Hemogenyx Pharmaceuticals PLC Announces Half-Year Report

Interim Results for the period ended 30 June 2023

LONDON, UK / ACCESSWIRE / September 28, 2023 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the Standard Listed biopharmaceutical group developing therapies designed to transform blood disease treatment, announces its unaudited interim results for the six-month period ended 30 June 2023.

All financial amounts are stated in GBP British pounds unless otherwise indicated.

Key Highlights

• Applied for Investigational New Drug ("IND") status for the Company's lead product HEMO-CAR-T with the U.S. Food and Drug Administration ("FDA").
• IND application placed on clinical hold, with the FDA later accepting the Company's plan for resolving outstanding issues.
• Continuing development of Chimeric Bait Receptor ("CBR") antiviral/biodefence platform.
• Following the period end, the Company received a strategic investment of US$833,000 from Prevail Partners, LLC ("Prevail Partners") at a large premium to share price.
• Entered into agreement with Prevail InfoWorks Inc. ("Prevail InfoWorks") to provide clinical services and technologies for the Company's upcoming Phase I clinical trial of HEMO CAR-T.

Fuller details of these developments are contained in the Interim Management Report below.

Commenting on the outlook for Hemogenyx Pharmaceuticals, Vladislav Sandler, Chief Executive Officer, said:
"While the placing of HEMO-CAR-T on clinical hold was a setback, we are clear on the particular area in which additional information is required, and we are encouraged by the FDA's response to our plans to resolve the issues. We remain confident and committed to progressing HEMO CAR-T to clinical trials as the Company's next step. We have put measures in place to allow us to achieve this milestone, including the new agreement with Prevail InfoWorks and the investment by Prevail Partners, which gives a clear signal of the project's value even at this pre-clinical phase. Meanwhile, the prospects for our other cutting-edge assets continue to be positive, and CBR in particular is beginning to attract real attention."

Interim Management Report

We are pleased to provide an update on the Company's activities over the six-month period ended 30 June 2023. Although it is not all plain sailing, we are now developing on a number of fronts which, while adding materially to operating costs, puts us into a far stronger position for further development. In particular, we are now seeing major benefits from our state-of-the-art research and manufacturing facilities and we have also made cautious but significant additions to our scientific and manufacturing team.