REG - Hemogenyx Pharma Plc - Strategic Investment from Prevail Partners, LLC

Hemogenyx PharmaceuticalsAnnouncement

02/10/2024 11:30

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RNS Number : 6680G  Hemogenyx Pharmaceuticals PLC  02 October 2024

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.

 

Enquiries:

 

 Hemogenyx Pharmaceuticals plc                                   https://hemogenyx.com (https://hemogenyx.com/)
 Dr Vladislav Sandler, Chief Executive Officer & Co-Founder      headquarters@hemogenyx.com (mailto:headquarters@hemogenyx.com)
 Peter Redmond, Director                                         peter.redmond@hemogenyx.com (mailto:peter.redmond@hemogenyx.com)

 SP Angel Corporate Finance LLP                                  Tel: +44 (0)20 3470 0470
 Matthew Johnson, Vadim Alexandre, Adam Cowl

 Peterhouse Capital Limited                                      Tel: +44 (0)20 7469 0930
 Lucy Williams, Duncan Vasey, Charles Goodfellow

 

 

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/ (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/ (https://prevailinfoworks.com/) .

 

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