Mineralys Therapeutics(MLYS)

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Mineralys Therapeutics(MLYS) - 2023 Q4 - Annual Results
2024-03-21 11:43
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 – • ...
Mineralys Therapeutics(MLYS) - 2023 Q4 - Annual Report
2024-03-21 11:14
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 ...
Mineralys Therapeutics(MLYS) - 2023 Q3 - Earnings Call Transcript
2023-11-12 05:06
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]
Mineralys Therapeutics(MLYS) - 2023 Q3 - Earnings Call Presentation
2023-11-12 05:03
– 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 ...
Mineralys Therapeutics(MLYS) - 2023 Q3 - Quarterly Report
2023-11-07 22:12
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 ...
Mineralys Therapeutics(MLYS) - 2023 Q2 - Earnings Call Transcript
2023-08-12 17:15
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].
Mineralys Therapeutics(MLYS) - 2023 Q2 - Quarterly Report
2023-08-07 21:16
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 ...
Mineralys Therapeutics(MLYS) - 2023 Q1 - Quarterly Report
2023-05-15 21:25
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 ...
Mineralys Therapeutics (MLYS) Investor Presentation - Slideshow
2023-03-29 12:38
| --- | --- | --- | |-------|-------|-------| | | | | | | | | 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 ...
Mineralys Therapeutics(MLYS) - 2022 Q4 - Annual Report
2023-03-15 21:17
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 ...