Company: DNLI
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001714899-25-000066
Chunk: 198

Company: Denali Therapeutics Inc.
Filing Date: 2025-02-27
Form: 10-K
Item: Item 9B
Chunk 198
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 and licensed to Sanofi under the Collaboration Agreement. Sanofi is currently conducting a Phase 2 clinical trial for eclitasertib in patients with UC, and we remain eligible to receive milestones and tiered royalties on net sales for Peripheral Products sold worldwide.

Entry into a Material Definitive Agreement

In February 2025, after mutual agreement to discontinue preclinical activities on ATV:TREM2, Takeda delivered notice of its election to terminate the ATV:TREM2 program on February 26, 2025, as per the terms of the Takeda Collaboration Agreement dated January 3, 2018. Under the Takeda Collaboration Agreement, Denali had granted Takeda options with respect to the ATV:BACE1/Tau, ATV:TREM2 and PTV:PGRN programs in exchange for an upfront payment of $40.0 million and an additional $110.0 million under a February 2018 share purchase agreement. The Takeda Collaboration Agreement became effective in February 2018, following satisfaction of certain requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976. 

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Table of Contents

The ATV:Tau program was substituted for the ATV:BACE1/Tau program via amendment of the Takeda Collaboration Agreement in February 2019, and in March 2022, the parties mutually agreed to terminate activity on the ATV:Tau program. Takeda exercised its option for the PTV:PGRN program in November 2021 and the parties have continuing obligations with respect to this program under the Takeda Collaboration Agreement. We are eligible to receive payments under the Takeda Collaboration Agreement for PTV:PGRN upon the achievement of certain clinical and sales-based milestones or upon achievement of certain regulatory milestones relating to regulatory approval in the United States, certain European countries, and Japan. Further, we and Takeda share equally the development and commercialization costs, and, if applicable, will share the profits, for the PTV:PGRN program.

Takeda exercised its option for the ATV:TREM2 program in December 2021. On February 26, 2025, after mutual agreement to discontinue preclinical activities on ATV:TREM2, we received notice of Takeda's election to terminate the ATV:TREM2 program effective sixty days following the date of the notice from Takeda, or earlier if mutually agreed by the parties. Takeda's notice terminated provisions of the Collaboration Agreement relating to the