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Mar 31, 2024
Denali Therapeutics Q1 2024 Earnings Report
Denali Therapeutics reported financial results for Q1 2024 and provided business highlights.
Key Takeaways
Denali Therapeutics reported a net loss of $101.8 million for the first quarter of 2024. The company completed a private investment in public equity (PIPE) financing with gross proceeds of $500 million and divested its preclinical small molecule portfolio. They are progressing with clinical trials for various programs, including tividenofusp alfa, DNL343, and DNL126.
Presented new positive two-year clinical data on tividenofusp alfa in MPS II at WORLDSymposiumTM.
Initiated the first clinical trial with DNL126 for children with MPS IIIA.
Completed enrollment in the Phase 2/3 HEALEY ALS Platform Trial for DNL343.
Completed a private investment in public equity (PIPE) financing with gross proceeds of $500 million.
Denali Therapeutics
Denali Therapeutics
Forward Guidance
This press release contains forward-looking statements regarding Denali's TV technology platform, clinical programs (DNL310, DNL343, DNL788, DNL151, DNL758, DNL126, DNL593, OTV:MAPT, ATV:Abeta), preclinical programs, future operating expenses, anticipated cash runway, PIPE financing, and participation in upcoming investor conferences.
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 as well as the likelihood of receiving accelerated approval
- 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
- Plans, timelines, and expectations regarding DNL151, including with respect to the ongoing LUMA study as well as enrollment and timing of the proposed Phase 2a study in PD patients with LRRK2 mutations
Challenges Ahead
- Risks related 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