News & Events

Inventiva to Present Corporate Overview at the Cowen and Company 39th Annual Health Care Conference

Inventiva to Present Corporate Overview at the Cowen and Company 39th Annual Health Care Conference

6 March 2019

Daix (France), March 6, 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 Frédéric Cren, Chairman, CEO and cofounder of Inventiva, will present a corporate overview, followed by a breakout session, at the upcoming Cowen and Company 39th Annual Health Care Conference, being held on March 11-13, 2019 at the Marriott Hotel in Boston, Massachusetts.

The event details are as follows:

Date: Monday, March 11, 2019

Time of presentation: 3:30 pm – 4:00 pm (Eastern Time)

Time of breakout session: 4:10 pm – 4:40 pm (Eastern Time)

Location of presentation: Orleans Room, 4th Floor, Boston Marriott Copley Place, Boston, Massachusetts

Location of breakout session: Hyannis Room, 4th Floor, Boston Marriott Copley Place, Boston, Massachusetts

Webcast: http://wsw.com/webcast/cowen52/iva/

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

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.

The FDA Grants Rare Pediatric Disease Designation to Odiparcil for the Treatment of MPS VI

The FDA Grants Rare Pediatric Disease Designation to Odiparcil for the Treatment of MPS VI

5 March 2019

Daix (France), March 05, 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 U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation (RPDD) to odiparcil, the Company’s product candidate in development for the treatment of mucopolysaccharidosis (MPS) VI, a type of rare, progressive genetic disorder characterized by a deficiency in the lysosomal enzymes responsible for the normal degradation of glycosaminoglycans (GAGs). The designation of rare pediatric disease status confirms odiparcil’s eligibility to receive a Priority Review Voucher upon FDA approval of a new drug application (NDA) to be filed for odiparcil for the treatment of MPS VI.

Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, declared: “This important designation from the FDA illustrates the severity of MPS VI in the pediatric population. We look forward to continued collaboration with the FDA in advancing odiparcil as a therapy in such a rare and life-threatening disease for which there is still a significant unmet medical need .

The FDA defines “rare pediatric diseases” as diseases with serious or life-threatening manifestations that primarily affect people who are less than 18 years old and that affect fewer than 200,000 people in the United States. Under the FDA’s RPDD program, a sponsor who receives approval of an NDA or a biologics license application (BLA) for a product for the prevention or treatment of a designated rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain priority review for a future submission of an NDA or BLA. Redeemed vouchers can reduce FDA review time from twelve to six months. Priority Review Vouchers may be used by the sponsor, or sold or transferred to a third party, with prices ranging from $67.5 million to $350 million since the first one was issued in 2009. The last voucher was sold in October 2018 for $80 million.[1]

About odiparcil

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

Inventiva is currently evaluating odiparcil in a Phase IIa clinical study for the treatment of adult patients with MPS VI.

Odiparcil has been granted orphan drug status for the treatment of MPS VI by the FDA and the European Medicines Agency.

About the Phase IIa iMProveS clinical trial

The iMProveS (Improve MPS treatment) clinical trial is a 26-week Phase IIa clinical trial evaluating odiparcil for the treatment of adult patients with MPS VI. The primary endpoint of the trial is safety, as assessed by clinical and biological standard tests. Secondary endpoints include changes from baseline in leukocyte, skin and urinary GAG content, and improvements of activity and mobility, cardiovascular, lung and respiratory function, and vision and hearing impairments.

Inventiva expects to enrol 18 adult MPS VI patients currently receiving enzyme replacement therapy (ERT) in a double-blind placebo-controlled study and six patients not receiving ERT in an open label cohort at two sites in Europe. Results of the trial are expected in the second half of 2019.

[1] Source: Biocentury May 4, 2018 “Voucher Equilibrium”; Biocentury November, 1st 2018 “Lilly buys Siga’s priority review voucher gained via smallpox approval”.

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 further progress achieved in the clinical development of lanifibranor for the treatment of NASH

Inventiva announces further progress achieved in the clinical development of lanifibranor for the treatment of NASH

21 February 2019

Daix (France) February 21st, 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 screening of the first patient in the United States 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 common and progressive chronic liver disease for which there is currently no approved therapy. Inventiva also announced that the NATIVE Data Safety Monitoring Board (DSMB) held its second meeting and recommended that the trial continue as planned.

The screening of the first patient in the United States follows the positive review by the U.S. Food and Drug Administration (FDA) of the NATIVE trial protocol and the inclusion of 14 sites in the United States in the trial, which brought the total number of sites involved to 91. Out of 225 patients expected to be enrolled in the trial, 155 patients have been randomized, and 71 patients have already completed the six-months treatment. The NATIVE trial continues to progress as planned and results are anticipated in the first half of 2020.

Pr Sven Francque, M.D., Ph.D. from the Antwerp University Hospital and Co-Principal Investigator, said: “The news of the first patient screened in the U.S. and the opening of 14 sites represents great progress. We expect to open 5 additional sites in Europe to further accelerate patient recruitment. Given the study design and lanifibranor’s mechanism of action, we believe that the results of the NATIVE trial, if positive, will support lanifibranor’s move into the pivotal Phase III trial.”

Pr Manal Abdelmalek, M.D., M.P.H. from Duke University, who agreed to act as Co-Principal Investigator with Pr Sven Francque, stated: “I am very pleased to be a part of this important trial and am excited by the profile of lanifibranor, a drug that is designed to act on many features of NASH by combining anti-fibrotic and anti-inflammatory activities with metabolic benefits, including improvement of insulin sensitivity.”

“The NATIVE trial is rolling out in the United States as planned and we are excited to add U.S. sites to the study, making NATIVE a truly international trial. We are thrilled to welcome Pr Abdelmalek, a renowned hepatologist, to the Steering Committee of the NATIVE trial and we look forward to finalizing recruitment over the coming months,” added Inventiva’s Chief Medical Officer, Marie-Paule Richard, M.D.

In addition, the NATIVE DSMB has reviewed the available safety data from the trial and recommended, for the second time, that the trial continue without modification to the protocol. The positive outcome of this second DSMB review is consistent with the results of long-term toxicological studies, as well as of Phase I and Phase II clinical trials, which have shown that lanifibranor is associated with a favorable safety profile.

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, 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.

About the NATIVE Phase IIb trial

The NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial is a 24-week treatment, randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating lanifibranor in the treatment of patients with non-alcoholic steatohepatitis (“NASH”). The goal of the trial is to assess the effect of lanifibranor on the improvement in liver inflammation and ballooning, which are two of the markers of the resolution of NASH. To be considered for inclusion, patients must have: a diagnosis of NASH confirmed by liver biopsy; a cumulative score of inflammation and ballooning (as measured using the steatosis, activity and fibrosis, or “SAF”, scoring system) of three or four out of four, indicating the presence of moderate to severe inflammation and ballooning; a steatosis score greater than or equal to one, indicating the presence of moderate to severe steatosis; and a fibrosis score less than four, indicating the absence of cirrhosis. The primary endpoint of the trial is a reduction in the combined inflammation and ballooning score of two points compared to baseline, without worsening fibrosis. Secondary endpoints include NASH resolution, improvements in each of the steatosis, inflammation, ballooning and fibrosis scores from baseline as measured using the SAF score, improvements in various other fibrosis measures, improvements in several metabolic markers, improvements in steatosis, inflammation and ballooning as measured using the “NAS” score, and safety.

The trial is expected to enrol 225 patients with NASH at more than 90 sites in Europe, the United States, Canada, Australia and Mauritius. Results of the trial are expected in the first half of 2020.

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 Results From Phase IIb Clinical Trial with Lanifibranor in Systemic Sclerosis

Inventiva Announces Results from Phase IIb Clinical Trial with Lanifibranor in Systemic Sclerosis

18 February 2019

Daix (France), February 18, 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 results from the FASST (For A Systemic Sclerosis Treatment) clinical trial evaluating lanifibranor for the treatment of patients with diffuse cutaneous systemic sclerosis (“dcSSc”), a rare, progressive autoimmune, rheumatic disease with frequent serious adverse events and high unmet medical need.

The FASST clinical trial, a one-year,  double-blind, randomized, placebo-controlled Phase IIb study, included 145 patients suffering from the early phase of dcSSc, who received lanifibranor in either two doses of 400mg per day or two doses of 600mg per day over 48 weeks in addition to their existing standard of care, which in most cases included immunosuppressive therapy.

The FASST clinical trial did not meet its primary endpoint of a mean absolute change from baseline to week 48, relative to placebo, in the modified Rodnan Skin Score (“mRSS”), which assesses skin thickness across 17 defined points on the body on a scale of zero, indicating normal skin, to three, indicating severe thickness. There was a decrease in the average mRSS observed in active and placebo arms with only four patients reporting to have increases in mRSS scores over the course of the trial.

800mg lanifibranor1200mg lanifibranorPlacebo
Number of patients494848
Mean baseline mRSS (SD[1])18.2 (3.8)17.8 (3.9)17.1 (-3.7)
Mean absolute change of mRSS from baseline to week 48 (SD3)-3.7 (4.2)-4.3 (5.0)-4.9 (4.6)

While the trial did not meet any of the secondary endpoints, lanifibranor showed a favorable trend in patients’ global assessment of disease activity with a mean absolute change in visual analog scale[2] (p=0.08) from baseline versus placebo indicating a perceived benefit by patients.

Within this fragile and poly-medicated population, lanifibranor was observed to be associated with a favorable safety profile, with no adverse interactions with immunosuppressive background therapies observed. The proportion of patients with at least one adverse event was similar across the three patient groups.

As reported in established literature, patients in the early phase of SSc population have an increased susceptibility to edema.[3] In the FASST clinical trial, fluid retention was observed related to lanifibranor but was only judged severe in one patient in each dose group, and a single serious adverse event of peripheral edema was observed at the highest lanifibranor dose. Furthermore, no cardiac or renal safety concerns were observed in the trial.

Yannick Allanore, co-principal investigator of the FASST clinical trial and professor of rheumatology at the Hôpital Cochin in Paris, commented: “The FASST clinical trial was well-conducted and represents the first study in dcSSc with a stratified background on immunosuppressive therapy. It appears that the presence of background therapy produced a strong placebo effect and limited the number of patients progressing in dcSSc.”

Professor Christopher Denton, co-principal investigator of the FASST clinical trial and professor at the University College of London, added: “We regret the study results but we are satisfied both by lanifibranor patients’ well-being, expressed in their global assessment, and lanifibranor’s favorable safety profile observed in the trial, including in combination with immunosuppressive drugs.”

Based on the FASST clinical trial results, Inventiva plans to discontinue lanifibranor’s clinical development for the treatment of dcSSc in order to fully focus on the development of lanifibranor for the treatment of NASH, of odiparcil for the treatment of mucopolysaccharidoses (MPS), and of YAP-TEAD in the field of oncology.

Frédéric Cren, Chairman and CEO of Inventiva, said: “We are disappointed by the results of the FASST clinical trial in dcSSc, a challenging disease as evidenced by the recent failure of three other late-stage trials. While we have decided to discontinue the lanifibranor program in SSc, we are very grateful for the dedication and commitment of patients, caregivers, investigators and our team to this program. We remain confident in lanifibranor’s unique mechanism of action and will therefore continue to move forward, as planned, with its clinical development in the treatment of NASH. Beyond lanifibranor, we have a promising and diversified development pipeline, backed by a strong discovery engine, notably with odiparcil for the treatment of mucopolysaccharidoses, and look forward to the upcoming clinical milestones.”

Results presentation

Inventiva’s management team will present the trial results in the context of the Company’s 2018 full-year results which will be published on Wednesday February 27, 2018 at 5:45 pm (Paris time).

On that occasion, the Company will host  a conference call in English at 6:15 pm (Paris time). The conference call will be simultaneously webcast and accessible on Inventiva’s website in the “Investors” – “Financial Results & Presentations” section. A replay of the conference call and webcast will also be available following the event.

More details on the conference call and webcast will be provided in the Company’s 2018 full-year results’ press release.

About the FASST Phase IIb trial

The FASST (For A Systemic Sclerosis Treatment) clinical trial was a one-year randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating lanifibranor in the treatment of patients with diffuse cutaneous systemic sclerosis (“dcSSc”), which affects approximately 35% of patients with systemic sclerosis (“SSc”). The primary endpoint of the trial was a mean absolute change from baseline to week 48 in the modified Rodnan Skin Score (“mRSS”), which assesses skin thickness across 17 defined points on the body on a scale of zero, indicating normal skin, to three, indicating severe thickness. The mRSS is a clinically validated and FDA‑accepted endpoint measuring the evolution of skin fibrosis, which is known to be correlated with internal organ fibrosis. In addition, secondary endpoints for the trial included changes in forced vital capacity (“FVC”), which is an FDA‑accepted endpoint measuring pulmonary function, overall progression of the disease (assessed as the absence of rescue therapy and of severe organ involvement, such as kidney failure), changes in gastrointestinal health, and safety.

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.

About Systemic Sclerosis

SSc is a rare, progressive and debilitating chronic autoimmune rheumatic disease that is characterized by microvascular damage, dysregulation of the immune system and generalized fibrosis in multiple organs. As such, SSc affects the skin, lungs, heart, gastrointestinal tract and kidneys, with the impairments of the internal organs the most disabling and life-threatening manifestations of the disease.

It causes patients to suffer from major disability, significantly impaired quality of life and shorter life expectancy, primarily due to organ failure. SSc is potentially fatal, with the cause typically being cardio-respiratory failure. SSc patients have a greater mortality rate than patients with any other rheumatic disease. The prevalence of SSc is estimated to be 154 people per million in each of the United States and Europe and women are five times more likely than men to develop the disease.

As of today, there are no approved treatments for SSc.

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

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

4 February 2019

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

 

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

 

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

 

Event:                                              International Liver Congress™ 2019, Vienna, Austria

Date:                                                Thursday, April 11th, 2019

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

Session:                                           NAFLD Pathophysiology – Target identification

Speakers:                                        Sander Lefere[2]

 

Background on PPARs

 

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

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

[2]PhD student, Ghent University

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Julien Trosdorf / Yannick Tetzlaff

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

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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

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

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

December 10, 2018

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

The event details are as follows:

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

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

 

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Julien Trosdorf / Yannick Tetzlaff

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

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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

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

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

Novembre 7, 2018

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

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

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

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

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

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

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

The event details for the presentations are as follows:

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

About the EORTC-NCI-AACR Symposium

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

 

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Julien Trosdorf / Yannick Tetzlaff

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

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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

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

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

October 30, 2018

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

The details of the events are as follows:

Stifel 2018 Healthcare Conference

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

Jefferies 2018 London Healthcare Conference

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

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Julien Trosdorf / Yannick Tetzlaff

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

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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

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

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

October 17, 2018

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

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

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

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

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

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

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

Biographies

Dr Marie-Paule Richard, M.D.

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

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

Dr David Nikodem, Ph.D.

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Julien Trosdorf / Yannick Tetzlaff

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

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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

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

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

October 15, 2018

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

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

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

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

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

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

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

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

About the Phase IIb FASST trial

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

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

About the Phase IIb NATIVE trial

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

About lanifibranor

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Julien Trosdorf / Yannick Tetzlaff

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

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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

1