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OpGen, Inc. (NASDAQ: OPGN) is a leader in the field of precision medicine, leveraging advanced molecular diagnostics and bioinformatics to address the pressing issue of infectious diseases. By utilizing their expansive Acuitas Lighthouse® knowledgebase, which contains pathogen data from around the globe, OpGen aims to revolutionize the management of infectious diseases and combat antibiotic resistance.
The company's core offerings include CLIA-certified clinical laboratory services that provide rapid detection and analysis of antibiotic resistance, as well as high-resolution microbial sequence analysis. Their FDA-cleared IVD products are instrumental in identifying pathogens in positive blood cultures swiftly and accurately.
OpGen's groundbreaking products and services are designed to guide healthcare professionals by providing rapid and actionable information about life-threatening infections. This ultimately helps to improve patient outcomes and reduce the spread of infections caused by multi-drug resistant organisms (MDROs). The company’s proprietary DNA tests and informatics tools are pivotal in optimizing care decisions for patients with acute infections.
Among its innovative solutions are the Unyvero platform and the ARES Technology Platform, which includes ARESdb, NGS technology, and AI-powered bioinformatics solutions such as ARESiss, ARESid, ARESasp, and AREScloud. These technologies collectively enhance the ability to predict antibiotic responses and manage infectious threats effectively.
OpGen also collaborates with its subsidiaries, Curetis GmbH and Ares Genetics GmbH, albeit both subsidiaries are currently undergoing insolvency proceedings under German and Austrian laws, respectively. Despite these challenges, OpGen continues to focus on developing and commercializing comprehensive molecular microbiology solutions.
Recent achievements of OpGen include the introduction of new features in their AREScloud technology, the announcement of their second and third-quarter financial results for 2023, and ongoing adjustments to their corporate strategy to navigate the dynamic healthcare landscape.
For more detailed information about the company and its latest developments, visit www.opgen.com.
OpGen has successfully completed enrollment for its multicenter clinical trial of the Unyvero Urinary Tract Infection (UTI) Panel, collecting over 1,800 urine samples from patients at four U.S. sites. This milestone aligns with the FDA's guidance to ensure comprehensive data collection. The company is now preparing for data analysis and aims to submit a regulatory package to the FDA. The Unyvero UTI Panel targets a wide range of bacterial and fungal pathogens, addressing antimicrobial resistance.
OpGen has entered into a securities purchase agreement with an institutional investor for a registered direct offering of approximately 9.66 million shares of common stock at $0.35 each, alongside Series C preferred stock and unregistered warrants. The total gross proceeds are expected to be around $3.38 million. The funds will support the commercialization of its Acuitas AMR Gene Panel test and other products, enhance sales efforts, and repay outstanding debt. A reverse stock split proposal will also be presented to shareholders.
OpGen has announced an R&D collaboration with FIND to develop the Unyvero A30 RQ platform for rapid pathogen identification and antimicrobial resistance (AMR) testing in low and middle-income countries (LMICs). The project, co-funded by FIND with €700,000, will focus on a feasibility study expected to conclude by Q1 2023. The Unyvero A30 RQ platform is designed for quick testing from blood cultures, providing results in under 90 minutes for most applications. Success could lead to future collaborations for commercialization in LMICs, addressing a critical unmet medical need.
OpGen announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference, taking place from September 12-14, 2022, in New York City as a hybrid event. Oliver Schacht, CEO, and Albert Weber, CFO, will present the company's business overview on September 12 at 4:00 PM ET. The event will feature over 500 company presentations available via live feed and on-demand options. Interested individuals can register for the conference to access OpGen's presentation and learn more about its molecular diagnostics solutions aimed at combating infectious diseases.
OpGen, Inc. (Nasdaq: OPGN) has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement under Listing Rule 5550(a)(2). The company must ensure its stock closes at or above $1.00 for ten consecutive trading days by February 27, 2023. This extension allows OpGen to continue trading on the NASDAQ Capital Market while they explore options to meet compliance. However, there is no guarantee that compliance will be achieved or maintained.
OpGen (Nasdaq: OPGN) announced the launch of next generation sequencing (NGS) services in the U.S. through its subsidiary Ares Genetics. This service aims to enhance revenue opportunities within the infectious disease sector by offering validated whole genome sequencing for bacterial isolates, rapid turnaround times, and comprehensive outbreak analysis through the AREScloud web application. The services cater to the needs of clinical microbiologists and public health specialists, addressing antimicrobial resistance and enabling timely responses to local outbreaks.
OpGen reported total Q2 2022 revenues of approximately $1.0 million, up from $0.8 million in Q2 2021. For the first half of 2022, revenues were about $1.4 million, compared to $1.6 million in H1 2021. Operating expenses decreased to approximately $6.2 million in Q2 2022 from $7.0 million a year prior. The net loss for Q2 2022 was $5.8 million, or $0.13 per share. The company signed contracts for its Acuitas AMR Gene Panel and is progressing on its Unyvero UTI Panel clinical trial with 1,300 samples enrolled, targeting 1,500.
OpGen, Inc. (NASDAQ: OPGN) announced a business update and the release of its second quarter 2022 financial results on August 11, 2022, post-market close. A conference call will occur at 4:30 PM ET to discuss financial outcomes and business activities. Interested parties can access the call via U.S. and international dial-in numbers or through a live audio webcast on the Company’s website. The details for the replay will also be provided. OpGen specializes in precision medicine and molecular diagnostics to address infectious diseases.
OpGen's subsidiary Ares Genetics has partnered with UZ Leuven to develop computational tools for antibiotic susceptibility testing of Streptococcus pneumoniae.
This collaboration seeks to enhance Ares Genetics' proprietary knowledgebase, ARESdb, by collecting crucial AMR data from UZ Leuven.
Ares will also implement its AREScloud web application at UZ Leuven for pathogen typing and outbreak analysis, enhancing the fight against antimicrobial resistance, which is responsible for approximately 1.27 million deaths annually.
OpGen reported preliminary total revenue for Q2 2022 of approximately $1.0 million, a rise from $0.8 million in Q2 2021. As of June 30, 2022, the company has about $16.6 million in cash. Key developments include signing the first commercial contract for the Acuitas AMR Gene Panel and expanding a distribution agreement with Menarini, increasing revenue commitments. Additionally, OpGen announced milestones in clinical trials and new partnerships. Notably, these financial results are preliminary and subject to adjustments.
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