Day One Biopharmaceuticals, Inc. Annual Report - Your Investment Snapshot for 2025

Considering an investment in Day One Biopharmaceuticals? This guide offers a clear overview of the company's performance, particularly for the fiscal year ending December 31, 2025, and its potential implications for investors. We've translated key financial and operational details into plain language, making it accessible without requiring a finance background.

Business Overview

Day One Biopharmaceuticals, Inc. (trading as DAWN on the Nasdaq Global Select Market) is a clinical-stage biopharmaceutical company. It focuses on developing innovative, targeted therapies for cancer patients, especially those with limited treatment options. The company specializes in precision oncology, aiming to deliver medicines that address specific genetic drivers of cancer. As a "well-known seasoned issuer" and a "large accelerated filer," Day One demonstrates a strong track record of financial reporting and a significant market presence. As of February 19, 2026, approximately 103.3 million shares of common stock were outstanding. The market value for shares held by public investors (non-affiliates) was roughly $567.0 million as of June 30, 2025.

The year 2025 marked a transformative period for Day One, characterized by significant advancements in its drug pipeline and a strategic acquisition designed to accelerate growth and diversify its therapeutic portfolio.

Financial Performance

Day One's financial performance in 2025 reflects its continued investment in research and development and strategic expansion.

• Revenue: The company reported $15.2 million in collaboration revenue for the year ended December 31, 2025. This revenue primarily came from existing partnerships, marking an increase from $8.5 million in 2024 and indicating growing engagement in its early-stage programs.
• Net Loss: As is common for clinical-stage biopharmaceutical companies, Day One reported a net loss of $210.5 million for 2025, compared to a net loss of $165.8 million in 2024. Increased research and development (R&D) expenses, particularly those associated with advancing lead programs and integrating the Mersana acquisition, primarily drove this expanded loss.
• Research & Development (R&D) Expenses: R&D remained the largest expense, totaling $185.3 million in 2025, up from $130.1 million in 2024. This significant investment underscores Day One's commitment to advancing innovative therapies through clinical trials.
• General & Administrative (G&A) Expenses: G&A expenses reached $55.0 million in 2025, compared to $44.0 million in 2024, reflecting increased operational costs associated with the company's growth and the acquisition.

Management Discussion and Analysis (MD&A) Highlights

Management's discussion and analysis (MD&A) outlines the company's operational results and financial condition, emphasizing strategic decisions and their impact. The increased net loss in 2025 stemmed primarily from substantial investments in research and development, reflecting the advancement of key pipeline programs and the strategic acquisition of Mersana Therapeutics. Day One completed this acquisition in Q3 2025 for approximately $150 million in cash and stock, adding the promising antibody-drug conjugate (ADC) candidate, emiltatug ledadotin, to its pipeline. Emiltatug ledadotin is currently in Phase 2 clinical trials for platinum-resistant ovarian cancer, an area of high unmet need, significantly expanding Day One's oncology pipeline beyond its existing focus on pediatric and adult brain cancers.

Beyond the acquisition, Day One continued to advance its lead program, Tovorafenib (DAY101). In 2025, the company successfully completed patient enrollment for its pivotal FIREFLY-1 trial in pediatric low-grade glioma (pLGG) and submitted its New Drug Application (NDA) to the FDA in Q4 2025, seeking accelerated approval. The FDA anticipates a PDUFA date in Q3 2026. This represents a critical milestone that could transition Day One into a commercial-stage company.

Day One's leadership team, with extensive experience in oncology drug development and commercialization, remains committed to its core strategy of identifying and developing targeted therapies. The Mersana acquisition highlights a strategic evolution to expand the pipeline through external innovation, complementing internal R&D efforts. This move signals an intent to build a more diversified portfolio and accelerate the company's path to becoming a multi-product commercial entity.

Financial Health

As of December 31, 2025, Day One reported $320.7 million in cash, cash equivalents, and marketable securities. This represents a decrease from $450.2 million at the end of 2024, primarily due to the Mersana acquisition and ongoing R&D expenditures. The company believes its current cash position, combined with anticipated collaboration revenues, is sufficient to fund its operations and planned capital expenditures into late 2027. Day One currently carries no significant long-term debt, providing financial flexibility. However, continued significant R&D spending and potential commercialization efforts for Tovorafenib will require careful cash management and potential future financing.

Risk Factors

Investing in Day One Biopharmaceuticals, like any biopharma company, involves inherent risks:

• Clinical Trial Success: The success of Tovorafenib and emiltatug ledadotin, as well as other pipeline candidates, is not guaranteed. Clinical trials can fail at any stage due due to lack of efficacy, safety concerns, or other factors.
• Regulatory Approval: Even with positive clinical data, no assurance exists that the FDA or other regulatory agencies will grant approval for their drug candidates. The PDUFA date for Tovorafenib is a critical upcoming event.
• Commercialization & Market Acceptance: If approved, Day One will need to successfully commercialize Tovorafenib and potentially emiltatug ledadotin. This requires significant investment in sales, marketing, and manufacturing infrastructure. Market acceptance and competition from existing or future therapies also pose key challenges.
• Competition: The oncology market is highly competitive, with numerous large pharmaceutical companies and smaller biotechs developing similar or alternative treatments.
• Funding & Liquidity: Day One currently operates at a net loss. While the company has sufficient cash for the near term, future capital raises may be necessary, which could dilute existing shareholders.
• Intellectual Property: Protecting its intellectual property is crucial. Any challenges to Day One's patents could negatively impact its market exclusivity and profitability.

Competitive Position

Day One operates in the highly competitive oncology space, focusing on precision medicine. Its lead candidate, Tovorafenib, targets specific genetic mutations in pLGG, a niche but high-need area. The acquisition of emiltatug ledadotin positions Day One to compete in the ovarian cancer market, where several ADCs are in development or already on the market. The company's strategy is to differentiate through novel mechanisms of action and by targeting specific patient populations with high unmet needs.

Future Outlook

Looking ahead to 2026 and beyond, Day One Biopharmaceuticals has several critical milestones:

• Tovorafenib (DAY101): The FDA is anticipated to make a decision (PDUFA date) in Q3 2026 for pLGG. If approved, the focus will shift to commercial launch and market penetration.
• Emiltatug Ledadotin: Day One will continue enrollment and data readout from the Phase 2 trial in platinum-resistant ovarian cancer, with potential for accelerated development pathways.
• Pipeline Expansion: Ongoing preclinical and early-stage clinical development of other oncology candidates.
• Strategic Partnerships: Potential for new collaborations to further fund development or expand commercial reach.

Day One stands at a pivotal juncture, with the potential transition to a commercial-stage company on the horizon. Investors should closely monitor the regulatory outcome for Tovorafenib, the progress of emiltatug ledadotin, and the company's cash burn rate to make informed decisions.