OpGen Provides Business Update and Announces Preliminary Unaudited Revenue and Cash Position for Third Quarter 2021
04 October 2021 - 10:30PM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, announced today that total
preliminary unaudited revenue for the third quarter of 2021 was
approximately $1.2 million, up from $1.1 million in the third
quarter of 2020. Cash as of September 30, 2021 was approximately
$25.4 million, an increase from the $13.4 million as of December
31, 2020.
The company announced accomplishment of the
following key milestones and recent developments in the third
quarter as well as 2021 to date:
- OpGen received 510(k) FDA clearance for its Acuitas AMR Gene
Panel
- OpGen initiated prospective multicenter clinical trial in the
U.S. for the Unyvero UTI application
- OpGen concluded search and expects to announce new CFO once
appointment has been formalized
- OpGen announced data from prospective randomized controlled
multicenter clinical study using the Unyvero HPN panel for
hospitalized patients with suspicion of pneumonia
- OpGen filed a universal shelf registration statement on Form
S-3 for up to $ 150 million
- OpGen achieved key milestone in Unyvero A30 RQ development
program with 10 systems now available for verification and
validation testing which is ongoing
- OpGen subsidiary Ares Genetics completed another project with
Sandoz and continued commercial roll-out and growth of the ARESiss
isolate sequencing service business
Mr. Schacht commented, “As we continue into the
fourth quarter, we are extremely excited by the recent FDA 510(k)
clearance of our Acuitas AMR Gene Panel which we believe to have
the potential to aid clinicians in the diagnosis of and treatment
decision making for patients with severe, life-threatening
infections who are suffering from multi drug resistant organisms.
We are getting ready for a swift commercial launch of the Acuitas
AMR Gene Panel this quarter here in the U.S. We are also in regular
dialog with the Chinese NMPA via our strategic partner Beijing
Clear Bio. The Chinese NMPA has requested supplemental clinical
data to be generated and submitted in China. We are working with
our partners to finalize study design and prepare for subsequent
study execution in due course, and we anticipate receiving feedback
on the submission of the pneumonia application cartridge documents
filed with the NMPA thus far. We are also thrilled to have
successfully completed the search for our new Chief Financial
Officer to join the OpGen team and we anticipate making the
announcement upon formalizing the appointment. Together with our
board, we are continuing to evaluate alternatives for financing the
future growth of OpGen and believe these are steps that will help
drive the company forward and on its desired path.”
The preliminary Q3-2021 financial results are
estimates prior to the completion of OpGen’s financial closing
procedures and review procedures by its external auditors and
therefore may be subject to adjustment when the actual results are
available.
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, USA) 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 product
portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas®
Lighthouse, and the ARES Technology Platform including ARESdb,
using NGS technology and AI-powered bioinformatics solutions for
antibiotic response prediction.
For more information, please visit
www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding
OpGen’s third quarter 2021 results and the current business of
OpGen. These statements and other statements regarding OpGen’s
future plans and goals 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
to qualify for the safe harbor from liability established by the
Private Securities Litigation Reform Act of 1995. Such statements
are subject to risks and uncertainties that are often difficult to
predict, are beyond our control, and which may cause results to
differ materially from expectations. Factors that could cause our
results to differ materially from those described include, but are
not limited to, our ability to successfully, timely and
cost-effectively develop, seek and obtain regulatory clearance for
and commercialize our product and services offerings, the rate of
adoption of our products and services by hospitals and other
healthcare providers, the fact that we may not effectively use
proceeds from our financings, the realization of expected benefits
of our business combination transaction with Curetis GmbH, the
success of our commercialization efforts, the impact of COVID-19 on
the Company’s operations, financial results, and commercialization
efforts 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 competitive
factors. For a discussion of the most significant risks and
uncertainties associated with OpGen's business, please review 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 undertake no obligation to publicly update or revise
any forward-looking statement, whether as a result of new
information, future events or otherwise.
OpGen:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:Joe GreenEdison
Groupjgreen@edisongroup.com
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