OpGen Announces Preliminary Unaudited Revenue and Cash Position for Third Quarter 2022 and Provides Business Update

• Preliminary Total Revenue for Q3 2022 was approximately $0.4 million
• Cash as of September 30, 2022 was approximately $10.3 million and as of October 3, 2022 was approximately $13.3 million
• Additional customer contract for Acuitas AMR Gene Panel signed in Q3 2022
  
  

ROCKVILLE, Md., Oct. 27, 2022 (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 2022 was approximately $0.4 million, down from $1.2 million in the third quarter of 2021. Cash as of September 30, 2022 was approximately $10.3 million and, following the successful closing of a financing transaction, was approximately $13.3 million as of October 3, 2022.

The company announced accomplishment of the following key milestones and recent developments in the third quarter of 2022:

• OpGen subsidiary Curetis and BioVersys signed a collaboration agreement for clinical trial support
• OpGen signed another commercial customer contract for the Acuitas AMR Gene Panel
• OpGen closed a registered direct offering for gross proceeds of $3.38 million on October 3, 2022
• OpGen announced successful completion of clinical trial enrollment for the Unyvero Urinary Tract Infection Panel
• OpGen subsidiary Curetis and FIND signed a R&D collaboration agreement for the Unyvero A30 RQ platform
• Nasdaq granted OpGen a 180-day extension to meet Nasdaq’s minimum bid price requirement
• OpGen launched ARES sequencing services in the U.S. from its Rockville, Maryland laboratory
• OpGen subsidiary Ares Genetics GmbH entered into a collaboration agreement with the Belgian national reference center for invasive S. pneumoniae at University Hospital Leuven

Mr. Schacht commented, “We have seen a decrease in revenue in Q3 2022 compared to last year’s third quarter due to the completion of the New York State Department of Health project in Q3 last year, and lower than expected ARES sales. Our preliminary quarterly results do not reflect the potential impact from the FIND collaboration agreement, which is expected to culminate with a series of milestones and deliverables at the end of Q1 2023. Acuitas sales are not reflected in the third quarter numbers at a material level either, since the first couple of sites became operational with completed systems installations and trainings in October. We have been informed by Beijing Clear Biotech’s regulatory advisors about NMPA feedback regarding our Unyvero A50 pneumonia product which would require us to re-submit in China under a new electronic filing regime. We are in dialog with them to gain further insights and assess the potential impact on the overall process and timelines and will provide an update as soon as practicable.”

The preliminary Q3 2022 financial results are estimates prior to the completion of OpGen’s financial closing procedures and review procedures by its external auditors and therefore may be subject to adjustment when the actual results are available.

About OpGen, Inc.

OpGen, Inc. (Rockville, MD, U.S.A.) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction including ARESiss, ARESid, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.

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Forward-Looking Statements

This press release includes statements regarding OpGen’s third quarter 2022 results and the current business of OpGen. These statements and other statements regarding OpGen’s future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the success of our commercialization efforts, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the fact that we may not effectively use proceeds from recent financings, the continued realization of expected benefits of our business combination transaction with Curetis GmbH, the continued impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, our ability to satisfy debt obligations under our loan with the European Investment Bank, the effect of the military action in Russia and Ukraine on our distributors, collaborators and service providers, our liquidity and working capital requirements, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

OpGen:

Oliver Schacht

President and CEO

OpGen Press Contact:

Matthew Bretzius 

FischTank Marketing and PR

OpGen Investor Contact:

Alyssa Factor

Edison Group