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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 reported a total revenue of approximately $0.8 million for Q2 2021, a 32% decline compared to Q2 2020's $1.2 million. This decrease is attributed to the exit from the FISH business and the conclusion of prior R&D collaborations. Operating expenses decreased to $7.0 million from $7.7 million year-over-year. Despite net losses of $7.1 million ($0.19 per share), cash reserves improved significantly to $31.2 million, up from $13.4 million at the end of 2020. Key milestones include the assembly of Unyvero A30 RQ analyzers and progress in FDA submissions.
OpGen, Inc. (Nasdaq: OPGN) announced it will withdraw Proposal 2 from its Definitive Proxy Statement regarding an increase in authorized shares, leading to the cancellation of the reconvened Annual Meeting set for August 5, 2021. This decision follows the approval of all other proposals during the Annual Meeting on June 9, 2021. The company is exploring alternatives for financing its future growth. OpGen focuses on precision medicine through molecular diagnostics and aims to improve treatment outcomes for infectious diseases.
OpGen, Inc. (NASDAQ: OPGN) will report its Q2 2021 financial results and provide a business update on August 12, 2021, after U.S. market close. The management team will host a live conference call at 4:30 p.m. ET to discuss these results and business activities. Interested parties may join via the U.S. or International dial-in numbers provided or through a webcast link. A replay will be accessible until August 26, 2021. OpGen focuses on precision medicine and developing molecular diagnostics for infectious diseases to improve patient outcomes.
OpGen has announced the completion of assembly for 10 pre-series Unyvero A30 RQ analyzers by its subsidiary Curetis. This marks a significant milestone as these instruments will enter final verification and validation testing. The A30 RQ platform aims to provide rapid, multiplexed testing from various clinical specimens, yielding results in as little as 30 minutes. Future product developments are being evaluated, and the platform is open for licensing opportunities, enhancing OpGen's strategic partnerships.
OpGen, Inc. has adjourned its annual stockholders meeting to allow additional time for votes on Proposal 2, which seeks to increase the authorized shares of common stock. The meeting will resume on August 5, 2021, at 10:00 AM ET. CEO Oliver Schacht emphasized the importance of this proposal for the company's future and potential financing needs, noting a strong cash position of $39.4 million as of Q1 2021. However, at least 66.67% of shares must vote in favor for it to pass. The Board is also exploring alternative financing options.
OpGen, Inc. (Nasdaq: OPGN) shared promising prospective clinical data on its Unyvero LRT BAL panel during a recent webinar. The panel demonstrated its ability to adjust antimicrobial therapy in 53% of ICU patients, providing results 21 hours faster than conventional tests. With 99.2% concordance for organism targets and significant detection of pneumonia-causing bacteria, the panel reduces unnecessary antibiotic use and associated adverse effects. Additionally, the Acuitas AMR Gene Panel showcased potential in infection control at the World Microbe Forum, further underscoring OpGen's commitment to combating antimicrobial resistance.
OpGen, Inc. (Nasdaq: OPGN) announced promising preliminary data from Ares Genetics’ multicenter validation of long-read nanopore sequencing. The results showed 100% accuracy in pathogen identification, with up to 97% accuracy for antimicrobial resistance (AMR) markers. Ares Genetics aims to enhance AMR surveillance through cost-effective and efficient sequencing technologies, particularly in low to mid-income countries, where AMR outbreaks are a rising concern. The AREScloud software will facilitate data analysis and interpretation, supporting clinical adoption and accurate diagnostics.
OpGen, Inc. (Nasdaq: OPGN) announced the adjournment of its 2021 Annual Stockholders Meeting specifically for Proposal 2, which seeks to increase the company's authorized shares from 60 million to 110 million. The proposal received favorable initial votes, with over two-thirds in support from approximately 43% of voting shareholders. The meeting will resume on July 7, 2021. CEO Oliver Schacht emphasized the necessity of this proposal for the company's growth and flexibility, especially in managing long-term debt and raising capital. OpGen held $39.4 million in cash at Q1-end 2021.
OpGen announced its subsidiary Ares Genetics is developing a culture-free genomic assay for antimicrobial resistance (AMR) surveillance. The Ares universal pathogenome assay (ARESupa) aims to surpass limitations of current methods by using over 8,000 genetic markers. Preliminary studies indicate sensitivity rates between 94% and 100% for detecting AMR markers. A paid early access program has signed five public health organizations. This initiative supports OpGen's commercial strategies in pathogen and AMR surveillance, showcasing potential for improved diagnostic capabilities.
OpGen has submitted an updated 510(k) summary document to the U.S. FDA for its Acuitas AMR Gene Panel for Isolates. This includes essential updates as requested by the FDA, with an anticipated review completion by August 2021, though timelines may vary. The company has moved its headquarters and operations to a new 10,000 sq. ft. facility in Rockville, Maryland, expected to yield $600,000 in annual savings. OpGen also ordered 30 additional Unyvero Analyzers, aiming to meet increasing demand for their molecular diagnostic solutions.
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