RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) ended the second quarter with $661.4 million in cash, cash equivalents and investments after raising equity and debt capital and spending $200 million to eliminate royalty obligations on lorundrostat, positioning the company to fund a potential U.S. launch of the hypertension drug and planned operations into 2028.
The FDA is reviewing Mineralys’ new drug application for lorundrostat in combination with other antihypertensive drugs, with a Prescription Drug User Fee Act target date of Dec. 22. Mineralys is preparing to launch the drug if approved.
The company completed a follow-on offering of about 5.66 million common shares during the quarter, generating approximately $150 million in gross proceeds. It also secured a senior secured term loan facility of up to $500 million from funds managed by Pharmakon Advisors LP and drew an initial $100 million tranche in June.
Mineralys simultaneously reworked its licensing arrangement with Tanabe, paying $200 million upfront to eliminate royalty obligations tied to lorundrostat. Tanabe also agreed to eventually assign Mineralys its rights in the licensed intellectual property.
The revised agreement leaves Mineralys with potential commercial milestone obligations to Tanabe of as much as $255 million, triggered by the first commercial sale and certain annual sales targets. Another $10 million could become payable for commercialization in a potential second indication.
The $200 million payment drove a sharp increase in second-quarter research and development expenses, which reached $221.4 million from $38.3 million a year earlier.
Excluding that payment, R&D costs were affected by higher personnel, clinical supply, manufacturing and regulatory expenses, partially offset by $17.8 million in lower preclinical and clinical costs following completion of lorundrostat’s pivotal program in the second quarter of 2025.
Mineralys recorded a second-quarter net loss of $241.1 million, compared with $43.3 million a year earlier.
General and administrative expenses rose to $24.7 million from $8.5 million, driven primarily by $8 million in higher professional fees and another $8 million in increased personnel-related expenses as the company added employees and increased compensation.
Other income, net, increased to $5 million from $3.5 million. Higher interest income from larger average cash balances was partly offset by $800,000 of interest and amortization expense associated with the new secured loan.
Mineralys had $661.4 million of cash, cash equivalents and investments at June 30, up from $656.6 million at the end of 2025. Management expects those resources to fund planned operations, including a potential lorundrostat launch, into 2028.
Preparations for commercialization are already underway. Mineralys has established a commercial leadership team, identified initial sales territories and priority markets, and is engaging with hypertension specialists and payers. The company expects its sales organization to be established before the December FDA decision date.
Lorundrostat is being developed for hypertension and other conditions associated with dysregulated aldosterone. Mineralys’ Transform-HTN open-label extension study continues to provide participants with the drug while generating additional long-term safety and efficacy data.
The company also appointed James J. “Terry” Ferguson III, M.D., as chief medical officer effective Aug. 10. Ferguson, whose cardiovascular drug-development experience includes roles at Amgen, AstraZeneca and The Medicines Company, will oversee medical and late-stage clinical activities.
David Rodman, M.D., who helped guide lorundrostat from proof of concept through its pivotal program and NDA filing, will remain with Mineralys as a full-time strategic advisor.
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