Mineralys Therapeutics, Inc. (MLYS) AI Stock Analysis

• Market Cap: $920.43M
• Dividend Yield: N/A
• Average Volume (3M): 1.49M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.57
• Revenue Growth: N/A
• EPS Growth: -106.10%
• Country: US
• Employees: 51
• Sector: Healthcare
• Sector Strength: 72
• Industry: Biotechnology
• EPS (TTM): -3.64
• Shares Outstanding: 62,784,878
• 10 Day Avg. Volume: 1,281,500
• 30 Day Avg. Volume: 1,492,809
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• Price to Cash Flow (P/CF): -3.20
• P/FCF Ratio: 0.00
• Enterprise Value/Market Cap: N/A
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $34.50
• Price Target Upside: 135.33% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 7

Mineralys Therapeutics' stock is rated moderately due to significant financial challenges from ongoing losses and negative cash flows, typical of an early-stage biotech firm. However, strong technical momentum and positive clinical trial results support future growth potential. The company's solid cash reserves and promising drug pipeline offer potential upside, but risks remain due to reliance on successful commercialization and market entry.

Positive Factors

Clinical Trials

Lorundrostat demonstrated a significant reduction in systolic blood pressure, which was particularly impressive to experts at the conference.

Regulatory Approval

The safety profile of lorundrostat was acceptable, with manageable hyperkalemic events, supporting regulatory approval prospects.

Negative Factors

Market Challenges

The heavily genericized hypertension market means that marketing and payer-related challenges are anticipated for Mineralys Therapeutics.

Market Competition

A smaller company like Mineralys Therapeutics may face challenges competing against larger companies, indicating a need for partnership to succeed commercially.

Mineralys Therapeutics, Inc. Business Overview & Revenue Model

Company Description

Mineralys 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 Money

Mineralys 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.

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.

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.

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

• Technical Analysis Sentiment: Positive
• Last Price: 14.66
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• STOCH: 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 14.66 is above the 20-day moving average (MA) of 13.94, above the 50-day MA of 11.48, and above the 200-day MA of 12.22, indicating a bullish trend. The MACD of 1.39 indicates Positive momentum. The RSI at 56.01 is Neutral, neither overbought nor oversold. The STOCH value of 31.03 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for MLYS.

Mineralys Therapeutics, Inc. Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
AMPH	69 Neutral	$1.35B	9.28	23.26%	―	13.59%	15.72%
KNSA	66 Neutral	$1.68B	―	-9.85%	―	56.60%	-403.56%
ARDX	60 Neutral	$1.18B	―	-23.01%	―	168.06%	44.66%
MLYS	55 Neutral	$920.43M	―	-82.24%	―	―	-106.10%
Sector *	49 Neutral	$6.85B	0.81	-52.91%	2.50%	17.48%	1.17%
KZR	41 Neutral	$35.94M	―	-55.00%	―	-100.00%	18.17%
RCKT	32 Underperform	$809.32M	―	-54.14%	―	―	6.99%

Mineralys Therapeutics, Inc. Corporate Events

Mineralys Therapeutics Reports Positive Phase 3 Trial Results

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.

Mineralys Therapeutics Completes Enrollment for Key Trial

On February 4, 2025, Mineralys Therapeutics announced the completion of enrollment for its Explore-CKD Phase 2 trial, which evaluates the efficacy and safety of lorundrostat for treating hypertension in patients with CKD and albuminuria. This trial aims to address poorly controlled hypertension, a major cause of renal failure and cardiovascular events, with results expected in the second quarter of 2025. This development marks a significant step in expanding treatment options for high-risk patients, potentially impacting the company’s competitive position in the market.

Mineralys Therapeutics Advances Lorundrostat to Phase 2 Trials

Mineralys Therapeutics announced that the U.S. FDA has cleared their Investigational New Drug Application for a Phase 2 clinical trial of lorundrostat, aimed at treating moderate-to-severe obstructive sleep apnea (OSA) and hypertension. This trial is expected to begin in the first quarter of 2025 and represents an expansion of lorundrostat’s market potential into OSA, furthering Mineralys’ positioning in the treatment of aldosterone-driven diseases. The study will evaluate the drug’s efficacy in reducing the frequency of apnea-hypopnea episodes and controlling nocturnal hypertension, which could have significant implications for patient health and industry stakeholders.