HEMOGENYX PHARMACEUTICALS - HOPHF STOCK NEWS

Hemogenyx Pharmaceuticals has announced the successful completion of analytical tests for its HEMO-CAR-T production across three Process Qualification (PQ) runs. These PQ runs, conducted in cGMP compliant facilities, are crucial for ensuring the quality of the manufactured cells, focusing on attributes like viability, potency, and sterility. This achievement fulfills the last manufacturing requirement for submitting an Investigational New Drug (IND) application to the FDA, which is currently being prepared. The IND is necessary to initiate Phase I clinical trials for HEMO-CAR-T, marking a significant step forward in the Company's development of new therapies for blood diseases.

Hemogenyx Pharmaceuticals announced total voting rights as of February 28, 2023, confirming the issuance of 1,141,999,321 ordinary shares with a nominal value of 1 pence each. The company holds no treasury shares, resulting in the same number of voting rights available to shareholders. This figure is crucial for shareholders to determine their reporting obligations concerning changes in their shareholdings under the Financial Conduct Authority's Disclosure Guidance and Transparency Rules.

Hemogenyx Pharmaceuticals has successfully raised £4,056,250 through the issuance of 162,250,000 new ordinary shares at 2.5 pence per share. This fundraising effort will support the advancement of their HEMO-CAR-T product candidate into clinical trials and the development of their Chimeric Bait Receptor (CBR) platform. The shares are expected to be admitted for trading on the London Stock Exchange around February 2, 2023, increasing the total issued capital to 1,141,999,321 shares. CEO Dr. Vladislav Sandler highlighted the importance of moving forward with their key products to combat viral infections.

Hemogenyx Pharmaceuticals plc has successfully completed its third Process Qualification run for the manufacturing of HEMO-CAR-T cells in cGMP compliant facilities. This achievement is crucial for the submission of an Investigational New Drug (IND) application to the FDA, required for initiating Phase I clinical trials. The company will conduct analytical release tests to ensure the quality of these cells, which will also be tested by a third party before the data is compiled for the IND submission.

Hemogenyx Pharmaceuticals has completed its second Process Qualification run for the manufacturing of HEMO-CAR-T cells in compliant clean rooms. This step is crucial for filing an Investigational New Drug application with the FDA, necessary for starting Phase I clinical trials. The company plans to execute a minimum of three identical manufacturing runs to meet regulatory requirements. The progress underscores Hemogenyx's commitment to advancing therapies for severe blood diseases.

Hemogenyx Pharmaceuticals has successfully completed its first Process Qualification (PQ) run for the manufacture of HEMO-CAR-T cells, a crucial step in preparing for the Investigational New Drug (IND) application to the FDA. This PQ run is part of at least three required identical runs to facilitate the IND submission necessary for Phase I clinical trials. The process was executed in a cGMP-compliant environment, followed by quality verification tests on the manufactured cells, indicating readiness for further regulatory steps in the development of new therapies for blood diseases.

Hemogenyx Pharmaceuticals plc has successfully completed its second and final Process Development run for HEMO-CAR-T cell manufacturing in cGMP-compliant facilities. This advancement is a crucial step towards submitting the Investigational New Drug application to the FDA for initiating Phase I clinical trials of HEMO-CAR-T. The company is now preparing for engineering runs as part of its Process Qualification phase. Hemogenyx focuses on developing innovative therapies for serious blood diseases and aims to enhance patient access to life-saving bone marrow transplants.