Denali Therapeutics Q2 2024 Earnings Report
Key Takeaways
Denali Therapeutics reported a net loss of $99.0 million for the second quarter of 2024, compared to a net income of $183.4 million for the same period in 2023. The company had no collaboration revenue for the quarter, a decrease from $294.1 million in the previous year, primarily due to Biogen exercising their option to license the ATV:Abeta program in 2023. Cash, cash equivalents, and marketable securities were approximately $1.35 billion as of June 30, 2024.
Enzyme Transport Vehicle franchise gained momentum with continued engagement with the FDA on an accelerated approval pathway for tividenofusp alfa (DNL310, ETV:IDS) in MPS II.
FDA selected DNL126 (ETV:SGSH) in MPS IIIA for the START program.
Regained the rights to TfR-based ATV:Abeta program from Biogen, expanding opportunities for addressing Alzheimer's disease.
COMPASS, the global Phase 2/3 study, is expected to complete enrollment in 2024.
Denali Therapeutics
Denali Therapeutics
Forward Guidance
This press release contains forward-looking statements regarding expectations for Denali’s TV technology platform, plans and timelines for clinical trials, potential regulatory approvals, and financial forecasts. Actual results are subject to risks and uncertainties, including adverse economic conditions, reliance on collaborations, clinical trial outcomes, and regulatory approvals.
Positive Outlook
- Expectations regarding Denali’s TV technology platform
- Plans, timelines, and expectations regarding DNL310 and the ongoing Phase 2/3 COMPASS and Phase 1/2 studies
- The timing and likelihood of accelerated approval, and the timing and availability of program updates
- Plans and timelines regarding DNL343, including in Regimen G of the Phase 2/3 HEALEY ALS Platform Trial
- Plans, timelines, and expectations of both Denali and Sanofi regarding DNL788, including the Phase 2 study in MS
Challenges Ahead
- Risks related to any and all risks to Denali’s business and operations caused by adverse economic conditions
- Risk of the occurrence of any event, change, or other circumstance that could give rise to the termination of Denali’s agreements with Sanofi, Takeda, or Biogen, or any of Denali’s other collaboration agreements
- Denali’s transition to a late-stage clinical drug development company
- Denali’s and its collaborators’ ability to complete the development and, if approved, commercialization of its product candidates
- Denali’s and its collaborators’ ability to enroll patients in its ongoing and future clinical trials