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Denali Therapeutics (DNLI) guidance and outlook

Denali Therapeutics (DNLI) gave its guidance on Nov 3, 2026: Revenue (segment) $30.0M–$32.0M for Q4 2026. Denali Therapeutics' 10-Q filed Nov 3, 2026 makes 26 forward-looking statements.

Guidance and outlook

Latest guidance

From the earnings release filed Nov 3, 2026 (8-K on EDGAR).

Forward-looking statements, 10-Q filed Nov 3, 2026

• • the commercial success of AVLAYAH and any other products for which we obtain marketing approval, including sales and revenue forecasts;
• • the expected potential benefits and potential revenue resulting from strategic collaborations with third parties and our ability to attract collaborators with development, regulatory, and commercialization expertise;
• A Biologic License Application seeking accelerated approval remains on track for submission in 2027, and we are conducting start-up activities for a global Phase 3 confirmatory study.
• We expect it to take time to generate sufficient revenue to offset our expenses, and we can provide no assurance as to when, if ever, this will occur.
• We have incurred significant operating losses to date and expect to continue to incur operating losses for the foreseeable future.
• Going forward, we plan to use both our SLC facility and third-party contract manufacturers to supply our preclinical and clinical materials.
• We currently use third-party contract manufacturers to supply commercial product of AVLAYAH, and expect to continue to do so for the foreseeable future.
• It is challenging to predict the nature, timing and estimated long-range costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates.
• • our ability to discover, develop and utilize biomarkers to demonstrate target engagement, pathway engagement and the impact on disease progression of our molecules;
• We expect our research and development expenses to increase at least over the next several years as we continue to implement our business strategy, advance our current programs, expand our research and development efforts, seek regulatory approvals for any product candidates that successfully complete clinical trials, access and develop additional product candidates and incur expenses associated with hiring…
• We have increased our headcount to support the commercialization of AVLAYAH and may continue to increase headcount to support our commercial and research and development activities, which we expect will increase selling, general and administrative expenses.
• As of September 30, 2026, we had $4.5 million of expensed pre-launch inventory, which we expect to be sold through by December 2026.

Denali Therapeutics' latest quarter

Questions

Did Denali Therapeutics raise or lower its guidance?

Denali Therapeutics (DNLI) gave its guidance on Nov 3, 2026: Revenue (segment) $30.0M–$32.0M for Q4 2026.

What does Denali Therapeutics expect?

• the commercial success of AVLAYAH and any other products for which we obtain marketing approval, including sales and revenue forecasts; • the expected potential benefits and potential revenue resulting from strategic collaborations with third parties and our ability to attract collaborators with development, regulatory, and commercialization expertise; A Biologic License Application seeking accelerated approval remains on track for submission in 2027, and we are conducting start-up activities for a global Phase 3 confirmatory study.

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Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.