Company: DNLI
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001714899-25-000193
Chunk: 209

Company: Denali Therapeutics Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 1
Chunk 209
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 our BLA for tividenofusp alfa for priority review, assigning a Prescription Drug User Fee Act (PDUFA) target action date of January 5, 2026;

•In August 2025, we announced we reached alignment with the FDA that cerebrospinal fluid heparan sulfate (CSF HS) may be considered a reasonably likely surrogate endpoint to predict clinical benefit and may therefore be used to support accelerated approval of DNL126 for MPS IIIA. Additional 49-week data from the ongoing open-label Phase 1/2 study are consistent with previously announced 25-week data, demonstrating a significant reduction in CSF HS from baseline, including normalization, and a safety profile that supports continued development; 

•In September 2025, we completed enrollment in the ongoing Phase 1/2 study of DNL126 to support an accelerated approval pathway in MPS IIIA, and a global Phase 3 confirmatory study is being planned;

•In October 2025, we announced that the FDA has extended its review timeline of the BLA seeking accelerated approval of tividenofusp alfa. The PDUFA target date has been extended from January 5, 2026, to April 5, 2026. We continue to prepare for commercial launch;

•In October 2025, we submitted a Clinical Trial Application ("CTA") for DNL628 (OTV:MAPT) to initiate clinical studies in Alzheimer’s disease; and

•In October 2025, we submitted an Investigational New Drug ("IND") application for DNL952 (ETV:GAA) to begin clinical studies in Pompe disease.

We do not have any products approved for sale and have not generated any product revenue since our inception. We have funded our operations primarily from the issuance and sale of convertible preferred stock, the sale of common stock and pre-funded warrants to purchase shares of our common stock in public offerings and private placements, and payments received from our collaboration and funding agreements with Takeda, Sanofi, Biogen and other third parties.

We have incurred significant operating losses to date and expect to continue to incur operating losses for the foreseeable future. We had net losses of $126.9 million and $384.0 million for the three and nine months ended September 30, 2025, respectively, and $107.2 million and $308.0 million for the three and nine months ended September 30, 2024. As of September 30, 202