Chimerix, Inc.

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

Thank you, Operator. Good morning, everyone, and welcome to the Chimerics First Quarter 2024 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 Investors section of the website. With me on today's call are President and Chief Executive Officer Mike Andreol, Chief Medical Officer Alan Melamed, Chief Operating and Commercial Officer Tom Riga, Chief Financial Officer Michelle Laspelluto, and Chief Technology Officer Josh Allen. Before we begin, I'd like to remind you that the statements made on today's call will 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 Chimeric's President and Chief Executive Officer, Mike Andreol.

Thanks, Will, and good morning, everyone, and thank you for joining us. I'm pleased to be joined this morning by other members of our senior leadership team to share an update. on a productive quarter across several key initiatives. A primary strategic importance to Chimerics this year is the continued focus and drive of enrollment in the phase three action study, for which the team continued to execute at a high level during the first quarter. The study remains on track for first interim readout next year and is reaching steady state accrual. The success of the action study, which is the most advanced trial on H3K27M mucleoma, is central to our strategy as a positive outcome likely represents approval of the first medicine to treat this specific disease. As the organization drives action enrollment, we are keenly aware of the significant unmet need for patients with this disease, as there are no approved treatment options available that have proven a clinical benefit beyond radiation therapy in H3K27M mutant glioma. As a result, our team is continuously evaluating registration pathways globally to accelerate commercial access to Dordavaprone, also known as ONC201, where possible. As we undertake this effort, we are also aware that having a pivotal phase three study well underway is an important consideration in global regulatory conversations that contemplate accelerated approval and the ongoing maturation of action enrollment enables such discussions. To that end, I want to share a set of experiences that have been complementary to our strategy and underscore the magnitude of the unmet need we see every day with this lethal disease. Late last year, I received a communication from the Australian Minister of Health inquiring about Dordaviprone for patients in need within his country. During this interaction, the topic of provisional approval in Australia was raised, which is similar to the accelerated approval pathway in the United States. This interaction was the catalyst to our recent pre-submission meeting in Australia with the Therapeutic Goods Administration, or TGA, to explore Dordaviprone's eligibility to advance for provisional registration in Australia. That pathway is a three-step process which begins with a pre-submission evaluation of the current data set in recurrent disease, as well as other program features, including the status of pivotal studies. We're pleased with the outcome from this meeting and intend to advance Dordaviprone to the second step in the process, the provisional determination application. I'll let Alan provide more details on the process going forward. To be clear, we recognize that Door-to-Avaprone remains early in the provisional registration process. However, we are sharing the outcome of this meeting now as we are encouraged by TGA's review of the program to date and their conclusion that the phase two data set does potentially meet their criteria for provisional approval. This, along with the status of the phase three action study, supports advancement in the provisional registration process. This example is emblematic of our overall strategy to accelerate global access to durodaviprone, and we're eager to partner with the TGA in Australia to further advance durodaviprone towards potential provisional registration. Turning to our second generation of Microdone, ONC206, we have increasing confidence in the safety profile, therapeutic window, and potential for novel and differentiated indications from the parent compound durodaviprone. While phase one safety studies are not yet complete, We are nevertheless preparing development strategies for this program that we expect to share before the end of the year as we near a phase two investment decision. I'll let Josh frame this process further as we look into the second half of 2024. Finally, financially, the company remains on strong footing and we continue to execute with financial discipline. Michelle will provide a full summary of our financial performance in the first quarter and insights into cash runway. I'll now turn the call over to Alan to discuss the process and path we're undertaking in Australia. Alan?