• Faron has been granted a patent for treatment of Clever-1 positive cancers with bexmarilimab and related structures in the USA.
• This extends key patent rights around bexmarilimab from an initial 2037 to 2040 in the USA.

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunological pathways, today announces that the United States Patent and Trademark Office has granted a new US Patent, No. 12,371,486 for treatment of Clever-1 positive cancers with bexmarilimab and related structures that would bind to Clever-1 molecule for the wanted re-programming effect.

The patent is granted based on divisional application from the original “composition of matter” patent covering the structure of bexmarilimab. The original application included the composition matter claims as well as the treatment method. The new granted patent covers treating cancers that have Clever-1 positive cells in the tumour microenvironment with such structures. As previously announced a patent covering the composition of matter of bexmarilimab was already granted four years ago with patent life up to 2037 without extensions. Based on the long application process of the division application, the term of the newly granted patent has been adjusted beyond the standard twenty years lasting until February 2040.

“This significantly extends our key patent life on the use of bexmarilimab for the treatment of relevant cancers, that have Clever-1 positive tumour associated macrophages or blasts cells, such as in AML & MDS.”, says Faron’s CEO Juho Jalkanen. ”The patent family around targeting Clever-1 in cancer is strong and we believe bexmarilimab will enjoy a long patent life once marketed, given how far it is in clinical development already”, continues Dr. Jalkanen.

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.

Turku, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company developing novel immunotherapies, announces that new clinical and translational data from the Phase I/II BEXMAB study evaluating bexmarilimab in combination with azacitidine in higher-risk myelodysplastic syndromes (HR-MDS) will be presented as a part of a Mini Oral Abstract Session at the 2025 European Society for Medical Oncology (ESMO) Congress, taking place from October 17-21, 2025, in Berlin, Germany.

The oral presentation, by Dr. Amer Zeidan, MBBS, MHS, Professor of Medicine and Chief of Hematologic Malignancies at Yale School of Medicine and Yale Cancer Center, will feature the first full disclosure of pharmacokinetic (PK) and pharmacodynamic (PD) data from the BEXMAB study. These results will be presented alongside promising efficacy and biomarker findings, which indicate bexmarilimab’s potential to address a significant unmet need in HR-MDS, a condition with a poor prognosis.

The data from both frontline and relapsed/refractory (r/r) patient cohorts demonstrates that bexmarilimab, a novel macrophage checkpoint inhibitor targeting Clever-1, induces significant immune activation and hematological improvement within the bone marrow. This includes an increase in the antigen presentation capacity of monocytes and a rise in CD8+ T cells. These biological changes correlate with promising overall response rates of 85% in frontline and 63% in r/r patients with HR-MDS, and a median overall survival of 13.4 months in the latter group.

“HR-MDS is a devastating disease with limited effective treatment options,” said Dr. Petri Bono, Chief Medical Officer of Faron. “The BEXMAB data to be presented at ESMO annual meeting, the flagship event of ESMO and one of the largest global cancer congresses, provides a comprehensive overview of bexmarilimab’s activity, combining promising efficacy with a deep dive into its pharmacokinetic and pharmacodynamic profile. These findings reinforce our belief that targeting Clever-1 is the right approach and supports the advancement of bexmarilimab into Phase III trials, offering a potential new therapeutic strategy for these patients.”

The findings support a dual mechanism of action for bexmarilimab with direct metabolic effects on malignant blasts and a powerful, immune-mediated response. By reprogramming macrophages, bexmarilimab remodels the bone marrow and tumor microenvironment, overcoming immune and myelosuppression.

Faron’s presence at ESMO 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:

For more information, please contact:

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.

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 the acceptance of two studies involving its lead candidate, bexmarilimab, for presentation at the 19th IUIS International Congress of Immunology in Vienna, Austria, from August 17-22, 2025.

The oral presentation will feature new translational data from the Phase 1/2 BEXMAB clinical study in myelodysplastic syndrome (MDS). The second study, accepted as a poster, details the identification of secreted Clever-1 (sClever-1) as a key driver of immune suppression and immunotherapy resistance. Together, these presentations underscore the growing body of evidence supporting bexmarilimab’s mechanism of action.  

The oral presentation, entitled ‘Dual Mechanisms of Clever-1 Inhibition with Bexmarilimab Plus Azacitidine in Myelodysplastic Syndrome: Translational Insights from the Phase 1/2 BEXMAB Study,’ will be presented by Faron’s Chief Scientific Officer, Dr. Maija Hollmén. The BEXMAB study is a Phase I/II trial investigating bexmarilimab with standard of care in patients with aggressive hematological malignancies. The study provides insights into how directly targeting the Clever-1 receptor, which is highly expressed in acute myeloid leukemia (AML) and MDS, ignite an immune response, and make current treatments more effective.  

Dr. Maija Hollmén, senior author of both studies, MediCity Research Laboratory and InFLAMES Flagship, University of Turku, Turku, Finland, said, “The BEXMAB data provides translational insights into bexmarilimab’s dual impact in a clinical setting, while our sClever-1 findings elucidate a fundamental mechanism of systemic immune suppression. Showing that bexmarilimab can block sClever-1 release suggests our drug candidate fights cancer on two fronts: reprogramming macrophages locally and preventing this inhibitory molecule’s systemic effects. We look forward to sharing these insights with the global scientific community.”  

The research accepted for a poster presentation and also published in the peer-reviewed journal Theranostics, ‘Secreted Clever-1 modulates T cell responses and impacts cancer immunotherapy efficacy,’ reveals that a soluble form of Clever-1 is significantly enriched in the blood of cancer patients. This circulating sClever-1 directly binds to and neutralizes activated T cells, impairing their ability to fight cancer. High levels of sClever-1 are associated with resistance to anti-PD-1 therapies. Importantly, the research demonstrates that bexmarilimab treatment can inhibit the release of sClever-1, highlighting a key and previously undescribed therapeutic mechanism.  

“Having two distinct and complementary datasets accepted at this prestigious congress is very encouraging and a testament to the depth of our research,” said Dr. Petri Bono, Chief Medical Officer of Faron. “High-risk MDS is associated with poor outcomes and therapy resistance. The BEXMAB study data demonstrates a dual mechanism of action in MDS, while sClever-1 research redraws a part of the cancer immunology map. These data provide a strong scientific rationale for why targeting Clever-1 is the right approach.”  

For more information, please contact:

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.