Core Insights - The Launch-HTN trial is the largest trial of an aldosterone synthase inhibitor for uncontrolled or treatment-resistant hypertension [1][2] - Lorundrostat 50 mg once daily showed significant reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 and a 19.0 mmHg reduction at Week 12 [1][5] - The trial demonstrated a favorable safety profile, with treatment-emergent adverse events being mostly mild and transient [1][6] Company Overview - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA) driven by dysregulated aldosterone [1][11] - The company’s lead product candidate, lorundrostat, is a highly selective aldosterone synthase inhibitor designed to reduce aldosterone levels [10][11] Trial Details - The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial involving 1,083 participants who were on two to five antihypertensive medications [4] - The trial utilized automated office blood pressure measurements and allowed participants to continue their existing medications, reflecting real-world clinical practice [4] Efficacy Results - Lorundrostat demonstrated statistically significant mean reductions in automated office blood pressure, with a placebo-adjusted reduction of -9.1 mmHg at Week 6 and -11.7 mmHg at Week 12 [5] - The efficacy of lorundrostat was consistent across various demographics, including age, sex, race, body mass index, and baseline medication regimen [5] Safety Profile - The safety and tolerability profile of lorundrostat was favorable, with only a small percentage of participants experiencing elevated serum potassium levels [6][7] - There was no observed suppression of cortisol production, and serious adverse events leading to discontinuation were very low [7] Industry Context - Hypertension is a leading cause of cardiovascular disease, with less than 50% of patients achieving their blood pressure goals with current medications [8][9] - Dysregulated aldosterone levels contribute to hypertension in approximately 30% of hypertensive patients, highlighting the need for effective treatments like lorundrostat [9]

Mineralys Therapeutics cautions you that statements contained in this presentation regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of and market opportunity for lorundrostat; the Company's expectation that aldosterone synthase inhibitors with a sodium-glucose cotransporter 2 inhibitor may provide additiv ...

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 ...

Core Insights - Mineralys Therapeutics announced positive topline data from its Phase 2 Explore-CKD trial, demonstrating the efficacy and safety of lorundrostat in treating hypertension and chronic kidney disease (CKD) [1][2][3] Efficacy, Safety and Tolerability Results - The Explore-CKD trial was a randomized, double-blind, placebo-controlled crossover trial involving 59 subjects, focusing on the efficacy of 25 mg lorundrostat in reducing systolic blood pressure (BP) and urine albumin-to-creatinine ratio (UACR) [4][13] - Lorundrostat achieved a 9.3 mmHg reduction in systolic BP and a 31% reduction in UACR, both statistically significant [7][5] - The trial showed a favorable safety profile, with treatment-emergent adverse events (TEAEs) leading to discontinuation in 3% of subjects during lorundrostat treatment [8][9] Clinical Significance - The trial results support the potential of lorundrostat as a treatment option for patients with hypertension and comorbid CKD, addressing the underlying mechanisms of these conditions [10][11] - The findings contribute to a growing body of evidence validating aldosterone synthase inhibitors in managing hypertension and CKD [10][18] Future Development - Mineralys plans to submit a New Drug Application (NDA) based on the successful outcomes of the Explore-CKD trial, along with previous pivotal trials [2][18] - Ongoing studies, including the Transform-HTN extension trial and the Explore-OSA trial, aim to further evaluate the long-term efficacy and safety of lorundrostat [11][19]

Core Insights - The Launch-HTN trial demonstrated the efficacy of lorundrostat in reducing systolic blood pressure in over 1,000 participants with uncontrolled or resistant hypertension [1][2][3] - Lorundrostat 50 mg once daily resulted in a 16.9 mmHg reduction at Week 6 and a 19.0 mmHg reduction at Week 12, both statistically significant [1][4][5] - The trial showed a favorable safety and tolerability profile for lorundrostat [1][6] Company Overview - Mineralys Therapeutics, Inc. is focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea driven by dysregulated aldosterone [1][15] - The company aims to deliver the first targeted aldosterone synthase inhibitor to patients suffering from uncontrolled or resistant hypertension [2][15] Trial Details - The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial involving participants on two to five antihypertensive medications [3][12] - The trial utilized automated office blood pressure measurement to reflect real-world clinical settings [3][12] - Results were presented at the 34th European Meeting on Hypertension and Cardiovascular Protection [2] Efficacy Results - At Week 6, lorundrostat showed a -16.9 mmHg absolute change in systolic blood pressure, with a -9.1 mmHg placebo-adjusted change [4] - At Week 12, the absolute change was -19.0 mmHg, with a -11.7 mmHg placebo-adjusted change [4][5] - The trial met its primary endpoint with statistically significant reductions in blood pressure [3][4] Safety Profile - Lorundrostat exhibited a favorable safety profile, with modest and reversible effects on serum electrolytes [6][12] - The incidence of treatment-emergent serious adverse events was low, with only one participant experiencing a treatment-related serious adverse event [12][6] Industry Context - Hypertension is a significant health issue, contributing to over 685,000 deaths in the U.S. in 2022 and resulting in an estimated economic burden of $219 billion in 2019 [8] - Less than 50% of hypertension patients achieve their blood pressure goals with existing medications, highlighting the need for new treatment options [9]

Core Viewpoint - The sustainability of a trend is crucial for successful short-term investing, and confirming fundamental factors is essential to maintain momentum in stocks [1][2]. Group 1: Stock Performance - Mineralys Therapeutics, Inc. (MLYS) has shown a solid price increase of 72.1% over the past 12 weeks, indicating strong investor interest [4]. - The stock has also increased by 23.1% in the last four weeks, suggesting that the upward trend is still intact [5]. - MLYS is currently trading at 83% of its 52-week high-low range, indicating a potential breakout [5]. Group 2: Fundamental Strength - MLYS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [6]. - The stock has an Average Broker Recommendation of 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [7]. Group 3: Investment Strategy - The "Recent Price Strength" screen is a useful tool for identifying stocks with strong fundamentals that can maintain their upward trends [3]. - In addition to MLYS, there are other stocks that meet the criteria of the "Recent Price Strength" screen, providing additional investment opportunities [8].

Core Insights - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases related to dysregulated aldosterone [1][5] - The company announced that data from the pivotal Phase 3 Launch-HTN trial for lorundrostat, targeting uncontrolled hypertension (uHTN) and resistant hypertension (rHTN), will be presented at the 34th European Meeting on Hypertension and Cardiovascular Protection [1][2] Group 1: Lorundrostat Overview - Lorundrostat is an orally administered, highly selective aldosterone synthase inhibitor designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production [3] - It has a 374-fold selectivity for aldosterone-synthase inhibition compared to cortisol-synthase inhibition in vitro, with a half-life of 10-12 hours and a demonstrated 70% reduction in plasma aldosterone concentration in hypertensive subjects [3] Group 2: Clinical Trial Details - The Phase 2 proof-of-concept trial (Target-HTN) showed that once-daily lorundrostat resulted in clinically meaningful blood pressure reduction in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring [4] - Adverse events included a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection, and one serious adverse event of hyponatremia possibly related to the study drug [4] Group 3: Company Background - Mineralys Therapeutics is based in Radnor, Pennsylvania, and was founded by Catalys Pacific, focusing on cardiorenal conditions affected by dysregulated aldosterone [5]

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell even higher, with the expectation that established trends will continue [1] Company Overview: Mineralys Therapeutics, Inc. (MLYS) - MLYS currently holds a Momentum Style Score of A, indicating strong momentum characteristics [3] - The company has a Zacks Rank of 2 (Buy), suggesting a favorable outlook compared to the market [4] Performance Metrics - Over the past week, MLYS shares increased by 4.78%, outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 0.92% [6] - In a longer timeframe, MLYS shares have shown a monthly price change of 14.98%, significantly higher than the industry's 3.03% [6] - Over the last quarter, MLYS shares surged by 60.56%, while the S&P 500 index declined by 2.26% during the same period [7] - Year-to-date, MLYS shares are up 18.08%, compared to the S&P 500's increase of 13.85% [7] Trading Volume - MLYS has an average 20-day trading volume of 794,549 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - In the past two months, two earnings estimates for MLYS have been revised upwards, while none have been lowered, leading to an increase in the consensus estimate from -$4.36 to -$3.77 [10] - For the next fiscal year, two estimates have also moved upwards with no downward revisions [10] Conclusion - Given the strong performance metrics and positive earnings outlook, MLYS is positioned as a promising investment opportunity with a Momentum Score of A and a Zacks Rank of 2 (Buy) [12]

Summary of Mineralys Therapeutics Conference Call Company Overview - **Company**: Mineralys Therapeutics (MLYS) - **Focus**: Targeting aldosterone and cardiorenal metabolic conditions [4][36] Industry Context - **Market Size**: Approximately 60 million treated patients for hypertension, with 30 million unable to reach treatment goals [37] - **Patient Risk**: About 20 million patients at risk of stroke, heart disease, or kidney disease due to uncontrolled hypertension [37] Core Points and Arguments - **Aldosterone's Role**: 25-30% of hypertension patients have dysregulated aldosterone, linked to visceral adiposity [4][5] - **Therapeutic Gap**: Limited effective therapeutics targeting aldosterone, highlighting the need for new treatments [5] - **Positive Study Results**: - LAUNCH study showed a 19 mmHg reduction in blood pressure in real-world settings [6] - ADVANCE study demonstrated a 15 mmHg reduction in a rigorous hypertension study [6] - **Mechanism of Action**: Lorundestat, an aldosterone synthase inhibitor (ASI), targets both sides of aldosterone's effects, offering a dual mechanism of action [9][10] - **Selectivity and Efficacy**: Lorundestat has best-in-class selectivity for aldosterone over cortisol, with a half-life of 10-12 hours, allowing for effective blood pressure management [10][11] Clinical Data Highlights - **Patient Demographics**: - 40% of trial patients were uncontrolled on two medications, 60% were resistant to hypertension [14] - 30% were African American, and about 90% were overweight or obese [14] - **Statistical Significance**: - 17 mmHg absolute reduction in blood pressure at six weeks, with 44% of patients achieving treatment goals compared to 24% on placebo [15][18] - **Safety Profile**: - Low incidence of serious adverse events (2.4%) and discontinuation (2.6%) [24] - Mild potassium profile changes, with only 0.6% of subjects having confirmed readings above 6 [21][28] Future Studies and Pipeline - **Upcoming Studies**: - EXPLORER CKD study to assess blood pressure and kidney function in patients with chronic kidney disease [32] - OSA study initiated to explore the relationship between sleep apnea and hypertension [34] - **Regulatory Plans**: Pre-NDA meeting planned for Q4 2025 following successful study outcomes [36] Financial Position - **Cash Balance**: $343 million as of Q1 reporting [39] Strategic Developments - **Commercial Strategy**: Eric Warren appointed as Chief Commercial Officer to enhance commercial opportunities and strategic partnerships [39] Conclusion - Mineralys Therapeutics is positioned to address significant unmet needs in hypertension treatment, with promising clinical data supporting the efficacy and safety of lorundestat, alongside a robust pipeline and strategic leadership to drive future growth [36][39]