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Mineralys Therapeutics, Inc. (Nasdaq: MLYS) is a clinical-stage biopharmaceutical company based in Radnor, Pennsylvania, dedicated to developing innovative medicines for managing hypertension, chronic kidney disease (CKD), and other conditions driven by abnormally elevated aldosterone levels. The company's flagship product, lorundrostat, is an orally administered, highly selective aldosterone synthase inhibitor. This medication is designed to treat patients with uncontrolled hypertension—defined as those unable to achieve blood pressure below 130/80 mmHg even with two or more antihypertensive medications—and resistant hypertension, affecting those who cannot reach the target BP despite taking three or more medications, including a diuretic.
Mineralys Therapeutics aims to revolutionize hypertension management by moving away from the traditional trial-and-error approach and introducing a more personalized treatment strategy. The company’s recent accomplishments underscore this commitment: the publication of their proof-of-concept study, Target-HTN, in the Journal of the American Medical Association, and the initiation of the Phase 3 Launch-HTN and Phase 2 Explore-CKD trials.
The company recently revealed robust financial results for the third quarter of 2023, reporting cash, cash equivalents, and investments totaling $265.9 million as of September 30, 2023, ensuring sufficient funding for planned clinical studies and operations through mid-2025. Mineralys also saw significant increases in both R&D and G&A expenses, attributed to the ramp-up in clinical activities and the transition to operating as a public company.
Mineralys’ lorundrostat has shown promising results in early trials, demonstrating a substantial reduction in plasma aldosterone concentration and clinically meaningful reductions in blood pressure among participants. The company is actively enrolling subjects in pivotal trials and expects to commence the Launch-HTN trial by the end of 2023, targeting real-world applications and responder profiling through biomarker-driven approaches.
Moreover, Mineralys is also focused on chronic kidney disease, which affects over 10% of the global population. Lorundrostat’s potential to treat CKD by targeting aldosterone—an underlying driver in cardiorenal conditions—positions Mineralys at the forefront of tackling complex, interrelated health issues.
For more information, visit their official website at https://mineralystx.com and follow Mineralys on LinkedIn and Twitter.
Mineralys Therapeutics (NASDAQ: MLYS) has completed enrollment ahead of schedule for Launch-HTN, the second pivotal trial evaluating lorundrostat for uncontrolled and resistant hypertension treatment. The trial's topline data is now expected in mid-first half of 2025, earlier than initially planned.
Launch-HTN is a global, randomized, double-blinded, placebo-controlled Phase 3 trial enrolling adults who failed to achieve blood pressure goals despite taking 2-5 antihypertensive medications. Participants were randomized into three groups: placebo, lorundrostat 50mg daily, and lorundrostat 50mg daily with potential titration to 100mg at week six.
Mineralys Therapeutics (Nasdaq: MLYS) will host a virtual KOL event on October 30, 2024, at 10:00 AM ET to discuss the unmet medical need in uncontrolled and resistant hypertension and the potential of lorundrostat as a treatment. The event will feature experts including Luke J. Laffin, MD (Cleveland Clinic), James M. Luther, MD, MSCI (Vanderbilt University Medical Center), and Rhian Touyz, MBBCh, MSc (Med), PhD (McGill University Health Centre). Topics will include the ongoing Advance-HTN and Launch-HTN pivotal trials, as well as results from the Phase 2 Target-HTN proof-of-concept trial. A live Q&A session will follow.
Mineralys Therapeutics (Nasdaq: MLYS) has achieved the target enrollment of 261 subjects in its pivotal Advance-HTN trial, evaluating lorundrostat for uncontrolled or resistant hypertension. The trial tests lorundrostat as an add-on therapy to standardized background treatment of two or three antihypertensive medications. Topline data is expected in Q1 2025.
The Advance-HTN trial is a randomized, double-blind, placebo-controlled Phase 2 study. Subjects are treated for twelve weeks in three cohorts: lorundrostat 50 mg QD, lorundrostat 50 mg QD with option to titrate to 100 mg QD at week four, or placebo.
Mineralys will host a virtual KOL event for investors on October 30, 2024, discussing the unmet need in hypertension and reviewing the ongoing pivotal clinical program for lorundrostat.
Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company, has announced its participation in the Wells Fargo Healthcare Conference in Boston, MA from September 4-6, 2024. The company's management will engage in a fireside chat on Thursday, September 5, 2024, at 1:30pm EDT.
Mineralys focuses on developing medicines for hypertension, chronic kidney disease (CKD), and other aldosterone-related disorders. Investors and interested parties can access a live webcast of the fireside chat through the company's website under the 'News and Events' section of Investor Relations. A replay will be available for approximately 90 days after the event.
Mineralys Therapeutics (MLYS) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- Advance-HTN trial is ~90% enrolled, with topline data expected in Q1 2025
- Launch-HTN Phase 3 trial enrollment is ahead of schedule, with topline data anticipated in 2H 2025
- Explore-CKD Phase 2 trial enrollment is ramping up, with topline data expected in 1H 2025
Financial highlights:
- Cash, cash equivalents, and investments: $311.1 million as of June 30, 2024
- R&D expenses: $39.3 million for Q2 2024
- G&A expenses: $5.9 million for Q2 2024
- Net loss: $41.0 million for Q2 2024
The company believes its current financial position will fund planned clinical studies and operations into 2026.
Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focusing on developing medicines for hypertension, chronic kidney disease (CKD), and aldosterone-related disorders, has announced its plan to release second quarter 2024 financial results on Tuesday, August 13, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET on the same day to discuss the results. Interested parties can access the call via domestic (1-877-407-9127) or international (1-201-689-8574) phone numbers, or through a webcast link available on the company's Investor Relations webpage.
Mineralys Therapeutics (NASDAQ: MLYS) has appointed Dr. Alexander M. Gold to its Board of Directors, effective June 13, 2024. Dr. Gold, a cardiologist with over 20 years of experience, has a strong background in developing and commercializing new therapies. His previous roles include Chief Medical Officer at Sanifit-CSL and Senior Vice President at Portola Pharmaceuticals. Concurrently, Dr. Olivier Litzka has resigned from the Board to focus on his venture capital investments. Mineralys is currently advancing the late-stage clinical development of lorundrostat, aimed at treating hypertension and other cardiorenal metabolic disorders.
Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company, will participate in the Goldman Sachs 45th Annual Global Healthcare Conference in Miami, FL from June 10-13, 2024. The company's management will engage in a fireside chat on June 11, 2024, at 4:00 pm EDT. The discussion will be webcast live and accessible through the Investor Relations section on the Mineralys website, with a replay available for 90 days.
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, reported its first quarter 2024 financial results and provided a corporate update. The company is focused on developing medicines targeting hypertension, chronic kidney disease, and other diseases related to dysregulated aldosterone. Their ongoing clinical trials for lorundrostat are expected to deliver topline data in Q4 2024 and 2H 2025. Mineralys also highlighted its strengthened balance sheet after completing a private placement financing in Q1 2024, providing them with sufficient funds until 2026.
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, will participate in a fireside chat at the Bank of America Securities Health Care Conference. The company focuses on developing medicines for hypertension, chronic kidney disease, and diseases driven by dysregulated aldosterone. The event will take place in Las Vegas on May 14-16, 2024. Investors can access a live webcast and replay of the chat on the company's website.
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