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Milestone Pharmaceuticals(MIST) - 2025 Q2 - Quarterly Results
2025-08-12 11:16
Milestone Strengthens Balance Sheet to Fully Commercialize CARDAMYST if Approved Public Of ering Raised Total Gross Proceeds of up to $170 Million if all Warrants are Exercised $75 Million Royalty Purchase Agreement Payment from RTW Extended Through End of 2025 Exhibit 99.1 Milestone Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Regulatory and Corporate Update FDA Accepted the Company's Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray; New PDUFA Target Date of December ...
Milestone Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Regulatory and Corporate Update
Globenewswire· 2025-08-12 11:05
FDA Accepted the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray; New PDUFA Target Date of December 13, 2025 Milestone Strengthens Balance Sheet to Fully Commercialize CARDAMYST if Approved Public Offering Raised Total Gross Proceeds of up to $170 Million if all Warrants are Exercised $75 Million Royalty Purchase Agreement Payment from RTW Extended Through End of 2025 MONTREAL and CHARLOTTE, N.C., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today re ...
Milestone Pharmaceuticals(MIST) - 2025 Q2 - Quarterly Report
2025-08-12 10:59
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 June 30, 2025 OR (514) 336-0444 ☐ 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) (Stat ...
Milestone Pharmaceuticals Remains A Buying Opportunity Despite Recent Dilution
Seeking Alpha· 2025-07-18 18:16
Our last article on Milestone Pharmaceuticals Inc. (NASDAQ: MIST ), which saw tremendous interest from the community, discussed the solid clinical data set and market potential of Milestone's intranasally administered calcium channel blocker, etripamil. Milestone experienced a major setback, receivingWe target small and microcap biopharmaceuticals companies where our advantage is greatest and mispricing is most intense. These young, often clinical stage companies have little to no institutional attention. A ...
Milestone Pharmaceuticals Announces Pricing of $52.5 Million Public Offering of Common Shares, Pre-Funded Warrants, Series A Common Warrants and Series B Common Warrants
Globenewswire· 2025-07-11 13:30
Core Viewpoint - Milestone Pharmaceuticals Inc. has announced a public offering of common shares and warrants, aiming to raise approximately $52.5 million to fund the clinical development and commercialization of its lead drug, etripamil, for treating paroxysmal supraventricular tachycardia (PSVT) [1][2]. Group 1: Offering Details - The public offering includes 31,500,000 common shares and accompanying Series A and Series B common warrants, priced at $1.50 per share and warrant [1]. - Additionally, pre-funded warrants to purchase 3,502,335 common shares are offered at a price of $1.499, which includes accompanying Series A and Series B common warrants [1]. - The offering is expected to close around July 14, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized alongside existing cash to support the clinical development and commercial launch of etripamil for PSVT, as well as for working capital and general corporate purposes [2]. Group 3: Company Background - Milestone Pharmaceuticals is focused on developing and commercializing innovative cardiovascular medicines, with a recent New Drug Application (NDA) submitted to the FDA for etripamil targeting PSVT [5].
Milestone Pharmaceuticals Announces Proposed Public Offering
GlobeNewswire· 2025-07-11 10:01
Core Viewpoint - Milestone Pharmaceuticals Inc. has initiated an underwritten public offering of its common shares and warrants to fund the clinical development and commercial launch of etripamil for paroxysmal supraventricular tachycardia (PSVT) [1][2]. Group 1: Offering Details - The offering includes common shares, Series A warrants, Series B warrants, and pre-funded warrants for certain investors [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1]. - The offering is conducted under a shelf registration statement declared effective by the SEC on November 22, 2024 [3]. Group 2: Use of Proceeds - Net proceeds from the offering will be used alongside existing cash to fund the clinical development and commercial launch of etripamil for PSVT, as well as for working capital and general corporate purposes [2]. Group 3: Company Overview - Milestone Pharmaceuticals is focused on developing and commercializing innovative cardiovascular medicines, with a recent New Drug Application submitted to the FDA for etripamil targeting PSVT [5].
Milestone Pharmaceuticals Announces FDA Acceptance of the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray
Globenewswire· 2025-07-11 10:00
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]
Watch Milestone Pharmaceuticals For (Likely) Upcoming FDA Approval For Cardamyst
Seeking Alpha· 2025-07-07 14:01
Company Overview - Milestone Pharmaceuticals Inc. is a microcap biotech company founded in 2003, based in Montreal with a subsidiary in Charlotte, NC, employing over 30 staff members [1] Investment Philosophy - The investment philosophy emphasizes the importance of compounding, dividend reinvesting, and patient investing through various market conditions to achieve wealth creation [1] - The approach combines steady accumulation of high-quality assets with high-risk/high-reward opportunities, underappreciated turnaround plays, and transformative technologies [1] Academic Background - The individual has over 20 years of teaching experience at the college/university level and holds a PhD from Brunel University, indicating a strong academic foundation [1]
Milestone Pharmaceuticals to Present at the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 12:00
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]
Milestone Pharmaceuticals (MIST) Upgraded to Buy: Here's Why
ZACKS· 2025-05-22 17:01
Core Viewpoint - Milestone Pharmaceuticals (MIST) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with stock price movements, particularly due to institutional investors' reliance on these estimates for valuation [4][6]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, thus affecting stock prices [4]. Company Performance and Outlook - The recent upgrade for Milestone Pharmaceuticals suggests an improvement in its underlying business, which should lead to increased investor interest and a potential rise in stock price [5][10]. - The Zacks Consensus Estimate for Milestone Pharmaceuticals has increased by 25.4% over the past three months, although the company is expected to report a loss of -$0.75 per share for the fiscal year ending December 2025, reflecting a year-over-year change of -11.9% [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating, indicating superior earnings estimate revisions [9][10]. - Stocks rated Zacks Rank 1 have historically generated an average annual return of +25% since 1988, showcasing the effectiveness of the system in identifying potential investment opportunities [7].