Faron Hits Key Milestone With Bexmab Phase 2 Completion, Advances To Registrational Trial With Fda Alignment

TURKU, FI / ACCESS Newswire / November 3, 2025 / Faron Pharmaceuticals (HEL:FARON)(LSE:FARN) - Having achieved all primary endpoints and secured FDA alignment, Faron formally concludes enrolment of the BEXMAB Phase 2 trial as Company's focus shifts to a registrational trial

TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM:FARN, First North:FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through immunotherapies, today announces the official completion of patient enrolment in its BEXMAB Phase 2 trial. The trial is evaluating bexmarilimab, Faron's wholly owned immunotherapy candidate, in combination with standard of care for patients with higher-risk myelodysplastic syndromes (HR-MDS).

This planned milestone is a direct result of the trial successfully meeting all of its primary endpoints for the selected indications as per protocol, and subsequently receiving positive, constructive feedback from the U.S. Food and Drug Administration (FDA) on the registrational path forward.

The formal decision to conclude enrolment was supported by the trial Steering Group. The BEXMAB data generated has consistently demonstrated clinical benefit and a manageable safety profile, with results presented at major scientific congresses, including MDS Foundation, ASCO, EHA, and ESMO.

The trial will continue with ongoing patient treatment and follow-up, and a final data update is scheduled for an upcoming major scientific meeting.

"Completing this milestone is a clear and confident step closer to offering a new therapeutic option for those suffering from HR-MDS. We are immensely grateful to the patients, their families, and the dedicated investigators whose participation made this possible," said Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals.

"This milestone is built upon a foundation of strong and consistent clinical data from the BEXMAB trial. The constructive guidance we've received from the FDA is a critical validation, providing us with a clear, de-risked regulatory pathway and adding significant momentum to our program. We will now focus on conducting the registrational Phase 2/3 trial for bexmarilimab in treatment-naïve patients with HR-MDS," added Dr. Petri Bono, Chief Medical Officer of Faron.

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About BEXMAB

The BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

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 and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: 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. Further information is available at www.faron.com.

SOURCE: Faron Pharmaceuticals