Faron Announces Collaboration with Parexel to Support Phase IIb BEXERA Trial in Treatment-Naïve HR-MDS

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (“Faron”) (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies, today announces that it has entered into an agreement with Parexel International (IRL) Limited, a leading global clinical research organization (CRO), to support the upcoming randomized Phase IIb BEXERA trial in treatment-naïve patients with higher-risk myelodysplastic syndromes (HR-MDS).

Parexel was selected based on its extensive global expertise in hematology and its proven track record in supporting complex, multinational clinical programs. The collaboration is focused on ensuring disciplined trial execution, with close alignment between the teams to support timely delivery and operational efficiency as the program progresses.

The BEXERA trial (FP2CLI012) is a randomized, double-blind, placebo-controlled Phase IIb trial in treatment-naïve HR-MDS. Planned to start in the second half of 2026, the trial will evaluate bexmarilimab at doses of 1 mg/kg and 3 mg/kg in combination with azacitidine, compared with placebo plus azacitidine.

The trial is expected to enroll 90 participants across sites in North America and Europe. The objective of the trial is to select the recommended Phase III dose, and to demonstrate the efficacy and safety of the combination in a randomized, controlled setting to support later registrational filings in frontline HR-MDS.

Partnering with Parexel is a key operational milestone as we prepare to advance bexmarilimab into the randomized BEXERA trial,” said Dr. Petri Bono, Chief Medical Officer of Faron. “Their deep experience in hematology and oncology, combined with their global reach will ensure reliable and efficient execution of this trial, which is a critical step in our mission to bring a new treatment option to frontline HR-MDS patients with high unmet needs.”

Dr. Charlotte Moser, Chief Medical Officer of Parexel, added, “We are excited to partner with Faron on this highly significant clinical program. This study represents an important opportunity to create a novel approach for patients with high-risk MDS, where treatment is difficult to dose and alterative treatment options remain limited. Through Parexel Biotech, we bring innovation and agility alongside our global capabilities and deep

hematology expertise to ensure rigorous, high-quality execution, working closely with Faron as they advance bexmarilimab.”

About Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes by targeting myeloid cell function. It binds to Clever-1, a receptor on immunosuppressive macrophages that helps cancer evade the immune system. By targeting Clever-1, bexmarilimab reprograms the tumor microenvironment to ignite a potent anti-tumor immune response.

About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a clinical-stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company's pipeline is built on its scientific understanding of the regulation of the immune system in cancer.

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