OpGen

OpGen, Inc. is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. It engages in the development of molecular information products and services for global healthcare settings. The firm's also offers guidance to clinicians about life threatening infections, improving patient outcomes, and decreasing the spread of infections caused by multidrug-resistant microorganisms. Its products include Unyvero, Acuitas AMR Gene Panel and Acuitas Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction. The company was founded on January 22, 2001 and is headquartered in Gaithersburg, MD.

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GAITHERSBURG, Md., Nov. 24, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced it has entered into a definitive agreement for a private placement with one healthcare-focused U.S. institutional investor of (i) 2,245,400 shares of common stock together with 2,245,400 warrants (the “Common Warrants”) to purchase up to 2,245,400 shares of common stock and (ii) 2,597,215 pre-funded warrants (the “Pre-Funded Warrants”), with each Pre-Funded Warrant exercisable for one share of common stock, together with 2,597,215 Common Warrants to purchase up to 2,597,215 shares of common stock. Each share of common stock and accompanying Common Warrant are being sold together at a combined offering price of $2.065, and each Pre-funded Warrant and accompanying Common Warrant are being sold together at a combined offering price of $2.055. The Pre-Funded Warrants are immediately exercisable, at an exercise price of $0.01, and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. The Common Warrants will have an exercise price of $1.94 per share, will be exercisable commencing on the six month anniversary of the date of issuance, and will expire five and one half (5.5) years from the date of issuance (collectively, the “Private Placement”).

OpGen, Inc. Announces $10 Million Private Placement Priced at the Market

Early access program launched for the next generation of the ARESupa Universal Pathogenome Assay based on targeted next-generation sequencing (NGS) of native specimens

OpGen Group Company Ares Genetics Commercially Launches NGS-based Antibiotic Resistance Testing Service for Native Specimens and Receives Bulk Order from Public Health Agency

OpGen, Inc. (OPGN) CEO Oliver Schacht on Q3 2020 Results - Earnings Call Transcript

Conference call to be held at 4:30 p.m. Eastern Time today

OpGen Reports Third Quarter 2020 Financial Results and Provides Business Update

GAITHERSBURG, Md., Oct. 29, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc. (NASDAQ: OPGN) (“OpGen” or “the Company”) announced today that the Company will provide a business update and report its third quarter 2020 financial results after the close of the U.S. financial markets on Wednesday, November 11, 2020. OpGen's management team will host a live conference call and audio webcast at 4:30 p.m. Eastern Time to discuss the Company's financial results and provide an update on business activities.

OpGen to Provide Business Update and Financial Results for the Third Quarter 2020

GAITHERSBURG, Md. and HOLZGERLINGEN, Germany, Oct. 28, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today the award of a German Federal Government grant to its subsidiary, Curetis GmbH, and collaborators Carpegen GmbH (Muenster, Germany) and the Clinic for Small Animal Internal Medicine of the LMU Ludwig-Maximilians- University (Munich, Germany).

OpGen Announces Award of German Government Grant Funding to its Subsidiary Curetis and Collaborators

GAITHERSBURG, Md., Oct. 15, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that total preliminary unaudited revenue for the third quarter of 2020 was approximately $1.0 million, up from $648 thousand in the third quarter of 2019. The preliminary financial results for the three months ended September 30, 2020 reflect the consummation of our business combination with Curetis GmbH on April 1, 2020. The results for the nine months ended September 30, 2020 will be included in the Company’s Quarterly Report on Form 10-Q and earnings release for the third quarter of 2020. OpGen’s cash as of September 30, 2020 was approximately $10.4 million. The company also expanded its capacity under its ATM program by an additional $6.4 million, and continues to have access to an additional EUR5.0 million tranche of non-dilutive debt financing for COVID-19 related R&D programs from the European Investment Bank.

OpGen Provides Business and Pipeline Update and Announces Preliminary Unaudited Revenue and Cash Position for the Third Quarter 2020

GAITHERSBURG, Md., Oct. 13, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that it has issued its formal response to the second of the FDA’s AI Requests (Additional Information Request) for the Acuitas AMR Gene Panel pre-market submission, addressing what OpGen believes to be all of the FDA’s questions and open items.

OpGen Issues Formal Response to FDA’s Requests for Additional Information and Expects Near Term FDA Clearance Decision for Acuitas AMR Gene Panel

Ares Genetics wins Austrian Digitization Award for Digital Products and Solutions

OpGen Group Company Ares Genetics Wins Austrian Digitization Award for ares-genetics.cloud

GAITHERSBURG, Md. and HOLZGERLINGEN, Germany, Sept.  28, 2020  (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today the successful completion of the clinical study between its subsidiary, Curetis GmbH, and Karolinska Institutet, Stockholm, Sweden. The collaboration was set out to identify bacterial co-infections in hospitalized patients with COVID-19 pneumonia. The patients in this study had been admitted to the ICU after respiratory deterioration during hospital stay, and their lower respiratory tract samples were analyzed with the Unyvero HPN panel.

OpGen Announces Successful Completion of Study Collaboration with Karolinska Institutet on Bacterial Co-Infections in COVID-19 Pneumonia Patients and Presents Data on Unyvero HPN Panel at ECCVID 2020

GAITHERSBURG, Md., Sept.  18, 2020  (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or the “Company”) announced today that it has changed the venue of its 2020 Annual Meeting of Stockholders due to continuing health and safety considerations arising from the COVID-19 pandemic. As a result, the Company’s 2020 Annual Meeting of Stockholders will now be held at OpGen’s corporate headquarters at 708 Quince Orchard Road, Gaithersburg, Maryland 20878.

OpGen, Inc. Announces Notice of Annual Meeting Venue Change

Published Study on Modifiable Risk Factors for the Emergence of Ceftolozane-Tazobactam Resistance

Collaborative Research by OpGen Group Company Ares Genetics and Johns Hopkins Researchers Demonstrates Potential of Next-Generation Sequencing for Investigation of Genetic Antimicrobial Resistance Mechanisms and Molecular Susceptibility Testing

Ares Genetics nominated for the 40th Austrian Innovation Award by Federal Ministry for Digital and Economic Affairs

OpGen Group Company Ares Genetics Nominated for Austrian Innovation Award for AI-powered Molecular Antibiotic Susceptibility Test

GAITHERSBURG, Md., and HOLZGERLINGEN, Germany, Sept.  02, 2020  (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today the release of a new peer-reviewed publication that demonstrates the clinical utility of the Unyvero LRT panel and its potential impact on antibiotic use in hospitalized patients with suspected pneumonia compared to treatment directed based on microbiological culture results.

Key Publication of Clinical Study Demonstrates Unyvero Lower Respiratory Tract (LRT) Panel is Likely to Alter Antibiotic Management of Significant Numbers of Patients Presenting with Suspected Pneumonia

OpGen (NASDAQ: OPGN) shares are trading higher after the company announced its subsidiary obtained the CE mark certification in the European Union for its own SARS-CoV-2 Kit with PULB detection of SARS-CoV-2.

Why OpGen's Stock Is Trading Higher Today

Shares of Maryland-based OpGen Inc. OPGN, -0.96% rocketed 43% in active premarket trading Thursday, after the molecular diagnostics company said its Germany-based Curetis GmbH subsidiary obtained the CE mark certification in the European Union for its SARS-CoV-2 test kit.

OpGen's stock soars after Curetis sub obtains CE mark certification in the EU for COVID-19 test

- Own developed SARS-CoV-2 Kit with PULB for COVID-19 uses real-time PCR (RT-PCR) technology on open PCR platforms, designed to provide results in approximately one hour

OpGen Announces CE-IVD Marking and Commercial Launch in Europe of its Own Developed Molecular Diagnostic SARS-CoV-2 Kit with PULB for Detection of the Virus Causing COVID-19

OpGen, Inc. (OPGN) CEO Oliver Schacht on Q2 2020 Results - Earnings Call Transcript

Shares of OpGen (NASDAQ:OPGN) rose 4.98% in after-market trading after the company reported Q2 results.

Recap: OpGen Q2 Earnings

OpGen Reports Second Quarter 2020 Financial Results and Provides Business Update

OpGen (NASDAQ: OPGN) will be releasing its next round of earnings this Wednesday, August 12.

A Preview Of OpGen's Earnings

Accurate identification of antibiotic resistance markers based on the ARESdb QIAGEN CLC Module leveraging Ares Genetics’ proprietary antibiotic resistance database

OpGen Group Company Ares Genetics Demonstrates Feasibility of CLIA-compliant Next Generation Sequencing Workflow for Identification of Bacterial Pathogens and Antibiotic Resistance Markers

GAITHERSBURG, Md., Aug.  09, 2020  (GLOBE NEWSWIRE) -- As disclosed in OpGen, Inc.’s (NASDAQ: OPGN) (“OpGen” or “the Company”) July 13, 2020 press release, we have commenced marketing and promotion, on a non-exclusive basis, of certain products offered by Menarini Silicon Biosystems (MSB) to infectious disease healthcare providers and researchers.  As part of the co-promotion relationship, OpGen is marketing and promoting the CELLSEARCH system, CELLSEARCH CEC kit, and certain COVID-19 related products that are sold and distributed by MSB on a non-exclusive basis.  OpGen is authorized to market and promote such products in the United States, Canada, and Mexico under a strategic co-promotion agreement entered into by OpGen and MSB.  As described in our tweet on August 7, 2020, the COVID-19 related products include an IgG/IgM Rapid Test Cassette that is manufactured by Healgen and sold by MSB, which is an antibody test that provides results in as fast as 10 minutes.  As further described at  http://www.siliconbiosystems.com/covid-19-tests , the IgG/IgM Rapid Test Cassette has been authorized by the FDA under an emergency use authorization for use by authorized laboratories.  The test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.  Under the terms of the co-promotion agreement, OpGen is entitled to certain payments based on MSB’s net sales from customers referred by OpGen for such products, including the IgG/IgM Rapid Test Cassette.  The parties expect to continue to expand the portfolio of COVID-19 products available as part of the non-exclusive co-promotion relationship.

OpGen Co-Markets COVID-19 Antibody Test Kit

GAITHERSBURG, Md., Aug.  05, 2020  (GLOBE NEWSWIRE) -- OpGen, Inc. (NASDAQ: OPGN) (“OpGen” or “the Company”) announced today that the Company will provide a business update and report its second quarter 2020 financial results after the close of the U.S. financial markets on Wednesday, August 12, 2020. OpGen’s management team will host a live conference call and audio webcast at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide an update on business activities.

OpGen to Provide Business Update and Financial Results for the Second Quarter 2020

GAITHERSBURG, Md., July  15, 2020  (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN)(“OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced today that total preliminary unaudited revenue for the second quarter of 2020 was approximately $1.2 million up from $1.0 million in the second quarter of 2019. The preliminary financial results for the three months ended June 30, 2020 reflect the consummation of our business combination with Curetis GmbH on April 1, 2020.  The results for the six months ended June 30, 2020 will be included in the Company’s Quarterly Report on Form 10-Q and earnings release for the second quarter of 2020.  Cash as of June 30, 2020 was approximately $12.8 million, an increase from the $11.5 million as of March 31, 2020.

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