MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the pricing of its previously announced underwritten public offering (the “Offering”) of (i) 31,500,000 of its common shares (the “Shares”), accompanying Series A common warrants (the “Series A Common Warrants”) to purchase an aggregate of 31,500,000 co ...

MONTREAL, Quebec and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST) today announced that it has commenced an underwritten public offering (the “Offering”) of its common shares, accompanying Series A warrants to purchase common shares (the “Series A Warrants”) and accompanying Series B warrants to purchase common shares (the “Series B Warrants”), and, in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase ...

Core Points - The FDA has accepted Milestone Pharmaceuticals' response to the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) nasal spray, with a new PDUFA target action date set for December 13, 2025 [1][5] - Milestone has extended its $75 million Royalty Purchase Agreement with RTW Investments until December 31, 2025, to support the planned launch of CARDAMYST following FDA approval [2][4] FDA Review and Response - The FDA's acceptance of the response to the CRL is a significant milestone for CARDAMYST, and the company is optimistic about a potential approval decision later this year [3] - Milestone's response to the CRL included results from additional in-vitro studies and a plan to transfer manufacturing duties to vendors with recent FDA inspection history [5][6] Royalty Purchase Agreement - The Royalty Purchase Agreement allows RTW to purchase tiered royalty payments on etripamil's annual net product sales in exchange for a $75 million purchase price, contingent on FDA approval by December 31, 2025 [4] - The amendment to the agreement reflects RTW's ongoing commitment to Milestone and provides a future funding source for the company [2][3] Product Overview - Etripamil is a novel calcium channel blocker nasal spray designed for self-administration to treat paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with rapid ventricular response (AFib-RVR) [7][9] - If approved, CARDAMYST™ aims to offer a new treatment option for patients, allowing for on-demand care and self-management [7][9] Clinical Development - Etripamil has completed a Phase 3 clinical program for PSVT and a Phase 2 trial for AFib-RVR, indicating a robust clinical development pathway [8]

Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing innovative cardiovascular solutions aimed at improving the lives of patients with complex heart conditions [3] - The company's lead investigational product is etripamil, a novel calcium channel blocker nasal spray designed for self-administration by patients to treat symptomatic episodic attacks associated with PSVT and AFib-RVR [3] Upcoming Events - Amit Hasija, Chief Financial Officer, and Lorenz Muller, Chief Commercial Officer, will present at the Jefferies Healthcare Conference from June 3 to June 5, 2025, in New York [1] - A webcast of the presentation will be available on June 5 at 8:10 AM EDT, with a replay accessible for approximately 90 days on Milestone's website [2]