Core Viewpoint - The article aims to provide informational content regarding investment opportunities and risks, emphasizing the importance of independent research and verification by readers [2][3]. Group 1: Company Analysis - The article does not provide specific details about any particular company or its financial performance, focusing instead on general investment advice [2][3]. Group 2: Industry Insights - The content does not delve into specific industry trends or analyses, maintaining a broad perspective on investment practices rather than focusing on particular sectors [2][3].

Financial Data and Key Metrics Changes - For Q2 2025, the company reported net product revenue of $33.6 million, representing a 10% increase over Q1 2025 [7][21] - The cumulative net revenue for the last twelve months reached $113.1 million, exceeding initial expectations [6][14] - The company provided full-year 2025 net product revenue guidance of $140 million to $150 million, indicating approximately 150% year-over-year growth [22] Business Line Data and Key Metrics Changes - The company achieved over 1,000 prescriptions in Q2 for the first time, with a 15% quarter-over-quarter growth in prescriptions [7][13] - The growth in prescriptions was driven by both the number of prescribing accounts and the number of patients per account [13][19] - The company noted that over 60% of prescribing accounts have initiated multiple patients on Ogenda, indicating strong physician confidence [19] Market Data and Key Metrics Changes - The company reported that over 95% of patients on Ogenda are covered by payers, with less than 5% receiving free drug [14] - Approximately 90% of patients received approval upon initial submission, which helps reduce administrative burdens [14] Company Strategy and Development Direction - The company aims to establish Ogenda as the standard of care in second-line plus PLGG and is focused on expanding its commercial presence [8][11] - The company is advancing its PTK7 targeted ADC Day 301 through the dose escalation portion of its Phase 1a trial [11][57] - The company has discontinued investment in the VRK1 program to focus on more promising opportunities [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued adoption of Ogenda, citing predictable trends in new patient starts and persistence on therapy [30] - The company remains well-capitalized with $453 million in cash and no debt, allowing it to execute its plans without reliance on capital markets [24] Other Important Information - The company welcomed a new Head of Research and Development, Mike Baskinsells, who brings extensive experience in oncology [10] - The company is actively generating additional data and publications to enhance the Ogenda value proposition [20] Q&A Session Summary Question: What levers will you focus on to increase growth rate given the 2025 guidance? - Management highlighted continued adoption through new patient starts and persistence on therapy as critical variables for achieving revenue guidance [30] Question: What proportion of Q2 scripts are new versus continuing patients? - Management noted that the two-year data has positively impacted growth, leading to an uptick in new patient starts [34][35] Question: What are you seeing regarding durability or persistence now that you are one year into launch? - Management indicated that physician intent is to keep patients on treatment for two years, and the three-year data will provide more insights [40][42] Question: Is the distribution of total scripts attributed to repeat versus new prescriptions holding constant? - Management stated that while they haven't calculated the exact ratio, they continue to focus on driving new patient starts [44][46] Question: Can you provide additional color on your guidance in terms of new additions versus discontinuations? - Management emphasized the importance of continued persistence and new patient starts in meeting their guidance range [53]

Day One Biopharmaceuticals Targeted therapies for people of all ages August 2025 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management's beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. In some cases, you can identify forward-looking statements by terminology such as "may ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Interim Condensed Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Interim%20Condensed%20Financial%20Statements%20(Unaudited)) Presents unaudited financial statements showing a Q2 2025 net loss of $30.3 million and significant OJEMDA revenue growth Condensed Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $494,428 | $562,330 | | **Total Assets** | $519,037 | $582,788 | | **Total Current Liabilities** | $51,221 | $73,451 | | **Total Liabilities** | $58,203 | $80,037 | | **Total Stockholders' Equity** | $460,834 | $502,751 | Condensed Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Product revenue, net** | $33,562 | $8,192 | $64,065 | $8,192 | | **Total revenues** | $33,908 | $8,192 | $64,669 | $8,192 | | **Loss from operations** | $(34,974) | $(114,807) | $(76,041) | $(181,574) | | **Gain from sale of PRV** | — | $108,000 | — | $108,000 | | **Net loss** | $(30,322) | $(4,407) | $(66,318) | $(66,819) | | **Net loss per share** | $(0.29) | $(0.05) | $(0.64) | $(0.77) | Condensed Statement of Cash Flows Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(83,803) | $(98,858) | | **Net cash (used in) provided by investing activities** | $(6,291) | $106,345 | | **Cash provided by financing activities** | $748 | $1,345 | | **Net (decrease) increase in cash** | $(89,346) | $8,832 | | **Cash and cash equivalents, end of period** | $35,622 | $239,616 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the commercial launch of OJEMDA™, clinical pipeline progress, and financial results [Overview](index=30&type=section&id=Overview) The company is a commercial-stage entity focused on its newly FDA-approved product, OJEMDA™, for pediatric glioma - The FDA granted **accelerated approval for OJEMDA™** (tovorafenib) on April 23, 2024, for patients with relapsed or refractory pLGG, and the company has commenced its commercial launch in the U.S[130](index=130&type=chunk) - The pivotal Phase 3 trial, FIREFLY-2, is evaluating tovorafenib as a front-line therapy in pLGG, with **enrollment expected to be completed in the first half of 2026**[134](index=134&type=chunk) - In June 2024, the company licensed DAY301, a novel Antibody Drug Conjugate (ADC) targeting PTK7, and a Phase 1a/b clinical trial is ongoing[142](index=142&type=chunk) - An agreement with Ipsen grants exclusive rights to commercialize tovorafenib outside the United States in exchange for an upfront payment, milestones, and royalties[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20operations) Total revenues increased to $33.9 million in Q2 2025, driven by OJEMDA sales, while R&D expenses decreased Comparison of Three Months Ended June 30, 2025 and 2024 (in thousands) | Account | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | **Product revenue, net** | $33,562 | $8,192 | $25,370 | | **Total revenues** | $33,908 | $8,192 | $25,716 | | **Research and development** | $36,149 | $92,106 | $(55,957) | | **Selling, general and administrative** | $28,968 | $30,186 | $(1,218) | | **Net loss** | $(30,322) | $(4,407) | $(25,915) | Comparison of Six Months Ended June 30, 2025 and 2024 (in thousands) | Account | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | **Product revenue, net** | $64,065 | $8,192 | $55,873 | | **Total revenues** | $64,669 | $8,192 | $56,477 | | **Research and development** | $75,768 | $132,316 | $(56,548) | | **Selling, general and administrative** | $58,293 | $56,743 | $1,550 | | **Net Loss** | $(66,318) | $(66,819) | $501 | - The decrease in R&D expenses for Q2 2025 was primarily due to a **$55.0 million upfront payment** related to the MabCare License Agreement in Q2 2024, which was not repeated[190](index=190&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $453.1 million in cash and equivalents, sufficient to fund operations for at least twelve months - As of June 30, 2025, the company had **$453.1 million in cash, cash equivalents, and short-term investments**[206](index=206&type=chunk) - Management believes current cash reserves are **sufficient to fund capital requirements for at least twelve months** from the filing date of this report[206](index=206&type=chunk)[217](index=217&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(83,803) | $(98,858) | | **Net cash (used in) provided by investing activities** | $(6,291) | $106,345 | | **Cash provided by financing activities** | $748 | $1,345 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no material changes to its market risks from the prior year's annual report - There were **no material changes** to the company's market risks from those described in the 2024 Form 10-K[228](index=228&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of the end of the quarter - Based on an evaluation as of June 30, 2025, the Principal Executive Officer and Principal Financial Officer concluded that the company's **disclosure controls and procedures were effective**[229](index=229&type=chunk) - There were **no changes in internal control over financial reporting** during the three months ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[230](index=230&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any material legal proceedings - The company is **not presently a party to any legal proceedings** that would have a material adverse effect on its business[232](index=232&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its commercial operations, financial position, and regulatory environment [Risks Related to Our Financial Position](index=49&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position) Financial risks include a limited operating history, a history of net losses, and reliance on a single product - As a commercial-stage company with a **limited operating history** and only one approved product, it is difficult for investors to evaluate the company's likelihood of success[235](index=235&type=chunk) - The company has incurred significant net losses since inception, with an **accumulated deficit of $620.4 million** as of June 30, 2025, and expects to incur continued losses[238](index=238&type=chunk) - The company **may require additional capital** to finance its operations and may be forced to delay, reduce, or eliminate its R&D programs if unable to raise it[250](index=250&type=chunk) [Risks Related to Development and Commercialization of OJEMDA and our Product Candidates](index=56&type=section&id=Risks%20Related%20to%20Development%20and%20Commercialization%20of%20OJEMDA%20and%20our%20Product%20Candidates) The company's development and commercialization efforts face significant risks from clinical trials and competition - **Clinical trials are expensive, time-consuming, and involve uncertain outcomes**, with failure possible at any stage[257](index=257&type=chunk)[258](index=258&type=chunk) - The company faces **substantial competition from major pharmaceutical companies** with greater financial resources and established products[287](index=287&type=chunk)[290](index=290&type=chunk) - The commercial success of OJEMDA depends on achieving **market acceptance among physicians and securing adequate reimbursement** from third-party payors, which is uncertain[313](index=313&type=chunk)[315](index=315&type=chunk) [Risks Related to Government Regulation](index=75&type=section&id=Risks%20Related%20to%20Government%20Regulation) The company operates in a highly regulated industry, facing extensive oversight and risks from healthcare reform - The development and commercialization of pharmaceutical products are subject to **extensive, lengthy, and uncertain regulation** by the FDA and other global authorities[325](index=325&type=chunk) - OJEMDA's accelerated approval is **subject to post-marketing requirements**, and failure to confirm clinical benefit could lead to the FDA withdrawing approval[341](index=341&type=chunk)[368](index=368&type=chunk) - The company is subject to **healthcare fraud and abuse laws**, such as the federal Anti-Kickback Statute, which could expose it to significant penalties[378](index=378&type=chunk) - Recent legislation, such as the **Inflation Reduction Act (IRA)**, could increase costs and put downward pressure on drug prices, affecting profitability[380](index=380&type=chunk)[384](index=384&type=chunk) [Risks Related to Our Reliance on Third Parties](index=103&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) The business model relies heavily on third-party CROs, CMOs, and licensing partners like Ipsen - The company **relies on third-party CROs** to conduct clinical trials and is responsible for ensuring their compliance with GCP requirements[412](index=412&type=chunk)[413](index=413&type=chunk) - The company **depends on third-party manufacturers**, including some in China, exposing it to production difficulties, quality control issues, and geopolitical risks[418](index=418&type=chunk)[419](index=419&type=chunk) - The **license agreement with Ipsen is crucial** for the ex-U.S. commercialization of tovorafenib, and non-performance by Ipsen could harm the business[432](index=432&type=chunk)[435](index=435&type=chunk) [Risks Related to Our Intellectual Property](index=124&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success depends on obtaining, maintaining, and enforcing intellectual property protection for its products - The company's commercial success depends on its ability to **obtain and maintain patent protection**, but the patent position of biopharmaceutical companies is highly uncertain[490](index=490&type=chunk)[491](index=491&type=chunk)[492](index=492&type=chunk) - The company may face claims that it **infringes on third-party patents**, which could lead to costly litigation or prevent commercialization of its products[507](index=507&type=chunk) - The company **relies on license agreements** with third parties like Viracta, Takeda, and MabCare, and a termination could result in the loss of rights to its products[516](index=516&type=chunk)[518](index=518&type=chunk)[519](index=519&type=chunk) [Risks Related to Our Common Stock](index=145&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The company's common stock faces risks including high price volatility and significant stockholder control - The market price of the company's common stock is likely to be **highly volatile** and subject to wide fluctuations[574](index=574&type=chunk) - The company **does not intend to pay dividends**, so any return on investment will depend on the appreciation of the stock's value[579](index=579&type=chunk) - As of June 30, 2025, executive officers, directors, and 5% stockholders beneficially owned **45.0% of the voting stock**, giving them significant influence[586](index=586&type=chunk) - **Anti-takeover provisions** in the company's charter documents and Delaware law could prevent or delay an acquisition[587](index=587&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=96&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reports no unregistered sales, use of proceeds, or repurchases of its equity securities - There were **no unregistered sales of equity securities**, use of proceeds, or issuer purchases of equity securities during the period[604](index=604&type=chunk)[605](index=605&type=chunk)[606](index=606&type=chunk) [Item 3. Defaults Upon Senior Securities](index=96&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that there have been no defaults upon its senior securities - None[607](index=607&type=chunk) [Item 4. Mine Safety Disclosures](index=96&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[608](index=608&type=chunk) [Item 5. Other Information](index=96&type=section&id=Item%205.%20Other%20Information) No directors or Section 16 officers adopted or terminated a Rule 10b5-1 trading plan during the quarter - During the three months ended June 30, 2025, **none of the Company's Section 16 officers or directors adopted or terminated any Rule 10b5-1 trading plan**[609](index=609&type=chunk) [Item 6. Exhibits](index=97&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed with the Form 10-Q - The report includes **certifications from the Principal Executive Officer and Principal Financial Officer** pursuant to the Sarbanes-Oxley Act of 2002[611](index=611&type=chunk) - **Inline XBRL Instance Document** and Taxonomy Extension Schema are filed with the report[611](index=611&type=chunk)

[Day One Second Quarter 2025 Financial Results and Corporate Progress](index=1&type=section&id=Day%20One%20Second%20Quarter%202025%20Financial%20Results%20and%20Corporate%20Progress) [Financial & Commercial Highlights](index=1&type=section&id=Financial%20%26%20Commercial%20Highlights) The company reports strong OJEMDA revenue growth, raises full-year guidance, and maintains a robust cash position Q2 2025 Performance Metrics | Metric | Q2 2025 | Change vs. Q1 2025 | Change vs. Q2 2024 | | :--- | :--- | :--- | :--- | | OJEMDA Net Product Revenue | $33.6 million | +10% | +310% | | OJEMDA Prescriptions | >1,000 | +15% | +346% | - The company provides full-year 2025 net product revenue guidance of **$140 to $150 million**[1](index=1&type=chunk)[3](index=3&type=chunk) - The company ended the second quarter with **$453.1 million in cash**, cash equivalents, and short-term investments[1](index=1&type=chunk)[15](index=15&type=chunk) - Achieved **$113.1 million in OJEMDA net product revenue** for the trailing twelve-month period ending June 30, 2025[3](index=3&type=chunk) [Pipeline and Corporate Updates](index=2&type=section&id=Pipeline%20and%20Corporate%20Updates) The company advances its clinical pipeline, provides trial updates, and announces key leadership and collaboration changes - Key pipeline progress includes the DAY301 trial actively enrolling patients, with 3-year FIREFLY-1 data expected in Q4 2025[7](index=7&type=chunk) - The research collaboration and license agreement with Sprint Bioscience AB for the VRK1 program was **terminated** based on strategic objectives[7](index=7&type=chunk) - Dr. Michael Vasconcelles, an industry leader with over 25 years of oncology R&D experience, was appointed as **Head of Research and Development** in June 2025[5](index=5&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reports total revenues of $33.9 million and a net loss of $30.3 million, with a notable decrease in R&D expenses year-over-year [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Net product revenue grew significantly while R&D expenses decreased due to a one-time license payment in the prior year Key Financial Metrics | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Product Revenue | $33.6 million | $8.2 million | | R&D Expenses | $36.1 million | $92.1 million | | SG&A Expenses | $29.0 million | $30.2 million | - The decrease in R&D expenses was primarily due to the upfront payment of **$55.0 million** for the MabCare Therapeutics license agreement in the second quarter of 2024[8](index=8&type=chunk) Net Loss and Cash Position | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $30.3 million | $4.4 million | | Cash Position (end of period) | $453.1 million | N/A | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) The unaudited income statement details revenues, expenses, and net loss for the three and six months ended June 30, 2025 Unaudited Condensed Consolidated Statements of Operations | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Total revenues** | **$33,908** | **$8,192** | | Total cost and operating expenses | $68,882 | $122,999 | | Loss from operations | $(34,974) | $(114,807) | | Total non-operating income, net | $4,652 | $111,952 | | **Net loss** | **$(30,322)** | **$(4,407)** | | **Net loss per share - basic & diluted** | **$(0.29)** | **$(0.05)** | [Selected Condensed Balance Sheets](index=5&type=section&id=Selected%20Condensed%20Balance%20Sheets) The balance sheet shows the company's financial position, comparing key assets and liabilities at June 30, 2025, and December 31, 2024 Unaudited Selected Condensed Consolidated Balance Sheets | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $453,103 | $531,720 | | Total assets | $519,037 | $582,788 | | Total liabilities | $58,203 | $80,037 | | Total stockholders' equity | $460,834 | $502,751 | [Company and Product Overview](index=3&type=section&id=Company%20and%20Product%20Overview) Day One Biopharmaceuticals focuses on targeted cancer therapies, with its lead product OJEMDA™ approved for pediatric low-grade glioma - OJEMDA (tovorafenib) is indicated for patients 6 months and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a **BRAF fusion, rearrangement, or V600 mutation**[11](index=11&type=chunk) - The indication for OJEMDA was granted under **accelerated approval** by the FDA, with continued approval contingent on confirmatory trials[11](index=11&type=chunk)[12](index=12&type=chunk) - Day One's mission is to address the critical unmet need for therapeutic development in **pediatric cancer**[13](index=13&type=chunk) [Legal Disclaimers](index=4&type=section&id=Legal%20Disclaimers) This section contains forward-looking statements and cautions that actual results may differ due to various risks and uncertainties - The press release includes forward-looking statements concerning plans to develop and commercialize cancer therapies and expectations from clinical trials[18](index=18&type=chunk) - These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially[20](index=20&type=chunk)

BRISBANE, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its second quarter 2025 financial results and highlighted recent corporate achievements. "We have strong momentum going into the second half of 2025. We continue to focus on our three core priorities: accelerating revenu ...

Core Viewpoint - Day One Biopharmaceuticals, Inc. (DAWN) shows significant upside potential with a mean price target of $28, indicating a 303.5% increase from its current trading price of $6.94 [1] Price Targets and Analyst Consensus - The average price target consists of eight estimates ranging from $20.00 to $36.00, with a standard deviation of $5.07, suggesting a high variability in analyst predictions [2] - The lowest estimate indicates a potential increase of 188.2%, while the highest suggests an upside of 418.7% [2] - A low standard deviation among price targets indicates a strong agreement among analysts regarding the stock's price direction [9] Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about DAWN's earnings prospects, with a positive trend in earnings estimate revisions correlating with potential stock price increases [11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has risen by 2.1%, with one estimate moving higher and no negative revisions [12] - DAWN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Caution on Price Targets - While price targets are a common tool for investors, they can often mislead, and reliance solely on them may not yield favorable returns [7][10] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [8]

BRISBANE, Calif., July 22, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced it will host a live conference call and webcast on Tuesday, August 5, 2025 at 4:30 p.m. ET to report financial results and discuss corporate progress for the second quarter 2025. DAY ONE INVESTORS LifeSci Advisors, PJ Kelleher ...

Company Overview and Financial Highlights - Day One is a commercial-stage biopharmaceutical company focused on developing targeted medicines for childhood and adult diseases[11] - As of March 31, 2025, Day One had approximately $473 million in cash, cash equivalents, and short-term investments[16,82] - OJEMDA net product revenue since launch reached $87.7 million[43] - Q1 2025 OJEMDA net product revenue was $30.5 million, representing an 11% increase compared to Q4 2024[43,47] - Cumulative prescriptions for OJEMDA since launch totaled 2,571 as of March 31, 2025[43] OJEMDA Clinical Data and Market Opportunity - OJEMDA demonstrated an overall response rate (ORR) of 51% in 76 evaluable patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation[29,30] - The addressable U.S opportunity for OJEMDA is estimated to be approximately 2,000-3,000 patients[38,39] Pipeline Development - Enrollment completion is expected in the first half of 2026 for the FIREFLY-2 pivotal Phase 3 trial in front-line pLGG[18] - The first dose cohort for DAY301, a PTK7-targeted ADC, was cleared in January 2025[18,65]

Summary of Day One Biopharmaceuticals (DAWN) FY Conference Call - June 10, 2025 Company Overview - **Company**: Day One Biopharmaceuticals - **Product**: Ogemda (for treating pediatric low-grade gliomas, PLGG) Key Industry Insights - **Market Dynamics**: Ogemda has been on the market for over a year, with a strong initial launch due to an expanded access program that established a patient base early on [3][5] - **Patient Population**: The estimated U.S. relapsed PLGG patient population is around 26,000, with 2,000 to 3,000 patients on treatment at any given time [7][8] - **Adoption Rate**: The launch is expected to be slow and steady, akin to a rare disease launch, with gradual physician adoption and experience being critical for establishing Ogemda as a standard of care [11][12] Financial Performance - **Growth**: The company has seen steady and incremental gains, with double-digit growth anticipated moving forward [5][31] Clinical Insights - **Treatment Duration**: The median duration of treatment observed in clinical trials is approximately 24 months, consistent with commercial settings [34][45] - **Adverse Events (AEs)**: There is a noted increase in early dropouts due to skin toxicities, which are common with MAP kinase inhibitors [38][41] Physician Engagement - **Prescribing Behavior**: Efforts are focused on encouraging physicians to transition from off-label treatments to Ogemda, with educational initiatives and data publication being key strategies [13][14] - **Physician Confidence**: The adoption of Ogemda is heavily influenced by physician experiences regarding efficacy and safety, with a need for ongoing education about managing AEs [27][28][30] Regulatory and Market Expansion - **European Filing**: The European Medicines Agency (EMA) has received the filing for Ogemda, with expectations for additional filings in other countries [51] - **Frontline Study**: The FIREFLY two trial is progressing well, with enrollment expected to complete in the first half of next year [52] Strategic Development - **Business Development**: The company is actively pursuing additional high-quality assets for clinical development, focusing on both adult and pediatric oncology indications [60][64] - **Leadership Changes**: A new head of R&D has been appointed, expected to enhance the company's strategic direction in oncology [68] Additional Considerations - **Off-Label Use**: Approximately 10% of prescriptions are for off-label use, primarily in adult solid tumors, but this proportion is expected to decrease as the PLGG market grows [35][42] - **Long-Term Data**: There is a strong emphasis on generating long-term data to reassure physicians and support the adoption of Ogemda [15][16] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic focus, market dynamics, and clinical insights related to Ogemda and its patient population.