Day One Biopharmaceuticals announced the closing of a $130 million Series B financing, led by RA Capital Management with participation from additional new investors Boxer Capital, BVF Partners L.P., Franklin Templeton, Janus Henderson Investors, Perceptive Advisors, funds and accounts advised by T. Rowe Price Associates, Inc., and Viking Global Investors. Existing investors Canaan, Access Biotechnology, and Atlas Venture also participated.
Proceeds from the Series B financing will support drug development efforts and continue advancing commercial launch plans for the Company’s lead program, DAY101. Day One has now raised more than $190 million from leading life science investors since the Company initiated operations in late 2019.
DAY101 is a first-in-class, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor.
Over 250 patients have received DAY101 in clinical trials to date. Early studies demonstrated evidence of anti-tumor activity in adult and pediatric populations with specific genetic alterations in the RAS/MAPK pathway. A pivotal Phase 2 study, FIREFLY-1, is underway in pediatric low-grade glioma (pLGG), which is the most common form of childhood brain cancer and has no approved therapies. In addition, Day One plans to initiate an adult solid tumor study to further evaluate DAY101 in patients with RAF-altered tumors for which there are no currently approved therapies. DAY101 has been granted Breakthrough Therapy designation by the U.S. FDA for the treatment of pediatric patients with low-grade glioma harboring an activating RAF alteration who have progressed after one or more prior systemic therapies. DAY101 has also received Orphan Drug designation from the FDA for the treatment of malignant glioma.
“Day One was founded to solve a critical unmet need: Children are being left behind during a cancer treatment revolution,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “We have made significant and rapid progress since our recent inception, including initiating our first sites for the pivotal FIREFLY-1 study, which has the potential to make DAY101 the first approved targeted therapy for pediatric low-grade glioma, the receipt of FDA Breakthrough Therapy designation for DAY101, and the continued build-out of our senior leadership team. The completion of this financing will enable us to accelerate and expand our efforts even further. We are thrilled to have the support of this exceptional group of investors, are pleased to welcome Derek to our Board, and look forward to the next chapter of growth for Day One.”