Hemogenyx Pharmaceuticals PLC
11 August 2026
11 August 2026
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
Hemogenyx Pharmaceuticals Signs Definitive Collaboration Agreement with Cellin Technologies for Manufacturing and Commercialization of HG-CT-1 CAR-T Therapy in Estonia
Binding Agreement Converts LOI into Execution of First Potential Near-Term Revenue Opportunity
Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce that it has signed a definitive Collaboration Agreement (the "Agreement") with Cellin Technologies OÜ ("Cellin"), a leading Estonian cell therapy company, for the manufacturing and clinical implementation of the Company's HG-CT-1 CAR-T cell therapy for the treatment of relapsed or refractory acute myeloid leukemia ("R/R AML") under the Hospital Exemption framework in Estonia. The Agreement converts into binding commitments the non-binding Letter of Intent between the parties announced on 23 September 2025 and marks a significant step toward the generation of the Company's first revenues from HG-CT-1.
The Hospital Exemption pathway permits the use of advanced therapy medicinal products ("ATMPs") that have not yet received a commercial marketing authorization, prepared on a non-routine basis under the responsibility of a medical practitioner, subject to authorization by the Estonian State Agency of Medicines. The framework also allows innovators to apply for reimbursement of the cost of treatment of patients insured within the Estonian national social security system through the Estonian Health Insurance Fund ("EHIF"). This provides Hemogenyx Pharmaceuticals with the opportunity to generate early revenues from HG-CT-1 while expanding the body of real-world clinical data to complement its ongoing Phase I clinical trial.
Under the Agreement:
• Hemogenyx Pharmaceuticals will transfer knowledge of its proprietary manufacturing process for HG-CT-1 to Cellin, enabling Cellin to manufacture the therapy at its GMP-compliant facility in Tallinn, Estonia. The technology transfer is anticipated to take approximately four months, followed by an approximately 90-day regulatory review of the Hospital Exemption dossier;
• Cellin will act as the Company's exclusive manufacturing and operational partner for HG-CT-1 in Estonia for a term of five years, preparing and submitting the Hospital Exemption dossier to the Estonian State Agency of Medicines, subject to Hemogenyx Pharmaceuticals' review and approval, and coordinating clinical implementation and reimbursement;
• Patients, including cross-border patients, will be treated at Taastava Kirurgia Kliinik AS, a clinical institution in Tallinn;
• Hemogenyx Pharmaceuticals retains full ownership of all intellectual property relating to HG-CT-1, including the manufacturing process, all improvements thereto and the Hospital Exemption dossier, and retains all rights to develop and commercialize HG-CT-1 outside Estonia and outside the Hospital Exemption framework; and
• The parties will share the net operating margin generated from each patient treatment, calculated after deduction of direct therapy costs, providing the Company with a direct economic interest in every treatment delivered under the Agreement.
The commencement of patient treatment, and any revenues arising under the Agreement, remain subject to, among other things, completion of the technology transfer, authorization of the Hospital Exemption by the Estonian State Agency of Medicines, and reimbursement decisions by EHIF. The Agreement does not guarantee any minimum number of patients or minimum revenue. Further announcements will be made as appropriate.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, said:
"The signing of this definitive agreement with Cellin transforms our plans in Estonia from intent into execution. Our first priority remains saving the lives of patients with relapsed or refractory AML, for whom treatment options remain scarce. With the framework now in place for manufacturing, regulatory submission and reimbursement, we have a clear, binding path to delivering HG-CT-1 to patients and to generating the Company's first revenues from the therapy, while gathering valuable real-world data to complement our ongoing Phase I trial."
Ivari Saar, Board Member of Cellin Technologies, said:
"Moving from a letter of intent to a definitive agreement in under a year reflects the commitment of both teams to bringing next-generation CAR-T therapy to patients in Estonia. Cellin's GMP manufacturing infrastructure and regulatory expertise are now formally engaged to deliver HG-CT-1 under the Hospital Exemption framework, positioning Estonia at the forefront of advanced cell therapy in Europe."
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:
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Hemogenyx Pharmaceuticals plc |
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Dr Vladislav Sandler, Chief Executive Officer & Co-Founder |
headquarters@hemogenyx.com |
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Peter Redmond, Director |
peterredmond2@btinternet.com |
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SP Angel Corporate Finance LLP |
Tel: +44 (0)20 3470 0470 |
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Matthew Johnson, Vadim Alexandre, Adam Cowl |
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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