Want to see MLYS full AI Analyst Report?
Top Page
Mineralys Therapeutics, Inc.
(NASDAQ:MLYS)
Select Model
Select Model
Rating:62Neutral
Price Target:
$23.50
▼(-10.78% Downside)
Action:Reiterated
Date:09/09/26
The score is supported by strong technical trend signals and a generally positive earnings call centered on regulatory progress toward the December PDUFA date, launch readiness, and stated funding runway into 2028. These positives are weighed down by weak financial performance typical of a pre-revenue biotech—accelerating losses and ongoing negative free cash flow—and limited valuation support given the negative P/E and no dividend yield.
Positive Factors
Clinical efficacy
Meaningful and durable blood-pressure reductions, alongside improved albuminuria, support lorundrostat’s potential differentiation in uncontrolled hypertension and cardiorenal disease. These signals could broaden its clinical relevance and strengthen adoption if regulatory review confirms the observed benefits.
Negative Factors
Pre-revenue losses
Mineralys has no operating revenue to offset research, regulatory, and commercial spending, while losses have widened sharply. The business therefore remains dependent on successful development and eventual product approval, leaving earnings quality and profitability highly uncertain over the medium term.
Read all positive and negative factors
Positive Factors
Negative Factors
Clinical efficacy
Meaningful and durable blood-pressure reductions, alongside improved albuminuria, support lorundrostat’s potential differentiation in uncontrolled hypertension and cardiorenal disease. These signals could broaden its clinical relevance and strengthen adoption if regulatory review confirms the observed benefits.
Read all positive factors
Mineralys Therapeutics, Inc. (MLYS) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.97B
Dividend YieldN/A
Average Volume (3M)1.40M
Price to Earnings (P/E)―
Beta (1Y)1.30
Revenue GrowthN/A
EPS Growth-19.00%
CountryUS
Employees76
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-4.24
Shares Outstanding88,406,880
10 Day Avg. Volume1,447,981
30 Day Avg. Volume1,395,786
Financial Highlights & Ratios
PEG Ratio0.42
Price to Book (P/B)3.80
Price to Sales (P/S)0.00
P/FCF Ratio-17.24
Enterprise Value/Market Cap0.88
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-82.01K
Enterprise Value/Ebitda-4.93
Forecast
1Y Price Target
$47.86Price Target Upside81.69% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
EPS Forecast (FY)-4.49
Revenue Forecast (FY)N/A
Mineralys Therapeutics, Inc. Business Overview & Revenue Model
Company Description
Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on developing medicines to target diseases driven by abnormally elevated aldosterone. Its clinical-stage product candidate, lorundrostat, is a proprietary, o...
Mineralys Therapeutics, Inc. Earnings Call Summary
Earnings Call Date:Aug 11, 2026
(Q2-2026)
| % Change Since: |
Next Earnings Date:Nov 16, 2026
Earnings Call Sentiment Positive
The call emphasized strong clinical data, regulatory progress toward a December 22, 2026 PDUFA, significant commercial launch preparation, and strategic actions (royalty repurchase and financing) intended to enhance long-term value and provide runway into 2028. These positive, strategic developments were tempered by materially higher near‑term expenses and a widened quarterly net loss driven largely by a one-time $200 million upfront payment and increased commercial hiring and professional fees. Management framed the elevated costs as deliberate investments to support launch readiness and future value capture.Positive Updates
Robust Clinical Efficacy and Biomarker Signals
Pivotal and follow-on data (LAUNCH-HTN, ADVANCED-HTN, Transform HTN OLE and EXPLORER-CKD) show meaningful, durable blood pressure reductions; participants with baseline albuminuria achieved a 52% placebo-adjusted reduction in urine albumin-to-creatinine ratio (UACR). Proteomic data presented at ENDO 26 demonstrated significant reductions in multiple biomarkers of heart failure risk, supporting broader biological benefits beyond BP lowering.
Negative Updates
Substantial Increase in Quarterly Net Loss
Net loss for Q2 2026 was $241.1 million versus $43.3 million in Q2 2025, an increase of approximately +457%, driven primarily by the $200.0 million upfront payment related to the royalty repurchase and increased operating expenditures.
Read all updates
Q2-2026 Updates
Positive
Negative
Robust Clinical Efficacy and Biomarker Signals
Pivotal and follow-on data (LAUNCH-HTN, ADVANCED-HTN, Transform HTN OLE and EXPLORER-CKD) show meaningful, durable blood pressure reductions; participants with baseline albuminuria achieved a 52% placebo-adjusted reduction in urine albumin-to-creatinine ratio (UACR). Proteomic data presented at ENDO 26 demonstrated significant reductions in multiple biomarkers of heart failure risk, supporting broader biological benefits beyond BP lowering.
Read all positive updates
Company Guidance
Management reiterated near‑term regulatory and commercial guidance: a December PDUFA target date (with label/post‑approval discussions expected in Oct–Nov) and plans to staff the sales organization ahead of that date to target ~50,000 high‑volume prescribers, while payer engagement already covers the vast majority of U.S. covered lives and coverage is expected to progress through 2027 (Medicare access initially via medical exception). Financially, Mineralys reported $661.4M in cash, cash equivalents and investments as of 6/30/2026 (vs. $656.6M at 12/31/2025), said this runway should fund operations including launch into 2028, closed a $200M upfront royalty repurchase (plus up to $100M in milestones; aggregate potential payments cited as up to $205M), completed a $150M equity offering and secured a $500M committed senior secured term loan; Q2 results included R&D expense of $221.4M (vs. $38.3M YOY), G&A $24.7M (vs. $8.5M), other income $5.0M (vs. $3.5M), and a net loss of $241.1M (vs. $43.3M). Clinically and commercially, they highlighted a U.S. addressable population of ~20M adults with uncontrolled/resistant hypertension, LAUNCH‑HTN/EXPLORER data showing a 52% placebo‑adjusted reduction in UACR for albuminuric patients, a lorundrostat half‑life of ~10–12 hours, and said pricing will be finalized at approval and announced at/near launch.Mineralys Therapeutics, Inc. Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
58
Neutral
Cash Flow
24
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -21.00K | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| EBITDA | -349.54M | -154.59M | -177.77M | -71.90M | -28.12M | -19.38M |
| Net Income | -349.58M | -154.65M | -177.81M | -71.90M | -29.80M | -19.41M |
Balance Sheet | ||||||
| Total Assets | 667.85M | 661.81M | 205.90M | 251.64M | 114.44M | 11.13M |
| Cash, Cash Equivalents and Short-Term Investments | 661.41M | 656.63M | 198.19M | 236.57M | 110.11M | 10.61M |
| Total Debt | 97.62M | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Total Liabilities | 116.94M | 15.11M | 14.65M | 10.48M | 166.71M | 34.05M |
| Stockholders Equity | 550.92M | 646.69M | 191.26M | 241.15M | -52.27M | -22.93M |
Cash Flow | ||||||
| Free Cash Flow | -138.80M | -142.43M | -166.41M | -81.17M | -29.22M | -14.56M |
| Operating Cash Flow | -138.79M | -142.42M | -166.31M | -81.17M | -29.22M | -14.56M |
| Investing Cash Flow | -484.16M | -389.75M | 114.96M | -160.47M | -21.76M | 0.00 |
| Financing Cash Flow | 659.42M | 591.00M | 116.14M | 203.25M | 128.02M | 23.81M |
Mineralys Therapeutics, Inc. Technical Analysis
Negative
26.34
Price Trends
26.39
Negative
26.69
Negative
27.99
Negative
Market Momentum
-1.36
Positive
35.09
Neutral
27.00
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For MLYS, the sentiment is Negative. The current price of 26.34 is above the 20-day moving average (MA) of 25.37, below the 50-day MA of 26.39, and below the 200-day MA of 27.99, indicating a bearish trend. The MACD of -1.36 indicates Positive momentum. The RSI at 35.09 is Neutral, neither overbought nor oversold. The STOCH value of 27.00 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for MLYS.
Mineralys Therapeutics, Inc. Risk Analysis
Mineralys Therapeutics, Inc. disclosed 74 risk factors in its most recent earnings report. Mineralys Therapeutics, Inc. reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Mineralys Therapeutics, Inc. Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
75 Outperform | $1.55B | 4.40 | 30.03% | 7.39% | 18.17% | 693.83% | |
62 Neutral | $1.97B | -5.24 | -57.97% | ― | ― | -19.00% | |
52 Neutral | $1.71B | -7.89 | -16.91% | ― | ― | 1.47% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
49 Neutral | $1.51B | -2.62 | 392.35% | ― | 17.50% | -5.66% | |
47 Neutral | $804.88M | -14.31 | -36.00% | ― | 16.77% | 4.11% |
* Healthcare Sector Average
MLYS
Mineralys Therapeutics, Inc.
22.23
-20.82
-48.36%
INVA
Innoviva
21.45
4.51
26.62%
RARE
Ultragenyx Pharmaceutical
15.30
-16.72
-52.22%
ARDX
Ardelyx
3.23
-1.78
-35.53%
GPCR
Structure Therapeutics, Inc. Sponsored ADR
23.91
-6.28
-20.80%
KLRA
Kailera Therapeutics, Inc.
11.33
-14.67
-56.42%
Mineralys Therapeutics, Inc. Corporate Events
Business Operations and StrategyExecutive/Board ChangesFinancial DisclosuresPrivate Placements and Financing
Mineralys Therapeutics Appoints New Chief Medical Officer
Positive
Aug 11, 2026
Mineralys Therapeutics reported second-quarter 2026 results on August 11, 2026, highlighting progress toward the potential commercialization of its hypertension drug candidate lorundrostat. The company is preparing for a possible U.S. launch, with...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.