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Nilo Therapeutics startet mit einer Serie-A-Finanzierung in Höhe von 101 Mio. USD zur Entwicklung einer neuen Medikamentenklasse, die auf neuronale Schaltkreise bei Immunerkrankungen abzielt, und ernennt Kim Seth zum Chief Executive Officer

NEW YORK, Oct. 09, 2025 (GLOBE NEWSWIRE) — Nilo Therapeutics, ein Biotechnologieunternehmen, das neuronale Schaltkreise nutzt, um die Immunhomöostase bei Krankheiten wiederherzustellen, startete heute mit einer Serie–A–Finanzierung in Höhe von 101 Mio. USD unter der Leitung von The Column Group (TCG), DCVC Bio und Lux Capital, unter Beteiligung der Gates Foundation und Alexandria Venture Investments. Zeitgleich mit der Markteinführung hat Nilo die Ernennung von Dr. Kim Seth zum Chief Executive Officer und Vorstandsmitglied bekanntgegeben.

Nilo wurde von den weltweit führenden Wissenschaftlern Dr. Charles Zuker (Columbia University), Dr. Ruslan Medzhitov (Yale University) und Dr. Steve Liberles (Harvard University) gegründet und entstand in Zusammenarbeit mit TCG, um bahnbrechende wissenschaftliche Erkenntnisse in der Neuroimmunologie in neue therapeutische Strategien umzusetzen. Dr. Seth wird gemeinsam mit Chief Scientific Officer Dr. Laurens Kruidenier die Umwandlung des Unternehmens von einem Stealth–Unternehmen in die nächste Wachstumsphase leiten. Die Finanzierung dient der Einrichtung von Nilos Labors in New York City, dem Ausbau seines interdisziplinären Forschungs– und Entwicklungsteams und der Weiterentwicklung der präklinischen Programme des Unternehmens.

Nilo entwickelt Medikamente, die neuronale Schaltkreise nutzen, um die Immunhomöostase zentral wiederherzustellen. Damit bietet das Unternehmen einen differenzierten Ansatz zur Immunmodulation, der über die herkömmliche Immunsuppression hinausgeht. Das Unternehmen baut auf bahnbrechenden wissenschaftlichen Entdeckungen aus dem Labor von Dr. Charles Zuker (Hauptforscher an der Columbia University und Forscher am Howard Hughes Medical Institute) auf, der bestimmte vagale Neuronen identifiziert hat, die die systemische Immunaktivierung und Entzündung regulieren. Durch die gezielte Beeinflussung dieser zentralen „Master–Regulator“–Kreisläufe zwischen Gehirn und Körper nutzt Nilo seinen neuartigen therapeutischen Ansatz, um mehrere Immunwege gleichzeitig zu modulieren, wodurch das Risiko einer Therapieresistenz verringert und die potenzielle Wirkung auf ein breites Spektrum von Autoimmun– und Entzündungskrankheiten mit großem ungedecktem Bedarf erweitert wird.

Dr. Seth verfügt über mehr als 25 Jahre Erfahrung in der Biopharmaindustrie und war in verschiedenen Führungspositionen bei mehreren Start–ups und börsennotierten Biotech–Unternehmen sowie großen Pharmaunternehmen tätig. Er hat zudem umfassende Fachkenntnisse in den Bereichen Unternehmensaufbau, Strategie und F&E–Aktivitäten, Geschäftsentwicklung, Finanzen und Kapitalmärkte. Vor seiner Tätigkeit bei Nilo war Dr. Seth als Chief Business Officer bei Repare Therapeutics tätig, einem Unternehmen im Bereich der Präzisionsonkologie. Dort war er Mitglied der Geschäftsleitung und maßgeblich daran beteiligt, das Unternehmen von der Pre–Series–A–Finanzierungsrunde über die Series–B–Finanzierungsrunde bis hin zum Börsengang zu skalieren. Er war für den Aufbau des US–Geschäfts des Unternehmens verantwortlich und leitete die Geschäftsentwicklung, um über eine Reihe globaler Plattform–, Vermögens– und klinischer Partnerschaften Finanzierungen in Höhe von über 250 Mio. USD zu generieren, was einem potenziellen Gesamtwert von über 4 Mrd. USD entspricht. Vor seiner Tätigkeit bei Repare hatte Dr. Seth Führungspositionen in den Bereichen Geschäftsentwicklung, Strategie und Betrieb bei einer Reihe von Biopharmaunternehmen, darunter Pfizer, inne und war Research Analyst für Large–Cap–Pharmaunternehmen/Spezialpharmaunternehmen bei Goldman Sachs. Er erwarb seinen BA cum laude in Wirtschaftswissenschaften am Harvard College und seinen Ph.D. in Neurobiologie in der Abteilung für Medizinische Wissenschaften an der Harvard University.

Dr. Seth schließt sich Dr. Laurens Kruidenier, Chief Scientific Officer, einem erfahrenen Experten für Immunologie und Arzneimittelforschung, an. Dr. Kruidenier war zuvor als CSO bei Cellarity und Prometheus Biosciences (von Merck übernommen) tätig, wo er mehrere innovative Therapien für Autoimmun– und Entzündungskrankheiten vom Konzept bis zur klinischen Anwendung vorantrieb. Zu Beginn seiner Karriere bei Takeda Pharmaceuticals und GSK leitete er Teams für präklinische Forschung und Entdeckungsforschung sowie die Strategie für Geschäftsentwicklung. Er promovierte in Immunologie an der Universität Leiden und seine Forschungsergebnisse wurden in führenden wissenschaftlichen Fachzeitschriften, darunter Nature, veröffentlicht.

„Nilo befindet sich in einer Phase des Wandels“, so Dr. Laurens Kruidenier, Chief Scientific Officer von Nilo Therapeutics. „Die Führungsqualitäten und Erfahrung von Dr. Seth werden unsere Mission beschleunigen, bahnbrechende Erkenntnisse aus der Neuroimmunologie in Medikamente umzusetzen, von denen Patienten mit einer Vielzahl von immunbedingten Erkrankungen profitieren könnten.“

„Wir freuen uns sehr, Dr. Seth als CEO begrüßen zu dürfen“, so Dr. Tim Kutzkey, Managing Partner bei The Column Group. „Mit seiner Erfolgsbilanz bei der Begleitung von Unternehmen von ihren Anfängen bis zum Börsengang und der erfolgreichen Umsetzung von Programmen bringt Dr. Seth sowohl Weitblick als auch Visionen mit. Seine Leidenschaft, bahnbrechende wissenschaftliche Erkenntnisse in innovative Medikamente umzusetzen, macht ihn zum idealen Partner, um Laurens' wissenschaftliche Führungsrolle zu ergänzen und Nilo in die nächste Wachstumsphase zu führen.“

„Es ist mir eine Ehre, Teil des unglaublich talentierten und engagierten Teams von Nilo zu werden“, so Kim Seth, Chief Executive Officer von Nilo Therapeutics. „Gemeinsam mit Laurens, unseren wissenschaftlichen Gründern von Weltklasse, und unseren Investoren bauen wir ein Unternehmen auf, das eine neue Generation von Therapien entwickeln wird, die die Gehirn–Immun–Achse nutzen, um die Behandlung von Autoimmun– und Entzündungserkrankungen zu revolutionieren.“

Über Nilo Therapeutics

Nilo Therapeutics ist ein Biotechnologieunternehmen, das eine neue Klasse von Medikamenten entwickelt, die neuronale Schaltkreise nutzen, um die Immunhomöostase bei Krankheiten wiederherzustellen. Durch die gezielte Beeinflussung der Master–Regulator–Schaltkreise zwischen Gehirn und Körper, die systemische Entzündungen zentral steuern, leistet Nilo Pionierarbeit bei einem differenzierten Ansatz zur Immunmodulation, der das Potenzial hat, ein breites Spektrum von Autoimmun– und Entzündungskrankheiten mit großem ungedecktem Bedarf zu behandeln. Das Unternehmen hat seinen Hauptsitz in New York, NY. www.nilotx.com

Weitere Informationen erhalten Sie unter [email protected].


GLOBENEWSWIRE (Distribution ID 9542701)

Lancement de Nilo Therapeutics avec un financement de série A de 101 millions de dollars en vue de développer une nouvelle classe de médicaments ciblant les circuits neuronaux dans les maladies immunitaires, et nomination de Kim Seth au poste de directeur général

 NEW YORK, 09 oct. 2025 (GLOBE NEWSWIRE) — Nilo Therapeutics, une société de biotechnologie qui mise sur les circuits neuronaux pour rétablir l’homéostasie immunitaire chez les patients malades, a été lancée aujourd’hui avec un financement de série A de 101 millions de dollars mené par The Column Group (TCG), DCVC Bio et Lux Capital, avec la participation de la Fondation Gates et d’Alexandria Venture Investments. Parallèlement à son lancement, Nilo a annoncé la nomination de Kim Seth, Ph.D., au poste de directeur général et membre du conseil d’administration.

Fondée par des scientifiques de renommée mondiale, Charles Zuker, Ph.D. (Université Columbia), Ruslan Medzhitov, Ph.D. (Université Yale) et Steve Liberles, Ph.D. (Université Harvard), Nilo a été créée en collaboration avec TCG afin de traduire des découvertes scientifiques révolutionnaires en neuro–immunologie en nouvelles stratégies thérapeutiques. Le Dr Seth rejoint le directeur scientifique Laurens Kruidenier, Ph.D., pour mener la transition de l’entreprise vers sa prochaine phase de croissance. Le financement permet la création des laboratoires de Nilo à New York, la croissance de son équipe de recherche et développement interdisciplinaire et l’avancement des programmes précliniques de l’entreprise.

Nilo développe des médicaments exploitant les circuits neuronaux dans le but de rétablir l’homéostasie immunitaire au niveau central, offrant ainsi une approche différenciée de l’immunomodulation allant bien au–delà de l’immunosuppression conventionnelle. La société s’appuie sur les découvertes scientifiques fondamentales du laboratoire de Charles Zuker, Ph.D. (responsable de recherche à l’université Columbia et chercheur à l’Institut médical Howard Hughes), qui a identifié des neurones spécifiques du nerf vague régulant l’activation immunitaire systémique et l’inflammation. En ciblant ces circuits cerveau–corps « régulateurs principaux », Nilo utilise son approche thérapeutique novatrice pour moduler plusieurs voies immunitaires de manière concertée, réduisant ainsi le risque de résistance thérapeutique et élargissant l’impact potentiel sur un large éventail de maladies auto–immunes et inflammatoires. Cette approche répond à un besoin important non satisfait.

Le Dr Seth apporte plus de 25 ans d’expérience dans l’industrie biopharmaceutique, ayant occupé des postes opérationnels dans plusieurs sociétés biotechnologiques en phase de démarrage et cotées en bourse, ainsi que dans de grandes sociétés pharmaceutiques. Il possède une vaste expertise dans la création d’entreprises, la stratégie et les opérations de R&D, le développement commercial, la finance et les marchés de capitaux. Avant de rejoindre Nilo, le Dr Seth a occupé le poste de directeur commercial chez Repare Therapeutics, une société spécialisée dans l’oncologie de précision, où, en tant que membre de l’équipe de direction, il a joué un rôle déterminant dans le développement de la société, depuis le financement de série A jusqu’au financement de série B et à l’introduction en bourse. Il était chargé de mettre en place les activités commerciales de l’entreprise aux États–Unis dont il a dirigé le développement commercial afin de générer plus de 250 millions de dollars de financement grâce à une série de partenariats mondiaux en matière de plateformes, d’actifs et de cliniques, représentant une valeur potentielle totale de plus de 4 milliards de dollars. Avant de rejoindre Repare, le Dr Seth a occupé des postes de direction dans les domaines du développement commercial, de la stratégie et des opérations au sein de plusieurs entreprises biopharmaceutiques, dont Pfizer, et a été analyste de recherche dans le domaine des produits pharmaceutiques à grande capitalisation et des produits pharmaceutiques spécialisés chez Goldman Sachs. Il a obtenu une licence en économie avec mention très bien au Harvard College et un doctorat en neurobiologie à la Division des sciences médicales de l’université de Harvard.

Le Dr Seth rejoint Laurens Kruidenier, Ph.D., directeur scientifique, un leader accompli dans le domaine de l’immunologie et de la découverte de médicaments. Le Dr Kruidenier a précédemment occupé le poste de directeur scientifique chez Cellarity et Prometheus Biosciences (racheté par Merck), où il a fait progresser plusieurs thérapies innovantes, du concept à la clinique, dans le domaine des maladies auto–immunes et inflammatoires. Au début de sa carrière chez Takeda Pharmaceuticals et GSK, il a dirigé des équipes de recherche préclinique et de découverte, ainsi que la stratégie de développement commercial. Il a obtenu son doctorat en immunologie à l’université de Leyde et ses recherches ont été publiées dans des revues scientifiques de premier plan, notamment Nature.

« Nilo se trouve à un moment charnière », a déclaré Laurens Kruidenier, Ph.D., directeur scientifique de Nilo Therapeutics. « Le leadership et l’expérience de Kim permettront d’accélérer notre mission consistant à traduire les avancées révolutionnaires en neuro–immunologie en médicaments pouvant bénéficier aux patients atteints d’un large éventail de maladies immunitaires. »

« Nous sommes ravis d’accueillir Kim au poste de PDG », a déclaré le Dr Tim Kutzkey, associé directeur chez The Column Group. « Fort d’une expérience éprouvée dans l’accompagnement d’entreprises depuis leurs débuts jusqu’à leur introduction en bourse et dans la mise en œuvre réussie de programmes, Kim apporte à la fois une grande expérience et une vision. Sa passion pour la transformation de la science audacieuse en médicaments révolutionnaires fait de lui le partenaire idéal pour compléter le leadership scientifique de Laurens et mener Nilo vers sa prochaine phase de croissance. »

« C’est un honneur de rejoindre l’équipe incroyablement talentueuse et engagée de Nilo », a déclaré Kim Seth, PDG de Nilo Therapeutics. « Avec Laurens, nos fondateurs scientifiques de renommée mondiale et nos investisseurs, nous bâtissons une entreprise bien placée pour fournir une nouvelle génération de traitement exploitant l’axe cerveau–immunité afin de transformer le traitement des maladies auto–immunes et inflammatoires. »

À propos de Nilo Therapeutics

Nilo Therapeutics est une société de biotechnologie qui développe une nouvelle classe de médicaments exploitant les circuits neuronaux dans le but de rétablir l’homéostasie immunitaire chez les patients malades. En ciblant les principaux circuits cerveau–corps responsables de la régulation centrale de l’inflammation systémique, Nilo est à l’avant–garde d’une approche différenciée de l’immunomodulation qui pourrait permettre de traiter un large éventail de maladies auto–immunes et inflammatoires. Une approche qui répond à un besoin important non satisfait. La société a son siège à New York, NY. www.nilotx.com

Pour plus d’informations, veuillez contacter [email protected].


GLOBENEWSWIRE (Distribution ID 9542701)

Nilo Therapeutics é lançada com financiamento de US $101 milhões da Série A para promover uma nova classe de medicamentos direcionados a circuitos neurais em doenças imunológicas e nomeia Kim Seth como CEO

NOVA YORK, Oct. 08, 2025 (GLOBE NEWSWIRE) — A Nilo Therapeutics, uma empresa de biotecnologia que utiliza circuitos neurais para restaurar a homeostase imunológica em doenças, foi lançada hoje com um financiamento de US $101 milhões da Série A liderado por The Column Group (TCG), DCVC Bio e Lux Capital, com participação da Gates Foundation e da Alexandria Venture Investments. No seu lançamento, a Nilo Therapeutics anunciou a nomeação de Kim Seth, Ph.D. como Diretor Executivo e Diretor do Conselho.

Fundada pelos cientistas líderes mundiais Charles Zuker, Ph.D. (Columbia University), Ruslan Medzhitov, Ph.D. (Yale University) e Steve Liberles, Ph.D. (Harvard University), a Nilo foi criada em colaboração com a TCG para transformar conhecimentos científicos inovadores em neuroimunologia em novas estratégias terapêuticas. O Dr. Seth junta–se ao Diretor Científico Laurens Kruidenier, Ph.D., na liderança da transição da empresa da invisibilidade para a sua próxima fase de crescimento. O financiamento estimula o estabelecimento dos laboratórios da Nilo em Nova York, o crescimento da sua equipe interdisciplinar de pesquisa, e o desenvolvimento e o avanço dos programas pré–clínicos da empresa.

A Nilo está desenvolvendo medicamentos que utilizam os circuitos neurais para restaurar centralmente a homeostase imunológica, oferecendo uma abordagem diferenciada à imunomodulação e indo além da imunossupressão convencional. A empresa baseia–se nas descobertas científicas seminais do laboratório de Charles Zuker, Ph.D. (Pesquisador Principal da Columbia University e Pesquisador do Howard Hughes Medical Institute), que identificou neurônios vagais específicos que regulam a ativação imune sistêmica e a inflamação. Ao direcionar esses circuitos centrais do corpo cerebral “regulador mestre”, a Nilo está empregando sua nova abordagem terapêutica para modular múltiplas vias imunológicas em conjunto, reduzindo o risco de resistência terapêutica e ampliando o impacto potencial em um amplo espectro de doenças autoimunes e inflamatórias com grandes necessidades não atendidas.

O Dr. Seth tem mais de 25 anos de experiência no setor biofarmacêutico, tendo ocupado cargos operacionais em várias empresas de biotecnologia em estágio inicial e públicas, e grandes empresas farmacêuticas. Ele tem ampla experiência no estabelecimento de empresas, estratégia e operações de P&D, desenvolvimento de negócios, finanças e mercados de capitais. Antes da Nilo, o Dr. Seth atuou como Diretor de Negócios da Repare Therapeutics, uma empresa de oncologia de precisão, onde foi membro da Equipe de Liderança Executiva e foi fundamental para a expansão da empresa desde a pré–Série A até o financiamento e IPO da Série B. Ele foi responsável por estabelecer as operações comerciais da empresa nos EUA e liderou o desenvolvimento de negócios para gerar mais de US $250 milhões em financiamento por meio de várias plataformas globais, ativos e parcerias clínicas, representando mais de US $4 bilhões em valor potencial total. Antes da Repare, o Dr. Seth ocupou cargos de liderança em BD, estratégia e operações em várias empresas biofarmacêuticas, incluindo a Pfizer, e foi analista de pesquisa de Large–cap Pharmaceuticals/Specialty Pharmaceuticals da Goldman Sachs. Ele obteve seu BA cum laude em Economia no Harvard College e seu Ph.D. em Neurobiologia na Divisão de Ciências Médicas da Harvard University.

O Dr. Seth se junta a Laurens Kruidenier, Ph.D., Diretor Científico, um renomado líder em imunologia e descoberta de medicamentos. O Dr. Kruidenier atuou anteriormente como CSO na Cellarity e na Prometheus Biosciences (adquirida pela Merck), onde avançou várias terapias inovadoras do conceito à clínica em doenças autoimunes e inflamatórias. No início da sua carreira na Takeda Pharmaceuticals e na GSK, ele liderou equipes de pesquisa pré–clínica e de descoberta, bem como a estratégia de desenvolvimento de negócios. Ele obteve seu doutorado em imunologia pela Leiden University e sua pesquisa foi publicada nas principais revistas científicas, incluindo a Nature.

“A Nilo está em um momento de transformação”, disse Laurens Kruidenier, Ph.D., Diretor Científico da Nilo Therapeutics. “A liderança e a experiência de Kim acelerarão nossa missão de transformar a neuroimunologia inovadora em medicamentos que possam beneficiar os pacientes em uma ampla gama de doenças imunológicas.”

“Estamos contentes em receber Kim como CEO”, disse o Dr. Tim Kutzkey, sócio–gerente do The Column Group. “Com um histórico de orientação de empresas desde seus estágios iniciais até o IPO e programas de avanço bem–sucedidos, Kim tem amplitude e visão. Sua paixão por transformar a ciência ousada em medicamentos inovadores faz dele o parceiro ideal para complementar a liderança científica de Laurens e levar a Nilo à sua próxima fase de crescimento.”

“É uma honra me juntar à equipe incrivelmente talentosa e dedicada da Nilo”, disse Kim Seth, Diretor Executivo da Nilo Therapeutics. “Juntamente com Laurens, nossos fundadores científicos de classe mundial e nossos investidores, estamos criando uma empresa posicionada para oferecer uma nova geração de terapias que utilizam o eixo imune cerebral para transformar o tratamento de doenças autoimunes e inflamatórias.”

Sobre a Nilo Therapeutics

A Nilo Therapeutics é uma empresa de biotecnologia que desenvolve uma nova classe de medicamentos que utiliza os circuitos neurais para restaurar a homeostase imune na doença. Ao direcionar circuitos cérebro–corpo reguladores mestres que controlam centralmente a inflamação sistêmica, a Nilo é pioneira com uma abordagem diferenciada para imunomodulação com potencial para tratar um amplo espectro de doenças autoimunes e inflamatórias com grandes necessidades não atendidas. A empresa está localizada em New York, NY. www.nilotx.com

Para mais informações, contacte: [email protected].


GLOBENEWSWIRE (Distribution ID 9542701)

Nilo Therapeutics launches with $101 million Series A financing to advance a new class of medicines targeting neural circuits in immune disease and appoints Kim Seth as Chief Executive Officer

NEW YORK, Oct. 08, 2025 (GLOBE NEWSWIRE) — Nilo Therapeutics, a biotechnology company harnessing neural circuits to restore immune homeostasis in disease, launched today with a $101 million Series A financing led by The Column Group (TCG), DCVC Bio, and Lux Capital, with participation from the Gates Foundation and Alexandria Venture Investments. Coinciding with its launch, Nilo announced the appointment of Kim Seth, Ph.D., as Chief Executive Officer and Board director.

Founded by world–leading scientists Charles Zuker, Ph.D. (Columbia University), Ruslan Medzhitov, Ph.D. (Yale University), and Steve Liberles, Ph.D. (Harvard University), Nilo was created in collaboration with TCG to translate groundbreaking scientific insights in neuro–immunology into new therapeutic strategies. Dr. Seth joins Chief Scientific Officer Laurens Kruidenier, Ph.D., in leading the company’s transition from stealth into its next stage of growth. The financing fuels the establishment of Nilo’s laboratories in New York City, growth of its interdisciplinary research and development team, and advancement of the company’s preclinical programs.

Nilo is developing drugs that harness neural circuits to restore immune homeostasis centrally, offering a differentiated approach to immunomodulation and moving beyond conventional immunosuppression. The company builds on seminal scientific discoveries from the laboratory of Charles Zuker, Ph.D. (Columbia University Principal Investigator and Howard Hughes Medical Institute Investigator), which identified specific vagal neurons that regulate systemic immune activation and inflammation. By targeting these central “master regulator” brain–body circuits, Nilo is employing its novel therapeutic approach to modulate multiple immune pathways in concert, reducing the risk of therapeutic resistance and broadening potential impact across a wide spectrum of autoimmune and inflammatory diseases with large unmet need.

Dr. Seth brings over 25 years of biopharma industry experience, with operating roles across multiple early–stage and public biotech companies and large pharma. He has broad expertise in company building, strategy and R&D operations, business development, finance and capital markets. Prior to Nilo, Dr. Seth served as Chief Business Officer at Repare Therapeutics, a precision oncology company, where he was a member of the Executive Leadership Team and was instrumental in scaling the company from pre–Series A through its Series B financing and IPO. He was responsible for establishing the company’s US business operations and led business development to generate over $250 million in financing through a range of global platform, asset, and clinical partnerships, representing over $4 billion in total potential value. Prior to Repare, Dr. Seth held leadership positions in BD, strategy, and operations across a number of biopharma companies including Pfizer, and was a Large–cap Pharmaceuticals /Specialty Pharmaceuticals research analyst at Goldman Sachs. He earned his BA cum laude in Economics at Harvard College, and his Ph.D. in Neurobiology in the Division of Medical Sciences at Harvard University.

Dr. Seth joins Laurens Kruidenier, Ph.D., Chief Scientific Officer, an accomplished immunology and drug discovery leader. Dr. Kruidenier previously served as CSO at Cellarity and at Prometheus Biosciences (acquired by Merck), where he advanced multiple innovative therapies from concept to clinic in autoimmune and inflammatory diseases. Earlier in his career at Takeda Pharmaceuticals and GSK, he led preclinical and discovery research teams as well as business development strategy. He earned his Ph.D. in immunology from Leiden University, and his research has been published in leading scientific journals, including Nature.

“Nilo is at a transformative moment,” said Laurens Kruidenier, Ph.D., Chief Scientific Officer of Nilo Therapeutics. “Kim’s leadership and experience will accelerate our mission to translate breakthrough neuro–immunology into medicines that could benefit patients across a broad range of immune–driven diseases.”

“We are thrilled to welcome Kim as CEO,” said Dr. Tim Kutzkey, Managing Partner at The Column Group. “With a track record of guiding companies from their earliest stages through IPO, and successfully advancing programs, Kim brings both breadth and vision. His passion for translating bold science into breakthrough medicines makes him the ideal partner to complement Laurens’ scientific leadership and lead Nilo into its next phase of growth.”

“It’s an honor to join the incredibly talented and committed team at Nilo,” said Kim Seth, Chief Executive Officer of Nilo Therapeutics. “Together with Laurens, our world–class scientific founders, and our investors, we are building a company positioned to deliver a new generation of therapies that harness the brain–immune axis to transform the treatment of autoimmune and inflammatory conditions.”

About Nilo Therapeutics

Nilo Therapeutics is a biotechnology company developing a new class of medicines that harness neural circuits to restore immune homeostasis in disease. By targeting master regulator brain–body circuits that centrally control systemic inflammation, Nilo is pioneering a differentiated approach to immunomodulation with the potential to treat a wide spectrum of autoimmune and inflammatory diseases with large unmet need. The company is headquartered in New York, NY. www.nilotx.com

For more information, contact [email protected]


GLOBENEWSWIRE (Distribution ID 9542136)

Kensana Health Lands $120 million from GEM, Fuelling a Global Plant Based Medicine Revolution

NEW YORK, Sept. 19, 2025 (GLOBE NEWSWIRE) — Kensana Health Inc. (“Kensana”) today announced it has entered into a share subscription facility of up to $120 million with GEM Global Yield LLC SCS (“GEM”), a Luxembourg–based alternative investment group. Under the agreement, GEM will provide Kensana up to $120 million for a 36–month period following a public listing of Kensana’s ordinary shares (“Investment Period”).

According to the agreement’s terms, Kensana will not be obligated to draw down the full $120 million but can do so in part or in whole at its discretion. Kensana can also set a threshold price as the lowest price at which Kensana may issue shares to GEM under a given drawdown. Kensana will control both the timing and amount of all drawdowns and will issue common shares to GEM on each drawn down from the facility. GEM shall pay 90% of the average daily closing price during the pricing period, which is a 30–day period after Kensana delivers a draw–down notice to GEM. During the lifetime of the investment facility, GEM will not, directly or indirectly, effect any short sale of Kensana’s common shares. GEM is a long–only investor and will not engage in shorting, hedging, or the use of derivatives or synthetic instruments against Kensana’s common shares or the issuance of any warrants.

Ken Clement, founder of Kensana, commented: “It has been determined that 90% of the world’s drugs are synthetically copied from naturally occurring plant compounds. (Bade, et al., 2010. European Journal of Medicinal Chemistry) According to the WHO, up to 80% of the world’s population believes that traditional herbal medicines are safer and have fewer side effects than traditional synthetic pharmaceuticals. Kensana plans to transform modern medicine by integrating its proprietary Artificial Intelligence (AI)–enhanced technology to harness naturally occurring compounds for drug development. Since the COVID pandemic, global markets have had an insatiable appetite for everything natural which positions Kensana and its phytopharmaceutical platform to become a global leader in plant–based medicine. Kensana has already demonstrated this capability through the development of its first FDA drug candidate, KV23A, which has shown incredible efficacy in white label trials outlined in numerous peer–reviewed medical journals. The share subscription facility with GEM demonstrates investor confidence in Kensana’s prospects, as well as GEM’s strategic understanding and vision for emerging markets and industries. This facility will be a very effective financial instrument that will complement our other fundraising efforts ahead of our anticipated NASDAQ listing in 2026.”

About Kensana

Kensana, is a Canadian Phytopharmaceutical company that has created a proprietary Generation 4 AI–enhanced phytobioreactor platform (EMOB) which enables the company to assume leadership in a new industry: Phytopharmaceuticals. The EMOB platform allows Kensana to standardize and convert an abundance of naturally occurring plant and compounds into U.S. FDA registered pharmaceuticals with global respectability. Kensana’s first patented formula is entering an international FDA–registerable Phase 3 clinical trial. Uniquely risk–mitigated, the KV23a formula has already successfully proven safety and efficacy via therapeutic applications in a clinical setting. KV23a is Kensana’s first targeted FDA– registered product within a global chronic wound market worth $300 Billion USD. The Patented Chronic Wound Formula, KV23a, has Proven Medical Efficacy which has been demonstrated in Published peer reviewed medical journals validating KV23a and its efficacy while demonstrating no toxicity issues. Phytopharmaceuticals largely work by targeting specific receptors, interrupting disease pathways and disrupting pathogenic life cycles. The Kensana Platform, EMOB, has the ability to produce proprietary therapies as well as re–engineer synthetic drugs originally derived from natural plant compounds.

Kensana Health has a uniquely risk–mitigated business model and is currently entering a Series C Investment Round. For more information, please visit the website at www.kensana.health or contact Randy Uens at [email protected].

About GEM

GEM is a $3.4 billion, Luxembourg–based alternative investment group with offices in Paris, New York, and Nassau (Bahamas). GEM manages a diverse set of investment vehicles focused on emerging markets and has completed over 590 transactions in over 75 countries. Each investment vehicle has a different degree of operational control, risk–adjusted return, and liquidity profile. Its family of funds and investment vehicles provide GEM and its partners with exposure to Small–Mid Cap Management Buyouts, Private Investments in Public Equities and select venture investments. For more information: www.gemny.com


GLOBENEWSWIRE (Distribution ID 9532205)

Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic Syndrome

HAIFA, Israel, Sept. 18, 2025 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical–stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age–related decline, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the Company’s lead investigational compound, MNV–201 for Myelodysplastic Syndrome (MDS), a serious age–related hematopoietic disease. This designation is in addition to the existing FDA Fast Track and Rare Pediatric Disease Designations for MNV–201 in the treatment of Pearson Syndrome, an ultra–rare and life–threatening mitochondrial disorder affecting children and for which the Company is currently conducting a Phase 2 clinical trial.

“The Fast Track Designation in MDS is further validation of the urgency and potential for our science, which targets the mitochondria, a critical multi–functional organelle. FDA designations such as the FTD help us to decrease the potential time to market and provide additional benefits across the FDA process that, we expect, will prove both medically and financially valuable,” said Minovia Co–founder and CEO, Natalie Yivgi–Ohana, Ph.D.

FDA’s Fast Track Designation is designed to accelerate the development and review of therapies for serious or life–threatening conditions with unmet medical need. The designation provides Minovia with the opportunity for increased FDA interactions, potential eligibility for priority review, and the opportunity for a rolling submission of a future Biologics License Application (BLA) for MNV–201.  

The Company also recently announced entry into a definitive business combination agreement (the “Business Combination Agreement”) with Launch One Acquisition Corp. (Nasdaq: LPAA, “Launch One”), a publicly traded special purpose acquisition company. Following the expected closing of the transaction contemplated by this Business Combination Agreement (the “Business Combination”), projected for late 2025, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.

About MDS

MDS is defined by ineffective hematopoiesis resulting in blood cytopenia, and clonal instability with a risk of evolution to Acute Myeloid Leukemia (AML). Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenia and AML. The goals of therapy for patients with MDS are to improve cytopenia, reduce disease–associated symptoms and the risk of disease progression and death, thereby improving both quality of life and lifespan. The median age at diagnosis of MDS is ~70 years, but surprisingly some of the Pearson Syndrome patients develop MDS in a much higher prevalence relative to the disease population. About 15% of the MDS patients will present with Sideroblastic Anemia, the most common symptom in Pearson Syndrome. Minovia developed novel blood biomarkers to measure mitochondrial health and has been able to demonstrate for the first time that MDS is presumably an age–related mitochondrial disease. As such, Minovia is currently conducting a Phase Ib study of MNV–201 in low–risk MDS patients. Six out of the nine expected patients in the study have been dosed so far.

About MNV–201

MNV–201 is a first–in–class cell therapy that uses Minovia’s proprietary Mitochondrial Augmentation Technology (MAT) to add healthy, energy–producing mitochondria into a patient’s own stem cells — aiming to restore organ function and improve health. In early–stage clinical studies, MAT has demonstrated a strong safety profile and signs of multi–system benefit in patients with Pearson Syndrome, including improvements in growth, muscle function, hematologic stability, and improved quality of life.

About Minovia Therapeutics

Minovia Therapeutics, chaired by John Cox, is a clinical–state biotechnology company working on treatments to replace dead or defective mitochondria with new healthy mitochondria, helping people with mitochondrial diseases and fighting aging. Minovia’s main treatment, MNV–201, is already being tested for Pearson Syndrome and Myelodysplastic Syndrome. Minovia is also developing ways to help people live longer, healthier lives. Based in Haifa, Israel, where it operates a GMP facility for mitochondrial drug substance and drug product manufacturing for clinical trials related to its therapy, Minovia is planning to expand operations to the U.S. For more information, visit www.minoviatx.com.

About Launch One Acquisition Corp.

Launch One Acquisition Corp. is a company set up to merge with and take public an exciting business in healthcare or technology. Listed on Nasdaq under the ticker LPAA, Launch One is led by experienced leaders who want to support game–changing solutions. For more information, contact Jurgen van de Vyver at [email protected].

Additional Information and Where to Find It

In connection with the Business Combination and the Business Combination Agreement, among Launch One, Minovia and Mito US One Ltd., a newly formed Israeli company limited by shares (“Pubco”), and certain other parties named therein. Launch One and Minovia intend to file relevant materials with the U.S. Securities and Exchange Commission (“SEC”), including a Registration Statement on Form F–4 of Pubco (the “Registration Statement”), which will include a proxy statement/prospectus of Launch One, and will file other documents regarding the proposed Business Combination with the SEC. This communication is not intended to be, and is not, a substitute for the proxy statement/prospectus or any other document that Launch One has filed or may file with the SEC in connection with the proposed Business Combination. The Registration Statement has not been filed or declared effective by the SEC. Following such filing and upon such declaration of effectiveness, the definitive proxy statement/prospectus contained within the Registration Statement and other relevant materials for the proposed Business Combination will be mailed or made available to stockholders of Launch One as of a record date to be established for voting on the proposed Business Combination.

Before making any voting or investment decision, investors and stockholders of Launch One are urged to carefully read, when they become available, the entire Registration Statement, the proxy statement/prospectus, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, and the documents incorporated by reference therein, because they will contain important information about Launch One, Minovia, Pubco and the proposed Business Combination . Launch One’s investors and stockholders and other interested persons will also be able to obtain copies of the Registration Statement, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, other documents filed with the SEC that will be incorporated by reference therein, and all other relevant documents filed with the SEC by Launch One and/or Pubco in connection with the Business Combination, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a request to Launch One or Minovia at the addresses set forth below.

Participants In the Solicitation

Launch One, Minovia, Pubco and their respective directors, executive officers, other members of management and employees may be deemed participants in the solicitation of proxies from Launch One’s stockholders with respect to the Business Combination. Investors and security holders may obtain more detailed information regarding the names, and interests in the Business Combination, of Launch One’s directors and officers in Pubco's and Launch One’s filings with the SEC, including, when filed with the SEC, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, amendments and supplements thereto, and other documents filed with the SEC. Such information with respect to Minovia’s directors and executive officers will also be included in the proxy statement/prospectus. You may obtain free copies of these documents as described above under the heading “Additional Information and Where to Find It.”

Non–Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Launch One, Pubco, or Minovia, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

Forward–Looking Statements

This press release includes certain statements that may be considered forward–looking statements within the meaning of the federal securities laws. Forward–looking statements include, without limitation, statements about future events or Minovia’s, Launch One's, or Pubco's future financial or operating performance. For example, statements regarding the development and regulatory approval of MNV–201, the implications of Fast Track Designation, RPD and PRVs and the timing of future clinical trials or potential applications are forward–looking statements. In some cases, you can identify forward–looking statements by terminology such as “may,” “should,” “could,” “might,” “plan,” “possible,” “project,” “strive,” “budget,” “forecast,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue,” or the negatives of these terms or variations of them or similar terminology.

These forward–looking statements regarding future events and the future results of Minovia or Launch One are based on current expectations, estimates, forecasts, and projections about the industry in which Minovia or Launch One operates, as well as the beliefs and assumptions of Minovia’s and Launch One's management. These forward–looking statements are only predictions and are subject to, without limitation, (i) known and unknown risks, including the risks and uncertainties indicated from time to time in the final prospectus of Launch One relating to its initial public offering filed with the SEC, including those under “Risk Factors” therein, and other documents filed or to be filed with the SEC by Launch One or Pubco; (ii) uncertainties; (iii) assumptions; and (v) other factors beyond Minovia’s or Launch One's control that are difficult to predict because they relate to events and depend on circumstances that will occur in the future. They are neither statements of historical fact nor promises or guarantees of future performance. Therefore, Minovia’s actual results may differ materially and adversely from those expressed or implied in any forward–looking statements and Minovia and Launch One therefore caution against relying on any of these forward–looking statements.

These forward–looking statements are based upon estimates and assumptions that, while considered reasonable by Minovia and its management, as the case may be, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Minovia’s or Launch One's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the Business Combination Agreement and any subsequent definitive agreements with respect to the Business Combination; (ii) the outcome of any legal proceedings that may be instituted against Launch One, Minovia, Pubco, or others following the announcement of the Business Combination and any definitive agreements with respect thereto; (iii) the inability to complete the Business Combination due to the failure to obtain consents and approvals of the shareholders of Launch One and Minovia, to obtain financing to complete the Business Combination or to satisfy other conditions to closing, or delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals required to complete the transactions contemplated by the Business Combination Agreement; (iv) changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; (v) projections, estimates and forecasts of revenue and other financial and performance metrics, projections of market opportunity and expectations, and the estimated implied enterprise value of Minovia; (vi) Minovia’s ability to scale and grow its business, and the advantages and expected growth of Minovia; (vii) Minovia’s ability to source and retain talent, and the cash position of Minovia following closing of the Business Combination; (viii) the ability to meet stock exchange listing standards in connection with, and following, the consummation of the Business Combination; (ix) the risk that the Business Combination disrupts current plans and operations of Minovia as a result of the announcement and consummation of the Business Combination; (x) the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of Minovia to grow and manage growth profitably, maintain key relationships and retain its management and key employees; (xi) costs related to the Business Combination; (xii) changes in applicable laws, regulations, political and economic developments; (xiii) the possibility that Minovia may be adversely affected by other economic, business and/or competitive factors; (xiv) Minovia’s estimates of expenses and profitability; (xv) the failure to realize estimated shareholder redemptions, purchase price and other adjustments; and (xvi) other risks and uncertainties set forth in the filings by Launch One and Minovia with the SEC. There may be additional risks that neither Launch One nor Minovia presently know or that Launch One and Minovia currently believe are immaterial that could also cause actual results to differ from those contained in the forward–looking statements. Any forward–looking statements made by or on behalf of Launch One or Minovia speak only as of the date they are made. Neither Launch One nor Minovia undertakes any obligation to update any forward–looking statements to reflect any changes in their respective expectations with regard thereto or any changes in events, conditions or circumstances on which any such statements are based.  

Contact

Minovia Therapeutics Ltd.
Natalie Yivgi Ohana, Co–Founder and CEO
+972–74–7039954
[email protected]

Launch One Acquisition Corp.
Jurgen van de Vyver
[email protected]
+1–510–692–9600

Investor Relations
Dave Gentry, CEO
RedChip Companies
+1–407–644–4256
[email protected]

Investor Relations
Jules Abraham
Managing Director, Communications
CORE IR
1–212–655–0924
[email protected]


GLOBENEWSWIRE (Distribution ID 9531105)

Entera Bio Presents Positive Effects of EB613 on Both Trabecular and Cortical Bone in Postmenopausal Women with Osteoporosis at ASBMR 2025

EB613 Demonstrates Significant Effects on Both Trabecular and Cortical Bone Compartments After Just 6 Months of Treatment in Phase 2 Study; Cortical Improvements Comparable to Injectable Teriparatide and Abaloparatide

Company Plans to Initiate Global Registrational Phase 3 Study Following July 2025 FDA Concurrence

Entera also Presented Promising Pharmacokinetic Data for Next–Gen EB613 Single Tablet Candidate as Potential Future Franchise Extension

JERUSALEM, Sept. 08, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, today announced data selected for presentation at the American Society for Bone and Mineral Research (“ASBMR”) 2025 Annual Meeting in Seattle, Washington, for its lead program EB613 which is in late stage clinical development for post–menopausal women with 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 less than 30% of patients are adequately treated with available medications.

“The data presented at ASBMR this year marks important progress for our EB613 program,” said Miranda Toledano, Chief Executive Officer of Entera. “Available injectable anabolic treatments, while efficacious and recommended across medical guidelines, are only accessible to a minority of patients globally. Our EB613 program is being developed to address the treatment chasm in osteoporosis care with a viable anabolic treatment in tablet format for patients to adequately protect their bones.”

In the oral presentation titled “Effects of EB613 Tablets [Oral PTH(1–34)] on Trabecular and Cortical Bone Using 3D–DXA: Results from Phase 2 Study,” Rachel B. Wagman, MD presented data using 3D–DXA modelling in a post–hoc analysis of EB613 Phase 2 results to look at the treatment’s impact on trabecular and cortical bone. After 6 months of treatment, EB613 2.5 mg demonstrated significant increases in both trabecular and cortical bone parameters as compared with placebo. Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613.

“The improvements across multiple parameters, including integral volumetric BMD, cortical thickness, and cortical surface BMD, suggest that there is an early strengthening effect with EB613 and a deterioration with placebo,” said Dr. Wagman. “We look forward to studying the safety and efficacy of EB613 in Phase 3.”

  • Increases in integral volumetric BMD of the TH and FN by 1.7% (p<0.08) and 2.6% (p<0.03), respectively
  • Increases in FN trabecular volumetric BMD by 4.4% vs. placebo (p<0.03) and increases in TH trabecular volumetric BMD by 2.8% (p=0.05 vs. baseline, NS compared with placebo)
  • Increases in cortical thickness at the TH and FN by 1.3% (p=0.04) and 1.7% (p=0.056), respectively Improvements in cortical surface BMD at the TH and FN by 1.5% and 2.1%, respectively (both p<0.05)

In a poster presentation titled “Advancing Oral Anabolic Treatments for Osteoporosis: Pre–Clinical Data for Next–Gen EB613 Tablet Utilizing N–Tab™ Proprietary Technology,” Entera presented preclinical data for its Next–Gen EB613 candidate. In a cross–over pharmacokinetic study in minipigs, a single 1.5 mg Next–Gen EB613 tablet demonstrated comparable PK to the current formulation of EB613, with identical AUClast and Tmax values (1.2 min*ng/ml and 20 min, respectively), and comparable Cmax. A Phase 1 clinical trial of Next–Gen EB613 is planned to begin in late 2025.

About EB613

Substantial evidence supports the efficacy of anabolic treatments over anti–resorptive drugs for lowering fracture risk in osteoporosis patients. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. EB613 (oral PTH (1–34)), is being developed as the first oral, once–daily anabolic tablet treatment for osteoporosis. EB613 completed a phase 2, 6–month, 161–patient, placebo–controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose–proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and 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 of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34), teriparatide), 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). 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 metabolic syndromes; and first oral GLP–2 peptide 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, and Facebook.

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 ability to establish and maintain development and commercialization collaborations; Entera's operation as a development stage company with limited operating history; Entera's competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; 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 Statement 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 Entera'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 9524990)

Entera Bio to Unveil Clinical and Non-Clinical Data Across 3 Oral Peptide Programs at Upcoming September Conferences

  • Osteoporosis Program: Phase 2 analysis exploring the dual actions of oral PTH(1–34) tablet treatment, EB613 on trabecular and cortical bone, and Next–Gen EB613 PK/PD data slated for oral and poster presentations at ASBMR
  • Short Bowel Syndome and Rare GI Disorders: PK/PD of oral GLP–2 tablet candidate poster presentation at ESPEN
  • Corporate Overview at H.C. Wainwright Investor Conference

JERUSALEM, Aug. 28, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, today announced that the Company will present data across three key programs during September 2025. Details on the presentations are available below:

American Society for Bone and Mineral Research (ASBMR) 2025 Annual Meeting:
Oral Presentation – Dr. Rachel B. Wagman

  • Title: Effects of EB613 Tablets [Oral PTH(1–34)] on Trabecular and Cortical Bone Using 3D–DXA: Results from Phase 2 Study (1014)
  • Time: Friday, September 5, 2025, 11:45 AM
  • Location: General Session Room, 6BC (6th Floor, Seattle Convention Center)

EB613 is being developed as the first, once–daily oral anabolic (bone forming) tablet treatment for postmenopausal women with osteoporosis. A placebo–controlled Phase 2 study in 161 post–menopausal women produced a rapid onset of action with increases in BMD at both cortical bone (femoral neck and hip region) and cancellous bone (spine). Based on a July 2025 alignment with FDA, Entera is planning a global Phase 3 registration study of EB613 in women with osteoporosis.

Poster Presentation – Next–Gen EB613

  • Title: Advancing Oral Anabolic Treatments for Osteoporosis: Pre–Clinical Data for Next–Gen EB613 Tablet Utilizing N–Tab™ Proprietary Technology (581)
  • Time: Sunday, September 7, 2025, 2:00 PM – 3:30 PM
  • Location: Discovery Hall, Hall 4B (4th Floor, Seattle Convention Center)

47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress

Poster Presentation – GLP–2 Short Bowel Syndrome:

  • Title: A First–in–Class Oral GLP–2 Analog for Treatment of Short Bowel Syndrome
  • Time: Saturday, September 13, 2025, 3:30 PM – 4:00 PM
  • Location: Forum Hall Foyer 3, Prague, Czech Republic

The oral GLP–2 tablet program combines a proprietary long acting GLP–2 agonist developed by OPKO Health with Entera's proprietary N–Tab™ technology for patients suffering from short bowel syndrome and additional disorders involving gastrointestinal mucosal inflammation and nutrient malabsorption. Currently, the only approved GLP–2 agonist requires daily subcutaneous injections.

H.C. Wainwright Conference

Entera’s Chief Executive Officer Miranda Toledano will present at the H.C. Wainwright 27th Annual Global Investment Conference. The virtual presentation will be available on Friday, September 5, 2025 at 7:00 AM ET at:

https://journey.ct.events/view/0f59c59b–da4e–4dc2–a865–4f1883eca26f

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and 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 a pipeline of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34)teriparatide), 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 with alignment from FDA on the use of BMD as its primary endpoint. 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 presentation 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 presentation 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 and OPKO’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, whether by Entera, OPKO or their respective collaboration and laboratory partners; impacts to research and development or clinical activities that Entera or OPKO 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 our product candidates; the parties’ reliance on third parties to conduct clinical trials; Entera’s and OPKO’s expectations regarding licensing, business transactions, including OPKO’s development efforts should Entera opt–out, 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 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 and OPKO’s intellectual property positions and their ability to protect their respective 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 each of Entera’s and OPKO’s most recent Annual Reports on Form 10–K filed with the SEC, as well as the companies’ respective 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 and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO, as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward–looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and neither Entera nor OPKO undertakes any 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 9519749)

Sarborg Limited Closes $10 Million Seed Round to Expand Proprietary Agentic Approach

  • Funding supports next–generation AI agent development and proprietary Intellectual Property, focused initially on pharmaceutical drug–repurposing
  • Initial clients reporting commercial success, revolutionizing indication selection of lead programs
  • Early commercial success and key partnerships signal strong market traction and scalability potential into multiple commercial verticals

WILMINGTON, Del., Aug. 27, 2025 (GLOBE NEWSWIRE) — Sarborg Limited (“Sarborg” or the “Company”), a technology–driven company that integrates mathematical algorithm–led approaches with complementary cybernetics to optimize decision–making processes, is pleased to announce the successful closing of its $10 million Seed funding round, led by third–party investor, Corvus Capital.

Sarborg has achieved significant commercial and technical milestones from its development plan, since its inception in 2024. The issuance of $10 million of Convertible Promissory Notes highlights investor confidence in Sarborg’s novel approach and rapid development delivering commercial milestones.

Looking forward, the proceeds of the fundraising will enable Sarborg to scale its AI–driven drug development and deploy agents across expanded client portfolios, while diversifying its client and equity partnership base. Sarborg will continue to deepen its intellectual property portfolio and look to broaden its agentic approach to fields beyond pharmaceuticals.

Successful Launch and Strong Commercial Validation

Sarborg has quickly capitalized on early revenue–generation, with the successful execution of an initial services agreement with a NASDAQ–listed Pharmaceutical Company, validating its core technologies and a repurposing strategy based on their lead–program drug–signature model.

Sarborg has delivered personalized dashboards to clients, a critical tool designed to provide key personnel with real–time access to data related to deliverables, research and development oversight, and drug discovery. Furthermore, Sarborg has built a proprietary portfolio of over 800 disease signatures, each uniquely mapped using its proprietary data–driven approach and now focusing on an agentic–approach to repurposing without human intervention.

Proceeds from the fundraising will be strategically deployed to:

  • Advance Sarborg’s proprietary AI agents focused on drug repurposing, target identification, and clinical trial optimization.
  • Develop novel pharmaceutical IP, transforming underused molecules into novel IP through solid–form engineering and formulation expertise.
  • Grow Sarborg’s internal pipeline of pharmaceutical assets for monetization via outlicensing or royalty–based deal structures.
  • Expand the client base and revenue–generating service business to fund ongoing innovation and reduce dilution in future rounds.

Following the demand for its seed financing, the Company expects to shortly launch a follow–on Series A financing round to enable Sarborg to scale globally and solidify its position as a category leader in AI–driven agentic innovation, combining new equity, tokenized securities and crypto–based blockchain technologies across multiple verticals.

About Sarborg Limited

Sarborg is a technology–driven company that integrates proprietary AI–agents and mathematical algorithm–based approaches with complementary cybernetics and extensive neural networks, to optimize decision–making processes. Its current principal vertical is focused on evaluating drug repurposing matching unique drug and disease signatures for pharmaceutical companies, leveraging machine learning and algorithmic strategies to enhance asset portfolio management and improve the probability of success in clinical trials. The Company is planning its expansion into further analytic areas beyond pharmaceuticals.

The company is composed of a seasoned and highly experienced team in cybernetics and signature development, drug development, medical affairs and commercialization, regulatory affairs, IP and manufacturing. Since its inception in 2024, Sarborg has applied its suite of AI agents, cybernetic algorithms, and machine learning capabilities across various sectors, enabling a highly efficient decision–making process throughout its portfolio.

Investors & Media:
[email protected]
www.sarborg.com


GLOBENEWSWIRE (Distribution ID 9519004)

Minovia Therapeutics Announces $350,000 Grant from Countdown for a Cure Foundation to Develop Mitochondria Blood-Based Biomarkers

HAIFA, Israel, Aug. 27, 2025 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical–stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age–related decline, announces that it has been chosen to receive a $350,000 grant from Countdown for a Cure for a research proposal related to the development of novel mitochondrial blood–based biomarkers.

Minovia Chief Scientific Officer Dr. Noa Sher, commented, “We are grateful to the Countdown for a Cure Foundation, whose funds are expected to be instrumental in our advancing development of blood–based functional mitochondrial biomarkers. These biomarkers will enable identification of patients who may benefit from our mitochondrial augmentation technology, or MAT, proprietary platform, as well as patient follow–up after MAT treatment. Given how critical mitochondria are to human health, we envision a world in which assessment of mitochondrial biomarkers is available in routine checkups for individuals of all age groups. We look forward to optimizing this technology.”

In addition to the novel MAT–based mitochondrial therapies under development, Minovia has set dual goals of developing biomarkers to quantify mitochondrial content, quality and function and of using these biomarkers to determine mitochondrial scores in healthy individuals relative to mitochondrial disease patients. For this reason, Minovia opened a clinical trial in Sheba Medical Center to collect blood samples from both healthy volunteers and patients suffering from mitochondrial diseases. The Countdown for a Cure grant will fund clinical operations for blood sample collection from approximately 30 patients with primary mitochondrial diseases, and 140 samples from healthy controls. The samples collected will be analyzed in Minovia’s labs with its newly developed biomarkers, and a “MitoScore” will be determined for each sample. In addition, the Countdown for a Cure funding will support the development of new biomarkers using novel research tools.

Mitochondrial dysfunction is known to occur in rare genetic mitochondrial diseases, as well as in chronic and age–related diseases. There is a profound unmet need for treatment of these devastating diseases, as there are currently no approved therapies for mitochondrial dysfunction and no functional tests to diagnose and quantify mitochondrial dysfunction in individuals of all ages.

The Company also recently announced entry into a definitive business combination agreement (the “Business Combination Agreement”) with Launch One Acquisition Corp. (Nasdaq: LPAA, “Launch One”), a publicly traded special purpose acquisition company. Following the expected closing of the transaction contemplated by this Business Combination Agreement (the “Business Combination”), projected for late 2025, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.

About Minovia Therapeutics

Minovia Therapeutics, chaired by John Cox, is a clinical–state biotechnology company working on treatments to replace dead or defective mitochondria with new healthy mitochondria, helping people with mitochondrial diseases and fighting aging. Its main drug product, MNV–201, is already being tested for Pearson Syndrome and Myelodysplastic Syndrome. Minovia is also developing ways to help people live longer, healthier lives. Based in Haifa, Israel, where it operates a GMP facility for mitochondrial drug substance and drug product manufacturing for clinical trials related to its therapy, Minovia is planning to expand to the U.S. For more information, visit www.minoviatx.com.

About Countdown for a Cure

Countdown For A Cure (CFAC) is a non–profit organization dedicated to advancing mitochondrial research and medicine, improving the lives of those affected by diseases linked to mitochondrial dysfunction. Founded in 2024 by Mitzi and Jeff Solomon, who experienced mitochondrial dysfunction and its impact on their family firsthand, CFAC partners with leading research institutions and patient advocacy groups to fund cutting–edge science and provide critical support to families. Mitzi and Jeff are driven by an unwavering commitment to supporting families, accelerating research, and uniting a community determined to make a tangible difference in the lives of those affected by mitochondrial disease and all diseases connected to mitochondrial dysfunction.

About Launch One Acquisition Corp.

Launch One Acquisition Corp. is a company set up to merge with and take public an exciting business in healthcare or technology. Listed on Nasdaq under the ticker LPAA, Launch One is led by experienced leaders who want to support game–changing solutions. For more information, contact Jurgen van de Vyver at [email protected].

Additional Information and Where to Find It

In connection with the Business Combination and the Business Combination Agreement, among Launch One, Minovia and Mito US One Ltd., a newly formed Israeli company limited by shares (“Pubco”), and certain other parties named therein. Launch One and Minovia intend to file relevant materials with the U.S. Securities and Exchange Commission (“SEC”), including a Registration Statement on Form F–4 of Pubco (the “Registration Statement”), which will include a proxy statement/prospectus of Launch One, and will file other documents regarding the proposed Business Combination with the SEC. This communication is not intended to be, and is not, a substitute for the proxy statement/prospectus or any other document that Launch One has filed or may file with the SEC in connection with the proposed Business Combination. The Registration Statement has not been filed or declared effective by the SEC. Following such filing and upon such declaration of effectiveness, the definitive proxy statement/prospectus contained within the Registration Statement and other relevant materials for the proposed Business Combination will be mailed or made available to stockholders of Launch One as of a record date to be established for voting on the proposed Business Combination.

Before making any voting or investment decision, investors and stockholders of Launch One are urged to carefully read, when they become available, the entire Registration Statement, the proxy statement/prospectus, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, and the documents incorporated by reference therein, because they will contain important information about Launch One, Minovia, Pubco and the proposed Business Combination. Launch One’s investors and stockholders and other interested persons will also be able to obtain copies of the Registration Statement, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, other documents filed with the SEC that will be incorporated by reference therein, and all other relevant documents filed with the SEC by Launch One and/or Pubco in connection with the Business Combination, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a request to Launch One or Minovia at the addresses set forth below.

Participants In the Solicitation

Launch One, Minovia, Pubco and their respective directors, executive officers, other members of management and employees may be deemed participants in the solicitation of proxies from Launch One’s stockholders with respect to the Business Combination. Investors and security holders may obtain more detailed information regarding the names, and interests in the Business Combination, of Launch One’s directors and officers in Pubco's and Launch One’s filings with the SEC, including, when filed with the SEC, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, amendments and supplements thereto, and other documents filed with the SEC. Such information with respect to Minovia’s directors and executive officers will also be included in the proxy statement/prospectus. You may obtain free copies of these documents as described above under the heading “Additional Information and Where to Find It.”

Non–Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Launch One, Pubco, or Minovia, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

Forward–Looking Statements

This press release includes certain statements that may be considered forward–looking statements within the meaning of the federal securities laws. Forward–looking statements include, without limitation, statements about future events or Minovia’s, Launch One's, or Pubco's future financial or operating performance. For example, statements regarding the development and regulatory approval of MNV–201, the implications of Fast Track Designation, RPD and PRVs and the timing of future clinical trials or potential applications are forward–looking statements. In some cases, you can identify forward–looking statements by terminology such as “may,” “should,” “could,” “might,” “plan,” “possible,” “project,” “strive,” “budget,” “forecast,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue,” or the negatives of these terms or variations of them or similar terminology.

These forward–looking statements regarding future events and the future results of Minovia or Launch One are based on current expectations, estimates, forecasts, and projections about the industry in which Minovia or Launch One operates, as well as the beliefs and assumptions of Minovia’s and Launch One's management. These forward–looking statements are only predictions and are subject to, without limitation, (i) known and unknown risks, including the risks and uncertainties indicated from time to time in the final prospectus of Launch One relating to its initial public offering filed with the SEC, including those under “Risk Factors” therein, and other documents filed or to be filed with the SEC by Launch One or Pubco; (ii) uncertainties; (iii) assumptions; and (v) other factors beyond Minovia’s or Launch One's control that are difficult to predict because they relate to events and depend on circumstances that will occur in the future. They are neither statements of historical fact nor promises or guarantees of future performance. Therefore, Minovia’s actual results may differ materially and adversely from those expressed or implied in any forward–looking statements and Minovia and Launch One therefore caution against relying on any of these forward–looking statements.

These forward–looking statements are based upon estimates and assumptions that, while considered reasonable by Minovia and its management, as the case may be, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Minovia’s or Launch One's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the Business Combination Agreement and any subsequent definitive agreements with respect to the Business Combination; (ii) the outcome of any legal proceedings that may be instituted against Launch One, Minovia, Pubco, or others following the announcement of the Business Combination and any definitive agreements with respect thereto; (iii) the inability to complete the Business Combination due to the failure to obtain consents and approvals of the shareholders of Launch One and Minovia, to obtain financing to complete the Business Combination or to satisfy other conditions to closing, or delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals required to complete the transactions contemplated by the Business Combination Agreement; (iv) changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; (v) projections, estimates and forecasts of revenue and other financial and performance metrics, projections of market opportunity and expectations, and the estimated implied enterprise value of Minovia; (vi) Minovia’s ability to scale and grow its business, and the advantages and expected growth of Minovia; (vii) Minovia’s ability to source and retain talent, and the cash position of Minovia following closing of the Business Combination; (viii) the ability to meet stock exchange listing standards in connection with, and following, the consummation of the Business Combination; (ix) the risk that the Business Combination disrupts current plans and operations of Minovia as a result of the announcement and consummation of the Business Combination; (x) the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of Minovia to grow and manage growth profitably, maintain key relationships and retain its management and key employees; (xi) costs related to the Business Combination; (xii) changes in applicable laws, regulations, political and economic developments; (xiii) the possibility that Minovia may be adversely affected by other economic, business and/or competitive factors; (xiv) Minovia’s estimates of expenses and profitability; (xv) the failure to realize estimated shareholder redemptions, purchase price and other adjustments; and (xvi) other risks and uncertainties set forth in the filings by Launch One and Minovia with the SEC. There may be additional risks that neither Launch One nor Minovia presently know or that Launch One and Minovia currently believe are immaterial that could also cause actual results to differ from those contained in the forward–looking statements. Any forward–looking statements made by or on behalf of Launch One or Minovia speak only as of the date they are made. Neither Launch One nor Minovia undertakes any obligation to update any forward–looking statements to reflect any changes in their respective expectations with regard thereto or any changes in events, conditions or circumstances on which any such statements are based.

Contacts:

Minovia Therapeutics Ltd.
Natalie Yivgi Ohana, Co–Founder and CEO
+972–74–7039954
[email protected]

Launch One Acquisition Corp.
Jurgen van de Vyver
[email protected]
+1–510–692–9600

Investor Relations
Dave Gentry, CEO
RedChip Companies
+1–407–644–4256
[email protected]

Investor Relations
Jules Abraham
Managing Director, Communications
CORE IR
1–212–655–0924
[email protected]


GLOBENEWSWIRE (Distribution ID 9518763)