Company: DAWN
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0000950170-25-026654
Chunk: 67

Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1
Chunk 67
---
, randomized, multicenter study to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care chemotherapy. FIREFLY-2 is the confirmatory trial that will support the conversion of tovorafenib’s accelerated approval by the FDA into a full approval. Approximately 400 patients, less than 25 years of age with an activating RAF alteration pediatric LGG requiring first-line systemic therapy, will be randomized 1:1 to receive either tovorafenib (Arm 1) or an investigator choice of standard of care chemotherapy (Arm 2). The first patient was dosed in FIREFLY-2 in March 2023; we expect to complete enrollment of FIREFLY-2 in the first half of 2026.

•Deploy our differentiated and proven business development expertise to further expand our targeted oncology pipeline for patients with large unmet medical needs.    Our team has diverse backgrounds—from academia and drug research and development, to biopharmaceutical industry and business development experience. We have a proven track record of identifying and acquiring drug candidates and programs with potentially significant commercial opportunities, including successfully in-licensing our current drug candidates, tovorafenib from Takeda, DAY301 from MabCare and VRK1 from Sprint. We will continue to utilize our broad experience, as well as our network of trusted relationships, to source additional high-impact assets to further expand our targeted oncology pipeline.

•Evaluate opportunities to accelerate development timelines and enhance the commercial potential of our programs in collaboration with third parties.    We have entered, and may selectively in the future enter, into collaborations where we believe there is an opportunity to accelerate the development and commercialization of our products and product candidates—for example, in July 2024 we entered into the Ipsen License Agreement, pursuant to which we licensed to Ipsen, on an exclusive basis, the right to commercialize tovorafenib in all territories outside the United States. We intend to commercialize our product candidates in key markets either alone or with partners in order to maximize the worldwide commercial potential of our programs.

Our Approach: Focused on Advancing First- or Best-in-Class Medicines for People of All Ages with Life-Threatening Diseases

Our company is focused on prioritizing the clinical development of novel targeted therapeutics in children and adults with equal intensity. Historically, most pharmaceutical companies focused discovery and development efforts for new cancer therapies on adult tumor types. An analysis of agents for which the first-in-adult trial, or