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Mineralys Therapeutics, Inc.
(NASDAQ:MLYS)
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Rating:55Neutral
Price Target:
$29.00
▼(-5.17% Downside)
Action:Reiterated
Date:06/04/26
The score is held back primarily by weak financial performance (no revenue, large losses and continued cash burn) and a weak price trend versus major moving averages. Offsetting this are meaningful near-term fundamentals from the earnings call (NDA acceptance with a clear PDUFA timeline and runway into 2028) and supportive, though dilutionary, financing to fund upcoming milestones.
Positive Factors
Regulatory Milestone
NDA acceptance with a defined PDUFA date materially reduces the regulatory timing uncertainty that typically plagues clinical‑stage biotechs. This milestone permits focused resource allocation for label negotiation, launch planning, and partner decisions over the next 6–18 months, improving strategic clarity and de‑risking near‑term development cadence.
Negative Factors
Persistent Cash Burn
Sustained large operating and free cash outflows indicate the company remains dependent on external capital to fund operations. Over the next 2–3 years, continued negative FCF increases the probability of dilution or debt draws, constraining strategic optionality and elevating financing risk as commercialization investments accelerate.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory Milestone
NDA acceptance with a defined PDUFA date materially reduces the regulatory timing uncertainty that typically plagues clinical‑stage biotechs. This milestone permits focused resource allocation for label negotiation, launch planning, and partner decisions over the next 6–18 months, improving strategic clarity and de‑risking near‑term development cadence.
Read all positive factors
Mineralys Therapeutics, Inc. (MLYS) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$2.50B
Dividend YieldN/A
Average Volume (3M)1.95M
Price to Earnings (P/E)―
Beta (1Y)1.34
Revenue GrowthN/A
EPS Growth44.87%
CountryUS
Employees76
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-2.05
Shares Outstanding88,158,480
10 Day Avg. Volume1,164,085
30 Day Avg. Volume1,945,399
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 Cap0.62
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-73.96K
Enterprise Value/Ebitda-10.24
Forecast
1Y Price Target
$50.40Price Target Upside64.81% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
EPS Forecast (FY)-2.32
Revenue Forecast (FY)N/A
Mineralys Therapeutics, Inc. Business Overview & Revenue Model
Company Description
Mineralys Therapeutics, Inc. (MLYS) is a pioneering biopharmaceutical company currently advancing through clinical trials. Its primary focus lies in creating innovative treatments for high blood pressure and its related cardiovascular complication...
How the Company Makes Money
As a clinical-stage biopharmaceutical company, Mineralys does not have marketed products and therefore does not generate product sales revenue; its operations have primarily been funded through capital raising (e.g., equity financings such as its ...
Mineralys Therapeutics, Inc. Earnings Call Summary
Earnings Call Date:May 06, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 18, 2026
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.Positive Updates
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.
Negative Updates
Significant Increase in G&A Expenses
G&A expenses rose to $21.0M in Q1 2026 from $6.6M in Q1 2025, an increase of approximately +218.2%, driven by higher professional fees ($7.9M), increased personnel-related expenses (+$6.1M) and other general administrative costs — reflecting elevated prelaunch spending.
Read all updates
Q1-2026 Updates
Positive
Negative
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.
Read all positive updates
Company Guidance
On the call Mineralys said the FDA accepted the lorundrostat NDA in Q1 2026 with a PDUFA target date of December 22, 2026, supported by five trials (Launch HTN, Advance HTN, TRANSFORM HTN OLE, TARGET HTN, EXPLORE CKD) demonstrating durable, well‑tolerated blood‑pressure reductions (e.g., ~19 mmHg systolic in Launch) across diverse populations (Black/African‑American representation ~28% to >50%), addressing >20 million U.S. patients with uncontrolled/resistant hypertension and ~8.8M third‑line‑or‑later patient turnover (IQVIA 2024); financially, cash, cash equivalents and investments were $646.1M as of March 31, 2026 (down from $656.6M at 12/31/25) and management said this funding should be sufficient to support planned trials, regulatory activities and operations into 2028; Q1 results included R&D expense $24.4M (Q1’25: $37.9M; driven by a $15.5M reduction in preclinical/clinical costs), G&A $21.0M (Q1’25: $6.6M; including $7.9M higher professional fees and $6.1M higher personnel costs), total other income, net $6.0M (Q1’25: $2.2M) and net loss $39.3M (Q1’25: $42.2M); operational guidance focused on pre‑launch readiness—early market access and payer engagement, expanding sales/marketing and MSL teams—continuing evaluation of partnering opportunities, and plans to publish long‑term OLE/120‑day safety data.Mineralys Therapeutics, Inc. Financial Statement Overview
Summary
Income Statement
18
Very Negative
Balance Sheet
72
Positive
Cash Flow
29
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 | -151.73M | -154.59M | -177.77M | -71.90M | -28.12M | -19.38M |
| Net Income | -151.78M | -154.65M | -177.81M | -71.90M | -29.80M | -19.41M |
Balance Sheet | ||||||
| Total Assets | 652.86M | 661.81M | 205.90M | 251.64M | 114.44M | 11.13M |
| Cash, Cash Equivalents and Short-Term Investments | 646.06M | 656.63M | 198.19M | 236.57M | 110.11M | 10.61M |
| Total Debt | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Total Liabilities | 14.72M | 15.11M | 14.65M | 10.48M | 166.71M | 34.05M |
| Stockholders Equity | 638.14M | 646.69M | 191.26M | 241.15M | -52.27M | -22.93M |
Cash Flow | ||||||
| Free Cash Flow | -136.41M | -142.43M | -166.41M | -81.17M | -29.22M | -14.56M |
| Operating Cash Flow | -136.40M | -142.42M | -166.31M | -81.17M | -29.22M | -14.56M |
| Investing Cash Flow | -341.82M | -389.75M | 114.96M | -160.47M | -21.76M | 0.00 |
| Financing Cash Flow | 425.99M | 591.00M | 116.14M | 203.25M | 128.02M | 23.81M |
Mineralys Therapeutics, Inc. Technical Analysis
Positive
30.58
Price Trends
27.38
Positive
27.29
Positive
32.45
Negative
Market Momentum
0.72
Negative
55.84
Neutral
66.79
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 30.58 is above the 20-day moving average (MA) of 26.54, above the 50-day MA of 27.38, and below the 200-day MA of 32.45, indicating a neutral trend. The MACD of 0.72 indicates Negative momentum. The RSI at 55.84 is Neutral, neither overbought nor oversold. The STOCH value of 66.79 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 |
|---|---|---|---|---|---|---|---|
63 Neutral | $6.66B | -14.41 | -49.23% | ― | -100.00% | -46.29% | |
56 Neutral | $4.51B | -9.21 | -71.31% | ― | ― | -259.98% | |
55 Neutral | $2.50B | -13.46 | -27.92% | ― | ― | 44.87% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
46 Neutral | $4.12B | -18.39 | -29.80% | ― | -52.13% | 3.91% |
* Healthcare Sector Average
MLYS
Mineralys Therapeutics, Inc.
27.59
12.57
83.69%
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NAMS
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33.28
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50.11%
Mineralys Therapeutics, Inc. Corporate Events
Business Operations and StrategyPrivate Placements and Financing
Mineralys announces $150 million equity offering and financing
Positive
Jun 3, 2026
On June 3, 2026, Mineralys Therapeutics, Inc. priced an underwritten public offering of 5,660,378 shares of common stock at $26.50 per share, with underwriters purchasing at $25.3075 per share. Before underwriting discounts and expenses, gross pro...
Business Operations and StrategyPrivate Placements and Financing
Mineralys Secures Lorundrostat Rights and Major Financing Facility
Neutral
Jun 3, 2026
On June 2, 2026, Mineralys Therapeutics, Inc. amended its license agreement with Tanabe Pharma to secure an exclusive, worldwide, royalty-free, perpetual license to lorundrostat, eliminating future royalty and diligence obligations while retaining...
Executive/Board ChangesShareholder Meetings
Mineralys Shareholders Approve Directors and Auditor at Meeting
Positive
May 22, 2026
On May 21, 2026, Mineralys Therapeutics, Inc. held its 2026 annual meeting of stockholders, where shareholders elected three directors, Srinivas Akkaraju, Brian Taylor Slingsby and Daphne Karydas, to serve as Class III directors with terms expirin...
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.