Financial Results

Inventiva annonce la création de son Conseil Scientifique

Inventiva annonce la création de son Conseil Scientifique

13 juin 2019

Daix (France), le 13 juin 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 création de son Conseil Scientifique (Scientific Advisory Board, SAB) qui aura pour mission d’apporter à la direction de la Société des avis scientifiques et des conseils extérieurs de haut niveau sur ses activités de R&D et son portefeuille de produits.

Le SAB couvrira les domaines de recherche clés d’Inventiva, en particulier la stéatohépatite non alcoolique (NASH), la mucopolysaccharidose (MPS) et l’oncologie. Dans le cadre de ses fonctions, il soutiendra la direction d’Inventiva en ce qui concerne les aspects précliniques et cliniques des programmes de développement de la Société et sa politique scientifique générale, y compris les cibles, les domaines de recherche, les partenariats et l’accès au marché.

Présidé par Jean-Louis Junien, ancien membre du Conseil d’Administration d’Inventiva et un cadre dirigeant avec une grande expérience dans l’industrie pharmaceutique, le SAB réunira l’expertise de chercheurs et de cliniciens internationaux indépendants dans les domaines précités. Le SAB devrait en outre accueillir prochainement un membre supplémentaire spécialisé dans les maladies rares pour soutenir le développement d’odiparcil dans la MPS. Les deux premières réunions du SAB ont déjà été programmées dans le courant de ce mois-ci et porteront sur la NASH et l’oncologie.

Pierre Broqua, Directeur Scientifique et cofondateur d’Inventiva, a déclaré : « La création du Conseil Scientifique constitue une étape importante pour notre développement futur car il nous aidera à la fois à accélérer et sécuriser nos programmes de découverte et à valider nos choix de R&D. Les membres du Conseil apporteront des connaissances considérables, des compétences hautement complémentaires et une perspective extérieure, qui seront extrêmement précieuses pour informer notre stratégie à mesure que nous nous développerons. »

Jean-Louis Junien, Président du Conseil Scientifique d’Inventiva, a commenté : « Je suis honoré d’assumer le rôle de Président du Conseil Scientifique d’Inventiva, qui réunit des experts reconnus à l’international dans les domaines de la NASH, de la MPS et de l’oncologie. Ensemble, nous sommes impatients d’accompagner la direction d’Inventiva dans sa responsabilité de porter des jugements importants en connexion avec les activités de R&D et le portefeuille de produits de la Société. »

La composition du SAB d’Inventiva est la suivante :

– Dr Sven Francque, Professeur de Médecine à la Faculté de Médicine et de Sciences de la vie de l’Université d’Anvers et Président du Département de Gastroentérologie et d’Hépatologie. Son unité de recherche se concentre sur les mécanismes pathophysiologiques de la NASH.

– Dr Manal Abdelmalek, Professeur de Médecine au Département de Gastroentérologie et d’Hépatologie de Duke University et Directeur du Programme de Recherche Clinique sur la NAFLD de Duke University. Elle est membre permanent du réseau de recherche clinique sur la NASH (NASH Clinical Research Network (NASH CRN)).

– Dr Glen Clack, Professeur honoraire de Médecine Translationnelle au Département d’Oncologie et de Métabolisme de l’Université de Sheffield et anciennement Directeur Médical Senior de l’Unité de Médecine Translationnelle en Oncologie d’Astra Zeneca.

– Dr Hedy Lee Kindler, Professeur de Médecine à l’Université de Chicago, Directrice du Programme sur le Mésothéliome et Vice-Présidente Associée pour la Recherche Clinique. Elle a précédemment présidé le Groupe d’Intérêt International sur le Mésothéliome (International Mesothelioma Interest Group), l’organisation internationale de recherche scientifique de renom spécialisée dans cette maladie.

– Dr Gérard Zalcman, Professeur de Médecine, Chef du Département d’Oncologie Thoracique de l’Hôpital Bichat à Paris (Université Paris-Diderot) et membre du laboratoire INSERM U830, « Génétique & Biologie des cancers », au Centre de Recherche de l’Institut Curie.

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 la fin du recrutement des patients pour son étude de Phase IIa dans le traitement de la MPS VI

Inventiva annonce la fin du recrutement des patients pour son étude de Phase IIa dans le traitement de la MPS VI

11 juin 2019

Daix (France), le 11 juin 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 fin du recrutement des patients dans son étude de Phase IIa iMProveS (improve MPS treatment) en Europe évaluant odiparcil dans le traitement de la mucopolysaccharidose de type VI (MPS VI).

Au total, 20 patients ont été inclus dans cette étude de Phase IIa, contre un objectif de 24 initialement. Compte tenu du mécanisme d’action d’odiparcil, la Société estime que ce nombre de patients est suffisant pour évaluer le profil de sécurité d’odiparcil et son impact sur des biomarqueurs d’efficacité pertinents (mesure des glycoaminoglycanes (GAGs) dans l’urine, la peau et les leucocytes). Par ailleurs, Inventiva est également convaincu que ce nombre de patients est suffisant pour identifier les signes précoces d’efficacité clinique chez les patients traités par thérapie enzymatique de remplacement (TER) et chez ceux non traités par TER. Par conséquent, Inventiva prévoit d’amender le protocole de l’étude afin de modifier la population cible à 20 patients.

Les patients inclus dans l’étude sont répartis entre les différents groupes, avec quinze patients traités par TER et recevant l’une des deux doses d’odiparcil ou placebo et cinq patients non traités par TER et uniquement recevant la forte dose d’odiparcil. Les principaux résultats des groupes en double aveugle, avec un contrôle placebo, qui inclut les quinze patients traités par TER, sont attendus d’ici la fin de l’année. Les résultats de la cohorte ouverte, qui comprend les cinq patients non traités par TER et uniquement recevant la forte dose d’odiparcil, sont attendus au premier trimestre 2020 étant donné que le dernier patient pour ce sous-groupe a été inclus en mai 2019.

Dr. Marie-Paule Richard, Directeur Médical d’Inventiva, a déclaré : « Nous sommes ravis d’avoir atteint ce nombre de patients souffrant de cette maladie très rare et nous leurs sommes ainsi qu’aux cliniciens qui participent à cette étude très reconnaissants. La MPS VI est une maladie orpheline très invalidante, dont le traitement actuel est insuffisant laissant les patients avec des besoins médicaux élevés non satisfaits. Odiparcil a le potentiel d’améliorer les symptômes cliniques de la maladie, en particulier dans les tissus et organes où l’efficacité des traitements actuels est limitée. La formulation orale d’odiparcil pourrait également apporter une vraie valeur ajoutée aux patients par rapport aux perfusions hebdomadaires actuellement nécessaires pour la TER. Nous attendons donc avec impatience les résultats de cette étude de Phase IIa afin d’évaluer des signes précoces d’efficacité d’odiparcil dans le traitement de la MPS VI et, s’ils sont positifs, d’en poursuivre le développement. »

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.

Nawal Ouzren et Heinz Maeusli nommés au Conseil d’Administration d’Inventiva

Nawal Ouzren et Heinz Maeusli nommés au Conseil d’Administration d’Inventiva

29 mai 2019

Daix (France), le 29 mai 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 nomination de Nawal Ouzren et Heinz Maeusli comme membres de son Conseil d’Administration à la suite de la réunion de l’Assemblée Générale mixte (ordinaire annuelle et extraordinaire) qui s’est tenue le 27 mai 2019.

A ce titre, Mme Nawal Ouzren et Mr Heinz Maeusli remplaceront Mr Chris Newton, Mme Nanna Lüneborg et Mr Jean-Louis Junien dont les mandats d’administrateurs ont officiellement pris fin. Mr Jean-Louis Junien va désormais se concentrer sur la création du Conseil Scientifique d’Inventiva. Par ailleurs, lors de l’Assemblée Générale, les mandats de Frédéric Cren, Pierre Broqua, CELL + et Pienter-Jan BVBA ont été renouvelés.

Frédéric Cren, Président-directeur général d’Inventiva, a déclaré : « Nous sommes ravis d’accueillir Nawal et Heinz comme nouveaux membres du Conseil d’Administration d’Inventiva. Leur expérience de l’industrie pharmaceutique et leurs profils complémentaires constitueront un atout supplémentaire pour le Conseil d’Administration d’Inventiva. Leurs parcours au sein de sociétés cotées de différentes tailles, associées à une connaissance approfondie des marchés financiers européens et américains, seront très précieuses pour le développement futur d’Inventiva. Au nom de tout le Conseil d’Administration, je tiens à remercier Chris, Nanna et Jean-Louis pour leur implication et leur contribution au développement d’Inventiva au cours des dernières années. »

Les résultats des votes portant sur la composition du Conseil d’Administration ainsi que ceux relatifs aux autres résolutions sont disponibles sur le site internet d’Inventiva : http://inventivapharma.com/fr/investisseurs/assemblees-generales/.

À propos de Nawal Ouzren

Forte d’une expérience de quinze ans dans le management opérationnel et stratégique de l’industrie pharmaceutique, Mme Ouzren est Directrice Générale et membre du Conseil d’Administration de Sensorion depuis 2017. Elle a débuté sa carrière chez Baxter, où elle était manager des opérations, puis directeur qualité et directeur de la stratégie, avant de devenir Vice-Président de la division BioSimilaires. En 2014, Mme Ouzren est devenue Vice-Président de la division mondiale Hémophilie chez Baxalta qui a été intégrée au groupe Shire. En 2016, elle dirigeait la division mondiale Maladies Génétiques du groupe Shire, où elle supervisait tous les aspects marketing, business et stratégie de l’ensemble du portefeuille de produits de cette division mondiale du groupe.

Nawal Ouzren est titulaire d’un Master en génie chimique de l’Université technique de Berlin (Allemagne) et d’un Master en génie chimique de l’Université de Technologie de Compiègne (France).

À propos de Heinz Maeusli

Directeur financier d’Advanced Accelerator Applications (AAA) de 2003 à 2018, Heinz Maeusli a contribué à faire de cette société un leader mondial dans son secteur. A ce titre, il a conduit l’introduction en bourse d’AAA sur le Nasdaq en novembre 2015 et a contribué à la vente d’AAA à Novartis en janvier 2018. Tout au long de sa carrière, il a développé une expertise sur les aspects opérationnels, organisationnels, financiers et culturels relatifs à la croissance et à l’intégration de sociétés internationales.

Heinz Maeusli est titulaire d’un MBA de l’Université de Columbia, New York, USA et d’une licence en sciences économiques de l’Université de Saint-Gall en Suisse.

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 « Jefferies 2019 Healthcare Conference »

Inventiva participera à la « Jefferies 2019 Healthcare Conference »

24 mai 2019

Daix (France), le 24 mai 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 que Frédéric Cren, Président-directeur général et cofondateur d’Inventiva, présentera la Société et ses activités, suivi d’une séance de questions-réponses, lors de la « Jefferies 2019 Healthcare Conference » qui se tiendra du 4 au 7 juin 2019 à l’hôtel Grand Hyatt New York, New York, Etats-Unis.

Les détails de l’événement sont les suivants :
Date : Vendredi, 7 juin 2019
Heure de la présentation : 13h00 – 13h25 (heure de la côte Est)
Heure de la séance questions-réponses : 13h30 – 13h55 (heure de la côte Est)
Lieu de la présentation : Ballroom 5, hôtel Grand Hyatt New York, New York, Etats-Unis
Lieu de la séance questions-réponses : Alvin, hôtel Grand Hyatt New York, New York, Etats-Unis
Webcast : http://wsw.com/webcast/jeff118/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 annonce que la FDA a levé la suspension clinique applicable aux agonistes PPAR ce qui permet de réaliser des études cliniques à long terme avec lanifibranor dans la NASH

Inventiva annonce que la FDA a levé la suspension clinique applicable aux agonistes PPAR ce qui permet de réaliser des études cliniques à long terme avec lanifibranor dans la NASH

23 mai 2019

Daix (France), le 23 mai 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 que la FDA (Food and Drug Administration) aux États-Unis a levé la suspension clinique en vigueur pour les proliférateurs de peroxysomes (PPAR). Cette décision permet à Inventiva de mener des essais cliniques de six mois ou plus pour évaluer lanifibranor dans le traitement de la NASH. Cette autorisation survient après la revue des études de carcinogénicité d’une durée de deux ans par le Comité exécutif d’évaluation des études de carcinogénicité (ECAC) de la FDA.

La décision de la FDA, qui confirme le profil de sécurité bénin de lanifibranor, représente une étape clé pour Inventiva puisqu’elle élimine un obstacle majeur qui l’empêchait de démarrer des études cliniques de phase III à long terme, nécessaires à l’obtention de l’autorisation de mise sur le marché de lanifibranor pour le traitement de la NASH.

Certains PPAR et PPAR ont été associés à une toxicité et à des effets indésirables affectant le coeur, les reins, les muscles squelettiques et la vessie, ainsi que le poids corporel, la rétention d’eau et la densité minérale osseuse. Par conséquent, la réglementation de la FDA concernant les composés PPAR exige la réalisation d’études de carcinogénicité d’une durée de deux ans et d’études de toxicité in vivo d’une durée d’un an avant qu’un essai clinique de plus de six mois puisse être initié avec un candidat médicament. Conformément à cette réglementation, Inventiva a lancé trois études toxicologiques à long terme avec lanifibranor en 2015. La première étude toxicologique, évaluant lanifibranor chez des primates durant 12 mois, n’a mis en évidence quelle que soit la dose étudiée aucune toxicité ni aucun des effets indésirables associés à des agonistes PPAR sélectifs ou dual. En parallèle, lanifibranor a été évalué dans le cadre de deux études de cancérogénicité d’une durée de deux ans chez le rat et la souris visant à identifier un potentiel risque cancérigène. Lors de ces deux études, lanifibranor n’a été associé à aucun effet cancérigène transposable à l’homme et cela jusqu’à la dose la plus élevée.

Pierre Broqua, Directeur Scientifique et cofondateur d’Inventiva, a commenté : « L’avis positif de la FDA confirme le profil de sécurité favorable et différentiant de notre principal candidat médicament que nous avions déjà observé lors des études précliniques et cliniques antérieures, et constitue une preuve supplémentaire de la différentiation de lanifibranor par rapport aux autres PPAR agonistes. Cette décision est très importante puisqu’elle lève un obstacle significatif en nous permettant de démarrer les études de Phase III planifiées pour le développement de lanifibranor dans la NASH. »

A propos de lanifibranor

Lanifibranor, le candidat médicament le plus avancé d’Inventiva, est une petite molécule administrée par voie orale dont l’action consiste à induire des effets anti-fibrotiques, anti-inflammatoires ainsi que des changements métaboliques positifs en activant les trois isoformes de proliférateurs de peroxysomes (« PPAR »). Les PPAR sont des récepteurs nucléaires bien connus qui régulent la modulation épigénétique. Lanifibranor est un agoniste PPAR conçu pour activer de façon modérée et équipotente les trois isoformes de PPAR, avec une activation équilibrée des PPARα et PPARδ, et une activation partielle de PPARγ. S’il existe d’autres agonistes de PPAR qui ciblent un ou deux isoformes de PPAR, lanifibranor est le seul agoniste de pan-PPAR actuellement en développement clinique. La Société estime que le profil de modulateur pan-PPAR modéré et équilibré de lanifibranor contribue également au bon profil de sécurité et de tolérance qui a été observé dans les essais cliniques et les études précliniques dans lesquels il a été évalué.
Inventiva évalue actuellement lanifibranor dans un essai clinique de Phase IIb pour le traitement de la stéatohépatite non alcoolique (« NASH »), maladie hépatique chronique et progressive pour laquelle il n’existe actuellement aucun traitement approuvé.

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.

Assemblée Générale Mixte du 27 mai 2019 – Modalités de mise à disposition des documents préparatoires

Assemblée Générale Mixte du 27 mai 2019 – Modalités de mise à disposition des documents préparatoires

9 mai 2019

Daix (France) le 9 mai 2019 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules actives par voie orale pour le traitement de maladies fibrotiques, de maladies de surcharge lysosomale et de cancers, informe ses actionnaires et l’ensemble de la communauté financière que les documents relatifs à l’Assemblée Générale Mixte qui se tiendra le lundi 27 mai 2019 à 14h, à l’Hôtel Oceania Le Jura (Salon Pasteur), 14 avenue Foch – 21000 Dijon, France, sont disponibles sur simple demande auprès de la société, ou peuvent être consultés sur le site internet http://inventivapharma.com/fr/accueil/, rubrique Investisseurs / Assemblées Générales.

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 présentera de nouveaux résultats de son programme YAP-TEAD en oncologie lors de la conférence spéciale de l’AACR dédiée à la voie Hippo

Inventiva présentera de nouveaux résultats de son programme YAP-TEAD en oncologie lors de la conférence spéciale de l’AACR dédiée à la voie Hippo

23 avril 2019

Daix (France), le 23 avril 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 que l’abstract relatif à l’évaluation de ses inhibiteurs de l’interaction protéine-protéine YAP-TEAD pour le traitement du mésothéliome pleural malin (MPM) soumis à l’AACR (American Association for Cancer Research) a été retenu pour être présenté lors de la conférence spéciale de l’AACR consacrée à la voie de signalisation Hippo (« AACR Special Conference on the Hippo Pathway: Signaling, Cancer, and Beyond ») qui se tiendra du 8 mai au 11 mai 2019 à San Diego en Californie.

Cette étude, qui visait à valider une approche pluridimensionnelle du traitement du MPM, sera présentée par Anne Soudé, Senior Scientist en charge du programme YAP-TEAD chez Inventiva. Les résultats ont notamment montré que les inhibiteurs YAP-TEAD d’Inventiva réduisaient significativement la croissance tumorale dans des modèles de xénogreffes et orthotopiques de MPM. Des effets synergiques ont également été mis en évidence dans un modèle tridimensionnel sphéroïde, suggérant que les inhibiteurs YAP-TEAD de la Société associés à des approches de chimiothérapie existantes, pourraient atténuer la résistance aux traitements médicamenteux et resensibiliser les cellules cancéreuses résistantes à la chimiothérapie.

À la suite de ces résultats prometteurs, Inventiva a décidé d’étendre ses recherches à d’autres indications en oncologie et à d’autres stratégies d’association dans lesquelles les traitements de référence se sont révélés inefficaces et où l’activation de YAP intervient. Inventiva projette par ailleurs d’étudier les effets de ses molécules sur les mécanismes d’échappement au système immunitaire qui se traduisent par l’incapacité du système immunitaire à reconnaître et détruire les tumeurs ce qui constitue un autre défi communément rencontré dans le traitement du cancer.

Pierre Broqua, Directeur Scientifique et cofondateur d’Inventiva, a déclaré : « Ces nouveaux résultats renforcent l’hypothèse selon laquelle nos inhibiteurs YAP-TEAD pourraient constituer une approche efficace pour traiter le mésothéliome. Nous sommes particulièrement enthousiasmés par le potentiel de nos molécules pour atténuer la résistance médicamenteuse dans plusieurs cancers grâce à une association efficace avec des traitements de référence. Nous sommes en train de sélectionner un candidat médicament pour notre programme en oncologie et nous sommes impatients d’en démarrer le développement préclinique au cours de cette année. »

L’abstract, intitulé « Discovery of YAP-TEAD Protein-Protein Interaction inhibitors (PPI) for treating Malignant Pleural Mesothelioma (MPM) », sera présenté le vendredi 10 mai 2019.

Les détails relatifs à cette présentation sont les suivants :
Titre de l’abstract : « Discovery of YAP-TEAD Protein-Protein Interaction inhibitors (PPI) for treating Malignant Pleural Mesothelioma (MPM) »
Séance : Poster Session B
Conférencière : Anne Soudé, Senior Scientist en charge de l’identification et de la validation des cibles, Inventiva
Date : vendredi 10 mai 2019
Heure : 12h30 à 14h30 (heure avancée du Pacifique)
Adresse : Hôtel Marriott Marquis San Diego Marina, San Diego, Californie
Congrès : « AACR Special Conference on The Hippo Pathway: Signaling, Cancer, and Beyond »

 

À propos du programme YAP-TEAD

Le programme YAP-TEAD vise à interrompre les interactions entre la protéine YAP (yes-associated protein), et les facteurs de transcription du domaine associé à l’activateur de transcription, ou TEAD (transcription enhancer associated domain transcription factors). Ces interactions interviennent le long de la voie de signalisation Hippo et jouent un rôle clé dans le processus oncogénique. La voie de signalisation Hippo est impliquée dans les processus de différenciation et de prolifération cellulaires, la croissance tissulaire et la taille des organes. La résistance médicamenteuse, les mécanismes d’échappement au système immunitaire, la croissance tumorale et les métastases ont été associés au dérèglement de la voie de signalisation Hippo. Un dysfonctionnement de la voie Hippo est présent dans de nombreux cancers, tels que le mésothéliome malin, le cancer du poumon, le cancer du sein triple négatif, le carcinome hépatocellulaire et l’hépatoblastome ainsi que dans des maladies fibrotiques.

Des études précliniques ont montré que les molécules d’Inventiva étaient capables d’empêcher la formation du complexe transcriptionnel YAP/TEAD, de diminuer l’expression de gènes cibles YAP/TEAD et d’inhiber la prolifération de cellules dans des lignées cellulaires contrôlées par la voie de signalisation Hippo, tant en monothérapie qu’en association avec des traitements anticancéreux approuvés. Par ailleurs, dans des modèles de xénogreffes de mésothéliome pleural malin (MPM), les molécules ont induit une régression tumorale significative après administration par voie orale.

Inventiva est en train de sélectionner un candidat médicament pour son programme en oncologie et prévoit d’en démarrer le développement préclinique au cours de cette année.

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.

Communiqué de mise à disposition du Document de Référence 2018

Communiqué de mise à disposition du Document de Référence 2018

15 avril 2019

Daix (France), le 15 avril 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 avoir déposé le 12 avril 2019 son Document de Référence relatif à l’exercice clos le 31 décembre 2018 auprès de l’Autorité des marchés financiers (AMF), sous le numéro R.19-006.

Le Document de Référence intègre notamment :

  • le rapport financier annuel 2018 ;
  • le rapport de gestion ;
  • le rapport du Président du Conseil d’administration sur le gouvernement d’entreprise et le contrôle interne ; et
  • les informations requises au titre du descriptif du programme de rachat d’actions.

Le Document de Référence est tenu gratuitement à la disposition du public dans les conditions prévues par la réglementation en vigueur. Ce document peut être consulté et téléchargé sur l’espace « Investisseurs », rubrique « Information réglementée », du site Internet d’Inventiva : www.inventivapharma.com. Il est également disponible sur le site de l’AMF (www.amf-france.org).

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 « H.C. Wainwright Global Life Sciences Conference »

Inventiva participera à la
« H.C. Wainwright Global Life Sciences Conference »

3 avril 2019

Daix (France), le 3 avril 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 que Frédéric Cren, Président-directeur général et cofondateur d’Inventiva, présentera la Société et ses activités, suivi de rendez-vous individuels, lors de la « H.C. Wainwright Global Life Sciences Conference » qui aura lieu du 7 au 9 avril 2019 à la Grosvenor House, à Londres.

 

Les détails de la présentation sont les suivants :

Date : Mardi 9 avril 2019

Heure de la présentation : 9h50 – 10h10 (GMT)

Lieu de la présentation : North Suite, Grosvenor House, Londres

 

Le document de présentation sera également disponible 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 / Aude Hillion

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.