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Jun 30
Denali Therapeutics Q2 2025 Earnings Report
Denali Therapeutics posted a wider net loss in Q2 2025 as R&D and G&A expenses rose due to pipeline progress and launch preparations.
Key Takeaways
Denali Therapeutics reported a net loss of $124.1 million for Q2 2025 driven by increased investments in research, manufacturing, and commercial readiness. Cash and marketable securities stood at $977.4 million, supporting ongoing development programs.
Net loss expanded to $124.1 million compared to $99.0 million in Q2 2024.
R&D expenses rose to $102.7 million due to higher investment in TV programs and manufacturing capacity.
G&A expenses increased to $32.3 million, largely related to commercial launch planning.
The company held $977.4 million in cash, cash equivalents, and marketable securities at quarter-end.
Denali Therapeutics
Denali Therapeutics
Forward Guidance
Denali aims to continue progressing multiple programs across clinical and preclinical stages, supported by its cash position and ongoing regulatory engagement.
Positive Outlook
- FDA accepted BLA for tividenofusp alfa with priority review.
- Alignment with FDA on accelerated approval path for DNL126.
- Strong cash position of nearly $1 billion.
- Advancement of multiple TV-enabled preclinical programs.
- Publication of promising Alzheimer’s preclinical data in *Science*.
Challenges Ahead
- Increased operating expenses widened quarterly losses.
- Negative operating income of $134.9 million.
- No revenue recognized in the quarter.
- Higher G&A costs due to commercial readiness.
- Dependency on future regulatory approvals for key assets.