Day One Announces Q1 2024 Financial Results and Corporate Progress

Day One Biopharmaceuticals, based in Brisbane, California, has announced significant progress in the first quarter of 2024. With a focus on developing targeted cancer therapies for people of all ages, the company is celebrating the recent U.S. FDA accelerated approval of OJEMDA™ (tovorafenib) for treating pediatric patients with relapsed or refractory low-grade glioma (pLGG) harboring specific BRAF genetic alterations.

OJEMDA represents a breakthrough as the first and only FDA-approved therapy for this condition, catering to patients as young as six months old. This achievement is a milestone for Day One, reinforcing its commitment to addressing critical unmet needs in pediatric oncology. The launch has been supported by the pediatric brain tumor community, whose involvement has been crucial to the program's success.

The company has initiated the distribution of OJEMDA, with the first prescriptions already received in the U.S. Additionally, patients are enrolling in the EveryDay Support From Day One™ program, which provides personalized services, including insurance support, financial assistance, and educational resources to aid patients and their care teams during treatment.

The pivotal Phase 3 FIREFLY-2/LOGGIC trial continues to enroll participants across multiple regions, including the U.S., Canada, Europe, Australia, and Asia, with over 90 sites activated. This trial aims to evaluate tovorafenib as a front-line therapy for pLGG in patients aged six months to 25 years. Simultaneously, the Phase 1b/2 substudy of the FIRELIGHT-1 trial is ongoing, assessing the combination of tovorafenib with pimasertib, an investigational MEK inhibitor, in combating recurrent or progressive solid tumors with MAPK pathway alterations.

Day One also achieved a significant corporate milestone by receiving a rare pediatric disease priority review voucher from the FDA upon OJEMDA’s approval. This voucher is a valuable asset that can expedite the review of future drug applications. The company anticipates sharing results from the FIRELIGHT-1 Phase 1b trial and outlining next steps in the second half of 2024.

Financially, Day One reported a cash position of $317.9 million as of March 31, 2024, providing a substantial runway to fund operations into 2026 based on the current operating plan. Research and development expenses for the first quarter of 2024 increased to $40.2 million, compared to $27.8 million in the same period the previous year. This rise was driven by higher employee compensation costs, a payment for the buyback of a priority review voucher obligation, and increased clinical trial and manufacturing activities related to OJEMDA.

General and administrative expenses also saw an increase, amounting to $26.6 million for the first quarter of 2024, up from $18.0 million in the first quarter of 2023. This increment was primarily due to additional employee compensation, ongoing commercialization efforts, and enhanced professional services to support the company's growth.

Overall, Day One recorded a net loss of $62.4 million for the first quarter of 2024, which included a non-cash stock compensation expense of $12.6 million. This compares to a net loss of $42.4 million for the first quarter of 2023, which had a non-cash stock compensation expense of $9.4 million.

Looking ahead, Day One is preparing for several important events, including presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the Goldman Sachs 45th Annual Global Healthcare Conference in June. The company remains focused on its mission to provide innovative cancer treatments and improve outcomes for patients of all ages.