Day One Biopharmaceuticals (DAWN) FY Conference Transcript

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.