Faron H2'25 preview: Funding the research program is the next endeavor

Translation: Original published in Finnish on 03/03/2026 at 07:40 am EET

Source: Inderes

Faron will publish its H2 report on Wednesday, March 4, 2026, and the company's earnings release can be followed here at 4:00 pm EET. Faron is preparing for a registration study, and the company is planning a 40 MEUR share issue to finance it. In the report, we are particularly interested in any potential clarifications and timelines regarding the financing round.

The main role of the research pipeline is in high-risk MDS

Faron completed the Phase I/II BEXMAB study last year. The project investigated the tolerability, safety, and preliminary efficacy of the drug candidate bexmarilimab in high-risk myelodysplastic syndrome. Based on the results, the combination of bexmarilimab and the standard drug azacitidine is well tolerated and, in our assessment, sufficiently safe. Initial positive signals were seen in terms of efficacy. Due to the study design and the rather small number of patients, reliable conclusions regarding potential efficacy cannot yet be drawn.

Based on the results and dialogue with the FDA, Faron developed a plan for a study aiming at registration, which the company recently updated. Next, Faron plans a financing round to carry out the first part of the registration study. The first part is scheduled for completion by the end of 2027. The randomized and controlled study will have a high-quality study design. The first part is expected to include 30 patients per group, which is still a relatively low number from a statistical power perspective. In the best-case scenario, the first part may be sufficient for submitting a marketing authorization application, but we estimate that the application will most likely be relevant after the second part is completed. Based on the company's plan, this would mean the year 2030 in terms of timing.

Financing arrangements are the next major milestone

Faron's most important milestone in the near future is the planned rights issue of around 40 MEUR. In connection with this, the EGM decided on Monday on an authorization to issue 80 million shares. The company had to change its financing strategy after the ASH conference in December, when a potential partner withdrew due to negative results from another company (VERONA study). We expect further details on the timing and terms of the share issue in connection with the H2 report, as successful financing is a prerequisite for initiating the bexmarilimab registration study. The success of the issue and the issue price are important for the development of the share's value.

On the research front, we look for more detailed plans for bexmarilimab's HR-MDS registration study in the report. The new plan is based on a 90-patient Phase II study, with the primary endpoint being the number of complete responses (CR) and their duration. This is a smaller patient population than previously planned, which saves costs but, on the other hand, weakens statistical power. In addition, the expansion of bexmarilimab into new patient groups, such as the BEAM-X study in acute myeloid leukemia (AML), which is scheduled to start in the second half of 2026, is of interest.

Reported figures reflect the costs of the BEXMAB study

We expect Faron's adjusted EBIT to be -10.7 MEUR in H2. For the full year 2025, we expect adjusted EBIT to be -22.6 MEUR. Earnings are weighed down by the completion of bexmarilimab's clinical trials and preparation costs for the upcoming registration study. Faron is now primarily seeking to finance the registration study through a share issue instead of a partnership agreement. Therefore, cost control and successful financing are critical for the company's continuity.