Denali Therapeutics Inc. (DNLI)

Key figures

The last twelve months reported, with the latest price and balance sheet.

Market value

$3.1B

Cash

$201.5M

Debt

$0

Debt to equity

0.00

Shares outstanding

159.8M

Financial statements

Revenue, profit and cash flow by fiscal year, each year linked to its annual report.

By quarter

What the company said with its results

From the second quarter 2026 results, filed 6 August 2026.

• First full quarter of AVLAYAH sales. Revenue came from the first full quarter after the March 2026 FDA approval of AVLAYAH. The company reported net product revenue for the quarter.
• Net loss rose year over year. Net loss was $127.6 million, compared with $124.1 million in the second quarter of 2025. The increase followed higher selling, general and administrative expense.
• Loss per share narrowed slightly. Net loss per share, basic and diluted, was $(0.68), compared with $(0.72) a year earlier. The weighted share count rose to about 187.3 million from 171.4 million.
• Third-quarter AVLAYAH revenue projected. Management projected third-quarter 2026 AVLAYAH net product revenue of $10.0 million to $12.0 million, a range the prior release did not give.
• Most eligible treating sites reached. About 80% of healthcare organizations that treat eligible MPS II patients were reached through launch webinars and the Denali field team.
• Payer coverage widened quickly. Published commercial policies now cover more than 50% of covered lives. Fourteen state Medicaid programs have published coverage of AVLAYAH.
• Access work continues across functions. Launch work continues in patient access services, physician engagement and payer access, supported by an established commercial infrastructure.
• DNL151 development ended in idiopathic PD. After the Phase 2b LUMA study did not meet its primary or secondary endpoints, the companies stopped developing DNL151 in idiopathic Parkinson's disease.
• DNL593 results moved to 2027. Enrollment in the DNL593 Phase 1/2 study is complete at 40 participants. Results are now expected in 2027, allowing more time to observe the NfL biomarker.
• Zafinofusp heading toward a 2027 filing. Zafinofusp alfa for Sanfilippo syndrome type A is in a Phase 1/2 study. A BLA submission and potential accelerated approval are expected in 2027.
• DNL952 Pompe dosing began. Dosing of late-onset Pompe patients in the Phase 1 study began in the second quarter. Initial clinical data are expected in 2027.
• Two Alzheimer's programs in clinic. The company now has two clinical-stage Alzheimer's programs. DNL628 biomarker data are expected in the first half of 2027, and DNL921 data in 2027.
• Cost of goods sold stayed low. Cost of goods sold was $0.1 million. Pre-approval manufacturing costs were expensed to R&D, so inventory sold now carries a lower per-unit cost.
• R&D spending declined year over year. Lower small molecule program costs and lower clinical expenses for tividenofusp alfa reduced research spending by about $5.7 million.

Company events

The newest 8-K filings of 101 held.

Every filing

The newest filings with the SEC of 202 held.

Insider trades

Form 4 trades by officers, directors and 10% owners, last 12 months.

Planned insider sales

Form 144 notices, filed when the sell order goes to the broker.

Large holders

Schedule 13D and 13G filings by holders of more than 5% of the voting shares.

Short interest

Shares sold short and not yet bought back, on each FINRA settlement date.

Funds that hold it

From each fund's latest Form 13F.

322 funds held it at 30 Jun 2026: 161 added and 67 trimmed in the quarter. The largest:

Peers

Companies in the same industry.

• Amgen Inc. (AMGN): revenue $38.1B, market value $244.4B
• Gilead Sciences, Inc. (GILD): revenue $30.5B, market value $197.6B
• Moderna, Inc. (MRNA): revenue $2.2B, market value $85.4B
• argenx SE (ARGX): revenue $4.2B, market value $55.2B
• Biogen Inc. (BIIB): revenue $10.3B, market value $36.1B
• BioNTech SE (BNTX): revenue $3.2B, market value $22.1B
• Exelixis, Inc. (EXEL): revenue $2.4B, market value $16.5B
• Halozyme Therapeutics, Inc. (HALO): revenue $1.7B, market value $14.8B
• Neurocrine Biosciences Inc. (NBIX): revenue $3.4B, market value $14.8B
• Bio-Techne Corp. (TECH): revenue $1.2B, market value $11.3B

What the company does

Denali Therapeutics discovers and develops biotherapeutics designed to reach the brain and the rest of the body. It built a proprietary delivery technology called the TransportVehicle ("TV") to carry large molecules across the blood-brain barrier after systemic administration. Its most advanced program, tividenofusp alfa for Hunter syndrome (MPS II), had a biologics license application under priority review by the United States Food and Drug Administration (FDA), with a target action date of 5 April 2026.

How the technology works

The TV is modular and can carry enzymes, oligonucleotides and antibodies. It engages the transferrin receptor ("TfR"), a natural transport route into the brain. Other approaches use the Fab portion of a full-length antibody to bind the receptor. Denali instead builds the binding site into the Fc domain. The company is also working on a second receptor, CD98hc, and on a dual platform that engages both TfR and CD98hc.

The technology is organised into franchises: Enzyme TV ("ETV"), Oligonucleotide TV ("OTV") and Antibody TV ("ATV"). The filing says more than 200 subjects have joined clinical studies of TV-enabled programs, and more than 11,000 doses have been given, for up to over five years, as of 3 November 2025.

What is in the pipeline

- Tividenofusp alfa (ETV:IDS) is for MPS II, which affects over 2,000 individuals in commercially accessible geographies. The global Phase 2/3 COMPASS study runs in North America, South America and Europe. Cohort A completed enrollment of 44 participants in December 2025. The FDA has granted Fast Track and Breakthrough Therapy designations. - DNL126 (ETV:SGSH) is for Sanfilippo syndrome type A (MPS IIIA), for which the filing says there are no approved treatments. Its Phase 1/2 study enrolled 20 participants. - TAK-594/DNL593 (PTV:PGRN) is for frontotemporal dementia caused by granulin mutations (FTD-GRN). Its Phase 1/2 study has enrolled 40 participants. - DNL952 (ETV:GAA) is for Pompe disease. The FDA placed its Phase 1 application on clinical hold in December 2025 and lifted the hold in January 2026. - Alzheimer's disease: DNL628 (OTV:MAPT) targets tau and is moving into a Phase 1b study. DNL921 (ATV:Abeta) targets amyloid. - BIIB122/DNL151 is a small molecule LRRK2 inhibitor for Parkinson's disease that does not use the TV. Biogen runs the Phase 2b LUMA study, which enrolled 650 participants.

Its partners

- Biogen: The two companies co-develop and co-commercialise the LRRK2 inhibitors. Biogen funds 60% of development costs and Denali funds 40%. Profits and losses are shared equally in the United States. In China, Biogen takes 60% and Denali 40%. Biogen ended its license to the ATV:Abeta program in July 2024. - Takeda: The two companies share development and commercialisation costs, and profits, for PTV:PGRN equally. Takeda leads commercialisation in the United States and China. - Sanofi: Sanofi is solely responsible for developing eclitasertib, a peripherally restricted RIPK1 inhibitor, in ulcerative colitis. Denali is entitled to royalties. - Genentech: Denali holds a license to Genentech's LRRK2 inhibitor program. - Royalty Pharma: In December 2025 the two companies agreed a funding arrangement in exchange for a 9.25% royalty on future net sales of tividenofusp alfa. It is subject to closing conditions, including FDA accelerated approval on or before 30 June 2026.

Making and selling medicines

Denali relies on contract development and manufacturing organisations, including Lonza, for most clinical supply. Its own clinical biomanufacturing facility in Salt Lake City, Utah, opened in 2025. It uses standard antibody processes, including Chinese hamster ovary cell culture and Protein A affinity purification. The company says it expects to keep a hybrid approach that combines internal capability with outside manufacturers.

For tividenofusp alfa, the company has built United States marketing, distribution and sales capabilities. It is in discussions with possible regional partners for markets outside the United States. Its stated geographic focus is the United States and the European Union. For programs under the Takeda, Sanofi and Biogen agreements, it says it expects to commercialise only in certain geographies and to rely on partners elsewhere.

Who it competes with

The company lists efficacy, safety profile, method of administration, cost, level of promotional activity and intellectual property protection as the key competitive factors. Approved Alzheimer's therapies it names include LEQEMBI (Eisai and Biogen) and KISLUNA (Eli Lilly). In lysosomal storage diseases it names JCR Pharmaceuticals, RegenxBio, Kyowa Kirin and Orchard Therapeutics, and Ultragenyx. Companies developing competing blood-brain barrier delivery technologies include JCR Pharmaceuticals, Roche, Eli Lilly, AbbVie, Regeneron and Sanofi, among others.

How it protects its inventions

As of 31 December 2025, the owned and licensed patent portfolio included over 1,600 patents and patent applications. Of these, over 30 are licensed United States issued patents and 40 are owned United States issued patents. Denali owns 10 patent families on the TV platform, and the earliest are expected to expire in 2038. The company also relies on trademarks, trade secrets and know-how, and requires employees and consultants to sign confidentiality agreements.

*From Denali Therapeutics's annual report on Form 10-K for the year ended 31 December 2025. [The filing](https://www.sec.gov/Archives/edgar/data/1714899/000171489926000021/dnli-20251231.htm)*

From the company's 10-K.