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].

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 ...

– Pivotal Advance-HTN and Launch-HTN trials successfully achieved statistical significance in primary efficacy endpoints and demonstrated a favorable safety and tolerability profile – – Anticipate Explore-CKD Phase 2 trial to deliver topline data in Q2 2025 – – Initiated Explore-OSA Phase 2 Trial in Q1 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing med ...

RADNOR, Pa., May 07, 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 management will be participating in the Bank of America Securities 2025 Health Care Conference being held in Las Vegas on May 12-15, 2025. Bank of America Securities Health Care Conferen ...

RADNOR, Pa., May 05, 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 it will report its financial results from the first quarter ended March 31, 2025, after the financial markets close on Monday, May 12, 2025. Monday, May 12th @ 4:30 p.m. ET Domestic:1-800-717 ...

– Significant blood pressure reductions among patients with uncontrolled or resistant hypertension treated with lorundrostat reinforce key role of dysregulated aldosterone in disease onset and progression – – Detailed results from the second pivotal Phase 3 Launch-HTN trial to be presented at an upcoming medical conference and published in a peer-reviewed publication – RADNOR, Pa., April 23, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focu ...

RADNOR, Pa., March 25, 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 it will host a conference call and webinar featuring Dr. Luke Laffin of the Cleveland Clinic, who will discuss the latest results from the pivotal Advance-HTN and Launch-HTN clinical trials, ...

RADNOR, Pa., March 18, 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, announced today the closing of the sale of an additional 1,944,444 shares of its common stock at a public offering price of $13.50 per share pursuant to the exercise in full of the underwriters’ option to ...