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Denali Therapeutics DNLI

Denali Therapeutics reports Q3 2026 results

Item 2.02 Reports results

Form
8-K
Filed
Importance
Major
  1. AVLAYAH net product revenue was $17.8 million in Q3 2026
  2. Q4 2026 net product revenue guidance is $30.0 million to $32.0 million
  3. Denali reported a Q3 2026 net income of $70.1 million
  4. Zafinofusp alfa BLA submission is on track for 2027

Written from the 8-K on EDGAR. AI can make mistakes. Check the filing.

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The reading, claim by claim

  1. The filing includes a press release with details about the company's financial performance and business highlights.
  2. The press release is attached as Exhibit 99.1 and is incorporated by reference.
  3. The press release states that AVLAYAH® generated $17.8 million in net product revenue during its second full commercial quarter.
  4. The company expects Q4 2026 net product revenue to range between $30.0 million and $32.0 million.
  5. AVLAYAH was also recognized as the 'Best Biotechnology Product' of 2026 by The Galien Foundation.
  6. Denali reported a Q3 2026 net income of $70.1 million, which included a one-time $194.0 million net gain on the sale of a Priority Review Voucher.
  7. This brought the company's cash, cash equivalents, and marketable securities to $1.0 billion.
  8. Denali's Zafinofusp alfa is advancing as a second potential product, with a BLA submission planned for 2027 for Sanfilippo syndrome type A.
  9. Five TransportVehicle™ programs are expected to generate data in 2027, including DNL921 (ATV:Abeta) and DNL952 (ETV:GAA).

9 of 9 claims matched the filing text.

From the filing

Item 2.02 Results of Operations and Financial Condition.

Item 2.02 Results of Operations and Financial Condition.

On November 3, 2026, Denali Therapeutics Inc. (the "Company") issued a press release announcing its financial results for the third quarter ended September 30, 2026.1 The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.2

All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description

99.1 Press Release dated November 3, 2026.

104 Cover Page Interactive Data File (formatted as Inline XBRL)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

DENALI THERAPEUTICS INC.

Date: November 3, 2026 By: /s/ Alexander O. Schuth

Alexander O. Schuth, M.D.

Chief Operating and Financial Officer

Denali Therapeutics Reports Third Quarter 2026 Financial Results and Business Highlights

• AVLAYAH® (tividenofusp alfa-eknm) net product revenue accelerated to $17.8 million in its second full commercial quarter3

• Continued growth expectations drive Q4 2026 net product revenue guidance of $30.0 million to $32.0 million4

• AVLAYAH recognized as the "Best Biotechnology Product" of 2026 by The Galien Foundation5

• Zafinofusp alfa advancing as Denali's second potential product, with BLA submission on track for 2027 seeking accelerated approval for Sanfilippo syndrome type A (MPS IIIA)8

• Five TransportVehicle™ (TV) programs expected to generate data in 2027: zafinofusp alfa (ETV:SGSH), DNL593 (PTV:PGRN), DNL628 (OTV:MAPT), DNL921 (ATV:Abeta) and DNL952 (ETV:GAA)9 • Q3 2026 net income of $70.1 million included a one-time $194.0 million net gain on the sale of a Priority Review Voucher6, bringing cash, cash equivalents and marketable securities to $1.0 billion7

• Conference call and webcast today at 4:30 p.m. ET

SOUTH SAN FRANCISCO, Calif. – November 3, 2026 – Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2026, and provided business highlights.

"Families and physicians are telling us that AVLAYAH is making a difference for children with Hunter syndrome, and the results this quarter reflect that," said Ryan Watts, Ph.D., Chief Executive Of

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Data on this page was fetched . The filing on SEC.gov is the record.