Hemogenyx Pharma Stock Price, News & Analysis

Hemogenyx Pharmaceuticals (HOPHF) announced that an independent DSMB has cleared its Phase I CAR-T candidate HG-CT-1 to escalate to the next adult dose cohort after reviewing safety data from the first three patients, with no dose-limiting toxicities observed.

The clearance also permits initiation of pediatric recruitment at the same lowest dose used in adults. The Phase I trial evaluates safety, tolerability and preliminary efficacy with secondary endpoints including AML-specific responses, progression-free survival, duration of response and overall survival. The company also granted 6,000 Restricted Share Units to key team members under existing equity incentive arrangements.

Hemogenyx Pharmaceuticals (HOPHF) announced on October 6, 2025 that the Institutional Review Board at MD Anderson Cancer Center approved an amendment to its Phase I HG-CT-1 clinical protocol to include children and adolescents with relapsed or refractory acute myeloid leukemia (R/R AML).

The PR states this expansion builds on safety and early efficacy signals observed in adult participants and allows the company to begin pediatric enrolment in the HG-CT-1 trial; the company says it will provide further updates as adult and pediatric enrolment progresses.

Hemogenyx Pharmaceuticals (LSE:HEMO) has reported significant progress in its H1 2025 interim results, highlighting key developments in its HG-CT-1 clinical program for treating relapsed/refractory acute myeloid leukemia (R/R AML). The company successfully treated three patients in its Phase I trial, with all passing initial safety evaluations and showing encouraging efficacy signs.

Financial results show a loss before taxation of £5,006,415, with the company raising £2.24 million in H1 2025. Notable developments include FDA clearance for pediatric trial expansion and a strategic manufacturing partnership with Made Scientific. Post-period, Hemogenyx signed an LOI with Cellin Technologies for potential early commercialization in Estonia under a hospital exemption pathway.

The company had £226,727 in cash as of June 30, 2025, and raised an additional £2.2 million post-period.

Hemogenyx Pharmaceuticals (LSE:HEMO) has signed a Letter of Intent (LOI) with Cellin Technologies to explore the commercialization of its HG-CT-1 CAR-T cell therapy for relapsed/refractory acute myeloid leukemia (R/R AML) in Estonia. The collaboration leverages Estonia's hospital exemption pathway, which allows use of unauthorized advanced therapy medicinal products with sufficient preclinical or Phase I data.

This partnership represents Hemogenyx's first potential near-term revenue opportunity for HG-CT-1. Under the LOI, Hemogenyx retains full intellectual property rights while Cellin provides local manufacturing, regulatory, and operational support. The arrangement also enables treatment cost reimbursement through Estonia's National Health Fund while generating valuable real-world clinical data alongside the ongoing Phase I trial.

Hemogenyx Pharmaceuticals (HOPHF) has announced successful safety evaluation of the third patient treated with HG-CT-1, their proprietary CAR-T therapy for relapsed/refractory acute myeloid leukemia (R/R AML) in adults. The Phase I clinical trial has shown promising early results, with the treatment being well-tolerated and meeting predefined safety criteria.

Early efficacy signals were observed as AML cells became undetectable using standard testing methods. The Data Safety Monitoring Board (DSMB) will review safety data from the first three patients treated at the lowest dose to determine if dose escalation can proceed. The trial includes secondary endpoints focusing on efficacy, overall survival, progression-free survival, and duration of response.

Hemogenyx Pharmaceuticals (OTCQB:HOPHF) has been invited to present at the prestigious DCNY Summit, taking place in Washington, DC on September 18, 2025, and in New York on September 22, 2025. The summit, co-hosted by the Alliance Indus Foundation and various international partners, brings together policymakers, investors, and corporate leaders.

During the event, Hemogenyx will showcase its clinical progress, including updates on its Phase I clinical trial of CAR-T cell therapy for acute myeloid leukemia (AML). The company will have the opportunity to engage with key stakeholders and potential investors, as the summit has previously helped participants secure significant growth capital.

Hemogenyx Pharmaceuticals (HOPHF) has announced a strategic manufacturing partnership with Made Scientific to advance its HG-CT-1 CAR-T therapy for relapsed/refractory acute myeloid leukemia (r/r AML) in adults. The collaboration will utilize Made Scientific's GMP facilities in Newark and Princeton, NJ, for both clinical and commercial supply of cell therapies.

The partnership aims to accelerate Hemogenyx's ongoing Phase I clinical trial of HG-CT-1 and potentially expand to include pediatric r/r AML patients. Early clinical data has shown promising results in both safety and potential efficacy. Made Scientific will provide specialized expertise in CAR-T cell therapy technology transfer and manufacturing support.

Hemogenyx Pharmaceuticals (LSE:HEMO) has announced the exercise of warrants for 67,371 new ordinary shares. The warrants, originally granted on March 11, 2025, have generated subscription monies of £235,799 for the company.

The Warrant Shares will be admitted to trading on the LSE's main market on September 10, 2025. Following admission and including the previously announced 250,000 new ordinary shares, the company's total issued shares and voting rights will increase to 5,361,267.

Hemogenyx Pharmaceuticals (LSE:HEMO) announced the exercise of warrants for 250,000 new ordinary shares. The warrants, originally granted on May 8, 2025, had their exercise price adjusted to 180p per share, resulting in subscription monies of £450,000 received by the company.

Following admission of these shares and including the previously announced 316,667 new ordinary shares from August 26, 2025, the company's total issued shares and voting rights will increase to 5,293,896. The new shares are expected to be admitted to trading on the LSE main market on September 9, 2025.