Faron announces new data that highlight patient populations with cancer that are most likely to benefit from first-in-class immunotherapy bexmarilimab

Faron Pharmaceuticals Ltd | Press Release | May 23, 2025 at 09:00:00 EEST

New data published in the Journal for ImmunoTherapy of Cancerreveals how tumor microenvironment shapes response to bexmarilimab along with a gene signature that can predict sensitivity to treatment

Study highlights:

  • Tissuemicroenvironments showed three distinct response patterns to bexmarilimab, driven by the level of inflammation, macrophage type, and their location within the tissue.
  • Bexmarilimab stimulated response in immunologically-cold tumors and inhibited inflammation in treatment resistant tumors.
  • New patent filed around gene signature validated to predict bexmarilimab sensitivity, offering a tool for patient selection.
  • Cancer-free adjacent tissues also responded to bexmarilimab, primarily through B cell activation, hinting towards long lasting systemic beneficial affects against cancer.

Turku, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company, today announced the publication of a new study in the peer-reviewed Journal for ImmunoTherapy of Cancer, shedding new light on how the tumor microenvironment (TME) influences the response to bexmarilimab, the company’s investigational macrophage-targeting immunotherapy.

The study, conducted by researchers at the University of Turku and Turku University Hospital, used advanced patient-derived explant culture (PDEC) models and cutting-edge transcriptomic profiling to map the immunological landscape surrounding tumors and their adjacent tissues. It identified critical molecular and cellular factors that determine how patients respond to bexmarilimab therapy.

Dr. Maija Hollmén, Chief Scientific Officer of Faron Pharmaceuticals and senior author of the study from MediCity Research Laboratory and InFLAMES Flagship, University of Turku, Finland, said, “This work gives us a mechanistic framework for understanding why some patients respond remarkably well to bexmarilimab while others do not in solid tumors. By recognizing that macrophage response is governed by the tissue’s immunological state, we open new possibilities for tailored therapy. This could help guide both clinical trial design and eventual treatment decisions, ensuring patients are matched with the right therapy to have a better chance at survival.”

Tumor-associated macrophages, or TAMs, are specific immune cells found within and around solid tumors. Depending on their type, they can either help the body fight cancer (immunostimulatory) or protect the tumor (immunosuppressive) and help it grow. Hence, it is important to study them in the tumor microenvironment (TME or the area around the tumor where these cells are present). By understanding how TAMs behave in different tumors, researchers can find better ways to treat cancer with medicines that reprogram these cells to attack the tumor instead of helping it. Bexmarilimab is a first-in-class humanized anti–Clever-1 antibody designed to reprogram TAMs from an immunosuppressive to an immunostimulatory phenotype. By inhibiting the scavenger receptor Clever-1, bexmarilimab enhances antigen presentation and promotes anti-tumor immunity. This study addresses the heterogeneity of TAMs by showing how their type, origin, and the tumor environment influence response to therapy.

Researchers analyzed samples of tumor and adjacent cancer-free tissue from patients with breast cancer who underwent mastectomy (PDEC model). They also applied a combination of single-cell RNA sequencing, spatial transcriptomics, and cytokine profiling to identify the genes associated with bexmarilimab’s response.

Bexmarilimab stimulated response in immunologically “cold” tumors (low inflammation) and reduced inflammation in TMEs with strong IFN signaling and advanced TAM activity. The analysis validated five genes (including CXCL9, FCGR1A, GBP5, SLAMF7, and SERPING1) that accurately predicted sensitivity to bexmarilimab. This allows for a potential biomarker-based strategy to enrich patient populations in clinical trials in solid tumors and optimize therapeutic outcomes. A new patent application has been filed for using this method for patient selection.

Dr. Petri Bono, Chief Medical Officer, Faron Pharmaceuticals, said, “As the immunotherapy landscape evolves, understanding the TME’s influence on treatment response is becoming increasingly critical. These findings lay a scientific foundation for advancing macrophage-targeting therapies beyond trial-and-error toward a more predictive treatment. It can potentially impact the design of future trials for bexmarilimab in solid tumors, including potential companion diagnostics based on the identified gene signature.”

Moreover, despite that macrophage are known to be crucial for innate immune responses cancer-free adjacent tissues consistently showed B cell activation regardless of the corresponding tumor’s response, hinting at systemic immune benefits as a part of adaptive immunity, i.e. the memory side of the immune system. These findings underscore the context-dependent nature of macrophage reprogramming and the need for precise patient selection in clinical development.

The study also highlighted that bexmarilimab may complement existing immune checkpoint therapies. Bexmarilimab targeted tumor environments that are immunologically opposite to those responsive to anti-PD-(L)1 therapy. While each associated differently with baseline IFN signaling, both triggered IFN responses when effective.

For the latest findings in Finnish, see the University of Turku press release.

Bexmarilimab is currently under investigation for both hematological cancers and advanced solid tumors. The ongoing BEXMAB clinical study is evaluating bexmarilimab in combination with azacitidine in relapsed/refractory AML and MDS patients. The trial’s most recent phase II data, to be presented at ASCO and EHA 2025, showed promising response rates in pretreated populations.

Faron will be hosting a virtual webinar to discuss the full analysis of r/r MDS as well as new frontline HR MDS patient data on Monday, 2 June 2025. To register for the event visit: BEXMAB Phase II study results

For more information, please contact:

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

Faron Appoints Ralph Hughes as Chief Business Officer (CBO)

Faron Pharmaceuticals Ltd | Company announcement | May 21, 2025 at 09:00:00 EEST

Ralph Hughes joins Faron to strengthen Commercial Strategy, Business Development and Market Assessment function

Turku, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company advancing next-generation immunotherapies, is pleased to announce the appointment of Ralph Hughes as the new Chief Business Officer, starting on the 28 May 2025. Mr. Hughes will be part of the Management Team and Business Development Committee.

Prior to joining Faron, Mr. Hughes worked as Senior Vice President at PharmaVentures, serving multiple clients with expertise in Commercial Strategy, Business Development and Market Access.

Mr. Hughes has extensive experience in commercial due diligence, market access and business development processes through his various roles in the pharmaceutical industry. At Mundipharma, he was responsible for the commercial launch strategy for pipeline assets and commercial assessment of new assets. At Pfizer, he developed global commercial, market access and pricing strategies across multiple disease areas for early-stage and in-market assets.

Mr. Hughes holds an MSc in Public Health and Health Economics from the London School of Hygiene and Tropical Medicine, and a BSc in Biomedical Sciences from Newcastle. Throughout his career, Mr. Hughes has developed a strong understanding of what it takes to overcome access hurdles and commercialize novel therapeutics.

“I am honoured to step into this role at such a critical time for Faron”, says Mr. Hughes the in-coming CBO of Faron. “I look forward to putting my experience to good use and fostering partnerships that will further the Company’s mission and fulfil our promise of bringing this exciting immunotherapy closer to patients”

“We are delighted to have such an experienced pharmaceutical market access and strategic commercial development expert to join us as the new CBO”, says Dr. Juho Jalkanen, CEO of Faron. “Ralphs’s proven track record in biopharma leadership and his experience aligns perfectly with our corporate development efforts and strategic growth initiatives.”

For more information, please contact:

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

Faron Announces Acceptance of Bexmarilimab Data for Oral Presentation at EHA 2025 Congress

Faron Pharmaceuticals Ltd | Press Release | May 15, 2025 at 09:00:00 EEST

Overcoming immune resistance in HR-MDS: Detailed safety and efficacy Phase II data on bexmarilimab to be presented at EHA 2025

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, today announced that data from its ongoing BEXMAB study evaluating bexmarilimab in patients with high-risk myelodysplastic syndromes (HR-MDS) have been accepted for an oral presentation at the 30th European Hematology Association’s (EHA 2025) Congress, taking place in Milan from June 12–15, 2025.

The oral presentation will feature detailed efficacy and safety results from the study of bexmarilimab in combination with standard-of-care (azacitidine) in frontline with HR-MDS and those with refractory or relapsed HR-MDS who have failed hypomethylating agent (HMA) therapies (r/r MDS). This follows the recent positive findings of the Phase II data from the BEXMAB study, and reaffirms bexmarilimab’s mechanism of action and its potential in improving outcomes for patients with MDS.

Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals, said: “We are thrilled to see bexmarilimab’s data receive acceptance for oral presentation at EHA, following similar recognition at MDS and ASCO. This continued momentum reinforces our belief that bexmarilimab holds real promise as a much-needed therapeutic option for patients with higher-risk MDS, a rare and challenging condition with few effective treatments. We remain deeply committed to advancing its development and bringing meaningful innovation to those who need it most.”

The details of the oral presentation are as follows:

Presentation title: Efficacy of Macrophage Checkpoint Clever-1 Inhibition with bexmarilimab plus Azacitidine in Myelodysplastic Syndrome: Results from the Ph1/2 BEXMAB Study

Session: Oral presentation 

Presenter: Dr. Mika Kontro, MD, PhD

Date and Time: 15 June 2025 11:00 – 12:15 CEST

Location: Milan, Italy

Abstract no: S178

Further details will be shared closer to the conference dates.

For more information, please contact:

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

Faron Pharmaceuticals Ltd: Grant of Options

Faron Pharmaceuticals Ltd | Company announcement | May 14, 2025 at 16:00:00 EEST

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 Company’s board has confirmed the grant of a total of 876,000 options over ordinary shares in the Company (“Options”) under the Company’s Share Option Plan 2019 (including its UK and US sub plans).

The Options have been allocated under the Share Option Plan 2019 and are exercisable between April 4, 2026 and April 4, 2031, vesting 25% per annum over four years. The exercise price for Options allocated under the Share Option plan is €2.20 per share, which is calculated based on the average price per share at which the ordinary shares in the Company have been traded on AIM for 90 days preceding the allocation date of 4 April 2025. The exercise price for Options allocated under the US sub plan is €2.31 per share, which is calculated based on the average price per share at which the ordinary shares in the Company have been traded on AIM for 30 days preceding the allocation date of 4 April 2025. The terms of the Share Option Plan 2019 are available on the Company’s website at https://faron.com/wp-content/uploads/2025/04/20250321_Share-Option-Plan-2019_Rules_EN_clean.pdf

The granted 876,000 Options entitle the option holders to subscribe for a total of 876,000 new ordinary shares in the Company, if exercised in full, and represent 0.78 % of the fully diluted ordinary share capital of the Company.

Included in the number of Options granted are the following Options which were issued to directors, other persons discharging managerial responsibilities (“PDMRs”) and Company personnel:

Director Options granted
Colin Bond 30,000
Marie-Louise Fjällskog 30,000
Juho Jalkanen 200,000
Markku Jalkanen 30,000
John Poulos 30,000
Tuomo Pätsi 100,000
Christine Roth 30,000
Total directors 450,000
Other PDMR
Maija Hollmén 6,000
Vesa Karvonen 30,000
Yrjö Wichmann 60,000
Kaisa Kyttä 11,000
Petri Bono 30,000
Total other PDMRs 137,000
Total Company personnel 876,000

For more information, please contact:

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

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014
1 Details of the person discharging managerial responsibilities/person closely associated
a. Name a) Colin Bond
b) Marie-Louise Fjällskog
c) Juho Jalkanen
d) Markku Jalkanen
e) John Poulos
f) Tuomo Pätsi
g) Christine Roth
h) Maija Hollmén
i) Vesa Karvonen
j) Yrjö Wichmann
k) Kaisa Kyttä
l) Petri Bono
2 Reason for notification  
 
 
a. Position/Status Person discharging managerial responsibilities/person closely associated
b. Initial notification/
Amendment
Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a. Name Faron Pharmaceuticals Oy
b. LEI 7437009H31TO1DC0EB42
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a. Description of the financial instrument, type of instrument

Identification Code

Options over new ordinary shares

ISIN: FI4000153309

b. Nature of the transaction Grant of options made under the Faron Share Option Plan 2019 – under the UK and US sub plans the options are exercisable at €2.20 per ordinary share, and at €2.31 per ordinary share respectively.
c. Price(s) and volume(s)
Price(s) Volume(s)
a) €2.20
b) €2.31
c) €2.20
d) €2.20
e) €2.31
f) €2.20
g) €2.31
h) €2.20
i) €2.20
j) €2.20
k) €2.20
l) €2.20
a) 30,000
b) 30,000
c) 200,000
d) 30,000
e) 30,000
f) 100,000
g) 30,000
h) 6,000
i) 30,000
j) 60,000
k) 11,000
l) 30,000
 
 
d. Aggregated information
 
– Aggregated Volume
 
– Price
 
 
Nil
 
 
e. Date of the transaction 14 May 2025
f. Place of the transaction Turku
 

Faron Pharmaceuticals presents promising Phase 1/2 data from BEXMAB Study at MDS 2025 plenary session

Faron Pharmaceuticals Ltd | Press Release | May 12, 2025 at 09:00:00 EEST

BEXMAB data highlights meaningful clinical benefit, with beneficial immunological and hematological impact in r/r MDS

  • Encouraging survival; Median overall survival 13.4 months in 20 high and very high-risk r/r MDS patients treated with bexmarilimab + azacitidine; 4 patients successfully bridged to hematopoietic stem cell transplant
  • 55% patients showed ≥50% reduction in bone marrow; 21% of transfusion-dependent patients became transfusion-independent
  • Faron will be hosting a virtual webinar to discuss the full analysis of r/r MDS as well as new frontline HR MDS patient data on Monday, 2 June 2025. To register for the event visit: BEXMAB Phase II study results

Turku, Finland Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company advancing next-generation immunotherapies, presented updated data from its ongoing BEXMAB Phase 1/2 trial at plenary oral session at the 18th International Congress on Myelodysplastic Syndromes (MDS 2025) on May 10, 2025, in Rotterdam, Netherlands.

The presentation, led by Dr. Amer Zeidan, MBBS, MHS, focused on the preliminary efficacy, safety, and immune biomarker data from 20 first patients with relapsed or refractory high-risk myelodysplastic syndromes (r/r MDS) who had failed prior hypomethylating agent (HMA) therapies. 90% of the patients were very high/high risk at baseline and 50% had tp53 mutations. These patients represent a population with extremely limited treatment options and aggressive and difficult-to-treat disease. The BEXMAB Phase 1 & 2 MDS patients with prior HMA failure experienced an estimated median overall survival (mOS) of approximately 13.4 months, compared to the 5-6 months that would typically be expected under standard of care historically.

The BEXMAB study evaluated 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 HMA. By blocking Clever-1, bexmarilimab reprograms macrophages in the bone marrow, enhancing anti-tumor immunity. The combination was well tolerated, with no Grade 3–5 adverse events attributed to bexmarilimab and no treatment discontinuations due to related toxicity.

Clinically, the combination of bexmarilimab and azacitidine demonstrated encouraging efficacy in patients with r/r MDS. A reduction of 50% or more in bone marrow blast counts was observed in 55% of patients, indicating clinically significant disease control. Additionally, 21% of patients who were transfusion dependent at baseline achieved transfusion independence, reflecting a potential improvement in quality of life and a reduced need for supportive care. Importantly, four patients were able to proceed to hematopoietic stem cell transplantation, the only potentially curative treatment, suggesting that this regimen may serve as an effective bridge to transplant.

Dr. Amer Zeidan, MBBS, MHS, Professor of Medicine and Chief of Hematologic Malignancies at Yale School of Medicine and Yale Cancer Center, and the lead presenter said, “While we have a small number of patients treated on trial to date, I am encouraged by the safety and efficacy data we are observing to date with the the combination of bexmarilimab and azacitidine in patients with higher risk MDS, especially after HMA failure. If these trends continue to hold, they would provide strong rationale for pursuing a registrational approach with a randomized phase 3 trial, and could potentially offer a new therapeutic option for this difficult-to-treat patient population.”

Biomarker analysis revealed that treatment with bexmarilimab plus azacitidine was associated with a rise in immune activation markers in the bone marrow, suggesting that Clever-1 blockade enhances immune activation and engagement. Additionally, despite all patients being Clever-1 positive responding patients had higher pre-treatment Clever-1 expression on monocytes/macrophages than non-responding patients confirming the importance of Clever-1 as a target and the mode of action of bexmarilimab in the treatment of MDS patients.

Juho Jalkanen, MD, PhD, Chief Executive Officer of Faron Pharmaceuticals, said, We are deeply encouraged by these results, which show that bexmarilimab has the potential to significantly alter the treatment landscape for patients with relapsed or refractory MDS that have no further treatment options. The combination’s favorable safety profile and promising clinical activity in last line MDS strengthen our belief in the mechanism of action and therapeutic promise of Clever-1 inhibition. These results also support the company’s plans toward initiating a randomized study in frontline HR-MDS patients as suggested by the FDA earlier. New frontline data together with the fully enrolled r/r MDS Phase 2 will also be presented soon at ASCO 2025 and followed up with a webcast hosted by the company.”

Details of the presentation

  • Title: Preliminary efficacy of bexmarilimab with azacitidine in relapsed or refractory MDS in BEXMAB Ph1/2 study
  • Session: Plenary Session 08: Treatment High Risk
  • Presenter: Dr. Amer Zeidan, MBBS, MHS
  • Date & Time: May 10, 2025 | 09:50 – 11:20 CEST
  • Location: Rotterdam, Netherlands
  • Abstract Number: 225

Faron Pharmaceuticals remains committed to accelerating the clinical development of bexmarilimab for patients with high-risk myeloid malignancies.

Faron will be hosting a virtual webinar to discuss the full analysis of r/r MDS as well as new frontline HR MDS patient data on Monday, 2 June 2025 at 4pm EEST/9am ET.

To register for the event visit: BEXMAB Phase II study results

Amer Zeidan consulted and received honoraria from Faron. The views expressed represent his own and do not necessarily reflect those of his employer.

For more information, please contact:

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

Faron announces acceptance of bexmarilimab Phase II data for oral presentation at ASCO 2025

Faron Pharmaceuticals Ltd | Press Release | April 24, 2025 at 09:00:00 EEST

Data from the BEXMAB study marks a significant milestone for next-generation cancer immunotherapies

Turku, Finland, – Faron Pharmaceuticals Ltd. (AIM: FARN), a clinical-stage biopharmaceutical company developing novel immunotherapies, announces that new Phase II data from its ongoing BEXMAB study evaluating bexmarilimab in high-risk myelodysplastic syndromes (HR-MDS) will be presented as a part of a Rapid Oral Abstract Session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from 30 May to 3 June 2025, in Chicago, Illinois, USA.

The abstract, selected for oral communication, highlights the efficacy and tolerability of bexmarilimab, Faron’s novel humanized anti-Clever-1 antibody, with no dose-limiting toxicities during dose escalation, when used in combination with standard-of-care, azacitidine, treatment in patients with both treatment naïve (frontline) and relapsed/refractory (r/r) HR MDS patients.

“We are thrilled to see bexmarilimab’s potential continuing to translate into clinical benefit for patients with this challenging hematologic malignancy,” said Dr. Petri Bono, Chief Medical Officer of Faron Pharmaceuticals. “The Phase II results build on our understanding of Clever-1 biology and bexmarilimab’s mode of action, and we believe this novel immunotherapy could offer a meaningful new treatment pathway for patients. The acceptance of our results for an oral presentation also represents an important company milestone, as it reflects the scientific interest we have generated, as recognized by the largest global oncology community — ASCO “

Faron’s presence at ASCO 2025 reinforces the Company’s commitment to advancing science-driven novel immunotherapy solutions and to addressing unmet medical needs in oncology.

The details of the oral presentation are as follows:

Presentation title Efficacy of macrophage checkpoint Clever-1 inhibition with bexmarilimab plus azacitidine in myelodysplastic syndrome: Results from the ph1/2 BEXMAB study.
Session type and title Rapid Oral Abstract – Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session date 30 May 2025
Time 1:00 PM – 2:30 PM CDT
Abstract no 6513
Presenter Dr. Naval Daver, MD | Department of Leukemia, The University of Texas MD Anderson Cancer Center

For more information, please contact:

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

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.

Faron Announces Acceptance of Bexmarilimab Data for Oral Presentation at 2025 Annual MDS Foundation Congress

Faron Pharmaceuticals Ltd | Press Release | March 27, 2025 at 09:00:00 EET

New analysis and biomarker data strengthens understanding of bexmarilimab’s potential

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, today announces that data from its ongoing BEXMAB study evaluating bexmarilimab in patients with high-risk myelodysplastic syndromes (HR-MDS) have been accepted for an oral presentation on May 10th in a plenary session at the 18th International Congress on Myelodysplastic Syndromes (MDS 2025), taking place on May 7-10, 2025 in Rotterdam, Netherlands.

The oral presentation will feature updated clinical results from the BEXMAB study, including data previously presented at the ASH Annual Meeting 2024, now analyzed with the International Working Group (IWG) 2023 response criteria. Additionally, the presentation will include updated bone marrow Clever-1 expression biomarker data, further elucidating bexmarilimab’s mechanism of action and its potential in improving outcomes for patients with refractory or relapsed MDS who have failed hypomethylating agent (HMA) therapies (r/r MDS).

Dr. Petri Bono, Chief Medical Officer of Faron Pharmaceuticals, said: “Patients with relapsed or refractory high-risk MDS have very limited treatment options, and the need for novel, effective therapies is urgent. The data we are presenting at MDS 2025 incorporates the latest IWG 2023 response criteria and biomarker insights, which strengthens our understanding of bexmarilimab’s potential to modulate the immune system and improve patient outcomes. These findings bring us another step closer to the possibility of offering a meaningful new treatment approach for this devastating disease.”

The details of the oral presentation are as follows:

Presentation title: Preliminary efficacy of bexmarilimab with azacitidine in relapsed or refractory MDS in BEXMAB Ph1/2 study
Session: Plenary Session 08: Treatment high risk 
Presenter: Dr. Amer Zeidan, MBBS, MHS
Date and Time: 10th May 2025, 09:50 – 11:20
Location: Rotterdam, Netherlands
Abstract no: 225

Further details will be shared closer to the conference dates.

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.

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