Chimerix, Inc.

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, and Chief Financial and Business Officer, Mike Andriel. Alan Melamed, our Chief Medical Officer, and Josh Allen, our Chief Technologist Officer of Iniperdyne, are here to participate in Q&A. Before we begin, I would like to remind you that 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 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 thanks for joining us. We've made considerable progress through the first half of 2021, highlighted first by the acquisition of Oncosudix, then the initiation of the Phase 3-AML trial, and finally the FDA approval of Tembexa as the medical countermeasure for smallpox. This last milestone marks Chimeric's first FDA-approved drug and is the first smallpox antiviral approved for all age groups, including infants. The addition of tabexa to the Strategic National Stockpile is important for several reasons. As we've seen with COVID, having multiple tools to counter a viral outbreak is really critical. Strains of the smallpox virus that are resistant to the currently stockpiled countermeasure whether that resistance is engineered intentionally or occurs naturally, are not anticipated to be resistant to Timbexa. The reverse is true as well. In fact, the mutations required for resistance to Timbexa significantly weaken the virus and reduce its lethality. And having both tablet and suspension formulations covering all age groups is also an essential enhancement to our readiness. BARDA remains actively involved in our current development contract and celebrated the approval of Tembexa as their 60th such approval in partnership with industry. Anticipating the RFP associated with a procurement contract, we have already completed work likely required for a response to that RFP. That puts us in a position to possibly expedite the time from RFP to contract. We've also continued to execute the necessary steps to support the first shipment of up to $100 million of product into the stockpile. And from a communications standpoint, we will issue an 8K so investors are notified as the RFP is posted to the government website, as is their practice. Moving now to ONC 201 and particularly our work in H3K27M mutant glioma. In preparation for an updated efficacy analysis, including a blinded independent central review, we've spent the last several weeks querying, cleaning, and locking the databases comprising the registration cohort of 50 patients with recurrent H3K27M mutant diffuse midline glioma who received single agent OCTO-01. And recall that these patients represent the first 50 patients enrolled across five different studies who met very specific criteria for inclusion in the registration cohort. The inclusion criteria were really designed to create the most homogenous patient population and isolate the treatment effect for measurement of the primary overall response endpoint. All these patients have measurable diffuse midline glioma. They harbor the H3K27M mutation. and have evidence of progression following radiation therapy administered at least 90 days prior. And in many cases, these patients had progressed following an additional post-radiation therapy as well. We're also gathering the data associated with the handful of patients who met all of those criteria for that cohort and have disease outside the midline. This data will be evaluated by a team of blinded independent central reviewers, or BICR, and we expect to share the efficacy analysis arising from that effort in the fourth quarter of this year. Key elements of that analysis will include overall response rate as assessed by Raynaud criteria, the durability of those responses, and then other supporting evidence of clinical benefit, including neurological improvements as measured by performance status and reduction in the use of corticosteroids. We anticipate sharing this same data along with other information, such as an ongoing natural history study with the FDA and the EMA, which may then form the basis of an accelerated approval of ONC-201. Turning now to our D-STAT program, earlier this year we initiated enrollment of patients in the DASH-AML study, our Phase III trial, evaluating D-STAT in combination with standard chemotherapy for the treatment of AML. This multicenter, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of D-STAT in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly diagnosed AML patients. We expect unblind data following enrollment of the first 80 evaluable patients in this study to assess minimal residual disease and complete response rates between the study arm and the control arm. This analysis we expect to take place in the second half of 2022. With that, I'll now turn the call over to Mike Andrews for review of the financials. Mike?

Mike Andrews Thanks, Mike, and good morning, everyone. As Michelle mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the second quarter of 2021. Starting with our balance sheet, we remain well capitalized and ended the second quarter of 2021 with approximately $140 million in capital to fund operations. We have several key milestones upcoming on PEMBEXA, ONC201, and D-STAT, and are well funded through those milestones. Additionally, funding from a possible part of procurement contract could provide $80 to $100 million annually to support our ongoing research and development programs. Turning to our statement of operations, the company reported a net loss of $17.8 million or 21 cents per basic and diluted share for the second quarter of 2021 compared with a net loss of $10 million or 16 cents per basic and diluted share in the second quarter of 2020. Revenues for the second quarter of 2021 were $0.4 million compared to $1.4 million for the same period of 2020. Research and development expenses increased to $13.8 million for the second quarter of 2021 compared to $8.6 million for the same period in 2020. The main driver of this increase was the addition of personnel, clinical, and development expenses following the acquisition of Oncocytics to support the addition of Onc201 to the pipeline. General and administrative expenses increased to $4.4 million for the second quarter of 2021 compared to $3.1 million for the same period in 2020. With that overview, I'll now turn the call back over to Mike for closing remarks. Mike?