REG - Hemogenyx Pharma Plc - Hemogenyx Signs Letter of Intent

Hemogenyx PharmaceuticalsAnnouncement

23/09/2025 07:00

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RNS Number : 2993A  Hemogenyx Pharmaceuticals PLC  23 September 2025

 

23 September 2025

 

Hemogenyx Pharmaceuticals plc

 

("Hemogenyx Pharmaceuticals" or the "Company")

 

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."

 

 

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:

 Hemogenyx Pharmaceuticals plc                                   https://hemogenyx.com (https://hemogenyx.com/)
 Dr Vladislav Sandler, Chief Executive Officer & Co-Founder      headquarters@hemogenyx.com (mailto:headquarters@hemogenyx.com)
 Peter Redmond, Director                                         peter.redmond@hemogenyx.com (mailto:peter.redmond@hemogenyx.com)
 SP Angel Corporate Finance LLP                                  Tel: +44 (0)20 3470 0470
 Matthew Johnson, Vadim Alexandre, Adam Cowl
 Peterhouse Capital Limited                                      Tel: +44 (0)20 7469 0930
 Lucy Williams, Duncan Vasey, Charles Goodfellow

 

 

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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