REG - Hemogenyx Pharma Plc - Tech Transfer Completion and Clinical Trial Update

Hemogenyx PharmaceuticalsAnnouncement

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RNS Number : 8122Y  Hemogenyx Pharmaceuticals PLC  31 March 2026

31 March 2026

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK
VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF ENGLISH
LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL) ACT 2018, AS AMENDED.  ON
PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS
INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

Tech Transfer Completion and Clinical Trial Progress

Hemogenyx Pharmaceuticals plc (LSE: HEMO), a biopharmaceutical company focused
on the development of innovative therapies for the treatment of blood
diseases, is pleased to provide the following update on its HG-CT-1 CAR-T cell
therapy program for relapsed/refractory acute myeloid leukemia (R/R AML):

Completion of Manufacturing Tech Transfer and FDA Submission

The Company announces that the technology transfer of the manufacturing
process for its HG-CT-1 CAR-T cell therapy has been successfully completed to
Made Scientific, a contract development and manufacturing organization (CDMO).

A comprehensive comparability data package has been submitted to the U.S. Food
and Drug Administration (FDA). The submitted data demonstrate that HG-CT-1
manufactured by Made Scientific is comparable to that produced by Hemogenyx
Pharmaceuticals, confirming the robustness and reproducibility of the
manufacturing process across sites.

Clinical Trial Progression

Hemogenyx Pharmaceuticals is now ready to initiate recruitment of adult
patients for treatment with the second, increased dose level of HG-CT-1 as
part of its ongoing Phase 1 clinical trial in R/R AML.

In parallel, the Company will begin recruitment of pediatric patients, who
will receive the lowest dose level of HG-CT-1. This marks an important
expansion of the clinical program into pediatric populations suffering from
R/R AML.

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented:

"We are pleased to have successfully completed the tech transfer of HG-CT-1
manufacturing and to have demonstrated comparability between internally and
externally manufactured product. This is a critical milestone as we advance
our clinical program.

With recruitment set to begin at the next dose level in adults and to expand
into pediatric patients, we are well-positioned to accelerate the development
of HG-CT-1 for patients with relapsed or refractory AML who have limited
treatment options."

While the Company's efforts remain primarily focused on the HG-CT-1 clinical
trials, it continues to advance its CDX and CBR product candidates where
possible and expects to report further progress on these programmes in due
course."

UK Market Abuse Regulation (UK 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. The person responsible for
arranging for the release of this announcement on behalf of Hemogenyx
Pharmaceuticals plc is Dr Vladislav Sandler, Chief Executive Officer &
Co-Founder.

 

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
 AlbR 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.

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