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Denali Therapeutics
(NASDAQ:DNLI)
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Rating:61Neutral
Price Target:
$19.50
▼(-21.78% Downside)
Action:Reiterated
Date:08/07/26
DNLI scores moderately due to a strong balance sheet but very weak profitability and significant ongoing cash burn, which remains the central financial risk. Technicals are supportive with price above key moving averages and positive momentum indicators. Earnings call takeaways were favorable on early commercialization and near-term revenue guidance, partially offset by launch variability and longer-dated pipeline readouts; valuation is less informative given negative earnings and no dividend yield data.
Positive Factors
Strong balance sheet
A cash position above $1.1 billion, combined with low leverage, gives Denali substantial funding capacity for commercialization and clinical development. This reduces near-term financing pressure and supports continued investment across the pipeline while AVLAYAH revenue scales.
Negative Factors
Heavy cash burn and losses
Large recurring losses and cash outflows show that Denali remains dependent on its balance-sheet resources while commercial revenue is still small. Continued burn can reduce financial flexibility over time and makes execution, cost control, and successful product expansion especially important.
Read all positive and negative factors
Positive Factors
Negative Factors
Strong balance sheet
A cash position above $1.1 billion, combined with low leverage, gives Denali substantial funding capacity for commercialization and clinical development. This reduces near-term financing pressure and supports continued investment across the pipeline while AVLAYAH revenue scales.
Read all positive factors
Denali Therapeutics (DNLI) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$2.94B
Dividend YieldN/A
Average Volume (3M)1.90M
Price to Earnings (P/E)―
Beta (1Y)1.91
Revenue GrowthN/A
EPS Growth-1.07%
CountryUS
Employees503
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-2.84
Shares Outstanding159,847,400
10 Day Avg. Volume1,750,835
30 Day Avg. Volume1,900,567
Financial Highlights & Ratios
PEG Ratio-0.36
Price to Book (P/B)2.86
Price to Sales (P/S)0.00
P/FCF Ratio-6.86
Enterprise Value/Market Cap1.41
Enterprise Value/Revenue1.15K
Enterprise Value/Gross Profit-1.88K
Enterprise Value/Ebitda-8.32
Forecast
1Y Price Target
$36.11Price Target Upside44.85% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering11
EPS Forecast (FY)-2.25
Revenue Forecast (FY)$38.91M
Denali Therapeutics Business Overview & Revenue Model
Company Description
Denali Therapeutics Inc. is a biopharmaceutical firm, founded in 2013 and based in South San Francisco, California, which focuses on identifying and advancing treatments for neurodegenerative conditions within the United States. The company, initi...
Denali Therapeutics Earnings Call Summary
Earnings Call Date:Aug 06, 2026
(Q2-2026)
| % Change Since: |
Next Earnings Date:Nov 03, 2026
Earnings Call Sentiment Positive
The earnings call communicated a strong, constructive start to commercialization with meaningful early revenue ($3.6M), rapid payer progress (>50% commercial lives) and platform validation via AVLAYAH, supported by a robust pro forma cash position (> $1.1B) and multiple clinical programs advancing toward 2027 readouts. Near-term challenges include variability in revenue and patient initiation timing due to weight-based dosing and infusion logistics, limited disclosed patient-level metrics, some program timing shifts (DNL593), and competitive/coverage risks. On balance, the positive commercial and platform milestones materially outweigh the near-term operational and timing uncertainties.Positive Updates
Successful First Full Commercial Quarter for AVLAYAH
AVLAYAH generated $3.6 million in net product revenue in its first full commercial quarter, marking Denali's transition to a commercial company and the first FDA-approved biologic using its transport vehicle platform.
Negative Updates
Revenue Predictability and Variability
Early-stage launch uncertainty: AVLAYAH is weight-based (maintenance ranges from ~ $270k/yr for a 10 kg patient to ~ $800k/yr for a 30 kg patient) and vial usage varies by patient, contributing to variability in short-term revenue visibility; company will only provide quarter-ahead revenue guidance for the next two quarters.
Read all updates
Q2-2026 Updates
Positive
Negative
Successful First Full Commercial Quarter for AVLAYAH
AVLAYAH generated $3.6 million in net product revenue in its first full commercial quarter, marking Denali's transition to a commercial company and the first FDA-approved biologic using its transport vehicle platform.
Read all positive updates
Company Guidance
Denali's guidance emphasized early-launch trajectory and near-term milestones: AVLAYAH generated $3.6M of net product revenue in Q2 and management expects Q3 net product revenue of $10–12M, with the company providing next-quarter revenue guidance for the first two quarters of the launch; balance sheet strength includes ~ $940M in cash, cash equivalents and marketable securities at quarter end plus $195M PRV proceeds in July for pro forma cash > $1.1B. Key financials: R&D expense was $97M (vs. $102.7M a year ago) and SG&A was $36.3M (vs. $32.3M). Commercial and access metrics: an estimated ~2,000 worldwide MPS II addressable patients (~500 U.S. prevalent, ~375 U.S. label-eligible), ~30 births/year, >50% of commercial lives already covered, 14 state Medicaid programs publicly listing coverage, and >100 families engaged (>25% of eligible U.S. patients). Clinical and pipeline timing: DNL628 biomarker data expected H1 2027, DNL921 initial safety/POC data in 2027, DNL593 databook moved to H1 2027, the COMPASS confirmatory study completes at the end of next year, and corporate 2026–2028 goals include building two commercial brands, generating five clinical PoCs, and advancing 4–6 additional programs into the clinic.Denali Therapeutics Financial Statement Overview
Summary
Income Statement
18
Very Negative
Balance Sheet
74
Positive
Cash Flow
27
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 3.60M | 0.00 | 0.00 | 330.53M | 108.46M | 48.66M |
| Gross Profit | -2.20M | -11.18M | 0.00 | 330.53M | 108.46M | 48.66M |
| EBITDA | -498.21M | -497.63M | -492.89M | -128.47M | -315.59M | -282.56M |
| Net Income | -511.45M | -512.54M | -422.77M | -145.22M | -325.99M | -290.58M |
Balance Sheet | ||||||
| Total Assets | 1.16B | 1.14B | 1.37B | 1.15B | 1.46B | 1.40B |
| Cash, Cash Equivalents and Short-Term Investments | 710.47M | 867.88M | 832.33M | 1.03B | 1.34B | 865.41M |
| Total Debt | 27.50M | 36.76M | 48.71M | 52.24M | 60.35M | 64.01M |
| Total Liabilities | 322.78M | 131.09M | 144.50M | 122.96M | 417.81M | 441.87M |
| Stockholders Equity | 835.18M | 1.01B | 1.23B | 1.03B | 1.04B | 962.29M |
Cash Flow | ||||||
| Free Cash Flow | -437.46M | -422.10M | -363.61M | -370.93M | -262.55M | -219.89M |
| Operating Cash Flow | -434.04M | -412.60M | -347.69M | -357.99M | -244.72M | -211.39M |
| Investing Cash Flow | 68.98M | 255.28M | -88.76M | 249.31M | -141.39M | -21.63M |
| Financing Cash Flow | 425.38M | 189.22M | 484.30M | 17.82M | 310.67M | 19.35M |
Denali Therapeutics Technical Analysis
Negative
24.93
Price Trends
21.21
Negative
22.48
Negative
21.20
Negative
Market Momentum
-0.78
Negative
39.88
Neutral
56.83
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For DNLI, the sentiment is Negative. The current price of 24.93 is above the 20-day moving average (MA) of 19.17, above the 50-day MA of 21.21, and above the 200-day MA of 21.20, indicating a bearish trend. The MACD of -0.78 indicates Negative momentum. The RSI at 39.88 is Neutral, neither overbought nor oversold. The STOCH value of 56.83 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for DNLI.
Denali Therapeutics Risk Analysis
Denali Therapeutics disclosed 75 risk factors in its most recent earnings report. Denali Therapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Denali Therapeutics Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
61 Neutral | $2.94B | -6.48 | -55.27% | ― | ― | -1.07% | |
55 Neutral | $1.62B | -7.45 | -59.36% | ― | -86.20% | -476.63% | |
53 Neutral | $1.56B | -5.55 | -111.96% | ― | 30.24% | -3.25% | |
52 Neutral | $3.42B | -7.46 | -43.98% | ― | -100.00% | -33.88% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $1.29B | -9.37 | -56.19% | ― | -32.27% | -21.09% | |
47 Neutral | $627.19M | -2.92 | -50.12% | ― | -30.42% | -23.31% |
* Healthcare Sector Average
DNLI
Denali Therapeutics
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2.20
13.57%
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Denali Therapeutics Corporate Events
Business Operations and StrategyPrivate Placements and Financing
Denali Therapeutics Sells Priority Review Voucher for Capital
Positive
Jul 28, 2026
On July 27, 2026, Denali Therapeutics completed the sale of its Rare Pediatric Disease Priority Review Voucher to a large pharmaceutical company, receiving gross proceeds of $195 million. The voucher had been granted by the U.S. Food and Drug Admi...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.