Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights

Core Insights - Denali Therapeutics is preparing for the launch of tividenofusp alfa and has submitted regulatory applications for two additional programs targeting Alzheimer's and Pompe diseases [2][3][8] Clinical Programs - Tividenofusp alfa (DNL310) for Hunter syndrome: The FDA has extended the review timeline for the Biologics License Application (BLA) from January 5, 2026, to April 5, 2026, due to a Major Amendment submission [3][8] - DNL126 for Sanfilippo syndrome type A: Enrollment in the Phase 1/2 study has been completed, showing significant reduction in cerebrospinal fluid heparan sulfate levels [4][8] - DNL628 for Alzheimer's disease: A Clinical Trial Application has been submitted to initiate studies, marking a key milestone for the Oligonucleotide TransportVehicle platform [6][8] - DNL952 for Pompe disease: An Investigational New Drug application has been submitted to begin clinical studies [9][8] - DNL151 for Parkinson's disease: Co-development with Biogen continues, with a Phase 2b study expected to read out data in 2026 [10] Financial Results - For Q3 2025, the net loss was $126.9 million, compared to a net loss of $107.2 million in Q3 2024 [14] - Research and development expenses totaled $102.0 million, up from $98.2 million in the same quarter last year, driven by increased operational costs [15] - General and administrative expenses rose to $35.5 million from $24.9 million, primarily due to preparations for the commercial launch of tividenofusp alfa [16] Corporate Updates - Tim Van Hauwermeiren has been appointed to the Board of Directors, while Carole Ho, M.D., is departing the company [12] - Peter Chin, M.D., will serve as Acting Chief Medical Officer [12] - Denali will host an Investor Day on December 4, 2025, to discuss progress and strategic priorities [13] Cash Position - As of September 30, 2025, Denali had approximately $872.9 million in cash, cash equivalents, and marketable securities [18]