Translation: Original published in Finnish on 02/20/2026 at 07:00 am EET

Faron announced on Thursday that it 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 investigator-initiated approach is well-suited to the company's current resource situation and enables the accumulation of clinical evidence in new indications at a low cost. The news does not cause immediate changes to our estimates.

Does the combination prevent relapse?

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. Dr. Mika Kontro, the principal investigator, is also a Member of Faron’s Scientific Steering Committee. This is an open-label, two-stage Phase II study that aims to recruit 24 patients. Due to the study design, the efficacy results are rather indicative and do not allow for strong conclusions. 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.

The investigator-initiated model supports strategy and saves resources

Faron's research program has recently focused on blood cancers, and the company's primary goal is to advance bexmarilimab towards marketing authorization for the treatment of high-risk myelodysplastic syndrome (HR-MDS). The BEAM-X study is in line with this focus and utilizes the results obtained from the BEXMAB study. For example, previous results on the safety and tolerability of the bexmarilimab and azacitidine combination allow for a direct start from Phase II in this study.

As with the previously announced BEXAR study focusing on solid tumors, BEAM-X will also be conducted on an investigator-initiated basis. We consider this model strategically sound for Faron, as it 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. Although investigator-initiated studies do not typically aim directly for marketing authorization, they generate valuable information that can enhance the commercial potential and attractiveness of a drug candidate for potential partnership negotiations.