Hemogenyx Pharmaceuticals (LSE:HEMO) has signed a definitive collaboration agreement with Cellin Technologies OÜ, an Estonian cell therapy company, to manufacture and commercialise HG-CT-1 for relapsed or refractory acute myeloid leukaemia under Estonia's Hospital Exemption framework.
The agreement converts a non-binding letter of intent from 23 September 2025 into binding commitments, and represents what the AIM and LSE-listed biotech calls its first potential near-term revenue opportunity.
The Hospital Exemption route allows advanced therapies not yet commercially authorised to be administered under a doctor's responsibility, subject to sign-off from Estonia's State Agency of Medicines, with treatment costs potentially reimbursed through the Estonian Health Insurance Fund.
Hemogenyx will transfer its manufacturing know-how to Cellin's GMP-compliant Tallinn facility, a process expected to take around four months, followed by a around 90-day regulatory review.
Cellin becomes Hemogenyx's exclusive manufacturing and operational partner in Estonia for five years, handling the regulatory dossier and reimbursement coordination, while patients will be treated at Taastava Kirurgia Kliinik AS in Tallinn.
Hemogenyx retains full ownership of the HG-CT-1 intellectual property and all rights outside Estonia and outside the Hospital Exemption framework, with the two parties sharing net operating margin per patient treatment after direct therapy costs.
The company cautioned that patient treatment and any resulting revenue depend on completing the technology transfer, regulatory authorisation and reimbursement approval, with no minimum patient numbers or revenue guaranteed.
"The signing of this definitive agreement with Cellin transforms our plans in Estonia from intent into execution," said chief executive Dr Vladislav Sandler, adding it gives the company "a clear, binding path to delivering HG-CT-1 to patients."
News Intelligence what this means for the company
Hemogenyx has converted a non-binding letter of intent into a definitive five-year manufacturing and commercialisation agreement with Estonian cell therapy company Cellin Technologies for its HG-CT-1 CAR-T therapy. The deal represents the company's first potential near-term revenue opportunity, with a clear timeline: four months for technology transfer to Cellin's GMP-compliant facility in Tallinn, followed by approximately 90 days of regulatory review under Estonia's Hospital Exemption framework. Hemogenyx retains full IP ownership and rights outside Estonia, while sharing net operating margin per patient with Cellin after direct therapy costs.
This binding agreement de-risks the Estonia pathway by replacing intent with executable commitments and a defined regulatory timeline, moving HG-CT-1 closer to its first patient revenue. However, the company explicitly cautioned that treatment and revenue depend on completing technology transfer, regulatory authorisation, and reimbursement approval, with no minimum patient numbers or revenue guaranteed—so execution risk remains material.
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