Faron presented updated BEXMAB data at the ASH meeting

Translation: Original published in Finnish on 12/9/2025 at 8:00 am EET.

Faron announced on Monday the updated results of the BEXMAB trial, which were presented at the American Society of Hematology (ASH) annual meeting. The updated results refined the life expectancy of patients with relapsed or refractory (r/r) myelodysplastic syndrome (HR-MDS) to 14.5 months (previously 13.4). 13.4). In addition, the recent analysis focused on the responses of patients with TP53 mutations. The results support the company's plans to proceed to a Phase II/III registration trial, and the release has no immediate impact on our forecasts. Key to the investment story's progress is the funding of the upcoming trial and its initiation on schedule in Q2'26.

Life expectancy increased in a difficult-to-treat patient group

A new observation from the updated data was an increase in the median overall survival (mOS) of patients with relapsed or refractory (r/r) HR-MDS to 14.5 months from the previously reported 13.4 months. Historically, the life expectancy in this patient group has been only about 5–6 months.

The recent analysis also focused on patients with TP53 mutations, whose prognosis is typically poor. In first-line treatment, 70% of TP53-mutated patients achieved a complete response (CR). Of patients without the mutation, who are inherently easier to treat, 20% achieved a complete response. Half of the first-line and one-fifth of r/r disease TP53 patients were able to proceed to curative stem cell transplantation (SCT). Due to the trial design and small sample size, the role of chance in the results is significant. More robust conclusions regarding efficacy can be drawn from the interim readout of the upcoming randomized trial.

Transfusion independence improves quality of life

As new information, Faron reported in more detail on patients achieving transfusion independence (TI). Of the first-line patients who were transfusion-dependent at baseline, 57% achieved independence during treatment. In the entire trial population, the corresponding figure was 23%. Transfusion independence is a clinically significant factor, as it improves patients' quality of life and reduces the burden on healthcare. Azacitidine monotherapy is known to lead to transfusion independence in some patients. Bexmarilimab's role in TI is difficult to assess at this stage.

A Phase II/III registration trial is planned for next year

The results presented at the ASH meeting complement the topline readout previously presented at the ASCO and ESMO meetings. Updates on TP53 responses, overall survival, and more detailed data on transfusion independence clarify the overall picture. The safety profile remained good, and no bexmarilimab-related fatal adverse events were observed in the trial. We do not expect tolerability and safety to cause concerns in the upcoming Phase II/III trial.

Overall, the BEXMAB results provide Faron with a good starting point for initiating the planned randomized Phase II/III registration trial (BEXMAB-02). The company has previously stated that it aims to start the trial during Q2’26. We believe the schedule is tight and requires a quick financing solution to be realized. Faron has stated that it is seeking a partnership agreement to fund the trial. Other options, such as a combination of a convertible bond and a share issue to carry out the first part of the upcoming trial, are also realistic in our view.