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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.
Denali Therapeutics
Denali Therapeutics
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