Day One Biopharmaceuticals, Inc.

Hello, ladies and gentlemen, and welcome to the Day 1 Biopharmaceuticals 3rd Quarter of 2024 Financial and Operating Results Conference Call. At this time, all participants are in 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 conference call over to 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 third quarter 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 make on this call and information presented in this 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 except 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. Samuel Blackmon, Co-Founder and Head of R&D. I will now turn the call over to Jeremy.

Thank you, Joey, and good afternoon, everyone. I'm pleased to share our third quarter earnings results with you today. I will also provide an update on the three priorities we've emphasized for 2024. First, the successful launch and commercialization of Agenda. Second, progress advancing our pipeline. And third, the expansion of our portfolio. Day one had a remarkable third quarter. Our Ojemda net product revenue for Q3 was $20.1 million, more than double what we reported last quarter. Our early commercial experience is laying the groundwork for the company's future growth. We see Ojemda in relapsed refractory PLGG as a foundational opportunity for day one. Our commercial execution following approval in April of this year has driven persistent and steady growth of Ojemda sales. We believe that growth reflects the significant unmet need for new treatment options in the relapsed refractory pediatric low-grade glioma space. We previously disclosed that the median duration of treatment observed for patients in Arm 1 of Firefly 1 is 23.7 months. As we work towards a more complete analysis of the follow-up data from our registrational Firefly 1 trial, the median duration of response for patients in Arm 1 has now extended from 13.8 months to 18 months, which we believe speaks to the value Ojemda is bringing to patients. Given that unmet need, we remain confident in continued future growth in Ojemda sales and in the opportunity to increase the breadth and depth of Ojemda prescribers. As we look ahead to 2025, we remain focused on enrollment in Firefly 2, our global phase three frontline PLGG trial, and the opportunity it provides to demonstrate the clinical benefit of tovaraphanib as a standard of care in the frontline setting. You may also recall that we established an ex-US partnership for OJEMDA with Ipsen earlier this year. We are working closely with our partners there to support successful registration and commercialization of OJEMDA in the EU and additional territories. We are also on track and on plan to dose the first patients in Q4 this year or early Q1 next year in the phase one trial of day 301. Day 301 is the PTK7 targeted ADC we in-licensed mid-year following clearance of the IND by the US FDA for that program. In day 301, we have an opportunity to establish a first and or best-in-class program with potential across a broad set of adult and pediatric solid tumors. Finally, as always, we continue to seek opportunities to drive value for our shareholders. Our business development team continues to actively look for differentiated, high-quality clinical stage programs that fit our portfolio criteria and provide opportunities to improve patients' lives and build value. We are in a strong financial position with over half a billion dollars in cash to fund our operating plan and to expand our portfolio in 2025. We've made great early strides toward delivering on our mission in 2024 to develop new medicines for people of all ages with life-threatening diseases, and we're looking forward to continuing that work ahead.