OPGEN INC - OPGN STOCK NEWS

OpGen, Inc. (NASDAQ: OPGN) announced it will release its first quarter 2021 financial results on May 13, 2021, before U.S. markets open. The company will also host a live conference call at 8:30 a.m. ET to discuss the findings and provide business updates. OpGen specializes in molecular diagnostics and bioinformatics aimed at combating infectious diseases, with notable products like Unyvero and Acuitas AMR Gene Panel. The call will be accessible via U.S. and international dial-in numbers and a webcast available on their website.

OpGen, Inc. (Nasdaq: OPGN) announced an extension of its collaboration with the New York State Department of Health’s Wadsworth Center for six months, lasting until September 30, 2021. This partnership focuses on developing a solution to detect and manage antimicrobial-resistant infections using OpGen's Acuitas® AMR Gene Panel and Lighthouse® Software. The contract is valued at up to $540,000, allowing for increased testing and data collection due to rising volumes since fall 2020. This initiative aims to improve patient outcomes and reduce healthcare costs from antibiotic resistance.

OpGen (Nasdaq: OPGN) presented results from a webinar on its Unyvero panels for diagnosing pneumonia in COVID-19 patients. Findings indicate Unyvero detected bacterial pathogens up to 7 days earlier than traditional culture methods, allowing for timely, targeted antibiotic therapy in 41.3% of cases, reducing appropriate therapy time by 25.7 hours. The Unyvero Hospitalized Pneumonia (HPN) panel shows a 99.8% negative predictive value, enhancing antibiotic stewardship. These advancements could significantly improve patient outcomes in critical care settings.

OpGen reported 2020 financial results, revealing total pro-forma revenue of $5.2 million, a decline from $6.1 million in 2019. Despite an increase in fourth-quarter revenue to $1.4 million, the company faced a net loss of $26.2 million for the year, compared to $12.4 million in 2019. Operating expenses surged to $26.9 million in 2020 from $15.8 million in 2019. OpGen maintained a cash position of $13.4 million and raised an additional $34.7 million in early 2021. The FDA review of the Acuitas AMR Gene Panel has resumed, offering potential growth opportunities.

OpGen (NASDAQ: OPGN) is set to report its fourth quarter and full year 2020 financial results on March 25, 2021, after U.S. market close. The management will hold a conference call at 4:30 p.m. ET to discuss these results and other business updates. The call will be available via live webcast, with a replay accessible until April 8, 2021. OpGen specializes in precision medicine and molecular diagnostics to combat infectious diseases, aiming to enhance patient outcomes and address multidrug-resistant microorganisms.

OpGen's recent study published in the European Journal of Clinical Microbiology & Infectious Diseases showcases the Unyvero Hospitalized Pneumonia (HPN) panel's superior diagnostic capabilities. The panel achieves a 99.8% negative predictive value, crucial for reducing unnecessary antibiotic use. The rapid test can identify bacterial co-infections from lower respiratory samples in less than 5 hours, significantly faster than the average 2.5 days for standard cultures. This rapid detection aids in timely treatment decisions, especially among critically ill COVID-19 patients.

OpGen has secured regulatory approval from the NMPA for the Curetis Unyvero System in China, enabling its use as an in vitro diagnostic (IVD) instrument. This approval follows an extensive review process that began with a submission in 2019. The company is now awaiting approval for the Unyvero pneumonia cartridge, which, once granted, is anticipated to lead to rapid commercialization with expected revenue of approximately $180 million from contractual commitments with Beijing Clear Biotech for 360 systems and more than 1.5 million cartridges over eight years.

Ares Genetics GmbH, a subsidiary of OpGen (Nasdaq: OPGN), published a peer-reviewed study focusing on best practices for predicting antibiotic susceptibility from whole-genome sequencing (WGS) data. The research, led by Ares Genetics in collaboration with the University of Vienna, evaluated machine learning techniques across thousands of genome assemblies. It aligns with the FDA’s AI/ML Software as a Medical Device Action Plan, enhancing the reliability of WGS-based antibiotic susceptibility testing (AST). CEO comments emphasize the importance of this work in establishing Ares Genetics as a leader in AI-driven solutions for infectious disease testing.

OpGen, Inc. (Nasdaq: OPGN) announced a definitive agreement with a U.S.-based institutional investor for the purchase of 2,784,184 shares of common stock and 5,549,149 pre-funded warrants. The combined offering price is set at $3.00 per common share and $2.99 per pre-funded warrant. Additionally, 4,166,666 common share purchase warrants will be issued in a concurrent private placement. The closing is expected on or about February 11, 2021. This transaction follows an effective shelf registration statement filed with the SEC.