Mineralys Therapeutics, Inc.

What they do

Mineralys is developing lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor that inhibits CYP11B2, the enzyme responsible for producing aldosterone. The compound was licensed from Tanabe Pharma Corporation, which discovered it and ran Phase 1 development. The company is developing lorundrostat for hypertension and related comorbidities including chronic kidney disease (CKD) and obstructive sleep apnea (OSA). It has completed six clinical trials of lorundrostat and has no products approved for sale.

Revenue drivers

• Lorundrostat (pre-approval) — The company's only product candidate and sole potential source of revenue. It has not generated any revenue since inception and has no products approved for sale; the NDA for hypertension in combination with other antihypertensive drugs was submitted in December 2025 and accepted by the FDA.
• Hypertension indication — The lead indication, targeting third-line or later treatment of uncontrolled or resistant hypertension. The company cites approximately 120 million U.S. patients with hypertension, over 30 million not at BP goal, and dysregulated aldosterone as a key factor in roughly 30% of uHTN or rHTN patients.
• CKD and OSA expansion opportunities — Additional indications under study but not yet approved. Phase 2 Explore-CKD reduced UACR, a marker of kidney disease progression; the Phase 2 Explore-OSA trial did not show a reduction in apnea-hypopnea index, though BP reductions were described as clinically meaningful.

Recent performance

Mineralys reported a net loss of $154.7 million for 2025, narrower than the $177.8 million loss in 2024, with diluted EPS of $-2.29 versus $-3.66. Operating cash flow was $-142.4 million in 2025 versus $-166.3 million in 2024. As of June 30, 2026, total assets were $667.9 million, total liabilities $116.9 million, shareholder equity $550.9 million, and cash and equivalents $138.3 million. During the second quarter of 2026 the company raised approximately $150.0 million in gross proceeds from a follow-on offering of 5,660,378 shares and drew an initial $100.0 million tranche of a senior secured term loan facility of up to $500.0 million from funds managed by Pharmakon Advisors, LP.

Strategy

The company's stated priority is commercial launch preparation for lorundrostat ahead of the December 22, 2026 PDUFA target date, with an experienced commercial leadership team in place, initial sales territories and priority geographies identified, and engagement with hypertension experts and payers covering a substantial majority of U.S. lives. It expects to have the sales organization established in advance of the PDUFA date. It also continues the Transform-HTN open-label extension trial to generate long-term safety and efficacy data. In the second quarter of 2026 it amended the Tanabe license agreement to eliminate royalty obligations and entered a term loan facility, which it describes as strengthening its balance sheet and the long-term economics of lorundrostat. It appointed Dr. Terry Ferguson as Chief Medical Officer effective August 10, 2026, with David Rodman continuing as a full-time Strategic Advisor.

Risks

• No approved product or revenue — The company has no products approved for sale and has not generated any revenue since inception, so its prospects depend entirely on lorundrostat receiving FDA approval.
• Regulatory approval uncertainty — The NDA for lorundrostat is under FDA review with a PDUFA target action date of December 22, 2026, and the company notes the timing, volume, and nature of FDA feedback or requests could differ from expectations.
• Significant continuing losses — The company has incurred significant operating losses since inception, including net losses of $177.8 million in 2024 and $154.7 million in 2025, and expects significant losses for the foreseeable future.
• Indication and trial risk — The Phase 2 Explore-OSA trial did not demonstrate a reduction in apnea-hypopnea index, illustrating that lorundrostat may not succeed in indications beyond hypertension.

Outlook

Management states that lorundrostat commercial preparations are on track for launch upon approval, with the sales organization expected to be established before the December 22, 2026 PDUFA target date. The FDA continues its review of the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs. The company also continues the Transform-HTN open-label extension trial to generate additional long-term safety and efficacy data.