Hemogenyx Pharmaceuticals PLC Announces Half-year Report

Half-year Report
Interim Results for the period ended 30 June 2022

LONDON, UK / ACCESSWIRE / September 29, 2022 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the Standard Listed biopharmaceutical group developing therapies designed to transform blood disease treatment, announces its unaudited interim results for the six-month period ended 30 June 2022.

All financial amounts are stated in GBP British pounds unless otherwise indicated.

Key Highlights

• In final stages of preparation for filing an Investigational New Drug ("IND") application to commence clinical trials for HEMO-CAR-T, following positive feedback from the US Federal Drug Administration
• Continuing development of CDX antibody and Chimeric Bait Receptor antiviral/biodefence platform
• Bolstered the scientific team in preparation for clinical trials and cell manufacturing with two key appointments
• Following the period end, moved into state-of-the-art new laboratory facilities in Manhattanville, New York, with clean rooms and equipment enabling in-house cell manufacturing
• On track and on budget for initiating phase I clinical trials of HEMO-CAR-T, subject to approval

Fuller details of these developments are contained in the Interim Management Report below.

Commenting on the outlook for Hemogenyx Pharmaceuticals, Sir Marc Feldmann, Chairman, said:
"The Board is delighted with the continued high quality work of the Company and in particular with the steps taken to ensure that the difficult task of submitting a comprehensive IND application for HEMO-CAR-T is delivered efficiently. We anticipate taking HEMO-CAR-T, and indeed the Company, to their next phase of development, entering the clinical stage. At the same time, the Company's roster of other cutting-edge assets gives confidence that Hemogenyx Pharmaceuticals will make further important contributions to healthcare. We look forward to providing shareholders with more news as we gear up to becoming a clinical-stage company."

Interim Management Report

We are pleased to provide an update on the Company's activities over the six-month period ended 30 June 2022.

The six months concerned were a period of steady but very definite progress. This has been aided by our move to a state-of-the-art purpose-built laboratory facility which enables us to undertake research and manufacturing processes that we were previously unable to carry out in-house, and more importantly to progress our three main programmes, in particular HEMO-CAR-T. During the period under review, work also continued both on our CDX bi-specific antibody and Chimeric Bait Receptor ("CBR") platform.

HEMO-CAR-T

HEMO-CAR-T, a CAR-T therapy targeting Acute Myeloid Leukaemia ("AML"), is our lead product candidate, the intellectual property and development of which are in the Company's sole control. We have been working toward completing the necessary IND application for HEMO-CAR-T, having held detailed discussions with the US Federal Drug Administration ("FDA") during the period and received constructive feedback through a pre-IND submission that confirmed our development process and our proposals for clinical trials. Most of the data required for the IND application has been compiled and the components for manufacturing HEMO-CAR-T have been produced. We are now engaged in the final stages of establishing the production of HEMO-CAR-T cells for the treatment of patients. We are confident of completing the IND application in the near future and are working on detailed protocols for carrying out clinical trials.

The work is necessarily very detailed as the main concern in the process is to ensure patients' safety, which requires great care on the FDA's part and of course ours. We have been working with a group of Key Opinion Leaders in the treatment of acute leukaemias that has helped us to hone our approach to clinical trials. We are now in the process of finalising our trial protocol, which will involve a relationship with at least one major hospital, likely to include the University of Pennsylvania with whom we already have a working arrangement.

CDX Antibody

With the help of Selexis SA, we are in the process of establishing a CDX master cell line and a research cell bank ("RCB") which are necessary for the manufacturing of CDX for both IND-enabling studies and clinical trials. On 20 July, following the end of this reporting period, the Company's existing intellectual property protection for CDX was further strengthened by the China National Intellectual Property Administration granting patent number 201780034711.2, titled Method of Eliminating Hematopoietic Stem Cells/Hematopoietic Progenitors (HSC/HP) In a Patient Using Bi-specific Antibodies. This patent joins patents previously granted in the US for CDX and monoclonal antibodies used for the development of CDX and HEMO-CAR-T. The Company is exploring partnership options for taking CDX through final IND-enabling studies and into clinical trials.

CBR

We have also made significant progress with CBR, a novel platform technology that constitutes a new paradigm for treating viral infections. The essence of the CBR-based approach is programming immune cells using a novel type of modifiable synthetic receptor to destroy viral pathogens. This approach can also potentially be used to programme immune cells to destroy malignant cells causing certain types of cancer. Our scientists have achieved in vitro proof of concept for a CBR construct that neutralises all known variants of the SARS-CoV-2 virus that causes COVID, and have now completed preparations to test it against live replicating virus in a Biosafety Level 3 facility. The Company has filed a seminal provisional patent application protecting its rights to the intellectual property ("IP") covering CBR.

Personnel and Establishment

While we continue to keep a tight rein on costs, our preparations for clinical trials and manufacturing of HEMO-CAR-T have been greatly enhanced through the recruitment of a Medical Director and a Director of Quality. Dr Koen van Besien, one of America's top bone marrow transplant and oncology doctors joined us as Medical Director. Dr van Besien will oversee the development of the clinical trial programme for our HEMO-CAR-T. He is uniquely positioned to accelerate studies of HEMO-CAR-T in the clinic due to his rich experience and deep insight into the cutting-edge treatments of patients suffering from blood cancers.

We have also appointed Mr Stuart Tinch as Director of Quality. His great understanding and experience into the cutting-edge GMP manufacturing of viral vectors and cell therapies as well as his expertise in establishing and maintaining quality systems will help to accelerate Hemogenyx Pharmaceuticals' product candidates. Stuart will help us to establish manufacturing of our lead product candidate, HEMO-CAR-T, as well as potentially other cell therapies, according to the highest standards of quality to facilitate their transition into the clinic.

Finally, following the end of this reporting period we moved into our custom-built research and manufacturing facility in the Manhattanville district of New York City. The new facility includes two clean rooms for the cGMP ("current Good Manufacturing Practice") manufacturing of cell therapies including our own HEMO-CAR-T cells for the treatment of AML. These clean rooms have been through commissioning and validation and are ready to be certified. The new facility will allow us to take matters further in-house in areas which we previously outsourced as well as potentially to achieve significant savings.

Fundraising

During the period, the Company did not undertake any fundraising.

Financial Results

During the six months ended 30 June 2022, the Company recorded a loss of £1,300,653 (2021: £3,632,338 loss). During the six months ended 30 June 2022, the Company recorded a loss from operations of £1,143,243 (2021: £1,161,497 loss). The loss in the 2021 period includes financing related expenses of £2,650,232. The losses from operations in both the 2022 and 2021 periods were relatively consistent, reflecting the similar size of the employee base and conservative spending of our funding. The Company had cash and cash equivalents totalling £5,799,495 as at 30 June 2022.

The Company recorded no consultancy income during the period ended 30 June 2022 (2021: £98,995, relating to funds received from a third party under a research collaboration associated with humanised mice).

The Future

Hemogenyx Pharmaceuticals, aided by its commercial and scientific advisers, has continued to advance its programme of work across its portfolio while making optimal use of its financial resources. Current scientific work is focused primarily on preparations for taking HEMO-CAR-T to clinical trials which will constitute a significant milestone for the Company. Meanwhile, the team continues to progress its CDX and CBR assets, and to seek ways to further their development.

We have made good progress on multiple fronts over the period and I thank our dedicated staff, distinguished advisory team and our directors.

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 2022.

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

29 September 2022

Market Abuse Regulation (MAR) Disclosure

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation ("MAR") (EU) No. 596/2014, as incorporated into UK law by the European Union (Withdrawal) Act 2018. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

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SOURCE: Hemogenyx Pharmaceuticals PLC