As filed with the Securities and
Exchange Commission on June 17, 2020
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
____________________
OPGEN, INC.
(Exact Name of Registrant as Specified
in Its Charter)
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Delaware
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06-1614015
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(State or Other Jurisdiction of
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(I.R.S. Employer
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Incorporation or Organization)
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Identification Number)
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708 Quince Orchard Road, Suite 205
Gaithersburg, MD 20878
(301) 869-9683
(Address, Including Zip Code, and
Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
____________________
Oliver Schacht, Ph.D.
Chief Executive Officer
708 Quince Orchard Road, Suite 205
Gaithersburg, MD 20878
(301) 869-9683
(Name, Address, Including Zip Code, and
Telephone Number, Including Area Code, of Agent for Service)
____________________
With a copy to:
Peter Jaslow, Esquire
Ballard Spahr LLP
1735 Market Street, 51st Floor
Philadelphia, PA 19103
(215) 665-8500
____________________
Approximate date of commencement of
proposed sale to the public: From time to time after this registration statement becomes effective.
If the only securities being registered
on this form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. [_]
If any of the securities being registered
on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than
securities offered only in connection with dividend or interest reinvestment plans, check the following box. [X]
If this form is filed to register additional
securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same offering. [_]
If this form is a post-effective amendment
filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering. [_]
If this form is a registration statement
filed pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the
Commission pursuant to Rule 462(e) under the Securities Act, check the following box. [_]
If this form is a post-effective amendment
to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes
of securities pursuant to Rule 413(b) under the Securities Act, check the following box. [_]
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth
company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act (Check one):
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Large Accelerated Filer
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[_]
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Accelerated Filer
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[_]
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Non-Accelerated Filer
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[_]
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Smaller Reporting Company
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[X]
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Emerging Growth Company
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[X]
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If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for comply with
any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. [_]
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CALCULATION OF REGISTRATION
FEE
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Title of Securities to be Registered
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Amount to be Registered (1)
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Proposed Maximum Offering Price Per Share(2)
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Proposed Maximum Aggregate Offering Price
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Amount of Registration Fee
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Common stock, par value $0.01 per share
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450,000
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$1.94
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$873,000.00
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$113.32
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(1)
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Represents 450,000 shares of common stock issuable upon conversion of certain convertible notes
of the Registrant, and acquired by the selling stockholder pursuant to a subscription agreement dated October 2, 2018.
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(2)
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Estimated solely for the purpose of calculating the registration fee
in accordance with Rule 457(c) under the Securities Act, based
upon the average of the high and low sales price of our common stock as reported on the Nasdaq Capital Market on June 11, 2020.
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THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT
ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH
SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES
ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID
SECTION 8(a), MAY DETERMINE.
The information in this prospectus is not complete
and may be changed. The holders of the common stock may not sell these securities until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting
an offer to buy these securities in any state where the offer or sale is not permitted.
Subject to Completion,
Dated June 17, 2020
PROSPECTUS
450,000 Shares of Common Stock
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This prospectus relates to the resale
from time to time by the selling stockholder identified in this prospectus of up to 450,000 shares (the “Shares”) of
our common stock, par value $0.01 per share (the “Common Stock”), that are issuable upon conversion of certain convertible
notes of OpGen, Inc. (the “Convertible Notes”) as further described in this prospectus.
The Shares may be sold from time to
time by the selling stockholder directly or through one or more broker-dealers, in one or more transactions on the Nasdaq
Capital Market, in the over-the-counter market, in negotiated transactions or otherwise, at prices related to the prevailing
market prices or at negotiated prices, all as more fully described in the section entitled “Plan of Distribution”
beginning on page 11 of this prospectus.
We are not selling any Shares under this
prospectus and will not receive any proceeds from the sale by the selling stockholder of such Shares.
Our common stock is traded on the Nasdaq
Capital Market under the symbol “OPGN.” On June 16, 2020, the closing price of our common stock was $2.00 per share.
____________________
Investing in our securities involves a high degree of
risk. Before making an investment decision, please read the information under "Risk Factors" beginning on page 9 of
this prospectus and under similar headings in any amendment or supplement to this prospectus or in any filing with the Securities
and Exchange Commission that is incorporated by reference herein.
____________________
Neither the Securities and Exchange Commission nor any
other regulatory body has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus.
Any representation to the contrary is a criminal offense.
____________________
The date of this Prospectus is .
2020
TABLE OF CONTENTS
Page
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PROSPECTUS SUMMARY
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1
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ABOUT THIS PROSPECTUS
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7
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
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7
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RISK FACTORS
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9
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USE OF PROCEEDS
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9
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DETERMINATION OF OFFERING PRICE
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9
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SELLING STOCKHOLDER
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9
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PLAN OF DISTRIBUTION
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11
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LEGAL MATTERS
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13
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EXPERTS
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13
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INCORPORATION BY REFERENCE
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WHERE YOU CAN FIND MORE INFORMATION
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PROSPECTUS SUMMARY
This summary highlights information
contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing
in our securities. You should read this entire prospectus carefully, especially the “Risk Factors” section beginning
on page 9 and our financial statements and the related notes incorporated by reference into this prospectus, before making an
investment decision. As used in this prospectus, the terms “OpGen,” “the Company,” “we,” “us,”
and “ours” refer to OpGen, Inc.
Business Combination Transaction with Curetis N.V.
On April 1, 2020, or the Closing Date, the Company completed
its business combination transaction, or the Transaction, with Curetis N.V., a public company with limited liability under the
laws of the Netherlands, or the Seller,, as contemplated by the Implementation Agreement, dated as of September 4, 2019, or the
Implementation Agreement, by and among the Company, the Seller, and Crystal GmbH, a private limited liability company organized
under the laws of the Federal Republic of Germany and wholly owned subsidiary of the Company, or the Purchaser. Pursuant to the
Implementation Agreement, the Purchaser acquired all of the shares of Curetis GmbH, a private limited liability company organized
under the laws of the Federal Republic of Germany, or Curetis, and certain other assets and liabilities of the Seller, as further
described below, and paid, as the sole consideration, 2,028,208 shares of the Company’s common stock, par value $0.01 per
share, or the Common Stock, to the Seller, and reserved for future issuance (a) 134,356 shares of Common Stock, in connection with
its assumption of the Seller’s 2016 Stock Option Plan, as amended (the “Seller Stock Option Plan”), and the outstanding
awards thereunder, and (b) 500,000 shares of Common Stock to be issued upon the conversion, if any, of certain convertible notes
issued by the Seller, of which 390,891 shares have been issued as of June 12, 2020, in satisfaction of approximately $768,000 of
outstanding principal and indebtedness under the assumed convertible notes. The 2,028,208 shares of Common Stock issued to the
Seller represented approximately 13.8% of the outstanding Common Stock of the Company as of the Closing Date.
At the closing, the Company assumed all of the liabilities
of the Seller solely and exclusively related to the acquired business, which is providing innovative solutions, through development
of proprietary platforms, diagnostic content, applied bioinformatics, lab services, research services and commercial collaborations
and agreements, for molecular microbiology, diagnostics designed to address the global challenge of detecting severe infectious
diseases and identifying antibiotic resistances in hospitalized patient, or the Curetis business. Pursuant to the Implementation
Agreement, the Company also assumed and adopted the Seller Stock Option Plan as an Amended and Restated Stock Option Plan of the
Company. In connection with the foregoing, the Company assumed all awards thereunder that were outstanding as of the Closing Date
and converted such awards into options to purchase shares of the Company’s Common Stock pursuant to the terms of the applicable
award. In addition, the Company assumed, at the closing, all of the outstanding convertible notes issued by Seller in favor of
YA II PN, LTD, or Yorkville, which is the selling stockholder under this prospectus, pursuant to the previously disclosed Assignment
of the Agreement for the Issuance of and Subscription to Notes Convertible into Shares, dated February 24, 2020, or the Assignment
Agreement, and entered into pursuant to the Implementation Agreement. In this prospectus, we refer to the combined business following
the consummation of the Transaction as “Newco.”
OpGen Overview
OpGen is a precision medicine company harnessing the power
of molecular diagnostics and informatics to help combat infectious disease. The Company is 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. Its 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.
The Company’s molecular diagnostics and informatics
products, product candidates and services combine its Acuitas molecular diagnostics and Acuitas Lighthouse informatics platform
for use with its proprietary, curated MDRO knowledgebase. The Company is working to deliver products and services, some in development,
to a global network of customers and partners.
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The Company’s Acuitas molecular diagnostic tests provide rapid microbial identification and antibiotic resistance gene
information. These products include its Acuitas antimicrobial resistance, or AMR, Gene Panel Urine test in development for patients
at risk for complicated urinary tract infection, or cUTI, and its Acuitas AMR Gene Panel test for use with bacterial isolates in
development for testing bacterial isolates, and its QuickFISH and PNA FISH FDA-cleared and CE-marked diagnostics used to rapidly
detect pathogens in positive blood cultures. Each of the Acuitas AMR Gene Panel tests is available for sale for research use only,
or RUO and is not for use in diagnostic procedures.
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The Company’s Acuitas Lighthouse informatics systems are cloud-based HIPAA compliant informatics offerings that combine
clinical lab test results with patient and hospital information to provide analytics and actionable insights to help manage MDROs
in the hospital and patient care environment. Components of the informatics systems include the Acuitas Lighthouse Knowledgebase
and the Acuitas Lighthouse Software. The Acuitas Lighthouse Knowledgebase is a relational database management system and a proprietary
data warehouse of genomic data matched with antibiotic susceptibility information for bacterial pathogens. The Acuitas Lighthouse
Software system includes the Acuitas Lighthouse Portal, a suite of web applications and dashboards, the Acuitas Lighthouse Prediction
Engine, which is a data analysis software, and other supporting software components. The Acuitas Lighthouse Software can be customized
and made specific to a healthcare facility or collaborator, such as a pharmaceutical company. The Acuitas Lighthouse Software is
not distributed commercially for antibiotic resistance prediction and is not for use in diagnostic procedures.
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The Company’s operations are subject to certain risks
and uncertainties. The risks include the risk that the Company will not receive 510(k) clearance for its Acuitas AMR Gene Panel
test for use with bacterial isolates on a timely basis, or at all, the timing and ultimate success of future 510(k) and De Novo
submissions for additional Acuitas AMR Gene Panel tests and Acuitas Lighthouse Software, rapid technology changes, the need to
retain key personnel, the need to protect intellectual property and the need to raise additional capital financing on terms acceptable
to the Company. The Company’s success depends, in part, on its ability to develop, obtain regulatory approval for and commercialize
its proprietary technology as well as raise additional capital.
Curetis Overview
The Curetis business develops, manufactures and commercializes
innovative solutions for molecular microbiology. The Curetis business is based on two complementary business pillars:
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The Unyvero A50 is a high-plex polymerase chain reaction, or PCR, platform for comprehensive and rapid diagnosis of severe
infectious diseases in hospitalized patients. The platform is based on proven, intelligently integrated technologies, allowing
for the testing of broad panels of pathogens and antibiotic resistance markers and the processing of a large variety of native
patient samples with an intuitive workflow. The Unyvero A50 high-plex PCR platform’s advantage is the timely access to comprehensive,
actionable and reliable data. Curetis’ molecular tests for different indications are commercially available in Europe, the
United States, Asia and the Middle East. Curetis is also developing the Unyvero A30 RQ Analyzer, which is designed to serve
as a platform with low-to medium-plex capabilities that it ultimately intends to commercially leverage predominantly in collaborations
with one or more diagnostics industry partners.
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The ARES AMR database, or ARESdb, is a comprehensive database of the genetics of antimicrobial resistance, or AMR, which
permits Curetis to increasingly utilize the proprietary biomarker content in its own assay and cartridge development, as well as
to build an independent business in next-generation sequencing, or NGS, based offerings for AMR research and diagnostics in collaboration
with partners in the life science, pharmaceutical and diagnostics industries. ARESdb is not commercially available
in the United States for diagnostic use, as it has not been cleared by the FDA. In September 2019, Ares Genetics, a wholly owned
subsidiary of Curetis, or Ares Genetics, signed a technology evaluation agreement with an undisclosed global IVD corporation. In
the first phase of the collaboration, expected to take about 10 months, Ares Genetics expects to further enrich ARESdb with
a focus on certain pathogens relevant in a first, undisclosed infectious disease indication.
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Curetis GmbH’s offices and R&D laboratories are
based in Holzgerlingen, near Stuttgart with its cartridge manufacturing facility in Bodelshausen also in southern Germany, in addition
to subsidiaries located in San Diego, California, USA and Vienna, Austria.
Newco Overview
We anticipate that the focus of Newco will
be on combined broad portfolio of products of OpGen and Curetis, which include high impact rapid diagnostics and bioinformatics
to interpret AMR genetic data. The products we expect Newco to focus on are for lower respiratory infection and urinary tract or
invasive joint infection:
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The Unyvero Lower Respiratory Tract, or LRT, test is the first FDA cleared test that can be used for more than 90% of infection
cases of hospitalized pneumonia patients. According to the National Center for Health Statistics (2018), pneumonia is a leading
cause of admissions to the hospital and is associated with substantial morbidity and mortality. The Unyvero LRT automated test
detects 19 pathogens within less than five hours, with approximately two minutes of hands-on time and provides clinicians with
a comprehensive overview of 10 genetic antibiotic resistance markers. We are also commercializing the Unyvero LRT test for testing
bronchoalveolar lavage, or BAL, specimens of U.S. patients with lower respiratory tract infections following FDA clearance received
by Curetis in December 2019. We believe the Unyvero LRT test has the ability to help address a significant, previously unmet medical
need that causes over $10 billion in annual costs for the U.S. healthcare system, according to the Centers for Disease Control,
or CDC.
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The Acuitas AMR Gene Panel (Urine) test is being developed for patients at risk for cUTI, and is designed to test for up to
five pathogens and up to 47 antimicrobial resistance genes. When paired with the Acuitas Lighthouse software, we believe the test
will be able to help improve management of the more than one million patients in the United States with cUTI. The AMR Gene Panel
(Urine) is in testing for preparation of a De Novo submission with the FDA. We are pursuing a Class I designation through a De
Novo Request for the test in connection with an initial clinical indication to test bacterial isolates.
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Newco will have an extensive offering of additional in
vitro diagnostic tests including CE-marked Unyvero tests for implant and tissue infections, intra-abdominal infections,
cUTI, and blood stream infections, and the QuickFISH and PNA FISH FDA-cleared and CE-marked diagnostics used to rapidly detect
pathogens in positive blood cultures, which we believe have an established market position in the United States.
Newco’s combined AMR informatics offerings, once all
such products are cleared for marketing, if ever, will offer important new tools to clinicians treating patients with AMR infections.
OpGen has collaborated with Merck, Inc. to establish the Acuitas Lighthouse Knowledgebase, which is currently commercially available
in the United States for RUO. The Acuitas Lighthouse Knowledgebase includes approximately 15,000 bacterial isolates from the Merck
SMART surveillance network of 192 hospitals in 52 countries and other sources. The Curetis ARESdb is a comprehensive
database of genetic and phenotypic information. ARESdb was originally designed based on the SIEMENS microbiology strain
collection covering resistant pathogens over the last 30 years and its development has significantly expanded to now include approximately
55,000 sequenced isolate strains and phenotypic correlation data against over 100 antibiotics. In September 2019, Ares Genetics
signed a technology evaluation agreement with an undisclosed global IVD corporation. In the first phase of the collaboration, expected
to take about 10 months, Ares Genetics expects to further enrich ARESdb with a focus on certain pathogens relevant
in a first, undisclosed infectious disease indication. We anticipate that Newco will utilize the proprietary biomarker content
in these databases, as well as to build an independent business in NGS and AI based offerings for AMR research and diagnostics
in collaboration with partners in the life science, pharmaceutical and diagnostics industries.
The Unyvero A50 tests for up to 130 diagnostic targets (pathogens
and resistance genes) in under five hours with approximately two minutes of hands-on time. The system was first CE Marked in 2012
and was FDA cleared in 2018 along with the LRT test through De Novo process. As of December 31, 2019, there
is an installed base of 173 Unyvero A50 Analyzers globally. The Unyvero A30 RQ is a new device designed to address
the low to mid-plex testing market for 5-30 DNA targets and to provide results in 45 to 90 minutes with 2-5 minutes of hands on
time. The Unyvero A30 has a small laboratory footprint and has an attractive cost of goods profile. Curetis has been following
a partnering strategy for the Unyvero A30.
Newco has extensive partner and distribution relationships
to help accelerate the establishment of a global infectious disease diagnostic testing and informatics business. Partners will
include A. Menarini Diagnostics for pan-European distribution to currently 11 countries; MGI/BGI for NGS-based molecular microbiology
applications in China; and Beijing Clear Biotech Co. Ltd. for Unyvero A50 product distribution in China. Newco has a network currently
consisting of 18 distributors covering 43 countries.
Newco will continue to develop and seek FDA and other regulatory
clearances or approvals, as applicable, for the Acuitas AMR Gene Panel (Urine) diagnostic test and the Acuitas Lighthouse Software
products. Newco will continue to offer the Acuitas AMR Gene Panel (Isolates) and Acuitas Lighthouse Software as well as the Unyvero
UTI Panel as RUO products to hospitals, public health departments, clinical laboratories, pharmaceutical companies and contract
research organizations, or CROs.
Yorkville Financing
As discussed above, at the closing of the Transaction pursuant
to the Assignment Agreement, the Company assumed all of the outstanding convertible notes, or the Convertible Notes, issued
by Curetis in favor of Yorkville, under that certain Agreement for the Issuance of and Subscription to Notes Convertible into
Shares and Share Subscription Warrants, dated October 2, 2018, by and between Curetis and Yorkville. Pursuant to the
Assignment Agreement, upon assumption of the Convertible Notes by the Company, the Convertible Notes ceased to be convertible
into shares of Curetis and instead became convertible into shares of Common Stock of the Company. Under the Assignment
Agreement, an amount of 500,000 shares of Common Stock that comprise a portion of the consideration payable by the Company
under the Implementation Agreement were reserved for issuance upon conversion of the Convertible Notes. The Company also
agreed to register for sale up to 1,000,000 shares of its Common Stock issuable upon conversion of the Convertible Notes.
In furtherance of such agreement, this prospectus and the registration statement of which it is a part relates to the sale
of up to 450,000 shares of Common Stock issuable upon conversion of the Convertible Notes.
Each Convertible Note has a maturity of 12 months from its date
of issuance. The Company, has the right to extend such maturity by an additional 12-month period, while paying a cash fee equal
to 5% of the principal amount of the relevant Convertible Notes. Subject to certain limitations, the maturity period can be extended
up to four times.
The Convertible Notes do not accrue interest, except in the case
of an event of default under the Convertible Notes, in which case the Convertible Notes shall accrue default interest at a rate
of 15% per annum until the earlier of the date that the event of default is cured or the date on which the Convertible Notes have
been fully converted or redeemed.
The Convertible Notes may be converted at any time until they are
fully redeemed. Upon conversion of the Convertible Notes, the number of shares of Common Stock will be calculated by dividing the
aggregate principal amount of the relevant Convertible Notes by 93% of the lowest daily volume weighted average price of the Company
common stock on the Nasdaq Capital Market over the 10 trading days prior to the conversion date.
The Convertible Notes may be freely transferred, except to retail
investors, and subject to compliance with applicable securities laws. The Convertible Notes contain anti-dilution protection, which
protects the holder of the security from equity dilution resulting from later issues of shares at a lower price or value than that
provided for in the security. The protection in the Convertible Notes takes the form of tying the conversion price of the Convertible
Notes to the prevailing market price of the underlying shares of Common Stock so that changes to the share price due to share issuances,
share splits or other potentially dilutive events will result in a corresponding change in the number of shares of Common Stock
issuable upon conversion of a Convertible Note.
Company Information
OpGen was incorporated
in Delaware in 2001. On July 14, 2015, OpGen completed the Merger with AdvanDx. Pursuant to the terms of a Merger Agreement, Velox
Acquisition Corp., OpGen’s wholly-owned subsidiary formed for the express purpose of effecting the Merger, merged with and
into AdvanDx with AdvanDx surviving as OpGen’s wholly-owned subsidiary. On April 1, 2020, the Company completed the Transaction,
pursuant to which it acquired Curetis. The Company’s headquarters and principal operations are in Gaithersburg, Maryland,
and our telephone number is (240) 813-1260. Our website address is www.opgen.com. We do not incorporate the information on or accessible
through our website into this prospectus, and you should not consider any information on, or that can be accessed through, our
website as part of this prospectus.
THE OFFERING
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Common stock offered by the selling stockholder
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Up to 450,000 shares of our common stock
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Terms of the offering
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The selling stockholder will determine when and how it will sell the common stock offered in this prospectus, as described in "Plan of Distribution."
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Use of proceeds
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We will not receive any proceeds from the sale of the shares of common stock covered by this prospectus.
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Risk factors
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See "Risk Factors" beginning on page 9, for a discussion of factors you should carefully consider before deciding to invest in our common stock.
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Nasdaq Capital Market symbol
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Our Common Stock is listed on the Nasdaq Capital Market under the symbol “OPGN.” On June 16, 2020 the last reported sale price of our common stock was $2.00 per share.
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ABOUT THIS PROSPECTUS
This prospectus is part of a resale registration statement
that we filed with the U.S. Securities and Exchange Commission, or SEC. By using a resale registration statement, the selling stockholder
may sell from time to time in one or more offerings the Common Stock described in this prospectus.
This prospectus provides you with a general description of
the Company and our securities. For further information about our business and our securities, you should refer to the registration
statement and the reports incorporated by reference in this prospectus, as described in “Where You Can Find More Information.”
We have not authorized anyone to provide you with information
other than the information that we have provided or incorporated by reference in this prospectus and your reliance on any unauthorized
information or representation is at your own risk. This prospectus may be used only in jurisdictions where offers and sales of
these securities are permitted. You should assume that the information appearing in this prospectus is accurate only as of the
date of this prospectus and that any information we have incorporated by reference is accurate only as of the date of the document
incorporated by reference, regardless of the time of delivery of this prospectus, or any sale of our common stock. Our business,
financial condition and results of operations may have changed since those dates.
We own various U.S. federal trademark registrations and applications
and unregistered trademarks and servicemarks, including OpGen®, Curetis®, Unyvero®,
ARES® and ARES GENETICS®, Acuitas®, Acuitas Lighthouse®, AdvanDx®,
QuickFISH®, and PNA FISH®. All other trademarks, servicemarks or trade names referred to in this
prospectus are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus
are sometimes referred to without the ® and ™ symbols, but such references should not be construed as any indicator that
their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend the
use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship
of us by, any other companies, products or services.
SPECIAL NOTE REGARDING
FORWARD-LOOKING STATEMENTS
This prospectus contains “forward-looking statements”
within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E
of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of historical
fact, included or incorporated in this prospectus regarding our strategy, future operations, collaborations, intellectual property,
cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management are forward-looking
statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,”
“intends,” “may,” “could,” “should,” “potential,” “likely,”
“projects,” “continue,” “will,” and “would” and similar expressions are intended
to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
We have based these forward-looking statements on our current
expectations and projections about future events and trends that we believe may affect our financial condition, results of operations,
strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements are subject
to a number of risks, uncertainties and assumptions, including those described under the heading “Risk Factors.” In
light of these risks, uncertainties and assumptions, the forward-looking events and circumstances included herein may not occur,
and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Given
these uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements include,
but are not limited to, statements about:
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our ability to integrate the OpGen, Curetis, and Ares Genetics businesses;
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our liquidity and working capital requirements, including our cash requirements over the next 12 months;
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our ability to maintain compliance with the ongoing listing requirements for the Nasdaq Capital Market;
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receipt of regulatory clearance of our submitted 510(k) pre-market submission for our Acuitas AMR Gene Panel test for use with
bacterial isolates;
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the impact of the coronavirus pandemic on our business and operations;
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the completion of our development efforts for the Acuitas AMR Gene Panel Urine test and Acuitas Lighthouse Software, Unyvero
IJI and SHR panels, Unyvero A30 RQ platform and Aresdb and the timing of regulatory submissions;
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our ability to sustain or grow our customer base for our current research use only and rapid pathogen ID testing products;
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regulations and changes in laws or regulations applicable to our business, including regulation by the FDA;
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anticipated trends and challenges in our business and the competition that we face;
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the execution of our business plan and our growth strategy;
|
|
|
·
|
our expectations regarding the size of and growth in potential markets;
|
|
|
·
|
our opportunity to successfully enter into new collaborative or strategic agreements;
|
|
|
·
|
compliance with the U.S. and international regulations applicable to our business; and
|
|
|
·
|
our expectations regarding future revenue and expenses.
|
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements.
In addition, neither we nor any other person assumes responsibility for the accuracy and completeness of any of these forward-looking
statements. These risks should not be construed as exhaustive and should be read in conjunction with our other disclosures, including
but not limited to the risks described under the heading “Risk Factors.” Other risks may be described from time to
time in our filings made under the securities laws. New risks emerge from time to time. It is not possible for our management to
predict all risks. All forward-looking statements in this prospectus speak only as of the date made and are based on our current
beliefs and expectations. We undertake no obligation to update or revise any forward-looking statement, whether as a result of
new information, future events or otherwise.
RISK FACTORS
Investing in our securities involves substantial risks. In
addition to other information contained in this prospectus and in any accompanying prospectus supplement, before investing in our
securities, you should carefully consider the risks described under the heading “Risk Factors” in our most recent Annual
Report on Form 10-K and Quarterly Report on Form 10-Q and any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form
8-K and in any other documents incorporated by reference into this prospectus, as updated by our future filings. These risks are
not the only ones faced by us. Additional risks not known or that are deemed immaterial could also materially and adversely affect
our financial condition, results of operations, our products, business and prospects. Any of these risks might cause you to lose
all or a part of your investment.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale or other
disposition of the Shares held by the selling stockholder pursuant to this prospectus.
DETERMINATION OF OFFERING PRICE
The prices at which the Shares may actually be sold will be
determined by the prevailing public market price for shares of common stock, by negotiations between the selling stockholders and
buyers of our common stock in private transactions or as otherwise described in “Plan of Distribution.”
SELLING STOCKHOLDER
We are registering the resale of up to 450,000 shares of Common
Stock issuable upon conversion of the Convertible Notes held by Yorkville, the selling stockholder in this prospectus, to permit
it, or its permitted transferees or other successors-in-interest that may be identified in a supplement to this prospectus or,
if required, a post-effective amendment to the registration statement of which this prospectus is a part, to resell or otherwise
dispose of such shares in the manner contemplated under the section entitled "Plan of Distribution" in this prospectus
(as may be supplemented and amended).
The selling stockholder may sell some, all or none of the Shares.
We do not know how long the selling stockholder will hold the Shares before selling them, and we currently have no agreements,
arrangements or understandings with the selling stockholder regarding the sale or other disposition of any of the Shares. The Shares
covered hereby may be offered from time to time by the selling stockholder. As a result, we cannot estimate the number of Shares
the selling stockholder will beneficially own after termination of sales under this prospectus. In addition, the selling stockholders
may have sold, transferred or otherwise disposed of all or a portion of its Shares since the date on which it provided information
for this table.
The following table sets forth information as of June 16,
2020, and includes the number of shares of our Common Stock beneficially owned by the selling stockholder prior to the offering,
the number of shares of Common Stock offered by the selling stockholder, and the number of shares of Common Stock that will be
owned by the selling stockholder upon completion of the offering or offerings pursuant to this prospectus, assuming that the selling
stockholder sells all of the Shares. Only the selling stockholder listed below or their transferees, pledgees, donees, assignees,
distributees, successors and others who later come to hold any of such selling stockholder’s interest may offer and sell
Shares pursuant to this prospectus. The selling stockholder may offer the shares listed in the table below for sale pursuant to
this prospectus and any accompanying prospectus supplement from time to time.
|
|
|
Beneficial Ownership
Prior to this Offering
|
|
Shares Being
Offered
|
|
Beneficial Ownership
After this Offering
|
|
Name of Selling Stockholder
|
|
Number
|
|
Percent
|
|
(1)
|
|
Number
|
|
Percent
|
|
YA II PN, Ltd.
|
|
|
0
|
|
|
|
*
|
|
|
|
450,000
|
|
|
|
0
|
|
|
|
*
|
|
____________________
* Represents beneficial ownership of less than 1%.
|
|
(1)
|
The shares being offered consist solely of shares of Common Stock underlying the Convertible Notes.
|
Relationship
with Selling Stockholder
As discussed in greater detail above under the section "Prospectus
Summary—Yorkville Financing," on February 24, 2020, we entered into the Assignment Agreement with the selling stockholder
to assume the Convertible Notes, and agreed with the selling stockholder to file a registration statement to enable the resale
of the shares of common stock covered by this prospectus.
PLAN OF DISTRIBUTION
We are registering the Shares issued to the selling stockholder
to permit the resale of these Shares by the selling stockholder from time to time after the date of this prospectus. We will not
receive any of the proceeds from the sale by the selling stockholder of the Shares.
Yorkville, the selling stockholder, may sell all or a portion
of the Shares beneficially owned by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers
or agents. If the Shares are sold through underwriters or broker-dealers, the selling stockholder will be responsible for underwriting
discounts or commissions or agent's commissions. The Shares may be sold on the Nasdaq Capital Market or any other stock exchange,
market or trading facility on which the Shares are traded or in private transactions. These dispositions may be at fixed prices,
at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined
at the time of sale, or at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions.
The selling stockholder may use any one or more of the following methods when selling shares:
|
|
·
|
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
|
|
|
·
|
block trades in which the broker-dealer will attempt to sell the Shares as agent but may position and resell a portion of the
block as principal to facilitate the transaction;
|
|
|
·
|
purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
|
|
|
·
|
an exchange distribution in accordance with the rules of the applicable exchange;
|
|
|
·
|
privately negotiated transactions;
|
|
|
·
|
broker-dealers may agree with the selling stockholder to sell a specified number of such Shares at a stipulated price per share;
|
|
|
·
|
through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
|
|
|
·
|
a combination of any such methods of sale; or
|
|
|
·
|
any other method permitted pursuant to applicable law (including underwritten transactions).
|
The selling stockholder may also sell shares under Rule 144
under the Securities Act, if available, rather than under this prospectus.
The selling stockholder has informed us that they do not
have any agreement or understanding, directly or indirectly, with any person to distribute the shares covered under this prospectus.
If the selling stockholder notifies us that a material arrangement has been entered into with a broker-dealer for the sale of some
or all of the Shares through a block trade, secondary distribution or a purchase by a broker or dealer, we may be required to file
a prospectus supplement pursuant to the applicable rules promulgated under the Securities Act.
Broker-dealers, underwriters and agents engaged by the selling
stockholder may arrange for other broker-dealers, underwriters or agents to participate in sales. Broker-dealers, underwriters
or agents may receive commissions, discounts or concessions from the selling stockholder (or, if any broker-dealer acts as agent
for the purchase of Shares, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus,
in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA rules.
In connection with the sale of the Shares, the selling stockholder
may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales
of the Shares in the course of hedging the positions they assume. The selling stockholder may also sell the Shares and deliver
these securities to close out their short positions, or loan or pledge the common stock to broker-dealers that in turn may sell
these securities. The selling stockholder may also enter into option or other transactions with broker-dealers or other financial
institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial
institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant
to this prospectus (as supplemented or amended to reflect such transaction).
The selling stockholder and any broker-dealers, underwriters
or agents that are involved in selling the Shares may be deemed to be “underwriters” within the meaning of the Securities
Act in connection with such sales. In such event, any commissions received by such broker-dealers, underwriters or agents and any
profit on the resale of the Shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities
Act. If the selling stockholder qualifies as an “underwriter,” it will be subject to the prospectus delivery requirements
of Section 5(b)(2) of the Securities Act.
All costs and expenses incurred in connection with the registration
under the Securities Act of the offering made hereby will be paid by us, other than any brokerage fees and commissions, fees and
disbursements of legal counsel for the selling stockholder and stock transfer and other taxes attributable to the sale of the Shares,
which will be paid by the applicable selling stockholder.
Because the selling stockholder may be deemed to be an “underwriter”
within the meaning of the Securities Act, they will be subject to the prospectus delivery requirements of the Securities Act including
Rule 172 thereunder. In addition, any securities covered by this prospectus which qualify for sale pursuant to Rule 144 under the
Securities Act may be sold under Rule 144 rather than under this prospectus.
To the extent required, the Shares to be sold; the names
of the selling stockholder; the respective purchase prices and public offering prices; the names of any agents, dealers or underwriters;
and any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus
supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus. The resale
shares will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws.
In addition, in certain states, the resale shares may not be sold unless they have been registered or qualified for sale in the
applicable state or an exemption from the registration or qualification requirement is available and is complied with.
Under applicable rules and regulations under the Exchange
Act, any person engaged in the distribution of the resale shares may not simultaneously engage in market making activities with
respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the
distribution. In addition, the selling stockholder will be subject to applicable provisions of the Exchange Act and the rules and
regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of shares of our common stock
by the selling stockholder or any other person. We will make copies of this prospectus available to the selling stockholder and
have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including
by compliance with Rule 172 under the Securities Act).
LEGAL MATTERS
Certain legal matters with respect to the securities offered
hereby have been passed upon by Ballard Spahr LLP.
EXPERTS
The consolidated financial statements of OpGen, Inc. and
its subsidiaries as of December 31, 2019 and 2018, and for the years then ended, have been incorporated by reference herein in
reliance upon the report, also incorporated by reference herein, of CohnReznick LLP, an independent registered public accounting
firm, and upon the authority of said firm as experts in accounting and auditing. The audit report covering the December 31, 2019
consolidated financial statements contains an explanatory paragraph that states that the Company has experienced losses and negative
cash flows from operations since its inception, has an accumulated deficit, and has debt obligations which raise substantial doubt
about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might
result from the outcome of that uncertainty.
WHERE YOU CAN
FIND MORE INFORMATION
We filed with the SEC a registration statement under the
Securities Act of 1933 for the Shares under this prospectus. This prospectus does not contain all of the information in the registration
statement and the exhibits and schedule that were filed with the registration statement. For further information with respect to
us and our common stock, we refer you to the registration statement and the exhibits and schedule that were filed with the registration
statement. Statements contained in this prospectus about the contents of any contract or any other document that is filed as an
exhibit to the registration statement are not necessarily complete, and we refer you to the full text of the contract or other
document filed as an exhibit to the registration statement. The SEC maintains a website that contains reports, proxy and information
statements, and other information regarding registrants that file electronically with the SEC. The address of the website is www.sec.gov.
We file periodic reports under the Securities Exchange Act
of 1934, including annual, quarterly and special reports, and other information with the Securities and Exchange Commission. These
periodic reports and other information are available for inspection and copying at the SEC regional offices, public reference facilities
and on the website of the SEC referred to above.
We make available free of charge on or through our internet
website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports
filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 as soon as reasonably practicable
after we electronically file such material with, or furnish it to, the SEC. The information found on our website, www.opgen.com,
other than as specifically incorporated by reference in this prospectus, is not part of this prospectus.
INCORPORATION
BY REFERENCE
The SEC allows us to “incorporate by reference”
in this prospectus the information in other documents that we file with it, which means that we can disclose important information
to you by referring you to those documents containing such information. This prospectus is part of a registration statement we
filed with the SEC. You should rely on the information incorporated by reference in this prospectus and the registration statement.
The information incorporated by reference is considered to be part of this prospectus and information we file later with the SEC
will automatically update and supersede this information and information contained in documents filed earlier with the SEC. We
incorporate by reference the documents listed below, any filings made with the SEC after the date of the initial registration statement
and prior to effectiveness of the registration statement, and any future filings made with the SEC under Section 13(a), 13(c),
14 or 15(d) of the Exchange Act prior to the termination of the offering; provided, that we are not incorporating by reference
any documents or information deemed to have been furnished and not filed in accordance with SEC rules. The documents we are incorporating
by reference are:
|
· our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 24, 2020;
|
|
· our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on May 8, 2020;
|
|
· our Current Reports on Form 8-K filed with the SEC on January 23, 2020 (Item 8.01); January 30, 2020 (Item 8.01 and 9.01); February 12, 2020 (Items 1.01 and 9.01); February 12, 2020 (Items 8.01 and 9.01); February 20, 2020 (Items 8.01 and 9.01); February 28, 2020 (Items 1.01 and 9.01); March 10, 2020 (Items 8.01 and 9.01); and March 16, 2020 (Items 8.01 and 9.01); March 19, 2020 (Items 8.01 and 9.01); March 24, 2020 (Items 8.01 and 9.01, but only exhibit 99.2 thereof) March 30, 2020 (Items 5.07, 8.01 and 9.01); April 2, 2020 (Items 2.01, 5.02, 8.01 and 9.01), as amended on June 15, 2020; April 16, 2020 (Item 8.01); April 28, 2020 (Items 1.01, 2.03 and 9.01); May 7, 2020 (Item 5.02); May 11, 2020 (Items 8.01 and 9.01); and June 3, 2020 (Items 8.01 and 9.01);
|
|
· our proxy statement for the Annual Meeting of Stockholders held on August 2019, filed with the SEC on July 12, 2019; and
|
|
· the description of our common stock contained in the Registration Statement on Form 8-A filed on April 30, 2015 and any amendments to such Registration Statement filed subsequently thereto, including all amendments or reports filed for the purpose of updating such description.
|
We will furnish to you, on written or oral request, a copy
of any or all of the documents that have been incorporated by reference, including exhibits to these documents. You may request
a copy of these filings at no cost by writing or telephoning our Secretary at the following address and telephone number:
OpGen, Inc.
Attention: Timothy C. Dec, Corporate Secretary
708 Quince Orchard Road, Suite 205
Gaithersburg, MD 20878
Telephone No.: (240) 813-1260
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance
and Distribution.
The costs and expenses payable by the Company in connection
with the offerings described in this registration statement are set forth below. The selling stockholder will not bear any portion
of such expenses.
|
SEC registration fee
|
|
$
|
113.32
|
|
|
Legal fees and expenses
|
|
$
|
10,000
|
*
|
|
Accounting fees and expenses
|
|
$
|
10,000
|
*
|
|
Printer costs and expenses
|
|
$
|
386.68
|
*
|
|
|
|
|
|
|
|
Total
|
|
$
|
20,500
|
|
_____________
*Estimated as permitted under Rule 511 of Regulation S-K.
Item 15. Indemnification of Directors
and Officers.
Section 145 of the Delaware General Corporation Law, or the
DGCL, authorizes a corporation to indemnify its directors and officers against liabilities arising out of actions, suits and proceedings
to which they are made or threatened to be made a party by reason of the fact that they have served or are currently serving as
a director or officer to a corporation. The indemnity may cover expenses (including attorneys’ fees) judgments, fines and
amounts paid in settlement actually and reasonably incurred by the director or officer in connection with any such action, suit
or proceeding. Section 145 permits corporations to pay expenses (including attorneys’ fees) incurred by directors and officers
in advance of the final disposition of such action, suit or proceeding. In addition, Section 145 provides that a corporation has
the power to purchase and maintain insurance on behalf of its directors and officers against any liability asserted against them
and incurred by them in their capacity as a director or officer, or arising out of their status as such, whether or not the corporation
would have the power to indemnify the director or officer against such liability under Section 145.
We have adopted provisions in our certificate of incorporation
and bylaws that limit or eliminate the personal liability of our directors to the fullest extent permitted by the DGCL, as it now
exists or may in the future be amended. Consequently, a director will not be personally liable to us or our stockholders for monetary
damages or breach of fiduciary duty as a director, except for liability for:
|
|
·
|
any breach of the director’s duty of loyalty to the Company or its stockholders;
|
|
|
·
|
any act or omission not in good faith or which involve intentional misconduct or a knowing violation of law;
|
|
|
·
|
any unlawful payment related to dividends or unlawful stock purchases, redemptions or other distributions; or
|
|
|
·
|
any transaction from which the director derived an improper personal benefit.
|
These limitations of liability do not alter director liability
under the federal securities laws and do not affect the availability of equitable remedies such as an injunction or rescission.
In addition, our bylaws provide that:
|
· we will indemnify our directors, officers and, in the discretion of our board of directors, certain employees to the fullest extent permitted by the DGCL, as it now exists or may in the future be amended; and
|
|
|
·
|
we will advance reasonable expenses, including attorneys’ fees, to our directors and, in the discretion of our board of directors, to our officers and certain employees, in connection with legal proceedings relating to their service for or on behalf of us, subject to limited exceptions.
|
We have entered into indemnification agreements with each
of our directors and executive officers. These agreements provide that we will indemnify each of our directors, such executive
officers and, at times, their affiliates to the fullest extent permitted by Delaware law. We will advance expenses, including attorneys’
fees (but excluding judgments, fines and settlement amounts), to each indemnified director, executive officer or affiliate in connection
with any proceeding in which indemnification is available and we will indemnify our directors and officers for any action or proceeding
arising out of that person’s services as a director or officer brought on behalf of us and/or in furtherance of our rights.
Additionally, each of our directors may have certain rights to indemnification, advancement of expenses and/or insurance provided
by their affiliates, which indemnification relates to and might apply to the same proceedings arising out of such director’s
services as a director referenced herein. Nonetheless, we have agreed in the indemnification agreements that our obligations to
those same directors are primary and any obligation of the affiliates of those directors to advance expenses or to provide indemnification
for the expenses or liabilities incurred by those directors are secondary.
We also maintain general liability insurance which covers
certain liabilities of our directors and officers arising out of claims based on acts or omissions in their capacities as directors
or officers, including liabilities under the Securities Act.
A stockholder’s investment may be adversely affected
to the extent we pay the costs of settlement and damage awards against directors and officers as required by these indemnification
provisions. At present, there is no pending litigation or proceeding involving any of our directors, officers or employees regarding
which indemnification is sought, nor are we aware of any threatened litigation that may result in claims for indemnification.
Insofar as indemnification for liabilities arising under
the Securities Act may be permitted to directors, officers or persons controlling us pursuant to the foregoing provisions, we have
been informed that, in the opinion of the SEC, this indemnification is against public policy as expressed in the Securities Act
and is therefore unenforceable.
Item 16. Exhibits.
The following exhibits are filed as part of, or incorporated
by reference into this registration statement:
|
Exhibit
Number
|
|
Identification of Exhibit
|
|
2.1
|
|
Implementation Agreement, dated as of September 4, 2019, by and among Curetis N.V., Crystal GmbH, and OpGen (incorporated by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K, filed on September 4, 2019).
|
|
4.1
|
|
Form of Common Stock Certificate of the Registrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Annual Report on Form 10-K, filed on March 24, 2020).
|
|
5.1 *
|
|
Opinion of Ballard Spahr LLP
|
|
10.1 *
|
|
Agreement for the Issuance of and Subscription to Notes Convertible into Shares and Share Subscription Warrants, dated October 2, 2018, by and between Curetis GmbH and Yorkville.
|
|
10.2
|
|
Assignment of the Agreement for the Issuance of and Subscription to Notes Convertible into Shares, dated February 24, 2020, among OpGen, Inc., YA II PN, LTD, and Curetis N.V. (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on February 28, 2020).
|
|
23.1 *
|
|
Consent of CohnReznick LLP
|
|
23.2 *
|
|
Consent of Ballard Spahr LLP (included in Exhibit 5.1)
|
|
24.1 *
|
|
Power of Attorney (on signature page)
|
_____________
Item 17. Undertakings.
(a)
The undersigned registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration
statement:
(i)
To include any prospectus required by section 10(a)(3) of the Securities Act of 1933;
(ii)
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or
the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the
information in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or
high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule
424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii)
To include any material information with respect to the plan of distribution not previously disclosed in the registration
statement or any material change to such information in the registration statement;
Provided, however, that:
Paragraphs (1)(i), (1)(ii) and (1)(iii)
of this section do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained
in reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange
Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant
to Rule 424(b) that is part of the registration statement.
(2)
That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment
shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
(3)
To remove from registration by means of a post-effective amendment any of the securities being registered which remain
unsold at the termination of the offering.
(4)
That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
(i)
If the registrant is relying on Rule 430B:
(A)
Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration
statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
(B)
Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement
in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing
the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration
statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract
of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer
and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof, provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by
reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with
a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement
or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date;
or
(ii)
If the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration
statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in
reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used
after effectiveness, provided, however, that no statement made in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede
or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or
made in any such document immediately prior to such date of first use.
(5)
That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser
in the initial distribution of the securities:
The undersigned registrant undertakes
that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the
underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means
of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to
offer or sell such securities to such purchaser:
(i)
Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed
pursuant to Rule 424;
(ii)
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used
or referred to by the undersigned registrant;
(iii)
The portion of any other free writing prospectus relating to the offering containing material information about the
undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
(iv)
Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
(b)
The undersigned registrant hereby further undertakes that, for purposes of determining any liability under the Securities
Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange
Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of
the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed
to be the initial bona fide offering thereof.
(c)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors,
officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed
in the Securities Act of 1933, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection
with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by
controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against
public policy as expressed in said act and will be governed by the final adjudication of such issue.
(d)
The undersigned registrant hereby undertakes that:
(1)
For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form
of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed
by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration
statement as of the time it was declared effective.
(2)
For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that
contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
SIGNATURES
Pursuant to the requirements of the
Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements
for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Gaithersburg, State of Maryland on the 17th day of June, 2020.
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OpGen, Inc.
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By:
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/s/ Oliver Schacht, Ph.D.
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Oliver
Schacht, Ph.D
Chief Executive Officer and Director
(principal
executive officer)
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POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that
each person whose signature appears below constitutes and appoints each of Oliver Schacht, Ph.D. and Timothy C. Dec as true and
lawful attorney-in-fact and agent, with full power of substitution and re-substitution, for them and in their name, place and stead,
in any and all capacities, to sign any and all amendments (including pre-effective and post-effective amendments) to this registration
statement and any additional registration statements filed pursuant to Rule 462, and to file the same, with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange Commission (the SEC), and generally to do all such
things in their names and behalf in their capacities as officers and directors to enable the Company to comply with the provisions
of the Securities Act of 1933 and all requirements of the SEC, granting unto each said attorney-in-fact and agent full power and
authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to
all intents and purposes as he or she might or could do in person, ratifying and confirming all that said attorney-in-fact and
agent, or their or his or her substitutes or substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities
Act of 1933, as amended, this registration statement has been signed by the following persons in the capacities and on the dates
indicated.
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Signature
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Title
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Date
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/s/ Oliver Schacht, Ph.D.
Oliver Schacht, Ph.D.
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Chief Executive Officer and Director (principal executive officer)
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June 17, 2020
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/s/ Timothy C. Dec
Timothy C. Dec
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Chief Financial Officer (principal financial officer and principal
accounting officer)
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June 17, 2020
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/s/ Mario Crovetto
Mario Crovetto
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Director
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June 17, 2020
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/s/ R. Donald Elsey
R. Donald Elsey
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Director
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June 17, 2020
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/s/ Prabhavathi Fernandes, Ph.D.
Prabhavathi Fernandes, Ph.D.
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Director
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June 17, 2020
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/s/ Evan Jones
Evan Jones
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Director
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June 17, 2020
|
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/s/ William Rhodes
William Rhodes
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Director
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June 17, 2020
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