Chimerix, Inc.

Good morning, everyone, and thank you for joining us. I'm delighted to be hosting the call for the first time as CEO and to provide an update on our second quarter results, which were characterized by focused execution across both the ONC201 and ONC206 clinical programs. Starting first with ONC201 and the action study, we've experienced strong engagement and enthusiasm across the neuro-oncology community globally for this study, driven in part by the scale of the unmet need in H3K27M glioma, where there are very few treatment options for these patients beyond radiation therapy. Additionally, high-grade glioma is a subset within the broader field of oncology, particularly in pediatrics, that sees relatively few randomized controlled Phase III studies. This reality further adds to the engagement we are seeing from investigators and sites which have few competing studies in the field. Regulatory approvals to proceed in each of the 11 countries where we are now opening sites came quickly earlier in the year, and the pace with which we are moving through IRBs and contracting reflects the pull we're seeing from investigators to participate in the study. In fact, our team opened sites at a pace of nearly one a day during the second quarter, and we now have 77 sites open across 11 countries. We expect to have more than 100 sites open by the end of the third quarter. Importantly patient enrollment continues on schedule and we expect to have our first interim overall survival assessment in early 2025 Final progression free survival data will likely follow next in mid 2025 and a second interim overall survival assessment is expected to occur later that year if needed followed by final overall survival data in 2026 also if needed in parallel We've started the process of preparing the organization, the program, and the market for the potential launch of ONC201, and have undertaken as many activities as possible prior to recruiting a chief commercial officer. While the action study progressing on schedule, we have recently begun an external search for this commercial leader. I expect to have an update on that process later in the year. Turning briefly to ONC206, the open label dose escalation and intensification studies are expected to complete in the first half of 2024. To date, dose escalation has included once a week dosing. But looking forward, future dose levels include twice a day dosing for three consecutive days. This is where we expect to capture the range of continual exposures that should increase the likelihood of seeing consistent monotherapy activity with this agent. Allen will provide more color on that design. The safety profile we've observed to date as well as provide an update on the previously reported GBM response on the once-a-week schedule. Finally, turning to finance, we've been deliberate and disciplined with tight expense control and capital allocation, even as we ramp investment in the action study. Our burn in the first half of 2023 was $33 million as the full effect of our previously announced reduction in force began to be realized in Q2. We ended the second quarter with $233 million in cash and equivalents, right on plan to meet our previous guidance of approximately $200 million in cash at the end of the year. Under our current operational plan, we expect to have runway through each of the expected action data points and into 2027. Our financial plan does not contemplate receipt of near-term non-dilutive milestone payments from our Pembexa partnership with Emergent, but as we observed last week, BARDA remains active in the smallpox procurement space and a Tembexa option exercise is possible even if unlikely in the near term. As a reminder, each future full option exercise under the current BARDA contract equates to a $31 million milestone payment to Chimerix. Chimerix also earns a 20% royalty on gross profits in the U.S. beyond 1.7 million treatment courses and a 15% royalty on all international gross profits. For more details on our second quarter balance sheet and income statement, please refer to the press release which we released earlier today. Lastly, we've begun a process to backfill the CFO, CBO role, and I expect to have an update on that process later in the year. In the meantime, we're fortunate to have a strong finance, accounting, and internal control capability that allows us a bit of time to finalize that search. With that, I'll turn the call over to Josh to provide additional color on the action study. and our recent engagements within the neuro-oncology community. Josh?

Thanks, Mike. As you all can tell from Mike's overview, our team has aggressively rolled out the ACTION trial with global coverage. For several geographies, the ACTION trial represents the first time that OCTO-1 will be made available through official channels to patients with H3K27 and mutant glioma who are in desperate need. We have worked closely with multiple stakeholders across the global neuro-oncology community to optimize the clinical trial design in a way that balances the need for scientific rigor with consideration of patient burden. Furthermore, we have identified creative solutions to support patients and their families when possible. This has had a direct impact on our ability to utilize referral networks as the action study site availability widens over time so that we maximize the capture of eligible patients. who are in need today. As a result of these efforts, our connection to the global neuro-oncology community has broadened in scope and has gained momentum. Over the last quarter, we have participated in multiple neuro-oncology forums aimed at identifying the most important issues facing the brain tumor community and how innovative solutions could be identified and expedited. These forums included participation in the White House Cancer Moonshot Forum on brain cancers, and the National Brain Tumor Society Research Roundtable event. In addition, several team members have represented chimerics and the action trial at the annual British Neuro-Oncology Society, Pediatric SNOW, and the Canadian Neuro-Oncology Conferences following study activation in their respective regions. Our representation at these important events is another step forward towards building our global presence in the neuro-oncology community, and you can expect that trend to increase throughout the year via direct engagements of our team at regional conferences where action is now open. Note that our regional event presence will be in addition to some of the larger conferences where we have engaged historically, such as the Snow Conference in November that will be hosted this year in Vancouver, as well as the European Association for Neuro-Oncology, or IANO, conference in Rotterdam, where we hope to see you later this year in September. With that overview, I'll turn the call over now to Alan for a more detailed clinical update on the AUG206 program. Alan?

Thank you, Josh. I'm excited to provide an update on the AUG206 program, which is progressing well in dose escalation studies that contemplate both escalating the dose and increasing the dose frequency, where we hope to achieve therapeutic exposures that may yield consistent monotherapy efficacy. We have two separate trials ongoing, one at the NIH in adult patients and one at the children in a specific pediatric neuro-oncology consortium or PNUC. Both trials have escalated safely under once-weekly schedules through dose level 5, and the NIH trial has safely completed dose level 6. There have been no related dose-limited toxicities in either study, and we've observed similar safety profile between pediatric and adult patients. Overall, the most common treatment-related adverse events were fatigue, leukopenia, and vomiting, which are all generally low-grade with no events greater than a grade 3. We are now moving to a dose and schedule that will allow for more frequent dosing. Our next dose level will include twice-daily dosing for three consecutive days to enable a pharmacokinetic profile exposure that is demonstrated optimal efficacy in multiple in vitro models and may increase clinical therapeutic response. As you may recall, in March, we reported an investigative set response in a patient with recurrent glioblastoma without the HPK27M mutation. This patient's response remains ongoing, and the patient has been on OCT206 for 15 months now. We encourage that the response of this patient is proving endurable on the once-weekly dose schedule so far, and the patient is tolerating, so far, intrapatient dose escalation. With that overview, I'll turn it over to Mike for closing remarks.