Chimerix, Inc.

Good morning, ladies and gentlemen, and welcome to Chimeric's first quarter 2021 earnings conference call. I would now like to introduce you to your host for today's call, Michelle Lespiluto, Vice President of Strategic Planning and Investor Relations at Chimerics. Please proceed.

Thank you. Good morning, everyone, and welcome to the Chimerics first quarter 2021 financial and operating results conference call. This morning, we issued a press release which outlines the topics we plan to discuss today. You can access the press release 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 Andreol, Chief Scientific Officer Randall Lanier, and Chief Technology Officer of Amipridone, 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 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 findings 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.

Thanks, Michelle, and good morning, everyone, and thank you for joining us. We've certainly had an eventful first few months of 2021. We're extremely focused on execution, and we remain on track for several important milestones in the second half of the year. We look forward to the potential approval of brinsidafavir as a medical countermeasure for smallpox by the July 7th PDUFA date. we would, you know, of course, that would mark Hymeric's first product approval. And with this promising pipeline, of course, I'm counting on it not being our last. On the NDA review of brenzodofovir, I can say that process has continued to go extremely well. No surprises to date. As it relates to the potential procurement contract, in late March, BARDA published a sources sought notice seeking information regarding the availability of capability for procuring, stockpiling, and investing in the development of an FDA-approved smallpox antiviral with an alternative mechanism of action relative to TPOX. And you can see with that very specific request, and particularly because the qualifying parameters they outline in the request require a drug currently under NDA review, we believe brinsidofovir is the only drug meeting those criteria. So as such, we have responded to the request and are currently awaiting the next steps from BARDA. The sources sought notice, of course, brings us one step closer to a possible procurement contract. You'll note that we did expect the RFP to have been issued by now. Based on our frequent and positive interaction with BARDA, I'm confident the RFP delay is driven by COVID-19 activity that has kept the HHS Division of Government Contract Review busy. Our timelines always anticipated delivery into the stockpile in the second half of the year, and that expectation remains on track. BARDA is intimately aware of our manufacturing schedule. Responding to an RFP is not a trivial undertaking, so we've been doing as much of that work in advance as possible, and that should allow us to respond quickly and potentially shorten the window from RFP to contractor. Moving now to our imiprodones program, we remain on track there as well to report the blinded independent central review of response rate in the 50-patient registration cohort in the second half of this year. This response data, along with other important measures of clinical benefit and safety, may form the basis of accelerated approval of ALK-201 for the treatment of patients with H3K27M mutant gliomas. Turning now to our D-STAT program, earlier today we reported partial data from the second cohort of our Phase II study of D-STAT for COVID-19 patients. Alan will provide additional detail in a moment. With the updated randomization schedule of two to one, the placebo group consisted of just three patients and excluding a patient who withdrew shortly after randomization. All three placebo patients that entered the trial had less severe disease as measured by the NIAID score, and each recovered quickly. As a result, our ability to gain insight into efficacy signals in this cohort is limited. However, the upcoming biomarker analysis may offer important additional insight to potential efficacy signals. We've been really transparent about the data as we've received it and our decision-making process for this trial. As I've mentioned before, we're continually assessing the path forward for acute lung injury indications for D-STAT based on, first, the clinical data, second, the rate of trial enrollment, and third, the ever-evolving standard of care. And remember, this trial was as much about gaining insight into the potential use of D-STAT in acute lung injury unrelated to COVID as it was about bringing a potentially important therapy to COVID patients. In the meantime, the team has done a nice job getting D-STAT-AML trial up and running and now enrolling. With that overview, let me turn the call over to Alan, who I've asked to give a little more detail on the second cohort of data from the COVID trial.