Faron Pharmaceuticals Oy has released its audited full-year financial results for January 1 to December 31, 2023, along with an overview of recent corporate developments. The company's highlights for 2023 include significant overall response rates in both previously hypomethylating agent (HMA)-failed and higher-risk myelodysplastic syndrome (MDS) patient populations in the completed Phase I part of the BEXMAB study. The Phase II part of the BEXMAB study, based on guidance from the U.S. Food and Drug Administration (FDA), has commenced, investigating bexmarilimab in combination with standard of care in patients with HMA-refractory or -relapsed MDS.
Additionally, the FDA granted bexmarilimab Orphan Drug Designation for the treatment of acute myeloid leukemia (AML). The first in human MATINS study was completed in advanced solid tumor patients, with published results showing that bexmarilimab was well tolerated and provided significant clinical benefit. The company conducted three successful fundraising rounds in 2023, raising EUR 25.7 million.
Subsequent events include the dosing of the first patients in the Phase II part of the BEXMAB Study in January 2024, and Faron's successful raising of a total of EUR 3.2 million in subordinated convertible loan arrangements in March 2024. The company is in compliance with all IPF financial covenants as agreed with the waiver letter. Faron is also in active discussions to secure short- and long-term funding.
Dr. Markku Jalkanen, Chief Executive Officer of Faron, expressed confidence in the potential of bexmarilimab, stating, "These are highly significant findings, given the combinations of treatments these patients had previously failed on and the very limited options available for future therapy. They provide us with a path to market and only bolster our confidence in the potential of this novel immunotherapy to treat patients with aggressive hematological malignancies."
Faron's pipeline highlights include Bexmarilimab, the company's wholly owned, novel precision cancer immunotherapy candidate, in Phase I/II development for difficult-to-treat hematological and solid tumor cancers. The Phase II part of the BEXMAB study has commenced, and data from the completed Phase I part demonstrated significant overall response rates in both previously HMA-failed and higher-risk MDS patient populations.