– Late-breaking presentation of Explore-CKD trial at ASN Kidney Week –

– Pivotal Phase 3 Launch-HTN trial featured in the “Best of JAMA and NEJM” session -

RADNOR, Pa., Nov. 07, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company developing therapies to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that clinical data for lorundrostat were presented at the American Society of Nephrology (ASN) Kidney Week 2025. Findings included a late-breaking oral presentation of the Phase 2 Explore-CKD trial and recognition of the pivotal Phase 3 Launch-HTN trial in the “ Best of the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine (NEJM)” session.

“The presentations at ASN Kidney Week demonstrated the breadth and strength of lorundrostat’s clinical program. As previously announced, the compelling results from multiple trials in this program have positioned us well for the planned filing of a New Drug Application to the FDA in the fourth quarter of 2025 or the first quarter of 2026,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “In Explore-CKD, lorundrostat reduced both blood pressure and albuminuria in participants with chronic kidney disease. We are pleased that the significant and consistent blood pressure reduction previously reported with lorundrostat in the Launch-HTN trial was selected for the “Best of JAMA” presentation at ASN’s Kidney Week 2025. With consistent benefits across blood pressure and kidney outcomes, lorundrostat is uniquely positioned to address the growing burden of cardio-renal-metabolic disease.”

Late-breaking presentation on the Explore-CKD trial (NCT06150924) of lorundrostat 25 mg once daily added to standard-of-care therapy, including sodium-glucose cotransporter-2 (SGLT2) inhibitors, demonstrated statistically significant and clinically meaningful reductions in blood pressure and albuminuria in participants with uncontrolled hypertension and CKD at four weeks of treatment. The trial met its primary endpoint, showing a reduction of 9.3 mmHg in automated office systolic blood pressure (AOSBP), and a placebo adjusted reduction of 7.5 mmHg (p-value=0.0024) at week four. Lorundrostat also achieved a reduction in spot urinary albumin-to-creatinine ratio (UACR), a marker of kidney protection, of 25.6% placebo-adjusted reduction (p=0.0015) at week four.

In Explore-CKD, lorundrostat demonstrated a favorable safety and tolerability profile. Serious adverse events occurred in two participants (3%) during lorundrostat treatment and none on placebo. Discontinuations due to treatment-emergent adverse events occurred in two participants (3%) during the lorundrostat treatment period and one participant (2%) during the placebo treatment period.

“These results are important because they show that lorundrostat, when added to standard-of-care therapy, reduced both blood pressure and proteinuria in patients with hypertension and chronic kidney disease,” said Dr. Matthew Weir, Director of the Division of Nephrology at the University of Maryland Medical Center, Professor of Medicine at the University of Maryland School of Medicine, and a scientific consultant to Mineralys Therapeutics. “The parallel reductions in systolic blood pressure and albuminuria underscore the potential of lorundrostat to improve cardio-renal outcomes in this high-risk population.”

In addition, the pivotal Phase 3 Launch-HTN trial was recognized in ASN’s “Best of JAMA and NEJM” session following publication earlier this year in JAMA . Lorundrostat demonstrated a statistically significant 16.9 mmHg absolute reduction in systolic blood pressure (SBP) at week 6 (9.1 mmHg placebo-adjusted, p<0.0001) and a 19 mmHg reduction in SBP at week 12 (11.6 mmHg placebo-adjusted, p<0.0001) in participants with uncontrolled and resistant hypertension, with a blood pressure-lowering effect observed as early as 2 weeks.

“Across trials, lorundrostat showed efficacy in diverse and difficult-to-treat patient groups, including those with confirmed uncontrolled and resistant hypertension, chronic kidney disease, obesity, and in Black or African American participants. Launch-HTN results demonstrated that lorundrostat lowers blood pressure with a persistent, clinically meaningful benefit a full 24-hours following administration,” said Dr. Manish Saxena, MBBS, Hypertension Specialist and Clinical Co-Director at William Harvey Heart Centre, Barts Health NHS Trust and QMUL. “Taken together with Advance-HTN and Explore-CKD, these results show lorundrostat has broad clinical potential across some of the most challenging patient populations.”

Lorundrostat continues to be evaluated in the ongoing Transform-HTN open-label extension study, which is assessing long-term safety and durability of response. The Company also completed enrollment in Explore-OSA, the first trial to evaluate lorundrostat in participants with hypertension and moderate-to-severe obstructive sleep apnea (OSA). Lorundrostat is the only ASI being studied to address both apnea-hypopnea index (AHI) and nighttime systolic blood pressure in this population, with data anticipated in the first quarter of 2026.

About Explore-CKD

The Explore-CKD trial (NCT06150924) was a randomized, double-blind, placebo-controlled, two-period, two-sequence (2x2) crossover trial. This Phase 2 trial was designed to evaluate BP reduction and safety of 25 mg QD lorundrostat when added to background treatment with an ACEi or ARB and an SGLT2 inhibitor for the treatment of hypertension in subjects with CKD subjects with an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 and albuminuria (UACR of 200-5,000 mg/g). The primary efficacy endpoint of the trial was change from baseline in systolic BP at week four in the active versus placebo treatment period. Exploratory endpoints included change from baseline in UACR and eGFR at week four in the active versus placebo treatment period.

About Chronic Kidney Disease (CKD)

CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than 10% of the global population and is one of the leading causes of mortality worldwide. According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 1-in-7 (approximately 37 million) U.S. adults have CKD, and approximately 22 million people in the United States are living with both hypertension and CKD. The relationship between these conditions is tightly linked: sustained hypertension may contribute to impaired kidney function, and progressive decrease in kidney function may lead to worsening BP control. When CKD is present in patients with hypertension, the risk of cardiovascular disease and mortality rises significantly.

Emerging evidence points to dysregulated aldosterone as a key driver of both diseases. Excess aldosterone promotes sodium retention, vascular inflammation, and fibrosis, contributing to both uncontrolled BP and kidney injury. Despite the availability of existing therapies, a significant proportion of patients remain uncontrolled or undertreated. Early detection and targeted interventions that address underlying mechanisms, such as aldosterone dysregulation, may offer the potential to slow CKD progression, reduce cardiovascular risk, and improve long-term outcomes. Without effective management, CKD can advance to kidney failure, requiring dialysis or transplantation.

About Launch-HTN

Launch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic blood pressure at six weeks versus placebo, measured by automated office blood pressure monitoring.

About Hypertension

Having sustained, elevated blood pressure (or hypertension) (BP) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019.

Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients.

About Lorundrostat

Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants.

The Company has now completed four successful clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The Company has completed two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile.

About Mineralys

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com . Follow Mineralys on LinkedIn , Twitter and Bluesky .

Forward Looking Statements

Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the anticipated timing of NDA submission and the FDA’s review of the same; the Company’s ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of participants in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; any delays in the FDA’s review of our planned NDA submission, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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