IVA Inventiva S.A.

14.4
-0.02  -0%
Previous Close 14.42
Open 14.51
52 Week Low 9.01
52 Week High 19.0636
Market Cap $556,275,758
Shares 38,630,261
Float 38,630,261
Enterprise Value $436,601,132
Volume 7,374
Av. Daily Volume 27,349
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
ABBV-157
Psoriasis
Phase 1
Phase 1
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Lanifibranor
Nonalcoholic fatty liver disease (NAFLD)
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

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

Latest News


  1. 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



    +33 3 80 44 75 00
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations



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

    Patricia L. Bank



    Investor relations



    +1 415 513-1284

    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic 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.

    Attachment



    Primary Logo

    View Full Article Hide Full Article
  2.  ►     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



    +33 3 80 44 75 00
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations



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

    Patricia L. Bank

    Investor relations



    +1 415 513-1284



    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

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

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






    1 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.



    Attachment



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

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

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

                 

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

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

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

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

                 

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

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

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

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

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



    Biography – Jérôme Boursier

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



    About Inventiva

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

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

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

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

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

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

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



    Contacts

    Inventiva

    Frédéric Cren

    Chairman & CEO



    +33 3 80 44 75 00
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations



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

    Patricia L. Bank



    Investor relations



    +1 415 513-1284



    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

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

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






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

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



    Attachment



    View Full Article Hide Full Article
  4. - 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.

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

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

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

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

                    

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



    Cash Position

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

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

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

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

    Revenues

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

    ***

    Next key milestones expected

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

             

    Upcoming investor conference participation

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

    Upcoming scientific conference participation

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

    Next financial results publication

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



    About Inventiva

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

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

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

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

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

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

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



    Contacts

    Inventiva

    Frédéric Cren

    Chairman & CEO



    +33 3 80 44 75 00
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations



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

    Patricia L. Bank



    Investor relations



    +1 415 513-1284



    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

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

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






    1 Non-audited financial information.

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

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

    4 Source: clinicaltrials.gov.



    Attachment



    View Full Article Hide Full Article
View All Inventiva S.A. News