATIVE clinical trial. Inventiva believes that lanifibranor is the first drug candidate to receive “Breakthrough Therapy Designation” from both the FDA and the NMPA for the treatment of NASH. As of December 20, 2023, 468 clinical sites have been activated in 24 countries, including China, and a total of 793 patients have been randomized, of which 657 in the main cohort and 136 in the exploratory cohort. 607 patients are in the screening process and, based on the recent screen failure rate of approximately 80%, Inventiva expects 121 additional patients to be randomized in the main cohort in the next 10 weeks. Since July, with limited contribution from the sites in China, the newly opened sites and a third party clinical network in Mexico, between 250 to 300 patients are screened and approximately 50 patients are randomized in the main cohort each month, and the monthly enrolment rate is averaging 0.14 patient/site/month in the main cohort. Therefore, if the current screen failure rate for the main cohort and the number of patients entering the screening process are maintained, Inventiva now expects the first visit of the last patient to be in the first quarter of 2024 and to complete randomization in the second quarter of 2024. Topline results for the Phase III NATiV3 clinical trial are now expected to be published in the first half of 2026 versus the second half of 2025, as previously communicated. If the results of the trial confirm sufficient clinical benefit and a continued good safety profile, Inventiva plans to submit an application for accelerated approval in the United States and conditional approval in the European Union for the marketing of lanifibranor. In addition, CTTQ would also be in capacity to submit an application for a marketing authorization in Greater China. Approximately 70% of the patients randomized in the main and exploratory cohorts are from the United States, 20% from Europe and 10% from Latin America and the rest of the world. At baseline, 13% of patients randomized in the main cohort are receiving a stable dose GLP1 receptor agonists and 8% are receiving stable SGLT2 inhibitors. The baseline characteristics of the patients enrolled so far in the main cohort are in line with expectations and the patient population in the NATIVE Phase IIb clinical trial. The main difference in patient characteristics observed thus far is that there is a higher percentage of patients with type 2 diabetes (T2D) in the main cohort of the NATiV3 Phase III trial compared to the NATIVE Phase IIb trial (55% vs 42%, respectively). The effect size of lanifibranor therapy over placebo in the Phase IIb clinical trial on the composite endpoint “NASH resolution and fibrosis improvement” (which corresponds to the primary efficacy endpoint in the NATiV3 Phase III clinical trial), was higher in patients with T2D than in patients without diabetes: 21% and 26% for lanifibranor 800 and 1200 mg/day, respectively, in patients with T2D compared to 7% and 22%, respectively, in patients without T2D. Given the higher risk of hepatic and extrahepatic morbidity in patients with T2D and NASH3, the higher effect size observed in patients with NASH and T2D treated with lanifibranor in the Phase IIb trial is an important result for this specific patient population if confirmed in the larger clinical trial. As of December 20, 2023, 136 patients are randomised in the exploratory cohort including approximately 30% of patients with fibrosis stage F4. Inventiva believes that this subgroup of patients will provide valuable data on lanifibranor efficacy and safety. Lanifibranor continues to show a favorable tolerability profile as confirmed by the third Data Monitoring Committee (DMC) that took place late November 20232. This safety assessment was based on the review of safety data from more than 500 patients, including patients that have been treated with lanifibranor for more than 72 weeks. Enrolment in the proof of concept, LEGEND Phase II clinical trial evaluating lanifibranor in combination with the SGLT2 inhibitor empagliflozin in patients with NASH has been stopped, and data collection and cleaning is ongoing. The first topline results on primary and secondary endpoints are expected for the end of the first quarter of 2024. The primary efficacy endpoint of the trial is a change in Hemoglobin A1c (“HbA1c”) at the end of the 24-week treatment compared to baseline. Secondary endpoi nts include changes in liver enzymes, glycaemic and lipids parameters, and inflammatory markers. The trial has been designed to provide valuable information on body weight evolution in patients with NASH and T2D when treated with lanifibranor and empagliflozin, and on the reduction of hepatic steatosis using magnetic resonance imaging (MRI).

Interest coverage ratio	n/a
Cash	€99.84m
Equity	-€28.52m
Total liabilities	€278.03m
Total assets	€249.51m

Data	Last Updated (UTC time)
Company Analysis	2026/07/27 14:17
End of Day Share Price	2026/07/27 00:00
Earnings	2025/12/31
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Eliana Merle	Barclays
Edward Nash	Canaccord Genuity
Prakhar Agrawal	Cantor Fitzgerald & Co.

Inventiva Balance Sheet Health

Financial Health criteria checks 1/6

Key information

Recent financial health updates

Recent updates

Inventiva S.A. has completed a Follow-on Equity Offering in the amount of $119.999999 million.

Inventiva S.A. announced that it expects to receive €130 million in funding from BlackRock, Inc., Claret Capital Partners Limited

Inventiva S.A., Annual General Meeting, Jun 30, 2026

Inventiva's Speculative Upside Through MASH Is Promising

Inventiva Announces Chief Financial Officer Changes

Inventiva S.A. to Report Fiscal Year 2025 Results on Mar 30, 2026

Inventiva S.A. has completed a Follow-on Equity Offering in the amount of $149.999996 million.

Inventiva S.A. has filed a Follow-on Equity Offering in the amount of $125 million.

Inventiva S.A. has filed a Follow-on Equity Offering in the amount of $100 million.

Inventiva Announces CEO Changes

Inventiva Announces Executive Appointments

Inventiva Announces the Publication in 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

Inventiva Announces the Appointment of Renée Aguiar-Lucander to Its Board of Directors

Inventiva Announces the Publication in Clinical Gastroenterology and Hepatology of Its Analysis of New Biomarker Signatures Predictive of Histological Response in Patients with Mash Treated with Lanifibranor

Inventiva S.A., Annual General Meeting, May 22, 2025

Inventiva S.A. and Hepalys Pharma, Inc. Announce the Initiation of the Clinical Development Program of Lanifibranor in Japan

Inventiva S.A. to Report First Half, 2025 Results on Sep 25, 2025

Inventiva to Present Data from the Final Analysis of the Phase 2 Study Evaluating the Combination of Lanifibranor with Empagliflozin in Patients with Mash and T2d At the Aasld the Liver Meeting® Late-Breaker Session

Inventiva Announces the Positive Recommendation of the Fifth DMC of the Nativ3 Phase 3 Clinical Trial with Lanifibranor in Patients with Mash

Inventiva S.A. announced that it expects to receive €348 million in funding from a group of investors

Inventiva: Solid MASH Program With Potential For Strategic Partnership Advancement

Inventiva Announces the Publication in Nature Communications of Additional Results from Native Phase IIb Clinical Trial Demonstrating Improvement of Markers of Cardiometabolic Health in Patients with MASH/NASH Treated with Lanifibranor

Inventiva: Biotech To Consider Despite Short NASH Study Enrollment Pause

Inventiva S.A. Provides Update on its Clinical Trial NATiV3

Inventiva S.A. to Report First Half, 2024 Results on Sep 25, 2024

Inventiva Announces the Randomization of the First Patient in China in the NATiV3 Clinical Trial and Provides an Update on Its Clinical Development Program

Inventiva S.A. to Report Fiscal Year 2023 Results on Mar 27, 2024

Inventiva S.A. to Report Nine Months, 2023 Results on Sep 28, 2023

Inventiva Announces Positive Topline Results from the Investigator-Initiated Phase Ii Clinical Trial Evaluating Lanifibranor in Patients with T2d and NAFLD

Inventiva S.A. Announces Changes to the Clinical Development of Lanifibranor, Including Plans for New Phase III Trial in Patients with NASH and Compensated Cirrhosis

Inventiva, Sino Biopharm sign licensing pact to develop, commercialize NASH treatment

Financial Position Analysis

Debt to Equity History and Analysis

Balance Sheet

Cash Runway Analysis

Discover healthy companies

Company Analysis and Financial Data Status

Data Sources

Analysis Model and Snowflake

Industry and Sector Metrics

Analyst Sources