OpGen Provides Business Update and Announces Preliminary Unaudited Q3 2021 Revenue and Cash Position

  • Preliminary total revenue for the third quarter of 2021 was approximately $ 1.2 million

  • Cash at September 30, 2021 was approximately $ 25.4 million, up sharply from $ 13.4 million at the end of 2020

  • OpGen has completed the search and plans to announce a new CFO once the appointment is formalized

ROCKVILLE, Maryland, October 04, 2021 (GLOBE NEWSWIRE) – OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to fight infectious diseases, today announced that total unaudited preliminary revenue for the third quarter of 2021 was approximately $ 1.2 million, compared to $ 1.1 million in the third quarter of 2020. Cash flow as of September 30, 2021 was approximately $ 25.4 million, an increase from $ 13.4 million as of Dec.31. 2020.

The company announced the completion of the following key milestones and recent developments in the third quarter as well as 2021 to date:

  • OpGen has received 510 (k) clearance from the FDA for its AMR Acuitas gene panel

  • OpGen has launched a prospective multicenter clinical trial in the United States for the Unyvero UTI application

  • OpGen has completed the search and plans to announce a new CFO once the appointment is formalized

  • OpGen announced data from a prospective randomized controlled multicenter clinical study using the Unyvero HPN panel for hospitalized patients with suspected pneumonia

  • OpGen has filed a Universal Registration Statement on Form S-3 for up to $ 150 million

  • OpGen achieves milestone in Unyvero A30 QR development program with 10 systems now available for ongoing verification and validation testing

  • Ares Genetics, a subsidiary of OpGen, completed another project with Sandoz and continued to commercialize and grow the ARESiss isolate sequencing services business.

Mr Schacht commented: “As we move into the fourth quarter, we are extremely excited about the recent FDA 510 (k) clearance of our AMR Acuitas gene panel which we believe has the potential to help clinicians in diagnosing and deciding on treatment. do for patients with serious and life-threatening infections who suffer from multidrug-resistant organisms. We are preparing for a rapid commercial launch of the Acuitas AMR gene panel this quarter here in the United States. We are also in regular dialogue with the Chinese NMPA via our strategic partner Beijing Clear Bio. The Chinese NMPA has requested that additional clinical data be generated and submitted to China. We are working with our partners to finalize the study design and prepare for subsequent study execution in a timely manner, and we expect to receive feedback on the submission of pneumonia claim cartridge documents filed with the NMPA. until now. We are also delighted to have completed the search for our new CFO to join the OpGen team and plan to make the announcement when the appointment is formalized. Together with our Board of Directors, we continue to assess alternatives to fund OpGen’s future growth and believe these are steps that will help the company move forward and on the desired path. “

The preliminary financial results for Q3-2021 are estimates prior to the completion of financial close procedures and OpGen review procedures by its external auditors and therefore may be subject to adjustments when actual results become available.

About OpGen, Inc.

OpGen, Inc. (Rockville, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to fight infectious disease. Together with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we develop and market molecular microbiology solutions that help guide clinicians with faster, actionable information on life-threatening infections to improve patient outcomes and reduce the spread. infections caused by multidrug-resistant bacteria. microorganisms or MDRO. OpGen’s product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas® Lighthouse, as well as the ARES technology platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for prediction of response to antibiotics.

For more information, please visit www.opgen.com.

Forward-looking statements

This press release includes statements regarding OpGen’s third quarter 2021 results and OpGen’s current business. These statements and other statements regarding OpGen’s future plans and objectives 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 for benefit from the safe harbor of responsibility established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties which are often difficult to predict, are beyond our control, and which may lead to materially different results expectations. Factors that could cause our results to differ materially from those described include, without limitation, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance to and market our offerings of products and services, the rate of adoption of our products and services by hospitals and other healthcare providers, the fact that we may not effectively use the proceeds of our financings, the realization of the expected benefits of our transaction of business combination with Curetis GmbH, the success of our marketing efforts, the impact of COVID -19 on the operations, financial results and marketing efforts of the Company as well as on capital markets and general economic conditions , the effect on our business of existing and new regulatory requirements, and other economic and competing factors. tials. For a discussion of the most important risks and uncertainties associated with OpGen’s business, please see 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 assume no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

OpGen:
Olivier Schacht
President and CEO
Investor [email protected]

OpGen press contact:
Matthew Bretzius
Marketing and public relations FischTank
[email protected]

Contact for OpGen investors:
Joe green
Edison Group
[email protected]

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