- Year-end cash resources, together with $125 million proceeds from March 2023 strategic financing, expected to fund operations into mid-2025
- NDA submission for etripamil in patients with PSVT expected for 3Q23
MONTREAL and CHARLOTTE, N.C., March 29, 2023 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the fourth quarter and year ended December 31, 2022 and provided a clinical and corporate update.
"Following our strategic financing, we believe we are securely positioned to advance etripamil for paroxysmal supraventricular tachycardia (PSVT) through the approval process and into launch," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "With U.S. Food and Drug Administration (FDA) guidance in hand and our Phase 3 studies complete, we are one step closer to achieving our goal of establishing etripamil as the first fast-acting, patient-administered treatment for PSVT. We remain on track for a New Drug Application (NDA) submission in the third quarter of this year."
Corporate Updates
- Announced $125 Million Strategic Financing with RTW Investments to Support the Advancement of Etripamil for PSVT. In March 2023, Milestone announced that it has entered into a $125 million strategic financing with existing shareholder, RTW Investments, LP and certain of its affiliates ("RTW"). RTW has extended its investment relationship with Milestone by purchasing $50 million of senior secured convertible promissory notes in a private placement transaction. In addition, under the terms of a purchase and sale agreement, following FDA approval of etripamil and subject to certain conditions, RTW provided a $75 million non-dilutive synthetic royalty financing commitment to Milestone in return for tiered rate, cash royalty payments based on aggregate net sales of etripamil within the United States.
- Seth H.Z. Fischer Appointed to Board of Directors. Milestone appointed Seth H.Z. Fischer to the Company's Board of Directors, effective March 21, 2023. Mr. Fischer brings deep operational and commercial expertise, gained through over 40 years in the pharmaceutical and medical device industry. He previously served as the chief executive officer and as a director of Vivus, Inc. Prior to Vivus, Mr. Fischer served in senior positions of increasing responsibility at Johnson & Johnson, most recently as company group chairman, Johnson & Johnson and worldwide franchise chairman of Cordis Corporation. Mr. Fischer also currently serves on the boards of Agile Therapeutics, Inc., Marinus Pharmaceuticals, Inc., Spectrum Pharmaceuticals, Inc., and Esperion Therapeutics.
Mr. Oliveto added, "It Is a pleasure to welcome Seth Fischer to our Board of Directors. Equipped with his commercialization experience, Seth will be an important expert for Milestone as we work to gain market approval of etripamil for patients with PSVT."
Recent Program Updates
- NDA Submission for Etripamil Nasal Spray in Patients with PSVT on Track for the Third Quarter of 2023. In March 2023, Milestone announced completion and database closures of the NODE-303 open-label safety and RAPID extension studies of etripamil, the Company's investigational calcium channel blocker that is administered by patients outside of the healthcare setting, in patients with PSVT. Data from these studies are being included in the PSVT NDA for etripamil which is currently expected to be submitted to the FDA in the third quarter of 2023. The Company believes feedback received from the FDA supports the proposed approach for the NDA.
- Data from a Subset of Patients with Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) to be Presented at Heart Rhythm 2023 Annual Meeting. Data from a subset of patients with AFib-RVR in the NODE-303 study, which evaluated etripamil in patients with PSVT, will be featured during an oral session at the Heart Rhythm 2023 Annual Meeting: "Effect of Etripamil Nasal Spray on Ventricular Rate in Patients Experiencing Symptomatic Atrial Fibrillation," on Friday, May 19, 2023 at 3:00 p.m. CT.
- Announced Positive Topline Efficacy and Safety Results from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with PSVT. In October 2022, the Company announced that the Phase 3 RAPID clinical trial of etripamil in patients with PSVT met its primary endpoint, with 64.3% of patients self-administering etripamil converting to sinus rhythm within 30 minutes compared to 31.2% on placebo (HR = 2.62, p