Denali Therapeutics Inc · Q1 2022 earnings

Briefing

Denali Therapeutics' financial results for Q1 2022 were reported, highlighting progress in clinical programs and collaborations.

Denali Therapeutics reported a net loss of $65.2 million for the first quarter of 2022, with collaboration revenue increasing to $42.1 million due to partnerships with Takeda and Biogen. The company's research and development expenses also increased, driven by advancements in its ETV:IDS program and overall portfolio development.

• Sanofi began dosing with SAR443820 in a Phase 2 study for ALS, triggering a $40 million milestone payment to Denali.
• Dosing commenced in a Phase 1/2 clinical study of DNL593 for FTD-GRN, with plans to begin dosing individuals with FTD-GRN in the second half of 2022.
• Interim data from the Phase 1/2 trial of DNL310 in MPS II patients demonstrated sustained normalization of CSF heparan sulfate.
• The FDA placed a clinical hold on the Investigational New Drug application for DNL919, delaying the program by at least three months.

Headline financials

Revenue & EPS history

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding Denali's progress, business plans, business strategy, product candidates, planned preclinical studies and clinical trials and expected milestones; plans to conduct clinical development activities across various programs; plans, timelines and expectations related to Denali’s Transport Vehicle (TV) platform, including its Enzyme Transport Vehicle (ETV), Antibody Transport Vehicle (ATV), and Protein Transport Vehicle (PTV) technologies; plans for advancing new TV programs into the clinic for the potential treatment of FTD-GRN and Alzheimer's disease; expectations regarding DNL151 for the treatment of Parkinson's disease in collaboration with Biogen; plans, timelines and expectations regarding DNL310, including advancement into a potentially registrational Phase 2/3 study; plans, timelines and expectations regarding DNL919 for the treatment of Alzheimer's disease, including with respect to the DNL919 program delay related to the FDA's clinical hold letter; plans, timelines and expectations regarding DNL788 of both Denali and Sanofi, including with respect to dosing and expected enrollment for a Phase 2 trial in ALS and Denali's expected milestone payment from Sanofi; plans, timelines and expectations regarding DNL593, including Phase 1/2 trial dosing and initial clinical data from the Phase 1 portion of such trial; Denali's priorities, regulatory approvals, timing and likelihood of success and expectations regarding collaborations; and statements made by Denali’s Chief Executive Officer.