Company: DNLI
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001714899-25-000193
Chunk: 207

Company: Denali Therapeutics Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 1
Chunk 207
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 gene and is being developed in collaboration with Takeda;

•BIIB122/DNL151, a small molecule LRRK2 inhibitor, is being developed in collaboration with Biogen for the potential treatment of Parkinson's disease ("PD"); 

•Eclitasertib (SAR443122/DNL758), a peripheral and non-central nervous system ("CNS") penetrant small molecule RIPK1 inhibitor, is being developed by Sanofi to address peripheral inflammatory diseases such as ulcerative colitis ("UC");

•DNL628 (OTV:MAPT), composed of an antisense oligonucleotide ("ASO") against MAPT fused to TV, designed to suppress gene expression of MAPT encoding the tau protein with the goal of treating Alzheimer's disease ("AD"); and

•DNL952 (ETV:GAA), composed of acid alpha-glucosidase ("GAA") fused to TV and engineered to replace GAA in all tissues, with the goal of treating Pompe disease.

The following table summarizes key information about our clinical stage programs:

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ProgramProduct CandidateClinical Study(ies)IndicationOperational ControlETV:IDStividenofusp alfa, or DNL310Ph 1/2                             Hunter syndrome (MPS II)DenaliPh 2/3ETV:SGSHDNL126Ph 1/2Sanfilippo syndrome Type A (MPS IIIA)DenaliPTV:PGRNTAK-594/DNL593Ph 1/2FTD-GRNJoint with TakedaLRRK2BIIB122/DNL151Ph 2aParkinson's diseaseDenaliPh 2bJoint with BiogenRIPK1 (Peripheral)eclitasertib, or SAR443122/DNL758Ph 2UCSanofiOTV:MAPTDNL628*Ph 1b plannedAlzheimer’s diseaseDenaliETV:GAADNL952*Ph 1 plannedPompe diseaseDenali______________________________________________________________________________

*Regulatory application has been submitted to begin clinical testing

Since we commenced operations, we have devoted substantially all of our resources to discovering, acquiring and developing product candidates, building our TV platform, assembling our core capabilities in understanding key neurodegenerative and lysosomal storage disease pathways, operationalizing clinical trials, building manufacturing capabilities and establishing commercial capabilities.

Key operational milestones in 2025 to date include:

•In January 2025, we announced topline results that the primary endpoint was