Servier

Orléans, France
Orléans, France
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Servier et Transgene (Paris:TNG), société de biotechnologie qui conçoit et développe des immunothérapies reposant sur des vecteurs viraux, annoncent aujourd’hui avoir signé un accord de recherche portant sur l’application des technologies de vectorisation virale pour la production de thérapies cellulaires CAR-T allogéniques. L’objectif est d’obtenir des produits toujours plus performants pour les patients. « Les thérapies cellulaires allogéniques utilisant les CAR-T ouvrent un champ d’innovation majeur pour la prise en charge des cancers, » indique Patrick Therasse, Directeur Recherche et Développement Oncologie chez Servier. « Mais chacune des étapes de leur processus complexe de fabrication nécessite des efforts de mise au point et d’optimisation spécifiques, afin d’offrir aux patients les meilleures options thérapeutiques possibles. Et nous cherchons les meilleurs partenaires pour faire avancer ces produits. » La collaboration entre les équipes scientifiques de Servier et de Transgene vise à évaluer et sélectionner des technologies de vectorisation innovantes basées sur la collection de vecteurs viraux de Transgène, et qui pourront être appliquées à l’ingénierie des thérapies cellulaires CAR-T. Au-delà de la mise au point de technologies plus simples, rapides et efficaces, l’objectif est également d’obtenir un contrôle fin des zones du génome modifiées. Servier et Transgene visent ainsi à aboutir à un procédé original de préparation des CAR-T allogéniques avec de meilleurs rendements d’intégration des transgènes et un nombre réduit d’étapes. Transgene possède une large collection de vecteurs viraux et une compétence reconnue en ingénierie du génome de ces vecteurs. Ces atouts seront utilisés pour développer de nouveaux outils de vectorisation permettant d’augmenter les possibilités de modification fine et précise du génome des cellules CART, afin d’adapter les propriétés de ces cellules à l’environnement tumoral et d’en améliorer l’efficacité thérapeutique. « Cellectis se réjouit de cette collaboration sur les CAR-T allogéniques entre Servier et Transgene », a affirmé André Choulika, Président-Directeur Général de Cellectis. « Transgene compte parmi les sociétés les plus avancées au monde dans le développement des technologies de vectorisation. Nous sommes convaincus que leur collaboration sur ces thérapies cellulaires ouvrira la voie à l'optimisation de leur production, de leur coût et potentiellement à l'exploration de leur utilisation dans d'autres indications de leucémies ». Servier est un laboratoire pharmaceutique international gouverné par une Fondation, et dont le siège se trouve à Suresnes (France). S’appuyant sur une solide implantation internationale dans 148 pays et sur un chiffre d’affaires de 4 milliards d’euros en 2016, Servier emploie 21 000 personnes dans le monde. La croissance du groupe repose sur la recherche constante d’innovation dans cinq domaines d’excellence : les maladies cardiovasculaires, immuno-inflammatoires et neurodégénératives, l’oncologie et le diabète, ainsi que sur une activité dans les médicaments génériques de qualité. Totalement indépendant, sans actionnaires, le Groupe réinvestit 25 % de son chiffre d’affaires hors génériques en Recherche et Développement et utilise tous ses bénéfices au profit de sa croissance. Servier s’est donné comme objectif à long terme de devenir un acteur clé en oncologie. Actuellement, neuf entités moléculaires sont en développement clinique dans ce domaine, ciblant les cancers de l’estomac, du poumon, et d’autres tumeurs solides ainsi que diverses leucémies et lymphomes. Ce portefeuille de traitements innovants contre les cancers est développé avec des partenaires dans le monde entier, et couvre différentes stratégies anticancéreuses incluant les cytotoxiques, les proapoptotiques, les thérapies ciblées, les immunothérapies et les thérapies cellulaires, pour mettre à disposition des patients des médicaments qui changent la vie. Transgene (Euronext : TNG), qui fait partie de l’Institut Mérieux, est une société de biotechnologie qui conçoit et développe des produits d’immunothérapie ciblée contre les cancers et les maladies infectieuses. Ces produits utilisent des vecteurs viraux pour détruire directement ou indirectement les cellules infectées ou cancéreuses. Transgene a deux produits principaux en développement clinique : TG4010, un vaccin thérapeutique contre le cancer du poumon non à petites cellules et Pexa-Vec, un virus oncolytique contre le cancer du foie. La Société a également plusieurs autres programmes en recherche et en développement préclinique et clinique basés sur sa technologie des vecteurs viraux, dont TG4001. Transgene est basée à Strasbourg et a des activités opérationnelles à Lyon et une joint-venture en Chine. Plus d’informations sur www.transgene.fr. Ce communiqué de presse contient des informations et/ou déclarations prospectives de Transgene concernant sa situation financière, y compris sa consommation de trésorerie. Bien que la Société considère que ces informations et projections sont fondées sur des hypothèses raisonnables, elles peuvent être remises en cause par un certain nombre d’aléas et d’incertitudes, de sorte que les résultats effectifs pourraient différer significativement de ceux anticipés et pourraient avoir un impact négatif significatif sur les activités de la Société, ses perspectives, sa situation financière, ses résultats ou ses développements. La capacité de la Société à commercialiser ses produits est soumise notamment, mais pas exclusivement, aux facteurs suivants : la reproduction chez l’homme de résultats précliniques positifs ; la réussite d’essais cliniques, la capacité à obtenir des financements et/ou des partenariats pour le développement et la commercialisation des produits, et l’obtention des autorisations réglementaires de mise sur le marché. Pour une description des risques et incertitudes de nature à affecter les résultats, la situation financière, les performances ou les réalisations de la Société et ainsi à entraîner une variation par rapport aux déclarations prospectives, veuillez-vous référer à la section « Facteurs de Risque » du Document de Référence et de son Actualisation déposés auprès de l’AMF et disponibles sur les sites internet de l’AMF (www.amf-france.org) et de la Société (www.transgene.fr).


Servier and Transgene (Paris:TNG), a biotechnology company that designs and develops immunotherapies based on viral vectors, announced today the signature of a research agreement on the application of viral vectorization technology for the production of allogenic CAR-T cell therapies. The aim is to obtain more efficient products for patients. “Allogenic cell therapies using CAR-T open a major field of innovation in the treatment of cancer,” stated Patrick Therasse, Oncology Research and Development Director at Servier. “However, each of the steps in their complex manufacturing process requires specific development and optimization efforts, in order to provide patients with the best possible therapeutic options. And we look for the best partners to move these products forward. ". The aim of the collaboration between the scientific teams at both Servier and Transgene is to evaluate and select innovative vectorization methods based on Transgene’s viral vector collection, which may be applied to the engineering of CAR-T cell therapies. In addition to the development of simpler, faster and more effective methods, the aim is also to obtain a tighter control of the modified genome areas. Servier and Transgene thus aim to achieve an original allogenic CAR-T preparation method with better transgene integration yields and fewer steps. Servier has been engaged in the development of cell therapies since November 2015 (see About UCART19). Transgene has a large collection of viral vectors and is renowned for its competence in the genome engineering of these vectors. These assets will be used to develop new vectorization tools that will allow us to increase the possibility of fine and precise modification of the genome of CART cells, in order to adapt these cells’ properties to the tumor environment and improve the therapeutic efficacy. Eric Quéméneur, Scientific Director of Transgene, explains: “We are proud of the recognition of our vectorization know-how and of our capacity for innovation by a pharmaceutical company of importance such as Servier. We will enthusiastically contribute to the development of CAR-T, these new promising products in cancer immunotherapy. Thanks to this collaboration, Transgene broadens the domain of the application of viral vectors from its technological platform. ". “Cellectis is pleased about Servier and Transgene’s collaboration on allogenic CAR-T cell therapies, stated André Choulika, Chairman and Chief Executive Officer of Cellectis. “Transgene stands among the most advanced companies in the world in the development of vector technologies. We are convinced that this collaboration will result in a next generation of UCART19 that will confirm the initial results of this product candidate, but also, will lead to ways to optimize production, costs, and potentially explore its use in other leukemia indications”. Transgene may receive more than 30 million Euro for this contract, with an initial duration of three years. As for Servier, it will be able to use these new vectors to develop its cell immunotherapy portfolio. Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 148 countries and a turnover of 4 billion euros in 2016, Servier employs 21,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric disease, oncology and diabetes, as well as by its activities in high-quality generic drugs. Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are nine molecular entities in clinical development in this area, targeting gastric and lung cancers and other solid tumors, as well as different types of leukemia and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, immune, cellular and targeted therapies, to deliver life-changing medicines to patients. Transgene (Euronext: TNG), part of Institut Mérieux, is a biotechnology company focused on discovering and developing immune-targeted therapies for the treatment of cancer and infectious diseases. These products use viral vectors to destroy, directly or indirectly, infected or cancer cells. Transgene has two main products in clinical development: TG4010, a therapeutic vaccine against non-small cell lung cancer and Pexa-Vec, an oncolytic virus against liver cancer. The Company also has several other pre-clinical and clinical research and development programmes based on its viral vector technology, including TG4001. Transgene is based in Strasbourg and has operational activities in Lyons and a joint-venture in China. For further information on www.transgene.fr. In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy, currently I phase I. Pfizer has exclusive rights from Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries. This press release contains forward-looking information and/or statements of Transgene concerning its financial situation, including its cash flow. Although the Company considers that this information and expectations are based on reasonable assumptions, they may be subject to a certain number of risks and uncertainties, which could cause the actual results to differ significantly from those expected and could have a significant negative impact on the activities of the Company, its prospects, financial situation, results or developments. The capacity of the Company to market its products is subject primarily, but not exclusively, to the following factors: the reproduction in humans of positive pre-clinical results; the success of clinical trials, the capacity to obtain funding and/or partnerships for the development and marketing of its products, and obtaining regulatory marketing authorisations. For a description of risks and uncertainties which could affect the results, financial situation, performance or achievements of the Company, and thus cause a fluctuation with respect to the forward-looking statements, please refer to the “Risk Factors” section of the Reference Document and its Update filed with the AMF and available on the AMF website (www.amf-france.org) and the Company website (www.transgene.fr).


News Article | May 24, 2017
Site: www.reuters.com

PARIS (Reuters) - The Paris prosecutor's office said on Wednesday that drugmaker Servier as well as the French drug regulator should face trial over weight-loss pill Mediator, believed to have caused at least 500 deaths in one of France's worst health scandals.


Company to Host an Investor Conference Call Tomorrow at 10:00 AM EDT BOSTON, MA--(Marketwired - May 10, 2017) - Pieris Pharmaceuticals, Inc. ( : PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer, respiratory and other diseases, today reported financial results for the first quarter of 2017 and provided an update on the Company's recent developments, including: During the first quarter of 2017, Pieris announced two significant partnerships. In January, the Company announced a global, multi-target, multi-year alliance in immuno-oncology with Servier to jointly pursue up to eight bispecific therapeutic programs, including Pieris' proprietary dual checkpoint inhibitor, PRS-332. Under the terms of the alliance, Pieris received an upfront payment of EUR30.0 million (approximately $32.3 million), and stands to receive, collectively, up to EUR1.7 billion (approximately $1.8 billion) in success-based milestone payments and up to double-digit royalties from potential sales. Pieris and Servier will jointly develop PRS-332, with Pieris retaining all commercial rights in the United States and Servier having commercial rights in the rest of the world. Pieris has the option, at a predefined time point, to co-develop and retain commercial rights in the United States for up to three programs beyond PRS-332. In February, Pieris announced that it had granted ASKA Pharmaceutical Co. an exclusive option to license development and commercial rights in Japan for its most advanced drug candidate, PRS-080, to treat anemia in dialysis-dependent patients. Under the terms of the agreement, Pieris received an option payment of $2.75 million, and should ASKA exercise its option to develop and commercialize PRS-080 following positive results from the forthcoming Phase 2a study, Pieris would be eligible for more than $80 million in combined option exercise fee and milestone payments stemming from successful commercialization of PRS-080 in the first indication in Japan. Pieris may receive further development milestones for additional indications, as well as in other countries within the ASKA territory, and may receive double-digit royalties on net sales of PRS-080 up to the mid- to high-teens. Following the close of the first quarter, the Company also announced a global strategic co-development and co-commercialization respiratory-focused alliance including PRS-060 with AstraZeneca. Details of this alliance are summarized below, and were also previously disclosed in a May 3, 2017 press release. During the first quarter, the Company made substantial advances across its key pipeline programs, covering all of its lead therapeutic areas: "During the first quarter of 2017 and the early part of the second quarter, we have built dramatically on the foundational work that was put into place last year. We have secured two global and transformative alliances in our two core therapeutic areas of immuno-oncology and respiratory diseases, and an important regional alliance for our anemia program, PRS-080, as we seek to divest that asset in a careful manner while we focus our organization on high-value therapies within immunology. Our partnerships with global leaders like AstraZeneca and Servier, and regional partners like ASKA, have generated approximately $80 million in cash flow in 2017, while our combined partnerships could result in more than $4.5 billion in potential milestone payments, plus royalties from future product sales, not to mention opportunities for direct commercial sales for several products in the United States. With our current balance sheet, we have the financial resources to invest more robustly into our proprietary pipeline, while extending our financial runway through a series of critical value inflection points," said Stephen Yoder, President and CEO of Pieris. "We also advanced our clinical and preclinical programs, and remain on track to take our wholly-owned lead IO asset, PRS-343, into a Phase 1 trial during the current quarter, while planning to advance our now-partnered lead respiratory asset, PRS-060, into first in human trials in the second half of this year in collaboration with AstraZeneca, in addition to making steady progress across all of our additional partnerships. Based on not only the corporate milestones achieved to date, but also the additional corporate milestones we intend to achieve later this year, we continue to believe that 2017 can be the most value-creating year in the history of our company." Cash Position -- Cash and cash equivalents totalled $55.2 million as of March 31, 2017, compared to $29.4 million as of December 31, 2016. This increase in cash was driven primarily by the upfront payment received from Servier and the option payment received from Aska, offset principally by $8.8 million operating expenditures during the quarter. R&D Expense­ -- Research and development expenses were $5.4 million for the quarter ended March 31, 2017, compared to $3.7 million for the quarter ended March 31, 2016. The $1.7 million increase was primarily attributable to a $0.9 million increase in pre-clinical development, CMC, and clinical costs for PRS-343 as we carry out IND-enabling studies and a $0.5 million net increase in CMC and other costs associated with PRS-060 as we continue IND-enabling studies. G&A Expense -- General and administrative expenses for the quarter ended March 31, 2017 were $4.0 million, compared to $2.0 million for the quarter ended March 31, 2016. The $2.0 million increase in G&A expenses was primarily due to $0.8 million in higher personnel related costs, including stock compensation, $0.9 million increase for professional fees principally on account of success-based fees, and $0.3 million increase in for administrative travel, recruiting, and other administrative costs. Net Loss -- Net loss was $8.0 million or ($0.19) per share for the quarter ended March 31, 2017, compared to a net loss $4.2 million or ($0.10) per share for the quarter ended March 31, 2016. Pieris management will host a conference call beginning at 10:00 AM Eastern Daylight Time on Thursday, May 11, 2017, to discuss the first quarter financial results and provide a corporate update. To access the call, participants may dial 877-407-8920 (US & Canada) or 1-412-902-1010 (International) at least 10 minutes prior to the start of the call. An archived replay of the call will be available by dialling 877-660-6853 (US & Canada) or 1-201-612-7415 (International) and providing the Conference ID #: 13652361. Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin® protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes immuno-oncology multi-specifics tailored for the tumor microenvironment, an inhaled Anticalin protein to treat uncontrolled asthma and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin is a registered trademark of Pieris. For more information, visit www.pieris.com. This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to novel technologies and methods; our business and product development plans; the timing and progress of our studies, our liquidity and ability to fund our future operations; our ability to achieve certain milestones and receive future milestone or royalty payments; or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates; competition in the industry in which we operate and market conditions. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents we file with the SEC available at www.sec.gov, including without limitation the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and the Company's Quarterly Reports on Form 10-Q.


News Article | May 9, 2017
Site: www.businesswire.com

Situation de la trésorerie : Au 31 mars 2017, Cellectis disposait de 258,5 M€ de trésorerie, équivalents de trésorerie et actifs financiers courants à comparer aux 276,2 M€ au 31 décembre 2016. Cette diminution de 17,7 M€ reflète en particulier (i) ) les flux de trésorerie consommés par les activités d’exploitation pour 15,3 M€, (ii) les décaissements liés aux acquisitions d’immobilisations pour 0,5 M€ et (iii) l’effet de change latent défavorable lié aux fluctuations de taux sur les comptes de trésorerie et équivalents de trésorerie ainsi que sur les actifs financiers courants libellés en dollars pour 1,9 M€. Chiffre d'affaires et autres revenus : Au cours des premiers trimestres 2016 et 2017, nous avons enregistré respectivement 9,5 M€ et 9,7 M€ en chiffre d’affaires et autres produits. Cette variation est principalement due à (i) l’augmentation de 0,8 M€ du crédit impôt recherche, (ii) la diminution des revenus des contrats de collaboration pour 0,4 M€, due, entre autres, à une diminution de 1,4 M€ de l’étalement des paiements initiaux, et à une diminution de 0,3 M€ des remboursements de frais de recherche et développement, qui sont partiellement compensées par une augmentation de 1,3 M€ des revenus liés aux accords d’approvisionnement en matières premières avec Servier, et (iii) la diminution des revenus des licences pour 0,2 M€. Frais de recherche et développement : au cours des premiers trimestres 2016 et 2017, les dépenses de recherche et développement ont diminué de 0,5 M€ (18,9 M€ en 2016 contre 18,4 M€ en 2017). Les frais de personnel ont diminué de 2,1 M€ (de 11,9 M€ en 2016 à 9,8 M€ en 2017), notamment en raison de la diminution des charges sociales relatives à l’attribution d’options de souscription d'actions pour 1,7 M€ et des charges liées aux rémunérations fondées sur des actions sans impact sur la trésorerie pour 0,5 M€, partiellement compensée par une augmentation des charges de personnel pour 0,1 M€. Les achats externes et autres charges ont augmenté de 1,5 M€ (6,6 M€ en 2016 contre 8,2 M€ en 2017), en raison de l'augmentation des dépenses liées à au développement d’UCART123 et le développement d’autres candidats médicaments, incluant les paiements à des tiers participant au développement de produits, les achats de matières premières biologiques et les frais associés à l'utilisation de laboratoires et d'autres installations. Frais administratifs et commerciaux : Au cours des premiers trimestres 2016 et 2017, les frais administratifs et commerciaux s’élevaient respectivement à 10,5 M€ et 9,1 M€. La diminution de 1,4 M€ reflète (i) la baisse des charges de personnel de 1,1 M€ (8,3 M€ en 2016 contre 7,2 M€ en 2017), imputable à une diminution de 1,5 M€ des charges sociales relatives à l’attribution d’options de souscription d'actions et une diminution de 0,1 M€ des charges liées aux rémunérations fondées sur des actions sans impact sur la trésorerie, en partie compensée par une augmentation de 0,5 M€ des charges de personnel, et (ii) une diminution de 0,4 M€ en achats et charges externes. Résultat financier : La perte financière était de 9,1 M€ pour le premier trimestre 2016 comparée à un résultat financier quasi nul pour le premier trimestre 2017. Cette variation est principalement attribuable à la diminution de la perte de change de 7,6 M€ dû à l’effet des fluctuations des taux de change sur la trésorerie et les équivalents de trésorerie libellés en dollars US, l’augmentation de 1,0 M€ de charges liées à l’ajustement de juste valeur sur les instruments dérivés et actifs financiers courants, ainsi qu’au gain de 0,2 M€ réalisé sur le repositionnement des instrument dérivés de change. Résultat net attribuable aux actionnaires de Cellectis : Au cours des premiers trimestres 2016 et 2017, nous avons enregistré une perte nette de 29,5 M€ (soit 0,84 € par action avec ou sans effet dilutif) et une perte nette de 18,6 M€ (soit 0,53 € par action avec ou sans effet dilutif), respectivement. La perte ajustée attribuable aux actionnaires de Cellectis pour le premier trimestre 2017, s'est élevée à 5,8 M€ (soit 0,16 € par action avec ou sans effet dilutif) comparée à 16,1 M€ (0,46 € par action avec ou sans effet dilutif) pour le premier trimestre 2016. Ces résultats ajustés attribuables aux actionnaires de Cellectis pour les premiers trimestres 2017 et 2016 excluent la charge liée aux rémunérations fondées sur des actions sans impact sur la trésorerie, de respectivement 12,8 M€ et 13,4 M€. Veuillez consulter la « Note relative à l'utilisation de mesures financières non IFRS » pour le rapprochement du résultat IFRS attribuable aux actionnaires de Cellectis et du résultat ajusté attribuable aux actionnaires de Cellectis. Dans ce communiqué de presse, Cellectis S.A. présente un résultat ajusté attribuable aux actionnaires de Cellectis qui n’est pas un agrégat défini par le référentiel IFRS. Nous avons inclus dans ce communiqué de presse une réconciliation de cet agrégat avec le résultat attribuable aux actionnaires de Cellectis, élément le plus comparable calculé en accord avec le référentiel IFRS. Ce résultat ajusté attribuable aux actionnaires de Cellectis exclut les charges liées aux rémunérations fondées sur des actions sans impact sur la trésorerie. Nous estimons que cet agrégat financier, quand il est comparé avec les états financiers IFRS, peut améliorer la compréhension globale de la performance financière de Cellectis. De plus, notre direction suit les opérations de la société, et organise ses activités, en utilisant entre autres, cet agrégat financier. Talking about gene editing? We do it. TALEN® est une marque déposée, propriété du Groupe Cellectis. Ce communiqué contient des déclarations prospectives relatives à Cellectis et à ses activités. Cellectis estime que ces déclarations prospectives reposent sur des hypothèses raisonnables. Cependant, aucune garantie ne peut être donnée quant à la réalisation des prévisions exprimées dans ces déclarations prospectives qui sont soumises à des risques dont ceux décrits dans le prospectus de Cellectis disponible sur le site internet de la SEC (www.sec.gov), et à l’évolution de la conjoncture économique, des marchés financiers et des marchés sur lesquels Cellectis est présente. Les déclarations prospectives figurant dans le présent communiqué sont également soumises à des risques inconnus de Cellectis ou que Cellectis ne considère pas comme significatifs à cette date. La réalisation de tout ou partie de ces risques pourrait conduire à ce que les résultats réels, conditions financières, performances ou réalisations de Cellectis diffèrent significativement des résultats, conditions financières, performances ou réalisations exprimés dans ces déclarations prospectives. Cellectis ne s'engage en aucune façon à mettre à jour ou modifier l'information contenue dans ce communiqué de presse, que ce soit à raison de faits nouveaux, d'événements ou circonstances futurs ou de toute autre raison.


News Article | May 11, 2017
Site: globenewswire.com

SOUTH SAN FRANCISCO, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that its Annual Meeting of Stockholders will be held on Thursday, May 18, 2017 at 10:30 AM Pacific Time at the Embassy Suites Hotel, located at 250 Gateway Boulevard in South San Francisco, CA. Robert I. Blum, President and Chief Executive Officer, is scheduled to present an overview of Cytokinetics’ performance. Interested parties may access the live webcast of this presentation by visiting the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 62643654. An archived replay of the webcast will be available via Cytokinetics' website until May 25, 2017. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 62643654 from May 18, 2017 at 1:30 PM Pacific Time until May 25, 2017. Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics’ lead drug candidate is tirasemtiv, a fast skeletal troponin activator (FSTA). Tirasemtiv is the subject of VITALITY-ALS, an international Phase 3 clinical trial in patients with ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency. Cytokinetics is preparing for the potential commercialization of tirasemtiv in North America and Europe and has granted an option to Astellas for development and commercialization in other countries. Cytokinetics is collaborating with Astellas to develop CK-2127107, a next-generation fast skeletal muscle activator. CK-2127107 is the subject of two ongoing Phase 2 clinical trials enrolling patients with spinal muscular atrophy and chronic obstructive pulmonary disease. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of GALACTIC-HF, an international Phase 3 clinical trial in patients with heart failure. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Astellas holds an exclusive worldwide license to develop and commercialize CK-2127107. Licenses held by Amgen and Astellas are subject to Cytokinetics' specified co-development and co-commercialization rights. For additional information about Cytokinetics, visit http://www.cytokinetics.com/. This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act’s safe harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to planned presentations, and the properties and potential benefits of Cytokinetics’ drug candidates and potential drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approval and production of Cytokinetics' drug candidates and potential drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results and that Cytokinetics' drug candidates and potential drug candidates may have unexpected adverse side effects or inadequate therapeutic efficacy. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.


News Article | May 11, 2017
Site: globenewswire.com

SOUTH SAN FRANCISCO, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that its Annual Meeting of Stockholders will be held on Thursday, May 18, 2017 at 10:30 AM Pacific Time at the Embassy Suites Hotel, located at 250 Gateway Boulevard in South San Francisco, CA. Robert I. Blum, President and Chief Executive Officer, is scheduled to present an overview of Cytokinetics’ performance. Interested parties may access the live webcast of this presentation by visiting the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 62643654. An archived replay of the webcast will be available via Cytokinetics' website until May 25, 2017. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 62643654 from May 18, 2017 at 1:30 PM Pacific Time until May 25, 2017. Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics’ lead drug candidate is tirasemtiv, a fast skeletal troponin activator (FSTA). Tirasemtiv is the subject of VITALITY-ALS, an international Phase 3 clinical trial in patients with ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency. Cytokinetics is preparing for the potential commercialization of tirasemtiv in North America and Europe and has granted an option to Astellas for development and commercialization in other countries. Cytokinetics is collaborating with Astellas to develop CK-2127107, a next-generation fast skeletal muscle activator. CK-2127107 is the subject of two ongoing Phase 2 clinical trials enrolling patients with spinal muscular atrophy and chronic obstructive pulmonary disease. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of GALACTIC-HF, an international Phase 3 clinical trial in patients with heart failure. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Astellas holds an exclusive worldwide license to develop and commercialize CK-2127107. Licenses held by Amgen and Astellas are subject to Cytokinetics' specified co-development and co-commercialization rights. For additional information about Cytokinetics, visit http://www.cytokinetics.com/. This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act’s safe harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to planned presentations, and the properties and potential benefits of Cytokinetics’ drug candidates and potential drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approval and production of Cytokinetics' drug candidates and potential drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results and that Cytokinetics' drug candidates and potential drug candidates may have unexpected adverse side effects or inadequate therapeutic efficacy. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.


News Article | May 9, 2017
Site: www.businesswire.com

Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced its results for the three-month period ended March 31, 2017. Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“IASB”). Cash: As of March 31, 2017 Cellectis had €258.5 million in total cash, cash equivalents and current financial assets compared to €276.2 million as of December 31, 2016. This decrease of €17.7 million reflects (i) net cash flows used by operating activities of €15.3 million, (ii) capital expenditures of €0.5 million and (iii) the unrealized negative translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €1.9 million. Cellectis expects that its cash, cash equivalents and current financial assets of €258.5 million as of March 31, 2017 will be sufficient to fund its current operations to 2019. Revenues and Other Income: During the quarters ended March 31, 2016 and 2017, we recorded €9.5 million and €9.7 million, respectively, in revenues and other income. This increase primarily reflects (i) an increase of €0.8 million in research tax credit, (ii) a decrease of €0.4 million in collaboration revenues, due primarily to a decrease of €1.4 million in upfront recognition and a decrease of €0.3 million in R&D costs reimbursement, been partially offset by an increase of €1.3 million in supply agreements with Servier, and (iii) a decrease in revenue from licenses of €0.2 million. Total Operating Expenses: Total operating expenses for the first quarter of 2017 were €28.2 million, compared to €29.9 million for the first quarter of 2016. The non-cash stock-based compensation expenses included in these amounts were €12.8 million and €13.4 million, respectively. R&D Expenses: For the quarters ended March 31, 2016 and 2017, research and development expenses decreased by €0.5 million from €18.9 million in 2016 to €18.4 million in 2017. Personnel expenses decreased by € 2.1 million from €11.9 million in 2016 to €9.8 million in 2017, primarily due to a €1.7 million decrease in social charges on stock option grants and a €0.5 million decrease in non-cash stock based compensation expense, partly offset by a €0.1 million increase in wages and salaries. Purchases and external expenses increased by €1.5 million from €6.6 million in 2016 to €8.2 million in 2017, mainly due to increased expenses related to UCART123 and the development of other product candidates, including payments to third parties, purchases of biological materials and expenses associated with the use of laboratories and other facilities. SG&A Expenses: During the quarters ended March 31, 2016 and 2017, we recorded €10.5 million and €9.1 million, respectively, of selling, general and administrative expenses. The increase of €1.4 million primarily reflects (i) a decrease of €1.1 million in personnel expenses from €8.3 million to €7.2 million, attributable, to a decrease of €1.5 million of social charges on stock options grants and a decrease of €0.1 million of non-cash stock-based compensation expense, partly offset by a €0.5 million increase in wages and salaries, and (ii) a decrease of €0.4 million in purchases and external expenses. Financial Gain (Loss): The financial loss was €9.1 million for the first quarter of 2016 compared with an almost nil financial result for the first quarter of 2017. The change in financial result was primarily attributable to a decrease in net foreign exchange loss of €7.6 million due to the effect of exchange rate fluctuations on our USD cash and cash equivalent accounts, an increase of €1.0 million in fair value adjustment income on our foreign exchange derivatives and current financial assets and a €0.2 million net gain realized on the repositioning of foreign exchange derivative instruments. Net Income (Loss) Attributable to Shareholders of Cellectis: During the quarters ended March 31, 2016 and 2017, we recorded a net loss of €29.5 million (or €0.84 per share on both a basic and a diluted basis) and a net loss of €18.6 million (or €0.53 per share on both a basic and a diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the first quarter of 2017 was €5.8 million (€0.16 per share on both a basic and a diluted basis) compared to adjusted income attributable to shareholders of Cellectis of €16.1 million (€0.46 per share on both a basic and a diluted basis), for the first quarter of 2016. Adjusted income (loss) attributable to shareholders of Cellectis excludes non-cash stock-based compensation expense of €12.8 million and €13.4 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis. Note Regarding Use of Non-GAAP Financial Measures Cellectis S.A. presents Adjusted Income (Loss) attributable to shareholders of Cellectis in this press release. Adjusted Income (Loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We have included in this press release a reconciliation of this figure to Net Income (Loss) attributable to shareholders of Cellectis, the most directly comparable financial measure calculated in accordance with IFRS. Because Adjusted Income (Loss) attributable to shareholders of Cellectis excludes Non-cash stock-based compensation expense—a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of Non-cash stock-based expenses from Net Income (Loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of Adjusted Income (Loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of Non-cash stock-based compensation expense differently; and (b) other companies may report Adjusted Income (Loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider Adjusted Income (Loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net Income (Loss) attributable to shareholders of Cellectis. Cellectis is a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART). The company’s mission is to develop a new generation of cancer therapies based on engineered T-cells. Cellectis capitalizes on its 17 years of expertise in genome engineering - based on its flagship TALEN® products and meganucleases and pioneering electroporation PulseAgile technology - to create a new generation of immunotherapies. CAR technologies are designed to target surface antigens expressed on cells. Using its life-science-focused, pioneering genome-engineering technologies, Cellectis’ goal is to create innovative products in multiple fields and with various target markets. Cellectis is listed on the Nasdaq market (ticker: CLLS) and on the Alternext market (ticker: ALCLS). To find out more about us, visit our website: www.cellectis.com Talking about gene editing? We do it. TALEN® is a registered trademark owned by the Cellectis Group. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. This press release contains certain “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions and include, but are not limited to, statements regarding the outlook for Cellectis’ future business and financial performance. Forward-looking statements are based on management’s current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances, many of which are beyond Cellectis’ control. Actual outcomes and results may differ materially due to global political, economic, business, competitive, market, regulatory and other factors and risks. Cellectis expressly disclaims any obligation to update or revise any of these forward-looking statements, whether because of future events, new information, a change in its views or expectations, or otherwise. 1 Translated only for convenience into U.S. dollars at an exchange rate of €1.00=$1.0691, the daily reference rate reported by the European Central Bank (“ECB”) as of March 31, 2017


News Article | May 11, 2017
Site: globenewswire.com

SOUTH SAN FRANCISCO, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that its Annual Meeting of Stockholders will be held on Thursday, May 18, 2017 at 10:30 AM Pacific Time at the Embassy Suites Hotel, located at 250 Gateway Boulevard in South San Francisco, CA. Robert I. Blum, President and Chief Executive Officer, is scheduled to present an overview of Cytokinetics’ performance. Interested parties may access the live webcast of this presentation by visiting the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 62643654. An archived replay of the webcast will be available via Cytokinetics' website until May 25, 2017. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 62643654 from May 18, 2017 at 1:30 PM Pacific Time until May 25, 2017. Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics’ lead drug candidate is tirasemtiv, a fast skeletal troponin activator (FSTA). Tirasemtiv is the subject of VITALITY-ALS, an international Phase 3 clinical trial in patients with ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency. Cytokinetics is preparing for the potential commercialization of tirasemtiv in North America and Europe and has granted an option to Astellas for development and commercialization in other countries. Cytokinetics is collaborating with Astellas to develop CK-2127107, a next-generation fast skeletal muscle activator. CK-2127107 is the subject of two ongoing Phase 2 clinical trials enrolling patients with spinal muscular atrophy and chronic obstructive pulmonary disease. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of GALACTIC-HF, an international Phase 3 clinical trial in patients with heart failure. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Astellas holds an exclusive worldwide license to develop and commercialize CK-2127107. Licenses held by Amgen and Astellas are subject to Cytokinetics' specified co-development and co-commercialization rights. For additional information about Cytokinetics, visit http://www.cytokinetics.com/. This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act’s safe harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to planned presentations, and the properties and potential benefits of Cytokinetics’ drug candidates and potential drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approval and production of Cytokinetics' drug candidates and potential drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results and that Cytokinetics' drug candidates and potential drug candidates may have unexpected adverse side effects or inadequate therapeutic efficacy. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.


GeNeuro (Paris:GNRO) (Euronext Paris: CH0308403085 – GNRO) and Servier announced today that 6-month data from the CHANGE-MS Phase 2b study will be presented at MSParis2017, the 7th Joint ECTRIMS-ACTRIMS meeting held 25-28 October 2017, in Paris, France. The presentation will cover efficacy and safety data, and will include post-hoc analyses supporting the hypothesis of a delayed onset of action of GNbAC1 as well as target engagement in the central nervous system. Further details will be communicated right after the conference. CHANGE-MS is an international, randomized, double-blind, placebo-controlled study of 270 RRMS patients, investigating GNbAC1 for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). GNbAC1 is a monoclonal antibody which neutralizes a retroviral envelope protein encoded by a pathogenic member of the HERV-W family (pHERV-W env). CHANGE-MS is fully funded through a partnership with Servier signed in 2014, in which Servier is involved in the development and potential commercialization of GNbAC1 in MS in territories ex USA and Japan. Under this agreement and depending on achievement of development milestones, GeNeuro could receive a maximum of €362.5M, excluding royalties. The development of GNbAC1 is the result of more than 25 years of research into human endogenous retroviruses (HERVs), including 15 years at Institut Mérieux and INSERM, a French national medical research institute. Found in the human genome, certain HERVs have been linked to various autoimmune and neurodegenerative diseases. Researchers have demonstrated that the retroviral envelope protein associated with a pathogenic form of HERV-W [pHERV-W, formerly referred to as the Multiple Sclerosis RetroVirus (MSRV)] has been identified in brain lesions of patients with MS, particularly in active lesions, and in the pancreas of T1D patients. By neutralizing pHERV-W env, GNbAC1 could at the same time block these pathological inflammatory processes and restore remyelination in MS patients and maintain insulin production in T1D patients. As pHERV-W env has no known physiological function, GNbAC1 is expected to have a good safety profile, without directly affecting the patient’s immune system, as observed in all clinical trials to date. GeNeuro‘s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis and Type 1 diabetes, by neutralizing causal factors encoded by HERVs, which represent 8% of human DNA. GeNeuro is based in Geneva, Switzerland and has R&D facilities in Lyon, France. It has 30 employees and rights to 16 patent families protecting its technology. Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 148 countries and a turnover of 4 billion euros in 2016, Servier employs 21,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric disease, oncology and diabetes, as well as by its activities in high-quality generic drugs. Servier has a solid commitment to neuropsychiatry and to proposing innovative therapies to patients suffering from neurological conditions. Its research teams are investigating new ways of treating diseases such as Alzheimer’s and Parkinson’s, as well as a broad range of neurodegenerative disorders, by targeting the toxic proteins that lead to neuron degeneration. The priority is to focus on the causes of the diseases rather than their symptoms. Currently, there are 5 projects at different stages of research in this promising area. Regarding development, where Servier’s team has a strong expertise in international clinical development and in investigator training in neurology and psychiatry, current phase II/III projects focus on autism, major depressive disorder, post-stroke functional recovery and multiple sclerosis. This press release contains certain forward - looking statements and estimates concerning GeNeuro’s financial condition, operating results, strategy, projects and future performance and the markets in which it operates. Such forward-looking statements and estimates may be identified by words, such as “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions. They incorporate all topics that are not historical facts. Forward looking statements, forecasts and estimates are based on management’s current assumptions and assessment of risks, uncertainties and other factors, known and unknown, which were deemed to be reasonable at the time they were made but which may turn out to be incorrect. Events and outcomes are difficult to predict and depend on factors beyond the company’s control. Consequently, the actual results, financial condition, performances and/or achievements of GeNeuro or of the industry may turn out to differ materially from the future results, performances or achievements expressed or implied by these statements, forecasts and estimates. Owing to these uncertainties, no representation is made as to the correctness or fairness of these forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates speak only as of the date on which they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law.

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