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 revenue
for 2019 increased 18.7% to $3.5 million, up from $3.0 million in
2018. The company also announced accomplishment of the following
key milestones:
- Patient accrual underway since December to support FDA
submission for the company’s lead rapid molecular diagnostic test,
the Acuitas® AMR Gene Panel Urine for the Acuitas AMR Gene Panel
(Urine) FDA De Novo clearance clinical trial;
- OpGen working interactively with the FDA to provide final
responses to Additional Information Request Letters for the Acuitas
AMR Gene Panel (Isolates) pending FDA 510(K) submission. Response
process to FDA anticipated to be completed in February to be
followed by formal response filings; and
- Achievement of planned program milestone under the New York
State Infectious Disease Digital Health Initiative demonstration
project.
OpGen revenue growth during 2019 was from
Acuitas AMR Gene Panel and Acuitas® Lighthouse revenue which
increased 147% to approximately $1.4 million while revenues from
the company’s rapid FISH products decreased approximately 12% to
$2.1 million. Preliminary, unaudited operating loss for fiscal year
2019 was approximately $12.4 million compared with $13.4 million in
2018. The company expects to provide full year 2019 financial
results during its fourth quarter 2019 earnings call in March
2020.
Evan Jones, Chairman & CEO of OpGen
commented, “We were pleased with the initial results from fiscal
year 2019 and we look forward to further progress following the
expected first FDA clearance of our AMR Gene Panel products. Our
teams have been working closely with Curetis to complete the
planned business combination of our two companies. Together we have
exciting prospects for growth from our combined product
portfolios.”
Business combination with Curetis
Group
The company also announced the following updates
relating to the planned business combination with Curetis:
- Curetis Group Company, Ares Genetics’, collaboration with BGI
Group to offer Next-Generation Sequencing and PCR-based Coronavirus
(2019-nCoV) testing in Europe;
- Curetis launches Unyvero LRT Panel for BAL Specimens in the
U.S. following receipt of 510(k) clearance by the U.S. FDA;
- LRT BAL Panel recently FDA cleared with labeling expanded to
include atypical pathogens such as Pneumocystis jirovecii important
for immunocompromised patients;
- LRT BAL panel commercially available to Curetis’ U.S. customers
beginning at the end of January. Expected to substantially increase
total addressable market for Unyvero System;
- OpGen filed and furnished to its stockholders a proxy
statement/prospectus and a notice of special meeting of OpGen
stockholders to be held on March 10, 2020 to approve the business
combination with Curetis;
- Curetis will host its shareholder meeting on March 10, 2020 at
1:00pm CET with the same objective.
Oliver Schacht, CEO Curetis, N.V commented, “We
are encouraged by the significant progress with our planned
business combination with OpGen and the initial launch of the new
LRT BAL indication. Several prestigious medical centers, including
a major cancer center and a large academic institution, have
already committed to evaluate the Unyvero LRT BAL panel for routine
use in patients hospitalized for suspected pneumonia. The Unyvero
LRT BAL application is the first and only FDA-cleared molecular
diagnostic pneumonia panel that includes Pneumocystis jirovecii.
This difficult to diagnose pathogen is a leading cause of pneumonia
in immunocompromised individuals.”
The preliminary financial results and product
growth rates are estimates prior to the completion of
OpGen’s financial closing procedures and audit procedures by
its external auditors and therefore may be subject to adjustment
when the actual results are available.
OpGen and Curetis entered into a definitive
agreement to combine businesses on September 4, 2019. The
closing of the transaction under such definitive agreement has not
yet occurred and is subject to a number of significant closing
conditions, including receipt of approval from the stockholders of
OpGen, Inc. and the shareholders of Curetis, N.V. Until the
closing occurs, each of OpGen and Curetis are operating as
stand-alone businesses.
Forward-Looking Statements
This press release includes statements relating
to the proposed business combination transaction between OpGen and
Curetis and a planned collaboration between Curetis Group company,
Ares Genetics, and BGI Group for next-generation sequencing and
PCR-based coronavirus testing in Europe. 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 and timely seek approval of, and obtain
approval of our stockholders for the transaction, satisfy the
closing conditions under the implementation agreement between OpGen
and Curetis, successfully combine the businesses of OpGen and
Curetis, comply with the complexities of a global business, achieve
the synergies we expect, successfully implement the combined
company’s strategic and business goals and objectives, and advance
our current and planned 510(k) clearance submissions with the FDA,
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 success of our commercialization efforts, 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.
No Offer or Solicitation
This press release is neither an offer to
purchase, nor a solicitation of an offer to sell, any securities or
the solicitation of any vote in any jurisdiction pursuant to the
proposed transactions or otherwise, nor shall there be any sale,
issuance or transfer or securities in any jurisdiction in
contravention of applicable law. No offer of securities shall be
made except by means of a prospectus meeting the requirements of
Section 10 of the Securities Act of 1933, as amended.
Additional Information and Where to Find
It
In connection with the transactions contemplated
by the Implementation Agreement (the definitive agreement related
to the proposed business combination between the Company and
Curetis GmbH), a Registration Statement on Form S-4 (File No.
333-234657) has been filed with and declared effective by the
Securities and Exchange Commission (the “SEC”). Investors and
security holders are encouraged to read the registration statement
and any other relevant documents filed with the SEC, including the
proxy statement/prospectus that forms a part of the registration
statement. Such documents contain important information about
the proposed transaction. The definitive proxy statement/prospectus
was first mailed to stockholders of the Company on or about January
27, 2020. This communication is not a substitute for the
registration statement, the proxy statement/prospectus or any other
document that OpGen may send to its stockholders in connection with
the proposed transaction. Investors and security holders will
be able to obtain the documents free of charge at the SEC’s
website, www.sec.gov, or from the Company at its website,
www.opgen.com.
About OpGen
OpGen, Inc. is a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease. We are developing molecular
information products and services for global healthcare settings,
helping to guide clinicians with more rapid and actionable
information about life threatening infections, improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs.
Our molecular diagnostics and informatics
products, product candidates and services combine our Acuitas
molecular diagnostics and Acuitas Lighthouse informatics platform
for use with our proprietary, curated MDRO knowledgebase. We are
working to deliver our products and services, some in development,
to a global network of customers and partners. The Acuitas AMR Gene
Panel (RUO) is intended for Research Use Only and is not for use in
diagnostic procedures. The Acuitas Lighthouse Software is not
distributed commercially for antibiotic resistance prediction and
is not for use in diagnostic procedures. For more information,
please visit www.opgen.com.
OpGen, Acuitas, and Acuitas Lighthouse are
registered trademarks of OpGen, Inc.
About Curetis
Curetis N.V.’s (Euronext: CURE) goal is to
become a leading provider of innovative solutions for molecular
microbiology diagnostics designed to address the global challenge
of detecting severe infectious diseases and identifying antibiotic
resistances in hospitalized patients.
Curetis’ Unyvero System is a versatile, fast and
highly automated molecular diagnostic platform for easy-to-use,
cartridge-based solutions for the comprehensive and rapid detection
of pathogens and antimicrobial resistance markers in a range of
severe infectious disease indications. Results are available within
hours, a process that can take days or even weeks if performed with
standard diagnostic procedures, thereby facilitating improved
patient outcomes, stringent antibiotic stewardship and
health-economic benefits. Unyvero in vitro diagnostic (IVD)
products are marketed in Europe, the Middle East, Asia and the
U.S.
Curetis’ wholly-owned subsidiary Ares Genetics
GmbH offers next-generation solutions for infectious disease
diagnostics and therapeutics. The ARES Technology Platform combines
what the Company believes to be the most comprehensive database
worldwide on the genetics of antimicrobial resistances, ARESdb,
with advanced bioinformatics and artificial intelligence.
For further information, please visit
www.curetis.com and www.ares-genetics.com.
OpGen: Michael Farmer Vice
President, Marketing (240) 813-1284 mfarmer@opgen.com
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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