News & Events

New results on lanifibranor to be presented at the International Liver Congress™ 2019

New results on lanifibranor to be presented at the International Liver Congress™ 2019

4 February 2019

Daix (France), February 4, 2019 – Inventiva S.A. (“Inventiva”), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (“NASH”), systemic sclerosis and mucopolysaccharidosis (“MPS”), today announced that the abstract submitted by Pr Frank Tacke[1] MD, PhD, to the European Association for the Study of the Liver comparing in a mouse model the effects on the disease characteristics of NASH of the pan-PPAR agonist lanifibranor against the effects of certain single PPARα, PPARγ and PPARδ agonists has been accepted for an oral presentation at the International Liver Congress™ 2019 (April 10-14, 2019, Vienna, Austria).

 

The study, led by Pr Frank Tacke, found that administration of lanifibranor was associated with a combination of beneficial effects on many NASH characteristics, as well as with more potent effects on inflammation and disease progression than the tested single PPAR agonists. More specifically, administration of lanifibranor was associated with increased circulating adiponectin, reduced triglycerides and attenuated hepatocyte ballooning. Additionally, administration of lanifibranor and, to a lesser extent the tested single PPARa agonist, were associated with improvements in steatosis and lobular inflammation. Administration of lanifibranor was also associated with a more pronounced improvement of fibrosis than all of the other tested single PPAR agonists, suggesting that lanifibranor may combine the beneficial effects of single PPAR agonists and may counter inflammation and disease progression more potently. As a result, the study suggests that pan-PPAR agonists, such as lanifibranor, have the potential for more therapeutic effectiveness than single-PPAR agonists in the treatment of NASH.

 

The abstract, which is entitled “Differential therapeutic effects of pan- and single PPAR agonists on steatosis, inflammation, macrophage composition and fibrosis in a murine model of non-alcoholic steatohepatitis,” will be presented on April 11th.  The details of the presentation are as follows:

 

Event:                                              International Liver Congress™ 2019, Vienna, Austria

Date:                                                Thursday, April 11th, 2019

Time of the presentation:           5.30 pm to 5.45 pm (Central European Time)

Session:                                           NAFLD Pathophysiology – Target identification

Speakers:                                        Sander Lefere[2]

 

Background on PPARs

 

Peroxisome proliferator-activated receptors (“PPARs”) are nuclear receptors essential for the regulation of glucose and lipid metabolism in the liver and adipose tissue. They are also expressed in immune cells, notably macrophages, where they act as modulators of inflammation and fibrogenesis. Various single or dual PPAR agonists have been clinically evaluated in NASH, yielding variable effects on aspects of NASH pathogenesis.

[1] Dept. of Gastroenterology, Metabolic Diseases and Intensive Care Medicine, University Hospital Aachen, Germany / Department of Hepatology/Gastroenterology, Charité University Medical Center, Berlin, Germany

[2]PhD student, Ghent University

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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.

Inventiva invited to present at the 37th Annual J.P. Morgan Healthcare Conference

Inventiva invited to present at the 37th Annual J.P. Morgan Healthcare Conference

December 10, 2018

Daix (France), December 10, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company
developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and
mucopolysaccharidosis (MPS), today announced that Frédéric Cren, Chairman, CEO and cofounder of Inventiva,
has been invited to present a corporate overview, followed by a Q&A session, at the upcoming 37th Annual J.P.
Morgan Annual Healthcare Conference, being held on January 7-10, 2019 at the Westin St. Francis Hotel in San
Francisco, California.

The event details are as follows:

Date: Wednesday, January 9, 2019
Time of the presentation: 12:00 pm to 12:25 pm (Pacific Standard Time)
Time of the Q&A session: 1:30 pm to 1:55 pm (Pacific Standard Time)
Location: The Westin St. Francis Hotel, San Francisco, California

The presentation document and the link to the webcast will also be available on Inventiva’s website in the
“Investor” – “Documentation” – “Investor presentations” section.

 

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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.

Inventiva Announces Poster Presentation on Its YAP/TEAD Inhibitor Program at the EORTC-NCI-AACR Symposium in Dublin

Inventiva Announces Poster Presentation on Its YAP/TEAD Inhibitor Program at the EORTC-NCI-AACR Symposium in
Dublin

Novembre 7, 2018

Recent results reveal potential of oral small molecules in pre-clinical development by Inventiva targeting the YAP/TEAD pathway as a potential therapy in the treatment of mesothelioma and non-small cell lung cancer

Daix (France), November 7, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company developing innovative therapies in non-alcoholic steatohepatitis (NASH), systemic sclerosis (SSc), and mucopolysaccharidosis (MPS), today announced that it will be presenting a poster on its YAP/TEAD pre-clinical program at the upcoming EORTC-NCI-AACR Molecular Targets and Therapeutics Symposium being held on November 13-16, 2018 in Dublin, Ireland.

The poster to be presented, entitled “Discovery of promising anti-cancer drug combination using YAP-TEAD inhibitors with standard of care treatment in mesothelioma and NSCLC cells”, illustrates some of the recent data observed by Inventiva in pre-clinical studies, which suggest that the YAP/TEAD inhibitor molecules being investigated by the Company may have potential as a therapy in the treatment of mesothelioma, Non-Small Cell Lung Cancer (NSCLC) and other cancers.

Inventiva’s YAP/TEAD approach aims at disrupting the formation of the transcriptional complex formed by YAP and TEAD, which are believed to be key players in the oncogenic process as well as in fibrogenesis.

Inventiva has observed that its lead YAP/TEAD inhibitor molecules have prevented the formation of the YAP/TEAD transcriptional complex in vitro and are associated with a reduction of YAP/TEAD target genes expression and anti-proliferative effects in cancer cell lines where proliferation is under the control of the Hippo pathway. The Company has also observed in xenograft and patient-derived xenograft (PDX) mice models that its YAP/TEAD inhibitor molecules exhibited activity both as a stand-alone treatment or in combination with standard of care.

Based on these promising results, the Company plans to finalize the toxicological studies necessary to advance its YAP/TEAD program into Phase I/II clinical development in 2019.

“We have made significant progress in our understanding of the Hippo pathway, which offers exciting potential for the treatment of rare and prevalent cancers,” stated Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva. “We have observed that our patented small molecules exhibited activity both as a stand-alone treatment and in combination with standard of care in pre-clinical models. In addition, molecules that inhibit the YAP/TEAD interaction have already shown a potential to overcome drug resistance and tumor escape mechanisms, which makes this pathway particularly interesting. Our program is advancing well and we are looking forward to see it progressing into Investigational New Drug (IND) enabling studies.”

The event details for the presentations are as follows:

Poster Title: “Discovery of promising anti-cancer drug combination using YAP-TEAD inhibitors with standard of care treatment in mesothelioma and NSCLC cells”
Session Title: Drug Resistance and Modifiers
Date: Tuesday, November 13th
Time: 10am to 2pm
Location: The Convention Centre, Spencer Dock, North Wall Quay, Dublin, Ireland

About the EORTC-NCI-AACR Symposium

Hosted by the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR), the 30th edition of the EORTC-NCI-AACR Symposium in 2018 brings together academics, scientists and industry representatives to discuss the latest developments in drug development, target selection and the impact of new discoveries in molecular biology.

 

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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.

Inventiva invited to present at Stifel 2018 Healthcare Conference in New York and at Jefferies 2018 London Healthcare Conference

Inventiva invited to present at Stifel 2018 Healthcare Conference in New York and at Jefferies 2018 London Healthcare Conference

October 30, 2018

Daix (France), October 30, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced that Frédéric Cren, Chairman, CEO and co-founder of Inventiva, will present the company and its activities at the upcoming Stifel 2018 Healthcare Conference;, being held on November 12-14 in New York, USA, as well as at the Jefferies 2018 London Healthcare Conference;, which will be taking place on November 14-15 in London, UK.

The details of the events are as follows:

Stifel 2018 Healthcare Conference

Date: Tuesday, November 13, 2018
Time: 10:15am (Eastern Time)
Room: Hubbard
Location: Hotel Lotte New York Palace, 455 Madison Ave, New York, USA

Jefferies 2018 London Healthcare Conference

Date: Wednesday, November 14, 2018
Time: 2:40pm (UK time)
Room: Westminster
Location: The Waldorf Hilton, Aldwych, London, UK

The presentation of this last event can be followed simultaneously and in replay at the following address: http://wsw.com/webcast/jeff115/iva/

The presentation document will also be available on the Inventiva website in the “Investor” section

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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.

Inventiva announces two appointments to its management team ahead of future key development milestones

Inventiva announces two appointments to its management team ahead of future key development milestones

October 17, 2018

Marie-Paule Richard appointed as Chief Medical Officer and David Nikodem as Vice President of US Operations

Daix (France), October 17, 2018– Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company developing innovative therapies in non-alcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), announces today the appointment of Dr Marie-Paule Richard, M.D., as Chief Medical Officer (CMO) and Dr David Nikodem, Ph.D., as Vice President of US Operations in anticipation of the Company’s next development milestones.

Dr Jean-Louis Abitbol, M.D., who has been Inventiva’s CMO for the past three years and at the helm of the Company’s medical development team, will retire at the end of April 2019. The arrival of Marie-Paule Richard as CMO today will ensure a smooth transition ahead of the coming key developments that are expected over the course of 2019 such as the presentation of top-line results from the Company’s Phase IIb FASST (For A Systemic Sclerosis Treatment) trial in early 2019 and the results from the Phase IIa iMProveS (Improve MPS treatment) trial during the second-half of 2019. Dr Richard will bring to Inventiva her extensive experience in clinical development and regulatory strategy. Her successful experience in both filing and finalising approvals with the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will be a key asset for the Company given its anticipated interactions with these regulatory agencies.

Inventiva will also benefit from the appointment of David Nikodem who joined the Company as Vice President of US Operations in September. His deep industry knowledge and experience of the US markets from both a biopharmaceutical and financial perspective will be critical in reinforcing the Company’s increasingly active presence in the United States. Dr Nikodem’s international profile, experience and instrumental roles at Ally Bridge Group, Exane Asset Management and BNP Paribas amongst others will surely be valuable to the development of Inventiva.

To mark these movements, Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “We look forward to welcoming Marie-Paule and David to the Inventiva team. Their international profiles combined with their healthcare and financial expertise will be critical in the achievement of new milestones, starting with the presentation of top-line results from the SSc trial in early 2019. Marie-Paule and David will also serve a crucial role in helping to reinforce our expanding presence abroad. My team and I would like to thank Jean-Louis for his continued commitment and dedication to Inventiva over the past years. He has indeed been an important pillar in Inventiva’s development and we already wish him all the best for his retirement next year.”

I am very pleased to be joining Inventiva during this pivotal time,” added Marie-Paule Richard. “I believe that Inventiva’s differentiated programs have real potential to address unmet medical needs and I am excited to be a contributing factor to the many developments that lie ahead of us.”

David Nikodem commented: “This is an exciting time for Inventiva, particularly given the coming development milestones that are to take place both in France and abroad. I am honoured to be joining the team and look forward to help bring novel therapies to patients on a global scale.;”

Biographies

Dr Marie-Paule Richard, M.D.

Marie-Paule Richard is a seasoned medical leader who brings a long and diverse international experience acquired in senior executive positions for leading pharmaceutical and biotechnology companies. She is particularly accredited in the field of clinical development strategy and regulatory affairs, having driven several drug approvals and international license agreements in both Europe and the United States.

Prior to joining Inventiva, Marie-Paule Richard acted as CMO of the Belgian biotech firm Tigenix from 2014, which was recently acquired by Takeda. Before this, she was the CMO of AiCuris GmbH from 2010 to 2012 in Germany and held several international management positions at Bristol Myers Squibb, Aventis Pharma, GlaxoSmithKline and Sanofi Pasteur. Marie-Paule Richard holds a medical degree from the University of Nancy in France, and a certification in Clinical Immunology among other qualifications.

Dr David Nikodem, Ph.D.

David Nikodem has a wide experience of over 15 years across all healthcare subsectors, as a portfolio manager, analyst and risk manager in both public equities and public investments listed in the United States, France and Hong Kong. He is based in the United States, in Washington, D.C.

Prior to joining Inventiva, David Nikodem founded Sapidus Partners LLC in 2014, a US-based consulting group, where he has acted as a senior consultant for Ally Bridge Group for the past four years, with a focus on the biopharmaceutical sector, and at which he will continue his efforts in parallel with his new role at Inventiva. Previously, he worked as a Portfolio Manager for Exane Asset Management in Paris (2010-2013), as a Director and Portfolio Manager for BNP Paribas in New York (2005-2009), and as a Senior Healthcare Analyst for Blumberg Capital Management in New York (2002-2005). David Nikodem has also previous experience as a Patent Examiner at the USPTO and as a basic science researcher at the National Institutes of Health. Dr Nikodem holds a Ph.D. in Biochemistry and Molecular Biology from Georgetown University and a double B.A. in Chemistry and in English Language and Literature from the University of Virginia.

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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.

Inventiva Announces Last Visit by Last Patient in its Phase IIb SSc Trial and Second Positive DSMB Review in its Phase IIb NASH Trial with Lanifibranor

Inventiva Announces Last Visit by Last Patient in its Phase IIb SSc Trial and Second Positive DSMB Review in its Phase IIb NASH Trial with Lanifibranor

October 15, 2018

> Top-line results of the Phase IIb systemic sclerosis (SSc) trial are expected for early 2019

> Second NASH DSMB recommends to continue the trial with lanifibranor without changing the protocol

Daix (France), October 15, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced the last visit by the last patient in its Phase IIb FASST (For A Systemic Sclerosis Treatment) trial as well as the second positive review of the Data Safety Monitoring Board (DSMB) in its Phase IIb NATIVE (NASH Trial to Validate IVA337 Efficacy) trial, both conducted with lanifibranor.

The last visit of the last patient of the 12-month FAAST study took place on October 12 and data-base lock is planned for early January 2019. With this positive background, the Company confirmed that it expects to announce top-line results of the study in early 2019 as previously announced.

“SSc is a debilitating disease with no disease-modifying treatments approved so far where lanifibranor mechanism of action could prove beneficial for our patients. Given that all three DSMB meetings regarding the FASST trial recommended to pursue with the study without any modifications to the protocol, we are very eager to see the results of this study,” said Yannick Allanore, co-principal investigator of the FASST trial and professor of rheumatology at the Hôpital Cochin in Paris.

Professor Christopher Denton, co-principal investigator of the FASST trial and professor at the University College London, added: “The FASST trial is a long-term study in SSc patients that will evaluate clinical endpoints highly relevant to clinicians, patients and health authorities. Positive results in this study would therefore be very supportive to the development of lanifibranor as a treatment in this very severe disease.”

Additionally, the DSMB from the Company’s NATIVE trial in NASH patients held its second meeting. Out of the 101 patients randomized so far, the DSMB had access to the data of 95 patients of which 36 had completed the 6 month treatment period of the study. Based on its analysis, the DSMB recommended the study to continue without any modification of the protocol.

Pierre Broqua, CSO and cofounder of Inventiva, stated: “We are very satisfied with the progress of the FASST study and excited by the prospect of publishing the head-line results early next year. The results of the second DSMB meeting regarding our NATIVE study are also very encouraging and headline results are expected for the first half of 2020.”

About the Phase IIb FASST trial

The Phase IIb FASST trial is a one-year randomized double-blind study designed to measure the effect of lanifibranor on the progression of SSc. Patients receive either lanifibranor or placebo according to the study protocol, approved by the European Medicines Agency (EMA). The primary endpoint is change in the Modified Rodnan Skin Score (MRSS), which is a measure of disease progression accepted by both the Food and Drug 1

Administration (FDA) and EMA. Inclusion criteria are based on a MRSS between 10 and 25 points, and diffuse SSc diagnosed from less than 3 years. Patients are allowed to continue their ongoing treatments, including immunosuppressive therapies. Lanifibranor has been granted Orphan Drug status for the treatment of SSc by the EMA and the FDA (respectively in November 2014 and March 2015). Orphan Drug status provides certain advantages for the sponsor, such as reduced procedure costs and commercial exclusivity.

About the Phase IIb NATIVE trial

The Phase IIb NATIVE trial is a 24-week randomized double-blind study designed to assess the efficacy of lanifibranor on ballooning and inflammation without worsening of fibrosis. Patients receive either lanifibranor or placebo. This trial also evaluates the safety of lanifibranor treatment. The main inclusion and assessment criteria of the study are based on the hepatic histology of each patient: (i) NASH histological diagnosis according to the NASH Clinical Research Network criteria (steatosis, lobular inflammation of any degree and liver cell ballooning of any amount) and (ii) SAF activity score of 3 or 4 (> 2), SAF Steatosis score >= 1 and SAF Fibrosis score < 4. The primary endpoint of the study is a decrease in relation to the baseline of >= 2 points of the SAF activity score combining hepatocellular inflammation and ballooning.

About lanifibranor

Lanifibranor is a next generation panPPAR modulator, designed as a moderately potent and well-balanced PPAR α, γ and δ. This unique profile was conceived in order to obtain an optimal therapeutic margin with strong efficacy and tolerance. Lanifibranor is currently being evaluated in two parallel Phase IIb clinical studies in NASH and SSc as well as in a Phase II trial in diabetic patients with NAFLD (non-alcoholic fatty liver disease).

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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.

Inventiva to Participate in the “ROTH Battle of the NASH Thrones Investor Conference”

Inventiva to Participate in the “ROTH Battle of the NASH Thrones Investor Conference”

October 12, 2018

Daix (France), October 12, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced that Pierre Broqua, Chief Scientific Officer and co-founder of Inventiva, will participate in the upcoming “ROTH Battle of the NASH Thrones Investor Conference” being held on October 17, 2018 at the Park Hyatt New York hotel, New York, USA.

Pierre Broqua will be speaking in the panel entitled “House of PPARs vs. House of THR-beta”;, one of the conference’s four panel discussions covering topics currently at the forefront of drug development in NASH. The event details are as follows:

Panel: “House of PPARs vs. House of THR-beta”
Date: Wednesday, October 17, 2018
Time: 12:00 pm – 1:00 pm (Eastern Time)
Location: Park Hyatt New York hotel, 153 West 57th St., New York, NY 10019, USA

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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.

Inventiva Announces Two Poster Presentations at the American College of Rheumatology Conference

Inventiva Announces Two Poster Presentations at the American College of Rheumatology Conference

October 10, 2018

Posters to focus on the anti-fibrotic effect of lanifibranor and the alteration of the PPAR pathway in a mouse model of systemic sclerosis (SSc)

Daix (France), October 10, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced that two abstracts on the anti-fibrotic effect of lanifibranor and the alteration of the PPARpathway in a mouse model of systemic scleorderma will be presented at the upcoming American College of Rheumatology (ACR) conference being held on October 19-24, 2018 in Chicago, Ilinois. These two posters were prepared as part of the development of lanifibranor as a treatment for SSc, for which the results of the Phase IIb study FASST (For a Systemic Sclerosis Treatment) are expected in early 2019.

The first abstract, entitled “In vivo assessment of lung fibrosis’ prevention using the pan-PPAR agonist lanifibranor in the TβRIIΔk-fib (Transgenic Mouse Model of Scleroderma) mouse model of systemic sclerosis”, shows the impact of Inventiva’s lanifibranor in the treatment of lung fibrosis in a mouse model of SSc. In this model, where transgenic (TG) mice display severe and persistent fibrosis compared to wildtype (WT), lanifibranor produced a significant protection from lung fibrosis compared to controls, reinforcing the rationale for lanifibranor trials in SSc, especially for patients showing lung fibrosis.

The second abstract, entitled “Evidence for Altered Peroxisome Proliferator Activated Receptor (PPAR) Pathway Activity in a Transgenic Mouse Model of Scleroderma (TβRIIΔk-fib): Analysis of Mouse Skin, Lung and Explanted Cells;”, examines the evidence of PPAR pathway perturbations in whole tissue or explanted cells from adult or neonatal TβRIIΔk-fib;TG mice compared to WT littermates. Results suggests that the PPARpathway is downregulated in TG mice.

Pierre Broqua, Chief Scientific Officer and Co-Founder of Inventiva, commented “The data to be presented at the ACR reinforces our confidence in the potential of our lead product lanifibranor, with which we aim to address important unmet medical needs in the treatment of NASH and SSc;. We are currently evaluating lanifibranor in two parallel Phase IIb clinical studies in NASH and SSc and look forward to presenting top-line results from the SSc trial in early 2019;.”

The event details for the presentations are as follows:

Poster Titles: “In vivo assessment of lung fibrosis’ prevention using the pan-PPAR agonist lanifibranor in the TβRIIΔk-fib mouse model of systemic sclerosis”;“Evidence for Altered Peroxisome Proliferator Activated Receptor (PPAR) Pathway Activity in a Transgenic Mouse Model of Scleroderma (TβRIIΔk-fib): Analysis of Mouse Skin, Lung and Explanted Cells;”
Session Title: Systemic Sclerosis and Related Disorders – Basic Science Poster I & Poster II
Date: Sunday, October 21st and Monday, October 22nd
Time: 9:00AM- 11:00AM (CST)
Location: ACR poster sessions A and B

About lanifibranor

Lanifibranor is a next generation panPPAR modulator, designed as a moderately potent and well-balanced PPAR α, γ and δ. This unique profile was conceived in order to obtain an optimal therapeutic margin with strong efficacy and tolerance. Lanifibranor is currently being evaluated in two parallel Phase IIb clinical studies in NASH and SSc as well as in a Phase II trial in diabetic patients with NAFLD (non-alcoholic fatty liver disease).

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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.

Inventiva launches an independent working group to help increase NASH awareness and establish best practices for its treatment

Inventiva launches an independent working group to help increase NASH awareness and establish best practices for its treatment

September 24, 2018

Daix (France), September 24th, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), announced today the creation of the panNASH?* initiative, 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.

The initiative, which is supported by Inventiva, includes European and American medical experts in areas related to NASH such as hepatology, diabetes and cardiology, along with renowned scientific experts focused on promoting a better understanding of the physiopathological mechanisms involved in NASH (see the list of the founding members at the end of this press release);. Their aim will therefore be 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 intends to help develop and share new findings about NASH through publications, conferences and training sessions. It will particularly focus 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 will help to increase knowledge of pathological mechanisms ranging from metabolic disorders to fibrosis and comorbidities, with a focus on the modulating role played by PPARs (peroxisome proliferator-activated receptors, subtypes).

Frédéric Cren, Chairman, Chief Executive Officer and co-founder of Inventiva, stated: “This working group brings together recognized NASH experts with unique and complementary skills and represents a further commitment by Inventiva to become a key player in the development of a treatment for this disease. I am confident that the program will lead to a better understanding of NASH by the various stakeholders. The group’s work will play a key role in establishing best practices for the treatment of NASH, a serious disease for which there is not yet any approved treatment, but which is one of society’s most widespread metabolic diseases, with 30 million patients already affected in the USA alone.”

The first meeting of the panNASH(TM) initiative took place in Geneva on September 22, 2018 following the NAFLD Summit 2018 ;organized by European Association for the Study of the Liver (EASL).

Committee members

Specialist field

Country

Name

Affiliation

Hepatology

Belgium

Pr. Sven Francque

Antwerp University Hospital

Hepatology

Germany

Pr. Frank Tacke

University Hospital Aachen

Hepatology

Switzerland

Pr. Jean-François Dufour

University Clinic Bern

Hepatology

US

Pr. Manal Abdelmalek

Duke University

Hepatology

US

Pr. Gyongyi Szabo

University of Massachusetts

Diabetology

Germany

Pr. Michael Roden

Heinrich Heine University

Diabetology

US

Pr. Kenneth Cusi

University of Florida

Cardiology

UK

Pr. Christopher Byrne

University of Southampton

Cardiology

US

Pr. Frank Sacks

Harvard T.H. Chan School of Public Health

*panNASH is an initiative coordinated by Terra Firma

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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.

Inventiva advances in the development of lanifibranor with the achievement of three key milestones

Inventiva advances in the development of lanifibranor with the achievement of three key milestones

August 30, 2018

> New patent granted by the USPTO protecting the use of lanifibranor in numerous fibrotic diseases

> Enrolment of first patient in the United States Phase II study for the treatment of NAFLD in patients with type 2 diabetes

> FDA approval of the IND application enabling to launch the clinical development plan in the United States

Daix (France), August 30, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced the successful completion of three key milestones in the development of its lead product, lanifibranor.

New patent granted by the USPTO protecting the use of lanifibranor in numerous fibrotic diseases

On August 21, 2018, the United States Patent and Trademark Office (USPTO) granted a new patent protecting until June 2035 the therapeutic use of lanifibranor in the treatment of various fibrotic conditions, including NASH and SSc.

This patent strengthens and extends in the United States the term of protection of lanifibranor derived from the New Chemical Entity (NCE) patent expiring in December 2031 (this expiration date includes a possible five-year extension to compensate for regulatory delays in obtaining the marketing approval).

Enrolment of the first patient in the United States Phase II study for the treatment of NAFLD in patients with type 2 diabetes

Following the agreement with the University of Florida to conduct a Phase II study in the United States with lanifibranor for the treatment of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes, the first of 64 patients for this study has been enrolled in August 2018. The recruitment of the other patients continues in accordance with the planned schedule and top line results are expected in early 2020.

The overall objective of the study , led by Dr Kenneth Cusi, Head of the Department of Endocrinology, Diabetes & Metabolism in the Department of Medicine at the University of Florida at Gainesville, is to measure the metabolic improvements induced by lanifibranor, as well as its effects on hepatic steatosis in patients with type 2 diabetes and NAFLD. In addition, this study will examine the impact of lanifibranor on fibrosis using the latest imaging and biomarker technologies.

FDA approval of the IND application enabling to launch the clinical development plan in the United States

On August 24, 2018, the Company received the approval of its IND (Investigational New Drug) application from the gastroenterology division of the FDA (Food and Drug Administration) for lanifibranor in order to conduct a drug interaction study required to pursue the development program.

This approval is an important milestone as it will allow Inventiva to use this IND to initiate further clinical studies for lanifibranor’s development in NASH in the United States.

Frédéric Cren, CEO and co-founder of Inventiva, said: “These three important achievements demonstrate the continued progress made in the clinical development of lanifibranor and confirm our confidence in the future of our lead product. The new patent granted by the USPTO is a tangible proof of the innovative nature of our therapeutic approach with lanifibranor and above all extends the date of exclusivity by several years.”;

About lanifibranor

Lanifibranor is a next generation panPPAR modulator, designed as a moderately potent and well balanced PPAR ?, ? and ?. This unique profile was conceived in order to obtain an optimal therapeutic margin with strong efficacy and tolerance. Inventiva is currently evaluating lanifibranor in two parallel Phase IIb clinical studies in NASH and SSc.

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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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