Milestone Pharmaceuticals Inc. (NASDAQ: MIST ) is a microcap biotech company that was founded in 2003. It is based in Montreal, but also has a subsidiary in Charlotte, NC, with 30+ employees split fairly evenly between the two locations. Milestone IPO'd in I have been investing in the stock market since I was 17 years old, and over the 25+ years since I have learned the joy of compounding, the value of dividend reinvesting, and the principle that patient investing through good times and bad brings the great ...

MONTREAL AND CHARLOTTE, N.C., May 28, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced that Amit Hasija, Chief Financial Officer, and Lorenz Muller, Chief Commercial Officer, will present at the Jefferies Healthcare Conference, to take place June 3 - 5, 2025, in New York. A webcast of the presentation will be available on June 5 at 8:10 AM EDT. The webcast will be available to watch live and there will be a replay for approximately 90-days following the presentation on ...

Milestone Pharmaceuticals (MIST) appears an attractive pick, as it has been recently upgraded 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.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a changing ...

Exhibit 99.1 Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) Milestone Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Regulatory and Corporate Update Resolution of CRL Manufacturing issues in progress - Type A meeting requested No clinical safety or ef icacy concerns raised by FDA MONTREAL and CHARLOTTE, N.C., May 14, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the first quarter ...

Core Viewpoint - Milestone Pharmaceuticals is actively addressing the Chemistry, Manufacturing, and Controls (CMC) issues raised by the FDA regarding its lead product CARDAMYST for the treatment of paroxysmal supraventricular tachycardia (PSVT) and is preparing for a Type A meeting with the FDA to resolve these issues [1][2][6]. Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and short-term investments totaling $56.0 million, a decrease from $69.7 million as of December 31, 2024 [11]. - The company reported no revenue for the first quarter of 2025, consistent with the same period in 2024 [11]. - Research and development expenses increased to $5.0 million in Q1 2025 from $3.6 million in Q1 2024, primarily due to higher consulting costs [11]. - General and administrative expenses rose to $5.2 million in Q1 2025 from $4.0 million in the prior year, driven by increased outside service costs [11]. - Commercial expenses surged to $10.4 million in Q1 2025 from $2.9 million in Q1 2024, reflecting preparations for the launch of CARDAMYST [11]. - The net loss for the first quarter of 2025 was $20.8 million, compared to a net loss of $10.4 million in the same period last year [11]. Product Development and Regulatory Updates - The FDA issued a Complete Response Letter (CRL) for CARDAMYST in March 2025, citing two key CMC issues: the need for additional information on nitrosamine impurities and a new facility inspection to ensure compliance with Good Manufacturing Practices (GMP) [6]. - The Phase 3 study protocol for etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) has been finalized, but enrollment is paused to focus on resolving the CRL for PSVT [4]. - A new method of use patent for etripamil nasal spray was issued, potentially extending intellectual property protection until July 2042 [6]. - CARDAMYST was recognized in an independent survey as a new drug expected to significantly impact patient health, with 40% of respondents selecting it [6]. Company Overview - Milestone Pharmaceuticals is focused on developing innovative cardiovascular solutions, with etripamil as its lead investigational product designed for self-administration in treating symptomatic episodes of PSVT and AFib-RVR [9][8].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (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, 2025 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 ...

Key Takeaways Shares of MIST plunged 66.2% since the CRL issuance, reflecting the delay in the launch of Cardamyst. The company's shares have lost 67.8% so far this year against the industry's 2.2% growth. Despite this regulatory roadblock, analysts remain cautiously optimistic about the drug's prospects. Milestone Pharmaceuticals (MIST) recently announced that the FDA has issued a Complete Response Letter (“CRL”) for its New Drug Application (“NDA”) seeking approval for CARDAMYST (etripamil) nasal spray. ...

Core Viewpoint - Milestone Pharmaceuticals received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, which is intended for the treatment of acute episodes of PSVT in adults, with no clinical safety or efficacy issues raised by the FDA [1][2] Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing innovative cardiovascular solutions to improve the lives of patients with complex heart conditions [4] - The company's lead investigational product, etripamil, is a novel calcium channel blocker nasal spray designed for self-administration to treat symptomatic episodes associated with PSVT and AFib-RVR [3][4] Financial Position - As of December 31, 2024, Milestone Pharmaceuticals had $69.7 million in cash, cash equivalents, and short-term investments [1][2] Regulatory Feedback - The FDA's CRL highlighted two key Chemistry, Manufacturing and Controls (CMC) issues that need to be addressed, but did not raise concerns regarding the clinical safety or efficacy of etripamil [2][6] - The company plans to request a Type A meeting with the FDA to discuss the issues raised in the CRL and is committed to addressing these concerns for a potential resubmission [2][6] Product Development - Etripamil is designed as a self-administered rapid response therapy, allowing patients to manage their condition without immediate medical oversight [3] - The product has undergone a robust clinical trial program, including a completed Phase 3 clinical-stage program for PSVT and a Phase 2 trial for AFib-RVR [3]

Group 1 - The focus is on small and microcap biopharmaceutical companies where mispricing is most intense and institutional attention is minimal [1] - These companies are often in clinical stages and experience significant market movements due to retail ownership and analyst coverage from investment banks with vested interests [1] - The research team consists mainly of high-ranking Life Sciences students from top UK universities, aiming to improve the accuracy of clinical stage equity research [1] Group 2 - Excidium Research maintains a long position in Milestone Pharmaceuticals, indicating a potential bias in their analysis [2] - The report emphasizes the importance of conducting independent due diligence and considering multiple perspectives before making investment decisions [2] - Investing in biotechnology and pharmaceutical companies carries significant risks, including clinical trial failures and regulatory challenges [2]

Core Insights - Milestone Pharmaceuticals Inc. is set to present findings on etripamil's effectiveness in treating Paroxysmal Supraventricular Tachycardia (PSVT) at the American College of Cardiology annual meeting [1][2] - The data suggests that etripamil can convert multiple PSVT episodes to restore normal sinus rhythm, potentially enhancing patient quality of life [2][3] Company Overview - Milestone Pharmaceuticals focuses on developing innovative cardiovascular solutions aimed at improving the lives of patients with complex heart conditions [3] - The company's lead product, etripamil, is a novel calcium channel blocker nasal spray designed for self-administration by patients experiencing symptomatic episodic attacks associated with PSVT and AFib-RVR [3] Presentation Details - The moderated poster presentation titled "Consistency and Predictiveness of Conversion Among Multiple Episodes of Paroxysmal Supraventricular Tachycardia (PSVT) Treated with Etripamil: Outcomes from the NODE-303 trial" will be presented by Dr. James Ip [2] - The presentation is scheduled for March 30, 2025, from 11:42 to 11:49 AM Central Time at the ACC25 event in Chicago [2]