Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Regulatory and Corporate Update

Core Insights - Milestone Pharmaceuticals is awaiting FDA approval for CARDAMYST™ (etripamil) nasal spray for the treatment of Paroxysmal Supraventricular Tachycardia (PSVT), with a PDUFA review goal date set for March 27, 2025, and a proposed launch targeted for mid-2025 [1][5] - The company is well-capitalized to commercialize CARDAMYST upon approval, having secured resources for its launch preparations [2][5] - Milestone is also on track to initiate a Phase 3 trial for etripamil in patients with AFib-RVR in 2025, with the study protocol finalized [3] Financial Performance - As of December 31, 2024, Milestone reported cash, cash equivalents, and short-term investments totaling $69.7 million, an increase from$66.0 million at the end of 2023 [4] - The company recorded no revenue for the fourth quarter or full year ended December 31, 2024, compared to $1.0 million in 2023, which was related to a milestone payment [10] - Research and development expenses for Q4 2024 were$3.9 million, down from $5.5 million in the prior year, while full-year expenses were$14.4 million compared to $31.1 million in 2023 [10] - The net loss for Q4 2024 was$12.4 million or $0.19 per share, compared to a net loss of$13.6 million or $0.32 per share for the same period in 2023 [10] Regulatory and Intellectual Property Updates - The New Drug Application (NDA) for CARDAMYST is currently under review by the FDA, with acceptance received in May 2024 [5] - A Notice of Allowance was received from the U.S. Patent and Trademark Office for a new Method of Use patent for etripamil nasal spray, potentially extending intellectual property protection until July 2042 [5] Product Overview - Etripamil is a novel calcium channel blocker nasal spray designed for self-administration to treat symptomatic episodes of PSVT and AFib-RVR, allowing patients to manage their condition without immediate medical oversight [7][8] - The product has undergone a robust clinical trial program, including a completed Phase 3 study for PSVT and a Phase 2 trial for AFib-RVR [7]