Hemogenyx Pharmaceuticals plc announced the successful completion of its Process Qualification ("PQ") run of the end-to-end process for the manufacture of HEMO-CAR-T cells. This PQ run was a part of the Company's plan to address the U.S. Food and Drug Administration ("FDA") concerns that resulted in a Clinical Hold ("CH") of the HEMO-CAR- T-T Investigational New Drug ("IND") application, as announced previously. The FDA has accepted the Company's plan.

The process was carried out in the Company's current Good Manufacturing Practice compliant clean rooms. It was followed by analytical release tests conducted by the Company required to verify the quality of the manufactured HEMO- CAR-T cells. The HEMO-CAR-t cells are also being tested by a third party to ensure they comply with a set of required quality attributes. This PQ run is the only manufacturing run required for the submission of a complete response to the CH of the IND application to the FDA for HEMO-CAR- t. It was the key remaining step prior to applying for the lifting of the CH which is needed to obtain consent from the FDA to commence Phase I clinical trials of HEMO-CAR -T. Following the successful completion of all tests across the PQ run, data will be compiled for inclusion in the complete response submission pack.