OpGen Announces Preliminary Unaudited Income for Fiscal 2020 and Offers Business enterprise Update

• Preliminary total pro-forma mixed earnings for 2020 was roughly $5.2 million
  
• Maintained solid equilibrium sheet with $13.3 million hard cash as of December 31, 2020 and whole capital elevated in 2020 of $35.3 million
• OpGen subsidiary Ares Genetics to investigate many collaboration prospects with numerous functions
  

GAITHERSBURG, Md., Jan. 13, 2021 (World NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision drugs business harnessing the power of molecular diagnostics and bioinformatics to assistance combat infectious disorder, announced currently that total pro-forma preliminary unaudited income (such as profits from discontinued functions) for OpGen in 2020 was somewhere around $5.2 million, compared to about $6. million in 2019. Fourth quarter 2020 profits for OpGen was around $1.3 million as opposed to
$ .8 million in Q4-2019. The business expects to give fourth quarter 2020 and comprehensive calendar year 2020 economic final results all through its approaching earnings connect with in March 2021. OpGen’s funds situation as of December 31, 2020 was about $13.3 million, an enhance from $2.7 million in 2019.

The corporation also announced accomplishment of the adhering to key milestones and recent developments in the fourth quarter and comprehensive year 2020 as effectively as 2021 to day:

• Following the declared hold off in Food and drug administration evaluate of the Acuitas AMR Gene Panel 510(k) submission owing to the agency’s prioritization of COVID-19 linked EUAs, OpGen anticipates the re-allocation of Fda staff towards the evaluate of non-COVID-19 similar submissions and a in the vicinity of time period clearance determination for the Acuitas AMR Gene Panel in Q1-2021.
• The 90-working day exceptional negotiation period with a international main IVD company partner in direction of a opportunity collaboration and licensing deal lately expired. Although a bigger strategic offer and licensing agreement is not anticipated to materialize with these kinds of husband or wife in the around phrase, the functions proceed to examine on a non-exceptional foundation potential specific and targeted R&D collaboration as very well as possible licensing options. Ares Genetics expects to interact in multiple even further partnering and licensing conversations with added IVD companions that expressed fascination in collaborating in the coming months.
• OpGen subsidiary Curetis entered into unique distribution partnership in Colombia with Annar Health and fitness Technologies 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 bacteria along with Pneumocystis jirovecii and 10 antibiotic resistance genes immediately from bronchoalveolar lavage fluid, letting increased prognosis of reduce respiratory tract bacterial infections.
• OpGen done a $ 10 million private placement priced at the sector with 1 healthcare-concentrated U.S. institutional trader, bringing the total sum of money lifted in 2020 to $35.3 million, such as the proceeds of the company’s ATM facility and warrant workout routines.
• Ares Genetics extended its collaboration with Sandoz inside of its pharma partnering program. Ares Genetics presented advances of its analysis use only (RUO) dependent ares-genetics.cloud platform for predictive antibiotic susceptibility testing (AST) at different scientific conferences and expects granting of essential patent on genetic resistance prediction.
• OpGen’s wholly owned subsidiary, Ares Genetics GmbH, completed the changeover of leadership to Dr. Arne Materna, who was appointed as Handling Director and CEO of Ares Genetics successful January 1, 2021.
• OpGen’s subsidiary, Curetis GmbH, attained CE mark certification in the European Union for its very own SARS-CoV-2 Package with PULB for the detection of SARS-CoV-2, the virus that will cause COVID-19.
• Streamlined portfolio of platforms and products and solutions with target going ahead on Unyvero UTI and IJI for approaching medical trials in 2021 and subsequent Food and drug administration submissions.
• Exiting FISH business by mid 2021 and finished Acuitas AMR Gene Panel urine demo in drop of 2020.

Oliver Schacht, President & CEO of OpGen, commented, “We are happy with our fourth quarter and comprehensive year 2020 preliminary success and are off to a solid begin into 2021. With our new company tactic defined and portfolio consolidation efficiently accomplished, a robust cash place and robust world wide partnerships, there is no doubt that our organization has the prospective to mature substantially in the coming years. I am in particular psyched about future key milestones these kinds of as an Food and drug administration clearance decision on the Acuitas AMR Gene Panel for isolates.”

Mr. Schacht ongoing, “We have potent traces of conversation open up with the Fda pertaining to the Acuitas AMR Gene Panel for Isolates. Centered on the most modern comments from the Food and drug administration, we expect them to resume evaluate functions following a COVID-19 similar staffing surge, and we reiterate anticipation of a in close proximity to phrase clearance conclusion in Q1-2021 and are thoroughly organized to abide by with a swift industrial start when Fda cleared. Although a strategic collaboration and licensing offer did not materialize all through the 90-working day exclusive negotiation time period among Ares Genetics and our IVD spouse, discussions to take a look at additional possible collaboration chances continue on. In addition, we are on the lookout ahead to getting capable to re-engage and continue our dialog with a number of additional functions based on modern inbound expressions of interest, on a non-unique foundation in excess of the coming months. In closing, we completed the calendar year potent with a sound equilibrium sheet, entry to additional funds and a pipeline and R&D portfolio that permit us to produce and commercialize industry-top, details-driven methods in infectious sickness diagnostics.”

The preliminary fiscal final results are estimates prior to the completion of OpGen’s financial closing methods and review strategies by its exterior auditors and hence might be subject matter to adjustment when the genuine outcomes are out there.

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, Usa) is a precision drugs enterprise harnessing the electrical power of molecular diagnostics and bioinformatics to aid fight infectious sickness. Together with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology remedies encouraging to guide clinicians with much more swift and actionable information and facts about daily life threatening bacterial infections to enhance client outcomes, and lessen the unfold of bacterial infections triggered by multidrug-resistant microorganisms, or MDROs. OpGen’s merchandise portfolio involves Unyvero, Acuitas AMR Gene Panel and Acuitas® Lighthouse, and the ARES Technology System like ARESdb, using NGS engineering and AI-powered bioinformatics answers for antibiotic response prediction.

For additional data, you should go to www.opgen.com.

Ahead-Wanting Statements

This push release consists of statements regarding OpGen’s fourth quarter 2020 and whole year results, envisioned Fda critique and clearance final decision regarding the Acuitas AMR Gene Panel for isolates, possible strategic partnering and licensing options for Ares Genetics, and the impact of COVID-19 on the business and typical sector conditions. These statements and other statements with regards to OpGen’s Unyvero products and solutions, their commercialization and launch, upcoming designs and aims represent “forward-on the lookout statements” in the which means of Portion 27A of the Securities Act of 1933 and Part 21E of the Securities Exchange Act of 1934 and are meant to qualify for the safe and sound harbor from legal responsibility established by the Personal Securities Litigation Reform Act of 1995. These statements are topic to pitfalls and uncertainties that are generally challenging to predict, are over and above our command, and which may possibly cause final results to vary materially from expectations. Things that could lead to our outcomes to differ materially from those described incorporate, but are not confined to, our potential to properly, well timed and expense-proficiently create, search for and receive regulatory clearance for and commercialize our product or service and companies offerings, the charge of adoption of our items and providers by hospitals and other healthcare vendors, the simple fact that we may not proficiently use proceeds from the latest financings, such as our November 2020 private placement, the realization of predicted positive aspects of our organization blend transaction with Curetis GmbH, the success of our commercialization efforts, the impression of COVID-19 on the company’s functions, monetary benefits, and commercialization efforts as perfectly as on funds markets and general economic circumstances, the outcome on our business enterprise of present and new regulatory needs, and other financial and aggressive factors. For a discussion of the most major challenges and uncertainties related with OpGen’s small business, please critique our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these ahead-hunting statements, which are based on our anticipations as of the day of this push release and talk only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, no matter if as a result of new facts, foreseeable future activities or or else.

OpGen:
Oliver Schacht
President and CEO
[email protected]

OpGen Press Contact:
Matthew Bretzius 
FischTank Advertising and PR
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OpGen Trader Get in touch with:
Megan Paul
Edison Group 
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