Mineralys Therapeutics (MLYS) Update / Briefing June 17, 2025 08:00 AM ET Speaker0 Welcome to the Minerals Therapeutics Conference Call to Report Top Line Results from the EXPLORER CKD Phase II Trial. At this time, all participants are in listen only mode. After management completes their prepared remarks, we'll As a reminder, this conference call is being recorded. I would now like to turn the call over to John Conkleton, Chief Executive Officer of Mineralis Therapeutics. Thank you. You may now begin. Spea ...

以下文章来源于和谐汇一资产管理 ，作者和谐汇一 和谐汇一资产管理 . 和谐汇一是一家专注于权益类二级市场投资的私募基金管理公司，由林鹏先生发起创立。旨在为投资者、为所投资 公司及社会发展发现持久价值，做中国最优秀企业的长期陪伴者。 创新药，可以是资本市场一时的热点，但资本市场的聚光灯总是追逐着最耀眼的那一刻，而往往会忽视了那些 引发股价飙升的"热点时刻"，其实是漫长创新征途中最后结出的果实。在每一款划时代新药背后，是数十年冷 板凳上的靶点探索，也是临床研究中的折戟与不折不挠的反复迭代。 所以，研究与跟踪新药研发，需要非常前置的研究投入。 今年初，和谐汇一的医药研究员陈倩慧就把她的目光放到了高血压领域。作为全球最常见的疾病之一，高血压 影响着约10亿人的生活，核心治疗靶点的创新已经沉寂了40多年。尽管现有的降压药物在许多情况下有效，但 仍有部分患者（尤其是顽固性高血压患者）难以有效控制血压，或因药物副作用（如高钾血症或低血压）而无 法耐受。 随着3月10日，Mineralys宣布Advance-HTN和Launch-HTN III期成功，降压药领域似乎迎来了新的可能。这 背后究竟会带来什么样的变化？我们又该如何 ...

– Conference call today at 8:00 a.m. ET – RADNOR, Pa., June 17, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other cardiovascular diseases driven by dysregulated aldosterone, today announced positive topline data from its Phase 2 Explore-CKD trial evaluating the safety and efficacy of 25 mg of lorundrostat in subjects with ...

– Largest hypertension trial of an aldosterone synthase inhibitor to date demonstrated the efficacy of lorundrostat in over 1,000 participants with uncontrolled or resistant hypertension in a real-world setting – – Lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted) and a 19.0 mmHg reduction at Week 12 (-11.7mm placebo adjusted) – – Lorundrostat demonstrated a favorable s ...

Details for the Late-Breaking Clinical Trial Abstract: | Abstract | Phase 3 Efficacy and Safety of a Novel Aldosterone Synthase Inhibitor in Patients with | | --- | --- | | Title: | Uncontrolled and Treatment-Resistant Hypertension: Launch-HTN Study | | Presenter: | Manish Saxena MBBS, Hypertension Specialist from Barts Health NHS Trust and William Harvey Heart Centre, Queen Mary University London | | Session Date/Time: | Saturday, May 24th, at 10:00-11:00am CEST | | Session | Late Breakers 1 | | Title: | | ...

Mineralys Therapeutics (MLYS) Q1 2025 Earnings Call May 12, 2025 04:30 PM ET Company Participants Dan Ferry - Managing DirectorJon Congleton - CEODavid Rodman - Chief Medical OfficerAdam Levy - CFOMichael Difiore - Managing DirectorSeamus Fernandez - Senior Managing DirectorAlice Nettleton - VP - US Pharmaceutical & Biotechnology Equity ResearchJayed Momin - Biopharma Equity Research AssociateSadia Rahman - Vice President, Biopharma Equity Research Conference Call Participants Richard Law - AnalystRami Katk ...

Mineralys Therapeutics (MLYS) Q1 2025 Earnings Call May 12, 2025 04:30 PM ET Speaker0 Good afternoon, ladies and gentlemen, and welcome to the Minauralis First Quarter twenty twenty five Earnings Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press 0 for the operator. This call is being recorded on Monday, 05/12/2025. I would now like to turn ...

Core Insights - Mineralys Therapeutics announced positive topline results from pivotal trials Launch-HTN and Advance-HTN, demonstrating the efficacy and safety of lorundrostat for treating uncontrolled or resistant hypertension [2][3] - The company anticipates topline data from the Explore-CKD Phase 2 trial in Q2 2025 and has initiated the Explore-OSA Phase 2 trial in Q1 2025 [1][12] - The company reported a net loss of $42.2 million for Q1 2025, an increase from $31.5 million in Q1 2024, primarily due to rising research and development expenses [8][22] Clinical Trials and Results - The Launch-HTN trial achieved a 16.9 mmHg reduction in systolic blood pressure at the 50 mg dose, with a placebo-adjusted reduction of 9.1 mmHg, and sustained benefits through week 12 [3] - The Advance-HTN trial reported a 15.4 mmHg absolute reduction in systolic blood pressure at the 50 mg dose, with a placebo-adjusted reduction of 7.9 mmHg [3] - Both trials demonstrated a favorable safety profile, with low incidences of hyperkalemia at 1.1% and 1.5% for the 50 mg and 50 to 100 mg arms in the Launch-HTN trial, respectively [3] Financial Performance - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $343.0 million, up from $198.2 million at the end of 2024 [5][24] - Research and development expenses for Q1 2025 were $37.9 million, compared to $30.8 million in Q1 2024, driven by increased clinical costs and compensation expenses [6][22] - General and administrative expenses rose to $6.6 million in Q1 2025 from $4.6 million in Q1 2024, attributed to higher compensation and professional fees [7][22] Corporate Developments - Eric Warren has been appointed as Chief Commercial Officer, bringing extensive experience in cardiovascular disease to support the company's commercial strategy [2][12] - The company completed a public equity financing on March 18, 2025, raising approximately $201.2 million to strengthen its balance sheet [12] Upcoming Milestones - The Explore-CKD Phase 2 trial is expected to deliver topline data in Q2 2025, focusing on the safety and efficacy of lorundrostat in patients with chronic kidney disease [1][12] - The Explore-OSA Phase 2 trial has been initiated to evaluate lorundrostat in overweight and obese subjects with moderate-to-severe obstructive sleep apnea and hypertension [1][12]

RADNOR, Pa., May 07, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that management will be participating in the Bank of America Securities 2025 Health Care Conference being held in Las Vegas on May 12-15, 2025. Bank of America Securities Health Care Conferen ...

Company Overview - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing medicines targeting hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases driven by dysregulated aldosterone [3] - The company's initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions affected by dysregulated aldosterone [3] Financial Results Announcement - Mineralys Therapeutics will report its financial results for the first quarter ended March 31, 2025, after the financial markets close on May 12, 2025 [1] - A live conference call will take place on May 12 at 4:30 p.m. ET, with details provided for both domestic and international participants [2]