Company: DNLI
Filing Date: 2025-04-17
Form Type: DEF 14A
Source: 0001714899-25-000087
Chunk: 42

Company: Denali Therapeutics Inc.
Filing Date: 2025-04-17
Form: DEF 14A
Chunk 42
---
 normalization. We expanded the study to support a potential accelerated approval path.

TAK-594/DNL593 (PTV:PGRN): We recommenced dosing of participants with granulin (GRN)-related frontotemporal dementia (FTD-GRN) in the Phase 1/2 study following a voluntarily pause to implement protocol modifications.

<div align='center'>-31-</div>

Advanced our small molecule clinical portfolio

BIIB122/DNL151 (LRRK2 inhibitor) for Parkinson's disease: In collaboration with Biogen, we continued to enroll the global Phase 2b LUMA study evaluating BIIB122 in early-stage Parkinson's disease. In addition, we executed a Collaboration and Development Funding Agreement with a third party including committed funding of $75.0 million, and we initiated the related global Phase 2a BEACON study to evaluate safety and biomarkers associated with BIIB122 in participants with LRRK2-associated Parkinson’s disease (LRRK2-PD).

DNL343 (eIF2B agonist) for amyotrophic lateral sclerosis (ALS): The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital ("MGH") in collaboration with the Northeast ALS Consortium ("NEALS") completed enrollment in Regimen G (DNL343) of the Phase 2/3 HEALEY ALS Platform Trial.

SAR443820/DNL788 (CNS-penetrant RIPK1 inhibitor): Our partner Sanofi provided topline results that the primary endpoints were not met in the Phase 2 HIMALAYA study in ALS and the Phase 2 K2 study in multiple sclerosis.

SAR443122/DNL758 (peripherally restricted RIPK1 inhibitor): Our partner Sanofi continued to enroll a Phase 2 study of SAR443122 for ulcerative colitis.

Other

• I n January 2024, we announced our intention to divest our preclinical small molecule portfolio, which was completed effective March 1, 2024. We maintain ownership of, and continue to advance, our current portfolio of clinical stage small molecule programs, in collaboration with our partners. The decision was made based on clinical validation and prioritization of our TV-enabled platforms for brain delivery of large molecules;

• In February 2024, we announced that we entered into a securities purchase agreement with certain existing accredited investors for the private placement of 3,244,689 shares of our common stock at a price of $17.07 per