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Recursion Announces Phase 2 Data of REC-994, a First-in-Disease Investigational Treatment for Symptomatic Cerebral Cavernous Malformation (CCM), has Met its Primary Endpoint of Safety and Tolerability

SALT LAKE CITY, Sept. 03, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, today announced top–line results of the SYCAMORE trial, a 12–month Phase 2 randomized double–blind, placebo–controlled, safety, tolerability and exploratory efficacy study for REC–994 in symptomatic CCM patients.

REC–994 met its primary endpoint of safety and tolerability, demonstrating a similar profile across placebo and both 200mg and 400mg dosage–arms with regard to the frequency and severity of adverse events after 12 months of treatment. Magnetic resonance imaging–based secondary efficacy endpoints showed a trend towards reduced lesion volume and hemosiderin ring size in patients at the highest dose (400mg) as compared to placebo. Time–dependent improvement in these trends at the 400mg dose was also observed in this signal–finding study. Improvements in either patient or physician–reported outcomes were not yet seen at the 12 month time point. A meeting with the FDA is anticipated as soon as practical to discuss plans for an additional clinical study. Recursion plans to present data from this trial at a forthcoming medical conference and intends to submit these data for publication in a peer reviewed scientific journal.

“These studies are making significant strides in the development of therapeutics for CCM. The data from this readout is an impressive start and will provide a valuable contribution to the existing CCM literature and strongly supports the need for a future study, with a longer duration and a larger patient cohort,” said Dr. Jan–Karl Burkhardt, MD, Division Head, Cerebrovascular Surgery, University of Pennsylvania and Principal Investigator of the study. Connie Lee, Psy.D., founder and CEO of the Alliance to Cure Cavernous Malformation added: “I speak for the patients who have participated in the trial and those who have been cheering from the sidelines while waiting for news. This promising start is a critical step forward and will bring hope to thousands of families who currently have no options but brain or spinal cord surgery. The Alliance to Cure Cavernous Malformation looks forward to partnering with Recursion as they move to the next stage of the REC–994 program.”

“We are encouraged by the recent data from our signal–finding Phase 2 study in CCM, where the trial successfully met its primary safety endpoint and became the first investigational therapy to demonstrate safety alongside some promising trends in exploratory efficacy endpoints. These results provide critical insights that will inform our next study design, including exploring study duration, higher doses, and a larger cohort of patients,” said Najat Khan, Ph.D., Chief R&D Officer and Chief Commercial Officer of Recursion. “This is the first of several key clinical readouts for the company and represents an early proof–of–platform milestone for our constantly evolving Recursion OS, as we build upon our success in drug discovery with expertise and execution in mid–phase development. We are deeply grateful to the patients and investigators, and we are committed to advancing potential transformational therapies for CCM and beyond.”

Background on Cerebral Cavernous Malformation (CCM)

CCM is a neurovascular condition that impacts approximately 360,000 symptomatic individuals in the US and EU5. The disease is often underdiagnosed and potentially affects over 1 million patients worldwide. CCM manifests as vascular malformations of the spinal cord and brain characterized by abnormally enlarged capillary cavities without intervening brain parenchyma. Patients with CCM lesions are at substantial risk for seizures, headaches, progressive neurological deficits, and potentially fatal hemorrhagic stroke. Currently, only non–pharmacologic treatments including microsurgical resection and stereotactic radiosurgery are available options for this high unmet need patient population. However, surgical resection or stereotactic radiosurgery is not always feasible because of location and may not be curative.

About REC–994

REC–994 is an orally bioavailable, superoxide scavenger small molecule under development for the treatment of symptomatic CCM. The potential of REC–994 in CCM was demonstrated using the earliest version of what would become the foundational technology underlying the Recursion OS. Subsequently, REC–994 demonstrated preclinical activity in models for CCM and tolerability and suitability for chronic dosing in Phase 1 single ascending dose escalation (SAD) and multiple ascending dose escalation (MAD) trials in healthy volunteers directed and executed by Recursion. Recursion has sought and received Orphan Drug Designation for REC–994 in symptomatic CCM in the US and Europe.

About the Trial

Our Phase 2 SYCAMORE clinical trial is a randomized, double–blind, placebo–controlled study of two doses of REC–994 in participants with CCM. The primary endpoint of the study is safety and tolerability. Secondary efficacy endpoints include MRI–based endpoints, clinician and patient reported outcomes, as well as selected biomarkers. This trial was fully enrolled in June 2023 with 62 participants, and 80% of participants who completed 12 months of treatment have entered the long–term extension study. This signal–finding study was not powered to demonstrate statistical significance.

About Recursion

Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, London, and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

Forward–Looking Statements

This document contains information that includes or is based upon “forward–looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding Recursion’s anticipated meeting with the FDA; Recursion’s plans to present SYCAMORE trial data at a medical conference and submit the data for publication; the clinical relevance of the SYCAMORE trial data and obtaining additional confirmatory data; promising trends in REC–994 efficacy endpoints; advancing potential transformational therapies for CCM and beyond; subsequent REC–994 studies and their results and advancing Recursion’s REC–994 program further; the size of the potential CCM patient population; Recursion OS and other technologies potential and advancement of the future of medicine; business and financial plans and performance; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10–K, our subsequent Quarterly Reports on Form 10–Q, and our Current Reports on Form 8–K. All forward–looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.


GLOBENEWSWIRE (Distribution ID 9223929)

Brains Bioceutical s’apprête à obtenir l’une des premières certifications CEP pour le cannabidiol au monde auprès de la Direction européenne de la qualité du médicament et soins de santé

SANDWICH, Royaume–Uni, 23 août 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (BBC) a franchi une étape décisive en soumettant l’une des premières demandes de CEP (Certification de conformité) au monde pour sa substance pharmaceutique active (API) à base de cannabidiol (CBD) à la Direction européenne de la qualité du médicament et soins de santé (EDQM). Cette démarche historique démontre que le CBD de BBC répond aux normes les plus strictes de l’industrie en matière de cannabinoïdes de qualité pharmaceutique.

La CEP confirme que le CBD de BBC répond aux normes de la Pharmacopée européenne (Ph. Eur.), une reconnaissance cruciale pour les fabricants de produits pharmaceutiques en Europe, au Canada, en Australie, au Japon et aux États–Unis. Cette certification facilite les processus réglementaires et garantit une qualité, une uniformité et une sécurité élevées sur les marchés mondiaux.

Parmi les autres avantages de la CEP, citons :

  • Faciliter et simplifier les interactions entre les régulateurs et l’industrie, en veillant à ce que les substances utilisées dans la production pharmaceutique répondent aux normes de la Pharmacopée européenne et soient conformes à la législation européenne pertinente.
  • Faciliter la gestion des médicaments expérimentaux pour les produits médicinaux.
  • Compléter et rapprocher les monographies de la Pharmacopée européenne et les exigences des dossiers réglementaires pour les médicaments.
  • Faire le lien entre les autorités sanitaires et l’industrie, en améliorant la communication et la coopération.

Ricky Brar, PDG et président de Brains Bioceutical Corp. a souligné l’importance de cette certification dans la stratégie à long terme de l’entreprise. « L’obtention d’une CEP pour notre substance pharmaceutique active à base de cannabidiol est une étape cruciale dans notre stratégie pour devenir le leader du marché mondial des cannabinoïdes. Elle renforce notre engagement en faveur de la qualité et de l’innovation et permet à Brains Bio d’établir une nouvelle norme pour l’industrie. Il ne s’agit pas seulement de répondre aux exigences réglementaires, mais de les dépasser et d’établir une nouvelle référence en matière de produits cannabinoïdes de qualité pharmaceutique. »

Dean Billington, directeur de l’exploitation de Brains Bioceutical Corp. a ajouté : « Notre demande auprès de l’EDQM témoigne du travail acharné et du dévouement de notre équipe. La CEP nous offrira un avantage concurrentiel significatif, en garantissant que notre IPA de cannabidiol sera reconnu comme un ingrédient de premier ordre pour l’usage pharmaceutique. Nous sommes fiers d’être des pionniers dans ce secteur qui évolue rapidement et de rechercher l’excellence dans tous les aspects de nos activités. »

La demande mondiale de produits pharmaceutiques à base de cannabinoïdes reste soutenue, comme en témoigne Epidiolex, dont Jazz Pharmaceuticals prévoit qu’il générera un chiffre d’affaires d’environ 1,4 milliard de dollars en 2024 [1]. Cela reflète une croissance et une demande continues pour des produits pharmaceutiques à base de cannabinoïdes de haute qualité.

La procédure d’examen de l’EDQM, qui a débuté le 8 août 2024, durera environ 115 jours ouvrables. L’obtention d’une CEP confirmera que le CBD de Brains Bio répond aux exigences rigoureuses de la Ph. Eur.

Cette demande de CEP souligne la détermination sans faille de Brains Bio à établir de nouvelles normes pour l’industrie des cannabinoïdes. Elle vient s’ajouter aux licences de BPF et de substances contrôlées de l’UE dont dispose Brains Bio. En alignant son IPA CBD sur les critères rigoureux de la Pharmacopée européenne, Brains Bio participe non seulement au marché, mais façonne aussi activement son avenir.

Dans le cadre de notre partenariat stratégique, Brains Bioceutical et DSM–Firmenich ont uni leurs forces pour mettre à profit leur expertise combinée dans la recherche et le développement des cannabinoïdes. En collaboration avec Brains Bioceutical, fabricant de cannabinoïdes de qualité pharmaceutique, DSM–Firmenich offre une plateforme d’innovation de bout en bout conçue pour accompagner les premières étapes du développement de médicaments à base de cannabinoïdes et optimiser le potentiel des formulations à base de CBD. Cette plateforme offre une expertise de pointe en matière de formulation, un réseau mondial de spécialistes de la réglementation et des compétences en matière d’études précliniques et cliniques. L’entreprise est également en mesure de fournir des solutions personnalisées en fonction du domaine thérapeutique et de l’objectif de délivrance du médicament. Pour en savoir plus sur la façon dont la plateforme d’innovation des cannabinoïdes de DSM–Firmenich contribue à améliorer la santé des patients, visitez le site : www.dsm.com/cannabinoid–actives.

À propos de Brains Bioceutical Corp.

Brains Bioceutical est le leader des solutions de santé et de bien–être à base de plantes naturelles, fondées sur l’expérience clinique et la recherche scientifique.

Brains Bio est un fabricant de premier plan de substances pharmaceutiques actives (IPA) naturelles et pures de la plus haute qualité. Grâce à un ensemble unique de licences et de certifications, Brains Bio est stratégiquement positionné pour tirer parti de l’environnement réglementaire complexe, en garantissant son avantage en tant que pionnier et en termes de qualité des produits. Brains Bio a des activités diversifiées dans les secteurs pharmaceutiques, médicaux et nutraceutiques au sein du marché des cannabinoïdes, qui connaît une croissance rapide, ce qui lui confère une proposition de valeur forte et unique.

[1] https://investor.jazzpharma.com/investors

Une photo accompagnant cette annonce est disponible à l’adresse : https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


GLOBENEWSWIRE (Distribution ID 9219428)

Brains Bioceutical steht kurz vor Erhalt einer der weltweit ersten CEP-Zertifizierungen für Cannabidiol vom Europäischen Direktorat für die Qualität von Arzneimitteln und Gesundheitsfürsorge

SANDWICH, Vereinigtes Königreich, Aug. 23, 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (BBC) hat einen bahnbrechenden Meilenstein erreicht, indem es einen der weltweit ersten CEP–Anträge (Eignungszertifikat) für seinen pharmazeutischen Wirkstoff Cannabidiol (CBD) beim Europäischen Direktorat für die Qualität von Arzneimitteln und Gesundheitsfürsorge (EDQM) eingereicht hat. Diese bahnbrechende Leistung zeigt, dass das CBD von BBC den höchsten Branchenstandard für Cannabinoidprodukte in pharmazeutischer Qualität erfüllt.

Die CEP–Zertifizierung bestätigt, dass das CBD von BBC den Standards des Europäischen Arzneibuchs (Ph. Eur.) entspricht, eine wichtige Bestätigung für Pharmahersteller in Europa, Kanada, Australien, Japan und den USA. Diese Zertifizierung vereinfacht die regulatorischen Prozesse und gewährleistet eine hohe Qualität, Konsistenz und Sicherheit für globale Märkte.

Zu den weiteren Vorteilen des CEP gehören:

  • Erleichterung und Vereinfachung der Interaktion zwischen Regulierungsbehörden und der Industrie, um sicherzustellen, dass die in der pharmazeutischen Produktion verwendeten Substanzen den Standards des Europäischen Arzneibuchs und den einschlägigen EU–Rechtsvorschriften entsprechen.
  • Erleichterung der Verwaltung von Prüfpräparaten für Arzneimittel.
  • Ergänzung und Brücke zwischen den Monografien des Europäischen Arzneibuchs und den Anforderungen an das Zulassungsdossier für Arzneimittel.
  • Bindeglied zwischen Gesundheitsbehörden und Industrie und Verbesserung der Kommunikation und Zusammenarbeit.

Ricky Brar, CEO und Vorstandsvorsitzender von Brains Bioceutical Corp., betonte die Bedeutung dieser Zertifizierung für die langfristige Strategie des Unternehmens. „Die Erlangung einer CEP–Zertifizierung für unseren aktiven pharmazeutischen Cannabidiol–Wirkstoff ist ein entscheidender Schritt auf unserem Weg, den globalen Cannabinoid–Markt anzuführen. Dies bestärkt uns in unserem Engagement für Qualität und Innovation und positioniert Brains Bio als Maßstab für die Branche. Hier geht es nicht nur darum, die gesetzlichen Anforderungen zu erfüllen – es geht darum, sie zu übertreffen und einen neuen Maßstab dafür zu setzen, wie Cannabinoidprodukte in pharmazeutischer Qualität aussehen sollten.“

Dean Billington, Chief Operating Officer von Brains Bioceutical Corp., fügte hinzu: „Unsere Einreichung beim EDQM ist ein Zeugnis für die harte Arbeit und das Engagement unseres Teams. Die CEP–Zertifizierung wird einen erheblichen Wettbewerbsvorteil bieten und sicherstellen, dass unser Cannabidiol–Wirkstoff als erstklassiger Inhaltsstoff für pharmazeutische Zwecke anerkannt wird. Wir sind stolz darauf, in dieser sich schnell entwickelnden Branche an vorderster Front zu stehen und in allen Aspekten unserer Geschäftstätigkeit Spitzenleistungen zu erbringen.“

Die weltweite Nachfrage nach Arzneimitteln auf Cannabinoidbasis ist nach wie vor hoch, wie das Beispiel Epidiolex zeigt, mit dem Jazz Pharmaceuticals im Jahr 2024 voraussichtlich einen Umsatz von etwa 1,4 Mrd. USD erzielen wird [1]. Dies spiegelt das anhaltende Wachstum und die Nachfrage nach hochwertigen pharmazeutischen Cannabinoidprodukten wider.

Der am 8. August 2024 eingeleitete Überprüfungsprozess des EDQM wird etwa 115 Arbeitstage dauern. Die erfolgreiche Erteilung einer CEP–Zertifizierung bestätigt, dass das CBD von Brains Bio die strengen Anforderungen des Ph. Eur. erfüllt.

Diese Bemühungen um die Zulassung von Cannabidiol unterstreichen das unerschütterliche Engagement von Brains Bio, neue Standards für die Cannabinoid–Branche zu setzen. Dies baut auf den EU–GMP– und den Lizenzen für kontrollierte Substanzen von Brains Bio auf. Durch die Anpassung seines CBD–Wirkstoffs an die strengen Kriterien des Europäischen Arzneibuchs nimmt Brains Bio nicht nur am Markt teil, sondern gestaltet dessen Zukunft aktiv mit.

Im Rahmen unserer strategischen Partnerschaft haben sich Brains Bioceutical und DSM–Firmenich zusammengeschlossen, um ihr gemeinsames Know–how in der Cannabinoid–Forschung und –Entwicklung zu nutzen. Zusammen mit Brains Bioceutical – einem Hersteller hochwertiger Cannabinoide in pharmazeutischer Qualität – bietet DSM–Firmenich eine umfassende Innovationsplattform an, die darauf ausgelegt ist, die Entwicklung von Cannabinoid–Arzneimitteln in der Anfangsphase zu unterstützen und das Potenzial von CBD–basierten Formulierungen auszuschöpfen. Zu den Kompetenzen des Unternehmens gehören modernste Formulierungskenntnisse, ein globales Netzwerk von Zulassungsspezialisten sowie die Durchführung präklinischer und klinischer Studien. Das Unternehmen ist auch in der Lage, maßgeschneiderte Lösungen je nach Therapiebereich und Ziel der Arzneimittelabgabe anzubieten. Weitere Informationen darüber, wie die Cannabinoid–Innovationsplattform von DSM–Firmenich zur Verbesserung der Gesundheit von Patienten beiträgt, finden Sie unter: www.dsm.com/cannabinoid–actives.

Über die Brains Bioceutical Corp.

Brains Bioceutical ist der führende Pionier im Bereich der Entwicklung von evidenzbasierten und wissenschaftlich fundierten natürlichen, pflanzlichen Gesundheits– und Wellnesslösungen.

Brains Bio ist ein führender Hersteller von natürlichen und reinen pharmazeutischen Wirkstoffen (APIs) höchster Qualität. Mit einem einzigartigen Paket an Lizenzen und Registrierungen ist Brains Bio strategisch positioniert, um das komplexe regulatorische Umfeld zu nutzen und sich seinen Vorsprung als Vorreiter und in der Produktqualität zu sichern. Brains Bio ist diversifiziert über die pharmazeutischen, medizinischen, und nutrazeutischen Sektoren innerhalb des schnell wachsenden Cannabinoidmarktes, was zu einem starken und einzigartigen Wertversprechen führt.

[1] https://investor.jazzpharma.com/investors

Ein Foto zu dieser Mitteilung ist verfügbar unter https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


GLOBENEWSWIRE (Distribution ID 9219428)

Brains Bioceutical Deve Obter o Primeiro Certificado CEP do Mundo para Canabinóides, do European Directorate de Qualidade de Medicamentos e Cuidados de Saúde

SANDWICH, Reino Unido, Aug. 22, 2024 (GLOBE NEWSWIRE) — A Brains Bioceutical Corp. (BBC) alcançou um marco inovador ao fazer um dos primeiros pedidos de CEP (Certificação de Adequação) do mundo para seu Ingrediente Farmacêutico Ativo (API) de Canabidiol (CBD) ao European Directorate para Qualidade de Medicamentos e Cuidados de Saúde (EDQM). Esta conquista histórica demonstra que o CBD da BBC atende ao mais alto padrão da indústria para produtos canabinóides de grau farmacêutico.

O CEP confirma que o CBD da BBC está em conformidade com a Farmacopeia Europeia (Ph. Eur.), um endosso crucial para fabricantes farmacêuticos da Europa, Canadá, Austrália, Japão e EUA. Esta certificação agiliza os processos regulatórios, garantindo alta qualidade, consistência e segurança para os mercados globais.

Outras vantagens do CEP incluem:

  • Facilitar e simplificar as interações entre os reguladores e a indústria, garantindo que as substâncias utilizadas na produção farmacêutica estejam em conformidade com as normas da Farmacopeia Europeia e a legislação pertinente da UE.
  • Facilitar o gerenciamento de medicamentos experimentais para produtos medicinais.
  • Servir de complemento e ponte entre as monografias da Farmacopeia Europeia e os requisitos do dossiê regulamentar para medicamentos.
  • Atuar como elo entre as autoridades de saúde e a indústria, potencializando a comunicação e a cooperação.

Ricky Brar, CEO e Presidente da Brains Bioceutical Corp., enfatizou a importância dessa certificação na estratégia de longo prazo da empresa. “A obtenção de um CEP para o nosso Ingrediente Farmacêutico Ativo de Canabidiol é um passo fundamental na nossa jornada para liderar o mercado global de canabinóides. Isto reforça o nosso compromisso para com a qualidade e a inovação, e posiciona a Brains Bio para definir o padrão para a indústria. Não se trata apenas de atender aos requisitos regulamentares – e sim de exceder e de estabelecer uma nova referência para os produtos canabinóides de grau farmacêutico.”

Dean Billington, Diretor de Operações da Brains Bioceutical Corp., acrescentou: “Nosso pedido junto ao EDQM é um testemunho do trabalho árduo e da dedicação da nossa equipe. O CEP nos dará uma vantagem competitiva significativa, garantindo que nosso API de Canabidiol seja reconhecido como um ingrediente de primeira linha para uso farmacêutico. Temos orgulho de estar na vanguarda desta indústria em rápida evolução e de impulsionar a excelência em todos os aspectos das nossas operações.”

A demanda global por produtos farmacêuticos com base em canabinóides permanece robusta, evidenciada pelo Epidiolex, que a Jazz Pharmaceuticals projeta gerar aproximadamente US $ 1,4 bilhão em receita em 2024 [1]. Isso demonstra o crescimento e a demanda contínuos de produtos farmacêuticos de canabinóides de alta qualidade.

O processo de análise da EDQM, iniciado em 8 de agosto de 2024, levará aproximadamente 115 dias úteis. O recebimento de um CEP confirmará que o CBD da Brains Bio atende às rigorosas exigências da Ph. Eur.

Esta solicitação de um CEP ressalta o compromisso inabalável da Brains Bio em estabelecer novos padrões para a indústria de canabinóides que se baseia nas BPF da UE e nas licenças de substâncias controladas da Brains Bio. Ao alinhar seu API CBD com os rigorosos critérios da Farmacopeia Europeia, a Brains Bio, além de participar do mercado molda ativamente seu futuro.

Como parte da nossa parceria estratégica, a Brains Bioceutical e a DSM–Firmenich uniram forças para alavancar sua experiência conjunta em pesquisa e desenvolvimento de canabinóides. Juntamente com a Brains Bioceutical – fabricante de canabinóides de alta qualidade de grau farmacêutico – a DSM–Firmenich oferece uma plataforma de inovação completa projetada para apoiar o desenvolvimento de medicamentos canabinóides em estágio inicial e realizar o potencial das formulações à base de CBD. Suas capacidades incluem experiência em formulação de ponta, uma rede global de especialistas em regulamentação e proficiência em estudos pré–clínicos e clínicos. A empresa também tem a capacidade de fornecer soluções personalizadas dependendo da área terapêutica e do objetivo de entrega do medicamento. Para mais informações sobre como a plataforma de inovação de canabinóides da DSM–Firmenich está ajudando a melhorar a saúde do paciente, visite: www.dsm.com/cannabinoid–actives.

Sobre a Brains Bioceutical Corp.

A Brains Bioceutical é líder em soluções de saúde e bem–estar com base em evidências e lideradas pela ciência.

A Brains Bio é fabricante líder de insumos farmacêuticos ativos (APIs) naturais e puros da mais alta qualidade. Com um conjunto exclusivo de licenças e registros, a Brains Bio está estrategicamente posicionada para aproveitar o complexo ambiente regulatório, garantindo sua vantagem de qualidade em primeiro lugar e produto. A Brains Bio é ativa nos setores farmacêutico, médico e nutracêutico dentro do mercado de canabinóides em rápido crescimento, sendo uma proposta de valor potente e única.

[1] https://investor.jazzpharma.com/investors

Foto deste comunicado disponível em https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


GLOBENEWSWIRE (Distribution ID 9219428)

Brains Bioceutical Set to Achieve One of the World’s First CEP for Cannabidiol Certification with the European Directorate for the Quality of Medicines & Healthcare

SANDWICH, United Kingdom, Aug. 22, 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (BBC) has achieved a groundbreaking milestone by submitting one of the world’s first CEP (Certification of Suitability) application for its Cannabidiol (CBD) Active Pharmaceutical Ingredient (API) to the European Directorate for the Quality of Medicines & Healthcare (EDQM). This landmark achievement demonstrates BBC’s CBD as meeting the highest industry standard for pharmaceutical–grade cannabinoid products.

The CEP confirms that BBC’s CBD meets European Pharmacopoeia (Ph. Eur.) standards, a crucial endorsement for pharmaceutical manufacturers in Europe, Canada, Australia, Japan, and the US. This certification streamlines regulatory processes, ensuring high quality, consistency, and safety for global markets.

Additional advantages of the CEP include:

  • Facilitating and simplifying interactions between regulators and industry, ensuring that substances used in pharmaceutical production meet European Pharmacopoeia standards and comply with relevant EU legislation.
  • Easing the management of investigational medicinal product for medicinal products.
  • Serving as a complement and bridge between European Pharmacopoeia monographs and the regulatory dossier requirements for medicinal products.
  • Acting as a link between health authorities and industry, enhancing communication and cooperation.

Ricky Brar, CEO and Chairman of Brains Bioceutical Corp., emphasized the importance of this certification in the company’s long–term strategy. “Achieving a CEP for our Cannabidiol Active Pharmaceutical Ingredient is a pivotal step in our journey to lead the global cannabinoid market. It reinforces our commitment to quality and innovation, and it positions Brains Bio to set the standard for the industry. This is not just about meeting regulatory requirements—it's about exceeding them and setting a new benchmark for what pharmaceutical–grade cannabinoid products should be.”

Dean Billington, Chief Operating Officer of Brains Bioceutical Corp., added, “Our submission to the EDQM is a testament to the hard work and dedication of our team. The CEP will provide a significant competitive advantage, ensuring that our Cannabidiol API is recognized as a top–tier ingredient for pharmaceutical use. We are proud to be at the forefront of this rapidly evolving industry, driving excellence in every aspect of our operations.”

The global demand for cannabinoid–based pharmaceuticals remains robust, evidenced by Epidiolex, which Jazz Pharmaceuticals projects will generate approximately $1.4 billion in revenue in 2024 [1]. This reflects ongoing growth and demand for high–quality pharmaceutical cannabinoid products.

The EDQM’s review process, initiated on August 8, 2024, will take approximately 115 working days. Successful granting of a CEP will confirm that Brains Bio’s CBD meets, the stringent Ph. Eur. requirements.

This CEP application effort underscores Brains Bio’s unwavering commitment to setting new standards for the cannabinoid industry. This builds on Brains Bio’s EU GMP and controlled substances licenses. By aligning its CBD API with the rigorous criteria of the European Pharmacopoeia, Brains Bio is not only participating in the market but actively shaping its future.

As part of our strategic partnership, Brains Bioceutical and DSM–Firmenich have joined forces to leverage their combined expertise in cannabinoid research and development. Together with Brains Bioceutical – manufacturer of high–quality pharma–grade cannabinoids – DSM–Firmenich offers an end–to–end innovation platform designed to support early–stage cannabinoid drug development and realize the potential of CBD– based formulations. Its capabilities include leading–edge formulation expertise, a global network of regulatory specialists, and preclinical and clinical study proficiency. The company also has the capacity to provide customized solutions depending on the therapeutic area and drug delivery objective. To learn more about how DSM–Firmenich’s cannabinoid innovation platform is helping to elevate patient health, visit: www.dsm.com/cannabinoid–actives.

About Brains Bioceutical Corp.

Brains Bioceutical is the leader in evidence–based and science–led pioneer of natural plant–based health and wellness solutions.

Brains Bio is a leading manufacturer of the highest quality natural and pure active pharmaceutical ingredients (APIs), with a unique suite of licenses and registrations, Brains Bio is strategically positioned to take advantage of the complex regulatory environment, securing its first mover and product quality advantage. Brains Bio is diversified across the pharmaceutical, medical, and nutraceutical sectors within the rapidly growing cannabinoid market, resulting in a strong and unique value proposition.

[1] https://investor.jazzpharma.com/investors

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


GLOBENEWSWIRE (Distribution ID 9218790)

Entera Bio to Participate in Upcoming Investor and Scientific Conferences

JERUSALEM, Aug. 20, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today announced that management will be participating in the following investor and scientific conferences:

H.C. Wainwright 26th Annual Global Investment Conference (Presentation and 1×1)

Date and Time: September 9, 2024 at 7am ET
Location: Virtual, September 9–11, 2024

American Society for Bone and Mineral Research 2024 Annual Meeting (Poster and 1×1)

Date and Time: Saturday, September 28, 2024, 2:15 – 3:45PM 
Location: In person, September 26–29, 2024 Toronto, Canada

7th Annual Evercore ISI HealthCONx Conference (Fireside Chat and 1×1)

Date and Time: December 4, 2024 at 3:25–3:45PM in Track 2 – Sevilla A
Location: In person, December 3–5, 2024 Coral Gables, Florida

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9217620)

Infectious Disease Expert Kelly Warfield Named Sabin’s New R&D President

caption: Sabin Vaccine Institute Research & Development President Kelly Warfield

WASHINGTON, Aug. 20, 2024 (GLOBE NEWSWIRE) — Virologist and vaccine development leader Kelly Warfield has joined the Sabin Vaccine Institute as its Research & Development President to drive Sabin’s current candidate vaccines toward licensure and expand its pipeline.

A member of Sabin’s executive team, Warfield will manage the R&D program and team, collaborating with peers, cross–functional heads, and the Board of Trustees to shape Sabin’s strategic vision. She will report to CEO Amy Finan, who has led the R&D team since 2017 and revitalized it by launching new programs, securing new funding, and enhancing its capabilities.

“With our success comes the need for a new leader with the scientific, regulatory, and business experience to propel our R&D work forward and enable me to focus on growing Sabin,” says Finan. “This is the right time to make that move, and we have the right person for the role in Kelly Warfield.”

A seasoned executive and scientist, Warfield brings a wealth of experience in guiding life science teams to build new competencies and advance vaccine programs across various sectors, including government, start–ups, and mid–sized biotech/pharma companies. In her most recent role as senior vice president for science & development at Emergent BioSolutions, she managed a multinational team of over 300 scientists with an annual budget exceeding $100 million, and coordinated partnerships with BARDA, NIAID, the U.S. Department of Defense, and CEPI.

“Kelly brings the strategic and scientific leadership needed to advance Sabin’s two vaccine candidates to licensure and expand our vaccine portfolio. Just as importantly, she has the passion and expertise to tackle the technical and operational challenges of developing vaccines for diseases that disproportionately impact people in under–resourced settings,” says Finan.

Warfield says she’s honored to be Sabin’s first R&D president and deeply inspired by the organization’s ethos. “Throughout my career, I have focused on addressing unmet medical needs via public–private partnerships,” she says. “My greatest fulfillment comes from developing vaccines to combat those emerging disease threats. So, this role at Sabin aligns perfectly with my long–held interest in using science to help those most in need.”

A critical priority for Warfield will be to work with partners to bring Sabin’s candidate vaccines against Marburg and Sudan ebolavirus diseases to licensure. “These vaccines, if licensed, could be game–changers, especially for communities in outbreak–prone regions of Africa,” says Warfield.

Beyond her expertise in vaccine development, Kelly has a deep understanding of novel regulatory pathways, including the Animal Rule and Accelerated Approval processes. She has successfully navigated U.S. FDA and European Medicines Agency regulations for product approvals.

Prior to joining Emergent in 2014, Warfield co–founded Integrated Biotherapeutics, Inc. and led its vaccine development, specializing in the development of antivirals and vaccines for Ebola and Marburg viruses. She has also led preclinical development for a wide array of antivirals, including influenza and dengue.

Warfield began her research career as a student intern at the National Cancer Institute. As a National Research Council postdoctoral fellow at the United States Army Medical Research Institute of Infectious Diseases, she developed vaccines and therapeutics for highly lethal filoviruses and received training to work in advanced biosafety (BSL–3 and BSL–4) containment laboratories.

Warfield has authored over 100 publications and book chapters and holds more than 15 patents.

In addition to her professional achievements, Warfield has served on the boards of non–profits and start–ups, and currently advises an organization that provides STEM opportunities to underserved communities.

About the Sabin Vaccine Institute

The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non–profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X, @SabinVaccine.

Media Contact:
Monika Guttman
Media Relations Specialist
Sabin Vaccine Institute
+1 (202) 662–1841
press@sabin.org

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/440f3fa4–a78f–4d8a–85c4–e84724a6c69b


GLOBENEWSWIRE (Distribution ID 9217160)

Entera Bio Reports Q2 2024 Financial Results and Provides Business Updates

JERUSALEM , Aug. 09, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended June 30, 2024.

“We continue to deliver strong execution with key milestones achieved during the second quarter of 2024 across each of our N–Tab™ oral peptide programs dedicated to patients with OBGYN/endocrinology, GI and metabolic diseases,” said Miranda Toledano, Entera’s CEO. “Importantly, we are now just five months away from FDA’s potential landmark ruling on the ASBMR–FNIH SABRE regulatory endpoint for osteoporosis drugs, which we view as a major catalyst for EB613. We are especially keen to start our pivotal study of EB613 in a much wider population where injectable anabolic drugs do not play a dominant role. Because of its potential dual mechanism of action, faster onset of action as an anabolic boosting agent and oral minitablet format, we believe EB613 is uniquely positioned to support earlier osteoanabolic intervention in post–menopausal women at high risk of fracture,” she added.

EB613: First Oral PTH(1–34) Daily Osteoanabolic Tablets for Osteoporosis

  • In April 2024, the Journal of Bone and Mineral Research (JBMR) published “Oral daily PTH(1–34) Tablets [EB613] in Postmenopausal Women with Low BMD or Osteoporosis: A Randomized, Placebo–Controlled, 6–Month, Phase 2 Study”
  • In May 2024, Entera welcomed Dr. Rachel Wagman as Key Clinical Advisor to lead EB613 clinical development. Wagman has successfully advanced the development of five molecules, including the osteoporosis products Forteo®, Prolia® and Evenity® through registration
  • In June 2024, the JMBR published an independent editorial titled “A Novel Oral hPTH(1–34) [EB613] Unveils the Promise of Modeling–Based Anabolism with No Increase in Bone Remodeling”
  • In July 2024, Entera announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® was selected for presentation at the ASBMR September 2024 Annual Meeting in Toronto
  • In July 2024, Entera announced that the SABRE (Study to Advance BMD as a Regulatory Endpoint) is expected to provide an update at the ASBMR September 2024 Annual Meeting in Toronto

EB612: First Oral PTH(1–34) Peptide Replacement Therapy Tablets for Hypoparathyroidism

  • In June 2024, Entera presented Phase 1 clinical data for its hypoparathyroidism focused investigational program, EB612, at the Endocrine Society ENDO 2024 Annual Meeting. Entera showed that the data supports potentially moving the BID (twice–daily) tablet dose to Phase 2 development in patients with hypoparathyroidism
  • Entera continues to collaborate with a third party on the development of another PTH replacement treatment for hypoparathyroidism

First GLP–2 Peptide Tablets for Short Bowel Syndrome

  • In March 2024, Entera announced positive in vivo PK results from its program combining OPKO Health, Inc.’s (Nasdaq: OPK) long acting GLP–2 analogue with N–Tab™ technology. Pharmacology data is expected early in the second half of 2024

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity

  • Collaborative work is ongoing combining N–Tab™ with OPKO’s long–acting Oxyntomodulin (OXM) analogues for potential treatment for obesity and other metabolic diseases. PK data for the oral OXM tablet are expected early in the second half of 2024

Financial Results for the Quarter Ended June 30, 2024

As of June 30,2024, Entera had cash and cash equivalents of $9.1 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2025.

Research and development expenses for the three months ended June 30, 2024 were $1.1 million, as compared to $1.2 million for the three months ended June 30, 2023. The decrease of $0.1 million was primarily due to a decrease of $0.3 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612, which completed its first stage in 2023.

General and administrative expenses for both the three months ended June 30, 2024 and 2023 were $1.1 million.

Operating expenses for the period ended June 30, 2024 were $2.2 million, as compared to $2.3 million for the quarter ended June 30, 2023.

Net loss was $2.1 million, or $0.06 per ordinary share (basic and diluted), for the quarter ended June 30, 2024, as compared to $2.3 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended June 30, 2023.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
 
  June 30,   December 31,
  2024   2023
  (Unaudited)   (Audited)
   
Cash and cash equivalents 9,056   11,019
Accounts receivable and other current assets 539   238
Property and equipment, net 76   100
Other assets, net 364   408
Total assets 10,035   11,765
       
       
Accounts payable and other current liabilities 1,294   1,091
Total non–current liabilities 219   288
Total liabilities 1,503   1,379
Total shareholders' equity 8,532   10,386
       
Total liabilities and shareholders' equity 10,035   11,765
 

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
 
  Three Months Ended
June 30,
  2024   2023  
REVENUES 57   –  
COST OF REVENUES 48   –  
GROSS PROFIT 9   –  
OPERATING EXPENSES:    
Research and development 1,086   1,209  
General and administrative 1,088   1,135  
Other income –   (14)  
TOTAL OPERATING EXPENSES 2,174   2,330  
OPERATING LOSS 2,165   2,330  
FINANCIAL INCOME, NET (20)   (5)  
NET LOSS 2,145   2,325  
     
LOSS PER SHARE BASIC AND DILUTED 0.06   0.08  
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING         
USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 37,090,160   28,812,375  
     


GLOBENEWSWIRE (Distribution ID 9202470)

Recursion and Exscientia Enter Definitive Agreement to Create a Global Technology-Enabled Drug Discovery Leader with End-to-End Capabilities

  • Brings together Recursion’s scaled biology exploration and translational capabilities with Exscientia’s precision chemistry design and small molecule automated synthesis capabilities to create a leading technology–first, end–to–end drug discovery platform
  • Combined business positioned to leverage latest advances in the life sciences and technology to deliver better novel treatments to patients, faster and at a lower cost relative to traditional drug discovery and development methods
  • Highly complementary pipeline with approximately 10 clinical readouts expected over the next 18 months
  • Industry–leading portfolio of pharma partnerships with the potential for approximately $200 million in milestone payments over the next 24 months, and over $20 billion overall before potential royalties over the course of the partnership
  • Well–capitalized balance sheet with approximately $850 million in cash and cash equivalents between the two companies as of the end of Q2 2024
  • Operational complementarities expected to yield annual synergies in excess of $100 million

SALT LAKE CITY and OXFORD, United Kingdom, Aug. 08, 2024 (GLOBE NEWSWIRE) — Recursion (Nasdaq: RXRX) and Exscientia plc (Nasdaq: EXAI) today announced the companies have entered into a definitive agreement, combining Recursion, a leading clinical stage technology–enabled biotech company decoding biology to industrialize drug discovery, with Exscientia, a technology–driven clinical stage drug design and development company, committed to creating more effective medicines for patients, faster.

“We believe the proposed combination is deeply complementary and aligned with our missions to industrialize drug discovery to deliver high quality medicines and lower prices for consumers,” said Chris Gibson, Ph.D., Co–Founder and CEO of Recursion as well as the planned CEO of the combined entity. “Exscientia’s precision chemistry tools and capabilities, including its newly commissioned automated small molecule synthesis platform, will augment our tech–enabled biology and chemistry exploration, hit discovery and translational capabilities. I am excited to continue building the best example of the next generation of biotechnology companies. It still feels like we are just getting started.”

“Adding Exscientia’s best–in–class focused precision oncology internal pipeline to Recursion’s first–in–class focused pipeline spanning rare disease, precision oncology and infectious disease is highly complementary as we look to bring treatments to patients faster,” said David Hallett, Ph.D., Interim Chief Executive Officer and planned Chief Scientific Officer of Recursion post–closing of the transaction. “We look forward to bringing our teams together and integrating Recursion's high throughput and target biology capabilities with Exscientia's highly scalable molecular design and automated chemistry synthesis capabilities to truly accelerate the discovery of better drugs for patients.”

Once integrated, the companies believe the extended and evolved Recursion OS will enable the discovery and translation of higher quality medicines more efficiently and at a higher scale with a full–stack technology–enabled small molecule discovery platform. In addition, the combined company expects to read out approximately 10 clinical trials in the next 18 months.

The proposed business combination will also advance significant therapeutic discovery collaborations with some of the most prominent biopharma companies in the world, including Roche–Genentech, Sanofi, Bayer, and Merck KGaA. Moreover, there is the potential for approximately $200 million in milestone payments over the next 2 years from these current partnerships and there is the potential for more than $20 billion in revenue before royalties on net–sales of partnership programs which range from mid single–digit to double–digit royalties over the course of the partnership.

Strategic Rationale

  • Pipeline: The combination would create a diverse portfolio of clinical and near–clinical programs (approximately 10 clinical readouts expected in the next 18 months) where most of these programs, if successful, could have annual peak sales opportunities in excess of $1 billion. In addition to Recursion’s internal pipeline, Exscientia has wholly–owned oncology programs associated with targets CDK7 (clinical), LSD1, and MALT1 as well as partnered programs associated with targets PKC–Theta (clinical) and ENPP1. Across the combined pipeline there is no competitive overlap, with Recursion’s pipeline focusing on first–in–class drug candidates within oncology, rare disease, and infectious disease and Exscientia’s focus on best–in–class drug candidates within oncology. Additionally, for both companies there are many research and discovery stage pipeline programs that would benefit from the complementary combination of the two platforms.
  • Partnerships: The proposed business combination would bring together transformational partnerships with leading large pharma companies with a total of 10 programs already optioned across oncology and immunology. In addition to Recursion’s transformational partnerships with Roche–Genentech (neuroscience and a gastrointestinal oncology indication) and Bayer (undruggable oncology), Exscientia has partnerships with Sanofi (immunology and oncology) and Merck KGaA (oncology and immunology). In addition, Exscientia has a partnership with BMS (oncology and immunology) where an optioned program related to PKC–Theta has already shown positive early Phase 1 results. Furthermore, the combined company expects potential additional milestone payments of approximately $200 million over the next 2 years from its current partnerships.
  • Platform: The combination will help enable a full–stack technology–enabled platform spanning patient–centric target discovery, structure based drug design including hotspot analysis, quantum mechanics and molecular dynamics modeling, 2D and 3D generative AI design, encode and automate design–make–test–learn cycles with active learning, automated chemical synthesis, predictive ADMET and translation, biomarker selection, clinical development, and more. Furthermore, Exscientia’s automated chemistry design and synthesis capabilities are expected to allow Recursion to more rapidly and effectively run SAR cycles during hit to lead and lead optimization. These capabilities are expected to generate diverse chemistry to experimentally improve our predictive maps of biology and chemistry.

Transaction Details
Under the terms of the transaction agreement, which were unanimously approved by the boards of directors of both companies, Exscientia shareholders will receive 0.7729 shares of Recursion Class A common stock for each Exscientia ordinary share they own, with fractional shares paid in cash. Based on the fixed exchange ratio, Recursion shareholders will own approximately 74% and Exscientia shareholders will own approximately 26% of the combined company, in each case assuming no additional issuance by either company before closing. Major shareholders of each company, including holders of more than 40% of Exscientia shares, have entered into agreements on customary terms and conditions under which they have agreed to vote all their shares in favor of the transaction. There is approximately $850 million in cash and cash equivalents held by both companies at the end of Q2 2024. The combined company is estimated to achieve annual synergies of approximately $100 million with a runway extending into 2027.

The combination is expected to be implemented through a court sanctioned scheme of arrangement under English law and is subject to the satisfaction of customary closing conditions, including the approval of Exscientia shareholders, the approval of Recursion’s stockholders, and the sanction of the High Court of Justice of England and Wales, and the receipt of required regulatory approvals. Subject to the satisfaction or waiver of the closing conditions, the transaction is expected to close by early 2025.

Listing, Governance and Management
The combined company, which will be named Recursion, will continue to be headquartered in Salt Lake City, Utah, and trade on the NASDAQ, while maintaining a significant presence in the U.K. Chris Gibson, Ph.D., Co–Founder & CEO of Recursion, will serve as CEO of the combined company and David Hallett, Ph.D., Interim Chief Executive Officer & Chief Scientific Officer of Exscientia, plans to join the combined company as Chief Scientific Officer. Two existing Exscientia directors will join the Board of Recursion following the closing of the transaction.

Advisors
Allen & Company LLC acted as exclusive financial advisor to Recursion and Wilson Sonsini Goodrich & Rosati acted as legal counsel. Centerview Partners LLC acted as exclusive financial advisor to Exscientia and A&O Shearman acted as legal counsel.

About Recursion
Recursion is a leading clinical stage TechBio company decoding biology to industrialize drug discovery. Central to its mission is the Recursion Operating System (OS), a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological, chemical and patient–centric datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale—up to millions of wet lab experiments weekly—and massive computational scale—owning and operating one of the most powerful supercomputers in the world—Recursion is uniting technology, biology, chemistry and patient–centric data to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montreal, the San Francisco Bay Area and London.

About Exscientia
Exscientia is a technology–driven drug design and development company, committed to creating more effective medicines for patients, faster. Exscientia combines precision design with integrated experimentation, aiming to invent and develop the best possible drugs in the most efficient manner. Operating at the interfaces of human ingenuity, artificial intelligence (AI), automation and physical engineering, we pioneered the use of AI in drug discovery as the first company to progress AI–designed small molecules into a clinical setting. We have developed an internal pipeline focused on oncology, while our partnered pipeline extends to many other therapeutic areas. By leading this new approach to drug creation, we believe we can change the underlying economics of drug discovery and rapidly advance the best scientific ideas into medicines for patients.

Recursion Investor Relations
investor@recursion.com

Recursion Media
media@recursion.com

Exscientia Investor Relations
investors@exscientia.ai

Exscientia Media
media@exscientia.ai

Forward Looking Statements
Statements contained herein which are not historical facts may be considered forward–looking statements under federal securities laws and may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “potential,” “predicts,” “projects,” “seeks,” “should,” “will,” or words of similar meaning and include, but are not limited to, statements regarding the proposed business combination of Recursion and Exscientia and the outlook for Recursion’s or Exscientia’s future business and financial performance such as delivering better treatments to patients, faster and at a lower cost; the discovery and translation of higher quality medicines more efficiently and at a higher scale; helping to enable a full–stack technology–enabled platform; allowing Recursion to more rapidly and effectively run SAR cycles during hit to lead optimization; generating the diverse chemistry to experimentally improve predictive maps; the number and timing of clinical program readouts over the next 18 months; the combined company’s first–in–class and best–in–class opportunities; potential for sales from successful programs with annual peak sales opportunities of over $1 billion each; potential for approximately $200 million in milestone payments over the next 24 months, and over $20 billion in revenue before royalties over the course of the partnerships; percentage of the combined company to be received by Exscientia shareholders; cash runway extending into 2027; the value of estimated annual synergies; implementing the combination through a UK scheme of arrangement; the expected closing of the transaction by early 2025; continuing to build the best example of the next generation of biotechnology companies; the plans for David Hallett, Ph.D. to join the combined company as Chief Scientific Officer; and many others. Such forward–looking statements are based on the current beliefs of Recursion’s and Exscientia’s respective management as well as assumptions made by and information currently available to them, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may vary materially from these forward–looking statements based on a variety of risks and uncertainties including: the occurrence of any event, change or other circumstances that could give rise to the termination of the transaction agreement; the inability to obtain Recursion’s  stockholder approval or Exscientia’s shareholder approval or the failure to satisfy other conditions to completion of the proposed combination, including obtaining the sanction of the High Court of Justice of England and Wales to the Scheme of Arrangement, on a timely basis or at all, and the receipt of required regulatory approvals; risks that the proposed combination disrupts each company’s current plans and operations; the diversion of the attention of the respective management teams of Recursion and Exscientia from their respective ongoing business operations; the ability of either Recursion, Exscientia  or the combined company to retain key personnel; the ability to realize the benefits of the proposed combination, including cost synergies; the ability to successfully integrate Exscientia's business with Recursion’s business, at all or in a timely manner; the outcome of any legal proceedings that may be instituted against Recursion, Exscientia or others following announcement of the proposed combination; the amount of the costs, fees, expenses and charges related to the proposed combination; the effect of economic, market or business conditions, including competition, regulatory approvals and commercializing drug candidates, or changes in such conditions, have on Recursion’s, Exscientia’s and the combined company’s operations, revenue, cash flow, operating expenses, employee hiring and retention, relationships with business partners, the development or launch  of technology enabled drug discovery, and commercializing drug candidates; the risks of conducting Recursion’s and Exscientia’s business internationally; the impact of changes in interest rates by the Federal Reserve and other central banks; the impact of potential inflation, volatility in foreign currency exchange rates and supply chain disruptions; the ability to maintain technology–enabled drug discovery in the biopharma industry; and risks relating to the market value of Recursion’s common stock to be issued in the proposed combination.

Other important factors and information are contained in Recursion’s most recent Annual Report on Form 10–K and Exscientia’s most recent Annual Report on Form 20–F, including the risks summarized in the section entitled “Risk Factors,” Recursion’s most recent Quarterly Reports on Form 10–Q and Exscientia’s filing on Form 6–K filed May 21, 2024, and each company’s other periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), which can be accessed at https://ir.recursion.com in the case of Recursion, http://investors.exscientia.ai in the case of Exscientia, or www.sec.gov. All forward–looking statements are qualified by these cautionary statements and apply only as of the date they are made. Neither Recursion nor Exscientia undertakes any obligation to update any forward–looking statement, whether as a result of new information, future events or otherwise.

Additional Information and Where to Find It
This communication relates to a proposed business combination of Recursion and Exscientia that will become the subject of a joint proxy statement to be filed by Recursion with the SEC. The joint proxy statement will provide full details of the proposed combination and the attendant benefits and risks, including the terms and conditions of the scheme of arrangement and the other information required to be provided to Exscientia's shareholders under the applicable provisions of the U.K. Companies Act 2006. This communication is not a substitute for the joint proxy statement or any other document that Recursion or Exscientia may file with the SEC or send to their respective stockholders in connection with the proposed combination. Investors and security holders are urged to read the definitive joint proxy statement and all other relevant documents filed with the SEC or sent to Recursion’s stockholders or Exscientia’s shareholders as they become available because they will contain important information about the proposed combination. All documents, when filed, will be available free of charge at the SEC’s website (www.sec.gov). You may also obtain these documents by contacting Recursion’s Investor Relations department at investor@recursion.com; or by contacting Exscientia’s Investor Relations department at investors@exscientia.ai. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval.

Participants in the Solicitation
Recursion, Exscientia and their respective directors and executive officers may be deemed to be participants in any solicitation of proxies in connection with the proposed business combination. Information about Recursion’s directors and executive officers is available in Recursion’s proxy statement dated April 23, 2024 for its 2024 Annual Meeting of Stockholders. Information about Exscientia’s directors and executive officers is available in Exscientia’s proxy statement dated March 21, 2024 for its 2024 Annual Meeting of Stockholders. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the joint proxy statement and all other relevant materials to be filed with the SEC regarding the proposed combination when they become available. Investors should read the joint proxy statement carefully when it becomes available before making any voting or investment decisions.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/83e2ee85–7b58–4008–b558–a17965edff48


GLOBENEWSWIRE (Distribution ID 9201657)

Entera’s EB613, the First Once Daily PTH(1-34) Tablet Treatment Dedicated to Post-Menopausal Women with High Risk Osteoporosis Abstract Selected for Presentation at the ASBMR 2024 Annual Meeting – Key SABRE Update Also Expected

JERUSALEM, Aug. 01, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of orally delivered peptides and therapeutic proteins, today announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® was selected for presentation at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting which will be held on September 27–30, 2024 in Toronto, ON, Canada.

EB613 is being developed as the first once–daily oral anabolic (bone forming) PTH(1–34) mini tablet therapy for post–menopausal women with high risk osteoporosis. It is estimated that 50 percent of women and 20 percent of men over the age of 50 are at risk of a fragility fractures and approximately 1 in 5 adults will die within the year following a hip fracture. Post menopausal osteoporosis afflicts more women than cancer and cardiovascular disease and is a serious health concern for an estimated 200 million women globally.

“Available injectable anabolic treatments, while efficacious and recommended across medical guidelines, unfortunately do not provide a viable solution for most women with high–risk osteoporosis requiring an anabolic intervention. Our EB613 program is dedicated to address the treatment chasm in current osteoporosis care and hopefully present a treatment for the majority of women to adequately manage their post–menopause bone health with a simple once daily tablet treatment. Importantly, we look forward to the SABRE (Study to Advance BMD as a Regulatory Endpoint) UPDATE at the ASBMR 2024 meeting. On March 26th 2024, Entera echoed the ASBMR announcement that the U.S. Food and Drug Administration (FDA) had communicated to SABRE that a ruling to qualify bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs would be provided within 10 months. The proposed registrational Phase 3 study for EB613, is designed to meet the quantitative BMD thresholds proposed by SABRE,” said Miranda Toledano, Chief Executive Officer at Entera.

Abstract Title:  3079 – EB613 (Oral PTH(1–34) Tablets) Shows Differentiated Pharmacokinetic Profile From Forteo – New Results from Phase 1b Open–Label Study
Presentation Number:  Sat–LB 589
Session Date/Time: Saturday, September 28, 2024, 2:15 – 3:45 PM 

SABRE Project Update

Speakers: Dennis M. Black , PhD, University of California, United States; Theresa E. Kehoe , MD, CDER/FDA, United States

Session Date / Time: Sunday September 29, 2024 9:45 – 10:45 AM

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9197414)