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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 met several key milestones in collaboration with FIND, triggering milestone payments as of the end of 2022. Key achievements include:
- Demonstration of DNA isolation on the Unyvero A30 cartridge.
- Successful 3-plex assays for pathogen detection and AMR markers.
- Defined product requirements for the target product profile.
OpGen's subsidiary, Curetis, also provided a report on genetic diversity and resistance profiles of pathogens in low and middle-income countries. Looking ahead, the company expects to expand collaboration with FIND, potentially including clinical studies.
OpGen (Nasdaq: OPGN) has successfully closed a public offering of 2,586,207 shares of common stock at $2.90 per share, raising approximately $7.5 million in gross proceeds. The offering includes Series A-1 and Series A-2 warrants with an exercise price of $2.65. The net proceeds will be utilized for various purposes including the commercialization of the Acuitas AMR Gene Panel test, development of the Ares Genetics database, and repayment of certain debts. The offering was conducted under an SEC registration statement effective January 6, 2023.
OpGen, Inc. (Nasdaq: OPGN) has announced a public offering of 2,586,207 shares of common stock at $2.90 per share, with Series A-1 and A-2 warrants also included. The total gross proceeds are expected to be approximately $7.5 million. The funds will support the commercialization of FDA-cleared tests, expand the Ares Genetics database, enhance manufacturing, and pay off outstanding debt. The offering, managed by H.C. Wainwright & Co., is projected to close around January 11, 2023, pending customary conditions.
OpGen, Inc. (Nasdaq: OPGN) announced a 1-for-20 reverse stock split effective January 5, 2023, at 12:01 a.m. EST. This decision, approved by stockholders on November 30, 2022, aims to increase the market price per share to meet Nasdaq's minimum bid requirement of $1.00. The reverse split will reduce outstanding shares from approximately 58 million to about 2.9 million. No fractional shares will be issued, and stockholders entitled to a fractional share will receive cash instead. The change will not affect stockholders' percentage ownership.
OpGen has completed its clinical trial for the Unyvero UTI Panel, enrolling over 1,800 patient samples across four U.S. sites. Preliminary results indicate high performance, with a sensitivity of 96.4% and specificity of 97.4%. The panel is designed to detect a wide range of bacterial and fungal pathogens directly from urine, aiming to improve diagnosis and treatment of urinary tract infections (UTIs). OpGen will use these results to prepare a De Novo request for FDA submission, marking a significant step towards commercialization of this diagnostic tool.
OpGen reported its third quarter 2022 results, highlighting a decline in revenue to approximately $0.4 million from $1.2 million year-over-year. Total revenue for the nine months ended September 30, 2022, was $1.9 million compared to $2.9 million for the same period in 2021. Operating expenses rose significantly to about $14.0 million, leading to a net loss of $14.1 million ($0.30 per share). The company completed two commercial installations of the Acuitas AMR Gene Panel and entered several collaborations, including agreements with BioVersys AG and FIND, while maintaining a cash position of $10.3 million.
OpGen, a precision medicine company, reported preliminary Q3 2022 revenue of approximately $0.4 million, a decline from $1.2 million in Q3 2021. The company's cash position improved to about $13.3 million after a successful financing close. Notable developments included a collaboration agreement with BioVersys, completion of clinical trial enrollment for the Unyvero Urinary Tract Infection Panel, and a registered direct offering grossing $3.38 million. The Nasdaq granted OpGen an extension to meet its bid price requirement, while the company anticipates future impacts from its partnerships.
OpGen, Inc. (NASDAQ: OPGN) will report its third quarter 2022 financial results on November 10, 2022, after U.S. market close. A conference call will follow at 4:30 p.m. EST, where management will discuss the results and business updates. The presentation will be accessible via audio webcast and can be replayed until November 24, 2022. OpGen specializes in molecular diagnostics for infectious diseases and includes products like Unyvero and Acuitas AMR Gene Panel aimed at combating multidrug-resistant organisms.
OpGen has announced a collaboration with BioVersys to deploy its Unyvero platform in a Phase II clinical trial of BV100, an injectable formulation targeting Carbapenem Resistant Acinetobacter baumannii infections. The trial aims to combat high mortality rates associated with ventilator-associated and hospital-acquired pneumonia by improving rapid diagnostics. The Unyvero HPN system will assist in patient enrollment by detecting various pathogens and AMR markers. OpGen's Unyvero platform is positioned as the first market CE IVD marked and FDA cleared sample-to-answer platform for pneumonia diagnostics.
OpGen, Inc. (Nasdaq: OPGN) has completed a registered direct offering with a single institutional investor, raising approximately $3.38 million. The offering includes the sale of 9,660,000 shares of common stock, 33,810 shares of Series C preferred stock, and unregistered warrants to purchase up to 9,660,000 shares of common stock. The proceeds will be used for commercialization of the Acuitas AMR Gene Panel, further development of Ares Genetics database, and general corporate purposes. A special stockholder meeting will be called to approve a reverse stock split.
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