Mineralys Therapeutics, Inc. (MLYS)
NASDAQ:MLYS
Earnings Data
Report Date
May 18, 2026After Close (Confirmed)
Period Ending
2026 (Q1)Consensus EPS Forecast
-0.48Last Year’s EPS
-0.79Same Quarter Last Year
Strong Buy
Based on 6 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed substantial progress: regulatory advancement with FDA NDA acceptance and a PDUFA date, a comprehensive positive clinical dataset for hypertension, strong cash reserves (cash runway into 2028), and reduced net loss and R&D spend following completion of the pivotal program. Notable concerns included missing the EXPLORER-OSA primary endpoint, small exploratory trial limitations, increased G&A tied to commercialization build, competition potentially launching earlier, and remaining uncertainty around partnership timing and international strategy. On balance, the favorable regulatory milestone, robust liquidity, and strong trial results outweigh the identified challenges, while management is actively preparing market access and commercialization efforts.Company Guidance
FDA Acceptance of NDA and PDUFA Date Set
The FDA accepted the NDA for lorundrostat for treatment of adult patients with hypertension in combination with other antihypertensive drugs and assigned a PDUFA target action date of December 22, 2026, advancing regulatory clarity and near-term commercialization planning.
Comprehensive Positive Clinical Program
Completed five positive clinical trials (including pivotal LAUNCH-HTN and ADVANCE-HTN, EXPLORER-CKD, and TRANSFORM-HTN open-label extension) demonstrating clinically meaningful blood pressure reduction, 24-hour control, and a favorable safety profile across diverse populations, supporting differentiated value of targeting aldosterone.
EXPLORER-OSA Blood Pressure Findings and Safety
In the 48-participant EXPLORER-OSA exploratory trial, lorundrostat showed clinically meaningful blood pressure reductions: 11.1 mmHg reduction (lorundrostat) vs 1.0 mmHg (placebo) at four weeks in the pre-planned parallel-arm analysis, and a 6.2 mmHg placebo-adjusted reduction in crossover analysis. Safety was favorable with no serum potassium excursions above 5.5 mmol/L.
Strong Liquidity Position
Cash, cash equivalents, and investments were $656.6 million as of 12/31/2025 versus $198.2 million as of 12/31/2024, representing a ~231.3% increase year-over-year. Management expects this liquidity to fund planned clinical trials and regulatory activities and support operations into 2028.
Reduced R&D Spend Following Pivotal Program Completion
Full-year R&D expense decreased to $132.0 million in 2025 from $168.6 million in 2024 (a decline of ~$36.6 million, ~21.7% year-over-year), driven mainly by a $49.3 million reduction in preclinical and clinical costs after concluding lorundrostat's pivotal program. Quarter-over-quarter R&D also declined to $24.4 million from $44.6 million (≈45.3% reduction).
Improvement in Net Loss
Net loss narrowed to $154.7 million for the year ended 12/31/2025 from $177.8 million in 2024 (a reduction of ~$23.1 million, ~13.0% year-over-year). Quarterly net loss improved to $32.2 million versus $48.9 million in the prior-year quarter (~34.1% improvement).
Increased Other Income from Higher Cash Balances
Total other income, net, rose to $16.0 million for the year (from $14.6 million in 2024, ~9.6% increase) and to $6.0 million for the quarter (from $2.8 million in the prior-year quarter, ~114.3% increase), driven by higher interest earned on investments and money market funds as cash balances grew.
Proactive Commercial and Market Access Preparation
Company initiated payer engagement, market access planning, expanded medical communications and MSL headcount, and pre-approval information exchange (PIE) conversations with payers to support a targeted launch in third-line/resistant hypertension and drive rapid uptake if approved.
MLYS Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
MLYS Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
Mar 12, 2026 | $26.99 | $26.19 | -2.96% |
Nov 10, 2025 | $44.50 | $47.11 | +5.87% |
Aug 12, 2025 | $13.51 | $13.56 | +0.37% |
May 12, 2025 | $15.01 | $15.19 | +1.20% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Mineralys Therapeutics, Inc. (MLYS) report earnings?
Mineralys Therapeutics, Inc. (MLYS) is schdueled to report earning on May 18, 2026, After Close (Confirmed).
What is Mineralys Therapeutics, Inc. (MLYS) earnings time?
Mineralys Therapeutics, Inc. (MLYS) earnings time is at May 18, 2026, After Close (Confirmed).
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What is MLYS EPS forecast?
MLYS EPS forecast for the fiscal quarter 2026 (Q1) is -0.48.