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Inventiva S.A. (IVA) Analyst/Investor Day Transcript
Seeking Alpha· 2025-10-08 23:16
PresentationMark Pruzanski Okay. Why don't we kick things off. Hi, everyone. I'm Mark Pruzanski, I'm the Chairman of the Board of Inventiva and welcome to our investor event. We're going to be telling you today about the next and hopefully best-in-category oral therapy to get to patients with MASH, lanifibranor. We're going to be making forward-looking statements. Here's the agenda. It's going to be pretty packed, and I'm going to get out of your way and introduce you to Andrew in a minute followed by 3 we ...
Inventiva (NasdaqGM:IVA) Investor Day Transcript
2025-10-08 17:02
Summary of Inventiva Investor Day - October 08, 2025 Company Overview - **Company**: Inventiva (NasdaqGM:IVA) - **Focus**: Development of lanifibranor, an oral therapy for MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [1][2] Key Points and Arguments Management Changes - Recently raised over $400 million through a PIPE, enhancing the company's position for the global Phase 3 NATIVE 3 trial [2] - New Chief Medical Officer Jason Campagna and new CEO Andrew Ovenshain have joined the management team, bringing extensive experience in the biopharma sector [3][4] Market Opportunity - MASH is a progressive liver disease, underdiagnosed with only 10% of the 18 million patients in the U.S. diagnosed [9] - There are approximately 367,000 under-treated patients in the U.S., a 70% increase from four years ago, indicating a growing market [10] - Despite existing treatments, 90% of physicians believe there is a need for more effective products targeting liver diseases [10] Lanifibranor's Unique Positioning - Lanifibranor is a pan-PPAR agonist designed specifically for MASH, showing an 18% improvement in fibrosis in just six months during Phase 2b trials [11] - The therapy is an oral once-a-day monotherapy with a manageable safety profile, addressing both liver fibrosis and cardiovascular markers [11] Clinical Development and Future Milestones - The company aims to deliver top-line results from the NATIVE 3 trial in the second half of 2026 and plans to launch the therapy in 2028 [13] - The NATIVE 3 trial is fully enrolled, focusing on non-cirrhotic F2/F3 patients, with a primary endpoint of MASH resolution and fibrosis improvement [42] Additional Important Insights Mechanism of Action - Lanifibranor targets multiple pathways involved in MASH progression, including inflammation and fibrosis, through its action on PPAR receptors [20][21] - The drug has shown improvements in metabolic parameters, including reductions in fasting glucose and triglycerides, and increases in HDL cholesterol [24][25] Real-World Application and Treatment Landscape - The treatment landscape for MASH includes lifestyle modifications, GLP-1 agonists, and potential combination therapies with lanifibranor [55][63] - The real-world application of therapies is complex, with many patients already on GLP-1s and requiring careful management of their treatment regimens [62][64] Challenges and Considerations - The under-treatment and over-treatment of patients based on clinical risk factors highlight the need for better diagnostic and treatment strategies [65] - The integration of new therapies like lanifibranor into existing treatment protocols will require careful consideration of patient profiles and potential synergies with other medications [27][63] This summary encapsulates the key points discussed during the Inventiva Investor Day, focusing on the company's strategic direction, market potential, and the clinical development of lanifibranor as a treatment for MASH.
Inventiva (NasdaqGM:IVA) Earnings Call Presentation
2025-10-08 16:00
The Comprehensive Impact of Lanifibranor: Addressing the Full MASH Spectrum Through Intra - and Extrahepatic Mechanisms of Action October 8, 2025 Property of Inventiva │ Forward Looking Statement This presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, included in this presentation are forward-looking statements. Certain of these statements, forecasts and estimates ...
Inventiva to Present Multiple Abstracts at AASLD The Liver Meeting® 2025
Globenewswire· 2025-10-07 20:00
Presentation of a comparison between digital and glass slide histology from screening biopsies in the Phase 3 NATiV3 studyPresentation of digital pathology data from preclinical studies with lanifibranor Daix (France), New York City (New York, United States), October 7, 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 ...
Inventiva Appoints Andrew Obenshain as Chief Executive Officer
Globenewswire· 2025-10-01 06:30
Core Points - Inventiva has appointed Andrew Obenshain as the new CEO, succeeding co-founder Frédéric Cren, who has led the company since its inception in 2012 [1][2][3] - The leadership transition is part of a strategic decision to support Inventiva's growth, particularly in preparing for potential commercialization in the U.S. market for metabolic dysfunction-associated steatohepatitis (MASH) [2][3] - The company is currently evaluating lanifibranor in a pivotal Phase 3 clinical trial, which is crucial for its future development and potential market entry [4] Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral therapies for MASH, a progressive chronic liver disease [4] - The company is publicly listed on Euronext Paris and Nasdaq, indicating its established presence in the financial markets [5] Leadership Insights - Andrew Obenshain brings over 20 years of experience in drug development and commercialization, having previously served as CEO of bluebird bio and held senior roles at Shire and Genzyme/Sanofi [3][4] - Frédéric Cren expressed pride in the company's transformation from a private biotech to a recognized leader in the MASH field, highlighting the achievements made under his leadership [3]
Inventiva reports its unaudited 2025 first-half financial results and provides a corporate update  
Globenewswire· 2025-09-29 06:30
Core Insights - Inventiva has made significant progress in its clinical program and financial position during the first half of 2025, particularly in its Phase 3 clinical trial for MASH [2][23] - The company reported revenues of €4.5 million for the first half of 2025, a substantial increase from €41,000 in the same period of 2024 [4][11] - A net loss of €175.9 million was recorded for the first half of 2025, compared to a net loss of €49.0 million in the first half of 2024 [11][12] Financial Performance - Revenues for the first half of 2025 were primarily driven by a €10 million milestone payment from Chia Tai Tianqing Pharmaceutical Group and €5 million in credit notes under a license agreement [5] - Other income decreased to €1.2 million in the first half of 2025 from €2.7 million in the same period of 2024, attributed to changes in R&D tax credit eligibility [6] - Research and development expenses were €44.9 million, down 4% from €46.8 million in the first half of 2024, reflecting a decrease in costs related to discontinued preclinical programs [7] Cash Position - As of June 30, 2025, cash and cash equivalents totaled €146.7 million, including €24.6 million in short-term deposits, with a cash runway projected until the end of Q3 2026 [8][16] - The company generated €104.8 million from financing activities in the first half of 2025, primarily from the second tranche of structured financing [14] Corporate Developments - A leadership transition occurred with the appointment of Jason Campagna as President of R&D and Chief Medical Officer [18] - The company received authorization for a workforce reduction plan, which began implementation in May 2025 [18] - The completion of enrollment for the pivotal Phase 3 clinical trial, NATiV3, was announced on April 1, 2025 [18] Future Outlook - Topline results from the NATiV3 trial are expected in the second half of 2026 [20] - The company plans to raise additional funds for long-term objectives, including potential public offerings or strategic partnerships [17]
Inventiva to Host Analyst and Investor Event on October 8, 2025
Globenewswire· 2025-09-24 20:00
Core Viewpoint - Inventiva is hosting an analyst and investor event to provide a strategic update ahead of the anticipated Phase 3 topline results for lanifibranor, its lead asset for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) [1] Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for MASH [3] - The company is evaluating lanifibranor, a novel pan-PPAR agonist, in the pivotal Phase 3 NATiV3 clinical trial for adult patients with MASH, a progressive chronic liver disease [3] Event Details - The event will take place on October 8, 2025, from 11:30 am to 2:00 pm ET in New York City, with a live webcast available [1] - The program will include presentations from Inventiva's leadership and insights from key opinion leaders in the MASH field, along with a patient representative [2][5] Key Topics of Discussion - An update on lanifibranor ahead of the anticipated Phase 3 NATiV3 topline results expected in the second half of 2026 [5] - A deep dive into lanifibranor's mechanism of action and clinical evidence, including findings from the Phase 2b trial [6] - Discussion on the design and objectives of the ongoing Phase 3 study, including patient baseline characteristics [6] - Insights from renowned experts in the field, including Dr. Nezam Afdhal, Dr. William Alazawi, Henry E. Chang, and Dr. Arun Sanyal [6]
Inventiva to Participate in Upcoming September Investor Conferences
Globenewswire· 2025-09-04 20:00
Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and other diseases with significant unmet medical needs [2][4] - The company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for treating adult patients with MASH, a common and progressive chronic liver disease [2] Upcoming Investor Events - The company will participate in several upcoming investor events, including: - H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 3:00 PM EDT in New York, NY [1] - 8th Edition of the Lyon Pôle Bourse Forum on September 23, 2025, in Lyon, France [1] - KBC Life Sciences Conference on September 25, 2025, at 5:00 AM EDT in Brussels, Belgium [2] - Stifel 2025 Virtual Cardiometabolic Forum on September 30, 2025, at 9:30 AM EDT, virtually [2] - European MIDCAP Event 2025 from September 30 to October 1, 2025, in Paris, France [2]
Inventiva to Participate in Fireside Chat at the Canaccord Genuity 45th Annual Growth Conference
Globenewswire· 2025-08-11 20:00
Core Insights - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) [1][3] - The company will participate in the Canaccord Genuity 45th Annual Growth Conference, highlighting updates on lanifibranor and the Phase III NATiV3 trial [2][3] Company Overview - Inventiva is listed on Euronext Paris and NASDAQ, focusing on oral small molecule therapies for MASH and other diseases with significant unmet medical needs [3][4] - The company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in a pivotal Phase 3 clinical trial for adult patients with MASH [3]
抢滩MASH药物下一站
3 6 Ke· 2025-08-05 23:26
Core Insights - The MASH market is experiencing significant growth, with Madrigal's drug Rezdiffra achieving sales of $317 million in its first year, including $137 million in Q1 of this year [1][3][5] - The competitive landscape is intensifying, with multiple companies developing drugs targeting various mechanisms, including THRβ, GLP-1, and FGF21 [1][2][11] - Madrigal has entered a collaboration with CSPC to acquire global rights to the oral GLP-1 agonist SYH2086, aiming to combine it with Rezdiffra for enhanced treatment [1][8] Group 1: Market Performance - Rezdiffra has shown strong sales performance, exceeding market expectations, with quarterly sales increasing significantly since its launch [3][5] - The drug has demonstrated clear clinical benefits in a Phase 3 study, with 25.9% and 29.9% of patients achieving MASH resolution without worsening fibrosis [6] - The patient penetration rate for Rezdiffra remains low at 5%, indicating substantial growth potential in the target population [6][7] Group 2: Competitive Landscape - The MASH treatment landscape is evolving from single-target competition to multi-target strategies, with a focus on combination therapies [2][11] - GSK's acquisition of FGF21 agonist Efimosfermin alfa for $2 billion highlights the increasing interest in this therapeutic area [1][11] - Companies like Akero are also making strides with their FGF21-based therapies, showing promising results in reversing liver fibrosis [11][12] Group 3: Strategic Collaborations - Madrigal's partnership with CSPC to develop a dual oral therapy combining Rezdiffra and SYH2086 reflects a strategic move to enhance treatment efficacy and patient compliance [1][8][9] - The collaboration aims to leverage the strengths of both drugs, addressing the complex mechanisms involved in MASH treatment [9][10] - The focus on combination therapies is seen as a necessary approach to navigate the competitive landscape and improve patient outcomes [10][12]