Denali Therapeutics Inc. reported a net loss of $124.1 million for the second quarter ended June 30, 2025, an increase from a net loss of $99.0 million in the second quarter of 2024. Total research and development expenses increased by approximately $11.3 million to $102.7 million, driven by increased spending on multiple preclinical Transport Vehicle (TV) programs, and higher other R&D and personnel-related expenses due to the commencement of operations at the Salt Lake City manufacturing facility. These increases were partially offset by a $9.8 million decrease in small molecule programs, primarily from winding down DNL343 activities.
General and administrative expenses rose by $7.1 million to $32.3 million for the second quarter of 2025, compared to $25.2 million in the prior-year quarter. This increase was primarily driven by activities related to preparations for a potential commercial launch of tividenofusp alfa. As of June 30, 2025, Denali held approximately $977.4 million in cash, cash equivalents, and marketable securities.
In a significant pipeline development, Denali announced that it has reached alignment with the FDA’s Center for Drug Evaluation and Research (CDER) that cerebrospinal fluid heparan sulfate (CSF HS) may be considered a reasonably likely surrogate endpoint to predict clinical benefit for DNL126 in Sanfilippo syndrome type A (MPS IIIA). This alignment supports an accelerated approval pathway for DNL126.
Additional 49-week data from the ongoing open-label Phase 1/2 study for DNL126 were consistent with previously announced 25-week data, demonstrating a significant reduction in CSF HS from baseline, including normalization, alongside a supportive safety profile. Enrollment in the Phase 1/2 study is nearing completion, and planning is underway for a confirmatory global Phase 3 study.
Furthermore, preclinical data on the Antibody TransportVehicle (ATV):Abeta program were published in Science on August 7, 2025. The research showed that delivering an anti-amyloid beta antibody across the blood-brain barrier using Denali's TV platform improved brain distribution and reduced the risk of amyloid-related imaging abnormality (ARIA) in a mouse model of Alzheimer’s disease, compared to conventional antibody treatment. This finding suggests a potential strategy to mitigate ARIA risk seen with first-generation anti-amyloid therapies.
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