Summary of Day One Biopharmaceuticals FY Conference Call Company Overview - **Company**: Day One Biopharmaceuticals (NasdaqGS:DAWN) - **Industry**: Biopharmaceuticals, focusing on treatments for pediatric patients with life-threatening diseases Key Points and Arguments Product Development and Pipeline - **Ojenda**: Over 1,000 children treated; positioned to become the standard of care for relapsed or refractory pediatric lobar glioma (PLGG) [3][4] - **Firefly-2 Trial**: Enrollment completion anticipated in the first half of 2026, aiming to expand Ojenda's use into frontline PLGG [3][19] - **Acquisition of Mersana**: Completed in Q4 2025, adding the Emmy Lee program to the portfolio, which is expected to contribute significantly to revenue [4][20] - **Day 301 Program**: Early clinical results are promising, with potential applications in multiple adult and pediatric indications [6][23] Financial Performance - **Cash Position**: Ended 2025 with over $440 million in cash and no debt, allowing for continued investment in high-potential programs [5] - **Revenue Growth**: - Q4 2025 net product revenue reached $52.8 million, a 37% increase from Q3 [12] - Full-year 2025 net product revenues totaled $155.4 million, up 172% year-over-year [12] - Guidance for 2026 net product revenue for Ojenda is projected at $225-$250 million [16] Market Dynamics - **Patient Population**: Approximately 1,100 treatment-eligible relapsed refractory PLGG patients annually [17] - **Market Expansion**: Anticipated EME approval in 2026 for global expansion, led by partner Ipsen [17] - **Physician Adoption**: Increasing confidence in multi-year treatments, contributing to growth in patient persistence and treatment duration [17][31] Clinical Data and Efficacy - **Ojenda's Efficacy**: - 19.4 months duration of response and 42.6 months median time to next treatment observed [10] - 75% of patients who took a drug holiday after 24 months remained treatment-free for 12 months [11] - **Emmy Lee Program**: Early evidence of monotherapy efficacy in adenoid cystic carcinoma (ACC), with a potential market opportunity of $300 million [20][21] Strategic Focus - **Dual Growth Model**: Combination of durable revenue from Ojenda and clinical catalysts from new programs like Emmy Lee and Day 301 [24] - **Commitment to Patients**: Focus on developing new medicines that significantly improve patient outcomes [24] Additional Important Content - **Payer Dynamics**: High reimbursement rates (over 90%) and favorable gross-to-net dynamics due to a significant percentage of Medicaid patients [37] - **Physician Education**: Increased efforts in educating physicians and caregivers to improve treatment management and patient outcomes [33][34] - **Future Updates**: Anticipated updates on Emmy Lee and Day 301 programs in mid to late 2026, with a focus on safety and efficacy data [43][44]

Summary of Day One Biopharmaceuticals FY Conference Call Company Overview - **Company**: Day One Biopharmaceuticals (NasdaqGS:DAWN) - **Focus**: Developing new medicines for life-threatening diseases, particularly cancer, with an emphasis on pediatric patients [4][4] Key Products and Programs - **Ojemda**: - Approved in April 2024 for relapsed or refractory pediatric low-grade glioma (PLGG) - Exceeded initial expectations and has driven significant growth in 2024 and 2025 [4][4] - Aims to become the standard of care in the second-line treatment for PLGG patients with BRAF alterations [8][8] - **Day 301**: - A PTK7-targeted antibody-drug conjugate currently in phase 1A trial [5][5] - **Mersana Therapeutics Acquisition**: - Agreement to acquire Mersana for the MELE program, targeting adenoid cystic carcinoma (ACC), which has significant unmet medical needs [5][5] Market Insights and Learnings - **Ojemda Launch**: - The launch has been successful with extraordinary access and reimbursement for both on-label and off-label patients [10][10] - Physicians' experiences significantly influence treatment decisions due to the lack of rigorous clinical research in this area [13][13] - **Clinical Data**: - Follow-up data on Ojemda has shown promising results, with 77% of patients not requiring additional systemic therapy after 24 months of treatment [17][17] - The three-year data set is expected to address long-term efficacy and treatment duration questions [16][16] Future Growth Opportunities - **FIREFLY-2 Trial**: - Expected to complete enrollment in the first half of 2026, with data anticipated in mid-2027 [40][40] - **Day 301 Updates**: - Further data expected in 2026, with a focus on establishing expansion arms based on initial dose escalation results [48][48] - **Mersana Acquisition**: - Anticipated to close in early Q1 2026, with updates on the MELE program expected in the same year [42][42] Financial Considerations - **Investment in Mersana**: - Total investment for the registrational trial and associated costs is projected to be at or below $200 million, which aligns well with the company's size and potential opportunity [70][70] Strategic Direction - **Business Development**: - The company plans to remain active in business development to expand its pipeline, focusing on programs that fit strategically and can provide short-term value [74][74] Conclusion - Day One Biopharmaceuticals is positioned for growth with its innovative therapies targeting significant unmet needs in pediatric oncology, particularly through the successful launch of Ojemda and the strategic acquisition of Mersana Therapeutics. The company is focused on leveraging clinical data to enhance physician adoption and drive future growth.