Company: DNLI
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001714899-25-000066
Chunk: 128

Company: Denali Therapeutics Inc.
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1
Chunk 128
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 patients and families, clinical trial sites, industry partners and research collaborators to evaluate multiple investigational therapies simultaneously with the goal of accelerating the development of potential new treatments for ALS. Therapeutic candidates that enter the platform trial are chosen by a group of expert ALS scientists and members of the Healey & AMG Center. 

In May 2024, we announced completion of enrollment in Regimen G. In January 2025, we announced that the primary and key secondary endpoints were not met in the HEALEY ALS platform trial and that further analyses are anticipated later in 2025, including NfL and other fluid biomarkers, data from pre-specified subgroups, as well as extended findings from the active treatment extension period.

2025 expected progress and milestones:

•Further analyses from Regimen G (DNL343) in Phase 2/3 HEALEY ALS Platform Trial.

Eclitasertib (SAR443122/DNL758) RIPK1 Inhibitor Program for Peripheral Inflammatory Diseases: UC

As part of our parallel development strategy, we have also developed a number of other structurally diverse CNS-penetrant and peripherally-restricted RIPK1 inhibitor molecules, which are included as part of the collaboration agreement with Sanofi, described in more detail in “Business - Licenses and Collaborations” below. Sanofi is solely responsible for the development and commercialization of peripherally restricted RIPK1 inhibitors.

Sanofi is conducting a Phase 2 study of eclitasertib in patients with ulcerative colitis. Recruitment for the trial is ongoing and data are expected in 2026. 

2025 expected progress and milestones:

•Continue Phase 2 UC study

IND-Enabling Stage Programs

Beginning in 2025, we expect to advance one to two additional programs to the clinic per year over the next three years across our TV-enabled franchises (ETV, OTV, and ATV). IND-enabling stage programs include:

ETV

•DNL952 (ETV:GAA) for Pompe disease

•DNL111 (ETV:Gcase) for Parkinson’s disease and Gaucher disease

•DNL622 (ETV:IDUA) for Hurler syndrome (MPS I)

OTV

•DNL628 (OTV:MAPT) targeting tau for Alzheimer’s disease

•DNL422 (OTV:SNCA) targeting alpha synuclein for Parkinson’s disease

ATV

•DNL921 (ATV