Company: DNLI
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001714899-25-000193
Chunk: 214

Company: Denali Therapeutics Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 1
Chunk 214
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, primarily due to the winding down of activities related to the Phase 2/3 HEALEY ALS Platform Trial in 2025.

Nine Months Ended September 30, 2025Change20252024$%External research and development expenses - TV programs, including cost sharing$119,209 $101,367 $17,842 18 %External research and development expenses - small molecule programs, including cost sharing13,689 37,944 (24,255)(64)Other research and development expenses65,714 45,643 20,071 44 Personnel related expenses(1)122,261 111,699 10,562 9 Total research and development expenses$320,873 $296,653 $24,220 8 %

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(1)Personnel related expenses include stock-based compensation expense of $45.5 million and $44.8 million for the nine months ended September 30, 2025 and 2024, respectively, reflecting an increase of $0.7 million.

The increase in research and development expenses of approximately $24.2 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024, was primarily attributable to the following:

•an increase of $17.8 million in TV program external research and development expenses, primarily attributable to increased spend on multiple preclinical programs including OTV:MAPT and ETV:GAA, as well as an increase in expenses of $4.9 million on our DNL126 program. These increases were partially offset by a decrease in expenses related to our DNL310 program of $6.5 million;

•an increase of $20.1 million in other research and development expenses, including lab consumables, consultants and general facilities costs, driven by the commencement of operations at our large molecule manufacturing facility in Salt Lake City, Utah; and

•an increase of $10.6 million in personnel-related expenses, including salaries and stock-based compensation, primarily driven by higher headcount related to the commencement of operations at our large molecule manufacturing facility in Salt Lake City, Utah.

These increases were partially offset by a $24.3 million decrease in small molecule external research and development expenses primarily attributable to the following: 

•a decrease of $16.3 million related to the winding down of activities related to our DNL343 program including the Phase 2/3 HEALEY ALS Platform Trial in