SSc

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 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 Announces Positive DSMB Reviews in both NASH and Systemic Sclerosis Phase IIb Trials with Lanifibranor

Inventiva Announces Positive DSMB Reviews in both NASH and Systemic Sclerosis Phase IIb Trials with Lanifibranor

July 10, 2018

> Both DSMB recommend trials to continue without changing the protocol

> Lanifibranor safety is confirmed

> Trials to continue as planned

Daix (France) June 20, 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 the FASST (For A Systemic Sclerosis Treatment) Data Safety Monitoring Board (“DSMB”) held its third and last meeting before the end of the trial of lanifibranor in SSc. Similarly to the conclusions of the first two DSMBs , the board recommended that the study continue without any modification to the protocol. Similarly the NATIVE (NASH Trial to Validate IVA337 Efficacy) DSMB met for the first time and after reviewing all safety data came to a similar conclusion and recommended to continue the study without any modification of the protocol. The positive outcomes of these two DSMBs confirm the good safety of lanifibranor, already demonstrated in long-term toxicological studies as well as in phase I and phase II clinical trials. Both studies are progressing as planned with no specific concerns and topline results are anticipated in early 2019 for the FASST trial in SSc and second half of 2019 for the NATIVE trial in NASH.

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. Inventiva is currently evaluating lanifibranor in two parallel Phase IIb clinical studies in NASH and SSc.

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 systemic sclerosis (SSc). Patients will 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 Food and Drug Administration (FDA) and the EMA. Inclusion criteria are based on a MRSS between 10 and 25, and diffuse systemic sclerosis 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 systemic sclerosis by the EMA and the FDA. The 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 will receive either lanifibranor or placebo. This trial will also evaluate 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 inflammatory and ballooning.

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.

FDA Approval of an Investigator Initiated IND Application to Conduct Phase II Study of Lanifibranor in Type 2 Diabetic Patients with Non-Alcoholic Fatty Liver Disease

FDA Approval of an Investigator Initiated IND Application to Conduct Phase II Study of Lanifibranor in Type 2 Diabetic Patients with Non-Alcoholic Fatty Liver Disease

June 20, 2018

> Study to enroll first patient in the third quarter 2018 with topline results expected early 2020

> FDA approval is a positive signal for SSc and NASH IND applications

Daix (France) June 20, 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 the U.S. Food and Drug Administration (FDA) has accepted the investigator initiated Investigational New Drug (IND) application providing clearance to proceed with the Phase II study of lanifibranor in type 2 diabetic patients with nonalcoholic fatty liver disease (NAFLD). This FDA approval is also a positive signal for the planned Company IND applications in SSc and NASH.

The trial to be conducted by Dr. Kenneth Cusi, Chief of the Division of Endocrinology, Diabetes & Metabolism in the Department of Medicine at the University of Florida, Gainesville, is expected to enroll 64 patients treated for a 24-week period with a single daily dose of lanifibranor (800 mg/day) or placebo and 10 subjects in a healthy, non-obese control group. The study’s overall objective is to measure the metabolic improvements induced by lanifibranor, and its effect on steatosis in type 2 diabetic patients with NAFLD. Additionally, this study will detect lanifibranor’s impact on fibrosis using the most recent imaging and biomarker technology. Its main endpoints are a decrease of liver steatosis assessed by state-of-the-art imaging, including H-MRS (Proton Magnetic Resonance Spectroscopy), a decrease of insulin resistance (glucose clamp, HBA1c), a decrease in de novo lipogenesis, and safety. The first patient is expected to be enrolled in the third quarter of 2018 and topline results are expected beginning of 2020.

“With its unique pan-PPAR profile, lanifibranor has shown very good safety features, relevant efficacy data in NASH preclinical models as well as positive metabolic effects in a Phase IIa study in diabetic patients,” Dr. Cusi said. “We anticipate the results of this study to translate well to diabetic patients with NAFLD or NASH and look forward to demonstrating that lanifibranor could become a very valuable drug for these patients.”

Jean-Louis Abitbol, MD, MSC, Chief Medical Officer of Inventiva, added: “We are delighted that the FDA has allowed Dr Cusi and his team to proceed with this exciting metabolic and imaging study and we very much look forward to the enrollement of US patients as these results will provide additional supporting data for our regulatory filings with US and European regulators.”

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 Positive DSMB Review in Phase IIb FASST Trial in Systemic Sclerosis with Lanifibranor

Inventiva Announces Positive DSMB Review in Phase IIb FASST Trial in Systemic Sclerosis with Lanifibranor

January 04, 2018

> DSMB recommends trial to continue unchanged

> 145 patients randomized in trial

> Topline results anticipated early 2019

Daix (France) January 4, 2018 – Inventiva, a biopharmaceutical company developing innovative breakthrough therapies, particularly for the treatment of fibrotic diseases, today announced that the Data Safety Monitoring Board (DSMB) has completed its review of the Phase IIb FAAST (For A Systemic Sclerosis Treatment) trial in systemic sclerosis with lanifibranor. After reviewing all safety data, including adverse events, and the study’s conduct, the DSMB recommended that the study continue without any modifications to the protocol. Of the 145 randomized patients enrolled into the trial, 100 patients have been treated for 6 months including 54 patients that have already completed the one year treatment. The study is progressing as planned with no specific concerns and topline results are anticipated in early 2019.

About Lanifibranor:

Lanifibranor is a next generation panPPAR modulator designed as a moderately potent and well balanced PPAR α δ and y. This unique profile was conceived in order to obtain an optimal therapeutic margin with strong efficacy and tolerance. Lanifibranor displayed an antifibrotic efficacy superior to selective PPARα, PPAR δ or PPARy agonists in several relevant preclinical models. Inventiva is also conducting a Phase IIb clinical study in NASH with lanifibranor.

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 systemic sclerosis (SSc). Patients will 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 Food and Drug Administration (FDA) and the EMA. Inclusion criteria are based on a MRSS between 10 and 25, and diffuse systemic sclerosis 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 systemic sclerosis by the EMA and the FDA. The orphan drug status provides certain advantages for the sponsor such as reduced procedure costs and commercial exclusivity.

About systemic sclerosis:

Systemic sclerosis is a rare and complex disease affecting the auto-immune system, the microvascular system and conjunctive tissues. This fibrotic disease mainly affects the skin, but also the lungs, the heart, the gastro-intestinal tract, and the kidneys. Due to the progressive failure of different organs, systemic sclerosis is a severe disease with a high mortality rate. Once patients are diagnosed with systemic sclerosis, generally between the ages of 40 and 50, the median survival period is of 11 years. Close to 170,000 people suffer from systemic sclerosis worldwide, with women outnumbering men by a ratio of more than five to one1.

The disease owes its original name to scleroderma, the skin condition that it provokes, which derives from the Greek words skleros (hard) and derma (skin). The disease causes severe physical and psycho-social consequences; the former may be fatal for patients whose vital organs are affected. Deeper study of this skin fibrosis has led to its classification into two sub-categories, respectively called limited cutaneous systemic sclerosis and diffuse cutaneous systemic sclerosis. The latter is more serious and is targeted in the FASST trial.

To date, only symptomatic drugs with limited therapeutic effects are available in order to attenuate the consequences of fibrosis progression. However, they do not prevent, delay or reverse the disease’s devastating process.

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’s Phase IIb FASST Trial in Systemic Sclerosis with Lanifibranor Completes Enrollment

Inventiva’s Phase IIb FASST Trial in Systemic Sclerosis with Lanifibranor Completes Enrollment

October 17, 2017

> Enrollment complete – 145 patients randomized

> A total of 47 clinical sites in 10 countries actively recruited patients

> Headline results expected in early 2019

Daix (France) October 17, 2017 – 06:00 pm CEST – Inventiva, a biopharmaceutical company developing innovative breakthrough therapies, particularly for the treatment of fibrotic diseases, today announced that it has completed the enrollment of its Phase IIb FASST (For A Systemic Sclerosis Treatment) trial in Systemic Sclerosis (SSc) with lanifibranor, formerly known as IVA337. FASST is progressing well and investigators have enrolled and randomized 145 patients. Headline results are expected in early 2019.

“We are pleased to have achieved this important enrollment milestone in the development of lanifibranor for the treatment of systemic sclerosis,” said Dr. Jean-Louis Abitbol, Chief Medical Officer and Head of Development of Inventiva. “The decision to open new countries and sites has resulted in a larger number of patients recruited and a slightly longer than anticipated recruitment period. We are very grateful to the patients and our network of investigators for the achievement of this important milestone.”

The FASST trial protocol meets EMA and FDA approval standards. Therefore, if the results of the FASST Phase IIb are positive, we are very confident that lanifibranor will be successful in the pivotal Phase III,;” added Professor Yannick Allanore, Professor of Rheumatology at Ho?pital Cochin ;in Paris and co-Principal Investigator of the FASST trial with Professor Chris Denton, Professor of Experimental Rheumatology at University College London.

Systemic sclerosis is a serious disease with a high unmet medical need. Current treatments mainly manage complications or provide symptomatic relief whereas lanifibranor has the potential to modify the course of the disease, thus representing a significant step forward for patients. We are looking forward to the result of this trial and to lanifibranor further development,;” said Dominique Godard, President of the French SSc Association.

Lanifibranor is a next generation panPPAR modulator designed as a moderately potent and well balanced PPAR α δ and y agonist. This unique profile was designed in order to obtain an optimal therapeutic margin with strong anti-fibrotic efficacy and tolerance. Preclinical data also demonstrate that lanifibranor has the potential to treat pulmonary arterial hypertension a condition often associated with SSc. Inventiva is also progressing a Phase IIb clinical study in NASH (non-alcoholic steatohepatitis) with lanifibranor.

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 will 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 FDA and the EMA. Inclusion criteria are based on a MRSS between 10 and 25, and diffuse systemic sclerosis diagnosed from less than 3 years. Patients are permitted to continue with their ongoing treatments, including immunosuppressive therapies. Lanifibranor has been granted orphan drug status for the treatment of systemic sclerosis by the EMA and the FDA. The orphan drug status provides certain advantages for the sponsor such as reduced procedure costs and commercial exclusivity.

About systemic sclerosis:

Systemic sclerosis is a rare and complex disease affecting the auto-immune system, the microvascular system and conjunctive tissues. This fibrotic disease mainly affects the skin, but also the lungs, the heart, the gastro-intestinal tract, and the kidneys. Due to the progressive failure of different organs, systemic sclerosis is a severe disease with a high mortality rate. Once patients are diagnosed with systemic sclerosis, generally between the ages of 40 and 50, the median survival period is of 11 years. Close to 170,000 people suffer from systemic sclerosis, with women outnumbering men by a ratio of more than five to one 1.

.The disease owes its original name of scleroderma, which derives from the Greek words skleros (hard) and derma (skin), to the skin condition it provokes. The disease causes severe physical and psycho-social consequences; the former may be fatal for patients whose vital organs are affected. Deeper study of this skin fibrosis has led to its classification into two sub- categories, respectively called limited cutaneous systemic sclerosis and diffuse cutaneous systemic sclerosis. The latter is more serious and is targeted in the FASST trial.

To date, only symptomatic drugs with limited therapeutic effects are available in order to attenuate the consequences of fibrosis progression. However, they do not prevent, delay or reverse the disease’s devastating process.

1 Journal of Rheumatology, 2013

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 Hits Clinical Milestone with Enrollment of 100th Patient in IVA337 Phase 2b FASST Trial in Systemic Sclerosis (SSc)

Inventiva Hits Clinical Milestone with Enrollment of 100th Patient in IVA337 Phase 2b FASST Trial in Systemic Sclerosis (SSc)

April 10, 2017

> FASST Phase 2b Clinical Trial on Track to Complete Enrollment in 2nd Half of 2017

> Topline Results Anticipated in 2nd Half of 2018

Daix (France) April 10, 2017 – 06:00 pm CEST – Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, announced today that it has achieved an important milestone in its development of IVA337 for the treatment of systemic sclerosis (SSc), by enrolling the 100th patient into the Phase IIb FASST trial. The trial, which began in December 2015, is now 75% enrolled. The Company is currently on track to complete enrollment in the second half of 2017, with topline results expected to be available in the second half of 2018.

“We are pleased that the FASST study is proceeding on schedule, underscoring the interest we are seeing from physicians and patients in IVA337,” said Frédéric Cren, CEO and co-founder of Inventiva. “To deliver on the recruitment timelines is of major importance for Inventiva. With the opening of additional sites in new countries, we are confident that enrollment will be finalized by the end of this year, delivering the first results in the second half of 2018” said Pierre Broqua, CSO and co-founder.

“Systemic sclerosis is a fatal orphan disease with no approved treatment. Current treatment is directed mainly toward managing complications and providing symptomatic relief,” said Professor Chris Denton, Professor of Experimental Rheumatology at University College London and co-Principal Investigator of the FASST trial. “IVA337 has a unique mechanism of action and has demonstrated evidence of a therapeutic benefit in prior studies. It has the potential to be a true disease modifying agent and potentially highly effective treatment in this disease. I look forward to completing this important study and reporting results in 2018.”

“The anti-fibrotic activity of IVA337 has been demonstrated in preclinical studies, including recent experiments demonstrating anti-fibrotic activities in relevant models of lung and kidney fibrosis,” said Professor Yannick Allanore, Professor of Rheumatology at Ho?pital Cochin in Paris and co-Principal Investigator in the FASST trial. “These studies reinforce the rationale of developing IVA337 in the SSc population. The FASST clinical trial will generate further insight into the beneficial effects of IVA337 in humans, and I look forward to the results next year.”

FASST is a one-year randomized double-blind study designed to enroll up to a total of 132 patients at 50+ sites across eight European countries. Patients are being administered one of the two doses of IVA337 or placebo. The study protocol, approved by the European Medicines Agency (EMA), has been designed to demonstrate the beneficial effect of IVA337 on progression of SSc. The primary endpoint is a measure of the change in the modified Rodnan skin score, a measure of disease progression accepted by both FDA and the EMA. Inclusion criteria are based on a MRSS (Modified Rodnan Skin Score) between 10 and 25, and diffuse systemic sclerosis diagnosed from less than 3 years. Patients are permitted to continue with their ongoing treatments, including immunosuppressive therapies.

In November 2014, the European Medicines Agency (EMA) granted IVA 337 the orphan drug status for the treatment of systemic sclerosis. The orphan drug status provides certain advantages for the sponsor such as reduced procedure costs and ten years of commercial exclusivity.

“Much in line with this Phase IIb study in which patient enrollment is progressing very well, we are pursuing the execution of our clinical development plan we announced during our initial public offering in February. We remain on schedule to report important clinical results from mid-2018 in our three main indications, which are NASH, MPS VI and systemic sclerosis,” concluded Frédéric Cren, Inventiva’s CEO and co-founder.

About systemic sclerosis:

Systemic sclerosis is a rare and complex disease affecting the auto-immune system, the microvascular system and conjunctive tissues. This fibrotic disease mainly affects the skin, but also the lungs, the heart, the gastro-intestinal tract and the kidneys. Due to the progressive failure of different organs, systemic sclerosis is a severe disease with a high mortality rate. Once patients are diagnosed with systemic sclerosis, generally between the ages of 40 and 50, the median survival period is of 11 years. Close to 170,000 people suffer from systemic sclerosis, with women outnumbering men by a ratio of more than five to one1.

The disease owes its original name of scleroderma, which derives from the Greek words skleros (hard) and derma (skin), to the skin condition it provokes. The disease causes severe physical and psycho-social consequences; the former may be fatal for patients whose vital organs are affected. Deeper study of this skin fibrosis has led to its classification into two sub- categories, respectively called limited cutaneous systemic sclerosis and diffuse cutaneous systemic sclerosis. The latter is more serious and is targeted in the FASST trial.

To date, only symptomatic drugs with limited therapeutic effects are available in order to attenuate the consequences of fibrosis progression. However, they do not prevent, delay or reverse the disease’s devastating process.

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 rewarded for its innovative approach with IVA337 at the 4th Systemic Sclerosis World Congress

Inventiva rewarded for its innovative approach with IVA337 at the 4th Systemic Sclerosis World Congress

February 25, 2016

> Presentation on IVA337’s anti?fibrotic properties receives award and picked out from over 400 submissions

> Oralpresentation by Professor Yannick Allanore, Professor of Rheumatology at Hôpital Cochin, on the preventive and curative properties of IVA337 in a systemic sclerosis model

> Confirmation of IVA337’s potential in the treatment of systemic sclerosis (phase IIb trial ongoing)

Daix (France), February 25th 2016 – Inventiva, a biopharmaceutical company specialised in nuclear receptors, transcription factors and epigenetics for the development of innovative therapies for fibrosis, oncology and orphan diseases, announces that the organising committee of the 4th Systemic Sclerosis World Congress awarded Inventiva with a prize for the innovative approach it has taken with its lead product, IVA337, currently in a Phase 2b trial for the treatment of systemic sclerosis.

The research presented shows that IVA337 can treat the fibrosis of organs affected by systemic sclerosis via a unique mechanism of action. More than 400 submissions were presented at this congress of reference held by the World Scleroderma Foundation which brings together for three days the world experts of the disease and representatives from patient associations.

In its poster entitled “Pan PPAR agonist IVA337 has an anti?fibrotic effect in multiple in vitro and in vivo fibrosis models;”, Inventiva demonstrated in several in vitro ;and in vivo ;fibrosis models (lungs, liver, kidneys, etc.) the anti?fibrotic action of its lead product IVA337, a next?generation Pan PPAR agonist. This provides further evidence of the major role played by PPARs in fibrogenesis.

Additional data concerning the effects of IVA337 on skin fibrosis were also presented during the Congress by Professor Yannick Allanore, Professor of Rheumatology at Hôpital Cochin in Paris, in his presentation entitled: “Pan PPAR agonist IVA337 is effective in prevention and treatment of experimental skin fibrosis”.

We are very proud to have been selected from over 400 high?level research submissions presented at this Congress, which is the most important scientific global event in the field of systemic sclerosis,;” commented Pierre Broqua, Chief Scientific Officer and co?Founder of Inventiva. “This recognition reflects IVA337’s promising therapeutic potential, not only in systemic sclerosis, but also in other indications involving fibrosis, such as NASH, for which no effective treatments exist yet.

Alongside the ongoing phase IIb trial in the treatment of systemic sclerosis, in which it plans to enrol a total of 135 patients in 8 European countries, Inventiva also shortly intends to launch a phase IIb clinical trial for the treatment of NASH. NASH is a severe fibrotic disease of the liver that may cause cirrhosis or cancer and that affects several million people worldwide.

About the Systemic Sclerosis World Congress:

The Systemic Sclerosis World Congress is held by the World Scleroderma Foundation, an organisation dedicated to initiating and supporting research into systemic sclerosis. This globally renowned conference aims to bring together and facilitate the sharing of expertise by all those involved in the field of systemic sclerosis through presentations, workshops and a programme specifically dedicated to patients.

About systemic sclerosis:

Systemic sclerosis is a rare and complex disease affecting the auto?immune system, the microvascular system and conjunctive tissues. This fibrotic disease mainly affects the skin, but also the lungs, the heart, the gastro? intestinal tract and the kidneys. Due to the progressive failure of different organs, systemic sclerosis is a severe disease with a high mortality rate. Once patients are diagnosed with systemic sclerosis, generally between the ages of 40 and 50, the median survival period is of 11 years. Close to 170,000 people suffer from systemic sclerosis, with women outnumbering men by a ratio of more than five to one1.

The disease owes its original name of scleroderma, which derives from the Greek words skleros (hard) and derma (skin), to the skin condition it provokes. The disease causes severe physical and psycho-social consequences that may be deadly for patients whose vital organs are affected. The extension of this skin fibrosis has led to the classification of two sub-categories, respectively called limited systemic sclerosis and diffuse systemic sclerosis. The latter is more serious and is targeted in the FASST trial.

To date, only symptomatic drugs with limited therapeutic effects are available in order to attenuate the consequences of fibrosis progression. However, they do not prevent, delay nor reverse the disease’s devastating process.

1 Journal of Rheumatology, 2013

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.

IVA337 delivers significant therapeutic advances in fibrosis, a major public health challenge

IVA337 delivers significant therapeutic advances in fibrosis, a major public health challenge

January 28, 2016

> Enrolment of the first systemic sclerosis patients in the Phase IIb trial of IVA337, one of Inventiva’s lead products

> Preparation of a new Phase IIb study in the treatment of NASH1

Daix (France), January 28, 2016 – Inventiva, a biopharmaceutical company specialized in nuclear receptors, transcription factors and epigenetics for the development of innovative therapies for fibrosis, oncology and rare diseases, is announcing today the enrolment of the first patients in its international Phase IIb FASSTtrial of IVA337, its lead anti-fibrotic therapy, in the treatment of systemic sclerosis.

Systemic sclerosis is a severe auto-immune disease, which can prove fatal in many cases. It is characterized by significant progressive fibrosis of the skin and several vital organs such as the lungs, kidneys, digestive tract and heart, leading to their failure. It affects close to 170,000 patients around the world and represents a market estimated to be worth over €1 billion in the United States3, with no effective treatment currently available.

IVA337, a highly promising drug candidate for the treatment of fibrotic diseases

Fibrotic diseases, which are responsible every year for close to 45% of deaths worldwide4, pose a major public health challenge. A distinguishing feature of IVA337 is that it activates a specific class of nuclear receptors – the PPARs (Peroxisome Proliferator Activated Receptors) – that are involved in the fibrotic process. IVA337 is a new-generation PanPPAR, which has demonstrated anti-fibrotic properties in several tissues alongside good clinical tolerance. Its unique mechanism of action goes through the activation of all three alpha, gamma and delta PPARs to slow, halt or reverse the progression of fibrosis.

The anti-fibrotic effects of IVA337 on the skin, lungs, kidneys and liver open up a pathway for the treatment of numerous fibrotic diseases. Inventiva therefore decided to pursue the development of IVA337 in the treatment of two fibrotic diseases with very high unmet medical needs: NASH and Systemic Sclerosis. NASH, is a severe liver fibrotic condition that may cause cirrhosis or even cancer and which affects over 30 million people in the United States5. Systemic sclerosis is an orphan disease with no available treatment to date, for which Inventiva has already obtained orphan drug status in Europe and the United States.

Encouraging results obtained for the treatment of systemic sclerosis, a complex and severe disease with no known effective treatment

After successfully completing its Phase I and Phase IIa trials, Inventiva is advancing with the development of its anti-fibrotic lead drug candidate by launching the Phase IIb FASST trial for the treatment of systemic sclerosis.

Enrolments for this randomised, double-blind year-long trial have begun. It will include a total of 135 patients in 8 European countries, who will be given a placebo or one of the two doses of IVA337 being tested. The study protocol, which was endorsed by the European Medicines Agency, aims to demonstrate the positive impact of IVA337 on disease progression in patients who have contracted the most severe form of systemic sclerosis.

“To date, no drug has demonstrated an ability to either slow down or reduce fibrosis in the course of systemic sclerosis. Various therapeutic trials have failed. These results show the increasing need for a whole new generation of drugs. IVA337 developed by Inventiva is a moderate and balanced activator of the alpha, gamma and delta PPARs and has demonstrated very good tolerance and highly attractive anti-fibrotic properties in preliminary trials. These results and this original mechanism of action led to set-up Phase IIb trials and allow patients to carry on with their ongoing treatment, including immunosuppressive therapies. This should facilitate recruitment for the FASST trial”, comments Yannick Allanore, Professor of Rheumatology at Hôpital Cochin in Paris and coordinator of the FASST study.

“With more than 50 hospitals taking part in the trial in 8 countries, the FASST study is to date one of the largest initiatives launched to develop an anti-fibrotic therapeutic strategy for systemic sclerosis. This trial was designed to establish IVA337 as the cornerstone treatment for systemic sclerosis patients”, adds Pierre Broqua, CSO and co-founder of Inventiva.

The positive results generated during the pre-clinical and clinical studies with IVA337 represent a key step in the design of a new high-potential therapeutic approach against fibrosis;” concludes Frédéric Cren, Inventiva’s CEO and co-founder. “Thanks to the unique anti-fibrotic properties of our drug candidate IVA337, we aim to bring to market a curative treatment for systemic sclerosis and NASH, a disease for which another Phase IIb trial with IVA337 is due to be launched this year.

About systemic sclerosis

Systemic sclerosis is a rare and complex disease affecting the auto-immune system, the microvascular system and conjunctive tissues. This fibrotic disease mainly affects the skin, but also the lungs, the heart, the gastro- intestinal tract and the kidneys. Due to the progressive failure of different organs, systemic sclerosis is a severe disease with a high mortality rate. Once patients are diagnosed with systemic sclerosis, generally between the ages of 40 and 50, the median survival period is of 11 years. Close to 170,000 people suffer from systemic sclerosis, with women outnumbering men by a ratio of more than five to one6.

The disease owes its original name of scleroderma, which derives from the Greek words skleros (hard) and derma (skin), to the skin condition it provokes. The disease causes severe physical and psycho-social consequences that may be deadly for patients whose vital organs are affected. The extension of this skin fibrosis has led to the classification of two sub-categories, respectively called limited systemic sclerosis and diffuse systemic sclerosis. The latter is more serious and is targeted in the FASST trial.

To date, only symptomatic drugs with limited therapeutic effects are available in order to attenuate the consequences of fibrosis progression. However, they do not prevent, delay nor reverse the disease’s devastating process.

1 Non-Alcoholic Steato-Hepatitis
2 FASST: For A Systemic Sclerosis Treatment
3 Corbus Investor Presentation; Cytori Therapeutics Investor Presentation
4 The Journal of Clinical Investigation; Common and unique mechanisms regulate fibrosis in various fibroproliferative diseases; March 2007
5 Angulo et al. Hepatology 1999; 30(6):1356-62. ; Minervini et al. J Hepatology 2009; 50:501–510.
6 Journal of Rheumatology, 2013

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.

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