Denali Therapeutics Inc. reported a net loss of $114.8 million for the fourth quarter ended December 31, 2024, and a full-year net loss of $422.8 million for 2024. This compares to net losses of $119.5 million for Q4 2023 and $145.2 million for full-year 2023. Collaboration revenue for the full year 2024 was $0, a significant decrease from $330.5 million in 2023, primarily due to a $293.9 million revenue recognition in April 2023 from Biogen's option exercise for the ATV:Abeta program, and decreases from Sanofi and Takeda collaboration agreements.
Total research and development expenses decreased by $27.4 million to $396.4 million for the full year 2024, compared to $423.9 million in 2023. This reduction was mainly attributable to decreases in personnel-related expenses, other R&D expenses, and small molecule programs, driven by the divestiture of preclinical small molecule programs in March 2024 and a strategic focus on the company's Transport Vehicle (TV)-enabled portfolio. General and administrative expenses increased to $105.4 million for full-year 2024, up from $103.4 million in 2023, largely due to activities related to the planned Biologics License Application (BLA) submission for tividenofusp alfa and preparations for its commercial launch.
As of December 31, 2024, Denali held approximately $1.19 billion in cash, cash equivalents, and marketable securities. For 2025, the company anticipates an increase of approximately 10% to 15% in cash operating expenses compared to 2024, reflecting continued investment in its pipeline and commercialization efforts.
Regarding pipeline updates, tividenofusp alfa (DNL310) for Hunter syndrome remains on track for a BLA submission under the accelerated approval pathway in early 2025, with preparations for a U.S. commercial launch in late 2025 or early 2026. The FDA granted Breakthrough Therapy designation in January 2025, providing enhanced regulatory support. For DNL126 in Sanfilippo syndrome Type A, Denali plans to engage with the FDA to align on an accelerated approval pathway. The company also expects to advance one to two additional TV-enabled programs to the clinic per year over the next three years.
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