Hemogenyx Pharmaceuticals PLC Signs Letter of Intent
Hemogenyx Pharmaceuticals (LSE:HEMO) has signed a Letter of Intent (LOI) with Cellin Technologies to explore the commercialization of its HG-CT-1 CAR-T cell therapy for relapsed/refractory acute myeloid leukemia (R/R AML) in Estonia. The collaboration leverages Estonia's hospital exemption pathway, which allows use of unauthorized advanced therapy medicinal products with sufficient preclinical or Phase I data.
This partnership represents Hemogenyx's first potential near-term revenue opportunity for HG-CT-1. Under the LOI, Hemogenyx retains full intellectual property rights while Cellin provides local manufacturing, regulatory, and operational support. The arrangement also enables treatment cost reimbursement through Estonia's National Health Fund while generating valuable real-world clinical data alongside the ongoing Phase I trial.
Hemogenyx Pharmaceuticals (LSE:HEMO) ha firmato una **Carta di Intenti** con Cellin Technologies per esplorare la commercializzazione della sua terapia CAR-T HG-CT-1 per la leucemia mieloide acuta ricorrente/refrattaria (R/R AML) in Estonia. La collaborazione sfrutta il percorso di hospital exemption estone, che consente l’uso di prodotti medicinali avanzati non autorizzati con dati preclinici o di Fase I sufficienti.
Questa partnership rappresenta la **prima potenziale opportunità di reddito a breve termine** per HG-CT-1. Secondo la LOI, Hemogenyx mantiene pieni diritti di proprietà intellettuale mentre Cellin fornisce produzione locale, supporto regolatorio e operativo. L’accordo consente anche il rimborso dei costi di trattamento attraverso il National Health Fund estone, generando allo stesso tempo dati real-world insieme al trial in fase I in corso.
Hemogenyx Pharmaceuticals (LSE:HEMO) ha firmado una Carta de Intención (LOI) con Cellin Technologies para explorar la comercialización de su terapia HG-CT-1 CAR-T para leucemia mieloide aguda recaída/refractaria (R/R AML) en Estonia. La colaboración aprovecha la vía de exención hospitalaria de Estonia, que permite el uso de productos medicinales avanzados no autorizados con datos preclínicos o de Fase I suficientes.
Esta asociación representa la primera oportunidad de ingresos a corto plazo potencial para HG-CT-1. Según la LOI, Hemogenyx mantiene plenos derechos de propiedad intelectual mientras Cellin proporciona fabricación local, apoyo regulatorio y operativo. El acuerdo también permite el reembolso de los costos de tratamiento a través del National Health Fund estoniano, al tiempo que genera datos del mundo real junto con el ensayo de fase I en curso.
Hemogenyx Pharmaceuticals (LSE:HEMO)는 Cellin Technologies와 함께 에스토니아에서 재발/난치성 급성 골수성 백혈병(R/R AML)을 위한 HG-CT-1 CAR-T 세포 치료법의 상용화를 모색하는 의향서(LOI)를 체결했습니다. 이 협력은 에스토니아의 병원 면제 경로를 활용하며, 충분한 전임상 또는 1상 데이터를 가진 비허가 고급 치료 의약품 사용을 허용합니다.
이 파트너십은 HG-CT-1에 대한 가까운 시일 내 첫 수익 기회를 나타냅니다. LOI에 따르면 Hemogenyx는 지적 재산권을 완전히 보유하고, Cellin은 현지 제조, 규제 및 운영 지원을 제공합니다. 이 합의는 또한 에스토니아의 National Health Fund를 통한 치료 비용 상환을 가능하게 하고, 진행 중인 1상 시험과 함께 실제 세계 임상 데이터를 수집합니다.
Hemogenyx Pharmaceuticals (LSE:HEMO) a signé une lettre d’intention (LOI) avec Cellin Technologies pour explorer la commercialisation de sa thérapie CAR-T HG-CT-1 pour la leucémie aiguë myéloïde REL/refractaire (R/R AML) en Estonie. La collaboration exploite la voie d’exemption hospitalière estonienne, qui permet l’utilisation de médicaments avancés non autorisés avec des données précliniques ou de phase I suffisantes.
Ce partenariat représente la première opportunité de revenu à court terme pour HG-CT-1. Selon la LOI, Hemogenyx conserve l’ensemble des droits de propriété intellectuelle tandis que Cellin assure la fabrication locale, le soutien réglementaire et opérationnel. L’accord permet également le remboursement des coûts de traitement via le National Health Fund estonien tout en générant des données réelles en parallèle de l’essai de phase I en cours.
Hemogenyx Pharmaceuticals (LSE:HEMO) hat eine Absichtserklärung (LOI) mit Cellin Technologies unterzeichnet, um die Kommerzialisierung der HG-CT-1 CAR-T-Zelltherapie bei rezidivierter/refraktärer akuter myeloischer Leukämie (R/R AML) in Estland zu prüfen. Die Zusammenarbeit nutzt den estnischen Hospital Exemption-Weg, der die Verwendung von unverifizierten fortgeschrittenen Therapien mit ausreichenden präklinischen oder Phase-I-Daten erlaubt.
Diese Partnerschaft stellt Hemogenyx' erste potenzielle kurzfristige Einnahmequelle für HG-CT-1 dar. Gemäß der LOI behält Hemogenyx alle geistigen Eigentumsrechte, während Cellin lokale Herstellung, regulatorische und operative Unterstützung bereitstellt. Die Vereinbarung ermöglicht außerdem die Erstattung der Behandlungskosten durch Estlands National Health Fund und erzeugt gleichzeitig wertvolle Real-World-Daten neben der laufenden Phase-I-Studie.
Hemogenyx Pharmaceuticals (LSE:HEMO) وقعت خطاب نوايا مع Cellin Technologies لاستكشاف تسويق علاج HG-CT-1 CAR-T لابيضاض الدم النقوي الحاد المتكرر/المقاوم (R/R AML) في إستونيا. يستفيد التعاون من مسار استثناء المستشفيات الاستوني، الذي يسمح باستخدام منتجات طبية متقدمة غير مُرخَّصة مع وجود بيانات ما قبل السريرية أو بيانات المرحلة I كافية.
يمثل هذا الشراكة أول فرصة محتملة للإيرادات القريبـة الأجل لـ HG-CT-1. وفقاً للLOI، تحتفظ Hemogenyx بجميع حقوق الملكية الفكرية بينما توفر Cellin التصنيع المحلي والدعم التنظيمي والتشغيلي. كما يتيح الترتيب تعويض تكاليف العلاج من خلال صندوق الصحة الوطني الاستوني، مع توليد بيانات حقيقية واقعية جنباً إلى جنب مع تجربة المرحلة I الجارية.
Hemogenyx Pharmaceuticals (LSE:HEMO) 已与Cellin Technologies签署意向书（LOI），在爱沙尼亚探索其HG-CT-1 CAR-T细胞治疗用于复发/难治性急性髓系白血病（R/R AML）的商业化可能性。该合作利用爱沙尼亚的医院豁免途径，允许在具备足够的前临床或I期数据的情况下使用未获授权的先进治疗药物。
此项合作代表 Hemogenyx 针对 HG-CT-1 的首个潜在短期收入机会。根据 LOI，Hemogenyx 保留全部知识产权，而 Cellin 提供本地制造、监管和运营支持。该安排还通过爱沙尼亚的国家卫生基金实现治疗成本的报销，同时与正在进行的I期试验一道，生成有价值的真实世界临床数据。
- First potential revenue opportunity for HG-CT-1 therapy
- Access to Estonian market through hospital exemption pathway
- Retention of full IP ownership and regulatory rights
- Opportunity to gather real-world clinical data while generating revenue
- Potential treatment cost reimbursement through Estonian National Health Fund
- LOI is non-binding and requires further definitive agreements
- Limited to Estonian market initially
- Revenue sharing terms with Cellin not yet defined
Hemogenyx Pharmaceuticals Signs Letter of Intent with Cellin Technologies to Advance Commercialization of HG-CT-1 CAR-T Therapy in Estonia
First Potential Near-Term Revenue Opportunity
LONDON / ACCESS Newswire / September 23, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) is pleased to announce that it has signed a Letter of Intent ("LOI") with Cellin Technologies OÜ ("Cellin"), a leading Estonian cell therapy company, to explore the commercialization of the Company's HG-CT-1 CAR-T cell therapy for the treatment of relapsed or refractory acute myeloid leukemia ("R/R AML") through the hospital exemption pathway under Estonia's Medicinal Products Act. This collaboration represents the first potential near-term revenue opportunity for HG-CT-1.
The hospital exemption pathway, as amended by the Estonian government in April 2025, permits the use of certain advanced therapy medicinal products ("ATMPs") that have not yet been authorized for commercial marketing to treat an unlimited number of patients, subject to sufficient preclinical or Phase I clinical trials data. The scheme also allows innovators to apply for reimbursement of treatment costs through the Estonian National Health Fund. This framework offers Hemogenyx Pharmaceuticals the opportunity to generate early revenue from HG-CT-1 while simultaneously expanding the body of real-world clinical data to complement its ongoing Phase I trial.
Under the LOI:
Hemogenyx Pharmaceuticals will retain full ownership of all intellectual property, know-how, data and regulatory rights relating to HG-CT-1 and will be entitled to revenues from commercialization.
Cellin will act as Hemogenyx Pharmaceuticals' local partner in Estonia, providing manufacturing, regulatory, and operational support, including securing permits from the Ministry of Health and facilitating administration of the therapy through attending physicians. Cellin will receive fair compensation for its services, to be defined in subsequent definitive agreements.
The LOI is non-binding and serves as a framework for further discussions between the parties. Binding commitments will be established only upon execution of definitive agreements.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, said:
"Our first priority is to save the lives of patients with relapsed or refractory AML, for whom treatment options remain scarce. Building on this mission, the partnership with Cellin also creates a path to generate initial revenues from HG-CT-1 under Estonia's hospital exemption pathway, while providing valuable real-world patient data to complement our Phase I trial and support the future development and commercialization of the therapy."
Ivari Saar, Board Member of Cellin Technologies, said:
"We are thrilled to partner with Hemogenyx Pharmaceuticals to bring next-generation CAR-T therapy to Estonia, marking a major milestone for patients with acute myeloid leukemia and other hard-to-treat blood cancers. This collaboration positions Estonia at the forefront of advanced cell therapy in Europe, combining scientific innovation with a commitment to accessible care. Together, we aim to demonstrate how CAR-T can deliver transformative outcomes for patients across the EU."
Market Abuse Regulation (MAR) Disclosure
Certain information contained in this announcement would have been inside information for the purposes of Article 7 of Regulation No 596/2014 (as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018) until the release of this announcement.
Enquiries:
Hemogenyx Pharmaceuticals plc | |
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder | |
Peter Redmond, Director | |
SP Angel Corporate Finance LLP | Tel: +44 (0)20 3470 0470 |
Matthew Johnson, Vadim Alexandre, Adam Cowl | |
Peterhouse Capital Limited | Tel: +44 (0)20 7469 0930 |
Lucy Williams, Duncan Vasey, Charles Goodfellow | |
About Hemogenyx Pharmaceuticals plc
Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City.
The Company is a clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as platform technologies that it uses as engines for novel product development.
About Cellin Technologies OÜ
Cellin Technologies has established itself as a leading Baltic player in bringing advanced cell therapies to patients, supported by recent reforms in Estonia's hospital exemption legislation. Its lead program, AngioARC, an autologous MSC-based therapy, has already shown encouraging clinical outcomes under this pathway. Cellin's integrated infrastructure spans the full value chain, from R&D laboratories to technology transfer and GMP-compliant manufacturing, ensuring rapid and reliable scale-up.
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SOURCE: Hemogenyx Pharmaceuticals PLC
View the original press release on ACCESS Newswire
FAQ
What is the significance of Hemogenyx's LOI with Cellin Technologies?
How will the Estonian hospital exemption pathway benefit Hemogenyx's HG-CT-1 therapy?
What are the key terms of the Hemogenyx-Cellin Technologies partnership?
What is HG-CT-1 and what condition does it treat?
What is the current development stage of Hemogenyx's HG-CT-1 therapy?
