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Sep 30, 2022
Denali Therapeutics Q3 2022 Earnings Report
Reported financial results for the third quarter ended September 30, 2022, and provided business highlights.
Key Takeaways
Denali Therapeutics reported a net loss of $103.3 million for the third quarter of 2022, compared to a net loss of $84.6 million for the same period in 2021. Collaboration revenue was $3.6 million, a decrease from $5.3 million in the prior year. The company's cash, cash equivalents, and marketable securities were approximately $1.11 billion as of September 30, 2022.
Presented new, interim data from the ongoing Phase 1/2 study at the 2022 SSIEM Annual Symposium demonstrating achievement of healthy normal levels of heparan sulfate measured in cerebrospinal fluid (CSF) in all participants in the Phase 1/2 study.
Announced interim results from Part A of the Phase 1/2 study evaluating TAK-594/DNL593 (PTV:PGRN) in healthy subjects.
Denali and Biogen announced initiation of the global Phase 3 LIGHTHOUSE study of BIIB122 in up to 400 participants with Parkinson's disease and a confirmed LRRK2 pathogenic variant.
Sanofi presented Phase 1 healthy volunteer data on SAR443820 at the Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting demonstrating a safety profile that was well-tolerated after single ascending doses and 14 days of multiple ascending doses taken orally once or twice daily, with favorable pharmacokinetic properties and excellent CNS penetrance.
Denali Therapeutics
Denali Therapeutics
Forward Guidance
This press release contains forward-looking statements regarding Denali's progress, business plans, product candidates, planned clinical trials, and expected milestones, which are subject to risks and uncertainties.
Positive Outlook
- Plans, timelines and expectations regarding DNL151 for the treatment of Parkinson's disease in collaboration with Biogen, including the ongoing Phase 2b LUMA study and the ongoing Phase 3 LIGHTHOUSE study.
- Plans, timelines and expectations regarding DNL310, including the presentation of data from the ongoing Phase 1/2 study and the potential for the DNL310 combined data package to support registration of DNL310.
- Plans, timelines and expectations regarding DNL788 of both Denali and Sanofi, including with respect to expected enrollment for a Phase 2 trial in ALS.
- Plans, timelines and expectations regarding DNL758 of both Denali and Sanofi, including with respect to the planned Phase 2 study in ulcerative colitis.
- Plans, timelines and expectations regarding DNL593, including Phase 1/2 trial dosing and initial clinical data from the Phase 1 portion of such trial.
Challenges Ahead
- Any and all risks to Denali’s business and operations caused directly or indirectly by the ongoing 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 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