Company: DNLI
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001714899-25-000066
Chunk: 88

Company: Denali Therapeutics Inc.
Filing Date: 2025-02-27
Form: 10-K
Item: Item 7
Chunk 88
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 eIF2B activator program, is under evaluation in ALS; and

•Eclitasertib (SAR443122/DNL758), a peripheral and non-CNS penetrant small molecule RIPK1 inhibitor, is being developed by Sanofi, to address peripheral inflammatory diseases such as UC.

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

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Table of Contents

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 BiogeneIF2BDNL343Ph 2/3ALSJoint with Healey CenterRIPK1 (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. 

Key operational and financing milestones for the year ended December 31, 2024 and in 2025 to date include:

•Tividenofusp alfa DNL310 (ETV:IDS)

◦In February 2024, we presented new positive data from the ongoing Phase 1/2 study of tividenofusp alfa in MPS II at the 20th Annual WORLDSymposiumTM demonstrating sustained normalization of heparan sulfate in cerebrospinal fluid ("CSF HS"), robust and sustained reductions in biomarkers of lysosomal dysfunction and neuronal damage (neurofilament light; "NfL"), and improvements and stabilization of multiple clinical outcomes measures over two years of treatment. Also in February, we participated in the Reagan-Udall Foundation for the FDA workshop on CSF heparan sulfate as a potential surrogate biomarker to support accelerated approval in MPS. 

◦In April 2024, we completed enrollment of 47 participants