Day One Biopharmaceuticals, Inc.

At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star then zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Joey Peroni, Senior Vice President of Finance and Investor Relations. Please go ahead, sir.

Thank you. Hello, everyone, and good afternoon. Welcome to Day One's Second Quarter 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 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 accept, 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 Michael Vasconcellos, Head of Research and Development. I will now turn the call over to Jeremy.

Thank you, Joey. Good afternoon, and thank you all for joining us. This quarter marks a pivotal moment, one full year since the approval of Agenda. In just 12 months, Agenda has not only met expectations, it has exceeded them. With $113.1 million in cumulative net revenue for the most recent 12 months, we've demonstrated clear commercial momentum, strong physician adoption, and sustained patient demand. With Agenda's approval, we've transformed Day One into a commercial organization and laid the groundwork for long-term value creation. We built a high-performing, focused company with demonstrated execution, a solid financial position, and a portfolio that will deliver durable growth. For the second quarter, we again delivered double-digit top-line revenue growth, generating $33.6 million in net product revenue, up 10% over our first quarter. Our total volume in Q2 exceeded 1,000 scripts for the first time, underscoring Agenda's continued adoption in the market. Our continued growth and performance highlight the importance of this medicine to the physicians, patients, and caregivers in the PLGT community. Today, we're also issuing net product revenue guidance for the first time. We project total net revenues of between $140 and $150 million for full year 2025. This guidance is grounded in strong and persistent demand, deepening prescriber adoption, and consistent payer coverage. Looking forward, we remain sharply focused on OJEMDA commercialization and expansion. We have a clear opportunity to establish OJEMDA as a standard of care in Second Line Plus PLGG. We also have opportunities in the near term for significant potential indication expansion for OJEMDA in Frontline PLGG here in the U.S. through our Firefly 2 trial and in Second Line Plus PLGG in Europe through our partner Ipsen's filing of an MAA. Our global Firefly 2 confirmatory first-line trial remains on track for completion of enrollment in the first half of 2026. And our partner Ipsen announced EMA acceptance of the agenda filing in Q1 and potential EMA approval mid-2026. We share Ipsen's commitment to patients and will continue to support their filings to help more patients and physicians gain access to agenda. In Q2, we also welcomed Mike Vasconcellos to the company as head of research and development. Mike brings decades of experience and success in oncology development and will play a pivotal role in driving the next phase of day one's growth. We are also prosecuting our broader portfolio beyond OJUNDA. We recently discontinued our investment in the VRK1 program. We hit in license from Sprint Biosciences. Importantly, we are advancing our PTK-7 targeted ADC, Day 301, through the dose escalation portion of our Phase 1A trial, and we continue to actively evaluate new opportunities for portfolio expansion. Our strong financial position remains a strategic advantage. We closed Q2 with a strong balance sheet and growing product revenue, giving us the flexibility to execute our plans without reliance on the capital markets. We are focused, well-capitalized, and committed to delivering meaningful value for patients and shareholders through our strategy to develop and commercialize new medicines. I'll now turn the call over to Lauren to discuss our commercial progress in greater detail.