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Sep 30, 2022
Day One Q3 2022 Earnings Report
Announced third quarter 2022 financial results and highlighted recent corporate achievements.
Key Takeaways
Day One Biopharmaceuticals reported financial results for the third quarter of 2022. They had cash, cash equivalents and short-term investments totaling $374.3 million on September 30, 2022. Research and development expenses were $22.0 million and general and administrative expenses were $17.7 million for the third quarter of 2022. Net loss totaled $37.8 million for the third quarter of 2022.
Topline results for full pivotal FIREFLY-1 study population with tovorafenib in relapsed or progressive pediatric low-grade glioma (pLGG) are expected in the first quarter of 2023
Day One is conducting a pivotal Phase 3 clinical trial (FIREFLY-2/LOGGIC) evaluating tovorafenib as a front-line therapy for patients newly diagnosed with pLGG.
Patient enrollment continues in the Phase 2 FIRELIGHT-1 trial evaluating tovorafenib as a monotherapy and as a combination with the company’s investigational MEK inhibitor, pimasertib, in adults and adolescents with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations.
Day One recently entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's (NCI) to expand therapeutic research opportunities using tovorafenib.
Forward Guidance
Day One anticipates releasing topline results for the full FIREFLY-1 pivotal study population in the first quarter of 2023. If the data are supportive, Day One expects to submit a new drug application (NDA) to the United States Food and Drug Administration (FDA) in the first half of 2023. Day One expects to dose the first patient in FIREFLY-2/LOGGIC trial in the fourth quarter of 2022.
Positive Outlook
- Topline results for full pivotal FIREFLY-1 study population expected in Q1 2023
- Potential NDA submission to the FDA in the first half of 2023.
- FIREFLY-2/LOGGIC trial evaluating tovorafenib as a front-line therapy for patients newly diagnosed with pLGG is underway.
- Patient enrollment continues in the Phase 2 FIRELIGHT-1 trial.
- Day One has sufficient capital resources to fund anticipated operations into 2025.
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