DNLI at a glance
Denali Therapeutics Inc. (DNLI, SEC CIK 1714899) filed its latest 10-K annual report on February 26, 2026, a 10-Q quarterly report on August 6, 2026, an 8-K current report on August 6, 2026 and Form 4 insider filings as recently as September 9, 2026. SignalX summarizes each filing with AI and tracks the company's insider trades and institutional holders.
- For the fiscal year ended December 31, 2025 (FY2025), Denali Therapeutics Inc. (DNLI) reported revenue of $0 and a net loss of $512.5 million. Diluted EPS was -$2.97.
- As of June 30, 2026, 29 institutional investment managers tracked by SignalX reported holding Denali Therapeutics Inc. (DNLI) shares worth $1.5 billion in 13F-HR filings.
- The most recent insider open-market sale reported on Form 4 was by Chin Peter Scott on September 4, 2026 of 1,654 shares at $22.29 per share.
- In the last 90 days, DNLI insiders reported 0 open-market purchases ($0) and 5 open-market sales ($435K) on Form 4, a net sale of $435K.
Source: SEC EDGAR (XBRL financial data, 13F-HR and Form 4 filings).
- Revenue · FY2025
- $0
- 10-K XBRL
- Insiders · 90 days
- 0 buys · 5 sells
- Net −$435K
- 13F holders
- 29 funds
- $1.5B · +1 vs prior quarter
- Latest 8-K
- Aug 6, 2026
- Item 2.02
AI 10-K Annual Report Analysis
Latest 10-K, fiscal year ended Dec 31, 2025
Risk Factors
- FDA regulatory risk: Phase 2/3 HEALEY ALS trial of DNL343 missed primary endpoints in Jan 2025, risking program discontinuation or delays
- Geopolitical/macro exposure: $966.2M cash runway through 12+ months threatened by inflation, tariffs, foreign currency risks, and economic downturns
- Supply chain: Reliance on third parties for clinical trial manufacturing and raw materials may cause shortages or delays in product supply
- Competition: Risk from other neurodegenerative disease biotech firms as limited approved therapies increase pressure to demonstrate efficacy first
- Financial risk: Accumulated deficit $2.05B with $512.5M net loss in 2025; no product revenue, ongoing need for additional financing to continue development
Management Discussion & Analysis
- Revenue recognition requires significant judgment on collaboration arrangements; no material revenue true ups reported to date
- Research & development (R&D) expenses mainly external, based on estimates from progress reports; no material true ups in R&D expenses or reimbursements to date
- Increasing judgment required for R&D expense estimates due to more extensive late-stage clinical trials
- R&D funding payments recorded as liability and offset to R&D expenses; no material true ups in funding recognition
- No specific revenue, profitability, segment performance, cash flow, or forward-looking guidance disclosed in this section
Business Overview
- Core business: Developing biotherapeutics using proprietary TransportVehicle™ (TV) technology to cross blood-brain barrier and treat neurodegenerative and lysosomal storage diseases
- New emphasis: Advancing two near-launch products (tividenofusp alfa for MPS II (Hunter syndrome) and DNL126 for MPS IIIA) with $1B+ initial market opportunity
- Strategic shift: Transitioning from platform validation to commercial delivery with D3X3 strategy targeting two commercial brands, five clinical proof-of-concept readouts, and 4-6 new clinical programs (2026-2028)
- Quantitative highlight: Over 200 clinical trial participants dosed with 11,000+ TV-enabled therapeutic doses; commercial readiness established including dedicated commercial team
- Noteworthy fact: April 5, 2026 PDUFA date for tividenofusp alfa’s FDA accelerated approval BLA with expected first product launch, despite regulatory review extension due to major amendment
AI summary of the DNLI 10-K filed . Generated from the filing text; verify against the original.View on SEC EDGARHow to read a 10-K
AI 10-Q Quarterly Report Analysis
Latest 10-Q, quarter ended Jun 30, 2026
Management Discussion & Analysis
- Revenue $3.6M, versus $0 prior-year quarter, driven by AVLAYAH commercial launch
- Operating loss $130.5M, with operating margin -3,624.4% versus not meaningful prior-year margin
- Net loss $127.6M versus $124.1M, with net margin -3,539.3% versus not meaningful
- Best-performing product AVLAYAH, generating $3.6M revenue; no other commercial products
- PRV sale generated $195.0M gross proceeds, received July 2026; Royalty Pharma funding added $200.0M gross proceeds in March
- Continued operating losses expected as AVLAYAH commercialization and clinical programs advance; Takeda collaboration termination and failed LUMA endpoints emerging headwinds
Risk Factors
- No risk-factors section provided; supplied text covers Items 2–6 rather than changed or carried-forward risks
- Financing risk: $499.3 million private-placement proceeds subject to dilution from 26,046,065 pre-funded warrants
- Compliance risk: private placement relies on Section 4(a)(2) and Rule 506(b) Regulation D exemptions
- Governance risk: investor received director-nomination and additional registration rights
- Market risk: director trading plan permits sales of up to 35,377 shares through September 2, 2027
AI summary of the DNLI 10-Q filed . Generated from the filing text; verify against the original.View on SEC EDGAR10-K vs 10-Q vs 8-K
AI 8-K Current Report Analysis
The most recent material events, by 8-K item
Item 2.02: Results of Operations and Financial Condition
- Q2 2026 financial results for quarter ended June 30, 2026
- Press release issued August 6, 2026
Item EX-99.1: Item EX-99.1
- AVLAYAH launch generated $3.6M Q2 net product revenue; projected Q3 revenue of $10.0M-$12.0M signals rapid commercial ramp
- Coverage expanded to more than 50% of covered lives and 14 Medicaid programs, supporting near-term prescription growth
Item 2.01: Completion of Acquisition or Disposition of Assets
- Denali completed sale of its Rare Pediatric Disease PRV on July 27, 2026
- $195.0 million gross proceeds received at closing, providing substantial non-dilutive liquidity
Item 1.01: Entry into a Material Definitive Agreement
- $195 million cash proceeds upon closing from sale of FDA Rare Pediatric Disease Priority Review Voucher
- Voucher awarded after AVLAYAH approval for Hunter syndrome in March 2026
Item 7.01: Regulation FD Disclosure
- Denali issued a June 18, 2026 press release under Regulation FD, making material information broadly available
- Full disclosure details appear in Exhibit 99.1, which investors should review for the event’s financial or clinical implications
AI summaries of DNLI 8-K current reports filed with the SEC. What 8-K item codes mean
SignalX for DNLI
Don't miss the next DNLI filing
- Alerts as it files. A push when DNLI files an 8-K or an insider trades.
- Fund moves. Which tracked funds opened, added or cut DNLI, by share count.
- Ask anything. An AI agent that reads every DNLI filing and answers with sources.
DNLI alerts on your phone. Follow it in the SignalX Android app.
Recent Insider Transactions (Form 4)
Latest reported trades by officers, directors and 10% owners
| Insider | Type | Date | Shares | Price |
|---|---|---|---|---|
| Chin Peter Scott | Sell | Sep 4, 2026 | 1,654 | $22.29 |
| Thornberry Nancy | Sell | Sep 2, 2026 | 615 | $23.74 |
| Thornberry Nancy | Sell | Sep 2, 2026 | 10,824 | $22.85 |
| Schuth Alexander O. | Sell | Sep 1, 2026 | 2,768 | $23.44 |
| Watts Ryan J. | G | Aug 12, 2026 | 32,220 | - |
| Schuth Alexander O. | Sell | Aug 11, 2026 | 2,857 | $25.07 |
| Cook Jennifer E. | A | Jun 3, 2026 | 6,408 | - |
| Thornberry Nancy | A | Jun 3, 2026 | 19,226 | - |
Financial SummaryXBRL
| Metric | FY2023 | FY2024 | FY2025 |
|---|---|---|---|
| Profitability | |||
| Revenue | - | $0 | $0 |
| Operating Income | - | -$487.3M | -$555.3M |
| Net Income | -$145.2M | -$422.8M | -$512.5M |
| Balance Sheet | |||
| Total Assets | - | $1.4B | $1.1B |
| Equity | $1.0B | $1.2B | $1.0B |
| ROE | -14.1% | -34.4% | -50.6% |
| Per Share | |||
| EPS | $-1.06 | $-2.57 | $-2.97 |
| Cash Flow | |||
| Operating CF | - | -$347.7M | -$412.6M |
| CapEx | $12.9M | $15.9M | $9.5M |
Source: XBRL data in Denali Therapeutics Inc. (DNLI)'s 10-K filings on SEC EDGAR, in USD. Compare across companies →
13F Fund Holdings: Quarterly Trend
Latest: Q2 2026Aggregate DNLI share value held by 13F filers tracked by SignalX, by quarter.
Quarterly totals table
| Quarter | Funds | Total value |
|---|---|---|
| Q2 2026 | 29 | $1.49B |
| Q1 2026 | 28 | $1.04B |
| Q4 2025 | 26 | $936.8M |
| Q3 2025 | 28 | $794.5M |
| Q2 2025 | 28 | $773.8M |
| Q1 2025 | 23 | $491.0M |
| Q4 2024 | 18 | $650.1M |
| Q3 2024 | 16 | $318.7M |
- BlackRock+992.0K (+8%)
- State Street Corp+777.3K (+12%)
- T. Rowe Price Group+672.0K (+27%)
- Citigroup+448.0K (+1141%)
- Vanguard Portfolio Management LLC+356.9K (+6%)
- Goldman Sachs Group−251.4K (-6%)
- Morgan Stanley−143.7K (-13%)
- Millennium Management−132.2K (-11%)
- Citadel Advisors LLC−114.4K (-63%)
- Principal Financial Group−58.4K (-4%)
- Allstate+19.3K
Source: 13F-HR filings on SEC EDGAR (aggregated from 196 fund-quarter rows). Reflects only 13F filers tracked by SignalX, not the full institutional ownership universe. How 13F filings work
DNLI filing archive
AI analysis pages for each 10-K, 10-Q and 8-K
10-K annual reports
10-Q quarterly reports
Latest 2026 SEC Filings: 10-K, 10-Q, 8-K & Form 4
| Form | Filing date | Period | Analysis | SEC |
|---|---|---|---|---|
| 4 | Sep 9, 2026 | - | - | - |
| 4 | Sep 4, 2026 | - | - | - |
| 4 | Sep 3, 2026 | - | - | - |
| 4 | Aug 14, 2026 | - | - | - |
| 4 | Aug 13, 2026 | - | - | - |
| 10-Q | Aug 6, 2026 | Jun 30, 2026 | Analysis | |
| 8-K | Aug 6, 2026 | - | Analysis | - |
| 8-K | Jul 28, 2026 | - | Analysis | - |
| 8-K | Jun 18, 2026 | - | Analysis | - |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 8-K | Jun 4, 2026 | - | Analysis | |
| 8-K | May 22, 2026 | - | Analysis | |
| SC 13G | May 15, 2026 | - | - | |
| 10-Q | May 7, 2026 | Mar 31, 2026 | Analysis | |
| 8-K | May 7, 2026 | - | Analysis | |
| 8-K | Apr 3, 2026 | - | Analysis | - |
| 8-K | Mar 31, 2026 | - | - | - |
| 8-K | Mar 25, 2026 | - | - | - |
Related Health Care companies
- FDMT · 4D Molecular Therapeutics, Inc.Biological Products, (No Diagnostic Substances)
- ADPT · Adaptive Biotechnologies CorpBiological Products, (No Diagnostic Substances)
- ADMA · ADMA BIOLOGICS, INC.Biological Products, (No Diagnostic Substances)
- ALEC · Alector, Inc.Biological Products, (No Diagnostic Substances)
- ALLO · Allogene Therapeutics, Inc.Biological Products, (No Diagnostic Substances)
- AMGN · AmgenBiological Products, (No Diagnostic Substances)
- AVXL · ANAVEX LIFE SCIENCES CORP.Biological Products, (No Diagnostic Substances)
- APGE · Apogee Therapeutics, Inc.Biological Products, (No Diagnostic Substances)
DNLI SEC filings: frequently asked questions
Are DNLI insiders buying or selling?
In the last 90 days, Denali Therapeutics Inc. (DNLI) officers, directors and 10% owners reported no open-market purchases and 5 open-market sales worth $435,303 by 3 insiders on Form 4. Many insider sales are pre-planned or for taxes, so purchases usually carry more information.
Which institutions hold DNLI stock?
As of June 30, 2026, the largest Denali Therapeutics Inc. (DNLI) holders among the 13F filers tracked by SignalX were BlackRock ($360.8 million), State Street Corp ($181.3 million), Vanguard Portfolio Management LLC ($166.6 million), Vanguard Capital Management LLC ($161.4 million), FMR LLC (Fidelity) ($116.7 million). 13F-HR reports are filed up to 45 days after each quarter ends.
What was DNLI's revenue in fiscal year 2025?
For the fiscal year ended December 31, 2025 (FY2025), Denali Therapeutics Inc. (DNLI) reported revenue of $0 and a net loss of $512.5 million. Diluted EPS was -$2.97. The figures come from the XBRL data in the 10-K.
What are the main risks in DNLI's latest 10-K?
In the 10-K filed February 26, 2026, Denali Therapeutics Inc. (DNLI) flagged: FDA regulatory risk: Phase 2/3 HEALEY ALS trial of DNL343 missed primary endpoints in Jan 2025, risking program discontinuation or delays. Geopolitical/macro exposure: $966.2M cash runway through 12+ months threatened by inflation, tariffs, foreign currency risks, and economic downturns. (AI summary of the Risk Factors section.)
What did DNLI report in its latest 8-K?
Denali Therapeutics Inc. (DNLI) filed an 8-K on August 6, 2026 reporting Item 2.02 (Results of Operations and Financial Condition). Q2 2026 financial results for quarter ended June 30, 2026.
What are the latest DNLI SEC filings?
Denali Therapeutics Inc. (DNLI) filed its latest 10-K annual report on February 26, 2026, a 10-Q quarterly report on August 6, 2026, an 8-K current report on August 6, 2026 and a Form 4 insider filing on September 9, 2026.
What is DNLI's SEC CIK number?
Denali Therapeutics Inc. (DNLI)'s SEC Central Index Key (CIK) is 1714899. EDGAR lists every DNLI filing under that number.
Ask anything about DNLI
The research agent reads DNLI's filings, financials, insider trades and 13F holders, then answers with sources.