– 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 ...

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 September 30, 2023 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 ...

Financial Data and Key Metrics Changes - The company ended Q2 2023 with cash, cash equivalents, and investments of $282.8 million, up from $110.1 million as of December 31, 2022, indicating strong liquidity to fund clinical trials and operations through mid-2025 [14]. - R&D expenses increased to $11.9 million in Q2 2023 from $5.6 million in the same period last year, primarily due to higher preclinical and clinical costs [14]. - G&A expenses rose to $3.9 million in Q2 2023 compared to $0.9 million in the same period last year, driven by higher compensation and professional fees [5][14]. - The net loss for Q2 2023 was $12.1 million, compared to $6.5 million for the same period last year, reflecting increased operational costs [5]. Business Line Data and Key Metrics Changes - The company is advancing its pivotal clinical program for lorundrostat, with the Advance-HTN trial already initiated and expected to provide top-line data in the first half of 2024 [48][49]. - The Launch-HTN trial is set to begin in the second half of 2023, aiming to enroll a larger population of uncontrolled or resistant hypertension subjects, with data expected in mid-2025 [48][49]. Market Data and Key Metrics Changes - The overlap between chronic kidney disease (CKD) and hypertension is significant, with approximately 25% to 33% of the hypertension population having some form of CKD, and 60% to 80% of the CKD population having hypertension [22]. Company Strategy and Development Direction - The company is focused on addressing aldosterone-driven cardio-renal disorders, including hypertension and CKD, with lorundrostat positioned as a selective aldosterone synthase inhibitor [48]. - The expansion into CKD trials is seen as a natural fit, leveraging the established link between elevated aldosterone levels and disease progression [49]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of lorundrostat to address significant unmet needs in both hypertension and CKD populations [43][48]. - The company anticipates continued momentum through the second half of 2023 and into 2024, with a focus on achieving key milestones in clinical development [48]. Other Important Information - The company plans to offer subjects from pivotal trials the opportunity to participate in an open-label extension trial to gather long-term safety data [49]. - The anticipated top-line data from the CKD trial is expected between Q4 2024 and Q1 2025, highlighting the dual purpose of the study in both CKD and hypertension populations [49]. Q&A Session Summary Question: What are the expectations for proteinuria reduction in the CKD trial? - Management indicated that a clinically meaningful reduction beyond the typical 30% to 40% seen with SGLT2 inhibitors is desired, but specific guidance on ranges was not provided [7]. Question: How does BMI affect the efficacy of lorundrostat in CKD? - Management noted that while BMI may influence aldosterone levels, the majority of subjects in the trial are expected to be obese, making it difficult to statistically analyze non-obese responses [8][11]. Question: What is the monitoring burden for lorundrostat compared to MRAs regarding hyperkalemia? - Management believes that the monitoring burden will not be more than that of MRAs, with a standard follow-up for potassium levels expected [32]. Question: What is the overlap between CKD and hypertension? - Management confirmed that there is a significant overlap, with a substantial portion of both populations affected by the other condition [22][34]. Question: What are the requirements for FDA approval of the higher 100 mg dose? - Management explained that the trial design includes a dose escalation approach, with safety profiles expected to be similar to the 50 mg dose [26][29].

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, 2023 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 ...

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, 2023 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 ...

| --- | --- | --- | |-------|-------|-------| | | | | | | | | Lorundrostat substantially lowered BP compared to placebo by 9.1mmHg at 50mg QD and 10.0 at 100mg QD in uncontrolled and resistant hypertension. Lorundrostat Was Effective At Lowering Blood Pressure In Individuals With Uncontrolled And Resistant Hypertension All measures represent mean placebo-adjusted reductions. No notable effect on cortisol and moderate increase in potassium * Part 1 of Phase 2 Target-HTN Proof of Concept Trial Mineralys Thera ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ____________________________________ (Exact name of registrant as specified in its charter) (Primary Standard Industrial Delaware 2834 84-1966887 (I.R.S. Employer Identification No.) (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, 2022 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the tra ...

As filed with the Securities and Exchange Commission on February 2, 2023 Registration No. 333-269282 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MINERALYS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 84-1966887 (I.R.S. Employer Identific ...

As filed with the Securities and Exchange Commission on January 18, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MINERALYS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 84-1966887 (I.R.S. Employer Identification No.) 150 N. Radnor Chester Road, Suite F2 ...