Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to the Chimerics Third Quarter 2024 Earnings Conference Call. I would now like to introduce you to your host for today's call, Will O'Connor from Sturm Investor Relations. Please proceed.

Thank you, Operator. Good morning, everyone, and welcome to the Chimerics Third Quarter 2024 Financial and Operating Results Conference Call. This morning, we issued a press release related to our third quarter operating update. You can access the press release in our Investors section of the website. With me on today's call are President and Chief Executive Officer Mike Andreol, Chief Scientific Officer Josh Allen, Chief Financial Officer Michelle Laspaluto, Chief Medical Officer Alan Melamed, and Chief Operating and Commercial Officer Tom Riga for questions. 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'll now turn the call over to President and Chief Executive Officer Mike Andriel.

Thank you, Will. Good morning, everyone, and thanks for joining us. The third quarter was marked by continued execution across our pipeline, including continued enrollment in our global phase three action study of Dorgaviprone, and we are nearing complete enrollment of our phase one dose escalation studies for our second generation Imipridone Onc206. The phase three action study is active in 15 countries worldwide, and our first interim data readout is potentially less than a year away. During this past quarter, we received confirmation from the pre-specified interim safety review undertaken by the studies independent data monitoring committee, which recommended the action study continue as is with no change to study conduct. This is always welcome news, but even more so in the case of the action study, where we have two treatment arms, one at the phase two 625 milligram dose administered once per week, and a second treatment arm administering 625 milligrams twice per week on consecutive days, or essentially a double dose of the phase two schedule. Passing this IDMC safety review with no change to study conduct to any arm is a meaningful milestone and underscores the well-documented safety profile of Dordavacrone that makes it both a promising profile as a potential monotherapy, but also an ideal candidate as a potential backbone therapy. Last month, we participated in the European Association for Neuro-Oncology Annual Meeting in Glasgow, Scotland. It was evident that the enthusiasm across the European community for this program and the degree of support from so many investigators who recognize the very high unmet need in this patient population only continues to strengthen with time. Turning a little closer to home, the annual meeting for the Society for Neuro-Oncology, also known as SNOW, will occur in Houston, Texas later this month where we're planning a large presence. We view our partnership with the SNO organizers and engagement at this pivotal conference as important to the success of our programs. Not only will we have presentations for Dordaviprone, but we'll also showcase ONC206. Abstracts for that conference will release next week, so please stay tuned for more details. For those attending, we're looking forward to seeing many of you and our investigators in person. We continue to make progress with the Therapeutic Goods Administration, or TGA, to file for provisional approval in Australia. While this was not on our radar last year, we were agile when an opportunity arose earlier this year, and we're now in a position to file an NDA for provisional approval around year end. Having the NDA document ready for submission in Australia also aids our capacity and timelines should we have a positive interim overall survival outcome for action next year. To that end, we are judiciously preparing the company and the market for Dordavacron's potential commercialization, as we may be within a year from the first interim readout. With our phase three action study and our expanded access programs in the U.S. and Europe, we now have a well-laid foundation with hospitals and physicians who have ongoing treatment experience with Dordaviprone. Recall there are no approved therapies specific to this patient population, and we consequently expect a rapid uptake upon potential commercialization, forecasting a potential global market opportunity over $750 million. Turning to our second generation of Microdone, Onc206. Our objective for the year is to gather safety and PK data in an unselected CNS patient population and to evaluate lead indications for the program. I'm happy to report the phase one dose escalation is nearing completion and the lab has been working diligently on non-clinical studies to inform the next step for the program. We continue to see ONK206 as well tolerated in adult and pediatric patients as we near completion of the dose escalation studies. As we review the incoming clinical and preclinical data, we plan to announce next steps for the program in the coming months. Before I turn the call over to Michelle for a review of the financials, I'd like to take a brief moment to recognize the recent promotion of Josh Allen as our Chief Scientific Officer. Since joining Chimerics in 2021 with the acquisition of Oncosutics, Josh has been an integral team leader and a trusted colleague to many across the company. and has continually advanced the research and development of the Imipridone class of compounds from academic discovery to the lead registration phase program. Please join me in congratulating Josh on this well-deserved promotion. With that, I'll turn the call over to Michelle for a brief review of our financials.