Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to the Chimeric's fourth quarter and year-end 2023 earnings conference call. I would now like to introduce you to your host for today's call, Bill O'Connor of Stern Investor Relations. Please proceed.

Thank you, Operator. Good morning, everyone, and welcome to the Chimeric's fourth quarter and year-end 2023 financial and operating results conference call. This morning, we issued a press release related to our fourth quarter operating update, you can access the press release in our investor section of the website. With me on today's call are President and Chief Executive Officer Mike Andriel, Chief Operating and Commercial Officer Tom Riga, Chief Financial Officer Michelle Espeludo, Chief Medical Officer Alan Melamed, and Chief Technology Officer Josh Allen. Before we begin, I'd like to remind you that the statements made on today's call include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995-2022. and are subject to risks and uncertainties and other factors. These risks and uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. Please refer to our filings with the SEC for a more complete disclosure of these risks and uncertainties. At this time, I'll now turn the call over to Chimeric's President and Chief Executive Officer, Mike Andriel.

Thanks, Will, and good morning, everyone, and thank you for joining us. We're excited to be with you this morning to share the considerable corporate and clinical progress made throughout 2023, highlighted by key management appointments and meaningful advancements across our Microdome pipeline. During the fourth quarter, we welcome Dr. Lisa Decker to our board of directors. Dr. Decker brings 25 years of drug development, strategic partnership, and corporate transaction experience to our board. We also continue to strengthen our management team with the additions of Tom Riga as Chief Operating and Commercial Officer, Michelle Laspaluto as Chief Financial Officer, and Dr. Pablo Lee as Vice President of Medical Affairs. They have collectively made a strong and immediate impact on the organization, and I'm confident their collective expertise will be invaluable as we seek to maximize our future growth potential for both patients and shareholders. Before I jump into an operational update, I want to share some insights since becoming CEO last August. I joined Chimerics five years ago, and I am as confident now in our future and the positive impact I expect us to have on patients as at any point during that time. This confidence is guided by the very real impact our team is having against this lethal disease and the meaningful progress I see us making toward our number one objective, to bring AUC-201 to patients as soon as possible. For context, when I started in this role, I heard about a number of challenges chimerics might face. I heard about the challenges of operating in an indication where the mere existence of the mutation our lead program is intended to treat confers an automatic grade four by WHO criteria, the most aggressive form of brain cancer. I also heard about the difficulty in operating in the brain cancer field in general, and even when developing an agent with activity, the difficulty of enrolling studies in rare diseases, any rare disease. And all of this, in many respects, is true. It's true that the field of neuro-oncology really is the last frontier in cancer research. As a subspecialty, it's arguably the one that has advanced least in the last 25 years, as the mortality rate of most other cancers has improved meaningfully over that time. But I've also heard about the resilience that patients and their families who participate in our studies demonstrate. That resilience continues to amaze me, and it motivates our team to bring the best version of themselves every day. Rather than be intimidated by these challenges, our team is energized and motivated by them. It's a team that is working tirelessly to enroll the action study to bring a definitive answer for this patient population. And I'm proud to say we're on track to do just that as early as next year. So turning to our operational update, we remain laser focused on advancing the phase three action study of OCTO-01 and completing OCTO-06 dose escalation studies to identify a recommended phase two dose and schedule later this year. I'll begin with an update on the 201 program. Our team is focused on the disciplined execution of the action study as our top priority. And while 2023 was largely centered on site activation for most of the year, 2024 is the year we expect to hit our full stride in enrollment rate for this study. We're currently open in over 130 sites across 13 countries. When you consider the number of sites we opened last year, we're proud of where we stand today, not just in terms of the quantity of sites and the geographic coverage, but as importantly, the quality of those sites and engagement with our investigators. We expect continued acceleration of enrollment this year as data indicate that a site becomes productive typically in the second quarter following activation. This is largely due to the frontline study protocol where the radiation window, combined with any necessary temozolomide washout, takes approximately three months from treatment start. Additionally, we've observed that the recent publication of the ONC201 Phase II data in the Journal of Clinical Oncology has accelerated broader awareness of the program, especially outside of the U.S., and is providing yet another tailwind to enrollment early this year. This publication provides additional patient-level detail and attributes of response, which Josh will delve deeper into during this call. The guidance we reiterated today for first interim data readout in 2025 reflects our current enrollment trends. Importantly, the enrollment rate and event rate error bars, while still wide, are beginning to narrow as the study continues to progress and mature. There are scenarios where the first OS interim occurs earlier in 2025 and scenarios where it occurs later in the year. We're encouraged by early indicators, but also understand the importance of continued execution of the study to get the data as quickly as possible. We'll continue to narrow our guidance as the error bars come into focus during the year. As the study has progressed, we've been heartened by the global demand we've experienced, even beyond the 13 countries we're currently operating in. For example, we currently have patients traveling from South America to the southeastern United States to participate in the study. We're also experiencing a similar dynamic in Southeast Asia, where patients are traveling between countries to gain access to Onc201. This is a reminder that the unmet need in this population knows no borders. In an attempt to address this global demand, we are in the process of assessing the feasibility of expanding the action study into the specific parts of the world where demand is high and the catchment area isn't readily convenient to our current action footprint. We intend to be prudent in our evaluation. We understand we can't address every situation, but we are receptive to opening a limited number of additional sites. For example, Brazil, Argentina, Hong Kong, and Singapore are among geographies where the proactive outreach has been significant. The population density is high and where there is a high likelihood to expand catchment. These geographies will not only accelerate time to data but will also be beneficial to the regulatory process within these strategic markets around the world. We expect any potential expansion to be with highly productive sites in these key markets and limited to 10 to 15 additional sites. Strong execution of the action study is our top priority and we're excited to be in a position to have potentially pivotal data next year for this first-in-class agent and the first potential approval in this aggressive form of high-grade glioma, which represents an unmet need as high as any across the field of oncology. With that, I'd like to turn the call over to Tom Riga, who joined us last November, just in time to accompany the team to the Society of Neuro-Oncology Conference. Tom?