LOS ANGELES, Sept. 09, 2024 (GLOBE NEWSWIRE) -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Mineralys Therapeutics, Inc. ("Mineralys" or "the Company") (NASDAQ: MLYS) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Mineralys released its second quarter 2024 financial results ...

"I am honored to join the Mineralys Board of Directors," stated Dr. Gold. "I look forward to working with the Company's executive team and fellow Board members to advance the treatment of cardiorenal metabolic disorders. There is significant potential with lorundrostat in offering a targeted treatment approach for hypertension and other diseases driven by dysregulated aldosterone." "The Board and I would like to express our collective gratitude to Olivier for his contributions and dedication to the Board. W ...

Core Insights - Mineralys Therapeutics has appointed Dr. Alexander M. Gold to its Board of Directors, effective June 13, 2024, to support the late-stage clinical development of lorundrostat for hypertension and related cardiorenal metabolic disorders [1][5][10] - Dr. Gold brings over 20 years of experience in biopharmaceuticals, having held executive roles in various companies and currently serving as Chief Medical Officer at a clinical-stage biotech firm [6][10] - The company also announced the resignation of Olivier Litzka from the Board, expressing gratitude for his contributions [3][10] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), and other diseases linked to dysregulated aldosterone [12] - The primary product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor designed to treat uncontrolled hypertension and CKD [7][12] Product Development - Lorundrostat has shown a 70% reduction in plasma aldosterone concentration in hypertensive subjects and has a selectivity of 374-fold for aldosterone-synthase inhibition compared to cortisol-synthase inhibition [7] - In a Phase 2 trial, lorundrostat demonstrated clinically meaningful blood pressure reduction in individuals with uncontrolled hypertension [11]

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 March 31, 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 registrant as specified in its charter) Delaware 84-1966887 (Sta ...

Exhibit 99.1 Mineralys Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update • Pivotal Advance-HTN Trial – The ongoing Advance-HTN trial is evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications. • Pivotal Launch-HTN Phase 3 Trial – The Company's second ongoing pivotal trial of ...

Minji Kim, PhD. Chief Business Officer 20+ years of experience: Affamed, Jounce, Curis, Hoffman-LaRoche, Genentech Cindy Berejikian Balance sheet supports activities to execute on upcoming milestones | --- | --- | --- | |------------------------------------------------------------------|-------|-------| | | | | | | | | | Targeting Aldosterone in the Treatment of Cardiorenal Diseases | | | | Mar ch 2024 | | | We caution you that this presentation contains forward-looking statements. All statements other than ...

Mineralys Therapeutics, Inc. (OTCQX:HCHDF) Q4 2023 Earnings Conference Call March 21, 2024 8:30 AM ET Company Participants Daniel Ferry - IR, LifeSci Advisors Jon Congleton - Chief Executive Officer Adam Levy - Chief Financial Officer and Chief Business Officer David Rodman - Chief Medical Officer Conference Call Participants Michael DiFiore - Evercore ISI Mary Kate - Bank of America Seamus Fernandez - Guggenheim Securities Operator Welcome to the Mineralys Therapeutics Fourth Quarter and Full Year 2023 Con ...

Exhibit 99.1 Mineralys Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update – Enrollment in the two pivotal trials of lorundrostat for the treatment of uHTN or rHTN is on track, with topline data expected for Advance-HTN trial in Q4 2024 and Launch-HTN trial in 2H 2025 – – Explore-CKD Phase 2 trial, a study for lorundrostat in hypertensive patients with stage 2-3b CKD on track for Q4 2024 to Q1 2025 topline data – – Conference call today at 8:30 a.m. ET – • ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o 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) (State or other jurisdic ...

Financial Data and Key Metrics Changes - The company ended Q3 2023 with cash, cash equivalents, and investments of $265.9 million, a significant increase from $110.1 million as of December 31, 2022, indicating strong liquidity to fund clinical trials and operations through mid-2025 [13] - R&D expenses rose to $22.5 million for Q3 2023, compared to $6.1 million in Q3 2022, primarily due to increased preclinical and clinical costs associated with the lorundrostat pivotal program [13] - The net loss for Q3 2023 was $22.8 million, up from $6.7 million in Q3 2022, reflecting the increased R&D expenses [14] Business Line Data and Key Metrics Changes - The Advanced-HTN trial continues to enroll subjects, designed to demonstrate the value of lorundrostat in uncontrolled or resistant hypertension [9] - The Launch-HTN Phase III trial is expected to initiate by the end of 2023, aiming to model real-world settings for lorundrostat in primary care [21] - The Explore-CKD trial is set to begin by the end of 2023, focusing on lorundrostat as a therapy for hypertension in patients with stage 2 to 3B chronic kidney disease [7] Market Data and Key Metrics Changes - The company is observing a growing awareness among healthcare providers regarding the role of aldosterone in cardio-renal disorders, which is expected to enhance interest in lorundrostat [43] - The market for lorundrostat is anticipated to expand as more data is published, highlighting its potential benefits in treating hypertension and chronic kidney disease [66] Company Strategy and Development Direction - The company is focused on advancing its clinical programs for lorundrostat, with a strategy to optimize trial execution and subject selection [6][8] - The management emphasizes the importance of demonstrating the dual benefits of lorundrostat in reducing both systolic blood pressure and proteinuria, which aligns with the unmet needs in the market [59] - The company aims to leverage insights from competitor trials to refine its own trial designs and patient populations for future studies [79] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in 2023 and the upcoming milestones for the clinical programs, indicating a strong commitment to advancing lorundrostat's development [74] - The management acknowledged the challenges faced in the Advanced-HTN trial but remains committed to maintaining the trial's rigor while adapting to improve enrollment rates [47][81] Other Important Information - The company has added two new independent members to its Board of Directors, enhancing its governance and strategic oversight [8] - Total other income for Q3 2023 was $3.5 million, up from $0.7 million in Q3 2022, primarily due to increased interest earned on investments [29] Q&A Session Summary Question: How many patients were past the 12-week endpoint in the Advanced-HTN study? - The company has not disclosed the number of subjects enrolled at different points in the trial [31] Question: How do recent analyses highlight the importance of targeting aldosterone? - Management noted an increase in awareness among healthcare providers regarding aldosterone's role in cardio-renal disorders, driven by compelling data [43] Question: How is the exposure from recent presentations affecting interest in the ASI class? - Management confirmed a growing interest in aldosterone as a driver of cardio-renal disorders, supported by robust data from lorundrostat [43] Question: What are the learnings from competitor CKD trials? - The company plans to leverage insights from competitor trials to inform its own trial designs and patient populations [79] Question: How does the company view the combination of lorundrostat with other treatments? - Management believes that lorundrostat's unique profile can provide benefits across multiple conditions, including hypertension and chronic kidney disease [66]