PresentationI will now hand the call over to Mr. Ryan Watts, Chief Executive Officer. Please go ahead, sir.Good day, and thank you for standing by. Welcome to Denali Analyst Call 2026 WORLDSymposium. [Operator Instructions]Ryan WattsCo-Founder, President, CEO & Director Great. Thank you. We're looking forward to previewing our enzyme transport vehicle highlights from the WORLDSymposium, which we're here attending in San Diego. Slide 2 is our forward-looking statements. On to Slide 4, just a reminder that De ...

Denali Therapeutics (NasdaqGS:DNLI) Update / briefing February 05, 2026 03:30 PM ET Company ParticipantsAnanda Ghosh - Managing DirectorJoseph Lewcock - Chief Scientific OfficerPeter Chin - Acting Chief Medical Officer and Head of DevelopmentRyan Watts - CEOConference Call ParticipantsAndrew Tsai - Senior Research AnalystCharles Moore - AnalystDavid Hoang - AnalystJay Olson - Senior Research AnalystJoseph Thome - AnalystMayank Mamtani - AnalystMichael DiFiore - AnalystMichael Yee - AnalystMyles Minter - Ana ...

February 5, 2026 Analyst Call 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 "anticipate," "believe," "could," "estimate," "expected," "forecast," "intend," "may," "plan," "potential," "possible," "future," "will" and other words and terms of similar meaning. All statements other than statements ...

Analysis from continued follow-up of Phase 1/2 clinical trial data in Hunter syndrome (MPS II) reinforces potential for tividenofusp alfa (DNL310) to address full disease spectrumLaunch readiness established in anticipation of April 5, 2026, Prescription Drug User Fee Act (PDUFA) date for tividenofusp alfaPreliminary Phase 1/2 study data show treatment with DNL126 (ETV:SGSH) substantially reduced disease biomarkers in cerebrospinal fluid (CSF) and peripheral tissues, including an 80% mean reduction in CSF h ...

The fourth-quarter 2025 reporting cycle for the Medical sector is about to pick up pace this week, as most firms are slated to share their earnings results over the next two weeks. The sector mainly comprises pharma/biotech and medical device companies. The earnings season for the drug and biotech sector kicked off in late January when bellwether Johnson & Johnson reported strong fourth-quarter results, beating estimates for earnings and sales. While most of the pharma bigwigs are slated to report their ear ...

SOUTH SAN FRANCISCO, Calif., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that management will host a live webcast to review presentations on its Enzyme TransportVehicle™ (ETV) programs at the upcoming 22nd Annual WORLDSymposium™ being held February 2-6, 2026, in San Diego, California. These presentations will demonstrate the broad potential of the ETV to enable the delivery of enzyme replacement therapies to the whole body, including the brain. Titles and times ...

Hunter syndrome (MPS II) presentations will include analysis from continued follow-up of Phase 1/2 data for tividenofusp alfa (DNL310), currently under FDA Priority ReviewPreliminary data from Phase 1/2 study of DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA) to be featured in oral presentationPhase 1 study design of DNL952 (ETV:GAA) for Pompe disease and supporting preclinical data will appear in poster session SOUTH SAN FRANCISCO, Calif., Jan. 29, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics I ...

Core Insights - The biotech sector has experienced a resurgence after a decade of stagnation, attracting increased investor interest [1] - Growth in other economic sectors has resulted in elevated valuations for those sectors compared to the biotech sector [1] Industry Summary - Investors are focusing on top biotech names in the market, indicating a shift in investment strategy towards biotech [1] - The current market conditions suggest that biotech valuations may appear more attractive relative to other sectors [1]

Core Insights - Denali is focused on delivering biotherapeutics to the brain and has expanded its technology to target other regions of the body [2] - The company has seen significant maturation in both clinical and preclinical data, highlighting the effectiveness of using transferrin receptor technology for biotherapeutics [3] Company Overview - Denali was founded with the mission to develop biotherapeutics that can effectively access the brain [2] - The company is positioned in a competitive field, indicating a growing interest and activity in biotherapeutics targeting the central nervous system [3]

Denali Therapeutics FY Conference Summary Company Overview - **Company**: Denali Therapeutics (NasdaqGS:DNLI) - **Industry**: Biotechnology, focusing on biotherapeutics for neurological diseases Key Messages and Core Points 1. **Transport Vehicle Technology**: Denali emphasizes its transport vehicle technology as a validated and clinically proven platform for delivering biotherapeutics across the blood-brain barrier (BBB) [3][4][12] 2. **Market Potential**: The company anticipates capturing a market exceeding $1 billion with upcoming launches for treatments targeting rare diseases such as Hunter syndrome and Sanfilippo [3] 3. **Clinical Programs**: Denali is advancing multiple clinical programs, including: - TIVI for Hunter syndrome, with a BLA filing and a PDUFA date set for April 5, 2026 [16][33] - OTV MAPT and ATV A beta for Alzheimer's disease, with clinical studies expected to start soon [4][27] - DNL126 for Sanfilippo, aiming for accelerated approval by 2027 [18][44] Financial and Market Strategy 1. **Launch Strategy for TIVI**: The company plans a seamless transition for patients currently on standard care, focusing on engaging centers of excellence and ensuring payer coverage [34][38] 2. **Revenue Expectations**: Minimal revenues are expected in 2026 due to the nature of rare disease launches, with a significant increase anticipated in 2027 as coverage expands [37] 3. **Pricing Strategy**: Denali aims to price TIVI at a premium compared to current treatments, ensuring broad access and affordability for patients [38] Clinical Data and Safety 1. **TIVI Clinical Data**: Safety data shows a decline in infusion-related reactions over time, with normalization of biomarkers indicating efficacy in halting neurodegeneration [15][16] 2. **Sanfilippo Program**: The ongoing phase one-two study for DNL126 is designed to leverage learnings from TIVI, with a focus on CSF heparan sulfate as a surrogate biomarker [41][44] 3. **Alzheimer's Programs**: ATV-A shows promise in reducing amyloid-related imaging abnormalities (ARIA) and improving plaque reduction compared to standard treatments [23][25] Research and Development Focus 1. **Broad Portfolio**: Denali is expanding its portfolio to include treatments for lysosomal storage diseases and common neurodegenerative diseases, with a focus on both enzyme replacement and oligonucleotide therapies [6][22] 2. **Innovative Approaches**: The company is committed to advancing its transport vehicle technology to enhance drug delivery across the BBB and improve treatment outcomes [11][52] Competitive Landscape 1. **Market Position**: Denali acknowledges the competitive nature of the field but believes its unique technology and clinical validation position it favorably [2][3] 2. **Future Opportunities**: The company is exploring additional indications for its transport vehicle platform, prioritizing diseases with well-understood biology and significant unmet needs [52] Conclusion Denali Therapeutics is poised for significant growth with its innovative transport vehicle technology, targeting both rare diseases and common neurodegenerative conditions. The company is strategically positioned to launch its products, engage with the medical community, and ensure patient access while navigating the complexities of the biotechnology market.