DURHAM, N.C., Aug. 08, 2018 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today reported financial results and provided a corporate update for the second quarter ended June 30, 2018.
“Throughout the second quarter of 2018, we continued to make steady progress advancing our novel antivirals across a number of important clinical studies. Our lead product candidate, brincidofovir (BCV), is moving forward as a treatment for life-threatening adenovirus infection in the AdAPT study, which we expect to be fully enrolled in 2019. We are opening sites for our Phase 2 studies for intravenous (IV) BCV in the United States and Europe. In addition to brincidofovir, we are advancing CMX521 in the clinic for the treatment and prevention of norovirus supported by results from a single dose study in healthy subjects and strong preclinical data,” said M. Michelle Berrey, MD, MPH, President and Chief Executive Officer of Chimerix.
Corporate Highlights
Addressed Congressional Subcommittee in Support of Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA)
In June, Dr. Berrey delivered remarks before the House Committee on Energy and Commerce Subcommittee on Health at a hearing titled “Examining the Reauthorization of the Pandemic and All-Hazards Preparedness Act” in Washington, D.C. The purpose of the hearing was to reauthorize certain programs under the Pandemic and All-Hazards Preparedness Act (PAHPA), which originally passed in 2006 and seeks to improve the United States’ public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental or natural.
Program Updates
Oral BCV
The AdAPT study (Adenovirus after Allogeneic Pediatric Transplantation) is open for enrollment in the United States (US), the United Kingdom (UK), and Europe. Four of nine planned countries are currently undergoing regulatory or central ethics review; additional sites in the US, UK and Europe are also in the process of opening for enrollment.
IV BCV Phase 2 Studies Initiating in the US, UK and Europe
The Company is opening sites in the US, UK and Europe for enrollment in IV BCV Phase 2 studies in adult hematopoietic cell transplant recipients with adenovirus. Chimerix anticipates interim data in the second half of 2018.
Received Orphan Drug Designation for Brincidofovir for the Treatment of Smallpox
In June, Chimerix announced that the US Food and Drug Administration (FDA) granted Orphan Drug Designation for brincidofovir for the treatment of smallpox. The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the United States. Orphan Drug Designation provides manufacturers with many benefits, including a waiver of the FDA Prescription Drug User Fee Act.
Chimerix intends to submit marketing applications for smallpox following the completion of the rabbit and mouse efficacy studies.
Presented Preclinical CMX521 Data at 31st International Conference on Antiviral Research (ICAR)
In June, Chimerix presented results from preclinical studies supporting clinical evaluation of CMX521, the first clinical-stage direct-acting antiviral specifically for the treatment and prevention of norovirus. CMX521 showed activity in vitro against all strains of norovirus tested, suggesting broad efficacy against human noroviruses and supporting the ongoing Phase 1 study. These data were presented in oral and poster presentations at the 31st International Conference on Antiviral Research (ICAR) in Porto, Portugal.
In late 2017, Chimerix initiated a first-time-in-human Phase 1 study of CMX521 to evaluate the pharmacokinetics, safety and tolerability of CMX521 in healthy adult subjects. The first presentation of clinical data on CMX521 will be in September at the European Society for Clinical Virology in Athens, Greece.
Second Quarter 2018 Financial Results
Chimerix reported a net loss of $18.6 million, or $0.39 per basic and diluted share, for the second quarter of 2018. During the same period in 2017, Chimerix recorded a net loss of $16.7 million, or $0.36 per basic and diluted share.
Revenues for the second quarter of 2018 increased to $1.2 million, compared to $0.7 million for the same period in 2017.
Research and development expenses increased to $13.7 million for the second quarter of 2018, compared to $11.6 million for the same period in 2017.
General and administrative expenses increased to $6.7 million for the second quarter of 2018, compared to $6.3 million for the same period in 2017.
Loss from operations was $19.2 million for the second quarter of 2018, compared to a loss from operations of $17.2 million for the same period in 2017.
Chimerix's balance sheet at June 30, 2018 included $195.7 million of capital available to fund operations, no debt, and approximately 47.9 million outstanding shares of common stock.
About Brincidofovir
Chimerix's lead product candidate, brincidofovir, is a nucleotide analog that has antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenoviruses. Brincidofovir has a high barrier to resistance, no myelosuppression and a low risk of nephrotoxicity. Brincidofovir has received Fast Track designation from the FDA and Orphan Medicinal Product Designation from the European Commission for adenovirus, cytomegalovirus, and smallpox.
About CMX521
CMX521 is a nucleoside antiviral identified from the Chimerix Chemical Library as a potential treatment and/or prevention for norovirus, the most common cause of acute gastroenteritis worldwide. An ongoing Phase 1 study is evaluating the pharmacokinetics, safety and tolerability of CMX521.
About Chimerix
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing medicines that improve outcomes for immunocompromised patients. Chimerix's proprietary lipid conjugate technology and compound library have produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals; and CMX521, the first clinical-stage direct-acting antiviral for the treatment and prevention of norovirus. For further information, please visit Chimerix's website, www.chimerix.com.
