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]