Company: DNLI
Filing Date: 2025-12-04
Form Type: 8-K
Source: 0001714899-25-000208
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Company: Denali Therapeutics Inc.
Filing Date: 2025-12-04
Form: 8-K
Item: Item 1.01
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Item 1.01 Entry into a Material Definitive Agreement

On December 4, 2025, Denali Therapeutics Inc. (“ Denali” or the “ Company”) entered into a synthetic royalty funding agreement (the “ Royalty Agreement”) with Royalty Pharma plc (“ Royalty Pharma”). Pursuant to the Royalty Agreement, Royalty Pharma has agreed to provide up to $275 million in funding to the Company in exchange for a 9.25% royalty on future net sales of tividenofusp alfa, Denali’s investigational TransportVehicle™-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (Hunter syndrome).

The transaction is subject to various closing conditions, including Denali achieving U. S. Food and Drug and Administration (FDA) accelerated approval of tividenofusp alfa on or before June 30, 2026. At the closing, Royalty Pharma will make an initial payment of $200 million. Denali will receive an additional payment of $75 million upon approval of tividenofusp alfa by the European Medicines Agency (EMA) on or before December 31, 2029.

In exchange for these payments, Royalty Pharma will be entitled to receive a 9.25% royalty on worldwide net sales of tividenofusp alfa. The royalty payments to Royalty Pharma will cease upon reaching a multiple of 3.0x, or 2.5x if achieved by the first quarter of 2039. Denali will retain all worldwide development and commercialization rights to tividenofusp alfa.

Tividenofusp alfa is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 5, 2026.

The foregoing description of the Royalty Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Royalty Agreement, which will be filed as an exhibit to a subsequent filing with the Securities and Exchange Commission (SEC).

Forward-Looking Statements

Certain statements made in this report are forward looking, such as those relating to: plans, timelines and expectations related to tividenofusp alfa and Denali’s TransportVehicle platform; expectations regarding the collaboration with Royalty Pharma, including financial aspects of the royalty financing agreement; the potential benefits and results of the royalty financing agreement; expectations regarding achieving accelerated approval from the FDA; plans to conduct development