Mineralys Therapeutics, Inc. (MLYS)
NASDAQ:MLYS
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Mineralys Therapeutics, Inc.
(NASDAQ:MLYS)
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Rating:61Neutral
Price Target:
$31.00
▲(1.37% Upside)
Action:ReiteratedDate:05/07/26
The score is driven primarily by strong regulatory progress and supportive earnings-call catalysts (NDA acceptance with a defined PDUFA timeline) alongside a well-capitalized, debt-free balance sheet. Offsetting these positives are the company’s lack of revenue with ongoing losses/cash burn and a valuation profile constrained by negative earnings; technicals are mildly supportive but not strongly bullish longer-term.
Positive Factors
Balance Sheet Strength
A debt-free balance sheet with roughly $646M in cash and rising shareholders' equity gives durable funding flexibility to finish regulatory work, support prelaunch activities, and absorb near-term losses. That liquidity materially reduces near-term refinancing risk and supports commercialization planning into 2028.
Negative Factors
No Revenue / Widening Losses
The company remains pre-revenue with materially larger net losses over recent years, meaning it is dependent on external capital until commercialization. Persistent negative operating and free cash flow represent a structural financing and dilution risk if capital markets tighten or approval/launch timelines slip.
Read all positive and negative factors
Positive Factors
Negative Factors
Balance Sheet Strength
A debt-free balance sheet with roughly $646M in cash and rising shareholders' equity gives durable funding flexibility to finish regulatory work, support prelaunch activities, and absorb near-term losses. That liquidity materially reduces near-term refinancing risk and supports commercialization planning into 2028.
Read all positive factors
Mineralys Therapeutics, Inc. (MLYS) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$2.48B
Dividend YieldN/A
Average Volume (3M)1.40M
Price to Earnings (P/E)―
Beta (1Y)1.22
Revenue GrowthN/A
EPS Growth34.72%
CountryUS
Employees51
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-2.37
Shares Outstanding82,451,950
10 Day Avg. Volume1,337,411
30 Day Avg. Volume1,395,830
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 Cap0.76
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-31.93K
Enterprise Value/Ebitda-11.33
Forecast
1Y Price Target
$51.14Price Target Upside67.24% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
EPS Forecast (FY)-2.17
Revenue Forecast (FY)N/A
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 biotechnology company, Mineralys Therapeutics does not have product sales and has not established recurring commercial revenue streams. Its funding has primarily come from financing activities (e.g., equity offerings and other ...
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
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
30.58
Price Trends
27.39
Positive
31.61
Negative
30.32
Positive
Market Momentum
0.76
Negative
65.13
Neutral
84.67
Negative
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 26.53, above the 50-day MA of 27.39, and above the 200-day MA of 30.32, indicating a bullish trend. The MACD of 0.76 indicates Negative momentum. The RSI at 65.13 is Neutral, neither overbought nor oversold. The STOCH value of 84.67 is Negative, 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 | -19.24 | -50.66% | ― | ― | 26.67% | |
61 Neutral | $2.48B | -14.26 | -32.94% | ― | ― | 34.72% | |
58 Neutral | $5.59B | -8.44 | -55.81% | ― | ― | -44.99% | |
56 Neutral | $5.26B | -13.43 | 8.20% | ― | 28.46% | ― | |
55 Neutral | $3.62B | -13.39 | -27.47% | ― | -50.61% | 32.78% | |
53 Neutral | $3.75B | -5.94 | -71.31% | ― | ― | -259.98% | |
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.