Experts who follow these stocks think they can fly higher despite already gaining over 100% since the end of July.Investors in search of stocks that can produce dramatic gains in a short time frame will want to turn their heads toward the healthcare sector. A handful of stocks in the space more than doubled in price recently.Shares of Precigen (PGEN -4.61%) and Mineralys Therapeutics (MLYS 5.07%) have already risen more than 100% since the end of July. Despite the recent run-ups, Wall Street experts who fol ...

~Pivotal Launch-HTN trial of novel aldosterone synthase inhibitor lorundrostat enrolled a diverse range of participants with uncontrolled or resistant hypertension~ ~Subgroups - including Black or African American adults, older adults, women, and participants with comorbid obesity – face heightened risk of poor cardiovascular outcomes and represent high unmet need~ ~Lorundrostat demonstrated significant and clinically meaningful blood pressure reductions across all participant subgroups, with a favorable s ...

~Pivotal Launch-HTN trial of novel aldosterone synthase inhibitor lorundrostat enrolled a diverse range of participants with uncontrolled or resistant hypertension~ ~Subgroups - including Black or African American adults, older adults, women, and participants with comorbid obesity – face heightened risk of poor cardiovascular outcomes and represent high unmet need~ ~Lorundrostat demonstrated significant and clinically meaningful blood pressure reductions across all participant subgroups, with a favorable sa ...

RADNOR, Pa., Sept. 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 chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today the closing of its previously announced underwritten public offering of 11,274,509 shares of its common stock, which includes the exercise in full of the un ...

Core Viewpoint - Mineralys Therapeutics, Inc. has announced an upsized underwritten public offering of 9,803,921 shares at a price of $25.50 per share, aiming to raise approximately $250 million before expenses [1][3]. Group 1: Offering Details - The public offering consists of 9,803,921 shares priced at $25.50 each, with expected gross proceeds of around $250 million [1]. - Mineralys has granted underwriters a 30-day option to purchase an additional 1,470,588 shares [1]. - The offering is anticipated to close on or about September 4, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the clinical development of lorundrostat, including research, development, manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes [3]. Group 3: Underwriters - BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel, and Wells Fargo Securities are serving as joint book-running managers for the offering [2]. - LifeSci Capital is acting as the lead manager, while H.C. Wainwright & Co. is the co-manager for the offering [2]. Group 4: Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related comorbidities, including chronic kidney disease and obstructive sleep apnea [6]. - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [6].

Shares of Mineralys Therapeutics, Inc. (MLYS) have gained 2% over the past four weeks to close the last trading session at $14.52, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $36.25 indicates a potential upside of 149.7%. The average comprises eight short-term price targets ranging from a low of $15.00 to a high of $48.00, with a standard deviation of $11.25. While the lowes ...

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission file number 001-41614 MINERALYS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 84-1966887 (Stat ...

Mineralys Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update Exhibit 99.1 – 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 pa ...

Core Insights - Mineralys Therapeutics, Inc. announced positive results from pivotal trials for lorundrostat, a treatment for hypertension and related conditions, and plans to meet with the FDA for a pre-NDA meeting in Q4 2025 [1][3][4] Clinical Developments - The Launch-HTN Phase 3 trial met its primary endpoint, demonstrating efficacy and safety for lorundrostat in uncontrolled or resistant hypertension [4] - The Advance-HTN trial also met its primary endpoints, reinforcing the favorable benefit-risk profile of lorundrostat in high-risk populations [4] - The Explore-CKD Phase 2 trial showed significant reductions in systolic blood pressure (9.25 mmHg) and urine albumin-to-creatinine ratio (30.51%) [4] - Ongoing Explore-OSA Phase 2 trial is expected to report topline results in 1H 2026 [1][4] Financial Performance - As of June 30, 2025, the company reported cash, cash equivalents, and investments of $324.9 million, up from $198.2 million at the end of 2024, sufficient to fund operations into 2027 [5][31] - R&D expenses for Q2 2025 were $38.3 million, a decrease from $39.3 million in Q2 2024, primarily due to the conclusion of the lorundrostat pivotal program [6] - General and Administrative expenses increased to $8.5 million in Q2 2025 from $5.9 million in Q2 2024, driven by higher compensation and professional fees [7] - The net loss for Q2 2025 was $43.3 million, compared to $41.0 million in Q2 2024 [9][29] Market Context - Hypertension affects a significant portion of the population, with less than 50% of patients achieving blood pressure goals with current medications [11][12] - Chronic kidney disease (CKD) affects over 10% of the global population and is closely linked to hypertension, increasing cardiovascular risks [13][15] - Obstructive sleep apnea (OSA) is prevalent among hypertensive patients, with untreated cases contributing to resistant hypertension [17][18] Product Overview - Lorundrostat is a selective aldosterone synthase inhibitor designed to treat uncontrolled and resistant hypertension, CKD, and OSA [19][21] - The drug has shown a 40-70% reduction in plasma aldosterone concentration in hypertensive participants [19][20]