Business
Faron 2024 Half-Year Financial Results
Faron 2024 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, 1 January - 30 June 2024\n \n \nCompany Announcement, 27 August 2024\n \nSummary Highlights \n \n· Initial preliminary phase II data read-out from the BEXMAB trial confirmed earlier positive phase I findings in myelodysplastic syndrome (MDS) patients that have failed with hypomethylating agent (HMA), reinforcing 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· The Company reported that there was a total of 14 HMA-failed MDS patients who had been treated in both the phase I and II arms of the BEXMAB trial with a combination of bexmarilimab and azacitidine, with an overall response rate (ORR) of 79% (11/14). For The BEXMAB Phase I MDS patients with prior HMA failure with adequate follow-up available the estimated median overall survival (mOS) was 13.4 months compared to the 5-6 months that would typically be expected under standard of care historically.\n· Dr. Juho Jalkanen was appointed as Faron's new Chief Executive Officer, Mr. Tuomo Pätsi was elected as the Chair of the Board.\n· Faron founders and bexmarilimab developers, Dr. Markku Jalkanen and Dr. Sirpa Jalkanen, were selected as finalists for the European Inventor Award 2024.\n· Cash position was strengthened through a convertible loan issuance and two share placements successfully raising a total of EUR 35.5 million (gross).\n· Hybrid briefing and Q&A to be held tomorrow on 28 August 2024, at 8:00 am (EST) / 1:00 pm (BST) / 3:00 pm (EEST).\n \nPost period events\n \n· The U.S. Food and Drug Administration (FDA) granted bexmarilimab Fast Track Designation (FTD) for the treatment of relapsed or refractory myelodysplastic syndrome (r/r MDS) in combination with azacitidine.\n· The Company announced positive feedback from the FDA regarding the registrational clinical development plan for bexmarilimab for the treatment of higher-risk (HR) MDS, wit...