Denali Therapeutics Inc. reported a net loss of $107.2 million for the third quarter ended September 30, 2024, an increase from a net loss of $99.4 million in the same period of 2023. Collaboration revenue for the quarter was $0, down from $1.3 million in the prior-year quarter, primarily due to activities under the Biogen Collaboration Agreement.
Total research and development expenses increased by approximately $8.5 million to $98.2 million for the third quarter of 2024, compared to $89.7 million in the third quarter of 2023. This increase was driven by higher costs in various clinical stage programs, including ETV:IDS, eIF2B, ETV:SGSH, and LRRK2, reflecting continued progress in clinical trials and investment in TV-enabled product candidates. General and administrative expenses remained stable at $24.9 million.
As of September 30, 2024, Denali held approximately $1.28 billion in cash, cash equivalents, and marketable securities. The company updated its guidance for full-year 2024 cash operating expenses, anticipating an increase of approximately 5-10% compared to 2023, an upward revision from previous guidance. This adjustment is attributed to increased activities supporting the planned Biologics License Application (BLA) filing and commercial readiness for tividenofusp alfa, as well as accelerating other therapeutic programs within Denali's Transport Vehicle (TV) platform portfolio.
Regarding pipeline advancements, tividenofusp alfa (DNL310) for Hunter syndrome remains on track for an accelerated approval filing in early 2025, following a successful meeting with the FDA in the third quarter. Preliminary data from the Phase 1/2 study of DNL126 in Sanfilippo syndrome Type A demonstrated a robust reduction from baseline in CSF heparan sulfate levels, including normalization, leading to an expansion of the study to support a potential accelerated path. Additionally, a preclinical publication on the oligonucleotide TV (OTV) technology in Science Translational Medicine described broad and deep brain biodistribution of oligonucleotides following systemic administration.
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