Day One Biopharmaceuticals (DAWN) Investor Presentation - Slideshow

Tovorafenib (DAY101) Clinical Trials and Designations - Tovorafenib (DAY101) received FDA Breakthrough Therapy Designation for relapsed pLGG and FDA Rare Pediatric Disease Designation (PRV Eligible) for pLGG[10] - FIREFLY-1, a pivotal Phase 2 trial of Tovorafenib in relapsed or progressive pLGG, showed a 64% ORR (Overall Response Rate) in RANO-evaluable patients (n=22)[21] - The clinical benefit rate (CBR) in the FIREFLY-1 trial was 91%[25] - The median time to response in the FIREFLY-1 trial was 2.8 months[25] - FIREFLY-2/LOGGIC is a pivotal Phase 3 trial of Tovorafenib in newly diagnosed pLGG, with first patient dosing expected in Q4 2022[5, 33] Safety and Tolerability of Tovorafenib - In the FIREFLY-1 trial, 28% of patients required dose modifications due to treatment-related AEs[25] - The majority (96%) of treatment-emergent AEs were grade 1 or 2[25] - The most common treatment-related AEs (Any Grade) were Blood creatine phosphokinase increased (72%), Hair color changes (68%), and Rash (52%)[24] Market and Financial Information - Day One Biopharmaceuticals projected cash runway into 2025[5, 49] - As of September 30, 2022, Day One Biopharmaceuticals had $374.3 million in cash, cash equivalents, and short-term investments[50] - For the nine months ended September 30, 2022, R&D expense was $59.6 million, G&A expense was $44.6 million, and the net loss was $102.1 million[50] Tovorafenib and Pimasertib Combination - FIRELIGHT-1 is evaluating the combination of Tovorafenib (DAY101) and Pimasertib, with the first patient dosed in May 2022[10, 49]