REG - Hemogenyx Pharma Plc - Clinical Trial Update and Grant of Share Awards

Hemogenyx PharmaceuticalsAnnouncement

29/10/2025 07:02

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RNS Number : 1973F  Hemogenyx Pharmaceuticals PLC  29 October 2025

 

29 October 2025

 

Hemogenyx Pharmaceuticals plc

 

("Hemogenyx Pharmaceuticals" or the "Company")

DSMB Clearance to Proceed to the Next Dose Level of HG-CT-1 in Adult Patients,
Opening Pediatric Recruitment, and Grant of Restricted Share Units to
Hemogenyx Team

Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce that the
independent Data Safety Monitoring Board ("DSMB") overseeing the Company's
ongoing Phase I clinical trial of HG-CT-1, its proprietary Chimeric Antigen
Receptor T-cell (CAR-T) therapy for the treatment of relapsed or refractory
acute myeloid leukemia ("R/R AML") in adults, has reviewed safety data from
the first three patients treated at the initial dose level and has recommended
continuation of the trial with escalation to the next dose level.

The DSMB's positive recommendation follows the successful completion of
initial safety assessments for all three patients treated at the lowest dose,
with no dose-limiting toxicities observed. The trial will now proceed to the
next planned dose cohort in accordance with the FDA-approved clinical
protocol.

Importantly, clearance to proceed to the next adult dose also enables the
initiation of pediatric patient recruitment for the Phase I clinical trial at
the lowest dose of HG-CT-1, the same dose level already used in the first
cohort of adults. This expansion reflects the Company's ongoing commitment to
extending the potential benefits of HG-CT-1 to children and adolescents
suffering from this aggressive and difficult to treat form of leukemia.

The Phase I study of HG-CT-1 is a dose-escalation trial designed to evaluate
the safety, tolerability, and preliminary efficacy of the Company's
proprietary CAR-T therapy in adult and pediatric patients with R/R AML. In
addition to safety, the trial includes secondary endpoints such as assessment
of AML-specific responses, progression-free survival, duration of response,
and overall survival.

The DSMB's clearance to proceed represents a key de-risking milestone in the
clinical development of HG-CT-1. It reinforces the favorable safety profile
observed to date and signals continued regulatory and operational momentum.
For investors, this milestone marks a potential value-inflection point as the
Company advances into higher dose cohorts where enhanced efficacy signals are
anticipated, paving the way toward broader clinical validation and future
pivotal studies.

As a reward for the Hemogenyx team's outstanding contribution to the HG-CT-1
program and their dedication to advancing this groundbreaking therapy, the
Company has granted a total of 6,000 Restricted Share Units ("RSUs") to key
team members under its existing equity incentive arrangements. These RSUs
align the team's interests with those of shareholders and recognize their
ongoing efforts in driving Company's clinical and operational success.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented: "We are very pleased to have received DSMB clearance to advance
HG-CT-1 to the next dose level. This important milestone marks continued
progress in our clinical development program and further validates the safety
profile of our CAR-T therapy.

I would also like to express my deep appreciation to the entire Hemogenyx
Pharmaceutical team, whose dedication, scientific rigor, and perseverance have
made this achievement possible. Their commitment to excellence continues to
drive our success and to move this potentially life-saving therapy closer to
patients in need.

We remain encouraged by the early clinical findings and are committed to
advancing HG-CT-1 through its dose-escalation phase to unlock its full
therapeutic potential for patients with relapsed or refractory AML."

Further updates will be provided as the trial progresses.

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.

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