Analyst Comment

Faron and City of Hope plan new study

Summary

Faron plans a new investigator-initiated Phase II study for bexmarilimab in collaboration with City of Hope, focusing on relapsed or refractory myelodysplastic syndrome (r/r MDS).
The investigator-initiated trial model allows Faron to expand clinical evidence cost-effectively, as external researchers conduct the study, aligning with the company's strategy.
The study targets a difficult-to-treat patient group with limited options, building on encouraging preliminary data from Faron's BEXMAB study.
Preparations are underway, with the first patient enrollment expected in the second half of 2026, aiming to generate valuable data for future commercialization and partnerships.

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Translation: Original published in Finnish on 03/03/2026 at 07:35 am EET

Faron announced on Monday that it is planning a new investigator-initiated Phase II study for bexmarilimab in relapsed or refractory myelodysplastic syndrome (r/r MDS). The company intends to conduct the study on an investigator-initiated basis in collaboration with the esteemed US cancer research organization City of Hope. The initiative helps expand bexmarilimab’s clinical evidence in a cost-effective way for the company. The news does not cause changes to our estimates.

Investigator-initiated model saves the company's resources

The planned Phase II study will be conducted as an investigator-initiated trial (IIT), which is in line with Faron's current strategy. In this model, external researchers are responsible for conducting the study and bear operational responsibility. The model allows for the accumulation of clinical evidence in new indications and drug combinations without the company having to bear all costs or commit significant resources. We consider this critical in a situation where Faron's own resources are primarily directed towards the registration study of bexmarilimab for the first-line treatment of high-risk MDS (HR-MDS). City of Hope is one of the largest and most advanced cancer research organizations in the US, which, in turn, supports the quality stamp of Faron's research pipeline.

Additional data from a difficult-to-treat patient group

The study focuses on MDS patients whose disease has relapsed or who have not responded to previous treatments. Treatment options for this patient group are currently very limited. The scientific basis for the study stems from Faron's own BEXMAB study, which has observed preliminary encouraging responses and longer life expectancy in r/r MDS patients. In a new study, bexmarilimab is evaluated in combination with an oral hypomethylating agent (decitabine/cedazuridine).

Preparations for the study are currently underway, and the company expects the first patient to enroll in the second half of 2026. While investigator-initiated trials are not typically aimed directly at marketing authorization, they generate valuable clinical and biological data that can support bexmarilimab's commercialization and attractiveness in future partnership negotiations.

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.

Key Estimate Figures09/02

	2024	25e	26e
Revenue	0.0	0.0	0.0
growth-%
EBIT (adj.)	-18.7	-22.6	-30.5
EBIT-% (adj.)	-466,750.0 %	-565,225.0 %	-762,390.0 %
EPS (adj.)	-0.24	-0.15	-0.19
Dividend	0.00	0.00	0.00
Dividend %
P/E (adj.)	neg.	neg.	neg.
EV/EBITDA	neg.	neg.	neg.