Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to the Chimerics fourth quarter and year-end 2021 earnings conference call. I would now like to introduce your host for today's call, Michelle Laspaluto, Vice President of Strategic Planning and Investor Relations at Chimerics. Please proceed.

Thank you. Good morning, everyone, and welcome to the Chimerics fourth quarter and year-end 2021 financial and operating results conference call. This morning, we issued a press release on our fourth quarter operating results. You can access this press release in our investor section of the website. With me on today's call are President and Chief Executive Officer Mike Sherman, Chief Medical Officer Ellen Melamed, Chief Financial and Business Officer Mike Andreol, Chief Science Officer Randall Lanier, and our Chief Inifredone 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 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 statement. Please refer to our filings with the SEC for a more complete disclosure of these risks and uncertainties. At this time, I would like to turn the call over to our President and Chief Executive Officer, Mike Sherman.

Thanks, Michelle. Good morning, everyone, and thanks for joining us. Reflecting on 2021, it was certainly a pivotal year for the company. As you know, the foundation of our strategy has been built around the Timbexa program, which will satisfy the course of critical need to protect the population from the threat of a smallpox outbreak. Public awareness of this threat has certainly increased in the last couple of years. The human health and economic consequences would be substantial. The Timbexa program is also strategically important to the company as it's expected to provide access to considerable non-dilutive capital to fund our oncology drug development. This potential long-term source of capital is particularly valuable and somewhat unique among our peers in this period of financial market uncertainty. With the FDA approval in June and then the BARDA request for proposal in December, this strategy is coming to fruition. The FDA summary of Tim Bex's approval provided a very attractive and independent perspective on the value of this drug. easily administered in a crisis situation indicated for all ages and with a robust resistance profile. As expected, BARDA's request called for up to 1.7 million courses of treatment. The contract will cover procurement of Tembexa for the strategic national stockpile as well as the execution of post-marketing approval commitments. The most important elements of the negotiation include product pricing and initial order quantities, and we'll report on the outcome of the negotiation as it concludes. We remain well positioned financially ahead of the first shipment, which we are poised to trigger upon the signing of a contract. We started 2021 with the acquisition of Oncosudix, which brought to the organization some outstanding people and a pipeline of promising oncology assets. Compelling response data had already been reported for AUG201 in glioma, although it had not been confirmed. And during the course of the year, we were able to confirm that response data through a rigorous regulatory quality blinded independent central review. And in the process, we revealed an even stronger data set to support this drug as a treatment for H3K27M mutant glioma. In particular, those responses were more durable than expected. Initial response of at least 50% tumor reduction was achieved at a median of just over eight months after the start of treatment and was followed by a median of an additional 11 months of durability. Importantly, it was apparent that these responses mattered as they were associated with performance status improvement, a reduction in steroid use, and longer survival. It's always reassuring when the data has this kind of internal consistency across endpoints. The fact that many of the patients continue to receive Onc201 even after progression is probably the most compelling evidence for the safety profile of the drug, but also is a sobering confirmation of the lack of treatment options for these patients. During 2021, we held a number of meetings with the FDA to discuss our preparations for a potential new drug application for Onc201 and have been executing on those deliverables in the meantime. This work includes important CMC and ClinPharm activities as well as the collection and validation of safety data from more than 200 patients. We're also engaged with the FDA in the review of a frontline randomized trial design we plan to initiate in the second half of this year in this H3K27M population. We want this trial to be up and running during FDA's review of a potential NDA. We've also collaborated with the FDA on a natural disease history study. Because the H3K27M mutation is relatively newly discovered, we plan to submit data related to what the field and, frankly, the WHO have already recognized, the fact that it is rare to observe responses from current standards of care in this post-radiation setting. We've initiated this work in sites under a protocol which was submitted to the FDA, and we're actively gathering that data now for patients to meet the same criteria as was used for the 50-patient efficacy analysis. In this case, of course, these patients were not treated with OCTO-01. You can imagine this won't be a large data set as awareness of ONC-201 has been high and many patients sought out treatment with ONC-201 through clinical trials or expanded access. We'll know more about the size of that data set in the next couple of months as that information is collected and verified. Keep in mind this is a retrospective study which will collect data from previously treated patients. For the response analysis, we plan to subject this data to the same blinded independent central review process we used for the ONC-201 efficacy analysis. We expect to be far enough along in each of these work streams and ongoing consultation with the FDA to provide guidance on our regulatory timelines by mid-year. Now let me turn to our D-STAT program, the DASH Phase III trial and frontline AML. Enrollment of this study has proceeded more slowly than expected due to the ongoing hospital staffing shortages related to COVID-19 and the competitive environment for enrolling subjects in this population. As a result, we don't expect a complete enrollment of the first 80 patients by year end and are currently reviewing a number of options to accelerate these stats development. One tailwind in that space, in AML in particular, The momentum we anticipated supporting MRD as a potential surrogate endpoint has materialized, and this may serve to help accelerate our longer-term development. With that, I'd like to hand the call over to Dr. Lin here to discuss recent developments with CMX521. You've heard me mention previously that while our focus has shifted to oncology, we expected that we may be sitting on potential value with our legacy antiviral library. As the world begins to focus on pandemic preparedness by identifying molecules that have potential against entire families of viruses, the potential value of this library has been highlighted. This collaboration with the University of North Carolina has really been phenomenal in helping us identify that value without losing focus on other projects. As this highly credible team of collaborators saw the results of initial experiments, This project became their highest priority, and this subsequent work has progressed very quickly. Let me stop there and let Randall share what we've learned on one of the more mature assets from this library. Randall?