Mineralys Widens Loss as Commercial Build-Out Accelerates

The Tip Desk · November 11, 2026 · 3 min read

Net loss reached $57.3 million, or $0.64 a share, as general and administrative spending rose to $37.4 million while the company prepared for a December 22 PDUFA decision on lorundrostat.

Mineralys Therapeutics, Inc. (MLYS), a biopharmaceutical company developing medicines for hypertension and aldosterone-related conditions, reported a wider net loss for the third quarter ended September 30, 2026, as it prepared for a commercial launch of lorundrostat ahead of a December 22, 2026 PDUFA target date.

Net loss was $57.3 million, or $0.64 a share, compared with $36.9 million, or $0.52 a share, a year earlier. Total operating expenses increased to $60.1 million from $41.1 million. The company said the increase was primarily attributable to the expense drivers it described.

General and administrative expenses were $37.4 million, up from $9.7 million a year earlier. Mineralys said the rise was primarily due to investments to expand operations in preparation for commercialization, including $15.4 million in higher professional fees and $11.4 million in increased personnel-related expenses from headcount growth and higher compensation, as well as $0.9 million of other administrative costs.

Research and development expenses were $22.7 million, down from $31.5 million a year earlier. The company said the decrease was primarily due to $8.5 million of lower preclinical and clinical costs after the lorundrostat pivotal program concluded in the second quarter of 2025, and $0.3 million of decreased clinical supply, manufacturing, regulatory and other costs.

Commercial-launch readiness moved from an expected sales organization in advance of PDUFA to an expanded medical affairs team and sales force already in place. Brand marketing preparations were well underway, and the company said it was finalizing a full-service patient support program. Chief Executive Officer Jon Congleton said commercialization plans were on track and that the company’s focus was on completing launch preparations so it would be ready to reach patients quickly, pending approval.

The FDA continues its review of the NDA for lorundrostat for hypertension in combination with other antihypertensive drugs. New Launch-HTN analyses showed that at Week 12, 46% of participants with uncontrolled or resistant hypertension receiving lorundrostat 50 mg achieved the AHA/ACC guideline systolic blood pressure target of less than 130 mmHg, with more than two-thirds achieving a reduction of at least 10 mmHg. Another analysis showed similar blood pressure reductions with and without chronic kidney disease and a 52% reduction in albuminuria versus placebo. Final Phase 2 Explore-OSA results showed an 11.1 mmHg morning systolic reduction at Week 4 versus 1.0 mmHg with placebo. Long-term Transform-HTN extension data were selected for a late-breaking presentation at the American Heart Association Scientific Sessions.

Cash, cash equivalents and investments were $624.7 million as of September 30, 2026, compared with $656.6 million as of December 31, 2025. A senior secured term loan of $98.3 million, net, appeared on the balance sheet versus none at year-end 2025. Interest expense was $3.2 million in the quarter versus none a year earlier. Total other income, net was $2.8 million, down from $4.2 million a year earlier, as the higher interest expense more than offset $1.8 million of increased interest earned on higher average cash.

The company said it believes current cash, cash equivalents and investments will be sufficient to fund planned operations, including the commercial launch of lorundrostat, into 2028.