Mineralys Therapeutics, Inc. (MLYS) AI Stock Analysis

• Market Cap: $2.48B
• Dividend Yield: N/A
• Average Volume (3M): 1.37M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.19
• Revenue Growth: N/A
• EPS Growth: 9.60%
• Country: US
• Employees: 51
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -0.52
• Shares Outstanding: 79,139,950
• 10 Day Avg. Volume: 1,293,253
• 30 Day Avg. Volume: 1,373,058
• PEG Ratio: -0.04
• Price to Book (P/B): 3.12
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -3.59
• Enterprise Value/Market Cap: 0.84
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -45.29K
• Enterprise Value/Ebitda: -11.58
• 1Y Price Target: $52.60
• Price Target Upside: 67.62% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 6
• EPS Forecast (FY): -2.19
• Revenue Forecast (FY): N/A

• Rating: 52 Neutral
• Price Target: $32.00 ▲(1.98% Upside)

The score is held back primarily by weak financial performance (no revenue, sizable ongoing losses and cash burn) and bearish near-term technicals. These are partially offset by a favorable earnings-call outlook highlighting strong clinical data and regulatory momentum toward an NDA, plus a sizable cash runway that reduces near-term funding risk.

Positive Factors

Pivotal clinical trial efficacy

Robust pivotal trial efficacy across diverse subgroups strengthens the drug's clinical profile and supports a durable competitive advantage. Sustained, once-daily BP reductions increase likelihood of favorable labeling and clinician adoption, underpinning long-term commercial potential if approved.

Regulatory progress (NDA filed)

An NDA filing is a structural de-risking event that shortens the timeline to potential approval and commercialization. This regulatory milestone reduces uncertainty, enabling planning for manufacturing, market access, and partnerships that materially affect the company's long-term trajectory.

Sizable cash runway and no debt

A multi-year cash runway and zero debt materially reduce near-term financing pressure, supporting completion of regulatory activities and commercialization preparation. This financial flexibility preserves strategic optionality and lowers bankruptcy/interest-rate vulnerability over the medium term.

Negative Factors

Pre-revenue development-stage profile

Being pre-revenue means long-term value depends entirely on successful approval and commercialization of pipeline assets. Absent product sales, the company must continuously finance operations, increasing dilution risk and making long-term stability contingent on clinical and regulatory execution.

High and persistent cash burn

Sustained ~-$171M annual cash burn pressures the balance sheet if approval or partnering is delayed. Even with current runway, prolonged commercialization timelines or higher launch costs would force financings or asset monetization, increasing dilution and strategic constraint over time.

Clinical data analysis concerns

Data imputation and missing-data scrutiny can trigger regulatory requests for additional analyses or datasets, potentially delaying review or necessitating further trials. Such reproducibility concerns create durable regulatory and commercial execution risk beyond short-term market reactions.

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	-46.00K	-43.00K	0.00	0.00	0.00	0.00
EBITDA	-179.83M	-192.36M	-84.66M	-31.48M	-19.38M	-3.31M
Net Income	-171.36M	-177.81M	-71.90M	-29.80M	-19.41M	-3.43M
Balance Sheet
Total Assets	599.95M	205.90M	251.64M	114.44M	11.13M	1.49M
Cash, Cash Equivalents and Short-Term Investments	217.60M	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	23.52M	14.65M	10.48M	166.71M	34.05M	5.08M
Stockholders Equity	576.43M	191.26M	241.15M	-52.27M	-22.93M	-3.60M
Cash Flow
Free Cash Flow	-171.37M	-166.41M	-81.17M	-29.22M	-14.56M	-2.46M
Operating Cash Flow	-171.37M	-166.31M	-81.17M	-29.22M	-14.56M	-2.46M
Investing Cash Flow	-202.69M	114.96M	-160.47M	-21.76M	0.00	0.00
Financing Cash Flow	494.39M	116.14M	203.25M	128.02M	23.81M	3.83M

Mineralys Therapeutics, Inc. Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 31.38
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Positive
• MACD: Positive
• RSI: Positive
• STOCH: Positive

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For MLYS, the sentiment is Negative. The current price of 31.38 is below the 20-day moving average (MA) of 35.43, below the 50-day MA of 38.49, and above the 200-day MA of 25.94, indicating a neutral trend. The MACD of -1.60 indicates Positive momentum. The RSI at 26.18 is Positive, neither overbought nor oversold. The STOCH value of 17.11 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for MLYS.

Mineralys Therapeutics, Inc. Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
XENE	59 Neutral	$3.21B	―	-45.14%	―	―	-38.30%
NAMS	55 Neutral	$3.61B	-15.50	-39.94%	―	―	―
MLYS	52 Neutral	$2.48B	-11.07	-42.14%	―	―	9.60%
VKTX	52 Neutral	$3.60B	-16.01	-29.23%	―	―	-126.16%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
APLS	50 Neutral	$2.60B	67.16	14.10%	―	42.11%	―
CNTA	48 Neutral	$3.01B	-12.20	-60.45%	―	117.83%	-18.91%

Mineralys Therapeutics, Inc. Corporate Events

Mineralys updates lorundrostat program and upcoming data milestones

On January 6, 2026, Mineralys Therapeutics provided a corporate update detailing significant recent clinical and regulatory milestones for its lead drug candidate, lorundrostat, and announced management’s participation in the LifeSci Partners Corporate Access event scheduled for January 12-14, 2026, in San Francisco. The company disclosed that it had filed a new drug application for lorundrostat with the U.S. Food and Drug Administration in late 2025, following a series of positive clinical readouts, including successful pivotal trials (Launch-HTN and Advance-HTN) in uncontrolled and resistant hypertension and favorable Phase 2 data in chronic kidney disease, as well as ongoing long-term safety evaluation via the Transform-HTN open-label extension. Mineralys also confirmed it remained on track to report topline results in the first quarter of 2026 from its Phase 2 Explore-OSA trial in patients with moderate to severe obstructive sleep apnea and hypertension, a data event that could further support the drug’s positioning as a potential best-in-class therapy for hypertension and comorbid conditions and influence its future regulatory and commercial trajectory.

The most recent analyst rating on (MLYS) stock is a Hold with a $37.00 price target. To see the full list of analyst forecasts on Mineralys Therapeutics, Inc. stock, see the MLYS Stock Forecast page.