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Post# of 4983909
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Re: dirkv post# 4939952

Thursday, 08/10/2023 5:33:57 PM

Thursday, August 10, 2023 5:33:57 PM

Post# of 4983909
OpGen, Inc. (OPGN) : 0.3377-0.1033 (-23.42%)
At close: 03:59PM EDT
0.2998 -0.0379 (-11.2230%)
After hours: 5:31PM EDT

Total assets $ 22,434,962
Total liabilities $ 15,575,072
Total stockholders’ equity $ 6,859,890
Weighted average shares outstanding - basic and diluted 6,246,326
= $1.10 share


Total revenue for the first half of 2023 was approximately $1.65 million, an increase of approximately 15% compared to approximately $1.44 million in the first half of 2022

Signed FIND R&D collaboration contract extension

Entered distribution agreement with Fisher Healthcare for the distribution of the Unyvero A50 platform in the U.S.

Management conference call is scheduled for August 10, 2023, at 4:30 p.m. ET

ROCKVILLE, Md., Aug. 10, 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 second quarter and first half of 2023 financial and operating results. Management will host an investor call to discuss quarterly results and provide a business update.

Second Quarter 2023 and First Half 2023 Financial Results of OpGen, Inc.

Total revenue for the second quarter of 2023 was approximately $0.7 million compared to the company’s revenue of approximately $1.0 million in the second quarter of 2022, which was primarily driven by the one-time sale of a pool of Unyvero instrument systems to Menarini in Q2-2022. Total revenue for the first half of 2023 was approximately $1.65 million, an increase of approximately 15% compared to the company’s revenue of approximately $1.44 million in the first half of 2022.

Total operating expenses decreased in the second quarter of 2023 to approximately $5.9 million compared to approximately $6.2 million for the second quarter of 2022. Total operating expenses decreased by approximately 6% in the first half of 2023 to approximately $11.9 million compared to approximately $12.6 million for the same period in 2022.

Cash and cash equivalents were approximately $3.2 million as of June 30, 2023, compared with approximately $7.4 million as of December 31, 2022.

As previously reported, and in light of the Company’s business performance and current cash position, the Company does not expect that its current cash will be sufficient to fund operations beyond September 2023. Since the end of the second quarter, the Company has pursued options to improve its cash position or mitigate a liquidity shortfall. Nevertheless, the Company has concluded that there is substantial doubt about the Company’s ability to continue as a going concern. The Company continues to consider all alternatives, including restructuring or refinancing its debt, seeking additional debt or equity capital, reducing or delaying the Company’s business activities, selling assets, and other strategic transactions or other measures, including obtaining relief under U.S. as well as applicable foreign bankruptcy laws. There is no guarantee that the Company will be able to identify and execute on any of these alternatives or that any of them will be successful.

In the reporting quarter and year to date, the Company reached the following key milestones:

OpGen subsidiary, Curetis, and FIND signed an extension to their R&D collaboration agreement for the development of an AMR panel on the Unyvero A30 RQ platform for low- and middle-income countries. This next phase covers full development of AMR assay and cartridge, analytical testing and software development.

Curetis successfully completed the first phase of its FIND collaboration, including the expanded scope of the FIND project in Q1 and Q2, respectively. The FIND collaboration contributed $609 thousand to first half 2023 revenue.

In June 2023, OpGen received ten Unyvero A30 C-Series instruments which will be used in the next phase of the FIND collaboration.

Curetis announced the completion of two interim milestones of its collaboration project with InfectoGnostics under the PREPLEX grant.

The Company submitted a De Novo classification request to the FDA for marketing authorization of the Unyvero Urinary Tract Infection (UTI) panel. Following the FDA’s substantive review of the Company’s submission, the Company received a formal communication from the FDA requesting certain additional information on June 30, 2023. The FDA has provided OpGen with 180 days to fully respond to their requests.

OpGen entered into a distribution agreement with Fisher Healthcare, a division of Thermo Fisher Scientific, for the distribution of the Unyvero A50 platform and in vitro diagnostic tests for pneumonia and urinary tract infections in the U.S. During the second quarter and year-to-date, the Company successfully completed vendor set-up of OpGen under Fisher Healthcare’s systems, trained the Fisher Healthcare sales teams across the U.S., created digital marketing campaigns, and identified several hundred potential high priority leads with the Fisher Healthcare team. In several territories, the teams are already working towards commercial customer contract opportunities.

With the assistance of a U.S.-Chinese strategic advisory firm, OpGen continues to have an active strategic corporate business development campaign to over 40 Chinese corporate IVD companies potentially interested in the Unyvero A30 RQ.

Following a successful feasibility assessment, the Ares team recently signed an annual genomic surveillance contract with a major U.S. healthcare network to sequence and analyze pathogen isolates on a twice weekly basis. In addition, the team has signed multiple new ARESiss contracts for isolate sequencing and new AREScloud subscriptions for web-based sequence analysis.

On the IP front, OpGen’s subsidiary, Ares Genetics, successfully defended a key patent that was being contested in Europe. In the ruling, the European Patent Office ruled in favor of maintaining the patent, which broadly covers the prediction of AMR in pathogens based on any genetic determinants involving two or more nucleotides.

Ares recently announced a new feature release for its AREScloud software designed to enhance genomic surveillance. These features include a Single Nucleotide Polymorphism (SNP) analysis module and interpretation of plasmids with reporting customized for the needs of hospital epidemiologists.
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