Financial Results

Inventiva participera à la « H.C. Wainwright 3rd Annual NASH Investor Conference » et au « Gilbert Dupont NASH Day »

Inventiva participera à la « H.C. Wainwright 3rd Annual NASH Investor Conference » et au « Gilbert Dupont NASH Day »

16 octobre 2019

Daix (France), le 16 octobre 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, a été invité à une table ronde lors de la « H.C. Wainwright 3rd Annual NASH Investor Conference » (New York, Etats-Unis). Cette table ronde portera sur les programmes PPAR les plus prometteurs en cours de développement pour le traitement de la NASH. Par ailleurs, Inventiva participera aussi au « Gilbert Dupont NASH Day » (Paris, France) et présentera le potentiel de lanifibranor, le candidat médicament pan-PPAR et le plus avancé de la Société, dans cette indication.

Les détails des événements sont les suivants :

Conférence n°1 : « H.C. Wainwright 3rd Annual NASH Investor Conference »
Table ronde : « All-PPAR Fireside Chat »
Date : Lundi 21 octobre 2019
Heure : 9h00 – 10h00 (heure de la côte Est)
Lieu : Versailles Room, Hôtel St. Regis, Two East 55th Street, New York, NY 10022, Etats-Unis
Webcast : http://www.wsw.com/webcast/hcw6/panel2/

La table ronde pourra être suivie en simultané et en replay à l’adresse mentionnée ci-dessus.

Conférence n°2 : « Gilbert Dupont NASH Day »
Table ronde : « Défis thérapeutiques et diagnostics : des solutions prometteuses »
Date : Mardi 29 octobre 2019
Heure : 10h50 – 12h30 (heure de Paris)
Lieu : Crédit du Nord, 59 Boulevard Haussmann, 75008 Paris, France

Contacts

Inventiva
Frédéric Cren

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

Brunswick
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 625.000 euros souscrite par Sofinnova Partners, au travers de son fonds Sofinnova Crossover I Fund

Inventiva réalise une augmentation de capital de 625.000 euros souscrite par Sofinnova Partners, au travers de son fonds Sofinnova Crossover I Fund

30 septembre 2019

Daix (France), le 30 septembre 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 réalisation d’une augmentation de capital de 625.000 euros au bénéfice de Sofinnova Partners, administrateur et actionnaire existant de la Société, au travers de son fonds Sofinnova Crossover I SLP, un des leaders du capital-risque spécialisé dans les sciences de la vie. L’augmentation de capital social a été réalisée à des conditions similaires à celles de l’augmentation de capital de 8,2 millions d’euros annoncée par la Société le 18 septembre dernier.

Frédéric Cren, Président et Directeur Général d’Inventiva, a commenté: «Nous sommes ravis de réaliser aussi rapidement cette levée de fond qui fait suite à celle du 20 septembre. Sofinnova est un expert reconnu en France et à l’international du monde de la biotech : pouvoir compter sur leur soutien est une reconnaissance des progrès réalisés sur l’ensemble de nos programmes et un signe de confiance dans les études cliniques que nous conduisons avec lanifibranor et odiparcil et dont les résultats sont attendus respectivement pour le premier semestre 2020 et d’ici la fin de l’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.

Inventiva obtient le statut « Fast Track » de la FDA pour son produit candidat phare, lanifibranor, dans la NASH

Inventiva obtient le statut « Fast Track » de la FDA pour son produit candidat phare, lanifibranor, dans la NASH

26 septembre 2019

Daix (France), le 26 septembre 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 accordé le statut « Fast Track » au produit candidat phare de la Société, lanifibranor, pour le traitement de la stéatohépatite non alcoolique (NASH).
Le programme « Fast Track » de la FDA est destiné à faciliter le développement et à accélérer l’examen et l’approbation potentielle de candidats médicaments. Son objectif global est d’améliorer l’accès des patients à des traitements destinés à traiter des pathologies graves et à répondre à d’importants besoins médicaux non satisfaits.

Pierre Broqua, Directeur Scientifique et cofondateur d’Inventiva, commente : « Nous sommes très heureux que la FDA ait accordé le statut « Fast Track » à lanifibranor pour le traitement de la NASH. Cela souligne l’important besoin médical non satisfait pour cette maladie hépatique progressive, sévère et néanmoins courante, pour laquelle il n’existe actuellement aucun traitement autorisé. Nous sommes convaincus du mécanisme d’action unique de lanifibranor, le seul agoniste pan-PPAR en cours de développement, et de son potentiel thérapeutique dans la NASH. Cette décision est une étape importante pour l’atteinte de notre objectif de fournir un traitement approprié aux patients le plus rapidement possible. Nous sommes satisfaits des échanges ouverts et constructifs que nous avons eus jusqu’à présent avec la FDA, et nous nous réjouissons de continuer à collaborer étroitement avec eux pour accélérer le développement de lanifibranor. »

Une fois qu’un produit thérapeutique reçoit le statut « Fast Track », la société concernée a la possibilité de communiquer plus fréquemment avec la FDA pour discuter du plan de développement du candidat médicament, de la conception des essais cliniques, de l’utilisation de biomarqueurs, et de la collecte des données requises nécessaires à l’approbation du médicament. Ce statut s’accompagne aussi d’un processus d’autorisation accéléré et d’un examen prioritaire, ainsi que d’un examen continu. Ce dernier donne la possibilité à la société de soumettre individuellement des sections du dossier de demande d’autorisation d’un produit biologique (BLA) ou d’un nouveau médicament (NDA), plutôt que d’attendre que le dossier complet soit terminé.

La décision de la FDA fait suite à la fin du recrutement des patients dans l’étude clinique de Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) d’Inventiva évaluant le candidat médicament pour le traitement de la NASH. L’étude progresse conformément aux attentes et la publication des résultats est prévue pour le premier semestre 2020. S’ils sont positifs, ces résultats permettront le démarrage de l’étude pivot de Phase III, dernière phase du développement de lanifibranor avant sa mise sur le marché.

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.

Résultats financiers du 1er semestre 2019 et point sur l’activité

Inventiva franchit une étape clé avec la fin du recrutement des patients dans son étude clinique de Phase IIb avec lanifibranor dans la NASH

25 septembre 2019

Daix (France), le 25 septembre 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 ses résultats financiers semestriels, clos au 30 juin 2019 et fait le point sur son activité.

Frédéric Cren, Président-directeur général et cofondateur d’Inventiva, a déclaré : « Nous avons réalisé des progrès importants dans nos programmes les plus avancés dédiés à la stéatohépatite non alcoolique (NASH) et la mucopolysaccharidose de type VI (MPS VI) avec notamment la fin du recrutement des patients dans les études de Phase IIb et Phase IIa respectivement. La décision de la FDA de lever pour lanifibranor la suspension clinique qui s’applique à cette classe de médicaments est aussi une étape clé franchie nous permettant le lancement des études cliniques à long-terme en vue de sa commercialisation éventuelle. Par ailleurs, nous avons renforcé la protection de lanifibranor dans le domaine de la NASH et des maladies fibrotiques dans deux marchés clés, l’Europe et les Etats-Unis, grâce à des nouveaux brevets illustrant notre approche innovante en matière de R&D. Le lancement par notre partenaire AbbVie d’une nouvelle étude clinique avec ABB-157 chez les patients avec un psoriasis modéré à sévère est également une excellente nouvelle pour ce programme dans lequel Inventiva reste éligible à recevoir des paiements d’étapes ainsi que des redevances sur les ventes. La réussite de notre dernière augmentation de capital, qui vient renforcer notre base d’investisseurs aux Etats-Unis et en Europe, et les différentes avancées à travers notre portefeuille de produit nous permettent de nous focaliser avec sérénité et confiance sur l’exécution de notre stratégie. »

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 8,2 millions d’euros souscrite par des investisseurs américains et européens de premier plan dans le secteur des biotechnologies

Inventiva réalise une augmentation de capital de 8,2 millions d’euros souscrite par des investisseurs américains et européens de premier plan dans le secteur des biotechnologies

19 septembre 2019

Daix (France), le 19 septembre 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 le succès de la réalisation d’une augmentation de capital de 8,2 millions d’euros souscrite par New Enterprise Associates (NEA), un investisseur américain de premier plan dans le secteur des biotechnologies, et par BVF Partners L.P. et Novo Holdings A/S, deux actionnaires existants de la Société. L’augmentation de capital social a été réalisée au cours de la clôture en date du 18 septembre 2019 sans décote. Par ailleurs, Sofinnova Partners, membre du Conseil d’administration et actionnaire existant de la Société, au travers de son fonds Sofinnova Crossover I Fund, un des leaders du capital-risque spécialisé dans les sciences de la vie, a fait part de son intention d’acquérir, dans le cadre d’une prochaine levée de fonds susceptible d’invervenir d’ici la fin du mois d’octobre 2019, jusqu’à 313.936 actions de la Société à des conditions similaires à la présente augmentation de capital sous réserve des conditions de marché et conformément aux délégations financières.

Frédéric Cren, Président et Directeur Général d’Inventiva, a commenté: « Nous sommes très heureux de la réussite de ce placement, qui soutient notre élan positif dans l’ensemble de notre portefeuille de produits et qui nous permettra de faire progresser davantage nos programmes cliniques et précliniques. Nous sommes heureux d’accueillir parmi nos actionnaires un nouvel investisseur américain de premier plan dans le secteur des biotechnologies, NEA, qui possède une solide expérience dans notre secteur. De même, nous sommes ravis que BVF Partners LP et Novo Holding A/S aient renouvelé leur confiance en Inventiva. Nous les remercions pour leur soutien continu. Grâce à cette base d’investisseurs renforcée aux Etats-Unis et en Europe, nous attendons maintenant avec impatience les résultats cliniques de nos deux molécules les plus avancées, le lanifibranor et l’odiparcil, qui devraient intervenir respectivement au premier semestre 2020 et à la fin 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.

Inventiva annonce l ’avis positif du 4 ème et dernier DSMB de l’étude clinique de Phase IIb avec lanifibranor dans la NASH

Inventiva annonce l ’avis positif du 4 ème et dernier DSMB de l’étude clinique de Phase IIb avec lanifibranor dans la NASH

10 septembre 2019

Daix (France), le 10 septembre 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 l’avis positif du quatrième et dernier Data Safety Monitoring Board (DSMB) de l’étude clinique de Phase IIb NATIVE évaluant lanifibranor dans la NASH. Aucun problème de sécurité n’a été constaté et, comme lors des trois premières réunions du DSMB, celle-ci a recommandé que l’étude se poursuive sans modification du protocole. Ces conclusions sont d’autant plus significatives que la revue des données de sécurité a porté sur 228 patients dont 139 patients traités pendant toute la durée de l’étude. Cette recommandation positive confirme le bon profil de sécurité de lanifibranor.

L’étude clinique de Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) évalue lanifibranor, le candidat médicament le plus avancé de la Société, dans le traitement de la stéatose hépatique non-alcoolique (NASH), une maladie hépatique chronique et progressive pour laquelle il n’existe actuellement aucun traitement approuvé. Suite aux conclusions positives du dernier DSMB et la fin du recrutement des patients dans l’étude annoncée le 4 septembre 2019, Inventiva confirme la publication des résultats de l’étude au 1er semestre 2020.

Pierre Broqua, Directeur Scientifique et cofondateur d’Inventiva, a commenté : « Nous sommes particulièrement satisfaits par le profil de sécurité de lanifibranor auprès des patients atteints de la NASH. L’avis positif du DSMB ainsi que la décision de la FDA de lever pour lanifibranor la suspension clinique applicable aux agonistes PPAR nous confortent quant au mécanisme d’action unique de notre candidat médicament. Nous attendons avec impatience la publication, au premier semestre 2020, des résultats de l’étude et, s’ils sont positifs, le démarrage de la dernière phase de développement avant la mise sur le marché de 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 franchit une étape clé avec la fin du recrutement des patients dans son étude clinique de Phase IIb avec lanifibranor dans la NASH

Inventiva franchit une étape clé avec la fin du recrutement des patients dans son étude clinique de Phase IIb avec lanifibranor dans la NASH

4 septembre 2019

Daix (France), le 4 septembre 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 clinique de Phase IIb NATIVE (NASH Trial to Validate IVA337 Efficacy) évaluant lanifibranor, le produit candidat le plus avancé de la Société, dans le traitement de la stéatohépatite non alcoolique (NASH).

Au total, 247 patients ont été randomisés dans l’étude de Phase IIb NATIVE, soit plus que l’objectif initial de 225 patients suite à une accélération des inclusions ces derniers mois. Les patients ont été recrutés principalement dans des sites en Australie, au Canada, aux États-Unis et en Europe. L’objectif de recrutement de patients atteints d’une forme sévère de NASH a été atteint, car environ 73% d’entre eux ont un score NAS supérieur ou égal à six, et 76% ont un score de fibrose égal à F2 ou F3. Par ailleurs, plus de 40% des patients inclus dans l’étude sont atteints d’un diabète de type 2 (T2DM), ce qui permettra à Inventiva d’effectuer les sous-analyses prévues dans ce groupe clé de patients, chez qui la capacité de lanifibranor à améliorer la sensibilité à l’insuline devrait être particulièrement bénéfique. On estime qu’environ la moitié des patients atteints de la NASH dans le monde souffrent aussi d’un DT2M, et qu’ils présentent un risque plus élevé d’accidents cliniques. À ce jour, 146 patients ont déjà achevé avec succès l’étude de 6 mois, confirmant la bonne tolérance du traitement.

Cette étape cruciale du recrutement franchie, la publication des principaux résultats de l’étude est prévue pour le 1er semestre 2020.

La fin du recrutement des patients dans l’étude NATIVE intervient après trois réunions du Data Safety Monitoring Board (DSMB), qui avait examiné les données de sécurité des patients et recommandé à chaque fois la poursuite de l’étude sans modification du protocole, confirmant ainsi le profil de sécurité favorable de lanifibranor. Ces résultats positifs corroborent les résultats des études toxicologiques à long terme, les résultats des études cliniques de Phase I et II, ainsi que la décision de la FDA en mai 2019 de lever, pour lanifibranor, la suspension clinique en vigueur pour les proliférateurs de peroxysomes (PPAR).

Le Prof. Sven Francque, M.D., PhD, Hôpital Universitaire d’Anvers et Co-Investigateur Principal de l’étude, a déclaré : « Grâce au mécanisme d’action des agonistes PPAR largement validé pour le traitement de la NASH, et au profil unique de lanifibranor en tant qu’agoniste pan-PPAR, ce candidat médicament devrait être capable de réduire la NASH ainsi que la fibrose qui lui est associée, tout en apportant des bénéfices métaboliques. L’évaluation des patients atteints de diabète de type 2 sera également importante pour confirmer que lanifibranor est particulièrement adapté à cette population de patients. »

Le Prof. Manal Abdelmalek, M.D., MPH, Duke University et Co-Investigateur Principal de l’étude, a ajouté : « La fin du recrutement des patients dans cette étude internationale est une excellente nouvelle. L’étude a été correctement menée, et grâce aux résultats précliniques et cliniques de lanifibranor recueillis à ce jour, nous sommes convaincus que ce traitement s’avérera être une approche prometteuse pour le traitement de la NASH. »

Le Dr. Marie-Paule Richard, Directrice médicale chez Inventiva, a ajouté : « Nous remercions chaleureusement l’ensemble des cliniciens et des patients qui ont participé à cette étude internationale. Le profil de sécurité de lanifibranor et la manière dont l’étude a été menée jusqu’à maintenant sont très encourageants. Nous sommes confiants dans le fait que le critère d’évaluation principal de l’étude sera atteint, et nous sommes impatients d’en publier les résultats au premier semestre 2020, qui, s’ils sont positifs, permettront à lanifibranor d’entrer en étude pivot de Phase III. »

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.

Le développement d’odiparcil progresse avec le recrutement des premiers patients dans une nouvelle étude biomarqueur menée chez des adultes et enfants atteints de la MPS VI

Le développement d’odiparcil progresse avec le recrutement des premiers patients dans une nouvelle étude biomarqueur menée chez des adultes et enfants atteints de la MPS VI

2 septembre 2019

Daix (France) le 2 septembre 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 le recrutement des premiers patients dans une nouvelle étude biomarqueur chez des adultes et enfants atteints de mucopolysaccharidose de type VI (MPS VI).

Menée aux Etats-Unis, au centre de recherche de l’hôpital pour enfants d’Oakland, Californie (UCSF Benioff Children’s Hospital), par le Dr Paul R. Harmatz, cette étude évaluera les taux de glycosaminoglycanes dans les leucocytes (leukoGAGs) chez trois enfants et dans la peau (skinGAGs) chez trois patients adultes atteints de la MPS VI avant et après un traitement enzymatique de remplacement (TER), ainsi que chez six volontaires sains de même âge. Cette étude fait partie de la stratégie d’Inventiva de développer des biomarqueurs qui permettront d’évaluer l’efficacité d’odiparcil, le candidat médicament de la Société pour le traitement de la MPS, dans la réduction des leukoGAGs et des skinGAGS. Cette approche a été lancée suite à la recommandation de la Food and Drug Administration (FDA) quant à l’importance des biomarqueurs dans des maladies telles que les MPS1. Les résultats de cette étude sont attendus au premier semestre 2020.

Une première étude biomarqueur menée à l’initiative d’Inventiva avait montré que malgré l’administration du TER, le traitement de référence actuel, les taux de leukoGAGs restaient très élevés et qu’ils n’étaient pas modifiés une heure après l’administration du TER, alors que l’activité de l’enzyme arylsulfatase B2 était très élevée. Cette découverte suggère que les taux de leukoGAGs pourraient être réduits davantage avec un nouveau traitement, tel qu’odiparcil.

L’évaluation du niveau des leukoGAGs et des skinGAGs est réalisée dans l’étude clinique de Phase IIa iMProveS (improve MPS treatment) en cours évaluant odiparcil dans le traitement des patients atteints de la MPS VI. Suite aux récents progrès réalisés dans l’étude iMproveS, les premiers résultats pour l’ensemble des cohortes de patients sont désormais attendus d’ici la fin de l’année. Initialement, Inventiva prévoyait de publier les résultats de l’étude en deux temps: les résultats des groupes en double aveugle avec un contrôle placebo d’ici la fin de l’année suivis des résultats de la cohorte ouverte au premier trimestre 2020.

Le Dr Paul R. Harmatz, investigateur principal de cette nouvelle étude biomarqueur, a déclaré : « Je me réjouis du lancement de cette deuxième étude biomarqueur avec le recrutement des premiers patients. Après notre première étude sur des biomarqueurs qui avait démontré les limites du TER pour réduire les taux de leukoGAGs, cette nouvelle étude devrait nous permettre de mieux comprendre la dynamique de la réponse au traitement au niveau des leucocytes. Elle pourrait également nous fournir une deuxième mesure de l’accumulation de GAGs dans un tissu facilement accessible, tel que la peau, et améliorer ainsi la mesure des variations des taux intracellulaires de GAGs. »

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 enregistre un nouveau brevet européen renforçant et étendant la protection de son candidat médicament phare lanifibranor

Inventiva enregistre un nouveau brevet européen renforçant et étendant la protection de son candidat médicament phare lanifibranor

28 août 2019

Daix (France), le 28 août 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’Office Européen des Brevets (OEB) a approuvé le 28 août 2019 un nouveau brevet qui protège jusqu’en juin 2035 l’utilisation de lanifibranor dans 38 pays européens dans le traitement de nombreuses maladies fibrotiques dont la stéatohépatite non alcoolique (NASH).
Ce nouveau brevet renforce et étend la durée de la protection de lanifibranor en Europe qui y était déjà établie avec le brevet de composé (New Chemical Entity, NCE) lequel expirera au mois d’août 2031 (cette date d’expiration tient compte d’une éventuelle prolongation de cinq ans pour compenser les délais réglementaires liés à l’obtention d’une autorisation de mise sur le marché).
En plus de l’Europe, l’utilisation de lanifibranor dans diverses indications fibrotiques dont la NASH est déjà protégée aux Etats-Unis. Inventiva a déposé des demandes de brevet ayant des caractéristiques similaires dans d’autres marchés de référence de l’industrie pharmaceutique, dont la Chine et le Japon, qui sont en cours d’examen.

Pierre Broqua, Ph.D., Directeur Scientifique et cofondateur d’Inventiva, a déclaré : « L’obtention de ce brevet en Europe est une excellente nouvelle qui nous permet de renforcer et d’étendre la protection de lanifibranor dans de nombreuses indications fibrotiques, notamment la NASH, dans un de nos marchés clés. Conjugué aux décisions de l’USPTO aux Etats-Unis, nous consolidons considérablement notre portefeuille de brevets pour notre candidat médicament phare dans des régions et pays où le besoin de traitement des maladies fibrotiques est très élevé. Cette dynamique positive confirme notre approche innovante en matière de R&D qui est au coeur de notre stratégie. »

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.

De nouveaux résultats prometteurs de lanifibranor seront présentés lors du The Liver Meeting® 2019

De nouveaux résultats prometteurs de lanifibranor seront présentés lors du The Liver Meeting® 2019

26 août 2019

Daix (France), le 26 août 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 lanifibranor dans un modèle préclinique de cirrhose a été sélectionné par l’American Association for the Study of Liver Diseases (AASLD) pour une présentation orale lors du The Liver Meeting® 2019, à Boston, Massachusetts, États-Unis (8-12 novembre 2019).

L’étude, menée par le professeur Jordi Gracia-Sancho1, visait à évaluer lanifibranor dans un modèle préclinique de cirrhose. Les résultats montrent clairement que lanifibranor induit une régression significative de la fibrose hépatique et une baisse de l’hypertension portale. Lanifibranor a par ailleurs considérablement réduit l’inflammation hépatique et amélioré le phénotype des cellules endothéliales sinusoïdales du foie et des cellules stellaires hépatiques. Ces résultats sont très prometteurs et démontrent le potentiel de lanifibranor dans le traitement de la maladie chronique avancée du foie.
L’abstract intitulé « The pan-PPAR agonist lanifibranor improves portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease » sera présenté le 10 novembre 2019 dans le cadre du The Liver Meeting® 2019 (voir détails ci-dessous).

Parallèlement, Inventiva organisera une réunion avec des leaders d’opinion portant sur lanifibranor comme traitement potentiel de la NASH avec la participation des docteurs Manal Abdelmalek2, Pierre Bedossa3, Kenneth Cusi4 et Sven Francque5. Cette réunion aura lieu de 8h00 à 9h30 (heure locale) le 11 novembre 2019 à l’hôtel Mandarin Oriental Boston (Bar Bouloud), à Boston, Massachusetts, États-Unis.

Pierre Broqua, Directeur Scientifique et cofondateur d’Inventiva, a déclaré : « Ces résultats sont une excellente nouvelle pour lanifibranor et démontrent son potentiel dans le traitement de la maladie chronique avancée du foie. Ils marquent une étape importante dans le développement de lanifibranor et s’inscrivent dans la continuité de nos résultats qui mettaient déjà en évidence les effets bénéfiques de notre produit candidat dans des modèles
précliniques pertinents de la NASH. L’ensemble de ces résultats renforcent notre confiance dans le mécanisme d’action unique de lanifibranor et dans son potentiel pour traiter les patients atteints de la NASH. J’attends avec impatience le The Liver Meeting® 2019 ainsi que la réunion organisée par Inventiva pour présenter nos derniers résultats et discuter de façon plus approfondie du potentiel de lanifibranor dans le traitement de la NASH. »
Les détails relatifs à la présentation orale d’Inventiva lors du The Liver Meeting® 2019 sont les suivants :

Titre de l’abstract : « The pan-PPAR agonist lanifibranor improves portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease »
N° de publication : 0063
Titre de la séance : Parallel 6: Novel Therapeutics for NASH
Date : dimanche 10 novembre 2019
Heure de la séance : 10h30 (heure locale)
Heure de la présentation : 11h00 (heure locale)
Adresse : Auditorium, John B. Hynes Memorial Convention Center, Boston,
Massachusetts, États-Unis
Congrès : The Liver Meeting® 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.

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