OpGen Provides Business Update and Announces Preliminary Unaudited Revenue and Cash Position for Second Quarter 2020
July 15 2020 - 6:30AM
OpGen, Inc. (Nasdaq: OPGN)(“OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease, announced today that total
preliminary unaudited revenue for the second quarter of 2020 was
approximately $1.2 million up from $1.0 million in the second
quarter of 2019. The preliminary financial results for the three
months ended June 30, 2020 reflect the consummation of our business
combination with Curetis GmbH on April 1, 2020. The results
for the six months ended June 30, 2020 will be included in the
Company’s Quarterly Report on Form 10-Q and earnings release for
the second quarter of 2020. Cash as of June 30, 2020 was
approximately $12.8 million, an increase from the $11.5 million as
of March 31, 2020.
The company also announced accomplishment of the
following key milestones in the second quarter of 2020 and year to
date:
- OpGen announced a strategic co-promotion partnership with
Menarini Silicon Biosystems to market and sell Menarini’s
CELLSEARCH system, CELLSEARCH CEC kit and COVID-19 related products
to infectious disease healthcare providers and researchers in North
America;
- OpGen’s subsidiary Curetis GmbH secured access to an additional
EUR 5 million tranche in non-dilutive debt financing for COVID-19
related research and development. Subject to certain conditions,
Curetis can draw down the tranche at its sole discretion during a
nine-month period and the tranche will have a five-year maturity
and is interest-only until then;
- Preliminary data was released from an investigator-initiated
collaboration with Karolinska Institutet, Stockholm, Sweden, to
identify bacterial co-infections in hospitalized patients with
COVID-19 pneumonia. OpGen’s Unyvero HPN Panel for Pneumonia
identifies life-threatening bacterial co-infections in COVID-19
patients in just five hours, and Unyvero LRT and LRT BAL panels are
FDA-cleared in the U.S. for rapid detection of lower respiratory
tract infections such as pneumonia. Furthermore, performance of the
Unyvero system was highlighted in several posters and abstracts in
ASM Microbe 2020 online;
- OpGen expanded their partnership with the New York State
Department of Health and IDC (Infectious Disease Connect), to
continue the collaborative program to detect, track, and manage
antimicrobial-resistant infections at healthcare institutions
statewide. In response to the COVID-19 pandemic in New York State,
testing under the program was put on hold by the Wadsworth Center
and participating hospitals during Q2 with sites expecting to begin
running tests again in Q3;
- OpGen announced results from a study on the feasibility and
potential of antibiotic susceptibility testing and bacterial
pathogen identification using next-generation sequencing (NGS) have
been pre-published in the Journal of Clinical Microbiology. The
study was performed by OpGen’s recently acquired subsidiaries Ares
Genetics GmbH and Curetis GmbH;
- OpGen expects that its submission to the U.S. Food and Drug
Administration (“FDA”) for clearance of the Acuitas® AMR Gene Panel
(Isolates) for the detection of antimicrobial resistance genes in
bacterial isolates is nearing completion. OpGen has responded, and
is continuing to respond, to the FDA’s additional information
requests and anticipates approaching a clearance decision for the
Acuitas® AMR Gene Panel for isolates; exact timing cannot be
projected due to the COVID-19 pandemic. As a result of the
COVID-19 pandemic, the FDA has granted a 90-day extension to
marketing submissions and applications on hold as of June 2020,
which resulted in OpGen’s original submission deadline of
July 15, 2020 being extended to October 13, 2020;
- Clinical trials were initiated during the first quarter of 2020
at nine participating sites for the Company’s Acuitas AMR Gene
Panel (Urine) test. Testing and the trial have been suspended
during most of the second quarter of 2020 due to hospitals focusing
resources on the COVID-19 pandemic, however, a number of sites have
re-initiated enrollment at the end of the second quarter;
- OpGen significantly improved its working capital position in
the second quarter of 2020 through the sale of approximately 2.7
million shares of common stock for gross proceeds of $6.1 million
under the company’s ATM program during the second quarter.
During the six months ended June 30, 2020, the Company sold
approximately 5.6 million shares of common stock for gross proceeds
of $11.9 million under the company’s ATM program; and
- The German Federal Ministry for Economic Affairs and Energy
(BMWi) initiated an investigation of the OpGen business combination
with Curetis with regards to its impact on the public order and
security of the Federal Republic of Germany as well as national
healthcare interests in the light of the current COVID-19 pandemic.
OpGen has already responded to all questions currently raised by
the BMWi and will remain in constructive dialogue with the BMWi
with a view to completing the process as swiftly as possible.
Oliver Schacht, President & CEO of OpGen
commented, "While the current pandemic and subsequent economic
disruptions have continued to affect our business, we are pleased
with our robust second quarter 2020 initial results and have taken
decisive action in re-prioritizing our R&D efforts to ensure
the long-term durability of our business. We continue to expect an
FDA clearance for the Acuitas® AMR Gene Panel albeit somewhat
delayed due to the FDA’s unilateral decision to extend submission
deadlines and thereby extending their review timelines."
Mr. Schacht continued, “We also anticipate final
clinical data with our Unyvero HPN Panel for Pneumonia as it
relates to rapid testing for bacterial co-infections in COVID-19
patients. With Q2 being the first quarter of operating as a
combined company, our business has grown year-over-year during
these challenging and unprecedented times. We have successfully
integrated our R&D portfolios, operations and teams, allowing
us to develop and commercialize industry-leading, data-driven
solutions in infectious disease diagnostics. I am especially
pleased with the swift combination of our U.S. sales and marketing
teams that have been operating as a single integrated team since
the 1st of May.”
The preliminary 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. (Gaithersburg, MD, USA) is a
precision medicine company harnessing the power of molecular
diagnostics and bioinformatics to help combat infectious disease.
Along with 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 second quarter 2020 results, the integration of OpGen with
its acquired subsidiaries, Curetis GmbH and Ares Genetics GmbH, the
pursuit of FDA clearance for the Acuitas® AMR Gene Panel for use
with bacterial isolates, the current business and strategic
initiatives of OpGen, and the impact of COVID-19 on the company and
general market conditions. 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 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 Schacht President and CEO
InvestorRelations@opgen.com
OpGen Press Contact: Matthew Bretzius
FischTank Marketing and PR matt@fischtankpr.com
OpGen Investor Contact: Joe Green Edison
Group jgreen@edisongroup.com
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