Mineralys Therapeutics, Inc. (MLYS)
NASDAQ:MLYS
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Mineralys Therapeutics, Inc.
(NASDAQ:MLYS)
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Rating:57Neutral
Price Target:
$28.00
▲(2.49% Upside)
Action:ReiteratedDate:04/01/26
The score is driven primarily by weak current fundamentals (no revenue and ongoing cash burn) tempered by a strong, debt-free balance sheet and a constructive earnings update highlighting NDA acceptance, a defined PDUFA timeline, and substantial cash runway. Technical signals and valuation metrics provide limited additional support.
Positive Factors
Regulatory milestone — NDA acceptance
Official FDA acceptance and a fixed PDUFA date materially reduce regulatory timing uncertainty and create a clear near-term binary for clinical-stage value realization. This structural clarity enables concrete commercialization planning, partner negotiations, and payer engagement ahead of a potential approval.
Negative Factors
No commercial revenue and ongoing cash burn
As a pre‑commercial biotech, Mineralys generates no product revenue and records growing net losses and negative operating cash flow. Continued cash burn demands either successful approval and uptake or fresh capital; adverse market conditions or delayed approval could force dilutive funding before sustainable revenue emerges.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory milestone — NDA acceptance
Official FDA acceptance and a fixed PDUFA date materially reduce regulatory timing uncertainty and create a clear near-term binary for clinical-stage value realization. This structural clarity enables concrete commercialization planning, partner negotiations, and payer engagement ahead of a potential approval.
Read all positive factors
Mineralys Therapeutics, Inc. (MLYS) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$2.51B
Dividend YieldN/A
Average Volume (3M)1.34M
Price to Earnings (P/E)―
Beta (1Y)1.23
Revenue GrowthN/A
EPS Growth9.60%
CountryUS
Employees51
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.40
Shares Outstanding82,399,475
10 Day Avg. Volume1,235,103
30 Day Avg. Volume1,337,016
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 Cap0.74
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-31.25K
Enterprise Value/Ebitda-11.08
Forecast
1Y Price Target
$52.67Price Target Upside92.79% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering6
EPS Forecast (FY)-2.23
Revenue Forecast (FY)$3.30M
Mineralys Therapeutics, Inc. Business Overview & Revenue Model
Company Description
Mineralys Therapeutics, Inc., a clinical-stage biopharmaceutical company that develops therapies for the treatment of hypertension and associated cardiovascular diseases. It clinical-stage product candidate is lorundrostat, a proprietary, orally a...
How the Company Makes Money
As a clinical-stage biopharmaceutical company, Mineralys does not have publicly established recurring revenue from product sales unless otherwise disclosed; accordingly, detailed ongoing operating revenue streams are null. The company’s funding an...
Mineralys Therapeutics, Inc. Earnings Call Summary
Earnings Call Date:Mar 12, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 18, 2026
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.Positive Updates
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.
Negative Updates
EXPLORER-OSA Missed Primary Endpoint (AHI)
The EXPLORER-OSA trial did not meet its primary endpoint of change in apnea-hypopnea index (AHI) at four weeks, limiting potential regulatory claims for OSA despite meaningful blood pressure reductions observed in the study population.
Read all updates
Q4-2025 Updates
Positive
Negative
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.
Read all positive updates
Company Guidance
The company reiterated that the FDA has accepted the lorundrostat NDA and set a PDUFA target action date of December 22, 2026, following a five‑trial clinical program (LAUNCH‑HTN, ADVANCE‑HTN, EXPLORER‑CKD, TRANSFORM‑HTN and EXPLORER‑OSA) that showed consistent 24‑hour blood pressure control and meaningful BP reductions; in the 48‑patient EXPLORER‑OSA trial (mean BMI 38, mean AHI 48, baseline systolic BP 142 mmHg) lorundrostat reduced BP by 11.1 mmHg vs 1.0 mmHg for placebo at four weeks (6.2 mmHg placebo‑adjusted in crossover analysis) with no potassium >5.5 mmol/L. Management emphasized a launch focus in third‑line+ / resistant (and initial fourth‑line) hypertension prescribers (roughly 60,000 physicians responsible for ~50% of third‑line+ scripts), noted the large U.S. unmet need (~20 million patients, ~700,000 deaths/year; ~30% with aldosterone dysregulation), and said payer engagement (pre‑approval PIEs), expanded medical affairs/MSL coverage, publications and meeting activity are underway to support market access. Financially, Mineralys ended 12/31/2025 with $656.6M in cash, cash equivalents and investments (vs $198.2M a year earlier) and expects funding into 2028; 2025 R&D was $132.0M (Q4 $24.4M) vs $168.6M in 2024, G&A was $38.6M (Q4 $13.9M) vs $23.8M in 2024, other income was $16.0M, and net loss narrowed to $154.7M in 2025 (Q4 loss $32.2M) from $177.8M in 2024.Mineralys Therapeutics, Inc. Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
74
Positive
Cash Flow
18
Very Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -59.00K | -43.00K | 0.00 | 0.00 | 0.00 |
| EBITDA | -170.60M | -192.36M | -84.66M | -31.48M | -19.38M |
| Net Income | -154.65M | -177.81M | -71.90M | -29.80M | -19.41M |
Balance Sheet | |||||
| Total Assets | 661.81M | 205.90M | 251.64M | 114.44M | 11.13M |
| Cash, Cash Equivalents and Short-Term Investments | 656.63M | 198.19M | 236.57M | 110.11M | 10.61M |
| Total Debt | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Total Liabilities | 15.11M | 14.65M | 10.48M | 166.71M | 34.05M |
| Stockholders Equity | 646.69M | 191.26M | 241.15M | -52.27M | -22.93M |
Cash Flow | |||||
| Free Cash Flow | -142.43M | -166.41M | -81.17M | -29.22M | -14.56M |
| Operating Cash Flow | -142.42M | -166.31M | -81.17M | -29.22M | -14.56M |
| Investing Cash Flow | -389.75M | 114.96M | -160.47M | -21.76M | 0.00 |
| Financing Cash Flow | 591.00M | 116.14M | 203.25M | 128.02M | 23.81M |
Mineralys Therapeutics, Inc. Technical Analysis
Positive
27.32
Price Trends
27.42
Negative
31.97
Negative
30.06
Negative
Market Momentum
0.06
Negative
53.12
Neutral
49.08
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For MLYS, the sentiment is Positive. The current price of 27.32 is above the 20-day moving average (MA) of 25.56, below the 50-day MA of 27.42, and below the 200-day MA of 30.06, indicating a neutral trend. The MACD of 0.06 indicates Negative momentum. The RSI at 53.12 is Neutral, neither overbought nor oversold. The STOCH value of 49.08 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for MLYS.
Mineralys Therapeutics, Inc. Risk Analysis
Mineralys Therapeutics, Inc. disclosed 72 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 |
|---|---|---|---|---|---|---|---|
66 Neutral | $5.91B | -17.18 | -50.66% | ― | 117.83% | -18.91% | |
58 Neutral | $5.62B | -10.27 | -55.81% | ― | ― | -38.30% | |
57 Neutral | $2.51B | -22.67 | -32.94% | ― | ― | 9.60% | |
56 Neutral | $5.22B | 141.40 | 8.20% | ― | 42.11% | ― | |
55 Neutral | $3.91B | -19.69 | -28.29% | ― | ― | ― | |
52 Neutral | $4.10B | -6.36 | -48.04% | ― | ― | -126.16% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% |
* Healthcare Sector Average
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Mineralys Therapeutics, Inc. Corporate Events
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Mineralys Reports Mixed Phase 2 Results for Lorundrostat
Positive
Mar 9, 2026
On March 6, 2026, Mineralys Therapeutics received U.S. Food and Drug Administration acceptance of its New Drug Application for lorundrostat to treat adult patients with hypertension in combination with other antihypertensive drugs, with a target a...
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.