Denali Therapeutics Inc.
DNLI · Biological Products, (No Diagnostic Substances) · 158.7M shares · +9%/yr ↑ dilution · EDGAR filings ↗
Reference price $16.50 · est. market cap ~$2.6B — last insider sale, 2026-01-06 (estimated from the dated SEC Form 4 price × shares outstanding — not a live quote)
Grade
D46Clinical/early-stage biotech — neuro clinical, heavy burn ($422M), very well-funded.
Strengths
- Liquidity — current ratio 9.2 (80th)
Risks
- Pre-revenue, deep losses — per metrics
- Pre-revenue/clinical-stage — history of losses & need for capital per risk factors
- Binary clinical & funding risk — per 10-K
Notable findings
- Fund exitedNotable fund(s) exited this quarter: VANGUARD GROUP INC, RENAISSANCE TECHNOLOGIES LLC
- Cash burnNegative free cash flow (-422.1M)
- Chronic dilutionShare count +9%/yr over 4y (dilution, book value/share -27%)
- Strong balance sheetStrong balance sheet — $966M cash & investments, ~9 quarters of runway
- Insider sellingInsider selling — 2 open-market sale(s) by 2 insider(s) (cluster of 2 insiders, ~$864,864, last 6mo) Form 4 ↗
- Trial readout soonUpcoming trial readout ~2026-12 — PHASE1/PHASE2 · Frontotemporal Dementia
- Trial resultTrial topline data reported — see 8-K for outcome 8-K ↗
- Notable holderHeld by 4 notable fund(s): STATE STREET CORP, FMR LLC, GOLDMAN SACHS GROUP INC +1 more (as of 2026-03-31)
Quarterly revenue
Last 4 quarters · from SEC filings.
Key metrics
Return on equity
-50.6%
Return on assets
-44.8%
Current ratio
9.2×
Free cash flow
-$422M
EBITDA
-$544M
Tangible book value
$1.0B
Cash & investments
$966M
Cash runway
9q
Insider transactions · last 18 months
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| 2026-06-03 | Van Hauwermeiren Timothy | Grant | 6.4K | — |
| 2026-06-03 | Thornberry Nancy | Grant | 6.4K | — |
| 2026-06-03 | Cook Jennifer E. | Grant | 6.4K | — |
| 2026-06-03 | Krognes Steve E. | Grant | 6.4K | — |
| 2026-06-03 | Schenkein David P | Grant | 6.4K | — |
| 2026-06-03 | Klein Peter S | Grant | 6.4K | — |
| 2026-06-03 | BAKER BROS. ADVISORS LP | Grant | 6.4K | — |
| 2026-06-03 | BAKER BROS. ADVISORS LP | Grant | 6.4K | — |
| 2026-06-03 | FLATLEY JAY T | Grant | 6.4K | — |
| 2026-01-06 | Schuth Alexander O. | Sell | 17K | $16.50 |
| 2026-01-06 | Watts Ryan J. | Sell | 35K | $16.50 |
| 2026-01-03 | Schuth Alexander O. | Grant | 58K | — |
| 2026-01-03 | Watts Ryan J. | Grant | 79K | — |
| 2025-11-04 | Van Hauwermeiren Timothy | Grant | 11K | — |
| 2025-09-03 | Watts Ryan J. | Gift | 50K | — |
| 2025-08-13 | Ho Carole | Sell | 806 | $14.64 |
| 2025-08-12 | Schuth Alexander O. | Sell | 2.9K | $13.58 |
| 2025-08-12 | Ho Carole | Sell | 2.9K | $13.58 |
| 2025-08-05 | Ho Carole | Option exercise | 45K | $0.68 |
| 2025-07-09 | Watts Ryan J. | Sell | 495K | $15.00 |
| 2025-07-09 | Watts Ryan J. | Option exercise | 455K | $0.68 |
| 2025-07-09 | Watts Ryan J. | Option exercise | 40K | $5.28 |
| 2025-06-03 | Cook Jennifer E. | Grant | 6.0K | — |
| 2025-06-03 | FLATLEY JAY T | Grant | 6.0K | — |
| 2025-06-03 | Klein Peter S | Grant | 6.0K | — |
| 2025-06-03 | Krognes Steve E. | Grant | 6.0K | — |
| 2025-06-03 | Schenkein David P | Grant | 6.0K | — |
| 2025-06-03 | Thornberry Nancy | Grant | 6.0K | — |
| 2025-06-03 | Tessier-Lavigne Marc | Grant | 6.0K | — |
| 2025-06-03 | BAKER BROS. ADVISORS LP | Grant | 11K | — |
| 2025-06-03 | BAKER BROS. ADVISORS LP | Grant | 11K | — |
| 2025-01-07 | Ho Carole | Sell | 2.9K | $20.81 |
| 2025-01-07 | Schuth Alexander O. | Sell | 2.9K | $20.81 |
| 2025-01-07 | Watts Ryan J. | Sell | 7.7K | $20.81 |
| 2025-01-07 | Krognes Steve E. | Sell | 3.3K | $20.81 |
| 2025-01-06 | Watts Ryan J. | Sell | 29K | $20.22 |
| 2025-01-06 | Schuth Alexander O. | Sell | 12K | $20.22 |
| 2025-01-06 | Ho Carole | Sell | 12K | $20.22 |
| 2025-01-03 | Ho Carole | Grant | 54K | — |
| 2025-01-03 | Watts Ryan J. | Grant | 54K | — |
| 2025-01-03 | Schuth Alexander O. | Grant | 54K | — |
| 2025-01-02 | SATO VICKI L | Sell | 3.1K | $20.91 |
| 2024-12-31 | Krognes Steve E. | Sell | 30K | $20.25 |
All non-derivative Form 4 activity (SEC), newest first.
Clinical trials
| Trial | Title | Phase | Status | Primary completion |
|---|---|---|---|---|
| NCT04251026 ↗ | A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome Mucopolysaccharidosis II | PHASE1/PHASE2 | Active Not Recruiting | 2031-02-01 |
| NCT07354724 ↗ | A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease Late-onset Pompe Disease | PHASE1 | Recruiting | 2028-08-01 |
| NCT06181136 ↗ | Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A) Mucopolysaccharidosis Type IIIA | PHASE1/PHASE2 | Active Not Recruiting | 2028-08-01 |
| NCT05371613 ↗ | A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II) Mucopolysaccharidosis II | PHASE2/PHASE3 | Recruiting | 2027-12-01 |
| NCT06075537 ↗ | An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007 Mucopolysaccharidosis II | PHASE2/PHASE3 | Enrolling By Invitation | 2027-06-01 |
| NCT06602193 ↗ | Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) Parkinson Disease | PHASE2 | Active Not Recruiting | 2027-03-01 |
| NCT07328451 ↗ | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease Alzheimer Disease, Early Onset | PHASE1 | Recruiting | 2027-02-01 |
| NCT05262023 ↗ | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN) Frontotemporal Dementia | PHASE1/PHASE2 | Active Not Recruiting | 2026-12-01 |
| NCT06281158 ↗ | A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants Healthy Volunteers | PHASE1 | Completed | 2024-04-30 |
| NCT04007536 ↗ | A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome Mucopolysaccharidosis II | — | Completed | 2024-03-01 |
| NCT05450549 ↗ | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants Healthy Participant | PHASE1 | Completed | 2023-06-08 |
| NCT05006352 ↗ | A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis | PHASE1 | Completed | 2022-12-15 |
| NCT04268784 ↗ | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers Healthy Volunteers | PHASE1 | Completed | 2021-08-03 |
| NCT04581772 ↗ | A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers Healthy Volunteers | PHASE1 | Completed | 2021-06-04 |
| NCT04557800 ↗ | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers Healthy Volunteers | PHASE1 | Completed | 2021-02-19 |
| NCT03710707 ↗ | Study to Evaluate DNL201 in Subjects With Parkinson's Disease Parkinson Disease | PHASE1 | Completed | 2019-12-06 |
| NCT03757325 ↗ | Study to Evaluate DNL747 in Subjects With Alzheimer's Disease Alzheimer Disease | PHASE1 | Completed | 2019-12-05 |
| NCT04551534 ↗ | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers Healthy Volunteers | PHASE1 | Completed | 2018-08-08 |
Source: ClinicalTrials.gov (U.S. NIH) · active studies first.
Notable events (8-K)
Recent filings
| Form | Filed | Period | Accession |
|---|---|---|---|
| 8-K | 2026-06-18 | 2026-06-12 | 0001714899-26-000081 ↗ |
| 8-K | 2026-06-04 | 2026-06-03 | 0001714899-26-000074 ↗ |
| 8-K | 2026-05-22 | 2026-05-21 | 0001714899-26-000070 ↗ |
| 8-K | 2026-05-07 | 2026-05-07 | 0001714899-26-000062 ↗ |
| 10-Q | 2026-05-07 | 2026-03-31 | 0001714899-26-000064 ↗ |
| 8-K | 2026-04-03 | 2026-04-03 | 0001714899-26-000042 ↗ |
| 8-K | 2026-03-31 | 2026-03-27 | 0001714899-26-000036 ↗ |
| 8-K | 2026-03-25 | 2026-03-25 | 0001714899-26-000030 ↗ |
| 8-K | 2026-02-26 | 2026-02-26 | 0001714899-26-000020 ↗ |
| 10-K | 2026-02-26 | 2025-12-31 | 0001714899-26-000021 ↗ |
| 8-K | 2026-01-06 | 2026-01-06 | 0001714899-26-000004 ↗ |
| 8-K | 2025-12-10 | 2025-12-09 | 0001628280-25-056363 ↗ |