Faron, etusivu

Updated BEXMAB Phase I/II Data presented at ESMO 2025 shows further improvement, strengthening the clinical profile of bexmarilimab in treatment-naïve HR-MDS patients

Faron Pharmaceuticals Ltd | Company announcement | October 20, 2025 at 09:00:00 EEST

Updated BEXMAB Phase I/II Data presented at ESMO 2025 shows further improvement, strengthening the clinical profile of bexmarilimab in treatment-naïve HR-MDS patients with an 85% ORR and a 45% CR rate, bolstered by pharmacodynamic insights

New biomarker data reveals strong correlation between target engagement and clinical response with 100% ORR in treatment-naïve, low blast count (<5%) patients

Key highlights:

  • Bexmarilimab and azacitidine combination resulted in an 85% objective response rate (ORR; 17/20 evaluable patients) and a 45% complete remission (CR) rate (9/20) in treatment-naïve patients with higher-risk myelodysplastic syndrome (HR-MDS)
  • 55% (11/20) of treatment-naïve patients with HR-MDS showed full clearance of bone marrow (BM) blasts
  • Deeper BM engagement in treatment-naïve patients with <5% bone marrow blasts at baseline translated to 100% ORR, one of the best results ever reported in this patient population
  • 23% of patients across the BEXMAB study were successfully bridged to a potentially curative stem cell transplant (SCT)
  • Faron will be hosting a virtual webinar to discuss the updated BEXMAB data presented at ESMO 2025 on 23 October at 4pm EEST/9am ET.

Turku, Finland– Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunotherapies, today announced that updated data from the Phase I/II BEXMAB study continues to show significant clinical activity for bexmarilimab. The findings, presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2025 by Dr. Mika Kontro from Helsinki University Hospital, not only confirm the high response rates seen in earlier analyses but also provide a clear pharmacodynamic rationale linking the drug’s mechanism of action directly to patient outcomes.  

The BEXMAB study evaluates bexmarilimab (1, 3, or 6 mg/kg weekly in 28-day cycles), a first-in-class monoclonal antibody targeting the Clever-1 receptor, in combination with azacitidine, a standard-of-care hypomethylating agent (HMA). By blocking Clever-1, bexmarilimab reprograms macrophages in the bone marrow, enhancing anti-tumor immunity. The data presented at ESMO 2025 included 21 treatment-naïve (20 evaluable for efficacy) and 32 relapsed/refractory (r/r) HMA-failed patients with HR-MDS.

The updated data presented at ESMO 2025 reinforces the efficacy previously observed for the bexmarilimab and azacitidine combination. In 20 evaluable treatment-naïve patients, the study confirmed an 85% ORR and a 45% CR rate. These high response rates were observed in a difficult-to-treat population, where over 66% of patients were classified as high to very high risk at baseline. The combination also showed robust activity in patients with high-risk mutations like mTP53, achieving an ORR of 78%.  

In the r/r HMA-failed population (n=32), the combination achieved a 63% ORR and a median overall survival (mOS) of 13.4 months. Notably, nearly a third of these patients (31.3%) had received prior therapy with the Bcl-2 inhibitor venetoclax.  

About 23% of patients across the BEXMAB study were successfully bridged to a potentially curative stem cell transplant (SCT).

The most significant update is the new pharmacodynamic data that provided a clear biological explanation for the strong clinical results. The analysis showed a statistically significant correlation (p=0.0006) between deeper engagement of the Clever-1 target in the bone marrow and a positive clinical response. This correlation was particularly striking in the subgroup of treatment-naïve patients with <5% bone marrow blasts at baseline (38% of the cohort), a population for which effective, non-intensive therapies are urgently needed. In these patients, deeper target engagement translated to a 100% ORR, supporting bexmarilimab’s unique mechanism of action as a truly disease modifying agent, differentiating it from other investigational HR-MDS therapies, such as Bcl-2 inhibitors. For patients with a higher blast count (>5% at baseline), the ORR remained high at 75%.

With the result of this data, Faron is preparing for the next stage of development. Following guidance from the FDA announced on 18 August 2025, the Company has begun preparations for the dose-optimization stage of its Phase II/III trial for bexmarilimab, after which the trial will transition into the registrational stage with accelerated approval possibility. The combination therapy continues to be well-tolerated, with a safety profile similar, or even better to, azacitidine monotherapy. Only 36% of treatment-emergent adverse events were considered related to bexmarilimab, with no Grade 5 events.

Dr. Mika Kontro, MD, PhD, Associate Professor at University of Helsinki and Helsinki University Hospital Comprehensive Cancer Center, Department of Hematology said, “The BEXMAB data are encouraging, and the new biomarker analysis provides a clear pharmacodynamic rationale for bexmarilimab’s clinical activity. The direct correlation between how deeply we engage the Clever-1 target in the bone marrow and a patient’s clinical response reinforces the drug’s mechanism. The 100% ORR in patients with low blast counts suggest that this therapy may help in a population where current investigational treatments, including Bcl-2 inhibitors, have significant limitations.”

Dr. Maija Hollmén, PhD, Chief Scientific Officer of Faron Pharmaceuticals, added, “The selection of this BEXMAB data for an oral presentation at ESMO is a significant external validation of our science and the clinical potential of bexmarilimab. These findings help us understand why the drug works and for whom it works best. The clear biomarker impact in the bone marrow and unique efficacy in patients with low blast counts highlights Bex’s ability to change the course of the disease and provides a solid foundation for our late-stage clinical development, bringing this promising therapy to patients who desperately need better options.”

To register for the event visit: ESMO 2025. The details of the ESMO oral presentation are as follows:

Presentation title: Macrophage reprogrammer Bexmarilimab Plus Azacitidine in Myelodysplastic Syndrome: PK/PD and biomarker results from the Phase I/II BEXMAB Study

Presented by: Dr. Mika Kontro

Session type and title: Mini Oral Session: Haematological Malignancies

Room: Solingen Auditorium – Hall 23

Session date & time: Oct 19, 2025 (9:31 to 9:36 am CEST)

Abstract no.: 1249MO

This announcement contains inside information for the purposes of Article 7 of the EU Regulation 596/2014 (“MAR”) and Article 7 of MAR as incorporated into UK domestic law by virtue of the European Union (Withdrawal) Act 2018 (“UK MAR”).

For more information, please contact:

IR Partners, Finland
(Media)

Kare Laukkanen

 +358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi
FINN Partners, US
(Media) 
Alyssa Paldo 		 +1 847 791-8085 
alyssa.paldo@finnpartners.com
Cairn Financial Advisers LLP
(Nominated Adviser and Broker)
Sandy Jamieson, Jo Turner		 +44 (0) 207 213 0880
Sisu Partners Oy
(Certified Adviser on Nasdaq First North)
Juha Karttunen
Jukka Järvelä		 +358 (0)40 555 4727
+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.

Inside Information: Faron to advance bexmarilimab into a registrational Phase 2/3 study in treatment-naïve (frontline) HR-MDS after positive meeting with the FDA

Faron Pharmaceuticals Ltd | Company announcement | August 18, 2025 at 09:00:00 EEST

Inside Information: Accelerated approval pathway confirmed for frontline patients with CR + CReq, and Overall Survival as primary endpoints

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunotherapies, today announces it has received positive and valuable feedback from the U.S. Food and Drug Administration (FDA) regarding the proposed clinical development plan leading to approval for bexmarilimab, its wholly-owned, novel precision cancer immunotherapy.

The feedback was received as part of the Company’s recent BEXMAB study’s end-of-phase 2 (EOP2) meeting with the FDA. The FDA advised Faron to focus on frontline development since possible frontline approval enables use across the entire HR MDS indication. The meeting was requested to gain alignment on the design of a planned registrational phase 2/3 trial evaluating bexmarilimab in combination with azacitidine for patients with treatment-naïve (frontline) higher-risk myelodysplastic syndrome (HR-MDS). Key objectives included obtaining the FDA’s input on the proposed trial design, dosing strategy and clinical endpoints intended to support regulatory approval.

Following the FDA’s guidance, the trial will begin with a dose optimisation run-in period comparing 1 mg/kg and 3 mg/kg regimens with placebo, all in combination with azacitidine. Once the optimal dose has been determined, the trial will seamlessly transition into the registrational stage, which includes an interim analysis to support accelerated approval based on IWG 2023 response criteria in frontline patients.

“We are extremely encouraged by the collaborative and highly productive dialogue with the FDA, which provided a clear and actionable path for the clinical development of bexmarilimab in frontline HR-MDS, an area of profound unmet medical need,” said Dr. Juho Jalkanen, Chief Executive Officer of Faron. “The agency’s guidance has endorsed a direct route towards accelerated approval using Complete Response (CR) + CR equivalent (CReq) per International Working Group (IWG) 2023 criteria as a co-primary endpoint with Overall Survival (OS). This is a significant step forward in our mission to provide a potentially transformative new treatment option to patients and represents a major regulatory de-risking milestone, as we are now only one study away from getting bexmarilimab approved for the benefit of HR MDS patients.”

The FDA confirmed IWG 2023-defined CR + CReq as an acceptable primary endpoint to support an application for accelerated approval in frontline patients. In line with this guidance, Faron will include CR + CReq as a co-primary efficacy endpoint along with Overall Survival (OS) in the phase 2/3 trial. The Company will seek accelerated approval based on an interim readout on the CR + CReq data in frontline patients. Composite complete remission (cCR) will be evaluated as the key secondary endpoint. In addition to the clinical discussion, the FDA was satisfied with Faron’s approach to non-clinical and CMC activities for phase 2/3 and subsequent steps to approval.

“Improving outcomes of patients with HR-MDS continues to be a top priority for our field. Bexmarilimab is an antibody with a novel mechanism of action that has demonstrated promising safety and activity in combination with azacitidine in phase 1/2 clinical trials in the first- and second-line settings for HR-MDS,” added Dr. Amer Zeidan, MBBS, MHS, Professor of Medicine at Yale School of Medicine and Chief of the Division of Hematologic Malignancies at Yale Cancer Center and Smilow Cancer Hospital. “I am thrilled that we have agreed with the regulators on a pathway to explore the full potential of bexmarilimab in the frontline setting for patients with HR-MDS. I also would like to highlight the FDA accepting the use of CR+CReq IWG 2023 criteria as part of the primary endpoint, making this the first registrational clinical trial to do so. Many experts, including myself, strongly believe the IWG 2023 criteria to be more patient centric and reflect clinically meaningful benefits to patients in a more robust fashion than the old IWG 2006 criteria, which have been used for all past (and failed) phase 3 clinical trials for HR-MDS,” concluded Dr. Zeidan.

Disclosure: Dr Amer Zeidan has consulted and received honoraria from Faron. The views expressed as his personal views and not necessarily those of his employer.

For more information, please contact:

IR Partners, Finland
(Media)

Kare Laukkanen

+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi
FINN Partners, US
(Media) 
Alyssa Paldo 		 +1 847 791-8085 
alyssa.paldo@finnpartners.com
Cairn Financial Advisers LLP
(Nominated Adviser and Broker)
Sandy Jamieson, Jo Turner		 +44 (0) 207 213 0880
Sisu Partners Oy
(Certified Adviser on Nasdaq First North)
Juha Karttunen
Jukka Järvelä		 +358 (0)40 555 4727
+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.

Inside Information: Faron to present updated BEXMAB data in frontline HR-MDS to FDA; complete remission rate substantially increased to 43%

Faron Pharmaceuticals Ltd | Company announcement | August 06, 2025 at 09:00:00 EEST

Inside Information: Complete remission rate in frontline HR-MDS patients rose from 28% to 43% in latest data cut, confirming the deepening of responses over time.

TURKU, FINLAND– Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunological pathways, today announced an increase in the complete remission (CR) rate in patients with frontline or treatment-naïve high-risk myelodysplastic syndrome (HR-MDS), based on updated efficacy data from its Phase 1/2 BEXMAB trial.

According to the investigator-assessed response using IWG 2006 criteria, as per protocol, the CR rate (as explained below) has increased to 43% (9 out of 21 patients), a substantial improvement from the 28% rate, seen in the earlier data cut. This data builds on the phase II results featured in recent oral presentation at the 2025 American Society of Clinical Oncology (ASCO) congress. This improvement in CR is a result of patient responses improving as they continue longer on the combination therapy of bexmarilimab and the standard-of-care, azacitidine. This updated efficacy data was prepared for an upcoming End-of-Phase 2 (EOP2) meeting with the US Food and Drug Administration (FDA).

CR signifies a return to normal blood cell counts and bone marrow cellularity. This rate was measured using the internationally recognized and stringent, protocol pre-specified criteria. The 43% CR rate achieved with the bexmarilimab combination is more than double the 16-17% historical rate seen in patients treated with azacitidine alone, representing a major therapeutic advance. Earlier data from the BEXMAB study had also reported an encouraging 50% composite CR rate (cCR) in frontline HR-MDS patients, and in essence more and more of these cCR responses are turning into CR over time.

“The continued maturation of the BEXMAB data demonstrates bexmarilimab’s profound impact as a disease-modifying agent,” said Dr. Petri Bono, Chief Medical Officer of Faron. “Seeing the CR rate strengthen over time to 43%, which complements the robust 50% cCR we have already reported, is very encouraging. It provides us with two compelling and clinically meaningful data sets for discussion with the FDA and gives us confidence in proposing a randomized registrational trial designed for accelerated approval with either CR or cCR as the primary endpoint.”

For more information, please contact:

IR Partners, Finland (media)
Riina Tuominen
+358 44 313 5005
riina.tuominen@irpartners.fi

Kare Laukkanen
+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi

FINN Partners, US (media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com

Cairn Financial Advisers LLP, Nominated Adviser and Broker
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880

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.

Holding in Company

Faron Pharmaceuticals Ltd | Company announcement | April 17, 2025 at 15:15:00 EEST

Holding in Company

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, announces that, on 16 April 2025, A&B (HK) Company Ltd (“A&B”) divested its entire shareholding of 3,559,893 ordinary shares representing approximately 3.40% of the Company’s issued share capital.

A&B (HK) Company Ltd, an investment and development company based in Hong Kong, initially invested in the Company in 2015. This investment was part of a strategic agreement involving Faron’s lead drug candidate, Traumakine®, which was developed for the treatment of moderate to severe acute respiratory distress syndrome (ARDS). As Faron’s focus is on the development of its lead asset, bexmarilimab, this strategic investment by A&B no longer serves its original purpose and as such, A&B sold its holding and created a significant increase in the liquidity of Faron’s shares in the market.

For more information please contact:

IR Partners, Finland (media)
Riina Tuominen
+358 44 313 5005
riina.tuominen@irpartners.fi

Kare Laukkanen
+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi

FINN Partners, US (media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com

Cairn Financial Advisers LLP, Nominated Adviser and Broker
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880

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.

Inside Information: Faron Announces Positive Phase II results in higher-risk myelodysplastic syndrome

Faron Pharmaceuticals Ltd | Stock Exchange Release | April 15, 2025 at 09:00:00 EEST

Inside Information: BEXMAB Phase II trial met its primary endpoint in treatment-resistant High Risk MDS (r/r HR MDS)

Key Highlights

  • Topline read-out from the Phase II BEXMAB trial confirms earlier positive findings in both frontline and relapsed/refractory higher-risk myelodysplastic syndrome (HR MDS) patients
  • The combination of bexmarilimab and azacitidine remains very well tolerated
  • Full data has been submitted to the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
  • Faron is planning for a Phase III trial, pending U.S Food and Drug Administration (FDA) End of Phase II meeting Feedback

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, today announced positive topline results of the BEXMAB trial, which shows a high overall response rate (ORR) among both frontline as well as relapsed/refractory (r/r) HR MDS patients treated with a combination of bexmarilimab and azacitidine.

According to this first fully enrolled Phase II analysis, the treatment continues to be well tolerated without any dose-limiting toxicity in r/r HR MDS patients with no other currently effective treatment options. A high objective response rate of 63% was observed in this initial data cut. The median overall survival remains at the same level as previously reported. Among treatment naïve (frontline phase 1) HR MDS patients, an ORR of 76% was observed. Many patients are still early in their treatment, which means responses may deepen over time and results are subject to minor changes as data matures. The full data has been submitted to the 2025 ASCO Annual Meeting.

“This is one of the strongest data set ever seen in an all-comer population of treatment resistant HR MDS”, says Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. “There is a significant unmet need in the treatment of HR MDS, as drug development in HR MDS and macrophage re-programming has proven to be extremely challenging, with a lot of previous failures. What really makes bexmarilimab stand out in this field is its good safety profile combined with very high efficacy especially in last line HR MDS. This gives us conviction that bexmarilimab is the long-awaited drug to overcome treatment resistance”.

For more information please contact:

IR Partners, Finland (media)
Riina Tuominen
+358 44 313 5005
riina.tuominen@irpartners.fi

Kare Laukkanen
+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi

FINN Partners, US (media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com

Cairn Financial Advisers LLP, Nominated Adviser and Broker
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880

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.

Inside Information: Faron enters into an up to EUR 35 million convertible bond arrangement and issues first tranche of bonds with a principal amount of EUR 15 million

Faron Pharmaceuticals Ltd | Stock Exchange Release | April 03, 2025 at 09:00:00 EEST

Inside Information: Faron enters into an up to EUR 35 million convertible bond arrangement to repay its secured loan to IPF and strengthen its financial position, and issues first tranche of bonds with a principal amount of EUR 15 million

Key highlights

  • Faron has entered into a convertible bond arrangement for to up to EUR 35 million with an entity managed by Heights Capital Management, Inc. and resolved to issue amortising unsecured convertible bonds with an aggregated principal amount of EUR 15 million with an option to issue, subject to certain conditions, two additional tranches of similar convertible bonds, each with a principal amount of EUR 10 million.
  • Bondholders have the option to convert the bonds into shares at an initial conversion price of EUR 2.94 per share, subject to adjustments in accordance with the terms and conditions of the bonds.
  • The bonds generally amortise in equal instalments every two months and the Company has the option to redeem the bonds by issue of shares against such repayment instalment or by payment in cash during the three year term of the bonds.
  • In order to facilitate conversion of the bonds into shares, Faron issues special rights entitling into shares, as referred to in the Finnish Companies Act, to the bondholder in connection with the issuance of the first tranche bonds.
  • The proceeds from the first tranche bonds will be used to repay the outstanding senior, secured loan from IPF and for general corporate purposes, extending the Company’s cash runway into Q1 2026 assuming that amortisations on the bonds are made in shares.
  • The Company’s assets will be released from security as a result of the early loan repayment to IPF.
  • The Company substantially strengthens its financial position and flexibility by reducing restrictive cash covenants with a runway extending well beyond the phase II topline readout in the BEXMAB r/r MDS study anticipated in April 2025.

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumors, today announces that it has entered into a subscription agreement (the “Subscription Agreement”) with an entity managed by Heights Capital Management, Inc. (“HCM”) regarding the issuance and subscription of amortising senior unsecured convertible bonds with an aggregated principal amount of EUR 15 million (the “First Tranche Bonds”) with an option to issue, subject to certain conditions, two additional tranches of convertible bonds (the “Second Tranche Bonds” and “Third Tranche Bonds”, respectively, and collectively with the First Tranche Bonds, the “Bonds”) with an aggregated principal amount of EUR 10 million each, convertible into new and/or existing shares in the Company (the “Shares”) (the “Arrangement”). Bryan, Garnier & Co acted as Sole Placement Agent and Financial Adviser on the convertible bond arrangements.

In connection with the private placement announced on 5 February 2025, the Company communicated that it would continue to actively evaluate further financing alternatives and business transactions that would allow continued flexibility in pursuing the best commercial outcome for the Company and its shareholders with BEXMAB Phase II efficacy and safety readout available. The Arrangement will be used to finance early repayment in full of the Company’s outstanding senior secured loan pursuant to the facilities agreement entered into with IPF Fund II SCA, SICAV-FIAR (“IPF”) (the “IPF Facility”) and strengthen its financial position, while increasing its financial flexibility with fewer restrictive financial commitments. After the early repayment of the outstanding loan, the restrictive cash covenants set out in the IPF Facility will no longer apply, unlocking previously restricted cash reserves, and the Company’s assets, including valuable intellectual property rights, will be released from any pledges granted in favour of IPF. The remainder of the proceeds from the First Tranche Bonds will be used for general corporate purposes, such as the continuation of the BEXMAB Phase II trial to produce follow-up data (duration of response and survival), prepare the package for end of Phase II FDA meeting and for Phase III trial preparations, and to strengthen the Company’s balance sheet. The Arrangement with HCM will also enable the Company to continue evaluating further business transactions, such as licensing agreements, with a stronger financial position in addition to which the Company will, subject to certain conditions, also have access to additional financing in the aggregate amount of up to EUR 20 million, through the issuance of the Second Tranche Bonds and the Third Tranche Bonds. The Board has conducted an overall assessment of the Arrangement, considering its key terms and commercial merits, the reputable standing of the investor as well as other explored financing alternatives potentially available to the Company, and concluded that the issuance of the First Tranche Bonds, including the Special Rights to be attached to the bonds, is in the best interest of the Company and all of its shareholders, and that there is a weighty financial reason for the Company to issue the Special Rights to HCM.

“We are very happy to announce that Faron has secured new financing through convertible loans. The new funding and repayment of our outstanding loans significantly strengthens the Company’s financial position that importantly improves our ability to execute on the Company’s business opportunities. After finalisation of this arrangement the Company will no longer have restrictive cash covenants, and the security over the patents that have been pledged as security for the IPF loan will be released. The Board and management feel even more confident about the Company’s future as one of the leading Biotech companies in the Nordics with access to meaningful amounts of capital if needed. Having HCM, a well-respected global financier, on our side is very important as they have a long track record in supporting their portfolio companies in their journey and growth.” says Yrjö Wichmann, Chief Financial Officer.

The Convertible Bonds

Pursuant to the Subscription Agreement, the Board has resolved upon the issuance of EUR 15 million of First Tranche Bonds due 2 April 2028 to HCM, convertible into new and/or existing Shares in the Company. The First Tranche Bonds consists of 150 bonds with a principal value of EUR 100,000 each. The First Tranche Bonds will be issued at 92.5 per cent of their principal amount and carry an interest rate of 7.5 per cent per annum, payable every two months in arrears.

A holder of the First Tranche Bonds, shall be able to convert the outstanding principal amount of a First Tranche Bond or any instalment amount at any time during the term of the First Tranche Bonds. The initial Conversion Price (as defined in terms and conditions of the First Tranche Bonds, (“First Tranche Conditions”)) has been set at EUR 2.93952, which equals a 20 per cent premium to the reference share price, being the EUR price per Share that is the lowest of the six Volume Weighted Average Prices of a Share listed on Nasdaq First North Growth Market Finland on each of the six consecutive dealing days ending on (and including) the Issue Date of the First Tranche Bonds, representing EUR 2.4496. The Conversion Price is subject to adjustments in the event of certain corporate actions as well as customary anti-dilution adjustments and price reset mechanisms pursuant to the First Tranche Conditions.

The First Tranche Bonds will amortise in 18 equal instalments every two months during the term of the First Tranche Bonds (each an “Amortisation Payment Date”). Faron will have the option to elect, in its sole discretion, to make amortisation and/or interest payments either in cash or by converting the relevant amounts due into Shares (“Share Settlement Option”). In case the Company exercises its Share Settlement Option to amortise the principal amount of the First Tranche Bonds, the subscription price for the Shares will be the lower of (a) the Conversion Price in effect at the time, and (b) 90 per cent of the lowest of (i) the VWAP of a Share on the relevant payment date, and (ii) the lowest of the VWAPs of a Share on each of the five consecutive dealing days ending on (and including) the dealing day immediately preceding the relevant payment date.

The Board has, in light of the frequent amortisations and need to secure continuous adherence with the Market Abuse Regulation obligating the Company to make payments in Shares in certain situations, resolved to make amortisations and interest payments by exercising its Share Settlement Option, unless it separately decides to make payments in cash. Pursuant to the First Tranche Conditions, the exercise of the Share Settlement Option is subject to certain liquidity conditions and HCM’s (including its affiliates) ownership in the Company not exceeding 9.99 per cent of the Shares at any time. The Company will publish an announcement each time the number of outstanding Shares in the Company increases following the issuance of Shares pursuant to the Arrangement.

In addition to the scheduled amortisation payments, HCM (or any future holders of the majority of the First Tranche Bonds) may, at any time between scheduled amortisations, exercise their right to bring forward up to two (2) additional amortisation payments (an “Accelerated Amortisation”) to be paid in advance on a date specified in a notice sent to the Company, with a limit of no more than nine (9) Accelerated Amortisations in the first year of the term of the First Tranche Bonds. Additionally, HCM (or any future holders of the majority of the First Tranche Bonds) will also have the right to defer any upcoming amortisation payment to be paid on a later Amortisation Payment Date specified in the notice sent to the Company.

The exercise of the bondholders’ right to convert the First Tranche Bonds into Shares as well as the exercise of the Company’s Share Settlement Option will be effected by the bondholders exercising special rights entitling into Shares, as referred to in Chapter 10 of the Finnish Companies Act (“Special Rights”), issued in connection with the issuance of the First Tranche Bonds. The Special Rights will be attached to the First Tranche Bonds, and the subscription price for the Shares to be subscribed for pursuant to the Special Rights (in accordance with the First Tranche Conditions) will be paid by setting off the Company’s debt to pay relevant amounts due under the First Tranche Bonds.

The First Tranche Conditions include certain covenants and undertakings by the Company, including a negative pledge provision and restrictions to the incurrence of additional indebtedness as well as on the conduct of business by the Company such that it may only carry on matters in the ordinary course of business and not enter into certain transactions such as mergers, demergers or reorganisations, or disposal of assets, except in relation to any partnering or licencing arrangements related to development of its business, or on terms approved by the majority bondholders.

Second Tranche Bonds and the Third Tranche Bonds

If the Board considers it to be in the best interest of the Company and all of its shareholders at the time, the Company may, in its sole discretion, during a twelve-month period following the announcement of the Phase II topline readout (expected to be released in April 2025) require HCM to subscribe for the Second Tranche Bonds. During a period starting on the date falling six months and ending on the date falling 18 months after the issuance of the Second Tranche Bonds, either party may require that the Third Tranche Bonds are issued and subscribed for. The issuance and subscription of Second Tranche Bonds and the Third Tranche Bonds, respectively, are subject to certain customary conditions precedent, including that no material adverse change has occurred and that there has been no adverse change in the international financial markets.

  • With respect to the Second Tranche Bonds, it is further required that (a) Phase II topline readout in respect of its BEXMAB r/r MDS Study indicates an objective response rate of at least 60 per cent, (b) that the arithmetic mean of the daily traded value of the Shares on each dealing day comprised in the three-month period preceding the issuance of the Second Tranche Bonds is greater than EUR 500,000, and (c) that the Company has a market capitalisation greater than EUR 200 million on the date of issuance of the Second Tranche Bonds.
  • In order for the Company to have the right to require HCM to subscribe for the Third Tranche Bonds, it is required that (a) the arithmetic mean of the daily traded value of the Shares on each dealing day comprised in the three-month period preceding the issuance of the Third Tranche Bonds is greater than EUR 500,000, and (b) the Company’s market capitalisation on the date of issuance of the Third Tranche Bonds is greater than 120 per cent of its market capitalisation on the date of issuance of the Second Tranche Bonds.
  • HCM’s right to require issuance of the Third Tranche Bonds is not subject to the above conditions.

HCM may, at its discretion, waive any of conditions precedent in respect of both Second Tranche Bonds and Third Tranche Bonds.

The Second Tranche Bonds and the Third Tranche Bonds are intended to be issued on substantially same terms as the First Tranche Bonds. The initial Conversion Price of the Second Tranche Bonds and the Third Tranche Bonds, respectively, will be determined based on a 20 per cent premium to the reference share price, being the EUR price per Share that is the lowest of the six Volume Weighted Average Prices of a Share listed on Nasdaq First North Growth Market Finland on each of the six consecutive dealing days ending on (and including) the Issue Date of the Second Tranche Bonds and the Third Tranche Bonds, as the case may be.

Special Rights attached to the First Tranche Bonds

In connection with the issuance of the First Tranche Bonds, the Board has resolved, based on the authorisation granted by the General Meeting held on 5 April 2024, to issue 12,000,000 Special Rights. The Special Rights are issued in deviation from the shareholders’ pre-emptive rights (directed issue) without consideration to HCM as the initial subscriber of the First Tranche Bonds. The Special Rights are attached to the First Tranche Bonds and cannot be separated from them. Should HCM use its right to transfer First Tranche Bonds, the Special Rights attached to the relevant bonds that have not been exercised at the time of the transfer would be simultaneously transferred to the new bondholder.

A total of 80,000 Special Rights will be attached to each First Tranche Bond with a principal value of EUR 100,000. Each Special Right entitles to one (1) new or existing Share of the Company. Should all First Tranche Bonds be converted into Shares at the initial Conversion Price EUR 2.93952 (assuming no amortisation and/or interest payments have been made), the number of new Shares to be issued by the Company pursuant to the Special Rights would be 5,102,874 Shares, corresponding to approximately 4.57 per cent of the current total amount of Shares in the Company (approximately 4.37 per cent of a fully diluted basis). If the Conversion Price is adjusted, as set out in the First Tranche Conditions, the Company may be obligated to issue further Special Rights in which case the Board will resolve upon said issuance in accordance with the relevant provisions in the Finnish Companies Act.

The Special Rights may only be exercised, and Shares may only be issued pursuant to such exercised Special Rights, in accordance with the First Tranche Conditions.

Additionally, in order to prepare especially for any advanced amortisation situations, the Company’s Board may separately resolve to issue treasury shares to Faron itself without consideration. Such Shares could only be used to convert the First Tranche Bonds in accordance with their terms and conditions, and such issuance, if resolved, would be separately announced.

Early Repayment of IPF Facility

Faron has exercised its right of early repayment in full of the IPF Facility in accordance with its terms and conditions. The amount repayable by the Company will be EUR 9,079,832, including outstanding principal amount, accrued interest, capitalised payment-in-kinds, and the exit fee. Subject to the Company receiving the issue price for the First Tranche Bonds, the repayment is expected to be made on 3 April 2025.

“We are very grateful for IPF’s support over the past years during challenging capital markets in biotech. For the next stages of growth, we are very pleased to partner with HCM, a leading provider of growth capital globally. We believe Faron has now all the flexibility and fire power it needs to fulfil its objectives for 2025 and make the most out of the up-coming BEXMAB Phase 2 read-out”, says Dr. Juho Jalkanen, CEO 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, Nominated Adviser and Broker
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880

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.

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 Appoints Dr. Petri Bono as new CMO

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Faron Appoints Dr. Petri Bono as new CMO

Company announcement, 6 August 2024 at 8:30 a.m. BST / 10:30 a.m. EEST

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in treatment resistant hematological malignancies and solid tumors, is pleased to announce the appointment of Dr. Petri Bono (M.D., Ph.D.) as the new Chief Medical Officer (CMO) starting the 15th of August.

Previously Dr. Bono has served as the Chief Medical Officer and member of the Group executive team of Terveystalo, the largest private healthcare service provider in Finland. Prior to Terveystalo he was the Chief Medical Officer at Helsinki University Hospital. In addition to being Associate Professor of Cancer Biology at University of Helsinki, Dr. Bono has held various leadership positions within Helsinki University Hospital, including as the Director and Physician-in-Chief of the Comprehensive Cancer Center. Dr. Bono has participated in numerous oncology trials from Phase 1 to 3, including early phase immuno-oncological trials and published 102 peer reviewed papers in international journals including New England Journal of Medicine, Lancet Oncology, JAMA as well as Cancer Cell.

Dr. Bono’s own research has been focusing on molecular and immunological oncology. Given his translational and clinical studies in targeted therapies and applied immunology, he is uniquely suited to support Faron’s immuno-oncology program to tackle cancers via novel myeloid cell targeting immunotherapies that will bring the promise of immunotherapy to much broader patient populations, especially in the solid tumors space. 

“Bexmarilimab is an exceptional asset. It is an industry-leading agent in macrophage re-programming and has wide applicability in the treatment of a variety of cancers. Macrophages remain a key source of treatment resistance in solid tumors and in many instances bexmarilimab has shown it can induce responses and overcome this resistance. I am thrilled to develop further Faron’s novel and innovative immunotherapy program, and make bexmarilimab a cornerstone of future cancer care”, says Dr. Bono the in-coming CMO of Faron.

“We are delighted to have such an experienced and proactive oncologist join us as the new CMO”, says Dr. Juho Jalkanen, CEO of Faron . “This especially strengthens us in respect to our up-coming expansion plans into solid tumors, as we expect to benefit from the experience and broader shoulders of a partner for late-stage development in hematology. This means maximizing our expertise and development capabilities in both solid tumors and hematological malignancies using a mix of internal know-how and strategic partnerships to generate broader value for both patients and investors.”

Dr. Birge Berns, the acting CMO seconded from tranScrip Ltd. will continue her role as part of the medical leadership involved in developing bexmarilimab. “We are very grateful for tranScrip and Dr. Berns’ services and look forward to continuing this partnership. Dr. Berns has had a vital role in our success with the FDA and bringing Bexmarilimab to where it is today., She will continue to have an important role in shaping our development and regulatory strategy as we go forward”, continues Dr. Jalkanen.

For more information please contact:

Investor Contact

Faron Pharmaceuticals
 E-mail: investor.relations@faron.com

Media 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 1/2 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.

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