Day One Raises $172.5 Million in Public Offering to Advance Therapies for Pediatric Cancers

Rare Daily Staff

Day One Biopharmaceuticals raised $172.5 million in an underwritten public offering of 13.3 million shares of its common stock, including the full exercise of the underwriters’ option to purchase 1.7 million additional shares, at a public offering price of $13.00 per share.

Day One Biopharmaceuticals is a clinical-stage biopharmaceutical company founded to address a critical unmet need: the lack of therapeutic development in pediatric cancer. The company partners with clinical oncologists, families, and scientists to identify, acquire, and develop important emerging cancer treatments.

Dysregulation of the MAPK pathway has been shown to occur in many cancer types and it is one of the most commonly mutated oncogenic pathways in cancer. Day One’s lead product candidate, tovorafenib, is an investigational, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which may offer an important alternative for people with primary brain tumors or brain metastases of solid tumors. Currently tovorafenib is under evaluation in a pivotal phase 2 clinical trial (FIREFLY-1) for the treatment of pediatric low-grade glioma (pLGG). pLGG is the most common form of childhood brain cancer. The company has also initiated a phase 1/2 study (FIRELIGHT-1) with tovorafenib in patients with recurrent or progressive solid tumors with activating RAF alterations.

Tovorafenib has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options. The FDA has also granted Rare Pediatric Disease designation to tovorafenib for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children. Tovorafenib has also received Orphan Drug designation from both the FDA and the European Medicines Agency for the treatment of malignant glioma.

Day One’s pipeline also includes pimasertib, an investigational, oral, highly selective small molecule inhibitor of mitogen‐activated protein kinases 1 and 2 (MEK-1/-2).