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Mar 31, 2023
Denali Therapeutics Q1 2023 Earnings Report
Denali Therapeutics reported financial results for Q1 2023, highlighting progress across its therapeutic portfolio and advancements in late-stage programs.
Key Takeaways
Denali Therapeutics reported a net loss of $109.8 million for the first quarter of 2023, with collaboration revenue of $35.1 million. The company made significant progress across its therapeutic portfolio, including the advancement of multiple late-stage programs, and reported positive data from studies of DNL310 and DNL343.
Continued advancement of multiple late-stage programs.
Reported new interim data demonstrating positive changes in behavioral and cognitive aspects of MPS II with DNL310.
Reported positive biomarker and safety data from the Phase 1b study of DNL343.
Biogen exercised its option to license Denali’s ATV:Abeta program.
Denali Therapeutics
Denali Therapeutics
Forward Guidance
This press release contains forward-looking statements regarding Denali’s TV technology platform, plans, timelines, and expectations regarding its product candidates and studies, and the potential benefits of its manufacturing capabilities. Actual results are subject to risks and uncertainties.
Positive Outlook
- Expectations regarding Denali’s TV technology platform, including the Enzyme Transport Vehicle (ETV), Antibody Transport Vehicle (ATV) and Oligonucleotide Transport Vehicle (OTV).
- Plans, timelines, and expectations regarding DNL310 and the ongoing Phase 2/3 COMPASS and Phase 1/2 studies, including the continued recruitment of participants for the Phase 2/3 COMPASS study and the Phase 1/2 study interim data.
- Plans, timelines, and expectations of both Denali and Takeda regarding DNL593 and the ongoing Phase 1/2 study, including the recruitment of patients for the Part B study.
- Plans, timelines, and expectations of both Denali and Takeda regarding DNL919 and the ongoing Phase 1 study.
- Plans, timelines, and expectations related to DNL126, including plans for advancement into clinical development.
Challenges Ahead
- Risks related to any and all risks to Denali’s business and operations caused by adverse economic conditions, such as instability in the financial services sector, the impact of the COVID-19 pandemic and increased geopolitical uncertainty.
- 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.