Company: DNLI
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001714899-25-000193
Chunk: 435

Company: Denali Therapeutics Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 8
Chunk 435
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T 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 2025; 

•a decrease of $7.8 million for our LRRK2 program related to the R&D funding from our Collaboration and Development Funding Agreement with an unrelated third party, under which, starting in the second quarter of 2024, program expenses were offset; and

•the divestiture of our preclinical small molecule programs in March 2024.

31

General and administrative expenses. General and administrative expense was $35.5 million and $24.9 million for the three months ended September 30, 2025, and 2024, respectively, and $97.1 million and $75.4 million for the nine months ended September 30, 2025, and 2024, respectively. The increases of $10.6 million for the three month period, and $21.7 million for the nine months ended, were both primarily driven by activities related to preparations for a potential commercial launch for tividenofusp alfa.

Gain from divestiture of small molecule programs. For a full description, see Item 2. Components of Operating Results included in this Quarterly Report on Form 10-Q.

Liquidity and Capital Resources

Sources of Liquidity

As of September 30, 2025, we had cash, cash equivalents and marketable securities in the amount of $872.9 million. We fund our operations primarily with the proceeds from the sale of common stock and payments received from our collaboration partners,