September 30, 2025 — LONDON, UK — Leads & Copy — Hemogenyx Pharmaceuticals plc (LSE:HEMO) announced its unaudited interim results for the six-month period ended June 30, 2025, highlighting key achievements in its blood disease treatment development.
The biopharmaceutical group reported the successful first-in-human treatment with HG-CT-1, with three patients treated in the Phase I trial showing encouraging early signs of efficacy after passing initial safety evaluations. The FDA also accepted the Annual IND report for HG-CT-1 and cleared a pediatric expansion of the Phase I trial following a protocol amendment. In H1 2025, Hemogenyx raised £2.24 million to support ongoing clinical development.
The Phase I clinical trial of HG-CT-1 in adult R/R AML patients has been the company’s principal focus. Since the close of the reporting period, the third adult patient had passed the initial safety evaluation and early signs of clinical efficacy were observed. Leukemic cells were no longer detectable by standard assays, providing the first clear evidence that HG-CT-1 is beginning to deliver therapeutic benefit.
Hemogenyx has entered into a strategic manufacturing partnership with Made Scientific, a US-based contract development and manufacturing organisation, to support technology transfer and scale-up of HG-CT-1 production and secured a US$120,000 G-Rex® grant to optimise and scale CAR-T production.
A letter of intent has been signed with Cellin Technologies OÜ (“Cellin”), a leading Estonian cell therapy company. The agreement contemplates the commercialisation of HG-CT-1 under Estonia’s recently amended hospital exemption pathway for advanced therapy medicinal products.
The Group recorded a loss before taxation of £5,006,415 (2024: £2,815,604 loss), including operating costs of £4,819,980 (2024: £2,691,140). The Company had cash and cash equivalents totalling £226,727 as of June 30, 2025. The Company raised £2.24 million (before expenses) during H1 and has raised a further £2.2 million post period end.
Priorities for the remainder of 2025 include DSMB review and dose escalation, paediatric expansion, manufacturing scale-up, revenue optionality, and financial discipline.
Marc Feldmann, Chairman, stated that the first half of 2025 has confirmed both the safety and the promise of HG-CT-1.
Contact:
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder, headquarters@hemogenyx.com
Peter Redmond, Director, peter.redmond@hemogenyx.com
Source: Hemogenyx Pharmaceuticals plc
