March 31, 2023

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OpGen Announces Preliminary Unaudited Profits for Fiscal 2020 and Delivers Company Update

  • Preliminary overall pro-forma put together earnings for 2020 was around $5.2 million
  • Maintained solid balance sheet with $13.3 million hard cash as of December 31, 2020 and full funds elevated in 2020 of $35.3 million
  • OpGen subsidiary Ares Genetics to investigate numerous collaboration opportunities with numerous get-togethers

GAITHERSBURG, Md., Jan. 13, 2021 — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine organization harnessing the electrical power of molecular diagnostics and bioinformatics to aid overcome infectious condition, announced these days that full professional-forma preliminary unaudited profits (including earnings from discontinued functions) for OpGen in 2020 was somewhere around $5.2 million, when compared to about $6. million in 2019. Fourth quarter 2020 earnings for OpGen was close to $1.3 million compared to $ .8 million in Q4-2019. The company expects to offer fourth quarter 2020 and whole 12 months 2020 financial results for the duration of its approaching earnings simply call in March 2021. OpGen’s cash posture as of December 31, 2020 was close to $13.3 million, an boost from $2.7 million in 2019.

The corporation also introduced accomplishment of the adhering to crucial milestones and current developments in the fourth quarter and comprehensive year 2020 as nicely as 2021 to date:

  • Subsequent the announced delay in Food and drug administration review of the Acuitas AMR Gene Panel 510(k) submission due to the agency’s prioritization of COVID-19 connected EUAs, OpGen anticipates the re-allocation of Food and drug administration employees to the critique of non-COVID-19 linked submissions and a close to term clearance choice for the Acuitas AMR Gene Panel in Q1-2021.
  • The 90-working day distinctive negotiation period with a world foremost IVD company husband or wife to a likely collaboration and licensing offer not too long ago expired. Even though a larger sized strategic offer and licensing settlement is not expected to materialize with these kinds of husband or wife in the near expression, the functions proceed to go over on a non-unique foundation probable targeted and focused R&D collaboration as well as achievable licensing opportunities. Ares Genetics expects to engage in numerous further more partnering and licensing discussions with additional IVD companions that expressed interest in collaborating in the coming months.
  • OpGen subsidiary Curetis entered into exclusive distribution partnership in Colombia with Annar Health and fitness Systems for Curetis’ Unyvero A50 system.
  • OpGen declared the release of a new peer-reviewed publication that demonstrates that the Unyvero LRT BAL panel correctly detects 19 microbes along with Pneumocystis jirovecii and 10 antibiotic resistance genes straight from bronchoalveolar lavage fluid, making it possible for enhanced diagnosis of decrease respiratory tract infections.
  • OpGen accomplished a $ 10 million personal placement priced at the market with one health care-concentrated U.S. institutional trader, bringing the full amount of money of capital raised in 2020 to $35.3 million, which include the proceeds of the company’s ATM facility and warrant routines.
  • Ares Genetics prolonged its collaboration with Sandoz within just its pharma partnering program. Ares Genetics introduced improvements of its investigate use only (RUO) based platform for predictive antibiotic susceptibility testing (AST) at a variety of scientific conferences and expects granting of essential patent on genetic resistance prediction.
  • OpGen’s wholly owned subsidiary, Ares Genetics GmbH, finished the transition of leadership to Dr. Arne Materna, who was appointed as Controlling Director and CEO of Ares Genetics helpful January 1, 2021.
  • OpGen’s subsidiary, Curetis GmbH, attained CE mark certification in the European Union for its possess SARS-CoV-2 Package with PULB for the detection of SARS-CoV-2, the virus that brings about COVID-19.
  • Streamlined portfolio of platforms and products with concentrate heading forward on Unyvero UTI and IJI for impending scientific trials in 2021 and subsequent Fda submissions.
  • Exiting FISH organization by mid 2021 and finished Acuitas AMR Gene Panel urine demo in fall of 2020.

Oliver Schacht, President & CEO of OpGen, commented, “We are pleased with our fourth quarter and complete 12 months 2020 preliminary results and are off to a powerful begin into 2021. With our new corporate strategy described and portfolio consolidation correctly completed, a robust cash placement and powerful world partnerships, there is no doubt that our company has the likely to improve appreciably in the coming a long time. I am primarily energized about impending critical milestones this sort of as an Food and drug administration clearance determination on the Acuitas AMR Gene Panel for isolates.”

Mr. Schacht ongoing, “We have powerful strains of communication open with the Food and drug administration relating to the Acuitas AMR Gene Panel for Isolates. Based mostly on the most the latest opinions from the Fda, we be expecting them to resume critique actions next a COVID-19 linked staffing surge, and we reiterate anticipation of a close to time period clearance decision in Q1-2021 and are totally well prepared to follow with a swift commercial launch once Food and drug administration cleared. Although a strategic collaboration and licensing offer did not materialize throughout the 90-day distinctive negotiation interval involving Ares Genetics and our IVD husband or wife, discussions to take a look at even more probable collaboration alternatives keep on. In addition, we are seeking forward to staying in a position to re-engage and go on our dialog with a number of extra events primarily based on current inbound expressions of fascination, on a non-exceptional foundation more than the coming months. In closing, we concluded the calendar year strong with a stable harmony sheet, entry to supplemental funds and a pipeline and R&D portfolio that permit us to produce and commercialize business-foremost, knowledge-driven remedies in infectious sickness diagnostics.”

The preliminary economical benefits are estimates prior to the completion of OpGen’s financial closing strategies and assessment procedures by its external auditors and hence could be issue to adjustment when the real outcomes are readily available.

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, United states of america) is a precision medicine corporation harnessing the energy of molecular diagnostics and bioinformatics to assistance battle infectious ailment. Together with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are building and commercializing molecular microbiology answers encouraging to guideline clinicians with extra quick and actionable info about daily life threatening infections to make improvements to affected person outcomes, and minimize the unfold of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s product or service portfolio incorporates Unyvero, Acuitas AMR Gene Panel and Acuitas® Lighthouse, and the ARES Technology System which include ARESdb, employing NGS technologies and AI-driven bioinformatics options for antibiotic reaction prediction.

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Ahead-On the lookout Statements

This press launch consists of statements about OpGen’s fourth quarter 2020 and full year outcomes, expected Food and drug administration overview and clearance conclusion regarding the Acuitas AMR Gene Panel for isolates, probable strategic partnering and licensing chances for Ares Genetics, and the impact of COVID-19 on the corporation and common market place disorders. These statements and other statements with regards to OpGen’s Unyvero products and solutions, their commercialization and start, long run designs and goals represent “forward-hunting statements” inside of the that means of Segment 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are meant to qualify for the risk-free harbor from legal responsibility set up by the Personal Securities Litigation Reform Act of 1995. This sort of statements are subject to pitfalls and uncertainties that are typically challenging to predict, are past our manage, and which might bring about results to differ materially from expectations. Elements that could lead to our results to differ materially from all those explained consist of, but are not minimal to, our means to correctly, well timed and charge-properly develop, seek out and obtain regulatory clearance for and commercialize our merchandise and products and services offerings, the level of adoption of our products and solutions and solutions by hospitals and other healthcare companies, the truth that we may not efficiently use proceeds from modern financings, which include our November 2020 personal placement, the realization of expected gains of our enterprise mix transaction with Curetis GmbH, the achievements of our commercialization attempts, the effect of COVID-19 on the company’s functions, economical outcomes, and commercialization initiatives as very well as on funds markets and standard financial disorders, the influence on our enterprise of current and new regulatory requirements, and other economic and competitive things. For a discussion of the most substantial challenges and uncertainties connected with OpGen’s organization, be sure to critique our filings with the Securities and Exchange Fee. You are cautioned not to place undue reliance on these ahead-hunting statements, which are dependent on our expectations as of the day of this push release and discuss only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-wanting assertion, no matter whether as a outcome of new information, long run events or or else.

OpGen: Oliver Schacht President and CEO [email protected]

OpGen Push Make contact with: Matthew Bretzius  FischTank Internet marketing and PR [email protected]

OpGen Trader Speak to: Megan Paul Edison Group  [email protected]

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