LONDON, UNITED KINGDOM / ACCESSWIRE / September 27, 2024 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing therapies designed to transform blood disease treatment, whose shares are admitted to the equity shares (transition) category of the Official List, announces its unaudited interim results for the six-month period ended 30 June 2024.
All financial amounts are stated in GBP British pounds unless otherwise indicated.
Key Highlights
The U.S. Food and Drug Administration ("FDA") lifted the clinical hold on the Investigational New Drug ("IND") application for HEMO-CAR-T.
Raised £3.325 million to advance HEMO-CAR-T towards Phase I clinical trials.
Phase I clinical trials expected to begin shortly at M.D. Anderson Cancer Center ("MD Anderson") in Texas.
Continuing to make advancements with the Company's Chimeric Bait Receptor ("CBR") and bispecific antibody ("CDX") programmes.
Fuller details of these developments are contained in the Interim Management Report below.
Interim Management Report
We are pleased to present Hemogenyx Pharmaceuticals' half year report for the period ending 30 June 2024. The past six months have been a time of significant progress and strategic advancement for our company as we continue to develop novel therapies inter alia for the treatment of serious blood diseases.
During the first half of 2024, the Company has been mainly focussed on getting its lead product, HEMO-CAR-T, into clinical trials, while continuing to progress its other main product candidates, CBR and CDX.
HEMO-CAR-T
In February 2024, the FDA lifted the clinical hold on the IND application for HEMO-CAR-T, our treatment for acute myeloid leukemia ("AML"), which had been imposed in June 2023. The FDA confirmed that we have satisfactorily addressed all issues identified in its prior clinical hold letter, allowing us to proceed with the Phase I clinical study of HEMO-CAR-T. Following the reopening of the IND, we successfully raised £3.325 million (before expenses) at 2p per share, issuing 166,250,000 ordinary shares, to advance HEMO-CAR-T into Phase I clinical trials.
The trials are expected to begin shortly at MD Anderson in Texas, one of the leading cancer treatment centers in the U.S. As shareholders know, we have been collaborating with the University of Pennsylvania Medical Center ("Penn") to conduct the trials at their facility. While Penn remains supportive and wishes to participate, several issues have delayed their proposed schedule. Fortunately, we connected with MD Anderson regarding their participation in the trials. MD Anderson is a large and highly reputable centre for cancer treatment, including AML, and they are confident in maintaining a consistent and reliable flow of trial candidates. It is important to note that every patient from the very first one treated in the HEMO-CAR-T clinical study will produce valuable data regarding the safety and potentially efficacy of the treatment.
We are now in the final stages of the opening a clinical site at MD Anderson and expect to treat the first patient soon. Penn remains eager to participate in the trials at a later stage, and we hope they will do so, though likely not until 2025.
While we have been discussing partnerships with potential hospital collaborators, we have made significant progress with HEMO-CAR-T during the period under review. We have evaluated its potential to treat pediatric AML and a subset of pediatric acute lymphoblastic leukemia ("ALL") in young patients. An amendment to include pediatric AML in our clinical protocol has been reviewed by independent experts, and we will extend the protocol accordingly. If approved as expected, we plan to initiate clinical trials for pediatric AML and a subset of ALL at MD Anderson. These indications are of particular concern because current treatments are risky and have low success rates. There is an urgent need for effective therapies, and we believe HEMO-CAR-T can provide a valuable solution.
In addition, the Company recently announced that it has successfully completed the development of a clinical-grade assay for use in HEMO-CAR-T clinical trials, a project the Company has been working on for some time. This assay is designed to assess and ensure the proper identification and recruitment of suitable patients for the clinical trials.
We are continuing our collaboration with Prevail Infoworks, the contract research organization that will manage and oversee the planning and execution of our clinical trials. Currently, they are working closely with us to bring HEMO-CAR-T into the clinic. When the trials commence, we will manufacture the HEMO-CAR-T cells at our New York facility for use in each individual patient. Prevail Infoworks will coordinate the logistical aspects of the trials, including patient enrolment, data management, regulatory compliance, and overall trial monitoring, ensuring that the studies are conducted efficiently and effectively.
Although we had hoped to start the trials sooner, we have used this time to further advance development of the HEMO-CAR-T program, which will make the execution and assessment of the trials easier. Developing the clinical-grade assay and focusing on pediatric opportunities are significant steps forward. These advancements will help us carry out the clinical trials more effectively and broaden the potential use of HEMO-CAR-T to additional leukaemia patients who currently have very limited treatment options.
CBR and CDX
As we have been waiting for the HEMO-CAR-T clinical trials to commence, we have been able to apply more effort to progress our other product candidates, in particular the CBR and the CDX programs.
Our CBR platform is an advanced immunotherapy designed to reprogram or redirect immune cells, such as macrophages, to prevent and combat infections from both existing and emerging viral threats, as well as to eliminate specific types of cancer. Our research originally focused on the former where, for example, we established in vitro that CBR could treat viruses such as COVID and potentially a much wider range of viruses. More recently, we have established that it could also be used against a range of cancers. We are developing and testing multiple CBR constructs to identify the best candidates for targeting rare cancers such as epithelial ovarian carcinoma. Selected CBR candidates will undergo rigorous testing to advance them to IND enabling studies. In addition, we have established a means of delivering CBR intranasally, for treating airborne viral infections which would significantly ease the use of CBRs in the field. We have also recently made improvements in the stability of mRNA-based CBRs to further enhance the effectiveness of this treatment.
Regarding CDX, we have been advancing the studies required for an IND application. CDX is designed to prepare patients with AML for bone marrow transplants and, we believe, may also be directly capable of treating relapsed or refractory AML. Meanwhile, we have developed a new and improved version of CDX. Our scientists used bispecific pairing technology to create this version, and it has shown significantly enhanced effectiveness in the laboratory (in vitro) tests. Additional animal (in vivo) studies are currently underway.
HEMO-CAR-T and CDX offer different yet complementary approaches to treating AML. CDX is specifically designed to target AML cells and has the potential to condition patients for bone marrow transplants. By directly attacking AML and preparing patients for transplants, CDX provides a dual strategy in combating this aggressive cancer. On the other hand, HEMO-CAR-T involves modifying a patient's T-cells to seek out and destroy cancer cells. By developing both therapies, we increase our chances of success and aim to offer effective treatment options to a broader range of AML patients.
Financial Results
During the six months ended 30 June 2024, the Group recorded a loss before taxation of £2,815,604 (2023: £4,323,564 loss), including operating costs of £2,369,455 (2023: £3,896,308). For further comparison, the operating costs for the twelve months to 31 December 2023 were £5,820,165. The reduction in costs for the period ended 30 June 2024 compared to the same period in 2023 is due to two principal factors: a significant favourable movement in the UK sterling and US dollar exchange rate accounting for a variance of £1,039,436 and a reduction in research and development costs of £413,419. This is primarily due to a reduction in payments to WuXi in respect of the Company's advancement to the clinical trial phase. These costs concluded in March 2024.
The Company had cash and cash equivalents totalling £1,642,762 as of 30 June 2024.
Conclusion
We have now reached a pivotal stage where our lead product, HEMO-CAR-T, is set to enter the clinic, a development that undeniably elevates us to a clinical-stage company. Meanwhile, our other product candidates are also making significant strides forward. We are confident in our ability to finance their development through a combination of equity capital, industry partnerships, and non-dilutive funding. We look forward to bringing our potentially life-saving therapies into use and delivering positive returns to our shareholders.
Responsibility Statement
We confirm that to the best of our knowledge:
the Half Year Report has been prepared in accordance with International Accounting Standard 34 'Interim Financial Reporting'; and
gives a true and fair view of the assets, liabilities, financial position and loss of the Group; and
the Half Year Report includes a fair review of the information required by DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication of important events that have occurred during the first six months of the financial year and their impact on the set of interim financial statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and
the Half Year Report includes a fair review of the information required by DTR 4.2.8R of the Disclosure and Transparency Rules, being the information required on related party transactions; there were no such transactions in the six months ended 30 June 2024.
The Half Year Report was approved by the Board of Directors and the above responsibility statement was signed on its behalf by:
Dr Vladislav Sandler CEO
26 September 2024
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