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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, Inc. (Nasdaq: OPGN) reported preliminary pro-forma revenue for 2020 of $5.2 million, a decline from $6.0 million in 2019. Q4 2020 revenue increased to $1.3 million from $0.8 million in Q4 2019. The company maintained a strong balance sheet with $13.3 million in cash and raised a total of $35.3 million in 2020. OpGen anticipates a near-term FDA clearance decision for its Acuitas AMR Gene Panel. The company has also initiated partnerships and collaborations, including with Annar Health Technologies in Colombia.
OpGen, Inc. (Nasdaq: OPGN) announced a three-year exclusive distribution agreement with Annar Health Technologies for Unyvero products in Colombia. Annar commits to purchase a minimum of 10 Unyvero systems and numerous diagnostic cartridges during this term. The agreement enhances OpGen's commercial reach in Latin America and aims to improve healthcare outcomes in Colombia, where healthcare-associated infections are prevalent. Annar will seek regulatory clearance by late 2021, supporting product introduction and investment in the local market.
OpGen, Inc. (Nasdaq: OPGN) recently published a study indicating that its Unyvero LRT BAL panel can accurately detect 19 bacteria and Pneumocystis jirovecii from bronchoalveolar lavage fluid in approximately 4.5 hours. The study demonstrated a high negative predictive value of 97.2% and positive percent agreement of 93.4% when compared to standard microbiological testing. This rapid detection is vital for appropriate antibiotic choice and stewardship, enabling better patient outcomes, especially for those with challenging pneumonia cases.
OpGen, Inc. (Nasdaq: OPGN) announced a leadership transition at its subsidiary, Ares Genetics. Effective January 1, 2021, Dr. Arne Materna will become the new Managing Director and CEO, succeeding Dr. Andreas Posch, who is stepping down to pursue new opportunities. Both Posch and Dr. Achim Plum will remain as special advisors to ensure a smooth transition. Dr. Materna brings extensive experience in bioinformatics and next-generation sequencing, having previously worked at CosmosID and QIAGEN. This change is aimed at positioning Ares Genetics for future growth in AI-driven diagnostics.
OpGen has extended its collaboration with Sandoz to enhance antibiotic drug positioning through predictive antibiotic susceptibility testing. Ares Genetics, a subsidiary of OpGen, plans to present advancements in its ares-genetics.cloud platform at upcoming conferences. Additionally, OpGen anticipates receiving a significant patent for genetic resistance prediction against antimicrobial drugs. This partnership aims to develop a digital anti-infectives platform integrating microbiological methods with bioinformatics and AI.
OpGen, Inc. (Nasdaq: OPGN) announced a definitive agreement for a private placement with a U.S. institutional investor, involving the sale of 2,245,400 shares of common stock and warrants, as well as 2,597,215 pre-funded warrants. The placement, priced at $2.065 per share and $2.055 per pre-funded warrant, is expected to close on November 25, 2020, subject to regulatory approvals. Proceeds from the placement will support OpGen's efforts in developing and commercializing molecular diagnostics to combat infectious diseases.
OpGen, Inc. (Nasdaq: OPGN) announced the launch of an early access program for its ARESupa Universal Pathogenome Assay, a next-generation sequencing (NGS) test aimed at detecting antibiotic resistance markers from native specimens. This innovative assay, developed by Ares Genetics, is based on the proprietary ARESdb database and incorporates hybrid-capture NGS technology. The company has received commercial orders exceeding $250,000 from a public health agency, indicating substantial demand for its AMR profiling solutions. CEO Dr. Andreas Posch highlights this launch as a milestone in combating antibiotic resistance.
OpGen reported total revenue of approximately $1.1 million for Q3 2020, a significant increase from $0.6 million in Q3 2019. The company maintains a strong cash position of $10.5 million as of September 30, 2020, with an additional $6.4 million accessible via an expanded ATM program. However, operating expenses rose to $7.2 million for Q3 2020, leading to a net loss of $7.7 million or $0.40 per share. OpGen is focusing on the Unyvero platform and discontinuing certain product lines to realize operational efficiencies and cost savings.
OpGen, Inc. (NASDAQ: OPGN) will release its third quarter 2020 financial results and provide a business update on November 11, 2020, after U.S. market close. The management team will host a live call at 4:30 p.m. ET to discuss the results. Investors can join via U.S. dial-in at +1 (877) 705 6003 or international dial-in at +1 (201) 493 6725. A replay will be available until November 25, 2020. OpGen focuses on molecular diagnostics for infectious diseases, aiming to improve patient outcomes by addressing multidrug-resistant organisms.
OpGen, Inc. (Nasdaq: OPGN) announced a grant award to its subsidiary Curetis GmbH for a project aimed at developing rapid molecular diagnostics for travel-related and enteric diseases in small animals. The collaboration with Carpegen GmbH and LMU Munich will utilize the Unyvero A30 RQ platform. The project, funded by the German Federal Government, aims to address unmet clinical needs with a budget exceeding EUR 500,000, of which Curetis expects to receive EUR 152,000. The initiative starts on December 1, 2020, and highlights the potential to prevent zoonotic diseases affecting both animals and humans.
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