Core Insights - Day One Biopharmaceuticals has appointed Dr. Michael Vasconcelles as Head of Research & Development, bringing over 25 years of oncology expertise to the company [2][3][4] - Dr. Vasconcelles will play a crucial role in advancing the company's pipeline and supporting the growth of its lead product, OJEMDA [3][5] Company Overview - Day One Biopharmaceuticals is focused on developing targeted therapies for life-threatening diseases, particularly in pediatric cancer, addressing a significant unmet need in therapeutic development [6][7] - The company aims to redefine cancer drug development and improve outcomes for patients of all ages from the moment of diagnosis [6] Leadership and Experience - Dr. Vasconcelles has a robust background in oncology research and development, having held leadership roles at ImmunoGen, Flatiron Health, Unum Therapeutics, and Takeda [4][5] - His previous experience includes transforming ImmunoGen into a global biotech enterprise and overseeing clinical development at Genzyme [4] Strategic Goals - The company is committed to expanding its pipeline of first- or best-in-class medicines, with a focus on delivering transformative therapies for children with cancer [3][5] - Dr. Vasconcelles' leadership is expected to enhance the company's medical and scientific strategies, driving growth and innovation [3][5]

Core Insights - Day One Biopharmaceuticals (NASDAQ: DAWN) has completed one year since the launch of Ojemda (tovorafenib) for treating pediatric low-grade glioma, but the recent earnings updates did not lead to a stock price increase [1] Company Overview - The company focuses on developing treatments for pediatric low-grade glioma, a type of brain tumor [1] - Ojemda is the primary product launched by the company, aimed at addressing a significant medical need in the pediatric population [1] Market Performance - Despite the launch anniversary, the stock has not experienced a rally following the earnings updates, indicating potential investor concerns or market conditions affecting performance [1]

Summary of Conference Call Company and Industry Overview - The conference call discusses the performance and commercialization of **Ogemda**, a drug recently launched by the company, which has generated approximately **$90 million** in revenue within the first **11 months** of its launch [1][2] - The company is optimistic about achieving **double-digit growth** moving forward [2] Key Performance Metrics - The company reported **$54 million** in revenue for Ogemda in **2024**, significantly exceeding the initial consensus estimate of **$12 million** [3] - In **Q1**, net product sales reached over **$30 million**, indicating a potential annual run rate of **$120 million** if growth remains stable [4] Market Dynamics and Growth Potential - The company is focusing on expanding the use of Ogemda among prescribers, particularly in earlier lines of therapy, as many have initially used it in later line patients [5][6] - There is a significant opportunity to increase the number of patients treated with Ogemda, especially among healthier patients who are likely to stay on the drug longer [6] - The company has identified **200 centers** in the U.S. where **90%** of PLGG patients are treated, allowing for an efficient commercial model [11] Prescriber Engagement - The company has categorized prescriber accounts into three priority levels based on volume, with **100%** of priority one accounts having tried Ogemda, **75%** of priority two, and **35%** of priority three [11][12] - The focus is on deepening the engagement with prescribers to increase the number of patients treated and to educate them on the appropriate use of Ogemda [14] Compliance and Treatment Duration - Compliance with Ogemda has been reported as excellent, with high rates of on-time refills and minimal drug holidays observed [24][25] - The anticipated treatment duration in the commercial setting is expected to differ from clinical trials, with ongoing monitoring of patient experiences [22][23] Regulatory and Market Expansion - The company has filed for regulatory approval in the EU, with an anticipated decision by mid-2026, and expects a similar patient population in Europe as in the U.S. [40][41] - Pricing in Europe is expected to be lower than in the U.S., but the company sees this as a significant opportunity for market expansion [42] Business Development Strategy - The company is actively pursuing business development opportunities, particularly in oncology, and is interested in acquiring early clinical assets that align with its strategic focus [66][67] - The recent acquisition of **Day Three Zero One**, a PTK7 targeted ADC, exemplifies the company's strategy to invest in promising assets with clinical validation [56][63] Conclusion - The company is in a strong financial position and is focused on expanding the market for Ogemda while also exploring new business development opportunities in oncology [1][66] - The ongoing clinical trials and regulatory filings are expected to enhance the company's growth prospects and market presence in the coming years [48][49]

Company Performance - Day One Biopharmaceuticals reported a quarterly loss of $0.35 per share, better than the Zacks Consensus Estimate of a loss of $0.46, and an improvement from a loss of $0.72 per share a year ago, representing an earnings surprise of 23.91% [1] - The company posted revenues of $30.76 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 4.90%, compared to zero revenues a year ago [2] - The stock has lost about 41% since the beginning of the year, while the S&P 500 has declined by 3.9% [3] Earnings Outlook - The current consensus EPS estimate for the coming quarter is -$0.44 on revenues of $34.88 million, and for the current fiscal year, it is -$1.67 on revenues of $149.97 million [7] - The estimate revisions trend for Day One Biopharmaceuticals is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Day One Biopharmaceuticals belongs, is currently in the top 31% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - In Q1 2025, net product revenue for Ogemda reached $30.5 million, reflecting an 11% increase compared to the previous quarter, driven by a 16% growth in quarterly prescriptions [8][22][23] - Operating expenses, excluding cost of sales, were $68.9 million, which included $12.9 million in non-cash stock-based compensation [22][23] - The company maintained a cash balance of $473 million with no debt at the end of Q1 2025 [23][24] Business Line Data and Key Metrics Changes - Ogemda prescriptions grew to over 2,500 since launch, marking a 16% increase over the prior quarter [12][15] - The company reported a rebound in new patient starts in April, indicating strong demand despite initial seasonality effects in January [13][14] Market Data and Key Metrics Changes - The U.S. market for relapsed/refractory PLGG patients is estimated to have approximately 26,000 individuals, with about half likely in long-term remission [16][18] - The company aims to establish Ogemda as the second-line standard of care in this market, with a focus on increasing prescriber adoption and usage depth [19][20] Company Strategy and Development Direction - The company is focused on three priorities for 2025: establishing Ogemda as the standard of care, advancing the clinical development pipeline for FIREFLY two and DAY three zero one, and expanding the product portfolio [7][10] - The company is actively evaluating business development opportunities to enhance its clinical stage portfolio and drive long-term growth [10][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of Ogemda, citing high prescriber adoption rates and patient demand [9][11] - The company remains well-positioned financially, with a disciplined investment approach to support growth while managing resources responsibly [24][25] Other Important Information - The company anticipates that costs and operating expenses will remain relatively consistent throughout the year, allowing for strategic investments in growth opportunities [23][24] - Management highlighted the importance of educating physicians on the benefits and appropriate use of Ogemda to drive deeper adoption [20][21] Q&A Session Summary Question: What are you seeing in terms of duration of therapy in the marketplace and how docs plan to use the drug long term? - Management noted that it is early to comment on duration, but a high percentage of patients continue on therapy month after month, consistent with expectations from the FIREFLY one study [28][29] Question: Can you provide a rough percentage of revenue from new patients versus ongoing patients? - Management indicated that the dynamics of new patient starts and ongoing patients remain similar to previous discussions, with approximately 90% on-label usage [33][34] Question: What headwinds did you see in Q1 regarding gross to net and reimbursement? - Management acknowledged seasonality effects in January due to delays in scans and appointments, but noted a rebound in new patient starts in April [35][37] Question: How should we think about new patient starts from here? - Management expects a consistent and steady ramp of new patients over time, emphasizing that this is akin to a rare disease launch rather than typical oncology trajectories [43][44] Question: Can you discuss the penetration within each priority center? - Management reported that 100% of priority one accounts have tried Ogemda, with ongoing efforts to deepen prescribing among these accounts [51][52]

Financial Performance - Since launch, OJEMDA net product revenue reached $87.7 million[10, 14] - In Q1 2025, OJEMDA net product revenue was $30.5 million[10, 14, 19] - Q1 2025 saw a $3 million (+11%) increase in U S net product revenue compared to Q4 2024[14, 19] - Total revenue for Q1 2025 was $30.8 million[29] - The company holds a strong financial position with $473 million in cash[10, 29] - Net loss for the company was ($360) million[29] Commercial Performance - Cumulative prescriptions since launch totaled 2,571[14, 21] - Prescription growth in Q1 2025 was driven by new patient starts and continued therapy among on-label patients[21] Market Opportunity - Priority 1 centers manage approximately 4,000 estimated patients[24] - Priority 2 centers manage approximately 5,000 estimated patients[24] - Priority 3 centers manage approximately 4,000 estimated patients[24]

Financial Data and Key Metrics Changes - In Q1 2025, DayOne Biopharmaceuticals reported net product revenue of $30.5 million, reflecting an 11% increase compared to the previous quarter, driven by a 16% growth in quarterly prescriptions [7][22]. - Operating expenses, excluding cost of sales, were $68.9 million, which included $12.9 million in non-cash stock-based compensation. This represented approximately a 4% decline in operating expenses compared to the previous quarter when excluding a one-time charge of $20 million [23]. Business Line Data and Key Metrics Changes - Ogemda's quarterly prescriptions increased to over 900, marking a 16% growth over the prior quarter, contributing to the overall revenue growth [7][12]. - Cumulative U.S. Ogemda prescriptions reached over 2,500 since launch, indicating growing physician confidence and the drug's critical role in treating pediatric low-grade glioma [12][15]. Market Data and Key Metrics Changes - The estimated prevalent pool of approximately 26,000 relapsed or refractory BRAF altered PLGG patients in the U.S. suggests significant growth potential for Ogemda, with about half of these patients likely in long-term remission [16][20]. - The company noted that prescriber adoption continues to increase, with high payer approval rates and patients experiencing longer treatment periods on Ogemda [8][11]. Company Strategy and Development Direction - The company aims to establish Ogemda as the standard of care in second-line plus pediatric low-grade glioma and to drive revenue growth through clinical development and portfolio expansion [6][10]. - DayOne is focused on advancing its clinical development pipeline, particularly the FIREFLY two and DAY three zero one programs, while also exploring business development opportunities to expand its multi-program clinical stage portfolio [10][11]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the steady increase in Ogemda revenue, citing strong market dynamics and a solid financial foundation that allows for strategic investments despite macroeconomic challenges [11][24]. - The company does not project the need for additional financing in the future, emphasizing disciplined financial management alongside growth opportunities [24]. Other Important Information - The company reported a cash balance of $473 million and no debt at the end of Q1 2025, positioning it well for future growth [23][24]. - Management highlighted the importance of educating physicians on the long-term effects and benefits of Ogemda to enhance adoption rates [55][58]. Q&A Session Summary Question: What are you seeing in terms of duration of therapy in the marketplace and how docs plan to use the drug long term? - Management noted that it is early to comment on duration but observed a high percentage of patients continuing therapy month after month, consistent with expectations from the FIREFLY one study [27][29]. Question: Can you provide a rough percentage of revenue from new patients versus ongoing patients? - Management indicated that the dynamics of new patient starts and ongoing patients remain similar to previous discussions, with approximately 90% on-label and 10% off-label usage [33][34]. Question: What headwinds did you see in Q1 regarding gross to net and reimbursement? - Management acknowledged seasonality in January due to delays in scans and appointments but noted a strong rebound in new patient starts in April [35][36]. Question: How should we think about new patient starts from here? - Management expects a consistent and steady ramp of new patients over time, emphasizing that this is akin to a rare disease launch rather than typical oncology trajectories [44][45]. Question: Can you talk about penetration within each of the priority centers? - Management reported that 100% of priority one accounts have tried Ogemda, with ongoing efforts to deepen prescribing and expand usage among physicians [51][52].

PART I. FINANCIAL INFORMATION [Interim Condensed Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Interim%20Condensed%20Financial%20Statements%20%28Unaudited%29) Day One Biopharmaceuticals achieved its first product revenues in Q1 2025, significantly reducing its net loss while maintaining a solid financial position [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) The company's total assets decreased as of March 31, 2025, primarily due to reduced cash, while total liabilities also decreased and stockholders' equity remained substantial Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $33,358 | $124,968 | | Short-term investments | $439,662 | $406,752 | | Total current assets | $508,651 | $562,330 | | Total assets | $534,356 | $582,788 | | **Liabilities & Equity** | | | | Total current liabilities | $47,879 | $73,451 | | Total liabilities | $54,844 | $80,037 | | Total stockholders' equity | $479,512 | $502,751 | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company generated its first product revenue, significantly narrowing its net loss compared to the prior-year period Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Product revenue, net | $30,503 | $0 | | Total revenues | $30,761 | $0 | | Research and development | $39,619 | $40,210 | | Selling, general and administrative | $29,325 | $26,557 | | Loss from operations | ($41,067) | ($66,767) | | Net loss | ($35,996) | ($62,412) | | Net loss per share - basic & diluted | ($0.35) | ($0.72) | [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased in Q1 2025, primarily due to the purchase of short-term investments, resulting in a net decrease in cash and cash equivalents Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($58,997) | ($49,729) | | Net cash (used in) provided by investing activities | ($32,613) | $89,288 | | Cash provided by financing activities | $0 | $48 | | Net (decrease) increase in cash and cash equivalents | ($91,610) | $39,607 | | Cash and cash equivalents, end of period | $33,358 | $270,391 | [Notes to Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail the company's accounting policies, financial instruments, and significant agreements, including revenue concentration, milestone payments, and purchase commitments - For the three months ended March 31, 2025, two individual customers accounted for **98.4% of total net product revenue** and **96.2% of the accounts receivable balance**[39](index=39&type=chunk) - In March 2025, the company paid a **$4.0 million milestone** to XOMA following the European Medicines Agency's validation of the Marketing Authorization Application for tovorafenib[64](index=64&type=chunk) - The company has a manufacturing and supply agreement with Quotient Sciences that includes minimum purchase obligations of approximately **$12.6 million** over the next five years[94](index=94&type=chunk) - The company has an at-the-market (ATM) offering program for up to **$250.0 million**, but no shares had been sold under this agreement as of March 31, 2025[105](index=105&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transition to a commercial-stage entity following the FDA approval of OJEMDA™, detailing its commercial launch, ongoing clinical trials, strategic collaborations, and financial performance [Overview](index=30&type=section&id=Overview) Day One is a commercial-stage company focused on developing medicines for childhood and adult diseases, with its first product OJEMDA™ approved by the FDA in April 2024 - The FDA approved OJEMDA™ (tovorafenib) on **April 23, 2024**, for patients 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion/rearrangement or BRAF V600 mutation[128](index=128&type=chunk) - The pivotal Phase 3 FIREFLY-2 trial is evaluating tovorafenib as a front-line therapy in pLGG, with enrollment expected to be complete in the **first half of 2026**[135](index=135&type=chunk) - The company licensed exclusive rights to commercialize tovorafenib outside the U.S. to Ipsen in **July 2024**[136](index=136&type=chunk) - The pipeline includes DAY301, a novel ADC targeting PTK7, which cleared its first cohort in a Phase 1a/b trial in **January 2025**, and a preclinical VRK1 inhibitor program[140](index=140&type=chunk)[141](index=141&type=chunk) [Results of Operations](index=41&type=section&id=Results%20of%20Operations) The company's financial performance improved significantly in Q1 2025 due to the launch of OJEMDA, with net product revenue of **$30.5 million** and a reduced loss from operations Comparison of Results of Operations (in thousands) | Account | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $30,761 | $0 | $30,761 | N/A | | Research and development | $39,619 | $40,210 | ($591) | (1.5)% | | Selling, general and administrative | $29,325 | $26,557 | $2,768 | 10.4% | | Loss from operations | ($41,067) | ($66,767) | $25,700 | (38.5)% | | Net loss | ($35,996) | ($62,412) | $26,416 | (42.3)% | - The slight decrease in R&D expenses was mainly due to a **$4.0 million milestone payment** in Q1 2025 compared to a larger **$5.0 million amendment payment** in Q1 2024, partially offset by increased clinical trial costs for DAY301[188](index=188&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had **$473.0 million** in cash and investments, which management believes is sufficient to cover capital requirements for at least the next twelve months - As of March 31, 2025, the company had an accumulated deficit of **$590.1 million** and **$473.0 million** in cash, cash equivalents and short-term investments[195](index=195&type=chunk) - The company believes its current cash position is sufficient to fund operations for at least **twelve months** from the filing date of this report[195](index=195&type=chunk)[206](index=206&type=chunk) - Net cash used in operating activities was **$59.0 million** for the three months ended March 31, 2025[201](index=201&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there were no material changes to its market risks from those previously disclosed in its 2024 Form 10-K - There were no material changes to the company's market risks from those described in the 2024 Form 10-K[218](index=218&type=chunk) [Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective[219](index=219&type=chunk) - No changes occurred in the company's internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[220](index=220&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that management believes would have a material adverse effect on its business - The company is not presently a party to any legal proceedings that, in the opinion of management, would have a material adverse effect on its business[223](index=223&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks to its business, operations, and financial condition, including limited operating history, dependence on OJEMDA, ongoing net losses, and the need for additional capital [Risks Related to Financial Position](index=49&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position) The company faces risks due to its limited operating history as a commercial entity, a history of significant net losses, and its high dependence on OJEMDA for near-term revenue - The company is a commercial-stage entity with a **limited operating history**, making it difficult for investors to evaluate its business and prospects[226](index=226&type=chunk) - The company has a history of **significant net losses** (**$36.0 million** for Q1 2025) and an accumulated deficit of **$590.1 million** as of March 31, 2025, with losses expected to continue[230](index=230&type=chunk) - Near-term revenues are highly dependent on the **successful commercialization of OJEMDA**, its only approved product[234](index=234&type=chunk) [Risks Related to Development and Commercialization](index=56&type=section&id=Risks%20Related%20to%20Development%20and%20Commercialization) This section details risks associated with product development and commercialization, including the high cost and uncertain outcomes of clinical trials, intense competition, and challenges in market acceptance and reimbursement - Clinical trials are **expensive, time-consuming, and have uncertain outcomes**, with a high risk of failure for product candidates[250](index=250&type=chunk)[261](index=261&type=chunk) - The company faces **intense competition** from major pharmaceutical companies like Novartis, Pfizer, and BeiGene, which have approved or developing products targeting similar pathways[281](index=281&type=chunk)[282](index=282&type=chunk)[285](index=285&type=chunk) - Market acceptance of OJEMDA and future products is not guaranteed and depends on factors like **efficacy, safety, cost-effectiveness**, and physician willingness to prescribe[305](index=305&type=chunk) - Achieving and maintaining adequate coverage and reimbursement from third-party payors, including a fragmented mix of Medicaid and private insurers for pediatric products, is a **significant challenge**[307](index=307&type=chunk)[311](index=311&type=chunk) [Risks Related to Government Regulation](index=76&type=section&id=Risks%20Related%20to%20Government%20Regulation) The company is subject to extensive and evolving government regulation, facing risks from potential failures in marketing authorization, withdrawal of expedited approvals, and the impact of healthcare legislation like the Inflation Reduction Act - The development and commercialization of pharmaceutical products are subject to **extensive, lengthy, and uncertain regulation** by the FDA and other global authorities[320](index=320&type=chunk) - Products granted accelerated approval, like OJEMDA, require post-marketing confirmatory studies, and failure to complete these or confirm clinical benefit could lead to **withdrawal of approval**[336](index=336&type=chunk)[362](index=362&type=chunk) - Healthcare reform measures, such as the Inflation Reduction Act (IRA), could **increase pricing pressure**, introduce government price negotiation, and negatively impact revenue[375](index=375&type=chunk)[381](index=381&type=chunk) - The company's business is subject to **anti-kickback, fraud and abuse, and other healthcare laws**, violations of which can lead to significant penalties[370](index=370&type=chunk)[373](index=373&type=chunk) [Risks Related to Reliance on Third Parties](index=101&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) The company's business model relies heavily on third parties for clinical trials, manufacturing, and ex-U.S. commercialization, creating significant risks related to performance, supply chain, and geopolitical issues - The company depends on **third-party CROs** to conduct clinical trials and is responsible for ensuring their compliance with GCP regulations[409](index=409&type=chunk)[410](index=410&type=chunk) - The company relies on **third-party manufacturers**, some located in China, for the supply of OJEMDA and its product candidates, creating risks related to geopolitical issues, tariffs, and supply chain disruptions[414](index=414&type=chunk)[415](index=415&type=chunk) - The license agreement with Ipsen is crucial for ex-U.S. commercialization of tovorafenib, and **failure by Ipsen to perform its obligations** or termination of the agreement would materially harm the business[428](index=428&type=chunk)[430](index=430&type=chunk)[431](index=431&type=chunk) - A substantial portion of revenue comes from a **limited number of customers**, with two customers accounting for **98.4% of net product revenue** in Q1 2025[436](index=436&type=chunk) [Risks Related to Intellectual Property](index=122&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success is highly dependent on its ability to obtain, maintain, and defend its intellectual property, facing risks from uncertain patent issuance, potential infringement claims, and reliance on third-party licenses - The company's commercial success depends on its ability to **obtain and maintain patent protection** for its products and technology, which is an uncertain and complex process[483](index=483&type=chunk)[484](index=484&type=chunk) - The company may face claims that it **infringes on third-party patents**, which could result in costly litigation, liability for damages, or prevent commercialization[500](index=500&type=chunk) - The company relies on **licenses from third parties** (e.g., Viracta/XOMA, Takeda, MabCare) for its product candidates, and the termination or breach of these agreements would materially harm the business[508](index=508&type=chunk)[511](index=511&type=chunk) - Patent protection may not be available or enforceable in all countries, and changes in patent law in the U.S. and abroad could **diminish the value of the company's intellectual property**[534](index=534&type=chunk)[542](index=542&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=155&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reported no unregistered sales of equity securities, no use of proceeds from registered securities, and no issuer purchases of equity securities during the reporting period - There were no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities in the quarter[594](index=594&type=chunk)[595](index=595&type=chunk)[596](index=596&type=chunk) [Defaults Upon Senior Securities](index=155&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[597](index=597&type=chunk) [Mine Safety Disclosures](index=155&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[598](index=598&type=chunk) [Other Information](index=155&type=section&id=Item%205.%20Other%20Information) The company disclosed that its Chief Commercial Officer entered into a pre-arranged Rule 10b5-1 stock trading plan on February 28, 2025 - On February 28, 2025, Chief Commercial Officer Lauren Merendino adopted a Rule 10b5-1 trading plan for the potential sale of approximately **120,021 shares of common stock**[601](index=601&type=chunk) [Exhibits](index=158&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including required certifications and Inline XBRL data files - The report includes required certifications from the CEO and CFO under Sections 302 and 906 of the Sarbanes-Oxley Act, as well as XBRL financial data[604](index=604&type=chunk)

OJEMDA TM (tovorafenib) prescriptions grew 16% in Q1 2025 compared to Q4 2024 Exhibit 99.1 Day One Reports First Quarter 2025 Financial Results and Corporate Progress Achieved Q1 2025 OJEMDA TM (tovorafenib) net product revenue of $30.5 million Ended the first quarter with $473.0 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, May 6, 4:30 p.m. ET BRISBANE, Calif., May 6, 2025 – Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the " ...

Upcoming Events OJEMDA™ (tovorafenib) prescriptions grew 16% in Q1 2025 compared to Q4 2024 Achieved Q1 2025 OJEMDA™ (tovorafenib) net product revenue of $30.5 million Ended the first quarter with $473.0 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, May 6, 4:30 p.m. ET BRISBANE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to develo ...