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Here are 1-3 brief analogies for Denali Therapeutics (DNLI):

• Moderna for brain diseases: Denali is developing an innovative platform technology to deliver therapeutics across the blood-brain barrier, aiming to unlock treatments for complex neurological conditions, much like Moderna's mRNA platform opened new avenues for vaccines and other therapies.
• Vertex for neurological disorders: Denali aims to achieve transformative breakthroughs for a range of neurodegenerative diseases, similar to how Vertex Pharmaceuticals developed highly effective treatments for previously untreatable conditions like cystic fibrosis.
• Regeneron for brain drug delivery: Denali's core strength lies in its proprietary platform to transport medicines efficiently into the brain, akin to how Regeneron leverages its advanced technology platforms to discover novel antibodies and therapeutic proteins.

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• DNL310 (ETV:IDS): An investigational brain-penetrant enzyme replacement therapy for the treatment of Hunter syndrome (MPS II), a rare genetic neurodegenerative lysosomal storage disorder.
• DNL151 (LRRK2 inhibitor): An investigational small molecule designed to inhibit LRRK2 activity for the potential treatment of Parkinson's disease.
• DNL343: An investigational small molecule aimed at activating EIF2B for the treatment of amyotrophic lateral sclerosis (ALS).
• SAR443820 (RIPK1 inhibitor): Developed in collaboration with Sanofi, this investigational small molecule aims to inhibit RIPK1 to treat neurological and peripheral inflammatory diseases such as ALS, multiple sclerosis, and Alzheimer's disease.

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Denali Therapeutics (DNLI) is a biotechnology company focused on discovering and developing therapies for neurodegenerative diseases. As such, it does not sell directly to individuals. Instead, its primary "customers" are larger pharmaceutical companies with whom it forms strategic collaborations and licensing agreements to fund research, co-develop drug candidates, and eventually commercialize them.

Denali's major customers (collaborators) that provide significant revenue through upfront payments, milestone payments, and potential royalties include:

• Biogen Inc. (Symbol: BIIB): Biogen is a key partner for Denali's LRRK2 program (DNL151 / BIIB122), which is in development for Parkinson's disease.
• Sanofi S.A. (Symbol: SNY): Sanofi is a significant collaborator on Denali's RIPK1 inhibitor program for various inflammatory and neurodegenerative diseases.

These companies contribute substantially to Denali's revenue through the terms of their collaboration agreements, effectively acting as its major customers in the biopharmaceutical industry model.

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Ryan Watts, Chief Executive Officer

Ryan Watts is a co-founder of Denali Therapeutics and has served as its Chief Executive Officer since January 2015. Prior to co-founding Denali, Dr. Watts was the Director of the Department of Neuroscience at Genentech, where he spearheaded the company's re-entry into neuroscience and led drug discovery efforts for cancer and Alzheimer's disease, with a focus on understanding neurodegeneration mechanisms and blood-brain barrier biology. Denali was founded in 2015 with support from Flagship Pioneering.

Alexander Schuth, Chief Operating and Financial Officer

Alexander Schuth is a co-founder of Denali Therapeutics and has served as Chief Operating Officer and Secretary since 2015, assuming the Chief Financial Officer role in May 2022. He is responsible for portfolio management, corporate development, and finance, and has established numerous collaborations with industry and academic partners. Before Denali, Dr. Schuth held leadership positions in the business development and finance groups at Genentech and worked in investment banking at Merrill Lynch in London. He currently serves on the board of directors of Molecular Health, a privately held biopharmaceutical company.

Peter Chin, Acting Chief Medical Officer and Head of Development

Peter Chin is the Acting Chief Medical Officer and Head of Development at Denali Therapeutics, a role he assumed in November 2025. He joined Denali in 2019 and previously served as Senior Vice President of the Enzyme Transport Vehicle Franchise and Late-Stage Clinical Development. Dr. Chin, a neurologist, has led global late-stage clinical programs and overseen pivotal studies across multiple therapeutic areas at Denali.

Katie Peng, Chief Commercial Officer

Katie Peng is the Chief Commercial Officer at Denali Therapeutics, a position she has held since 2021. She is responsible for building and leading the commercial team to bring Denali's medicines to patients globally. With over 30 years of experience in the pharma/biotech industry, Ms. Peng spent almost two decades at Genentech and Roche, holding various senior leadership roles, including Senior Vice President, Head of the OMNI Business Unit at Genentech. During her tenure, she successfully launched multiple products in neurology, oncology, and rare diseases.

Dana Andersen, Chief Technical and Manufacturing Officer

Dana Andersen is the Chief Technical and Manufacturing Officer at Denali Therapeutics, responsible for overseeing manufacturing process development, production, quality control, and clinical supply. Prior to joining Denali, he spent nearly 23 years at Genentech, where his most recent role was Vice President and Global Head of Technical Development Project & Portfolio Management for Roche's large and small molecule development portfolio.

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Denali Therapeutics (DNLI), a biopharmaceutical company focused on neurodegenerative diseases, faces several significant risks inherent to the biotech industry.

1. Clinical Trial Failures: The most substantial risk for Denali Therapeutics is the potential for clinical trial failures. As a clinical-stage company, Denali's future success, financial stability, and ability to generate revenue are entirely dependent on its product candidates successfully progressing through clinical trials and ultimately receiving approval. Failures in late-stage trials can severely damage investor confidence and financial outlook.

2. Regulatory Hurdles and Delays: Denali operates within a stringent regulatory environment, and its product candidates are subject to rigorous review by health authorities like the FDA. Delays or outright denials of regulatory approvals for its therapies, such as the extended PDUFA date for tividenofusp alfa, can significantly postpone potential commercial launches and revenue generation, thereby increasing pressure on the company's cash reserves.

3. High Cash Burn and Lack of Approved Products/Revenue: As a pre-revenue biotech firm, Denali Therapeutics incurs substantial research and development (R&D) expenses, leading to a high cash burn rate. The company currently lacks approved products and, consequently, product sales revenue, making its financial health heavily reliant on successful clinical and regulatory outcomes, as well as external funding and collaborations. This dependency on outside factors and high expenses are considered vulnerabilities.

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Denali Therapeutics (DNLI) is a biotechnology company focused on developing therapies for neurodegenerative diseases and lysosomal storage disorders. The addressable markets for their main products or services are as follows:

• DNL310 (tividenofusp alfa) for MPS II (Hunter Syndrome):
  • The global Hunter syndrome treatment market size was valued at approximately USD 0.99 billion in 2024 and is projected to reach USD 1.60 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.2% from 2025 to 2032.
  • In North America, the MPS II treatment market size was USD 0.51 billion in 2024.
  • Another estimate places the Hunter Syndrome market in the 7 Major Markets (7MM) at USD 734.6 million in 2024, expecting it to reach USD 1,215.0 million by 2035, with a CAGR of 4.69% during that period.
  • A separate report indicates the Hunter syndrome treatment market reached USD 1.38 billion in 2025 and is projected to register a 5.3% CAGR to 2030, when it is forecast to be worth USD 1.78 billion.
• BIIB122/DNL151 (LRRK2 inhibitor) for Parkinson's Disease:
  • The Parkinson's disease market size across the 7MM (United States, France, Germany, Italy, Spain, UK, and Japan) was approximately USD 2,936.3 million in 2022.
  • The United States alone accounted for approximately USD 1,820 million of the Parkinson's disease market size in 2022.
• DNL343 (eIF2B activator) for Amyotrophic Lateral Sclerosis (ALS):
  • The Amyotrophic Lateral Sclerosis (ALS) market size in the seven major markets (7MM) was approximately USD 1,000 million in 2023.
  • The total ALS market size in the U.S. was estimated to be approximately USD 920 million in 2023, with expected growth through 2034.
  • The market for ALS medicines in major markets is projected to increase to USD 1.28 billion in 2029 from USD 317 million in 2019, representing a CAGR of 15%.
  • The global amyotrophic lateral sclerosis treatment market size is estimated to grow by USD 663.7 million from 2024-2028, at a CAGR of 12.79%.
• TAK-594/DNL593 (PTV:PGRN) for Frontotemporal Dementia (FTD-GRN) and DNL921 (ATV:Abeta) for Alzheimer's Disease:
  • The global neurodegenerative disease therapeutics market was valued at US$43.7 billion in 2024 and is projected to reach US$64.9 billion by 2030, with a CAGR of 6.8%.
  • The global neurodegenerative disorder therapeutics market size was valued at USD 17.30 billion in 2024 and is projected to reach USD 26.89 billion by 2032, with a CAGR of 5.67% during the forecast period of 2025 to 2032.
  • The Alzheimer's disease therapeutics market size is forecast to increase by USD 4,391.9 million from 2022 to 2027, at a CAGR of 8.91%.

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Denali Therapeutics (NASDAQ: DNLI) is poised for significant revenue growth over the next 2-3 years, driven primarily by the anticipated commercialization of its lead product candidates and the continued expansion of its proprietary TransportVehicle (TV) platform.

Key Drivers of Future Revenue Growth:

1. Commercial Launch of Tividenofusp Alfa (DNL310) for Hunter Syndrome (MPS II): Denali is actively preparing for the U.S. commercial launch of tividenofusp alfa in late 2025 or early 2026. This follows the submission of a Biologics License Application (BLA) under the accelerated approval pathway in early 2025 and the FDA's grant of Breakthrough Therapy Designation. If approved, tividenofusp alfa would be the first FDA-approved enzyme replacement therapy engineered to cross the blood-brain barrier for Hunter syndrome, addressing both body and brain manifestations of the disease. Analysts anticipate premium pricing for tividenofusp alfa compared to existing treatments. The Prescription Drug User Fee Act (PDUFA) target date for approval has been extended to April 5, 2026.
2. Potential Accelerated Approval and Commercialization of DNL126 for Sanfilippo Syndrome Type A (MPS IIIA): Denali is seeking an accelerated approval pathway for DNL126 for Sanfilippo syndrome Type A. Preliminary Phase 1/2 study data have shown a substantial reduction, including normalization, of cerebrospinal fluid heparan sulfate levels. DNL126 has Orphan Disease designation, Fast Track status, and has been selected for the FDA’s START program, designed to accelerate rare disease therapeutic development.
3. Expansion and Advancement of the TransportVehicle (TV) Platform: Denali plans to continually expand its TV-enabled pipeline, which includes enzyme, oligonucleotide, and antibody therapeutics, aiming to advance one to two additional TV programs into the clinic each year for the next three years. This platform is designed to deliver large molecules across biological barriers, including the blood-brain barrier, for various neurodegenerative and lysosomal storage diseases. This ongoing pipeline expansion offers multiple future opportunities for new product launches and revenue streams across both rare and common diseases.
4. Advancement of Collaborations and Other Clinical Programs: Denali continues to advance several programs in collaboration with partners. The co-development of BIIB122 with Biogen for Parkinson's disease, with a Phase 2b LUMA study readout expected in 2026, represents another potential future revenue stream. Additionally, Denali is advancing other programs such as DNL628 for Alzheimer's disease and DNL952 for Pompe disease, with regulatory applications submitted in October 2025 to initiate clinical studies for these TransportVehicle-enabled programs.

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Share Issuance

• In September 2020, Denali Therapeutics issued 13,310,243 new shares of common stock to Biogen for an equity investment of $465.0 million.
• In October 2022, the company announced its intent to offer and sell $250 million of common stock in an underwritten public offering, with an option for underwriters to purchase an additional 15% of shares.
• In February 2025, Denali entered into an equity distribution agreement to sell up to $400 million in common stock through an "at the market offering" program.

Inbound Investments

• In August and October 2020, Denali established a collaboration with Biogen, receiving a $465.0 million equity investment and $560.0 million in upfront payments, with potential for up to $1.125 billion in milestone payments.
• A pivotal $1.05 billion partnership with Takeda in 2024 provided significant capital to Denali.
• Denali maintains ongoing strategic collaborations with pharmaceutical companies, including Takeda, Sanofi, and AbbVie, which are crucial for funding, development, and commercialization of its pipeline.

Outbound Investments

• In early 2024, Denali made a $125 million stock acquisition of a small-molecule biotech, expanding its focus on lysosomal function targeting.
• Denali holds an equity investment in Tenvie Therapeutics, Inc., a privately held venture-backed company.

Capital Expenditures

• Denali's capital expenditures were $18.33 million in 2024, $15.91 million in 2023, $12.94 million in 2022, $17.83 million in 2021, and $8.50 million in 2020.
• Increased research and development expenses in Q3 2025 were partially driven by the commencement of operations at Denali's large molecule manufacturing facility in Salt Lake City, Utah.
• General and administrative expenses rose in Q3 2025 due to preparatory activities for a potential commercial launch of tividenofusp alfa.