Hemogenyx Pharmaceuticals PLC Announces Final Results

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU AS IT FORMS PART OF LAW IN THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018. UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Final Results

LONDON, UK / ACCESSWIRE / April 25, 2024 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, announces its final audited results for the year ended 31 December 2023. The Annual Report is available to view on the Company's web site at https://hemogenyx.com.

Key Highlights

· Investigational New Drug ("IND") application submitted in May 2023 seeking authorisation from the U.S. Food and Drug Administration ("FDA") to begin a Phase I clinical trial of HEMO-CAR-T for treating acute myeloid leukaemia (AML)

· After a clinical hold period, to address manufacturing issues, HEMO-CAR-T was granted authority from the FDA in February 2024 to commence Phase I clinical trials

· Continuing development of Chimeric Bait Receptor ("CBR") antiviral/biodefence platform and filed a patent application entitled Chimeric Bait Receptors and Uses Thereof

· Successfully raised £5.25 million (before expenses) in total through the allotment and issue of new ordinary shares during the year ended 31 December 2023, and a further £3.25 million in early 2024

· Entered into agreement with Prevail InfoWorks Inc. 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 Chairman's Statement below.

Chairman's Statement

I am pleased to report the Company's results for the year ended 31 December 2023. The period was a vital one in the progression of the Company. Development work on our lead HEMO-CAR-T product candidate was completed and we were able to submit an Investigational New Drug ("IND") application to the Food and Drug Administration ("FDA") to enable us to move into clinical trials for HEMO-CAR-T. Unfortunately, the FDA decided that certain aspects of the data initially provided did not meet its rigorous safety standards, so it imposed a clinical hold pending further development of the product. We worked hard in the final months of the year to meet the FDA's additional requirements and, as a result, the clinical hold was lifted in January 2024. Hemogenyx Pharmaceuticals is thereby established as a "clinical stage" company and we are now proceeding to the next step in the development of HEMO-CAR-T, the commencement of Phase I clinical trials.