Key Highlights

  • Third quarter net loss was USD 0.64 per share, versus an estimate of USD 0.55 and USD 0.52 in 2025.
  • Cash, cash equivalents and investments were USD 624.7 million at September 30, 2026, after a USD 100.0 million Loan draw.
  • The FDA assigned a PDUFA target date of December 22, 2026 for lorundrostat in hypertension, after a December 2025 submission.
  • General and administrative expenses were USD 37.419 million in the quarter, against USD 9.681 million a year earlier.

Mineralys Therapeutics, Inc. (NASDAQ:MLYS) is a clinical-stage company with no product revenue, and its third quarter centered on preparing for a regulatory decision on lorundrostat. The company reported a net loss of USD 57.328 million, or USD 0.64 per share, against an estimate of USD 0.55 and a loss of USD 36.932 million, or USD 0.52 per share, a year earlier.

Lorundrostat and the Regulatory Path

Lorundrostat is an orally administered aldosterone synthase inhibitor under development for uncontrolled or resistant hypertension, along with chronic kidney disease and obstructive sleep apnea. The company said it has completed six clinical trials, including the Phase 3 Launch-HTN and Phase 2 Advance-HTN pivotal studies. It submitted its new drug application in December 2025, and the FDA set a PDUFA target date of December 22, 2026.

In March 2026 the company reported topline data from its Explore-OSA trial. Lorundrostat 50 mg dosed in the evening did not show a clinically meaningful difference from placebo on the apnea-hypopnea index, the primary endpoint, though blood pressure fell 11.1 mmHg with lorundrostat against 1.0 mmHg with placebo in the first-period parallel analysis.

Quarterly Results

Research and development expenses were USD 22.668 million, against USD 31.45 million a year earlier, which the company linked to the conclusion of the pivotal program in the second quarter of 2025. General and administrative expenses rose to USD 37.419 million from USD 9.681 million. Management attributed the change to preparation for commercialization; the largest pieces were USD 15.4 million of professional fees and USD 11.4 million of personnel costs.

Other income, net was USD 2.759 million against USD 4.199 million, with USD 3.2 million of added interest expense on the June 2026 Loan Agreement partly offset by USD 1.8 million of higher Investment interest.

For the nine months, the net loss was USD 337.738 million against USD 122.417 million, or USD 3.95 per share against USD 1.94. Research and Development expenses for that period included a USD 200.0 million upfront payment to Tanabe made in June 2026 under the fourth amendment to the license, which ended royalties on net sales of lorundrostat.

Funding and Balance Sheet

Cash, cash equivalents and investments were USD 624.7 million, against an accumulated Deficit of USD 794.9 million. During the nine months the company sold 5,660,378 shares at USD 26.50 for net proceeds of about USD 143.6 million, borrowed USD 100.0 million, and sold 568,320 shares under its at-the-market program for net proceeds of about USD 20.2 million.

The Loan Agreement provides a five-year senior secured term loan of up to USD 500.0 million maturing June 3, 2031. Tranche B of USD 150.0 million must be drawn by April 30, 2027, subject to FDA approval of the application. Management said the cash on hand funds planned operations, including a commercial launch, for at least twelve months.

Signposts for the Next Quarter

A quarterly loss of USD 0.64 per share sits alongside USD 624.7 million of cash and investments, USD 100.0 million drawn on the loan and a December 22, 2026 FDA target date.

Management named several items it is tracking. These include responding to FDA information requests, building out sales, medical affairs and market access functions, and continuing the Transform-HTN extension trial. On the loan, it noted that if the approval condition for Tranche B is not met by September 30, 2027, mandatory principal repayments would commence on September 30, 2027. The company also signed a Lease for about 13,135 square feet of office space in Radnor, Pennsylvania, with commencement targeted for the fourth quarter of 2026.