Financial Data and Key Metrics Changes - The company ended Q2 2025 with cash, cash equivalents, and investments of $324.9 million, up from $198.2 million as of December 31, 2024, indicating a significant increase in liquidity [14] - R&D expenses for Q2 2025 were $38.3 million, a slight decrease from $39.3 million in Q2 2024, primarily due to reduced preclinical and clinical costs [15] - G&A expenses increased to $8.5 million in Q2 2025 from $5.9 million in Q2 2024, driven by higher compensation and professional fees [16] - The net loss for Q2 2025 was $43.3 million, compared to $41.0 million in Q2 2024, reflecting increased expenses [17] Business Line Data and Key Metrics Changes - The company is focused on developing aldosterone synthase inhibitors (ASIs) for hypertension and related conditions, with promising clinical data from trials such as LAUNCH HTN and ADVANCE HTN [6][10] - A survey indicated that 95% of clinicians would likely prescribe lorundrostat if approved, highlighting strong interest in the product [7] Market Data and Key Metrics Changes - Uncontrolled and resistant hypertension affects over 20 million patients in the U.S., representing a significant unmet medical need [8] - The company has identified nearly 9 million patients who started new treatments in the third line or later position in 2024, reflecting dissatisfaction with current options [7] Company Strategy and Development Direction - The company aims to enhance the profile of lorundrostat in treating hypertension with comorbid conditions like chronic kidney disease (CKD) and obstructive sleep apnea (OSA) [10][12] - A pre-NDA meeting with the FDA is scheduled for 2025, indicating progress towards regulatory approval [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data supporting lorundrostat's efficacy and safety, emphasizing the unmet need in the market [21][34] - The company is exploring partnership opportunities, particularly outside the U.S., to maximize the reach of lorundrostat [24] Other Important Information - The company is expanding its medical communications team to raise awareness and interest in lorundrostat ahead of its potential launch [9] - The EXPLORER OSA trial is expected to provide top-line data in 2026, focusing on the effects of lorundrostat on nighttime blood pressure [12] Q&A Session Summary Question: Thoughts on AstraZeneca's Phase III Vax HTN data - Management refrained from speculating on AstraZeneca's data but expressed confidence in lorundrostat's safety and efficacy based on their own trials [21][22] Question: Opportunities for lorundrostat beyond hypertension - Management indicated potential for lorundrostat in treating related comorbidities like CKD and OSA, emphasizing its role in managing dysregulated aldosterone [30] Question: Payer strategies and market access - Management does not anticipate a step edit through spironolactone, expecting payers to navigate access through generic classes instead [55] Question: Commercial strategy and market entry - The company is currently focused on payer strategy and medical affairs to build awareness for lorundrostat, with specific commercial strategies still in development [59][60] Question: Pre-NDA meeting expectations - Management is confident in the comprehensive data package prepared for the FDA, which includes insights from various clinical trials [62] Question: Concerns about drug-drug interactions - Management clarified that PPI use is allowed in trials, and the focus is on ensuring adequate blood pressure control rather than safety concerns [41] Question: Future data releases from ongoing trials - Management confirmed plans to publish data from the open-label extension trial, TRANSFORM HDN, as it becomes available [74]

– Presented and published the positive results from both the Launch-HTN and Advance-HTN pivotal trials at scientific meetings and in JAMA and NEJM – – Pre-NDA meeting scheduled to take place in 4Q 2025 – – Explore-CKD Phase 2 trial successfully achieved statistical significance in reduction of systolic BP and UACR, and demonstrated a favorable safety profile – – Explore-OSA Phase 2 trial in OSA participants with hypertension is ongoing; topline results anticipated in 1H 2026 – – Conference call today at 4:3 ...

RADNOR, Pa., Aug. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as hypertensive nephropathy, obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced it will report its financial results from the second quarter ended June 30, 2025, after the financial markets close on Tuesday, August 12, 2025. Tuesday, August ...

Core Viewpoint - AstraZeneca's innovative drug baxdrostat has shown significant blood pressure reduction in a late-stage trial for treatment-resistant hypertension, leading to a 2% increase in the company's stock price [1][2]. Group 1: Drug Development and Efficacy - Baxdrostat achieved both primary and secondary endpoints in the study, significantly lowering systolic blood pressure compared to the placebo group within 12 weeks, demonstrating both statistical and clinical significance [2]. - The drug targets aldosterone, a hormone that raises blood pressure, with approximately 25% of hypertension cases stemming from aldosterone level dysregulation, offering a new treatment option distinct from traditional ACE inhibitors [5]. Group 2: Market Potential and Sales Forecast - AstraZeneca anticipates that baxdrostat could exceed $5 billion in peak annual sales, potentially used alone or in combination with Farxiga, another cardiovascular therapy that currently generates over $1 billion in annual sales [8]. Group 3: Clinical Research and Global Impact - The World Health Organization reports that hypertension affects over 1 billion people globally, and AstraZeneca is conducting a large-scale clinical study involving over 20,000 patients to test baxdrostat's efficacy across four indications, including chronic kidney disease and heart failure prevention [6]. - Full trial results for baxdrostat are expected to be announced at the European Society of Cardiology (ESC) annual meeting in August, with participation from China in this global clinical trial [7].

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 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 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]

Financial Data and Key Metrics Changes - The company ended the first quarter of 2025 with cash, cash equivalents, and investments of $343 million, compared to $198.2 million as of December 31, 2024, indicating a significant increase in liquidity [23] - R&D expenses for the quarter were $37.9 million, up from $30.8 million in the same quarter of 2024, primarily due to increased preclinical and clinical costs [24] - The net loss for the quarter was $42.2 million, compared to $31.5 million for the same period in 2024, reflecting higher expenses [25] Business Line Data and Key Metrics Changes - The pivotal trials for lorundrostat, including LAUNCH HTN and ADVANCE HTN, achieved statistically significant results in reducing systolic blood pressure in patients with uncontrolled and resistant hypertension [6][9] - The LAUNCH HTN trial demonstrated a placebo-adjusted reduction in systolic blood pressure of 9.1 mmHg at week six and maintained a reduction of 11.7 mmHg at week twelve [14] - The ADVANCE HTN trial showed a placebo-adjusted reduction of 7.9 mmHg in systolic blood pressure, confirming the efficacy of lorundrostat in a high-risk population [17] Market Data and Key Metrics Changes - A survey indicated that 95% of physicians are likely to prescribe lorundrostat if approved, particularly for third and fourth-line treatment of hypertension [9] - The company is targeting approximately 47,000 physicians who account for a significant portion of prescriptions for uncontrolled and resistant hypertension [49] Company Strategy and Development Direction - The company aims to submit a New Drug Application (NDA) for lorundrostat, incorporating data from multiple pivotal trials, including the ongoing EXPLORER CKD trial [9][35] - The appointment of Eric Warren as Chief Commercial Officer is part of the strategy to prepare for potential FDA approval and to enhance commercial efforts [11] - The company is exploring the use of lorundrostat in treating comorbid conditions such as obstructive sleep apnea and hypertensive nephropathy, indicating a broader strategic focus [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the clinical profile of lorundrostat and its potential to address significant unmet medical needs in hypertension [9][93] - The company plans to engage with the FDA in a pre-NDA meeting in Q4 2025 to discuss the path forward for lorundrostat's approval [9] - Management highlighted the importance of the benefit-risk profile of lorundrostat, especially in populations with advanced kidney disease [28] Other Important Information - The company completed a public equity financing that raised approximately $201.2 million, strengthening its balance sheet [12] - The EXPLORER CKD trial is designed to evaluate the safety and efficacy of lorundrostat in patients with chronic kidney disease, which is a critical area of focus for the company [19] Q&A Session Summary Question: What would be the max level of grade two hyperkalemia that would be acceptable if lorundestat yields a high single-digit placebo-adjusted SBP reduction? - Management indicated that specialists are more comfortable with higher potassium levels if there is a significant benefit in blood pressure and kidney function [28] Question: Do you expect similar efficacy and safety with lorundestat as seen with other treatments? - Management anticipates clinically meaningful reductions in blood pressure based on previous studies, but specifics are too early to determine [30] Question: How does the EXPLORER CKD study fit into the strategy for regulatory submission? - The EXPLORER CKD study will be part of the NDA submission, providing clinical support for patients with lower eGFR [35] Question: What are the gating factors to finalizing and filing the NDA? - Key factors include the completion of the open-label extension study and the collection of sufficient data to support the NDA submission [53] Question: Can you discuss any early discussions with potential partners? - Management has not provided updates on partnering discussions but believes that partnerships will be part of the company's strategy moving forward [60] Question: What are the primary objectives for the EXPLORER CKD study? - The primary focus is on safety and clinically meaningful reductions in blood pressure in the CKD population [70] Question: What is the expected timeline for hypertension guidelines to include data from the LAUNCH and ADVANCE HTN studies? - Management noted that it is too early to predict when guidelines will be updated but emphasized the importance of the data for informing treatment paradigms [68]