Interactions with UK Regulatory Authorities

Faron Announces Positive Update on Recent Interactions with UK Regulatory Authorities regarding bexmarilimab and expanding the BEXMAB Study to the UK

• MHRA has awarded bexmarilimab an Innovation Passport for the treatment of relapsed/refractory Myelodysplastic Syndrome and given approval for the BEXMAB trial to be conducted in the UK
• UK sites to join the BEXMAB Study iminently

Press release, 2 December 2024

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 BEXMAB Study may proceed in the UK and bexmarilimab has received an Innovation Passport, under the Innovative Licensing and Access Pathway (ILAP) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA), for the treatment of relapsed/refractory Myelodysplastic Syndrome (r/r MDS).

The ILAP was introduced by the MHRA in 2021 to give patients quicker access to cutting-edge treatments and therapies for life-threatening or seriously debilitating conditions, or conditions for which there is a significant patient or public health need. The benefits of the ILAP include enhanced regulatory support from the MHRA and provides collaborative opportunities with health technology assessment bodies and other stakeholders, with the aim of accelerating the development, and improving patient access to promising new medicines.

The decision to award the Innovation Passport to bexmarilimab was made by the ILAP Steering Group, which is comprised of representatives from the MHRA, NICE, AWTTC and SMC, and provides further regulatory verification of bexmarilimab's potential to address significant unmet medical needs and positions the therapy for faster development and potentially earlier access for patients.

In addition, Faron today 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 haematology patients directly, accelerating its research efforts by increasing recruitment and enhancing the study's diversity and scope by expanding the participant pool.

Dr. Juho Jalkanen, Chief Executive Officer of Faron, said: "I am very pleased to announce this update today following our ongoing interactions with the MHRA regarding bexmarilimab. At Faron, we understand the importance of actively engaging with regulatory authorities and, as a result of those interactions and the promising data generated to date, I am very pleased that the MHRA has recognised the potential of bexmarilimab to treat r/r MDS patients. Receiving ILAP designation, coupled with regulatory approval to conduct the BEXMAB trial in the UK, will allow us to accelerate the development of bexmarilimab and give UK patients access to a promising novel therapeutic option through participation in the study. We are looking forward to continuing our discussions with the MHRA to further expedite bexmarilimab's path to market for patients as soon as possible."

About bexmarilimab