Day One Biopharmaceuticals Inc (DAWN) Reports Q3 2023 Financial Results and Corporate Progress

In this article:
  • Day One Biopharmaceuticals Inc (NASDAQ:DAWN) reported a net loss of $46.2 million for Q3 2023, compared to a net loss of $37.8 million for Q3 2022.

  • The company's cash, cash equivalents, and short-term investments totaled $405.5 million as of September 30, 2023.

  • Research and development expenses increased to $33.2 million in Q3 2023, up from $22.0 million in Q3 2022.

  • General and administrative expenses slightly increased to $18.3 million in Q3 2023, compared to $17.7 million in Q3 2022.

Day One Biopharmaceuticals Inc (NASDAQ:DAWN) announced its third quarter 2023 financial results on November 6, 2023. The company reported a net loss of $46.2 million for the third quarter of 2023, compared to a net loss of $37.8 million for the same period in 2022.

Financial Highlights

The company's cash, cash equivalents, and short-term investments totaled $405.5 million as of September 30, 2023. According to DAWN's current operating plan, the management believes it has sufficient capital resources to fund anticipated operations into 2026.

Research and development expenses were $33.2 million for the third quarter of 2023, compared to $22.0 million for the same period in 2022. The increase was primarily due to additional employee compensation costs, an upfront license payment, as well as clinical trial and manufacturing activities related to Day Ones lead product candidate, tovorafenib.

General and administrative expenses were $18.3 million for the third quarter of 2023, compared to $17.7 million for the same period in 2022. The increase was primarily due to additional employee compensation costs, as well as the ongoing build-out of commercial capabilities.

Corporate Highlights and Upcoming Milestones

In September 2023, DAWN announced updated FIREFLY-1 data for tovorafenib and completion of the rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for relapsed or progressive pediatric low-grade glioma (pLGG). In October 2023, the FDA accepted its NDA for Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.

In August 2023, DAWN entered into a research collaboration and license agreement with Sprint Biosciences AB for its Vaccinia Related Kinase 1 (VRK1) program, augmenting the Companys portfolio of targeted therapies in oncology.

Looking Forward

DAWN continues to make significant progress in its clinical trials and research collaborations. The company's lead product candidate, tovorafenib, is under evaluation in two pivotal clinical trials for pLGG. The company also continues to enroll patients in the Phase 1b/2 substudy of the FIRELIGHT-1 trial evaluating the combination of tovorafenib with the Companys investigational MEK inhibitor, pimasertib.

Explore the complete 8-K earnings release (here) from Day One Biopharmaceuticals Inc for further details.

This article first appeared on GuruFocus.

Advertisement