Day One Biopharmaceuticals, Inc.

Good evening, ladies and gentlemen, and welcome to Day 1 Biopharmaceuticals Fly 1 Trial Conference Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your host today, Joey Perrone, Senior Vice President of Finance and Investor Relations. Please go ahead.

Thank you. Good evening, and thank you for joining us. Earlier today, we issued a press release providing an update on the new clinical data from a registrational Phase II Firefly 1 clinical trial evaluating tovarapinib in relapsed or progressive pediatric low-grade glioma. Slides to accompany this conference call are posted on the Investors in Media section of our website at www.dayonebio.com. An audio webcast with the corresponding presentation 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 statement, including as a result of various risks, uncertainties, and other factors including the step forth in our most recent filings with the SEC. and any other future filings that we make with the SEC. You are cautioned not to place any undue reliance on these forward-looking statements, and day one disclaims any obligation to update such statements. Joining me on the call today are Dr. Jeremy Bender, Chief Executive Officer, Dr. Samuel Blackman, co-founder and head of R&D, and Charles York, Chief Operating and Financial Officer. For those of you following with the slide deck, that we have provided, Jeremy will begin on slide four. I will now turn the call over to Jeremy, CEO of Day One.

Thank you, Joey. Hello, everyone, and thank you for joining us on the call today. I'm excited to be in Chicago at ASCO 2023 with our team from Day One and with so many of our important partners, partners who've joined us on our mission to bring treatment options to children and adults suffering from the effects of cancer and other life-threatening diseases. Our data from Firefly 1, which is our pivotal study in relapsed or progressive pediatric low-grade glioma, were shared this morning in an oral session by Dr. Lindsay Kilburn of Children's National Hospital. In addition to reviewing these data, we'll provide additional updates on this call about Day 1, focusing on the regulatory and clinical impact of Firefly 1. As we provide this important update, it's critical to keep in mind that Day 1 was created to address the innovation gap between pediatric and adult patients living with cancer and other life-threatening diseases. That gap is approximately six years. That's how much longer, on average, children have to wait than adults for access to life-saving cancer treatments. At Day One, we aim to re-envision cancer drug development and redefine what's possible for all people living with cancer, regardless of age. Simply put, we're a targeted therapeutics company. We conduct clinical trials in patient populations with genetic alterations that our programs are specifically designed to address. What differentiates day one from other targeted oncology companies is our goal to move as quickly as we can into pediatric populations. We generate clinical data in the pediatric setting and then we move into registrational trials in that setting as early as possible in parallel with the work we do in adolescent and adult oncology populations. Since our launch in 2020, we've been successful in building a highly qualified and experienced team, advancing our lead program, tovirafinib, expanding our portfolio, and resourcing the organization as we prepare for potential registration and a U.S. commercial launch. Our lead product candidate is tovirafinib, an oral brain-penetrant type 2 RAF inhibitor. The lead indication under investigation is relapsed or progressive pediatric low-grade glioma, for which we have breakthrough therapy designation, orphan drug designation, and rare pediatric disease designation in the U.S. Today, we'll discuss new data from the Registrational Phase 2 Firefly 1 trial, evaluating tovirafinib as once-weekly monotherapy in patients aged six months to 25 years with recurrent or progressive PLGG. Before we review the data and provide color, I'd first like to hand the call over to my colleague, Sam Blackman, to provide perspective on pediatric low-grade glioma.