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Sep 30, 2021
Denali Therapeutics Q3 2021 Earnings Report
Denali Therapeutics reported financial results for the third quarter ended September 30, 2021 and provided business highlights.
Key Takeaways
Denali Therapeutics reported a net loss of $84.6 million for the third quarter of 2021, compared to a net loss of $58.2 million for the same period in 2020. Collaboration revenue was $5.3 million, a decrease from $9.4 million in the prior year. Total research and development expenses were $71.6 million, an increase from $53.7 million in the prior year. Cash, cash equivalents, and marketable securities were approximately $1.36 billion as of September 30, 2021.
Began a Phase 1b study of DNL343 in individuals with amyotrophic lateral sclerosis (ALS).
Sanofi has advanced RIPK1 inhibitor, SAR443820 (DNL788), into Phase 2 development for ALS.
Presented a progress update at Biogen’s R&D Day event on the LRRK2 inhibitor collaboration, highlighting data and activities to support late-stage development of BIIB122 (DNL151) for Parkinson’s disease (PD).
Phase 1/2 study of DNL310 (ETV:IDS) for Hunter syndrome is now enrolling Cohort C, and activities have begun to initiate a pivotal Phase 2/3 study in the first half of 2022.
Denali Therapeutics
Denali Therapeutics
Forward Guidance
The press release contains forward-looking statements regarding Denali's progress, business plans, product candidates, planned clinical trials, and expected milestones.
Positive Outlook
- Plans to conduct clinical development activities across various programs.
- Plans, timelines and expectations related to DNL310 and Denali’s TV technology, including enrollment in the Phase 1/2 study of DNL310 for Hunter Syndrome and the initiation of a Phase 2/3 study.
- Plans and expectations relating to the build-out of a clinical manufacturing facility in Utah to expand clinical manufacturing capabilities for biologic therapeutics, including the expansion of Denali's TV platform programs.
- Plans, timelines and expectations related to DNL151 of both Denali and Biogen, including with respect to progress updates in support of late-stage clinical development.
- Plans, timelines and expectations related to DNL343, including with respect to the Phase 1b study commenced in August, and the initiation of any future clinical trials.
Challenges Ahead
- Risks related to Denali’s business and operations caused directly or indirectly by the evolving COVID-19 pandemic.
- 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, Biogen, Secarna or any of Denali’s other collaboration agreements.
- Denali’s early stages of clinical drug development.
- Denali’s and its partners’ ability to complete the development and, if approved, commercialization of its product candidates.
- Denali’s and its partners’ ability to enroll patients in its ongoing and future clinical trials.