RADNOR, PA — Mineralys Therapeutics Inc. (Nasdaq: MLYS) reported a widening third-quarter loss as spending on commercial preparations for its experimental hypertension drug lorundrostat accelerated ahead of a Dec. 22, 2026, regulatory decision that could clear the way for its U.S. launch.
The Radnor-based biopharmaceutical company recorded a net loss of $57.3 million for the quarter ended Sept. 30, compared with $36.9 million a year earlier, as investments in staffing, professional services and launch infrastructure outweighed reductions in clinical research spending.
The U.S. Food and Drug Administration is reviewing lorundrostat for treating hypertension in combination with other blood pressure medications. The agency’s decision is scheduled for Dec. 22 under the Prescription Drug User Fee Act.
Mineralys held $624.7 million in cash, cash equivalents and investments at the end of September, down from $656.6 million at the end of 2025. Management expects those resources to fund operations, including a potential commercial launch, into 2028.
General and administrative expenses nearly quadrupled to $37.4 million from $9.7 million in the prior-year quarter, reflecting the company’s transition from late-stage clinical development toward potential commercialization.
The increase included $15.4 million in additional professional fees, $11.4 million in higher personnel-related expenses and $900,000 in other administrative costs.
Research and development expenses declined to $22.7 million from $31.5 million, primarily because Mineralys completed its pivotal lorundrostat clinical program in the second quarter of 2025.
The reduction included $8.5 million in lower preclinical and clinical costs and $300,000 in decreased manufacturing, regulatory, clinical supply and related spending.
Net other income fell to $2.8 million from $4.2 million. The decline reflected $3.2 million in additional interest expense associated with a senior secured term loan entered into in June 2026, partially offset by $1.8 million in higher investment interest income.
Mineralys has expanded its medical affairs organization and sales force while engaging physicians and health insurers ahead of the potential introduction of lorundrostat.
The company is also developing marketing programs and a patient support system intended to assist with treatment access and reimbursement.
“As we approach the December 22nd PDUFA target date for lorundrostat, our focus is on completing our launch preparations so that we are ready to reach patients quickly, pending approval,” Chief Executive Officer Jon Congleton stated.
The commercial investment follows clinical findings supporting lorundrostat’s potential use in patients whose blood pressure remains elevated despite treatment with multiple medications.
A new analysis of the pivotal Phase 3 Launch-HTN trial found that 46% of participants receiving a 50-milligram dose achieved a systolic blood pressure below 130 millimeters of mercury after 12 weeks, meeting the target recommended under American Heart Association and American College of Cardiology guidelines.
More than two-thirds of participants achieved a systolic blood pressure reduction of at least 10 millimeters of mercury.
The study included patients with uncontrolled or treatment-resistant hypertension who were already receiving between two and five blood pressure medications.
Additional analysis found that lorundrostat produced similar blood pressure reductions in participants with and without chronic kidney disease, including those with stages 1 through 3 of the condition.
The drug also reduced albuminuria, a measure of protein in the urine associated with kidney damage, by 52% compared with placebo. The result was consistent with findings from an earlier study involving patients with established chronic kidney disease.
Mineralys also reported final results from its Phase 2 Explore-OSA trial involving overweight or obese adults with moderate-to-severe obstructive sleep apnea and hypertension.
Participants receiving 50 milligrams of lorundrostat once daily in the evening experienced an average reduction in morning systolic blood pressure of 11.1 millimeters of mercury after four weeks, compared with a 1-millimeter reduction among placebo recipients.
The trial found no measurable improvement in the apnea-hypopnea index, which tracks the frequency of breathing interruptions during sleep.
Mineralys reported no serious safety events, including hyperkalemia, or elevated potassium levels, in the study.
The company also scheduled a presentation of longer-term efficacy and safety findings from its ongoing Transform-HTN open-label extension trial at the American Heart Association Scientific Sessions, held Nov. 6-9 in Chicago.
Lorundrostat is being developed to address hypertension associated with dysregulated aldosterone, a hormone involved in regulating blood pressure and fluid balance. Mineralys is also studying its potential relevance to related conditions, including chronic kidney disease and obstructive sleep apnea.
The company’s near-term financial and operational priorities are tied to the FDA’s December decision, which will determine whether lorundrostat can enter the U.S. market under the proposed indication.
With its commercial organization expanding and development expenses declining, Mineralys is directing a larger share of its spending toward preparing for that potential launch while maintaining funding for operations into 2028.
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