OPGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Revenue increases 12% to $0.8 million, net loss narrows 21% to $3.3 million
Conference call begins at 4:30 p.m. Eastern time today
GAITHERSBURG, Md. (August 2, 2018)
– OpGen, Inc. (NASDAQ: OPGN) today reported financial and operating results for the three and six months ended June 30, 2018 and provided a business update. Total revenue for the second quarter of 2018 was $0.8 million, up 12% from $0.7 million for the second quarter of 2017. The net loss for the second quarter of 2018 was $3.3 million, a 21% improvement compared with the net loss of $4.2 million for the second quarter of 2017.
“During the second quarter we continued to advance development of our lead rapid test, the Acuitas® AMR Gene Panel u5.47,” said Evan Jones, Chairman and CEO. “We reached agreement with the U.S. Food and Drug Administration (FDA) regarding the regulatory pathways and clinical trial protocols for clearance of the new AMR Gene Panel Tests and the Acuitas Lighthouse® Software. Our goal is to complete our first clinical trial for bacterial isolates and file an in vitro diagnostic (IVD) 510(k) submission for the Acuitas AMR Gene Panel u5.47 during the fourth quarter of 2018. Subsequent 510(k) submissions are expected to follow during the first quarter of 2019. We are encouraged by the introduction of the Acuitas AMR Gene Panel u5.47 Research Use Only (RUO) earlier this year and have been in discussions with leading CROs and hospital systems for its use and as participants in our clinical trials.
“At the ASM Microbe conference in June we presented positive data from our ongoing clinical verification studies for the Acuitas AMR Gene Panel u5.47 (RUO). In the study, 229 remnant urine specimens were provided by Intermountain Healthcare and Beth Israel Deaconess Medical Center and tested with the AMR Gene Panel test (link to poster: OPGN-ASM18). The test data were analyzed by the Acuitas Lighthouse (RUO) to predict antibiotic resistance and these predictions were then compared with conventional antibiotic susceptibility testing. For the four Gram-negative pathogens featured in the presentation, the accuracy for predicting resistance across 12 antibiotics ranged from 91% to 100%. This followed our presentation at April’s European Congress of Clinical Microbiology and Infectious Diseases, where we presented results with the Acuitas Lighthouse Software to predict phenotypic resistance for 35 isolates from the CDC and FDA Antibiotic Resistance Isolate Bank. The Acuitas AMR Gene Panel u5.47 was used for isolate testing along with conventional microbiology to determine antibiotic susceptibility. The Acuitas Lighthouse antibiotic resistance predictions had agreement to conventional microbiology ranging from 88% to 100%. Importantly, we were able to reduce the time to results to two hours, compared with three hours previously with our test and current microbiology standards that require up to two days.”
Mr. Jones continued, “At ASM Microbe we also presented results of a prospective clinical trial evaluating the impact of using rapid diagnostic testing for the identification and treatment of bacteremia and fungemia in hospital intensive care units in Colombia. The study showed the survival rate for patients tested with the OpGen QuickFISH® was 74%, compared with 47% for patients receiving current standard-of-care protocols.”