Hemogenyx Pharmaceuticals (LON: HEMO) Letter of Intent with Cellin Technologies

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

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.”

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