MIST

EX-99.1

2 tm2614433d1_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Milestone Pharmaceuticals Announces First Quarter 2026 Financial Results and Provides Corporate Update

·CARDAMYST™

(etripamil) nasal spray launch for PSVT is gaining traction; breadth of unique prescribers supports potential future adoption

·Express Scripts national formulary coverage secured as company makes progress toward broad patient access

·Atrial Fibrillation-RVR Phase 3 registration trial initiated: patient enrollment to begin in H2 2026

·Strong balance sheet of $184.2M provides runway into H2 2027 to fund commercial and operational priorities

·Company to host investor call and webcast at 8:30am ET today

Montreal and Charlotte, N.C., May 13, 2026 – Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced financial results for the first quarter ending March 31, 2026, and provided corporate and regulatory updates.

“We’re excited to report on our first quarter of sales for CARDAMYST for paroxysmal supraventricular tachycardia, or PSVT. Healthcare professionals’ initial reaction to the product is positive and we are very encouraged by the early breadth of unique prescribers writing for their patients,’’ said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “Gaining Express Scripts’ national formulary coverage in March reflects meaningful early payor adoption, highlighting the value CARDAMYST offers to insurers. We are also observing clinician enthusiasm for expanded development of etripamil in patients with AFib-RVR, as we have now kicked off our Phase 3 pivotal trial and are actively engaging potential clinical trial sites.”

Launch Progress for CARDAMYST

·Promotional launch for CARDAMYST™ (etripamil) nasal spray was initiated in mid-February 2026.  The product was commercialized within approximately eight weeks of U.S. Food and Drug Administration (FDA) approval, including a 60-person national sales force engaging primarily with cardiologists, electrophysiologists and advanced practice providers in an office-based setting.

·A total of approximately 600 scripts for CARDAMYST have been filled for 560 patients with PSVT through April.

·Approximately 400 unique prescribers have started patients on CARDAMYST.

·Over 25% of commercially insured lives in the U.S. now have coverage for CARDAMYST.

·Express Scripts added CARDAMYST nasal spray to its commercial national formularies, effective March 27, 2026. This inclusion made CARDAMYST broadly accessible and more affordable for their commercially insured lives across the United States.

·Etripamil global expansion advancing in Europe and China.

·The marketing authorization application (MAA) for etripamil nasal spray in PSVT was accepted for review by the European Medicines Agency (EMA). The MAA incorporates the global clinical data package that supported the FDA approval of etripamil for the treatment of PSVT. TACHYMIST™ is the conditionally approved brand name for etripamil nasal spray in Europe. A European decision on approval is expected by the first half of 2027.

·Separately, in March 2026, Everest Medicines announced it had acquired the rights from the Company’s China licensing partner, Corxel Pharmaceuticals to develop, manufacture, and commercialize CARDAMYST in Greater China, including Chinese Mainland, Hong Kong, Macao and Taiwan regions. In China, the New Drug Application (NDA) for etripamil nasal spray was accepted by the National Medical Products Administration (NMPA) on January 17, 2025.

Clinical Updates and Presentations

·Details on RESET-PSVT, a planned Phase 4, multicenter, prospective, observational registry intended to generate real-world evidence on the use of CARDAMYST in adults with PSVT were presented at the Preventive Cardiovascular Nurses Association (PCNA) 2026 Cardiovascular Nursing Symposium in Scottsdale, Ariz. The study will be led by the Duke Clinical Research Institute (DCRI).

·“Minimal Blood Pressure Effects of Intranasal Etripamil for PSVT” was presented at the American College of Cardiology (ACC) Annual Scientific Session in New Orleans. The

presentation summarizes analysis of mean heart rate and blood pressure changes measured during clinical trials of CARDAMYST. The

results demonstrate minimal blood pressure reductions during test dose and rare symptoms consistent with hypotension, supporting the potential safe self-administration of CARDAMYST for PSVT treatment.

·“Reduction in Health Care Utilization & Emergency Department Visits with Acutely Self-Administered Etripamil for SVT: Study Data” was presented at the Stanford BioDesign Arrhythmia Technologies Meeting held prior to HRS.2026 in Chicago, Ill. Data were described on the level and growth in U.S. healthcare burden from PSVT along with relevant data from the CARDAMYST development program.

Etripamil for Patients with Atrial Fibrillation w

EX-99.1

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EXHIBIT 99.1

Exhibit 99.1

Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Update on the Commercial Launch of CARDAMYST™ (etripamil) Nasal Spray for the Treatment of PSVT

·FDA approval of CARDAMYST represents first new option in 30 years for the more than two million patients with PSVT

·Participants using CARDAMYST in clinical studies were 2x more likely to convert symptomatic PSVT to sinus rhythm and did so more than 3x faster compared with placebo

·CARDAMYST launch execution on track with positive initial engagement in the product from healthcare providers and payers

·$200 million pro forma cash supports strong launch and operating runway into late 2027; includes $106 million of cash at year-end and net proceeds from subsequent financing activities1

·Company to host investor call and webcast at 8:30am ET today

MONTREAL and CHARLOTTE, N.C., March 20, 2026 (GLOBE NEWSWIRE) -- 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 full year ending December 31, 2025, and provided corporate and regulatory updates. The main drivers of the fourth quarter and full year 2025 activities include the U.S. Food and Drug Administration (FDA) approval of CARDAMYST™ (etripamil) nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults and product launch during this transformational year.

“We are excited to see that our commercial launch of CARDAMYST and the initial engagement with providers, patients and payers is tracking or exceeding our pre-launch expectations,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “Our national sales force was fully deployed within eight weeks of our mid-December approval. Feedback from prescribers supports our belief that there is meaningful demand for a convenient, self-administered option to treat episodes of PSVT, and patient reactions to having CARDAMYST in hand is inspiring.”

Launch Progress for CARDAMYST

·CARDAMYST

nasal spray was approved by the FDA on December 12, 2025. The FDA approval marks the first time that more than two million Americans with PSVT have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting.

·CARDAMYST

became broadly available through retail pharmacies in the United States in late January 2026.

·National sales force deployed with promotional launch initiated in mid-February. The sales force, consisting of approximately 60 sales representatives, is engaging primarily with cardiologists, electrophysiologists and advanced practice providers in the office-based setting.

·Initial prescription status. Early prescription fills support underlying demand and the effectiveness of our investments in reimbursement support ahead of coverage by payers. Most of the prescriptions filled to date are new patient starts and have been written by providers who are targeted by our sales force. As we accumulate a critical mass of data, future quarterly announcements are expected to report figures on prescriptions and prescribers, including total prescriptions, unique prescribers and new patient starts.

·Marketing authorization application (MAA) for etripamil nasal spray in PSVT accepted by the European Medicines Agency (EMA). The MAA incorporates the global clinical data package that supported the FDA approval of etripamil for the treatment of PSVT. A European decision on approval is expected by the first half of 2027. TACHYMIST™ is the conditionally approved brand name for etripamil nasal spray in Europe.

Presentation

of CARDAMYST at the American College of Cardiology (ACC) Scientific Session

·A poster “Minimal Blood Pressure Effects of Intranasal Etripamil for PSVT” will be presented at the ACC Annual Scientific Session, March 30, in New Orleans. The poster summarizes analysis of mean heart rate and blood pressure changes measured during clinical trials of CARDAMYST. The results demonstrate minimal blood pressure reduction during test dose and rare symptoms of hypotension or syncope, supporting the potential safe, self-administration of CARDAMYST for PSVT treatment.

·ACC

Scientific Session to serve as a major launch event for the cardiology community. The meeting will provide an opportunity to highlight CARDAMYST’s clinical profile and engage prescribing physicians as commercial activities accelerate.

Etripamil for Patients with Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR)

·Phase 3 program in AFib-RVR planned. The Company has developed a Phase 3 registrational program (incorporating the FDA’s guidance) to evaluate self-administered etripamil as a potential treatment for patients with AFib-RVR. The Company intends to fol

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

November 12, 2025

MILESTONE

PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

Québec

001-38899

Not applicable

(state or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer Identification No.)

1111 Dr. Frederik-Philips Boulevard,

Suite 420

Montréal, Québec CA

H4M 2X6

(Address of principal executive offices)

(Zip Code)

Registrant's telephone number, including area code: (514) 336-0444

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which

registered

Common Shares

MIST

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 2.02. Results of Operations and Financial Condition.

On November 12, 2025, Milestone Pharmaceuticals Inc. (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 2025, which also provided a regulatory and corporate update. A copy of the press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

99.1

Press Release, dated November 12, 2025

104

Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

MILESTONE PHARMACEUTICALS INC.

By: /s/Amit Hasija

Amit Hasija

Chief Financial Officer

Dated: November 12, 2025