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Faron H1'26 preview: BEXERA trial is being initiated

FARONAnalyst Comment25.08.2026 klo 10.37
Antti SiltanenAnalyst
Discuss

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.

This content is generated by AI. You can give feedback on it in the Inderes forum.

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.

 

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Faron is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company's lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments.

Read more on company page

Key Estimate Figures12.03.

202526e27e
Revenue0.00.00.0
growth-%
EBIT (adj.)-19.0-19.0-25.0
EBIT-% (adj.)-474,000.0 %-475,000.0 %-625,000.0 %
EPS (adj.)-0.23-0.10-0.11
Dividend0.000.000.00
Dividend %
P/E (adj.)neg.neg.neg.
EV/EBITDAneg.neg.neg.

Forum discussions

I tried asking yesterday whether Faron announces investigator-initiated trials for the first patient as well (like their own trials). I thought...
yesterday
by Vino Pino
62
Faron H1/26 Analysis: Inderes – 27 Aug 26 Faron H1'26: Uudet tutkimukset pian konkreettisesti käyntiin - Inderes Useampi uusi tutkimus alkaa...
yesterday
by jukkamu
6
Faron Faron Announces First Patient Enrolled in BEXAR Investigator-Initiated Trial... Faron Pharmaceuticals Ltd | Press Release | August 27,...
yesterday
by Samuel Benner
29
Ok, thank you. So we’ll get an interim readout from the Phase 3 trial. And if I see correctly on my small screen, that would be scheduled for...
yesterday
by Sebastian Soderholm
1
Here is a capture from Faron’s slide. The analysis planned for 2028, based on which response rates will be reviewed, the dose for Phase 3 will...
yesterday
by Antti Siltanen
9
You mentioned the 2b interim analysis. But since the trial is controlled and double-blinded, is there any interim readout coming at all? JJ ...
yesterday
by Sebastian Soderholm
2
Faron Faron Pharmaceuticals Ltd: Half-year financial results 1 January – 30 June... Faron Pharmaceuticals Ltd | Company announcement | August...
8/26/2026, 6:19 AM
by Kulkuri
14