FDA Accepted the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray; New PDUFA Target Date of December 13, 2025

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 common shares and accompanying Series B common warrants (the “Series B Common Warrants”) to purchase an aggregate of 31,500,000 common shares , at a combined public offering price of $1.50 per share and accompanying Series A Common Warrant and Series B Common Warrant and (ii) in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase 3,502,335 common shares, accompanying Series A Common Warrants to purchase an aggregate of 3,502,335 common shares and accompanying Series B Common Warrants to purchase an aggregate of 3,502,335 common shares, at a combined public offering price of $1.499 per pre-funded warrant and accompanying Series A Common Warrant and Series B Common Warrant, which represents the combined public offering price for the Shares and accompanying common warrants less the $0.001 per share exercise price for each such pre-funded warrant. The proceeds to Milestone from the Offering, before deducting underwriting commissions and offering expenses payable by Milestone, are expected to be approximately $52.5 million. The Offering is expected to close on or about July 14, 2025, subject to satisfaction of customary closing conditions.

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 common shares, accompanying Series A Warrants and accompanying Series B warrants. All securities to be sold in the Offering will be sold by Milestone. The Offering is subject to market and other conditions and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

New PDUFA Action Date of December 13, 2025

Resolution of CRL Manufacturing issues in progress - Type A meeting requested

CRL focused on CMC; no clinical issues relating to etripamil raised

FDA PDUFA review goal date of March 27, 2025 for CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT)

MONTREAL and CHARLOTTE, N.C., March 04, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) (the “Company” or “Milestone”), today announced that the Company granted equity awards, in the form of a total of 94,000 options (the “Options”) to purchase the Company’s common shares, pursuant to the Company’s 2021 Inducement Plan (the “Plan”), previously approved by the Company’s Compensation Committee and the Board of Directors, as a material inducement to employment of four new hires. 

MONTREAL and CHARLOTTE, N.C., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced further details on its in-person and virtual Commercial Launch Plan investor event to take place in New York on Tuesday, February 25, 2025 from 10:30 AM to 12:30 PM ET. Investors planning to attend the in-person event are required to register in advance. To register, click here.

MONTREAL and CHARLOTTE, N.C., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) (the “Company” or “Milestone”), today announced that the Company granted equity awards, in the form of a total of 113,000 options (the “Options”) to purchase the Company’s common shares, pursuant to the Company’s 2021 Inducement Plan (the “Plan”), previously approved by the Company’s Compensation Committee and the Board of Directors, as a material inducement to employment of three new hires. 

NDA for CARDAMYST™ in PSVT under review by FDA; PDUFA March 27, 2025

MONTREAL and CHARLOTTE, N.C., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced its licensing partner, Ji Xing Pharmaceuticals Ltd, released positive topline results from a multi-center, randomized, double-blind, placebo-controlled trial in China evaluating the efficacy and safety of etripamil nasal spray in paroxysmal supraventricular tachycardia (PSVT). The trial design closely matched the RAPID Phase 3 Study of etripamil in PSVT conducted by Milestone in North America and Europe.

MONTREAL and CHARLOTTE, N.C., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the appointment of Joseph Papa to its Board of Directors (“Board”), effective September 3, 2024.

– NDA for CARDAMYST™ in PSVT accepted by FDA in 2Q 2024; PDUFA in March 2025

MONTREAL and CHARLOTTE, N.C., June 12, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will host Part I of its virtual investor educational series on Thursday, June 20, 2024, at 8:00 AM ET. To register for “Learnings from the Field: Expert Perspectives on Managing PSVT in the Community Setting,” click here.

MONTREAL and CHARLOTTE, N.C., May 31, 2024 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (Nasdaq: MIST) today announced that members of its management team will participate in the Jefferies Global Healthcare Conference being held in New York City, NY from June 4-6, 2024.

MONTREAL and CHARLOTTE, N.C., May 29, 2024 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the United States Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) on May 26, 2024 for CARDAMYST (etripamil) nasal spray, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). The FDA Prescription Drug User Fee Act (PDUFA) target date is 10 months from the acceptance date of May 26, 2024.

– NDA for etripamil in PSVT resubmitted in 1Q 2024
– Cash resources as of March 31, 2024 expected to fund operations into 2026
– Dialogue with FDA to finalize Phase 3 protocol for etripamil in AFib-RVR is progressing