Faron's Bexmarilimab Data Accepted for BSH Presentation; New AML Study Launched

Faron Pharmaceuticals Ltd. (HEL:FARON)(LSE:FARN), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunotherapies, announced that data from its Phase I/II BEXMAB trial evaluating bexmarilimab in combination with azacitidine for the treatment of higher-risk myelodysplastic syndromes (MDS) have been accepted for presentation at the 66th Annual Scientific Meeting of the British Society for Haematology (BSH), taking place 19-21 April 2026 in Liverpool, UK.

The abstract, titled "Bexmarilimab Plus Azacitidine in Higher Risk Myelodysplastic Syndrome: Updated Results from the BEXMAB Study," has been selected for poster presentation (Poster P02.10) under the theme Myeloid Malignancies and Bone Marrow Failure Syndromes. The acceptance supports Faron's consistent scientific presence at major hematology and oncology meetings.

While the BSH poster contains updated figures from the latest data cut, the dataset itself is previously reported. Inclusion at BSH underscores the Company's ongoing engagement with the MDS community and its commitment to transparent, continuous reporting of BEXMAB clinical progress.

The poster presents the full dataset included in the accepted abstract based on the 3 November 2025 data cut (55 patients: 21 treatment‑naïve; 34 HMA‑refractory/relapsed). The results support the planned advancement of bexmarilimab into the next development phase in treatment‑naïve higher‑risk MDS.

The presenting author from The Christie NHS Foundation Trust and the University of Manchester commented: "We are pleased to share the BEXMAB data with the hematology community at BSH. The combination of bexmarilimab and azacitidine continues to show a favorable safety profile and encouraging response rates across both treatment‑naïve and HMA‑refractory higher‑risk MDS populations. Presenting this data at BSH offers a valuable opportunity to engage with investigators and KOLs who are eager for bexmarilimab's next HR‑MDS trial, exchange clinical insights, and help shape the field's continued progress."

Separately, Faron is initiating a new investigator-initiated Phase II BEAM-X study to evaluate bexmarilimab in combination with azacitidine in patients with acute myeloid leukemia (AML) after stem cell transplantation. The AML project benefits from the experience gained from the previous BEXMAB study.

The BEAM-X study expands bexmarilimab's clinical development program to a new patient group. Relapse in AML patients after stem cell transplantation is a significant problem, and measurable residual disease (MRD) is a strong predictor of relapse. The study aims to determine whether the combination of bexmarilimab and azacitidine can prevent leukemia recurrence.

The study will be carried out in cooperation with Nordic AML Group. This is an open-label, two-stage Phase II study that aims to recruit 24 patients. The study's primary endpoint is MRD negativity (i.e., residual disease is no longer measurable) at six months. The company expects the first patient to start the study in the third quarter of 2026, and efficacy results from the first part are expected approximately 12–15 months after recruitment begins.

Previous results on the safety and tolerability of the bexmarilimab and azacitidine combination allow for a direct start from Phase II in this study. The investigator-initiated model allows for the collection of clinical evidence in new indications without the company having to bear all research costs or operational responsibility itself. This is critical in a situation where the company's own resources are primarily directed towards the BEXMAB program's registration study, for which the company is considering a significant offering of 40 MEUR to finance it.

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.

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.