Day One Biopharmaceuticals, Inc.

Hello, ladies and gentlemen, and welcome to the day one biopharmaceuticals fourth quarter and full year 2025 financial and operating results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. Please be advised that this conference call is being recorded. I would now like to turn the call over to Joey Peroni, Senior Vice President of Finance and Investor Relations. Please go ahead.

Thank you. Hello, everyone, and good afternoon. Welcome to Day One's fourth quarter and full year 2025 Financial and Operating Results Conference Call. Earlier today, we issued a press release that outlines the topics we plan to discuss today. You can access the press release and the slides to accompany this conference call in the Investors and Media section of our website at www.dayonebio.com. An audio webcast with the corresponding slides is also available on the website. Before we get started, I'd like to remind everyone that some of the statements that we make on this call and information presented in the slide deck include forward-looking statements as outlined on slide two. Actual events and results could differ materially from those expressed or implied by any forward-looking statements. We encourage you to review the various risks, uncertainties, and other factors included in our most recent filings with the SEC and any other future filings that we may make with the SEC. These forward-looking statements are based on our current estimates and various assumptions and reflect management's intentions, beliefs, and expectations about future events, strategies, competition, products and product candidates, operating plans, and performance. You are cautioned not to place any undue reliance on these forward-looking statements, and as accepted as required by law, day one disclaims any obligation to update such statements. Today, I am joined by Dr. Jeremy Bender, Chief Executive Officer. Lauren Marandino, Chief Commercial Officer, Charles York, Chief Operating and Financial Officer, and Dr. Michael Vasconcellos, Head of Research and Development. I will now turn the call over to Jeremy.

Thank you, Joey. Good afternoon, and thank you for joining us. We are proud to present today our fourth quarter earnings and full year financial results for 2025. 2025 was our first full year as a commercial company. With the launch and uptake of Ojemda, in pediatric low-grade glioma, we've now demonstrated we can deliver on our mission to develop new medicines for people of all ages with life-threatening diseases. Importantly, we've also now taken the initial steps needed to repeat this success with meaningful pipeline advancements. Together, the day one team achieved seminal commercial and clinical milestones in 2025 that have positioned us for accelerated growth in 2026. Ojemda continues to be the primary revenue and growth driver for the company. Enthusiasm for Ojemda among the healthcare professionals, caregivers, and patients in the PLGG community expanded throughout 2025. I'm confident we're advancing and improving the PLGG treatment paradigm and moving towards establishing Ojemda as the standard of care therapy in second-line PLGG. For the year, we reported $155.4 million in net product revenue, which is up 172% year-over-year. We achieved double-digit sequential quarterly growth throughout 2025. That translates to more than 4,600 total prescriptions for the year, which is more than 180% growth compared with 2024. We'll dive further into that performance shortly. The momentum we're seeing has given us confidence in the path forward, and as such, we are reiterating our 2026 agenda net product revenue guidance of $225 to $250 million for 2026. We are just beginning to shape the market for PLGG, and we see considerable opportunity ahead for us to continue agenda growth. This will be driven in part by the three-year data we presented at the Society for Neuro-Oncology meeting, which Mike will review in a moment. As the community gains experience with and confidence in Ojemda, we are in parallel on track to establishing a strong scientific basis for use in the frontline setting in PLGG through the Firefly 2 trial. We expect to complete enrollment in Firefly 2 in the first half of this year, with a top-line readout occurring in mid-2027. These data represent an important opportunity to define our path towards standard of care across all lines of PLGG therapy, which would open up not only the opportunity to advance patient care earlier in the treatment paradigm, but also to broadly accelerate our growth. We also anticipate global expansion for Agenda this year, with our partner Ipsen preparing for ex-U.S. regulatory approvals, including in Europe. Beyond Ojemda, we are advancing numerous potential growth drivers with our expanding pipeline. We closed the acquisition of Mursana in January and are now integrating the lead program, MLE, into our pipeline. This is a promising antibody drug conjugate with early evidence of activity in adenoid cystic carcinoma, or ACC, a challenging and rare cancer with few therapeutic options today. This program represents a very real opportunity to extend our mission into a disease area with significant medical need. We'll share a bit more about this in a few moments, and additional clinical data on MLE will be reported in the middle of this year. We also continue to generate progress with day 301, a promising antibody drug conjugate with opportunities for development in multiple pediatric and adult indications. While we are still early in development, we are seeing encouraging signals of an efficacy and safety profile that could address persistent unmet medical needs as well. We are actively advancing the program and look forward to sharing an update on that trial later this year. Finally, we've maintained a strong financial position throughout this dynamic year, ending 2025 with more than $440 million in cash. We have no debt. Our disciplined approach has and will enable us to continue investment in high-value programs that can deliver meaningful impact to additional patient communities. Taken together, we are on a promising trajectory for 2026 and beyond. Let me now turn it to Mike to review the three-year data on Ojemda.