Financial Results

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

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

6 janvier 2019

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

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

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

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

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

18 décembre 2019

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

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

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

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

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

3 décembre 2019

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

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

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

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

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

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

13 novembre 2019

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

Situation de trésorerie

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

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

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

Contacts

Inventiva
Frédéric Cren

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

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

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

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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

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

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

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

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

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

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

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

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

Inventiva participera à la « Jefferies 2019 London Healthcare Conference »

Inventiva participera à la « Jefferies 2019 London Healthcare Conference »

12 novembre 2019

Daix (France), le 12 novembre 2019 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, 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 London Healthcare Conference » qui se tiendra du 20 au 21 novembre 2019 à Londres, Royaume-Uni.

Les détails de l’événement sont les suivants :

Date : Mercredi 20 novembre 2019
Heure de la présentation : 17h20 – 17h40 (heure du Royaume-Uni)
Heure de la séance questions-réponses : 17h40 – 17h55 (heure du Royaume-Uni)
Webcast : http://wsw.com/webcast/jeff123/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 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.