Interim Results for the period ended 30 June 2023
LONDON, UK / ACCESSWIRE / September 28, 2023 / 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 2023.
All financial amounts are stated in GBP British pounds unless otherwise indicated.
- Applied for Investigational New Drug ('IND') status for the Company's lead product HEMO-CAR-T with the U.S. Food and Drug Administration ('FDA').
- IND application placed on clinical hold, with the FDA later accepting the Company's plan for resolving outstanding issues.
- Continuing development of Chimeric Bait Receptor ('CBR') antiviral/biodefence platform.
- Following the period end, the Company received a strategic investment of US$833,000 from Prevail Partners, LLC ('Prevail Partners') at a large premium to share price.
- Entered into agreement with Prevail InfoWorks Inc. ('Prevail InfoWorks') to provide clinical services and technologies for the Company's upcoming Phase I clinical trial of HEMO CAR-T.
Fuller details of these developments are contained in the Interim Management Report below.
Commenting on the outlook for Hemogenyx Pharmaceuticals, Vladislav Sandler, Chief Executive Officer, said:
'While the placing of HEMO-CAR-T on clinical hold was a setback, we are clear on the particular area in which additional information is required, and we are encouraged by the FDA's response to our plans to resolve the issues. We remain confident and committed to progressing HEMO CAR-T to clinical trials as the Company's next step. We have put measures in place to allow us to achieve this milestone, including the new agreement with Prevail InfoWorks and the investment by Prevail Partners, which gives a clear signal of the project's value even at this pre-clinical phase. Meanwhile, the prospects for our other cutting-edge assets continue to be positive, and CBR in particular is beginning to attract real attention.'
Interim Management Report
We are pleased to provide an update on the Company's activities over the six-month period ended 30 June 2023. Although it is not all plain sailing, we are now developing on a number of fronts which, while adding materially to operating costs, puts us into a far stronger position for further development. In particular, we are now seeing major benefits from our state-of-the-art research and manufacturing facilities and we have also made cautious but significant additions to our scientific and manufacturing team.
The Company has continued to focus on its lead product candidate, HEMO-CAR-T, throughout 2023 and, as shareholders are aware, after substantial work we submitted an IND application to the FDA in May 2023. The FDA considered that in certain respects they needed additional information and therefore placed the project on clinical hold in June. We received a detailed explanation from the FDA as to the areas needing additional work and we have since then been working with our manufacturing partner, WuXi, to address FDA concerns.
We are taking great care to provide a very thorough response with the aim that the IND application, when resubmitted, is as full and complete as possible. Having responded to the FDA with a detailed plan, supported by laboratory tests, to address its comments, we were pleased earlier this month when the FDA confirmed that it accepts our plan and that this plan will satisfactorily address its comments. This will enable the agency to remove the clinical hold so that we can proceed to clinical trials. There remains work to be done on this, but we are confident of eventual success.
The reason for the clinical hold relates to a splicing that occurs during the manufacturing process of the lentivirus that is used to produce CAR-T cells. The Company has identified the source of the splicing deficiency and has already developed a method to eliminate it. The lentivirus is being remanufactured.
On 14 September, we were able to announce a very important further step towards the development of HEMO CAR-T which also represents a real validation of the product's perceived value. We received a strategic investment from Prevail Partners, a corporate investment fund investing in clinical stage therapeutics companies. Prevail Partners has agreed to invest in Hemogenyx Pharmaceuticals through a subscription to 11,066,667 new ordinary shares at a price of US$0.075 per share (approximately £0.06) for the total sum of US$830,000 (approximately £668,000). Such investment, at a significant premium to the Company's share price at the time, represents a vote of confidence by a specialist professional group with knowledge and experience of the pharmaceutical industry.
The investment by Prevail Partners sits alongside the agreement entered with Prevail Infoworks, a Philadelphia, PA based Contract Research Organization (CRO) and affiliate of Prevail Partners, to provide clinical services and technologies for the Company's upcoming Phase I study of its anti-FLT3 chimeric antigen receptor-redirected T cells ('CAR-T cells') in subjects with relapsed/refractory acute myeloid leukemia (AML). Further details may be found below in Note 10 to the financial statements titled 'Events after the reporting period'.
Meanwhile, we have continued to work on our other major product candidates, in particular our Chimeric Bait Receptor ('CBR') platform which, as shareholders are aware, is focussed on developing a new approach which we believe will provide effective cures for a wide range - indeed perhaps the full range - of viral infections, including diseases for which no cures are available at present. In the wake of the COVID-19 pandemic, and facing global threats of biological warfare and the fast spreading of pandemics from previously unknown diseases, the need for proactive solutions against future infectious agents has become clear. To address this imminent threat, our CBR immunotherapy is designed to prevent and combat infection by any known or emerging virus.
We have designed a set of novel CBR constructs to programme the immune cells that are responsible for innate immunity to eliminate viral infections. Additionally, we have designed and currently test bait-macrophage engagers ('BMEs') to redirect immune cells to fight viral infections. Our technology utilises a synthetic biology approach to advance medicine to protect society from future pandemics and even future bioweapons that may challenge the global economy and public health. Our early work concentrated on SARS-CoV-2 virus and its variants, but we also believe that CBR-based treatments will be able to deal with a much wider range of viruses.
We have strengthened our team with the recruitment of additional scientists during the period, inter alia to work on our CBR/BME platform. The project has begun to attract high-level interest from authorities. This interest is gratifying and, given our limited resources and the need to focus on our lead product HEMO-CAR-T, we have made considerable progress and plan to devote further internal resources to this project as soon as HEMO-CAR-T enters clinical trials.
CDX, our CD3-FLT3 bispecific antibody, will provide an alternative means of treating acute myeloid leukemia and of conditioning patients for bone marrow transplants when fully developed. We continue to explore potential partnership arrangements to take that forward. This remains a potentially valuable part of our portfolio and we will also work to take this forward once our lead product has moved into the clinic.
In January 2023, we announced that the Company had raised £4,056,250 before expenses through the placing and subscription of 162,250,000 new ordinary shares at a price of 2.5p per share.
In addition, following the period end, we raised a further US$833,000 (£668,000) at approximately £0.06, as more fully described in the section headed 'HEMO-CAR-T' above.
During the six months ended 30 June 2023, the Group recorded a loss before taxation of £4,323,564 (2022: £1,141,304 loss), including operating costs of £3,896,308 (2022: £1,111,010). For further comparison, the operating costs for the twelve months to 31 December 2022 were £3,433,476. The increased operating loss marks the increasing volume of work and need to engage external service providers as the Company's assets are taken towards the crucial clinical trial stage of their development. These include significant payments to WuXi and other consultants engaged in development services, increased costs for our research and manufacturing facility and additional payroll costs as we added to our specialist scientific team. The increase in cost is an inevitable corollary of developing the Company on a broader scale and moving forward its key projects.
The Company had cash and cash equivalents totalling £3,084,852 as of 30 June 2023.
In the immediate future, we remain laser-focused on resubmitting our IND application for HEMO-CAR-T to the FDA as soon as we can, and on preparing for its move into clinical trials.
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 2023.
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
28 September 2023
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SOURCE: Hemogenyx Pharmaceuticals PLC
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