Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to the Chimerics First Quarter 2023 Earnings Conference Call. I would now like to introduce you to your host for today's call, Michelle Laspaludo, Vice President of Strategic Planning and Investor Relations at Chimerics. Please proceed.

Thank you. Good morning, everyone, and welcome to the Chimerics First Quarter 2023 Financial and Operating Results Conference Call. This morning, we issued a press release related to our first quarter operating update. You can access the press release in our investor section of the website. With me on today's call are President and Executive Officer Ellen Melamed, Chief Financial and Business Officer Mike Andriels, and Chief 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 Act 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 morning, everyone, and thanks for joining us. 2023 is definitely off to a good start from an execution standpoint. We continue to open action study sites and now have regulatory approval for the protocol in nine countries. The latest approval was received a few weeks ago from the European Union and we're activating sites there now. We remain on schedule for our first efficacy analysis in early 2025, which includes an initial overall survival assessment. We were pleased in the meantime to have a strong showing at the American Association for Cancer Research annual meeting this year with more than a dozen presentations related to the OmepraDome platform. Those were presented by the company and our collaborators at Brown University and the University of Michigan. The presentation by Dr. Carl Kochman from the University of Michigan was the highlight. He presented clinical evidence of ONK201's ability to reverse H3K27 trimethyl loss. We've described previously the relationship between ONK201's molecular targets and the H3K27M target population, but this goes a step further. This is the first known example of any therapy reversing H3K27 trimethyl loss. This is a characteristic which you may know has been linked to tumor growth and poor prognosis. So on top of the durable tumor responses observed in the phase two data set, the overall survival advantage reported by multiple non-randomized analyses of patients treated with ONK201 compared to all others, This provides additional confidence in the outcome of the action trial. I'll let Josh dig a little bit deeper into the science and why it matters in a moment. We also continue to progress on 206 and the dose escalation studies. We expect the open label dose escalation to run into the first half of 2024. That will both inform the dosing strategy and create the opportunity to identify other signals of activity. As you recall, last quarter we reported an investigator-assessed response in a recurrent glioblastoma patient without the H3K27M mutation who received OCT206 at one of the lower doses. This signals the potential for this drug in much larger patient populations compared to the H3K27M glioma indication. With that, I'll turn the call over to Josh for a deeper review on ONC201's ability to reverse this trimethyl loss and ONC206 development.