Mineralys Therapeutics (MLYS) News & Sentiment

RADNOR, Pa., March 11, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today the pricing of an underwritten public offering of 12,962,962 shares of its common stock at a public offering price of $13.50 per share. The aggregate gross proceeds to Mineralys from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $175.0 million. In addition, Mineralys has granted the underwriters a 30-day option to purchase up to an additional 1,944,444 shares of its common stock. All of the securities to be sold in the offering are to be sold by Mineralys. The offering is expected to close on or about March 13, 2025, subject to the satisfaction of customary closing conditions.

Primary endpoints of both Advance-HTN and Launch-HTN studies, using lorundrostat to treat patients with hypertension were met with statistical significance. Upcoming catalysts include the full data release from Advance-HTN in March 2025 and phase 2 Explore-CKD trial results in Q2 2025. Financially, company has $198.2 million in cash but may need to raise funds soon, potentially diluting shareholders.

On Monday, Mineralys Therapeutics, Inc. MLYS released topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials of lorundrostat for uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).

Mineralys Therapeutics said on Monday its blood pressure drug, lorundrostat, met the main goal in late- and mid- stage trials.

– Launch-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at week 6 – – Launch-HTN met a predefined endpoint with lorundrostat 50 mg dose achieving a 19.0 mmHg reduction in systolic blood pressure, and an 11.7 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at end of treatment, week 12 – – Advance-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a highly statistically significant 7.9 mmHg placebo-adjusted reduction assessed by 24hr ABPM at end of treatment, week 12 – – Lorundrostat demonstrated a favorable safety and tolerability profile in both pivotal trials – – Full results from Advance-HTN to be presented on March 29, 2025, at the American College of Cardiology Scientific Sessions – – Conference call today at 8:00 a.m. ET – RADNOR, Pa.

RADNOR, Pa., March 07, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced it will host a conference call and webinar to announce topline results from its Launch-HTN and Advance-HTN pivotal trials on Monday, March 10, 2025, at 8:00 a.m. ET.

Mineralys Therapeutics, Inc. (NASDAQ:MLYS ) Q4 2024 Results Conference Call February 12, 2025 8:30 AM ET Company Participants Dan Ferry - LifeSci Advisors Jon Congleton - Chief Executive Officer Adam Levy - Chief Financial Officer David Rodman - Chief Medical Officer Conference Call Participants Michael DiFiore - Evercore ISI Rich Law - Goldman Sachs Annabel Samimy - Stifel Mohit Bansal - Wells Fargo Rami Khadkar - LifeSci Capital Matthew Caufield - H. C. Wainwright Operator Good morning, ladies and gentlemen, and welcome to the Mineralys Fourth Quarter and Full Year 2024 Earnings Conference Call.

I believe Mineralys Therapeutics has a promising candidate with Lorundrostat for hypertension, CKD, and OSA. It should report more key pivotal clinical data this year. MLYS has several Phase 2 and 3 trials on Lorundrostat that could position it favorably for a potential FDA submission by late 2026 or sometime in 2027. According to the company's slides, Lorundrostat seems to have superior selectivity in some patients that reduces cortisol suppression and other side effects.

– Completed enrollment in pivotal Advance-HTN trial and anticipate topline data in March 2025 – – Completed enrollment ahead of schedule in pivotal Phase 3 Launch-HTN trial and anticipate delivering topline data in mid first half of 2025 – – Ongoing enrollment in Explore-CKD Phase 2 trial and anticipate delivering topline data in Q2 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa.