Core Insights - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related comorbidities [3] - The company will report its financial results for the second quarter ended June 30, 2025, on August 12, 2025, after market close [1][2] Company Overview - Mineralys Therapeutics specializes in medicines targeting hypertension, hypertensive nephropathy, obstructive sleep apnea, and diseases driven by dysregulated aldosterone [3] - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [3] - Mineralys is headquartered in Radnor, Pennsylvania, and was founded by Catalys Pacific [3]

Core Insights - Mineralys Therapeutics, Inc. has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3] - The Zacks rating system is particularly useful for individual investors as it focuses on earnings estimate revisions rather than subjective factors that can affect Wall Street analyst ratings [2][4] Earnings Outlook - The recent upgrade reflects a positive outlook on the company's earnings, which is expected to lead to buying pressure and an increase in stock price [3][5] - The Zacks Consensus Estimate for Mineralys Therapeutics has increased by 19.6% over the past three months, indicating a favorable shift in earnings expectations [8] Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7] - The upgrade to Zacks Rank 2 places Mineralys Therapeutics in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10]

Core Viewpoint - Mineralys Therapeutics, Inc. (MLYS) shows significant upside potential with a mean price target of $36.25, indicating a 154.2% increase from the current price of $14.26 [1][2]. Price Targets and Analyst Estimates - The mean estimate consists of eight short-term price targets with a standard deviation of $11.25, suggesting variability in analyst predictions. The lowest estimate is $15.00 (5.2% increase), while the highest is $48.00 (236.6% increase) [2]. - A low standard deviation among price targets indicates a high degree of agreement among analysts regarding the stock's price movement direction [9]. Earnings Estimates and Analyst Sentiment - Analysts have shown increasing optimism about MLYS's earnings prospects, with a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [11]. - Over the last 30 days, the Zacks Consensus Estimate for the current year has risen by 1.6%, with one estimate moving higher and no negative revisions [12]. Zacks Rank and Investment Potential - MLYS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside in the near term [13]. - While the consensus price target may not be a reliable indicator of the extent of gains, it does provide a directional guide for potential price movement [14].

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]

Explore-CKD Trial Results - Lorundrostat 25mg demonstrated a 9.3 mmHg absolute reduction in systolic blood pressure (SBP) at week 4[8, 19] - The placebo-adjusted change in systolic blood pressure was -7.5 mmHg (90% C.I -11.6, -3.4, p=0.002)[19] - A 31% reduction in spot Urine Albumin-to-Creatinine Ratio (UACR) was observed with lorundrostat (p < 0.0001)[8, 20] Safety Profile - The mean change in serum potassium was 0.5 mmol/L in lorundrostat treatment periods[27] - One subject (1.7%) discontinued due to potassium >6.5 mmol/L and low eGFR[27] - One subject (1.7%) discontinued due to low eGFR[28] Patient Demographics - The study population was 69% male with a mean age of 65 years[11] - 76% of participants had diabetes[11] - Baseline geometric mean spot urine UACR was 516 mg/g[12] - Mean systolic AOBP was 149 mmHg[13] Overall Conclusions - The Explore-CKD trial is the fourth positive clinical trial of lorundrostat in uHTN or rHTN[7] - Lorundrostat shows potential for aldosterone synthase inhibition in cardiorenal disorders[7] - The data demonstrates a consistent, clinically meaningful profile with the potential to benefit a spectrum of hypertension patients[39]

Summary of Minerals Therapeutics Conference Call Company and Industry - **Company**: Mineralis Therapeutics - **Industry**: Pharmaceuticals, specifically focusing on treatments for hypertension and chronic kidney disease (CKD) Key Points and Arguments 1. **Positive Clinical Trial Results**: The EXPLORER CKD trial demonstrated positive top-line data for lorundrostat, a selective aldosterone synthase inhibitor, in patients with uncontrolled hypertension and CKD [5][22][31] 2. **Efficacy of Lorundrostat**: The trial showed a clinically meaningful reduction in systolic blood pressure of 7.5 mmHg (p=0.002) and a 30.1% reduction in urinary albumin to creatinine ratio (UACR) (p=0.0001), indicating renal protective properties [15][17][22] 3. **Safety Profile**: The incidence of hyperkalemia was 12.1%, with only modest changes in mean eGFR observed, suggesting a manageable safety profile for lorundrostat in CKD patients [19][20][22] 4. **Patient Population**: The study included patients with a mean age of 65, a mean eGFR of 55, and a significant percentage (76%) being diabetic, highlighting the trial's focus on a high-risk population [13][14] 5. **Comparison with Other Trials**: The results were consistent with previous trials (ADVANCE HTN and LAUNCH HTN), reinforcing the efficacy and safety of lorundrostat across different patient populations [15][31] 6. **Regulatory Plans**: The company plans to submit a New Drug Application (NDA) to the FDA, incorporating data from the EXPLORER CKD trial, with a pre-NDA meeting anticipated in Q4 2025 [32][53] 7. **Future Studies**: Ongoing trials (EXPLORER OSA and TRANSFORM HCM) aim to further explore the benefits of lorundrostat in related conditions, including obstructive sleep apnea (OSA) [9][31][66] Other Important Content 1. **Mechanism of Action**: Lorundrostat works by inhibiting aldosterone production, which may offer advantages over mineralocorticoid receptor antagonists (MRAs) that can lead to rebound increases in aldosterone levels [26][60] 2. **Monitoring and Management**: Recommendations for potassium monitoring include checking levels 2-3 weeks after starting treatment, with adjustments based on individual patient factors [82][83] 3. **Commercial Strategy**: The company is seeking partnerships for commercialization, particularly focusing on cardiovascular franchises that align with the drug's potential in treating cardio-metabolic disorders [100][101] 4. **Patient Compliance**: Emphasis on the importance of tolerability in CKD patients, as side effects can lead to noncompliance with treatment regimens [26][27] This summary encapsulates the critical insights from the conference call, highlighting the advancements in lorundrostat's clinical development and its implications for treating hypertension in CKD patients.

Core Viewpoint - The article emphasizes the long-term journey of innovation in the pharmaceutical industry, particularly in the hypertension treatment sector, highlighting the recent advancements and unmet needs in this area [3][4]. Group 1: Hypertension Overview - Hypertension affects approximately 1 billion people globally and has seen no significant breakthroughs in core treatment targets for over 40 years [4][5]. - It is a leading cause of cardiovascular diseases and overall mortality, with 10.8 million deaths attributed to high systolic blood pressure in 2019, accounting for about 20% of total deaths [6]. - The prevalence of hypertension is approximately 1.4 billion globally, with 80 million in the U.S. and 90 million in the EU, representing 31% and 24% of the adult population, respectively [6]. Group 2: Treatment Landscape - Current hypertension treatments include lifestyle changes, antihypertensive medications, and some devices [21]. - The article outlines the classification of hypertension into controlled and uncontrolled categories based on blood pressure readings and medication regimens [14]. - The recommended initial medications for hypertension treatment include ACE inhibitors, ARBs, thiazide diuretics, and calcium channel blockers [23]. Group 3: Recent Developments - The recent success of Mineralys in advancing hypertension treatment through innovative drug mechanisms has opened new possibilities in the field [4][5]. - The article discusses the concept of "aldosterone escape," where patients experience a rebound increase in aldosterone levels despite treatment, leading to resistant hypertension [36][39]. - Aldosterone synthase inhibitors (ASI) are highlighted as a promising new class of drugs that can directly inhibit aldosterone production, addressing both RAAS and non-RAAS pathways [40][42]. Group 4: Mechanisms of Hypertension - The pathophysiology of hypertension involves multiple systems, including renal, vascular, neural, and the RAAS system, with obesity also playing a significant role [26][27]. - The article explains the mechanisms by which aldosterone contributes to hypertension, including both direct and indirect pathways [29][36]. Group 5: Clinical Implications - The article emphasizes the importance of accurate blood pressure measurement techniques to avoid misdiagnosis of hypertension, such as white coat hypertension and masked hypertension [18][20]. - It also discusses the need for personalized treatment goals based on individual patient circumstances, particularly for older adults or those with multiple comorbidities [20].

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].