Denali Therapeutics Q2 2023 Earnings Report
Key Takeaways
Denali Therapeutics reported a net income of $183.4 million for the second quarter of 2023, a significant increase compared to the net loss of $58.8 million for the same period in 2022. The increase in revenue was primarily due to Biogen exercising their option to license Denali's ATV:Abeta program. Strategic decisions were made to discontinue development of TAK-920/DNL919 in Alzheimer’s disease and revise the BIIB122 clinical development plan.
New data demonstrated robust reduction in NfL in the Phase 1/2 MPS II trial with DNL310 (ETV:IDS) and target engagement with DNL343 (eIF2B activator) in the Phase 1b study in ALS patients.
Strategic decision with Takeda to discontinue development of TAK-920/DNL919 (ATV:TREM2) in Alzheimer’s disease.
Biogen exercised their option to Denali’s ATV-amyloid-beta program for Alzheimer’s disease.
Revisions to the BIIB122 (LRRK2 inhibitor) clinical development plan with Biogen to increase efficiency by focusing on one study in Parkinson’s disease.
Denali Therapeutics
Denali Therapeutics
Denali Therapeutics Revenue by Segment
Forward Guidance
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 expectations regarding Denali’s TV technology platform, including the Enzyme Transport Vehicle (ETV), Antibody Transport Vehicle (ATV) and Oligonucleotide Transport Vehicle (OTV); statements made by Denali’s Chief Executive Officer; plans, timelines, and expectations regarding DNL310 and the ongoing Phase 2/3 COMPASS and Phase 1/2 studies, including the continued recruitment of participants for the Phase 2/3 COMPASS study and the timing and availability of data for the Phase 1/2 study; plans, timelines, and expectations of both Denali and Takeda regarding DNL593 and the ongoing Phase 1/2 study, including the recruitment of patients for the Part B study; plans and expectations related to the therapeutic potential of DNL919 and any back-up molecules in preclinical development; plans, timelines, and expectations related to DNL126, including timing for initiation of recruitment for the Phase 1/2 study; plans, timelines, and expectations regarding the advancement of OTV candidates towards clinical development; plans, timelines, and expectations of both Denali and Biogen regarding the development of Denali's ATV:Abeta for the treatment of Alzheimer's disease; plans, timelines, and expectations of both Denali and Biogen regarding DNL151, the enrollment and timing and availability of data from the ongoing Phase 2b LUMA study; plans, timelines, and expectations regarding DNL788 of both Denali and Sanofi; plans, timelines, and expectations regarding DNL343, including plans for the Phase 2/3 HEALEY ALS Platform Trial; plans, timelines, and expectations regarding DNL758, including the availability of data from the completed Phase 2 study in patients with CLE and the ongoing Phase 2 study in patients with UC; and plans and expectations for Denali's preclinical programs.