UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
DC 20549
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FORM 8-K
_________________
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
January 28,
2020
Date of Report (date of earliest event reported)
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OpGen, Inc.
(Exact name
of Registrant as specified in its charter)
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Delaware
(State
or other jurisdiction of incorporation or organization)
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001-37367
(Commission
File
Number)
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06-1614015
(I.R.S.
Employer
Identification Number)
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708
Quince Orchard Road, Suite 205
Gaithersburg, MD 20878
(Address of principal executive offices)
(240)
813-1260
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
_________________
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2. below):
[X] Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[_] Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[_] Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[_] Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant
to Section 12(b) of the Act:
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Title
of each class
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Trading
Symbol(s)
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Name
of each exchange on which registered
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Common
Stock
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OPGN
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The
Nasdaq Capital Market
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Common
Stock Warrants (IPO)
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OPGNW
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The
Nasdaq Capital Market
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Indicate by check mark whether
the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter)
or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company [X]
If an emerging growth company,
indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [_]
Item 8.01 Other Events.
On January 28, 2020, OpGen, Inc.
(the “Company”) issued a press release announcing a special meeting date of March 10, 2020, for its stockholders to,
among other things, consider and vote on a proposal to adopt the previously announced business combination with Curetis GmbH (“Curetis”).
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
On January 30, 2020, the Company
issued a press release providing an update on the business of Curetis, a copy of which is attached as Exhibit 99.2 to this Current
Report and is incorporated herein by reference.
No Offer or Solicitation
These press releases filed herewith
are neither offers to purchase, nor solicitations 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), 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 the Company 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.
Item 9.01 Financial Statements
and Exhibits.
(d) Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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Date:
January 30, 2020
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OpGen,
Inc.
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By:
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/s/
Timothy C. Dec
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Name:
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Timothy
C. Dec
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Title:
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Chief
Financial Officer
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Exhibit 99.1
OpGen
Achieves Key Milestone in Planned Business Combination with Curetis
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Special
meetings of OpGen and Curetis shareholders are scheduled for March 10, 2020, at 10:00am
ET and 1:00pm CET, respectively
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Transaction
unanimously supported by the boards of OpGen and Curetis and supported by debt holders
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Gaithersburg,
MD – January 28, 2020 - 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 a key milestone has been accomplished
in the proposed business combination with Curetis, N.V. (Euronext: CURE, “Curetis”),
a developer of next-level molecular diagnostic solutions. On January 27, 2020, 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 at 10:00am ET at
the offices of Ballard Spahr LLP, 1909 K Street, NW, 12 th Floor, Washington DC. At the special meeting, OpGen is seeking
shareholder approval of the business combination of OpGen and Curetis. Curetis will host
its shareholder meeting on the same day at 1:00pm CET with the same objective. The Curetis extraordinary general meeting will
take place at Steigenberger Hotel, Stationsplein Zuid - West 951, 1117 CE Schiphol - Oost/Amsterdam, the Netherlands. Successful
votes of the shareholders of the respective companies are the last remaining major steps towards closing of the transaction.
“We
are confident that the combination of OpGen and Curetis will help maximize value for our stockholders and will result in an organization
with a robust pipeline of proprietary molecular diagnostic and bioinformatics products, significant management experience, and
unique assets for developing and commercializing novel data-driven solutions in infectious disease diagnostics,” said Evan
Jones, Chairman and CEO of OpGen.
“I
expect the combination with OpGen to accelerate the commercial development and revenue growth for both companies and that it will
ultimately bring tremendous value to the combined company and its current and future shareholders,” said Oliver Schacht,
CEO of Curetis. “We look forward to moving the Company ahead into this next exciting chapter.”
H.C.
Wainwright & Co., LLC and Crosstree Capital LLC acted as financial advisors to Curetis and OpGen, respectively. Linklaters
LLP and Ballard Spahr LLP acted as legal advisors to Curetis and OpGen, respectively.
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.
Forward-Looking
Statements – OpGen, Inc
This
press release includes statements relating to the proposed business combination between OpGen and Curetis. These statements and
other statements regarding OpGen’s and the combined company’s future plans 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 OpGen’s control, and which
may cause results to differ materially from expectations. Factors that could cause 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, and risks and uncertainties associated with market conditions, advance our current.
For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with
the SEC. 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:
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
Exhibit 99.2
OpGen Provides Update on Curetis Group Company
Ares Genetics’ Collaboration with BGI Group to Offer Next-Generation Sequencing and PCR-based Coronavirus (2019-nCoV) Testing
in Europe
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BGI Group responds
to coronavirus crisis by providing reagent kits for molecular 2019-nCoV testing by next-generation sequencing and RT-PCR
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Ares Genetics to launch
next-generation sequencing testing service for infection control and monitoring of 2019-nCoV evolution using BGI Group reagents
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Ares Genetics, Curetis
Group and BGI Group to collaborate in the distribution of next-generation sequencing and PCR testing kits for 2019-nCoV
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GAITHERSBURG, Md. – January, 30, 2020
– OpGen, Inc. (Nasdaq: OPGN) reported an update on the business of Curetis GmbH (“Curetis”), the other party
to the planned business combination with OpGen. Today, Curetis announced that Ares Genetics GmbH, a Curetis Group company, and
the Chinese genomics company BGI Group will collaborate in making molecular testing for the new coronavirus 2019-nCoV available
in Europe.
2019-nCoV is a new coronavirus variant
that has not been previously identified in humans but is responsible for the outbreak originating in the Chinese city of Wuhan
and rapidly spreading globally with first cases identified and confirmed in Europe already. In response to this situation, and
immediately after the occurrence of unexplained pneumonia in Wuhan on December 31, 2019, BGI was first to sequence the genome of
the new 2019-nCoV virus and successfully developed a Real-Time (RT) Fluorescent PCR (polymerase chain reaction) kit for detecting
2019-nCoV, which can provide results in a few hours and has already obtained approval by the Chinese National Medical Products
Administration.
In addition to the rapid detection kit
based on RT-PCR technology, the DNBSEQ-T7 sequencing platform developed by BGI Group’s instrument and reagent subsidiary,
MGI, passed the emergency approval procedure of the National Medical Products Administration, becoming the first officially approved
testing products in China for surveillance, discovery and identification of unknown infectious diseases.
In Europe, BGI and MGI will work with
their long-term strategic partner Ares Genetics to make its 2019-nCoV testing portfolio available to public health institutions
and hospitals for outbreak monitoring, infection control, and epidemiology. Ares Genetics expects to provide next-generation sequencing
services for 2019-nCoV out of its NGS laboratory in Vienna Austria for infection control and tracking of pathogen evolution from
February 2020 onwards based on MGI’s DNBSEQ sequencing platform. Further, Ares Genetics and the Curetis Group will support
BGI Group in the distribution of its PCR and NGS reagent kits to molecular testing laboratories in Europe that have the capability
for 2019-nCoV testing with reagent kits initially being marketed for research use only prior to regulatory approval in Europe.
Ares Genetics is a digital diagnostics company
utilizing artificial intelligence-powered molecular diagnostics to advance the field of infectious disease testing. Ares Genetics
recently launched ARESupa – Universal Pathogenome Assay for the broad identification of bacterial pathogens and the accurate
prediction of antibiotic susceptibility. The ARESupa test is based on the sequencing of bacterial DNA, combined with data analysis
and interpretation powered by ARESdb, Ares Genetics’ unique, proprietary reference database on genetic antimicrobial resistance
markers. The first generation of ARESupa is currently offered for non-diagnostic applications in epidemiology, infection control,
and outbreak analysis for customers in the public health sector and the pharmaceutical industry. A laboratory-developed test (LDT)
for human diagnostic use is under development.
“This collaboration highlights the importance
of rapid testing technologies in tracking the evolution of and containing global outbreaks. We congratulate Curetis on their collaboration
and commend them and BGI Group for their swift action to assist in the surveillance and identification of yet another infectious
disease with cases across the globe,” said Evan Jones, Chairman & CEO of OpGen.
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.
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 proprietary DNA tests and informatics address the rising threat of antibiotic resistance by helping
physicians and other healthcare providers optimize care decisions for patients with acute infections.
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. Currently we offer our Acuitas AMR Gene Panel tests for
research use only. For more information, please visit www.opgen.com.
OpGen, Acuitas, and Acuitas Lighthouse are
registered trademarks of OpGen, Inc.
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.
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