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]

Core Viewpoint - Mineralys Therapeutics, Inc. held its Q1 2025 earnings conference call on May 12, 2025, to discuss financial results and business updates [1]. Group 1: Financial Results - The company issued a press release earlier in the day detailing its Q1 2025 financial results [3]. - A replay of the conference call will be available on the Investors section of the company's website approximately one hour after the call's completion [3]. Group 2: Conference Call Structure - The call was structured to include a presentation followed by a question-and-answer session [1][3]. - Dan Ferry, representing LifeSci Advisors, initiated the call and welcomed participants [2].

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]

Clinical Trials and Efficacy - The pivotal trials Launch-HTN and Advance-HTN demonstrated statistically significant and clinically meaningful efficacy for lorundrostat in treating uncontrolled hypertension, with a placebo-adjusted systolic BP reduction of -9.1 mmHg at week 6 and -11.7 mmHg at week 12 for the Launch-HTN trial [99][100]. - The Launch-HTN trial enrolled 1,083 participants, with 63% having a BMI ≥30 kg/m² and 29% identifying as Black or African American, reflecting a diverse patient population [100]. - The Advance-HTN trial involved 285 participants, achieving a placebo-adjusted reduction of -7.9 mmHg in systolic BP at week 12, with 66% of subjects having a BMI ≥30 kg/m² [102]. - The company is exploring lorundrostat's potential in treating hypertension associated with chronic kidney disease (CKD) and obstructive sleep apnea (OSA), addressing multiple cardiorenal metabolic disorders [92][97]. - The FDA cleared the investigational new drug application for the Explore-OSA trial, which will evaluate lorundrostat's effects on overweight and obese subjects with moderate-to-severe OSA and hypertension [98]. - Safety data from the Launch-HTN trial indicated a low incidence of treatment-emergent serious adverse events (SAEs) at 2.2% for the 50 mg arm, supporting a favorable benefit-risk profile [104]. - The ongoing Transform-HTN trial allows subjects to continue receiving lorundrostat, generating additional long-term safety and efficacy data [92]. - The company plans to present the results of the Launch-HTN trial at the 2025 European Society of Hypertension Meeting, emphasizing its commitment to sharing clinical findings with the medical community [93]. Financial Performance and Projections - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $343.0 million [107]. - The net losses for the three months ended March 31, 2025, and 2024 were $42.2 million and $31.5 million, respectively, with an accumulated deficit of $344.7 million as of March 31, 2025 [108]. - The company has no products approved for sale and does not expect to generate revenue until lorundrostat is developed and approved [109]. - The company expects to significantly increase research and development expenses as it continues the development of lorundrostat [120]. - The company anticipates increased general and administrative expenses to support its research and development and commercialization efforts [121]. - Research and development expenses increased by $7.1 million to $37.9 million for the three months ended March 31, 2025, compared to $30.8 million in the same period of 2024 [126][127]. - General and administrative expenses rose by $2.0 million to $6.6 million for the three months ended March 31, 2025, compared to $4.6 million in the same period of 2024 [128]. - Net loss increased by $10.7 million to $42.2 million for the three months ended March 31, 2025, compared to a net loss of $31.5 million in the same period of 2024 [126]. - Net cash used in operating activities was $45.5 million for the three months ended March 31, 2025, compared to $19.1 million in the same period of 2024, reflecting an increase of $26.3 million [138]. - Net cash used in investing activities was $92.9 million for the three months ended March 31, 2025, compared to $56.0 million in the same period of 2024, an increase of $36.9 million [139]. - Net cash provided by financing activities increased to $189.3 million for the three months ended March 31, 2025, compared to $116.2 million in the same period of 2024 [140]. - The company raised approximately $700.0 million from various equity offerings since inception, including $188.7 million from a March 2025 stock sale [107][112]. - Future capital requirements will depend on various factors, including the progress of clinical trials and regulatory approvals for lorundrostat [134]. - The company anticipates continuing to incur net losses and negative cash flows from operations for the foreseeable future [130]. Obligations and Agreements - The company is obligated to pay Mitsubishi Tanabe up to $155.0 million in commercial milestone payments upon first commercial sale and meeting certain sales targets [110]. - The company entered into an ATM Equity Offering Sales Agreement with a potential offering price of up to $100 million [113]. - The company plans to use net proceeds from the private placement to fund research and development of lorundrostat and for working capital [115]. - The company has incurred no development or commercial expenses under the Mitsubishi License during the three months ended March 31, 2025, and 2024 [110]. Economic and Market Conditions - The company is exposed to interest income sensitivity due to changes in U.S. interest rates, but a hypothetical 10% change would not materially affect operations [149]. - The company contracts with vendors outside the U.S., exposing it to foreign currency exchange rate fluctuations, though these have not been significant to date [150]. - A hypothetical 10% change in foreign exchange rates would not materially impact the company's results of operations [150]. - Inflation has increased costs related to labor and research and development contracts, but has not materially impacted financial results to date [151]. - Future inflationary costs may adversely affect the company's business, financial condition, and results of operations [151]. Market Need - Approximately 120 million patients in the U.S. suffer from hypertension, with over 30 million not achieving their BP goals despite treatment, highlighting a significant unmet medical need [90]. - The company anticipates a pre-new drug application (NDA) meeting with the FDA in Q4 2025 for lorundrostat, targeting treatment for uncontrolled and resistant hypertension [91].

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 ...

Exhibit 99.1 RADNOR, PA – May 12, 2025 – 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 financial results for the first quarter ended March 31, 2025, and provided a corporate update. "We are pleased to have recently announced positive topline results from our pivotal trials, Launch-H ...

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]

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][3] - The company will participate in the Bank of America Securities 2025 Health Care Conference from May 12-15, 2025, with a presentation scheduled for May 14, 2025, at 4:35 PM PDT [1][2] Company Overview - Mineralys Therapeutics is developing its initial product candidate, lorundrostat, which is a proprietary, orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions influenced by dysregulated aldosterone [3] - The company is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [3]

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]