Mineralys Therapeutics, Inc. (MLYS)

Price$28.21Cached quoteAs of 2026-09-05 12:44 UTC

AI: Fair-priced

Price checkThe shares look fairly priced because strong drug data is offset by approval, launch, and dilution risks.

Using about 88.4 million shares, the observed market value is roughly $2.7 billion. Subtracting $661.4 million of cash and investments and adding $97.6 million of debt gives about $2.2 billion of enterprise value, meaning value assigned to the operating business. That is about four times liquid resources and roughly twenty times the latest four-quarter operating cash burn of $139 million. With no revenue or positive earnings, those multiples mainly price in approval and successful commercialization, so balanced evidence supports Fair-priced.

Big pictureMineralys has no product sales, so its value depends almost entirely on one drug reaching patients.

Mineralys reported zero revenue in every supplied year through 2025 and remains pre-commercial in 2026. Net loss was $154.7 million in 2025 after $177.8 million in 2024, while operating cash flow was negative $142.4 million in 2025. This is not a normal cyclical rebound: value changes mainly with regulatory approval, launch uptake, and spending needs. The bull case is a differentiated hypertension medicine; the bear case is years of cash burn without a saleable product.

Business strengthClinical results support a valuable hypertension product, but they do not yet prove durable earnings.

Clinical evidence is the strongest support for the valuation. In the 1,083-person Phase 3 Launch-HTN trial, the 50-milligram dose lowered systolic blood pressure 11.6 millimeters of mercury more than placebo at 12 weeks; Phase 2 Advance-HTN showed a 7.9-millimeter advantage. A kidney-disease analysis found a 52.2% placebo-adjusted reduction in urine albumin, with 2.4% confirmed high potassium. Still, the drug is unapproved, and the 48-person Explore-OSA trial missed its sleep-apnea endpoint.

What could change the storyApproval and early sales could justify upside, while a regulatory setback or more shares could erase the cash cushion.

Cash and investments were $661.4 million at June 30, 2026, versus $656.6 million at year-end, and management says planned operations can reach into 2028. The cushion is meaningful, but capital allocation was costly: 5.66 million new shares raised $150 million, $100 million of debt was drawn, and up to $400 million more may become available. The loan carries a floating rate plus 5.5%. Shares rose from 65.7 million to 88.4 million year over year. Approval by December 22, 2026 and credible early sales would strengthen the case; rejection, delay, or heavy launch spending would weaken it.

AI: News

Second-quarter updateSecond-quarter results showed ample funding and active launch preparation, but losses remain large before any sales.

On August 11, Mineralys reported $661.4 million of cash, cash equivalents, and investments, compared with $656.6 million on December 31, 2025, plus $97.6 million of senior secured debt. Management said this should fund planned operations through a commercial launch and into 2028. The quarter still produced a $241.1 million net loss, largely because research spending included a $200 million Tanabe payment. The update reduced near-term funding pressure but confirmed that value remains pre-revenue and spending-heavy.

Royalty and financing dealThe company removed future royalties but financed the move with new shares and debt, changing both upside and risk.

On June 3, Mineralys agreed to pay Tanabe $200 million upfront and up to $100 million in commercial milestones to eliminate future lorundrostat royalties. It also secured a $500 million loan facility, with $100 million drawn, and priced 5.66 million new shares for $150 million. Removing royalties can improve future product economics if sales arrive, but the transaction also increased debt, interest expense, and dilution. Its net effect on the stock depends on approval and eventual sales, not the financing alone.

Kidney-disease dataNew kidney-disease data strengthened the main drug’s potential market, especially for patients with harder-to-treat hypertension.

On May 30, the company presented a post hoc Phase 3 analysis in chronic kidney disease: placebo-adjusted systolic blood pressure reduction was 9.6 millimeters of mercury, and urinary albumin-to-creatinine ratio fell 52.2% versus placebo among 84 participants with albuminuria. Confirmed high potassium occurred in 2.4% of kidney-disease participants. These findings support a larger hypertension market and possible kidney benefits, but the analysis was not a new registration trial and does not establish future revenue.

Regulatory review acceptedThe regulator accepted the hypertension application and set a December decision date, bringing approval risk closer to a market-moving test.

On March 9, the U.S. Food and Drug Administration accepted Mineralys’ application for lorundrostat alongside other blood-pressure medicines and set a December 22, 2026 action date. Acceptance allows review; it is not approval. The filing rests on positive hypertension trials, while the 48-person Explore-OSA study missed its sleep-apnea endpoint despite blood-pressure improvement. Approval could unlock the planned launch and validate the single-asset strategy; delay or rejection would leave the company with no product revenue and ongoing cash use.

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Revenue

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2023

2024

2025

Net income

2022

2023

2024

2025

Free cash flow

2023

2024

2025

Total cash / debt

CashTotal debt

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2023

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2025

Financial statements

	2025	2024	2023	2022
Revenue	$0	$0	$0	$0
Research & development	$132.0M	$168.6M	$70.4M	$26.3M
Operating expenses	$170.6M	$192.4M	$84.7M	$31.5M
Operating income	−$170.6M	−$192.4M	−$84.7M	−$31.5M
EBITDA	−$170.5M	−$192.4M	−$84.7M	−$31.5M
Net income	−$154.7M	−$177.8M	−$71.9M	−$29.8M
Basic EPSper basic share	-$2.29	-$3.66	-$1.99	-$5.77
Diluted EPSper diluted share	-$2.29	-$3.66	-$1.99	-$5.77

Review official source filings ↗

Owners

Reported shareholders

Reference date Jun 30, 2026

≈8.96%of listed shares

Slingsby Brian Taylor7.92M shares · Feb 19, 2026

View holders

Top 20 reported holders of MLYS
Holder	% owned
Slingsby Brian Taylor	≈8.96%7.92M shares
Catalys Pacific, LLC	8.95%7.9M shares
RA CAPITAL MANAGEMENT, L.P.	8.71%7.69M shares
BlackRock, Inc.	6.66%5.89M shares
AKKARAJU SRINIVAS	≈6.65%5.88M shares
SAMSARA BIOCAPITAL, LLC	6.65%5.87M shares
Samsara BioCapital, L.P. / Samsara BioCapital GP, LLC	≈6.42%5.67M shares
FMR LLC	5.11%4.51M shares
STATE STREET CORP	4.69%4.14M shares
DEERFIELD MANAGEMENT COMPANY, L.P.	4.48%3.96M shares
VANGUARD CAPITAL MANAGEMENT LLC	3.12%2.76M shares
Laurion Capital Management LP	2.84%2.51M shares
PRICE T ROWE ASSOCIATES INC /MD/	2.56%2.26M shares
ORBIMED ADVISORS LLC	2.39%2.11M shares
Capital World Investors	2.26%2M shares
ARMISTICE CAPITAL, LLC	1.96%1.74M shares
Troluce Capital Advisors LLC	1.96%1.73M shares
Nantahala Capital Management, LLC	1.86%1.64M shares
FRANKLIN RESOURCES INC	1.85%1.64M shares
ANDERA PARTNERS	1.80%1.59M shares

Percentages use 88.35M shares of this listed class outstanding on Jun 30, 2026. ≈ compares the latest reported holding with a share total from a different date; it is not a confirmed current stake.

Gray completes the 100% scale. Reported positions may overlap; holders have different reporting dates.

Source: SEC Form 4 ↗Updated Sep 29, 2026 · Quarterly data

Insider buys & sells

Jul 1, 2024–Jun 30, 2026

Buys8$90.96M disclosed value

Sells (SEC code S)103$95.46M disclosed value

Transaction	Insider	Type	Shares	Price	Value	Owned after
Jun 30, 2026Form 4 · 10b5-1	Congleton JonChief Executive Officer	SellCommon Stock	17.0K	$26.82	$455.9K	614.3K
Jun 30, 2026Form 4 · 10b5-1	Congleton JonChief Executive Officer	SellCommon Stock	58.0K	$25.94	$1.50M	631.3K
Jun 26, 2026Form 4 · 10b5-1	Warren EricChief Commercial Officer	SellCommon Stock	104.1K	$25.90	$2.70M	38.4K
Jun 17, 2026Form 4 · 10b5-1	Rodman David MalcomChief Medical Officer	SellCommon Stock	4.6K	$25.00	$114.6K	57.1K
Jun 17, 2026Form 4 · 10b5-1	Karydas DaphneDirector	SellCommon Stock	3.0K	$25.00	$75.0K	6.2K

Review ownership filings at SEC.gov ↗

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Mineralys Therapeutics, Inc. (MLYS)

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