DURHAM, N.C., Aug. 10, 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 second quarter ended June 30, 2020 and provided an operational update.

Mike Sherman, Chief Executive Officer of Chimerix, commented, “Our enthusiasm for the potential of dociparstat sodium (DSTAT) to treat COVID-19 patients continues to grow as new data emerges on the role of high mobility group box 1 (HMGB1) which has recently been correlated with disease severity and survival. DSTAT’s key targets include both HMGB1 and platelet factor 4 (PF4). Inhibition of HMGB1 and PF4 with DSTAT could substantially address the excessive inflammation and coagulation disorders observed in these patients. We are currently enrolling our Phase 2/3 study of DSTAT as a treatment for acute lung injury (ALI) in patients with COVID-19 and expect to complete Phase 2 enrollment in the fourth quarter of 2020. We have also resumed work on our DSTAT program for the treatment of acute myeloid leukemia (AML) and now expect site activation for the Phase 3 study to begin in early 2021.”

Mr. Sherman continued, “With the recent additions of Dr. Allen Melemed as Chief Medical Officer and Caryn Barnett as Vice President of Clinical Operations, we have continued to enhance our strong leadership team. Both executives bring decades of successful drug development expertise to Chimerix as we advance our pipeline.”

“Importantly, we are in the midst of our rolling submission of the New Drug Application (NDA) for the approval of brincidofovir (BCV) as a medical countermeasure for smallpox and expect to complete it by the end of the third quarter. The COVID-19 pandemic has highlighted the importance of preparedness to treat future viral outbreaks, especially those as deadly as smallpox, and we look forward to a possible BCV regulatory approval and a potential procurement contract for the U.S. Strategic National Stockpile (SNS),” concluded Mr. Sherman.

Recent Highlights

• Began rolling NDA submission for the approval of BCV as a medical countermeasure for smallpox
• Initiated enrollment in Phase 2/3 trial of DSTAT in ALI patients with COVID-19

Expected Upcoming Milestones

• Completion of NDA submission of BCV in third quarter 2020
• Completion of enrollment of Phase 2 portion of DSTAT trial in COVID-19 in fourth quarter of 2020
• Initiate Phase 3 AML trial in early 2021
• Potential procurement agreement for BCV prior to FDA decision on smallpox NDA
• FDA decision on BCV smallpox NDA in 2021
• Completion of BCV drug product manufacturing to support a potential shipment to the SNS of up to $100 million in 2021

Second Quarter 2020 Financial Results

Chimerix reported a net loss of $10.0 million, or $0.16 per basic and diluted share, for the second quarter of 2020. During the same period in 2019, Chimerix recorded a net loss of $17.7 million, or $0.35 per basic and diluted share.

Revenues for the second quarter of 2020 were $1.4 million, equal to the same period of 2019.

Research and development expenses decreased to $8.6 million for the second quarter of 2020, compared to $13.8 million for the same period in 2019.

General and administrative expenses decreased to $3.1 million for the second quarter of 2020, compared to $6.3 million for the same period in 2019.

Loss from operations was $10.3 million for the second quarter of 2020, compared to a loss from operations of $18.7 million for the same period in 2019.

Chimerix's balance sheet at June 30, 2020, included $96 million of capital available to fund operations, no debt and approximately 62.2 million outstanding shares of common stock. The Company reaffirms its previous cash balance forecast of approximately $70 million at the end of 2020.

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 drug candidates 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. Inhibition of HMGB1 may be a primary anti-inflammatory target for DSTAT. HMGB1 induces downstream proinflammatory cytokines, including but not limited to, IL-6, TNF-?, monocyte chemoattractant protein-1 (MCP-1) and macrophage inflammatory protein-1? (MIP-1?), all of which are elevated in COVID-19. DSTAT also binds to and inhibits the activity of PF4 which appears to play a significant role in the coagulation disorders observed in severe COVID-19.

A Phase 3 trial protocol to study DSTAT in acute myeloid leukemia has been agreed to with the US Food and Drug Administration (FDA) and site activation is expected in early 2021. BCV is an antiviral drug candidate in development as a medical countermeasure for smallpox. For further information, please visit the Chimerix website, www.chimerix.com.