Third Patient Treated with HG-CT-1 CAR-T Therapy

Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce that the third patient has been successfully treated as part of the Company's ongoing Phase I clinical trial of HG-CT-1, its proprietary CAR-T cell therapy for relapsed or refractory acute myeloid leukemia ("R/R AML") in adults.

Treatment of this patient, the final participant in the first adult dose cohort, was made possible after the Company secured special permission from the U.S. Food and Drug Administration (FDA) to proceed under exceptional circumstances. This regulatory clearance reflects the Company's ability to navigate complex clinical challenges to ensure eligible patients can access potentially life-saving therapies.

Completion of the first adult dose cohort, which received the lowest dose of HG-CT-1, represents a pivotal milestone in the Company's trial. If no dose-limiting toxicities are observed, Hemogenyx Pharmaceuticals will:

• Advance to the second adult dose cohort at twice the initial dose, and
• Initiate recruitment for the pediatric arm of the trial, addressing a critical unmet need in childhood AML.

The Phase I trial is a dose-escalation study designed to assess safety and collect data on key secondary endpoints, including anti-leukemic activity, overall survival, progression-free survival, and duration of response. The Company is pleased to report that the first two patients treated with HG-CT-1 remain alive at six months and three months post-treatment, respectively.

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

"Completing the first adult dose cohort is a major achievement in our Phase I trial of HG-CT-1. I am proud of our team's persistence in working with the FDA to obtain the necessary clearance to treat this patient. With this milestone reached, we are well positioned to move into the higher-dose cohort and to open our pediatric arm, advancing our mission to deliver transformative therapies for AML patients of all ages."