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Day One Biopharmaceuticals (DAWN)
NASDAQ:DAWN
US Market

Day One Biopharmaceuticals (DAWN) AI Stock Analysis

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DAWN

Day One Biopharmaceuticals

(NASDAQ:DAWN)

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Neutral 65 (OpenAI - 5.2)
Rating:65Neutral
Price Target:
$12.00
▲(14.29% Upside)
The score is driven primarily by weak profitability and ongoing cash burn despite a strong, low-leverage balance sheet. Offsetting this, price momentum is strong and recent updates (raised revenue guidance and positive commercial/clinical progress, plus upbeat 2026 revenue guidance) improve the growth outlook. Valuation provides limited support given the negative P/E and no dividend yield.
Positive Factors
Strong balance sheet and low leverage
Very low debt versus sizeable equity and assets provides multi-quarter financial flexibility to fund commercialization and trials without immediate dilution. This conservatively financed position supports runway, strategic optionality, and resilience as the company scales OJEMDA and integrates acquisitions.
High gross margins and improving free cash flow
An ~89% gross margin indicates attractive unit economics for OJEMDA once scale is achieved, while a materially improving free cash flow trajectory shows operating leverage beginning to emerge. Together these durable trends improve the odds of eventual self-funding and sustainable commercial profitability over the medium term.
Accelerating commercial traction and guideline adoption
Consistent quarter-over-quarter revenue and prescription growth plus NCCN guideline inclusion strengthen prescriber adoption and payer recognition, creating durable demand. Raised guidance and high first-request payer approval rates signal structural commercial momentum likely to sustain growth into 2026 and beyond.
Negative Factors
Significant and ongoing cash burn
Persistent negative operating and free cash flow of roughly -$120M TTM means the business remains reliant on external capital to fund commercialization, trials, and new assets. Even with improving trends, continued cash burn constrains strategic flexibility and increases funding risk over the next several quarters.
Large operating losses and negative returns
Deep negative margins and negative ROE reflect a cost base that still far exceeds revenue, limiting near-term ability to generate shareholder returns. Structural profitability gaps increase dependence on scaling revenue and cost control to achieve sustainable earnings, raising execution risk over the medium term.
Mersana acquisition adds integration and contingent liability risk
Buying Mersana broadens the pipeline but consumes cash and creates contingent payout obligations (CVRs), while integrating an ADC program requires development investment and regulatory execution. These structural costs and execution risks could divert resources and increase uncertainty around near-term cash runway and strategic focus.

Day One Biopharmaceuticals (DAWN) vs. SPDR S&P 500 ETF (SPY)

Day One Biopharmaceuticals Business Overview & Revenue Model

Company DescriptionDay One Biopharmaceuticals, Inc., a clinical-stage biopharmaceutical company, develops and commercializes targeted therapies for patients with genetically defined cancers. Its lead product candidate is DAY101, an oral brain-penetrant type II pan-rapidly accelerated fibrosarcoma kinase inhibitor that is in Phase II clinical trial for pediatric patients with relapsed/progressive low-grade glioma. The company is also developing Pimasertib, an oral small molecule inhibitor of mitogen-activated protein kinase kinases 1 and 2. Day One Biopharmaceuticals, Inc. was incorporated in 2018 and is headquartered in South San Francisco, California.
How the Company Makes MoneyDay One Biopharmaceuticals makes money primarily through the development and eventual commercialization of its oncology therapies. The company invests in research and development to create novel cancer treatments, which, upon successful clinical trials and regulatory approval, can be marketed and sold. Revenue streams include potential product sales, licensing agreements, and partnerships with larger pharmaceutical companies for the co-development or commercialization of their therapies. Additionally, Day One may secure funding through grants, collaborations, and strategic alliances that provide financial support during the clinical development stages.

Day One Biopharmaceuticals Earnings Call Summary

Earnings Call Date:Nov 04, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 09, 2026
Earnings Call Sentiment Positive
The earnings call presented a positive outlook with strong revenue growth, increased prescriptions, and positive clinical data. The raised revenue guidance and inclusion in NCCN guidelines further support a positive trajectory. However, the high gross-to-net ratio and limited impact of EAP patients were noted challenges.
Q3-2025 Updates
Positive Updates
Quarterly Revenue Growth
Day One Biopharmaceuticals reported $38.5 million in net product revenue for Q3 2025, marking a 15% quarter-over-quarter increase, the strongest so far in 2025.
Steady Prescription Growth
Total prescriptions grew by 18% with over 1,200 total prescriptions. New patient starts accelerated by almost 20% quarter-over-quarter.
Raised Revenue Guidance
The company raised its full-year revenue guidance to a range of $145 million to $150 million for 2025, reflecting confidence in the growth trajectory of OJEMDA.
Positive Clinical Data
The 2-year FIREFLY-1 data included in the OJEMDA label demonstrate a manageable safety profile and durable clinical benefit, with median duration of response increasing from 13 to 18 months.
NCCN Guideline Inclusion
Tovorafenib was added to the National Comprehensive Cancer Network adult glioma treatment guidelines as a Category 2A recommended treatment option.
Negative Updates
Limited EAP Patient Impact
While EAP patients provided valuable insights, they currently represent a small fraction of Day One’s business, indicating limited impact on commercial operations.
High Gross-to-Net Ratio
The gross-to-net ratio was at the high end of the 12% to 15% range due to short-term increases in Medicaid rebates following a price increase.
Company Guidance
During the Day One Biopharmaceuticals Third Quarter 2025 Financial and Operating Results Conference Call, significant growth metrics were highlighted, particularly for their drug OJEMDA. Notably, net product revenue increased by 15% quarter-over-quarter to $38.5 million, marking the strongest revenue and sequential growth in 2025. Total prescriptions grew by 18%, with over 1,200 total prescriptions, and new patient starts surged by nearly 20% quarter-over-quarter. These dynamics drove a revision of the full-year revenue guidance, raising the low end to a range of $145 million to $150 million for 2025. The median duration of response to OJEMDA increased from 13 to 18 months based on the 2-year FIREFLY-1 data. Additionally, about 90% of patients received payer approval on the first request. The 3-year FIREFLY-1 data are anticipated to further inform on treatment duration and outcomes, with a presentation scheduled at the Society for Neuro-Oncology Annual Meeting. These developments underscore the strong commercial trajectory and expanding prescriber base for OJEMDA as it becomes the standard of care in second-line BRAF-altered pLGG.

Day One Biopharmaceuticals Financial Statement Overview

Summary
Mixed fundamentals: strong gross margin (~89%) and a very low-debt balance sheet support flexibility, but the income statement remains weak with deep operating losses, very negative net margin (~-114%), and meaningful cash burn (TTM FCF about -$121.4M). The noted TTM revenue decline also adds execution risk despite improving free cash flow trends.
Income Statement
38
Negative
TTM (Trailing-Twelve-Months) revenue is meaningful ($133.7M) with strong gross margin (~89%), indicating attractive unit economics once scaled. However, profitability remains weak with large operating losses (EBIT and EBITDA deeply negative) and net margin around -114%, implying the cost base is still far ahead of current revenue. Revenue also declined versus the prior period (about -29% growth), raising execution and demand-trajectory risk.
Balance Sheet
74
Positive
The balance sheet looks conservatively financed with very low debt (~$2.9M TTM) relative to equity (~$450.9M), keeping leverage minimal and financial flexibility high. Total assets are sizeable (~$513.8M), supporting runway. The key weakness is returns: return on equity is negative (about -32% TTM), reflecting ongoing losses and limited near-term earnings power.
Cash Flow
42
Neutral
Cash burn remains significant with TTM operating cash flow of about -$119.6M and free cash flow of about -$121.4M, consistent with an investment-heavy, loss-making biotech profile. A positive sign is that free cash flow has been improving versus prior periods (TTM growth ~69% and 2024 improvement as well), suggesting some cost discipline or working-capital benefits. Still, cash generation is not yet self-funding, and cash flow remains dependent on external financing over time.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue133.67M131.16M0.000.000.000.00
Gross Profit119.56M125.88M-383.00K-531.00K-199.00K-155.00K
EBITDA-141.73M-86.32M-188.53M-141.65M-72.56M-43.66M
Net Income-151.76M-95.50M-188.92M-142.18M-70.64M-40.51M
Balance Sheet
Total Assets513.78M582.79M376.05M349.06M289.82M45.66M
Cash, Cash Equivalents and Short-Term Investments451.58M531.72M366.35M342.27M284.31M43.73M
Total Debt2.89M2.60M408.00K813.00K220.00K402.00K
Total Liabilities62.91M80.04M29.51M17.02M8.67M2.20M
Stockholders Equity450.87M502.75M346.54M332.04M281.15M37.76M
Cash Flow
Free Cash Flow-121.36M-80.28M-150.08M-109.90M-56.54M-13.58M
Operating Cash Flow-119.62M-78.11M-146.85M-109.87M-48.54M-13.49M
Investing Cash Flow-262.47M-230.99M128.38M-255.07M-8.00M-92.00K
Financing Cash Flow2.60M203.29M164.00M165.90M297.12M29.98M

Day One Biopharmaceuticals Technical Analysis

Technical Analysis Sentiment
Positive
Last Price10.50
Price Trends
50DMA
9.16
Positive
100DMA
8.22
Positive
200DMA
7.51
Positive
Market Momentum
MACD
0.43
Negative
RSI
55.88
Neutral
STOCH
63.67
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For DAWN, the sentiment is Positive. The current price of 10.5 is above the 20-day moving average (MA) of 9.62, above the 50-day MA of 9.16, and above the 200-day MA of 7.51, indicating a bullish trend. The MACD of 0.43 indicates Negative momentum. The RSI at 55.88 is Neutral, neither overbought nor oversold. The STOCH value of 63.67 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for DAWN.

Day One Biopharmaceuticals Risk Analysis

Day One Biopharmaceuticals disclosed 93 risk factors in its most recent earnings report. Day One Biopharmaceuticals 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

Day One Biopharmaceuticals Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
67
Neutral
$1.02B35.5714.03%27.12%
65
Neutral
$1.11B-6.84-30.16%31.11%-46.75%
63
Neutral
$775.33M-3.41-65.10%-5.18%
54
Neutral
$1.23B-17.26-22.38%2147.20%-269.99%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
$943.56M-4.64-41.06%-30.56%48.79%
47
Neutral
$567.07M-3.67-58.17%-116.24%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
DAWN
Day One Biopharmaceuticals
10.16
-2.08
-16.99%
TBPH
Theravance Biopharma
20.01
10.86
118.69%
KURA
Kura Oncology
8.46
1.07
14.48%
GOSS
Gossamer Bio
2.52
1.60
173.91%
MRVI
Maravai Lifesciences Holdings
3.92
-1.31
-25.05%
SEPN
Septerna, Inc.
26.07
7.37
39.41%

Day One Biopharmaceuticals Corporate Events

Business Operations and StrategyFinancial Disclosures
Day One Biopharmaceuticals Announces Strong OJEMDA Revenue Outlook
Positive
Jan 12, 2026

On January 11, 2026, Day One Biopharmaceuticals reported preliminary unaudited 2025 OJEMDA net product revenue of $155.4 million, up 172% year over year, with fourth-quarter sales of about $52.8 million driven by rising patient demand and 1,394 prescriptions in the quarter. The company issued 2026 U.S. net product revenue guidance for OJEMDA of $225 million to $250 million, implying roughly 53% growth at the midpoint, and highlighted a cash, cash equivalents and short-term investment position of about $441.1 million as of December 31, 2025, prior to the Mersana acquisition, underscoring its capacity to fund ongoing commercialization and clinical programs. Management outlined 2026 priorities including expanding OJEMDA’s commercial footprint and solidifying its role as standard of care in second-line pediatric low-grade glioma, completing enrollment in the pivotal Phase 3 FIREFLY-2 trial in first-line pLGG in the first half of 2026, and delivering Phase 1 data for Emi-Le by mid-2026 and initial Phase 1a data for DAY301 in the second half of 2026, positioning the company for further growth and potentially broader oncology indications.

The most recent analyst rating on (DAWN) stock is a Buy with a $25.00 price target. To see the full list of analyst forecasts on Day One Biopharmaceuticals stock, see the DAWN Stock Forecast page.

Business Operations and StrategyDelistings and Listing ChangesM&A Transactions
Day One Biopharmaceuticals Completes Acquisition of Mersana Therapeutics
Positive
Jan 6, 2026

On January 6, 2026, Day One Biopharmaceuticals completed its acquisition of Mersana Therapeutics in an all-cash tender offer and follow-on merger, paying $25 per share plus a non-tradable contingent value right (CVR) per share that could deliver additional milestone payments of up to $30.25, for potential total consideration of $55.25 per share. The deal, funded with approximately $128.8 million of Day One’s cash on hand, results in Mersana becoming a wholly owned subsidiary and its stock being delisted from Nasdaq, while former Mersana shareholders receive the same mix of cash and CVRs whether they tendered in the offer or were converted in the merger. Each CVR entitles holders to a series of potential cash milestone payments tied to U.S. regulatory designations, clinical trial progress, FDA approval, commercial launches in major global markets, and specified annual net sales thresholds for Emi-Le, with deadlines running from 2026 through 2037, though these milestones are not guaranteed and the CVRs are generally non-transferable. Strategically, the transaction expands Day One’s oncology portfolio with a second clinical-stage antibody-drug conjugate and deepens its push into adult and rare cancers, notably ACC, as the company looks to build on momentum from OJEMDA and position itself as a more diversified player in targeted oncology while assuming the integration and development risks associated with the acquisition and milestone structure.

The most recent analyst rating on (DAWN) stock is a Hold with a $9.50 price target. To see the full list of analyst forecasts on Day One Biopharmaceuticals stock, see the DAWN Stock Forecast page.

Business Operations and StrategyProduct-Related Announcements
Day One Biopharmaceuticals Reveals Promising Phase 2 Trial Results
Positive
Nov 24, 2025

On November 24, 2025, Day One Biopharmaceuticals announced three-year results from its OJEMDA™ (tovorafenib) pivotal Phase 2 FIREFLY-1 trial, presented at the Society for Neuro-Oncology Annual Meeting. The updated data showed that 58% of patients completed 26 or more cycles of treatment, with a 53% overall response rate and a median duration of response of 19.4 months. The trial demonstrated that patients could maintain disease control during extended periods off therapy, with minimal tumor rebound and the option to reinitiate treatment if needed. These findings highlight tovorafenib’s potential as a second-line standard of care for pediatric low-grade glioma, offering patients meaningful time away from treatment.

The most recent analyst rating on (DAWN) stock is a Buy with a $16.00 price target. To see the full list of analyst forecasts on Day One Biopharmaceuticals stock, see the DAWN Stock Forecast page.

Business Operations and StrategyM&A Transactions
Day One Biopharmaceuticals Announces Mersana Acquisition Deal
Positive
Nov 13, 2025

On November 12, 2025, Day One Biopharmaceuticals announced a merger agreement to acquire Mersana Therapeutics, aiming to expand its oncology portfolio with Mersana’s novel ADC, emiltatug ledadotin (Emi-Le), which shows promise in treating adenoid cystic carcinoma type-1. The acquisition, valued at up to $285 million, is expected to close by January 2026, subject to regulatory approvals. This strategic move is anticipated to enhance Day One’s market position by leveraging its existing capabilities to develop and potentially commercialize Emi-Le, addressing unmet needs in cancer treatment.

The most recent analyst rating on (DAWN) stock is a Buy with a $27.00 price target. To see the full list of analyst forecasts on Day One Biopharmaceuticals stock, see the DAWN Stock Forecast page.

Business Operations and StrategyFinancial Disclosures
Day One Biopharmaceuticals Reports Strong Q3 2025 Results
Positive
Nov 4, 2025

Day One Biopharmaceuticals reported its third quarter 2025 financial results, highlighting a strong commercial performance of OJEMDA, with net product revenue reaching $38.5 million, a 15% increase from the previous quarter. The company raised its full-year 2025 net product revenue guidance to $145 to $150 million, reflecting strong demand. The company also announced progress in its clinical trials, including the Phase 3 FIREFLY-2 trial and the Phase 1a trial of DAY301, and noted the addition of tovorafenib to the NCCN treatment guidelines. Despite a net loss of $19.7 million for the quarter, Day One ended the period with $451.6 million in cash and investments, positioning it well for future growth.

The most recent analyst rating on (DAWN) stock is a Buy with a $17.00 price target. To see the full list of analyst forecasts on Day One Biopharmaceuticals stock, see the DAWN Stock Forecast page.

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.Date of analysis: Jan 13, 2026