Faron presents BEXMAB data at ASH Annual Meeting

Faron Presents Full Analysis of Positive Phase 2 Interim Data from BEXMAB Trial at the 66th American Society of Hematology (ASH) Annual Meeting

Press release, 10 December 2024

Poster highlights

• Overall response rate of 80% (16 out of 20) in refractory or relapsed HMA failed MDS patient population (r/r MDS)
• Observed responses were primarily deep and durable with 70% (14 out of 20) r/r MDS patients achieving complete response (CR) / marrow complete remission (mCR) / partial response (PR).
• Four patients have moved on to receive a bone marrow transplant
• Estimated median overall survival (mOS) of approximately 13.4 months in r/r MDS population
• The combination of bexmarilimab and azacitidine remains well tolerated
• Clever-1 target engagement and expression in the bone marrow with an increased antigen presentation capacity and presence of CD8 T and NK cells supports bexmarilimab mechanism-of-action
• Webinar scheduled today at 16.00 EET/9am ET/6am PT (please see link to register below)

TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announced full analysis of the positive Phase 2 interim readout presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

"The BEXMAB results continue to improve over time showing a remarkable 80% ORR in r/r MDS patients," said Dr. Juho Jalkanen, Chief Executive Officer of Faron. "The combination is well-tolerated and generates strong and durable cancer blast reduction and hematological improvements. This solidifies bexmarilimab's unique and leading mechanism of action for the treatment of MDS and in the field of myeloid cell re-programming. With this compelling evidence, we are well positioned to advance to the full Phase 2 efficacy readout and actively pursue further regulatory interactions to navigate and refine the pivotal pathway for BLA filing."

• Mika Kontro, MD, PhD, Associate Professor at the Helsinki University Hospital Comprehensive Cancer Center and Principal Investigator of the BEXMAB trial, said: "Addressing MDS remains a considerable therapeutic challenge due to the limited efficacy of the current standard of care, particularly in TP53 mutated and HMA-failed MDS patient populations. The data presented at ASH are highly promising, showing notable improvements in overall response rate and overall survival. These findings highlight the meaningful strides Faron is making in improving treatment outcomes for r/r MDS."

The BEXMAB study is a multicenter study, taking place in Finland, UK and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with standard of care in patients with aggressive myeloid leukemias.

Faron will host a virtual webinar to discuss the full analysis of data today, 10 December 2024 at 16.00 EET/9am ET/6am PT.

To register for the event visit: BEXMAB Study Update

The ASH Annual Meeting takes place from 7-10 December 2024, in San Diego, California and virtually.

ASH Poster presentation details:

Title: Encouraging Efficacy of Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in Bexmab Ph1/2 Study

Session Time: Monday, 9 December 2024, 6:00 PM - 8:00 PM PT

Session Title: Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III

Location: San Diego Convention Center, Halls G-H

Lead Authors: Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki; Dr. Naval Daver, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center

Abstract Number: 4265

The full Poster is available on the Company's website at https://www.faron.com/investors and contains updated clinical data from the BEXMAB trial.

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