Faron H1'26 preview: BEXERA trial is being initiated
Summary
- Faron's H1 report will focus on the progress of the bexmarilimab clinical development program, particularly the BEXERA registration trial, which is crucial for the company's value creation and is set to begin later this year.
- The company has no revenue, with value creation dependent on advancing its drug development projects, notably the BEXMAB trial for high-risk myelodysplastic syndrome, which has shown promising early results but requires cautious interpretation due to the lack of a control group.
- Faron's financials are heavily impacted by R&D costs, with an H1 EBIT estimate of -10.7 MEUR and a full-year forecast of -19.0 MEUR; recent fundraising is expected to support operations until November 2027, but additional funding will be needed for future trial phases.
- The initiation of the BEXERA trial is a key focus, with the 90-patient Phase IIb trial scheduled for the second half of 2026; potential recruitment delays pose a risk, and a partnership agreement is considered unlikely until high-quality data from the trial is available.
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| Estimates | H1'25 | H1'26 | H1'26e | 2026e | |
| MEUR/EUR | Comparison | Actualized | Inderes | Inderes | |
| Revenue | 0.0 | 0.0 | 0.0 | ||
| EBIT | -11.9 | -10.7 | -19.0 | ||
| Profit before tax | -19.4 | -11.3 | -23.0 | ||
| EPS (reported) | -0.16 | -0.07 | -0.10 |
Source: Inderes
Translation: Original published in Finnish on 8/25/2026 at 7:30 am EEST.
Faron will publish its H1 report on Wednesday, August 26. The earnings webcast can be followed here. In the report, our main attention is on the progress of bexmarilimab's clinical development program. We expect the company to provide more information, particularly on the timelines for the BEXERA registration trial, which is set to begin later this year and is central to the company's value creation.
Value creation relies on the progress of the research program
As a drug development company, Faron has no revenue, and value creation is based on advancing the bexmarilimab investigational drug program. The most significant project is to determine the safety and efficacy of the combination therapy of bexmarilimab and the standard drug azacitidine in high-risk myelodysplastic syndrome (first-line HR-MDS). Based on the results to date (BEXMAB trial), the combination is well tolerated and safe. More treatment responses have been observed than in previous trials, but caution is warranted in interpreting these responses, as the BEXMAB trial lacked a control group and the number of patients was relatively low. The company recently published the first overall survival (OS) readouts from the BEXMAB study in first-line high-risk MDS patients. Based on early-stage readouts, the median overall survival had not yet been reached in two subgroups, whereas in the most difficult-to-treat patient group, the combination did not appear to provide additional benefit compared to standard treatment. We still have to wait for the final OS results. In addition to the MDS project, the company recently updated the status of its investigator-initiated trials (IITs): The BLAZE and BEXAR trials are progressing towards patient recruitment in solid tumors. While these bring new potential indications for the drug candidate, they are secondary to the company's own MDS trial in terms of the investment story.
Earnings are depressed by research and development costs
As Faron has no revenue, the company's result is heavily loss-making. Our H1 EBIT estimate is -10.7 MEUR. We expect the loss to decrease as patient visits in the BEXMAB trial have ended. For the full year 2026, we forecast EBIT to be -19.0 MEUR. In addition to administration, costs are driven by the completion of the BEXMAB trial and preparation costs for the upcoming BEXERA registration trial. Faron raised 33 MEUR in net proceeds from the rights issue that ended in March, which the company estimates will be sufficient until November 2027. The significant decrease in financing risk gave the company breathing room to focus on advancing its clinical program, but we will still closely monitor the company's cost control and cash burn rate. Based on the clinical development program's timeline, the funding should be sufficient for the first readout of the BEXERA trial. The completion of the entire trial and preparations for a potential pivotal trial phase require additional funding, which the company aims to secure through a partnership agreement.
In the report, we are interested in information regarding the initiation of BEXERA
In the H1 report, our interest is primarily focused on the timeline for the initiation of the BEXERA trial. This 90-patient randomized Phase IIb trial is scheduled to begin in the second half of 2026 and is at the core of Faron's investment story and its most significant value driver. We will be looking for any updates in the report regarding the start of patient recruitment, as the goal is to achieve the first readout of the trial by the end of 2027. We believe the schedule is quite tight, so potential delays in recruitment are a key risk factor. Applying for marketing authorization will likely still require an extensive Phase III trial.
In addition, we expect potential updates on the broader BEXMAB data promised for the end of the year, as well as the expansion of bexmarilimab into new patient groups, such as the BEAM-X trial for acute myeloid leukemia (AML). We still consider the probability of a partnership agreement low at this stage and believe an agreement will only become realistic with high-quality data from the BEXERA trial.