Every 10-Q that Mineralys Therapeutics, Inc. (MLYS) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-Q covers the quarterly report filed between annual reports, so if you follow MLYS and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full MLYS filings page.
Mineralys Therapeutics, Inc. reported continued development-stage losses while advancing its hypertension candidate lorundrostat toward potential commercialization. For the six months ended June 30, 2026, the company recorded a net loss of $280.4 million, driven largely by $245.7 million in research and development expenses and $45.6 million in general and administrative costs, with no product revenue. Results include a $200.0 million upfront R&D charge tied to a fourth amendment of its license with Tanabe, which converts the lorundrostat license into a perpetual, royalty-free right and removes diligence obligations.
Cash, cash equivalents, and investments totaled $661.4 million as of June 30, 2026, supported by a June 2026 equity offering that raised about $143.6 million net and a new senior secured term loan facility of up to $500.0 million, of which $100.0 million is drawn. Management believes this liquidity will fund planned operations, including a potential commercial launch of lorundrostat, for at least twelve months. The FDA has accepted the lorundrostat NDA for hypertension in combination with other drugs and set a PDUFA target date of December 22, 2026, while the company builds out commercial infrastructure and continues an open-label extension trial.
Mineralys Therapeutics, Inc. reported a Q1 2026 net loss of $39.3 million, slightly improved from $42.2 million a year earlier, as late‑stage trial spending declined. Research and development expenses fell to $24.4 million while general and administrative costs rose to $21.0 million as the company builds commercial capabilities.
The biopharmaceutical company is developing lorundrostat, an aldosterone synthase inhibitor for hypertension and related conditions. The FDA has accepted its New Drug Application and set a PDUFA target date of December 22, 2026. An exploratory Phase 2 sleep apnea trial missed its primary endpoint but showed meaningful blood pressure reductions.
Mineralys ended March 31, 2026 with $646.1 million in cash, cash equivalents, and investments and an accumulated deficit of $496.5 million. Operating cash outflow was $39.5 million in the quarter. The company also raised $20.2 million of net proceeds through its at‑the‑market equity program and had 82.5 million common shares outstanding.
Mineralys Therapeutics (MLYS) filed its third‑quarter 2025 report, highlighting progress toward an NDA for lorundrostat and a strengthened balance sheet. The company completed two pivotal hypertension trials (Launch‑HTN and Advance‑HTN) that achieved statistical significance and plans to submit an NDA in late 2025 or during the first quarter of 2026.
Cash, cash equivalents, and investments totaled $593.6 million as of September 30, 2025. For the quarter, basic and diluted net loss per share was $0.52. For the nine months ended September 30, 2025, net loss was $122.4 million.
Mineralys raised capital through two underwritten offerings—$269.6 million in September 2025 and $188.7 million in March 2025—and an ATM program totaling $27.3 million in net proceeds before terminating the ATM in November 2025. These funds support clinical development, manufacturing, pre‑commercialization, and general corporate purposes. Common shares outstanding were 79,139,956 as of November 3, 2025.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing lorundrostat, an oral aldosterone synthase inhibitor for cardiorenal conditions. Two pivotal trials (Launch-HTN and Advance-HTN) met their primary endpoints with clinically meaningful, placebo-adjusted reductions in systolic blood pressure: Launch-HTN pooled 50 mg showed a placebo-adjusted reduction of ~9.1 mmHg at week 6 and ~11.6 mmHg at week 12; Advance-HTN demonstrated a placebo-adjusted ~7.9 mmHg reduction in 24-hour ambulatory systolic BP at week 12. A Phase 2 Explore-CKD crossover trial reported a placebo-adjusted systolic BP reduction of 7.5 mmHg (p=0.0024) and a 25.6% placebo-adjusted reduction in UACR (p=0.0015).
Safety signals included confirmed hyperkalemia in some cohorts (Launch-HTN confirmed rates up to 1.1%; Advance-HTN confirmed up to 3.2%; Explore-CKD 5% on drug) and modest mean eGFR declines in Explore-CKD. As of June 30, 2025, the company held $324.9 million in cash, cash equivalents, and investments, recorded a six-month net loss of $85.5 million, used $75.7 million of cash in operations in the six months, and had an accumulated deficit of $388.0 million. Management plans a pre-NDA meeting with the FDA in Q4 2025 and states current funds are sufficient for at least twelve months.