Denali Therapeutics (DNLI) investor relations material

Executive summary

• Achieved a transformative quarter with the first full commercial launch of AVLAYAH, generating $3.6 million in net product revenue and establishing a commercial foundation for the Enzyme Transport Vehicle (ETV) franchise.

• Advanced two Transport Vehicle-enabled Alzheimer's disease programs (DNL628 and DNL921) into clinical development, with initial data expected in 2027.

• Regained full ownership of DNL593 for FTD-GRN after Takeda terminated the collaboration; orphan drug designation granted and data expected in the first half of 2027.

• Ended Q2 with $940 million in cash and marketable securities, bolstered to over $1.1 billion after the $195 million sale of a Priority Review Voucher in July.

• Discontinued further development of BIIB122/DNL151 in idiopathic Parkinson's disease after Phase 2b LUMA study failed to meet endpoints; BEACON study continues for LRRK2 variant carriers.

Financial highlights

• AVLAYAH generated $3.6 million in net product revenue in its first full commercial quarter.

• Net loss for Q2 2026 was $127.6 million, compared to $124.1 million in Q2 2025.

• Research and development expenses were $97 million, down from $102.7 million year-over-year.

• Selling, general, and administrative expenses rose to $36.3 million from $32.3 million, driven by commercial launch activities.

• Cash and marketable securities totaled $940 million at quarter end, pro forma exceeds $1.1 billion after PRV sale.

Outlook and guidance

• Q3 net product revenue for AVLAYAH is expected to be $10–12 million, reflecting strong early adoption and expanding payer coverage.

• The adoption curve is expected to accelerate as payer coverage and treatment center experience grow, with continued focus on expanding access and preparing for international expansion.

• AVLAYAH product revenue anticipated to grow but not sufficient to offset operating expenses in the near term; continued operating losses expected as investments persist.

• Initial clinical data for Alzheimer's programs DNL628 and DNL921, as well as DNL593, DNL952, and DNL151, anticipated in 2027.

• Anticipates BLA submission and potential accelerated approval for zafinofusp alfa for Sanfilippo syndrome type A in 2027.