Hemogenyx Pharma - HOPHF STOCK NEWS

Hemogenyx Pharmaceuticals (LSE:HEMO) has submitted its Annual Report to the FDA under the active Investigational New Drug (IND) application for HG-CT-1, their CAR-T cell therapy targeting relapsed or refractory acute myeloid leukemia (R/R AML).

The report covers the first year of clinical trials through February 6, 2025, and includes:

• Study information detailing trial design, objectives, and confirmation of first patient enrollment
• Quality data on HG-CT-1 drug product stability and lentiviral vector manufacturing
• Forward-looking plans for continued patient enrollment

The submission represents a significant milestone in HG-CT-1's clinical development, demonstrating the company's progress in advancing a potential therapy for R/R AML patients.

Hemogenyx Pharmaceuticals (LSE:HEMO), a clinical stage biopharmaceutical company focused on blood and autoimmune disease treatments, has announced its total voting rights as of March 31, 2025. The company's total issued share capital consists of 4,093,539 ordinary shares of 1p each, with none held in treasury.

This figure serves as the denominator for shareholders calculating their notification requirements under the Financial Conduct Authority's Disclosure Guidance and Transparency Rules. The company operates through its US subsidiaries in New York City, where it maintains a state-of-the-art research facility developing several distinct product candidates and platform technologies.

Hemogenyx Pharmaceuticals (LSE: HEMO) has announced successful initial safety results for the first patient treated in its Phase I clinical trial of HG-CT-1, a proprietary CAR-T cell therapy targeting relapsed or refractory acute myeloid leukemia (R/R AML) in adults.

The treatment demonstrated favorable tolerability with no adverse effects, meeting the primary safety assessment criteria. Early efficacy signs are reported as encouraging, with ongoing patient monitoring to evaluate secondary endpoints including:

• AML-specific response criteria assessment
• Overall survival evaluation
• Progression-free survival measurement
• Duration of response determination

The company is currently manufacturing HG-CT-1 for a second patient as part of this dose-escalation study, which aims to evaluate the therapy's potential in treating one of the most challenging forms of leukemia.

Hemogenyx Pharmaceuticals (LSE:HEMO) has announced the recruitment of its second patient for the clinical trial of HG-CT-1, their proprietary CAR-T cell therapy. The trial focuses on treating relapsed or refractory acute myeloid leukemia (R/R AML) in adult patients.

The company's scientific team will soon begin manufacturing HG-CT-1 for the second patient. This development represents a significant milestone in advancing a potential breakthrough treatment for AML patients with therapeutic options.

The recruitment progress suggests promising initial trial results, demonstrating the company's commitment to addressing urgent unmet medical needs in blood disease treatment.

Hemogenyx Pharmaceuticals (LSE:HEMO) has secured institutional investment of £709,200 through the issuance of 394,000 new Ordinary Shares at £1.80 per share. The institutional investor will also receive one-for-two warrants, exercisable at £3.50 per share.

The funding will support the continuation of Phase I clinical trials for HG-CT-1, the company's Chimeric Antigen Receptor T-cell therapy targeting relapsed/refractory acute myeloid leukemia (R/R AML) in adults. The initial patient received HG-CT-1 treatment in February 2024, with plans to recruit a second patient pending satisfactory outcomes.

The new shares are expected to be admitted to trading on the Main Market of the London Stock Exchange around March 18, 2025. Following admission, the company's enlarged issued share capital will comprise 4,093,539 ordinary shares.

Hemogenyx Pharmaceuticals (LSE:HEMO) has announced a significant milestone with the first-in-human administration of HG-CT-1, their proprietary CAR-T cell therapy, for treating relapsed or refractory acute myeloid leukemia (R/R AML) in adults. This development represents a important step in the company's clinical development program, aiming to provide a potential life-saving treatment for AML patients with therapeutic options.

The company, headquartered in London with US operations in New York City, is a clinical-stage biopharmaceutical group focused on developing new treatments for blood and autoimmune diseases. Their mission includes expanding access to bone marrow transplantation's curative potential for patients with otherwise incurable life-threatening diseases.

Hemogenyx Pharmaceuticals (LSE:HEMO) has secured £285,000 through the issuance of convertible loan notes (CLNs) to support its clinical trial of HG-CT-1, a CAR-T cell therapy for relapsed or refractory acute myeloid leukemia. The funding comes primarily from existing shareholders.

The CLNs will automatically convert at a fixed price of £3.00 per share, expected around March 8, 2025. Subscribers will receive one-for-one warrants exercisable at £4.00 per share, valid for 15 months from March 1, 2025. The conversion shares will be admitted to trading on the London Stock Exchange, with admission expected by March 15, 2025.

Hemogenyx Pharmaceuticals (LSE:HEMO) has announced the opening of its first clinical site for the Phase I trial of HG-CT-1, targeting relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults. Patient recruitment has commenced for this dose-escalation study, which aims to evaluate the safety profile of the CAR-T cell therapy.

The trial's secondary objectives include assessing efficacy based on AML-specific response criteria, overall survival rates, progression-free survival, and duration of response in patients who achieve clinical responses. This development represents a significant milestone for the company in advancing its therapy into clinical testing at a leading cancer research institution.

Hemogenyx Pharmaceuticals (LSE:HEMO) has announced a strategic collaboration with Kure.ai to develop an ultrafast manufacturing process for CAR-T cell therapies targeting acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The partnership will integrate Kure's ultrafast manufacturing (UM) technology with Hemogenyx's proprietary HG-CT-1 therapy.

The collaboration includes initiating a clinical study, developing a customized UM process, sharing materials and expertise, conducting in vitro testing, and adapting manufacturing technology. Hemogenyx will have the option to license Kure's UM technology for clinical trial production upon successful development.

This partnership aims to address key challenges in CAR-T therapy production by reducing manufacturing timelines while maintaining therapeutic potency, ultimately accelerating patient access to treatment.