Hemogenyx Pharmaceuticals Regulatory News (HEMO)

Hemogenyx Pharmaceuticals plc

("Hemogenyx" or the "Company")

Operational Update

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments of blood diseases, is pleased to announce the following update on its activities.

CDX Antibodies

GlobalCo development agreement

Work with a global international pharmaceutical company ("GlobalCo") on the Company's CDX antibody ("CDX") as a clinical candidate, first announced on 14 May 2018, has entered its second phase. The Company and GlobalCo continue to develop CDX towards clinical readiness and have initiated manufacturability assessment and follow-up tests of the antibody.

Hemogenyx and GlobalCo remain optimistic as to the outcome of these tests based on results to date and look forward to providing further updates as the development work progresses.

Expansion of CDX into additional indications

In parallel to the work performed with GlobalCo, the Company is also progressing research into the use of CDX as a treatment for subsets of Acute Myeloid Leukemia ("AML"), Acute Lymphoblastic Leukemia ("ALL") and Myelodysplastic Syndrome ("MDS"). The antibody has been shown to be effective in vivo against AML-derived cells using the Company's proprietary humanised mice. These potential applications of the CDX product candidate could provide life-saving treatments against three forms of blood cancer which remain resistant to current modes of treatment.

The use of CDX as a therapy against blood malignancies is beyond what was anticipated when the Company listed in 2017. At this time CDX was being developed purely as a conditioning product for bone marrow transplantation.

Intellectual property

As announced on 12 July 2019, the Company filed a new patent application for CDX in relation to conditioning patients for bone marrow transplantation and treatments for blood cancers such as AML and ALL. An additional composition of matter patent application is expected to be filed upon the completion of the development agreement with the GlobalCo.

Humanised Mice

As announced on 23 October 2019, Immugenyx, LLC ("Immugenyx"), the Company's wholly-owned subsidiary, entered into a research agreement with the above-mentioned GlobalCo to develop Immugenyx's advanced humanised mice as a tool for drug development and testing. If the first phase of research produces successful results, Hemogenyx anticipates that further phases of the research will be commissioned, as has been the case with other trials using the Company's humanised mice.

Immugenyx has already completed or entered into humanised mouse related projects with a number of other large pharmaceutical companies, including the previously announced agreement with Janssen Research & Development, LLC ("Janssen"), to build a model of human systemic lupus erythematosus, an autoimmune disease. These agreements confirm the value of the new type of humanised mice within the pharmaceutical community and give the Company an immediate revenue stream which the Directors believe can be developed and promoted considerably more widely. Immugenyx is also in discussions with other pharmaceutical organisations for research agreements using its humanised mice.

Hu-PHEC Stem Cell Therapy

Hemogenyx-Cell SPRL is the Company's wholly-owned subsidiary, established to develop Hu-PHEC, the Company's stem cell therapy product, for the direct treatment of leukaemia and other blood diseases. This subsidiary has received an in principle offer of grant/loan funding from the South Belgian regional authorities. The Directors are currently reviewing the terms of this offer and the conditions attached.

Patents in relation to the Hu-PHEC development are also at an advanced stage in the pipeline.

The Directors are therefore pleased to announce positive progress in relation to all three of the Company's areas of activity.

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 until the release of this announcement.

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About Hemogenyx Pharmaceuticals plc

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

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

For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. Hemogenyx's technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation.