Day One Biopharmaceuticals, Inc.

Hello, ladies and gentlemen, and welcome to the Day 1 Biopharmaceuticals Fourth Quarter and Full Year 2024 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 Perrone, 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 2024 financial and operating results conference call. Earlier today, we issued a press release, which outlines the topics we plan to discuss today. You can access the press release and the slides to accompany this conference call on 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 made 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 accept as required by law if day one disclaims any obligation to update such statements. Today, I'm joined by Dr. Jeremy Bender, Chief Executive Officer, Lauren Marandino, Chief Commercial Officer, Charlie Short, Chief Operating and Financial Officer, and Ellie Berry, Chief Medical Officer. I will now turn the call over to Jeremy.

Thank you, Joey, and good afternoon. I'm pleased to share our fourth quarter earnings and full year financial results with you today following an exceptional 2024 for day one. I'll also provide an update on the significant progress we've made towards delivering on our mission of developing new medicines for people of all ages with life-threatening diseases. 2024 was a landmark year for our company and the patients we serve. Our most important achievement for the year was the FDA approval of our first new medicine, Ojemda, in relapsed refractory pediatric low-grade glioma. Ojemda's approval and launch are an important step forward for PLGG patients and for day one. We believe Ojemda commercialization will drive durable, long-term value creation. Our accomplishments in 2024 extend beyond the approval and commercial launch of Ojemda. We also advanced enrollment in our frontline Firefly 2 clinical trial of tovirafenib in pediatric low-grade glioma. We established an ex-US partnership for Ojemda with Ipsen, and we in-licensed day 301. All of this was achieved while also strengthening our financial position. Ojemda's launch performance in 2024 put us in a strong position to further advance day one's goals. Throughout the year, we observed consistent growth in quarterly net Ojemda revenues. For the full year 2024, net product revenues totaled more than $57 million. This represents approximately eight months of sales following Agenda's April approval. Fourth quarter net product revenues were $29 million, which represents 44% growth versus Q3. New patient starts exceeded our expectations and have set the foundation for Agenda's future growth. We also achieved modest improvements in our gross to net deductions in Q4, driven by CMS agreeing that Ojemda is approved exclusively for pediatric indications. We'll provide more detail on that topic later in this call. Importantly, in July, we entered into an exclusive licensing arrangement with Ipsen for ex-U.S. rights to Ojemda, which, if approved by regulatory authorities, will help patients who are living with relapsed or refractory PLGG outside of the United States to gain access to Ojemda. We also advanced our pipeline in 2024 through the Firefly 2 trial and the acquisition of day 301. Firefly 2, our phase 3 frontline PLGG trial, continues to enroll. It is now open at more than 110 sites in the United States, Canada, Europe, Australia, and Asia. In January, we announced that we expected to be fully enrolled in the first half of 2026. We also expanded our pipeline with the acquisition of Day 301 in June 2024. Day 301 is a clinical stage antibody drug conjugate targeting PTK7 in solid tumors in both adult and pediatric patients. This program has both first and best in class potential and is currently in the dose escalation portion of a phase 1A slash B clinical trial. In January of this year, we announced that we cleared the first dose cohort in that trial, and we're now enrolling patients in the second dose cohort. We also strengthened our financial position ending 2024 with over $500 million in cash. This strong cash position provides us with the ability to operate, to invest, and to advance our pipeline, all critical components of growing our company. We entered 2025 in a strong position, and we have three priorities this year to take advantage of and strengthen that position. The first is to continue driving Ojemda revenue growth. As Lauren will share with you shortly, the opportunity to drive growth through expansion of the prescriber and patient base for Ojemda is significant. Our second priority is to continue advancing our pipeline, specifically enrollment in the Firefly 2 trial and dose escalation in the Day 301 Phase 1 trial. Our third priority is to continue expanding our pipeline with programs that have the potential to become important new medicines for patients. We remain focused on acquiring and in licensing programs that have the potential to be first or best in class, and we are in a strong financial position to do so without requiring external financing. Two critical capabilities have driven our success last year and in the years leading up to 2024. The first is our team's expertise in the development, registration, and commercialization of new oncology medicines. The second is our ability to identify and acquire new programs such as Day 301. We have both the capability and the capital to identify high-value opportunities that will help lead us through the next stage of the company's growth. I'll now turn the call over to Lauren to discuss our commercial progress in greater detail.