Mineralys Therapeutics, Inc. (MLYS) AI Stock Analysis

• Market Cap: $909.20M
• Dividend Yield: N/A
• Average Volume (3M): 787.17K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.55
• Revenue Growth: N/A
• EPS Growth: -106.10%
• Country: US
• Employees: 51
• Sector: Healthcare
• Sector Strength: 40
• Industry: Biotechnology
• EPS (TTM): -0.79
• Shares Outstanding: 65,175,285
• 10 Day Avg. Volume: 775,140
• 30 Day Avg. Volume: 787,175
• PEG Ratio: -0.55
• Price to Book (P/B): -14.41
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -25.78
• Enterprise Value/Market Cap: 0.73
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -73.97K
• Enterprise Value/Ebitda: -0.96
• 1Y Price Target: $36.86
• Price Target Upside: 164.23% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 7

• Rating: 53 Neutral
• 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

Clinical Trial Success

Mineralys announced positive topline results from the Phase II Explore-CKD study.

Market Potential

Positive EXPLORE-CKD data will likely strengthen the label for Lorundrostat in hypertension and increase the likelihood of a strategic interest given the large market.

Product Efficacy

Lorundrostat demonstrated a 30.5% reduction in spot UACR, which is a surrogate for renal protection.

Negative Factors

Competition

Competitor AZN could launch around the same time with more marketing and commercial presence.

Market Access

There is debate around how quickly MLYS' drug would be adopted due to access barriers.

Revenue Expectations

Analyst expects lower revenue due to access and competition from AZN.

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 administered, highly selective aldosterone synthase inhibitor for the treatment of patients with uncontrolled or resistant hypertension. The company was incorporated in 2019 and is headquartered in Radnor, Pennsylvania.

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 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

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	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	0.00	0.00	0.00	0.00	0.00	0.00
Gross Profit	-9.00K	0.00	0.00	0.00	0.00	0.00
EBITDA	-201.45M	-177.77M	-84.66M	-31.48M	0.00	0.00
Net Income	-188.51M	-177.81M	-71.90M	-29.80M	-19.41M	-3.43M
Balance Sheet
Total Assets	354.94M	205.90M	251.64M	114.44M	11.13M	1.49M
Cash, Cash Equivalents and Short-Term Investments	165.01M	198.19M	236.57M	110.11M	10.61M	1.41M
Total Debt	0.00	0.00	0.00	0.00	0.00	4.50M
Total Liabilities	13.39M	14.65M	10.48M	166.71M	34.05M	5.08M
Stockholders Equity	341.56M	191.26M	241.15M	-52.27M	-22.93M	-3.60M
Cash Flow
Free Cash Flow	-192.70M	-166.41M	-81.17M	-29.22M	-14.56M	-2.46M
Operating Cash Flow	-192.66M	-166.31M	-81.17M	-29.22M	-14.56M	-2.46M
Investing Cash Flow	78.03M	114.96M	-160.47M	-21.76M	0.00	0.00
Financing Cash Flow	189.22M	116.14M	203.25M	128.02M	23.81M	3.83M

Mineralys Therapeutics, Inc. Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 13.95
• 50DMA: Negative
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• 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 13.95 is below the 20-day moving average (MA) of 14.15, below the 50-day MA of 14.90, and above the 200-day MA of 13.02, indicating a neutral trend. The MACD of -0.27 indicates Negative momentum. The RSI at 49.98 is Neutral, neither overbought nor oversold. The STOCH value of 49.32 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
VIR	56 Neutral	$732.66M	―	-44.59%	―	-73.79%	-5.24%
MLYS	53 Neutral	$909.20M	―	-56.31%	―	―	-106.10%
Sector *	46 Neutral	C$198.48M	-3.49	-23.22%	2.62%	21.07%	-1.26%
SYRE	43 Neutral	$942.12M	2.31	-50.47%	―	-100.00%	94.68%
ETNB	42 Neutral	$1.49B	―	-69.30%	―	―	-68.13%
ELVN	36 Underperform	$1.16B	―	-31.30%	―	―	12.85%

Mineralys Therapeutics, Inc. Corporate Events

Mineralys Therapeutics Unveils Promising Trial Results for Lorundrostat

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.

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.