Analyst Comment

Progress for Faron in the UK

Translation: Original published in Finnish on 12/3/2024 at 7:14 am EET.

Faron announced on Monday that it has been awarded an Innovation Passport for the treatment of relapsed/refractory myelodysplastic syndrome (r/r MDS). The Passport is part of the Innovative Licensing and Access Pathway (ILAP) program developed by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The Passport will expedite Faron's interactions with the regulatory agency in the future. In addition, Faron now has approval to conduct the BEXMAB trial in the UK.

BEXMAB trial extended to the UK

The ILAP program was introduced by the MHRA in 2021 to give patients quicker access to treatments and therapies for life-threatening and serious conditions. The benefits of the ILAP include enhanced regulatory support from the MHRA and it provides collaborative opportunities with health technology assessment bodies and other stakeholders. The aim of the program is to accelerate the development of medicines and improve patient access to new treatments.

In addition, Faron announced that it has received regulatory approval from the MHRA to conduct the BEXMAB trial in the UK. This approval will allow Faron to recruit UK patients directly, accelerating its research efforts and enhancing the study's diversity. We anticipate that the regulatory approval will help Faron to complete the BEXMAB trial within the targeted timeframe. Patient recruitment for BEXMAB is expected to be completed in January 2025, allowing for the important result read-out for all r/r MDS patients at the end of Q1'25.

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 Figures2024-08-28

	2023	24e	25e
Revenue	0.0	0.0	0.0
growth-%
EBIT (adj.)	-28.6	-26.1	-29.2
EBIT-% (adj.)	-714,200.0 %	-653,250.0 %	-730,500.0 %
EPS (adj.)	-0.45	-0.28	-0.30
Dividend	0.00	0.00	0.00
Dividend %
P/E (adj.)	neg.	neg.	neg.
EV/EBITDA	neg.	neg.	neg.