Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to the Chimerics First Quarter 2022 Earnings Conference Call. I would now like to introduce 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 the Chimerics First Quarter 2022 Financial and Operating Results Conference Call. This morning, we issued two press releases, one to announce the sale of Tembexa to Emergent BioSolutions and one announcing our first quarter operating operations. You can access these press releases 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, and our Chief Inifredone Technology Officer Josh Allens. Before we begin, I would like to remind you that the statements made on today's call include forward-looking statements within the meeting 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 would like to turn the call over to our President and Chief Executive Officer, Mike Sherman.

Thanks, Michelle. Good morning, everyone. Thanks for joining us. We've had an active couple of months, so let me get right to the updates, and I'll start with Tembexa. This program has been central to our strategy for a couple of reasons. First, we're fulfilling an important need to protect the population from the possibility of a smallpox outbreak, and we've done that with the first treatment approved for all ages, and one that's likely robust even in the face of the inevitable mutations that compromise the efficacy of other treatments. Our ongoing negotiations with BARDA are progressing well to satisfy this first objective. The second reason Timbexa is central to our strategy is because it will serve as an important mechanism to fund our ongoing development in oncology. This is of particular value at a time when access to capital within the biotech sector is so challenging. With that in mind, we're excited to announce this transaction with Emergent BioSolutions, the sale of worldwide rights to Timbexa. It secures substantial capital to fund our business. It allows us to focus our execution on the development pipeline, and it positions the asset in the hands of a company that's well-suited to maximize its value, value we will continue to participate in via milestones and royalties. Emergence, a leading biodefense company with substantial experience in working with government agencies to assure the protection of the population's health. In securing the upfront capital with this transaction, we positioned ourselves well to fund our pipeline without the ongoing uncertainty of future procurements, which, as you know, can be variable depending on the government's evolving priorities. We continue to control the BARDA contract negotiation to its completion, which we still expect to occur later this quarter. Following the signing of the procurement contract and closing of the emergent transaction, we look forward to facilitating a smooth transition, particularly as it relates to the well-established supply chain for Timbexa, which emergent intends to continue to utilize. I'll let Mike Andreol cover the key terms of this transaction in a moment. Suffice it to say, we're very pleased to bring this transaction to fruition as it just makes great strategic sense for both organizations. Let me now turn for a few minutes to Onc201. We recently engaged several key opinion leaders in the neuro-oncology field who participated in our advisory board. supporting the design of our Phase III randomized trial in H3K27M mutant glioma. That engagement has been a great reminder of both the unmet need in this population and the physician enthusiasm for Onc201 as a treatment. It's a combination of these two factors which drive physicians and patients to seek out this treatment today, and it will continue to be the engine driving enrollment in our Phase III trial. In our recent engagement with the FDA to discuss the phase three design and our analytical plans around the natural disease history study, they took the opportunity to provide feedback on potential accelerated approval path. To be clear, we did not seek formal feedback on that question as we anticipated those discussions would take place as we completed the safety database and some of the ongoing clinical pharmacology supporting work. In other words, when one would have had a more informed perspective on risk benefit. That being said, their feedback made it clear that an accelerated approval would be more challenging than we previously anticipated. To be sure, the FDA's recent public commentary on the accelerated approval path, particularly within oncology, has certainly not been supportive of single arm data going forward. The FDA also let us know it no longer plans to rely on a natural disease history study as a comparator due to its inherent limitations. We've had this study underway with the expectation it would be part of the potential submission. That being said, we plan to wrap it up, the study with the patient data we have already in process, and we'll look to publish our findings. Based on FDA's feedback, this data is likely less meaningful in their decision process, and yet we would still expect to include it in a potential accelerated approval submission. Let me underscore that we're not throwing in the towel on a potential accelerated approval pathway, but we need to prepare for the likelihood that the first approval may come with completion of the Phase III. We also need to prepare for the likelihood that if we do pursue accelerated approval, the FDA will be less likely to allow for certain work to be completed during a rolling submission or as part of a post-marketing commitment, as we had previously expected. Over the last year, we've successfully completed healthy volunteer safety and PK studies, improved the liquid formulation for pediatrics. We've evaluated concurrent medication and food effects on pharmacokinetics and are now evaluating special populations, including subjects with renal and and hepatic impairment. That work has all gone very well. Other work to be performed includes a cardiac safety study and POP-PK modeling. These studies extend into the first half of next year and would be gating items for a submission for accelerated approval. I need to hold off on sharing too many details of the Phase III trial design as we're working quickly to get closure with the FDA on a couple of elements, but I will make a few comments about it. The trial with initiation later this year will enroll H3K27M mutant glioma patients, both pediatric and adult. We'll treat newly diagnosed patients at the conclusion of their standard radiation regimen. Patients will be randomized to ONC201 or placebo at that time. We're planning on overall survival as the primary endpoint, which, of course, if successful, will maximize the value of this agent. We believe this trial can be completed quickly with rapid times to events and including early interim analyses. As we said all along, the strict criteria required for the cohort of patients evaluated to date is not likely the optimal setting for ONC201. It was defined more to ensure the single agent activity was isolated, and yet the data is still compelling. As a result, we're really excited about this phase three trial as it deploys ONC-201 at a time in the treatment cycle when it's most likely to show maximum benefit to patients. We'll come back with the final design elements, powering assumptions and timelines in the coming weeks as we have final alignment with the FDA. Finally, as we highlighted in our release, we've terminated our D-STAT program. Along with the sale of CEMBEXA, this will reduce our spending, and will give us tremendous focus on the Inifidome platform and execution there. With that, I'll turn it over to Mike Andriel to share more about the Tembexa transaction and the financial results for the quarter.