Hemogenyx Pharma Stock Price, News & Analysis

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.

Hemogenyx Pharmaceuticals announced changes to its share structure following an Extraordinary General Meeting on December 9, 2024. The company's 1,401,815,988 existing ordinary shares underwent a 1:2 subdivision and reclassification, followed by a 400:1 consolidation, resulting in 3,504,539 New Ordinary Shares in issue. Each existing share was split into one new ordinary share of £0.000025 and one deferred share of £0.009975, with the new shares subsequently consolidated.

The New Ordinary Shares will be admitted to trading on the London Stock Exchange's Main Market on December 13, 2024, with a new ISIN: GB00BQVXM815. The Deferred Shares will have no voting rights or capital participation and won't be traded on any exchange.

Hemogenyx Pharmaceuticals has successfully completed the Site Initiation Visit for its Phase I clinical trial of HG-CT-1 (HEMO-CAR-T) at the first clinical site. The trial is designed as a dose escalation study to evaluate the safety of HG-CT-1 in adult patients with relapsed/refractory (R/R) acute myeloid leukaemia (AML).

Patient recruitment will commence once the clinical site provides final details to the company's clinical trials manager, Prevail Infoworks. This milestone represents a significant advancement for the company's lead asset, demonstrating their commitment to developing innovative therapies for R/R AML patients who currently have treatment options.

Hemogenyx Pharmaceuticals has announced a breakthrough in delivering Chimeric Bait Receptors (CBR) to innate immune cells. The company has developed a novel method using lentiviral vectors to achieve highly efficient transduction of macrophages and monocytes, while maintaining durable CBR expression in these cells.

This innovative approach will extend both the efficacy and durability of CBR within transduced cells, significantly accelerating the development of CBR-based product candidates. The company plans to advance new CBR-based product candidates into clinical trials once sufficient resources are secured, aiming to address unmet medical needs.

Hemogenyx Pharmaceuticals announces an Extraordinary General Meeting on December 9, 2024, seeking shareholder approval for a capital reorganization. The company proposes a 1:2 subdivision of existing shares into new ordinary shares and deferred shares, followed by a 400:1 consolidation. This restructuring aims to address the 'penny share' perception deterring institutional investors. The company seeks authority to disapply pre-emption rights over 50% of issued shares to support HEMO-CAR-T clinical trials funding. Currently holding 1,401,815,988 ordinary shares, the reorganization will affect holdings below 400 shares, potentially resulting in fractional entitlements.

Hemogenyx Pharmaceuticals has received Institutional Review Board (IRB) approval to initiate a Phase I clinical trial of HEMO-CAR-T (HG-CT-1) for treating relapsed/refractory acute myeloid leukemia (R/R AML) in adults. The trial is designed as a dose escalation study to assess safety, with secondary objectives including efficacy evaluation, overall survival, progression-free survival, and duration of response in patients. This approval marks a significant milestone for the company, allowing clinical testing at a prestigious cancer research institution.