Faron H2'24 preview: BEXMAB results are maturing

Translation: Original published in Finnish on 2/26/2025 at 7:49 am EET.

Faron will publish its H2 report on Thursday, February 27. The webcast starting at 11 am (EET) can be viewed here. During the period, Faron updated its plans for the blood cancer study BEXMAB based on feedback from the FDA. The October Capital Markets Day provided further details on future plans for both blood cancers and solid tumors. Solid tumor trials are expected to begin in 2025. Patient enrollment in the BEXMAB study was completed in January after the period had ended, and future highlights include the planned readouts in April, which will now include all late-stage MDS patients for the first time. Faron raised 12 MEUR in a directed issue in early February and the current financing will last until December 2025, according to the company.

BEXMAB study in its final stages

In early H2'25, the FDA recommended that Faron conduct a Phase III study in first-line patients in combination with the standard of care, azacitidine. The comparator in the randomized study would be azacitidine + placebo, which in practice means that the study can be conducted to high standards and will produce high-quality data to support a potential marketing authorization application. Although the trial will be conducted in first-line patients, it will also allow for the filing of a marketing authorization application in late-stage patients whose HMA drug (e.g. azacitidine) is no longer effective. Based on the recommendation, Faron presented its updated trial plans for blood cancers and solid tumors at the Capital Markets Day. In solid tumors, the first investigator-initiated study (BLAZE) is scheduled to start in Q2'25. The start of the pivotal Phase III MDS study is not yet known, but it can be expected at the earliest around the turn of the year 2025-26. The next significant news expected is the final readout of responses from the BEXMAB study, which will be announced in April and include all late-stage MDS patients. Responses and their duration will also be monitored further into 2025. Response data from some of the first-line MDS patients may also be available in April. We expect statistically more significant results from first-line patients during H2’25.

Financing arranged for most of the current year

At the beginning of February, Faron completed a 12 MEUR rights issue, as a result of which the company expects to have sufficient liquidity until December 2025. The funds will be used to continue the follow-up of patients in the BEXMAB trial. As part of the 31 MEUR offering last summer, the company expected to sign a partnership agreement during 2024, which did not materialize. In connection with the financial statements, the market's interest may again focus on information about the agreement, even though the company cannot comment on the matter concretely. We expect the April readout to be an important step in the negotiations.