Core Viewpoint - Day One Biopharmaceuticals is focused on developing new medicines for individuals with life-threatening diseases, emphasizing their commitment to making a significant impact in the healthcare sector [3]. Company Overview - Day One Biopharmaceuticals has treated over 1,000 children with its approved product, OJEMDA, showcasing the company's progress and dedication to its mission [3]. - The leadership team includes CEO Jeremy Bender, CCO Lauren Merendino, COO and CFO Charles York, and Head of R&D Mike Vasconcelles, indicating a strong management structure [2]. Industry Context - The presentation took place at the 44th Annual JPMorgan Healthcare Conference, highlighting the importance of investor engagement in the biopharmaceutical industry [1]. - The company aims to address the needs of patients across all ages, reflecting a broad commitment to healthcare innovation [3].

Core Insights - Day One Biopharmaceuticals has successfully completed the acquisition of Mersana Therapeutics, meeting all tender offer conditions, with the tender offer expiring on January 5, 2026 [1] - The acquisition involved purchasing all outstanding shares of Mersana at $25 per share in cash, along with a non-tradable contingent value right (CVR) per share, which could yield potential milestone payments of up to $30.25 per CVR [1] - The total equity value of the deal at closing was approximately $129 million, with the overall deal valued at up to $285 million [2] Company Strategy - The acquisition allows Day One to incorporate a second new antibody-drug conjugate (ADC) into its clinical development pipeline, specifically Emi-Le (emiltatug ledadotin), which targets B7-H4 in various cancers, including adenoid cystic carcinoma (ACC) [2][4] - Day One's CEO emphasized that this acquisition aligns with the company's mission to expand into adult oncology while focusing on rare cancers [3] - The company aims to leverage its capabilities to rapidly develop Emi-Le and pursue registration to provide treatment options for patient communities lacking approved therapies [4] Market Position - The acquisition strengthens Day One's overall position in the market, building on the momentum of its existing product OJEMDA and enhancing its pipeline for sustainable business growth [4] - Day One previously entered the ADC field through an exclusive licensing agreement with MabCare Therapeutics for its ADC MTX-13 in June 2024, indicating a strategic focus on expanding its ADC portfolio [4]

Financial Data and Key Metrics Changes - In Q3 2025, Day One Biopharmaceuticals reported net product revenue of $38.5 million, a 15% increase quarter-over-quarter, marking the strongest quarter for total revenue and sequential growth in 2025 [4][19] - Year-to-date net product revenue reached $102.6 million, reflecting an 89% increase compared to the full year 2024 [9][19] - The company raised its full-year revenue guidance to a range of $145-$150 million for 2025, indicating confidence in the growth trajectory of OJEMDA [5][20] Business Line Data and Key Metrics Changes - Total prescriptions for OJEMDA grew by 18% in Q3, with over 1,200 total prescriptions [9][10] - New patient starts accelerated by almost 20% quarter-over-quarter, contributing to the overall growth [9][10] - The median duration of response to OJEMDA increased from 13 to 18 months based on two-year FIREFLY-1 data [5] Market Data and Key Metrics Changes - Approximately 90% of PLGG patients received payer approval on their first request, facilitating rapid initiation post-prescription [10][12] - Second-line adoption of OJEMDA grew more than 60% over the past 12 months, reflecting increased physician confidence [10][12] Company Strategy and Development Direction - The company aims to drive adoption of OJEMDA as the standard of care in second-line PLGG, advance its pipeline, and maintain disciplined expense management to achieve profitability [7][8] - Upcoming milestones include a mid-2026 EMA approval decision for OJEMDA in Europe and full enrollment of the FIREFLY-2 trial in the first half of 2026 [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the durability of OJEMDA's growth story, supported by strong performance indicators and physician feedback [4][20] - The company remains focused on financial discipline and operational excellence, with a commitment to advancing long-term value creation [20][24] Other Important Information - The company reported total operating expenses of $59.6 million in Q3, a 9% decrease compared to Q2, reflecting effective cost management [20] - Day One ended the quarter with $451.6 million in cash and no debt, indicating a strong financial position [23] Q&A Session Summary Question: Impact on Discontinuations and Duration of Therapy - Management noted that data on non-EAP commercial patients is still maturing, but the median duration of therapy in EAP patients is 20 months, which serves as a leading indicator [26][28] Question: Three-Year Data Expectations - The three-year data from the FIREFLY-1 study will focus on safety, duration of response, and time-to-event analyses, particularly regarding tumor rebound growth and treatment-free intervals [34][36][74] Question: Off-Label MEK Inhibitor Usage - Management indicated that while the NCCN listing could influence off-label use, it is too early to determine any material impact [42][46] Question: Gross to Net Changes and DAY 301 Enrollment - The company confirmed being at the high end of the gross to net range due to a price increase and reported that enrollment in the DAY 301 program is proceeding as expected [50][53] Question: Patient Population Breakdown - Management highlighted a significant increase in second-line usage, with a 60% growth in physician-reported prescribing behavior [61][64] Question: New Patient Starts and Dose Modifications - New patient starts are viewed as key revenue drivers, with second-line patients considered more desirable due to their health status and larger patient pool [82][86]