OpGen Provides Business and Pipeline Update and Announces Preliminary Unaudited Revenue and Cash Position for the Third Quart...
October 15 2020 - 7:30AM
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 2020 was
approximately $1.0 million, up from $648 thousand in the third
quarter of 2019. The preliminary financial results for the three
months ended September 30, 2020 reflect the consummation of our
business combination with Curetis GmbH on April 1, 2020. The
results for the nine months ended September 30, 2020 will be
included in the Company’s Quarterly Report on Form 10-Q and
earnings release for the third quarter of 2020. OpGen’s cash as of
September 30, 2020 was approximately $10.4 million. The company
also expanded its capacity under its ATM program by an additional
$6.4 million, and continues to have access to an additional EUR5.0
million tranche of non-dilutive debt financing for COVID-19 related
R&D programs from the European Investment Bank.
In addition, the company announced details
regarding a strategic reprioritization of its product portfolio,
platform pipeline and priorities going forward. This
reprioritization was based on feedback from extensive market
research, a customer survey of 150 stakeholders in the decision
making on new diagnostic platforms, and key opinion leader
interviews conducted by an independent market research firm over
the past two quarters. Following a review of this research, OpGen
and its Board decided to consolidate the company’s product
portfolio on its proprietary Unyvero platform and unique
bioinformatics capabilities. As a result of this change in
priority, the company anticipates the following key impacts:
- Product portfolio going forward to be centered around rapid,
molecular diagnostic platform offerings and increased focus on
value added bioinformatics solutions, including Ares Genetics’ next
generation sequencing-based and artificial intelligence powered AMR
and AST prediction capabilities.
- Following the successful completion of the three phases of the
partnered R&D program as announced in the H1-2020 earnings
call, Ares Genetics has recently received formal notification from
its undisclosed global leading IVD corporation partner that they
have exercised their option to exclusively negotiate with Ares
Genetics the scope and terms of a potential exclusive license or
other arrangement with Ares to Ares Genetics’ technology in the
field of human clinical diagnostics in the coming months.
- Platform consolidation to realize significant operational
synergies and cost savings over time as fewer products and
platforms would need to be maintained from a regulatory, quality
management and logistics and service standpoint.
- Unyvero platform and product portfolio to be expanded beyond
lower respiratory tract infections such as pneumonia (LRT / LRT
BAL) to include complicated urinary tract infections (cUTI) and
invasive joint infections (IJI) in the U.S. with clinical trials
for future FDA submission and clearance anticipated to start in
2021. Products in both indications are fully developed and already
CE-IVD marked and commercially available in Europe and other
markets.
- Acuitas AMR Gene Panel for Isolates expected to see near term
clearance decision by the U.S. FDA after OpGen’s October 2020
submission of a formal response to the FDA’s January 2020 Request
for Additional Information (AI) request. If cleared by the FDA,
OpGen anticipates swift commercial launch in the U.S. in the
following months.
- Legacy FISH products business including Quick FISH® and PNA
FISH® to be discontinued by mid-2021 in Europe, the U.S. and rest
of world with last production lots to be manufactured in early
2021.
- Acuitas AMR Gene Panel (urine) clinical trial to be
discontinued as focus shifts to Unyvero platform for complicated
UTI indication as well as additional future applications.
The company also announced accomplishment of the
following key milestones in the third quarter of 2020 and year to
date:
- OpGen’s subsidiary Curetis GmbH obtained CE mark certification
in the European Union for its own SARS-CoV-2 Kit with PULB for the
detection of SARS-CoV-2, the virus that causes COVID-19.
- OpGen announced that subsidiary Ares Genetics GmbH won the
Austrian national digitization award and was also nominated for the
40th Austrian Innovation Award for its artificial intelligence
powered, next-generation sequencing based molecular antibiotic
susceptibility test marketed under the brand name ARESupa –
Universal Pathogenome Assay.
- OpGen’s subsidiary Curetis GmbH received EUR 350 thousand in
grant funding in a collaboration project with InfectoGnostics
campus at Jena University Hospital.
- OpGen’s subsidiary Ares Genetics GmbH in collaboration with
researchers from the Johns Hopkins University School of Medicine,
announced the publishing of a peer-reviewed study on modifiable
risk factors for the emergence of ceftolozane-tazobactam resistance
in P. aeruginosa in the journal Clinical Infectious Diseases.
- OpGen announced the release of a new peer-reviewed publication
that demonstrates the clinical utility of the Unyvero LRT panel and
its potential impact on antibiotic use in hospitalized patients
with suspected pneumonia compared to treatment directed based on
microbiological culture results.
- OpGen successfully completed its study collaboration with
Karolinska Institutet on bacterial co-infections in COVID-19
pneumonia patients and data on the Unyvero HPN Panel was presented
by the Karolinska investigators at ECCVID 2020.
- OpGen significantly improved its working capital position in
the third quarter of 2020 through the sale of approximately 1.8
million shares of common stock under the company’s ATM program and
the exercise of warrants from the October 2019 financing for gross
proceeds of $4.4 million during the third quarter. During the nine
months ended September 30, 2020, the Company sold approximately
11.4 million shares of common stock under the company’s ATM program
and upon exercise of warrants from the October 2019 offering for
gross proceeds of $24.4 million.
- The German Federal Ministry for Economic Affairs and Energy
(BMWi) concluded its 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. No further action is expected from the Federal government
on this matter.
Oliver Schacht, President & CEO of OpGen
commented, “OpGen reported a solid third quarter given the
persistent challenging environment caused by the COVID-19 pandemic.
In addition to announcing the CE mark certification for our
SARS-CoV-2 Kit, we also highlighted the publication of several
peer-reviewed studies. We believe that following the portfolio
consolidation and strategic product pipeline decisions taken by the
board, OpGen along with its subsidiary companies Curetis GmbH and
Ares Genetics GmbH has a focused molecular diagnostics platform
strategy and growing emphasis on bioinformatics offerings that will
further generate shareholder value. I am truly excited about the
future prospect of this company and I am convinced that our
strategic initiatives will provide strong growth opportunities and
secure our future as a global leader in infectious diseases and AMR
diagnostics.”
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 third quarter 2020 results, the company’s strategic
portfolio and product pipeline priorities, the ongoing integration
of OpGen with its acquired subsidiaries, Curetis GmbH and Ares
Genetics GmbH, 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 SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR matt@fischtankpr.com
OpGen Investor Contact:Megan Paul Edison
Group mpaul@edisongroup.com
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