Financial Results

Inventiva annonce avoir réalisé la dernière visite de patient pour son étude clinique de Phase IIb avec lanifibranor dans la NASH

Inventiva annonce avoir réalisé la dernière visite de patient pour son étude clinique de Phase IIb avec lanifibranor dans la NASH

17 mars 2020

Daix (France), le 17 mars 2020 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, annonce aujourd’hui avoir réalisé la dernière visite du dernier patient sur les 247 recrutés dans son étude clinique de Phase IIb avec lanifibranor pour le traitement de la NASH. La biopsie du dernier patient a été réalisée en février et la dernière visite de contrôle a eu lieu aux États-Unis le 16 mars 2020. Toutes les biopsies ont été analysées par l’hépatologue principal et la publication des principaux résultats est prévue en juin 2020, conformément aux prévisions de la Société.

L’étude NATIVE (NAsh Trial to Validate IVA337 Efficacy) est une étude clinique de Phase IIb randomisée, en double aveugle, contrôlée par placebo, d’une durée de 24 semaines, évaluant lanifibranor dans le traitement de patients atteints de la stéatohépatite non alcoolique (NASH). L’objectif principal de l’étude est d’évaluer l’efficacité de lanifibranor dans l’amélioration de l’inflammation du foie et du « ballooning », les deux marqueurs histologiques de la NASH inclus dans la définition du critère d’évaluation réglementaire de résolution de la NASH. Les critères d’évaluation secondaires de l’étude incluent également la résolution de la NASH ainsi que l’amélioration de chacun des scores de stéatose, d’inflammation, de « ballooning » et de fibrose, mesurés par rapport à la valeur initiale.

Pendant toute la durée de l’étude, le profil de sécurité de lanifibranor a été évalué régulièrement par le Data Safety Monitoring Board (DSMB). Le DSMB s’est réuni quatre fois entre juin 2018 et septembre 2019 et aucun problème de sécurité n’a été constaté. Le DSMB a systématiquement recommandé la poursuite de l’étude sans modification du protocole, confirmant ainsi le bon profil de sécurité de lanifibranor.

Le Prof. Sven Francque, M.D., Ph.D. de l’Hôpital Universitaire d’Anvers et Co-Investigateur principal de l’étude, a déclaré : « Je suis très heureux de voir que l’étude se déroule comme prévu, et que cette dernière étape avant la publication des résultats de l’étude ait été franchie conformément au calendrier. L’engagement et la qualité du travail des cliniciens et des centres impliqués dans l’étude ont été remarquables et je suis certain que cela se traduira par des données cliniques de grande qualité. J’attends les résultats de cette étude avec impatience et me réjouis de continuer à travailler sur le développement de lanifibranor. »

Le Prof. Manal Abdelmalek, M.D., M.P.H. Duke University et Co-Investigateur principal de l’étude avec le Prof. Sven Francque, a ajouté : « Je suis ravi que nous ayons effectué cette dernière visite, et je suis fier de notre équipe qui a pu accélérer le recrutement des patients aux États-Unis. Le profil de lanifibranor, en tant que candidat médicament potentiellement bénéfique pour le traitement de la NASH dans le monde entier, est solide et convaincant. J’attends avec impatience la conclusion positive de cette étude et la publication prochaine des principaux résultats. »

Pierre Broqua, Directeur Scientifique et cofondateur d’Inventiva, a expliqué : « Grâce au design et au bon déroulement de l’étude clinique NATIVE, et aux résultats précliniques et cliniques générés jusqu’à présent, nous sommes convaincus que son profil d’agoniste pan-PPAR et sa capacité à associer les effets bénéfiques des trois isoformes PPAR constituent un avantage indéniable pour le traitement de la NASH. Ces caractéristiques confèrent à notre principal candidat médicament un mécanisme d’action différencié qui devrait lui permettre de remplir les critères d’efficacité de notre étude clinique de Phase IIb. Nous sommes impatients de publier les principaux résultats dans les prochains mois, qui, s’ils sont positifs, permettront le lancement de l’étude pivot de Phase III avec lanifibranor. »

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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 participera à la « Cowen and Company 40th Annual Health Care Conference »

Inventiva participera à la « Cowen and Company 40th Annual Health Care Conference »

19 février 2020

Daix (France), le 19 février 2020 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, annonce aujourd’hui que Frédéric Cren, Président-directeur général et cofondateur d’Inventiva, fera une présentation de la Société et de ses activités, suivie d’un échange en comité réduit, lors de la « Cowen and Company 40th Annual Health Care Conference » qui se tiendra du 2 au 4 mars 2020 à l’hôtel Boston Marriott Copley Place, Boston, Etats-Unis.

Les détails de la présentation sont les suivants :

Date : Lundi 2 mars 2020
Heure de la présentation : 16h10 – 16h40 (heure de la côte Est)
Heure des sessions de travail : 16h50 – 17h20 (heure de la côte Est)
Lieu de la présentation : Hôtel Boston Marriott Copley Place, 110 Huntington Avenue, Boston, Etats-Unis
Webcast : http://wsw.com/webcast/cowen57/iva/

Le document de présentation et le lien vers le webcast seront également disponibles sur le site Internet d’Inventiva dans la section « Investisseurs » – « Présentations investisseurs ».

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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 met à disposition un prospectus dans le cadre de l’admission d’actions nouvelles sur Euronext Paris

Inventiva met à disposition un prospectus dans le cadre de l’admission d’actions nouvelles sur Euronext Paris

10 février 2020

Daix (France), le 10 février 2020 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, annonce aujourd’hui que l’Autorité des marchés financiers (l’« AMF ») a approuvé un prospectus sous le n°20-034, le 7 février 2020, dans le cadre de l’admission sur le marché réglementé d’Euronext à Paris d’actions nouvelles. 3 778 338 actions nouvelles sont émises par voie d’une augmentation de capital avec suppression du droit préférentiel de souscription au profit de catégories de personnes répondant à des caractéristiques déterminées, d’un montant brut de 15 millions d’euros, pour un prix de souscription de 3,97 euros chacune (prime d’émission incluse).

Le prospectus est constitué:

– du document d’enregistrement universel déposé auprès de l’AMF le 7 février 2020 sous le n° D.20-0038 ;

– de la note d’opération ; et

– du résumé du prospectus (inclus dans la note d’opération).

Ces documents peuvent être consultés sur le site internet de la Société à l’adresse www.inventivapharma.com, section « Investisseurs », ainsi que sur le site de l’AMF à l’adresse www.amf-france.org. Des exemplaires du document d’enregistrement universel sont également disponibles gratuitement, sur demande, au siège social de la Société situé 50 Rue de Dijon, 21121 Daix, France.

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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 réalise une augmentation de capital de 15 M€ souscrite par des actionnaires existants

Inventiva réalise une augmentation de capital de 15 M€ souscrite par des actionnaires existants

7 février 2020

Daix (France), le 7 février 2020 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, annonce aujourd’hui le succès de la réalisation d’une augmentation de capital de 15 millions d’euros souscrite par certains de ses actionnaires principaux existants, BVF Partners L.P., NEA, Novo Holdings A/S et Sofinnova Partners. L’augmentation de capital social a été réalisée au cours de clôture en date du 6 février 2020 sans décote.

Frédéric Cren, Président-directeur général et cofondateur d’Inventiva, a commenté : « Nous sommes très heureux du succès de cette augmentation de capital qui a été réalisée au prix du marché et qui nous permet d’étendre notre visibilité financière jusqu’à la fin du deuxième trimestre 2021. Cette opération intervient après un deuxième semestre 2019 très riche en avancées cliniques pour Inventiva, avec notamment la fin du recrutement des patients dans notre étude clinique de Phase IIb avec lanifibranor dans la NASH, les résultats positifs de l’étude clinique de Phase IIa avec odiparcil dans la MPS VI ou encore le lancement, plus tôt que prévu, de l’étude clinique avec ABB-157 chez des patients atteints de psoriasis par notre partenaire AbbVie. Grâce à la confiance renouvelée de nos investisseurs principaux, BVF Partners L.P., NEA, Novo Holdings A/S et Sofinnova Partners et cela à quelques mois des résultats de notre étude clinique dans la NASH, nous abordons l’année 2020 avec une grande confiance et des moyens financiers renforcés pour poursuivre le développement clinique de lanifibranor et odiparcil, nos deux candidats médicaments clés. »

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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.

Exercice 2019 : Position de trésorerie et chiffre d’affaires

Exercice 2019 : Position de trésorerie et chiffre d’affaires

5 février 2020

Daix (France), le 5 février 2020 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, publie aujourd’hui sa position de trésorerie au 31 décembre 2019 et son chiffre d’affaires annuel pour l’exercice 2019.

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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 a été retenue pour présenter les résultats positifs de l’étude clinique de Phase IIa avec odiparcil dans la MPS VI lors du 16ème « Annual WORLDSymposiumTM »

Inventiva a été retenue pour présenter les résultats positifs de l’étude clinique de Phase IIa avec odiparcil dans la MPS VI lors du 16ème « Annual WORLDSymposiumTM »

3 février 2020

Daix (France), le 3 février 2020 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, annonce aujourd’hui que le docteur Nathalie Guffon (MD, Hôpital Femme-Mère-Enfant, Lyon, France), investigateur de l’étude clinique de Phase IIa iMProveS (improve MPS treatment), présentera un poster, intitulé « Treatment of mucopolysaccharidosis type VI patients with odiparcil alone or in addition to enzyme replacement therapy : A Phase IIa study », lors du 16ème « Annual WORLDSymposiumTM » qui se tiendra du 10 au 13 février 2020 au Hyatt Regency Orlando, Orlando, Floride.

Le docteur Nathalie Guffon reviendra sur les résultats positifs de l’étude clinique de Phase IIa iMProveS, publiés le 18 décembre 2019, qui ont montré l’impact positif d’odiparcil sur des symptômes cliniques clés chez plusieurs patients tels que l’opacification cornéenne et les fonctions cardiaques et respiratoires. Par ailleurs, l’étude clinique a atteint son critère principal en matière de sécuité, confirmant ainsi le bon profil de sécurité d’odiparcil observé lors des précédentes études cliniques de Phase I et de Phase II. Au regard des résultats de l’étude clinique iMProveS, Inventiva a décidé de poursuivre le développement clinique d’odiparcil pour le traitement de la MPS VI.

Pierre Broqua, Directeur Scientifique et cofondateur d’Inventiva, a déclaré : « Nous sommes très satisfaits des résultats de l’étude iMProveS qui montrent qu’odiparcil est capable de traiter des tissus difficiles à atteindre et d’améliorer les fonctions cardiaques et respiratoires. Etant donné que la thérapie enzymatique de remplacement, standard de soin actuel, montre une efficacité limitée dans ces organes, nous pensons qu’odiparcil pourrait devenir un traitement de référence dans la MPS VI. Nous sommes impatients de présenter nos résultats prometteurs lors du congrès à venir et poursuivre le développement clinique d’odiparcil ».

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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 éligible au SRD Long only sur le marché réglementé d’Euronext Paris

Inventiva éligible au SRD Long only sur le marché réglementé d’Euronext Paris

6 janvier 2019

Daix (France), le 6 janvier 2020 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, annonce que ses actions sont désormais éligibles au Service de Règlement Différé (« SRD ») sur le segment Long-seulement (« SRD Long only »), suite à la révision annuelle par Euronext Paris.

Le SRD Long only permettra aux personnes détenant un compte titres français d’acheter à découvert le titre Inventiva en différant leurs règlements, profitant ainsi d’un effet de levier à la hausse.

L’éligibilité au SRD Long only permettra d’accroitre l’attractivité d’Inventiva et favorisera la liquidité de son titre, l’exposant ainsi à une base d’investisseurs plus large.

Toute valeur cotée sur Euronext Paris réalisant un volume de transaction minimal quotidien de 100 000 euros sont éligibles au statut SRD Long only.

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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 annonce des résultats positifs de l’étude clinique de Phase IIa avec odiparcil dans la mucopolysaccharidose de type VI

Inventiva annonce des résultats positifs de l’étude clinique de Phase IIa avec odiparcil dans la mucopolysaccharidose de type VI

18 décembre 2019

Daix (France), le 18 décembre 2019 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, annonce aujourd’hui les résultats de son étude clinique de Phase IIa iMProveS (improve MPS treatment) évaluant odiparcil dans le traitement de la mucopolysaccharidose (MPS) de type VI, une maladie génétique rare et progressive dont les besoins médicaux non satisfaits sont importants.
L’étude clinique de Phase IIa d’une durée de 26 semaines portait sur 20 patients, âgés de 16 ans ou plus, atteints de stades avancés de MPS VI. 15 patients ont été randomisés dans une cohorte en double aveugle, contrôlée par placebo, et ont reçu une dose orale de 250 mg ou 500 mg d’odiparcil ou de placebo deux fois par jour pendant six mois, en plus de la thérapie enzymatique de remplacement (TER), le standard de soin actuel. Les cinq autres patients ont été inclus dans une cohorte dans laquelle ils ont tous reçu une dose orale de 500 mg d’odiparcil deux fois par jour pendant six mois, sans être traités par TER. 13 patients ont terminé l’étude : quatre patients ont reçu du placebo en plus de la TER, et neuf patients ont été répartis équitablement dans chacun des trois groupes traités par odiparcil.
Frédéric Cren, Président-directeur général et cofondateur d’Inventiva, a commenté : « Nous sommes très heureux des résultats positifs publiés aujourd’hui et je souhaite remercier tous les patients, soignants, chercheurs ainsi que notre équipe pour leur engagement et dévouement dans cette étude et dans ce programme. Nous pensons que l’efficacité démontrée après seulement six mois de traitement ainsi que son mode d’administration oral pourrait faire d’odiparcil un traitement de référence pour les patients atteints de MPS VI, particulièrement compte tenu des besoins médicaux importants non satisfaits dans ce domaine. Sur la base des données d’efficacité observées et du bon profil de sécurité d’odiparcil, nous avons décidé de poursuivre le développement clinique d’odiparcil notamment chez les enfants atteints de MPS VI, la population cible de ce traitement. »

Chris Hendriksz, membre du comité de pilotage de l’étude clinique iMProveS et professeur extraordinaire de pédiatrie et de santé infantile à l’Université de Pretoria, Afrique du Sud, a déclaré : « Il s’agit d’un moment important dans le domaine de la MPS puisque nous disposons désormais des premières données d’efficacité pour un composé oral qui montre des résultats prometteurs dans des tissus difficiles à atteindre par les traitements médicamenteux et particulièrement touchés chez les patients atteints de MPS. Malgré les traitements déjà commercialisés, il existe encore d’importants besoins médicaux non satisfaits, notamment au niveau oculaire, cardiaque et osseux. Avoir démontré des résultats positifs dans un délai aussi court est très prometteur pour les patients. »
L’étude clinique a atteint son critère principal en matière de sécurité, confirmant ainsi le bon profil de sécurité d’odiparcil observé dans les études cliniques de Phase I et de Phase II précédemment menées, pour la prévention de la thrombose. Tous les investigateurs de l’étude iMProveS ont fait part de retours positifs concernant la sécurité d’odiparcil. La majorité des événements indésirables reportés ont été légers ou modérés. Un décès est survenu dans le groupe placebo et trois événements indésirables graves (EIG), associés au traitement, sont survenus chez des patients traités par odiparcil. Deux de ces EIG étaient des résultats anormaux de laboratoire qui ont par la suite été qualifiés de faux positifs. La troisième EIG a été une réaction cutanée comme fréquemment observé chez les patients atteints de MPS VI traités par TER. Par rapport aux études cliniques de Phase I et II précédemment menées avec odiparcil pour la prévention de la thrombose, aucun nouvel événement de tolérance n’a été observé.
Compte tenu de la courte durée de l’étude et du statut avancé de la maladie chez les patients inclus dans l’étude,
l’étude iMProveS a montré des résultats positifs concernant l’efficacité d’odiparcil :
– Des améliorations ont été observées chez les patients traités avec odiparcil, en plus de la TER, en ce qui concerne l’opacité cornéenne et les fonctions cardiaques et respiratoires.
– Conformément au mécanisme d’action d’odiparcil, une élimination urinaire dose-dépendante des glycoaminoglycanes (GAGs), utilisés comme biomarqueur de l’activité, a clairement été démontrée chez l’ensemble des patients traités avec odiparcil. Comme la TER, odiparcil n’a pas induit de réduction des leukocytes glycoaminoglycanes (leukoGAGs), ce qui n’a donc pas permis de confirmer les leukoGAGs comme biomarqueur de la diminution des GAGs lors de l’étude. Des travaux sont prévus concernant l’analyse des GAGs contenus dans la peau.
– S’agissant de la mobilité, aucune différence claire n’a été observée entre les différents groupes de patients.
Les résultats de l’analyse pharmacocinétique ont été conformes aux attentes et seront utilisés pour la sélection de doses dans le cadre de la prochaine étude qui sera conduite chez des enfants atteints de MPS VI. Dans l’étude iMProveS, le profil pharmacocinétique obtenu chez les patients atteints de MPS VI traités avec odiparcil n’est pas affecté par la TER et correspond aux profils précédemment observés dans les études de Phase I et II pour la prévention de la thrombose.
Au regard des résultats de l’étude clinique iMProveS, Inventiva a décidé de poursuivre le développement clinique d’odiparcil pour le traitement de la MPS VI. Conformément au planning annoncé, la Société entend lancer une étude clinique évaluant odiparcil chez des enfants atteints de MPS VI qui est la population cible du traitement.
Inventiva est en train de revoir le protocole de l’étude pour prendre en compte les résultats d’aujourd’hui. Les détails seront publiés sur le site clinicaltrials.gov une fois que le protocole de  l’étude aura été finalisé et validé auprès des autorités réglementaires compétentes.

L’équipe de direction d’Inventiva présentera les résultats de l’étude publiés aujourd’hui lors d’une conférence téléphonique et d’un webcast le jeudi 19 décembre 2019 à 14h00 (heure de Paris).
Pour participer à la conférence téléphonique, veuillez saisir le code 9149459 après avoir composé l’un des numéros suivants :
France : +33 1 70 73 27 27
Belgique : +32 10 39 12 06
Danemark : +45 32 72 75 18
Allemagne : +49 69 22 22 49 10
Pays-Bas : +31 20 71 57 366
Suisse : +41 44 58 04 873
Royaume-Unis : +44 203 00 95 710
Etats-Unis : +1 917-720-0178

La présentation accompagnant cette conférence téléphonique sera disponible sur le site Internet d’Inventiva au même moment dans la section « Investisseurs » – « Résultats financiers ». Elle pourra être suivie en direct ou en différé dans la même section du site Internet de la Société et à l’adresse suivante : https://edge.mediaserver.
com/mmc/p/z5gurvgf.

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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 reçoit un paiement d’étape de 3,5 M€ de la part d’AbbVie

Inventiva reçoit un paiement d’étape de 3,5 M€ de la part d’AbbVie

3 décembre 2019

Daix (France), 3 décembre 2019 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, annonce aujourd’hui la réception d’un paiement d’étape de 3,5 millions d’euros suite à l’inclusion du premier patient atteint de psoriasis dans l’étude clinique en cours avec ABBV-157, un antagoniste RORy découvert conjointement par AbbVie et Inventiva pour le traitement de maladies auto-immunes.

L’étude clinique initiée par AbbVie avec ABBV-157 est une étude randomisée, en double aveugle, avec un contrôle placebo, durant laquelle des patients atteints de psoriasis en plaque chronique modéré à sévère recevront de multiples doses du candidat médicament par voie orale.

Frédéric Cren, Président-directeur général et cofondateur d’Inventiva, a commenté : « Cette étape clé est une excellente nouvelle pour Inventiva, d’autant que nous l’avons franchie beaucoup plus tôt que prévu. Nous sommes ravis des résultats obtenus avec ABBV-157 et très fiers de collaborer avec un partenaire aussi engagé qu’AbbVie, leader mondial dans le domaine des maladies auto-immunes, capable de faire d’ABBV-157 un traitement de référence. »

En 2012, Inventiva et AbbVie ont signé un partenariat pluriannuel de recherche afin d’identifier des antagonistes RORγ pour le traitement de plusieurs maladies auto-immunes. Dans le cadre de cette collaboration, Inventiva met à profit son expertise en matière de découverte et ses plateformes technologiques afin de développer des candidats médicaments visant le récepteur nucléaire RORy, une cible thérapeutique validée pour le traitement des troubles inflammatoires cutanés comme le psoriasis. Dans le domaine des maladies auto-immunes, Inventiva concentre ses activités de recherche et de développement sur des composés qui se distinguent par une posologie améliorée, une plus grande efficacité et potentiellement une meilleure sécurité/tolérance par rapport aux agents biologiques, traitements de référence actuels.

Dans le cadre de cette collaboration, Inventiva reste éligible à de nouveaux paiements d’étape et redevances sur les ventes futures d’ABBV-157.

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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.

Information financière du 3ème trimestre 2019 et point sur le partenariat avec Boehringer Ingelheim

Information financière du 3ème trimestre 2019 et point sur le partenariat avec Boehringer Ingelheim

13 novembre 2019

Daix (France), le 13 novembre 2019 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, publie aujourd’hui sa position de trésorerie au 30 septembre 2019, son chiffre d’affaires des neufs premiers mois de 2019 et fait un point sur son partenariat avec Boehringer Ingelheim.

Situation de trésorerie

Au 30 septembre 2019, la trésorerie et les équivalents de trésorerie d’Inventiva s’élevaient à 35,3 millions d’euros contre 37,1 millions d’euros au 30 juin 2019, et 56,7 millions d’euros au 31 décembre 2018.

Les flux nets de trésorerie liés à l’activité opérationnelle se sont établis à – 28,4 millions d’euros sur les neufs premiers mois de l’exercice (vs. -22,9 millions d’euros sur la même période en 2018). Les dépenses de R&D sur la période, principalement liées au développement de lanifibranor dans la stéatohépatite non alcoolique (NASH) et d’odiparcil dans la mucopolysaccharidose de type VI (MPS VI), sont en hausse de 13,1% par rapport à la même période en 2018.

Les flux nets de trésorerie liés à l’activité de financement se sont élevés à 7,9 millions d’euros sur les neufs premiers mois de l’exercice (vs. 32,3 millions d’euros sur la même période en 2018 qui comprenait le produit d’un placement privé en avril 2018 à hauteur de 32,5 millions d’euros), grâce au succès de la levée de fond réalisée le 20 septembre 2019 auprès d’investisseurs américains et européens de premier plan dans le secteur des biotechnologies. Cette augmentation de capital et la nouvelle participation à hauteur de 0,6 millions d’euros de Sofinnova Partners début octobre 2019, permettent d’accroître la visibilité financière de la Société jusqu’à la fin du troisième trimestre 2020, au-delà de la publication des résultats de l’étude clinique de Phase IIa iMProveS évaluant odiparcil dans la MPS VI et de l’étude clinique de Phase IIb NATIVE évaluant lanifibranor dans la NASH.

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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.