OPGEN INC - OPGN STOCK NEWS

OpGen, Inc. (Nasdaq: OPGN) has scheduled a Special Meeting of stockholders for December 8, 2021, to vote on increasing its authorized shares from 50 million to 100 million. Additionally, the meeting will seek to lower the stockholder approval requirement for changes to the Company's Amended Certificate of Incorporation to a majority of outstanding shares. Stockholders eligible to vote are those on record as of October 19, 2021. Details are outlined in the Definitive Proxy Statement filed with the SEC on October 29, 2021.

OpGen, Inc. (NASDAQ: OPGN) announced it will report its third quarter 2021 financial results on November 11, 2021, after U.S. market close. A live conference call and audio webcast will start at 4:30 p.m. ET, where management will discuss the financial outcomes and current business activities. The call will be accessible via a U.S. dial-in number and an international dial-in number, with a replay available until November 25, 2021. OpGen focuses on precision medicine and molecular diagnostics to tackle infectious diseases.

OpGen has launched AREScloud, a web application aimed at enhancing the analysis of sequenced clinical isolates for infection control. The platform offers a comprehensive solution that automates data processing from raw sequence to actionable reports, supporting epidemiologists and microbiologists in combating antimicrobial resistance (AMR).

AREScloud includes access to ARESdb, a proprietary database for AMR markers. The application has been validated in clinical studies, successfully predicting antibiograms from genomic data, which is crucial for improving treatment outcomes.

OpGen, Inc. (Nasdaq: OPGN) has successfully closed a registered direct offering, raising $15 million through the issuance of 150,000 shares of convertible preferred stock and warrants for 7,500,000 shares of common stock. The preferred stock is convertible at $2.00 per share, subject to shareholder approval for increasing authorized shares. The funds will support the commercialization of the Acuitas AMR Gene Panel test, further development of the Unyvero platform, debt repayment, and general corporate purposes. The company plans to amend its bylaws to facilitate the offering.

OpGen, Inc. (Nasdaq: OPGN) announced a definitive agreement for a registered direct offering to a single institutional investor. This includes 150,000 shares of convertible preferred stock and warrants for gross proceeds of $15 million. The preferred stock is convertible into 7,500,000 shares of common stock at a price of $2.00 per share after shareholder approval. Proceeds will be used for commercialization of the Acuitas AMR Gene Panel, repayment of debt, and other corporate purposes. The offering is expected to close around October 18, 2021.

OpGen announced FDA 510(k) clearance for the Acuitas® AMR Gene Panel, allowing testing for 28 genetic antimicrobial resistance markers across 26 pathogens. This panel aids clinicians in managing antibiotic-resistant infections and is expected to launch commercially in Q4 2021. The panel provides rapid results, enhancing decision-making in antibiotic treatment, and is considered a vital tool in combatting the severe global threat of drug-resistant bacteria, which cause significant infections and deaths annually.

OpGen, Inc. (Nasdaq: OPGN) reported preliminary Q3 2021 revenue of approximately $1.2 million, a slight increase from $1.1 million in Q3 2020. Cash reserves surged to $25.4 million as of September 30, 2021, compared to $13.4 million at the end of 2020. Key developments include receiving FDA 510(k) clearance for the Acuitas AMR Gene Panel and initiating a clinical trial for Unyvero UTI. The company is also finalizing the appointment of a new CFO and filed a shelf registration for up to $150 million to support future growth.

OpGen has initiated a prospective multicenter clinical trial for its Unyvero Urinary Tract Infection (UTI) Panel, which tests for various pathogens and antimicrobial resistance directly from urine samples. The trial aims to include over 1,500 U.S. patients and evaluate the panel's clinical performance in comparison to standard culture-based testing. Following the study, OpGen intends to submit data to the FDA for clearance. The Unyvero platform previously obtained FDA clearance for other panels, enhancing its market potential in addressing UTIs, a significant public health issue with 3 million cases annually in the U.S.

OpGen announced significant clinical results from its Unyvero Hospitalized Pneumonia (HPN) panel, demonstrating a 45.1% reduction in inappropriate antibiotic therapy and an average therapy duration decrease of 39 hours. The study involving 208 patients showed a threefold increase in avoiding inappropriate therapy for those diagnosed using Unyvero. Results presented at the European Respiratory Society conference reflect the tool's effectiveness in managing pneumonia cases at risk for Gram-negative bacteria, underscoring its potential in antibiotic stewardship.