News & Events

Inventiva announces the positive recommendation of the 4 th and last DSMB of the Phase IIb clinical study with lanifibranor in NASH

Inventiva announces the positive recommendation of the 4 th
and last DSMB of the Phase IIb clinical study with lanifibranor in NASH

September 10, 2019

Daix (France), September 10, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the positive recommendation of the fourth and last Data Safety Monitoring Board (DSMB) of the NATIVE Phase IIb clinical study evaluating lanifibranor in NASH. No safety issues were reported and, as for the first three DSMB meetings, the DSMB recommended to continue the study without changing the protocol. These conclusions are all the more significant as this safety assessment was based on the review of data from 228 patients, including 139 patients treated for the whole study period. This positive recommendation confirms once again the good safety profile of lanifibranor.

The Phase IIb clinical study NATIVE (NAsh Trial to Validate IVA337 Efficacy) evaluates lanifibranor, the Company’s lead product candidate, for the treatment of non-alcoholic steatohepatitis (NASH), a chronic and progressive liver disease for which there is currently no approved treatment. Following the positive conclusions of the last DSMB and the successful completion of patient recruitment in the study announced on 4 September 2019, Inventiva confirms the publication of the study results in the first semester 2020.

Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, commented: “We are particularly satisfied with the safe profile of lanifibranor in patients with NASH. The DSMB’s recommendation, as well as the FDA’s decision to lift the clinical hold in place on PPAR agonists for lanifibranor, support the unique mechanism of action of our drug candidate. We look forward to the publication of the study results during the first half of 2020 and if positive, to initiate the last phase of development prior to the market launch of lanifibranor.”

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ 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 achieves a major milestone by completing patient recruitment for its Phase IIb clinical study with lanifibranor in NASH

Inventiva achieves a major milestone by completing patient recruitment for its Phase IIb clinical study with lanifibranor in NASH

September 4, 2019

Daix (France), September 4, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the successful completion of patient recruitment for its Phase IIb NATIVE (NASH Trial to Validate IVA337 Efficacy) clinical trial evaluating lanifibranor, the Company’s lead product candidate, for the treatment of non-alcoholic steatohepatitis (NASH).

A total of 247 patients have been randomized in the Phase IIb NATIVE trial, exceeding the initial target of 225 patients following an acceleration of inclusions over the last months. Patients were mainly recruited in sites located in Australia, Canada, Europe and the United States. The objective to recruit patients with a severe form of NASH was met as approximately 73% among them have a NAS score greater than or equal to six and 76% have a F2 or F3 fibrosis score. In addition, the study population includes more than 40% of patients with type 2 diabetes (T2DM), allowing Inventiva to conduct the planned subanalyses in this key patient group, where lanifibranor as an insulin sensitizer should be particularly beneficial. It is estimated that approximately half of the NASH patients globally have T2DM, and are at greater risk of poor clinical outcomes. To date, 146 patients have already successfully completed the six-month study confirming that the treatment is well tolerated.

Having reached this key recruitment milestone, the publication of the study’s headline results is expected for H1 2020.

The completion of patient recruitment follows three meetings of the NATIVE DSMB (Data Safety Monitoring Board), which had reviewed patient safety data and repeatedly recommended the continuation of the trial without changing the protocol, confirming the favorable safety profile of lanifibranor. These positive outcomes are consistent with the results of long-term toxicological studies and Phase I and Phase II clinical trials, as well as with the FDA’s decision in May 2019 to lift the peroxisome proliferator-activated receptor (PPAR) target class-related clinical hold for lanifibranor.

Prof. Sven Francque, M.D., Ph.D. from the Antwerp University Hospital and Co-Principal Investigator of the study, said: “Since the PPAR mechanism of action has already widely been validated for the treatment of NASH, and given lanifbranor’s unique profile as a pan-PPAR agonist, this drug candidate should be able to reduce NASH and the fibrosis associated with it as well as to provide metabolic benefits. The analysis of patients with type two diabetes will also be of importance to confirm that lanifibranor is particularly suited to this population.”

Prof. Manal Abdelmalek, M.D., M.P.H. from Duke University and Co-Principal Investigator of the study, stated: “The completion of patient recruitment in this international study is excellent news. The study has been well
conducted, and given the preclinical and clinical results generated by lanifibranor so far, we are confident that this treatment will prove to be a valuable approach to treat NASH patients.”

Marie-Paule Richard, M.D., Chief Medical Officer of Inventiva, added: “A great thank-you to all of the clinicians and patients participating in this international trial. The safety profile of lanifibranor and the way the study has been conducted so far are very encouraging. We are confident that this trial will reach its primary endpoint and we are looking forward to publishing the results in the first half of 2020, which, if positive, will support lanifibranor’s entry into the pivotal Phase III.”

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ 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.

Odiparcil development advances with recruitment of first patients in a new biomarker study in MPS VI children and adults

Odiparcil development advances with recruitment of first patients in a new biomarker study in MPS VI children and adults

September 2, 2019

Daix (France), September 2, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the recruitment of the first patients in a new biomarker study in children and adults with mucopolysaccharidosis type VI (MPS VI)

Conducted at the UCSF Benioff Children’s Hospital in Oakland, California, by Dr Paul R. Harmatz, the trial will investigate leukocyte glycosaminoglycan (leukoGAGs) levels in three children and skin glycosaminoglycan (skinGAGs) levels in three adults with MPS VI before and post enzyme replacement therapy (ERT), and in six age-matched control subjects not affected by MPS VI. This study is part of Inventiva’s strategy to develop biomarkers to evaluate the efficacy of odiparcil, the Company’s drug candidate for the treatment of MPS, in reducing leukoGAGs and skinGAGS. This approach has been launched following the Food and Drug Administration’s (FDA) guidance on the relevance of biomarkers for diseases such as MPS1. Results of this study are expected in the first half of 2020.

A first biomarker study sponsored by Inventiva showed that, despite ERT treatment, the current standard of care, leukoGAG levels remained very high and were not impacted when measured one hour after ERT infusion although the activity of the arylsulfatase B2 enzyme was very high. This finding suggests that leukoGAG levels may be further reduced with a new treatment such as odiparcil.

Measurement of leukoGAGs and skinGAGs is performed in the ongoing Phase IIa iMProveS (improve MPS treatment) clinical study evaluating odiparcil for the treatment of MPS VI patients. Given the recent progress achieved in the iMproveS study, headline results for all treatment arms are now expected by the end of the year.

Inventiva had initially planned to publish the study results in two steps: the headline results of the double-blind placebo controlled arms by the end of the year followed by the results of the open label cohort during Q1 2020.

Dr. Paul R. Harmatz, the principal investigator of this new biomarker study, said: “I am very excited about the launch of this second biomarker study with the recruitment of the first patients. Following our first biomarker study that demonstrated the limitations of ERT in reducing leukoGAGs, this trial will help us better understand the dynamic of the response to this therapy in leukocytes. It could also possibly provide a second measure of GAG storage in a readily accessible tissue such as the skin, thereby strengthening the appraisal of intracellular GAG variations.”

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ 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 secures a new European patent strengthening and extending the protection of its lead product candidate lanifibranor

August 28, 2019

Daix (France), August 28, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the European Patent Office (EPO) granted on August 28, 2019 a new patent protecting the use of lanifibranor in 38 European countries in the treatment of several fibrotic diseases, including non-alcoholic steatohepatitis (NASH), until June 2035.
This new patent strengthens and extends the term of protection of lanifibranor in Europe, which was already established with the New Chemical Entity (NCE) patent expiring in August 2031 (this expiration date includes a possible five-year extension to compensate for regulatory delays linked to obtaining the marketing approval).
In addition to Europe, the use of lanifibranor in several fibrotic conditions, including NASH, is already protected in the United States. Inventiva has filed patent applications with similar claims in other key markets for the pharmaceutical industry, such as China and Japan, which are currently under review.

Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, commented: “The grant of this patent in Europe is excellent news, as it strengthens and extends the protection of lanifibranor in numerous fibrotic indications, including NASH, in one of our key markets. Together with the USPTO’s decisions in the United States, it represents a tremendous boost to the patent portfolio covering our lead drug candidate in regions and countries where the need for treatment of fibrotic diseases is very high. This positive momentum confirms our innovative R&D approach underpinning our strategy.”

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ 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.

New promising results on lanifibranor to be presented at The Liver Meeting® 2019

New promising results on lanifibranor to be presented at The Liver Meeting® 2019

August 26, 2019

Daix (France), August 26, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that its abstract on the evaluation of lanifibranor in a pre-clinical model of cirrhosis has been selected by the American Association for the Study of Liver Diseases (AASLD) for an oral presentation at the upcoming The Liver Meeting® 2019 in Boston, Massachusetts, USA (November 8-12, 2019).

The study, which was led by Prof. Jordi Gracia-Sancho1, aimed at evaluating lanifibranor in a pre-clinical model of cirrhosis. The results clearly showed that lanifibranor exerts beneficial effects producing a marked regression of liver fibrosis and decreasing portal hypertension. In addition, lanifibranor strongly reduced hepatic inflammation, and improved the phenotype of liver sinusoidal endothelial cells and hepatic stellate cells. These promising results demonstrate the potential of lanifibranor for the treatment of advanced chronic liver disease.

The abstract, entitled “The pan-PPAR agonist lanifibranor improves portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease”, will be presented on November 10, 2019 as part of The Liver Meeting® 2019 (see details below).

In parallel, Inventiva will host a KOL meeting focusing on lanifibranor as a potential treatment for NASH with the participation of Dr. Manal Abdelmalek2, Dr. Pierre Bedossa3, Dr. Kenneth Cusi4 and Dr. Sven Francque5. This meeting will take place from 8:00 am – 9:30 am (local time) on November 11, 2019 at the Mandarin Oriental Boston hotel (Bar Bouloud), Boston, Massachusetts, USA.

Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, commented: “These results are excellent news for lanifibranor and demonstrate its potential for the treatment of advanced chronic liver disease. They mark an important step in the development of lanifibranor and follow our previous findings that already showed the beneficial effects of our product candidate in pre-clinical models relevant to NASH. All these results reinforce our confidence in the unique mechanism of action of lanifibranor and its potential to treat NASH patients. I am looking forward to the upcoming The Liver Meeting® 2019 as well as the KOL meeting hosted by Inventiva to present our recent findings and to further discuss lanifibranor’s potential for the treatment of NASH.”

The details of Inventiva’s oral presentation at The Liver Meeting® 2019 are as follows:
Abstract title: “The pan-PPAR agonist lanifibranor improves portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease”
Publication number: 0063
Session title: Parallel 6: Novel Therapeutics for NASH
Date: Sunday, November 10, 2019
Session time: 10:30 am (local time)
Presentation time: 11:00 am (local time)
Location: Auditorium, John B. Hynes Memorial Convention Center, Boston, Massachusetts, USA
Event: The Liver Meeting® 2019

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ 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 secures new patent in the US strengthening the protection of its lead product candidate lanifibranor

Inventiva secures new patent in the US strengthening the protection of its lead product candidate lanifibranor

August 20, 2019

Daix (France), August 20, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the United States Patent and Trademark Office (USPTO) granted a new patent on August 20, 2019 that protects the use of lanifibranor for the treatment of fibrotic diseases until June 2035.

This new patent further strenghens Inventiva’s patent portfolio for lanifibranor, the Company’s lead product candidate, in the United States, which already comprised a New Chemical Entity (NCE) patent and a patent protecting the use of lanifibranor in several diseases including non-alcoholic steatohepatitis (“NASH”).

Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, stated: “This new patent represents an important milestone in the development of lanifibranor for the treatment of fibrotic diseases, particularly NASH, and confirms the innovative approach that we are pursuing in this treatment area. It is an additional positive news for our lead drug candidate after the FDA’s decision in May to lift the target class clinical hold for lanifibranor, and the significant recent progress in patient enrollment in our NATIVE Phase IIb clinical study in NASH.”

About lanifibranor

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

Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of non-alcoholic steatohepatitis (“NASH”), a common and progressive chronic liver disease, for which there is currently no approved therapy.

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ 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.

H1 20191 Financial Information and Corporate Business Update

H1 20191 Financial Information and Corporate Business Update

July 30, 2019

Daix (France), July 30, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today reported its cash position as at June 30, 2019 and revenues for the first half of 2019, and provided a corporate business update.

Key financial results

As at June 30, 2019, Inventiva’s cash and cash equivalents were €37.1 million, vs. €56.7 million on December 31, 2018, in line with Company expectations. Net cash flow related to operating activities amounted to -€19.6 million in the first half of 2019 (vs. -€15.3 million in the first half of 2018). R&D expenses for the semester, mainly driven by lanifibranor and odiparcil programs, were up 21.8% compared to the first half of 2018.

Revenues for the first half of 2019 amounted to €1.2 million, compared to €1.4 million in the first half of 2018.

Key highlights of the second quarter

Lanifibranor for the treatment of non-alcoholic steatohepatitis (“NASH”)
In May, the U.S. Food and Drug Administration (FDA) lifted for lanifibranor the clinical hold in place on the peroxisome proliferator-activated receptor (PPAR) target class. This decision enables Inventiva to conduct clinical trials equal to or longer than six months evaluating lanifibranor for the treatment of NASH. It followed the review of the two-year carcinogenicity studies by the FDA’s Executive Carcinogenicity Assessment Committee (ECAC). This decision confirms lanifibranor’s benign safety profile and represents a key milestone for Inventiva as it removes a key obstacle that had prevented the Company from initiating long-term Phase III clinical trials necessary to obtain marketing approval with lanifibranor for the treatment of NASH.
1 Financial information not audited in accordance with IFRS standards.

PRESS RELEASE

The NATIVE (NASH Trial To Validate IVA337 Efficacy) Phase IIb clinical study is progressing as planned and, at the end of June, 211 patients out of a target of 225 had been randomized in the study. The results will be published, as expected, in the first half of 2020.

Odiparcil for the treatment of mucopolysaccharidoses (“MPS”)
Early June, Inventiva announced the completion of patient recruitment in its iMProveS (improve MPS treatment) Phase IIa clinical study in Europe evaluating odiparcil for the treatment of mucopolysaccharidosis type VI (MPS VI).

The patients participating in the trial are distributed among the various arms, with fifteen patients being treated with enzyme replacement therapy (ERT) and receiving one of the two doses of odiparcil or placebo and five patients not being treated with ERT and only receiving the high dose of odiparcil. The headline results of the fifteen ERT-treated patients are expected by the end of the year. The results of the five patients not being treated with ERT are expected during the first quarter of 2020.

YAP-TEAD in the field of oncology

In May, Inventiva presented new reslts from its YAP-TEAD oncology program at the AACR Special Conference on The Hippo Pathway: Signaling, Cancer, and Beyond. These results showed that Inventiva’s YAP-TEAD inhibitors significantly reduced tumor growth in Malignant Pleural Mesothelioma (MPM) xenograft and orthotopic models. In addition, synergistic effects were seen in a three-dimensional spheroid model suggesting that Inventiva’s YAP-TEAD inhibitors, when used in combination with existing chemotherapeutics, could attenuate multidrug resistance and re-sensitize chemo-resistant cancer cells.

Following these promising results, Inventiva has decided to expand its research to other cancer indications as well as other combination strategies where standard of care agents are proven to be ineffective and where YAP is activated.

ABBV-157 for the treatment of moderate to severe psoriasis
AbbVie has initiated a new clinical study with ABBV-157, the drug candidate resulting from its collaboration with Inventiva, aiming at assessing the compound’s pharmacokinetics, safety and tolerance in healthy volunteers and in patients with chronic plaque psoriasis. Inventiva could receive milestone payments as well as royalties on future sales. For further information on the new clinical trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03922607

Creation of a Scientific Advisory Board

Inventiva recently announced the creation of its Scientific Advisory Board (SAB) to provide scientific review and advice to the Company’s management with regards to its R&D activities and product portfolio. The SAB covers Inventiva’s key areas of research and development with a particular focus on NASH, MPS and oncology. The SAB also supports Inventiva’s management regarding the preclinical and clinical aspects of the Company’s development programs and its global scientific policy, including targets, fields of research, partnerships and market access.

Approval and implementation of a redundancy plan following the termination of the systemic sclerosis (“SSc”) program
Following the termination of the SSc program in February 2019 due to the failure to meet the primary endpoint of the FASST Phase IIb clinical study, the Company implemented a redundancy plan in the second quarter which was subject to a corporate agreement signed on June 11, 2019; combined with the non-renewal of fixed-term

PRESS RELEASE

contracts, the Company’s total workforce will be reduced from 118 to approximately 90 employees by the end of the year.

Key milestones expected

▪ Completion of patient recruitment in the NATIVE Phase IIb clinical study evaluating lanifibranor for the treatment of NASH
▪ Completion of patient recruitment in the Phase II clinical study evaluating lanifibranor for the treatment of NAFLD in patients with type 2 diabetes
▪ Launch of a new biomarker study in patients with MPS VI
▪ Results of the iMProveS Phase IIa clinical study
▪ Selection of the clinical candidate for the YAP-TEAD oncology program
Upcoming investor conferences
▪ Portzamparc Biotech Conference, Paris, September 10, 2019
▪ SFAF Meeting, Paris, September 17, 2019
▪ Forum Lyon Pôle Bourse, Lyon, September 25, 2019
▪ KBC Biotech Conference, Brussels, September 27, 2019
▪ Large & MidCap Event, Paris, October 14-15, 2019
▪ HC Wainwright NASH Conference, New York, October 21, 2019
▪ Gilbert Dupont NASH Day, Paris, October 29, 2019
▪ KOL and investors’ meeting at the American Association for the Study of Liver Diseases (AASLD) conference, Boston, November 9, 2019
▪ Jefferies 2019 London Healthcare Conference, London, November 20-21, 2019

Next financial results publication

▪ H1 2019 financial results: Thursday, September 26, 2019 (after market close)

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ 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 the creation of its Scientific Advisory Board

Inventiva announces the creation of its Scientific Advisory Board

June 13, 2019

Daix (France), June 13, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the creation of its Scientific Advisory Board (SAB) to provide external scientific review and high-level advice to the Company’s management with regards to its R&D activities and product portfolio.

The SAB will cover Inventiva’s key areas of research and development with a particular focus on non-alcoholic steatohepatitis (NASH), mucopolysaccharidosis (MPS) and oncology. As such, it will support Inventiva’s management regarding the preclinical and clinical aspects of the Company’s development programs and its global scientific policy, including targets, fields of research, partnerships and market access.

Chaired by Jean-Louis Junien, former Director of Inventiva’s Board of Directors and senior pharmaceutical executive with an extensive experience in the industry, the SAB will bring together the expertise of independent international scientists and clinicians in the above-mentioned fields. An additional member specialized in rare diseases to support the development of odiparcil in MPS should join the SAB shortly. The first two meetings of the SAB have already been scheduled for later this month and will focus on NASH and oncology.

Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, said: “The creation of a Scientific Advisory Board is an important step for our future development as it will help us to both accelerate and secure our discovery programmes and validate our R&D choices. The Board members will bring significant expertise, highly complementary skills and an external perspective, which will be very valuable in informing our strategy as we move forward.”

Jean-Louis Junien, Chairman of Inventiva’s Scientific Advisory Board, commented: “I am honoured to take on the role of Chairman of Inventiva’s Scientific Advisory Board, which gathers internationally recognized experts in the fields of NASH, MPS and oncology. Together, we are looking forward to accompanying Inventiva’s management in its responsibility to make important judgments related to the Company’s R&D activities and product portfolio.”

The expert members of Inventiva’s SAB are:

– Dr Sven Francque, Professor of Medicine at the Faculty of Medicine and Health Sciences at the University of Antwerp and Chairman of the Department of Gastroenterology and Hepatology. His research unit focuses on the pathophysiological mechanisms of NASH.

– Dr Manal Abdelmalek, Professor of Medicine in the Division of Gastroenterology and Hepatology at Duke University and Director of the NAFLD Clinical Research Program at Duke University. She is a standing member of the NASH Clinical Research Network (NASH CRN).

– Dr Glen Clack, Honorary Professor of Translational Medicine of the Department of Oncology and Metabolism at the University of Sheffield and previously Senior Medical Director of the Oncology Translational Medicine Unit of Astra Zeneca.

– Dr Hedy Lee Kindler, Professor of Medicine at the University of Chicago, Director of the Mesothelioma Program and Associate Vice Chair for Clinical Research. She is a past President of the International Mesothelioma Interest Group, the leading international scientific research organization dedicated to this disease.

– Dr. Gérard Zalcman, Professor of Medecine, Head of the Thoracic Oncology Department of Bichat Hospital, Paris (Paris-Diderot University), and member of the U830 INSERM laboratory, “Genetics & Biology of cancers“, at the Research Centre of the Curie Institute.

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ 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 End of Patient Recruitment for its Phase IIa Trial in the Treatment of MPS VI

Inventiva Announces End of Patient Recruitment for its Phase IIa Trial in the Treatment of MPS VI

June 11, 2019

Daix (France), June 11, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the end of patient recruitment for its Phase IIa iMProveS (improve MPS treatment) trial in Europe evaluating odiparcil for the treatment of mucopolysaccharidosis type VI (MPS VI).

A total of 20 patients have been included in this Phase IIa trial versus an initial target of 24. Given odiparcil’s mechanism of action, the Company believes that this number of patients is sufficient to evaluate odiparcil’s safety profile and its impact on relevant efficacy biomarkers (measurement of glycosaminoglycans (GAGs) in the urine, skin and leukocytes) as well as to identify first signs of clinical efficacy in patients receiving enzyme replacement therapy (ERT) and in non-ERT treated patients. Therefore, Inventiva plans to amend the study protocol to update the target patient population to 20 subjects.

The patients included in the trial are distributed among the various arms, with fifteen patients being treated with ERT and receiving one of the two doses of odiparcil or placebo and five patients not being treated with ERT and only receiving the high dose of odiparcil. The headline results of the double-blind placebo controlled arms, which include the fifteen ERT-treated patients, are expected by the end of the year. Results of the open label cohort, which includes the five patients not being treated with ERT and only receiving the high dose of odiparcil, are expected during Q1 2020 given that the last patient for this subgroup was included in May 2019.

Marie-Paule Richard, M.D., Chief Medical Officer of Inventiva, stated: “We are delighted to have achieved this number of very rare disease patients and we are grateful to them and the clinicians participating in this trial. MPS VI is an orphan, and very debilitating disease, with current treatment still leaving patients with high unmet medical needs. Odiparcil has the potential to improve clinical manifestations of the disease, especially in tissues and organs where the efficiency of current treatments is limited. Odiparcil’s oral formulation could also be a great improvement for patients compared to current weekly infusions required for ERT. We look forward to obtaining the results of this Phase IIa trial to evaluate early signals of odiparcil’s efficacy in the treatment of MPS VI and, if positive, to pursue its development.”

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ 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.

Nawal Ouzren and Heinz Maeusli appointed to Inventiva’s Board of Directors

Nawal Ouzren and Heinz Maeusli appointed to Inventiva’s Board of Directors

May 29, 2019

Daix (France), May 29, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the appointment of Nawal Ouzren and Heinz Maeusli as members of its Board of Directors following the Company’s Ordinary and Extraordinary Shareholders’ General Meeting on May 27, 2019.

As such, Mrs Nawal Ouzren and Mr Heinz Maeusli will follow Mr Chris Newton, Mrs Nanna Lüneborg and Mr Jean-Louis Junien whose terms of office as Directors have officially ended. Mr Jean-Louis Junien will now focus on the creation of Inventiva’s Scientific Advisory Board. In addition, during the Annual General Meeting, the mandates of Frédéric Cren, Pierre Broqua, CELL + and Pienter-Jan BVBA have been renewed.

Frédéric Cren, Chairman, CEO and Cofounder of Inventiva, said: “We are delighted to welcome Nawal and Heinz as new members of Inventiva’s Board of Directors. Their solid track records in the pharmaceutical industry and their complementary profiles will be a great addition to Inventiva’s Board. Their experiences in listed companies of various sizes paired with a strong knowledge of the European and US financial markets will be very valuable for Inventiva’s future development. On behalf of the whole Board, I would like to extend my thanks to Chris, Nanna and Jean-Louis for their continued dedication and contribution to Inventiva’s development in the past few years.

The results of the vote related to the composition of the Board of Directors as well as those related to the remaining resolutions are available on Inventiva’s website: http://inventivapharma.com/investors/shareholder-meetings/.

About Nawal Ouzren

With more than 15 years of experience in operational and strategic management within the pharmaceutical industry, Mrs Ouzren has been Chief Executive Officer and Director of Sensorion since 2017. She started her career at Baxter, where she was Strategy and Operational Excellence Manager, Quality Operations Director and Senior Director Strategy before becoming Vice President of the BioSimilars business unit. In 2014, Mrs Ouzren became Vice President of the Global Hemophilia Franchise at Baxalta, which had been incorporated within the Shire group. In 2016, she headed up the Global Genetic Diseases Franchise at Shire, where she supervised all marketing, business and strategy aspects of this global division’s product portfolio.

Nawal Ouzren holds a Master’s degree in Chemical Engineering from the Technical University of Berlin, Germany, and a Master of Science in Chemical Engineering from the Université de Technologie de Compiègne, France.

About Heinz Maeusli

Chief Financial Officer of Advanced Accelerator Applications (AAA) from 2003 to 2018, Heinz Maeusli has been instrumental in growing this company into a global leader in its sector. As such, he has driven the listing of AAA on the Nasdaq stock exchange in November 2015 and contributed to AAA’s sale to Novartis in January 2018. Throughout his career, he has developed an expertise in the operational, organizational, financial and cultural complexities of growing and integrating international companies.

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ 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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