MLYS Stock — Mineralys Therapeutics Inc.: Cash, EV, Pipeline

What they do

Our product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that we are developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension and related comorbidities such as chronic kidney disease (CKD) and obstructive sleep apnea (OSA).

Source: 10-K FY2025 via SEC EDGAR

Share price

$15.61

Market cap

$1,382.5M

Cash

$101.3M

Enterprise value

$1,281.3M

Balance sheet

Cash	$101.3M
Debt	$0.1M
Net cash	$101.2M
Enterprise value	$1,281.3M
Basic shares	88.6M shares
Fully diluted shares	98.1M shares
Fully diluted market cap	$1,531.3M
Cash per share	$1.14
Quarterly burn	$32.6M
Cash runway	3.1 quarters

Cash figures as of 2026-09-30. Database snapshot: 2026-11-10.

Share structure

Common

88.4M

Pre-funded warrants

0.5M

Options

7.1M

RSUs

0.0M

Warrants

0.0M

Converts

0.0M

Conv preferred

0.0M

ESPP reserve

2.1M

FDSO

98.1M

Cap table as of 2026-09-30.

Price history

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Next catalyst

Lorundrostat · Dec 22, 2026 · guided in 6 wks

Recently reported

lorundrostat Phase 3 Positive · 2026-11-08

hypertension

Primary: Change in automated office systolic blood pressure (AOSBP) from Launch-HTN baseline to Week 48 — 17.8 mmHg absolute reduction in AOSBP through Week 48 (p<0.0001)

· 56% of participants reached AOSBP below 130 mmHg at Week 48

· Efficacy analysis n=504

· 632 participants enrolled in the open-label extension; 583 (92%) completed 48 weeks of follow-up

· Results were similar among participants taking two background antihypertensive medications and those taking three or more

· U.S. FDA review of lorundrostat is underway, with a PDUFA target date of December 22, 2026

Safety: Well tolerated with no new clinically relevant safety findings beyond Launch-HTN; serious adverse events in 27 participants (4.3%), 37 participants (5.9%) discontinued trial drug because of an adverse event, hyperkalemia requiring a trial drug modification in 32 participants (5.1%)

Source release →

Upcoming catalysts

Expected	Drug	Phase	Indication	Mgmt guide
GUIDEDDec 22, 2026 in 6 wks	Lorundrostat Lorundrostat NDA (PDUFA)	Not disclosed	Lorundrostat ()	December 22, 2026 (PDUFA target action date)

Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.

Full readout calendar →

Pipeline assets

lorundrostat

Phase 3 · Active Modality: oral small molecule

Target CYP11B2 (aldosterone synthase)

Partnerships Tanabe Pharma Corporation: exclusive worldwide license (exclusive, royalty-free, sublicensable, perpetual, irrevocable as of Jun 2026 amendment); $200M upfront, up to $255M commercial milestones plus up to $10M for a potential second indication

Indications

Uncontrolled / resistant hypertension (Phase 3)
Chronic kidney disease (with hypertension) (Phase 2)
Obstructive sleep apnea (with hypertension) (Phase 2)

Catalysts

— December 22, 2026

Status note Sole clinical candidate. NDA submitted Dec 2025 for hypertension in combination with other antihypertensives; FDA accepted with PDUFA target Dec 22, 2026. Six lorundrostat trials completed, including two pivotal hypertension trials (Launch-HTN Phase 3, Advance-HTN Phase 2), Phase 2 Explore-CKD, and exploratory Phase 2 Explore-OSA; Transform-HTN open-label extension ongoing. Filing does not disclose further OSA development plans following the completed exploratory OSA trial.

Per-asset detail extracted from the 10-Q filed 2026-08-11. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.

Pipeline

Lead drug	lorundrostat
Lead indication	Hypertension
Lead phase	Phase 3
Active trials	1

Active clinical trials

Trial	Phase	Status	Role	Sponsor	BP	Condition(s)	Mgmt guide
NCT05968430	Phase 3	Active, not recruiting	Sponsor	MLYS	—	Hypertension	—

Sponsor-matched active trials from ClinicalTrials.gov (1 as sponsor, 0 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.

View all 1 active trials for Mineralys Therapeutics Inc. on ClinicalTrials.gov

Specialist fund holders

Tracked specialist funds: ADAR1 Capital Management, Aisling Capital, Ally Bridge Group, Avoro Capital Advisors, BVF Partners, Baker Bros. Advisors, Boxer Capital, Braidwell LP, Casdin Capital, Cormorant Asset Management, DAFNA Capital, Deerfield Management, EcoR1 Capital, Frazier Life Sciences, Great Point Partners, Ikarian Capital, Logos Global Management, OrbiMed Advisors, Perceptive Advisors, RA Capital Management, RTW Investments, Sphera Biotech, Stonepine Capital, Tang Capital Partners, Vivo Capital.

Fund	Shares	Q/Q change	% of portfolio	Filing
RA Capital Management	7,692,750	no change	1.80%	2026-08-14
Deerfield Management	3,958,000	+3,958,000	1.11%	2026-08-14
OrbiMed Advisors	2,110,300	+57,400	1.08%	2026-08-14
Sphera Biotech	1,469,971	+130,000	5.68%	2026-08-14
Logos Global Management	1,050,000	+1,050,000	1.22%	2026-08-14
ADAR1 Capital Management	298,886	+144,200	0.38%	2026-08-14
DAFNA Capital	44,490	+6,000	0.23%	2026-08-14

Specialist-fund positions from 13F filings. Q/Q change is vs the prior quarter's filing; % of portfolio is the fund's own reported portfolio weight.

Latest news

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MLYS — Mineralys Therapeutics Inc. ☆

What they do

Balance sheet

Share structure

Price history

Next catalyst

Recently reported

Upcoming catalysts

Pipeline assets

Pipeline

Active clinical trials

Specialist fund holders

Latest news

MLYS — Mineralys Therapeutics Inc.