RCS - Faron Pharma. Oy - Faron confirms plans under new leadership

Faron Pharmaceuticals OyAnnouncement

16/04/2024 07:00

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RNS Number : 6905K  Faron Pharmaceuticals Oy  16 April 2024

Faron Pharmaceuticals Oy

("Faron" or the "Company")

 

Faron confirms plans for the coming months under new leadership

 

-  Initial data from ongoing Phase 2 part of BEXMAB trial anticipated next
month

-  Incoming CEO, Juho Jalkanen, to accelerate discussions with US regulator
to coordinate plans for obtaining marketing approval for MDS patients that
have failed HMA

 

Press Release, April 16, 2024 at 9:00 (EEST) / 7:00 AM (BST) / 2:00 AM (EDT)
 

 

TURKU, FINLAND / BOSTON, MA - Faron Pharmaceuticals Ltd. (AIM: FARN, First
North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER
approach to reprogramming myeloid cells to activate anti-tumor immunity in
hematological and solid tumor microenvironments, today announces ongoing plans
and activities for the coming months following the recent announcement of the
proposed appointment of Dr. Juho Jalkanen as Chief Executive Officer,
effective 1 May 2024.

 

Initial data from the ongoing Phase 2 part of the BEXMAB trial, evaluating the
safety and efficacy of bexmarilimab in combination with standard of care
(SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed
myelodysplastic syndrome (MDS), is expected to be announced during the week
commencing 20 May 2024. This data read out will be important for ongoing
partnering discussions and the major upcoming industry events that Faron will
be attending, including the American Society for Clinical Oncology (ASCO)
annual meeting and the Bio International Convention, taking place in June
2024.

 

Given the promising data already seen in the Phase 1 part of the trial, among
HMA-failed MDS patients who have no approved treatment options, the Company
plans to approach the US Food and Drug Administration (FDA) earlier than
planned this year, seeking a Scientific Advice meeting regarding its
registrational study plan, in order to coordinate and finalize plans that may
lead to marketing approval.

 

"2024 is set to be a pivotal year for Faron in the delivery of key milestones
that will be critical to the further development of bexmarilimab," said Dr.
Juho Jalkanen, Faron's incoming Chief Executive Officer. "In my new role as
CEO I am excited to start executing on some of these key activities and to
accelerating important discussions with the FDA as we map our future plans for
bexmarilimab together. There is a tremendous need for an effective treatment
in HMA-failed MDS patients and so we are very keen to ensure we get this
treatment option to patients as soon as we can."

 

 

For more information please contact:

 

Faron Pharmaceuticals

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com (mailto:daniel@lifesciadvisors.com)

+1 (617) 430-7576

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com (mailto:faron@consilium-comms.com)

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

 

About Faron Pharmaceuticals Oy

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage
biopharmaceutical company, focused on tackling cancers via novel
immunotherapies. Its mission is to bring the promise of immunotherapy to a
broader population by uncovering novel ways to control and harness the power
of the immune system. The Company's lead asset is bexmarilimab, a novel
anti-Clever-1 humanized antibody, with the potential to remove
immunosuppression of cancers through targeting myeloid cell function.
Bexmarilimab is being investigated in Phase I/II clinical trials as a
potential therapy for patients with hematological cancers in combination with
other standard treatments and as a monotherapy in last line solid cancers.
Further information is available at www.faron.com (http://www.faron.com) .

 

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