Chimerix, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Chimerics second 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, and good afternoon, everyone. This afternoon, we issued a press release on our second quarter operating updates. You can access this press release in our investor section of our 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 Technology Officer of Omnipotence, 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 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.

Good afternoon, everyone. Thanks for joining us. today we've been busy the past few months so let me get right to the details of the progress we've made and i'll start with tembexa in july we marked a significant milestone recording our first tembexa product revenue covered by two international agreements of 35 million dollars in aggregate this was only possible because we made the decision a couple of years ago to manufacture over 300 000 treatment courses of tembexa at our own risk without a contract, somewhat atypical in the biodefense space. Because of that decision, we were able to take advantage of this opportunity immediately, completing contracts and shipping products in a matter of days. If you're looking to isolate and assess chimerics execution as it relates to creating and delivering on contracts, these are great examples. The same decision to manufacture product at risk will also position us to respond immediately to place Timbexa into the US stockpile once the BARDA agreement is in place. We mentioned previously that the monkeypox outbreak introduced some new considerations for both BARDA and Chimeric, so we are and have been thoughtful to address those urgently. In the meantime, the international sales we've recorded have satisfied our near-term capital needs. You may be aware that while Timbexa was approved for smallpox, preclinical data does support the activity of Timbexa against multiple orthopoxviruses, including monkeypox. The FDA commented on that potential in their post-approval manuscript. The fact of the matter is no randomized control studies have been performed in humans with monkeypox with either of the FDA-approved antivirals for smallpox and There are still a lot of unknowns as the virus spreads and mutates into potentially more resistant strains. We're working with leading infectious disease physicians on potential options to generate additional data. Let me now turn to ONC201. Pleased to announce today the design details of our phase three action study of ONC201. This is the most advanced study in this H3K27M population of patients. I'll let Alan go into the design details, but let me make a few points up front. We've worked with KOLs across disciplines and geographies to design a trial with a probability of success that's high and multiple ways to achieve this efficiently. The action study is highly differentiated from the other Phase III studies that have been performed in the broader glioblastoma space. It really comes down to the Phase II data we have in hand and the circumstance in which it was generated compared to other drugs that really differentiate this drug's likelihood of success. I should first note that about a third of the studies in this space advanced to phase three without phase two data. For those that did advance based on phase two data, it was rare that the patient population was associated with a targeted genetically specified mutation like H3K27M. With that target, we can focus on the same homogeneous population of patients in phase three that were the source of the data in phase two. We can also identify those patients with the same tools used in phase two, which are reliable diagnostic methods already nearly universally used. The isolation of single agent activity is also critical. Many previous phase two studies have been conducted with drug combinations and or have failed to have adequate washout periods to distinguish drug effects. They then relied on time point endpoints like PFS compared to historical benchmarks. And in contrast, we've carefully isolated the single agent activity of ONC201 in our Phase II data. Importantly, we've measured tumor response using Raynaud criteria, the most rigorous standard. This method was developed to address some of the shortcomings of prior response rate measures, such as the Levin and McDonald criteria. Our overall response rate of 20 to 30 percent in the relapse setting using Raynaud, complemented by the durability of those responses evaluated by blinded independent central review, also increase our confidence relative to prior studies done using less stringent criteria. It's also critically important that our efficacy data was generated in the absence of anti-angiogenic drugs like Avastin, which can confound imaging and yield false response and progression assessments, which have historically failed to translate to phase 3 success for other drugs. Finally, the consistency across multiple clinically meaningful endpoints is particularly convincing. The ONC-201 data demonstrates a clear association between response and a reduction in steroid use and an improvement in performance status. There's also an association with survival as all responders were alive at two years or were alive at the data lock if that was earlier than two years. For patients who did not achieve a response, none were alive at two years. The internal consistency of this data is striking. We previously noted the ongoing work related to compiling safety data to strengthen the risk-benefit assessment of ALK201. Last fall, we reported just a summary of of safety data from the 50 patient efficacy cohort. I'm now happy to say we've completed a more robust assessment of over 200 patients, and the results reveal a very attractive safety profile as expected. I'll turn the call over to Alan to share more about the details of the Phase III action study, as well as hit on those findings in the latest safety assessment. Alan?