IVA Inventiva S.A.

15.44
-0.31  -2%
Previous Close 15.75
Open 15.5
52 Week Low 9.01
52 Week High 19.0636
Market Cap $592,566,356
Shares 38,378,650
Float 38,378,650
Enterprise Value $544,109,154
Volume 5,362
Av. Daily Volume 46,903
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Upcoming Catalysts

Drug Stage Catalyst Date
ABBV-157
Psoriasis
Phase 1
Phase 1
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Lanifibranor
Nonalcoholic fatty liver disease (NAFLD)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Lanifibranor
Nonalcoholic steatohepatitis (NASH)
Phase 3
Phase 3
Phase 3 trial to be initiated 1H 2021.
Odiparcil
MPS VI
Phase 1/2
Phase 1/2
Development suspended (deprioritized) as of November 10, 2020.

Latest News

  1.  ►     The Company will collaborate with Professor Jérôme Boursier, M.D., Ph.D, a renowned scientist in the field of non-invasive diagnosis of liver lesions in chronic liver diseases

     ►     The collaboration aims at developing one or several biomarkers or a composite biomarker score to identify patients responding to lanifibranor with regards to NASH resolution and fibrosis improvement

     ►     The biomarker data from the NATIVE Phase IIb clinical trial with lanifibranor in NASH will be used as a first validation dataset and the lanifibranor biomarker signature would then be validated during upcoming NATIV3 Phase III clinical trial

                 

    Daix (France), February 25, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company…

     ►     The Company will collaborate with Professor Jérôme Boursier, M.D., Ph.D, a renowned scientist in the field of non-invasive diagnosis of liver lesions in chronic liver diseases

     ►     The collaboration aims at developing one or several biomarkers or a composite biomarker score to identify patients responding to lanifibranor with regards to NASH resolution and fibrosis improvement

     ►     The biomarker data from the NATIVE Phase IIb clinical trial with lanifibranor in NASH will be used as a first validation dataset and the lanifibranor biomarker signature would then be validated during upcoming NATIV3 Phase III clinical trial

                 

    Daix (France), February 25, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced a collaboration in the field of NASH biomarkers with Professor Jérôme Boursier, M.D., Ph.D, Professor of Medicine at the Faculty of Medicine of Angers University and renowned scientist in the area of non-invasive diagnosis of liver lesions in chronic liver diseases.

    The objective of the collaboration is to develop one or several biomarkers or a composite biomarker score to identify patients responding to lanifibranor with regards to NASH resolution and fibrosis improvement. More specifically, Professor Jérôme Boursier, M.D., Ph.D, and his team from the HIFIH1 Laboratory (UPRES EA3859, Angers University) will use a multivariate statistical approach to finding a biomarker signature of lanifibranor in NASH treatment.

    As part of this collaboration, the database from Inventiva's NATIVE Phase IIb clinical trial evaluating lanifibranor for the treatment of NASH and containing a list of around 80 biomarkers will be used as a first validation dataset. The selected biomarker(s) or biomarker composite score would then be validated during the upcoming NATIV3 (NASH lanifibranor Phase III trial) Phase III clinical trial with lanifibranor in NASH, the initiation of which is planned for the first half of 2021. As a reminder, several analyses of biomarkers and other non-invasive tests based on the results from the NATIVE Phase IIb trial had shown promising treatment effects of lanifibranor versus placebo and were presented during a webcast event from The Liver Meeting Digital Experience™ 2020 on November 16, 2020.2

    Pierre Broqua, CSO and cofounder of Inventiva, commented: "With an increasing number of patients developing NASH-related end-stage liver disease and pharmacological treatments on the horizon, there is a pressing need to develop NASH biomarkers for prognostication, patient selection and treatment monitoring. We are therefore very excited to start this collaboration with Professor Jérôme Boursier and his team, who have been extensively involved in the development of non-invasive tests to diagnose NASH patients over the past years. Developing a non-invasive biomarker signature to identify responders to lanifibranor is totally in line with our strategy to make our lead drug candidate a reference treatment for NASH patients."

    Jérôme Boursier, M.D., Ph.D., Professor of Medicine at the Faculty of Medicine of Angers University, stated: "The need to develop reliable NASH biomarkers is both clear and urgent as the utility of liver biopsy, the only diagnostic approach currently available, is limited due to its invasive nature, poor patient acceptability and sampling variability. So we are very much looking forward to working with Inventiva on lanifibranor, a drug candidate that has shown very promising results in the field of NASH. Given the efficacy shown by lanifibranor during the NATIVE Phase IIb trial and the promising biomarker dataset available, we are confident that we will be able to meet our objective to develop one or several robust biomarkers or composite biomarker score."



    Biography – Jérôme Boursier

    Jérôme Boursier, M.D., Ph.D., is Professor of Medicine at the Faculty of Medicine of Angers University, France. His main field of research covers the non-invasive diagnosis of liver lesions in chronic liver diseases, especially Non-Alcoholic Fatty Liver Disease (NAFLD). In parallel, Professor Boursier heads the HIFIH Laboratory (UPRES EA3859, SFR 4208) at Angers University and the Department of Hepato-Gastroenterology and Digestive Oncology at Angers University Hospital. Graduated from the Faculty of Medicine of Angers University, his Ph.D work focused on methodology to improve the accuracy of the non-invasive diagnosis of liver fibrosis in chronic hepatitis C. In the context of a research fellowship at the Anna Mae Diehl Lab of Duke University, Durham, United States, Professor Boursier investigated in the area of the gut microbiota and NAFLD. He currently leads many studies about the diagnosis, screening and prognosis assessment in NAFLD.



    About Inventiva

    Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

    Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of earlier stage programs.

    Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. In July 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH.

    Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients at the end of 2019 and received FDA Fast Track designation in MPS VI for odiparcil in October 2020.

    In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

    The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

    Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (NASDAQ:IVA) and on the Nasdaq Global Market in the United States (NASDAQ:IVA). www.inventivapharma.com.



    Contacts

    Inventiva

    Frédéric Cren

    Chairman & CEO



    +33 3 80 44 75 00
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations



    +33 1 53 96 83 83
    Westwicke, an ICR Company

    Patricia L. Bank



    Investor relations



    +1 415 513-1284



    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual 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 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, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

    Please refer to the Universal Registration Document filed with the Autorité des Marchés Financiers on June 19, 2020 under n° D.20-0551 and its amendment filed on July 10, 2020 under n° D. 20-0551-A01 as well as the half-year financial report on June 30, 2020 for additional information in relation to such factors, risks and uncertainties.

    Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.






    1 HIFIH: "Hémodynamique, Interaction Fibrose, Invasivité Tumorales Hépatiques" – Hemodynamics, Fibrosis Interaction and Hepatic Tumor Invasiveness.

    2 A replay of the presentation is accessible via the following link: https://edge.media-server.com/mmc/p/uy4bgbir.



    Attachment



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  2. - Industry veteran Garry Neil, MD, named Board Chair

    - Nawal Ouzren, CEO of Sensorion named to Board

    Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) today announced changes to the Company's Board of Directors. Garry Neil, MD, has been appointed Chair of the Board. Additionally, Nawal Ouzren has been appointed as a new Board member.

    "These changes in our Board leadership will help position Arena for the growth we anticipate and mark an important inflection point in our progress," said Amit D. Munshi, President and CEO of Arena. "Garry Neil has served on the Board for the past four years, providing exceptional leadership for our scientific direction. As a physician with extensive industry experience, his insight into successfully translating scientific…

    - Industry veteran Garry Neil, MD, named Board Chair

    - Nawal Ouzren, CEO of Sensorion named to Board

    Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) today announced changes to the Company's Board of Directors. Garry Neil, MD, has been appointed Chair of the Board. Additionally, Nawal Ouzren has been appointed as a new Board member.

    "These changes in our Board leadership will help position Arena for the growth we anticipate and mark an important inflection point in our progress," said Amit D. Munshi, President and CEO of Arena. "Garry Neil has served on the Board for the past four years, providing exceptional leadership for our scientific direction. As a physician with extensive industry experience, his insight into successfully translating scientific discoveries into marketable drugs will shape our approach going forward."

    Dr. Neil has served on our Board of Directors since February 2017. He serves as the Chief Scientific Officer of Cerecor, Inc., a publicly held biotechnology company focused on translating genetic discoveries into novel therapies to improve the lives of children and adults with life altering diseases, a position he has held since Cerecor's February 2020 merger with Aevi Genomic Medicine, Inc., a biotechnology company with the same focus, where Dr. Neil had served as Chief Scientific Officer since September 2013. Prior to joining Aevi Genomic Medicine, Dr. Neil was a Partner at Apple Tree Partners, a life science private equity firm, from September 2012 to September 2013, and held a number of senior positions in the pharmaceutical industry, including most recently as Corporate VP of Science & Technology at Johnson & Johnson from November 2007 to August 2012. Prior to these roles, Dr. Neil served as Group President at Johnson & Johnson Pharmaceutical Research and Development, VP of R&D at Merck KGaA/EMD Pharmaceuticals, and VP of Clinical Research at AstraZeneca and Astra Merck. Dr. Neil holds a BS from the University of Saskatchewan and an MD from the University of Saskatchewan College of Medicine. He completed postdoctoral clinical training in internal medicine and gastroenterology at the University of Toronto. Dr. Neil also completed a postdoctoral research fellowship at the Research Institute of Scripps Clinic. He served on the Board of GTx, Inc., a publicly traded biopharmaceutical company focused on cancer and other serious medical conditions, until its merger with Oncternal Therapeutics in March 2019. Dr. Neil is the Founding Chairman of TransCelerate Biopharma, Inc., a non-profit pharmaceuticals industry R&D consortium, and a past member of the TransCelerate Board. He also serves on the Board of the Reagan Udall Foundation and previously served on the Board of Foundation for the National Institutes of Health (NIH) and on the Science Management Review Board of the NIH. Dr. Neil is also the past Chairman of the Pharmaceutical Research and Manufacturers Association (PhRMA) Science and Regulatory Executive Committee and the PhRMA Foundation Board.

    "The appointment of Nawal Ouzren to the Board strengthens our Board leadership capabilities, and I am delighted to have the opportunity to work with her," commented Dr. Neil, newly appointed Chair of the Arena Board of Directors. "Nawal brings broad based management experience including in operations and manufacturing, with both large and small biopharmaceutical companies. We are fortunate to have someone with her experience join the Board as we move toward commercial launch."

    Ms. Ouzren brings 20 years of leadership and expertise across a range of areas, including clinical development, operations, manufacturing, quality, and commercialization. She currently serves as Chief Executive Officer and Member of the Board at Sensorion SAS (ALSEN.PA), a publicly traded biotechnology company based in Montpellier, FR. Prior to joining Sensorion, she served as Group Vice President, Rare Genetic Diseases at Shire International GmbH. In that role she led a cross-functional organization including clinical development, R&D, and global marketing. Before Shire, Ms. Ouzren held various positions at Baxalta from 2014 to June 2016 when Baxalta was acquired by Shire. During her career, Ms. Ouzren also held roles of increasing responsibility across multiple functions at Baxter BioScience and General Electric. In addition to her Board role at Sensorion, Ms. Ouzren serves on the Board of Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company. Ms. Ouzren holds a Master of Science Degree in Chemical Engineering from the Université de Technologie de Compiègne, France.

    "Since 2016, we have continued to evolve the Board of Directors to provide effective guidance and oversight as the company has continued to grow. These new Board appointments will help steer Arena Pharmaceuticals toward our next stage of growth. I look forward to working with Garry and Nawal," commented Mr. Munshi.

    About Arena Pharmaceuticals

    ARENA Pharmaceuticals is a team with a singular purpose – deliver our important medicines to patients.

    In a rapidly changing global market, we work with a sense of urgency every day to understand the needs of all our stakeholders, identify bold, sometimes disruptive, ideas to get our medicines to patients, and relentlessly execute until it's done.

    ARENA - Care More. Act Differently.

    Forward-Looking Statements

    Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include, without limitation, statements about Dr. Neil's and Ms. Ouzren's expected contributions, Arena's purpose, work, ideas, and execution. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include those disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

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    • Cash position2 at €113.0m as of December 31, 2020 compared to €124.6 million at September 30, 2020 and €35.8 million at December 31, 2019
    • Revenues of €0.4m in 2020 compared to €7.0m in 2019
    • Successful €94.9m3 initial public offering (IPO) on the Nasdaq Global Market in the United States, extending the Company's cash runway through Q4 2022

                    
    Daix (France), February 11, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today reported its cash position as of December 31, 2020 and its 2020 full-year revenues.

    • Cash position2 at €113.0m as of December 31, 2020 compared to €124.6 million at September 30, 2020 and €35.8 million at December 31, 2019

    • Revenues of €0.4m in 2020 compared to €7.0m in 2019
    • Successful €94.9m3 initial public offering (IPO) on the Nasdaq Global Market in the United States, extending the Company's cash runway through Q4 2022

                    

    Daix (France), February 11, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today reported its cash position as of December 31, 2020 and its 2020 full-year revenues.



    Cash Position

    As of December 31, 2020, Inventiva's cash position (excluding exchange rate effects) stood at €113.0 million compared to €124.6 million as of September 30, 2020, and €35.8 million as of December 31, 2019.

    Net cash used in operating activities amounted to (€30.6) million in 2020, compared to (€28.4) million in 2019. This increase is mainly due to higher general and administrative and non-recurrent expenses incurred during the second half of the year linked to the Company's IPO in the United States and listing on Nasdaq. These costs have been partly offset by the savings generated from the halt of the clinical development of lanifibranor in systemic sclerosis in 2019 and the Employment Safeguard Plan subsequently introduced mid-2019, as well as, to a lesser extent, the successful conclusion of the NATIVE Phase IIb clinical study in NASH in June 2020. Furthermore, the cash flow from operating activities was positively impacted by the receipt of €4.2 million in respect of the 2018 Research Tax Credit (CIR - Crédit Impôt Recherche) in January 2020, and the receipt of €4.2 million in total in respect of the 2019 Research Tax Credit in April and June 2020. In 2019, Inventiva recorded over the fourth quarter the payment of €3.6 million of the 2017 Research Tax Credit, the €3.5 million milestone payment from AbbVie following the enrollment of the first psoriasis patient in the clinical study underway with ABBV-157 and the payment of €2.6 million as part of the collaboration with Boehringer Ingelheim in November 2019.

    Net cash from investing activities (excluding the variation in short-term deposits) in 2020 remained stable compared to 2019 and amounted to (€0.9) million.              

    Net cash from financing activities in 2020 amounted to €111.7 million compared to €8.4 million in 2019, driven by: the issuance of €15.0 million (gross proceeds) of ordinary shares to certain existing investors in the Company in February 2020, the entry into a €10.0 million credit agreement, guaranteed by the French State, with a syndicate of French banks in May 2020, and the receipt of €94.9 million3 (gross proceeds) following the Company's successful U.S. IPO in July 2020, extending Inventiva's cash runway through the fourth quarter of 2022.

    Revenues

    The Company's revenues in 2020 amounted to €0.4 million compared to €7.0 million in 2019. This variation is linked to the fact that the Company had recorded the payment of €3.5 million received as part of the collaboration with AbbVie in December 2019 and the payment of €2.6 million received as part of the collaboration with Boehringer Ingelheim in November 2019. Additionally, €2.1 million were written back over the period, in accordance with IFRS 15 "Revenue from Contracts with Customer", generating a positive impact on IFRS revenue in 2019.

    ***

    Next key milestones expected

    • AbbVie's completion of its ongoing Phase I clinical trial with ABBV-157 in psoriasis patients – expected in the first quarter of 20214
    • Initiation of NATIVE3 (NASH lanifibranor Phase 3 trial) Phase III clinical trial evaluating lanifibranor in NASH – planned for the first half of 2021
    • Publication of Phase II clinical trial results evaluating lanifibranor in type 2 diabetes patients (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD) conducted by Pr. Cusi – expected in 2021

             

    Upcoming investor conference participation

    • Credit Suisse Virtual 2021 London Global Healthcare Conference, March 2-4, 2021
    • H.C. Wainwright Virtual Global Life Sciences Conference, March 9-10, 2021
    • 33rd Virtual Roth Conference, March 15-17, 2021
    • 7th Annual Truist Securities 2021 Life Sciences Summit, May 4-5, 2021
    • Jefferies Virtual Healthcare Conference, June 1-3, 2021

    Upcoming scientific conference participation

    • International Liver Congress™ 2021, June 23-26, 2021

    Next financial results publication

    • Full-year 2020 financial results: Thursday, March 4, 2021 (after U.S. market close)



    About Inventiva

    Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

    Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of earlier stage programs.

    Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. Inventiva recently announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH.

    Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients at the end of 2019 and received FDA Fast Track designation in MPS VI for odiparcil in October 2020.

    In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

    The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

    Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (NASDAQ:IVA) and on the Nasdaq Global Market in the United States (NASDAQ:IVA). www.inventivapharma.com



    Contacts

    Inventiva

    Frédéric Cren

    Chairman & CEO



    +33 3 80 44 75 00
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations



    +33 1 53 96 83 83
    Westwicke, an ICR Company

    Patricia L. Bank



    Investor relations



    +1 415 513-1284



    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual 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 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, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

    Please refer to the Universal Registration Document filed with the Autorité des Marchés Financiers on June 19, 2020 under n° D.20-0551 and its amendment filed on July 10, 2020 under n° D. 20-0551-A01 as well as the half-year financial report on June 30, 2020 for additional information in relation to such factors, risks and uncertainties.

    Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.






    1 Non-audited financial information.

    2 The cash position includes cash and cash equivalents as well as short-term deposits which are included in the category "other current assets" in the IFRS statement of financial position as of December 31, 2020. In fiscal year 2020, the increase in short-term deposits is included in the category "net cash flows from investing activities" in the IFRS cash flow statement.

    3 Based on an exchange rate of $1.1342 per euro, the exchange rate published by the European Central Bank on July 9, 2020.

    4 Source: clinicaltrials.gov.



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    • A single global Phase III clinical trial evaluating two doses of lanifibranor (800mg and 1200mg once daily) versus placebo is intended to support U.S. New Drug Application (NDA) / EU marketing authorization
    • Seeking of U.S. accelerated approval and EU conditional approval for lanifibranor to be based on 72-week histology analysis in approximately 900 patients
    • Use of primary composite endpoint combining NASH resolution and fibrosis improvement
    • Inventiva confirms planned initiation of pivotal Phase III clinical trial in H1 2021


    Daix (France), January 5, 2021
    – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses…

    • A single global Phase III clinical trial evaluating two doses of lanifibranor (800mg and 1200mg once daily) versus placebo is intended to support U.S. New Drug Application (NDA) / EU marketing authorization

    • Seeking of U.S. accelerated approval and EU conditional approval for lanifibranor to be based on 72-week histology analysis in approximately 900 patients
    • Use of primary composite endpoint combining NASH resolution and fibrosis improvement
    • Inventiva confirms planned initiation of pivotal Phase III clinical trial in H1 2021



    Daix (France), January 5, 2021
    – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced the details of the Phase III clinical trial with its lead drug candidate lanifibranor in NASH following the end-of-phase II meeting with the U.S. Food and Drug Administration (FDA) and the receipt of the Scientific Advice letter from the European Medicines Agency (EMA). The Phase III trial design and clinical strategy have been discussed with both regulatory authorities and the following key points can be confirmed:



    • Seeking of U.S. accelerated approval and EU conditional approval for lanifibranor to be based on a 72-week histology analysis – Inventiva will seek to obtain accelerated approval in the U.S. and conditional approval in the EU for lanifibranor based on a pre-specified histology analysis in approximately 900 patients after 72 weeks establishing a positive benefit-risk ratio.



    • Use of a primary composite endpoint combining NASH resolution and fibrosis improvement – The primary composite endpoint of patients having both NASH resolution and fibrosis improvement of at least one stage will be used for the 72-week histology analysis. The endpoint is designed to predict a significant improvement of prognostic risk and, if met, may support a label for the treatment of NASH and the improvement in liver fibrosis in adult non-cirrhotic NASH patients. During Inventiva's NATIVE Phase IIb clinical trial, this endpoint was met with statistical significance, including in NASH patients with F2/F3 fibrosis, the patient population that will be included in the Phase III trial, as well as in NASH patients with type two diabetes (TD2M). Endpoints of NASH resolution and no worsening of fibrosis, and improvement of fibrosis with no worsening of NASH will be included as key secondary endpoints. Additional supportive histologic endpoints, non-invasive markers of liver fibrosis and steatohepatitis as well as effects on lipids and insulin resistance will also be evaluated.



    Results from the NATIVE Phase IIb trial: ITT (intention-to- treat) population Placebo

    (N = 81)
    800mg

    (N = 83)
    1200mg

    (N = 83)
    Patients with both resolution of NASH and improvement of fibrosis (1)7%



     
    21%

    P=0.017*
    31%

    P<0.001*
    Results from the NATIVE Phase IIb trial: ITT population and patients with F2/F3 fibrosisPlacebo

    (N = 57)
    800mg

    (N = 68)
    1200mg

    (N = 63)
    Patients with both resolution of NASH and improvement of fibrosis (1)7%



     
    24%

    P = 0.012*
    33%

    P < 0.001*
    Results from the NATIVE Phase IIb trial: ITT population and patients with TD2MPlacebo

    (N = 35)
    800mg

    (N = 33)
    1200mg

    (N = 35)
    Patients with both resolution of NASH and improvement of fibrosis (1)3%



     
    24%

    P = 0.012**
    29%

    P = 0.003***

    * Two-sided p-values were calculated using Cochran Mantel Haenszel test, stratified on T2DM status

    ** Two-sided p-value from Fisher exact test

    *** Two-sided p-value from Chi-square test 



    • Adequacy of long-term use to be established after 72 weeks – The duration of 72 weeks was considered adequate by both the FDA and EMA to establish long-term use as well as dose and cumulative drug exposure. With this trial, the proposed size of the safety database required for marketing application would be consistent with regulatory guidelines.



    Named NATIVE3 (NASH lanifibranor Phase 3 trial), the planned trial has been designed as a double-blind, placebo-controlled global pivotal Phase III clinical trial to assess the potential benefit of lanifibranor treatment on liver-related clinical outcomes. Patients will be randomized 1:1:1 to receive lanifibranor (800mg once daily or 1200mg once daily) or placebo.

    The trial will remain blinded after the pre-specified histological analysis and continue in a total of approximately 2,000 patients until the occurrence of a pre-specified number of adverse liver-related clinical events, including progression to cirrhosis. The trial would be completed on a post-marketing basis in the event that accelerated (U.S.) / conditional (EU) approval is received. Statistical powering of 90% was considered for the sample size calculations of the Phase III clinical trial.

    The trial preparations are progressing according to schedule and Inventiva plans to initiate the trial in the first half of 2021.



    Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, commented
    : "We are very pleased to communicate today the design of our single pivotal Phase III trial evaluating lanifibranor in NASH with the perspective of seeking accelerated (U.S.) and conditional (EU) approvals in case of positive intermediary trial results. The primary endpoint, if met, would position lanifibranor as a drug that induces both NASH resolution and fibrosis improvement, which we believe would support its potential commercial success. Additional supportive efficacy analyses on lipids and insulin resistance are planned in order to further demonstrate the effect of lanifibranor in NASH patients. The preparation of this pivotal Phase III trial is well on track and we are looking forward to its initiation in the first half of 2021, as previously announced."  



    About lanifibranor

    Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (PPAR) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan‑PPAR agonist in clinical development. Inventiva believes that lanifibranor's moderate and balanced pan‑PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre‑clinical studies to date. In addition to Fast Track designation, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy to lanifibranor for the treatment of NASH based on Phase IIb data.



    About Inventiva

    Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

    Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of earlier stage programs.

    Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. Inventiva recently announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH.

    Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients at the end of 2019 and received FDA Fast Track designation in MPS VI for odiparcil, in October 2020.

    In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

    The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

    Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (NASDAQ:IVA) and on the Nasdaq Global Market in the United States (NASDAQ:IVA). www.inventivapharma.com



    Contacts

    Inventiva

    Frédéric Cren

    Chairman & CEO



    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations



    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations



    +1 415 513 1284 



    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual 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 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, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

    Please refer to the Universal Registration Document filed with the Autorité des Marchés Financiers on June 19, 2020 under n° D.20-0551 and its amendment filed on July 10, 2020 under n° D. 20-0551-A01 as well as the half-year financial report on June 30, 2020 for additional information in relation to such factors, risks and uncertainties.

    Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.






    1. Resolution of NASH and improvement of fibrosis at week 24: CRN-Inflammation = 0 or 1, CRN-Ballooning = 0 and an improvement of CRN-Fibrosis ≥ 1 stage compared to baseline. Patients with missing data were handled as non-responders.



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    • The underlying studies aimed at characterizing the effects of the pan-PPAR agonist lanifibranor in two pre-clinical models of cirrhosis and in liver cells from cirrhotic patients
    • Lanifibranor showed clear beneficial effects leading to a marked improvement of fibrosis, portal hypertension and liver vascular resistance, three key elements of cirrhosis pathophysiology
    • Results in hepatic cells from cirrhotic patients further encourage the clinical evaluation of lanifibranor for the treatment of cirrhosis


    Daix (France), December 7, 2020
    – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses…



    • The underlying studies aimed at characterizing the effects of the pan-PPAR agonist lanifibranor in two pre-clinical models of cirrhosis and in liver cells from cirrhotic patients
    • Lanifibranor showed clear beneficial effects leading to a marked improvement of fibrosis, portal hypertension and liver vascular resistance, three key elements of cirrhosis pathophysiology
    • Results in hepatic cells from cirrhotic patients further encourage the clinical evaluation of lanifibranor for the treatment of cirrhosis



    Daix (France), December 7, 2020
    – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced the publication of a scientific paper on the beneficial effects of lanifibranor on experimental advanced chronic liver disease (ACLD) by the peer-reviewed scientific journal Journal of Hepatology.

    The article, entitled "The pan-PPAR agonist lanifibranor improves portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease", discusses the effects of Inventiva's lead drug candidate lanifibranor, a pan-peroxisome proliferator-activated receptor (pan-PPAR) agonist, in two distinct pre-clinical models of cirrhosis and in human liver cells from cirrhotic patients. The objective of the underlying studies was to evaluate the therapeutic potential of lanifibranor for the treatment of advanced cirrhosis.

    Cirrhosis originates from a sustained hepatic injury that can vary in nature, with excessive alcohol consumption, unhealthy dietary habits and hepatitis B and C virus infections being the most common causes. As a consequence of long-term liver injury, tissue wound healing mechanisms may become deregulated, leading to hepatic fibrosis, which can ultimately progress to decompensated cirrhosis and, in some cases, hepatocellular carcinoma.1

    The results of the pre-clinical studies show that lanifibranor improved portal hypertension, fibrosis and liver vascular resistance, three frequent and severe clinical syndromes associated with cirrhosis. The drug candidate also reduced ascites, sinusoidal capillarization, liver sinusoidal endothelial cells (LSEC) and hepatic stellate cells (HSC) activated phenotypes as well as microvascular function and liver inflammation. Furthermore, the results show that all three PPAR isoforms were downregulated in both cirrhotic patients as well as in the

    pre-clinical models.

    Moreover, differential expression of PPAR isoforms was observed in different liver cell types, emphasizing the importance of targeting all three isoforms for the treatment of cirrhosis. Finally, the findings also indicate that lanifibranor improved the phenotypes of isolated hepatocytes and hepatic stellate cells from cirrhotic patients, suggesting that the positive effects observed in both pre-clinical models could be translated to these patients.



    Pierre Broqua, CSO and cofounder of Inventiva, commented
    : "We are very pleased to see our latest pre-clinical results on lanifibranor for the treatment of cirrhosis published in the renowned Journal of Hepatology. This scientific paper clearly illustrates that lanifibranor significantly improves key features of this severe disease, which still lacks a safe and effective treatment. The beneficial effects are based on our lead drug candidate lanifibranor's capacity to target all three PPAR isoforms concomitantly and further encourage its clinical evaluation for the treatment of cirrhosis."

    Dr Jordi Gracia-Sancho, Head of the Liver Vascular Biology Team of IDIBAPS – Hospital Clínic de Barcelona and co-author of the article, added: "These studies, which combine two pre-clinical models of cirrhosis and human liver cells cultured in advanced in vitro systems, show that the pan-PPAR agonist lanifibranor improves the functionality of the cells that compose the liver microcirculatory system, leading to an improvement in portal hypertension and fibrosis. Considering the lack of treatments for advanced chronic liver disease, and its most deleterious complication portal hypertension, the findings included in this manuscript shed light on the way to develop novel therapies for patients with chronic hepatopathies."



    Publication details

    Title of scientific paper:"The pan PPAR agonist lanifibranor improves portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease"
    Date of publication:December 2, 2020
    Authors:Zoe Boyer-Diaz2, Peio Aristu-Zabalza3, María Andrés-Rozas4, Claude Robert5, Martí Ortega-Ribera6, Anabel Fernández-Iglesias7, Pierre Broqua8, Jean-Louis Junien9, Guillaume Wettstein10, Jaime Bosch11, Jordi Gracia-Sancho12
    Link to the article:https://authors.elsevier.com/sd/article/S0168-8278(20)33832-0



     



    About lanifibranor

    Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (PPAR) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan‑PPAR agonist in clinical development. Inventiva believes that lanifibranor's moderate and balanced pan‑PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre‑clinical studies to date. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH.



    About Inventiva

    Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

    Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of earlier stage programs.

    Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. Inventiva recently announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH.

    Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients at the end of 2019 and received FDA Fast Track designation in MPS VI for odiparcil in October 2020.

    In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

    The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

    Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (NASDAQ:IVA) and on the Nasdaq Global Market in the United States (NASDAQ:IVA). www.inventivapharma.com



    Contacts

    Inventiva

    Frédéric Cren

    Chairman & CEO



    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations



    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations



    +1 415 513 1284 



    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual 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 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, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

    Please refer to the Universal Registration Document filed with the Autorité des Marchés Financiers on June 19, 2020 under n° D.20-0551 and its amendment filed on July 10, 2020 under n° D. 20-0551-A01 as well as the half-year financial report on June 30, 2020  for additional information in relation to such factors, risks and uncertainties.

    Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.






    1 Pellicoro A, Ramachandran P, Iredale JP, et al. Liver fibrosis and repair: Immune regulation of wound healing in a solid organ. Nat Rev Immunol 2014;14:181–194.

    2 Zoe Boyer-Diaz: MSc, Barcelona Liver Bioservices, Barcelona, Spain.

    3 Peio Aristu-Zabalza: MSc, Barcelona Liver Bioservices, Barcelona, Spain.

    4 María Andrés-Rozas: MSc, Barcelona Liver Bioservices, Barcelona, Spain.

    5 Claude Robert: MSc, Inventiva, Daix, France.

    6 Martí Ortega-Ribera: MSc, Liver Vascular Biology Research Group, IDIBAPS, Barcelona, Spain.

    7 Anabel Fernández-Iglesias: PhD, Liver Vascular Biology Research Group, IDIBAPS, Barcelona, Spain & PhD, CIBEREHD, Madrid, Spain.

    8 Pierre Broqua: PhD, Inventiva, Daix, France.

    9 Jean-Louis Junien: PhD, Inventiva, Daix, France.

    10 Guillaume Wettstein: PhD, Inventiva, Daix, France.

    11 Jaime Bosch: MD & PhD, Liver Vascular Biology Research Group, IDIBAPS, Barcelona, Spain, CIBEREHD, Madrid, Spain, Hepatology, Department of Biomedical Research, University of Bern, Bern, Switzerland.

    12 Jordi Gracia-Sancho: PhD, Barcelona Liver Bioservices, Barcelona, Spain, Liver Vascular Biology Research Group, IDIBAPS, Barcelona, Spain, CIBEREHD, Madrid, Spain, Hepatology, Department of Biomedical Research, University of Bern, Bern, Switzerland.



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