Mineralys Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and investments totaled $624.7 million as of September 30, 2026, a decrease from $656.6 million as of December 31, 2025.
• Research and development expenses were $22.7 million for the quarter ended September 30, 2026, compared to $31.5 million in the same period of 2025, a decrease primarily driven by the conclusion of the pivotal program and reduced clinical supply costs.
• General and administrative expenses were $37.4 million for the quarter ended September 30, 2026, compared to $9.7 million in the same period of 2025, an increase attributed to expanded commercialization preparations, including $15.4 million in higher professional fees and $11.4 million in increased personnel expenses.
• Total other income, net was $2.8 million for the quarter ended September 30, 2026, compared to $4.2 million in the same period of 2025, reflecting $3.2 million in increased interest expense from a senior secured term loan entered into in June 2026, partially offset by higher interest earned on investments.
• Net loss was $57.3 million for the quarter ended September 30, 2026, compared to $36.9 million in the same period of 2025.
• Net loss per share (basic and diluted) was $0.64 for the quarter ended September 30, 2026, compared to $0.52 in the same period of 2025.
• Senior secured term loan, net, was $98.3 million as of September 30, 2026, compared to $0 as of December 31, 2025.
• Total liabilities were $126.3 million as of September 30, 2026, compared to $15.1 million as of December 31, 2025.
• Total stockholders' equity was $503.8 million as of September 30, 2026, compared to $646.7 million as of December 31, 2025.

Guidance and Future Outlook:

• The company believes its current cash, cash equivalents, and investments will be sufficient to fund planned operations, including the commercial launch of lorundrostat, into 2028.
• The Prescription Drug User Fee Act (PDUFA) target date for the lorundrostat New Drug Application (NDA) is December 22, 2026.
• Commercial launch preparations are on track, with the company advancing readiness to reach patients quickly pending approval.

Business Segments and Product Lines:

• Lorundrostat is an investigational, orally administered, highly selective aldosterone synthase inhibitor being developed for uncontrolled hypertension, resistant hypertension, and comorbidities including chronic kidney disease and obstructive sleep apnea.
• New analyses from the pivotal Phase 3 Launch-HTN trial showed that 46% of participants with uncontrolled or resistant hypertension receiving lorundrostat 50 mg achieved the AHA/ACC guideline systolic blood pressure target of <130 mmHg at Week 12.
• In the Launch-HTN trial, more than two-thirds of participants achieved a systolic blood pressure reduction of ≥10 mmHg.
• Lorundrostat demonstrated similar blood pressure reductions in participants with and without chronic kidney disease, with consistent reductions across Stages 1-3 CKD, and reduced albuminuria by 52% versus placebo.
• Final results from the Phase 2 Explore-OSA trial showed that lorundrostat 50 mg reduced morning systolic blood pressure by 11.1 mmHg at Week 4 compared to a 1.0 mmHg reduction with placebo.
• The company has expanded its medical affairs team and sales force in preparation for commercialization.
• Brand marketing preparations are underway, and the company is finalizing a full-service patient support program.

Market and Competitive Landscape:

• Approximately 20 million adults in the U.S. live with uncontrolled or resistant hypertension despite treatment.
• The company is engaging with leading hypertension experts and payers regarding the potential launch of lorundrostat.
• Positive feedback has been received from providers, payers, and patients regarding the potential of lorundrostat.

Risks and Challenges:

• Actual results may differ from forward-looking statements due to risks including delays in FDA review, potential insufficiency of clinical trial results for regulatory approval, and failure to meet conditions for future funding under the secured debt facility.
• The company's future performance is dependent entirely on the success of lorundrostat.
• Risks include potential delays in clinical trials, dependence on third parties for manufacturing and testing, unexpected adverse side effects, unfavorable macroeconomic trends, and regulatory developments.

Management Commentary and Tone:

• Jon Congleton, Chief Executive Officer, stated that the company's focus is on completing launch preparations to reach patients quickly pending approval.
• Management highlighted the significant need for new treatment options for uncontrolled or resistant hypertension.
• The company continues to present data at scientific congresses, including recent updates at AHA-HTN and ASN Kidney Week, and an upcoming presentation at the AHA Scientific Sessions.

Other Key Points:

• The company entered into a senior secured term loan in June 2026.
• New long-term efficacy and safety data from the Transform-HTN open-label extension trial will be presented at the American Heart Association Scientific Sessions 2026.
• A conference call regarding these results was held on November 4, 2026, at 4:30 p.m. ET.