Financial Performance - Milestone Pharmaceuticals reported a net loss of $41.5 million or $0.67 per share for the full year ended December 31, 2024, compared to a net loss of $59.7 million or $1.39 per share for the prior year[6]. - The company recorded no revenue for the fourth quarter or full year 2024, compared to $1.0 million in 2023, which was related to a milestone payment from Corxel Pharmaceuticals[5]. - General and administrative expenses for the full year 2024 were $16.7 million, compared to $15.9 million in 2023, driven by increased outside service costs[5]. - Commercial expenses for the full year 2024 were $11.0 million, down from $15.1 million in the prior year, reflecting cost reductions following the resolution of a Refusal to File letter from the FDA[5]. Cash and Investments - As of December 31, 2024, Milestone had cash, cash equivalents, and short-term investments totaling $69.7 million, an increase from $66.0 million on December 31, 2023[5]. - Total assets as of December 31, 2024, were $75.5 million, slightly up from $75.2 million on December 31, 2023[12]. Research and Development - Research and development expenses decreased to $14.4 million for the full year 2024, down from $31.1 million in 2023, primarily due to lower clinical expenses following the completion of phase 3 studies[5]. - Milestone is preparing for the potential FDA approval of CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT), with a PDUFA review goal date set for March 27, 2025[1]. - A new Method of Use patent for etripamil nasal spray has been allowed, potentially extending intellectual property protection until July 2042[2]. - The company plans to initiate a Phase 3 trial for etripamil in AFib-RVR in 2025, with the protocol finalized and study start-up commenced[4].

Core Insights - Milestone Pharmaceuticals is awaiting FDA approval for CARDAMYST™ (etripamil) nasal spray for the treatment of Paroxysmal Supraventricular Tachycardia (PSVT), with a PDUFA review goal date set for March 27, 2025, and a proposed launch targeted for mid-2025 [1][5] - The company is well-capitalized to commercialize CARDAMYST upon approval, having secured resources for its launch preparations [2][5] - Milestone is also on track to initiate a Phase 3 trial for etripamil in patients with AFib-RVR in 2025, with the study protocol finalized [3] Financial Performance - As of December 31, 2024, Milestone reported cash, cash equivalents, and short-term investments totaling $69.7 million, an increase from $66.0 million at the end of 2023 [4] - The company recorded no revenue for the fourth quarter or full year ended December 31, 2024, compared to $1.0 million in 2023, which was related to a milestone payment [10] - Research and development expenses for Q4 2024 were $3.9 million, down from $5.5 million in the prior year, while full-year expenses were $14.4 million compared to $31.1 million in 2023 [10] - The net loss for Q4 2024 was $12.4 million or $0.19 per share, compared to a net loss of $13.6 million or $0.32 per share for the same period in 2023 [10] Regulatory and Intellectual Property Updates - The New Drug Application (NDA) for CARDAMYST is currently under review by the FDA, with acceptance received in May 2024 [5] - A Notice of Allowance was received from the U.S. Patent and Trademark Office for a new Method of Use patent for etripamil nasal spray, potentially extending intellectual property protection until July 2042 [5] Product Overview - Etripamil is a novel calcium channel blocker nasal spray designed for self-administration to treat symptomatic episodes of PSVT and AFib-RVR, allowing patients to manage their condition without immediate medical oversight [7][8] - The product has undergone a robust clinical trial program, including a completed Phase 3 study for PSVT and a Phase 2 trial for AFib-RVR [7]

Financial Performance - The company incurred a net loss of $41.5 million for the year ended December 31, 2024, compared to a net loss of $59.7 million for 2023, resulting in an accumulated deficit of $367.5 million as of December 31, 2024[162]. - The company expects its existing cash and cash equivalents will be sufficient to fund operations for at least the next 12 months, but substantial additional funding will be required for ongoing operations and planned activities[172]. - Economic uncertainty, including inflation and geopolitical tensions, may adversely affect the company's results of operations and access to capital[178]. - The company may need to raise additional capital through equity or debt financing, which could dilute shareholder ownership and restrict operational flexibility[179]. Product Development and Regulatory Approval - Etripamil is the only product candidate currently under development, with no regulatory approval obtained yet[184]. - The FDA accepted the NDA for etripamil in May 2024 after a resubmission following a Refusal to File letter in December 2023[189]. - The lengthy and unpredictable approval process may significantly harm the company's business and financial condition if regulatory approvals are not obtained[186]. - The FDA may require additional clinical trials or impose restrictions on marketing approvals, which could adversely affect the company's prospects[207]. - The company plans to conduct Phase 3 development for etripamil in treating AFib-RVR, anticipating patient enrollment in the first half of 2025[192]. - The establishment of sales and marketing capabilities is critical for the successful commercialization of etripamil, but this process is expected to be expensive and time-consuming[224]. Clinical Trials and Safety Concerns - The NODE-301 trial of etripamil for PSVT did not meet its primary endpoint, highlighting the uncertainty in achieving commercial success for etripamil and future product candidates[174]. - Clinical trials are expensive and time-consuming, with the possibility of delays impacting the commercialization timeline of product candidates[206]. - Three serious adverse events were reported in the Phase 2 clinical trial, which were considered possibly related to etripamil, highlighting potential safety concerns[214]. - In the Phase 2 clinical trial of etripamil for PSVT, only 104 out of 199 enrolled patients completed the trials, with 70 patients unable to induce or sustain episodes of SVT during the trial period[211]. Market and Competitive Landscape - The company anticipates that sales of etripamil will generate substantially all of its revenues for the foreseeable future, making market acceptance vital for business sustainability[229]. - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may hinder its ability to develop and commercialize drugs successfully[232]. - Coverage and adequate reimbursement for etripamil and future candidates may not be available, impacting market acceptance and sales[243]. - The market opportunities for etripamil and future product candidates may be smaller than estimated, potentially adversely affecting the business[231]. Intellectual Property and Patent Risks - The patent protection for etripamil is critical, and any failure to maintain or obtain sufficient patent rights could allow competitors to develop similar products[302]. - The company may need to defend its patents against challenges, which could result in loss of exclusivity or patent claims being invalidated, limiting its ability to prevent competitors from using similar technologies[309]. - Changes in patent laws may affect the scope and enforceability of the company's patent rights, creating uncertainty in the commercial value of its intellectual property[304]. - The company may face claims asserting that its employees have wrongfully used or disclosed trade secrets, which could result in litigation and substantial costs[324]. Regulatory Compliance and Legal Risks - Compliance with federal and state healthcare laws is critical, as non-compliance could lead to substantial penalties and affect business operations[263]. - The company must navigate complex healthcare regulations that vary by state and country, complicating compliance efforts[271]. - The company is dependent on third-party manufacturers for the production of clinical supplies, which must comply with FDA regulations[283]. - Ongoing regulatory oversight will apply to etripamil and future candidates even after obtaining approval, which may impose additional costs and requirements[255]. Cybersecurity and Data Privacy - Cybersecurity threats pose a significant risk to the company's operations, potentially leading to material disruptions and adverse consequences[346]. - The company has implemented security measures to protect its information technology systems, but future breaches could harm its competitive position and delay product development[349]. - The company is subject to various data privacy laws, including the EU GDPR, UK GDPR, and China's PIPL, which impose strict requirements for processing personal data[357]. - Compliance with evolving data privacy laws may increase operational costs and legal risks for the company and its third-party partners[356].

Core Insights - Milestone Pharmaceuticals Inc. will present at the TD Cowen 45th Annual Health Care Conference from March 3-5, 2025 [1] - A live webcast of the presentation will be available on March 4 at 9:10 AM EST, with a replay option for 90 days [2] - Milestone Pharmaceuticals focuses on developing innovative cardiovascular solutions, with its lead product being etripamil, a nasal spray for self-administration in treating symptomatic episodic attacks associated with PSVT and AFib-RVR [3]

Core Viewpoint - Milestone Pharmaceuticals has received a Notice of Allowance for a new Method of Use patent for its lead investigational product, etripamil nasal spray (proposed trade name CARDAMYST), aimed at managing paroxysmal supraventricular tachycardia (PSVT) [1][2] Group 1: Patent and Intellectual Property - The patent covers the repeat dose regimen used in the RAPID Phase 3 study for CARDAMYST, which is part of the New Drug Application (NDA) currently under FDA review [2][4] - The Notice of Allowance potentially extends intellectual property protection for CARDAMYST in the U.S. until July 2042, providing an additional 6 years of protection [2][3] Group 2: Product Development and Commercialization - 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 oversight [5][6] - The NDA for CARDAMYST is under FDA review with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025, and commercial preparations are advancing for an anticipated launch in mid-2025 [4][6] Group 3: Company Overview - Milestone Pharmaceuticals focuses on developing innovative cardiovascular solutions to improve the lives of patients with complex heart conditions, emphasizing unmet patient needs and self-management [6]

Core Viewpoint - Milestone Pharmaceuticals is preparing for the commercial launch of its lead investigational product, etripamil nasal spray (proposed trade name CARDAMYST™), aimed at managing paroxysmal supraventricular tachycardia (PSVT) with a launch expected in mid-2025 [2][4]. Group 1: 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 [5]. - The company emphasizes understanding unmet patient needs and enhancing the patient experience through new treatment approaches that allow for self-management [5]. Group 2: Product Details - Etripamil is a novel calcium channel blocker nasal spray designed for self-administration, targeting symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR) [4]. - The product is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025 [2]. - Etripamil aims to provide healthcare providers with a new treatment option for on-demand care and patient self-management, potentially enhancing patients' control over their condition [4]. Group 3: Upcoming Event - Milestone Pharmaceuticals will host an investor event on February 25, 2025, in New York, featuring presentations from the CEO and Chief Commercial Officer, detailing the commercial strategy for etripamil [1][2]. - A live question and answer session will follow the formal presentation, allowing for direct engagement with investors [3].

Core Insights - Milestone Pharmaceuticals is preparing for a transformative year in 2025 with the potential FDA approval of CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT) [3][8] - The company is building commercial capabilities for a targeted launch of CARDAMYST in mid-2025, pending FDA approval [8] - A Phase 3 study for etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) is set to begin in the first half of 2025 [6] Company Overview - Milestone Pharmaceuticals Inc. focuses on developing and commercializing innovative cardiovascular medicines to improve patient care [10] - Etripamil is the lead investigational product, designed as a self-administered nasal spray for managing symptomatic episodes of PSVT and AFib-RVR [7][10] Regulatory and Clinical Developments - The FDA Prescription Drug User Fee Act (PDUFA) target date for CARDAMYST is March 27, 2025, with no advisory committee planned [8] - The company has completed a Phase 3 clinical program for PSVT and a Phase 2 trial for AFib-RVR, indicating a robust clinical trial background [9] Commercial Strategy - Milestone is enhancing its commercial strategy with the hiring of key personnel, including a new VP of Sales, to prepare for the launch of CARDAMYST [8] - An investor event is scheduled for February 25, 2025, to provide updates on the commercial strategy and product launch [5][8] Upcoming Events - Assuming FDA approval, Milestone will have its first branded product presence at major medical conferences in 2025, including the American College of Cardiology annual meeting and the Heart Rhythm Society Annual Meeting [8]

Core Viewpoint - Milestone Pharmaceuticals Inc. (MIST) is showing potential for bullish momentum following a technical indicator known as a "golden cross" which occurred when its 50-day simple moving average surpassed its 200-day moving average [1][2] Technical Analysis - The golden cross is characterized by three stages: a downtrend that bottoms out, a crossover of the shorter moving average above the longer one, and continued upward momentum [1] - MIST has experienced a price increase of 15.7% over the last four weeks, indicating a possible breakout [2] - The current Zacks Rank for MIST is 3 (Hold), suggesting a neutral outlook [2] Earnings Outlook - There has been a positive shift in earnings estimates for MIST, with no estimates decreasing in the past two months and two revisions higher [2] - The Zacks Consensus Estimate for earnings has also increased, reinforcing the bullish sentiment around MIST [2]

MONTREAL and CHARLOTTE, N.C., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc.  (Nasdaq: MIST) today reported financial results for the third quarter ended September 30, 2024 and provided a corporate update. “Our primary focus at Milestone is preparing for potential FDA approval of CARDAMYST (etripamil) nasal spray for the management of PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We believe that CARDAMYST has the potential to improve how ...

MONTREAL and CHARLOTTE, N.C., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced its licensing partner, Ji Xing Pharmaceuticals Ltd, released positive topline results from a multi-center, randomized, double-blind, placebo-controlled trial in China evaluating the efficacy and safety of etripamil nasal spray in paroxysmal supraventricular tachycar ...