Schedule for Phase I Clinical Trial Opening

Hemogenyx Pharmaceuticals Announces Schedule for Opening First Clinical Site for Phase I Trial of HEMO-CAR-T (HG-CT-1)

Hemogenyx Pharmaceuticals plc (LSE: HEMO), a biopharmaceutical company focused on developing breakthrough therapies for blood diseases, is pleased to announce the schedule for the opening of the first clinical site for its lead asset, HEMO-CAR-T, formally designated HG-CT-1, targeting relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults.

The Company has successfully completed the necessary contracts and budgeting preparations to advance HG-CT-1 into clinical testing. Institutional Review Board (IRB) approval at the initial clinical site is anticipated by the second week of November. Following IRB clearance, a Site Initiation Visit (SIV) is expected to take place in the third week of November, marking the official launch of the Phase I clinical trial.

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 will represent 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:

"Launching this Phase I clinical trial for HG-CT-1 will mark a critical step forward in our mission to develop transformative therapies for patients battling relapsed and refractory acute myeloid leukemia. For patients who have few remaining treatment options, HG-CT-1 offers a potentially life-saving solution. We are eager to initiate this trial and generate data that will be essential in advancing this therapy toward broader clinical use. This milestone underscores our commitment to innovation and our dedication to addressing the urgent needs of patients with severe blood cancers."

About AML and CAR-T Therapy