Denali Therapeutics Inc.
DNLI evidence brief
What we can confirm
- BioSniper Score:
- 7.4 / 10
- Market Cap:
- $3.55B
- Lead Asset:
- avlayah (Approved)
What it means
What to watch
Prepared research question
What matters most for DNLI—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · DNLI
Denali Therapeutics Inc. is a biotechnology company developing a portfolio of transport vehicle (TV)-enabled therapeutics to cross the blood-brain barrier, targeting neurodegenerative and lysosomal storage diseases.
Key risk: No approved products
BioSniper Score
Based on 4 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 3 pipeline candidates · 10 clinical trials · 1 FDA decision for Denali Therapeutics Inc..
Denali Therapeutics Inc. is a biotechnology company developing a portfolio of transport vehicle (TV)-enabled therapeutics to cross the blood-brain barrier, targeting neurodegenerative and lysosomal storage diseases.
- Cash & equivalents of $201.5M as of 2026-06-30 [sec].
- Total revenue of $3.6M and net income of -$127.6M for the period ending 2026-06-30 [sec].
- Shareholders' equity of $835.2M as of 2026-06-30 [sec].
- Completed enrollment in Phase 1/2 study for DNL593 (PTV:PGRN) in FTD-GRN with 40 participants; initial data expected in 2026 [sec · filed 2026-04-21].
- Phase 1b study for DNL628 (OTV:MAPT) in Alzheimer's disease initiated; first patient dosed in March 2026 [sec_mda · as of 2026-05-07].
What works
- Denali's proprietary Transport Vehicle (TV) platform is designed to enable enzyme, oligonucleotide, and antibody therapeutics to cross the blood-brain barrier, addressing a key challenge in CNS drug delivery [sec · filed 2025-04-17].
- The company has a diversified pipeline with multiple clinical-stage programs, including partnerships with Biogen (LRRK2 program) and Sanofi (RIPK1 program), which may share development costs and risks [sec_mda · as of 2026-05-07].
- Denali has a strong cash position of $201.5M as of 2026-06-30, providing a runway to advance its clinical programs without immediate financing pressure [sec].
What to weigh
- Denali has not yet generated significant product revenue ($3.6M as of 2026-06-30) and reported a net loss of -$127.6M, reflecting the high cost of R&D and lack of approved products [sec].
- The company's Phase 2/3 HEALEY ALS Platform Trial for DNL343 (eIF2B) did not meet primary or key secondary endpoints, indicating a setback in one of its clinical programs [sec_mda · as of 2025-02-27].
- Denali's accumulated deficit and reliance on future financing or partnership milestones create uncertainty, as the company has devoted substantially all resources to R&D with no marketed products [sec_mda · as of 2026-08-06].
From the filings
Quoted directly from source documents.
Enrollment completed in Phase 1/2 for DNL593 in FTD-GRN
“We completed enrollment in the ongoing Phase 1/2 study with a total of 40 participants with FTD- GRN enrolled.”
SEC filings · April 21, 2026
Phase 1b for DNL628 in Alzheimer's disease started, first patient dosed March 2026
“In March 2026, the first patient was dosed in the Phase 1b stu”
SEC MD&A · May 7, 2026
DNL343 (eIF2B) did not meet primary or key secondary endpoints in ALS trial
“topline results that the primary and key secondary endpoints were not met.”
SEC MD&A · February 27, 2025
Catalyst timeline
- 2020-07-16 · Phase2_Start: A Phase 1/2, Multicenter, Open-Label Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL310 in Pediatric Participants With Hunter Syndrome — Initiation of a Phase 1/2 study for DNL310 in Hunter syndrome; watch for future efficacy and safety data.
- 2022-02-01 · Phase2_Start: A Phase 1/2, Multicenter, Randomized, Placebo-Controlled, Double Blind Single Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia Followed by an Open-Label Extension — Start of Phase 1/2 study for DNL593 in FTD; initial data expected in 2026.
- 2022-07-21 · Phase3_Start: A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronop — Initiation of a Phase 2/3 study for DNL310; watch for comparative efficacy results.
Risks & what to watch (3)›
Key risks
- No approved products — Denali has no marketed products; all revenue is from collaborations, with net losses of -$127.6M as of 2026-06-30 [sec].
- Clinical trial failure risk — The DNL343 ALS trial failed to meet endpoints; other pipeline programs face similar uncertainty [sec_mda · as of 2025-02-27].
- Cash runway dependency — With $201.5M cash but ongoing R&D spend, the company must manage burn rate until potential product approvals [sec].
What to watch
- Initial FTD-GRN patient data from the Phase 1/2 DNL593 study expected in 2026 [sec · filed 2026-04-21].
- Progress of Phase 1b study for DNL628 (OTV:MAPT) in Alzheimer's disease, with first patient dosed in March 2026 [sec_mda · as of 2026-05-07].
- Phase 1 study start-up for DNL952 (ETV:GAA) in Pompe disease, following FDA lift of clinical hold in January 2026 [sec_mda · as of 2026-05-07].
- Further analyses of DNL343 (eIF2B) ALS trial results anticipated later in 2025 [sec_mda · as of 2025-02-27].
Sources: Catalysts · SEC filings · SEC MD&A · Generated September 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.39 · 0% dilution
Lead: Approved
3 candidates
No upcoming catalysts tracked
0 buys · 1 sell (180d)
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
266
Total value held
$2.61B
| Holder | Shares | Value |
|---|---|---|
| blackrock, inc. | 13,034,434 | $250.3M |
| baillie gifford & co | 12,066,479 | $231.7M |
| temasek holdings (private) ltd | 7,012,974 | $134.6M |
| state street corp | 6,272,001 | $120.4M |
| vanguard capital management llc | 6,147,957 | $118.0M |
| vanguard portfolio management llc | 6,120,160 | $117.5M |
| fmr llc | 4,575,374 | $87.8M |
| ubs am, a distinct business unit of ubs asset management americas llc | 4,432,314 | $85.1M |
| goldman sachs group inc | 4,407,255 | $84.6M |
| baker bros. advisors lp | 3,731,695 | $71.6M |
Showing top 10 of 266 institutional holders of Denali Therapeutics Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 19, 2026- % of float
- 9.9%
- Days to cover
- 9.9
- Shares short
- 14,813,936
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
DNLI short interestGovernance
Frequently asked questions
What is the AI investment thesis for Denali Therapeutics Inc.?
Denali Therapeutics Inc. is a biotechnology company developing a portfolio of transport vehicle (TV)-enabled therapeutics to cross the blood-brain barrier, targeting neurodegenerative and lysosomal storage diseases.
What is Denali Therapeutics Inc.'s lead drug candidate?
Denali Therapeutics Inc.'s most advanced tracked candidate is avlayah (Approved).
Who is the CEO of Denali Therapeutics Inc.?
Dr. Ryan J. Watts Ph.D. is the chief executive officer of Denali Therapeutics Inc. (DNLI).
Where is Denali Therapeutics Inc. headquartered?
Denali Therapeutics Inc. (DNLI) is headquartered in South San Francisco, CA, United States.
What therapeutic areas does Denali Therapeutics Inc. focus on?
Denali Therapeutics Inc. develops therapies across Rare Disease, Neurology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.