Financial Results

Inventiva to participate at the H.C. Wainwright 3rd Annual NASH Investor Conference and the Gilbert Dupont NASH Day

Inventiva to participate at the H.C. Wainwright 3rd Annual
NASH Investor Conference and the Gilbert Dupont NASH Day

October 16, 2019

Daix (France), October 16, 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, has been invited to participate at a round table discussion during the upcoming H.C. Wainwright 3rd Annual NASH Investor Conference (New York, USA). This round table will focus on the most promising PPAR programs currently in development for the treatment of NASH. Furthermore, Inventiva will also attend the Gilbert Dupont NASH Day (Paris, France) and present the potential of lanifibranor, the Company’s pan-PPAR and lead drug candidate, as a treatment in this indication.

The event details are as follows:

Conference n°1 : H.C. Wainwright 3rd Annual NASH Investor Conference
Round table: “All-PPAR Fireside Chat”
Date: Monday, October 21, 2019
Time: 9:00 am – 10:00 am (Eastern Time)
Location: Versailles Room, St. Regis Hotel, Two East 55th Street, New York, NY 10022, USA
Webcast: http://www.wsw.com/webcast/hcw6/panel2/

The round table can be followed live and replayed at the above-mentioned link.

Conference n°2: Gilbert Dupont NASH Day
Round table: “Therapeutic challenges and diagnostics: promising solutions”
Date: Tuesday, October 29, 2019
Time: 10:50 am – 12:30 am (Paris Time)
Location: Crédit du Nord, 59 Boulevard Haussmann, 75008 Paris, France

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 completes a capital increase of € 625,000 subscribed by Sofinnova Partners through Sofinnova Crossover I Fund

Inventiva completes a capital increase of € 625,000 subscribed by Sofinnova Partners through Sofinnova Crossover I Fund

September 30, 2019

Daix (France), September 30th, 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 completion of a capital increase of € 625,000 subscribed by Sofinnova Partners, current Inventiva shareholder and board member, through Sofinnova Crossover I SLP, a leading European venture capital firm specialized in Life Sciences. The capital increase was performed on similar terms to the capital increase of € 8.2 million announced by the Company on last September 18th.

Frederic Cren, Inventiva’s Chairman and CEO, commented: “We are very pleased to complete this capital increase so quickly, following the one held on September 20th. Sofinnova is a recognized expert in France and internationally in Life Sciences sector: being able to count on their support is a recognition of the progress made on all of our programs and a mark of trust in the clinical studies we are conducting with lanifibranor and odiparcil and for which results are expected in the first half of 2020 and by the end of the year respectively ”

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 receives FDA Fast Track designation for lead asset lanifibranor in NASH

Inventiva receives FDA Fast Track designation for lead asset lanifibranor in NASH

September 26, 2019

Daix (France), September 26, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s lead product candidate, lanifibranor, for the treatment of non-alcoholic steatohepatitis (NASH).
The FDA’s dedicated Fast Track program is designed to facilitate the development and expedite the review and potential approval of drug candidates. Its overall objective is to improve patient access to therapies intended to treat serious conditions and to fill significant unmet medical needs.

Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, commented: “We are delighted that the FDA has granted Fast Track designation to lanifibranor for the treatment of NASH. It highlights the large and unmet medical need for this common, progressive and severe chronic liver disease, for which there is currently no approved therapy. We are convinced of the unique mechanism of action of lanifibranor, the only pan-PPAR agonist currently in development, and its potential to treat NASH patients. Today’s decision represents an important step towards achieving our objective of getting appropriate therapy to patients as quickly as possible. We are pleased with the constructive and open dialogue we had so far with the FDA and we look forward to continue working closely together with them to accelerate the development of lanifibranor.”

Once a therapeutic product receives Fast Track designation, the respective company is eligible for more frequent communication with the FDA to discuss the drug candidate’s development plan, the design of the proposed clinical trials, the use of biomarkers, and the collection of appropriate data required to support drug approval. It also provides the respective company with accelerated approval and priority review, as well as rolling review meaning that the respective company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review, rather than waiting until every section of the BLA or NDA is completed.

The FDA’s decision follows the completion of patient recruitment for Inventiva’s NATIVE (NAsh Trial to Validate IVA337 Efficacy) Phase IIb clinical study evaluating the drug candidate for the treatment of NASH. The study is progressing as planned and the publication of the results are expected in the first half of 2020. If positive, they will support the entry of lanifibranor into the pivotal Phase III trial, the last phase of its development prior to market launch.

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

H1 2019 financial results and corporate business update

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

September 25, 2019

Daix (France), September 25, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today reported its interim financial results for the six months ended June 30, 2019, and provided an update on its business activities.

Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “We have made significant progress in our most advanced programs dedicated to non-alcoholic steatohepatitis (NASH) and mucopolysaccharidosis type VI (MPS), especially with the completion of patient recruitment in the Phase IIb and Phase IIa studies respectively. The FDA’s decision to lift the clinical hold for lanifibranor, which generally applies to this type of drugs, also represents a key milestone enabling us to initiate long-term clinical studies ahead of its potential commercialization. In addition, we have reinforced the protection of lanifibranor in the areas of NASH and fibrotic diseases in two key markets, Europe and the United States, through new patents demonstrating our innovative R&D approach. The launch of a new clinical study with ABB-157 in patients with moderate to severe psoriasis by our partner AbbVie is also excellent news for this program in which Inventiva remains eligible to receive milestone payments as well as sales royalties. The success of our latest capital increase, which strengthens our investor base in the United States and Europe, and the various progress achieved across our product portfolio allows us to focus on executing our strategy with confidence and serenity.”

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 completes a capital increase of € 8.2 million subscribed by leading US and European biotech investors

Inventiva completes a capital increase of € 8.2 million subscribed by leading US and European biotech investors

September 19, 2019

Daix (France), September 19th, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the successful completion of a capital increase of €8.2 million subscribed by New Enterprise Associate (NEA), a leading US biotech investor and by BVF Partners L.P. and Novo Holdings A/S, two key current Inventiva shareholders. The capital increase was executed at the closing price of September 18, 2019 without any discount. In addition, Sofinnova Partners, current Inventiva shareholder and board member, through Sofinnova Crossover I Fund, a leading European venture capital firm specialized in Life Sciences, expressed an interest to acquire, as part of a future capital increase which may occur by the end of October 2019, up to additional 313,936 shares on similar terms, depending on the market conditions and in accordance with the corporate authorizations .

Frederic Cren, Inventiva’s Chairman and CEO, commented: “We are very pleased with the successful completion of this placement, which supports our positive momentum across our product portfolio and which will allow us to further progress with our clinical and preclinical programs. We are excited to welcome among our shareholders a new tier-one US biotech investor, New Enterprise Associate (NEA), who has a substantial track record and strong expertise in our industry. At the same time, we are delighted that BVF Partners L.P. and Novo Holdings A/S have renewed their trust in Inventiva. We thank them for their continued support. With this strengthened investor base in both the US and Europe, we now look forward to the clinical results of our two most advanced compounds, lanifibranor and odiparcil, which are expected in the first half of 2020 and by the end of this year respectively.”

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

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

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

September 10, 2019

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

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

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

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

September 4, 2019

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

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

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

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

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

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

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

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

September 2, 2019

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

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

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

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

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

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

August 28, 2019

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

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

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

August 26, 2019

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

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

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

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

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

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