Hemogenyx Pharmaceuticals Signs Binding Cellin Deal for Potential HG-CT-1 Revenue in Estonia

Hemogenyx Pharmaceuticals has taken a meaningful step towards generating its first revenue from HG-CT-1 by signing a definitive collaboration agreement with Estonia-based Cellin Technologies.

The agreement covers the manufacturing and clinical implementation of HG-CT-1 for patients with relapsed or refractory acute myeloid leukaemia, known as R/R AML, under Estonia's Hospital Exemption framework.

Crucially, this is now a binding agreement rather than the non-binding letter of intent announced in September 2025. However, investors should keep expectations measured. Patient treatment and revenue remain dependent on technology transfer, regulatory authorisation and reimbursement decisions.

What has Hemogenyx agreed with Cellin?

Hemogenyx will transfer knowledge of its proprietary HG-CT-1 manufacturing process to Cellin. This will enable Cellin to manufacture the therapy at its GMP-compliant facility in Tallinn.

GMP refers to the quality standards applied to pharmaceutical manufacturing.

Cellin will become Hemogenyx's exclusive manufacturing and operational partner for HG-CT-1 in Estonia for five years. It will prepare and submit the Hospital Exemption dossier to the Estonian State Agency of Medicines, subject to Hemogenyx's review and approval.

Cellin will also coordinate the clinical implementation and reimbursement process. Patients, including those travelling across borders, would be treated at Taastava Kirurgia Kliinik AS in Tallinn.

The original company announcement sets out the respective responsibilities and the conditions that must be met before treatments can begin.

The key agreement terms

Item	Detail
Therapy	HG-CT-1 CAR-T cell therapy
Target condition	Relapsed or refractory acute myeloid leukaemia
Market covered	Estonia
Cellin's role	Exclusive manufacturing and operational partner
Agreement term	Five years
Manufacturing location	Cellin's GMP-compliant facility in Tallinn
Technology transfer timetable	Approximately four months
Regulatory review timetable	Approximately 90 days after technology transfer
Treatment location	Taastava Kirurgia Kliinik AS, Tallinn
Revenue arrangement	Share of net operating margin from each patient treatment
Minimum patients or revenue	None guaranteed

The percentage split of the net operating margin was not disclosed. Expected treatment pricing, direct therapy costs and potential revenue per patient were also not disclosed.

How the Hospital Exemption pathway works

The Hospital Exemption framework permits certain advanced therapy medicinal products, or ATMPs, to be used before receiving full commercial marketing authorisation.

Treatments must be prepared on a non-routine basis under the responsibility of a medical practitioner and remain subject to authorisation by the Estonian State Agency of Medicines.

The framework also allows innovators to apply to the Estonian Health Insurance Fund, or EHIF, for reimbursement of treatments provided to patients insured through Estonia's national social security system.

For Hemogenyx, this creates a possible route to treating patients and earning revenue while HG-CT-1 remains in its ongoing Phase I clinical trial. It could also provide real-world clinical data to complement evidence collected through that trial.

This does not amount to full commercial approval for HG-CT-1. It is a specific pathway with its own regulatory, clinical and reimbursement requirements.

Why this announcement matters for investors

The clearest positive is that Hemogenyx and Cellin have moved from planning to contractual execution.

Cellin's manufacturing infrastructure and regulatory responsibilities are now formally engaged. The agreement gives the project a defined operational structure, including a manufacturing site, treatment institution, regulatory submission process and potential reimbursement route.

Hemogenyx will also retain full ownership of all intellectual property relating to HG-CT-1. This includes the manufacturing process, improvements to that process and the Hospital Exemption dossier.

The company is not giving up its rights elsewhere. It retains the ability to develop and commercialise HG-CT-1 outside Estonia and outside the Hospital Exemption framework.

That matters because the Estonian partnership is limited in geographical and regulatory scope. If successful, it could provide an early commercial opportunity without transferring ownership of the wider programme.

Investors following the broader clinical-stage business can find further coverage on the Hemogenyx Pharmaceuticals PLC company page.

Revenue is possible, but not yet secured

The headline reference to potential near-term revenue deserves careful reading.

Hemogenyx will receive a share of the net operating margin generated by each patient treatment. Net operating margin means the amount remaining after direct therapy costs have been deducted.

This gives Hemogenyx a direct financial interest in every treatment delivered under the agreement. It is a more tangible economic structure than a broad statement of future collaboration.

Nevertheless, the agreement contains no guaranteed minimum number of patients and no minimum revenue commitment. The margin-sharing percentage has not been disclosed either, making it impossible to estimate the potential financial contribution from the information provided.

No upfront payment, milestone payment or expected date for first revenue was disclosed.

What could delay the opportunity?

There are three main hurdles before the arrangement can generate revenue.

First, Hemogenyx and Cellin must complete the manufacturing technology transfer, which is expected to take approximately four months.

Second, the Hospital Exemption dossier must be authorised by the Estonian State Agency of Medicines. The regulatory review is expected to take approximately 90 days after the technology transfer.

Third, reimbursement decisions must be secured through EHIF where applicable. The timetable and outcome of that process were not disclosed.

These stages introduce execution risk. Technology transfer could take longer than anticipated, regulators could request additional information, and reimbursement may not be granted on the terms or timetable the parties seek.

Patient demand is another unknown. The agreement permits the treatment of Estonian and cross-border patients, but no estimate of the addressable patient population or expected treatment volumes was provided.

The milestones to watch next

The definitive agreement improves the credibility of Hemogenyx's plans in Estonia, but the next announcements will determine whether it becomes a genuine revenue stream.

Investors should now watch for:

• Completion of the HG-CT-1 manufacturing technology transfer
• Submission of the Hospital Exemption dossier
• Regulatory authorisation from the Estonian State Agency of Medicines
• Reimbursement decisions from EHIF
• Confirmation that patient treatment has commenced
• Disclosure of initial patient numbers or revenue, if material

For now, this is an important operational advance rather than a completed commercial launch. Hemogenyx has established a binding path towards local manufacturing, patient treatment and potential revenue while retaining ownership of its technology. The unanswered questions are whether the required approvals will arrive, how many patients will be treated and what the economics will ultimately look like.