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Mineralys Therapeutics, Inc. (MLYS)
NASDAQ:MLYS
RESEARCH TOOLSreports
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Mineralys Therapeutics, Inc.
(NASDAQ:MLYS)
Rating:53Neutral
Price Target:―
Positive Factors
Clinical Trials
The 50mg dose of the aldosterone synthase inhibitor demonstrated a placebo-adjusted SBP reduction of 9.1 mmHg at Week 6, which increased to an 11.70 mmHg delta at Week 12.
Financial Performance
Mineralys reported finishing the period with $343.0M in cash, cash equivalents, and investments, which is expected to fund operations into 2027.
Market Potential
Analyst reiterates a Buy rating and sets a $42 price target, reflecting confidence in lorundrostat's differentiated profile and market potential.
Negative Factors
Commercial Strategy
Management believes they can commercialize in the US themselves with a targeted approach focused on an initial base of the fourth line market.
Regulatory Challenges
Management plans to meet with the FDA to discuss a filing, expecting the NDA package to include data from pivotal trials and supportive data from the EXPLORE-CKD trial.
Mineralys Therapeutics, Inc. (MLYS) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.06B
Dividend YieldN/A
Average Volume (3M)850.39K
Price to Earnings (P/E)―
Beta (1Y)1.63
Revenue GrowthN/A
EPS Growth-106.10%
CountryUS
Employees51
SectorHealthcare
Sector Strength42
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.79
Shares Outstanding65,175,285
10 Day Avg. Volume1,053,763
30 Day Avg. Volume850,388
Financial Highlights & Ratios
PEG Ratio0.37
Price to Book (P/B)3.91
Price to Sales (P/S)0.00
P/FCF Ratio-4.48
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$38.14Price Target Upside133.70% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
Mineralys Therapeutics, Inc. Business Overview & Revenue Model
Company DescriptionMineralys Therapeutics, Inc. (MLYS) is a biopharmaceutical company focused on developing innovative therapies for the treatment of cardiovascular and renal diseases. The company operates within the healthcare sector and specializes in the research and development of novel therapeutic solutions aimed at addressing unmet medical needs in these areas. Mineralys’ core product pipeline is centered around the development of targeted treatments that leverage its expertise in mineralocorticoid receptor biology.
How the Company Makes MoneyMineralys Therapeutics, Inc. generates revenue primarily through the development and commercialization of its pharmaceutical products. The company aims to secure revenue through successful clinical trials and regulatory approvals, which can lead to product sales and potential licensing agreements. Mineralys may also engage in strategic partnerships or collaborations with other pharmaceutical companies, which can provide additional funding and revenue-sharing opportunities. These partnerships could involve co-development, co-marketing, or distribution agreements that help expand the reach and financial success of its therapies. Additionally, the company may receive milestone payments and royalties from licensing its technologies or products to third parties.
Mineralys Therapeutics, Inc. Financial Statement Overview
Summary
Mineralys Therapeutics faces financial challenges, typical for early-stage biotech firms, marked by zero revenue and continuous losses. Despite a strong cash position and no debt, the company has negative operating and free cash flows. The financial strength hinges on effective cash management and future revenue generation.Income Statement
Mineralys Therapeutics, Inc. has consistently reported zero revenue over multiple years, indicating a lack of product commercialization or monetization strategy. The net losses have widened significantly, with the latest EBIT and net income showing substantial negative figures. This suggests high operating costs not offset by income, posing sustainability challenges.20
Very Negative
Balance Sheet
The company shows a strong cash position with no debt, leading to a negative net debt, which is favorable. However, the consistent negative stockholders' equity until 2022 indicates a history of liabilities exceeding assets. In 2024, equity improved, reflecting some balance sheet recovery but with ongoing risks from potential liabilities.40
Negative
Cash Flow
Operating cash flows are consistently negative, suggesting a dependency on external financing for operations. There is a notable improvement in cash flows from financing activities, helping maintain liquidity. However, the negative free cash flow highlights operational inefficiencies and the need for sustainable cash generation.35
Negative
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | EBIT |
| -192.40M | -84.66M | -31.48M | -18.73M | -2.94M | EBITDA |
| -192.40M | -84.66M | -31.48M | 0.00 | 0.00 | Net Income Common Stockholders |
| -177.81M | -71.90M | -29.80M | -19.41M | -3.43M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 198.19M | 236.57M | 110.11M | 10.61M | 1.41M | Total Assets |
| 205.90M | 251.64M | 114.44M | 11.13M | 1.49M | Total Debt |
| 0.00 | 0.00 | 0.00 | 0.00 | 4.50M | Net Debt |
| -114.09M | -49.30M | -87.70M | -10.61M | 3.09M | Total Liabilities |
| 14.65M | 10.48M | 166.71M | 34.05M | 5.08M | Stockholders Equity |
| 191.26M | 241.15M | -52.27M | -22.93M | -3.60M |
| Cash Flow | Free Cash Flow | |||
| -166.41M | -81.17M | -29.22M | -14.56M | -2.46M | Operating Cash Flow |
| -166.31M | -81.17M | -29.22M | -14.56M | -2.46M | Investing Cash Flow |
| 114.96M | -160.47M | -21.76M | 0.00 | 0.00 | Financing Cash Flow |
| 116.14M | 203.25M | 128.02M | 23.81M | 3.83M |
Mineralys Therapeutics, Inc. Technical Analysis
Positive
16.32
Price Trends
14.61
Positive
12.57
Positive
12.53
Positive
Market Momentum
0.60
Negative
58.61
Neutral
80.15
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 16.32 is above the 20-day moving average (MA) of 15.18, above the 50-day MA of 14.61, and above the 200-day MA of 12.53, indicating a bullish trend. The MACD of 0.60 indicates Negative momentum. The RSI at 58.61 is Neutral, neither overbought nor oversold. The STOCH value of 80.15 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 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
Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
53 Neutral | $1.06B | ― | -56.31% | ― | ― | -106.10% | |
53 Neutral | $5.14B | 3.03 | -43.89% | 2.83% | 16.75% | -0.06% | |
44 Neutral | $622.07M | ― | -44.59% | ― | -73.79% | -5.24% | |
43 Neutral | $905.91M | 2.31 | -50.47% | ― | -100.00% | 94.68% | |
42 Neutral | $1.39B | ― | -69.30% | ― | ― | -68.13% | |
36 Underperform | $804.74M | ― | -31.30% | ― | ― | 12.85% |
* Healthcare Sector Average
Performance Comparison
MLYS
Mineralys Therapeutics, Inc.
15.96
3.80
31.25%
SYRE
Spyre Therapeutics
15.01
-18.08
-54.64%
VIR
Vir Biotechnology
4.50
-6.23
-58.06%
ETNB
89bio
9.49
1.17
14.06%
ELVN
Enliven Therapeutics
16.40
-6.82
-29.37%
Mineralys Therapeutics, Inc. Earnings Call Summary
Earnings Call Date:May 12, 2025
(Q1-2025)
| % Change Since: 8.73%|
Next Earnings Date:Aug 11, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant clinical and financial achievements, including successful trial results for lorundrostat, high physician interest, and strong financial backing. However, challenges remain, such as increased net loss and manageable concerns regarding hyperkalemia. Overall, the positive developments outweigh the challenges.Q1-2025 Updates
Positive Updates
Successful Pivotal Trials for Lorundrostat
The pivotal trials Launch-HTN and Advance-HTN achieved statistical significance and were clinically meaningful in efficacy endpoints, demonstrating a favorable safety and tolerability profile.
Publication and Presentation of Clinical Trial Results
Detailed results from the Advance-HTN trial were published in the New England Journal of Medicine and presented at the ACC '25 meeting, with Launch-HTN data accepted for a presentation at the European Society of Hypertension.
High Physician Interest in Lorundrostat
Survey results indicated that if approved, 95% of physicians are likely to prescribe lorundrostat for hypertension, specifically in third and fourth line positions.
Significant Financial Strength
Completion of a public equity financing raised gross proceeds of approximately $201.2 million before fees and expenses, contributing to a strong balance sheet.
New Appointment of Chief Commercial Officer
Eric Warren was appointed as Chief Commercial Officer, bringing 30 years of pharmaceutical industry experience.
Negative Updates
Increased Net Loss
Net loss for the quarter ended March 31, 2025, was $42.2 million compared to $31.5 million for the quarter ended March 31, 2024, primarily due to increased R&D and G&A expenses.
Challenges with Hyperkalemia
In the Advance-HTN trial, the incidence of hyperkalemia in the 50-mg lorundrostat arm was 2.1%, which is considered acceptable but still a point of concern.
Company Guidance
During the Mineralys First Quarter 2025 Earnings Conference Call, the company provided guidance on several key metrics and milestones. Mineralys reported achieving statistical significance and clinically meaningful results in the pivotal Launch-HTN and Advance-HTN trials, with a notable double-digit reduction in systolic blood pressure. They highlighted the favorable safety and tolerability profile of lorundrostat and its potential to transform hypertension treatment. Furthermore, Mineralys completed a $201.2 million public equity financing, contributing to a robust balance sheet with cash, cash equivalents, and investments totaling $343 million as of March 31, 2025. The company anticipates discussing trial results with the FDA in the fourth quarter of 2025, aiming for an NDA submission. Additionally, they reported a net loss of $42.2 million for the quarter, attributed to increased R&D and G&A expenses.Mineralys Therapeutics, Inc. Corporate Events
Product-Related Announcements
Mineralys Therapeutics Unveils Promising Trial Results for Lorundrostat
Positive
Mar 31, 2025
On March 29, 2025, Mineralys Therapeutics announced detailed results from the Advance-HTN pivotal trial of lorundrostat for uncontrolled and resistant hypertension. The trial demonstrated significant blood pressure reductions and a favorable safety profile, underscoring lorundrostat’s potential as a best-in-class treatment for high-risk patients. The results were presented at the American College of Cardiology’s Annual Scientific Session & Expo, highlighting lorundrostat’s clinical utility across diverse care settings and its potential impact on hypertension care.
Product-Related Announcements
Mineralys Therapeutics Reports Positive Phase 3 Trial Results
Positive
Mar 10, 2025
On March 10, 2025, Mineralys Therapeutics announced positive results from its pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials for lorundrostat, a treatment for uncontrolled or resistant hypertension. Both trials met their primary efficacy endpoints, showing statistically significant reductions in systolic blood pressure and a favorable safety profile, indicating potential for regulatory approval and commercial value.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
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.