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]

Core Viewpoint - Milestone Pharmaceuticals has submitted a response to the FDA's Complete Response Letter regarding its New Drug Application for CARDAMYST™ (etripamil) nasal spray, aimed at treating acute episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, with a new PDUFA date expected within the year [1][2]. Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing innovative cardiovascular solutions to enhance the lives of individuals with complex heart conditions [4]. - The company emphasizes understanding unmet patient needs and improving patient experiences through new treatment approaches that allow for self-management [4]. Product Information - Etripamil is the lead investigational product of Milestone, designed as a novel calcium channel blocker nasal spray for the rapid treatment of symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular response (AFib-RVR) [3]. - If approved, CARDAMYST™ will be the first self-administered therapy for the rapid termination of PSVT episodes, providing patients with greater control over their condition [2][3]. Regulatory Interaction - A recent Type A meeting with the FDA was deemed productive, providing necessary guidance for the resubmission of the NDA [2]. - The FDA's acceptance of the response and the determination of the new PDUFA date will occur within the next thirty days, with a review period expected to be between 2 to 6 months from resubmission [1].

Core Viewpoint - Milestone Pharmaceuticals has submitted a response to the FDA's Complete Response Letter regarding its New Drug Application for CARDAMYST™ (etripamil) nasal spray, aimed at treating acute episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, with a new PDUFA date expected within the year [1][2]. Group 1: Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing innovative cardiovascular solutions to enhance the lives of individuals with complex heart conditions [4]. - The company's lead investigational product, etripamil, is a novel calcium channel blocker nasal spray designed for self-administration, allowing patients to manage symptomatic episodes of PSVT and AFib-RVR without immediate medical supervision [3][4]. Group 2: Product Development - Etripamil is under clinical development for frequent and symptomatic episodes of PSVT and AFib-RVR, with a robust clinical trial program that includes a completed Phase 3 program for PSVT and a Phase 2 trial for AFib-RVR [3]. - If approved, CARDAMYST™ will be the first self-administered therapy for the rapid termination of PSVT episodes, providing patients with greater control over their condition [2][3]. Group 3: Regulatory Interaction - The recent Type A meeting with the FDA was deemed productive, providing necessary guidance for the resubmission of the NDA [2]. - The acceptance of the response and the corresponding PDUFA date will be determined within the next thirty days, with the review expected to take between 2 to 6 months from resubmission [1].

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)

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].