Opening of First Clinical Site

Patient Recruitment Begins for CAR-T Cell Therapy Targeting Relapsed/Refractory Acute Myeloid Leukemia in Adults

Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce the opening of the first clinical site for its lead asset, HG-CT-1, targeting relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults. Recruitment of patients for the trials has begun.

This Phase I trial is designed as a dose-escalation study to evaluate the safety profile of HG-CT-1 in adult patients with R/R AML. Key secondary objectives include assessing the therapy's impact on the following clinical outcomes:

• Efficacy of HG-CT-1 based on AML-specific response criteria
• Overall survival (OS) rates among participating subjects
• Progression-free survival (PFS) in evaluable subjects
• Duration of response (DoR) in those who achieve clinical responses.

These objectives are pivotal for assessing the overall clinical impact of HG-CT-1 on patients with R/R AML, a population with few remaining therapeutic options. The commencement of this trial represents a major milestone for Hemogenyx Pharmaceuticals, enabling the Company to advance this promising therapy into clinical testing at one of the world's most prestigious cancer research institutions.

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

" The opening of our first clinical site for the Phase I trial of HG-CT-1 is a milestone in our mission to revolutionize the treatment landscape for relapsed and refractory acute myeloid leukemia. This trial offers hope to patients who currently face limited treatment options by exploring the safety and potential efficacy of HG-CT-1. We are excited to start this pivotal study."

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