Phase 1 BEXMAB data presented at ASH

Inside information: Faron Presents Phase 1 Data from BEXMAB in Myeloid Malignancies Trial at the 65th American Society of Hematology (ASH) Annual Meeting

• Significant overall Response Rate (ORR) achieved in both HR-MDS (5/5) and HMA-failed MDS (5/5) patients
• The vast majority of responses are deep and durable with 7/10 MDS patients achieving CR/mCR and one additional patient transferred to stem cell transplantation

Company Announcement, Inside Information

TURKU, Finland / BOSTON, Massachusetts - December 11, 2023 - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announced very positive Phase 1 data from the ongoing BEXMAB study in myeloid malignancies, being presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place until tomorrow, December 12, 2023, in San Diego, California, and virtually.

The BEXMAB study is a multicenter study, taking place in Finland 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.

"The BEXMAB results continue to improve over time showing remarkable overall response rate in both higher-risk frontline as well as hypomethylating agent (HMA)-failed myelodysplastic syndrome (MDS) patients," said Dr. Markku Jalkanen, Chief Executive Officer of Faron. "The combination is well-tolerated and generates strong and durable leukemic blast eradication and immune responses. This solidifies bexmarilimab's unique and leading mechanism of action in the field of myeloid cell re-programming. With this compelling evidence we are well positioned to advance to the Phase 2 part of the BEXMAB study and actively pursue further regulatory interactions to navigate and refine the pivotal pathway for BLA filing".

Dr. Naval Daver, MD, Professor of Leukemia at The University of Texas MD Anderson Cancer Center and site Principal Investigator of the BEXMAB trial commented: "Addressing MDS poses a considerable therapeutic challenge given the limited efficacy of the current standard of care resulting in relatively low response rate and poor overall survival, especially in TP53 mutated and HMA-failed MDS patient populations. The data presented at ASH are promising, demonstrating a higher ORR and prolonged response duration in this trial compared to published historical benchmarks. These findings underscore the future potential of this combination in advancing the treatment of higher-risk and HMA-failed MDS."

Poster highlights include:

• Significant overall response rate observed in both previously HMA-failed (5 out of 5) and higher-risk MDS patient (5 out of 5) populations
• Observed responses were primarily deep and durable with 7/10 MDS patients achieving CR/mCR, and two demonstrating PR, out of which one moved on to receive a stem cell transplantation and one hematological improvement without remission (HI-P)
• The majority of higher-risk MDS patients were also TP53 mutated, typically associated with poor responsiveness to standard therapy, however all of them achieved CR/mCR upon receiving the treatment
• Clinical activity with 13/28 (48%) objective responses observed across all the indications, including r/r AML, and dose levels tested
• The combination of bexmarilimab and azacitidine remains well tolerated with immune-related adverse events observed at higher dose levels
• Clever-1 target engagement was confirmed in the bone marrow of treated patients together with an increased antigen presentation capacity and increased numbers of CD8 T and NK cells in patients

Poster presentation details:

Title: Encouraging Efficacy Observed in BEXMAB Study: A Phase 1/2 Study to Assess Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies

Session Date and Time: Sunday, December 10, 2023, 6:00 PM - 8:00 PM PST

Session Title: Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II

Location: San Diego Convention Center, Halls G-H

Lead Authors: Mika Kontro, Helsinki University Hospital and University of Helsinki and Naval Daver, The University of Texas MD Anderson Cancer Center

Abstract Number: 2915

For more information on BEXMAB, please visit ClinicalTrials.gov and reference Identifier NCT05428969.

About Bexmarilimab

About Faron Pharmaceuticals Ltd.