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Analyst Comment

Faron's BEXMAB update provided additional information on response duration

By Antti SiltanenAnalyst
Faron Pharmaceuticals

Summary

  • Faron presented updated results from the BEXMAB Phase I/II trial, showing extended treatment response duration in HR-MDS, supporting a transition to a broader Phase IIb BEXERA trial scheduled for H2'26.
  • The BEXMAB study reported an 85% Overall Response Rate and a 45% Complete Remission rate, with the median duration of CR responses increasing to 16.1 months, compared to around 10 months for azacitidine-only treatment in previous studies.
  • Biological data suggests that bexmarilimab combined with azacitidine alters the bone marrow immune landscape, potentially enhancing T cell activation and healthy cell recovery more effectively than azacitidine alone.
  • The company is on track to start the randomized Phase IIb BEXERA trial with 90 patients in H2'26, with results expected in Q4'27, marking key value drivers for Faron.

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

Translation: Original published in Finnish on 6/16/2026 at 7:24 am EEST.

On Monday, Faron presented updated clinical results from the BEXMAB Phase I/II trial of bexmarilimab at the EHA Congress. The results indicate that treatment response duration is extended in higher-risk myelodysplastic syndrome (HR-MDS). Accumulating evidence supports the company's transition to a broader Phase IIb BEXERA trial, which is on schedule to begin in H2'26, according to the company.

New information on response duration obtained through longer-term follow-up

In the BEXMAB study, the Overall Response Rate (ORR) for the combination of bexmarilimab and azacitidine in frontline HR-MDS patients was 85%, and the Complete Remission (CR) rate was 45%. The proportion of patients who achieved full clearance of bone marrow blasts increased from the previous 55% to 60%. The median duration of CR responses increased to 16.1 months as the follow-up period extended. These results are preliminarily promising as the duration of CR responses for azacitidine-only treatment in previous studies has been around 10 months, though there has been significant study-specific volatility. In general, results from different studies are not particularly comparable, and reliable data will only be available from appropriately designed comparative studies.

CR responses are a key data point, as Faron has previously agreed with the US Food and Drug Administration (FDA) that the number of CRs is the primary endpoint of the upcoming Phase IIb trial. The newly released data further supports the drug candidate's clinical profile and paves the way for the next phase of research.

Biological data supports the mode of action and prepares for the future

In addition to the clinical results, the company presented biological research data indicating that the combination of bexmarilimab and azacitidine changes the bone marrow immune landscape. The results suggest that the treatment may activate T cells that destroy cancer cells and promote recovery of healthy cells more effectively than azacitidine alone. In addition, the company observed differences in the baseline immune profiling between patients who responded to treatment and those who did not. The company also confirmed that it is fully on track to initiate its randomized Phase IIb BEXERA trial with 90 patients in the second half of 2026. This study and its expected readout in Q4'27 are key value drivers for the company.

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 Figures11.03

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

On the other hand, the effect of BEX is not directly related to P53. BEX appears (potentially) to function regardless of the cancer’s P53 status...
19 minutes ago
by jerej
0
Here are Antti’s comments on the updated clinical results from the Phase I/II BEXMAB study of bexmarilimab The results show an increase in the...
1 hour ago
by Sijoittaja-alokas
11
We just need to get the “muscles” (capital) to conduct research, so we don’t end up diluting the holdings of those who have been running this...
12 hours ago
by Sperakartio
9
That TP53 thing is interesting. Almost half of all human cancers of all types carry a TP53 mutation (just ask Google). If BEX’s capability, ...
13 hours ago
by Kulkuri
12
You just can’t win with you guys. Either he speaks too little or too much. Either he’s too apathetic or too positive. Well, pleasing internet...
14 hours ago
by OsakasOssi
34
I suppose it can be said more directly: the CEO apparently isn’t even trying to stay sharp in these appearances anymore. Showing up to the event...
15 hours ago
by Donkey
8
“The FDA have advised that CR + Durability of CR are the endpoints of interest for approval” (Slide no:8) Are there any predictable benchmarks...
16 hours ago
by Kulkuri
4