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CORPORATE OVERVIEW JANUARY 2025 CROSSING BARRIERS AND DEFEATING DEGENERATION ©2025 Denali Therapeutics Inc.
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DISCLAIMERS Forward-Looking Statements. This presentation contains forward -looking statements within the meaning of the Private Securities L itigation 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 “anticipate,” “believe,” “could,” “e stimate,” “expected,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” "future," “will” and other words and terms of similar meaning. All statements other than statements of historical facts containe d in this presentation, including, without limitation, statements regarding future results of operations and financial position of Denali Therapeutics Inc. (“Denali” or the “Company”); Denali’s business strategy and business plans, expected progress and expansion, and expected key milestones for Denali's therapeutic portfolio in 2025 and beyond; Denali’s ability to execute on its tailored commercial strateg ies and accelerate commercial launch readiness; the potential for Denali's product candidates to treat various neurodegenerative diseases including MPS I (Hurler Syndrome), MPS II (Hunter Syndrome), M PS IIIA (Sanfilippo Syndrome), PD, ALS, AD, FTD -GRN, UC, Gaucher's Disease, Pompe Disease, and related peripheral inflammatory diseases; planned preclinical studies and clinical trials and the ex pectations regarding the timing and availability of results and data from such studies and trials; plans, timelines, expectations related to Denali's TransportVehicle TM (TV) platform, including the Enzyme TV (ETV), Antibody TV (ATV), Protein TV (PTV), and Oligonucleotide TV (OTV), and its therapeutic and commercial opportunities; plans, timelines, and expectations related to the ETV platform and E TV-enabled programs, including ETV:GAA, ETV:GCase, and ETV:IDUA, their therapeutic and commercial potential, and the timing and likelihood of planned regulatory filings; plans, timelines, and expe ctations relating to DNL310, including the ongoing Phase 1/2 study and Phase 2/3 COMPASS study, the timing of planned regulatory filings, and the timing, likelihood, and scope of regulatory approvals an d commercial launch; plans, timelines, and expectations related to DNL126, including the timing and availability of data from the Phase 1/2 study and likelihood and pathway of regulatory approval; plans, timelines, and expectations related to the OTV and OTV -enabled programs, including OTV:MAPT and OTV:SNCA, their therapeutic and commercial potential, and the timing and likelihood of planned regulat ory filings; plans, timelines, and expectations relating to ATV:Abeta, including its therapeutic potential and the timing of planned regulatory filings; plans, timelines, and expectations relating to DNL151, including enrollment in the Ph2B LUMA study and Ph2A BEACON study; plans and expectations regarding DNL593, including enrollment of Cohort B in the Ph1/2 study; plans, timelines, and expec tations related to DNL758 and enrollment in the Ph2 RESOLUTE study; plans and expectations regarding Denali's global organization and clinical operations, the expected timing and likelihood of success of its commercial growth, and the potential value of Denali's programs, are forward-looking statements. Denali has based these forward -looking statements largely on its current expectations and projections about future events , and forward-looking statements regarding potential outcomes should not be interpreted as guarantees of future performance. These forward-looking statements speak only as of the date of this presentation and are subject to a number of risks, uncertaint ies and assumptions, including but not limited to: the risk of the occurrence of any circumstance that could give rise to the termination of Denali’s agreements with its collaborators; Denali’s and its c ollaborators’ ability to complete the development and, if approved, commercialization of its product candidates; Denali’s and its collaborators’ ability to enroll patients in its ongoing and futur e clinical trials; Denali’s reliance on third parties for the manufacture and supply of its product candidates for clinical trials; Denali’s dependence on successful development of its blood -brain barrier platform te chnology and TV-enabled product candidates; Denali’s and its collaborators’ ability to conduct or complete clinical trials on expected timelines; the predictive value of Denali's biomarker selection; the occurrence of significant adverse events, toxicities or other undesirable side effects; the potential for clinical trials of Denali’s product candidates to differ from preclinical, early clinical, prelimi nary or expected results; the uncertainty that product candidates will receive regulatory approval or be commercialized; Denali’s ability to continue to create a pipeline of product candidates or develop commerciall y successful products; Denali’s ability to obtain, maintain, or protect intellectual property rights related to its product candidates; Denali's achievement of planned milestones and realization of value; implemen tation of Denali’s strategic plans for its business, product candidates, and blood-brain barrier platform technology; and other risks. In light of these risks, uncertainties and assumptions, the forward-looking statements in this press release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward -looking statements. Accordingly, you should not rely upon forward -looking statements as predictions of future events. Information regarding additional risks and uncertainties may be found in Denali’s most recent q uarterly and annua reports filed with the Securities and Exchange Commission on Forms 10-Q and 10-K, respectively, as well as Denali’s future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward -looking statements, to conform these statements to actual results or to make changes in Denali’s expectations, except as required by law. The product candidates being developed by Denali are investigational and their safety and efficacy profiles remain unestablis hed. Denali's product candidates have not been approved by any health authority for any use. Accuracy of Data. This presentation contains statistical data based on independent industry publications or other publicly av ailable information, as well as other information based on Denali’s internal sources. Denali has not independently verified the accuracy or completeness of the data contained in these industry publicati ons and other publicly available information. Accordingly, Denali makes no representations as to the accuracy or completeness of that data. ©2025 Denali Therapeutics Inc.2
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Denali is the first fully integrated biotechnology company to deliver medicine to the brain at scale. OUR PURPOSE: CROSSING BARRIERS & DEFEATING DEGENERATION Crossing Barriers Defeating Degeneration ©2025 Denali Therapeutics Inc.3 Dominic, living with MPS II Seth, living with ALS Allan, living with PD Denali Team at AD Walk Taking on the blood-brain barrier challenge to enable delivery of medicines to the brain at scale Blood Brain Blood-Brain Barrier
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DELIVERING A NEW CLASS OF THERAPEUTICS ©2025 Denali Therapeutics Inc.4 The Transport Vehicle (TV) enables a new class of therapeutics that cross the blood-brain barrier (BBB) 2025 Priorities Potential launch of tividenofusp alfa in MPS II (Hunter syndrome) PREPARING TO LAUNCH EXPANDING ETV FRANCHISE Realize potential of TV platform for lysosomal storage diseases ADVANCING TV PORTFOLIO Progress TV programs for neurodegeneration and other indications Transforming treatment for people with rare and common diseases that impact the brain
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SETTING THE BAR FOR BRAIN DELIVERY PLATFORMS BBB receptor binding site engineered into the Fc for optimal properties and modularity Illustrative examples of other BBB technologies using the Fab to bind TfR Optimized Binding Affinity & Monovalency: Enhances brain delivery and limits receptor degradation Conditional Effector Function: Avoids reticulocyte loss and potentially minimizes anemia liability High Fidelity to Natural Protein: No appended sequences limits risk of immunogenicity and IRRs Modularity: Enables broadest utility to transport biologics, such as enzymes, oligos, antibodies Our Fc-based TransportVehicle (TV) is Designed and Engineered to Optimize Brain Delivery Conventional Fab Approaches >10>350 10 3 Clinical Programs Preclinical Programs High Impact Publications Patents and Applications 5 ©2025 Denali Therapeutics Inc. Leading BBB technology and broadest portfolio of TV-enabled therapeutics BBB – blood-brain barrier; TfR – transferrin receptor; IRRs – infusion related reactions
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Study Week % Change from Baseline Serum NfL 60 40 20 0 -20 -40 -60 -80 -100 BL 7 13 24 37 49 61 73 85 97104 117 129 ©2025 Denali Therapeutics Inc. OUR TV PLATFORM IS WELL CHARACTERIZED AND CLINICALLY VALIDATED Biodistribution Disease Biomarker TV enables ETV:IDS to reduce serum NfL by >80%, achieving normal levels TV provides high and uniform deposition of ATV across the brain with systemic delivery Target Engagement ETV TV enables sustained brain tau knockdown with OTV:MAPT systemic delivery Tau Knockdown NfL Correction 6 NfL – neurofilament light, a marker of neurodegeneration; Source: tau – Denali data on file, NfL – adapted from SSIEM 2024 Khoury et al. Nature Communications (in press) TransportVehicle (TV) enables broader brain biodistribution, enhanced target engagement, and normalization of key disease biomarkers 1.5 1.0 0.5 0.0 0 4 8 12 16 Relative Expression vs. Controls (RNA norm to Gapdh; Protein norm to BCA) Weeks Post Study Start Tau Protein MAPT RNA
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PREPARING FOR COMMERCIAL LAUNCH 7 • Market leading profile to treat MPS II phenotype spectrum • Only candidate therapy to normalize key biomarkers, CSF HS, urine HS, and NfL, in a lysosomal storage disease • Alignment with FDA on accelerated approval path • BLA filing early 2025 and preparing for U.S. launch • Ongoing Phase 2/3 COMPASS study to support global approval Paving the Path with Tividenofusp alfa Enzyme TransportVehicle (ETV): Expected Product Launches Validating the TransportVehicle platform and enabling a broad ETV portfolio ©2025 Denali Therapeutics Inc. MPS II – Mucopolysaccharidoses Type II ; CSF HS – cerebrospinal fluid heparan sulfate; HS – heparan sulfate; NfL – neurofilament light, a marker of neurodegeneration; BLA – Biologics License Application; MPS IIIA – Mucopolysaccharidoses Type IIIA; START – Support for clinical Trials Advancing Rare disease Therapeutics U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
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TRANSITIONING TO COMMERCIAL STAGE 8 • Market leading profile to treat MPS II phenotype spectrum • Only candidate therapy to normalize key biomarkers, CSF HS, urine HS, and NfL, in a lysosomal storage disease • Alignment with FDA on accelerated approval path • BLA filing early 2025 and preparing for U.S. launch • Ongoing Phase 2/3 COMPASS study to support global approval Paving the Path with Tividenofusp alfa Accelerating DNL126 • Achieved biomarker proof-of-concept in Phase 1/2 • Expanded study to support a potential accelerated approval path in MPS IIIA • Selected for FDA START program • Collaborating with FDA on path to approval Enzyme TransportVehicle (ETV): Expected Product Launches ©2025 Denali Therapeutics Inc. Apply Learnings MPS II – Mucopolysaccharidoses Type II ; CSF HS – cerebrospinal fluid heparan sulfate; HS – heparan sulfate; NfL – neurofilament light, a marker of neurodegeneration; BLA – Biologics License Application; MPS IIIA – Mucopolysaccharidoses Type IIIA; START – Support for clinical Trials Advancing Rare disease Therapeutics Validating the TransportVehicle platform and enabling a broad ETV portfolio
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ETV FRANCHISE OPPORTUNITY IN LYSOSOMAL STORAGE DISEASES 30,000 people with LSDs worldwide 2/3 LSDs with CNS manifestations LSDs are single-enzyme deficiency diseases ~90% historical approval rate Goal is to treat the full disease spectrum ETV ©2025 Denali Therapeutics Inc. Traditional ERTs partially address somatic but not CNS symptoms ETVs enable brain delivery of enzymes to address cognitive and behavioral symptoms Potential to enhance peripheral delivery 9 Targeting Brain & Body with ETVAddressing High Unmet Need ETV – enzyme transport vehicle; LSDs – lysosomal storage diseases ; CNS – central nervous system; ERTs – enzyme replacement therapies
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©2025 Denali Therapeutics Inc. First and only therapy in development for MPS II to achieve normalization of CSF HS and NfL TIVIDENOFUSP ALFA PHASE 1/2 IN MPS II: BRAIN BIOMARKERS MPS II – Mucopolysaccharidoses Type II; CSF HS – cerebrospinal fluid heparan sulfate; NfL – neurofilament light, a marker of neurodegeneration; CFB – Change from baseline; pts – participants; All bars represent 95% confidence intervals; Source: SSIEM 2024 ETV 10 CSF Heparan Sulfate Biomarker of neuronopathic disease Serum NfL Biomarker of neuronal damage Week n % pts w/ normal levels 49 23 13 117 14 100 129 12 100
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TIVIDENOFUSP ALFA PHASE 1/2 IN MPS II: PERIPHERAL BIOMARKERS ©2025 Denali Therapeutics Inc. Achievement of normalization of peripheral biomarkers suggests additional effects after switching from idursulfase to treatment with tividenofusp alfa ETV MPS II – Mucopolysaccharidoses Type II ; HS – heparan sulfate; DS – dermatan sulfate; Source: SSIEM 202411 Urine Heparan Sulfate Urine Dermatan Sulfate
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12 TIVIDENOFUSP ALFA PHASE 1/2 IN MPS II: EFFICACY AND SAFETY • Improvement or stabilization in adaptive behavior and cognitive scores, hearing, liver volume, and growth outcomes were observed • Generally well-tolerated based on 33 participants, median treatment duration 100 weeks • All study participants reported treatment-emergent adverse events (TEAEs), which were mostly mild or moderate. Infusion-related reactions (IRRs), the most common TEAEs, decreased in frequency and severity with continueddosing ETV ©2025 Denali Therapeutics Inc. Improvement in Adaptive Behavior VABS-II total raw score Improvement in Hearing Auditory brainstem response Data support broad indication: treating the full spectrum of MPS II disease across brain and body Worsened Improved Worsened Improved MPS II – Mucopolysaccharidoses Type II ; VABS-II – Vineland Adaptive Behavior Scales -Second Edition; Source: SSIEM 2024
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LEADERSHIP AND COLLABORATION IN TRANSFORMING MPS TREATMENT ©2025 Denali Therapeutics Inc. Dominic, living with MPS II We acknowledge the collective efforts advocating for faster, science-driven, paths to effective treatments for rare diseases that contribute to this opportunity and potentially others Workshop, February 2024 Muenzer et al. 2024 Mol. Genet. Metab. Data Driven and Action Oriented to Deliver Meaningful Impact for Patients Advocates, Academics, Industry, & FDA 13 Carole Ho, MD Feb 2024, BioSpace Accelerating a Path to New Treatments for Rare Neuropathic MPS Diseases Eliza, living with MPS IIIA ETV
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MPS II: PATIENTS, PRESCRIBERS, PRODUCT OPPORTUNITY IN U.S. Opportunity ©2025 Denali Therapeutics Inc. • 400-500 patients • 80-100 centers of excellence • Extended health care team • Weekly contact with patients • Normalize disease biomarkers • Address neuronopathic and peripheral disease • Slow/stop degeneration • Replace idursulfase as standard of care Prelaunch Activities Awareness • Ongoing dialogue with prescribers; full coverage by MSL team • Engaging with payers • Educating on unmet need across the phenotype spectrum • Demonstrating differentiated therapeutic profile Access & Support • Building a suite of patient support services and capabilities to enable broad access to tividenofusp alfa Team • Building a right-sized team in commercial and medical affairs to support tividenofusp alfa and additional ETV launches Preparing to launch tividenofusp alfa for MPS II in late 2025 / early 2026 MPS II Landscape Patients & Prescribers 14 MPS II – Mucopolysaccharidoses Type II ; MSL – medical science liaison; ETV – enzyme transport vehicle ETV
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MPS II GLOBAL MARKET OPPORTUNITY 15 • Invest in key markets with the highest opportunity: USA / EUCAN • Maximize global reach and value with potential distributors (or local partners) to accelerate access to medicine for patients and time to revenue in anchor markets Total Addressable Market ~2,000 Worldwide* Strategically Build & Collaborate ©2025 Denali Therapeutics Inc.*Excluding China and India; MPS II – Mucopolysaccharidoses Type II Denali Build Markets Potential Distributors (or Local Partners) LATAM Brazil, Colombia, Mexico, Argentina, Peru, Chile APAC Taiwan, S. Korea, Singapore, Australia MENA Saudi Arabia, Israel, Turkey, UAE, Oman, Lebanon Japan EUCAN EU5 + CA + other EU marketsUSA ETV
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Tividenofusp alfa (ETV:IDS; DNL310) ETV:SGSH (DNL126) PTV:PGRN (DNL593) ETV:GAA (DNL952) ETV:GCase (DNL111) ETV:IDUA (DNL622) MPS II (Hunter syndrome) MPS IIIA (Sanfilippo syndrome) FTD-GRN (Frontotemporal dementia) Pompe Disease Parkinson’s and Gaucher MPS I (Hurler syndrome) Patients WW1 ~2,000 ~1,500+ ~25,000+ ~5,000 – 10,000 ~300,000+ (GBA-PD) ~10,000 – 15,000 (GD) ~1,500+ Status Phase 2/3 BLA filing2 Phase 1/2 Phase 1/2 IND-enabling IND-enabling IND-enabling 16 ©2025 Denali Therapeutics Inc. EXPANDING OUR ETV DEVELOPMENT FRANCHISE We are developing the next generation of enzyme replacement therapies designed to treat brain and body manifestations of serious genetic diseases ETV PTV:PGRN WW – worldwide; BLA – biologics license application; IND – investigational new drug application; GBA-PD – Parkinson’s Disease with GBA mutation; GD – Gaucher’s Disease; 1. Excluding China and India; 2. Expected filing of BLA under accelerated approval pathway in early 2025.
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Tividenofusp alfa (ETV:IDS; DNL310) ETV:SGSH (DNL126) PTV:PGRN (DNL593) ETV:GAA (DNL952) ETV:GCase (DNL111) ETV:IDUA (DNL622) MPS II (Hunter syndrome) MPS IIIA (Sanfilippo syndrome) FTD-GRN (Frontotemporal dementia) Pompe Disease Parkinson’s and Gaucher MPS I (Hurler syndrome) Patients WW1 ~2,000 ~1,500+ ~25,000+ ~5,000 – 10,000 ~300,000+ (GBA-PD) ~10,000 – 15,000 (GD) ~1,500+ Status Phase 2/3 BLA filing2 Phase 1/2 Phase 1/2 IND-enabling IND-enabling IND-enabling 17 ©2025 Denali Therapeutics Inc. EXPANDING OUR ETV DEVELOPMENT FRANCHISE We are developing the next generation of enzyme replacement therapies designed to treat brain and body manifestations of serious genetic diseases ETV PTV:PGRN WW – worldwide; BLA – biologics license application; IND – investigational new drug application; GBA-PD – Parkinson’s Disease with GBA mutation; GD – Gaucher’s Disease; 1. Excluding China and India; 2. Expected filing of BLA under accelerated approval pathway in early 2025.
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ETV:GAA IS SUPERIOR TO STANDARD OF CARE IN BRAIN AND MUSCLE ETV Correction of Glycogen Load Lamp2 P62 Reduction of Lysosomal Volume and Autophagy in Muscle Vehicle Vehicle ETV:GAA Alglucosidase alfa Avalglucosidase TfRmu/hu ETV:GAA shows superior reduction of key biomarkers compared to standard of care ©2025 Denali Therapeutics Inc. Lysosomal Volume Alg. Aval. Mean Lamp2 volume (µm3) Autophagic Substrate Alg. Aval. % P62 volume / Image volume 18 Standard of care: Alg. – alglucosidase alfa; Aval. – avalglucosidase alfa-ngpt Alg. Aval. Alg. Aval. Brain Muscle GAA KO; TfRmu/hu
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ENGINEERED ETV:GCase SHOWS IMPROVED SUBSTRATE REDUCTION ©2025 Denali Therapeutics Inc. ETV Engineered ETV:GCase may enable highly stable and potent brain-penetrant enzyme replacement therapy for Parkinson’s disease and Gaucher SerumLiverBrain Reduction of GlcSph Substrate in Brain and Periphery • Coupling GCase with TV enables brain delivery • Engineered GCase improves potency in CNS and periphery 19
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CAPTURING THE FULL POTENTIAL OF THE TRANSPORTVEHICLETM (TV) Market Opportunity Investing now to unlock full potential ETV Enzymes >$5B $1-$5B Up to $1B Biological/Disease ComplexityLower Higher ©2025 Denali Therapeutics Inc. Each TV Franchise has a market potential of $3B+ Expect to file 1-2 INDs per year over the next 3 years 20 Neuromuscular Metabolic Inflammation Oncology Neurodegeneration Lysosomal Storage Diseases
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1.5 1.0 0.5 0.0 0 4 8 12 16 Relative Expression vs. Controls (RNA norm to Gapdh; Protein norm to BCA) Weeks Post Study Start Tau Protein MAPT RNA OTV ©2025 Denali Therapeutics Inc. DEVELOPING A FIRST-IN-CLASS ANTI-TAU THERAPY WITH OTV:MAPT • Brain MAPT RNA and tau protein knockdown persists for >15 weeks following four IV doses of OTV:MAPT • Extended knockdown duration of action enables less frequent maintenance dosing OTV provides uniform ASO deposition in the brain with intravenous (IV) delivery anti-ASO BRAIN NAKED ASO INTRATHECAL (IT) DELIVERY OTV INTRAVENOUS (IV) DELIVERY Barker et al. 2024 Sci. Transl. Med. Robust and sustained reduction in tau protein with OTV:MAPT 21
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ATV ©2025 Denali Therapeutics Inc. DEVELOPING A BEST-IN-CLASS ANTI-AMYLOID THERAPY WITH ATV:Aβ Greater Reductions in Oligomeric Aβ and Plaque and Less ARIA with ATV:Aβ 1. Xia et al., Molecular Neurodegeneration 2022; 2. Denali data on file; 3. Pizzo et al., bioRxiv 2024; *At experimental doses selected to yield equivalent brain exposure and plaque reduction ATV – Antibody Transport Vehicle; Aβ – Amyloid beta; huIgG – Human immunoglobulin G; ARIA – Amyloid related imaging abnormalities; MRI – Magnetic resonance imaging ARIA-Like MRI Events Weekly dosing x 11 wks, 5xFAD TfRmu/hu KI3 ATV:Aβ may enable better efficacy and safety in treating Alzheimer’s disease as compared to conventional anti-Abeta therapy Reticulocyte Numbers Single dose TfRmu/hu KI3 22 Oligomeric Aβ Load Single, mid dose, APPSAA KI2 Aβ Plaque Load Single, mid dose, APPSAA KI1 2 7 0.0 0.2 0.4 0.6 Days post-dose % Area of plaques Ab Plaque load Single dose 10 mg/kg, APPSAA KI naive anti-Abeta ATV:Abeta baseline naive anti-Abeta ATV:Abeta Days Post-Dose % Area of Plaques 2 7 0.0 0.2 0.4 0.6 Days post-dose % Area of plaques Ab Plaque load Single dose 10 mg/kg, APPSAA KI naive anti-Abeta ATV:Abeta
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PORTFOLIO EXECUTION ACROSS AN ARRAY OF RARE AND COMMON DISEASES DNL126 (ETV:SGSH) MPS IIIA (Sanfilippo Syndrome) Tividenofusp alfa (DNL310)* MPS II (Hunter Syndrome) DNL593 / TAK-594 (PTV:PGRN) FTD-GRN DNL952 (ETV:GAA) Pompe Disease IND-Enabling Neurodegeneration Lysosomal Storage Diseases DNL622 (ETV:IDUA) MPS I (Hurler Syndrome) DNL628 (OTV:MAPT) Alzheimer’s Disease DNL422 (OTV:SNCA) Parkinson’s Disease Oncology Inflammation DNL921 (ATV:Abeta) Alzheimer’s Disease Neuromuscular DNL111 (ETV:GCase) Parkinson’s / Gaucher Diseases ©2025 Denali Therapeutics Inc.23 Clinical Regulatory FilingDiscovery BIIB122 (LRRK2 inhibitor) Parkinson’s Disease DNL343 (eIF2B agonist) ALS Eclitasertib (SAR443122) Ulcerative Colitis ETV OTV ATV SM Broad portfolio across TV franchises with substantial opportunity for expansion Metabolic *Expect to file biologics license application under accelerated approval pathway in early 2025 Enzyme TransportVehicleTM Oligonucleotide TransportVehicleTM Antibody TransportVehicleTM Small Molecule
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OUR PURPOSE: CROSSING BARRIERS & DEFEATING DEGENERATION Deliver Meaningful Medicines2025 Priorities ©2025 Denali Therapeutics Inc.24 PREPARE TO LAUNCH Potential launch of tividenofusp alfa in MPS II (Hunter syndrome) EXPAND ETV FRANCHISE Realize potential of TV platform for lysosomal storage diseases ADVANCE TV PORTFOLIO Progress TV programs for neurodegeneration and other indications Transforming treatment for people with rare and common diseases that impact the brain Dominic, living with MPS II Seth, living with ALS Allan, living with PD Denali Team at AD Walk
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THANK YOU