OPGEN INC - OPGN STOCK NEWS

OpGen has successfully enrolled its 1,000th patient sample in the prospective multicenter trial for its Unyvero Urinary Tract Infection (UTI) Panel. This milestone reflects significant progress following earlier disruptions due to COVID-19. The trial, which aims for FDA submission, has expanded to four sites to enhance enrollment of various sample types and accelerate completion. The company expects to reach the goal of 1,500 samples as required by FDA guidance, with final data readout anticipated in the second half of 2022.

OpGen (Nasdaq: OPGN) announced a three-year exclusive distribution agreement with Leader Life Sciences for its Unyvero systems in the U.A.E. and Qatar. Leader Life Sciences will purchase at least 8 Unyvero systems, contributing approximately $1 million in revenue. The partnership aims to enhance pathogen detection and antibiotic resistance monitoring, addressing the high occurrence of healthcare-associated infections in the region. Leader Life Sciences is tasked with obtaining regulatory clearance and will invest significantly in marketing the Unyvero product line.

OpGen, Inc. (Nasdaq: OPGN) announced positive results from a multicenter, randomized controlled trial evaluating its Unyvero HPN panel for diagnosing pneumonia in hospitalized patients susceptible to Gram-negative bacteria. The trial enrolled 208 patients and demonstrated a 45% reduction in inappropriate antibiotic therapy use, shortening therapy duration by 39 hours. Additionally, the use of Unyvero increased the probability of appropriate antibiotic therapy threefold without increasing adverse outcomes. These findings highlight the significant role of rapid diagnostics in improving patient care.

OpGen reported total revenues of approximately $0.47 million for Q1 2022, a decline from $0.83 million in Q1 2021. Operating expenses decreased to $6.3 million from $7.1 million year-over-year. The net loss narrowed to $6.8 million or $0.15 per share, compared to $14.9 million or $0.50 per share in Q1 2021, largely due to a prior accounting charge. Cash reserves stood at $30.7 million. The company anticipates 50% growth in U.S. direct sales and revenue growth of 25% to 50% in 2022.

OpGen, Inc. (NASDAQ: OPGN) announced a business update and first quarter 2022 financial results will be revealed on May 12, 2022. The management team will conduct a live conference call at 4:30 p.m. ET to discuss financial outcomes and ongoing business activities. The call will be accessible via U.S. and international dial-in numbers, and a webcast will be available on the company's website. OpGen specializes in precision medicine focusing on molecular diagnostics and bioinformatics to address multidrug-resistant infections.

OpGen, Inc. (Nasdaq: OPGN) announces a restructuring of debt repayment terms with the European Investment Bank (EIB) through its subsidiary, Curetis GmbH. Curetis will repay EUR 5 million in cash due by April 2022, with the remaining EUR 8.35 million amortized in monthly payments of approximately EUR 0.7 million over 12 months starting May 2022. The current interest rate of 10% remains unchanged. The restructuring aims to minimize share dilution and maintain favorable financing conditions amidst market pressures.

OpGen, Inc. (Nasdaq: OPGN) has announced the launch of new genome sequencing and analysis services through its subsidiary, Ares Genetics. The services aim to enhance pathogen detection and microbiome profiling, responding to the WHO’s strategy for genomic surveillance. Key offerings include ARESid, which enables culture-free detection of microbes, and ARESiss Express, which reduces turnaround times for sequencing from over 30 days to five business days. Both services are available via the AREScloud platform, with U.S. services set to launch later in 2022.

OpGen has extended its master services agreement with Sandoz to January 31, 2025. This partnership aims to enhance antibiotic stewardship and develop a digital platform for antibiotic lifecycle management and resistance surveillance. The collaboration will leverage next-generation sequencing and AI for data-driven insights to combat antimicrobial resistance (AMR), which contributes to approximately 1.3 million deaths annually. Ares Genetics has already created a digital anti-infectives platform as part of the initiative, enabling better diagnosis and treatment options for resistant pathogens.

OpGen announced the continuation of its prospective multicenter trial for the Unyvero UTI panel after an interim analysis of the first 150 U.S. patient samples showed no significant performance variations. The reproducibility study was successfully completed, confirming the protocol's implementation across sites. The clinical evaluation aims for FDA submission, and enrollment is ongoing, targeting 1,500 samples. Archived urine samples will also be included to enhance data on rare pathogens and antimicrobial resistance.