• The FDA decision follows the Company's Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed in August 2021

    Daix (France), Long Island City (New York, United States), September 21, 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 that the U.S. Food and Drug Administration (FDA) has decided that the Fast Track designation previously granted to lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis.

    This decision follows…

    • The FDA decision follows the Company's Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed in August 2021

    Daix (France), Long Island City (New York, United States), September 21, 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 that the U.S. Food and Drug Administration (FDA) has decided that the Fast Track designation previously granted to lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis.

    This decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August 2021. Previously, the FDA had granted both Fast Track and Breakthrough Therapy designations to lanifibranor for the treatment of NASH in September 2019 and October 2020, respectively.

    The FDA's dedicated Fast Track program is designed to facilitate the development and expedite the review and potential approval of drug candidates demonstrating the capacity to treat serious conditions and fill significant unmet medical needs.

    Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, commented: "We are delighted to have a Fast Track designation for lanifibranor in NASH that extends to the treatment of NASH with compensated cirrhosis, a very severe stage of the disease where patients are in urgent need of treatment. The FDA decision does not only recognize this urgency but also the potential of lanifibranor to address this crucial unmet medical need. This news reinforces our confidence in the unique mechanism of action of our lead drug candidate and confirms our determination to accelerate the development of lanifibranor in its pivotal phase."

    NASH with compensated cirrhosis represents a serious stage of the disease and is becoming the leading cause for liver transplantation, which today represents the only available treatment option for patients who have progressed to end-stage NASH. There is thus an urgent need to develop pharmacological therapies to slow down or halt the progression towards NASH with compensated cirrhosis for NASH patients who are at an increased risk of liver-related morbidity and mortality.

    Given the broad range of activity of lanifibranor as a pan-PPAR agonist on multiple features of NASH, including beneficial effects on metabolism, inflammation, ballooning, fibrosis and vascular manifestations, Inventiva believes that there is a strong rationale to evaluate the efficacy of lanifibranor in NASH patients with compensated cirrhosis.



     

    About Fast Track designation1

    Fast track is a process designed to facilitate the development and expedite the review and potential approval of drug candidates to treat serious, life-threatening conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

    Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on factors such as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.

    Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Any drug being developed to treat or prevent a condition with no current therapy is obviously directed at an unmet need. If there are available therapies, a Fast Track drug must show some advantage over available therapy, which is assessed against a pre-defined set of criteria.

    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 preclinical 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 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained both FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial.

    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 in 2019 and received both FDA Fast Track and Rare Paediatric Disease designation for odiparcil in MPS VI.

    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

    Pascaline Clerc

    VP of Global External Affairs

    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +1 415 513 1284
         

    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, 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 the potential benefits Inventiva may realize from Fast Track designation granted to lanifibranor, its ability to accelerate the development of lanifibranor, or that lanifibranor 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 is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, 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 adverse drug reactions 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, and 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 for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021, Amendment No. 1 to the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 24, 2021, as well as the half-year financial report for the six months ended June 30, 2021 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.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track (12/09/2019).





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    • Cash and cash equivalents at €93.6 m as of June 30, 2021 compared to €105.7 m1 as of December 31, 2020
    • Initiation of the NATiV3 Phase III clinical study with lanifibranor in NASH
    • R&D expenses of €19.1 m in H1 2021, up 52% compared to H1 2020, mainly driven by the preparation and initiation of the NATiV3 Phase III clinical trial
    • Decision by AbbVie to initiate a Phase IIb clinical trial with cedirogant in patients with moderate to severe psoriasis following the demonstration of clinical proof of concept during AbbVie's Phase Ib clinical trial 
    • Publication by AbbVie of the design of the Phase IIb clinical trial with cedirogant to be initiated in November 2021 with completion expected in March 2023
    • Major recruitments to reinforce Inventiva's clinical…

     

    • Cash and cash equivalents at €93.6 m as of June 30, 2021 compared to €105.7 m1 as of December 31, 2020
    • Initiation of the NATiV3 Phase III clinical study with lanifibranor in NASH
    • R&D expenses of €19.1 m in H1 2021, up 52% compared to H1 2020, mainly driven by the preparation and initiation of the NATiV3 Phase III clinical trial
    • Decision by AbbVie to initiate a Phase IIb clinical trial with cedirogant in patients with moderate to severe psoriasis following the demonstration of clinical proof of concept during AbbVie's Phase Ib clinical trial 
    • Publication by AbbVie of the design of the Phase IIb clinical trial with cedirogant to be initiated in November 2021 with completion expected in March 2023
    • Major recruitments to reinforce Inventiva's clinical expertise, medical team and corporate functions, as well as its presence in France and the United States 
    • Implementation of an At-The-Market ("ATM") program in the United States providing the Company with important financial flexibility and additional funding possibility of up to $100.0 m

     

    Daix (France), Long Island City (New York, United States), September 20, 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 interim financial results for the six months ended June 30, 2021 and provided a corporate update.

    Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: "Over the first six months of this year, we continued to progress in the development of our programs for the treatment of NASH and in the area of autoimmune diseases with our partner AbbVie. The initiation of our highly anticipated Phase III clinical trial in NASH, with the opening of the first clinical sites in the United States and the start of patient screening, is a major milestone in the pivotal development phase of our drug candidate lanifibranor. Moreover, the decision by AbbVie to move into Phase IIb clinical development with cedirogant for the treatment of psoriasis and the recent publication of the trial design are excellent news for this program in which Inventiva remains eligible to receive milestone payments as well as sales royalties. Last month, we also took the step to implement an ATM program in the United States, which provides us with the financial flexibility to bolster funding of our R&D portfolio and should allow us to accelerate the development of our pipeline looking ahead. In parallel, we reinforced our teams across key markets through the recruitment of seven highly talented and seasoned professionals, ideally positioning us to master the upcoming milestones."

    Key financial results for the first half of 2021

    (in thousands of euros, except share and per share amounts)    June 30, 2021   June 30, 2020
    Revenues    139   161
    Other income    2,009   1,607
    Research and development expenses    (19,109)   (12,574)
    Marketing – business development expenses    (258)   (123)
    General and administrative expenses    (5,779)   (3,383)
    Other operating income (expenses)    (607)   (1,354)
    Net operating loss    (23,605)   (15,665)
    Net financial income    824   6
    Income tax    (355)   -
    Net loss for the period    (23,136)   (15,659)
          
    Basic/diluted loss per share (euros/share)    (0.60)   (0.40)
    Weighted average number of outstanding shares used for computing basic/diluted loss per share     38,677,187   38,677,187

    Revenues for the first half of 2021 reached €0.1 million, stable compared to the first half of 2020. As part of its collaboration with AbbVie in auto-immune diseases, Inventiva is eligible to receive development, regulatory and commercial milestone payments as well as royalty payments. As such, the Company expects to receive another milestone payment upon the initiation by AbbVie of the Phase IIb clinical trial with cedirogant (see details in the "Main areas of progress in the R&D portfolio" section below).

    R&D expenses amounted to €19.1 million in the first half of 2021, an increase of 52% compared to €12.6 million in the first half of 2020, mainly driven by the costs associated with the preparation and initiation of the NATiV3 Phase III clinical trial with lanifibranor in NASH.

    General and administrative expenses (G&A) amounted to €5.8 million, an increase of 71% compared to €3.4 million in the first half of 2020, mainly due to higher compliance costs resulting from Inventiva's new dual listing status since July 2020.

    Other operating income (expenses) stood at (€0.6) million compared to (€1.4) million in the first half of 2020. The lower expenses incurred during the first half of 2021 included costs related to the preparation of the ATM project and the amortization costs of the one-off POSI insurance covering the Company's Initial Public Offering (IPO) on the Nasdaq Global Market.

    Net financial income amounted to €0.8 million in the first half of 2021, mainly linked to exchange rate variation.

    The Company's net loss stood at (€23.1) million compared to (€15.7) million in the first half of 2020.

    Inventiva's net cash flow (excluding any exchange rate effect) amounted to (€15.0) million in the six months ended June 30, 2021 compared to €16.4 million in the same period in 2020.

    Net cash used in operating activities amounted to €19.8 million and €7.2 million in the first half of 2021 and 2020, respectively. This increase in cash use is due to higher R&D and G&A expenses.

    Cash flow from operating activities was also positively impacted in the first half of 2021 by the payment of €8.0 million of Research Tax Credit (CIR - Crédit Impôt Recherche) (€3.8 million related to complementary filings following the 2020 Conseil d'État judgement covering prior years, and €4.2 million related to the 2020 Research Tax Credit) received on June 30, 2021.

    Net cash generated by investing activities amounted to €4.7 million2 in the first half of 2021 compared to (€1.0) million for the same period in 2020. This variation is essentially due to the decrease in short term deposits.

    No net cash from financing activities was generated over the first half of 2021 while Inventiva recorded

    €24.6 million of net cash from financing activities for the same period in 2020, notably related to the issuance of €14.7 million (gross proceeds) of ordinary shares in February 2020 and the entry into a €10.0 million State-guaranteed loan with a syndicate of French banks in May 2020.

    Over the first half of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalents of €3.0 million2.

    As of June 30, 2021, Inventiva's cash and cash equivalents stood at €93.6 million compared to €105.7 million2 as of December 31, 2020.

    Considering its current R&D and clinical development programs, and excluding additional financial resources that may originate from funding activities such as the ATM program, Inventiva's cash runway will allow the Company to fund its operations through the third quarter of 2022.

    The financial statements of the first half of 2021 were approved by Inventiva's Board of Directors on September 16, 2021. The statutory auditors have issued a limited review report. For more details, the Half-Year Financial Report is available on the Company's website at: www.inventivapharma.com.

    Main areas of progress in the R&D portfolio

    Lanifibranor in non-alcoholic steatohepatitis (NASH)

    • Initiation of the NATiV3 Phase III clinical trial evaluating lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of liver fibrosis, with the activation of the first clinical sites in the United States and the start of patient screening – September 8, 2021

    Odiparcil in mucopolysaccharidosis type VI (MPS VI)

    • Inventiva continues to review all available options to optimize the development of its second clinical-stage asset odiparcil for the treatment of MPS VI. All MPS-related R&D activities remain on hold pending the outcome of this review process, now expected to conclude in 2022 (rather than in 2021 as previously anticipated).3

    Collaboration with AbbVie on cedirogant in autoimmune diseases

    • Decision by AbbVie to initiate a Phase IIb clinical trial with cedirogant4 in patients with moderate to severe psoriasis after having achieved clinical proof of concept during AbbVie's

      Phase Ib clinical trial – May 12, 20215
    • Publication by AbbVie of the study design of the Phase IIb clinical trial with cedirogant: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety and efficacy of cedirogant in adult patients with moderate to severe psoriasis. AbbVie plans to enroll about 200 adult participants in approximately 45 sites, who will receive oral daily doses of cedirogant or placebo capsules for 16 weeks. The primary endpoint has been defined as the percentage of participants achieving >=75% reduction from baseline on the Psoriasis Area Severity Index (PASI) score (PASI 75)6. The trial is expected to start in November 2021 and be completed in March 2023 – September 14, 20217

    Other significant milestones

    • Major recruitments to reinforce Inventiva's clinical expertise, medical team and corporate functions, as well as its presence in France and the United States – September 16, 2021
    • Implementation of an ATM program in the United States, to be activated if and when required, providing the Company with important financial flexibility to strengthen funding of its R&D pipeline by issuing and selling ordinary shares in the form of American Depositary Shares (ADSs), with aggregate gross sales proceeds of up to $100 million. The ATM program will be effective until August 2, 2024 – August 2, 2021
    • Appointment of Martine Zimmerman as Independent Director to Inventiva's Board of Directors to replace Nawal Ouzren. Martine Zimmerman's appointment will be submitted to Inventiva's shareholders for ratification at the Company's next Combined Shareholders' Meeting – April 19, 2021

    •••

    Next expected key milestones 

    • Initiation by AbbVie of the Phase IIb clinical trial with cedirogant in patients with moderate to severe psoriasis – planned for November 2021
    • Strategy update on the development of odiparcil – planned for 2022 vs the second half of 2021 as previously anticipated
    • Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2DM) led by Professor Cusi – planned for the first half of 2022

    Upcoming investor conference participation

    • Lyon Pôle Bourse Forum, September 27-28, 2021
    • HealthTech Innovation Days 2021, October 4-5, 2021Portzamparc Health Biotech Seminar 2021, October 6, 2021
    • H.C. Wainwright 5th Annual NASH Investor Conference, October 11, 2021
    • Stifel Healthcare Conference 2021, November 16-17, 2021
    • Jefferies 2021 London Healthcare Conference, November 16-18, 2021

    Upcoming scientific conference presentations

    • AASLD The Liver Meeting, November 12-15, 2021

    Conference call

    A conference call in English will be held tomorrow, Tuesday, September 21, 2021 at 2:00 pm (Paris time). To join the conference call, please use the code 8573858 after dialing one of the following numbers:

    France: +33 1 70 70 07 81

    Belgium: +32 27 93 38 47

    Germany: +49 69 22 22 26 25

    Netherlands: +31 20 79 56 614

    Switzerland: +41 44 58 07 145

    United Kingdom: +44 207 19 28 338

    United States: +1 646-741-3167

    The presentation accompanying this conference call will be available on Inventiva's website in the "Investors" – "Financial Results & Presentations" section at the same time and can be followed live at: https://edge.media-server.com/mmc/p/2kk6k5k7.

    A replay of the conference call and the presentation will be available after the event at: https://inventivapharma.com/investors/financial-results-presentations/.

    Next financial results publication

    • Q3 2021 Revenues and cash position: Wednesday, November 10, 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 preclinical 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 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. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial.

    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

    Pascaline Clerc

    VP of Global External Affairs



    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +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 is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, 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 adverse drug reactions 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, and 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 for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the half-year financial report for the six months ended June 30, 2021 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 The cash position as of December 31, 2020 amounted to €113.7 million as published in the press releases on March 4, 2021, May 12, 2021 and July 28, 2021 and included cash and cash equivalents as well as short-term deposits which were included in the category "other current assets" in the IFRS statement of financial position. Under IFRS, the variation of short-term deposits and its related exchange effects are reflected in the line items "net cash flows from investing activities" for €5.9 million and "exchange gains (losses)" for €1.4 million, respectively.

    2 The cash position as of December 31, 2020 amounted to €113.7 million, as published in the press releases on March 4, 2021, May 12, 2021 and July 28, 2021, and included cash and cash equivalents as well as short-term deposits which were included in the category "other current assets" in the IFRS statement of financial position. Under IFRS, the variation of short-term deposits and its related exchange effects are reflected in the line items "net cash flows from investing activities" for €5.9 million and "exchange gains (losses)" for €1.4 million, respectively.

    3 Please refer to Inventiva's press release entitled "Inventiva receives positive FDA feedback to advance its lead drug candidate lanifibranor into pivotal Phase III in NASH" and published on November 10, 2020.

    4 Cedirogant is a clinical stage RORγ inverse agonist co-discovered by Inventiva with potential in several auto-immune diseases.

    5 See AbbVie Q1 2021 earnings call on April 30, 2021, 9 AM ET; Transcript from FactSet. The Phase Ib clinical trial led by AbbVie was a randomized, double-blind, placebo-controlled, multiple-dose trial to evaluate the pharmacokinetics, safety and tolerability of cedirogant in 60 healthy volunteers and patients with chronic plaque psoriasis (clinicaltrials.gov identifier: NCT03922607).

    6 The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 to 72, with a higher score indicating a more severe form of the disease.

    7 For more details regarding the Phase IIb clinical trial, please refer to clinicaltrials.gov (NCT05044234).





     

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    • Seven recruitments with solid track records and complementary profiles to reinforce Inventiva's clinical expertise, medical team and corporate functions
    • New recruitments further expand the Company's footprint in the United States while consolidating its presence in France

    Daix (France), Long Island City (New York, United States), September 16, 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 series of recruitments with a view to accelerate the development of its lead drug candidate lanifibranor for the…

    • Seven recruitments with solid track records and complementary profiles to reinforce Inventiva's clinical expertise, medical team and corporate functions
    • New recruitments further expand the Company's footprint in the United States while consolidating its presence in France

    Daix (France), Long Island City (New York, United States), September 16, 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 series of recruitments with a view to accelerate the development of its lead drug candidate lanifibranor for the treatment of NASH.

    The complementary profiles of the new arrivals will allow Inventiva to strengthen its expertise in clinical operations and drug development while reinforcing its core corporate functions.

    Following the opening of Inventiva's subsidiary in the United States in January 2021, these recruitments will further expand the Company's footprint in this key geography and consolidate its presence in France.

    Recruitments – Clinical operations and medical team

    With over 20 years of experience in pharmaceutical and clinical development, Alice Roudot-Ketelers, PharmD, joins Inventiva as Vice President Clinical Operations and Pharmaceutical Development and member of its Executive Committee. Based in France, she will lead and oversee the Company's global clinical and pharmaceutical development activities, particularly focusing on the development of lanifibranor and the recently launched pivotal NATiV3 Phase III clinical trial in NASH. Prior to joining Inventiva, Alice was in charge of all drug development programs and oversaw cross-functional teams in Chemistry, Manufacturing and Controls (CMC), non-clinical and clinical development up to Phase III at one of the major biotech companies in the NASH field.

    Jean-Paul Dutertre, MD, joins the Company as Head of Pharmacovigilance in France, leading Inventiva's pharmacovigilance activities with a focus on lanifibranor. Leveraging 30 years of experience in pharmacovigilance, Jean Paul worked for large pharmaceutical groups, including Eli Lilly and Company and GlaxoSmithKline, as well as biotech companies following his first position as Phase I physician at Fournier. In his different roles, Jean-Paul has led the establishment and maintenance of pharmacovigilance systems and processes. In this context, he frequently interacted with the U.S Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and was in charge, amongst others, of drafting the safety components for the applications of various drug candidates.

    Sanjay Patel, MD, joins Inventiva in the role of Medical Director, with a proven expertise in diabetes and orphan diseases. Based in the United Kingdom, he reinforces Inventiva's clinical team to support the development of lanifibranor for the treatment of NASH. Sanjay is an experienced Global Clinical Research Physician who has over 20 years of experience in clinical development within both large pharmaceutical groups, including Eli Lilly and Company, GlaxoSmithKline and Boehringer Ingelheim, and biotech companies.

    Gerardo Rodriguez, MD, PhD, joins Inventiva as Senior Medical Director, based in the United States. With more than 17 years of experience in drug development, he will co-lead the Company's pivotal Phase III clinical study with lanifibranor in NASH. Gerardo is a widely recognized cardiovascular endocrinologist, gene therapist and researcher, with a strong expertise across hepatology, diabetes, endocrinology and cardiovascular research, having worked for large pharmaceutical groups, biotech companies and Contract Research Organizations (CROs). Prior to joining Inventiva, Gerardo was the Head of Therapeutic Area of the Liver Disease Program at AbbVie, where he was involved in the Phase III clinical trial with cenicriviroc in NASH and led more than 45 Phase II clinical studies in NASH, in big and small pharmaceutical companies. Previously, Gerardo served as scientific advisor on NASH, diabetes and cardiovascular diseases for leading pharmaceutical companies, including Pfizer, Eli Lilly and Company, and Astra Zeneca.

    Based in the United States, Joseph Covino, BS, joins the Company as Senior Director Clinical Operations to lead Inventiva's clinical operations in the Unites States, with a primary focus on the Phase III clinical trial with lanifibranor. Joseph has more than 15 years of experience in drug development and managing clinical research trials, focusing on hepatology, cardiology, respiratory and rare diseases as well as oncology.

    Recruitments – Corporate functions

    Based in France, Eric Duranson, LLM, joins Inventiva in the role of General Counsel and as member of its Executive Committee. At Inventiva, he will focus on the acceleration of the Company's strategy and further expansion. Eric has over 20 years of experience in the life sciences industry, supporting companies such as Thermo Fisher Scientific, Sanofi and bioMerieux, throughout all product development stages, from research and development to marketing.

    Pascaline Clerc, PhD, joins the Company as Vice President Global External Affairs to lead Inventiva's corporate and strategic communications, patient advocacy and stakeholder engagement to support the development of its pipeline, with a primary focus on lanifibranor and NASH. Based in the United States, Pascaline has more than 15 years of experience in patient engagement, particularly in the area of NASH as part of a Phase III clinical trial, public policy and scientific research.

    Frédéric Cren, Chairman, CEO and cofounder of Inventiva, said: "We are delighted to welcome these important new hires. Reinforcing our presence in the U.S. and consolidating our footprint in France, they join us at a critical time, as we advance with the pivotal development of lanifibranor in NASH and the recently launched Phase III clinical trial. Their solid track records and complementary expertise, spanning clinical operations, drug development and corporate functions, will be a great addition to our teams and key to accelerate both the development of lanifibranor and our R&D portfolio at large."

    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 preclinical 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 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial.

    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

    Pascaline Clerc

    VP of Global External Affairs

    media@inventivapharma.com



    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    Patti.bank@westwicke.com

    +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 is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, 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 adverse drug reactions 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, and 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 for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the full-year financial report for the year ended December 31, 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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  2. Daix (France), September 10, 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 that its management team will host a webcast to present the Company's first-half financial results for 2021 on Tuesday, September 21, 2021.

    Inventiva's 2021 first-half financial results will be released on Monday, September 20, 2021 at 4:00 pm (New York), 10:00 pm (Paris).


     

    Frédéric Cren, Chairman, CEO and cofounder of Inventiva and Jean Volatier, Chief Financial Officer of Inventiva, will hold a conference

    Daix (France), September 10, 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 that its management team will host a webcast to present the Company's first-half financial results for 2021 on Tuesday, September 21, 2021.

    Inventiva's 2021 first-half financial results will be released on Monday, September 20, 2021 at 4:00 pm (New York), 10:00 pm (Paris).



     

    Frédéric Cren, Chairman, CEO and cofounder of Inventiva and Jean Volatier, Chief Financial Officer of Inventiva, will hold a conference call in English, followed by a Q&A session, on Tuesday, September 21, 2021 at 8:00 am (New York), 2:00 pm (Paris).

    The conference call and the slides of the presentation will be webcast live at: https://edge.media-server.com/mmc/p/2kk6k5k7. They will also be available on Inventiva's website in the "Investors" – "Financial results" section.

    To join the conference call, please use the code 8573858 after dialing one of the following numbers:

    France: +33 1 70 70 07 81

    Belgium: +32 27 93 38 47

    Germany: +49 69 22 22 26 25

    Netherlands: +31 20 79 56 614

    Switzerland: +41 44 58 07 145

    United Kingdom: +44 207 19 28 338

    United States: +1 646-741-3167

    Please note that the line will be opened 10 minutes before the start of the conference call.

    A replay of the conference call and the presentation will be available after the event at: http://inventivapharma.com/investors/financial-results-presentations/.



    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

    Pascaline Clerc

    VP of Global External Affairs



    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    Patti.bank@westwicke.com

    +1 415 513 1284

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    • Activation of first clinical sites and start of patient screening
    • The two-part NATiV3 Phase III clinical trial will evaluate the long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of liver fibrosis
    • The primary endpoint of the trial's part 1 will evaluate the response to the treatment defined by both resolution of NASH and fibrosis improvement of at least one stage
    • Publication of topline results of part 1 of the trial is expected for H2 2024
    • Based on the results of part 1 of the NATiV3 trial, Inventiva intends to seek U.S. accelerated approval and EU conditional approval for lanifibranor

    Daix (France), September 8, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused…

    • Activation of first clinical sites and start of patient screening
    • The two-part NATiV3 Phase III clinical trial will evaluate the long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of liver fibrosis
    • The primary endpoint of the trial's part 1 will evaluate the response to the treatment defined by both resolution of NASH and fibrosis improvement of at least one stage
    • Publication of topline results of part 1 of the trial is expected for H2 2024
    • Based on the results of part 1 of the NATiV3 trial, Inventiva intends to seek U.S. accelerated approval and EU conditional approval for lanifibranor

    Daix (France), September 8, 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 initiation of its NATiV3 Phase III clinical trial evaluating lanifibranor for the treatment of NASH.1 The first clinical trial sites have been activated in the United States and first patients have been screened. In addition, more than 330 sites across 25 countries have already been qualified2 of which more than a third in the United States.

    NATiV3 (NASH lanifibranor Phase 3 trial) is a randomized, double-blind, placebo-controlled, Phase III clinical trial evaluating the long-term efficacy and safety of lanifibranor (800mg/daily and 1200mg/daily) in adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis.

    The clinical trial includes two parts: a 72-week treatment of approximately 900 patients to assess the effect of lanifibranor on the primary composite endpoint of NASH resolution and fibrosis improvement of at least one stage and on the key secondary endpoints of NASH resolution with no worsening of fibrosis, and improvement of fibrosis with no worsening of NASH (part 1). Following part 1, the trial will remain blinded and continue in approximately 2,000 patients to evaluate the effect of lanifibranor on delaying NASH disease progression, measured by a composite endpoint that includes progression to cirrhosis, liver-related clinical outcome events, and all-cause death, as compared to the placebo control arm (part 2).  

    The primary composite endpoint of part 1 of the NATiV3 Phase III clinical trial is identical to the composite efficacy endpoint used in Inventiva's NATIVE Phase IIb clinical trial which was met by both lanifibranor doses with statistical significance, including in NASH patients with F2/F3 fibrosis and NASH patients with type 2 diabetes (T2DM).

    The last visit of the last patient enrolled in part 1 of the NATiV3 Phase III clinical trial is planned for the first half of 2024, with the publication of the topline results of part 1 of the trial expected for the second half of 2024.

    If part 1 of the NATiV3 trial is successful, Inventiva intends to seek accelerated approval in the United States and conditional approval in the EU for lanifibranor. The study will also provide a comprehensive safety data set to evaluate, in combination with the therapeutic efficacy data, the benefit/risk ratio of lanifibranor therapy as the basis for full regulatory approval in both the United States and the EU following completion of part 2 of the trial.

    Prof. Sven Francque, M.D., Ph.D., Antwerp University Hospital and co-principal investigator of the NATiV3 Phase III clinical trial, said: "The start of the pivotal Phase III clinical trial with lanifibranor represents a key milestone in its development, as well as for the patient community and the NASH field more generally. During the NATIVE Phase IIb trial, 21% and 31% of patients in the lanifibranor 800mg/day and 1200mg/day dose groups respectively achieved the Phase III primary composite endpoint after only 24 weeks of treatment compared to 7% in the placebo arm. These results give us great confidence in the NATiV3 trial and the potential of lanifibranor."

    Prof. Arun Sanyal, M.D., Virginia Commonwealth University and co-principal investigator of the NATiV3 Phase

    III clinical trial, added: "As an orally-available small molecule and the only pan-PPAR agonist currently in clinical development for the treatment of NASH, lanifibranor has shown a unique and very promising mechanism of action thus far. Based on its favorable safety profile and efficacy results observed in the previous Phase IIb trial, we are very excited about the potential benefits lanifibranor could bring to patients."

    Dr. Michael Cooreman, Chief Medical Officer of Inventiva, commented: "We are pleased to announce the start of our highly-anticipated NATiV3 Phase III clinical trial in NASH. While NASH patients continue to suffer from this devastating disease without any approved treatment available today, our entire team is fully committed to addressing this critical, unmet medical need. We have decided to replicate several key elements of the previous Phase IIb trial, including using the same patient enrollment screening criteria, and have developed a central biopsy review process in alignment with regulatory authorities. We believe in the therapeutic potential of lanifibranor, which should put us in a strong position to seek accelerated approval in the US and conditional marketing authorization in the EU."

    The initiation of the NATiV3 trial follows the publication of positive results from Inventiva's NATIVE Phase IIb clinical trial with lanifibranor in NASH in June 2020 as well as its designation as Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) in October 2020.

    About the NATiV3 Phase III trial

    The two-part NATiV3 (NASH lanifibranor Phase 3 trial) clinical trial is a randomized, double-blind, placebo-controlled trial, evaluating the long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of liver fibrosis.

    Patients will be randomized 1:1:1 in placebo and treatment arms (800mg/daily or 1200mg/daily of lanifibranor) and stratified based on their fibrotic stage (F2 and F3) as well as presence or absence of type 2 diabetes (T2DM).

    Part 1 of the trial will assess the effect of lanifibranor (800mg/daily and 1200mg/daily) compared to placebo on the primary composite endpoint of NASH resolution and improvement of fibrosis of at least one stage. The key secondary enpoints include NASH resolution without worsening of fibrosis as well as improvement of fibrosis and no worsening of NASH. Part 1 is expected to recruit approximately 900 patients selected upon liver biopsy and enrolled in approximately 300 sites, with the objective to obtain accelerated approval from the Food and Drug Administration (FDA) in the United States and conditional approval from the European Medicines Agency (EMA) in the EU for lanifibranor based on a pre-specified histology analysis after 72 weeks of treatment. The last visit of the last patient for part 1 is scheduled for the first half of 2024 and the publication of topline results for the second half of 2024.

    Part 2 will follow the 72-week histology analysis and will assess the effect of lanifibranor (800mg/daily and 1200mg/daily) compared to placebo on delaying NASH disease progression measured by a composite endpoint that includes progression to cirrhosis, liver-related clinical outcome events, and all-cause death. In part 2, the trial will remain blinded and continue in a total of approximately 2,000 patients until the occurrence of a pre-specified number of liver-related clinical events. The trial would be completed on a post-marketing basis in the event that accelerated (U.S.) / conditional (EU) approval is received. Based on the results from part 2, Inventiva plans to seek full regulatory approval for lanifibranor in both the United States and the EU.

    In addition to the key primary and secondary endpoints, the impact of lanifibranor on biomarkers of metabolic health will be evaluated as part of the trial. The occurrence of Major Adverse Cardiovascular Events (MACE), such as myocardial infarction and stroke, will also be evaluated as an exploratory efficacy endpoint and to establish the safety profile of lanifibranor.

    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 FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH.

    About NASH

    Non-alcoholic steatohepatitis (NASH) is a serious liver disease characterized by excessive fat accumulation in the liver, chronic inflammation and tissue injury (hepatitis), resulting in progressive fibrosis that can lead to cirrhosis, and subsequently portal hypertension, liver insufficiency and potential liver cancer. The prevalence of NASH is rapidly increasing globally in parallel to the growing epidemics of obesity and type 2 diabetes (T2DM); correspondingly, the proportion and number of liver transplants attributable to NASH has expanded considerably in the past years. To date, there are still no drug therapies approved 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

    Pascaline Clerc

    VP of Global External Affairs



    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    Patti.bank@westwicke.com

    +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 is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, 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 adverse drug reactions 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, and 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 for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the full-year financial report for the year ended December 31, 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 For more details, please refer to: clinicaltrial.gov/NCT04849728.





    2 Site qualification is the process by which the study sponsor, in this case Inventiva, and/or clinical research organization determine whether the investigator and the clinical site have the resources and capabilities necessary to conduct the study.





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  3. Forbion Appoints Nanna Lüneborg as a General Partner

    - Brings extensive international investment and board experience in life sciences companies of all sizes including company creations, private venture deals and IPOs -

    Naarden, The Netherlands, 1 September 2021 – Forbion, a leading European life sciences venture capital firm, today announces the appointment of Nanna Lüneborg, PhD as a General Partner to work on the €360m Forbion Growth Opportunities Fund.

    Prior to joining Forbion, Nanna was a Partner at Novo Ventures and a key member of the European deal team focussing on late-stage biopharma investments across Europe. During her 10 years at Novo, Nanna was involved in numerous successful European growth stage investments including high-profile…

    Forbion Appoints Nanna Lüneborg as a General Partner

    - Brings extensive international investment and board experience in life sciences companies of all sizes including company creations, private venture deals and IPOs -

    Naarden, The Netherlands, 1 September 2021 – Forbion, a leading European life sciences venture capital firm, today announces the appointment of Nanna Lüneborg, PhD as a General Partner to work on the €360m Forbion Growth Opportunities Fund.

    Prior to joining Forbion, Nanna was a Partner at Novo Ventures and a key member of the European deal team focussing on late-stage biopharma investments across Europe. During her 10 years at Novo, Nanna was involved in numerous successful European growth stage investments including high-profile cross-over deals and IPOs. Notable investments led by Nanna include NBE Therapeutics GmbH, which was later acquired by Boehringer Ingelheim, LAVA Therapeutics N.V. (NASDAQ:LVTX) Orphazyme A/S (ORPHA.CO; ORPH), Inventiva S.A. (NASDAQ:IVA), ObsEva SA (NASDAQ:OBSV, SIX: OBSN))), Numab Therapeutics AG, Nodthera Limited and ReViral Ltd.

    Nanna began her career in venture capital at Apposite Capital and worked as a Senior Business Analyst at Cancer Research UK. Nanna holds an MBA from the University of Cambridge, a PhD in Neuroscience from University College London, and a BA in Physiology and Psychology from the University of Oxford.

    Sander Slootweg, Managing Partner at Forbion, commented, "Nanna is a highly respected and accomplished life sciences venture capitalist with a strong track record for building life science companies at all stages of development, leading deals with academic institutions and small start-ups, growth stage companies and larger public companies. We are delighted to welcome Nanna on board."

    Dirk Kersten, General Partner at Forbion, added, "I am excited that Nanna decided to join the Forbion Growth team. In her role as a General Partner, Nanna will play a pivotal role in sourcing new investment opportunities in late-stage European biotech companies. Over the past 13 years, Nanna built a very strong reputation in Europe and brings a unique network of biotech entrepreneurs and specialist life science investors. With Nanna joining, the Forbion Growth team expanded to a group of 8 life science investment professionals; with an exclusive focus on serving the European market of life sciences growth capital."

    Nanna Lüneborg, newly appointed General Partner at Forbion said, "Forbion is one of Europe's leading life science venture capital firms and its strength in the life science space is recognised globally. Forbion's philosophy distinguishes it from its peers, through the broad expertise of the team which supports portfolio companies as they grow, to develop and commercialize their products. I look forward to working closely with the Forbion team to help implement its strategy: to enable the most innovative companies to bring new impactful treatments and therapies to market."

    Nanna will relocate from Denmark to The Netherlands and will be working from the company's headquarters in Naarden.

    ENDS

    For more information please contact:

    Media Enquiries

    Laura Asbjornsen, Head of Communications

    Email: laura.asbjornsen@forbion.com

    Tel: +31 (0) 35 699 30 00

    Consilium Strategic Communications

    Ashley Tapp, Sue Charles

    Email: forbion@consilium-comms.com

    Tel: +44 (0)20 3709 5700

    About Forbion

    Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over EUR 1.7 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion's current team consists of 20 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in over 70 companies. The firm is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, "ERP – Venture Capital Fonds investments". Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany.

    For more information, please visit: www.forbion.com



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  4. Daix (France), August 30, 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 that the Company's leadership will participate in four upcoming investor conferences in September 2021.

    The event details are as follows:

    Conference n°1:              KBCs Life Sciences Conference

    Event type:                       One-on-one investor meetings

    Date:                                   Tuesday-Thursday, September 7-9, 2021

    Format:                              Virtual event

    Conference n°2:              Citi's 16th Annual BioPharma Virtual Conference

    Event type:                       One-on-one investor meetings

    Date:                                   Wednesday-Saturday, September 8-11, 2021

    Format:                              Virtual event

    Conference n°3:              H.C. Wainwright 23rd Annual Global Investment Conference

    Event type:                       Corporate presentation, fireside chat, one-on-one investor meetings

    Date:                                   Monday, September 13, 2021

    Time:                                  7:00 – 8:00 am (ET) / 1:00 – 2:00 pm (CET)

    Format:                              Hybrid event  

    Conference n°4:              Lyon Pôle Bourse Investment Forum

    Event type:                       One-on-one, one-to-few and group investor meetings

    Date:                                   Tuesday-Wednesday, September 28-29, 2021

    Format:                              Hybrid event

    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 preclinical 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 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

    Pascaline Clerc

    VP of Global External Affairs



    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +1 415 513 1284
       

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  5. Daix (France), August 2, 2021 (GLOBE NEWSWIRE) – Inventiva S.A. (NASDAQ:IVA) (the "Company"), a clinical-stage biotechnological company focused on the development of oral small molecule therapies for the treatment of patients with significant unmet medical need in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the implementation of an At-The-Market ("ATM") program allowing the Company to issue and sell, including with unsolicited investors who have expressed an interest, ordinary shares in the form of American Depositary Shares ("ADS"), each ADS representing one ordinary share of Inventiva, with aggregate gross sales proceeds of up to $100,000,000 (subject to a regulatory limit of 20% dilution and within the…

    Daix (France), August 2, 2021 (GLOBE NEWSWIRE) – Inventiva S.A. (NASDAQ:IVA) (the "Company"), a clinical-stage biotechnological company focused on the development of oral small molecule therapies for the treatment of patients with significant unmet medical need in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the implementation of an At-The-Market ("ATM") program allowing the Company to issue and sell, including with unsolicited investors who have expressed an interest, ordinary shares in the form of American Depositary Shares ("ADS"), each ADS representing one ordinary share of Inventiva, with aggregate gross sales proceeds of up to $100,000,000 (subject to a regulatory limit of 20% dilution and within the limits of the investors' requests expressed in the context of the program), from time to time, pursuant to the terms of a sale agreement with Jefferies LLC ("Jefferies"), acting as sales agent. The timing of any issuances in the form of ADSs will depend on a variety of factors. The ATM program will be effective until August 2, 2024, unless terminated prior to such date in accordance with the sale agreement or the maximum number of ADSs to be sold thereunder has been reached.

    The Company currently intends to use the net proceeds, if any, of sales of ADSs issued under the program to fund the research and development of its product candidates, and for working capital and general corporate purposes.

    Jefferies, as sales agent, will use commercially reasonable efforts to arrange on the Company's behalf for the sale of all ADSs requested to be sold by the Company, in accordance with standard market practices. Sales prices may vary based on market prices and other factors. Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM program.

    The ADSs and the underlying ordinary shares will be issued through a capital increase without shareholders' preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to the 20th resolution adopted by the annual general meeting of shareholders held on April 16, 2021 (or any substitute resolutions, adopted from time to time), for an aggregate offering amount of up to $100.0 million, being specified that the maximum number of new shares to be admitted on the regulated market of Euronext Paris is capped at 20% of the number of shares admitted to trading on such market, including shares admitted without prospectus during the last twelve months at the date of their issuance. The new ordinary shares to be sold in the form of ADSs would be issued in one or more offerings at the market price of each offering of the ADSs at the time of pricing of the considered capital increase.

    The ATM program may only be issued to the categories of investors defined in the 20th resolution adopted by the annual general meeting of shareholders held on April 16, 2021 (or any similar resolutions that may be substituted to them in the future), comprising (i) natural or legal persons (including companies) trusts or investment funds, or other investment vehicles, in any form, established under French or foreign law, which regularly invest in the pharmaceutical, biotechnological or medical technology sectors, and/or (ii) companies, institutions or entities, in any form, French or foreign, exercising a significant part of its activities in the pharmaceutical, cosmetic or chemical sectors, or medical devices and/or technologies, or researching in such sectors. The new ordinary shares will be admitted to trading on the regulated market of Euronext in Paris and the issued ADSs will trade on the Nasdaq Global Market ("Nasdaq").

    On an illustrative basis, assuming the issuance of the full amount of 7,593,015 ADSs at an assumed offering price of $13,17 (or €11,361), the last reported sale price of the ADSs on Nasdaq on July 29, 2021, for the maximum gross proceeds of $100,000,000 (or €84,224,712.502) under the ATM program, a holder of 1.0% of the outstanding Company's share capital as of the date of this press release, would hold 0.84% of the outstanding Company's share capital after the completion of the transaction (calculated on the basis of the number of outstanding shares on the date of publication of this press release).

    During the term of the ATM program, the Company will include in the publication of its quarterly results information about its use of the program during the preceding quarter and will also provide an update after each capital increase on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM program from time to time.

    A shelf registration statement on Form F-3, including a base prospectus relating to Inventiva's securities and a sales agreement prospectus relating to the ATM program, was filed with the SEC, but has not yet become effective. The securities referred to in the registration statement may not be sold, nor may offers to buy them be accepted, prior to the time the registration statement becomes effective. Before purchasing ADSs in the offering, prospective investors should read the base prospectus and the accompanying sales agreement prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC's website at www.sec.gov. Alternatively, a copy of the base prospectus and the accompanying sales agreement prospectus relating to the offering may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at Prospectus_Department@Jefferies.com. No prospectus will be subject to the approbation of the Autorité des Marchés Financiers ("AMF") pursuant to Regulation (EU) 2017/1129 of the European Parliament and of the Council dated June 14, 2017, as amended (the "Prospectus Regulation") since the contemplated share capital increase (for the issuance of the ordinary shares underlying the ADS) would be offered to qualified investors (as such term is defined in Article 2(e) of the Prospectus Regulation) and fall under the exemption provided for in Article 1(5)(a) of the Prospectus Regulation which states that the obligation to publish a prospectus shall not apply to admission to trading on a regulated market of securities fungible with securities already admitted to trading on the same regulated market, provided that they represent, over a period of 12 months, less than 20% of the number of securities already admitted to trading on the same regulated market.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.

    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 preclinical 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 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

    Pascaline Clerc

    VP of Global External Affairs



    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +1 415 513 1284
         

    Special Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements, forecasts and estimates with respect to the ATM program, 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. 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 the timing and use, if any, of the ATM program, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, 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 adverse drug reactions 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, and 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 for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, under number D.21-0124, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the full-year financial report for the year ended December 31, 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. This document, as well as other regulated information and all of the Company's press releases, are available on its website and on the AMF website (www.amf-france.org) and are available free of charge on request at the Company's registered office at 50, rue de Dijon, 21121 Daix, France.








     

    1 Based on a USD-EUR conversion rate of 1.1873





     

    2 Based on a USD-EUR conversion rate of 1.1873





     

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    • Cash and cash equivalents at €93.6 m as of June 30, 2021
    • Revenues of €0.2 m in H1 2021


    Daix (France), July 28, 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 June 30, 2021 and its revenues for the first half of 20211.

    Cash Position

    As of June 30, 2021, Inventiva's cash and cash equivalents stood at €93.6 million compared to €107.8 million as of March 31, 2021 and €113.02 million as of December 31, 2020.

    Net cash used in operating activities amounted to €19.8 million in the first…

    • Cash and cash equivalents at €93.6 m as of June 30, 2021
    • Revenues of €0.2 m in H1 2021



    Daix (France), July 28, 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 June 30, 2021 and its revenues for the first half of 20211.

    Cash Position

    As of June 30, 2021, Inventiva's cash and cash equivalents stood at €93.6 million compared to €107.8 million as of March 31, 2021 and €113.02 million as of December 31, 2020.

    Net cash used in operating activities amounted to €19.8 million in the first half of 2021 compared to €7.2 million for the same period in 2020. R&D expenses for the first half of 2021 were up 56% compared to the first half of 2020, mainly driven by the development of lanifibranor in NASH and costs linked to the preparation for the initiation of NATiV3, the Company's Phase III clinical trial evaluating lanifibranor in NASH. This amount includes the payment received on June 30, 2021 of €8.0 million of Research Tax Credit (CIR - Crédit Impôt Recherche) (€3.8 million related to complementary filings following the 2020 Conseil d'État judgement covering prior years, and €4.2 million related to the 2020 Research Tax Credit), while the first half of 2020 had been positively impacted by the receipt of a €4.2 million non-recurrent late payment of the 2018 Research Tax Credit and a €4.2 million payment in respect of the 2019 Research Tax Credit.

    Net cash used from investing activities amounted to €1.2 million in the first half of 2021 compared to 1.0 million for the same period in 2020.

    No net cash from financing activities was generated over the first half of 2021 while Inventiva recorded

    €24.6 million of net cash from financing activities for the same period in 2020, notably related to the issuance of €15 million (gross proceeds) of ordinary shares in February 2020 and the entry into a €10.0 million State-guaranteed loan, with a syndicate of French banks in May 2020.

    Over the first semester of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalent of €1.2 million.

    Considering its current R&D and clinical development programs, and excluding additional financial resources, Inventiva's cash runway will allow to fund its operating activities through the third quarter of 2022.

    Revenues

    The Company's revenues for the first half of 2021 amounted to €0.2 million, as compared to €0.1 million for the same period in 2020.

    As part of its collaboration with Abbvie in auto-immune diseases3, Inventiva is eligible to receive development, regulatory and commercial milestone payments as well as royalty payments. As such, the Company expects to receive another milestone payment upon the initiation by AbbVie of the Phase IIb clinical trial with cedirogant before the end of 2021.

                                                                                                          ***                                               

               

    Next key milestones expected

    • First patient first visit of NATiV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for the third quarter of 2021
    • Initiation by AbbVie of a Phase IIb clinical trial with cedirogant – expected in the second half of 2021
    • Strategy update on the development of odiparcil – planned for the second half of 2021
    • Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2DM) – planned for the first half of 2022

    Upcoming investor conference participation

    • Citi's 16th Annual BioPharma Conference 2021, September 8-9, 2021
    • KBC Virtual Life Science Conference, September 7-9, 2021
    • H.C. Wainwright 23rd Annual Global Investment Conference, September 13-15, 2021
    • Lyon Pôle Bourse Forum, September 27-28, 2021
    • HealthTech Innovation Days 2021, October 4-5, 2021
    • Portzamparc Health Biotech Seminar 2021, October 6, 2021
    • Guggenheim CV&M Disease Day, October 7, 2021
    • H.C. Wainwright 5th Annual NASH Investor Conference, October 11, 2021
    • Stifel Healthcare Conference 2021, November 16-17, 2021
    • Jefferies 2021 London Healthcare Conference, November 16-18, 2021

    Upcoming scientific conference participation

    • Paris NASH Meeting, October 22-23, 2021
    • AASLD The Liver Meeting, November 12-15, 2021

    Next financial results publication

    • H1 2021 Financial results: Monday, September 20, 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 preclinical 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 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

    Pascaline Clerc

    VP of Global External Affairs



    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +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 is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, 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 adverse drug reactions 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, and 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 for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the full-year financial report for the year ended December 31, 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.  

    3 See AbbVie Q1 2021 earnings call on April 30, 2021, 9 AM ET; Transcript from FactSet.



    Attachment



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    • Two oral presentations showing
      • the beneficial effects of lanifibranor on cardiovascular risk biomarkers in patients with NASH
      • the positive effects of lanifibranor on several biomarkers of disease activity and associated risks in patients with NASH and F2/F3 fibrosis
    • One poster presentation showing the beneficial effects of the combination treatment of lanifibranor and ACC1/2 inhibitor firsocostat from Gilead
    • Inventiva will host a dedicated Key Opinion Leader (KOL) webcast event for investors and analysts on June 29, 2021


    Daix (France), June 9, 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…



    • Two oral presentations showing
      • the beneficial effects of lanifibranor on cardiovascular risk biomarkers in patients with NASH
      • the positive effects of lanifibranor on several biomarkers of disease activity and associated risks in patients with NASH and F2/F3 fibrosis
    • One poster presentation showing the beneficial effects of the combination treatment of lanifibranor and ACC1/2 inhibitor firsocostat from Gilead
    • Inventiva will host a dedicated Key Opinion Leader (KOL) webcast event for investors and analysts on June 29, 2021



    Daix (France), June 9, 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 that three abstracts have been selected for presentation at the upcoming International Liver Congress™ 2021 hosted by the European Association for the Study of the Liver (EASL), June 23-26, 2021. Inventiva will also host a KOL webcast event on June 29, 2021, focusing on the three abstracts, the current NASH field and Inventiva's upcoming Phase III clinical trial on lanifibranor (further details below).

    The first abstract focusing on the beneficial effects of lanifibranor on cardiovascular risk biomarkers has been selected for an oral presentation. Based on the results of Inventiva's NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH, the authors of the abstract analyzed the change in the cardiovascular risk profile in patients with NASH by measuring several serum biomarkers. Lanifibranor showed beneficial effects on several cardiovascular risk biomarkers, including dyslipidemia, insulin resistance, inflammation and high blood pressure, confirming its promising profile as a potential treatment for NASH.

    The second abstract covering the positive effects of lanifibranor on biomarkers of disease activity and associated risks in patients with NASH and F2/F3 fibrosis has also been selected for an oral presentation. Based on the results of the Company's NATIVE Phase IIb clinical trial, the authors of the abstract evaluated the effects of lanifibranor on several serum biomarkers of lipid metabolism, insulin resistance, liver injury, inflammation and fibrosis in the patient subgroup with F2/F3 fibrosis. The data showed that lanifibranor improved all selected serum biomarkers, confirming its previously reported histological efficacy, and supporting Inventiva's focus on patients with NASH and F2/F3 fibrosis in its upcoming Phase III clinical trial with lanifibranor.

    The third abstract covering the beneficial effects of the combination treatment of lanifibranor and the ACC1/2 inhibitor firsocostat from Gilead in a non-clinical model of NASH and fibrosis has been accepted for a poster presentation. The results obtained in this diet-induced murine model showed the beneficial and complementary effects of the two compounds on metabolic lipids, demonstrating greater efficacy than the monotherapy for all parameters evaluated, and leading to further improvement of NASH and fibrosis. This data supports the clinical investigation of a combination of lanifibranor and firsocostat in NASH patients.

    The details of the various presentations are as follows:

    Abstract #1:

    Abstract title:"Lanifibranor therapy improves markers of lipid metabolism, insulin resistance, liver injury and fibrosis in patients with NASH and F2 and F3 fibrosis stages: a subgroup analysis of the Phase IIb NATIVE study"
    Publication number:1044
    Presentation type:Oral presentation, abstract session
    Authors:Sven Francque, Michael P. Cooreman, Martine Baudin, Philippe Huot-Marchand, Lucile Dzen, Jean-Louis Junien, Pierre Broqua, Manal F. Abdelmalek
    Presenting author:Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial
    Date:June 25, 2021
    Session time:2:15 pm - 2:30 pm CET



    Abstract #2
    :

    Abstract title:"The pan-PPAR agonist lanifibranor significantly improves cardiovascular risk biomarkers in patients with NASH "
    Publication number:1034
    Presentation type:Oral presentation, abstract session
    Authors:Sven Francque, Michael P. Cooreman, Martine Baudin, Philippe Huot-Marchand, Lucile Dzen, Jean-Louis Junien, Pierre Broqua, Manal F. Abdelmalek
    Presenting author:Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial
    Date:June 25, 2021
    Session time:3:00 pm - 3:15 pm CET
      



    Abstract #3
    :

    Abstract title:"Combination therapy of lanifibranor and firsocostat further improves steatohepatitis and fibrosis compared to monotherapy in a Diet-Induced Murine Model of NASH"
    Publication number:1727 
    Presentation type:Poster presentation
    Authors:



     
    Guillaume Wettstein, François Briand, Thierry Sulpice, Jean-Louis Junien and Pierre Broqua
    Date:June 23, 2021
      



    KOL webcast event

    To close Inventiva's participation to the EASL International Liver CongressTM 2021, the Company will host a dedicated KOL webcast event for investors and analysts at 10:00 am (ET) / 4:00 pm (CET) on June 29, 2021, covering the three abstracts mentioned above, the current NASH field, and Inventiva's upcoming Phase III clinical trial on lanifibranor.

    Introduced by Frédéric Cren, Chairman, CEO and cofounder of Inventiva, this event will be composed of three distinct parts, including dedicated Q&A sessions:

    Part #1 :

    Topic:"Review of EASL 2021 abstracts"
    Speaker:Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial



    Part #2
    :

    Topic:"Update on the NASH field"
    Speaker:Prof. Arun Sanyal, Virginia Commonwealth University, Member of Inventiva's Scientific Advisory Board



    Part #3
    :

    Topic:"Overview of Phase III NASH trial"
    Speaker:Dr. Michael Cooreman, Chief Medical Officer of Inventiva



    The details to connect to the webcast are the following:

    Date:Tuesday, June 29, 2021
    Time:10:00 am - 11:30 am (ET) / 4:00 pm - 5:30 pm (CET)
    Connection details:Option #1 – Webcast: https://edge.media-server.com/mmc/p/d7qtzuzi



    Option #2 – Conference call:



    France: +33 (0) 1 70 70 82 21

    Belgium: +32 (0) 2 400 3439

    Germany: +49 (0) 69 2443 7403

    Netherlands: +31 (0) 20 715 7566

    Switzerland: +41 (0) 44 580 6084

    United Kingdom: +44 (0) 203 009 5709

    United States: +1 646-787 1226





    Access code: 6207208#



    The presentation document and the link to the webcast (live and replay) will also be available on Inventiva's website in the "Investors – Investor Presentations" section: http://inventivapharma.com/investors/investor-presentations/.



    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 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

    Pascaline Clerc

    VP of Global External Affairs



    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +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 adverse drug reactions 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, and 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 for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the full-year financial report for the year ended December 31, 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.

    Attachment



    View Full Article Hide Full Article
    • Cash and cash equivalents at €107.8m as of March 31, 2021
    • Revenues of €0.1m in Q1 2021
    • Decision by AbbVie to move into Phase IIb clinical development with cedirogant in psoriasis, following promising results in its Phase Ib clinical trial


    Daix (France), May 12, 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 March 31, 2021 and its revenues for the first quarter of 2021, and provided an update on its collaboration with AbbVie in auto-immune diseases.

    Cash Position

    As of March…

    • Cash and cash equivalents at €107.8m as of March 31, 2021

    • Revenues of €0.1m in Q1 2021
    • Decision by AbbVie to move into Phase IIb clinical development with cedirogant in psoriasis, following promising results in its Phase Ib clinical trial



    Daix (France), May 12, 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 March 31, 2021 and its revenues for the first quarter of 2021, and provided an update on its collaboration with AbbVie in auto-immune diseases.

    Cash Position

    As of March 31, 2021, Inventiva's cash and cash equivalents stood at €107.8 million compared to €113.0 million as of December 31, 2020.

    Net cash used in operating activities amounted to €7.8 million in the first quarter of 2021 compared to €3.6 million for the same period in 2020. R&D expenses for the first quarter, mainly driven by the development of lanifibranor in NASH, were up 22% compared to the first quarter of 2020. This increase in cash used is due to the preparation for the initiation of NATIV3, a Phase III clinical trial evaluating lanifibranor in NASH, while the first quarter of 2020 had been positively impacted by the receipt of a €4.2 million non-recurrent late payment of the 2018 research tax credit.

    Net cash from investing activities for the first quarter of 2021 amounted to €1.1 million, as compared to no net cash from investing activities generated in the first quarter of 2020.        

    No net cash from financing activities was generated over the first quarter of 2021 while Inventiva recorded €14.6 million of net cash from financing activities for the same period in 2020, notably related to the issuance of €15 million (gross proceeds) of ordinary shares in February 2020.

    Over the first quarter of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalent of €3.7 million.

    Considering its current R&D and clinical development programs, and excluding additional financial resources, Inventiva has adjusted its projected cash runway by one quarter, allowing the Company to finance its operating activities through the third quarter of 2022 compared to the fourth quarter of 2022 as previously communicated.



    Revenues

    The Company's revenues for the first quarter of 2021 amounted to €0.1 million, similar to the amounts received in the first quarter of 2020.



    Update on the collaboration with AbbVie in auto-immune diseases
    2

    Cedirogant, a clinical stage RORγ inverse agonist co-discovered by Inventiva with potential in several auto-immune diseases, demonstrated promising activity as an oral psoriasis agent during a Phase Ib clinical trial3 led by AbbVie. Following these results, AbbVie has decided to move the drug candidate into a Phase IIb dose-ranging study, planned to be initiated in the second half of 2021.  

    As part of this collaboration, Inventiva is eligible to receive development, regulatory and commercial milestone payments as well as royalty payments. As such, the Company expects to receive another milestone payment upon the initiation by AbbVie of the Phase IIb clinical trial with cedirogant.

                                                                                                        

    ***

    Next key milestones expected

    • Initiation of NATIV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for the first half of 2021
    • Initiation by AbbVie of a Phase IIb clinical trial with cedirogant – expected in the second half of 2021
    • Strategy update on the development of odiparcil – planned for 2021
    • Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2DM) – planned for the first half of 2022



    Upcoming investor conference participation

    • Jefferies Virtual Healthcare Conference, June 1-4, 2021
    • SVB Leerink CybeRx Series: Liver Disease Day, June 17, 2021
    • Citi's 16th Annual BioPharma Conference 2021, September 8-9, 2021
    • H.C. Wainwright 23rd Annual Global Investment Conference, September 13-15, 2021
    • Portzampac Health Biotech Seminar 2021, October 6, 2021
    • Stifel Healthcare Conference 2021, November 16-17, 2021
    • Jefferies 2021 London Healthcare Conference, November 16-18, 2021     



    Upcoming scientific conference
    participation

    • International Liver Congress 2021, June 23-26, 2021
    • Paris NASH Meeting, October 22-23, 2021
    • AASLD The Liver Meeting, November 12-15, 2021



    Next financial results publication

    • Revenues and cash position for the first half of 2021: Wednesday, July 28, 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. In 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

    Pascaline Clerc

    VP of Global External Affairs



    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +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, and 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 for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the full-year financial report for the year ended December 31, 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 See AbbVie Q1 2021 earnings call on April 30, 2021, 9 AM ET; Transcript from FactSet.

    3 This Phase Ib clinical trial led by AbbVie was a randomized, double-blind, placebo-controlled, multiple-dose trial to evaluate the pharmacokinetics, safety and tolerability of cedirogant in 60 healthy volunteers and patients with chronic plaque psoriasis (clinicaltrials.gov identifier: NCT03922607).



    Attachment



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  6. Daix (France), April 19, 2021
    – Inventiva (NASDAQ:IVA) is pleased to announce the appointment of Martine Zimmermann to its Board of Directors as an independent director. Inventiva's Board of Directors appointed Martine Zimmerman to replace Nawal Ouzren, who resigned from the Board of Directors in order to focus on the growth of Sensorion. Martine Zimmerman's appointment will be submitted to the shareholders for ratification at the next general shareholders meeting.

    With over 25 years of global experience in the pharmaceutical industry, Martine Zimmermann has been the Senior Vice President and Head of Global Regulatory Affairs of Alexion Pharma International since June 2016. Throughout her career, she has acquired extensive expertise as…



    Daix (France), April 19, 2021
    – Inventiva (NASDAQ:IVA) is pleased to announce the appointment of Martine Zimmermann to its Board of Directors as an independent director. Inventiva's Board of Directors appointed Martine Zimmerman to replace Nawal Ouzren, who resigned from the Board of Directors in order to focus on the growth of Sensorion. Martine Zimmerman's appointment will be submitted to the shareholders for ratification at the next general shareholders meeting.

    With over 25 years of global experience in the pharmaceutical industry, Martine Zimmermann has been the Senior Vice President and Head of Global Regulatory Affairs of Alexion Pharma International since June 2016. Throughout her career, she has acquired extensive expertise as Regulatory Affairs Executive in both small and large pharmaceutical groups, holding senior roles in the United States, Europe and Asia-Pacific. Martine Zimmermann has worked across all phases of drug development within several therapeutic areas, interacting with relevant regulatory authorities in key markets, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). She is also an active member of several life-sciences trade associations and has been a member of the Board of Directors of U.S.-based Caelum Biosciences since 2019.

    Frédéric Cren, Chairman, CEO and co-founder of Inventiva, commented: "I am very pleased to welcome Martine Zimmermann to Inventiva's Board of Directors. Her deep knowledge of the industry and her international experience, paired with her expertise in regulatory matters across geographies, will be a great addition for the Company. At the same time, I would like to warmly thank Nawal Ouzren on behalf of the Board for her valuable contribution to Inventiva over the last two years and wish her all the best going forward."



    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 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

    info@inventivapharma.com

    +33 3 80 44 75 00
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +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 and that any new appointments may not be ratified by the shareholders. 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 for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the full-year financial report for the year ended December 31, 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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  7.  ►     Publication of positive topline results from the NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH and decision to move into pivotal Phase III development

     ►     Breakthrough Therapy Designation granted to lanifibranor in NASH by the U.S. Food and Drug Administration (FDA)

     ►     Finalization of Phase III clinical trial design with lanifibranor in NASH following end-of-phase II meeting with the FDA and receipt of Scientific Advice letter from the European Medicines Agency (EMA)

     ►     Expansion into the United States with appointment of Dr. Michael Cooreman, M.D., as Chief Medical Officer and opening of U.S. subsidiary

     ►     Announcement of timeline for Phase III clinical trial evaluating lanifibranor in NASH…

     ►     Publication of positive topline results from the NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH and decision to move into pivotal Phase III development

     ►     Breakthrough Therapy Designation granted to lanifibranor in NASH by the U.S. Food and Drug Administration (FDA)

     ►     Finalization of Phase III clinical trial design with lanifibranor in NASH following end-of-phase II meeting with the FDA and receipt of Scientific Advice letter from the European Medicines Agency (EMA)

     ►     Expansion into the United States with appointment of Dr. Michael Cooreman, M.D., as Chief Medical Officer and opening of U.S. subsidiary

     ►     Announcement of timeline for Phase III clinical trial evaluating lanifibranor in NASH

     ►     Confirmation by the FDA that the toxicology package regarding lanifibranor is complete and acceptable to support the filing of a New Drug Application (NDA) for the treatment of NASH and improvement of liver fibrosis

     ►     Completion of World Health Organization's (WHO) International Nonproprietary Names (INN) process by AbbVie for ABBV-157, now named cedirogant

     ►     Cash position1 at €113.0m as of December 31, 2020 compared to €35.8m as of December 31, 2019

     ►     Successful €94.9m2 initial public offering (IPO) on the Nasdaq Global Market in the U.S, extending the Company's cash runway through Q4 2022



    Daix (France), March 4, 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 full-year results for 2020.

    Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: "2020 has truly been one of the most transformative years since the establishment of Inventiva in 2012, driven by a series of major achievements. Following very promising results from our NATIVE Phase IIb clinical trial in NASH and the U.S. FDA ‘Breakthrough Therapy' designation of lanifibranor, the FDA and EMA have given us their green light to initiate the pivotal Phase III trial with our lead drug candidate, the design of which we have finalized in the beginning of this year. Based on these milestones, clearly confirming the potential of lanifibranor to become a reference treatment for NASH, we have decided to focus our efforts on this particular program while, in parallel, evaluating all options to optimize the development of our second clinical-stage asset odiparcil in MPS VI. At the same time, we were able to significantly extend our cash runway and boost our visibility in the United States thanks to the success of our IPO on the Nasdaq Global Market. Together with the appointment of Dr. Michael Cooreman as Chief Medical Officer and the very recent opening of Inventiva's subsidiary in the United States, we are on track to initiate the Phase III clinical trial with lanifibranor in NASH in the first half of this year."



    Key financial results

    Inventiva's key financial figures for its 2020 full-year results are as follows:

    As of December 31, 2020, the Company's cash position3 (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.

    • In 2020, net cash used in operating activities amounted to (€30.6) million compared to (€28.4) million in 2019. This increase was 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 U.S. 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 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 last payment from Boehringer Ingelheim as part of its collaboration with the Company.

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

       
    • Finally, net cash from financing activities amounted to €111.7 million in 2020 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 million4 (gross proceeds) following the Company's successful U.S. IPO in July 2020, extending Inventiva's cash runway through the fourth quarter of 2022.



    In 2020, Inventiva's revenues amounted to €0.4 million compared to €7.0 million in 2019.While Inventiva did not expect to generate any revenues in 2020, this decrease was driven by the Company recording the payment of €3.5 million under its collaboration with AbbVie in December 2019, the revenues of €2.6 million under its collaboration with Boehringer Ingelheim in November 2019, including the payment of €0.5 million and the €2.1 million write back entry, in accordance with IFRS 15 "Revenue from Contracts with Customer", following the end of this research collaboration after Inventiva fulfilled all its commitments.

    Other income amounted to €4.9 million in 2020 versus €4.3 million in 2019, up 14%, mainly driven by the receipt of the 2018 and 2019 Research Tax Credit.

    R&D expenses amounted to €23.7 million in 2020 versus €33.8 million in 2019, down 29%. These expenses were mainly dedicated to the development of lanifibranor in NASH and odiparcil in MPS VI. The decrease compared to the previous year was mainly due to the halt of the clinical development of lanifibranor in systemic sclerosis in February 2019 and the savings generated by the Employment Safeguard Plan subsequently introduced, with 2020 recording the full effect of the savings generated. In addition, while the Company had recorded R&D expenses related to the NATIVE Phase IIb clinical trial in NASH for the entire fiscal year in 2019, Inventiva did not record as significant clinical development expenses in the second half of 2020 as in the first half of 2020 given the successful conclusion of the NATIVE Phase IIb trial in June 2020.  

    General and administrative expenses amounted to €8.5 million in 2020 compared to €6.1 million in 2019, primarily driven by expenses related to the preparation of the Company's IPO in the U.S. and the increased operational recurring expenses linked to Inventiva's dual listing status following its listing on Nasdaq.

    Other operating income (expenses) amounted to €2.2 million in 2020 compared to €1.5 million in 2019. The first half of 2019 took into account the recording of a provision of €1.1 million relating to the Employment Safeguard Plan, while 2020 recorded non-recurring expenses incurred as part of the IPO in the U.S., not reflected in the share premium of issued shares, and a non-recurring net income related to the Research Tax Credit of previous years.

    Due to the unfavourable exchange rate between USD and Euro following the Company's IPO in the U.S. and listing on Nasdaq in July 2020, Inventiva has incurred a net financial loss of €3.9 million.

    The Company' net loss stood at €33.6 million in 2020 compared to a loss of €30.2 million in 2019.

    The following table presents Inventiva's income statement, prepared in accordance with IFRS, for the 2020 financial year, with comparatives for the 2019 financial year:

    (in thousands of euros, except share and per share amounts) December 31,

    2020
     December 31,

    2019
    Revenues 372 6,998
    Other income 4,891 4,293
    Research and development expenses (23,717) (33,791)
    Marketing – business development expenses (563) (249)
    General and administrative expenses (8,499) (6,088)
    Other operating income (expenses) (2,202) (1,475)
    Net operating loss (29,718) (30,312)
    Net financial income (loss) (3,902) 93
    Income tax - -
    Net loss for the period (33,619) (30,218)
    Basic / diluted loss per share (euros/share) (0.99) (1.28)
    Weighted average number of outstanding shares used for computing basic/diluted loss per share 33,874,751 23,519,897
         



    Announcement of the timeline for the Phase III clinical trial with lanifibranor in NASH

    Inventiva is progressing on the initiation of its NATIV3 (NASH lanifibranor Phase 3 trial) Phase III clinical trial evaluating lanifibranor in NASH, and has defined the following timeline for Part 1 of the study5:

    • First site active – expected for the second quarter of 2021
    • First Patient First Visit – expected in the third quarter of 2021
    • Last Patient First Visit – expected in the second half of 2022
    • Last Patient Last Visit – expected in the first half of 2024
    • Publication of headline results – expected in the second half of 2024



    Update on non-clinical toxicology data regarding lanifibranor

    During a type B meeting with the FDA, the regulatory body has confirmed that the non-clinical toxicology package available for lanifibranor is both complete and acceptable to support the filing of a NDA for the targeted indication of treatment of NASH and improvement of liver fibrosis. The package includes the results of two-year carcinogenicity studies in mice and rats as well as long-term toxicology studies of up to one year in monkeys.



    Update of the timeline for the Phase II clinical trial with lanifibranor in type 2 diabetes patients (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)

    The COVID-19 pandemic has had a large impact on patient enrollment during 2020. In this context, the publication of the study results are now expected in the first half of 2022 versus 2021 as previously announced.



    Update on the collaboration
    with AbbVie in auto-immune diseases

    Following the completion of the WHO INN process by AbbVie, the name of "cedirogant" has been attributed to ABBV-157, the selective and orally-available ROR-y inverse agonist jointly discovered with AbbVie for the treatment of auto-immune diseases.

    Due to the current COVID-19 context, the cedirogant Phase I clinical study in psoriasis patients led by AbbVie is now expected to read out in the second quarter of 2021 compared to the first quarter of 2021 as previously announced. 



    Main areas of progress in the R&D portfolio

    Lanifibranor in non-alcoholic steatohepatitis (NASH)

    • Launch of a collaboration with Professor Jérôme Boursier, M.D., Ph.D, Professor of Medicine at the Faculty of Medicine of Angers University, to develop one or several non-invasive biomarkers or a composite non-invasive biomarker score to identify patients responding to lanifibranor with regards to NASH resolution and fibrosis improvement – February 25, 2021

       
    • Finalization of the design of the pivotal Phase III clinical trial with lanifibranor in NASH following the receipt of the Scientific Advice letter from the EMA; confirmation of the initiation of the trial in the first half of 2021 – January 5, 2021

       
    • Publication of new pre-clinical data on lanifibranor for the treatment of cirrhosis by the peer-reviewed scientific journal Journal of Hepatology, showing the beneficial effects of its mechanism of action on portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease (ACLD) – December 7, 2020

       
    • Conclusions from Inventiva's end-of-phase II meeting with the U.S. FDA for lanifibranor following the publication of positive topline results from its NATIVE Phase IIb clinical trial in NASH – November 10, 2020

       
    • Receipt of the U.S. FDA "Breakthrough Therapy" designation for lanifibranor in NASH enabling the Company to expedite the development and review of the drug candidate – October 12, 2020

       
    • Decision by Professor Kenneth Cusi, the investigator of the ongoing Phase II clinical trial evaluating lanifibranor in T2DM patients with NAFLD, to reduce the number of patients following higher than expected observed effects of lanifibranor in reducing steatosis during the NATIVE Phase IIb clinical trial in NASH – July 6, 2020

       
    • Publication of positive topline results from the NATIVE Phase IIb clinical trial; decision to continue the clinical development of lanifibranor in NASH and enter into pivotal Phase III development – June 15, 2020

       
    • Approval of a new patent protecting the use of lanifibranor for the treatment of several fibrotic diseases, including NASH, in China until June 2035 by the China National Intellectual Property Administration (CNIPA) – May 25, 2020



    Odiparcil in mucopolysaccharidosis type VI (MPS VI)

    • Decision to review all available options to optimize the development of second clinical-stage asset odiparcil for the treatment of MPS VI ; suspension of all MPS-related R&D activities during such time – November 10, 2020

       
    • Receipt of the U.S. FDA "Fast Track" designation for odiparcil in MPS VI – October 19, 2020

       
    • Acceptance of the "Investigational New Drug" (IND) application for odiparcil in MPS VI by the U.S. FDA – August 10, 2020

       
    • Decision by Inventiva to extend the duration of the Phase I/II SAFE-KIDDS (SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study) clinical trial evaluating odiparcil in MPS VI children from 6 to 12 months following a scientific advice meeting with the EMA – July 23, 2020

       
    • Publication of latest data on odiparcil's mechanism of action in the leading scientific journal PLOS ONE, showing that the drug candidate was associated with decreased glycosaminoglycan (GAG) accumulation and increased GAG excretion, and highlighting its distribution in MPS VI disease-relevant tissues and organs – May 18, 2020



    Other significant milestones

    • Opening of Inventiva's subsidiary in the United States ahead of the initiation of the pivotal Phase III clinical trial with lanifibranor in NASH – January, 6, 2021

       
    • Appointment of Dr. Michael Cooreman, M.D., as Inventiva's Chief Medical Officer to succeed Dr. Marie-Paule Richard, M.D., who has decided to take her retirement as of December 17, 2020 – November 5, 2020

       
    • Appointment of Dr. Arun J. Sanyal to Inventiva's Scientific Advisory Board, further strengthening the Board's expertise in the field of NASH – July 29, 2020

       
    • Successful €94.96 million IPO on the Nasdaq Global Market in the United States, extending Inventiva's cash runway through the fourth quarter of 2022 – July 15, 2020

       
    • Entry into a €10.0 million non-dilutive loan facility guaranteed by the French State ("Prêt Garanti par l'Etat"), with the support of Bpifrance, Crédit Agricole Champagne-Bourgogne and Société Générale, contributing to strengthening the Company's cash position in the context of the COVID-19 pandemic – May 19, 2020

       
    • Capital increase of €15 million subscribed by BVF Partners L.P., New Enterprise Associates (NEA), Novo Holdings A/S and Sofinnova Partners – February 11, 2020



    Next key milestones expected

    • Initiation of NATIV3 Phase III clinical trial evaluating lanifibranor in NASH – planned in the first half of 2021

       
    • AbbVie's completion of its ongoing Phase I clinical trial with cedirogant (ABBV-157) in psoriasis patients – expected in the second quarter of 2021

       
    • Strategy update on the development of odiparcil – planned in 2021



    Upcoming investor conference participation

    • 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



    Conference call

    A conference call in English will be held tomorrow, Friday, March 5, 2021 at 2:00 pm (Paris time). To join the conference call, please use the code 3586531 after dialing one of the following numbers:

    France: +33 (0) 1 70 70 07 81

    Belgium: +32 (0) 2 793 3847

    Germany: +49 (0) 69 2222 2625

    Netherlands: +31 (0) 20 795 6614

    Switzerland: +41 (0) 44 580 7145

    United Kingdom: +44 (0) 207 192 8338

    United States: +1 646-741-3167

    The presentation accompanying this conference call will be available on Inventiva's website from 2:00 pm (Paris time) tomorrow, Friday, March 5, 2021 onwards in the "Investors" – "Financial Results & Presentations" section and can be followed live at: https://edge.media-server.com/mmc/p/wr8srgzq.

    A replay of the conference call and the presentation will be available after the event at: http://inventivapharma.com/investors/financial-results-presentations/.





    Next financial results publication

    §   Revenues and cash position for the first quarter of 2021: Thursday, May 13, 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. In 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

    info@inventivapharma.com

    +33 3 80 44 75 00
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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 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.

    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 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.

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

    5 Part 1 of the study refers to a 72-week treatment in approximately 900 patients allowing to seek accelerated approval in the U.S. and conditional approval in the EU for lanifibranor based on a pre-specified histology analysis. This part of the study is followed by an extension period (Part 2), the end date of which depends on a pre-defined number of clinical events. For more information, please refer to Inventiva's corporate presentation, accessible here:  https://inventivapharma.com/investors/investor-presentations/.

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



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  8.  ►     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

    info@inventivapharma.com

    +33 3 80 44 75 00
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +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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  9. - 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

    info@inventivapharma.com

    +33 3 80 44 75 00
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

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

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +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.



    Attachment



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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

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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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    • 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

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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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  10. 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

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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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  11.  

         ►     Presentation of the results from the NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH by Prof. Sven Francque
          
         ►     Presentation of the current NASH landscape by Prof. Arun Sanyal
                 
         ►     Discussion on management of NASH patients by Prof. Kenneth Cusi

         ►     Virtual webcast event on November 16, 2020 at 4:00 pm (ET) / 10:00 pm (CET)


    Daix (France), October 28, 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 it will host a webcast…

     

         ►     Presentation of the results from the NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH by Prof. Sven Francque

          

         ►     Presentation of the current NASH landscape by Prof. Arun Sanyal

                 

         ►     Discussion on management of NASH patients by Prof. Kenneth Cusi

         ►     Virtual webcast event on November 16, 2020 at 4:00 pm (ET) / 10:00 pm (CET)



    Daix (France), October 28, 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 it will host a webcast event focused on NASH with the participation of three Key Opinion Leaders (KOL) on November 16, 2020 from The Liver Meeting Digital Experience™ 2020, organized by the American Association for the Study of Liver Diseases (AASLD).

    Introduced by Frédéric Cren, Chairman, CEO and cofounder of Inventiva, this event will be composed of three distinct KOL presentations focused on various aspects related to NASH, including dedicated Q&A sessions.

    The presentation details are as follows:



    Presentation #1 :

    • Title:  "Discussion of the Phase IIb NATIVE clinical trial results evaluating lanifibranor in NASH"

    • Speaker: Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial  
    • Topics covered: Topline results from the NATIVE Phase IIb clinical trial including new data on:
      • Efficacy of lanifibranor on key endpoints in Type-2 diabetic (TD2M) vs. non-diabetic patients
      • Efficacy of lanifibranor on key endpoints in F2/F3 patients
      • Effect of lanifibranor on plasma biomarkers of liver necro-inflammation and fibrosis in non-cirrhotic NASH patients



    Presentation #2
    :

    • Title: "NASH field overview"

    • Speaker: Prof. Arun Sanyal, Virginia Commonwealth University, Member of Inventiva's Scientific Advisory Board  
    • Topics covered: 
      • Status of the NASH landscape, including lessons learned from recent clinical trial results and interactions with the FDA
      • Comparison of NATIVE Phase IIb clinical trial results with other recent clinical trial results in the NASH field



    Presentation #3
    :

    • Title:  "Management of NASH patients"

    • Speaker:Prof. Kenneth Cusi, University of Florida, Investigator of the Phase II clinical trial evaluating lanifibranor in patients with TD2M and NAFLD
    • Topics covered: Successful management of NASH patients



    The details to connect to the webcast are as follows:

    • Date: Monday, November 16, 2020  
    • Time: 4:00 pm - 5:30 pm (ET) / 10:00 pm - 11:30 pm (CET)  
    • Connection details :
      • Option #1 – Webcast: https://edge.media-server.com/mmc/p/uy4bgbir
      • Option #2 – Conference call:
        • France: +33 (0) 1 70 70 07 81
        • Belgium: +32 (0) 2 793 3847
        • Germany: +49 (0) 69 2222 2625
        • Netherlands: +31 (0) 20 795 6614
        • Switzerland: +41 (0) 44 580 7145
        • United Kingdom: +44 (0) 207 192 8338
        • United States: +1 646-741-3167
      •  
        • Access code: 5239026

    The presentation document and the link to the webcast (live and replay) will also be available on Inventiva's website in the "Investors – Investor Presentations" section: 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. AASLD advances 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

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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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    • The designation is intended to accelerate the regulatory review and facilitate the overall development of odiparcil for the treatment of MPS VI patients


    Daix (France), October 19, 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 the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to odiparcil, the Company's clinical-stage drug candidate for the treatment of MPS type VI (MPS VI), a rare and progressive genetic disorder.

    The Fast Track program of the FDA is designed to facilitate…

    • The designation is intended to accelerate the regulatory review and facilitate the overall development of odiparcil for the treatment of MPS VI patients



    Daix (France), October 19, 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 the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to odiparcil, the Company's clinical-stage drug candidate for the treatment of MPS type VI (MPS VI), a rare and progressive genetic disorder.

    The Fast Track program of the FDA is designed to facilitate the development and expedite the regulatory review and potential approval of drug candidates. Its overall objective is to improve patient access to therapies aimed at treating serious conditions and filling significant unmet medical needs.



    Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, commented
    : "We are very pleased by the FDA's decision to grant Fast Track designation to odiparcil for the treatment of MPS VI. It is a clear recognition of the existing unmet medical need for this rare and progressive genetic disorder. We believe that odiparcil has the potential to become a treatment of choice for MPS VI patients, especially due to its oral formulation and ability to reach organs and tissues which are poorly treated by the current standard of care. This designation represents an important step in the development of odiparcil towards becoming an additional treatment for MPS VI patients, who are looking for more efficacious and convenient therapies."

    Fast Track designation offers the possibility of more frequent communication with the FDA to discuss the drug candidate's development plan, the design of the proposed clinical trials, the use of biomarkers, and the collection of appropriate data required to support drug approval. It also offers access to accelerated approval and priority review, as well as to rolling review of its Biologic License Application (BLA) or New Drug Application (NDA) on a section by section basis, rather than waiting for the entire BLA or NDA to be completed.

    The Fast Track designation for odiparcil in MPS VI follows the acceptance by the FDA in August 2020 of Inventiva's Investigational New Drug (IND) application for odiparcil in the same indication and the publication at the end of 2019 of positive results from its iMProveS (improve MPS treatment) Phase IIa clinical trial evaluating odiparcil for the treatment of MPS VI adult patients.  



    About Fast Track designation1

    Fast Track is a process designed to facilitate the development and expedite the review and potential approval of drugs candidates to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious and life-threatening conditions.

    Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on factors such as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.

    Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Any drug being developed to treat or prevent a condition with no current therapy is obviously directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, which is assessed against a pre-defined set of criteria.



    About odiparcil


    Odiparcil is an orally-available small molecule that acts on the underlying cause of the symptoms of mucopolysaccharidosis ("MPS"), a group of rare, progressive genetic disorders. MPS is characterized by the accumulation of glycosaminoglycans ("GAGs"), polysaccharides which are important for the modulation of cell to cell signalling and the maintenance of tissue structure and function, in the lysosomes of cells. Due to genetic mutations, lysosomes in patients with MPS contain deficient versions of the enzymes necessary to break down GAGs. As a result, GAGs accumulate within the lysosomes, causing the latter to swell and interfere with the ordinary functioning of cells, leading to the symptoms associated with MPS. MPS is categorized by subtypes, depending on the enzyme that is deficient and the corresponding GAGs that accumulate. By modifying how GAGs are synthesized, odiparcil facilitates the production of soluble GAGs that can be excreted in the urine, rather than accumulating in cells. Specifically, odiparcil acts on chondroitin sulfate ("CS") and dermatan sulfate ("DS"), either or both of which accumulate in patients with MPS I, II, IVa, VI and VII.

    Odiparcil has been evaluated for the treatment of MPS VI adult patients during the iMProveS (improve MPS treatment) Phase IIa clinical trial with positive results published at the end of 2019.

    Odiparcil has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and has also obtained Rare Pediatric Disease Designation (RPDD) in the U.S. for the treatment of MPS VI.



    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

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.



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    • Designation based on positive topline results from NATIVE Phase IIb clinical trial evaluating lanifibranor in non-alcoholic steatohepatitis (NASH)
    • Lanifibranor believed to be the first drug candidate to receive Breakthrough Therapy designation in NASH since 2015
    • There are currently no FDA-approved treatments for this common and progressive chronic liver disease
    • This designation further supports the decision to initiate a Phase III pivotal clinical trial with lanifibranor in H1 2021

                    
    Daix (France), October 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…



    • Designation based on positive topline results from NATIVE Phase IIb clinical trial evaluating lanifibranor in non-alcoholic steatohepatitis (NASH)

    • Lanifibranor believed to be the first drug candidate to receive Breakthrough Therapy designation in NASH since 2015

    • There are currently no FDA-approved treatments for this common and progressive chronic liver disease

    • This designation further supports the decision to initiate a Phase III pivotal clinical trial with lanifibranor in H1 2021

                    

    Daix (France), October 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 announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to lanifibranor, the Company's lead drug candidate, for the treatment of NASH. Lanifibranor is believed to be the first drug candidate to be granted this status for the treatment of NASH since January 2015.

    The Breakthrough Therapy designation by the FDA is intended to expedite the development and review of drug candidates for serious or life-threatening conditions. To qualify for this designation, drug candidates must show preliminary clinical evidence that they may demonstrate a substantial improvement on at least one clinically significant endpoint over available therapies or over placebo if there are no approved therapies.

    The designation of lanifibranor as a Breakthrough Therapy for the treatment of NASH follows the publication in June 2020 of positive topline results from Inventiva's NATIVE Phase IIb clinical trial with lanifibranor in NASH patients. In this 24-week clinical trial, lanifibranor met the primary endpoint with a statistically significant reduction of the Steatosis Activity Fibrosis score (SAF), which combines assessments of hepatocellular inflammation and ballooning with no worsening of fibrosis in the Intention To Treat (ITT1) and Per Protocol populations (PP2). In addition, lanifibranor met key secondary endpoints, including NASH resolution with no worsening of fibrosis3 and improvement of liver fibrosis with no worsening of NASH4 in both ITT and PP populations. With regards to the secondary endpoints, lanifibranor is the first drug candidate to achieve statistically significant results on the FDA and European Medicine Agency (EMA) primary endpoints which are relevant for seeking accelerated approval during Phase III clinical development.

    Inventiva is expected to hold the end of NATIVE Phase IIb clinical trial meeting with the FDA and to receive regulatory feedback from the EMA during the fourth quarter of 2020 with the initiation of the Phase III clinical trial evaluating lanifibranor in NASH planned for the first half of 2021.

    Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, commented: "Ahead of our end of Phase IIb meeting with the FDA later this year, the Breakthrough Therapy designation for lanifibranor is a fantastic achievement and a regulatory recognition of the significant clinical benefits lanifibranor could provide to NASH patients as shown in our recent NATIVE Phase IIb clinical trial. This new status will allow us to pursue lanifibranor's development towards a safe and effective treatment for this devastating disease and we look forward to continue working closely with the FDA to this end."



    About Breakthrough Therapy designation5


    Breakthrough Therapy designation is a process designed to expedite the development and review of drugs in the United States that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

    A drug that receives Breakthrough Therapy designation is eligible for the following:

    • All Fast Track designation features ;
    • Intensive guidance on an efficient drug development program, beginning as early as Phase 1 ;
    • Organizational commitment involving senior managers.



    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. 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

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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 ITT: includes all patients randomized in the trial.

    2 PP: includes all patients with paired biopsies and without deviation impacting efficacy assessment.

    3 NASH resolution and no worsening of fibrosis defined as CRN Lobular inflammation score equal to 0 or 1 and CRN Hepatocyte ballooning score equal to 0 and no worsening of the CRN-Fibrosis score.

    4 Improvement of liver fibrosis with no worsening of NASH defined as improvement of CRN-Fibrosis score ≥ 1 stage and no increase of CRN-Steatosis score and no increase of CRN-Inflammation score and no increase of CRN-Ballooning score.

    5 https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy.



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  12. Daix (France), October 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 that it has been selected to present the results from its 24-week Phase IIb trial evaluating lanifibranor for the treatment of NASH in an oral plenary presentation at The Liver Meeting Digital Experience™ 2020, which will be held virtually November 13-16, 2020.

    Entitled "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…



    Daix (France), October 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 that it has been selected to present the results from its 24-week Phase IIb trial evaluating lanifibranor for the treatment of NASH in an oral plenary presentation at The Liver Meeting Digital Experience™ 2020, which will be held virtually November 13-16, 2020.

    Entitled "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", the abstract will be presented by Prof. Sven Francque, M.D., Ph.D. from Antwerp University Hospital and co-principal investigator of the trial.

    During this trial, lanifibranor met the primary endpoint with a statistically significant reduction of the Steatosis Activity Fibrosis score (SAF), which combines assessments of hepatocellular inflammation and ballooning, with no worsening of fibrosis in the Intention To Treat (ITT1) and Per Protocol populations (PP2). In particular, lanifibranor achieved statistically significant effects on NASH resolution with no worsening of fibrosis and improvement of fibrosis with no worsening of NASH, the US Food and Drug Administration (FDA) and European Medicine Agency (EMA) primary endpoints relevant for seeking accelerated approval during future Phase III clinical development.



    Oral presentation details

    Publication Number: 0012

    Session Title: Plenary: Clinical and Outcomes Discoveries

    Presentation Type: Oral presentation, Plenary Session

    Presenting Author: Sven Francque, M.D., Ph.D. from Antwerp University Hospital

    Session Broadcast Date and Time: Sunday, November 15, 2020, 9:00 AM (Eastern Time)



    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 is 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 is 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 is 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 include 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. 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 (OTC:IVEVF) and on the Nasdaq Global Market in the United States (NASDAQ:IVA). www.inventivapharma.com



    Contacts

    Inventiva

    Frédéric Cren

    Chairman & CEO

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +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 ITT: includes all patients randomized in the trial.

    2 PP: includes all patients with paired biopsies and without deviation impacting efficacy assessment.



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    • Cash and cash equivalents at €52.3 m as of June 30, 2020
    • Successful $107.7 m (€94.9 m1) initial public offering on the Nasdaq Global Market, extending the Company's cash runway through Q4 2022
    • Publication of positive topline results from the Phase IIb NATIVE clinical trial evaluating lanifibranor in NASH and decision to move into pivotal Phase III development
    • New data from Phase IIb NATIVE clinical trial in NASH showing significant decrease of fibrosis, apoptosis and inflammation biomarkers after 24 weeks of treatment with lanifibranor
    • Appointment of Dr Arun J. Sanyal to Inventiva's Scientific Advisory Board (SAB), further strengthening the Board's expertise in the field of NASH
    • Acceptance of Investigational New Drug (IND) application for…



    • Cash and cash equivalents at €52.3 m as of June 30, 2020
    • Successful $107.7 m (€94.9 m1) initial public offering on the Nasdaq Global Market, extending the Company's cash runway through Q4 2022
    • Publication of positive topline results from the Phase IIb NATIVE clinical trial evaluating lanifibranor in NASH and decision to move into pivotal Phase III development
    • New data from Phase IIb NATIVE clinical trial in NASH showing significant decrease of fibrosis, apoptosis and inflammation biomarkers after 24 weeks of treatment with lanifibranor
    • Appointment of Dr Arun J. Sanyal to Inventiva's Scientific Advisory Board (SAB), further strengthening the Board's expertise in the field of NASH
    • Acceptance of Investigational New Drug (IND) application for odiparcil in MPS VI by the U.S. Food and Drug Administration (FDA) enabling U.S. clinical trials



    Daix (France), September 16, 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 interim financial results for the six months ended June 30, 2020, and provided an update on its business activities.



    Frédéric Cren,
    Chairman, Chief Executive Officer and cofounder of Inventiva, stated: "The first half of 2020 has been one of the most decisive periods since the founding of Inventiva in 2012. Looking at the development of our R&D portfolio, our lead drug candidate lanifibranor has shown very promising results in our Phase IIb clinical trial in NASH: with statistically significant results on both the FDA and European Medical Agency (EMA) primary endpoints relevant for seeking accelerated approval during Phase III clinical development, this trial has paved the way for lanifibranor to enter into pivotal Phase III In parallel, we have progressed in the development of odiparcil for the treatment of MPS VI: the recent acceptance of our IND application by the FDA will allow us to launch our first clinical trial with odiparcil in the USA and will lay the groundwork for its future development in this important market. I would also like to thank the whole Inventiva team who worked tirelessly over the last few months in a difficult context. I am proud of their work and commitment that contributed to these achievements. Looking ahead, we are now fully focused on moving forward with the clinical development of lanifibranor in NASH with the anticipated pivotal Phase III trial, while continuing to advance our different programs across MPS, psoriasis and oncology, in line with our multi-asset strategy."

    Jean Volatier, Chief Financial Officer of Inventiva, added: "In addition to the significant progress of our R&D portfolio, especially in NASH, we were also able to considerably strengthen our financial position despite the challenging environment linked to the COVID-19 pandemic. Of particular note is our successful initial public offering on the Nasdaq Global Market in the U.S., which increases our visibility in this key market and has enabled us to extend our cash runway through the fourth quarter of 2022. Backed by a very solid financial position and important advances across our R&D portfolio, we are in an ideal position to pursue the development of our different drug candidates."

    Key financial results for the first half of 2020

    (in thousands of euros, except share and per share amounts) June 30, 2020 June 30, 2019
    Revenue 161 1,333
    Other income 1,607 2,198
    Research and development expenses (12,574) (19,646)
    Marketing – business development expenses (123) (135)
    General and administrative expenses (3,383) (3,132)
    Other operating income (expenses) (1,354) (1,274)
    Operating profit (loss) (15,665) (20,656)
    Financial income (loss) 6 111
    Income tax - -
    Net loss for the period (15,659) (20,545)
         
    Basic / diluted loss per share (euros/share) (0.52) (0.93)
    Weighted average number of outstanding shares used for computing basic/diluted loss per share  29,894,757 22,160,448



    Revenues
    for the first half of 2020 reached €0.2 million compared to €1.3 million in the first half of 2019 and related primarily to research services in connection with Inventiva's collaboration with Boehringer Ingelheim, which has since been terminated.

    R&D expenses amounted to €12.6 million in the first half of 2020, down 36% compared to the first half of 2019. These expenses were mainly dedicated to the development of lanifibranor in NASH and odiparcil in MPS VI. The decrease compared to the previous year is mainly due to the halt in the clinical development of lanifibranor in the treatment of systemic sclerosis in February 2019 and the savings generated by the Employment Safeguard Plan subsequently introduced, with the first half of 2020 recording the full effect of the savings generated.

    General and administrative expenses amounted to €3.4 million, compared to €3.1 million in the first half of 2019, up 8%, mainly due to increased labor costs.

    Other operating income (expenses) amounted to (€1.4) million (compared with (€1.3) million in the first half of 2019). The first half of 2019 took into account the recording of a provision of €1.1 million relating to the Employment Safeguard Plan, while the first half of 2020 takes into account part of the expenses incurred as part of the Initial Public Offering in the United States.

    Company's net loss stood at (€15.7) million, compared to (€20.5) million in the first half of 2019.

    Inventiva's net cash flow amounted to €16.4 million in the six months ended June 30, 2020 compared to (€19.6) million in the first half of 2019. Net cash used in operating activities was (€7.2) million and (€18.7) million in the first half of 2020 and 2019, respectively.

    In addition to the decrease in R&D expenses mentioned above, in the first half of 2020, cash flow from operating activities was positively impacted by the receipt in January 2020 of €4.2 million in respect of the 2018 Research Tax Credit (CIR), 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 €24.6 million in the first half of 2020, driven by: the issuance of €15 million (gross proceeds) of ordinary shares in February 2020 to certain existing investors in the Company and the entry into a €10.0 million credit agreement, guaranteed by the French State, with a syndicate of French banks.

    Consequently, Inventiva's cash and cash equivalents stood at €52.3 million as of June 30, 2020 compared to €35.8 million as of December 31, 2019.

    The financial statements of the first half of 2020 were approved by the Board of Directors on September 15, 2020. The statutory auditors have issued a limited review report. For more details, Inventiva's Half-Year Financial Report is available on the Company's website at: www.inventivapharma.com.



    Financial information after closing of the accounts

    On July 15, 2020, Inventiva successfully closed its initial public offering on the Nasdaq Global Market of an aggregate of 7,478,261 new ordinary shares in the form of American Depositary Shares (ADSs), each representing one ordinary share, at an offering price of $14.40 per ADS. Aggregate gross proceeds of the initial public offering, before deducting underwriting commissions and estimated expenses payable by the Company, were approximately $107.7 million (€94.9 million2). All of the securities as part of the initial public offering were offered by Inventiva. The Company's ADSs, listed under the symbol "IVA", began trading on the Nasdaq Global Market on July 10, 2020.

    The Company believes its cash, cash equivalents, short-term investments and non-current financial assets, together with the net proceeds of its successful initial public offering on the Nasdaq Global Market and its cash flow from operations will be sufficient to fund its operations through the fourth quarter of 2022.



    Main areas of progress in the R&D portfolio



    Lanifibranor in non-alcoholic steatohepatitis (NASH)

    • Following the publication of the positive results from the NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH in June 2020, Inventiva has progressed with the analysis of the circulating biomarkers. The first results of this analysis have shown a positive and statistically significant decrease of some biomarkers under lanifibranor treatment. Of importance and in line with the mechanism of action of lanifibranor, patients treated with the drug candidate showed improvements on biomarkers of fibrosis (Pro-C3 - a marker of fibrogenesis and ratio TIMP-1/MMP2 – a ratio depicting the inhibition of matrix remodeling process), apoptosis (CK18-M30 - a marker of apoptosis) and inflammation (Ferritin and hs-CRP – markers of inflammation). These findings, including the table in appendix of this press release, will be presented in more detail during tomorrow's webcast and conference call (see below for logistical details) – September 17, 2020

       
    • Following higher than expected observed effects of lanifibranor in reducing steatosis during the Phase IIb NATIVE clinical trial in NASH, Professor Kenneth Cusi, the investigator of the trial, decided to reduce the number of patients in the ongoing Phase II clinical trial evaluating lanifibranor in type 2 diabetes patients (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD); results are expected in 2021 – July 6, 2020

       
    • Publication of positive topline results from the Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial; decision to continue the clinical development of lanifibranor in NASH and enter into pivotal Phase III development – June 15, 2020

                 

    Inventiva announced positive topline results from the Phase IIb NATIVE clinical trial evaluating lanifibranor for the treatment of NASH on June 15, 2020.

    In this 24-week clinical trial, lanifibranor met the primary endpoint with a statistically significant reduction of the Steatosis Activity Fibrosis score (SAF), which combines assessments of hepatocellular inflammation and ballooning, with no worsening of fibrosis in the Intention To Treat (ITT3) and Per Protocol populations (PP4). The drug candidate also met key secondary endpoints, including NASH resolution with no worsening of fibrosis5 and improvement of liver fibrosis with no worsening of NASH6 in both ITT and PP populations. With these results, lanifibranor is the first drug candidate to achieve statistically significant results on NASH resolution with no worsening of fibrosis and improvement of fibrosis with no worsening of NASH, the two Food and Drug Administration (FDA) and European Medicine Agency (EMA) primary endpoints relevant for seeking accelerated approval during Phase III clinical development. Based on these positive topline results, Inventiva has decided to continue with the clinical development of lanifibranor in NASH and enter into pivotal Phase III development.

    §  Approval of a new patent directed at the use of lanifibranor for the treatment of several fibrotic diseases, including NASH, in China until June 2035 by the China National Intellectual Property Administration (CNIPA) – May 25, 2020

                 



    Odiparcil in mucopolysaccharidosis type VI (MPS VI)

    §  Acceptance of the Investigational New Drug (IND) application for odiparcil in MPS VI by the U.S. Food and Drug Administration (FDA) – August 10, 2020

    On August 10, 2020, the FDA accepted Inventiva's IND application for odiparcil for the treatment of MPS VI, allowing the Company to initiate clinical trials with this drug candidate in the United-States.

    • Decision by Inventiva to extend the duration of the Phase I/II SAFE-KIDDS (SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study) clinical trial evaluating odiparcil in MPS VI children from 6 to 12 months following a scientific advice meeting with the EMA in July; launch of the trial is expected in the first half of 2021 – July 23, 2020

       
    • Publication of Inventiva's latest research on odiparcil's mechanism of action in the leading peer-reviewed scientific journal PLOS ONE, showing that the drug candidate was associated with decreased glycosaminoglycan (GAG) accumulation and increased GAG excretion, and highlighting its distribution in MPS VI disease-relevant tissues and organs – May 18, 2020



    Other significant milestones

    §  Appointment of Dr Arun J. Sanyal to Inventiva's Scientific Advisory Board (SAB), further strengthening the Board's expertise in the field of NASH – July 29, 2020

    Inventiva has further reinforced its SAB in the field of NASH with the appointment of Dr Arun J. Sanyal on July 29, 2020. Professor of Medicine, Physiology and Molecular Pathology in the Division of Gastroenterology at Virginia Commonwealth University (VCU) Medical Center in Richmond, Virginia, Dr Sanyal's research focuses on all aspects of NAFLD and NASH as well as complications of cirrhosis and End-stage Liver Disease. He also serves as Chairman of the National Institutes of Health (NIH) NASH Clinical Research Network, the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) consortium and the Liver Forum for NASH and Fibrosis. In addition to his participation in the SAB, Dr Sanyal is involved in preparing the protocol of the Phase III clinical trial for the development of lanifibranor in NASH.

    • Entry into a €10.0 million non-dilutive loan facility guaranteed by the French State ("Prêt Garanti par l'Etat"), with the support of Bpifrance, Crédit Agricole Champagne-Bourgogne and Société Générale, contributing to strengthening the Company's cash position in the context of the COVID-19 pandemic – May 19, 2020

       
    • Capital increase of €15 million subscribed by BVF Partners L.P., New Enterprise Associates (NEA), Novo Holdings A/S and Sofinnova Partners – February 11, 2020

                 

    COVID-19 update

    Following the updated recommendations of domestic public health authorities and a continuous risk assessment of the COVID-19 pandemic situation, Inventiva is pursuing the implementation of measures to minimize risks for its employees and support their health and safety in this unprecedented time. As of today, the R&D internal and support activities are not expected to be significantly impacted in the future.

    The global pandemic of COVID-19 continues to evolve, and its ultimate impact remains uncertain. The Company cannot predict the full extent of potential delays or impacts on its clinical trials, or potential impact on its business. Inventiva is committed to continuing to implement measures aimed at minimizing any further potential business impact from the COVID-19 pandemic and continue to comply with the updated guidance documents of the regulatory authorities. The Company continues to closely monitor, assess and respond to the situation as it evolves overtime and continues to work closely with authorities, its contract research organizations, trial sites and investigators to critically reassess all its existing programs and communicates further when and if appropriate.

    •••

    Next expected key milestones

    • End of NATIVE Phase IIb clinical trial meeting with the FDA and Scientific Advice meeting with the EMA – planned for fourth quarter of 2020
    • AbbVie's completion of its ongoing Phase I clinical trial with ABBV-157 in psoriasis patients – expected fourth quarter of 2020
    • Preparation for commencement of the Phase III clinical trial evaluating lanifibranor in NASH – planned for the first half of 2021
    • Initiation of the Phase I/II SAFE-KIDDS (SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study) clinical trial evaluating odiparcil in MPS VI children – planned for the first half of 2021
    • Initiation of the Phase IIa extension clinical trial with odiparcil in MPS VI patients who completed the prior Phase IIa clinical trial (iMProveS) – planned for the first half of 2021

            

    Upcoming investor conference participation

    • H.C. Wainwright 22nd Annual Global Investment Virtual Conference, September 15-16, 2020
    • Roth Analyst Management Talk Series, September 21, 2020
    • 20th Annual Biotech in Europe Forum, September 21-24, 2020
    • KBC Securities Virtual Life Sciences Conference, September 22-23, 2020
    • Lyon Pôle Bourse Investment forum, Lyon, September 30, 2020
    • Portzamparc Health/Biotech Virtual Seminar, October 1, 2020
    • HealthTech Innovation Days, Paris, October 5-6, 2020
    • European Midcap Hybrid Event, Paris, October 19-20, 2020
    • Stifel Healthcare Conference 2020, New York, November 17-18, 2020
    • Jefferies 11th Global Healthcare conference, London, November 17-19, 2020
    • Piper Sandler 32nd Annual Healthcare Conference, New York, December 1-3, 2020



    Upcoming scientific conference presentations

     §   Presentation of the Phase IIb NATIVE clinical trial results at The Liver Meeting® of the AASLD (American Association for the Study of Liver Diseases), November 13-16, 2020



    Conference call

    A conference call in English will be held on Thursday, September 17, at 2:00 pm (Paris time). To join the conference call, please use the code 6617599 after dialing one of the following numbers:

    France: +33 1 70 70 07 81

    Belgium: +32 27 93 38 47

    Germany: +49 69 22 22 26 25

    Netherlands: +31 20 79 56 614

    Switzerland: +41 44 58 07 145

    United Kingdom: +44 207 19 28 338

    United States: +1 646-741-3167

    The presentation accompanying this conference call will be available on Inventiva's website in the "Investors" – "Results & Presentations" section at the same time and can be followed live at: https://edge.media-server.com/mmc/p/z3ek3api.

    A replay of the conference call and the presentation will be available from 6:00 pm (Paris time) onwards at: https://inventivapharma.com/investors/financial-results-presentations/.



    Next financial results publication

     §   Q3 2020 Revenues and cash position: Thursday, November 12, 2020 (after market close)



    Appendix

    Measure of circulating biomarkers in NATIVE Phase IIb trial: significant decrease under lanifibranor treatment compared to placebo after 24-weeks

    Median relative change from baseline at week 24 (%)LanifibranorPlaceboP-value
    FibrosisPro-C3-13.9%-4.1%p= 0.005*
    Pro-C3 >14 µg/mL(1) at baseline-20.5%-12.8%p= 0.017*
    Ratio TIMP-1/MMP2-22.5%-4.6%p < 0.001*
    ApoptosisCK18-M30-41.1%0.5%p < 0.001*
    InflammationFerritin-29.4%-9.1%p < 0.001*
    hs-CRP-35.5%13.0%p < 0.001*

    (1)   Level where it is estimated that fibrogenisis is active and corresponding to F2/F3 patients

    FAS (Full Analysis Set) population with available data at baseline (pre-treatment) and at week 24 (post-treatment)

    * Median change under lanifibranor are statistically significantly different compared to placebo, using the common threshold of 5% (Exploratory Wilcoxon test)



    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 (OTC:IVEVF) and on the Nasdaq Global Market in the United States (NASDAQ:IVA). www.inventivapharma.com



    Contacts

    Inventiva

    Frédéric Cren

    Chairman & CEO

    info@inventivapharma.com

    +33 3 80 44 75 00

    Brunswick Group

    Yannick Tetzlaff / Tristan Roquet Montegon / 

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83

    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

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

    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 ITT: includes all patients randomized in the trial.

    4 PP: includes all patients with paired biopsies and without deviation impacting efficacy assessment.

    5 NASH resolution and no worsening of fibrosis defined as CRN Lobular inflammation score equal to 0 or 1 and CRN Hepatocyte ballooning score equal to 0 and no worsening of the CRN-Fibrosis score.

    6 Improvement of liver fibrosis with no worsening of NASH defined as improvement of CRN-Fibrosis score ≥ 1 stage and no increase of CRN-Steatosis score and no increase of CRN-Inflammation score and no increase of CRN-Ballooning score.



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