Denali Therapeutics Inc

Latest Results (25.02.2026):

Denali Therapeutics Inc reported fourth quarter 2024 (and full‑year 2024) results showing a Q4 net loss of $114.8 million and a full‑year net loss of $422.8 million, with cash, cash equivalents and marketable securities of approximately $1.19 billion as of December 31, 2024; the company also highlighted significant clinical and regulatory progress for its Enzyme Transport Vehicle (ETV) programs, including plans to file a BLA for tividenofusp alfa in early 2025 and preparations for a potential U.S. launch in late 2025/early 2026.

Quarter & Full‑Year Results

Net loss for Q4 2024 was $114.8M (loss per share $0.67) and net loss for FY 2024 was $422.8M (loss per share $2.57). There was no collaboration revenue in Q4 2024 or for the full year 2024.

Collaboration Revenue Decline

Collaboration revenue fell from $330.5M in 2023 to $0 in 2024, primarily because $293.9M was recognized in April 2023 when Biogen exercised its option on the ATV:Abeta program; decreases under Sanofi and Takeda collaborations also contributed.

R&D and G&A Trends

Total R&D expense was $99.8M in Q4 and $396.4M for FY 2024 (down versus prior year), driven by lower personnel and small‑molecule program costs after a March 2024 divestiture; G&A was $30.1M in Q4 and $105.4M for the year, up modestly as the company prepared for a BLA submission and commercial readiness.

Cash Position & 2025 Guidance

Cash, cash equivalents and marketable securities totaled about $1.19B at year‑end 2024. Denali expects cash operating expenses to increase roughly 10–15% in 2025 versus 2024 as it advances prelaunch and clinical activities.

Balance Sheet and One‑Time Items

Denali recorded a $14.5M gain from the divestiture of preclinical small molecule programs in 2024; total assets were $1.374B and total stockholders’ equity was $1.230B as of December 31, 2024.

Lead Program — tividenofusp alfa (DNL310)

Denali reported primary analysis and long‑term data (presented Feb 2025) showing robust biomarker reductions and clinical improvements in MPS II; the company remains on track to submit a BLA under the accelerated approval pathway in early 2025 and received FDA Breakthrough Therapy designation in January 2025.

Pipeline & Clinical Updates

Denali is pursuing accelerated‑approval discussions for DNL126 (MPS IIIA), continues dosing for DNL593 (FTD‑GRN), reported a failed primary endpoint for DNL343 in the HEALEY ALS platform (further analyses planned), and is supporting BIIB122/LUMA and its own BEACON study in Parkinson’s disease; the company plans to advance one to two TV programs to the clinic per year beginning in 2025.