DNLI Stock — Denali Therapeutics Inc.: Cash, EV, Pipeline

What they do

We have invented, developed, and validated a proprietary technology, called the TransportVehicle TM ("TV"), to address the blood-brain barrier challenge and enable a new class of barrier-crossing therapeutics. The TV has a modular design enabling delivery of large molecules, i.e., enzymes, oligonucleotides, and antibodies, to all tissues of the body, including the brain, by crossing the blood-brain barrier after systemic administration.

Source: 10-K FY2025 via SEC EDGAR

Share price

$18.71

Market cap

$2,998.3M

Cash

$1,007.6M

Enterprise value

$2,200.4M

Balance sheet

Cash	$1,007.6M
Debt	$0.0M
Royalty-sale liability	$209.7M
Net cash	$1,007.6M
Enterprise value	$2,200.4M
Basic shares	160.3M shares
Fully diluted shares	216.1M shares
Fully diluted market cap	$4,042.8M
Cash per share	$6.29
Quarterly burn	$97.0M
Cash runway	10.4 quarters

Cash figures as of 2026-09-30. Database snapshot: 2026-11-13.

Royalty-sale liability as of 2026-09-30 (10-Q); included in enterprise value.

Share structure

Common

159.8M

Pre-funded warrants

28.3M

Options

21.0M

RSUs

5.3M

Warrants

0.0M

Converts

0.0M

Conv preferred

0.0M

ESPP reserve

1.6M

FDSO

216.1M

Cap table as of 2026-06-30.

Price history

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Next catalyst

DNL593 · Jan 12 - Feb 23 in 8 wks · Phase 2 · Frontotemporal Dementia

Upcoming catalysts

Expected	Drug	Phase	Indication	Mgmt guide
Jan 12 - Feb 23 in 8 wks	DNL593	Phase 2	Frontotemporal Dementia	—
GUIDEDEst. Apr 1, 2027 in 7 wks half midpoint	DNL151 Phase 2a BEACON study in LRRK2-variant Parkinson's disease	Phase 2a	LRRK2-variant Parkinson's disease	1H 2027
Mar 15 - Apr 26 in 4 mo	DNL628	Phase 1	Alzheimer Disease, Early Onset	1H 2027 Est. Apr 1, 2027 · half midpoint
GUIDEDEst. Jul 2, 2027 in 7 wks guidance midpoint	DNL593 Phase 1/2 study in FTD-GRN	Phase 1/2	FTD-GRN	2027
GUIDEDEst. Jul 2, 2027 in 7 wks guidance midpoint	DNL921 Phase 1/1b study in Alzheimer's disease	Phase 1/1b	Alzheimer's disease	2027
GUIDEDEst. Jul 2, 2027 in 7 wks guidance midpoint	DNL952 Phase 1 study in late-onset Pompe disease	Phase 1	late-onset Pompe disease	2027
GUIDEDEst. Jul 2, 2027 in 7 wks guidance midpoint	Zafinofusp alfa BLA submission and potential accelerated approval for Sanfilippo syndrome type A	Not disclosed	Sanfilippo syndrome type A	2027
Jul 13 - Aug 24 in 8 mo	tividenofusp alfa	Phase 3	Mucopolysaccharidosis II	—
Jan 12 - Feb 23 in 14 mo	tividenofusp alfa	Phase 3	Mucopolysaccharidosis II	—
Sep 12 - Oct 24 in 22 mo	DNL126	Phase 2	Mucopolysaccharidosis Type IIIA	—
Sep 12 - Oct 24 in 22 mo	DNL952	Phase 1	Late-onset Pompe Disease	—
May 13 - Jun 24 in 43 mo	DNL921	Phase 1	Alzheimer's Disease; Healthy Participants	—
Mar 15 - Apr 26 in 53 mo	tividenofusp alfa	Phase 2	Mucopolysaccharidosis II	—

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

AVLAYAH

Approved · Active Modality: enzyme replacement therapy (ETV-enabled, BBB-crossing biologic)

Aliases tividenofusp alfa, ETV:IDS, DNL310

Target IDS (iduronate 2-sulfatase)

Partnerships Company retains worldwide rights; Royalty Pharma synthetic royalty (9.25% of worldwide net sales, $200M received on approval plus $75M on EMA approval by December 31, 2029); Genentech license; F-star milestone ($36M due on FDA approval, $24M EU milestone pending)

Indications

Hunter syndrome (MPS II) neurologic manifestations (Approved)

Status note FDA accelerated approval March 24, 2026 for presymptomatic or symptomatic pediatric patients at least 5 kg; commercial distribution began April 2026. Continued approval contingent on confirmatory evidence from ongoing global Phase 2/3 COMPASS trial. Rare Pediatric Disease PRV sold for $195M (closed July 2026).

Zafinofusp alfa

Phase 2 · Active Modality: enzyme replacement therapy (ETV-enabled biologic)

Aliases DNL126, ETV:SGSH

Target SGSH (N-sulfoglucosamine sulfohydrolase)

Partnerships Company retains rights; START program selection (June 2024)

Indications

Sanfilippo syndrome type A (MPS IIIA) (Phase 2)

Status note Open-label Phase 1/2 study enrollment completed September 2025.

DNL593

Phase 2 · Active Modality: biologic (protein transport vehicle)

Aliases PTV:PGRN, TAK-594

Target PGRN (progranulin)

Partnerships Takeda collaboration terminated April 2026 (effective June 2026); all rights reverted to Company. Termination driven by strategic considerations, not efficacy or safety data

Indications

Frontotemporal dementia-granulin (FTD-GRN) (Phase 2)

Status note Company continues to conduct the Phase 1/2 study of DNL593 for FTD-GRN following Takeda termination.

DNL628

Phase 1 · Active Modality: oligonucleotide

Aliases OTV:MAPT

Target MAPT (tau)

Partnerships not disclosed

Indications

Alzheimer's disease (Phase 1)

Status note Phase 1b CTA approved January 2026; first patient dosed March 2026.

DNL952

Phase 1 · Active Modality: enzyme replacement therapy (ETV-enabled biologic)

Aliases ETV:GAA

Target GAA

Partnerships not disclosed

Indications

Pompe disease (Phase 1)

Status note FDA lifted IND clinical hold January 2026; Phase 1 study enrolling.

DNL921

Phase 1 · Active Modality: antibody (ATV-enabled)

Aliases ATV:Abeta

Target amyloid beta

Partnerships Biogen ROFN and Option Agreement includes option/right of first negotiation to ATV amyloid beta program

Indications

Alzheimer's disease (Phase 1)

Status note CTA submitted first half 2026 to initiate Phase 1/1b study in healthy volunteers and Alzheimer's participants; study underway.

DNL151

Phase 2 · Active Modality: small molecule (oral)

Target LRRK2

Partnerships Biogen: LRRK2 co-development/co-commercialization license (October 2020); R&D funding collaboration with unrelated third party (up to $75M) for BEACON study

Indications

Parkinson's disease (LRRK2 pathogenic variant carriers) (Phase 2)
Parkinson's disease (idiopathic) (Phase 2)

Status note Development in idiopathic Parkinson's discontinued (May 2026). Company continues Phase 2a BEACON study in LRRK2 variant carriers independently.

Per-asset detail extracted from the 10-Q filed 2026-08-06. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.

Pipeline

Lead drug	tividenofusp alfa
Lead indication	Mucopolysaccharidosis II
Lead phase	Phase 3
Active trials	9

Active clinical trials

Trial	Phase	Status	Role	Sponsor	BP	Condition(s)	Mgmt guide
NCT06075537	Phase 3	Enrolling by invitation	Sponsor	DNLI	—	Mucopolysaccharidosis II	—
NCT05371613	Phase 3	Active, not recruiting	Sponsor	DNLI	—	Mucopolysaccharidosis II	—
NCT05262023	Phase 2	Active, not recruiting	Sponsor	DNLI	TAK	Frontotemporal Dementia	—
NCT06602193	Phase 2	Active, not recruiting	Sponsor	DNLI	BIIB	Parkinson Disease	—
NCT06181136	Phase 2	Active, not recruiting	Sponsor	DNLI	—	Mucopolysaccharidosis Type IIIA	—
NCT04251026	Phase 2	Active, not recruiting	Sponsor	DNLI	—	Mucopolysaccharidosis II	—
NCT07328451	Phase 1	Recruiting	Sponsor	DNLI	—	Alzheimer Disease, Early Onset	1H 2027 Est. Apr 1, 2027 · half midpoint
NCT07354724	Phase 1	Recruiting	Sponsor	DNLI	—	Late-onset Pompe Disease	2027 Est. Jul 2, 2027 · guidance midpoint
NCT07758595	Phase 1	Recruiting	Sponsor	DNLI	—	Alzheimer's Disease; Healthy Participants	2027 Est. Jul 2, 2027 · guidance midpoint

Sponsor-matched active trials from ClinicalTrials.gov (9 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 9 active trials for Denali 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
Baker Bros. Advisors	3,734,336	+2,641	0.48%	2026-08-14
Casdin Capital	2,045,000	+205,000	2.63%	2026-08-14
ADAR1 Capital Management	1,029,080	-842,375	1.24%	2026-08-14
DAFNA Capital	739,014	+420,514	3.62%	2026-08-14
Braidwell LP	0	-296,324	0.00%	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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DNLI — Denali Therapeutics Inc. ☆

What they do

Balance sheet

Share structure

Price history

Next catalyst

Upcoming catalysts

Pipeline assets

Pipeline

Active clinical trials

Specialist fund holders

Latest news

DNLI — Denali Therapeutics Inc.