DURHAM, N.C., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today reported financial results for the third quarter ended September 30, 2020 and provided an operational update.

“Throughout the third quarter we continued to make significant progress across a number of key initiatives,” said Mike Sherman, Chief Executive Officer of Chimerix. “Of particular note was the completion of our rolling submissions to the U.S. Food and Drug Administration (FDA) for the approval of brincidofovir (BCV) as a medical countermeasure for smallpox. This milestone brings us one step closer to the company’s first regulatory approval and to securing a potential procurement contract with BARDA to supply the U.S. Strategic National Stockpile (SNS), which we expect to take place around the time of a potential FDA approval. In addition, we expect to be notified of our Prescription Drug User Fee Act (PDUFA) date relating to these submissions before the end of the year.”

“In addition, we expect to initiate our Phase 3 study of DSTAT for the treatment of acute myeloid leukemia (AML) in early 2021. We were particularly encouraged by a recent meta-analysis of 11,151 patients covering 81 separate studies published in the Journal of the American Medical Association Oncology (Short, et al) in which a link was suggested between minimal residual disease (MRD) status and outcomes in patients with AML. Specifically, this large cohort meta-analysis showed that MRD-negative AML patients experience superior disease-free survival and overall survival rates when compared to patients that are MRD-positive (average hazard ratios of 0.37 and 0.36, for overall survival and disease-free survival respectively). The study suggests that evaluation of MRD status in AML patients may allow for an earlier assessment of therapeutic effects and could lead to acceleration in the development of novel AML therapeutics. This meta-analysis underscores the importance of the MRD assessment that we will undertake following the first 80 evaluable patients in our Phase 3 study in order to better interpret the relapse-free survival and overall survival advantages observed with DSTAT in our smaller Phase 2 study.”

“Due to the complex and rapidly changing landscape of the current pandemic, we cannot predict when we will complete enrollment in our Phase 2 trial of DSTAT in acute lung injury (ALI) in COVID-19 but do anticipate sharing initial topline data in the first quarter of 2021,” concluded Mr. Sherman.

Recent Highlights

• Completed the rolling NDA submissions for BCV tablets and for BCV suspension as a medical countermeasure for smallpox
• Published manuscript in Advances in Therapy, titled "Design and Rationale of a Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study Evaluating Dociparstat in Acute Lung Injury Associated with Severe COVID-19.”
• Presented data in support of the multi-stage modeling and simulation approach used to determine BCV dosing for the treatment of smallpox in humans at the World Health Organization Advisory Committee on Variola Virus Research

Expected Upcoming Milestones

• FDA notification during the fourth quarter of 2020 regarding the acceptance of the BCV NDA submissions and assignment of a PDUFA date
• Initiation of Phase 3 trial of DSTAT in first line AML in early 2021
• Potential procurement agreement for BCV around the time of FDA decision on smallpox NDA
• FDA decision on BCV smallpox NDA in 2021
• Completion of Phase 2 trial of DSTAT in COVID-19 related ALI in 2021
• Completion of BCV drug product manufacturing to support potential shipments to the SNS of up to $100 million in 2021

Third Quarter 2020 Financial Results

Chimerix reported a net loss of $11.4 million, or $0.18 per basic and diluted share, for the third quarter of 2020. During the same period in 2019, Chimerix recorded a net loss of $73.7 million, or $1.26 per basic and diluted share.

Revenues for the third quarter of 2020 decreased to $1.6 million, compared to $2.0 million for the same period in 2019.

Research and development expenses increased to $10.0 million for the third quarter of 2020, compared to $7.5 million for the same period in 2019. The increase was driven by clinical trial expenses associated with the development of DSTAT.

General and administrative expenses decreased to $3.2 million for the third quarter of 2020, compared to $4.0 million for the same period in 2019.

Loss from operations was $11.6 million for the third quarter of 2020, compared to a loss from operations of $74.6 million for the same period in 2019, which included $65 million associated with the licensing of DSTAT in that period.

Chimerix's balance sheet at September 30, 2020 included $87.8 million of capital available to fund operations, no debt, and approximately 62.6 million outstanding shares of common stock.

About Chimerix

Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).

DSTAT is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that, compared to commercially available forms of heparin, may be dosed at higher levels without associated bleeding-related complications. DSTAT is being studied in a Phase 2/3 trial to assess safety and efficacy in adults with acute lung injury with underlying COVID-19. A Phase 3 trial protocol to study DSTAT in acute myeloid leukemia has been developed in alignment with the US Food and Drug Administration (FDA) and first patient visit is expected in early 2021. BCV is an antiviral drug candidate developed as a potential medical countermeasure for smallpox and is currently under review for regulatory approval in the United States. For further information, please visit the Chimerix website, www.chimerix.com.