Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to the Chimerics third quarter 2022 earnings conference call. I would now like to introduce you to 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 this morning we issued a press release on our third quarter operating updates. 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 Alan Melamed, Chief Financial and Business Officer Mike Andreou, Chief Science Officer Randall Lanier, and our Chief Technology Officer of Oniprodone, 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 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'd like to turn the call over to our President and Chief Executive Officer, Mike Sherman.

Good morning, everyone, and thanks for joining the call. The third quarter was really a watershed period for Chimerix. We recorded the company's first product revenues, secured substantial non-dilutive funding for our oncology development, and gained clarity with the FDA on the design of our Onc201 Phase III Action Study. Together, these milestones positioned Chimerix as an oncology-focused company with the financial resources to complete our late stage program while progressing our pipeline of promising early stage assets. This is precisely where this management team has deep expertise and a track record of creating value for both patients and shareholders. Let me begin with a brief recap of our sale of Tembexa to Emergent BioSolutions. As a result of some nimble and late-stage negotiations with BARDA, we were able to improve contract terms and increase the aggregate size of the contract and our upfront payment. Chimerix benefits from having a sizable upfront payment while removing the downside risk that BARDA doesn't choose to stockpile Timbexa beyond the first procurement. Emergent is the industry leader in delivering protections against public health threats through the execution of government procurement. So they're really the ideal partner to maximize the future potential of Timbexa. Importantly, Chimerix will continue to benefit through milestones or double-digit royalties should BARDA exercise future procurement options or additional international sales are recorded. I'll focus the rest of my comments on ONC201. With the alignment from the FDA on our planned study design, we're excited to be launching the Phase III Action Study at the Annual Society for Neuro-Oncology or SNO Conference taking place later this month in Tampa, Florida. This is an ideal forum to enhance engagement in this study with an audience of the world's leading neuro-oncologists. This is a small, tight-knit community of key opinion leaders who are already aware of Onc201 and its potential. and already creating momentum for the study's launch. We collaborated with many of these physicians to design a trial with a high probability of success and multiple paths to achieve success quickly. We view the probability of success for the ACTION trial as higher than that of other Phase III neuro-oncology trials. Our Phase II data demonstrated single-agent, durable responses in the relapse setting. which strictly followed FDA's guidance for patient selection. That approach to patient selection allowed for the isolation of single-agent activity. It undoubtedly made this an even more challenging treatment setting to generate responses. In that context, the durability of these responses is even more compelling. Among responders, median time of eight months to declaration of tumor response plus an additional median of 11 months durability meant that patients on average experienced more than 18 months of tumor regression in the disease where life expectancy upon relapse is less than six months. Likely driven by this durability, this compelling evidence of change in disease progression among responders included consistent and strong association with other clinical endpoints, including overall survivals. To be specific, among responders, no patients died within 24 months. Among non-responders, none survived that long. Again, this is in a setting where median survival is less than six months following relapse. As strong as this phase two data is, there are a number of aspects to the phase three trial that we believe will actually enhance our ability to see a positive efficacy signal. Typically, there's an increase in heterogeneity among patients as you move to a larger trial. For the action trial, this is controlled through the selection of the genetically defined target population. Separately, we observed in the Phase II relapse setting, the response rate was actually the highest among those patients whose disease was relatively less advanced, meaning their tumor burden tended to be lower and their performance status tended to be better when their recurrence was declared. In an earlier setting, our Phase III will focus on this very population, providing more time for the drug to have effect. The safety profile of ONC-201 has also opened the door for the inclusion of a more frequent dosing arm in the Phase III trial, providing another opportunity for enhanced effect, at the same time addressing the principles of the FDA's Project Optimist. While we launch this important phase three study, we'll continue to work closely with the FDA to determine if there's a potential accelerated regulatory path based on these strong phase two results. We have a meeting scheduled with the FDA for this discussion, and in the event we pursue that path and are successful, we'll use the action study as our post-marketing confirmatory study in that filing. We've been watching recent ODAC meetings closely, as I'm sure many of you have, noting the concerns FDA has highlighted with other drugs in the context of accelerated approval. We believe we're well-positioned to address each of them. Specifically, the FDA concerns expressed to others include, first, clarity of unmet needs. In this case, H3K27M mutant glioma is considered grade four by WHO. and all post-radiation therapies are considered palliative. Post-relapse survival is less than six months. Second, drug safety issues. In our case, ONG201 is very well tolerated. The 211 patient safety analysis was new information for the FDA and was included in our briefing document for this meeting. Third, the FDA observed with other programs the need to isolate single-agent activity unconfounded by combination drugs or insufficient washout periods. For Onc201, the FDA specifically defined our inclusion criteria to ensure washouts, and we confirmed responses to Onc201 monotherapy through blinded independent central assessments. Fourth, they expressed uncertainty around dose optimization work of other programs. In our case, in addition to phase one work, our inclusion of a second dose provides dose optimization in the phase three study. And finally, they cited poor enrollment in phase three for other programs. And in our case, we expect to have the action trial well underway and enrolling outside the U.S. during potential review period. While each of these points speak to our positioning for accelerated approval, they also provide evidence for why we have more confidence in Phase 3 success relative to other programs. With all of that said, we know the FDA has raised the bar for accelerated approval, and so that's why we're seeking additional clarity on their position now that they have more visibility into Onc201 safety and we're aligned on a Phase 3 plan. We'll determine our regulatory path following that meeting and share that with you before year end. Whether we rely on the action trial for first approval or have an opportunity for an accelerated path, we see tremendous value for patients and shareholders. With that, I'll turn the call over to Mike Andriel for a review of our financial results. Mike?