Day One Biopharmaceuticals pany(US:DAWN)2024-05-06 20:30Regulatory Approvals - OJEMDA (tovorafenib) received U.S. FDA accelerated approval for relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG) in April 2024[5]. - The company received a rare pediatric disease priority review voucher from the FDA upon OJEMDA's approval[5]. Financial Performance - Cash, cash equivalents, and short-term investments totaled $317.9 million as of March 31, 2024, sufficient to fund operations into 2026[11]. - Net loss for Q1 2024 was $62.4 million, compared to a net loss of $42.4 million in Q1 2023, with non-cash stock compensation expenses of $12.6 million[11]. - The accumulated deficit increased to $520.997 million as of March 31, 2024, from $458.585 million at the end of 2023[21]. Expenses - Research and development expenses increased to $40.2 million in Q1 2024, up from $27.8 million in Q1 2023, primarily due to higher employee compensation and clinical trial activities[11]. - General and administrative expenses rose to $26.6 million in Q1 2024, compared to $18.0 million in Q1 2023, driven by ongoing commercial buildout and professional service expenses[11]. - Total operating expenses for Q1 2024 were $66.8 million, up from $45.9 million in Q1 2023[19]. Clinical Trials - The pivotal Phase 3 FIREFLY-2/LOGGIC trial for tovorafenib continues to enroll patients across more than 90 sites globally[5]. - The company plans to present results from the FIRELIGHT-1 Phase 1b trial at the 2024 ASCO Annual Meeting scheduled for May 31-June 4, 2024[11].