Group 1 - The article discusses the significant interest in Milestone Pharmaceuticals Inc. (NASDAQ: MIST) due to its clinical data and market potential for etripamil, an intranasally administered calcium channel blocker [1] - Milestone Pharmaceuticals has faced a major setback, indicating challenges in its development or market strategy [1] - The focus is on small and microcap biopharmaceutical companies, which often lack institutional attention and are subject to mispricing [1] Group 2 - The article emphasizes the importance of clinical information in evaluating these companies, highlighting the expertise of the analysts involved, who are primarily high-ranking Life Sciences students from top UK universities [1] - There is a critique of the current state of clinical stage equity research, which is often inaccurate due to insufficient analyst coverage [1] - The article encourages readers to seek more information about the company's work and research approach [1]

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].

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].

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]

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]

MONTREAL and CHARLOTTE, N.C., June 16, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced submission of its response to the U.S. Food and Drug Administration (FDA)'s Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. The response follows a Type A meeting rece ...

MONTREAL and CHARLOTTE, N.C., June 16, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced submission of its response to the U.S. Food and Drug Administration (FDA)'s Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. The response follows a Type A meeting recen ...

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]

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].

[Q1 2025 Financial Results and Corporate Update](index=1&type=section&id=Milestone%20Pharmaceuticals%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Provides%20Regulatory%20and%20Corporate%20Update) Milestone Pharmaceuticals reported increased Q1 2025 net loss and no revenue, prioritizing FDA's CARDAMYST CRL resolution and pausing other clinical programs [Program and Regulatory Updates](index=1&type=section&id=First%20Quarter%20and%20Recent%20Program%20Updates) Milestone focuses on resolving FDA's CARDAMYST CRL for PSVT, securing a new patent, and pausing the AFib-RVR study - Received a **Complete Response Letter (CRL)** from the FDA for CARDAMYST™ for PSVT, citing two key Chemistry, Manufacturing and Controls (CMC) issues[4](index=4&type=chunk) - The CRL issues include a request for additional information on nitrosamine impurities and a required re-inspection of a third-party manufacturing facility[4](index=4&type=chunk) - The company requested a **Type A meeting** with the FDA to discuss and resolve the CRL issues[2](index=2&type=chunk)[3](index=3&type=chunk) - A new U.S. patent (No. 12,257,224) was issued, potentially extending CARDAMYST intellectual property protection until **July 2042**[4](index=4&type=chunk) - The Phase 3 study for etripamil in AFib-RVR is paused to prioritize resources for resolving the PSVT indication CRL[5](index=5&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Milestone Pharmaceuticals reported no Q1 2025 revenue, a **$20.8 million net loss**, and decreased cash due to higher operating expenses Q1 2025 Financial Highlights (in millions of US dollars) | Financial Metric | Q1 2025 (millions USD) | Q1 2024 (millions USD) | | :--- | :--- | :--- | | Revenue | $0.0 | $0.0 | | R&D Expense | $5.0 | $3.6 | | G&A Expense | $5.2 | $4.0 | | Commercial Expense | $10.4 | $2.9 | | **Net Loss** | **$20.8** | **$10.4** | | Cash, Cash Equivalents, and Short-term Investments | $56.0 | N/A | - The increase in commercial expense resulted from additional personnel, professional costs, and operational expenses for CARDAMYST launch preparation[8](index=8&type=chunk) - Due to the CRL, the company temporarily paused the ramping of operational expenditures related to the launch[8](index=8&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) The company's financial statements show a decrease in total assets, an increase in liabilities, and a doubled net loss for Q1 2025 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$61.9 million**, liabilities increased, resulting in a **$6.1 million shareholders' deficit** Condensed Consolidated Balance Sheets (Unaudited, in thousands of US dollars) | | March 31, 2025 (thousands USD) | December 31, 2024 (thousands USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $45,085 | $25,314 | | Short-term investments | $10,873 | $44,381 | | **Total current assets** | **$60,475** | **$73,926** | | **Total assets** | **$61,885** | **$75,499** | | **Liabilities & Equity** | | | | Total current liabilities | $12,963 | $8,126 | | Senior secured convertible notes | $54,287 | $53,352 | | **Total liabilities** | **$68,008** | **$62,352** | | **Total shareholders' (deficit) equity** | **($6,123)** | **$13,147** | [Condensed Consolidated Statements of Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss) For Q1 2025, Milestone reported no revenue, with loss from operations doubling to **$20.5 million** and a net loss of **$20.8 million** Condensed Consolidated Statements of Loss (Unaudited, in thousands of US dollars, except per share data) | | Three months ended March 31, 2025 (thousands USD) | Three months ended March 31, 2024 (thousands USD) | | :--- | :--- | :--- | | Revenue | $— | $— | | Research and development | $4,978 | $3,639 | | General and administrative | $5,167 | $3,953 | | Commercial | $10,378 | $2,884 | | **Loss from operations** | **($20,523)** | **($10,476)** | | **Net loss** | **($20,761)** | **($10,354)** | | **Net loss per share, basic and diluted** | **($0.31)** | **($0.21)** | [About Etripamil](index=3&type=section&id=About%20Etripamil) Etripamil is Milestone's lead investigational calcium channel blocker nasal spray for self-administration in PSVT and AFib-RVR [About Etripamil](index=3&type=section&id=About%20Etripamil) Etripamil is Milestone's investigational calcium channel blocker nasal spray for self-administration in PSVT and AFib-RVR - Etripamil is a novel calcium channel blocker nasal spray developed for patient self-administration[10](index=10&type=chunk) - It is being developed for **paroxysmal supraventricular tachycardia (PSVT)** and **atrial fibrillation with rapid ventricular rate (AFib-RVR)**[10](index=10&type=chunk) - The therapy aims to provide on-demand care and patient self-management, potentially bypassing immediate medical oversight[10](index=10&type=chunk)