Hemogenyx Pharmaceuticals encouraged by the FDA’s response to plans to resolve a setback

Hemogenyx Pharmaceuticals, the Standard Listed biopharmaceutical group developing therapies designed to transform blood disease treatment, amid taking a setback with the placing of HEMO-CAR-T on clinical hold, stays committed to progressing HEMO CAR-T to clinical trials as the its next step, with new funding of $833,000 from Prevail Partners.

Announcing its unaudited interim results for the six-month period ended 30 June 2023, Hemogenyx said it has entered into agreement with Prevail InfoWorks to provide clinical services and technologies for the Company’s upcoming Phase I clinical trial of HEMO CAR-T.

Commenting on the outlook for the company, Vladislav Sandler, CEO, 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.”

He pointed out 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,” he said.

 

Financial Results

During the six months ended 30 June 2023, the Group recorded a loss before taxation of £4,323,564 (2022: £1,141,304 loss), including operating costs of £3,896,308 (2022: £1,111,010).

The increase in cost is an inevitable corollary of developing the Company on a broader scale and moving forward its key projects, it is stated.

The Company had cash and cash equivalents totalling £3,084,852 as of 30 June 2023.

Outlook

“In the immediate future, we remain laser-focused on resubmitting our IND application for HEMO-CAR-T to the FDA as soon as we can, and on preparing for its move into clinical trials,” the company said in the press release.