Business
Full Year Results for the year ended 31 Dec 2019
Full Year Results for the year ended 31 Dec 2019.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \n \n RNS Number : 3152I\n Futura Medical PLC\n 01 April 2020\n \n \n \n \n Full Year Results for the year ended 31 December 2019\n \n \n \n \n \n Futura Medical plc (AIM: FUM) (\"Futura\" or the \"Company\"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology and currently focused on sexual health and pain, is pleased to announce its audited results for the year ended 31 December 2019.\n \n \n \n \n \n Key highlights\n \n \n \n MED3000 discussions progressing well with regulators; EU filing expected by end of July with good dialogue with US FDA providing optimism for submission for medical de novo device approval filing by end of Q3 2020\n \n \n Company expects cash runway to be sufficient to Q2 2021, based on significantly reduced R&D spend and current activities\n \n \n \n Currently expect limited impact from COVID-19 during 2020\n \n \n \n \n \n \n \n Operational highlights\n \n \n \n \n \n \n MED3000\n \n - Topical gel for the treatment of erectile dysfunction (ED)\n \n \n \n Top Line Results for European Phase 3 study (FM57) were reported in December 2019 with all treatment arms consistently meeting all primary endpoints against a pre-treatment baseline and across all ED severities as well as in a pooled ED patient population. \n \n \n \n FM57 demonstrated that MED3000 has the potential to be a highly effective, clinically proven, topical treatment for erectile dysfunction with a rapid onset of action\n and excellent safety profile in a $5 billion market1.\n \n \n \n \n \n New patent application filed in December 2019 around the novel and surprising effects of the MED3000 formulation shown in FM57 to potentially provide patent protection until 2040.\n \n \n \n \n \n \n \n Ongoing support from Key Opinion Leaders (KOLs) for an effective, fast acting, topically applied ED treatment with low side effects.\n \n \n \n \n \n \n \n \n \n MED3000 - Post period highlights\n \n \n \n Following positive interactions with an EU Notified Body2 as announced in February 2020 Futura subsequently commenced formal proceedings for MED3000 to be approved as a medical device for the treatment of ED with expected submission to EU regulators by the end of July 2020.\n \n \n \n Recent positive initial pre-submission...