Mineralys Therapeutics, Inc. (MLYS) AI Stock Analysis

• Market Cap: $2.42B
• Dividend Yield: N/A
• Average Volume (3M): 1.03M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.18
• 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: 962,880
• 30 Day Avg. Volume: 1,028,820
• 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: 0.68
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -35.93K
• Enterprise Value/Ebitda: -9.19
• 1Y Price Target: $52.60
• Price Target Upside: 71.78% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 6
• EPS Forecast (FY): -2.19
• Revenue Forecast (FY): $3.20M

• Rating: 52 Neutral
• Price Target: $32.00 ▲(4.51% 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 Efficacy

Robust, statistically significant pivotal results across Launch‑HTN and Advance‑HTN signal durable therapeutic value for uncontrolled and resistant hypertension. Consistent efficacy across diverse subgroups supports broader label potential, higher adoption likelihood, and sustained commercial relevance if approved.

Regulatory Progress (NDA Filed)

An actual NDA filing is a structural milestone that meaningfully de‑risks development execution versus earlier stages. It shifts the program into regulatory review, shortens time to potential approval/commercialization, and strengthens leverage in partner or payer discussions over the medium term.

Cash Runway Supports Development

A multi‑year cash runway materially reduces near‑term financing risk, enabling completion of ongoing trials, NDA activities, and regulatory interactions without immediate dilutive raises. This preserves strategic optionality for partnerships, label expansion, and launch planning over the next 2–3 years.

Negative Factors

Pre‑Revenue with High Cash Burn

Being pre‑commercial, Mineralys lacks operating revenue and relies on cash to fund R&D. TTM net loss and free cash flow near ‑$171M indicate sustained burn; persistent losses create ongoing funding needs and dilution risk if regulatory or commercialization timelines slip, a structural financial constraint.

Clinical Data Integrity Concerns

Methodological questions around imputation and missing data can trigger additional analyses, regulatory requests, or label limitations. Such issues have lasting impact on approval certainty, post‑market requirements, and payer confidence, increasing execution risk even with positive primary endpoints.

Rising G&A and Operating Spend

Higher G&A and growing operating costs widen cash burn and pressure the existing runway. As the company moves toward potential commercialization, sustained SG&A increases will be required; without revenue, this elevates financing needs and tests management's ability to scale cost structure efficiently.

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

Development-stage profile with zero revenue and large, persistent losses and cash burn (TTM net loss and free cash flow both about -$171M). Offsetting this, the company has no debt and a sizable equity base, with the earnings update citing $593.6M in cash/investments funding operations into 2028, which reduces near-term financing risk.

Income Statement

The company remains pre-revenue (zero revenue in annual periods and TTM (Trailing-Twelve-Months)), with large and widening operating losses versus earlier years. TTM (Trailing-Twelve-Months) net loss is about $171M (vs. ~$178M in 2024), and operating losses have expanded materially compared with 2022–2023, indicating a higher spend profile without an offsetting revenue base. A modest year-over-year improvement in the net loss is a positive, but overall profitability and operating leverage are still weak.

Balance Sheet

The balance sheet is supported by a sizable equity base in TTM (Trailing-Twelve-Months) (stockholders’ equity ~$576M) and reported total debt of $0 in recent periods, which meaningfully reduces financial risk and interest burden. However, returns on equity are strongly negative in TTM (Trailing-Twelve-Months) and 2024 due to sustained losses, and equity has been volatile historically (negative in 2020–2022 before improving), highlighting dilution/burn risk over time if losses persist.

Cash Flow

Cash generation is weak, with consistently negative operating and free cash flow each year. TTM (Trailing-Twelve-Months) operating cash flow and free cash flow are both about -$171M, and free cash flow deterioration versus 2024 suggests the cash burn rate is not yet stabilizing. A relative positive is that free cash flow broadly tracks net loss (similar magnitude), but the absolute level of cash burn remains high and ongoing funding needs are likely.

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: 30.62
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• 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 30.62 is below the 20-day moving average (MA) of 32.49, below the 50-day MA of 35.83, and above the 200-day MA of 27.18, indicating a neutral trend. The MACD of -1.32 indicates Positive momentum. The RSI at 36.12 is Neutral, neither overbought nor oversold. The STOCH value of 15.81 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	$3.18B	-10.59	-45.14%	―	―	-38.30%
NAMS	55 Neutral	$3.74B	-16.15	-39.94%	―	―	―
MLYS	52 Neutral	$2.42B	-10.35	-42.14%	―	―	9.60%
VKTX	52 Neutral	$3.34B	-13.96	-29.23%	―	―	-126.16%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
APLS	50 Neutral	$2.93B	77.97	14.10%	―	42.11%	―
CNTA	48 Neutral	$3.36B	-13.73	-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.