Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to the Chimeric Second Quarter 2024 Earnings Conference Call. I would now like to introduce to you your host for today's call, Will O'Connor for Stern Investor Relations. Please proceed.

Thank you, Operator. Good morning, everyone, and welcome to the Chimeric Second Quarter 2024 Financial and Operating Results Conference Call. This morning, we issued a press release related to our second quarter operating update. You can access the press release in the Investors section of the Chimerics website. With me on today's call are President and Chief Executive Officer Mike Andreol, Chief Financial Officer Michelle Laspelluto, and Chief Technology Officer Josh Allen. We also have Alan Melamed, our Chief Medical Officer, and Tom Riga, our Chief Operating and Commercial Officer, for questions. 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 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 more complete disclosure of these risks and uncertainties. At this time, I'll now turn the call over to Chimerics President and Chief Executive Officer, Mike Andreol.

Thanks, Will. Good morning, everyone, and thank you for joining us. It's been a busy summer at Chimerics, and we continue to make meaningful progress across our clinical programs. Starting with our lead program, Dordaviprone, our team continues to be laser-focused on the execution and enrollment of the Phase III Action Study, which is on track for the first interim overall survival readout in the third quarter of next year. We're executing with urgency as there remains a significant need for patients battling this lethal disease. With no approved treatment options available that have proven clinical benefit beyond radiation therapy, we're keenly aware of the importance of speed in addressing this unmet need. It's because of this need that we continuously evaluate registration pathways globally to accelerate commercial access to Dordavaproin where possible. Earlier this year, we initiated the evaluation process for Diverprone to be considered for provisional registration in Australia. Provisional registration is a three-step process that begins with a pre-submission meeting to evaluate current data, the status of pivotal studies, and other program features. Following a supportive pre-submission meeting earlier in the year, our team recently initiated the second step in this process, the filing of a provisional determination application. Should the regulators in Australia approve this application, the final step is to apply for provisional registration. If we proceed to this final step, it's expected that an NDA filing could occur as early as year-end 2024 with possible commercial availability in early 2026. This morning, we're also excited to provide a safety and PK update from our other clinical program, the second generation of Microdone AUC206. We're making great strides advancing this program through phase one studies, which recently began dosing within an expected therapeutic range, and we are now enrolling the first of two remaining dose cohorts. As we escalate and intensify the dose within this range, we're encouraged by ongoing pharmacokinetic data that is in line with modeled expectations for delivering dose proportionate exposures for extended durations. Importantly, these exposures have not been associated with dose-limiting toxicities thus far. With these data, we have increasing confidence in the safety profile and therapeutic window for Onc206, and we look forward to completing enrollment in our dose escalation trials by the end of the year. I'll now turn the call over to Josh for a more detailed discussion on the Onc206 data we announced this morning. Josh?