TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunotherapies, today announces a significant expansion of its clinical development program with the upcoming initiation of the Phase II BEAM-X Investigator-Initiated Trial (IIT) led by the Nordic AML Group with Dr. Mika Kontro serving as principal investigator. The trial evaluates bexmarilimab in combination with azacitidine for patients with measurable residual disease (MRD) positive acute myeloid leukemia (AML) following allogeneic stem cell transplantation.

Relapse after transplantation remains one of the most devastating challenges faced by AML patients, driven in large part by the persistence or return of MRD which is the strongest predictor of full leukemia relapse. Despite advances in transplant medicine, therapeutic options for MRD-positive patients after stem cell transplantation remain limited. The BEAM-X IIT advances bexmarilimab into this high-need clinical setting, targeting the MRD phase when disease burden is low and immune-mediated elimination is biologically most achievable. By combining azacitidine’s ability to enhance antigen presentation with bexmarilimab’s restoration of immune activation, the combination aims to create the conditions for early immune‑mediated clearance of residual disease and reduce the risk of relapse. Data from the BEXMAB Phase I/II trial support BEAM-X, where the combination of bexmarilimab and azacitidine has shown early MRD‑clearance signals in HR-MDS patients, reinforcing the mechanistic rationale for exploring this combination in the MRD‑positive post‑transplant AML population.

“Preventing relapse after transplantation is one of the greatest unmet needs in AML,” said Dr. Petri Bono, Chief Medical Officer of Faron. “The complementary biology of azacitidine and bexmarilimab makes this combination particularly compelling in the MRD setting, where timely immune activation may meaningfully alter the clinical trajectory. We are pleased to collaborate with the Nordic AML Group, a leading academic consortium with deep expertise in this field.” The BEAM-X trial is an open-label, two stage Phase II trial carried out with the Nordic AML Group, a long-established cooperative network of leading Nordic transplant and leukemia centres. The trial evaluates the combination of azacitidine and bexmarilimab to assess whether the regimen can achieve deep molecular responses and maintain remission. The trial will enrol 24 patients and aims for a primary endpoint of MRD negativity at six months, supported by key secondary endpoints including relapse-free survival, overall survival, safety and tolerability, and incidence of graft-versus-host disease. Patients may receive a short venetoclax intensification if MRD kinetics remain suboptimal. First patient in is expected in Q3 2026, with the initial stage-1 efficacy readout anticipated 12–15 months after enrolment begins.

“Patients who develop MRD after stem cell transplantation face a very high risk of relapse and poor survival, and we urgently need new strategies that intervene earlier and more effectively,” said Dr. Mika Kontro, trial Principal Investigator at Helsinki University Hospital. “Bexmarilimab offers a novel immunologic mechanism by activating both innate and adaptive immunity, and we look forward to evaluating whether this approach can help prevent progression and improve long-term outcomes for our patients.”

About bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments by targeting Clever-1, a receptor on immunosuppressive macrophages and malignant blasts. By inhibiting Clever-1, bexmarilimab reprograms the tumor microenvironment to ignite a potent anti-tumor immune response.

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).

About Faron Pharmaceuticals Ltd.

Faron Pharmaceuticals (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on creating innovative cancer treatments that leverage the patient’s own immune system. The Company’s lead asset bexmarilimab is currently being investigated in multiple Phase Ib/II clinical trials as a potential therapy for patients with hematological malignancies and solid tumors in combination with other standard treatments.

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Forward-Looking Statements

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