"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 ...

"We are delighted to welcome Alex to our Board of Directors as we advance the late-stage clinical development of lorundrostat for the treatment of hypertension and related cardiorenal metabolic disorders," stated Jon Congleton, Chief Executive Officer of Mineralys. "As a cardiologist and accomplished biopharmaceutical clinical development executive, Alex brings tremendous experience driving value for biopharmaceutical companies. We believe Alex's track record of successful pipeline development, regulatory a ...

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]

– On track to initiate planned Phase 3 pivotal Launch-HTN trial of lorundrostat to treat patients with uncontrolled or resistant hypertension in 2H 2023 – – Conference call today at 4:30 p.m. ET – "The third quarter was productive for Mineralys with ongoing progress in our clinical development of lorundrostat, the publication of our proof-of-concept study, Target-HTN, in the Journal of the American Medical Association and the addition of two new Board members. We have finalized the designs of Launch-HTN and ...