OpGen Provides Curetis Group Business Update and Announces Completion of Key Milestones in Planned Business Combination
02 December 2019 - 11:30PM
OpGen, Inc. (Nasdaq: OPGN) today provided a business update for the
Curetis Group and announced that key milestones in the planned
business combination have been achieved. Curetis recently announced
that it has filed its formal response to the FDA’s Additional
Information Request letter regarding Curetis’ filing for 510(k)
clearance of the Unyvero LRT – Lower Respiratory Tract Application
Cartridge for bronchoalveolar lavage (BAL) samples. The formal
response addressed all additional information requested by the FDA
regarding the original submission filed on July 23, 2019. Curetis
now expects a near term clearance decision. It is estimated that
BAL specimens account for half of the samples obtained for the
diagnosis of lower respiratory tract infections. The comprehensive
LRT BAL panel covers the most clinically relevant microbial and
fungal pathogens and antibiotic resistances in this indication
area.
Milestones in Planned Business Combination
- The European Investment Bank (the “EIB”), has advised Curetis
GmbH that the proposed merger between Curetis and OpGen has been
formally approved, subject to appropriate loan guarantees and legal
documentation.
- On October 28, 2019, OpGen completed a $9.4 million public
offering. Curetis has advised OpGen that the completion of this
equity financing meets the interim financing requirement specified
in the September 4, 2019 Implementation Agreement between OpGen and
Curetis N.V.
- On November 12, 2019, OpGen filed a Form S-4 with the
Securities and Exchange Commission (the “SEC”). The Form S-4
filing is currently under review by the SEC. Once finalized,
the Form S‑4 will serve two purposes - the proxy statement to be
sent to the OpGen stockholders seeking approval of the proposed
business combination, and the registration of the shares of OpGen
common stock to be issued to Curetis N.V. following approval by the
stockholders of OpGen and the shareholders of Curetis N.V.
Curetis Group Financial Results
For the nine-month period ending September 30,
2019, Curetis Group reported total revenue of €1.4 million, a 16%
increase from the €1.2 million reported in the prior year period.
Total comprehensive loss of the period was €16.3 million for the
2019 nine-month period compared with €17.9 million in the
comparable 2018 period. The 2019 nine-month Curetis financial and
business report can be found here. Commercial order volume and fees
contractually committed and received by Curetis and Ares Genetics
in 2019 have more than tripled from €1.1 million in 2018 to
approximately €3.4 million in 2019. This increase in orders
includes orders for Unyvero instruments and cartridges, and Ares
Genetics’ laboratory and advanced bioinformatics services, as well
as contractual fees for access to certain rights.
Evan Jones, Chairman & CEO of OpGen, stated,
“We are pleased with the progress Curetis has made towards
expanding the claims for their Unyvero LRT BAL test, and the
successful accomplishment of key milestones that are required to
complete the planned business combination of OpGen and Curetis. We
are currently preparing documentation for both OpGen and Curetis to
seek approval from stockholders and shareholders, and continuing
conversations with other lenders of the parties. The meetings to
support these approvals are anticipated to take place early in the
first quarter of 2020.”
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.
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 has been filed
with the SEC and is under review. 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 will be part of the final registration
statement, when they become available, because they will contain
important information about the proposed transaction. The final
proxy statement/prospectus will be mailed to stockholders of the
Company. 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.
Forward-Looking Statements
This press release provides an update on the
parties’ progress toward meeting closing conditions under the
announced business combination agreement between Curetis N.V. and
OpGen that has not yet closed, the status of the Curetis LRT BAL
specimen 510(k) FDA submission, and provides interim nine-month
financial results for the Curetis Group. These statements
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 the future to
differ materially from expectations. We cannot assure you that the
proposed business combination transaction with Curetis N.V., which
is subject to significant conditions to close, will occur.
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 Contact: Michael Farmer Vice President,
Marketing (240) 813-1284 mfarmer@opgen.com
InvestorRelations@opgen.com
Press Contact: Matthew Bretzius FischTank
Marketing and PR matt@fischtankpr.com
Investor Contacts: Joe Green Edison Group
jgreen@edisongroup.com
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