Day One Biopharmaceuticals, Inc.

Hello ladies and gentlemen and welcome to day one biopharmaceuticals second quarter of 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. Thank you. You may begin.

Thank you. Hello, everyone, and good morning. Welcome to Day One's second quarter 2024 Financial and Operating Results Conference Call. Earlier this morning, 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 our 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. We encourage you to review the various risks, uncertainties, and other factors including 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. There are cautions 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'm joined by Dr. Jeremy Bender, Chief Executive Officer, Laura Marandino, Chief Commercial Officer, Dr. Samuel Blackman, Co-Founder and Head of R&D, and Charles York, Chief Operating and Financial Officer. I will now turn the call over to Jeremy.

Thank you, Joey, and thanks to all of you for joining this call. This is the first time we're reporting earnings with a new medicine on the market. We had an outstanding second quarter on multiple fronts, and we are excited to tell you about our progress building day one. 2024 has been an extraordinary year for us. I'm so proud of the day one team, each of whom have been tightly focused on our mission and on executing on our priorities, specifically launching Ojemda, and advancing and expanding our pipeline of targeted therapeutics for people of all ages. Day one was created to address the innovation gap between pediatric and adult patients living with cancer and other life-threatening diseases. In April 2024, the U.S. Food and Drug Administration approved Ojemda, the brand name for toborafenib, for the treatment of relapsed or refractory pediatric low-grade glioma, or PLGG, in patients six months of age and older harboring a BRAF fusion, rearrangement, or BRAF V600 mutation. With this achievement, Day One became a commercial company. Our team, including clinical, regulatory, manufacturing, medical, and commercial, was well prepared to launch our first new medicine. As you will see from our Q2 earnings, we are beginning to see those efforts yield results. The interest in Ojemda, we have observed post-approval demonstrates the significant need that exists for new medicines for PLGG patients. PLGG is the most common brain tumor in children. Until Ojemda's approval, no approved therapies were available for the majority of patients in the relapsed or refractory setting, and there has been no clear standard of care for these patients. Our early launch progress suggests that physicians and families are excited to have Ojemda as a treatment option for this chronic and relentless disease. I'm excited to announce very strong early results from our launch. Our net revenue for Q2 was $8.2 million. As Lauren will discuss in more detail, significant new patient starts and the rapid transition of expanded access patients to Ojemda drove these results and set us on a path to future growth. Day one's long-term success will require continued value creation through execution of the commercial opportunity for Ojemda in relapsed refractory PLGG and through progress advancing our broader pipeline. Our global frontline PLGG trial, Firefly 2, continues to enroll and is now open at 100 sites. The opportunity to demonstrate clinical benefit for tovarapinib in frontline PLGG is a critical next step for the program. and for our goal to bring new medicines to patients. We also expanded our pipeline in the second quarter with an exciting new program. In June, we in-licensed Day 301, a potential first-in-class clinical stage antibody drug conjugate targeting PTK7. Our experienced clinical and regulatory team will develop Day 301 in adult and pediatric solid tumor patients. The Day 301 IND has been cleared by the FDA and we are on track to dose the first patient in our phase one trial of day 301 in adults by the end of this year or early next year. Finally, we have significantly strengthened our financial position throughout 2024. In May, we brought in approximately $100 million in net cash through the sale of a prior review voucher. Last week, we established an ex-U.S. partnership pro agenda with Ipsen that includes approximately $111 million in upfront payments And this morning, we announced an oversubscribed private placement financing, providing day one with an additional $175 million. We have ample capital to fund our growth and our program investments, and we look forward to continued future progress and updates throughout 2024 and beyond. I'll now turn the call over to Lauren.