Faron Pharmaceuticals Reports Full-Year 2023 Financial Results and Provides Corporate Update

Faron Pharmaceuticals Reports Full-Year 2023 Financial Results and Provides Corporate Update

Turku, Finland and Boston, MA, March 13, 2024 - Faron Pharmaceuticals Ltd. ("Faron" or "the Company") (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel myeloid cell targeted immunotherapies, today announced audited full-year financial results for January 1 to December 31, 2023 (the "Period") and provided an overview of recent corporate developments.

2023 Highlights:

Data from the completed Phase I part of the BEXMAB study demonstrated significant overall response rates (ORR) in both previously hypomethylating agent (HMA)-failed (5 out of 5) and higher-risk myelodysplastic syndrome (MDS) patient (5 out of 5) populations. Most responses were deep and durable with 7 out of 10 MDS patients achieving complete remission/ marrow complete remission (CR/mCR) and two demonstrating partial remission (PR), one of whom moved on to receive a stem cell transplantation and the other, hematological improvement without remission (HI-P).

Further analysis of the patient profiles of those treated in the Phase I part of the BEXMAB trial showed that prior to responding to bexmarilimab in combination with standard of care (SoC), patients had experienced disease progression following treatment with all of the leading azacitidine combinations such as venetoclax, sabatolimab and magrolimab.

The Company made the decision to commence the Phase II part of the BEXMAB study based on guidance from the U.S. Food and Drug Administration (FDA), investigating bexmarilimab in combination with SoC in patients with HMA-refractory or-relapsed MDS.

The FDA granted bexmarilimab Orphan Drug Designation (ODD) for the treatment of acute myeloid leukemia (AML).

The first in human MATINS study was completed in advanced solid tumor patients. The study results were published in the journal Cell Reports Medicine. Bexmarilimab was well tolerated, showed activation of intratumoral immunity and reprogramming tumor associated macrophages, resulting in an increase in IFN-gamma signature and changes in the tumor microenvironment (TME), and providing significant clinical benefit.

The Company conducted three successful fundraising rounds in 2023, successfully raising EUR 25.7 million.

A virtual briefing and Q&A will be held today, March 13, 2024, at 8:00 AM (EDT) / 12:00 PM (GMT) / 2:00 PM (EET).

In January 2024, Faron dosed the first patients in the Phase II part of its BEXMAB Study, to evaluate the safety and efficacy of bexmarilimab in combination with SoC, in HMA-refractory or relapsed MDS patients.

In February 2024, Faron announced that it was in breach of several undertakings agreed in the facilities agreement entered into on February 28, 2022,