HEMO Hemogenyx Pharmaceuticals Plc

2 October 2024

Hemogenyx Pharmaceuticals plc 

("Hemogenyx Pharmaceuticals" or the "Company")

Strategic Investment from Prevail Partners, LLC

·   Prevail Partners, LLC to invest again in Hemogenyx Pharmaceuticals

·   Prevail InfoWorks, Inc. to act as Clinical Research Organization (CRO) for upcoming Phase I pediatric clinical study

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 a total of $350,000 (approximately £269,000) in the Company through a subscription for ordinary shares in the Company at a price of US$0.075 per share (approximately 5.6p). This follows a similar investment in the Company by Prevail Partners announced on 18 September 2024. The subscription price represents a premium of approximately 275% to the Company's closing share price on 1 October 2024.

The subscription will take effect in March 2025 ahead of the planned HEMO-CAR-T pediatric study. This will follow the initiation of the adult clinical trial in HEMO-CAR-T at the MD Anderson Cancer Center, Texas, which is expected to commence later this year. The agreement governing the subscription contains customary warranties from the Company and Prevail Partners.

The Company's wholly owned subsidiary, Hemogenyx Pharmaceuticals LLC, has also signed an amendment to the Master Service and Technology Agreement ("MSTA"), (the "Amendment") with Prevail InfoWorks, Inc. ("InfoWorks"), the Philadelphia, PA based Clinical Research Organization ("CRO"), and affiliate of Prevail Partners. Infoworks is already contracted by the Company in relation to the existing planned HEMO-CAR-T clinical trials in adult patients.

Under the terms of the Amendment, 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 pediatric subjects with relapsed/refractory acute myeloid leukemia (AML) and a subset of acute lymphoblastic leukaemia (ALL). The Amendment will come into effect in March 2025.

Services to be provided under the terms of the Amendment 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 26 months, and Hemogenyx Pharmaceuticals LLC has agreed an initial statement of works relating to the Phase I pediatric AML/ALL study. The pediatric study is expected to commence in the first half of 2025.

The subscription funds received from Prevail Partners will in large part defray the payment made by the Company for the first stage of the work to be undertaken by InfoWorks under the Amendment.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "As we seek to bring the curative power of cell therapies to children suffering from the otherwise largely incurable life-threatening diseases, AML and ALL, we are very confident in Prevail InfoWorks' ability to coordinate our Phase I clinical trial in pediatric relapsed/refractory AML and ALL. 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, once again at a price very substantially above the Company's existing share price, 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 leukaemia and a subset of acute lymphoblastic leukaemia in children. 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.

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.

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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 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/.