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Mineralys Therapeutics, Inc. (MLYS)
NASDAQ:MLYS
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Mineralys Therapeutics, Inc. (MLYS) AI Stock Analysis

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MLYS

Mineralys Therapeutics, Inc.

(NASDAQ:MLYS)

Rating:53Neutral
Price Target:
Mineralys Therapeutics shows promise with positive clinical trial results and a strong cash position, but faces challenges with continuous losses and negative cash flows. Technical analysis suggests short-term momentum, while valuation remains a concern due to lack of revenue. The earnings call highlighted upcoming milestones that could enhance future prospects.
Positive Factors
Strong Clinical Progress
Successful enrollment and progress in pivotal trials indicate robust R&D capabilities and potential for future product approvals, enhancing long-term growth prospects.
Robust Financial Position
A strong cash position with no debt provides financial stability, enabling continued investment in R&D and strategic initiatives without immediate external financing.
Positive Market Potential for Lorundrostat
Lorundrostat's promising trial results suggest strong market potential, positioning it as a competitive therapy in the hypertension market, which could drive future revenue.
Negative Factors
Consistent Net Losses
Ongoing net losses highlight the challenge of achieving profitability, necessitating successful product commercialization to ensure long-term financial sustainability.
Increased R&D Expenses
Rising R&D costs, while essential for development, strain financial resources and emphasize the need for efficient management to balance innovation with fiscal responsibility.
Potential Challenges in Clinical Outcomes
Challenges in clinical trial outcomes could delay product approvals, affecting the timeline for revenue generation and market entry, impacting strategic planning.

Mineralys Therapeutics, Inc. (MLYS) vs. SPDR S&P 500 ETF (SPY)

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. Earnings Call Summary

Earnings Call Date:Aug 12, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 11, 2025
Earnings Call Sentiment Positive
The earnings call reflected a positive outlook with significant advancements in clinical trials, financial stability, and preparation for regulatory approval. However, increased net loss, rising G&A expenses, and potential market competition are noted challenges.
Q2-2025 Updates
Positive Updates
Clinical Trials Success and Publication
Mineralys announced pivotal data for their ASI, lorundrostat, from Launch-HTN and Advance-HTN trials, which were presented at leading conferences and published in prestigious journals.
Physician Survey Results
A survey of 300 cardiologists and primary care physicians indicated that 95% would likely prescribe lorundrostat broadly for patients with uncontrolled or resistant hypertension if approved.
Financial Position
Mineralys ended the quarter with $324.9 million in cash, cash equivalents, and investments, up from $198.2 million as of December 31, 2024, indicating financial stability to support operations into 2027.
Expansion of Medical Communications
Mineralys has expanded its medical communications team to support pre-launch readiness, indicating proactive steps towards commercialization.
Upcoming Regulatory Milestone
Mineralys has a pre-NDA meeting with the FDA scheduled for the fourth quarter of 2025, showing progress towards regulatory approval.
Negative Updates
Net Loss Increase
The net loss was $43.3 million for the quarter ended June 30, 2025, compared to $41 million for the same quarter in 2024, indicating increased financial loss.
R&D Expense Decrease
R&D expenses decreased from $39.3 million in Q2 2024 to $38.3 million in Q2 2025, mainly due to the conclusion of the lorundrostat pivotal program, which could suggest a slowdown in R&D activities.
G&A Expense Increase
G&A expenses increased to $8.5 million for Q2 2025 from $5.9 million in Q2 2024, primarily due to higher compensation expenses and professional fees.
Potential Market Competition
Concerns about potential competition from AstraZeneca's ASI were discussed, with uncertainties about how BAX-HTN data might impact lorundrostat's market positioning.
Company Guidance
During the Mineralys Second Quarter 2025 Earnings Call, the company provided several key metrics and insights into its financial and clinical progress. Mineralys ended the quarter with $324.9 million in cash, cash equivalents, and investments, up from $198.2 million at the end of 2024, and anticipates these funds will support operations into 2027. Research and Development (R&D) expenses slightly decreased to $38.3 million from $39.3 million year-over-year, while General and Administrative (G&A) expenses increased to $8.5 million from $5.9 million. The company reported a net loss of $43.3 million for the quarter, up from $41 million in the same period the previous year. CEO Jon Congleton highlighted the success of lorundrostat, an aldosterone synthase inhibitor, in reducing systolic blood pressure in clinical trials and its potential market impact given the unmet need in treating hypertension and related comorbidities like chronic kidney disease (CKD) and obstructive sleep apnea (OSA). Surveys indicated 95% of clinicians would likely prescribe lorundrostat if approved, especially for patients with uncontrolled or resistant hypertension. Mineralys is preparing for a pre-NDA meeting with the FDA in the fourth quarter of 2025, aiming to bring lorundrostat to market as an innovative solution for significant unmet medical needs.

Mineralys Therapeutics, Inc. Financial Statement Overview

Summary
Mineralys Therapeutics faces financial challenges typical of early-stage biotech firms, with consistent net losses and negative cash flows due to high R&D costs and no revenue. However, a strong cash position with no debt provides some financial stability.
Income Statement
20
Very Negative
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.
Balance Sheet
40
Negative
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.
Cash Flow
35
Negative
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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue34.00K0.000.000.000.000.00
Gross Profit-9.00K-43.00K0.000.000.000.00
EBITDA-203.04M-192.36M-84.66M-31.48M-19.38M-3.31M
Net Income-190.77M-177.81M-71.90M-29.80M-19.41M-3.43M
Balance Sheet
Total Assets335.72M205.90M251.64M114.44M11.13M1.49M
Cash, Cash Equivalents and Short-Term Investments101.79M198.19M236.57M110.11M10.61M1.41M
Total Debt0.000.000.000.000.004.50M
Total Liabilities22.17M14.65M10.48M166.71M34.05M5.08M
Stockholders Equity313.55M191.26M241.15M-52.27M-22.93M-3.60M
Cash Flow
Free Cash Flow-192.72M-166.41M-81.17M-29.22M-14.56M-2.46M
Operating Cash Flow-192.69M-166.31M-81.17M-29.22M-14.56M-2.46M
Investing Cash Flow27.42M114.96M-160.47M-21.76M0.000.00
Financing Cash Flow199.20M116.14M203.25M128.02M23.81M3.83M

Mineralys Therapeutics, Inc. Technical Analysis

Technical Analysis Sentiment
Positive
Last Price37.10
Price Trends
50DMA
17.90
Positive
100DMA
16.38
Positive
200DMA
14.19
Positive
Market Momentum
MACD
6.34
Negative
RSI
86.56
Negative
STOCH
93.04
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 37.1 is above the 20-day moving average (MA) of 23.92, above the 50-day MA of 17.90, and above the 200-day MA of 14.19, indicating a bullish trend. The MACD of 6.34 indicates Negative momentum. The RSI at 86.56 is Negative, neither overbought nor oversold. The STOCH value of 93.04 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 75 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 (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
54
Neutral
$694.58M-46.22%-75.91%-12.11%
53
Neutral
$2.88B-63.21%-32.33%
51
Neutral
$7.92B-0.36-43.38%2.24%22.38%-2.16%
43
Neutral
$945.28M2.31-41.00%-429.68%
42
Neutral
$1.20B-86.86%-82.75%
36
Underperform
$1.18B-25.26%-3.53%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
MLYS
Mineralys Therapeutics, Inc.
37.10
25.50
219.83%
SYRE
Spyre Therapeutics
15.65
-13.31
-45.96%
VIR
Vir Biotechnology
5.00
-2.87
-36.47%
ETNB
89bio
8.07
-0.14
-1.71%
ELVN
Enliven Therapeutics
19.96
-2.42
-10.81%

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
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.Date of analysis: Apr 10, 2025