Denali(US:DNLI)2023-03-10 13:44Pipeline and Programs - Denali has 10 INDs across 6 indications, with 7 programs in clinical development and 3 in late-stage[11] - Denali's discovery engine has yielded >14 programs in the discovery stage, 20+ publications in top-tier journals, and 90+ patents granted worldwide[3] - DNL310 (ETV:IDS) for MPS II (Hunter syndrome) is in Phase 2/3 development, with additional interim Phase 1/2 data expected in Early/Mid 2023[94] - DNL126 (ETV:SGSH) for MPS IIIA (Sanfilippo) is planned for IND submission in 1H:23, with recruitment activities in 2H:23[32, 135] - BIIB122 (LRRK2 inhibitor) for Parkinson's Disease is in Phase 3 for LRRK2+ PD and Phase 2b for Idiopathic PD, with recruitment ongoing[34, 199] - DNL593 (PTV:PGRN) for FTD-GRN is in Phase 1/2, with final Phase 1/2 Part A (HV) data expected Mid 2023 and recruitment for Part B ongoing[155] - DNL919 (ATV:TREM2) for Alzheimer's Disease is in Phase 1, with Phase 1 HV data expected YE 2023[34, 60] - SAR443820 (RIPK1 inhibitor) for ALS is in Phase 2, with complete recruitment expected in 2023[19, 210] - DNL343 (eIF2B activator) for ALS is in Phase 1b, with final 28-day Phase 1b data expected Mid 2023 and initiation of Phase 2/3 HEALEY study Mid 2023[19, 200] Strategic Partnerships - Denali has strategic partnerships with Biogen, Sanofi, and Takeda totaling $1.3 billion in upfront payments and >$3 billion in milestones[30, 171] - The LRRK2 inhibitor partnership with Biogen includes $1.025 billion upfront (cash/equity) and $2 billion in milestones, with a 50/50 profit share in the US and 40/60 in China[30] - The RIPK1 inhibitor partnership with Sanofi includes $125 million upfront and $1.1 billion in milestones, with ~50% profit sharing in key geographies[30] - Multiple TV-Platform Programs with Takeda including PTV:PGRN and ATV:TREM2 include $150 million upfront (cash/equity) and $1 billion in milestones, with 50/50 profit share worldwide[30] Technology and Platforms - Denali is focused on solving the blood-brain barrier (BBB) challenge for a broad range of therapeutics and indications[11] - Denali's Transport Vehicle (TV) platform includes Enzyme Transport Vehicle (ETV), Antibody Transport Vehicle (ATV), Protein Transport Vehicle (PTV), and Oligonucleotide Transport Vehicle (OTV) technologies[54] - OTV provides uniform ASO deposition across the CNS with IV delivery[38]