American Marconi Wireless News - Hemogenyx Pharmaceuticals PLC Signs Letter of Intent

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.

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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

P.Mathewson--AMWN