Faron: Treatment responses increased over time

Translation: Original published in Finnish on 08/07/2025 at 07:00 am EEST

Faron announced updates to the results of the Phase II BEXMAB study on Wednesday. According to the latest readout, the complete remission (CR) rate increased by 43% (9/21) of first-line patients with high-risk myelodysplastic syndrome (MDS). The share of CR treatment responses has increased from the previous readout as treatment continued longer, which is a positive signal for the future. In the big picture, we reiterate our assessment that the phase II results are good enough to justify moving to the pivotal phase III. A key question in the coming months is the financing of the pivotal study and the terms of the financing.

Additional responses in first-line MDS patients

High-risk MDS is a blood cancer with a poor prognosis, whose treatment Faron aims to improve by combining its investigational drug bexmarilimab with the standard treatment azacitidine. In first-line patients, we consider a 43% CR response to be a good result. We note that due to the small number of patients (21), the statistical power of the study does not allow for drawing strong conclusions. However, positive results from phase II may help in financing negotiations with potential partners to implement the pivotal phase. The increase in responses from the past was not entirely surprising, as Faron has systematically reminded that treatment responses can increase as treatment progresses. In late-stage, more difficult-to-treat r/r MDS patients, overall responses were 47% and CR/CReq responses were 6% according to the previous release. The figures in this set are also still subject to change. As for life expectancy, we are awaiting results for r/r MDS patients by year-end or early next year at the latest. Results for first-line patients are expected to take longer.

Overall, we believe that the results will enable the transition to phase III, the details of which will be discussed with the regulatory authority (FDA). Faron utilizes this latest treatment response data in discussions. In our view, the combination of bexirimab and azacitidine appears sufficiently good in terms of safety and tolerability, and we do not see any significant concerns related to it.

Finances are sufficient to complete phase II

Regarding financing, Faron's cash reserves are sufficient until Q1’26, according to the company. A convertible bond of up to 35 MEUR was added to the overall financing in spring 2025. The first 15 MEUR tranche of the loan has been drawn, which was primarily used for the repayment of IPF's loan. With the current financing, Faron can virtually complete the current BEXMAB study and make preparations for the phase III trial. However, carrying out the next phase will require significant new funding, the precise amount of which is likely determined once the research plan is finalized.