Company: DNLI
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0001714899-25-000170
Chunk: 3

Company: Denali Therapeutics Inc.
Filing Date: 2025-08-11
Form: 10-Q
Item: Part I, Item 2
Chunk 3
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 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"); and

•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").

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

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 2UCSanofi

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.

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Key operational and financing milestones in 2025 to date include:

•In January 2025, we announced topline results that the primary endpoint was not met in Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343 in the treatment of ALS. In March 2025, we provided an update that additional analyses did not demonstrate a treatment effect on neurofilament light ("NfL"), a biomarker of neuronal damage, over the 24-week, double-blind period and in a subset of participants that completed an additional 28 weeks in the open-label active treatment extension. Based on these outcomes, the active treatment extension in Regimen G was discontinued. Overall, DNL343 was found to be generally well tolerated; 

•In January 2025, we announced that the U.S. Food and Drug Administration ("FDA") granted Breakthrough Therapy Design