Denali Therapeutics Inc.

The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest and other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

Factors considered in making these evaluations include quoted market prices, recent financial results and operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, expected cash flows from securities, other publicly available information that may affect the value of the marketable security, duration and severity of the decline in value, and the Company's strategy and intentions for holding the marketable security.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

When determining the present value of lease payments, the Company uses its incremental borrowing rate on the date of lease commencement, or the rate implicit in the lease, if known.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

Liability Related to the Revenue Participation Right The Company accounts for the synthetic royalty funding agreement with Royalty Pharma Investments 2023 ICAV ("Royalty Pharma") pursuant to which Royalty Pharma agreed to provide up to $ 275.0 million in funding to the Company in exchange for a 9.25 % royalty on worldwide net sales of AVLAYAH as a debt financing under ASC Topic 470, Debt (ASC 470).

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

government treasuries 408,829 408,829 Corporate debt securities 100,112 100,112 Long-term marketable securities: U.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

government treasuries 163,401 163,401 Corporate debt securities 66,133 66,133 Total $ 720,254 $ 166,245 $ $ 886,499 December 31, 2025 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 149,874 $ $ $ 149,874 Commercial paper 24,899 24,899 Short-term marketable securities: U.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

The FDA s priority review of our BLA for tividenofusp alfa and alignment on an accelerated approval path for DNL126 are key milestones highlighting the potential of our Transport Vehicle (TV) platform to catalyze a new class of blood-brain barrier-crossing therapeutics, said Ryan Watts, Ph.

SEC original ↗Denali Therapeutics Inc. — Earnings release (8-K exhibit)EX-99Aug 11, 2025

Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for tividenofusp alfa for priority review, assigning a Prescription Drug User Fee Act (PDUFA) target action date of January 5, 2026.

SEC original ↗Denali Therapeutics Inc. — Earnings release (8-K exhibit)EX-99Aug 11, 2025

Denali is also conducting the Phase 2a BEACON study focused on LRRK2-associated PD.

SEC original ↗Denali Therapeutics Inc. — Earnings release (8-K exhibit)EX-99Aug 11, 2025

The findings suggest that TV platform-enabled brain delivery of immunotherapy bypasses amyloid-laden large vessels by traveling through smaller capillaries, offering a potential strategy to mitigate ARIA risk seen with first-generation anti-amyloid therapies.

SEC original ↗Denali Therapeutics Inc. — Earnings release (8-K exhibit)EX-99Aug 11, 2025

Factors considered in making these evaluations include quoted market prices, recent financial results and operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, expected cash flows from securities, other publicly available information that may affect the value of the marketable security, duration and severity of the decline in value, and the Company's strategy and intentions for holding the marketable security.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

Legal Proceedings 43 Item 1A.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities, and accounts receivable.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

Further, the Company is also subject to broad market risks and uncertainties, such as bank failures or instability in the financial services sector, geopolitical instability, war and armed conflicts, inflation, rising interest rates, and recession risks, as well as supply chain and labor shortages.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

The Company estimates variable consideration using the most-likely-amount method and includes it in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the related uncertainty is resolved.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

The Company s projections of future royalty payments are subject to estimation uncertainty and are based on various assumptions underlying projected net product sales over the term of the agreement.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026

Contingencies From time to time, the Company may be involved in lawsuits, arbitration, claims, investigations and proceedings consisting of intellectual property, employment and other matters which arise in the ordinary course of business.

SEC original ↗Denali Therapeutics Inc. — 10-Q Quarterly report10-QAug 6, 2026