Business
Faron 2023 Half-Year Financial Results
Faron 2023 Half-Year Financial Results.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n\nFaron Pharmaceuticals Ltd.\n(\"Faron\" or \"the Company\")\n \nFaron Reports Half-Year Financial Results, January 1 - June 30, 2023\n \nCompany Announcement, August 29, 2023\n \nSummary Highlights (including post-period events) \n \n· The US Food and Drug Administration (FDA) granted bexmarilimab Orphan Drug Designation (ODD) for the treatment of acute myeloid leukemia (AML).\n· The latest data from the Phase I/II BEXMAB study reinforces bexmarilimab's potential to improve the therapeutic benefit for patients with aggressive hematological malignancies who do not respond to the current standard of care (SoC). \n· Compelling data with objective responses were observed in three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort. \n· Eight of fifteen objective responses were observed across all three doublet dosing cohorts, with one patient still on treatment after 13 months. \n· Continued efficacy signals with the prolonged duration of responses thus far support advancement to Phase II in Q4 2023 in relapsed/refractory AML and myelodysplastic syndromes (MDS) patients failing hypomethylating agents (HMAs). \n· New biomarker data presented at the EHA2023 Congress indicates that bexmarilimab's mode of action in AML/MDS is supported by durable Clever-1 target engagement in the bone marrow. This mechanism results in notable increases in T and NK cells, along with enhanced antigen presentation. \n· The Phase II BEXCOMBO protocol has been approved by the FDA.\n· The Board was strengthened with the addition of Tuomo Pätsi, and the Leadership team was enhanced with the appointment of James O'Brien, CPA, MBA, as Chief Financial Officer. \n· Mr. Leopoldo Zambeletti stepped down from the Board to assume a business development consulting role at Faron. \n· Cash position was strengthened through two private placements directed to institutional and other investors, successfully raising EUR 18.6 million.\n· &...