Faron H1'25 preview: The company is preparing for a decisive trial phase

Translation: Original published in Finnish on 8/26/2025 at 8:08 am EEST.

Source: Inderes

Faron will publish its H1 report on Wednesday, August 27. The earnings call starting at 4 pm (EEST) can be viewed here. During the period, Faron has updated the results of the Phase I/II blood cancer study BEXMAB. The study is now in its final stages, and we believe the results will support the implementation of its final, crucial phase. During H1, Faron carried out a directed share issue of 12 MEUR and also agreed to a convertible bond of 35 MEUR. With these arrangements in place, current funding will suffice until Q1'26. Following the reporting period, the company announced a meeting with US authorities that provided additional information about the likely structure of the planned registrational-phase trial. Regarding the H1 report, we are primarily interested in obtaining more information about the plans for the new trial.

BEXMAB Phase I/II study nearing completion

Faron initiated Phase I/II of the BEXMAB study in summer 2022. In BEXMAB, Faron's investigational drug bexmarilimab is combined with standard-of-care azacitidine to treat blood cancers. In the early stages of the study, the dosage, tolerability, safety, and initial efficacy of bexmarilimab were tested in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). As the study progressed, the focus shifted to MDS patients in second line (r/r MDS), with other blood cancers taking a backseat, at least for the time being. Following last summer's FDA consultation, the study began to include first-line MDS patients, and the focus of development began to shift toward frontline treatment.

During H1’25, Faron has updated its research data several times. According to the latest readout on H2, complete remission (CR) was observed in 43% (9/21) of frontline MDS patients, which we consider a favorable outcome. From a tolerability and safety perspective, the results appear favorable, as the quantitative and qualitative disadvantages of the bexmarilimab and azacitidine combination seemed to be at an acceptable level in our assessment. We note that due to the small number of patients (21), the statistical power of the study does not allow for drawing strong conclusions about efficacy. However, the initially promising results from phase II may help in financing negotiations with potential partners to implement the pivotal phase. The increase in responses as the study progressed was not entirely surprising, as Faron has often reminded that treatment responses can increase during the course of treatment.

Steps for decisive trial are becoming clearer

Last week, Faron shared new information regarding the upcoming registrational-phase trial based on consultations with the US Food and Drug Administration. This end-of-phase II meeting is a standard meeting and discussion held with the authorities at the conclusion of clinical Phase II. According to the new information, the upcoming Phase II/III pivotal marketing authorization trial will focus on frontline MDS, with second-line (r/r MDS) remaining in the background. Another change compared to the previous plan relates to the dosage phase to be implemented first in the upcoming study, which will somewhat increase the total duration of the study and the number of patients compared to the previous outlook. The planned patient count was not commented on in the release, which is an interesting follow-up question ahead of the upcoming H1 report.

Funding arranged until the start of next year

During H1, Faron carried out a directed share issue worth 12 MEUR and a convertible bond worth a maximum of 35 MEUR, of which 15 MEUR has been drawn down to date. These measures have provided sufficient cash reserves until Q1’26, according to the company. According to our estimates, this will cover the completion of the Phase I/II trial and some preparations for the Phase II/III trial. The actual pivotal-phase trial requires significant additional funding, the exact amount of which can be estimated more accurately once the trial details are finalized (incl. the planned number of patients). Faron has stated that it is seeking a partnership agreement to carry out the registrational-phase trial. The key findings from the previous study are being finalized, so we believe the data is now mature enough for partner discussions.

In terms of H1 figures, we expect an EBIT of -14.8 MEUR. This is influenced by both patient activity in the current study and preparation costs for the next phase. Costs may arise, for example, from increasing the production capacity of bexmarilimab.