ACCEPTANCE OF BEXMARILIMAB DATA FOR ORAL PRESENTATION AT ESMO 2025

Presentation to include the first full pharmacokinetic and pharmacodynamic (PK/PD) data from the BEXMAB study; supports bexmarilimab’s advancement into Phase III

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:

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