Mineralys Therapeutics, Inc. (NASDAQ: MLYS) Q2 2025 Earnings | 08/13/2025

7 days ago

47:24

Inside Ticker

Earnings Calls

AI Summary

Key Business Updates:

Clinical Progress & Milestones:
- Positive pivotal data from LaunchHTN and AdvanceHTN trials for lorundrostat (ASI for hypertension) were published in top journals (NEJM, JAMA).
- Survey Results: 95% of physicians indicated they would prescribe lorundrostat for uncontrolled/resistant hypertension (3rd-line+).
- EXPLORE-CKD Trial: Demonstrated significant blood pressure reduction and UACR (urinary albumin-to-creatinine ratio) improvement in CKD patients on SGLT2 inhibitors.
- EXPLORE-OSA Trial: Evaluating lorundrostat’s effect on obstructive sleep apnea (AHI reduction & nighttime BP control); top-line data expected H1 2026.
Regulatory & Commercialization:
- Pre-NDA meeting with FDA scheduled for Q4 2025.
- Focus on market access, payer strategies, and medical communications (publications, conferences, MSLs).
- Partnering discussions ongoing (U.S. and ex-U.S.), aiming to maximize reach and commercial potential.
Financials (Q2 2025):
- Cash Position: $324.9M (vs. $198.2M at YE 2024), sufficient to fund operations into 2027.
- R&D Expenses: $38.3M (down from $39.3M YoY due to completion of pivotal trials).
- G&A Expenses: $8.5M (up from $5.9M YoY due to headcount growth).
- Net Loss: $43.3M (vs. $41M YoY).

Key Questions & Answers:

Competition (AstraZeneca’s Baxdrostat): Awaiting ESC data, but Mineralys emphasized lorundrostat’s selectivity, half-life, and robust clinical profile across four trials.
Safety (Hyperkalemia): Low rates (0.6% >6 mmol/L in trials), manageable with monitoring.
Commercial Strategy: Targeting ~50K high-prescribing cardiologists/PCPs; no expected step-through spironolactone requirement from payers.
Future Indications: Potential in CKD, OSA, heart failure, and primary aldosteronism; fixed-dose combinations under consideration.

Closing Remarks:
Mineralys highlighted strong clinical differentiation, upcoming regulatory milestones, and confidence in lorundrostat’s potential to address unmet needs in hypertension and related conditions.

About this video

Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on hypertension and related comorbidities, reported its second quarter 2025 financial results and provided a corporate update. The company achieved positive results from three pivotal clinical trials, including Launch-HTN and Advance-HTN, with findings published in JAMA and NEJM. Its Explore-CKD Phase 2 trial showed statistically significant reductions in systolic blood pressure (7.5 mmHg placebo-adjusted) and urinary albumin-to-creatinine ratio (25.6% placebo-adjusted), demonstrating both efficacy and a favorable safety profile. The Explore-OSA Phase 2 trial in obstructive sleep apnea patients with hypertension is ongoing, with topline results expected in the first half of 2026. A pre-NDA meeting with the FDA is scheduled for Q4 2025. Financially, Mineralys reported a net loss of $43.3 million for the quarter ended June 30, 2025, compared to $41.0 million for the same period in 2024. Research and development expenses were $38.3 million, slightly lower than last year due to the completion of pivotal programs, while general and administrative expenses increased to $8.5 million, driven by higher compensation and professional fees. The company ended Q2 2025 with a strong cash position of $324.9 million in cash, cash equivalents, and investments, providing a runway into 2027. Key growth drivers include the advancing clinical program for lorundrostat targeting hypertension, ongoing trials exploring chronic kidney disease and sleep apnea indications, and a strategic focus on regulatory milestones and market readiness. Despite increased G&A expenses and a higher net loss, the company's solid balance sheet supports continued development and regulatory engagement. Risks include the inherent uncertainties in clinical development, regulatory approvals, and market competition. About Inside Ticker: Inside Ticker delivers timely, in-depth financial news and earnings analysis to empower investors with actionable insights on global companies across sectors. For comprehensive video analysis and real-time updates, visit https://www.insideticker.com/. Hashtags: #MineralysTherapeutics #MLYS #Q22025 #Earnings #FinancialResults #NetLoss #RandD #Hypertension #Lorundrostat #ClinicalTrials #LaunchHTN #AdvanceHTN #ExploreCKD #ExploreOSA #BloodPressure #KidneyDisease #ObstructiveSleepApnea #FDA #PreNDA #CashPosition #InvestorRelations #Biopharma #DrugDevelopment #Cardiorenal #ClinicalProgress #RegulatoryMilestone #2027Runway #ResearchAndDevelopment #GeneralAndAdministrative #QuarterlyResults #EarningsReport #Nasdaq #HealthcareInnovation #MedicalResearch #PipelineDevelopment #StrategicUpdate #MarketReadiness

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