Final Patient Identified for BEXMAB Phase II Study

TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces that the final patient has been identified for the BEXMAB Phase II dose optimization study in refractory or relapsed myelodysplastic syndrome (r/r MDS), as well as the BEXMAB Phase I/II study in frontline high risk (HR) MDS. The topline response rate read out is thus expected to become available in April 2025. Detailed data will be presented later at upcoming major medical conferences. The reportable data set will consist of approximately 35 r/r MDS patients and 20 frontline HR MDS patients. The r/r MDS population will consist of 32 patients treated with either 3mg/kg or 6mg/kg dose of bexmarilimab per the U.S. Food and Drug Administration (FDA) Project Optimus guidance, and three r/r MDS patients treated with 1mg/kg dose of bexmarilimab in Phase I. A similar split between doses will be reported concerning the frontline HR MDS population.

"Achieving this milestone for our lead program, BEXMAB, in r/r MDS and frontline HR MDS, reflects not only our team's strength in executing on the Company's drug development strategy, but also the urgent unmet medical need for patients with this difficult to treat cancer," stated Petri Bono, M.D., Ph.D., Chief Medical Officer. "Backed by recently released Phase II Interim Results confirming the superior profile of bexmarilimab versus current treatment options, we remain highly confident about the potential of bexmarilimab to become an important new best-in-class treatment for MDS patients."

The BEXMAB Phase II Interim Results presented at the 66th American Society of Hematology (ASH) Annual Meeting on December 2024 showed a high objective response rate (ORR) at 80% (16/20). Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions. Previously reported estimated median overall survival of the 20 r/r MDS patients were 13.4 months compared to the 5-6 months that would typically be expected under standard of care historically.

The BEXMAB trial will continue enrolling CMML patients and there is also the possibility to expand the enrollment of r/r MDS patients under the current protocol. The Company is assessing expanding the enrollment of r/r MDS patients in order to have this treatment option available for patients and to strengthen the data set for upcoming regulatory purposes.

"Our BEXMAB Phase II trial has progressed as planned and our focus now is to take this data to the FDA and fine tune the registrational approach with the agency. We are committed to rapidly advancing bexmarilimab through clinical development, to bring it to treatment resistant MDS patients as soon as possible," said Dr. Juho Jalkanen, M.D., Ph.D., Chief Executive Officer. "I want to express my sincere gratitude to all the stakeholders working on the BEXMAB trial, especially our hardworking employees, study site professionals and investigators, but most of all the patients and their loved ones."

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