Mineralys Therapeutics, Inc. (MLYS)
NASDAQ:MLYS
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Earnings Data
Report Date
Aug 18, 2026After Close (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
-0.55Last Year’s EPS
-0.66Same Quarter Last Year
Strong Buy
Based on 8 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed strong positive progress on the clinical and regulatory front with NDA acceptance and a clear PDUFA date, supported by a broad dataset and active prelaunch preparations. Financially, the company retains a substantial cash balance with runway into 2028 and showed reduced R&D spend following completion of pivotal work. Offsetting risks include a sizeable increase in G&A/prelaunch costs, continued quarterly net losses, competitive timing and pricing pressure from AstraZeneca’s expected earlier launch, and unresolved partnering and labeling/pricing uncertainties. On balance, the company appears well positioned operationally and clinically, but near-term commercial and financial execution risks remain.Company Guidance
NDA Acceptance and Clear Regulatory Timeline
FDA accepted the NDA for lorundrostat for treatment of adult patients with hypertension in combination with other antihypertensives and assigned a PDUFA target date of December 22, 2026 — a major regulatory milestone moving the company closer to a potential U.S. launch.
Robust Supporting Clinical Data Package
NDA supported by five trials (Launch HTN, Advance HTN, TRANSFORM HTN OLE, TARGET HTN, EXPLORE CKD) demonstrating clinically meaningful and durable blood pressure reductions, tolerability across diverse populations, and signals relevant to comorbid populations (e.g., proteinuria in CKD).
Commercial Readiness and Market Engagement
Company is actively preparing for commercial launch: early market access planning, payer engagement, physician advocacy, publications, scientific meeting participation, expansion of MSL field team, and sales/marketing capability build-out to position lorundrostat for fourth-line (and potentially third-line) use.
Cash Position and Runway
Cash, cash equivalents and investments of $646.1M as of March 31, 2026 (down from $656.6M at 12/31/25), with management stating cash is expected to fund planned activities and operations into 2028 (cash decline of approximately -$10.5M, or -1.6%).
Reduced R&D Spend Following Pivotal Program Completion
R&D expenses for Q1 2026 were $24.4M versus $37.9M in Q1 2025, a decrease of about -35.6%, primarily driven by a reduction in preclinical/clinical costs after completion of the lorundrostat pivotal program.
Improved Net Loss and Higher Investment Income
Net loss narrowed to $39.3M in Q1 2026 from $42.2M in Q1 2025 (an improvement of ~6.9%). Total other income, net, increased to $6.0M from $2.2M (up ~172.7%) reflecting higher interest earned on invested cash balances.
Large Addressable Unmet Need and Positive Payer/Prescriber Feedback
Management cites over 20 million U.S. patients with uncontrolled or resistant hypertension; market research and payer discussions indicate willingness to provide coverage in the fourth-line setting and prescriber receptivity to a novel ASI with strong magnitude/consistency of BP reduction.
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 |
|---|---|---|---|
May 06, 2026 | $30.12 | $29.35 | -2.56% |
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% |
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 Aug 18, 2026, After Close (Confirmed).
What is Mineralys Therapeutics, Inc. (MLYS) earnings time?
Mineralys Therapeutics, Inc. (MLYS) earnings time is at Aug 18, 2026, After Close (Confirmed).
Where can I see when companies are reporting earnings?
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What companies are reporting earnings today?
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What is MLYS EPS forecast?
MLYS EPS forecast for the fiscal quarter 2026 (Q2) is -0.55.