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OpGen, Inc. (OPGN) : 0.7000-0.0600 (-7.89%)
After hours: 0.7500 +0.05 (+7.14%)

52 Week Range 0.5500 - 16.4000

Total revenue for the first quarter of 2023 was approximately $0.91 million, an increase of approximately 94% compared to the first quarter of 2022

Expanded U.S. growth opportunities with the Unyvero UTI De Novo FDA submission and Unyvero distribution partnership with Fisher Healthcare

Met all remaining key milestones of the FIND collaboration for Unyvero A30

Management conference call scheduled for May 15, 2023, at 4:30 p.m. EST

ROCKVILLE, Md., May 15, 2023 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported its first quarter 2023 financial and operating results. Management will host an investor call to discuss quarterly results and provide a business update.

Oliver Schacht, President & CEO of OpGen, commented, “The beginning of this year has been a news rich period. It's clear the momentum during the first quarter has carried over to the second quarter. We look forward to our near-term strategic goals and continue to focus on executing on our operational and commercial plans.”

Mr. Schacht continued, “We continue to see revenue growth opportunities for our Unyvero products and Ares Genetics’ services globally and especially here in the U.S. We recently announced our distribution partnership for Unyvero products with Fisher Healthcare, and we believe will create traction and momentum for our Unyvero sales in the U.S. under this distribution partnership in the coming quarters and beyond.”

First Quarter 2023 Financial Results of OpGen, Inc.

Total revenue for the first quarter of 2023 was approximately $0.91 million, an increase of approximately 94% over the company’s revenue of $0.47 million in the first quarter of 2022. Compared to the fourth quarter 2022 revenue of $0.72 million, OpGen achieved a 26% revenue increase in the first quarter of 2023.

Total operating expenses decreased in the first quarter of 2023 to $6.0 million compared to $6.3 million for the same quarter in 2022.

Cash and cash equivalents were approximately $7.0 million as of March 31, 2023, compared with $7.4 million as of December 31, 2022.

During the year to date period, the Company reached the following key milestones:

OpGen subsidiary, Curetis, met all remaining key milestones in its R&D collaboration project with the Foundation for Innovative New Diagnostics (FIND).

Signed a short-term expansion of Curetis’ R&D collaboration with FIND. The work already completed under the collaboration was expanded by three work packages, which increased total project volume to up to approximately $913 thousand in revenue.

Submitted a De Novo classification request to the FDA for the marketing authorization of Unyvero Urinary Tract Infection (UTI) panel. The Company received confirmation from the FDA that the submission is complete, and that they have initiated substantive review. If cleared, the Unyvero UTI would become the first ever rapid multiplex sample-to-answer IVD test for urinary tract infections available in the U.S.

Entered a non-exclusive distribution agreement with Fisher Healthcare, a part of Thermo Fisher Scientific. This agreement is for the distribution of the Unyvero A50 platform and in vitro diagnostic tests for pneumonia and urinary tract infections.

Entered into a strategic advisory agreement to support Unyvero A30 corporate business development in China and engage in frequent, ongoing dialog with our Chinese partners.

OpGen subsidiary, Ares Genetics, announced that they were granted a key patent in China. The patent covers the identification and diagnostic use of genomic variants for the diagnosis of antibiotic resistant bacteria infections.

Closed $7.5 million and $3.5 million public offerings with net proceeds to be used, among other things, for the support of commercialization of the Acuitas AMR Gene Panel, products on the Unyvero platform, development of the ARES database, and to support direct sales and marketing as well as repayment of certain indebtedness to the EIB.

The Company reiterates and updates its guidance for 2023 as follows:

net cash consumption of around $4.5 to $5 million per quarter from its current operations;

continue pursuing significant revenue growth opportunities, especially with Unyvero product sales and ARESiss services, both in the U.S. and internationally;

actively pursue the commercial opportunities in our funnel;

expect global revenues from our products, services and collaborations for 2023 to be in the range of approximately $4 to $5 million;

engage in interactive review with the FDA towards a clearance decision on the De Novo classification request for the Unyvero UTI panel;

recognize approximately $180 thousand in the second quarter for the additional work packages from the FIND collaboration;

expect continued revenue generation and growth under the collaboration between Curetis and BioVersys during 2023 and 2024 as the BioVersys clinical trial progresses;

prioritize non-dilutive financing with several multi-million dollar proposals already submitted or currently being prepared for submission, recognizing that the Company needs a strong balance sheet to support and provide co-funding for projects under any such agreements.

Conference Call Information

OpGen’s management will host a conference call today, May 15, 2023 at 4:30 p.m. EST, to review the first quarter 2023 financial results and business activities, as well as answer analyst questions.

Conference Call Details




U.S. Dial-in Number:


1-877-704-4453

International Dial-in Number:


1-201-389-0920

Conference ID:


13738364

Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1611539&tp_key=76976884dc

Following the conclusion of the conference call, a replay will be available through May 29th, 2023. The live, listen-only webcast of the conference call may also be accessed by visiting the Investors section of the Company’s website at www.opgen.com. A replay of the webcast will be available following the conclusion of the call and will be archived on the Company’s website under Financials & Filings. Replay access information is below:

Replay Details




U.S. Dial-in Number:


1-844-512-2921

International Dial-in Number:


1-412-317-6671

Replay PIN:


13738364






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, ARESasp, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.

For more information, please visit www.opgen.com