MLYS · Mineralys Therapeutics, Inc.

Mineralys Therapeutics reported first quarter 2026 financial results reflecting a strategic shift following the completion of its lorundrostat pivotal program in Q2 2025. Research and development expenses declined 36% year-over-year to $24.4 million, primarily from a $15.5 million reduction in preclinical and clinical costs, though partially offset by higher clinical supply, manufacturing, regulatory expenses ($1.1 million increase), and personnel costs ($0.8 million). This contributed to total operating expenses of $45.3 million, slightly above prior year, but a $6.0 million increase in other income, net from higher interest on elevated cash balances, drove net loss improvement to $39.3 million ($0.47 per share) from $42.2 million ($0.79 per share). CEO Jon Congleton highlighted progress toward lorundrostat approval, noting FDA acceptance of the NDA in Q1 2026 for hypertension treatment with other drugs, supported by five positive trials showing blood pressure reductions and favorable safety. The PDUFA target of December 22, 2026 positions the company for potential launch, with ongoing pre-commercial efforts including market access, medical advocacy, and sales preparation. Balance sheet remains robust with $646.1 million in cash, cash equivalents, and investments as of March 31, 2026 (down modestly from $656.6 million at year-end), funding operations into 2028. The Transform-HTN open-label extension continues gathering long-term data. These results underscore Mineralys' transition from clinical to commercial readiness while maintaining financial runway amid elevated G&A from headcount and professional fees supporting launch activities.