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Day One Biopharmaceuticals, Inc. (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 61 (OpenAI - 5.2)
Rating:61Neutral
Price Target:
$22.50
▲(5.68% Upside)
Action:DowngradedDate:03/07/26
The score is held back primarily by ongoing losses and substantial negative free cash flow despite strong revenue growth and gross margins. Offsetting this, the latest earnings call reinforced strong commercial momentum and confident 2026 revenue guidance supported by a strong cash position, while technicals show an uptrend but with overbought conditions that add near-term risk.
Positive Factors
Revenue Growth & High Gross Margins
Sustained top-line expansion combined with ~91% gross margins indicates strong product-level economics for OJEMDA. Durable high margins provide structural capacity to fund commercial expansion and R&D, improving long-term unit economics even while operating losses persist.
Commercial Execution & Payer Access
Broad payer coverage and rapid prescription growth reflect durable market access and physician adoption. High first-request approval rates and prescription momentum reduce reimbursement friction, supporting predictable revenue scaling and persistence of demand over the next several quarters to years.
Pipeline Diversification via Mersana Acquisition
Acquiring Mersana materially broadens Day One’s pipeline beyond a single marketed product, adding ADC assets (EMILY/Emi‑Le, DAY301) that target adult and rare cancers. This strategic step structurally reduces single‑product concentration risk if clinical/registrational milestones are achieved.
Negative Factors
Negative Free Cash Flow
Substantial negative operating and free cash flow represent ongoing cash burn that erodes reserves and creates potential future financing needs. Even with strong margins, persistent negative FCF raises risk of dilution or constrained investment if revenue growth or cost structure does not improve.
Single‑Product Concentration
Heavy reliance on one marketed product makes corporate results highly sensitive to safety signals, competitive entrants, or reimbursement shifts. Until acquired or internal pipeline assets are de‑risked commercially, revenue volatility and strategic vulnerability remain elevated.
Pediatric Safety & Pipeline Timing Risk
Safety issues in a pediatric population can lead to tighter labeling, added monitoring costs, and slower uptake, constraining long‑term penetration. Coupled with multi‑year timelines for pivotal readouts, this extends dependence on OJEMDA and delays diversified revenue generation.

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:Feb 24, 2026
(Q4-2025)
|
% Change Since: |
Next Earnings Date:May 13, 2026
Earnings Call Sentiment Positive
The call highlights strong commercial momentum for Ojemda with exceptional revenue growth (FY2025 revenue up 172% YoY; Q4 sequential growth of 37%), robust prescription trends (>4,600 scripts, +180% YoY) and a solid balance sheet (~$441M cash, no debt). Clinical readouts (FIREFLY-1 three-year data) provide compelling efficacy and long TTNT supporting clinical value, and the Mersana acquisition adds a promising near-term pipeline asset (EMILY) with mid-2026 data expected. Offsetting risks include pediatric safety considerations (decreased growth velocity, anemia, occasional severe rash), concentration on a single marketed product, expected gross-to-net pressure in 2026 (guidance rising to 16%–19%), and timing/regulatory uncertainties for pipeline readouts (FIREFLY-2 top-line mid-2027, EMILY data mid-2026). Overall the positives — strong commercial execution, clear growth guidance, healthy payer coverage, and a strong cash position — outweigh the challenges, though pipeline timing and safety management remain important watchpoints.
Q4-2025 Updates
Positive Updates
Strong Full-Year Revenue Growth Driven by Ojemda
Net product revenue of $155.4 million for FY2025, representing a 172% year-over-year increase and double-digit sequential quarterly growth throughout 2025; revenue exceeded combined cost of sales and SG&A within ~20 months of approval.
Robust Q4 Performance
Q4 2025 U.S. Ojemda net product revenue of $52.8 million, a 37% sequential increase over Q3; Q4 prescriptions exceeded 1,300, up 11% quarter-over-quarter despite typical holiday seasonality.
Rapid Adoption and Prescription Volume Growth
More than 4,600 total prescriptions in 2025, representing over 180% growth versus 2024; new patient starts in the second half of 2025 increased ~25% versus the first half.
Confident 2026 Revenue Guidance
Re-iterated 2026 Ojemda net product revenue guidance of $225 million to $250 million (midpoint implies greater than 50% year-over-year growth versus 2025).
Favorable Payer Coverage and Access
High payer dynamics with ~95% coverage, >90% of patients approved on first request, and over 95% of pLGG patients receiving paid drug — minimizing reliance on free drug programs and enabling quick therapy starts.
Strong Balance Sheet and Capital Position
Ended 2025 with approximately $441 million in net cash and no debt, providing financial flexibility to support commercial growth and pipeline advancement; acquisition of Mersana closed in January 2026 to add the EMILY program.
Compelling FIREFLY-1 Three-Year Efficacy Data
FIREFLY-1 three-year data showed a 53% objective response rate (vs 51% at approval), median response duration of 19.4 months, median time to response 5.4 months, median PFS 16.6 months and median time-to-next-treatment (TTNT) of 42.6 months; 45% of patients who progressed on therapy later demonstrated further tumor reduction after continuing treatment.
Pipeline Progress — EMILY and DAY301
Acquired EMILY (a B7-H4 ADC) with monotherapy antitumor activity in adenoid cystic carcinoma (ACC); additional EMILY data and expanded safety set expected mid-2026. DAY301 (PTK7 ADC) is in dose escalation with early signs of antitumor activity and a planned program update in 2026.
Improving Cost Efficiency
Total cost and operating expenses declined year-over-year to $286 million for FY2025 from $348 million in FY2024, and Q4 operating expenses were $81 million versus $95 million in Q4 2024, largely due to absence of one-time 2024 in-licensing expenses.
Negative Updates
Safety and Tolerability Considerations in Pediatric Patients
Three-year safety profile remains consistent with label but includes higher-grade events such as decreased growth velocity, anemia, occasional more severe rash, and asymptomatic lab abnormalities (elevated CPK or ALT), which require ongoing management in a pediatric population.
Concentration Risk — Heavy Reliance on Single Product
Ojemda continues to be the primary revenue and growth driver for the company, creating commercial concentration risk until additional pipeline programs (e.g., EMILY, DAY301) are de-risked and generate revenue.
Gross-to-Net Pressure Expected in 2026
Gross-to-net of Ojemda was within the 12%–15% guidance range for FY2025, but management now expects gross-to-net of 16%–19% in 2026, indicating a potential margin headwind.
Limited Immediate Commercial Impact from Conference Data
SNO presentation of the FIREFLY-1 three-year data had minimal impact on Q4 performance because broader promotion and uptake are constrained until peer-reviewed publication; broader physician adoption depends on wider dissemination of published data.
Pipeline and Regulatory Timing Risks
Key readouts and regulatory milestones are multi-year: FIREFLY-2 enrollment expected complete in H1 2026 with top-line readout mid-2027, EMILY registrational path reliant on mid-2026 data and subsequent FDA discussions, and DAY301 still in early dose-escalation — creating timing uncertainty for additional revenue streams.
Small Target Population for Key EMILY Indication (ACC)
ACC represents a small patient population (~1,300 US diagnoses/year); while EMILY could pursue an accelerated pathway, the limited patient pool and rarity of the disease constrain the near-term market size and increase dependency on clear, robust single-arm data for approval.
Company Guidance
Day One reiterated 2026 U.S. Ojemda net product revenue guidance of $225 million to $250 million (midpoint implying >50% YoY growth versus 2025 net product revenue of $155.4 million, which was up 172% year‑over‑year), while noting Q4'25 U.S. Ojemda revenue was $52.8 million (37% sequential growth) and full‑year 2025 delivered >4,600 prescriptions (>180% vs. 2024) with Q4 prescriptions >1,300 (11% QoQ); they said where 2026 lands will depend primarily on persistence (median commercial duration trending ~19 months) and new patient starts. Financial assumptions include gross‑to‑net of 12–15% in 2025 and guidance of 16–19% for 2026, channel inventory at about the midpoint of a targeted 2–4 weeks of days on hand, ending 2025 net cash of ~ $441 million with no debt, and total operating expenses of $81 million in Q4 and $286 million for FY'25; other clinical and commercial metrics cited supporting the revenue outlook included a 53% ORR, median response duration 19.4 months, median time to response 5.4 months, median PFS 16.6 months and median TTNT 42.6 months, and favorable payer metrics (95% coverage, >90% first‑request approval, >95% of pLGG patients receiving paid drug).

Day One Biopharmaceuticals Financial Statement Overview

Summary
Revenue growth and very strong gross margins are positives, and the balance sheet has minimal debt. However, the company remains meaningfully unprofitable with large operating losses and materially negative operating/free cash flow, implying ongoing cash burn risk.
Income Statement
42
Neutral
Revenue scaled meaningfully in 2024 ($131.2M) and grew again in 2025 ($158.2M; +18.3%), with very strong gross profitability (gross profit margin ~91% in 2025). However, the company remains structurally loss-making: 2025 net margin was deeply negative (about -68%), and operating losses remain sizable despite improvement versus 2024 (EBIT improved from -$217.3M to -$127.8M). Overall, strong product-level economics but profitability is still a key gap.
Balance Sheet
74
Positive
The balance sheet is conservatively levered with very low debt (2025 total debt ~$2.8M) against a large equity base (~$441.2M), keeping debt pressure minimal. That said, ongoing losses translate into negative returns on equity (about -24% in 2025), and equity has declined from 2024, reflecting continued cash burn and income statement losses. Financial risk from leverage is low, but value erosion risk persists if losses continue.
Cash Flow
35
Negative
Cash generation remains a weak spot: 2025 operating cash flow was -$103.8M and free cash flow was -$104.1M, worsening versus 2024 (free cash flow down ~14.2% year over year). While free cash flow roughly tracks reported losses (free cash flow to net income ~1.0), the business is still consuming substantial cash to operate, which raises future funding needs if the burn rate doesn’t improve.
BreakdownDec 2025Dec 2024Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue158.18M131.16M0.000.000.00
Gross Profit140.97M125.88M-383.00K-531.00K-199.00K
EBITDA-105.82M-86.32M-188.53M-141.65M-72.56M
Net Income-107.32M-95.50M-188.92M-142.18M-70.64M
Balance Sheet
Total Assets507.83M582.79M376.05M349.06M289.82M
Cash, Cash Equivalents and Short-Term Investments441.11M531.72M366.35M342.27M284.31M
Total Debt2.79M2.60M408.00K813.00K220.00K
Total Liabilities66.67M80.04M29.51M17.02M8.67M
Stockholders Equity441.16M502.75M346.54M332.04M281.15M
Cash Flow
Free Cash Flow-104.08M-80.28M-150.08M-109.90M-56.54M
Operating Cash Flow-103.76M-78.11M-146.85M-109.87M-48.54M
Investing Cash Flow174.65M-230.99M128.38M-255.07M-8.00M
Financing Cash Flow1.22M203.29M164.00M165.90M297.12M

Day One Biopharmaceuticals Technical Analysis

Technical Analysis Sentiment
Positive
Last Price21.29
Price Trends
50DMA
12.74
Positive
100DMA
10.69
Positive
200DMA
8.80
Positive
Market Momentum
MACD
2.83
Negative
RSI
82.03
Negative
STOCH
98.92
Negative
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 21.29 is above the 20-day moving average (MA) of 15.38, above the 50-day MA of 12.74, and above the 200-day MA of 8.80, indicating a bullish trend. The MACD of 2.83 indicates Negative momentum. The RSI at 82.03 is Negative, neither overbought nor oversold. The STOCH value of 98.92 is Negative, 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
$705.36M51.0114.69%27.12%
61
Neutral
$2.20B-8.98-23.43%31.11%-46.75%
59
Neutral
$1.13B-25.24-14.83%2147.20%-269.99%
53
Neutral
$802.05M-3.61-51.07%-30.56%48.79%
52
Neutral
$757.87M-3.27-102.59%-5.18%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
40
Underperform
$109.20M-4.16242.63%-58.17%-116.24%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
DAWN
Day One Biopharmaceuticals
21.29
13.13
160.91%
TBPH
Theravance Biopharma
13.92
4.71
51.14%
KURA
Kura Oncology
8.58
1.24
16.89%
GOSS
Gossamer Bio
0.47
-0.95
-66.83%
MRVI
Maravai Lifesciences Holdings
3.12
0.54
20.93%
SEPN
Septerna, Inc.
25.17
18.93
303.37%

Day One Biopharmaceuticals Corporate Events

Business Operations and StrategyM&A Transactions
Servier to Acquire Day One Biopharmaceuticals in Merger
Positive
Mar 6, 2026

On March 6, 2026, Servier Pharmaceuticals LLC and Day One Biopharmaceuticals entered into a definitive merger agreement under which Servier will acquire all outstanding Day One shares for $21.50 in cash per share, valuing the company at approximately $2.5 billion. The all-cash tender offer, representing a premium of about 68% to Day One’s prior close and 86% to its one-month VWAP, is not subject to a financing condition and will be followed by a second-step merger once customary conditions, including majority tender and U.S. antitrust clearance, are met.

Day One’s board has unanimously deemed the transaction fair, recommended that shareholders tender their shares and agreed to customary non-solicitation and termination provisions, including an $87.7 million break fee under certain circumstances. For Servier, the deal is intended to strengthen its rare oncology franchise and targeted therapy pipeline, particularly in pediatric low-grade glioma, while giving Day One investors a substantial premium and positioning the combined group as a more prominent player in pediatric and rare oncology markets.

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.

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Day One Highlights OJEMDA’s EMA Progress, Updates Strategy
Positive
Mar 2, 2026

On March 2, 2026, Day One Biopharmaceuticals updated its corporate presentation after Ipsen Pharma SAS received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending conditional marketing authorization of OJEMDA as a monotherapy for children with relapsed or refractory BRAF-altered pediatric low-grade glioma. The move underscores Day One’s strategy to build OJEMDA into a global standard of care in pediatric low-grade glioma through its exclusive ex-U.S. licensing deal with Ipsen, while advancing a broader oncology pipeline and signaling a path to sustained revenue growth and strengthened positioning in pediatric oncology therapeutics.

The CHMP’s favorable stance, following Day One’s April 2024 U.S. approval and July 2024 licensing agreement with Ipsen, highlights growing regulatory momentum for OJEMDA in a setting where few approved options exist. For stakeholders, the development points to expanding international commercialization opportunities, reinforces the value of Day One’s pediatric-focused model, and supports the company’s narrative of accelerating growth anchored by OJEMDA and its adjacent oncology programs.

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.

Business Operations and StrategyFinancial DisclosuresM&A Transactions
Day One Highlights Transformational 2025 and OJEMDA Growth
Positive
Feb 24, 2026

Day One Biopharmaceuticals reported on Feb. 24, 2026 that 2025 was a transformational year, driven by strong commercial uptake of its pediatric cancer drug OJEMDA and a broadened oncology pipeline following the January 2026 acquisition of Mersana Therapeutics. OJEMDA generated net product revenue of $52.8 million in the fourth quarter and $155.4 million for full year 2025, representing 172% year-over-year growth and sharp gains in prescription volumes, while the company reaffirmed its 2026 U.S. revenue guidance of $225 million to $250 million.

Clinically, updated three-year FIREFLY-1 data presented in November 2025 underscored the durability and safety of OJEMDA in relapsed or refractory pLGG, and enrollment in the pivotal frontline FIREFLY-2 Phase 3 trial is expected to complete in the first half of 2026. Financially, Day One narrowed its 2025 net loss to $107.3 million on reduced R&D spending and ended the year with $441.1 million in cash and investments, positioning it to advance Phase 1 programs for Emi-Le and DAY301 while maintaining an active presence at upcoming healthcare investor conferences.

The company’s strengthened balance sheet, accelerating OJEMDA franchise, and expanded ADC portfolio underscore its bid to cement a leading position in targeted therapies for rare and pediatric cancers. Stakeholders will closely watch 2026 clinical readouts for Emi-Le and DAY301, alongside completion of FIREFLY-2 enrollment, as key catalysts for Day One’s medium-term growth trajectory.

The most recent analyst rating on (DAWN) stock is a Buy with a $20.00 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 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.

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: Mar 07, 2026