– 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 ...

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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: | | ...

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].

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 ...

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 ...