Day One Announces Q3 2024 Financial Results and Corporate Updates

15 November 2024
Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN), a company dedicated to creating targeted therapies for life-threatening diseases, reported its financial results for the third quarter of 2024 along with other significant corporate achievements. The company, based in Brisbane, California, is focused on addressing the unmet needs in pediatric cancer treatment.

Day One registered a substantial increase in OJEMDA (tovorafenib) net product revenue, reaching $20.1 million in the third quarter of 2024. This figure represents a 145% rise from the second quarter of the same year. The company also saw a significant increase in quarterly prescriptions (TRx), which grew to 619—a 159% increase over the previous quarter. The demand for OJEMDA is driven by its role in treating pediatric low-grade glioma (pLGG), a type of brain tumor.

The company plans to continue this growth trajectory by advancing its clinical programs and pipeline. One of the key programs is DAY301, a potential first-in-class ADC targeting PTK7. The first patient in the Phase 1a portion of the Phase 1a/b clinical trial for DAY301 is expected to be dosed by the end of 2024 or the first quarter of 2025. Additionally, the company has provided updated data from the Phase 2 FIREFLY-1 trial for tovorafenib. Among 77 patients in Arm 1, the median duration of response was 18 months, underscoring the efficacy of OJEMDA.

The pivotal Phase 3 FIREFLY-2/LOGGIC clinical trial, which evaluates tovorafenib as a front-line therapy for patients aged 6 months to 25 years with pLGG, continues to enroll patients across the US, Canada, Europe, Australia, and Asia, with over 100 sites activated.

In corporate developments, Day One entered into an exclusive licensing agreement with Ipsen in July 2024 to commercialize tovorafenib outside the US. Under this agreement, Day One received approximately $111 million upfront in cash and equity investment, along with potential milestone payments up to $350 million and tiered royalties on net sales. Additionally, the company secured approximately $175 million through an oversubscribed private placement of its securities.

Financially, Day One reported a net income of $37.0 million for the third quarter of 2024, a significant turnaround from a net loss of $46.2 million in the same period of 2023. The increase is attributed to strong product and license revenues, the latter amounting to $73.7 million from selling ex-US commercial rights for tovorafenib. Research and development expenses were slightly higher at $33.6 million compared to $33.2 million in the previous year, largely due to ongoing clinical trials and increased employee compensation. Selling, general, and administrative expenses also rose to $29.0 million from $18.3 million, driven by commercial launch activities and professional services.

As of September 30, 2024, Day One had $558.4 million in cash, cash equivalents, and short-term investments. This strong cash position provides a solid foundation for ongoing and future operations.

Day One will present two posters at the Society for Neuro-Oncology Annual Meeting on November 22, 2024, and will participate in the Piper Sandler 36th Annual Healthcare Conference from December 3-5, 2024.

OJEMDA, a Type II RAF kinase inhibitor, is approved for treating patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma (LGG) that has a BRAF fusion or rearrangement, or a BRAF V600 mutation. This approval is based on response rate and duration, with continued approval contingent on further verification of clinical benefit.

Day One Biopharmaceuticals was founded to address the lack of therapeutic development in pediatric cancer. The company collaborates with clinical oncologists, families, and scientists to develop targeted cancer treatments. Its pipeline includes OJEMDA (tovorafenib), DAY301, and a VRK1 inhibitor program.

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