Denali Therapeutics Inc. · NASDAQ:DNLI
Denali Therapeutics — Q3 2026 Earnings Presentation
26 slides from Denali Therapeutics's earnings presentation, Nov 3, 2026
Slide 1: Transforming Life: 3Q 2026 Financial Results
1 November 3 | 3Q 2026 Financial Results Transforming Life
Slide 2: Forward-Looking Statements
2 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements do not relate strictly to historical or current facts and they may be accompanied by such words as “anticipa
Slide 3: Agenda and Speakers
3 Agenda and Speakers AG END A Opening Remarks – Ryan Watts, Ph.D., CEO Commercial Update – Katie Peng, CCO Ryan Watts, Ph.D. Alexander Schuth, M.D. Chief Executive Officer Chief Operating and Financial Officer Pipeline Highlights – Peter Chin, M.D., CMO Financials – Alexander Schuth, M.D., COO/CFO
Slide 4: Our Purpose: Transforming Life for People with Serious Diseases
4 Our Purpose: Transforming Life for People with Serious Diseases We bring the power of biotherapeutics to the whole body, including the brain.
Slide 5: A Powerful Combination: Product, Pipeline, Platform
5 A Powerful Combination: Product, Pipeline, Platform Leading the field in blood-brain barrier (BBB) therapeutics Commercial Validated BBB Broad a Product Platform Pipeline First FDA-approved product designed Leading BBB technology and team: 7 clinical programs from rare to cross the BBB; strong com
Slide 6: Our Broad Therapeutic Portfolio
6 Our Broad Therapeutic Portfolio Lysosomal Storage Disorders Common Neurodegenerative Diseases Molecule Indication Stage Molecule Indication Stage tividenofusp alfa-eknm FDA Approved DNL151 MPS II PD Phase 2a (LRRK2) (ETV:IDS) Phase 2/3 LRRK2 Inhibitor zafinofusp alfa DNL628 MPS IIIA Phase 1/2 AD P
Slide 7: 3Q 2026: Executing Across Our Strategic Priorities
7 3Q 2026: Executing Across Our Strategic Priorities Build on Strong AVLAYAH® $17.8 million net product revenue in the Launch second full quarter of launch Phase 1/2 study completed the prespecified Advance Zafinofusp Alfa treatment duration for the primary endpoint; Toward Approval & Launch on trac
Slide 8: Commercial Update
Commercial Update Katie Peng, Chief Commercial Officer
Slide 9: Strong Momentum in First Quarters of AVLAYAH Launch
9 Strong Momentum in First 2 Quarters of AVLAYAH® Launch 2026: Building the foundation across key stakeholders for revenue acceleration ~$30M $17.8M PA T I E N T S PHYSICIANS P AY E R S 3Q 2026 Interest is broad across the eligible MPS II High conviction and motivation translating Expanding coverage
Slide 10: Interest is Broad Across the Eligible MPS II Patient Population
10 Interest is Broad Across the Eligible MPS II Patient Population The first FDA-approved enzyme replacement therapy (ERT) to cross the blood-brain barrier to reach the brain in addition to the body ~500 prevalent ~75% eligible under the U.S. patients current FDA label Since my 16-year-old son, Domi
Slide 11: High Physician Conviction is Translating into Treatment Action
11 High Physician Conviction is Translating into Treatment Action PR E-LA UN CH 1 PO ST-LA UN CH >80% 90% ~90% Action Aware of AVLAYAH® Viewed the data as Of targeted HCOs reached Treatment centers before launch motivating to prescribe with launch messaging helping families navigate reimbursement an
Slide 12: Expanding Coverage is Accelerating the Treatment Path
12 Expanding Coverage is Accelerating the Treatment Path • Payer approvals Commercial Medicaid continue across Commercial and 20 Medicaid • Strong uptake in payer >70% policies at this phase in State Medicaid Programs list AVLAYAH® launch providing HCP as covered confidence that patients can access
Slide 13: AVLAYAH U.S. Launch Dynamics
13 AVLAYAH® U.S. Launch Dynamics 2026: Building the foundation to become the Standard of Care for MPS II pediatric patients * $17.8M >70% ~$30M to $32M 3Q 2026 Net Revenue Commercial Lives Covered Projected 4Q 2026 Net Revenue 2026 2027 2028+ Activation & Access Path to Market Leadership Broad Acces
Slide 14: AVLAYAH U.S. Launch Builds Foundation for Continued Growth
14 AVLAYAH® U.S. Launch Builds Foundation for Continued Growth Global Expansion Path to Market Label expansion and international Leadership launches broaden access to ~2,000 patients worldwide in commercially accessible geographies Strong Launch AVLAYAH® is on its way to becoming the U.S. market lea
Slide 15: Pipeline Highlights
Pipeline Highlights Peter Chin, M.D., Chief Medical Officer and Head of Development
Slide 16: Clear Path from Accelerated to Full Approval
16 Clear Path from Accelerated to Full Approval Phase 2/3 Phase 1/2 Study Confirmatory Study 47 Participants 65 Participants U.S. Accelerated Approval Achieved Supporting Conversion to U.S. Full Approval, Supports Select Country Approvals Label Expansion and Global Approvals
Slide 17: Zafinofusp Alfa (DNL126): Study Data for Accelerated Approval
17 Zafinofusp Alfa (DNL126): Study Data for Accelerated Approval Data for BLA Submission • At least 49 weeks of data for all participants (Cohorts A1-A3, B1; n=20) • CSF HS reduction from baseline in key efficacy cohorts (n=12) – surrogate endpoint reasonably likely to predict clinical benefit • Sup
Slide 18: Zafinofusp Alfa: Preliminary Data Phase 1 Dose-Finding Cohorts
18 Zafinofusp Alfa: Preliminary Data Phase 1 Dose-Finding Cohorts CNS Biomarkers Peripheral Effects -80% CSF HS -83% Urine HS Mean reduction at Mean reduction at Week 49; 3 of 7 within Week 49 normal range -61% CSF GM3 Liver Volume Mean reduction at Normalized in all Week 49; 6 of 7 within participa
Slide 19: Initial Clinical Data from Both AD Programs Expected in 2027
19 Initial Clinical Data from Both AD Programs Expected in 2027 DNL921 Phase 1/1b DNL628 Phase 1b Clinical Study Clinical Study Phase 1b • Phase 1/1b study is ongoing • Phase 1b study ongoing • Safety and clinical proof-of-concept data in 2027 • Clinical biomarker data expected in 1H 2027
Slide 20: Financial Update
Financial Update Alexander Schuth, M.D., COO/CFO
Slide 21: A Strong Enzyme Foundation with Broad Pipeline Upside
21 A Strong Enzyme Foundation with Broad Pipeline Upside BBB-Crossing Enzyme Replacement BBB-Crossing Biologics for Common Therapy for Rare Genetic Diseases Neurodegenerative Diseases Hunter (MPS II) / Sanfilippo (MPS IIIA) / Alzheimer’s disease / Parkinson’s disease FTD-GRN / Pompe / Gaucher / Hurl
Slide 22: 3Q 2026 Summary: Executing Across Our Strategic Priorities
22 3Q 2026 Summary: Executing Across Our Strategic Priorities Build on AVLAYAH®’s On track to be U.S. market leader Strong Launch Advance Zafinofusp Alfa BLA filing in 2027 Toward Approval & Launch Establish Proof-of-Concept Initial clinical data in 2027 in Alzheimer’s Disease Building commercial mo
Slide 23: Q3 2026 Financial Summary
23 Q3 2026 Financial Summary Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended $ in Millions September 30, 2026 September 30, 2025 September 30, 2026 September 30, 2025 AVLAYAH® Net Product Revenue $17.8 – $21.4 – Total Revenue 17.8 – 21.4 – Cost of Goods Sold 0.2 – 0.3 – R&D
Slide 24: Closing Remarks
Closing Remarks Ryan Watts, Ph.D., CEO
Slide 25: Entering a New Phase on the Path to the Summit
25 Entering a New Phase on the Path to the Summit 3-Year Goals (D3X3) 2026-2028 D3X3 2025 Deliver 2 Growing Brands 2020 Develop 5 Clinical Proofs of Concept 4-6 New Clinical Programs 2015 Discover Pioneering a new class of biotherapeutics and capturing the full potential of the TransportVehicle
Slide 26: Q&A
JENALI J Q&A