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 ...

MONTREAL and CHARLOTTE, N.C., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the appointment of Joseph Papa to its Board of Directors (“Board”), effective September 3, 2024. Mr. Papa is a renowned pharmaceutical and healthcare leader, with more than 35 years of experience navigating companies through periods of rapid growth, transformation, ...

财务状况 - 截至2024年6月30日,公司现金、现金等价物和短期投资为8330万美元,预计可为公司运营提供资金支持至2026年[9] - 公司总负债为57,254美元[28] - 公司总股东权益为31,978美元[31] - 公司总资产负债为89,232美元[31] - 公司发行在外的普通股为53,269,565股[29] - 公司发行在外的预付款认股权证为12,910,590份[30] - 公司累计亏损为345,743美元[30] - 公司应付账款和应计负债为4,000美元[28] - 公司经营租赁负债(流动部分)为567美元[28] - 公司经营租赁负债(非流动部分)为1,156美元[28] - 公司发行的优先有担保可转换票据为51,531美元[28] 研发和商业化 - FDA接受了CARDAMYST™(etripamil)鼻喷剂的新药申请(NDA)用于治疗阵发性室上性心动过速(PSVT)[4] - 公司计划于2025年上半年启动针对心房颤动伴快速室率(AFib-RVR)的III期临床试验[6] - 研发费用从2023年同期的1889万美元下降至650万美元,主要由于临床试验成本和人员成本的降低[10] - 商业化费用从2023年同期的570万美元下降至470万美元,主要由于人员成本、专业费用和其他运营费用的降低[12] 财务业绩 - 2024年第二季度净亏损940万美元,较2023年同期的1600万美元有所下降[13]

– NDA for CARDAMYST™ in PSVT accepted by FDA in 2Q 2024; PDUFA in March 2025 – Cash of $83.3 million as of June 30, 2024 expected to fund operations into 2026 – Stuart Duty and Andrew Saik Appointed as Independent Board Directors MONTREAL and CHARLOTTE, N.C., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the second quarter ended June 30, 2024 and provided a regulatory and corporate update. “The FDA acceptance of our New Drug Application ...

产品研发和临床试验 - 公司正在开发一种名为etripamil的新型钙离子通道阻滞剂，用于治疗阵发性室上性心动过速(PSVT)和心房颤动伴快速室率(AFib-RVR)[106][107][108] - 公司在2024年5月宣布FDA接受了etripamil的新药申请(NDA),正在寻求批准在美国销售和推广用于治疗PSVT的etripamil[109][110][111] - 公司在2024年4月宣布了一项开放标签的III期临床试验NODE-303的新数据,显示etripamil可以在门诊环境下自我给药治疗PSVT发作,有效率达到69.9%[112] - 公司在2022年10月宣布了III期RAPID临床试验的积极结果,etripamil在30分钟内将64.3%的PSVT患者转为窦性心律,优于安慰剂的31.2%[113] - 公司计划在2025年上半年启动一项III期临床试验,评估etripamil用于治疗AFib-RVR[117][118] - 公司在2023年11月发布了II期ReVeRA试验的积极结果,etripamil可以显著且迅速降低AFib患者的室速,29.91 bpm优于安慰剂[119][120][121] - etripamil的安全性数据良好,大多数不良事件为轻度或中度,无严重不良事件与药物相关[113][122] 商业化和市场预测 - 公司预计etripamil在美国PSVT市场的潜在需求为250万至400万次发作治疗[116] - 在RAPID和NODE-303试验中,使用etripamil的患者就医干预和急诊就诊次数分别减少43%和39%[114][115] 财务状况 - 公司自2003年开始运营以来一直专注于产品研发活动,尚未有任何获批上市的产品[124] - 公司预计未来几年内将持续亏损并大幅增加研发和管理费用,以完成产品候选物的监管审批和商业化准备[126,127,128] - 公司2024年上半年净亏损1970万美元,截至2024年6月30日累计亏损3.457亿美元[125] - 公司2024年6月30日现金及现金等价物为1330万美元,短期投资为7000万美元[125] - 公司2024年上半年研发费用下降65.8%至645.4万美元,主要由于临床试验费用和人员成本下降[154,155,156,157] - 公司2024年上半年商业化费用下降18.2%至468.5万美元,主要由于人员成本和其他运营费用下降[161] - 公司2024年上半年无收入,2023年上半年收入100万美元,系达成里程碑付款[151] 融资活动 - 公司于2024年2月28日完成了一项1,666.6667万股普通股的公开发行,募集资金净额为3,190万美元[167][169] - 公司于2023年3月29日发行了5,000万美元本金的6%2029年可转换优先票据[171][172][173] - 根据回购协议,公司有望在FDA批准etripamil后获得7,500万美元的额外融资[176] 会计政策和风险因素 - 临床试验费用包括与CRO、CMO制剂和包装临床试验材料以及在试验地点的研究者和患者相关费用的直接成本[197] - 公司采用Black-Scholes期权定价模型确定股份支付的公允价值,并在服务期内按直线法确认费用[198] - 公司将于2024年12月15日后开始适用新的分部报告准则,需要披露重大费用信息[199] - 公司将于2024年12月15日后开始适用新的所得税披露准则,需要披露更多税收调节信息[200] - 公司的投资组合主要为银行存款和保证投资证书,利率变动不会对公允价值产生重大影响[202] - 公司有少量加元计价的应付款项,汇率波动可能会影响损益和股东权益[203][204] - 公司面临通胀、利率上升、地缘政治等宏观经济挑战[130]

MONTREAL and CHARLOTTE, N.C., July 31, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (NASDAQ:MIST) today announced that President and CEO, Joe Oliveto, will participate in the BTIG Virtual Biotechnology Conference, to take place from August 5-6, 2024. The presentation will be in the form of a Fireside Chat to take place on August 6th at 8 AM EDT. The webcast will be available to watch both live and as a replay for approximately 90 days following the presentation in the News & Events section of Mi ...

MONTREAL and CHARLOTTE, N.C., May 22, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced it will partner with Arrhythmia Alliance to raise awareness of supraventricular tachycardia (SVT). SVT Awareness Day will be held on Wednesday June 5, 2024, during World Heart Rhythm Week (June 4-10), to raise awareness of SVT, a type of arrhythmia or rapid heart rhyth ...

Milestone Pharmaceuticals (MIST) could be a solid choice for investors given its recent upgrade 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. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years. Ind ...

Exhibit 99.1 Milestone Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Regulatory and Corporate Update - NDA for etripamil in PSVT resubmitted in 1Q 2024 - Cash resources as of March 31, 2024 expected to fund operations into 2026 - Dialogue with FDA to finalize Phase 3 protocol for etripamil in AFib-RVR is progressing MONTREAL and CHARLOTTE, N.C., May 13, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the first quarter en ...

– NDA for etripamil in PSVT resubmitted in 1Q 2024 – Cash resources as of March 31, 2024 expected to fund operations into 2026 – Dialogue with FDA to finalize Phase 3 protocol for etripamil in AFib-RVR is progressing MONTREAL and CHARLOTTE, N.C., May 13, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST) today reported financial results for the first quarter ended March 31, 2024 and provided a regulatory and corporate update. "We're currently on track for the potential FDA approval of CAR ...