Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to the Chimerics Third Quarter 2023 Earnings Conference Call. I would now like to introduce you to your host for today's call, Michelle Laspaludo, Vice President of Strategic Planning and Investment Relations at Chimerics. Please proceed.

Thank you, John. Good morning, everyone, and welcome to the Chimerics Third Quarter 2023 Financial and Operating Results Conference Call. This morning, we issued a press release related to our third quarter earnings update. you can access the press release in our investor section of our website. With me on today's call are President and Chief Executive Officer Mike Andreol, Chief Medical Officer Alan Melamed, and our Chief Technology Officer Josh Allen. Before we begin, I would 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 that 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 would now like to turn the call over to our President and Chief Executive Officer, Mike Andreuil.

Thank you, Michelle, and good morning, everyone. The third quarter was marked by continued execution across our pipeline including continued enrollment in our global phase three action study of ONC201 and phase one dose escalation studies for our second generation compound, ONC206. I'll start with ONC201 and the action study. We now have 113 sites open across 12 countries and tracking ahead of our prior guidance of activating 100 sites by September 30th. Enrollment is progressing with site activation and we continue to expect first and second interim overall survival data as well as PFS data in 2025. Geographically, we now have about an equal number of sites activated in Europe as the U.S. This past September, we participated in the European Association for Neuro-Oncology Conference, also known as IANO, in the Netherlands. And at that conference, we hosted a symposium on the current diagnosis, treatment strategies, and clinical trials for H3K27M mutant glioma. and engage with the neuro-oncology community broadly to drive ongoing awareness and interest in the action study. I was very pleased with the level of enthusiasm across the European community for this program and the degree of support from so many investigators who recognize the very high unmet need in this patient population. I was also reminded of the value to our industry of being back in person at medical conferences following the pandemic as attendance at IANA was at a new record high and we have seen a nice increase in site activity across Europe in the weeks since that conference ended. That increase is in addition to already strong engagement prior to IANO. Turning to North America, the annual meeting for the Society for Neuro-Oncology, also known as SNOW, will occur in Vancouver, Canada in just a couple weeks, where we are also planning a large presence. I'll let Josh comment on our plans around this conference, but we're looking forward to seeing many of our investigators in the action study. as well as other program collaborators later this month. Our efforts in enrolling the action study are also underpinned by a robust publication strategy that includes a recently published manuscript in Cancer Discovery this quarter, which focused on frontline ONC201 survival data and further explained its mechanism of action. The data from this peer-reviewed publication further strengthens our confidence in the action trial and also further supports its enrollment. I'll let Josh speak. more to the details included in this recent manuscript. As we continue to enroll the action study, we're also simultaneously preparing the company and the market for ARN201's potential commercialization. To that end, we're in the process of finalizing recruitment of a chief commercial officer, and I'm excited that that process is nearing completion. In fact, I expect to announce the hiring of that individual before the end of the year. Turning briefly to ARN206, The protocol amendments for each of our dose escalation studies have been approved as expected during the third quarter. These amendments allow for a more intense dose and schedule that includes twice-a-day dosing up to three consecutive days weekly in order to increase the duration of therapeutic exposure. We expect the continual 72-hour exposure of ARK206 to potentially generate additional monotherapy activity both in CNS tumors and potentially tumors outside of the CNS based on emergent in vivo data. The PNOC and NIH studies are enrolling at the more frequent dose levels, and we expect those to be complete in the first half of 2024. As you may recall, we previously reported a GBM response on the once-a-week schedule starting at dose level two, and that patient's response remains ongoing as the patient's dose level has increased. Since these studies began enrolling again, I'm also happy to report we have observed no dose-limiting toxicities thus far. Before I turn the call over to Josh, I'd like to reiterate our deliberate and disciplined approach to capital allocation. We ended the quarter with $217 million in cash and equivalents, which is on plan to meet our previous guidance of approximately $200 million in cash at the end of the year. We continue to expect our cash balance to be sufficient to support operations into the end of 2026 and through each of the expected action clinical endpoints. For more details on our third quarter balance sheet and income statement, please refer to the press release, which we released earlier today. With that, I'll turn the call over to Josh to provide additional color on our recent publication on cancer discovery and our recent engagements with the neuro-oncology community. Josh?