Financial Data and Key Metrics Changes - As of December 31, 2025, the company held approximately EUR 230.9 million in cash equivalents and short-term deposits, supported by significant financing events in 2025, including EUR 108 million from structured financing and EUR 139.4 million from a public offering [14][15] - R&D expenses for the full year were EUR 87 million, reflecting the prioritization of the pipeline, while marketing and business development expenses increased to EUR 5 million due to pre-commercial investments [15][16] - General and administrative expenses totaled EUR 47.9 million, including EUR 20.3 million in non-cash share-based compensation related to governance transitions [16] Business Line Data and Key Metrics Changes - The company has focused all resources on lanifibranor and MASH, selling global rights to odiparcil for up to $90 million in potential milestone payments and royalties [5][6] - The NATiV3 trial, a pivotal phase III clinical trial, completed enrollment in April 2025 with over 1,000 patients, exceeding original targets [12] Market Data and Key Metrics Changes - An estimated 18 million people in the U.S. live with MASH, with only about 10% diagnosed, a 25% increase from 2024 estimates [7] - Among those diagnosed with clinically actionable F2 or F3 disease, only around 40% are currently under the care of a physician, indicating a significant unmet need [7] Company Strategy and Development Direction - The company aims to advance lanifibranor towards approval for patients with MASH, with a top-line readout expected in Q4 2026 [4][17] - The leadership team has been strengthened to align with the opportunity, focusing on regulatory and commercial readiness for a potential launch [6][17] - The company plans to build awareness and improve screening for MASH, addressing the underdiagnosis and undertreatment of the condition [6] Management's Comments on Operating Environment and Future Outlook - Management believes that if the NATiV3 trial replicates the 18% fibrosis improvement seen in phase II, lanifibranor could be positioned as a leading oral therapy with significant commercial impact [7][21] - The company acknowledges the growing market interest in MASH treatments, particularly in the diabetic patient population, and sees a strong entry point for lanifibranor [21] Other Important Information - The company is preparing for potential commercialization of lanifibranor, with a focus on regulatory and commercial readiness [6][17] - The NATiV3 trial is designed to confirm findings from the phase IIb NATIVE trial, with a primary endpoint of fibrosis improvement and MASH resolution [10][11] Q&A Session Summary Question: Can you update us on the performance of the trial in terms of dropouts? - The dropout rate is below 30%, which was the threshold set for the trial, and the trial is well-powered to detect the primary endpoint [23][24] Question: How are you thinking about the performance of the 800 versus the 1200 milligram dose? - The 800 mg dose may catch up to the 1200 mg dose over time, and both doses are expected to have strong efficacy with different tolerability profiles [25][26] Question: What are you seeing in terms of overall market interest? - There is significant market growth due to increased awareness and unmet needs, particularly in the F3 diabetic patient population [21] Question: What quality control protocols are in place for analyzing biopsy samples? - The clinical development team has extensive experience, and quality control measures are in place to ensure proper biopsy collection and assessment [32] Question: What is the expected effect size for the primary endpoint in NATiV3? - The trial is powered to detect a smaller treatment effect than seen in phase II, with a focus on a composite endpoint that is less prone to placebo response [38][39] Question: How do you view the F3 diabetic population in terms of market opportunity? - Approximately 375,000 patients with F2 and F3 are currently in treatment, with a significant portion being diabetic, indicating a large market opportunity [41] Question: What are the expectations for the exploratory cohort of F4 patients? - The exploratory cohort will provide insights into safety and potential efficacy in a more advanced disease population, which will inform future trial designs [53] Question: How does background GLP-1 use impact lanifibranor's effect size? - Background GLP-1 use is expected to have minimal impact on treatment response, as patients enter the trial with active MASH regardless of other medications [87]

Financial Data and Key Metrics Changes - As of December 31, 2025, the company held approximately EUR 230.9 million in cash equivalents and short-term deposits, supported by significant financing events in 2025, including EUR 108 million from structured financing and EUR 139.4 million from a public offering [14][15] - R&D expenses for the full year were EUR 87 million, reflecting pipeline prioritization and completion of NATiV3 enrollment [15] - G&A expenses totaled EUR 47.9 million, including EUR 20.3 million in non-cash share-based compensation [16] Business Line Data and Key Metrics Changes - The company has focused all resources on lanifibranor and MASH, selling global rights to odiparcil for up to $90 million in potential payments and royalties [5] - The NATiV3 trial, a pivotal phase III clinical trial, completed enrollment in April 2025 with over 1,000 patients, exceeding original targets [12] Market Data and Key Metrics Changes - An estimated 18 million people in the U.S. live with MASH, with only about 10% diagnosed, a 25% increase from 2024 estimates [7] - Among diagnosed patients with clinically actionable F2 or F3 disease, only around 40% are currently under the care of a physician [7] Company Strategy and Development Direction - The company aims to advance lanifibranor towards approval for patients with MASH, with a top-line readout expected in Q4 2026 [4] - The leadership team has been strengthened to align with the demands of the opportunity, focusing on regulatory and commercial readiness [6] Management's Comments on Operating Environment and Future Outlook - Management believes that if the NATiV3 trial replicates the 18% fibrosis improvement seen in phase II, lanifibranor could be positioned as a leading oral therapy for MASH [7] - The company is optimistic about the growing awareness and diagnosis rates for MASH, indicating a significant unmet need in the market [6] Other Important Information - The company is well-funded, with a cash runway extending to mid-Q1 2027, and plans to commercialize lanifibranor independently [15][101] - The company is preparing for potential launch and has made pre-commercial investments in anticipation of lanifibranor's approval [15] Q&A Session Summary Question: Can you update on trial performance regarding dropouts? - The dropout rate is below 30%, which was the threshold set for the trial [23][24] Question: How do you view the performance of the 800 mg versus 1200 mg dose? - The 800 mg dose may catch up to the 1200 mg over time, and both doses are expected to have strong efficacy [25][26] Question: What is the market interest in MASH? - There is significant market growth, especially in the F3 diabetic patient population, where lanifibranor could have a strong entry point [21] Question: What quality control measures are in place for biopsy samples? - The clinical team has extensive experience, and quality control measures are in place to ensure proper biopsy handling and assessment [32] Question: What is the expected effect size for the primary endpoint? - The trial is powered to over 90% on a primary endpoint of composite fibrosis improvement and MASH resolution, with a conservative effect size expectation [38] Question: How many type 2 diabetes patients have undiagnosed MASH? - Approximately 18 million people in the U.S. have undiagnosed MASH, with a significant overlap with diabetes [71] Question: What are the plans for the exploratory cohort of F4 patients? - The exploratory cohort will provide insights into safety and potential efficacy in a more advanced disease population [53] Question: What is the status of the confirmatory trial for accelerated approval? - The trial must be structurally in place and moving at the time of filing for conditional approval [80]

Financial Data and Key Metrics Changes - As of December 31, 2025, the company held approximately EUR 230.9 million in cash equivalents and short-term deposits, bolstered by significant financing events in 2025, including EUR 108 million from structured financing and EUR 139.4 million from a public offering [13][14] - R&D expenses for the full year were EUR 87 million, reflecting the prioritization of the pipeline, while G&A expenses totaled EUR 47.9 million, including EUR 20.3 million in non-cash share-based compensation [14][15] Business Line Data and Key Metrics Changes - The company has focused all resources on lanifibranor and MASH, selling global rights to odiparcil for up to $90 million in potential milestone payments and royalties [4] - The NATiV3 trial, a pivotal phase III clinical trial, completed enrollment in April 2025 with over 1,000 patients, exceeding original targets [12] Market Data and Key Metrics Changes - An estimated 18 million people in the U.S. live with MASH, with only about 10% diagnosed, a 25% increase from 2024 estimates [6] - Among those diagnosed with clinically actionable F2 or F3 disease, only around 40% are currently under the care of a treating physician [6] Company Strategy and Development Direction - The company aims to advance lanifibranor towards approval for patients with MASH, with a top-line readout expected in Q4 2026 [3] - The strategic decision to concentrate resources on lanifibranor is expected to enhance the company's operational focus and market readiness [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that if the NATiV3 trial replicates the 18% fibrosis improvement seen in phase II, lanifibranor could be positioned as a leading oral therapy for MASH [7] - The company is preparing for commercialization in anticipation of potential approval, with a focus on addressing the unmet medical needs in the MASH patient population [5][16] Other Important Information - The company has strengthened its leadership team to align with the demands of the opportunity presented by lanifibranor [5] - The anticipated top-line readout in Q4 2026 is viewed as a significant inflection point for both the company and patients with MASH [16] Q&A Session Summary Question: Can you update us on the performance of the trial in terms of dropouts? - The dropout rate is below 30%, which was the threshold set for the trial, and the trial is well-powered to detect the primary endpoint [22][24] Question: How are you thinking about the performance of the 800 versus the 1200 milligram dose? - The 800 mg dose may catch up to the 1200 mg dose over time, and both doses are expected to have strong efficacy with potentially different tolerability profiles [25][26] Question: What are your expectations for the overall market interest? - The company believes that replicating an 18% effect on fibrosis would provide a strong market opportunity, especially in the F3 diabetic patient population [20] Question: What quality control protocols are in place for analyzing biopsy samples? - The clinical team has extensive experience in NASH trials, ensuring quality control at various stages of the biopsy process [31][33] Question: What is the expected effect size for the primary endpoint in NATiV3? - The trial is powered to over 90% on a primary endpoint of composite fibrosis improvement and MASH resolution, with a conservative view on effect size compared to phase II data [38][39] Question: How do you view the overlap of MASH and type 2 diabetes? - There are approximately 18 million patients with undiagnosed MASH in the U.S., with a significant portion also having diabetes, indicating a robust market opportunity [72][73] Question: What steps are being taken for regulatory and commercial readiness? - The regulatory team is fully staffed, and the company is focused on strategic commercial execution, preparing for a potential launch following positive trial data [105][106]

Core Insights - Inventiva reported its financial results for the full year ended December 31, 2025, highlighting its focus on developing oral therapies for MASH [1] Financial Performance - As of December 31, 2025, the Company's cash and cash equivalents were €99.3 million, with short-term deposits of €131.6 million, an increase from €96.6 million in cash and cash equivalents in 2024 [3] - Net cash used in operating activities was (€104.9) million in 2025, up 22% from (€85.9) million in 2024, primarily due to strategic pipeline prioritization and lower revenues from licensing agreements [4] - Revenues for 2025 were €4.5 million, a decrease from €9.2 million in 2024, mainly from milestone payments and credit notes under a licensing agreement [11] - R&D expenses decreased by 4% to €87.0 million in 2025 from €90.9 million in 2024, reflecting a focus on lanifibranor development [13] - General and administrative expenses rose significantly to (€47.9) million in 2025 from (€15.8) million in 2024, largely due to share-based compensation [15] - The net financial loss for 2025 was (€212.8) million, compared to (€86.0) million in 2024, driven by non-cash accounting treatments [17] - The Company's net loss for 2025 was (€354.1) million, compared to (€184.2) million in 2024 [18] Business Developments - The Company completed the sale of odiparcil, receiving an upfront payment of $600,000 and potential milestone payments of up to $90 million [24] - The topline results of the NATiV3 Phase 3 clinical trial for lanifibranor are expected in the fourth quarter of 2026 [9][26] - The Company has a cash runway expected to last until the middle of the first quarter of 2027, with potential additional proceeds from the exercise of warrants [8] Management Commentary - The CEO emphasized the Company's readiness to act swiftly upon receiving trial data and expressed confidence in the potential of lanifibranor to transform patient outcomes and create shareholder value [2]

Core Viewpoint - Inventiva, a clinical-stage biopharmaceutical company, is set to release its 2025 full-year financial results on March 30, 2026, after market close in the United States [1]. Group 1: Financial Results Announcement - The company will announce its 2025 full-year financial results on March 30, 2026 [1]. - A conference call will be held on March 31, 2026, at 8:00 am (New York) and 2:00 pm (Paris) to discuss the results [2]. - Participants must register in advance to join the conference call and ask questions [2]. Group 2: Company Overview - Inventiva focuses on developing oral small molecule therapies for metabolic dysfunction-associated steatohepatitis (MASH) and other diseases with significant unmet medical needs [4]. - The company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in a pivotal Phase 3 clinical trial for treating adult patients with MASH [4]. - Inventiva is publicly listed on Euronext Paris and the Nasdaq Global Market under the ticker IVA [5].

Core Insights - The company is focused on developing lanifibranor, a pan-PPAR agonist, currently in Phase III study for MASH [1] - Lanifibranor is designed to mitigate the liabilities associated with previous PPARs, such as Actos and Avandia, by creating a more moderate gamma binder [1] - The design approach emphasizes the interconnectedness of PPAR networks, aiming for a balanced effect across all PPARs [1]

Summary of Inventiva Conference Call Company Overview - **Company**: Inventiva (NasdaqGM:IVA) - **Location**: Dijon, France - **Focus**: Biotech company specializing in PPAR agonists, particularly lanifibranor for MASH (Metabolic Associated Steatotic Hepatitis) [6][7] Key Points Product Development - **Lead Program**: Lanifibranor, a pan PPAR agonist, currently in Phase 3 studies for MASH [5][6] - **Enrollment**: Completed in April 2024, with data readout expected in the second half of 2026 [7] - **Market Potential**: MASH market has gained attention, with Madrigal achieving over $1 billion in sales, indicating strong pharmaceutical interest [7] Clinical Data - **Phase 2b Results**: Showed a 26% placebo-adjusted NASH resolution rate and an 18% fibrosis improvement at a six-month time point [17] - **Phase 3 Study (NATiV3)**: Enrolling approximately 1,000 patients, focusing on F2 and F3 fibrosis stages, with a higher percentage of diabetic patients compared to previous studies [20][21] Mechanism of Action - **Lanifibranor's Mechanism**: A novel scaffold that engages all PPAR isoforms with a favorable safety profile, aiming to minimize the adverse effects seen in previous PPAR therapies [14][15][56] Market Strategy - **Target Population**: Approximately 375,000 patients with F2 and F3 MASH under treatment care, with a focus on diabetic patients [37] - **Competitive Advantage**: Lanifibranor is expected to outperform competitors like Rezdiffra, which has a lower effect size [38] Safety and Tolerability - **Safety Profile**: Predicted to have a muted PPAR-gamma effect, leading to less weight gain and fluid retention compared to traditional PPAR agonists [55][57] - **Dropout Rates**: Maintained below 30%, indicating good patient retention and tolerability [61] Future Studies - **Exploratory Cohort**: Includes 410 patients with varying fibrosis stages (F1-F4) to gather safety data and inform future studies [73][75] - **F4 Patient Population**: Plans to conduct an outcome study focused on patients with portal hypertension, aiming for accelerated approval [80][81] Commercialization Plans - **Market Entry**: Plans to self-commercialize lanifibranor, leveraging the successful strategies of mid-size biotech companies like Madrigal [99] - **Intellectual Property**: Exclusivity for lanifibranor extends to 2041 based on polymorph patents, with composition of matter expiring in December 2026 [101] Additional Insights - **Regulatory Alignment**: Continuous dialogue with the FDA regarding the design of outcome studies, ensuring compliance with regulatory expectations [86] - **Impact of Competitors**: Positive outcomes from competitors' studies could validate the efficacy of lanifibranor and enhance its market position [94] This summary encapsulates the critical aspects of Inventiva's conference call, highlighting the company's strategic direction, product development, and market positioning in the biotech industry.

Summary of Inventiva FY Conference Call (March 02, 2026) Company Overview - **Company**: Inventiva (NasdaqGM: IVA) - **Focus**: Ongoing phase three NATiV3 trial for NASH (Non-Alcoholic Steatohepatitis) treatment Key Points Industry and Product Insights - **NASH Market**: The NASH market is competitive, with existing players showing modest effect sizes. Inventiva aims to demonstrate a significant improvement in fibrosis and NASH resolution through its drug, lanifibranor [1][2] - **Phase Three NATiV3 Trial**: The trial is designed similarly to the previous NATIVE two trial, focusing on a combined primary endpoint of fibrosis and NASH resolution. The trial excludes F1 patients, potentially providing a competitive advantage [6][9] - **Expected Outcomes**: A target of approximately 20% effect on fibrosis is anticipated, which could significantly disrupt the current market by doubling existing effect sizes [9][10] Clinical Data and Safety - **Previous Trials**: The NATIVE two trial showed a 24% dual endpoint resolution and 18% fibrosis improvement at six months, setting a benchmark for NATiV3 [6][10] - **Safety Concerns**: Previous safety issues related to hepatic events have been addressed, with ongoing monitoring and assessments showing no significant concerns in the current trial [16][21] - **Weight Gain and Tolerability**: In phase IIb, 50% of patients showed no weight gain, while one-third experienced over 5% weight gain. The company emphasizes that treatment efficacy is not dependent on weight gain [26][37] Market Strategy and Commercialization - **Pre-commercialization Efforts**: A chief commercial strategy officer has been appointed to enhance market access and engage with key opinion leaders (KOLs) [73][80] - **Target Population**: The diabetic NASH population is identified as a significant opportunity, with about 70% of NASH patients also having diabetes. The company plans to focus on the full spectrum of F2 and F3 patients, including those with type 2 diabetes [210][217] Future Trials and Regulatory Considerations - **F4 MASH Confirmatory Trial**: Plans for a confirmatory trial in F4 MASH are in place, with the requirement to run an outcome study for full approval. The trial is expected to start around the time of the NDA filing in 2027 [94][104] - **Patient Selection**: The strategy involves enrolling patients with significant portal hypertension to ensure a higher event rate, which is crucial for powering the trial [135][144] Financial Position - **Cash Position**: As of the end of 2025, the company has EUR 231 million in cash, projected to last through Q3 2027, assuming positive trial data. A EUR 149 million raise was completed in November 2025 [195][196] Combination Therapies - **Potential for Combination**: Lanifibranor's unique mechanism allows for potential combination therapies, particularly with GLP-1s for diabetes management and cardiovascular risk reduction [197][205] Additional Insights - **Market Dynamics**: The company acknowledges the evolving landscape of combination therapies in the NASH space and is open to exploring these opportunities as data becomes available [197][205] - **Investor Communication**: The company aims to provide clear guidance on trial data and market strategies as they progress through the year [39][56] This summary encapsulates the key discussions and insights from the Inventiva FY Conference Call, highlighting the company's strategic direction, clinical trial progress, and market positioning in the NASH treatment landscape.

Core Viewpoint - Inventiva is actively engaging with investors through participation in multiple healthcare conferences in March 2026, showcasing its focus on developing a treatment for metabolic dysfunction-associated steatohepatitis (MASH) [1][2]. Group 1: Upcoming Investor Events - The company will participate in the TD Cowen 46th Annual Health Care Conference from March 2-4, 2026, with a fireside chat scheduled for March 2 at 10:30 am EST in Boston, Massachusetts [1]. - Inventiva will also be present at the Leerink Global Healthcare Conference from March 9-11, 2026, with a presentation on March 10 at 10:00 am EDT in Miami, Florida [1]. - Additionally, the company will take part in the Barclays 28th Annual Global Healthcare Conference from March 10-12, 2026, with a fireside chat on March 11 at 11:00 am EDT in Miami, Florida [1]. - The UBS Biotech Conference: Catalyst for Change will also feature Inventiva from March 8-10, 2026, in Miami, Florida [1]. Group 2: Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing an oral small molecule therapy for MASH, currently evaluating lanifibranor in a pivotal Phase 3 clinical trial [2]. - The company is publicly listed on Euronext Paris (ticker: IVA) and the Nasdaq Global Market in the United States (ticker: IVA) [3].

Core Viewpoint - Inventiva reported preliminary unaudited financial results for the full year ending December 31, 2025, highlighting significant changes in cash flow, revenues, and operational expenses as it continues to focus on developing therapies for metabolic dysfunction-associated steatohepatitis (MASH) [1]. Financial Position - As of December 31, 2025, the company's cash and cash equivalents were €99.3 million, with short-term deposits amounting to €131.6 million, an increase from €96.6 million in cash and cash equivalents in 2024 [2]. - The company estimates that its cash resources will support operations until the middle of the first quarter of 2027, potentially extending to the middle of the third quarter of 2027 with additional proceeds from the exercise of warrants [7]. Cash Flow Analysis - Net cash used in operating activities was (€104.6) million in 2025, a 22% increase from (€85.9) million in 2024, primarily due to a strategic pipeline prioritization plan and lower revenues from licensing agreements [3]. - Net cash used in investing activities was (€133.2) million in 2025, significantly higher than €8.7 million generated in 2024, mainly due to new short-term deposits [4]. - Net cash generated from financing activities was €241.1 million in 2025, up from €145.6 million in 2024, driven by proceeds from structured financing and a public offering in the United States [5]. Revenue Performance - The company's revenues for 2025 were €4.5 million, a decrease from €9.2 million in 2024, primarily consisting of milestone payments and credit notes from licensing agreements [8]. Future Financial Reporting - The company plans to publish its audited financial results for the full fiscal year 2025 on March 30, 2026, after the U.S. market close [9]. Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral therapies for MASH, currently evaluating lanifibranor in a pivotal Phase 3 clinical trial [10].