Translation: Original published in Finnish on 10/9/2026 at 9:00 am EEST.

On Thursday, Faron hosted an R&D Day providing background on its trial program, the recording of which can be watched here. The company's trial program is gradually expanding from myelodysplastic syndrome (MDS) to solid tumors and other blood cancers as well. Regarding its drug candidates, the company continues with a single-lead strategy focusing on bexmarilimab (BEX). The R&D day reviewed, detailed, and deepened the company's plans, but no significant new information regarding the content of the trial program was heard this time. Key to the investment story continues to be the progress of the BEXERA trial on schedule and within budget.

BEXERA blood cancer trial funded by Faron is the first opportunity for a marketing authorization

The most central part of Faron's research program is the Phase 2b/3 BEXERA trial. It investigates the safety and efficacy of the cancer drug candidate bexmarilimab in combination with the standard-of-care drug azacitidine in patients with high-risk MDS (HR-MDS). The earlier phases of the trial program (the Phase I/II non-randomized BEXMAB trial) have already provided evidence of the combination's good tolerability in first- and second-line HR-MDS patients. Patients treated with BEX have also shown signs of normalized bone marrow blood cell production, which may prove to be an additional benefit of the drug in further trials. There are preliminary indications of efficacy (41% CR+CReq, n=21), but the actual evidence of efficacy relies on the upcoming BEXERA trial.

The primary endpoint of the BEXERA trial is to identify the most appropriate dose for the subsequent pivotal trial for marketing authorization. The optimal dose is selected using a scoring system that weighs both efficacy (treatment responses) and safety and tolerability at three months following treatment initiation. Treatment responses are measured by complete responses under the IWG 2023 criteria (Complete Remission – CR and CReq). Safety and tolerability are measured by the incidence of treatment-related adverse events of grades 3–5 (TRAE). Secondary endpoints cover multiple efficacy and safety measures at 36 months from treatment initiation.

The randomized, controlled first part of the trial (Phase 2b) will enroll 90 patients: one group of 30 receiving placebo plus azacitidine (control group), and two treatment groups receiving different doses of BEX (1 and 3 mg/kg) in combination with azacitidine. BEXERA is a randomized controlled trial (RCT). The first primary endpoint readout is scheduled for end-2027. If results are sufficiently favorable, the trial will expand to Phase 3, with the patient count increasing to approximately 350 (including Phase 2b patients). Based on Phase 3 safety and response data, the company expects to receive marketing authorization in 2030. A subsequent follow-up period will provide data on whether BEX reduces patient mortality, with that readout expected in late 2031.

Two investigator-initiated trials are planned for other blood cancers We have previously covered the BEAM-X trial in AML here and the second-line r/r MDS trial here. Investigator-initiated trials broaden BEX’s potential and are highly cost-effective for Faron, though the company has limited influence over their design and scheduling.

Investigator-initiated trials in solid tumors have begun

Two investigator-initiated trials, BLAZE and BEXAR, have recently started in solid tumors. Both trials have recently recruited their first patients, and the first early-stage readouts can be expected during 2027. In the BLAZE trial, BEX is combined with a PD-1 inhibitor (nivolumab), one of the world’s best-selling drug classes. The combination is tested in common cancers, melanoma and lung cancer (NSCLC). These are indications with extremely high commercial potential, where, on the other hand, the bar is also very high due to competition. In the BEXAR trial, BEX is combined with the chemotherapy drug doxorubicin for soft tissue sarcoma. This cancer is extremely difficult to treat and there are limited treatment options available. The cancer also strongly expresses BEX's target (the Clever-1 protein), which is why testing the efficacy of BEX in this disease is biologically justified.

BEXERA is the core of the investment story, while other projects add some spice

Faron's current funding is sufficient until Q4’27, which the company intends to use to complete the readout of the BEXERA trial for the first primary endpoint. Based on previous results, we estimate that issues related to tolerability and safety are unlikely to arise. In terms of efficacy, complete responses (CR and CReq) should be observed more frequently in the treatment group than in the control group to justify conducting a significantly larger and more expensive Phase 3 trial. We estimate that it will be difficult for Faron to finance the large trial on its own. Financing the trial through partnering will likely require clear scientific evidence of the drug's efficacy in Phase 2b so that a partner can justify a large investment in the continuation of the project. Poor results can mean that Phase 3 will not be carried out. Next year's results will be extremely important for Faron and investors, especially because BEX is the company's only drug candidate under development. The progress of other projects is positive and they increase the long-term potential of BEX. However, commercialization for them is still quite far off, so their concrete significance to the company's value remains quite small for now. For the rest of the year, the key focus is on the initiation of the BEXERA trial on the planned schedule. Next year, on the other hand, rapid progress in the trial will be essential to enable the readout with current funding. Additional color for next year will be provided by the first readouts in solid tumors.