HEMOGENYX PHARMACEUTICALS - HOPHF STOCK NEWS

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.

Hemogenyx Pharmaceuticals has secured a £600,000 institutional investment through the issuance of 60,000,000 new Ordinary Shares at 1p per share. The funds will support the imminent commencement of Phase I clinical trials for their HEMO-CAR-T therapy, targeting acute myeloid leukemia (AML) treatment. The new shares are expected to be admitted to trading on the London Stock Exchange Main Market around November 15, 2024. Following admission, the company's total issued share capital will comprise 1,401,815,988 ordinary shares.

Hemogenyx Pharmaceuticals has announced the schedule for opening its first clinical site for the Phase I trial of HEMO-CAR-T (HG-CT-1), targeting relapsed/refractory acute myeloid leukemia in adults. The company expects Institutional Review Board approval by mid-November, followed by a Site Initiation Visit in the third week. The trial will evaluate HG-CT-1's safety profile and assess secondary objectives including efficacy, overall survival rates, progression-free survival, and duration of response in patients with R/R AML who have therapeutic options.

Hemogenyx Pharmaceuticals announces a strategic investment from Prevail Partners, , totaling $350,000 (£269,000) through a subscription for ordinary shares at $0.075 per share, a 275% premium to the closing price on October 1, 2024. The subscription will take effect in March 2025, supporting the planned HEMO-CAR-T pediatric study.

Additionally, Hemogenyx's subsidiary has signed an amendment with Prevail InfoWorks, Inc. to provide clinical services for the upcoming Phase I study of anti-FLT3 CAR-T cells in pediatric patients with relapsed/refractory acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The study is expected to commence in the first half of 2025.

The investment from Prevail Partners will largely cover the initial payment to InfoWorks for the pediatric study services.

Hemogenyx Pharmaceuticals plc (LSE: HEMO) has released its unaudited interim results for the six months ended 30 June 2024. Key highlights include:

• FDA lifted the clinical hold on the IND application for HEMO-CAR-T
• Raised £3.325 million to advance HEMO-CAR-T towards Phase I clinical trials
• Phase I trials expected to begin shortly at M.D. Anderson Cancer Center in Texas
• Advancements in Chimeric Bait Receptor (CBR) and bispecific antibody (CDX) programmes

The company has focused on getting HEMO-CAR-T into clinical trials while progressing other product candidates. They have evaluated its potential for pediatric AML and a subset of ALL. A clinical-grade assay for HEMO-CAR-T trials has been developed. The CBR platform is being tested against rare cancers and viral infections. CDX studies for IND application are advancing, with a new improved version showing enhanced effectiveness in lab tests.

Financial results show a loss before taxation of £2,815,604 for H1 2024, with cash and cash equivalents of £1,642,762 as of 30 June 2024.