Denali Therapeutics (DNLI) Q3 2026 earnings summary

Executive summary

• AVLAYAH generated $17.8M in Q3 net product revenue in its second full commercial quarter; Q4 guidance is $30.0M–$32.0M.

• Q3 net income was $70.1M, including a $194.0M net gain from the Priority Review Voucher sale; September-end cash, equivalents and marketable securities totaled $1.01B.

• Zafinofusp alfa and multiple TransportVehicle programs have 2027 milestones or data readouts planned.

Financial highlights

• Q3 revenue was $17.8M versus none in Q3 2025; 9M revenue was $21.4M versus none in 9M 2025.

• Q3 operating loss was $126.8M versus $137.4M; 9M operating loss was $394.6M versus $418.0M.

• 9M net loss was $185.9M versus $384.0M; Q3 EPS was $0.37 basic and diluted versus a $0.74 loss.

• Q3 R&D expense was $106.1M and SG&A was $37.5M; 9M R&D was $307.0M and SG&A was $107.3M.

• 9M operating cash use was $345.6M; ending cash, equivalents and restricted cash was $106.0M, alongside $1.0B in cash, equivalents and marketable securities.

Outlook and guidance

• Q4 2026 AVLAYAH net product revenue guidance is $30.0M–$32.0M; management cautioned Q3’s step-up is not a run rate.

• Zafinofusp alfa BLA submission seeking accelerated approval remains planned for 2027; additional Phase 1/2 data are expected in Q1 2027, subject to manufacturing readiness.

• Initial clinical data are expected in 2027 for Alzheimer’s programs DNL628 and DNL921; COMPASS data are expected in H1 2028.

• 2027 data are expected from DNL593, DNL628, DNL921, DNL952 and DNL151; DNL593 and DNL628 data are expected in H1.

• Through 2028, goals include two growing commercial brands, five clinical proofs of concept and four to six additional programs entering the clinic.