Core Insights - Mineralys Therapeutics is focused on developing lorundrostat, a treatment for hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA) [2][18] - The company anticipates significant clinical data releases in 2025, including topline data from pivotal trials for lorundrostat [1][5] Clinical Development - The pivotal Advance-HTN trial is expected to report topline data in March 2025, evaluating lorundrostat for uncontrolled or resistant hypertension [5] - The Launch-HTN Phase 3 trial is set to report topline data in the first half of 2025, focusing on patients who do not achieve blood pressure control with existing medications [5] - Enrollment for the Explore-CKD Phase 2 trial has been completed, with topline data anticipated in Q2 2025 [1][5] - A new Phase 2 trial for lorundrostat in patients with moderate-to-severe OSA and hypertension is planned to initiate in Q1 2025 [1][5] Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and investments totaling $198.2 million, down from $239.0 million in 2023 [4] - Research and Development (R&D) expenses for 2024 were $168.6 million, significantly higher than $70.4 million in 2023, primarily due to increased clinical costs [5][6] - General and Administrative (G&A) expenses rose to $23.8 million in 2024 from $14.3 million in 2023, driven by higher compensation and professional fees [7] - The net loss for 2024 was $177.8 million, compared to $71.9 million in 2023, reflecting increased operational expenses [9][22] Market Context - Hypertension affects a significant portion of the population, with less than 50% of patients achieving their blood pressure goals with current medications [12] - Dysregulated aldosterone levels contribute to hypertension in approximately 25% of hypertensive patients, indicating a potential market for aldosterone-targeting therapies like lorundrostat [12][16] - CKD affects over 10% of the global population, with diabetes and hypertension being major contributors [13] - OSA impacts nearly one billion people globally, with a significant overlap with hypertension, particularly in resistant cases [15]

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] Financial Results Announcement - The company will report its financial results for the fourth quarter and full year ended December 31, 2024, before the markets open on February 12, 2025 [1] Conference Call Details - A live conference call will take place on February 12 at 8:30 a.m. ET, with domestic and international dial-in numbers provided [2] Company Overview - Mineralys Therapeutics is developing lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions influenced by dysregulated aldosterone [3]

Continues to anticipate announcing topline data from Explore-CKD trial in Q2 2025RADNOR, Pa., Feb. 04, 2025 (GLOBE NEWSWIRE) -- 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 that it has completed enrollment in the Explore-CKD Phase 2 trial evaluating the efficacy and safety of lorun ...

– Estimated 54 million people suffer from obstructive sleep apnea in the U.S. including 30-50% of adults with hypertension, both conditions associated with excess morbidity and mortality – – Obstructive sleep apnea represents Mineralys’ third precision, targeted indication for lorundrostat, further expanding its market potential in aldosterone-driven diseases – – Initiation of the trial anticipated in the first quarter of 2025 – RADNOR, Pa., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Na ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Securities registered pursuant to Section 12(b) of the Act: 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 September 30, 2024 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 ...

Exhibit 99.1 Mineralys Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update – Completed enrollment in pivotal Advance-HTN trial and anticipate topline data in March 2025 – – Completed enrollment ahead of schedule in pivotal Phase 3 Launch-HTN trial and anticipate delivering topline data in mid first half of 2025 – – Ongoing enrollment in Explore-CKD Phase 2 trial and anticipate delivering topline data in Q2 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, PA – Nove ...

Mineralys Therapeutics, Inc. (NASDAQ:MLYS) Q3 2024 Earnings Conference Call November 11, 2024 4:30 PM ET Company Participants Dan Ferry - LifeSci Advisors Jon Congleton - Chief Executive Officer Adam Levy - Chief Financial Officer David Rodman - Chief Medical Officer Conference Call Participants Michael DiFiore - Evercore Richard Law - Goldman Sachs Annabel Samimy - Stifel Rami Katkhuda - LifeSci Capital Matthew Caufield - H.C. Wainright Operator Greetings. Welcome to Mineralys Third Quarter 2024 Financial ...

– Completed enrollment in pivotal Advance-HTN trial and anticipate topline data in March 2025 – – Completed enrollment ahead of schedule in pivotal Phase 3 Launch-HTN trial and anticipate delivering topline data in mid first half of 2025 – – Ongoing enrollment in Explore-CKD Phase 2 trial and anticipate delivering topline data in Q2 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical c ...

RADNOR, Pa., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by dysregulated aldosterone, today announced that management will be participating in fireside chats at three upcoming investor conferences. Guggenheim Healthcare Innovation Conference: Date: Tuesday, November 12, 2024 Time: 4:00pm EST Format: Fireside Chat Webcast ...

RADNOR, Pa., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by dysregulated aldosterone, today announced it will report its financial results from the third quarter ended September 30, 2024, after the financial markets close on Monday, November 11, 2024. Monday, November 11th @ 4:30 p.m. ET Domestic:1-877-407-9127Internation ...