OPGEN INC - OPGN STOCK NEWS

OpGen, Inc. (Nasdaq: OPGN) has submitted a De Novo classification request to the FDA for its Unyvero UTI panel aimed at detecting urinary tract infections from urine specimens. The submission follows a successful clinical trial involving over 1,800 patient samples, which demonstrated a high overall weighted average sensitivity of 96.8% and specificity of 97.4%. The Unyvero UTI Panel detects a variety of bacterial and fungal pathogens and antimicrobial resistance markers. This submission represents a major milestone for OpGen, as it aims to be the first high multiplex molecular diagnostic IVD for urine samples to receive FDA clearance. The company plans to present trial data at the ASM Microbe 2023 conference on June 17, 2023.

OpGen, Inc. (Nasdaq: OPGN) has announced an amendment to its R&D collaboration with FIND, significantly expanding the project's scope. The collaboration, which began in fall 2022, is projected to generate up to €830,000 in potential revenue. This expansion includes three new work packages: an Antimicrobial Stewardship Module, a 'Data everywhere' concept for remote connectivity in low- and middle-income countries, and Next Generation Sequencing strain analysis from several sub-Saharan African countries. The company is optimistic about enhancing solutions to combat infectious diseases through these initiatives.

OpGen, Inc. (Nasdaq: OPGN) announced the completion of two interim milestones in its PREPLEX project, part of the InfectoGnostics Research Campus in Jena, Germany. The total project volume is approximately $0.9 million. The milestones focus on AI-powered assay development for detecting carbapenemase resistance in Gram-negative bacteria, with specific biomarkers identified in Klebsiella pneumoniae and Pseudomonas aeruginosa. Dr. Gerd Luedke from Curetis emphasized the significance of these discoveries in combating antimicrobial resistance. The success of this collaboration may lead to additional funding opportunities for OpGen in the future.

OpGen, Inc. (Nasdaq: OPGN) reported a total revenue of approximately $2.6 million for 2022, with $722 thousand in Q4, marking a 61% increase over Q3 revenue. Operating expenses rose to $37.2 million, influenced by a $5.4 million impairment charge. Despite a revenue decline from 2021, the company achieved key milestones, including a successful UTI clinical trial and initial commercial contracts for the Acuitas AMR Gene Panel. OpGen anticipates global revenues of $4 to $5 million in 2023 and plans to pursue significant growth in its Unyvero and ARESiss products, indicating a focus on expanding market presence.

OpGen, Inc. (NASDAQ: OPGN) has announced it will release its fourth quarter and full year 2022 financial results on March 29, 2023, after U.S. market close. The management team will conduct a live conference call at 4:30 p.m. Eastern Time to discuss the results and provide a business update. Investors can join via U.S. dial-in at 1-877-704-4453 or international dial-in at 1-201-389-0920, with a replay available until April 12, 2023. OpGen focuses on molecular diagnostics and bioinformatics for infectious diseases, leveraging its product portfolio which includes Unyvero and the Acuitas AMR Gene Panel.

OpGen has relocated its subsidiary Ares Genetics to a new 5,000 sq. ft. facility in Vienna, Austria, consolidating its lab and office operations. The move aims to support growth in its product and NGS service business. In Q1 2023, ARESdb, OpGen's antimicrobial resistance database, expanded by 28%, with over 130,000 clinical isolates. Collaborations with U.S. and European labs are enhancing this unique asset. Additionally, OpGen completed sequencing of clinical isolates from a UTI study, positioning itself for future commercial projects. The company anticipates generating service revenue as it scales operations.

OpGen, Inc. (Nasdaq: OPGN) announced the full exercise of 2,265,000 prefunded warrants from its public offering that concluded on January 11, 2023. This exercise resulted in the issuance of an equal number of common shares, bringing the total shares outstanding as of February 15, 2023, to 5,483,919. As of February 16, 2023, all prefunded warrants have been fully exercised. OpGen specializes in precision medicine through molecular diagnostics and bioinformatics, aiming to combat infectious diseases. Its product portfolio includes Unyvero, Acuitas AMR Gene Panel, and various AI-powered solutions.

OpGen, Inc. (Nasdaq: OPGN) announced the granting of a significant patent by the China National Intellectual Property Administration (CNIPA) to its subsidiary, Ares Genetics. The patent, titled "Genetic resistance prediction against antimicrobial drugs in microorganism using structural changes in the genome," allows for identifying genetic variations linked to antibiotic resistance in bacteria. This innovation aims to enhance diagnostics for antibiotic-resistant infections, which currently result in 1.57 million deaths annually. OpGen's focus on whole genome sequencing (WGS) is expected to play a crucial role in managing healthcare-associated outbreaks and informing effective antibiotic therapy.

OpGen, Inc. announced preliminary unaudited revenue of approximately $2.7 million for 2022, aligning with its prior guidance. The cash position as of December 31, 2022, stood at $7.4 million. The recent $7.5 million public offering strengthened its balance sheet. Key milestones include a successful UTI clinical trial showing a weighted average sensitivity of 96.4% and specificity of 97.4%, and a collaboration with BioVersys to support a phase II clinical trial. The company has initiated multiple new commercial agreements, enhancing growth prospects for 2023.