Final Patient Identified for the BEXMAB Study

Faron Pharmaceuticals Ltd | Press Release | January 31, 2025 at 09:00:00 EET

Faron Announces Final Patient Identified for the BEXMAB Phase II Study in Myelodysplastic Syndrome

On track to report topline efficacy and safety data in April 2025

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces that, the final patient has been identified for the BEXMAB Phase II dose optimization study in refractory or relapsed myelodysplastic syndrome (r/r MDS), as well as the BEXMAB Phase I/II study in frontline high risk (HR) MDS. The topline response rate read out is thus expected to become available in April 2025. Detailed data will be presented later at upcoming major medical conferences. The reportable data set will consist of approximately 35 r/r MDS patients and 20 frontline HR MDS patients. The r/r MDS population will consist of 32 patients treated with either 3mg/kg or 6mg/kg dose of bexmarilimab per the U.S. Food and Drug Administration (FDA) Project Optimus guidance, and three r/r MDS patients treated with 1mg/kg dose of bexmarilimab in Phase I. A similar split between doses will be reported concerning the frontline HR MDS population.

“Achieving this milestone for our lead program, BEXMAB, in r/r MDS and frontline HR MDS, reflects not only our team’s strength in executing on the Company’s drug development strategy, but also the urgent unmet medical need for patients with this difficult to treat cancer,” stated Petri Bono, M.D., Ph.D., Chief Medical Officer. “Backed by recently released Phase II Interim Results confirming the superior profile of bexmarilimab versus current treatment options, we remain highly confident about the potential of bexmarilimab to become an important new best-in-class treatment for MDS patients.”

The BEXMAB Phase II Interim results presented at the 66th American Society of Hematology (ASH) Annual Meeting on December 2024 showed a high objective response rate (ORR) at 80% (16/20). Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions. Previously reported estimated median overall survival of the 20 r/r MDS patients were 13.4 months compared to the 5-6 months that would typically be expected under standard of care historically.

The BEXMAB trial will continue enrolling CMML patients and there is also the possibility to expand the enrollment of r/r MDS patients under the current protocol. The Company is assessing expanding the enrollment of r/r MDS patients in order to have this treatment option available for patients and to strengthen the data set for upcoming regulatory purposes.

“Our BEXMAB Phase II trial has progressed as planned and our focus now is to take this the data to the FDA and fine tune the registrational approach with the agency. We are committed to rapidly advancing bexmarilimab through clinical development, to bring it to treatment resistant MDS patients as soon as possible,” said Dr. Juho Jalkanen, M.D., Ph.D., Chief Executive Officer. “I want to express my sincere gratitude to all the stakeholders working on the BEXMAB trial, especially our hardworking employees, study site professionals and investigators, but most of all the patients and their loved ones.”

For more information please contact:
ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: 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.

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.

TEST IR Newsletter December 2024

We are excited to share the latest updates from Company X as we conclude a highly productive first quarter. Our team has been actively engaging with the industry through several key events and initiatives. This quarter, Company X participated in three major international seminars, including the Global Tech Leadership Summit and the Future of Innovation Conference, where our CEO was a featured keynote speaker.

In addition, we hosted our first in-house innovation workshop, bringing together cross-functional teams to collaborate on new product concepts and process improvements. Our executives were also invited to contribute to panel discussions at the Green Business Forum, highlighting our commitment to sustainable business practices.

We successfully strengthened ties with industry peers through collaborative sessions at the Regional Growth Forum. Our product development team showcased prototypes at two leading trade expos, receiving encouraging feedback from both partners and potential clients.

Internally, we launched a company-wide professional development program, focused on leadership and technical training. Employee participation exceeded expectations, reflecting the strong engagement and dedication of our workforce. We also rolled out a new mentorship initiative, pairing senior leaders with emerging talent across departments.

Faron’s Financial Calendar for 2025

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Faron’s Financial Calendar for 202 5

Company announcement, 13 December 2024

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces the following dates for the Company’s financial reporting in 202 5 :

February 27

Financial statement release for the full year 2024 and Annual Report 2024 including financial statements for the full year

August 2 7

Half-year financial report for the period January 1 to June 30, 2025

The Annual General Meeting is planned to be held on March 2 1 , 202 5 . A separate stock exchange notice will be issued by Faron’s Board of Directors to convene the meeting.

For more information please contact:

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: 
faron@icrhealthcare.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 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 .

Faron presents BEXMAB data at ASH Annual Meeting

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Faron Presents Full Analysis of Positive Phase 2 Interim Data from BEXMAB Trial at the 66th American Society of Hematology (ASH) Annual Meeting

Press release, 10 December 2024

Poster highlights

–      Overall response rate of 80% (16 out of 20) in refractory or relapsed HMA failed MDS patient population (r/r MDS)

–      Observed responses were primarily deep and durable with 70% (14 out of 20) r/r MDS patients achieving complete response (CR) / marrow complete remission (mCR) / partial response (PR).

–      Four patients have moved on to receive a bone marrow transplant

–      Estimated median overall survival (mOS) of approximately 13.4 months in r/r MDS population

–      The combination of bexmarilimab and azacitidine remains well tolerated

–      Clever-1 target engagement and expression in the bone marrow with an increased antigen presentation capacity and presence of CD8 T and NK cells supports bexmarilimab mechanism-of-action

–      Webinar scheduled today at 16.00 EET/9am ET/6am PT (please see link to register below)

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announced full analysis of the positive Phase 2 interim readout presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

“The BEXMAB results continue to improve over time showing a remarkable 80% ORR in r/r MDS patients,” said Dr. Juho Jalkanen, Chief Executive Officer of Faron. “The combination is well-tolerated and generates strong and durable cancer blast reduction and hematological improvements. This solidifies bexmarilimab’s unique and leading mechanism of action for the treatment of MDS and in the field of myeloid cell re-programming. With this compelling evidence, we are well positioned to advance to the full Phase 2 efficacy readout and actively pursue further regulatory interactions to navigate and refine the pivotal pathway for BLA filing.”

Dr. Mika Kontro, MD, PhD, Associate Professor at the Helsinki University Hospital Comprehensive Cancer Center and Principal Investigator of the BEXMAB trial, said : “Addressing MDS remains a considerable therapeutic challenge due to the limited efficacy of the current standard of care, particularly in TP53 mutated and HMA-failed MDS patient populations. The data presented at ASH are highly promising, showing notable improvements in overall response rate and overall survival. These findings highlight the meaningful strides Faron is making in improving treatment outcomes for r/r MDS .”

The BEXMAB study is a multicenter study, taking place in Finland, UK and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with standard of care in patients with aggressive myeloid leukemias.

Faron will host a virtual webinar to discuss the full analysis of data today, 10 December 2024 at 16.00 EET/9am ET/6am PT.

To register for the event visit:  BEXMAB Study Update

The ASH Annual Meeting takes place from 7-10 December 2024, in San Diego, California and virtually.

ASH Poster presentation details:

Title:                                  Encouraging Efficacy of Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in Bexmab Ph1/2 Study

Session Time :                  Monday, 9 December 2024, 6:00 PM – 8:00 PM PT

Session Title:                   Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III

Location:                         San Diego Convention Center, Halls G-H

Lead Authors:                  Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki; Dr. Naval Daver, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center

Abstract Number:           4265

The full Poster is available on the Company’s website at https://www.faron.com/investors and contains updated clinical data from the BEXMAB trial.

For more information please contact:

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@icrhealthcare.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 .

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.

Interactions with UK Regulatory Authorities

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Faron Announces Positive Update on Recent Interactions with UK Regulatory Authorities regarding bexmarilimab and expanding the BEXMAB Study to the UK

–      MHRA has awarded bexmarilimab an Innovation Passport for the treatment of relapsed/refractory Myelodysplastic Syndrome and given approval for the BEXMAB trial to be conducted in the UK

–      UK sites to join the BEXMAB Study iminently

Press release, 2 December 2024

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces that the BEXMAB Study may proceed in the UK and bexmarilimab has received an Innovation Passport, under the Innovative Licensing and Access Pathway (ILAP) from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), for the treatment of relapsed/refractory Myelodysplastic Syndrome (r/r MDS).

The ILAP was introduced by the MHRA in 2021 to give patients quicker access to cutting-edge treatments and therapies for life-threatening or seriously debilitating conditions, or conditions for which there is a significant patient or public health need. T he benefits of the ILAP include enhanced regulatory support from the MHRA and provides collaborative opportunities with health technology assessment bodies and other stakeholders, with the aim of accelerating the development, and improving patient access to promising new medicines.

The decision to award the Innovation Passport to bexmarilimab was made by the ILAP Steering Group, which is comprised of representatives from the MHRA, NICE, AWTTC and SMC, and provides further regulatory verification of bexmarilimab’s potential to address significant unmet medical needs and positions the therapy for faster development and potentially earlier access for patients.

In addition, Faron today announced that it has received regulatory approval from the MHRA to conduct the BEXMAB trial in the UK. This approval will allow Faron to recruit UK haematology patients directly, accelerating its research efforts by increasing recruitment and enhancing the study’s diversity and scope by expanding the participant pool.

Dr. Juho Jalkanen, Chief Executive Officer of Faron, said : “I am very pleased to announce this update today following our ongoing interactions with the MHRA regarding bexmarilimab. A t Faron, we understand the importance of actively engaging with regulatory authorities and, as a result of those interactions and the promising data generated to date, I am very pleased that the MHRA has recognised the potential of bexmarilimab to treat r/r MDS patients. Receiving ILAP designation, coupled with regulatory approval to conduct the BEXMAB trial in the UK, will allow us to accelerate the development of bexmarilimab and give UK patients access to a promising novel therapeutic option through participation in the study. We are looking forward to continuing our discussions with the MHRA to further expedite bexmarilimab’s path to market for patients as soon as possible.”

For more information please contact:

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@icrhealthcare.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 .

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.

Positive Phase 2 Interim Results from BEXMAB Trial

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Inside Information: Faron Announces Positive Phase 2 Interim Results from BEXMAB Trial to be presented at ASH

Company announcement, Inside Information , 27 November 2024

Key highlights

–      Interim Phase 2 read-out from the BEXMAB Trial confirms earlier positive Phase 1 & 2 findings in MDS patients with prior HMA failure

–      In Phases 1 & 2, 20 MDS patients who are refractory or relapsed on HMA (r/r MDS) and have no effective treatment options, continue to show high objective response rate (ORR) at 80%

–      The BEXMAB Phase 1 & 2 MDS patients with prior HMA failure are experiencing an estimated median overall survival (mOS) of approximately 13.4 months currently, compared to the 5-6 months that would typically be expected under standard of care historically

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today provides Interim Phase 2 results of the ongoing BEXMAB trial in myelodysplastic syndrome (MDS) patients that have failed a hypomethylating agent (HMA), also known as relapsed/refractory MDS (r/r MDS). Full analysis of the data will be presented at the 66th American Society of Hematology (ASH) Annual Meeting on 9 December 2024 in San Diego, US .

The initial BEXMAB Phase 2 results have already indicated a high ORR of 79% (11/14) amongst HMA-failed MDS patients treated with a combination of bexmarilimab + azacitidine. There is now a total of 20 HMA-failed MDS patients evaluable for read-out with this novel combination. The treatment has been well tolerated, without any dose-limiting toxicity. The ORR in this otherwise untreatable population is 80% (16/20). Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions. The estimated median overall survival of the 20 r/r MDS patients remains 13.4 months.


In summary, the updated BEXMAB results show very encouraging efficacy and robust treatment benefit for the r/r MDS patients. The detailed efficacy, safety and biomarker results of the 20 r/r MDS patients treated in the BEXMAB trial will be presented at the 66th American Society of Hematology Annual Meeting. The BEXMAB trial is continuing to enroll patients as planned with the next efficacy data readout for the fully recruited BEXMAB trial patients expected around the end of Q1 2025.

Dr. Petri Bono, Chief Medical Officer of Faron, said: “r/r MDS is a life-threatening haematological malignancy with limited treatment options and high unmet medical need. Our updated trial results in r/r MDS further enforces bexmarilimab’s ability to overcome treatment leading to clinically meaningful deep responses. We look forward to sharing the detailed results with the haematology community and discussing these data with health authorities in H1 2025.”

Dr. Juho Jalkanen, Chief Executive Officer of Faron, said: “It is remarkable seeing the ORR continuing to be so strong even as the patient population grows, as it would typically be expected to settle at a lower level. For patients, I believe these results are truly exciting as we take another step closer to providing an additional option for their poorly met treatment needs. With our repeatedly strong data, we are very much looking forward to our continuing discussions with regulatory agencies and partner candidates.”

Faron will be hosting a virtual webinar to discuss the full analysis of data on Tuesday, December 10, 2024 at 16.00 EET/9am ET.

To register for the event visit:  BEXMAB Study Update

The ASH Annual Meeting will take place from 7-10 December 2024, in San Diego, California and virtually. The poster will contain updated clinical data from the trial.

Poster presentation details:

Title:                            Encouraging Efficacy of Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in Bexmab Ph1/2 Study

Session Time :                   Monday, 9 December 2024, 6:00 PM – 8:00 PM PST

Session Title:                 Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III

Location:                      San Diego Convention Center, Halls G-H

Lead Authors:               Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki; Dr. Naval Daver, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center

Abstract Number:         4265

The full poster will be available on the Company’s website at https://www.faron.com/investors once presented at ASH.

For more information please contact:

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  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 .

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.

Targeting Soluble Clever-1 for Autoimmune Diseases

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

 Pipeline Update: Targeting Soluble Clever-1 for Autoimmune Diseases

Press release, 11 November 2024

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers and inflammation via novel immunotherapies, today announces the filing of a patent application around the use of soluble Clever-1 for inactivating T-cells and the treatment of autoimmune diseases and inflammatory disorders. The related manuscript can be read here https://www.biorxiv.org/content/10.1101/2024.10.23.619796v1 , which explains how soluble Clever-1 inactivates T-cells and makes anti-PD-1 based therapies ineffective in cancer. The key highlights of these findings are the following:

•     Clever-1-positive macrophages and endothelial cells secrete a soluble form of Clever-1;

•     Soluble Clever-1 binds activated T-cells and impairs their differentiation into anti-tumor effectors;

•     The Company and its researchers have identified the part of Clever-1 that binds to T-cells a nd inactivates them; and

•     The submitted patent application covers use of soluble Clever-1 or fragments of it to inactivate T-cells for the treatment of autoimmune diseases and inflammatory disorders.

The next phase for the Company is to take the identified part of soluble Clever-1 and design the optimal drug composition with the desired characteristics for treating autoimmune diseases. The Company will in due course elucidate this new addition to its pipeline in more detail to expand the pipeline beyond hematological cancers and solid tumor oncology.

“Clever-1 is a master regulator of the immune system. Through decades of pivotal research and our deep understanding of Clever-1 and its role in human biology we have now shown how it inactivates T-cells, drives immune tolerance, and may render anti-PD-1 based immune checkpoint therapies ineffective. In addition, we now have an understanding on how we can use this to our advantage in the treatment of unwanted inflammation where T-cells need to be inactivated. This lays the basis for a new class of drugs to treat autoinflammatory diseases”, says Dr. Maija Hollmén CSO of Faron Pharmaceuticals.

For more information please contact:

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@icrhealthcare.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 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 .

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.

Shareholders’ Nomination Board

(“Faron” or “the Company”)

 Composition of Faron Pharmaceutical’s Shareholders’ Nomination Board

Company Announcement, 5 November 2024

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces that the following members have been appointed by a meeting of the Company’s five largest shareholders to Faron Pharmaceuticals Oy’s Shareholders’ Nomination Board:

·    Timo Syrjälä, representing himself (Chair)

·    Erkka Kohonen, representing Varma Mutual Pension Insurance Company , and

·    Joonas Haakana, representing UMO Capital

Faron’s Shareholders’ Nomination Board consists of three members, which represent the Company’s shareholders. The Chair of Faron’s Board of Directors, Mr. Tuomo Pätsi, will serve as an expert in the Nomination Board without being a member.

The Shareholders’ Nomination Board prepares and presents proposals to the Annual General Meeting on the number, composition and remuneration of the members of the Board as well as the Chair of the Board of Directors.

For more information please contact:

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@icrhealthcare.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 .

Faron’s Capital Markets Day 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 immunotherap ies , 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), t he 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 . The CMD webcast can be followed online at https://faron.videosync.fi/cmd-2024

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

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 .

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.

Faron announces Capital Markets Day

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Faron announces Capital Markets Day to be held on 22 October 2024

Press release, 7 October 2024

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

The agenda is as follows:

·    Opening remarks

·    Faron’s strategy and key focus areas – Dr. Juho Jalkanen, MD, PhD, CEO

·    BEXMAB clinical data – Dr. Mika Kontro, MD, PhD, principal investigator of the BEXMAB trial

·    BEXMAB MDS market assessment – Mr. Ralph Hughes, MSc, BSc

·    Faron’s development plan for solid tumors – Dr. Petri Bono, MD, PhD, CMO

·    Who benefits from bexmarilimab and why – Future Addressable Markets – Dr. Maija Hollm én, PhD, CSO

·    Q&A session

·    Closing remarks

As part of the event, Juho Jalkanen, CEO of Faron, will discuss Faron’s strategy and key focus areas for the coming years. Dr. Kontro will share updated survival data from the ongoing BEXMAB Phase I/II trial. Mr. Hughes will present the results of recently conducted market research in MDS. Dr. Bono will provide Faron’s development plan for solid tumours, discuss bexmarilimab’s further potential as first-in-class immune-oncological treatment and introduce the Company’s new Scientific Advisory Board (SAB).

“I am delighted to be hosting this Capital Markets Day with our invited speakers and members of Faron’s senior management team who will provide important insights into the recent developments and further plan to bring the promise of immunotherapy to a broader patient group,” said Dr. Juho Jalkanen, Chief Executive Officer of Faron. “ In addition to providing the latest BEXMAB survival update, we will present the clinical development plan for bexmarilimab in solid tumors. The event will also feature an introduction to our new Scientific Advisory Board with world-leading clinical investigators,” said Dr. Petri Bono, Chief Medical Officer at Faron.

The event will be held as a live hybrid event. It will begin at 08:00 am (EDT) / 13:00 pm (BST) / 15:00 pm (EEST) on Tuesday, October 22, 2024. The duration of the event will be some 2.5 hours.

Webcast registration link:   https://faron.videosync.fi/cmd-2024

Live participation

In addition to the webcast, there are a limited number of seats available to attend the Capital Markets Day at Eliel in Sanomatalo at Töölönlahdenkatu 2, Helsinki. To register, please contact

investor.relations@faron.com  no later than 2 :00 pm ( EEST ) on Friday , 18 October 2024. Please note that places are limited, and you will receive a separate email if you get a seat confirmed.

A link to a recording of this Capital Markets Day will be made available on the “Investors” section on Faron’s website at:   https://www.faron.com/investors .

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

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 .

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