IVA Inventiva S.A.

12.8
-0.15  -1%
Previous Close 12.95
Open 12.99
52 Week Low 9.01
52 Week High 15.95
Market Cap $491,246,720
Shares 38,378,650
Float 38,378,650
Enterprise Value $465,329,085
Volume 37,746
Av. Daily Volume 30,674
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Upcoming Catalysts

Drug Stage Catalyst Date
ABBV-157
Psoriasis
Phase 1
Phase 1
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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


    • Cash and cash equivalents at €124.6m as of September 30, 2020, allowing the Company to finance its operating activities through Q4 2022
       
    • Revenues of €0.3m for the first nine months of 2020


    Daix (France), November 12, 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 reported its cash position as of September 30, 2020 and its revenues for the first nine months of 2020.


    Cash Position

    As of September 30, 2020, Inventiva's cash and cash equivalents stood at €124.6 million, compared to €52.2 million as…



    • Cash and cash equivalents at €124.6m as of September 30, 2020, allowing the Company to finance its operating activities through Q4 2022

       
    • Revenues of €0.3m for the first nine months of 2020



    Daix (France), November 12, 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 reported its cash position as of September 30, 2020 and its revenues for the first nine months of 2020.



    Cash Position

    As of September 30, 2020, Inventiva's cash and cash equivalents stood at €124.6 million, compared to €52.2 million as of June 30, 2020 and €35.8 million as of December 31, 2019.

    Inventiva's net cash flow amounted to €88.8 million (net of (€2.4) million exchange rate effect) for the nine months ended September 30, 2020, compared to (€21.3) million for the first nine months of 2019.

    Net cash used in operating activities was (€19.4) million for the first nine months of 2020, compared to (€28.3) million for the same period in 2019. This decrease is mainly due to the halt in the clinical development of lanifibranor for the treatment of systemic sclerosis in February 2019 and the savings generated by the Employment Safeguard Plan subsequently introduced mid-2019, with the first nine months of 2020 recording the full effect of the savings generated. The cash flow from operating activities was also positively impacted by the receipt in January 2020 of €4.2 million in respect of the 2018 Research Tax Credit (CIR - Crédit Impôt Recherche), and the receipt in April and June 2020 of €4.2 million in total in respect of the 2019 CIR.

    Net cash from financing activities amounted to €111.6 million for the first nine months of 2020, driven by: the issuance of €15.0 million (gross proceeds) of ordinary shares in February 2020 to certain existing investors in the Company, the entry into €10.0 million credit agreements, guaranteed by the French State, with a syndicate of French banks in May 2020, and the receipt of €94.9 million2 (gross proceeds) following the successful IPO on the Nasdaq Global Market in July 2020, extending Inventiva's cash runway through the fourth quarter of 2022.



    Revenues

    The Company's revenues for the first nine months of 2020 amounted to €0.3 million, compared to €3.4 million for the same period in 2019.

                                                                                                                ***



    Next key milestones expected

    • Regulatory feedback on Phase III development of lanifibranor in NASH from the European Medicines Agency (EMA) – planned for the fourth quarter of 2020
    • AbbVie's completion of its ongoing Phase I clinical trial with ABBV-157 in psoriasis patients – expected in the first quarter of 20213 vs fourth quarter of 2020 as initially planned
    • Initiation of Phase III clinical trial evaluating lanifibranor in NASH – planned for the first half of 2021



    Upcoming investor conference participation

    • Stifel Virtual Healthcare Conference 2020, November 17-18, 2020
    • Jefferies 11th Virtual Healthcare Conference, November 17-19, 2020
    • Piper Sandler 32nd Annual Virtual Healthcare Conference, November 30 - December 3, 2020



    Upcoming scientific conference presentations

    • Presentation of the NATIVE Phase IIb clinical trial results at The Liver Meeting Digital Experience™ 2020 of the AASLD (American Association for the Study of Liver Diseases), November 15, 2020
    • Key Opinion Leader webcast focused on NASH, hosted by Inventiva from The Liver Meeting Digital Experience™ 2020 of the AASLD, November 16, 2020



    Next financial results publication

    §   Q4 2020 Revenues and cash position: Thursday, February 11, 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 Based on an exchange rate of $1.1342 per euro, the exchange rate published by the European Central Bank on July 9, 2020.

    3 Source: clinicaltrials.gov.



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    • FDA confirms that a single Phase III clinical trial may be adequate for submitting U.S. marketing authorization application
    • Interim histology analysis may serve as the basis for seeking FDA accelerated approval
    • Inventiva confirms planned initiation of pivotal Phase III clinical trial for H1 2021
    • Based on positive feedback from the FDA, the Company has decided to focus its clinical efforts on the development of lanifibranor in NASH


    Daix (France), November 10, 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…



    • FDA confirms that a single Phase III clinical trial may be adequate for submitting U.S. marketing authorization application
    • Interim histology analysis may serve as the basis for seeking FDA accelerated approval
    • Inventiva confirms planned initiation of pivotal Phase III clinical trial for H1 2021
    • Based on positive feedback from the FDA, the Company has decided to focus its clinical efforts on the development of lanifibranor in NASH



    Daix (France), November 10, 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 conclusions from its end-of-phase II meeting with the U.S. Food and Drug Administration (FDA) for its lead drug candidate lanifibranor following the publication of positive topline results from its NATIVE Phase IIb clinical trial in NASH in June 2020.

    After the recent Breakthrough Therapy designation of lanifibranor in NASH, and based on the trial design presented by the Company, the FDA has indicated that Inventiva's clinical strategy to conduct a single pivotal Phase III trial may be sufficient to support the filing of a new drug application (NDA) in the U.S. The FDA also confirmed that Inventiva may request accelerated approval for lanifibranor in the event of a positive benefit-risk ratio determination based on an interim histology analysis to be conducted during the Phase III trial.

    The Phase III trial preparations are progressing according to schedule and Inventiva will communicate details of the trial once it receives regulatory feedback from the European Medicines Agency (EMA), which is expected in the fourth quarter of 2020. The initiation of the Phase III trial is planned for the first half of 2021.

    Given the positive feedback from the FDA, which builds on the positive topline results shown by lanifibranor in the NATIVE Phase IIb clinical trial and its designation as Breakthrough Therapy by the FDA in October, Inventiva has decided to focus its clinical efforts on the development of lanifibranor for the treatment of NASH. As part of this decision, the Company will be reviewing all available options to optimize the development of its second clinical-stage asset odiparcil for the treatment of MPS VI, and during such time, will suspend all MPS-related R&D activities. As a consequence, the Phase I/II SAFE-KIDDS (SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study) clinical trial evaluating odiparcil in MPS VI children and the Phase IIa extension clinical trial with odiparcil in MPS VI patients who completed the prior iMProveS Phase IIa clinical trial will not be initiated in the first half of 2021 as initially planned.

    Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, commented: "We are extremely pleased by the promising and constructive feedback from the FDA, which has given us the green light to initiate the pivotal Phase III trial with lanifibranor, our lead drug candidate for the treatment of NASH. Importantly, the FDA provided clear guidance that accelerated approval may be achievable with an interim analysis. The recent key milestones achieved with lanifibranor and the FDA feedback reinforce our confidence in its potential to become a reference treatment for NASH. With this very promising perspective ahead, we believe it is important to shift our clinical focus and concentrate on this program while ensuring the ideal development path for odiparcil in MPS. We now look forward to continue working closely with the EMA on finalizing lanifibranor's clinical development plan, with a view to the initiation of the Phase III trial in the first half of 2021."



    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.

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  1. Daix (France), November 5, 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 appointment of Dr. Michael Cooreman, M.D., as Chief Medical Officer (CMO). He joins Inventiva's Executive Committee and succeeds Dr. Marie-Paule Richard, M.D., who has decided to take her retirement as of December 17, 2020.

    Dr. Michael Cooreman will oversee the Company's medical and clinical activities and lead its medical development team, in particular with a view to the planned pivotal Phase III clinical trial evaluating…



    Daix (France), November 5, 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 appointment of Dr. Michael Cooreman, M.D., as Chief Medical Officer (CMO). He joins Inventiva's Executive Committee and succeeds Dr. Marie-Paule Richard, M.D., who has decided to take her retirement as of December 17, 2020.

    Dr. Michael Cooreman will oversee the Company's medical and clinical activities and lead its medical development team, in particular with a view to the planned pivotal Phase III clinical trial evaluating Inventiva's lead drug candidate lanifibranor for the treatment of NASH. Joining Dr. David Nikodem, Ph.D., Vice President of U.S. Operations, he will drive the establishment of Inventiva's clinical team in the U.S. and manage the Company's relationships with Key Opinion Leaders (KOL).

    Dr. Cooreman joins Inventiva from Ferring Pharmaceuticals where he has been Vice President, Science and Medicine, in charge of Global Research and Development, Gastroenterology and Hepatology, since 2017. He will bring to Inventiva his extensive experience in translational medicine, clinical pharmacology and clinical product development, especially in the areas of liver diseases, including NASH, cirrhosis and viral hepatitis, metabolic and immune-mediated diseases and oncology. Over his career, Dr. Cooreman has worked for several companies in the United States of America (US) and been involved in numerous clinical trials. He has successfully led clinical and project teams developing a variety of investigational compounds, including small molecules and biologics, several of which have been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other health authorities. His strong industry knowledge, established network and international profile, together with his deep expertise as an academic internist and gastroenterologist-hepatologist, will be important assets for Inventiva's future development.

    Dr. Cooreman's arrival will facilitate a smooth transition with Dr. Marie-Paule Richard ahead of the Company's next key milestones, including NASH-related meetings with the FDA and the EMA, planned for the fourth quarter of 2020, as well as the initiation of the pivotal Phase III clinical trial evaluating lanifibranor in patients with NASH, planned for the first half of 2021.

    Frédéric Cren, Chairman, CEO and cofounder of Inventiva, commented: "I am delighted to welcome Michael in the role of CMO at this exciting stage of Inventiva's development. His experience as both health practitioner and senior executive in leading pharmaceutical and biotech companies will be key to the deployment of our strategy going forward. As such, he will play a crucial role in the development of Inventiva in the US, especially with regards to the upcoming planned Phase III clinical trial of lanifibranor in NASH. I would like to take this opportunity to warmly thank Marie-Paule for her dedication, remarkable contribution and professionalism over the last two years and I wish her all the best in the future."



    Biography – Dr. Michael Cooreman, M.D.

    Prior to joining Inventiva, Dr. Michael Cooreman has been Vice President, Science and Medicine, in charge of Global Research and Development, Gastroenterology and Hepatology, at Ferring Pharmaceuticals in the U.S. since 2017. He previously held numerous U.S.-based positions as CMO and Executive Director in global roles at leading pharmaceutical and biotechnology companies, including Takeda Pharmaceuticals, Merck, Mitsubishi Tanabe, ImmusanT and Novartis, covering the four major regulatory regions U.S., EU, Japan and China. Over the years, Dr. Cooreman has developed a strong expertise in translational medicine, clinical pharmacology and clinical product development.  

    Of dual US and Belgian citizenship, Dr. Cooreman is trained as an internist and gastroenterologist-hepatologist, with a special interest in metabolic and immune-mediated liver and gastrointestinal diseases, as well as viral hepatitis, cirrhosis and oncology.

    He holds a Doctor of Medicine degree from the University of Louvain, Belgium, and a doctorate from the Heinrich Heine University in Dusseldorf, Germany.



    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.

    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. A Phase I/II clinical trial in children with MPS VI is currently under preparation following the release of positive results of the Phase IIa clinical trial in adult MPS VI patients at the end of 2019.

    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.

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    • PPARs are shown to be attractive therapeutic targets for the treatment of NASH, producing beneficial effects on the liver, improving features of the metabolic syndrome and mitigating the risk of related extra-hepatic diseases


    Daix (France), November 2, 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 role of peroxisome proliferator-activated receptors (PPARs) in the treatment of NASH by the peer-reviewed medical journal Nature Review Gastroenterology & Hepatology

    • PPARs are shown to be attractive therapeutic targets for the treatment of NASH, producing beneficial effects on the liver, improving features of the metabolic syndrome and mitigating the risk of related extra-hepatic diseases



    Daix (France), November 2, 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 role of peroxisome proliferator-activated receptors (PPARs) in the treatment of NASH by the peer-reviewed medical journal Nature Review Gastroenterology & Hepatology.

    Published in coordination with the panNASH™ initiative, the article, entitled "Non-alcoholic steatohepatitis: the role of peroxisome proliferator-activated receptors", discusses the current literature on Non-Alcoholic Fatty Liver Disease (NAFLD), describes the role of PPARs in NASH and related metabolic diseases, and summarizes the preclinical and clinical data on the use of PPAR agonists.

    NAFLD is a multisystem disease with extra-hepatic disease implications, including the development of type two diabetes (T2DM) and cardiovascular diseases (CVDs). As the paper highlights, patients with NAFLD tend to present many features of the metabolic syndrome, such as central obesity, atherogenic dyslipidemia, hypertension, abnormal glucose tolerance and insulin resistance, and, in progression of NAFLD towards NASH, develop hepatic inflammation and often fibrosis.

    According to the article, PPARs are key regulators of many of the adversely affected mechanistic pathways involved, making them attractive therapeutic targets for the treatment of NASH. Reportedly, PPARs produce beneficial effects on the liver, improve various features of the metabolic syndrome and mitigate the risk of developing related extra-hepatic diseases such as T2DM and CVDs.

    The paper also discusses the well-known side effects of PPARs, explaining that those, including excessive body weight gain and fluid retention, can be controlled by the use of biomarkers and recover after stopping the treatment.

    Jean-Louis Junien, Chairman of Inventiva's Scientific Advisory Board, commented: "This scientific paper clearly illustrates that, although previous studies have shown limited efficacy of individual PPARs, ongoing clinical trials suggest a broader and more efficacious therapeutic potential especially of pan-PPAR agonists to treat the multisystem disease of NASH. This can in particular be attributed to their capacity to target different interrelated mechanisms in the pathophysiology of NASH. As such, lanifibranor, Inventiva's lead drug candidate and only pan-PPAR agonist currently in development for the treatment of NASH, is ideally positioned in this field as evidenced by the recent topline results of the Company's Phase IIb NATIVE clinical trial."



    Publication details

    Title of scientific paper:"Non-alcoholic steatohepatitis: the role of peroxisome proliferator-activated receptors"
    Date of publication:October 22, 2020
    Authors:Sven Francque1, Gyongyi Szabo2, Manal F. Abdelmalek3, Christopher D. Byrne4, Kenneth Cusi5, Jean-François Dufour6, Michael Roden7, Frank Sacks8 and Frank Tacke9
    Link to the article:https://www.nature.com/articles/s41575-020-00366-5



     

    About panNASHTM

    The panNASH™ initiative is a working group consisting of a committee of international independent experts that aims to increase the visibility and contribute to a better understanding of NASH, to share their expertise and to establish best practices for the treatment of the disease.

    Established in 2018, the initiative is supported by Inventiva and includes European and American medical experts in areas related to NASH such as hepatology, diabetes and cardiology, along with renowned scientific experts dedicated to promoting a better understanding of the physiopathological mechanisms involved in the disease. Their aim is to play an active role in developing and disseminating their NASH expertise among the scientific community, patients and other key stakeholders within the healthcare system.

    In particular, the experts group helps to develop and share new findings about NASH through publications, conferences and training sessions, focusing on the development of the disease, the identification of patients at risk, clinical markers and associated health risks, as well as the development of new treatments. Specifically, the committee contributes to increasing the knowledge of pathological mechanisms ranging from metabolic disorders to fibrosis and comorbidities, with a focus on the modulating role played by PPARs (a,d,g subtypes).



    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.

    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. At the end of 2019, Inventiva published positive results from its Phase IIa clinical trial evaluating odiparcil for the treatment of MPS VI adult patients. 

    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 (OTC:IVEVF) 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 Sven Francque: Department of Gastroenterology and Hepatology, Antwerp University Hospital, Antwerp, Belgium.

    2 Gyongyi Szabo: Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

    3 Manal F. Abdelmalek: Division of Gastroenterology and Hepatology, Department of Medicine, Duke University Health System, Durham, NC, USA.

    4 Christopher D. Byrne: Nutrition & Metabolism, Human Development & Health, Faculty of Medicine, University Hospital Southampton, Southampton, UK.

    5 Kenneth Cusi: Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, FL, USA.

    6 Jean-François Dufour: Hepatology, Department of Clinical Research, University Hospital of Bern, Bern, Switzerland & University Clinic for Visceral Surgery and Medicine, Inselspital, Bern, Switzerland.

    7 Michael Roden: Division of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University Düsseldorf, University Clinics Düsseldorf, Düsseldorf, Germany & Institute for Clinical Diabetology, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.

    8 Frank Sacks: Departments of Nutrition and Molecular Metabolism, Harvard T.H. Chan School of Public Health, Boston, MA, USA & Channing Division, Department of Medicine Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.

    9 Frank Tacke: Department of Hepatology & Gastroenterology, Charité University Medical Center, Berlin, Germany.



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    • Two late-breaking abstracts covering new data from Inventiva's NATIVE Phase IIb clinical trial evaluating lanifibranor for the treatment of NASH have been selected for poster presentations during the congress
       
    • These abstracts focus on the efficacy of lanifibranor in type-2 diabetic (TD2M) patients and its positive effect on key plasma biomarkers
       
    • Presence during the congress will be highlighted with an oral plenary presentation and include a total of four presentations/abstracts


    Daix (France), November 2, 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…



    • Two late-breaking abstracts covering new data from Inventiva's NATIVE Phase IIb clinical trial evaluating lanifibranor for the treatment of NASH have been selected for poster presentations during the congress

       
    • These abstracts focus on the efficacy of lanifibranor in type-2 diabetic (TD2M) patients and its positive effect on key plasma biomarkers

       
    • Presence during the congress will be highlighted with an oral plenary presentation and include a total of four presentations/abstracts



    Daix (France), November 2, 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 that two late-breaking abstracts have been selected for poster presentations during the upcoming The Liver Meeting Digital Experience™ 2020, organized by the American Association for the Study of Liver Diseases (AASLD) on November 13-16, 2020.

    The two late-breaking abstracts cover new data from the Company's NATIVE Phase IIb clinical trial evaluating lanifibranor for the treatment of NASH, focusing on the efficacy of lanifibranor in type-2 diabetic (TD2M) patients and its positive effect on key plasma biomarkers.

    A third abstract covering the screening methodology used for patient selection during the NATIVE Phase IIb clinical trial has also been accepted for a poster presentation.

    These three abstracts complement Inventiva's presence at the AASLD The Liver Meeting Digital Experience™ 2020, where Inventiva had already been selected for an oral plenary presentation of the NATIVE Phase IIb clinical trial results, including new data on F2/F3 patients.

    The details of the various presentations are as follows:



    Late-breaking abstract #1
    :

    Abstract title:"Efficacy of the panPPAR agonist lanifibranor on the histological endpoints NASH resolution and fibrosis regression is similar in type-2 diabetic and non-diabetic patients: additional results of the NATIVE Phase IIb trial in non-cirrhotic NASH "
    Publication number:LP9
    Session title:Late-breaking Abstract Posters
    Presentation type:Poster presentation
    Author:Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial

    The abstract will also be featured in the December issue of the scientific journal Hepatology and is available on the website of the AASLD.



    Late-breaking abstract #2
    :

    Abstract title:"Effect of the panPPAR agonist lanifibranor on plasma biomarkers of liver necro-inflammation and fibrosis in non-cirrhotic NASH patients: additional results of the NATIVE Phase IIb trial"
    Publication number:LP36
    Session title:Late-breaking Abstract Posters
    Presentation type:Poster presentation
    Author:Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial
      

    The abstract will also be featured in the December issue of the scientific journal Hepatology and is available on the website of the AASLD.



    Abstract #3
    :

    Abstract title:"Selection based on SAF activity score, not NASH CRN NAFLD activity score, leads to selection of a patient cohort with more severe NASH with more advanced fibrosis: experience from the NATIVE Phase IIb study of the panPPAR agonist lanifibranor"
    Publication number:1696
    Session title:NAFLD and NASH: Therapeutics - Pharmacologic and Other
    Presentation type:Poster presentation
    Author:Prof. Manal Abdelmalek, Division of Gastroenterology and Hepatology at Duke University, Co-Principal Investigator of the NATIVE Phase IIb clinical trial



    Oral plenary presentation
    :

    Abstract title:"The panPPAR agonist lanifibranor induces both resolution of NASH and regression of fibrosis after 24 weeks of treatment in non-cirrhotic NASH: results of the NATIVE  Phase IIb trial"
    Publication number:0012
    Session title:Plenary: Clinical and Outcomes Discoveries
    Presentation type:Oral presentation, Plenary Session
    Presenting author:Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial
    Date:Sunday, November 15, 2020
    Session time:9:00 AM (ET) / 3:00 PM (CET)



    The content of the presentation will also be part of a dedicated Key Opinion Leader (KOL) webcast focused on NASH and hosted by Inventiva on November 16, 2020 on the sidelines of the AASLD The Liver Meeting Digital Experience™ 2020. This event can be followed both live and on-demand on Inventiva's website in the "Investors – Investor Presentations" section at: http://inventivapharma.com/investors/investor-presentations/.



    About the American Association for the Study of Liver Diseases (AASLD)1

    AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. AASLD fosters research that leads to improved treatment options for millions of liver disease patients. We advance the science and practice of hepatology through educational conferences, training programs, professional publications, and partnerships with government agencies and sister societies.



    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.



    About the NATIVE Phase IIb trial

    The NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial was a 24-week randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH. The main purpose of the trial was to assess the efficacy of lanifibranor in improving liver inflammation and ballooning, the two histological markers included in the definition of the regulatory endpoint of NASH resolution. To be considered for inclusion, patients were required to have: a diagnosis of NASH confirmed by liver biopsy; a cumulative score of inflammation and ballooning (as measured using the SAF scoring system) of three or four out of four, indicating the presence of moderate to severe inflammation and ballooning; a steatosis score greater than or equal to one, indicating the presence of moderate to severe steatosis; and a fibrosis score less than four, indicating the absence of cirrhosis. The primary endpoint of the trial was a reduction in the combined inflammation and ballooning score of two points compared to baseline, with no worsening fibrosis, as measured by the SAF score. Secondary endpoints included NASH resolution, improvements in each of the steatosis, inflammation, ballooning and fibrosis scores from baseline as measured using the SAF score, improvements in various other fibrosis measures, improvements in several metabolic markers, improvements in steatosis, inflammation and ballooning as measured using the NAS score (NAFLD activity score), and safety.

    The trial randomized 247 patients with NASH in 71 sites in Australia, Canada, Europe, Mauritius and the United States.





    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.

    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. At the end of 2019, Inventiva published positive results from its Phase IIa clinical trial evaluating odiparcil for the treatment of MPS VI adult patients. 

    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 (OTC:IVEVF) 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 https://www.aasld.org/



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