DNLI Denali Therapeutics Inc.

company

SEC Filings & Insider Trading Activity 2026

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

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

What are the latest DNLI SEC filings in 2026?

Denali Therapeutics Inc. (DNLI) has filed a 10-K annual report on February 26, 2026, a 10-Q quarterly report on May 7, 2026, an 8-K current report on August 6, 2026 with the SEC. SignalX tracks every new SEC EDGAR filing daily, including 10-K, 10-Q, 8-K, and Form 4 insider transactions, with AI-powered summaries of key sections.

When did DNLI file its most recent 10-K annual report?

Denali Therapeutics Inc. (DNLI) filed its most recent 10-K annual report on February 26, 2026. The 10-K includes audited financial statements, business overview, risk factors, and management discussion, all available on SignalX with AI-generated summaries and XBRL financial data.

How do I view DNLI 10-Q quarterly reports?

Denali Therapeutics Inc. (DNLI)'s most recent 10-Q quarterly report was filed on May 7, 2026. SignalX displays every DNLI 10-Q with AI-generated summaries of the MD&A (Management Discussion & Analysis) and Risk Factors sections, plus links to the original SEC EDGAR document.

What 8-K current reports has DNLI filed recently?

Denali Therapeutics Inc. (DNLI)'s most recent 8-K was filed on August 6, 2026. 8-K filings disclose material corporate events such as earnings releases, executive changes, mergers, and other significant developments. SignalX surfaces each 8-K with item-level summaries so you can quickly see what happened.

Where can I find DNLI insider trading activity (Form 4)?

SignalX aggregates every DNLI Form 4 insider transaction from SEC EDGAR. Form 4 reports show when officers, directors, and 10% shareholders buy or sell company stock, with transaction code, share count, and price per share.

How often does DNLI file with the SEC?

Denali Therapeutics Inc. (DNLI) files a 10-K annual report once per year (typically within 60 days of fiscal year-end) and 10-Q quarterly reports three times per year. 8-K current reports are filed as needed when material events occur, and Form 4 insider transaction reports are due within two business days of a trade. SignalX monitors SEC EDGAR daily to surface every new DNLI filing with AI-powered analysis.

What is the difference between 10-K, 10-Q, and 8-K SEC filings?

A 10-K is a comprehensive annual report with audited financials, business overview, and risk factors. A 10-Q is a shorter quarterly report with unaudited financials and management discussion. An 8-K is a current report filed when a material event occurs, such as earnings releases, executive changes, acquisitions, or other significant developments. SignalX provides AI-generated summaries for all three filing types for Denali Therapeutics Inc. (DNLI).

What is DNLI's SEC CIK number?

Denali Therapeutics Inc. (DNLI)'s SEC CIK (Central Index Key) number is 1714899. The CIK is a unique identifier assigned by the SEC to every filing entity. You can use CIK 1714899 to look up all DNLI filings on SEC EDGAR, or browse them here on SignalX with AI-powered analysis.

Where can I find DNLI return on equity (ROE) and financial data?

SignalX extracts XBRL financial data from Denali Therapeutics Inc. (DNLI) 10-K annual filings, including revenue, net income, gross profit, operating income, EPS, total assets, stockholders' equity, and operating cash flow. Return on equity (ROE) can be derived from net income divided by stockholders' equity. Multi-year financial trends are displayed in the Financial Summary table above.