Denali Therapeutics (DNLI) AI Stock Analysis

• Market Cap: $2.85B
• Dividend Yield: N/A
• Average Volume (3M): 1.56M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.93
• Revenue Growth: N/A
• EPS Growth: -5.30%
• Country: US
• Employees: 443
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -0.74
• Shares Outstanding: 156,158,370
• 10 Day Avg. Volume: 1,374,442
• 30 Day Avg. Volume: 1,555,888
• PEG Ratio: -0.06
• Price to Book (P/B): 2.73
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -9.22
• Enterprise Value/Market Cap: 0.86
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: -4.60
• 1Y Price Target: $32.36
• Price Target Upside: 78.69% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 13
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 46 Neutral
• Price Target: $15.50 ▼(-14.41% Downside)

The score is held down primarily by weak financial performance (zero-revenue TTM with large losses and significant cash burn) and bearish technical momentum (below key moving averages with negative MACD). A low-debt balance sheet provides some offset, but valuation support is limited due to negative earnings and no dividend.

Positive Factors

Proprietary BBB TransportVehicle Platform

Denali’s TransportVehicle (TV) platform that enables therapeutics to cross the blood-brain barrier is a durable competitive asset. It underpins multiple modality franchises and supports a steady stream of 1–2 new programs annually, increasing the odds of long-term clinical and commercial success.

Low Leverage, Financial Flexibility

Very low reported debt provides structural financial flexibility to fund R&D and partnerships without near-term interest burdens. This balance sheet strength reduces refinancing pressure and supports multi-year development timelines common in neurodegenerative drug development.

Secured Non-Product Funding

The $275M royalty funding (plus a late-2025 equity raise) materially extends runway and de-risks near-term program financing. Access to upfront capital tied to a lead asset allows continued clinical advancement and commercialization prep without solely relying on dilutive equity issuance in the immediate term.

Negative Factors

Zero Current Revenue and Large Losses

As a clinical-stage company with no recurring product revenue, sustained large operating losses erode equity and increase dependency on external capital. Persistent negative profitability raises financing and dilution risk and constrains ability to self-fund multi-program development over the next several quarters.

High Cash Burn and Negative Cash Flow

Very negative operating and free cash flow signals substantial ongoing funding needs to advance trials. Even with recent financing, sustained burn requires continued access to capital or monetization events, making program timelines and cash runway key structural risks for 2–6 months or longer.

Concentration Risk on Tividenofusp Approval

A material portion of near-term financing and future revenue expectations hinge on accelerated approval of tividenofusp alfa. Regulatory denial or delay would materially affect royalty proceeds, commercialization plans and the company’s ability to convert pipeline investments into sustainable revenues.

Denali Therapeutics Business Overview & Revenue Model

Company Description

Denali Therapeutics Inc., a biopharmaceutical company, discovers and develops therapeutic candidates for neurodegenerative diseases in the United States. It offers leucine-rich repeat kinase 2 (LRRK2) inhibitor product candidate, including BIIB122/DNL151, a small molecule inhibitor, which is in phase I and phase Ib clinical trials for the treatment of Parkinson's disease. The company also develops DNL310 that is in Phase I/II clinical trials for the treatment of hunter syndrome; DNL343, which is in phase 1 clinical trial the treatment of amyotrophic lateral sclerosis (ALS); AR443820/DNL788 completed a phase I clinical trial for the treatment of ALS, multiple sclerosis (MS), and Alzheimer's disease; and SAR443122/DNL758, which is in phase II clinical trial for the treatment of cutaneous lupus erythematosus. It has collaboration agreement with Takeda Pharmaceutical Company, Genentech, Inc., Sanofi, F-star Gamma Limited, F-star Biotechnologische Forschungs-Und Entwicklungsges M.B.H, F-star Biotechnology Limited, SIRION Biotech GmbH, Genzyme Corporation, Harvard University, the Michael J. Fox Foundation, and Centogene; and a research and option agreement with Secarna Pharmaceuticals GmbH & Co. KG. to develop antisense therapies in the field of neurodegenerative diseases. The company was formerly known as SPR Pharma Inc. and changed its name to Denali Therapeutics Inc. in March 2015. Denali Therapeutics Inc. was incorporated in 2013 and is headquartered in South San Francisco, California.

How the Company Makes Money

Denali Therapeutics generates revenue primarily through collaborations and licensing agreements with other pharmaceutical companies. These partnerships often involve milestone payments and royalties from the commercialization of co-developed products. Additionally, Denali may receive funding from research grants and government contracts to support its R&D activities. The company focuses on advancing its drug candidates through clinical trials, aiming for regulatory approval and subsequent market entry to drive future revenue growth. Key partnerships with industry leaders help bolster its financial position and expand its development capabilities.

Denali Therapeutics Financial Statement Overview

Summary

Denali Therapeutics is facing substantial financial challenges with declining revenues and persistent net losses. Despite a strong equity base and low leverage, negative cash flows highlight operational challenges, underscoring a need for strategic adjustments to improve profitability.

Income Statement

Denali Therapeutics has experienced significant revenue fluctuations, with no revenue in the most recent year compared to $330.5 million in the previous year. The company has faced consistent net losses, and its EBIT and EBITDA margins are negative, indicating ongoing operational challenges in achieving profitability.

Balance Sheet

The company maintains a strong equity position with a high equity ratio, suggesting good financial stability. The debt-to-equity ratio is low, reflecting limited leverage and reduced risk. However, the return on equity is negative due to sustained net losses, highlighting profitability issues.

Cash Flow

Denali's cash flow situation shows negative free cash flow, which has deteriorated over the period. The operating cash flow is also negative, indicating challenges in generating cash from core operations. However, strong financing cash flows have helped maintain liquidity.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	0.00	0.00	330.53M	108.46M	48.66M	335.66M
Gross Profit	0.00	0.00	330.53M	108.46M	48.66M	335.66M
EBITDA	-534.17M	-492.89M	-179.97M	-330.36M	-287.16M	71.25M
Net Income	-498.74M	-422.77M	-145.22M	-325.99M	-290.58M	71.14M
Balance Sheet
Total Assets	1.06B	1.37B	1.15B	1.46B	1.40B	1.60B
Cash, Cash Equivalents and Short-Term Investments	848.20M	832.33M	1.03B	1.34B	865.41M	1.47B
Total Debt	44.40M	48.71M	52.24M	60.35M	64.01M	68.86M
Total Liabilities	129.42M	144.50M	122.96M	417.81M	441.87M	453.75M
Stockholders Equity	926.20M	1.23B	1.03B	1.04B	962.29M	1.15B
Cash Flow
Free Cash Flow	-410.85M	-363.61M	-370.93M	-262.55M	-219.89M	413.06M
Operating Cash Flow	-397.78M	-347.69M	-357.99M	-244.72M	-211.39M	416.15M
Investing Cash Flow	406.72M	-88.76M	249.31M	-141.39M	-21.63M	-623.21M
Financing Cash Flow	-7.08M	484.30M	17.82M	310.67M	19.35M	634.75M

Denali Therapeutics Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 18.11
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: Negative

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For DNLI, the sentiment is Positive. The current price of 18.11 is above the 20-day moving average (MA) of 17.00, above the 50-day MA of 17.37, and above the 200-day MA of 15.21, indicating a bullish trend. The MACD of 0.07 indicates Negative momentum. The RSI at 59.91 is Neutral, neither overbought nor oversold. The STOCH value of 96.57 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for DNLI.

Denali Therapeutics Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
IDYA	63 Neutral	$3.25B	-19.96	-14.15%	―	5376.27%	20.97%
ARQT	60 Neutral	$3.27B	-75.40	-28.17%	―	129.21%	80.35%
CELC	56 Neutral	$5.30B	-31.18	-122.04%	―	―	-40.75%
BEAM	53 Neutral	$3.59B	-7.98	-47.19%	―	-84.07%	-157.71%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
AGIO	49 Neutral	$1.68B	-4.13	-27.57%	―	36.26%	-158.98%
DNLI	46 Neutral	$2.85B	-6.28	-44.44%	―	―	-5.30%

Denali Therapeutics Corporate Events

Denali Therapeutics Sets 2026 Priorities Ahead of Tividenofusp Decision

On January 6, 2026, Denali Therapeutics outlined its key priorities and expected milestones for 2026, positioning the year as a pivotal period as it prepares for a potential U.S. accelerated approval and commercial launch of tividenofusp alfa for Hunter syndrome, with an FDA decision due by April 5, 2026 and confirmatory data expected from the ongoing global Phase 2/3 COMPASS trial. The company also highlighted an anticipated wave of clinical readouts across its portfolio, including initial Phase 1/2 data for DNL126 in Sanfilippo syndrome Type A, patient data from the TAK-594/DNL593 frontotemporal dementia program, Phase 2b LUMA results for the LRRK2 Parkinson’s candidate BIIB122, and Phase 2 data for Sanofi-licensed eclitasertib in ulcerative colitis, alongside the initiation of first-in-human trials for multiple TV-enabled Alzheimer’s and Pompe disease therapies. Supported by roughly $873 million in cash and securities as of September 30, 2025, plus proceeds from a late-2025 equity raise and a royalty funding deal tied to future tividenofusp alfa sales, Denali signaled it has the capital to advance its clinical and commercial ambitions while reinforcing its strategy to establish leadership in transferrin receptor-enabled, blood-brain-barrier-crossing therapeutics.

The most recent analyst rating on (DNLI) stock is a Hold with a $16.50 price target. To see the full list of analyst forecasts on Denali Therapeutics stock, see the DNLI Stock Forecast page.

Denali Therapeutics Announces $200M Public Offering

On December 9, 2025, Denali Therapeutics entered into an underwriting agreement with major financial institutions for a public offering of its common stock and pre-funded warrants, aiming to raise approximately $200 million, potentially increasing to $230 million if additional shares are purchased. The offering is set to close on December 11, 2025, and is expected to strengthen Denali’s financial position, enhancing its ability to advance its therapeutic candidates and potentially impacting its market positioning in the biotechnology industry.

The most recent analyst rating on (DNLI) stock is a Buy with a $31.00 price target. To see the full list of analyst forecasts on Denali Therapeutics stock, see the DNLI Stock Forecast page.

Denali Therapeutics Secures $275M Royalty Funding Deal

On December 4, 2025, Denali Therapeutics entered into a $275 million synthetic royalty funding agreement with Royalty Pharma, which is contingent upon FDA approval of Denali’s investigational therapy, tividenofusp alfa, for Hunter syndrome. This agreement allows Denali to retain worldwide development and commercialization rights while providing Royalty Pharma a 9.25% royalty on future net sales, positioning Denali to advance its development programs and potentially transform treatment for Hunter syndrome.

The most recent analyst rating on (DNLI) stock is a Buy with a $32.00 price target. To see the full list of analyst forecasts on Denali Therapeutics stock, see the DNLI Stock Forecast page.

Denali Therapeutics Hosts Investor Day, Updates Pipeline

On December 4, 2025, Denali Therapeutics held its Investor Day, updating stakeholders on its development programs and future milestones. Key highlights include the ongoing FDA review of tividenofusp alfa for Hunter Syndrome, expected to conclude by April 2026, and the progression of other pipeline projects like DNL126 for Sanfilippo Syndrome and TAK-594 for Frontotemporal Dementia. The company anticipates minimal delays in its Pompe Disease program due to FDA requests for protocol amendments. These developments underscore Denali’s strategic focus on advancing its pipeline and preparing for potential commercial launches in 2026 and 2027.

The most recent analyst rating on (DNLI) stock is a Buy with a $32.00 price target. To see the full list of analyst forecasts on Denali Therapeutics stock, see the DNLI Stock Forecast page.

Denali Therapeutics Faces FDA Review Extension

On October 13, 2025, Denali Therapeutics announced that the FDA has extended the review timeline for its Biologics License Application for tividenofusp alfa, a treatment for Hunter syndrome. The extension, from January 5, 2026, to April 5, 2026, is due to the submission of updated clinical pharmacology information, classified as a Major Amendment, and is not related to the drug’s efficacy or safety. Denali remains committed to preparing for the potential approval and commercial launch of tividenofusp alfa, which aims to address both central nervous system and peripheral symptoms of Hunter syndrome.

The most recent analyst rating on (DNLI) stock is a Buy with a $37.00 price target. To see the full list of analyst forecasts on Denali Therapeutics stock, see the DNLI Stock Forecast page.