GAITHERSBURG, Md., Aug. 02, 2018 (GLOBE NEWSWIRE) -- 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.”

2018 Second Quarter and First Half Financial Results

• Revenue: Total revenue for the second quarter of 2018 was $0.8 million, compared with $0.7 million for the second quarter of 2017. Total revenue for the first half of 2018 was $1.6 million, compared with $1.5 million for the first half of 2017.
• Operating Expenses: Operating expenses for the second quarter of 2018 were $4.0 million, compared with $4.9 million for the second quarter of 2017. Operating expenses for the first half of 2018 were $7.9 million, compared with $10.6 million for the first half of 2017.
• Net Loss: The net loss for the second quarter of 2018 was $3.3 million or $0.57 per share, compared with a net loss of $4.2 million or $3.73 per share for the second quarter of 2017. The net loss for the first half of 2018 was $6.4 million or $1.29 per share, compared with a net loss of $9.2 million or $8.45 per share for the first half of 2017.
• Cash Position: Cash and cash equivalents were $7.4 million as of June 30, 2018, compared with $1.8 million as of December 31, 2017.

Second Quarter 2018 Enterprise Highlights and Recent Developments:

Summary highlights from the second quarter and recent weeks included:

• Completed preliminary reviews with the FDA resulting in plans to file two 510(k) submissions for the Acuitas AMR Gene Panel u5.47, one for bacterial isolates and a second de novo submission for urine specimens and a separate de novo 510(k) submission for the Acuitas Lighthouse Software.
• Completed planning for the Acuitas AMR Gene Panel (Isolates) 510(k) FDA submission with testing of approximately 900 stock bacterial isolates and analytical validation testing of IUO product to begin during August.
• Expanded the OpGen Clinical Advisory Board and Medical Affairs team with the addition of Patricia Simner, Ph.D. D(ABMM), Associate Professor of Pathology, Director of Bacteriology and Parasitology, the Johns Hopkins Medical Institutions, as an advisor to the company.
• Achieved development milestone in CDC funded program for development of smartphone-based clinical decision support software with hospital testing underway in Colombia.
• Presented data at ASM Microbe 2018 demonstrating 91% to 100% accuracy for predicting antibiotic resistance using the Acuitas® AMR Gene Panel u5.47 (RUO).
• Presented data at ASM Microbe 2018 from a prospective clinical trial in Colombia demonstrating a 57% improvement in survival and reductions in antibiotic usage with the Company’s QuickFISH rapid diagnostic test.
• Reported successful analytical validation and clinical verification results for the Acuitas AMR Gene Panel u5.47 (RUO).
• Modified the terms of the debt held by Merck Global Health Innovation Fund to extend the note’s maturity and satisfy interest payments with issuance of Company’s common stock.
• Continued to achieve stated operating expense reduction, down 17% compared with the second quarter of 2017 and down 26% for the six (6) months ended June 30, 2018 as compared to the six (6) months ended June 30, 2017.

“We made solid progress with research and development, operations and expense reduction during the quarter. We are encouraged by the progress to date with our Acuitas AMR Gene Panel for bacterial isolates and urine specimens and anticipate further progress towards our strategic objectives during 2018,” concluded Mr. Jones.

2018 Outlook

OpGen expects to achieve the following business objectives during the remainder of 2018 as it transitions to the commercial phase of its molecular informatics business:

• Derive revenue from the sale of the RUO Acuitas AMR Gene Panel u5.47 to large hospitals, pharmaceutical companies and clinical research organizations.
• Complete third-party clinical verification studies and clinical trials to support FDA clearance for IVD use of the Acuitas AMR Gene Panel u5.47 test and the Acuitas Lighthouse Software.
• File a first 510(k) submission with the FDA in the fourth quarter of 2018 for the Acuitas AMR Gene Panel u5.47 (IVD) to support full commercial launch for clinical use.
• Add QuantStudio 5® and EZ1 Advanced XL® revenue-generating system placements.
• Enter into additional supply and cooperation agreements in support of the new Acuitas product family under development.
• Decommission the company’s CLIA laboratory operations in the third quarter of 2018 to provide incremental resources in support of efforts to gain FDA clearance for the company’s new Acuitas products.
• Complete CDC contract demonstration in Colombia for development of smartphone-based clinical decision support solutions for anti-microbial stewardship and infection control in low- and middle-income countries.
• Continue to seek third-party funding for development programs.
• Maintain cost reductions and overall cash burn rate to extend operating cash runway.

About OpGen

OpGen, Inc. is harnessing the power of informatics and genomic analysis to provide complete solutions for patient, hospital and network-wide infection prevention and treatment. For more information, please visit www.opgen.com.

OpGen, Acuitas, Acuitas Lighthouse, and QuickFISH are registered trademarks of OpGen, Inc. QuantStudio is a registered trademarks of Thermo Fisher Scientific. EZ1 is a registered trademark of QIAGEN.

The Acuitas AMR Gene Panel u5.47 (RUO) is intended for Research Use Only and is not for use in diagnostic procedures. The Acuitas Lighthouse Software is not distributed commercially for antibiotic resistance prediction and is not for use in diagnostic procedures.