Hemogenyx Regulatory News (HEMO)

18 September 2023

Hemogenyx Pharmaceuticals plc 

("Hemogenyx Pharmaceuticals" or the "Company")

Hemogenyx Pharmaceuticals Announces Strategic Investment from Prevail Partners, LLC

· Prevail Partners, LLC to invest in Hemogenyx Pharmaceuticals.

· Prevail InfoWorks, Inc. to act as Contract Research Organization (CRO) for upcoming Phase I clinical study, expected to commence in 2023.

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, announces that Prevail Partners, LLC ("Prevail Partners"), an investment fund, has agreed to invest in the Company through a subscription for 11,066,667 ordinary shares (the "New Ordinary Shares") at a price of US$0.075 per share (approximately £0.06) for the total sum of $830,000 (approximately £668,000). The subscription price represents a premium of approximately 240% to the Company's closing share price on 14 September 2023, when agreement was reached as to the final terms of the investment. The agreement governing the subscription (the "Subscription Agreement") contains customary warranties from the Company and Prevail Partners. Following allotment, Prevail Partners will hold approximately 0.96% of the Company's issued share capital.

The Company's wholly owned subsidiary, Hemogenyx Pharmaceuticals LLC, has also signed a Master Service and Technology Agreement ("MSTA") with Prevail InfoWorks, Inc. ("InfoWorks"), a Philadelphia, PA based Contract Research Organization (CRO) and affiliate of Prevail Partners. Under the terms of the MSTA, InfoWorks is 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). Services include clinical site coordination, project management, data management, clinical monitoring, and pharmacovigilance (safety management) services, and the use of InfoWorks' integrated real-time data analytics platform, The Single Interface®, for clinical support and real-time data analysis. The MSTA has an initial term of 40 months, and Hemogenyx Pharmaceuticals LLC has agreed an initial statement of works relating to the Phase I AML study.

The subscription funds will in large part defray the payment made by the Company for the first stage of the work being undertaken by InfoWorks under the MSTA.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "As we seek to bring the curative power of cell therapies to a greater number of patients suffering from otherwise incurable life-threatening diseases, we are very confident in Prevail InfoWorks' ability to coordinate our Phase I clinical trial in relapsed/refractory AML. Their operational experience and expertise will enable a smooth execution of the study, while their specialization in real-time data integration and analytics will ensure fast, reliable data access to lower our clinical risk and potentially speed up our regulatory timeline. Prevail Partners' strategic investment in the Company demonstrates their confidence in our CAR-T program and in our ability to execute the upcoming clinical study."

Mary Schaheen, President of Prevail Partners, stated: "Everyone at our fund is confident in the growth and success of Hemogenyx Pharmaceuticals as they develop CAR-T cells to target acute myeloid leukemia. Furthermore, Hemogenyx Pharmaceuticals has a seasoned management team with the expertise to accelerate the company to a significant value inflection point through the completion of its planned clinical trial."

About AML and CAR-T Therapy

AML, the most common type of acute leukemia in adults, has poor survival rates (a five-year survival rate of less than 30% in adults) and is currently treated using chemotherapy, rather than the potentially more benign and effective form of therapy being developed by Hemogenyx Pharmaceuticals. The successful development of a new therapy for AML would have a major impact on treatment and survival rates for the disease.

CAR-T therapy is a treatment in which a patient's own T-cells, a type of immune cell, are modified to recognize and kill the patient's cancer cells. The procedure involves: isolating T-cells from the patient; modifying the isolated T-cells in a laboratory using a CAR gene construct (which allows the cells to recognize the patient's cancer); amplifying (growing to large numbers) the newly modified cells; and re-introducing the cells back into the patient.

Allotment of Ordinary Shares and Applications for Admission

The New Ordinary Shares will be allotted and issued subject to receipt of the subscription monies from Prevail Partners, which is to be made within 5 business days from the date of the Subscription Agreement and MSTA (such date being 14 September 2023). Applications will be made for the New Ordinary Shares to be admitted to the standard segment of the Official List and to trading on the Main Market for listed securities of London Stock Exchange plc. It is expected that admission will become effective on or around 29 September 2023.

The New Ordinary Shares will, on admission, rank pari passu in all respects with the ordinary shares currently in issue and will rank in full for all dividends and other distributions hereafter declared, paid or made on the ordinary share capital of the Company.

Total Voting Rights

Following the issue of the New Ordinary Shares, the Company will have 1,153,065,988 ordinary shares in issue, each share carrying the right to one vote.

This figure of 1,153,065,988 ordinary shares may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change in their interest in, the share capital of the Company under the FCA's Disclosure Guidance and Transparency Rules.

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement would have been inside information for the purposes of Article 7 of Regulation No 596/2014 (as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018) until the release of this announcement. The person responsible for arranging for the release of this announcement on behalf of Hemogenyx Pharmaceuticals plc is Dr Vladislav Sandler, Chief Executive Officer & Co-Founder.

Enquiries:

About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.

The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development.

About Prevail Partners, LLC

Prevail Partners, LLC is a corporate strategic investment fund investing in clinical stage therapeutics companies. More information is available at https://prevailpartners.com/.

About Prevail InfoWorks, Inc.

Prevail InfoWorks, Inc. is a global full-service CRO/FSP and one-stop-shop for clinical trial services and systems. More information is available at https://prevailinfoworks.com/.