REG - Faron Pharma. Oy - Faron’s Capital Markets Day 2024

Faron Pharmaceuticals OyAnnouncement

22/10/2024 07:00

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RNS Number : 0250J  Faron Pharmaceuticals Oy  22 October 2024

Faron Pharmaceuticals Ltd.

 

("Faron" or "the Company")

 

 Faron's Capital Markets Day 2024 - BEXMAB follow-up data and update on drug
development pipeline, partnering discussions and introducing new Scientific
Advisory Board

 

Company Announcement, 22 October 2024

 

TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a
clinical-stage biopharmaceutical company focused on tackling cancers via novel
immunotherapies, will host a Capital Markets Day for investors, analysts and
media today, Tuesday, 22 October 2024 at 08:00 am (EDT) / 13:00 pm (BST) /
15:00 pm (EEST). Speakers are Dr. Mika Kontro, MD, PhD, Associate Professor at
the University of Helsinki, Mr. Ralph Hughes, MSc, BSc, Senior Vice President
at PharmaVentures and Faron's senior management members.

 

BEXMAB Follow Up Data Continue to Indicate High Overall Response Rate

 

The BEXMAB Phase I/II trial results have already indicated a high overall
response rate (ORR) of 79% (11 out 14) amongst relapsed and refractory
myelodysplastic syndrome (r/r MDS) patients treated with a combination
of bexmarilimab + azacitidine. Similar size patient cohorts treated with
existing alternatives have reported 0-20% ORR, without deep and durable
remissions.

 

Previously estimated median overall survival (mOS) was approximately 13.4
months with 14 r/r MDS patients and subject to change with longer follow up.
Now, after median follow up of 275 days (doubled since May 2024), the mOS
among these 14 r/r MDS patients remains strong at 13.4 months, which is
significantly longer than the 5-6 months typically expected with standard
care, as reported in the literature. Median time on treatment for r/r MDS in
the BEXMAB trial at the moment is 7.9 months, exceeding any prior expectations
in this field. The treatment remains well tolerated according to the latest
safety follow up.

 

Previously there were two (2/14) patients who moved on to receive bone marrow
transplant and there are now a total of three patients (3/14) who have moved
to bone marrow transplant which is seen as the only possibility for curative
treatment of r/r MDS.

 

Business Update / Partnering Discussions

In June 2024, Faron completed a fully subscribed EUR 30.7 million share
offering and published its focus areas for 2024:

 

1.    To obtain regulatory feedback from the USA Food and Drug
Administration (FDA) regarding measures required to obtain regulatory approval
in the U.S.

2.    Aim to complete BEXMAB Phase II enrolment.

3.    Aim to conclude a global partnership deal to fund Phase III clinical
research and to commercialize bexmarilimab.

4.    To have sufficient funding until the latter half of March 2025,
allowing the Company to pursue readiness to move to Phase III in drug
development, and in compliance with the financial covenants of the IPF Fund II
SCA, SICAV-FIAR's Facilities Agreement.

 

In July, Faron obtained positive feedback from the FDA regarding the
registrational study plan for bexmarilimab in relapsed and refractory high
risk MDS (HR MDS). In August 2024, the FDA granted Fast Track Designation
(FTD) for bexmarilimab for the treatment of r/r MDS. Based on the FDA's
guidance, Faron made the decision to recruit additional frontline MDS
patients. Full BEXMAB enrolment will include 32 r/r MDS patients and also 20
frontline HR MDS patients. According to the latest enrolment estimate, the
BEXMAB trial (including also 20 frontline HR MDS patients) will be fully
recruited in January 2025.

 

Since the fundraise completed in June 2024, Faron has been in dialogue with
several partner candidates to fund Phase III development and to commercialize
bexmarilimab. These discussions have progressed according to Faron's
expectations. To date, the Company has chosen not yet to enter into a
partnership agreement or grant exclusivity to any negotiating party. Faron
continues to discuss and evaluate the received terms and their impact
diligently. To enable more flexibility in pursuing the best commercial outcome
for the Company and its shareholders in continued compliance with the
financial covenants and to facilitate availability of high-quality Phase II
BEXMAB efficacy data (also observing patient enrolment for full Phase II
readout), Faron may, subject to market conditions, consider strengthening its
financial position before concluding discussions concerning partnering.

 

Scientific Advisory Board Renewed

 

Faron has renewed its Scientific Advisory Board (SAB) to better correspond
with the Company's current drug development pipeline. The new Scientific
Advisory Board consists of prestigious and internationally recognized clinical
scientists with broad anti-cancer clinical development expertise within
haematological neoplasms and solid tumors. The SAB will assist Faron's
management in making significant scientific judgements related to
translational activities as well as its clinical portfolio. The members of
Faron's SAB are Dr. Toni Choueiri, Dr. Tom Powles, Dr. Amer Zeidan, Dr. Naval
G. Daver, Dr. Mika Kontro and Dr. Christophe Massard.

 

Toni Choueiri, MD is the Jerome and Nancy Kohlberg Chair and Professor of
Medicine at Harvard Medical School, Boston, MA, the Director of the Lank
Center for Genitourinary (GU) Oncology and co-leader of the Kidney Cancer
Program at Dana-Farber/Harvard Cancer Center. He serves on the US National
comprehensive cancer network (NCCN) expert panel. He has over 800
PubMed-indexed publications and is the lead investigator in multiple
international phase 1-3 clinical trials in genitourinary cancers. In a series
of NEJM articles on which Dr Choueiri was either first or last author, he has
made seminal observations leading to multiple FDA and EMA approvals.

 

Tom Powles, MBBS, MRCP, MD is a professor of urology cancer at the University
of London and the Director of Barts Cancer Centre which is one of the UKs
largest Cancer Centres. Prof Powles is also editor-in-chief of Annals of
Oncology, the leading European oncology scientific journal. He has had a major
role in the development of biomarkers and new drug strategies leading to
multiple FDA and EMA approvals. He has authored 10 NEJM or Lancet publications
with two first author NEJM publications and two first author Nature
publications. He was named in December 2023 in TIME's list among the most
influential people in global health.

 

Amer Zeidan, MD, MBBS, MHS is an Associate Professor of Medicine, Chief of
Hematologic Malignancies Division, Director of Hematology Early Therapeutics
Research, and leader of the clinical program and the Clinical Research Team
for Leukemia and Myeloid Malignancies at Yale Cancer Center.
Dr. Zeidan specializes in the management of myeloid malignancies especially
MDS and acute myeloid leukemia (AML). His research and clinical care focus on
targeting therapies to a patient's diagnosis and working with their own immune
system to counter the malignancies. He has published over 330 peer-reviewed
publications and is the principal investigator on numerous phase II and III
clinical trials in the areas of acute myeloid leukemia and myelodysplastic
syndromes.

 

Naval G. Daver, MD is a Professor and Director of the Leukemia Research
Alliance Program in the Department of Leukemia at MD Anderson Cancer Center
(MDACC) in Houston, TX. He is a clinical investigator with a focus on
molecular and immune therapies in acute myeloid leukemia (AML) and myeloid
disease and is principal investigator on more than 25 ongoing institutional,
national, and international clinical trials in these diseases, including
multiple registration and label enabling trials. Prof. Daver has published
over 400 peer-reviewed manuscripts and is on the editorial board of numerous
hemalotology journals.

 

Mika Kontro, MD, PhD is an adjunct professor and a consultant in clinical
hematology at the Helsinki University Hospital Comprehensive Cancer Center.
Dr. Mika currently works as K. Albin Johannson Cancer Research Fellow (Finnish
Cancer Institute) and as a group leader in Finnish Institute of molecular
medicine, FIMM. He has a strong background in running clinical trials and he
currently chairs the Finnish AML group and is a board member of the Nordic AML
Group.

 

Christophe Massard, MD, PhD is professor and a Head of Cancer Research at
Gustave-Roussy, the first leading cancer hospital in Europe and in the top
four in the world.  Dr. Christophe is a member of ESMO, ASCO and AACR and has
participated in over 130 trials in the past five years. He has been the
principal investigator over the last 10 years of 50 phase 1 trials and
co-investigator in more than 100 trialsHis research focuses on early clinical
trials and precision medicine. He has published over 100 peer-reviewed
publications.

 

Development Plan for Solid Tumors Progressing

 

Faron has made significant progress with its development plan regarding
bexmarilimab's future potential in treating solid tumors. In today's CMD,
Faron will present its oncology pipeline for solid tumors to illustrate
bexmarilimab's potential as a first-in-class macrophage reprogrammer in
various anti-cancer treatments. In addition, an update on the innovative
approaches in improving recognition of tumor cells and preventing
immunosuppression will be presented.

 

Dr. Juho Jalkanen, CEO of Faron, comments:

"As previously communicated, everything is progressing as planned and our
focus is to ensure that we are armed with adequate resources to be able to
meet our objectives of completing Phase II of the BEXMAB trial and optimizing
the outcome of partnering with Phase II data.  The next business decision we
make will be   crucial in how the value and future of bexmarilimab is
divided. There is more than two decades of hard work behind the development of
bexmarilimab, and our job is to see that the maximum potential of bexmarilimab
comes to life for both patients and investors."

Dr. Petri Bono, CMO of Faron, comments:

"We've continued to see extremely encouraging data from our ongoing BEXMAB
trial, and I am very pleased to see that the data encourage us systematically
as we go forward in our solid tumor development pipeline. Our purpose is to
establish bexmarilimab as a cornerstone drug for cancers where Clever-1
macrophages are a source of treatment resistance and cancer progression. Now
we've a world-leading Scientific Advisory Board supporting us, the likes of
which I have never seen before, and I am very excited about what future
holds."

 

Presentation Materials and Webcast

 

The Capital Markets Day presentation material will be available at
https://www.faron.com/investors (https://www.faron.com/investors) . The CMD
webcast can be followed online at https://faron.videosync.fi/cmd-2024
(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ffaron.videosync.fi%2Fcmd-2024&data=05%7C02%7C%7C8a10b91402394e05c18908dce120fe18%7Ca2d9b7a432f64a96b03727499230d5fd%7C1%7C0%7C638632779058056764%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=pVPpycYNfzWXHWXRI%2FVKZwwq6XNlTa8LGFE69VhBZ%2Fg%3D&reserved=0)

 

For more information please contact:

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 BEXMAB

 

The BEXMAB study is an open-label Phase I/II clinical trial investigating
bexmarilimab in combination with standard of care (SoC) in the aggressive
hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic
syndrome (MDS). The primary objective is to determine the safety and
tolerability of bexmarilimab in combination with SoC (azacitidine) treatment.
Directly targeting Clever-1 could limit the replication capacity of cancer
cells, increase antigen presentation, ignite an immune response, and allow
current treatments to be more effective. Clever-1 is highly expressed in both
AML and MDS and associated with therapy resistance, limited T cell activation
and poor outcomes.

 

About bexmarilimab

 

Bexmarilimab is Faron's wholly owned, investigational immunotherapy designed
to overcome resistance to existing treatments and optimize clinical outcomes,
by targeting myeloid cell function and igniting the immune system.
Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on
macrophages leading to tumor growth and metastases (i.e. helps cancer evade
the immune system). By targeting the Clever-1 receptor on macrophages,
bexmarilimab alters the tumor microenvironment, reprogramming macrophages from
an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating
interferon production and priming the immune system to attack tumors and
sensitizing cancer cells to standard of care.

 

About Faron Pharmaceuticals Ltd

 

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 reprogramming 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. Further information is available at www.faron.com
(http://www.faron.com) .

 

Forward-Looking Statements

 

Certain statements in this announcement are, or may be deemed to be,
forward-looking statements. Forward looking statements are identified by their
use of terms and phrases such as ''believe'', ''could'', "should", "expect",
"hope", "seek", ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'',
''potentially'', ''will'' or the negative of those, variations or comparable
expressions, including references to assumptions. These forward-looking
statements are not based on historical facts but rather on the Directors'
current expectations and assumptions regarding the Company's future growth,
results of operations, performance, future capital and other expenditures
(including the amount, nature and sources of funding thereof), competitive
advantages, business prospects and opportunities. Such forward-looking
statements reflect the Directors' current beliefs and assumptions and are
based on information currently available to the Directors.

 

A number of factors could cause actual results to differ materially from the
results and expectations discussed in the forward-looking statements, many of
which are beyond the control of the Company. In addition, other factors which
could cause actual results to differ materially include the ability of the
Company to successfully license its programs within the anticipated timeframe
or at all, risks associated with vulnerability to general economic and
business conditions, competition, environmental and other regulatory changes,
actions by governmental authorities, the availability of capital markets or
other sources of funding, reliance on key personnel, uninsured and
underinsured losses and other factors. Although any forward-looking statements
contained in this announcement are based upon what the Directors believe to be
reasonable assumptions, the Company cannot assure investors that actual
results will be consistent with such forward-looking statements. Accordingly,
readers are cautioned not to place undue reliance on forward-looking
statements. Subject to any continuing obligations under applicable law or any
relevant AIM Rule requirements, in providing this information the Company does
not undertake any obligation to publicly update or revise any of the
forward-looking statements or to advise of any change in events, conditions or
circumstances on which any such statement is based.

 

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