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Mar 31, 2021
Denali Therapeutics Q1 2021 Earnings Report
Reported financial results for the first quarter ended March 31, 2021 and provided business highlights.
Key Takeaways
Denali Therapeutics reported a net loss of $70.0 million for the first quarter of 2021, compared to a net loss of $56.8 million for the same period in 2020. Collaboration revenue increased to $7.9 million, driven by increased costs in partnered programs with Takeda. Total research and development expenses were $60.2 million, and general and administrative expenses were $18.9 million. Cash, cash equivalents, and marketable securities totaled $1.45 billion as of March 31, 2021.
DNL310 demonstrated normalization of GAG levels in cerebrospinal fluid and a favorable safety profile in Hunter syndrome patients.
DNL151 (BIIB122) met safety and biomarker goals in Phase 1/1b studies for Parkinson's disease, with late-stage clinical development planned by year-end 2021.
DNL343 met safety and pathway engagement biomarker goals in a Phase 1 healthy volunteer study, with plans to initiate a Phase 1b study in ALS patients in the second half of 2021.
Sanofi plans to commence dosing in a Phase 2 study of DNL758 (SAR443122) in cutaneous lupus erythematosus (CLE) patients in the first half of 2021.
Forward Guidance
Denali provided updates on expected key milestones for 2021.
Positive Outlook
- RIPK1 inhibitor (DNL758/SAR443122): Commence dosing in Phase 2 study in CLE patients (Sanofi) in 1H 2021
- ETV:IDS (DNL310): 6-month data from Cohort A of Phase 1/2 study in mid 2021
- EIF2B activator (DNL343): Initiate Phase 1b study in ALS patients in 2H 2021
- RIPK1 inhibitor (DNL788/SAR443820): Phase 1 data in healthy volunteers (Sanofi) in 2H 2021
- LRRK2 inhibitor (DNL151/BIIB122): Initiate late-stage clinical development in Parkinson’s patients in Late 2021
Historical Earnings Impact
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