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). Th ...

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). Th ...

SVT episodes can be short-lived for just a few minutes or last several hours. Diagnosis can be challenging as the timing of irregular heart rhythm is unpredictable, and, therefore, is difficult to identify unless an electrocardiogram can record an episode at the time it occurs. Another challenge is that despite treatment some people with SVT continue to have symptoms. In addition, some may stop taking medication because they cannot tolerate the side effects. For additional information on SVT, visit SVT Hear ...

Milestone Pharmaceuticals (MIST) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. For the fiscal year ending December 2024, this biotechnology company is expected to earn -$1.13 per share, which is a change of 18.7% from the year-ago reported number. Most Powerful Force Impacting Stock Prices The change in a company's future earnings ...

Exhibit 99.1 Milestone Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Regulatory and Corporate Update - 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 MONTREAL and CHARLOTTE, N.C., May 13, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the first quarter en ...

– 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 MONTREAL and CHARLOTTE, N.C., May 13, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST) today reported financial results for the first quarter ended March 31, 2024 and provided a regulatory and corporate update. "We're currently on track for the potential FDA approval of CARDA ...

(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38899 Milestone Pharmaceuticals Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jur ...

MONTREAL and CHARLOTTE, N.C., April 17, 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 present data on etripamil at the 30th Annual Cardiovascular Nursing Symposium held by the Preventive Cardiovascular Nurses Association on April 18-20th in Orlando, FL. The posters will be available following the embargo at https://MilestonePharma.com. Pos ...

Financial Performance - No revenue was recorded for Q4 2023, compared to $3.5 million in Q4 2022; total revenue for 2023 was $1.0 million, down from $5.0 million in 2022[8] - The net loss for Q4 2023 was $13.6 million, compared to $13.2 million in Q4 2022; the total net loss for 2023 was $59.7 million, up from $58.4 million in 2022[8] - Research and development expenses decreased to $31.1 million in 2023 from $39.8 million in 2022, primarily due to lower clinical expenses[8] - General and administrative expenses slightly increased to $15.9 million in 2023 from $15.7 million in 2022[8] - Commercial expenses rose to $15.1 million in 2023 from $9.1 million in 2022, reflecting increased personnel and professional costs[8] Cash and Investments - The company raised approximately $32.4 million from a public offering in March 2024, extending its cash runway into 2026[2] - As of December 31, 2023, cash, cash equivalents, and short-term investments totaled $66.0 million, up from $64.6 million in 2022[8] - Cash and cash equivalents rose significantly to $13,760 million in 2023, up from $7,636 million in 2022, marking an increase of 80%[17] Assets and Liabilities - Total assets increased to $75,226 million in 2023 from $74,483 million in 2022, representing a growth of 1%[17] - Total liabilities surged to $58,455 million in 2023, compared to $8,135 million in 2022, indicating a substantial increase[17] - Current liabilities increased to $7,226 million in 2023, up from $6,139 million in 2022, representing a growth of approximately 18%[17] Shareholder Equity - Shareholders' equity decreased to $16,771 million in 2023 from $66,348 million in 2022, reflecting a decline of approximately 75%[17] - The accumulated deficit widened to $(326,026) million in 2023 from $(266,341) million in 2022[17] - Additional paid-in capital rose to $33,834 million in 2023, up from $24,437 million in 2022, showing an increase of approximately 38%[17] Future Plans and Guidance - Milestone Pharmaceuticals plans to resubmit the NDA for etripamil in PSVT in early Q2 2024[1] - The FDA provided Phase 3 guidance for etripamil in AFib-RVR, with an End of Phase 2 meeting expected in mid-2024[4] - Etripamil is designed as a self-administered rapid response therapy for PSVT and AFib-RVR, aiming to improve patient self-management[11] Share Structure - The number of common shares issued and outstanding decreased from 34,286,002 in 2022 to 33,483,111 in 2023[17] - Pre-funded warrants increased to 9,577,257 issued and outstanding as of December 31, 2023, compared to 8,518,257 in 2022[17] Operating Assets - Operating lease right-of-use assets decreased to $1,917 million in 2023 from $2,423 million in 2022, indicating a decline of about 21%[17]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38899 Milestone Pharmaceuticals Inc. (Exact name of registrant as specified in its charter) | Québec | Not applicab ...