Filed pursuant to Rule 424(b)(5)
Registration No. 333-258646
Prospectus Supplement
(To the Prospectus dated August 19, 2021)
5,360,000 Shares of Common
Stock
33,810 Shares of Preferred
Stock
4,300,000 Shares of Common
Stock Underlying Pre-funded Warrants
We are offering (i) 5,360,000
shares of our common stock, par value $0.01 per share, or the Common Shares, (ii) 33,810 shares of our Series C Mirroring Preferred Stock,
par value $0.01 per share and stated value of $0.01 per share, or the Preferred Shares, and (iii) 4,300,000 shares of common stock underlying
pre-funded warrants to purchase shares of common stock, or the Pre-funded Warrants, to a single institutional investor pursuant to this
prospectus supplement, the accompanying prospectus and a securities purchase agreement, dated September 30, 2022, by and between us and
the investor signatory thereto, or the Securities Purchase Agreement. The Preferred Shares will not be convertible into shares of our
common stock and will automatically terminate and cease to be outstanding following the consummation of a reverse stock split of the Company’s
shares of common stock. Each Pre-funded Warrant will have an exercise price of $0.01, will be immediately exercisable and may be exercised
at any time until all of the Pre-Funded Warrants are exercised in full. Each Common Warrant will have an exercise price of $0.377, will
become exercisable six months following the date of issuance and will expire five years after their initial exercise date.
We have engaged H.C. Wainwright
& Co., LLC, or the Placement Agent, as our exclusive placement agent in connection with this offering. The Placement Agent has agreed
to use its reasonable best efforts to sell the securities offered by this prospectus supplement and the accompanying prospectus. The placement
agent is not purchasing or selling any shares offered by this prospectus supplement and the accompanying base prospectus. See “Plan
of Distribution” beginning on page S-20 of this prospectus supplement for more information regarding these arrangements.
In a concurrent private
placement, we are also issuing to the institutional investor, for no additional consideration, warrants to purchase 9,660,000 shares of
our Common Stock, or the Common Warrants. Each Common Warrant will have an exercise price of $0.377, will be exercisable beginning on
the six-month anniversary of the date of issuance, or the Initial Exercise Date, and will expire five and one half years from the Initial
Exercise Date. The Common Warrants and the shares of our Common Stock issuable upon exercise of the Common Warrants are not registered
under the Securities Act of 1933, as amended, or the Securities Act, are not being offered pursuant to this prospectus supplement and
the accompanying prospectus, and are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and
Rule 506(b) promulgated thereunder.
Our common stock is traded
on the Nasdaq Capital Market under the symbol “OPGN.” On September 30, 2022, the closing price of our common stock was $0.286
per share. There is no established public trading market for the Preferred Shares, the Pre-funded Warrants and the Common Warrants being
offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply for listing the Preferred Shares,
the Pre-funded Warrants and the Common Warrants on any national securities exchange or other trading market. Without an active market,
the liquidity of the Preferred Shares, the Pre-funded Warrants and the Common Warrants will be limited.
Investing in our securities involves a high
degree of risk, including that the trading price of our common stock has been subject to volatility. Please read the information contained
in or incorporated by reference under the heading “Risk Factors” in this prospectus supplement and in the accompanying prospectus.
__________________
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus
supplement or the accompanying prospectus. Any representation to the contrary is a criminal offense.
| |
Per Common Share | | |
Per Preferred Share | | |
Per Share Underlying Pre-funded Warrant | | |
Total | |
Offering price | |
$ | 0.35 | | |
$ | 0.01 | | |
$ | 0.34 | | |
$ | 3,381,338.10 | |
Placement agent fees | |
$ | 0.021 | | |
$ | 0.0006 | | |
$ | 0.021 | | |
$ | 202,880.29 | |
Proceeds before expenses to us | |
$ | 0.329 | | |
$ | 0.0094 | | |
$ | 0.319 | | |
$ | 3,178,457.81 | |
| (1) | We have agreed to pay the Placement Agent an aggregate cash placement fee
equal to 6.0% of the gross proceeds in this offering. For additional information on the placement agent’s compensation, see “Plan
of Distribution” beginning on page S-20 of this prospectus supplement |
____________________
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
supplement and the accompanying prospectus. Any representation to the contrary is a criminal offense.
___________________
H.C. Wainwright & Co.
___________________
The date of this prospectus supplement
is September 30, 2022
TABLE OF CONTENTS
Prospectus Supplement
Page
ABOUT THIS PROSPECTUS SUPPLEMENT |
S-i |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS |
S-iii |
PROSPECTUS SUPPLEMENT SUMMARY |
S-1 |
RISK FACTORS |
S-6 |
USE OF PROCEEDS |
S-11 |
DIVIDEND POLICY |
S-11 |
CAPITALIZATION |
S-12 |
DILUTION |
S-14 |
DESCRIPTION OF SECURITIES |
S-15 |
PRIVATE PLACEMENT TRANSACTION |
S-17 |
PLAN OF DISTRIBUTION |
S-20 |
LEGAL MATTERS |
S-22 |
EXPERTS |
S-22 |
WHERE YOU CAN FIND MORE INFORMATION |
S-22 |
INCORPORATION BY REFERENCE |
S-22 |
Prospectus
Page
ABOUT THIS PROSPECTUS |
ii |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS |
iii |
PROSPECTUS SUMMARY |
1 |
RISK FACTORS |
3 |
USE OF PROCEEDS |
4 |
PLAN OF DISTRIBUTION |
5 |
DESCRIPTION OF SECURITIES |
8 |
LEGAL MATTERS |
17 |
EXPERTS |
17 |
WHERE YOU CAN FIND ADDITIONAL INFORMATION |
17 |
INCORPORATION BY REFERENCE |
17 |
ABOUT THIS PROSPECTUS
SUPPLEMENT
This prospectus supplement
and the accompanying prospectus are part of a “shelf” registration statement on Form S-3 (File No. 333-258646) that we filed
with the Securities and Exchange Commission, or the SEC, on August 9, 2021, and that was declared effective on August 19, 2021.
This document is in two parts.
The first part is this prospectus supplement, which describes the terms of this offering and also adds to and updates information contained
in the accompanying prospectus and the documents incorporated by reference into this prospectus supplement and the accompanying prospectus.
The second part is the accompanying prospectus, which gives more general information about the securities we may offer from time to time
under our shelf registration statement, some of which does not apply to the securities offered by this prospectus supplement. Generally,
when we refer to this prospectus, we are referring to both parts of this document combined. To the extent there is a conflict between
the information contained in this prospectus supplement, on the one hand, and the information contained in the accompanying prospectus
or any document incorporated by reference herein or therein, on the other hand, you should rely on the information in this prospectus
supplement.
You should read this prospectus
supplement, the accompanying prospectus, the documents incorporated by reference in this prospectus supplement and the accompanying prospectus
and any free writing prospectus that we have authorized for use in connection with this offering before making an investment decision.
You should also read and consider the information in the documents referred to in the sections of this prospectus supplement entitled
“Where You Can Find More Information” and “Information Incorporated by Reference.”
We are not making an offer
to sell the securities covered by this prospectus supplement in any jurisdiction where the offer or sale is not permitted.
The information appearing
in this prospectus supplement, the accompanying prospectus, the documents incorporated by reference in this prospectus supplement and
the accompanying prospectus and any free writing prospectus that we have authorized for use in connection with this offering is accurate
only as of its respective date, regardless of the time of delivery of the respective document or of any sale of securities covered by
this prospectus supplement. You should not assume that the information contained in or incorporated by reference in this prospectus supplement
or the accompanying prospectus, or in any free writing prospectus that we have authorized for use in connection with this offering, is
accurate as of any date other than the respective dates thereof.
We further note that the
representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated
by reference herein were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating
risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such
representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and
covenants should not be relied on as accurately representing the current state of our affairs.
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 supplement and your
reliance on any unauthorized information or representation is at your own risk. This prospectus supplement 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 supplement
is accurate only as of the date of this prospectus supplement 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.
Note Regarding Trademarks
We own various U.S. federal trademark registrations
and applications and unregistered trademarks and service marks, including OpGen®, Curetis®, Unyvero®, ARES® and ARES GENETICS®,
and Acuitas®. All other trademarks, servicemarks or trade names referred to in this prospectus supplement 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 supplement contains “forward-looking
statements” within the meaning of Section 27A of the Securities and Section 21E of the Securities Exchange Act of 1934, as amended,
or 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:
| · | the continued impact of the COVID-19 pandemic on our business and operations; |
| · | our liquidity and working capital requirements, including our cash requirements over the next 12 months; |
| · | our use of proceeds from capital financing transactions; |
| · | our ability to maintain compliance with the ongoing listing requirements for the Nasdaq Capital Market; |
| · | the completion of our development efforts for our Unyvero UTI and IJI panels, Unyvero A30 RQ platform
and ARESdb and the timing of regulatory submissions; |
| · | our ability to establish a market for and sell our Acuitas AMR Gene Panel test for use with bacterial
isolates; |
| · | our ability to obtain regulatory clearance for and commercialize our product and services offerings; |
| · | our ability to sustain or grow our customer base for our Unyvero IVD and Acuitas AMR Gene Panel products
as well as our current research use only products; |
| · | regulations and changes in laws or regulations applicable to our business, including regulation by the
FDA, European Union, including pending IVDR requirements, and China’s NMPA; |
| · | our ability to further integrate the OpGen, Curetis, and Ares Genetics businesses; |
| · | our ability to satisfy our debt obligations; |
| · | adverse effects on our business condition and results of operations from general economic and market
conditions and overall fluctuations in the United States and international markets, including deteriorating market conditions due to investor
concerns regarding inflation and hostilities between Russia and Ukraine; |
| · | anticipated trends and challenges in our business and the competition that we face; |
| · | 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.
PROSPECTUS SUPPLEMENT
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
S-6 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.
OpGen Overview
We are a precision medicine
company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. Along with subsidiaries, Curetis
GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more
rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections
caused by multidrug-resistant microorganisms, or MDROs. Our current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the
ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction including
ARESiss, ARESid, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.
Our focus is on our combined
broad portfolio of products, which include high impact rapid diagnostics and bioinformatics to interpret antimicrobial resistance (AMR)
genetic data. We will continue to develop and seek FDA and other regulatory clearances or approvals, as applicable, for additional diagnostic
tests. We will continue to offer the FDA-cleared Unyvero LRT and LRT BAL Panels, Acuitas AMR Gene Panel diagnostic test, as well as the
Unyvero UTI Panel as a research-use-only products to hospitals, public health departments, clinical laboratories, pharmaceutical companies
and contract research organizations. We are also continuing to commercialize our CE Marked Unyvero Panels in Europe and other global markets
through distributors.
The Company currently expects
to focus on the following products for lower respiratory infection, urinary tract infection and invasive joint infection:
| · | The Unyvero Lower Respiratory Tract, or LRT, test (e.g. for bacterial pneumonias) is the first U.S.
Food and Drug Administration, or FDA, cleared test that can be used for the detection of more than 90% of common causative agents of hospitalized
pneumonia. 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 have commercialized the Unyvero LRT BAL test for testing bronchoalveolar lavage, or BAL, specimens from patients with lower
respiratory tract infections following FDA clearance received by Curetis in December 2019. The Unyvero LRT BAL automated test simultaneously
detects 20 pathogens and 10 antibiotic resistance markers, and it is the first and only FDA-cleared panel that also includes Pneumocystis
jirovecii, a key fungal pathogen often found in immunocompromised patients (such as AIDS and transplant patients) that can be difficult
to diagnose, as the 20th pathogen on the panel. We believe the Unyvero LRT and LRT BAL tests have 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. |
| · | Following registration of the Unyvero instrument system as an IVD for the Chinese market in early 2021,
we are supporting our strategic partner Beijing Clear Biotech (BCB) in pursuing execution of a supplemental clinical trial with the Unyvero
HPN test. As requested by the Chinese regulatory authority NMPA, this study is geared towards generating additional data in China that
will complement a larger data set with data from abroad compiled from other clinical and analytical studies performed in the past. |
| · | The Unyvero Urinary Tract Infection, or UTI, test, which is CE-IVD marked in Europe, is currently being
made available to laboratories in the United States as a research use only or RUO kit. The test detects a broad range of pathogens as
well as antimicrobial resistance markers directly from native urine specimens. We initiated a prospective multi-center clinical trial
for the Unyvero UTI in the United States in the third quarter of 2021 and completed enrollment at the end of the third quarter of 2022
and presented positive data from an interim analysis in Q1 of 2022. |
| · | The Unyvero Invasive Joint Infection, or IJI, test, which is a test specifically being developed for
the U.S. market on the Unyvero A30 platform, has also been selected for analytical and clinical performance evaluation including clinical
trials towards a future U.S. FDA submission. Microbial diagnosis of IJI is difficult because of challenges in sample collection, usually
at surgery, and patients being on prior antibiotic therapy which minimizes the chances of recovering viable bacteria. We believe that
Unyvero IJI could be useful in identifying pathogens as well as their AMR markers to help guide optimal antibiotic treatment for these
patients. |
| · | On September 30, 2021, we received clearance from the FDA for our Acuitas AMR Gene Panel for bacterial
isolates. The Acuitas AMR Gene Panel detects 28 genetic antimicrobial resistance, or AMR, markers in isolated bacterial colonies from
26 different pathogens. We believe the panel provides clinicians with a valuable diagnostic tool that informs about potential antimicrobial
resistance patterns early and supports appropriate antibiotic treatment decisions in this indication. We expect to commercialize the Acuitas
AMR Gene Panel for isolates to customers in the United States. |
| · | We are also developing novel bioinformatics tools and solutions to accompany or augment our current
and potential future IVD products and may seek regulatory clearance for such bioinformatics tools and solutions to the extent they would
be required either as part of our portfolio of IVD products or even as a standalone bioinformatics product. |
Special Meeting of Stockholders
Promptly after the closing of this offering,
the Company will call a special meeting of its stockholders, or the Special Meeting, to consider the approval of an amendment to the Company’s
Amended and Restated Certificate of Incorporation, as amended, to effect a reverse stock split at a ratio of not less than five-to-one
and not more than twenty-to-one, or the Reverse Stock Split, such ratio and the implementation and timing of such Reverse Stock Split
to be determined in the discretion of our Board of Directors. The Preferred Shares purchased in this offering will be outstanding and
entitled vote at the Special Meeting, and will be entitled to 100,000 votes for each share of Preferred Stock outstanding as of the record
date for the Special Meeting. The votes of the holders of the Preferred Stock will be counted with the shares of common stock as a class
on the proposed Charter amendment.
The approval of the amendment to the Charter
to effect the Reverse Stock Split will require the affirmative votes of a majority of the combined voting power of the outstanding shares
of common stock and Preferred Shares, voting together, present in person or represented by proxy and entitled to vote on the proposal.
The holders of common stock have the right to cast one (1) vote per share of common stock on this proposal. The holders of Preferred
Stock have the right to cast 100,000 votes per share of Preferred Stock on this proposal, provided that, pursuant to the Securities Purchase
Agreement, the holders of Preferred Stock agreed that such votes must be cast in the same proportion as the aggregate shares of common
stock are voted on this proposal (excluding any shares of common stock that are not voted). Therefore, the holders of a significant portion
of the common stock outstanding must vote their shares at the Special Meeting in order for the proposal to pass.
Recent Developments
Reverse Stock Split
On February 28, 2022, we received
a notice from The Nasdaq Stock Market LLC, or Nasdaq, notifying us that, based upon the closing bid price of our common stock, for the
30 consecutive business days prior to the notice, the Company no longer met the requirement to maintain a minimum closing bid price of
$1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2). The Company was originally granted 180 calendar days, or until August
29, 2022, to regain compliance with the minimum bid price rule. On August 30, 2022, Nasdaq notified the Company that it had been granted
an additional 180-calendar day compliance period, or until February 27, 2023, to regain compliance with the Minimum Bid Price Rule. In
connection with the grant of such additional compliance period, the Company provided notice to Nasdaq that it intended to cure the bid
price deficiency by effecting a reverse stock split, if necessary, prior to the end of the compliance period. While we have until February
27, 2023 to regain such compliance, we do not believe we will be able to do so without implementing a reverse stock split.
If we are not in compliance
with the minimum bid price requirement by February 27, 2023, we can appeal Nasdaq’s determination to a hearings panel in order to
present a plan to regain compliance. There can be no assurances however that we will be granted any relief or additional time to regain
compliance with the minimum bid price requirement and do not believe that any additional grace period will allow the Company to comply
with the minimum closing bid price requirement unless a reverse stock split is not approved.
Warrant Amendment Agreement
In connection with this offering,
the Company also entered into a warrant amendment agreement, or the Warrant Amendment Agreement, with the investor in this offering. Under
the Warrant Amendment Agreement, the Company agreed to amend certain existing warrants to purchase up to 14,829,751 shares of common stock
that were previously issued in 2018 and 2021 to such investor, with exercise prices ranging from $2.05 to $65.00 per share, or the Existing
Warrants, in consideration for their purchase of the securities in this offering, as follows: (i) lower the exercise price of the Existing
Warrants to $0.377 per share, (ii) provide that the Existing Warrants, as amended, will not be exercisable until six months following
the closing date of this offering, and (iii) extend the original expiration date of the Existing Warrants by five and one-half years following
the close of this offering.
Company Information
OpGen, Inc.
was incorporated in Delaware in 2001. On April 1, 2020, we completed a business combination transaction with Curetis GmbH. Our principal
executive office is located at 9717 Key West Avenue, Suite 100, Rockville, MD 20850, and our telephone number is (301) 869-9683. We also
have operations in Germany and Austria. 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 supplement.
THE OFFERING
Securities offered by us |
|
5,360,000 Common Shares
33,810 Preferred Shares
4,300,000 shares of common stock underlying the Pre-funded
Warrants at an exercise price of $0.01 per share. Each Pre-Funded Warrant will be exercisable immediately upon issuance and will not expire
until exercised in full. |
Common stock to be outstanding after this offering |
|
56,283,618 shares of Common Stock (assuming the issuance of all the shares underlying the Pre-funded Warrants, but not assuming the exercise of the Common Warrants) |
Use of proceeds |
|
We currently intend to use the net proceeds from this offering to: (i) continue commercialization of the FDA-cleared Acuitas AMR Gene Panel test for isolates in the U.S.; (ii) commercialize our other products with a focus on the Unyvero platform and diagnostic tests; (iii) support further development and commercialization of the Ares Genetics database; (iv) support directed sales and marketing efforts to the customers and collaborators for our products and services; (v) invest in manufacturing and operations infrastructure to support sales of products; and (vi) the repayment of certain outstanding indebtedness of the Company. We intend to use the remaining net proceeds for working capital and other general corporate purposes. See “Use of Proceeds” on page S-11. |
Concurrent Private Placement |
|
In a concurrent private placement, we are selling to the investor purchasing the Common Shares, Preferred Shares and Pre-funded Warrants in this offering, Common Warrants to purchase 9,660,000 of our shares of Common Stock at an exercise price of $0.377 per share. The Common Warrants will be exercisable beginning on the six-month anniversary of the date of issuance and expire five and one-half years from their date of issuance. We will receive gross proceeds from exercise of the Common Warrants in such concurrent private placement transaction solely to the extent such Common Warrants are exercised for cash. The Common Warrants and the shares of Common Stock issuable upon the exercise of the Common Warrants are not being offered pursuant to this prospectus supplement and the accompanying prospectus. See “Private Placement Transaction.” |
Risk factors |
|
Investing in our securities involves a high degree of risk. See "Risk Factors" beginning on page S-6 of this prospectus supplement and under the similar heading in the accompanying prospectus and the other information included or incorporated by reference herein or therein. |
Nasdaq Capital Market symbol |
|
“OPGN.” There is no established public
trading market for the Preferred Shares, the Pre-funded Warrants and the Common Warrants being offered in this offering, and we do not
expect a market to develop. In addition, we do not intend to apply for listing the Preferred Shares, the Pre-funded Warrants and the Common
Warrants on any national securities exchange or other trading market. Without an active market, the liquidity of the Preferred Shares,
the Pre-funded Warrants and the Common Warrants will be limited. |
The number of shares of common stock to be outstanding immediately after
this offering is based on 46,623,618 shares of our common stock outstanding as of June 30, 2022, and excludes:
| · | 2,215,755 shares of common stock issuable upon the exercise of outstanding options granted as of June
30, 2022, under our equity incentive plans at a weighted average exercise price of $4.66 per share; |
| · | 16,217,008 shares of common stock issuable upon the exercise of outstanding warrants issued as of June
30, 2022, at a weighted average exercise price of $3.98 per share; |
| · | 833,066 shares of common stock issuable upon vesting of outstanding restricted stock units granted as
of June 30, 2022; |
| · | 1,284,296 shares of common stock available for future issuance under our equity incentive plans as of
June 30, 2022; |
| · | 9,660,000 shares of our Common Stock issuable upon the exercise of the Common Warrants offered in the
concurrent private placement with an exercise price of $0.377 per share; and |
| · | 1,714,882 shares of our Common Stock issued since June 30, 2022 under our
current at-the-market offering. |
The number of outstanding options, restricted
stock units and shares of common stock available for future issuances under our equity incentive plans does not reflect:
| · | the forfeiture of restricted stock units and/or options to acquire 78,125 shares of our common stock
since June 30, 2022. |
Unless otherwise indicated, all information
contained in this prospectus supplement assumes (i) no exercise of options issued under our equity incentive plans and (ii) no exercise
of warrants.
RISK FACTORS
Investing in our securities involves a high
degree of risk. In addition to other information contained in this prospectus supplement and in the accompanying prospectus, 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.
Risks Related to this Offering
We need to raise capital in this offering to
support our operations. If we are unable to raise capital in this offering, our financial position will be materially adversely impacted.
We have incurred substantial losses since our inception,
and we expect to continue to incur additional losses for the next several years. For the three months ended June 30, 2022, we had a net
loss of $5.8 million. From our inception through June 30, 2022, we had an accumulated deficit of $248.2 million. We believe that current
cash on hand is not sufficient to fund operations beyond the first quarter of 2023. In addition, the report of our independent registered
public accounting firm on our financial statements for the years ended December 31, 2021 and 2020 contains explanatory language that substantial
doubt exists about our ability to continue as a going concern. In the event we are unable to successfully raise sufficient capital in
this offering, we will not have sufficient cash and liquidity to finance our business operations as currently contemplated. Accordingly,
in such circumstances we would be compelled to reduce general and administrative expenses and delay research and development projects,
including the purchase of scientific equipment and supplies, until we are able to obtain sufficient financing. We have no additional committed
sources of capital and may find it difficult to raise money on terms favorable to us or at all. The failure to obtain sufficient capital
to support our operations would have a material adverse effect on our business, financial condition and results of operations. If such
sufficient financing is not received timely, we would then need to pursue a plan to license or sell assets, seek to be acquired by another
entity, cease operations and/or seek bankruptcy protection.
If you purchase securities in this offering,
you may experience future dilution as a result of future equity offerings or other equity issuances.
In order to raise additional capital, we believe that
we will offer and issue additional shares of our common stock or other securities convertible into or exchangeable for our common stock
in the future. We cannot assure you that we will be able to sell shares or other securities in any other offering at a price per share
that is equal to or greater than the price per share paid by purchasers in this offering, and investors purchasing other securities in
the future could have rights superior to existing stockholders. The price per share at which we sell additional shares of our common stock
or other securities convertible into or exchangeable for our common stock in future transactions may be higher or lower than the price
per share in this offering.
In addition, we have a significant number of stock
options and warrants outstanding. To the extent that outstanding stock options or warrants have been or may be exercised or other shares
issued, you may experience further dilution. Further, we may choose to raise additional capital based on market conditions or strategic
considerations even if we believe we have sufficient funds for our current or future operating plans.
The Preferred Shares, Pre-funded Warrants and
Common Warrants are not listed for trading on any exchange, so the ability to trade the shares of Preferred Shares, Pre-funded Warrants
and Common Warrants is limited.
There is no established public trading market for
the Preferred Shares, Pre-funded Warrants and Common Warrants being offered in this offering, and we do not expect a market to develop.
In addition, we do not intend to apply for listing the Preferred Shares, Pre-funded Warrants or Common Warrants on any national securities
exchange or other trading market. Without an active market, the liquidity of the Preferred Shares, Pre-funded Warrants and Common Warrants
will be limited.
The market price of our common stock and
the trading volume of our common stock has been and may continue to be, highly volatile, and such volatility could cause the market price
of our common stock to decrease.
During the first three quarters of 2022, the market
price of our Common Stock fluctuated from a high of $1.11 per share to a low of $0.286 per share, and our stock price continues to fluctuate.
The market price and trading volume of our Common Stock may continue to fluctuate significantly in response to numerous factors, some
of which are beyond our control, such as:
| · | the continued impact of the COVID-19 pandemic on our business and operations; |
| · | our ability to grow our revenue and customer base; |
| · | the announcement of new products or product enhancements by us or our competitors; |
| · | the trading volume of our common stock; |
| · | developments concerning regulatory oversight and approvals; |
| · | variations in our and our competitors’ results of operations; |
| · | changes in earnings estimates or recommendations by securities analysts,
if our common stock is covered by analysts; |
| · | successes or challenges in our collaborative arrangements or alternative
funding sources; |
| · | developments in the health care and life science industries; |
| · | the results of product liability or intellectual property lawsuits; |
| · | adverse effects on our business condition and results of operations from
general economic and market conditions and overall fluctuations in the United States and international markets, including deteriorating
market conditions due to investor concerns regarding inflation and hostilities between Russia and Ukraine; |
| · | future issuances of common stock or other securities; |
| · | the addition or departure of key personnel; |
| · | announcements by us or our competitors of acquisitions, investments or strategic
alliances; and |
| · | general market conditions and other factors, including factors unrelated
to our operating performance. |
Further, the stock market in general, and the market
for health care and life sciences companies in particular, has recently experienced extreme price and volume fluctuations. The volatility
of our common stock is further exacerbated due to its low trading volume. Continued market fluctuations could result in extreme volatility
in the price of our common stock, which could cause a decline in the value of our common stock and the loss of some or all of your investment.
Management will have broad discretion as to
the use of the net proceeds from this offering, and we may not use the proceeds effectively.
Our management will have broad discretion as to the
application of the net proceeds and could use them for purposes other than those contemplated at the time of this offering. Our stockholders
may not agree with the manner in which our management chooses to allocate and spend the net proceeds. Moreover, our management may use
the net proceeds for corporate purposes that may not increase our results of operations or the market value of our common stock. Our failure
to apply these funds effectively could have a material adverse effect on our business, delay the development and approval of our products
and cause the price of our common stock to decline.
If you purchase common stock sold in this offering,
you will experience immediate dilution as a result of this offering.
Because the price per share of our common stock being
offered may be higher than the net tangible book value per share of our common stock, you will experience dilution to the extent of the
difference between the offering price per share of common stock you pay in this offering and the net tangible book value per share of
our common stock immediately after this offering. Our net tangible book value as of June 30, 2022, was approximately $7.5 million, or
$0.16 per share of common stock. Net tangible book value per share is equal to our total tangible assets minus total liabilities, all
divided by the number of shares of common stock outstanding.
Future sales of our common stock in the public
market could cause our stock price to fall.
Sales of a substantial number of shares of our common
stock in the public market, or the perception that these sales might occur, could depress the market price of our common stock and could
impair our ability to raise capital through the sale of additional equity securities. As of June 30, 2022, we had 46,623,618 shares of
common stock outstanding, all of which shares were, and continue to be, eligible for sale in the public market. In addition, all of the
shares offered under this prospectus will be freely tradable without restriction or further registration upon issuance.
Trading of our common stock is limited, and
trading restrictions imposed on us by applicable regulations may further reduce trading in our common stock, making it difficult for our
stockholders to sell their shares; and future sales of common stock could reduce our stock price.
Trading of our common stock is currently conducted
on the NASDAQ Capital Market. The liquidity of our common stock is limited, including in terms of the number of shares that can be bought
and sold at a given price and reduction in security analysts’ and the media’s coverage of us, if any. These factors may result
in different prices for our common stock than might otherwise be obtained in a more liquid market and could also result in a larger spread
between the bid and asked prices for our common stock. In addition, in the absence of a large market capitalization, our common stock
is less liquid than the stock of companies with broader public ownership, and, as a result, the trading prices of our common stock may
be more volatile. In the absence of an active public trading market, an investor may be unable to liquidate his investment in our common
stock. Trading of a relatively small volume of our common stock may have a greater impact on the trading price of our stock than would
be the case if our public float were larger. We cannot predict the prices at which our common stock will trade in the future, if at all.
The exercise of outstanding common stock purchase
warrants and stock options will have a dilutive effect on the percentage ownership of our capital stock by existing stockholders.
As of June 30, 2022, we had outstanding warrants to
acquire 16,217,008 shares of our common stock, and stock options to purchase 2,215,755 shares of our common stock. A significant number
of such warrants have exercise prices above our common stock’s recent trading prices, but the holders have the right to effect a
cashless exercise of such warrants. If a significant number of such warrants and stock options are exercised by the holders, the percentage
of our common stock owned by our existing stockholders will be diluted.
We have never paid dividends on our capital
stock, and we do not anticipate paying dividends in the foreseeable future.
We have never paid dividends on any of our capital
stock and currently intend to retain any future earnings to fund the growth of our business. We may also enter into credit agreements
or other borrowing arrangements in the future that will restrict our ability to declare or pay cash dividends on our common stock. Any
determination to pay dividends in the future will be at the discretion of our board of directors and will depend on our financial condition,
operating results, capital requirements, general business conditions and other factors that our board of directors may deem relevant.
As a result, capital appreciation, if any, of our common stock will be the sole source of gain, if any, for the foreseeable future.
We received a bid price deficiency notice from
the Nasdaq Capital Market. If we are unable to cure this deficiency and meet the NASDAQ continued listing requirements, we could be delisted
from the Nasdaq Capital Market, which would negatively impact the trading of our common stock.
On February 28, 2022, we received notice from Nasdaq
that we had failed to maintain a bid price of at least $1.00 per share for 30 successive trading days. We were originally granted six
months to regain compliance with the listing standard. On August 30, 2022, Nasdaq notified us that we had been granted an additional 180-calendar
day compliance period, or until February 27, 2023, to regain compliance with the minimum bid price rule. In connection with the grant
of such additional compliance period, the Company provided notice to Nasdaq that it intended to cure the bid price deficiency by effecting
a reverse stock split, if necessary, prior to the end of the compliance period. While we have until February 27, 2023 to regain such compliance,
we do not believe we will be able to do so without implementing a reverse stock split.
Our board of directors authorized the submission of
a proposal to effect a reverse stock split of the Company’s common stock in order to regain compliance with the minimum bid at the
Company’s 2022 Annual Meeting of Stockholders. However, such proposal was not approved at such Annual Meeting, and there can be
no assurance that we will be able to effect such a proposal in the future. Even if we are able to effect a reverse stock split in the
future, there is also no guarantee that we will be able to maintain the Nasdaq Capital Market listing of our common stock in the future.
If our common stock is delisted by Nasdaq, our common
stock may be eligible for quotation on an over-the-counter quotation system or on the pink sheets. Upon any such delisting, our common
stock would become subject to the regulations of the SEC relating to the market for penny stocks. A penny stock is any equity security
not traded on a national securities exchange that has a market price of less than $5.00 per share. The regulations applicable to penny
stocks may severely affect the market liquidity for our common stock and could limit the ability of stockholders to sell securities in
the secondary market. In such a case, an investor may find it more difficult to dispose of or obtain accurate quotations as to the market
value of our common stock, and there can be no assurance that our common stock will be eligible for trading or quotation on any alternative
exchanges or markets.
Delisting from Nasdaq could adversely affect our ability
to raise additional financing through public or private sales of equity securities, would significantly affect the ability of investors
to trade our securities and would negatively affect the value and liquidity of our common stock. Delisting could also have other negative
results, including the potential loss of confidence by employees, the loss of institutional investor interest and fewer business development
opportunities.
We may not obtain the required stockholder approval
for the Reverse Stock Split, which could result in in our common stock being delisted from Nasdaq.
Our common stock is currently listed on the NASDAQ
Capital Market. In order to maintain that listing, we must satisfy minimum bid price requirement for our common stock. On February 28,
2022, we received a notice from Nasdaq notifying us that, based upon the closing bid price of our common stock, for the 30 consecutive
business days prior to the notice, the Company no longer met the requirement to maintain a minimum closing bid price of $1.00 per share,
as set forth in Nasdaq Listing Rule 5550(a)(2). The Company was originally granted 180 calendar days, or until August 29, 2022, to regain
compliance with the minimum bid price rule. On August 30, 2022, Nasdaq notified the Company that it had been granted an additional 180-calendar
day compliance period, or until February 27, 2023, to regain compliance with the Minimum Bid Price Rule. In connection with the grant
of such additional compliance period, the Company provided notice to Nasdaq that it intended to cure the bid price deficiency by effecting
a reverse stock split, if necessary, prior to the end of the compliance period. While we have until February 27, 2023 to regain such compliance,
we do not believe we will be able to do so without implementing a reverse stock split.
If we are not in compliance with the minimum bid price
requirement by February 27, 2023, we can appeal Nasdaq’s determination to a hearings panel in order to present a plan to regain
compliance. If we are not in compliance by February 27, 2023 and are unable to successfully appeal the determination, Nasdaq will provide
notice that the Company’s shares of common stock will be subject to delisting.
There can be no assurances however that we will be
granted any relief or additional time to regain compliance with the minimum bid price requirement and do not believe that any additional
grace period will allow the Company to comply with the minimum closing bid price requirement unless a reverse stock split is not approved.
The Company expects to call a special meeting of stockholders following this offering in order for stockholders to vote on a proposal
to effect a reverse stock split of our outstanding common stock as a measure to regain compliance. There can be no assurances however
that we will obtain stockholder approval for a reverse stock split or that the reverse stock split will enable us to comply with the applicable
Nasdaq listing standards.
In the event that our common stock is delisted from
the NASDAQ, and is not eligible for quotation on another market or exchange, trading of our common stock could be conducted in the over-the-counter
market or on an electronic bulletin board established for unlisted securities such as the Pink Sheet or the OTC Bulletin Board. In such
event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely
also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline
further. Also, it may be difficult for us to raise additional capital if we are not listed on a major exchange.
The Company’s Charter provides that the
Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between the Company and
its stockholders, which could limit its stockholders' ability to obtain a favorable judicial forum for disputes with the Company or its
directors, officers or other employees.
The Company’s Charter provides that, unless
the Company consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole
and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Company, (ii) any action asserting a claim of
breach of a fiduciary duty owed by any director, officer or other employee of the Company or its stockholders, (iii) any action asserting
a claim arising pursuant to any provision of the DGCL or the Company’s Certificate of Incorporation or Bylaws, or (iv) any action
asserting a claim governed by the internal affairs doctrine. This exclusive forum provision is intended to apply to claims arising under
Delaware state law and would not apply to claims brought pursuant to the Securities Act of 1933, as amended, or the Securities Exchange
Act of 1934, as amended, or any other claim for which the federal courts have exclusive jurisdiction. The exclusive forum provision in
the Company’s Charter will not relieve the Company of its duties to comply with the federal securities laws and the rules and regulations
thereunder, and stockholders of the Company will not be deemed to have waived the Company’s compliance with these laws, rules and
regulations.
This exclusive forum provision may limit a stockholder’s
ability to bring a claim in a judicial forum of its choosing for disputes with the Company or its directors, officers or other employees,
which may discourage lawsuits against the Company and its directors, officers and other employees. In addition, stockholders who do bring
a claim in the Court of Chancery of the State of Delaware could face additional litigation costs in pursuing any such claim, particularly
if they do not reside in or near Delaware. The Court of Chancery of the State of Delaware may also reach different judgments or results
than would other courts, including courts where a stockholder would otherwise choose to bring the action, and such judgments or results
may be more favorable to the Company than to its stockholders. However, the enforceability of similar exclusive forum provisions in other
companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find this
type of provision to be inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings.
If a court were to find the exclusive forum provision contained in the Company’s Charter to be inapplicable or unenforceable in
an action, the Company might incur additional costs associated with resolving such action in other jurisdictions.
USE OF PROCEEDS
We estimate that the net proceeds
from the sale of the securities offered under this prospectus supplement, and accompanying prospectus, after deducting placement agent’s
fees and estimated offering expenses payable by us will be approximately $3.0 million.
We intend to use the net proceeds
from the sale of the shares to: (i) support continued commercialization of our FDA-cleared Acuitas AMR Gene Panel test for isolates in
the U.S.; (ii) commercialize our products with a focus on the Unyvero platform and diagnostic tests; (iii) support further development
and commercialization of the Ares Genetics database; (iv) support directed sales and marketing efforts to the customers and collaborators
for our products and services, (v) invest in manufacturing and operations infrastructure to support sales of products; and (vi) repayment
of certain outstanding indebtedness of the Company and its subsidiaries. We intend to use the remaining net proceeds for working capital
and other general corporate purposes.
This expected use of net proceeds from this offering
represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business
conditions evolve. Our management will have broad discretion in the application of the net proceeds from this offering and could use them
for purposes other than those contemplated at the time of this offering. Our stockholders may not agree with the manner in which our management
chooses to allocate and spend the net proceeds. Moreover, our management may use the net proceeds for corporate purposes that may not
result in our being profitable or increase our market value.
DIVIDEND POLICY
We have never declared or paid cash dividends
on our common stock. We currently intend to retain our future earnings, if any, for use in our business and therefore do not anticipate
paying cash dividends in the foreseeable future. Payment of future dividends, if any, will be at the discretion of our board of directors
after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs and
plans for expansion.
CAPITALIZATION
The following table sets forth our capitalization
as of June 30, 2022:
| · | on a pro forma basis to give effect to the issuance of the issuance of 1,714,882
shares of our common stock issued in an “at the market” equity offering since June 30, 2022; and |
| · | on an as adjusted basis giving effect to the issuance and sale of 5,360,000
Common Shares in this offering at the offering price of $0.35 per share and 4,300,000 shares of common stock underlying the Pre-funded
Warrants sold in this offering, before deducting placement agent’s compensation and other estimated offering expenses payable by
us. |
You should read this table together with the
information contained in this prospectus supplement and the accompanying prospectus and the information incorporated by reference from
our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 and our Annual Report on Form 10-K for the year ended December
31, 2021, including the historical financial statements and related notes included in each of those reports.
| |
As of June 30, 2022 | |
| |
Actual | | |
Pro Forma | | |
As Adjusted | |
| |
(in thousands) | |
Cash and cash equivalents | |
$ | 16,587 | | |
$ | 17,616 | | |
$ | 19,569 | |
Debt | |
$ | 14,912 | | |
$ | 14,912 | | |
$ | 14,912 | |
Stockholders’ equity: | |
| | | |
| | | |
| | |
Common stock, par value $0.01 per share: 100,000,000 shares authorized, 46,623,618 shares issued and outstanding as of June 30, 2022, actual; and 56,283,618 shares outstanding as adjusted | |
$ | 466 | | |
$ | 483 | | |
$ | 563 | |
Preferred stock, par value $0.01 per share; 10,000,000 shares authorized, no shares outstanding, actual and 33,810 shares outstanding as adjusted | |
$ | 0.00 | | |
$ | 0.00 | | |
$ | 0.30 | |
Additional paid-in capital | |
$ | 276,206 | | |
$ | 277,218 | | |
$ | 279,091 | |
Accumulated other comprehensive loss | |
$ | (1,125 | ) | |
$ | (1,125 | ) | |
$ | (1,125 | ) |
Accumulated deficit | |
$ | (248,186 | ) | |
$ | (248,186 | ) | |
$ | (248,186 | ) |
Total stockholders’ equity | |
$ | 27,361 | | |
$ | 28,390 | | |
$ | 30,343 | |
Total capitalization | |
$ | 27,361 | | |
$ | 28,390 | | |
$ | 30,343 | |
The number of shares of common stock to be
outstanding immediately after this offering is based on 46,623,618 shares of our common stock outstanding as of June 30, 2022, and excludes:
| · | 2,215,755 shares of common stock issuable upon the exercise of outstanding options granted as of June
30, 2022, under our equity incentive plans at a weighted average exercise price of $4.66 per share; |
| · | 16,217,008 shares of common stock issuable upon the exercise of outstanding warrants issued as of June
30, 2022, at a weighted average exercise price of $3.98 per share; |
| · | 833,066 shares of common stock issuable upon vesting of outstanding restricted stock units granted as
of June 30, 2022; |
| · | 1,284,296 shares of common stock available for future issuance under our equity incentive plans as of
June 30, 2022; |
| · | 9,660,000 shares of our Common Stock issuable upon the exercise of the Common Warrants offered in the
concurrent private placement with an exercise price of $0.377 per share; and |
| · | 1,714,882 shares of our Common Stock issued since June 30, 2022 under our
current at-the-market offering. |
The number of outstanding options, restricted
stock units and shares of common stock available for future issuances under our equity incentive plans does not reflect:
| · | the forfeiture of restricted stock units and/or options to acquire 78,125 shares of our common stock
since June 30, 2022. |
Unless otherwise indicated, all information
contained in this prospectus supplement assumes (i) no exercise of options issued under our equity incentive plans and (ii) no exercise
of warrants.
DILUTION
If you purchase shares in this offering, your ownership
interest will be diluted to the extent of the difference between the public offering price per security you will pay in this offering
and the as adjusted net tangible book value per share of our common stock after giving effect to this offering. Net tangible book value
per share is determined by dividing the number of outstanding shares of our common stock into our net tangible book value, which consists
of total tangible assets (total assets less intangible assets) less total liabilities. As of June 30, 2022, we had a historical net tangible
book value of $7.5 million, or approximately $0.16 per share.
Also, at June 30, 2022, on pro forma basis taking
into account the issuance of 1,714,882 shares of our common stock issued in an “at the market” equity offering since June
30, 2022, we had a pro forma net tangible book value of approximately $8.5 million corresponding to a pro forma net tangible book value
of $0.18 per share.
Purchasers participating in this offering will incur
immediate, substantial dilution. After giving effect to the sale of securities in this offering at the public offering price of $0.35
per share, and after deducting estimated offering expenses payable by us, our pro forma as adjusted net tangible book value per share
of our common stock at June 30, 2022 would have been approximately $10.5 million, or $0.19 per share. This represents an immediate increase
in our pro forma net tangible book value per share of our common stock of approximately $0.01 per share to existing stockholders and an
immediate dilution of approximately $0.16 per share to purchasers in this offering. The following table illustrates this per share dilution
on a pro forma as adjusted basis:
Assumed offering price per share of common stock |
|
|
|
|
|
$ |
0.35 |
|
Pro forma net tangible book value per share of as June 30, 2022 |
|
$ |
0.18 |
|
|
|
|
|
Increase in pro forma net tangible book value per share attributable to this offering |
|
$ |
0.01 |
|
|
|
|
|
Pro forma as adjusted net tangible book value per share as of June 30, 2022, after giving effect to this offering |
|
|
|
|
|
$ |
0.19 |
|
Dilution per share to investors in this offering |
|
|
|
|
|
$ |
0.16 |
|
The number of shares of common stock to be outstanding immediately after
this offering is based on 46,623,618 shares of our common stock outstanding as of June 30, 2022, and excludes:
| · | 2,215,755 shares of common stock issuable upon the exercise of outstanding options granted as of June
30, 2022, under our equity incentive plans at a weighted average exercise price of $4.66 per share; |
| · | 16,217,008 shares of common stock issuable upon the exercise of outstanding warrants issued as of June
30, 2022, at a weighted average exercise price of $3.98 per share; |
| · | 833,066 shares of common stock issuable upon vesting of outstanding restricted stock units granted as
of June 30, 2022; |
| · | 1,284,296 shares of common stock available for future issuance under our equity incentive plans as of
June 30, 2022; |
| · | 9,660,000 shares of our Common Stock issuable upon the exercise of the Common Warrants offered in the
concurrent private placement with an exercise price of $0.377 per share; and |
| · | 1,714,882 shares of our Common Stock issued since June 30, 2022 under our
current at-the-market offering. |
The number of outstanding options, restricted stock units and shares of
common stock available for future issuances under our equity incentive plans does not reflect:
| · | the forfeiture of restricted stock units and/or options to acquire 78,125 shares of our common stock
since June 30, 2022. |
Unless otherwise indicated, all information contained in this prospectus
supplement assumes (i) no exercise of options issued under our equity incentive plans and (ii) no exercise of warrants.
DESCRIPTION OF SECURITIES
Series C Mirroring Preferred Stock
The Company is offering up to 33,810 shares
of its Series C Mirroring Preferred Stock in this offering, with a stated value of $0.01 per share. The following are the principal terms
of the Preferred Shares:
Dividends
The holders of Preferred Shares will not be
entitled to dividends.
Voting Rights
The Preferred Shares has no voting rights,
except:
| · | the right to vote, with the holders of common stock, as a single class,
with each share of Preferred Shares entitled to 100,000 votes per share, on any resolution presented to stockholders for the purpose of
obtaining approval of the Reverse Stock Split, provided that, pursuant to the Securities Purchase Agreement, the holders of Preferred
Shares agreed that such votes must be cast in the same proportion as the aggregate shares of common stock are voted on such resolution
(excluding any shares of common stock that are not voted); and |
| · | otherwise, as long as any shares of Preferred Shares are outstanding, the
holders of the Preferred Shares will be entitled to approve, by a majority vote of the then outstanding shares of Preferred Shares if
the Company seeks to (a) alter or change adversely the powers, preferences or rights given to the Preferred Shares or alter or amend the
Certificate of Designation governing the Preferred Shares, (b) amend its Certificate or other charter documents in any manner that adversely
affects any rights of the holders of the Preferred Shares, (c) increase the number of authorized shares of Preferred Shares, or (d) enter
into any agreement with respect to any of the foregoing. |
Liquidation
Upon any liquidation, dissolution or winding-up
of the Company, whether voluntary or involuntary, or a Liquidation, the then holders of the Preferred Shares shall be entitled to receive
out of the assets, whether capital or surplus, of the Company an amount equal to $0.01 per Preferred Share, or the stated value of such
shares, which amount shall be paid to such holders prior to any distribution or payment made to holders of shares of common stock.
No Conversion
The Preferred Shares are not convertible into
common stock or other securities of the Company.
Termination
Upon
the effectiveness of the Reverse Stock Split, the Preferred Shares will automatically terminate and cease to be outstanding shares of
preferred stock of the Company.
Pre-funded Warrants
In connection
with the sale of our Common Shares in this offering, the Company is also offering 4,300,000 shares of common stock underlying Pre-funded
Warrants.
Duration
and Exercise Price
Each Pre-funded
Warrant offered hereby has an initial exercise price per share equal to $0.01. The Pre-funded Warrants will be immediately exercisable
and may be exercised at any time until the Pre-funded Warrants are exercised in full. The exercise price and number of shares of common
stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar
events affecting our common stock and the exercise price. The Pre-funded Warrants will be issued separately from the accompanying Common
Warrants, and may be transferred separately immediately thereafter.
Exercisability
The Pre-funded
Warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied
by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise
as discussed below). A holder (together with its affiliates) may not exercise any portion of the Pre-funded Warrant to the extent that
the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’
prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s
Pre-funded Warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise,
as such percentage ownership is determined in accordance with the terms of the Pre-funded Warrants. Purchasers of Pre-funded Warrants
in this offering may also elect prior to the issuance of the Pre-funded Warrants to have the initial exercise limitation set at 9.99%
of our outstanding common stock.
Cashless
Exercise
The holders
of Pre-funded Warrants may also elect to exercise such Pre-funded Warrants in a cashless exercise without making the cash payment otherwise
contemplated to be made to us upon exercise of such Pre-funded Warrant, in which event, the holders would instead receive upon such exercise
(either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the pre-funded warrants.
Transferability
Subject to
applicable laws, a Pre-funded Warrant may be transferred at the option of the holder upon surrender of the Pre-funded Warrant to us together
with the appropriate instruments of transfer.
Fractional
Shares
No fractional
shares of common stock will be issued upon the exercise of the Pre-funded Warrants. Rather, the number of shares of common stock to be
issued will, at our election, either be rounded up to the nearest whole number or we will pay a cash adjustment in respect of such final
fraction in an amount equal to such fraction multiplied by the exercise price.
Trading
Market
There is
no trading market available for the Pre-funded Warrants on any securities exchange or nationally recognized trading system.
Right
as a Stockholder
Except as
otherwise provided in the Pre-funded Warrants or by virtue of such holder’s ownership of shares of our common stock, the holders
of the Pre-funded Warrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they
exercise their Pre-funded Warrants.
PRIVATE PLACEMENT TRANSACTION
In a concurrent
private placement, we plan to issue and sell to same institutional investor the Common Warrants to purchase up to an aggregate of 9,660,000
shares of Common Stock at an exercise price equal to $0.377 per share. The Common Warrants and the shares of Common Stock issuable upon
the exercise of such warrants are not being registered under the Securities Act, are not being offered pursuant to this prospectus supplement
and the accompanying prospectus and are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and
Rule 506(b) promulgated thereunder. Accordingly, investors may only sell shares of Common Stock issued upon exercise of the Common Warrants
pursuant to an effective registration statement under the Securities Act covering the resale of those shares, an exemption under Rule
144 under the Securities Act or another applicable exemption under the Securities Act.
Common Warrants
The Company is also offering Common Warrants to purchase
an aggregate of 9,660,000 shares of our Common Stock.
Each Common Warrant issued in this offering
represents the right to purchase up to one share of Common Stock at an initial exercise price of $0.35 per share. Each Common Warrant
may be exercised, in cash or by a cashless exercise at the election of the holder at any time following the six month anniversary of the
date of issuance and from time to time thereafter through and including the fifth anniversary of the initial exercise date.
The Common Warrants will be exercisable in
whole or in part by delivering to the Company a completed instruction form for exercise and complying with the requirements for exercise
set forth in the Common Warrant. Payment of the exercise price may be made in cash or pursuant to a cashless exercise, in which case the
holder would receive upon such exercise the net number of shares of Common Stock determined according to the formula set forth in the
Common Warrant.
No Fractional Shares
No fractional shares or scrip representing
fractional shares shall be issued upon the exercise of the Common Warrant. As to any fraction of a share which the holder would otherwise
be entitled to purchase upon such exercise, the number of shares of common stock to be issued shall be rounded up to the nearest whole
number.
Failure to Timely Deliver Shares
If we fail to deliver to the holder a certificate
representing shares issuable upon exercise of a Common Warrant or to credit the holder’s balance account with Depository Trust Company
for such number of shares of common stock to which the holder is entitled upon the holder’s exercise of the Common Warrant, in each
case, by the delivery date set forth in the Common Warrant, and if after such date the holder is required by its broker to purchase (in
an open market transaction or otherwise) or the holder’s brokerage firm otherwise purchases, shares of common stock to deliver in
satisfaction of a sale by the holder of the warrant shares which the holder anticipated receiving upon such exercise, or a Buy-In, then
we shall (A) pay in cash to the holder the amount, if any, by which (x) the holder’s total purchase price (including brokerage commissions,
if any) for the shares of common stock so purchased exceeds (y) the amount obtained by multiplying (1) the number of warrant shares that
we were required to deliver to the holder in connection with the exercise at issue, times (2) the price at which the sell order giving
rise to such purchase obligation was executed, and (B) at the option of the holder, either reinstate the portion of the applicable warrant
and equivalent number of warrant shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded)
or deliver to the holder the number of shares of common stock that would have been issued had we timely complied with our exercise and
delivery obligations. In addition, if we fail to deliver to the holder any common stock pursuant to a validly-exercised Common Warrant,
we will be required to pay liquidated damages in the amount of $10 per trading day for each $1,000 of the shares of common stock exercised
but not delivered (and rising to $20 per trading day beginning the third trading day after the warrant share delivery date) until such
time the shares of common stock are delivered or the holder rescinds such exercise.
Exercise Limitation
In general, a holder will not have the right
to exercise any portion of a Common Warrant if the holder (together with its Attribution Parties (as defined in the Common Warrant)) would
beneficially own in excess of 4.99% or 9.99%, at the election of the holder, of the number of shares of our common stock outstanding immediately
after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the warrant. However,
any holder may increase or decrease such percentage to any other percentage not in excess of 9.99% upon notice to us, provided that any
increase in this limitation will not be effective until 61 days after such notice from the holder to us and such increase or decrease
will apply only to the holder providing such notice.
Adjustment for Stock Splits
The exercise price and the number of shares
of common stock purchasable upon the exercise of the Common Warrants are subject to adjustment upon the occurrence of specific events,
including sales of additional shares of Common Stock, stock dividends, stock splits, and combinations of our common stock.
Dividends or Distributions
If we declare or make any dividend or other
distribution of its assets (or rights to acquire its assets) to holders of shares of our common stock, by way of return of capital or
otherwise (including, without limitation, any distribution of cash, stock or other securities, property, options, evidence of indebtedness
or any other assets by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar
transaction) at any time after the issuance of the Common Warrants, then, in each such case, the holders of the Common Warrants shall
be entitled to participate in such distribution to the same extent that the holders would have participated therein if the holders had
held the number of shares of common stock acquirable upon complete exercise of the Common Warrants.
Purchase Rights
If we grant, issue or sell any shares of our
common stock or securities exercisable for, exchangeable for or convertible into our common stock, or rights to purchase stock, warrants,
securities or other property pro rata to the record holders of any class of shares of our common stock, referred to as Purchase Rights,
then each holder of the Common Warrants will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate
Purchase Rights which the holder could have acquired if the holder had held the number of shares of common stock acquirable upon complete
exercise of the Common Warrant immediately before the record date, or, if no such record is taken, the date as of which the record holders
of shares of common stock are to be determined, for the grant, issue or sale of such Purchase Rights.
Fundamental Transaction
If a Fundamental Transaction (as defined in
the Common Warrants and described below) occurs, then the successor entity will succeed to, and be substituted for us, and may exercise
every right and power that we may exercise and will assume all of our obligations under the Common Warrants with the same effect as if
such successor entity had been named in the warrant itself. Additionally, upon consummation of a Fundamental Transaction pursuant to which
holders of shares of our common stock are entitled to receive securities or other assets with respect to or in exchange for shares of
our common stock, we will make appropriate provision to ensure that the holder will thereafter have the right to receive upon an exercise
of the Common Warrants at any time after the consummation of the Fundamental Transaction but prior to the applicable expiration date of
the Common Warrants, in lieu of shares of our Common Stock (or other securities, cash, assets or other property) purchasable upon the
exercise of the Common Warrant prior to such Fundamental Transaction, at the option of each holder (without regard to any limitation in
the Common Warrant on the exercise of the Common Warrants), the number of shares of common stock of the successor or acquiring corporation
or of us, if we are the surviving corporation, and any additional consideration which the holder would have been entitled to receive upon
the happening of such Fundamental Transaction had the Common Warrant been exercised immediately prior to such Fundamental Transaction.
If holders of our common stock are given a
choice as to the securities, cash or property to be received in a Fundamental Transaction, then the holder shall be given the same choice
as to the consideration it receives upon any exercise of the Common Warrants, following such Fundamental Transaction. These provisions
apply similarly and equally to successive Fundamental Transactions and other corporate events described in the Common Warrants and will
be applied without regard to any limitations on the exercise of the warrant.
In the event of a Fundamental Transaction,
at the request of the holder, we or the successor entity shall purchase the unexercised portion of the Common Warrants from the holder
by paying to the holder, on or prior to the second trading day after such request (or, if later, on the effective date of the Fundamental
Transaction), cash in an amount equal to the Black-Scholes Value (as defined below) of the remaining unexercised portion of the Common
Warrants on the date of such Fundamental Transaction.
Transferability
Subject to applicable laws, the Common Warrants
may be offered for sale, sold, transferred or assigned. There is currently no trading market for the Common Warrants and a trading market
is not expected to develop.
Rights as a Stockholder
Except as otherwise provided in the Common
Warrants or by virtue of a holder’s ownership of shares of our common stock, the holders of the Common Warrants do not have the
rights or privileges of holders of our common stock, including any voting rights, unless and until they exercise their warrants.
Amendments
Each Common Warrant may be amended with the
written consent of the holder of such Common Warrant and us.
Listing
There is no established public trading market
for the Common Warrants, and we do not expect a market to develop. In addition, we do not intend to apply for listing of the Common Warrants
on any national securities exchange.
Definitions
“Black Scholes Value” means
the value of the Common Warrants based on the Black-Scholes Option Pricing Model obtained from the “OV” function on Bloomberg,
L.P. (“Bloomberg”) determined as of the day of consummation of the applicable Fundamental Transaction for pricing purposes
and reflecting (A) a risk-free interest rate corresponding to the U.S. Treasury rate for a period equal to the time between the date of
the public announcement of the applicable Fundamental Transaction and the Termination Date, (B) an expected volatility equal to the greater
of 100% and the 100 day volatility obtained from the HVT function on Bloomberg (determined utilizing a 365 day annualization factor) as
of the trading day immediately following the public announcement of the applicable Fundamental Transaction, (C) the underlying price per
share used in such calculation shall be the greater of (i) the sum of the price per share being offered in cash, if any, plus the value
of any non-cash consideration, if any, being offered in such Fundamental Transaction and (ii) the greater of (x) the last VWAP immediately
prior to the public announcement of such Fundamental Transaction and (y) the last VWAP immediately prior to the consummation of such Fundamental
Transaction and (D) a remaining option time equal to the time between the date of the public announcement of the applicable Fundamental
Transaction and the Termination Date, and (E) a zero cost of borrow.
“Fundamental Transaction”
means (i) we, directly or indirectly, in one or more related transactions effect any merger or consolidation with or into another Person,
(ii) we (and all of our subsidiaries, taken as a whole), directly or indirectly, effects any sale, lease, license, assignment, transfer,
conveyance or other disposition of all or substantially all of our assets in one or a series of related transactions, (iii) any, direct
or indirect, purchase offer, tender offer or exchange offer (whether by us or another Person) is completed pursuant to which holders of
common stock are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the
holders of 50% or more of the outstanding common stock, (iv) we, directly or indirectly, in one or more related transactions effect any
reclassification, reorganization or recapitalization of our common stock or any compulsory share exchange pursuant to which our common
stock is effectively converted into or exchanged for other securities, cash or property, or (v) we, directly or indirectly, in one or
more related transactions consummate a stock or share purchase agreement or other business combination (including, without limitation,
a reorganization, recapitalization, spin-off, merger or scheme of arrangement) with another Person or group of Persons whereby such other
Person or group acquires more than 50% of the outstanding shares of our common stock (not including any shares of common stock held by
the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock
or share purchase agreement or other business combination).
PLAN OF DISTRIBUTION
We engaged H.C. Wainwright & Co., LLC, or the placement agent,
to act as our exclusive placement agent to solicit offers to purchase the shares of our Common Shares, Preferred Shares, Pre-funded Warrants
and Common Warrants offered by this prospectus supplement and the accompanying prospectus. The placement agent is not purchasing or selling
any such securities, nor is it required to arrange for the purchase and sale of any specific number or dollar amount of such securities,
other than to use its “reasonable best efforts” to arrange for the sale of such securities by us. Therefore, we may not sell
all of the Common Shares, Preferred Shares, Pre-funded Warrants and Common Warrants being offered. The terms of this offering were subject
to market conditions and negotiations between us, the placement agent and prospective investors. The placement agent will have no authority
to bind us by virtue of the engagement letter. We have entered into a securities purchase agreement directly with an institutional investor
who has agreed to purchase the Common Shares, Preferred Shares, Pre-funded Warrants and Common Warrants in this offering. We will only
sell to investors who have entered into securities purchase agreements. The placement agent may retain sub-agents and selected dealers
in connection with this offering.
Delivery of the shares of Common Shares, Preferred Shares, Pre-funded
Warrants and Common Warrants offered hereby is expected to occur on or about October 3, 2022, subject to satisfaction of certain customary
closing conditions.
We have agreed to pay the placement agent an aggregate fee equal
to 6.0% of the gross proceeds received in the offering. In addition, we have agreed to reimburse the placement agent for its legal fees
and expenses and other out-of-pocket expenses in an amount up to $80,000 and clearing expenses of $15,950.
We estimate the total expenses of this offering paid or payable
by us, exclusive of the placement agent's cash fee of 6.0% of the gross proceeds and expenses, will be approximately $100,000. After deducting
the fees due to the placement agent and our estimated expenses in connection with this offering, we expect the net proceeds from this
offering will be approximately $3.0 million.
The following table shows the per share and
total cash fees we will pay to the placement agent in connection with the sale of the Common Shares, Preferred Shares, and shares of
common stock underlying the Pre-funded Warrants pursuant to this prospectus supplement and the accompanying prospectus.
| |
Per
Common Share | | |
Per
Preferred Share | | |
Per Share Underlying Pre-funded Warrant | | |
Total | |
Offering price | |
$ | 0.35 | | |
$ | 0.01 | | |
$ | 0.34 | | |
$ | 3,381,338.10 | |
Placement agent fees | |
$ | 0.021 | | |
$ | 0.0006 | | |
$ | 0.021 | | |
$ | 202,880.29 | |
Proceeds before expenses to us | |
$ | 0.329 | | |
$ | 0.0094 | | |
$ | 0.319 | | |
$ | 3,178,457.81 | |
Indemnification
We have agreed to indemnify the placement agent against certain
liabilities, including liabilities under the Securities Act and liabilities arising from breaches of representations and warranties contained
in our engagement letter with the placement agent. We have also agreed to contribute to payments the placement agent may be required to
make in respect of such liabilities.
Other Relationships
From time to time, the placement agent may provide in the future
various advisory, investment and commercial banking and other services to us in the ordinary course of business, for which they have received
and may continue to receive customary fees and commissions. However, except as disclosed in this prospectus supplement, we have no present
arrangements with the placement agent for any further services. Wainwright is currently acting as sales agent under our existing At the
Market, or ATM, Offering, which commenced in June 2022, for which it receives compensation.
Regulation M Compliance
The placement agent may be deemed to be an underwriter within the
meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the sale of our Shares
of Preferred Stock offered hereby by it while acting as principal might be deemed to be underwriting discounts or commissions under the
Securities Act. The placement agent will be required to comply with the requirements of the Securities Act and the Exchange Act, including,
without limitation, Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases
and sales of our securities by the placement agent. Under these rules and regulations, the placement agent may not (i) engage in any stabilization
activity in connection with our securities; and (ii) bid for or purchase any of our securities or attempt to induce any person to purchase
any of our securities, other than as permitted under the Exchange Act, until they have completed their participation in the distribution.
Trading Market
Our common stock is listed on the Nasdaq Capital Market under the
symbol “OPGN.” Our preferred stock is not listed for trading on any market.
LEGAL MATTERS
The validity of the securities being offered
hereby will be passed upon Ballard Spahr LLP, Philadelphia, Pennsylvania. Certain legal matters will be passed upon for the placement
agent by Ellenoff Grossman & Schole LLP, New York, New York.
EXPERTS
The consolidated financial statements of OpGen,
Inc. and its subsidiaries as of December 31, 2021 and 2020, 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, 2021 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
This prospectus supplement constitutes
a part of the registration statement on Form S-3 that we have filed with the SEC under the Securities Act. As permitted by the SEC’s
rules, this prospectus supplement and any accompanying prospectus, which forms a part of the registration statement, do not contain all
of the information that is included in the registration statement. You will find additional information about us in the registration statement.
Any statement made in this prospectus supplement or any accompanying prospectus concerning legal documents are not necessarily complete
and you should read the documents that are filed as exhibits to the registration statement or otherwise filed with the SEC for a more
complete understanding of the document or matter. 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
supplement 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 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 supplement, is not part of this prospectus supplement.
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 supplement is part of a registration
statement we filed with the SEC. You should rely on the information incorporated by reference in this prospectus supplement, the accompanying
prospectus and the registration statement. The information incorporated by reference is considered to be part of this prospectus supplement
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 Quarterly Reports on Form 10-Q for the quarters ended March 31, 2022, filed with the SEC on May
13, 2022, and June 30, 2022, filed with the SEC on August 12, 2022; |
| · | our Current Reports on Form 8-K, filed with the Commission on March 3, 2022 (Item 3.01), April 25, 2022
(Items 8.01 and 9.01), May 24, 2022 (Items 1.01, 2.03 and 9.01), June 9, 2022 (Item 5.07), June 24, 2022 (Items 1.01, 1.02 and 9.01),
August 31, 2022 (Items 3.01, 8.01 and 9.01), and September 20, 2022 (Item 8.01 and 9.01); |
| · | our Definitive Proxy Statement for the Company’s 2022 Annual Meeting of Stockholders filed with
the Commission on April 25, 2022; 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.
9717 Key West Avenue, Suite 100
Rockville, MD 20850
Attention: Albert Weber, Corporate Secretary
Telephone No.: (301) 869-9683
PROSPECTUS
Common Stock
Preferred Stock
Warrants
Units
____________________
We may offer and sell from time to
time, in one or more offerings, up to $150,000,000 of any combination of securities described in this prospectus, in one or more classes
or series and in amounts, at prices and on terms that we will determine at the time of the offerings.
This prospectus describes the general
manner in which our securities may be offered using this prospectus. Each time we sell securities pursuant to this prospectus, we will
provide the specific terms of the securities offered in a supplement to this prospectus. The prospectus supplements will also describe
the specific manner in which we will offer securities and may also supplement, update or amend information contained in this prospectus.
You should read this prospectus and any related prospectus supplement carefully before you invest in our securities.
The securities being registered for
the account of the company may be sold on a delayed or continuous basis directly by us, through dealers, agents or underwriters designated
from time to time, or through any combination of these methods. The prospectus supplements to this prospectus will provide the specific
terms of the plan of distribution. If any dealers, agents or underwriters are involved in the sale of securities in respect of which
this prospectus is being delivered, we will disclose their names and the nature of our arrangements with them in any prospectus supplement.
Our common stock is traded on the
NASDAQ Capital Market under the symbol “OPGN.” On August 9, 2021, the closing price of our common stock was $[_____] per
share.
____________________
Investing in
our securities involves a high degree of risk. See “Risk Factors” beginning on page [__] of this prospectus and any similar
heading in any prospectus supplement or other documents that are incorporated by reference into this prospectus.
____________________
This prospectus
may not be used to offer or sell securities unless accompanied by a prospectus supplement for the securities being sold.
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 August 19, 2021.
TABLE
OF CONTENTS
Page
ABOUT THIS PROSPECTUS |
ii |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENT |
iii |
PROSPECTUS SUMMARY |
1 |
RISK FACTORS |
2 |
USE OF PROCEEDS |
3 |
PLAN OF DISTRIBUTION |
4 |
DESCRIPTION OF SECURITIES |
6 |
LEGAL MATTERS |
14 |
EXPERTS |
14 |
WHERE YOU CAN FIND ADDITIONAL INFORMATION |
14 |
INCORPORATION BY REFERENCE |
14 |
ABOUT
THIS PROSPECTUS
This prospectus is part of a “shelf”
registration statement that we filed with the U.S. Securities and Exchange Commission, or SEC. By using a shelf registration statement,
we may, from time to time, issue any combination of the securities described in this prospectus in one or more offerings up to an aggregate
maximum offering price of $150,000,000. This prospectus sets forth the certain terms of the securities that we may offer. Each time we
sell any of our securities described in this prospectus, we will provide a prospectus supplement that will contain more specific information
about the offering and the terms of the securities being sold. We may also add, update or change in the prospectus supplement any of
the information contained in this prospectus or the documents incorporated by reference.
This prospectus provides you with
a general description of the company and our common stock. 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 Additional Information.”
You should rely only on the information
contained in this prospectus and in any prospectus supplement (including in any documents incorporated by reference herein or therein).
We have not authorized anyone to provide you with any different information. If anyone provides you with different or inconsistent information,
you should not rely on it.
This prospectus is not an offer to
sell securities in any state where the offer or solicitation is not permitted. We are offering to sell our common stock, and seeking
offers to buy, only in jurisdictions where offers and sales are permitted.
You should assume that the information
in this prospectus or any prospectus supplement is accurate only as of the date of this prospectus or any prospectus supplement and that
any information we have incorporated herein by reference is accurate only as of the date of the document incorporated by reference, regardless
of the time of delivery of this prospectus, any prospectus supplement or any sale of any security.
We further note that the representations,
warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference in
the accompanying prospectus were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose
of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you.
Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations,
warranties and covenants should not be relied on as accurately representing the current state of our affairs.
This prospectus may not be used to
consummate sales of our securities, unless it is accompanied by a prospectus supplement. To the extent there are inconsistencies between
any prospectus supplement, this prospectus and any documents incorporated by reference, the document with the most recent date will control.
We and our subsidiaries own various
U.S. federal trademark registrations and applications and unregistered trademarks and servicemarks, including OpGen®, Acuitas®,
Acuitas Lighthouse®, AdvanDx®, Curetis®, Unyvero®, ARES® and ARES GENETICS®. 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:
| · | our
ability to integrate the OpGen, Curetis, and Ares Genetics businesses; |
| · | receipt
of regulatory clearance of our submitted 510(k) pre-market submission for our Acuitas AMR
Gene Panel test for use with bacterial isolates; |
| · | the
impact of the COVID-19 pandemic on our business and operations; |
| · | our
use of proceeds from capital financing transactions; |
| · | the
completion of our development efforts for the Unyvero UTI and IJI panels, Unyvero A30 RQ
platform, Aresdb and Acuitas Lighthouse Software, and the timing of regulatory submissions; |
| · | our
ability to sustain or grow our customer base for our current research use only testing products; |
| · | regulations
and changes in laws or regulations applicable to our business, including regulation by the
FDA; |
| · | our
liquidity and working capital requirements, including our cash requirements over the next
12 months; |
| · | anticipated
trends and challenges in our business and the competition that we face; |
| · | 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; |
| · | our
ability to maintain compliance with the ongoing listing requirements for the Nasdaq Capital
Market; |
| · | 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.
PROSPECTUS
SUMMARY
This summary
highlights information contained in greater detail elsewhere in this prospectus. This summary is not complete and does not contain all
of the information you should consider in making your investment decision. You should read the entire prospectus carefully before making
an investment in our securities. You should carefully consider, among other things, our financial statements and the related notes and
the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” included elsewhere in, or incorporated by reference into, this prospectus. When we refer to OpGen, Inc., and its
subsidiaries, we use the terms “OpGen,” “the Company,” “us,” “we” and “our.”
OpGen Overview
We
are a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. Along
with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping
to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease
the spread of infections caused by multidrug-resistant microorganisms, or MDROs. Our current product portfolio includes Unyvero, Acuitas
AMR Gene Panel, Acuitas® Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics
solutions for antibiotic response prediction.
Our
focus is on our combined broad portfolio of products, which include high impact rapid diagnostics and bioinformatics to interpret AMR
genetic data. We currently expect to focus on the following products for lower respiratory infection, urinary tract infection and invasive
joint infection:
| · | The
Unyvero Lower Respiratory Tract, or LRT, test is the first U.S. Food and Drug Administration,
or FDA, cleared test that can be used for the detection of more than 90% of common causative
agents of hospitalized pneumonia. 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 BAL test for testing bronchoalveolar lavage, or
BAL, specimens from patients with lower respiratory tract infections following FDA clearance
received by Curetis in December 2019. The Unyvero LRT BAL automated test simultaneously detects
20 pathogens and 10 antibiotic resistance markers, and it is the first and only FDA-cleared
panel that also includes Pneumocystis jirovecii, a key fungal pathogen often found
in immunocompromised patients that can be difficult to diagnose, as the 20th pathogen on
the panel. We believe the Unyvero LRT and LRT BAL tests have 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. |
| · | The
Unyvero Urinary Tract Infection, or UTI, test which is CE-IVD marked in Europe is currently
being made available to laboratories in the U.S. as a research use only or RUO kit. The test
detects a broad range of pathogens as well as antimicrobial resistance markers directly from
native urine specimens. As part of our portfolio strategy update on October 13, 2020, we
have decided to proceed with the analytical and clinical performance evaluation including
clinical trials required for a subsequent U.S. FDA submission. |
| · | The
Unyvero Invasive Joint Infection, or IJI, test, which is a variant developed for the U.S.
market based on the CE-IVD-marked European Unyvero ITI test, has also been selected for analytical
and clinical performance evaluation including clinical trials towards a future U.S. FDA submission.
Microbial diagnosis of IJI is difficult because of challenges in sample collection, usually
at surgery, and patients being on prior antibiotic therapy which minimizes the chances of
recovering viable bacteria. We believe that Unyvero IJI could be useful in identifying pathogens
as well as their AMR markers to help guide optimal antibiotic treatment for these patients. |
| · | The
Acuitas AMR Gene Panel (Isolates) is currently pending final FDA review and a potential clearance
decision. The FDA recently notified us that completion of the FDA’s review would require
additional time due to the COVID-19 pandemic and ongoing public health crisis. The FDA also
informed us that it currently expects to complete its review by the end of August 2021 but
explained it still does not commit to any MDUFA timelines and that its timelines can be affected
by various factors, including the FDA’s other workload and public health priorities.
Once FDA cleared, we expect to commercialize the Acuitas AMR Gene Panel for isolates more
broadly to customers in the United States. The Acuitas AMR Gene Panel (Urine) test has been
discontinued as part of the October 13, 2020 portfolio and pipeline strategy review. |
| · | We
are also developing novel bioinformatics tools and solutions to accompany or augment our
current and potential future IVD products and may seek regulatory clearance for such bioinformatics
tools and solutions to the extent they would be required either as part of our portfolio
of IVD products or even as a standalone bioinformatics product. |
Company Information
OpGen, Inc. was
incorporated in Delaware in 2001. On July 14, 2015, we acquired AdvanDx, Inc., a Delaware corporation, as a wholly-owned subsidiary in
a merger transaction. On September 3, 2019, we formed Crystal GmbH for the sole purpose of completing our business combination with Curetis
GmbH, which closed on April 1, 2020. Our principal executive office is located at 9717 Key West Avenue, Suite 100, Rockville, MD 20850,
and our telephone number is (240) 813-1260. We also have operations in Germany and Austria. 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.
RISK
FACTORS
Investing in
our securities involves substantial risks. In addition to other information contained in this prospectus and any accompanying prospectus
supplement, before investing in our securities, you should carefully consider the risks described below and under the heading “Risk
Factors” in our Annual Report on Form 10-K or in our most recent Quarterly Report on Form 10-Q, as they may be amended, 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.
OpGen’s Certificate of
Incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all
disputes between the Company and its stockholders, which could limit its stockholders' ability to obtain a favorable judicial forum for
disputes with the Company or its directors, officers or other employees.
OpGen’s
Certificate of Incorporation provides that, unless OpGen consents in writing to the selection of an alternative forum, the Court of Chancery
of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of OpGen,
(ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of OpGen or its stockholders,
(iii) any action asserting a claim arising pursuant to any provision of the DGCL or the Company’s Certificate of Incorporation
or Bylaws, or (iv) any action asserting a claim governed by the internal affairs doctrine. This exclusive forum provision is intended
to apply to claims arising under Delaware state law and would not apply to claims brought pursuant to the Securities Act or Exchange
Act, or any other claim for which the federal courts have exclusive jurisdiction. The exclusive forum provision in OpGen’s Certificate
of Incorporation will not relieve OpGen of its duties to comply with the federal securities laws and the rules and regulations thereunder,
and stockholders of OpGen will not be deemed to have waived OpGen’s compliance with these laws, rules and regulations.
This exclusive forum provision may
limit a stockholder’s ability to bring a claim in a judicial forum of its choosing for disputes with OpGen or its directors, officers
or other employees, which may discourage lawsuits against OpGen and its directors, officers and other employees. In addition, stockholders
who do bring a claim in the Court of Chancery of the State of Delaware could face additional litigation costs in pursuing any such claim,
particularly if they do not reside in or near Delaware. The Court of Chancery of the State of Delaware may also reach different judgments
or results than would other courts, including courts where a stockholder would otherwise choose to bring the action, and such judgments
or results may be more favorable to OpGen than to its stockholders. However, the enforceability of similar exclusive forum provisions
in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could
find this type of provision to be inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings.
If a court were to find the exclusive forum provision contained in OpGen’s Certificate of Incorporation to be inapplicable or unenforceable
in an action, OpGen might incur additional costs associated with resolving such action in other jurisdictions.
USE
OF PROCEEDS
Unless otherwise
indicated in the applicable prospectus supplement, we intend to use the net proceeds from the sale of our securities under this prospectus
to: (i) support research and development and regulatory activities in support of our FDA 510(k) submission for the Acuitas AMR Gene Panel
test for isolates; (ii) commercialize our products with a focus on the Unyvero platform and diagnostic tests, and the Acuitas AMR Gene
Panel test for isolates; (iii) support further development and commercialization of the Ares Genetics database and Acuitas Lighthouse
Software; (iv) support directed sales and marketing efforts to the customers and collaborators for our products and services, (v) repay
outstanding indebtedness, and (vi) invest in manufacturing and operations infrastructure to support sales of products. We intend to use
the remaining net proceeds for working capital and other general corporate purposes.
Each time we
issue securities, we will provide a prospectus supplement that will contain information about how we intend to use the proceeds from
each such offering.
We cannot guarantee
that we will receive any proceeds in connection with any offering hereunder because we may choose not to issue any of the securities
covered by this prospectus.
PLAN
OF DISTRIBUTION
Primary Offerings by the Company
We may sell securities
registered hereunder:
| · | through
registered direct offerings; |
| · | through
“at the market” offerings, within the meaning of Rule 415(a)(4) of the Securities
Act, to or through a market maker or into an existing trading market on an exchange or otherwise;
or |
| · | through
a combination of any of these methods or any other method permitted by law. |
In addition,
we may issue the securities as a dividend or distribution or in a subscription rights offering to our existing security holders.
We may directly
solicit offers to purchase our securities, or agents may be designated to solicit such offers. In the prospectus supplement relating
to such offering, we will name any agent that could be viewed as an underwriter under the Securities Act and describe any commissions
that we must pay to any such agent. Any such agent will be acting on a best efforts basis for the period of its appointment or, if indicated
in the applicable prospectus supplement, on a firm commitment basis. This prospectus may be used in connection with any offering of our
securities through any of these methods or other methods described in the applicable prospectus supplement.
The distribution
of our securities may be effected from time to time in one or more transactions:
| · | at
a fixed price, or prices, which may be changed from time to time; |
| · | at
market prices prevailing at the time of sale; |
| · | at
prices related to such prevailing market prices; or |
Each prospectus
supplement will describe the method of distribution of the securities sold hereunder and any applicable restrictions.
The prospectus
supplement with respect to securities of a particular series will describe the terms of the offering of the securities, including the
following:
| · | the
name of the agent or any underwriters, if any; |
| · | the
public offering or purchase price; |
| · | any
discounts and commissions to be allowed or paid to the agent or underwriters; |
| · | all
other items constituting underwriting compensation; |
| · | any
discounts and commissions to be allowed or paid to dealers; and |
| · | any
exchanges on which the securities will be listed. |
If any underwriters
or agents are used in the sale of our securities in respect of which this prospectus is delivered, we will enter into an underwriting
agreement, sales agreement or other agreement with them at the time of sale to them, and we will set forth in the prospectus supplement
relating to such offering the names of the underwriters or agents and the terms of the related agreement with them.
In connection
with the offering of our securities, we may grant to the underwriters an option to purchase additional securities with an additional
underwriting commission, as may be set forth in the accompanying prospectus supplement. If we grant any such option, the terms of such
option will be set forth in the prospectus supplement for such securities.
If a dealer is
used in the sale of our securities in respect of which the prospectus is delivered, we will sell such securities to the dealer, as principal.
The dealer, who may be deemed to be an “underwriter” as that term is defined in the Securities Act, may then resell such
securities to the public at varying prices to be determined by such dealer at the time of resale.
If we offer securities
in a subscription rights offering to our existing security holders, we may enter into a standby underwriting agreement with dealers,
acting as standby underwriters. We may pay the standby underwriters a commitment fee for the securities they commit to purchase on a
standby basis. If we do not enter into a standby underwriting arrangement, we may retain a dealer-manager to manage a subscription rights
offering for us.
Agents, underwriters,
dealers and other persons may be entitled under agreements which they may enter into with us to indemnification by us against certain
civil liabilities, including liabilities under the Securities Act, and may be customers of, engage in transactions with or perform services
for us in the ordinary course of business.
Certain agents,
underwriters and dealers, and their associates and affiliates, may be customers of, have borrowing relationships with, engage in other
transactions with, or perform services, including investment banking services, for us or one or more of our respective affiliates in
the ordinary course of business.
In order to facilitate
the offering of our securities, any underwriters may engage in transactions that stabilize, maintain or otherwise affect the price of
our common stock or any other securities the prices of which may be used to determine payments on such common stock or other securities.
Specifically, any underwriters may over-allot in connection with the offering, creating a short position for their own accounts. In addition,
to cover overallotments or to stabilize the price of the common stock or of any such other securities, the underwriters may bid for,
and purchase, the common stock or any such other securities in the open market. Finally, in any offering of our securities through a
syndicate of underwriters, the underwriting syndicate may reclaim selling concessions allowed to an underwriter or a dealer for distributing
our securities in the offering if the syndicate repurchases previously distributed securities in transactions to cover syndicate short
positions, in stabilization transactions or otherwise. Any of these activities may stabilize or maintain the market price of our securities
above independent market levels. Any such underwriters are not required to engage in these activities and may end any of these activities
at any time.
We may engage
in “at the market offerings” within the meaning of Rule 415(a)(4) under the Securities Act, to or through a market maker
or into an existing trading market on an exchange or otherwise. In addition, we may enter into derivative transactions with third parties,
or sell securities not covered by this prospectus to third parties in privately negotiated transactions. If the applicable prospectus
supplement so indicates, in connection with those derivatives, the third parties may sell securities covered by this prospectus and the
applicable prospectus supplement, including in short sale transactions. If so, the third party may use securities pledged by us or borrowed
from us or others to settle those sales or to close out any related open borrowings of securities, and may use securities received from
us in settlement of those derivatives to close out any related open borrowings of securities. The third party in such sale transactions
will be an underwriter and, if not identified in this prospectus, will be named in the applicable prospectus supplement (or a post-effective
amendment). In addition, we may otherwise loan or pledge securities to a financial institution or other third party that in turn may
sell the securities short using this prospectus and an applicable prospectus supplement. Such financial institution or other third party
may transfer its economic short position to investors in our securities or in connection with a concurrent offering of other securities.
The specific
terms of any lock-up provisions in respect of any given offering will be described in the applicable prospectus supplement.
The underwriters,
dealers and agents may engage in transactions with us, or perform services for us, in the ordinary course of business for which they
receive compensation.
The anticipated
date of delivery of offered securities will be set forth in the applicable prospectus supplement relating to each offer.
We will bear
all costs, expenses and fees in connection with the registration of the securities, as well as the expense of all commissions and discounts,
if any, attributable to sales of the securities by us.
DESCRIPTION
OF SECURITIES
The following
is a summary of the rights of our common and preferred stock and our outstanding warrants, and some of the provisions of our amended
and restated certificate of incorporation, as amended, or our Certificate of Incorporation, and our amended and restated bylaws, or our
Bylaws, and the Delaware General Corporation Law, or the DGCL. Because it is only a summary, it does not contain all of the information
that may be important to you. Such summary is subject to and qualified in its entirety by our Certificate of Incorporation and our Bylaws,
a copy of each of which has been incorporated as an exhibit to the registration statement of which this prospectus forms a part.
Our common stock,
par value $0.01 per share, trading symbol OPGN is registered under Section 12(b) of the Securities Exchange Act of 1934, as amended.
General
We,
directly or through one or more underwriters, dealers and agents designated from time to time, or directly to purchasers, or through
a combination of these methods, may offer, issue and sell, together or separately, in one or more offerings, the following securities:
● shares
of our common stock;
● shares
of our preferred stock, in one or more series;
● warrants
to purchase shares of our common stock or preferred stock;
● units
consisting of any combination of the securities listed above, each on terms to be determined at the time of sale.
The preferred stock may also be exchangeable
for and/or convertible into shares of common stock, another series of preferred stock, or other securities. The common stock, preferred
stock, warrants, and units are collectively referred to in this prospectus as the “securities.” When a particular series
of securities is offered, a supplement to this prospectus will be delivered with this prospectus, which will set forth the terms of the
offering and sale of the offered securities.
Authorized Capital
Stock
As of July 31,
2021, our authorized capital stock consists of 50,000,000 shares of common stock, par value $0.01 per share, and 10,000,000 shares of
preferred stock, par value $0.01 per share. As of July 31, 2021, 38,270,250 shares of our common stock are issued and outstanding and
10,981,518 shares of common are reserved for future issuance upon exercise of outstanding stock options and warrants.
Common Stock
The
holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of the stockholders. The
holders of our common stock do not have any cumulative voting rights. Our Board of Directors are elected to a one year term; the Company
does not have a staggered board. Holders of our common stock are entitled to receive ratably any dividends declared by the Board of Directors
out of funds legally available for that purpose, subject to any preferential dividend rights of any outstanding preferred stock. Our
common stock has no preemptive rights, conversion rights or other subscription rights or redemption or sinking fund provisions.
In the event
of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in all assets remaining
after payment of all debts and other liabilities and any liquidation preference of any outstanding preferred stock.
Preferred Stock
Undesignated Preferred Stock
Our Board of
Directors has the authority, without further action by our stockholders, to issue from time to time 10,000,000 shares of preferred stock
in one or more series. Our Board of Directors will have the authority to establish the number of shares to be included in each series
and fix the powers, preferences and rights of the shares of each wholly unissued series and any of its qualifications, limitations or
restrictions. Our Board of Directors will also be able to increase or decrease the number of shares of any series, but not below the
number of shares of that series then outstanding, without any further vote or action by the stockholders.
The issuance
of preferred stock could decrease the amount of earnings and assets available for distribution to the holders of common stock or adversely
affect the rights and powers, including voting rights, of the holders of common stock. The issuance of preferred stock, while providing
flexibility in connection with possible acquisitions and other corporate purposes, could, among other things, have the effect of delaying,
deferring or preventing a change in control of our Company, which could depress the market price of our common stock.
Warrants
We
may issue warrants, in one or more series, for the purchase of our common stock or preferred stock. Warrants may be issued independently
or together with our common stock or preferred stock and may be attached to or separate from any offered securities.
A
prospectus supplement accompanying this prospectus relating to a particular series of warrants will describe the terms of those warrants,
including:
| · | the title and the aggregate number of warrants, |
| · | the security for which each warrant is exercisable, |
| · | the
date or dates on which the right to exercise such warrants commence and expire, |
| · | the price or prices at which such warrants are exercisable, |
| · | the periods during which and places at which such warrants are exercisable, |
| · | the terms of any mandatory or optional call provisions, |
| · | the price or prices, if any, at which the warrants may be redeemed at the option of the holder
or will be redeemed upon expiration, |
| · | the
identity of the warrant agent, and |
| · | the exchanges, if any, on which such warrants may be listed, if any. |
You should read the particular terms
of the documents pursuant to which the warrants will be issued, which will be described in more detail in the applicable prospectus supplement.
Outstanding Warrants
As of the date of this prospectus,
we have outstanding warrants to purchase shares of our common stock to various persons and entities, under which we could be obligated
to issue up to 8,717,963 shares of common stock, including:
| · | 986,931
shares of common stock issuable upon the exercise of outstanding warrants granted as of December
31, 2020, at a weighted average exercise price of $22.30 per share; |
| · | 4,583,332
shares of common stock issuable upon the exercise of common warrants issued to purchasers
and placement agent in our registered direct offering in February 2021, at an exercise price
of $3.55 per share; and |
| · | 3,147,700
shares of common stock issuable upon the exercise of common warrants issued to purchasers
in our warrant exercise transaction in March 2021, at an exercise price of $3.56 per share. |
Warrants issued
in Bridge Financing
Pursuant to the
Note Purchase Agreement and the underlying transactions, the Company has issued warrants to purchase shares of its common stock to jVen
Capital, LLC in an amount equal to 20% of the principal of each of the two bridge financing notes issued, or the jVen Capital Warrants,
and warrants to purchase shares of its common stock to Merck Global Health Innovation Fund in an amount equal to 20% of an amended and
restated note issued by the Company to Merck Global Health Innovation Fund on June 28, 2017, the date of issuance. The warrants each
have a five year term from issuance, are first exercisable on the date that is six months after the date of issuance and have an exercise
price equal to 110% of the closing price of the Company’s common stock on the date immediately prior to the date of issuance. The
terms of the warrants issued in connection with such notes (other than the exercise price and the number of shares) may be amended, in
the discretion of the holder, to reflect the terms of the warrants issued in our public offering transaction in July 2017 described below.
The jVen Capital
Warrants each include a blocker provision that prevents the exercise of the jVen Capital Warrants if such exercise, when aggregated with
the other issuances contemplated under the Note Purchase Agreement, would violate Nasdaq Listing Rule 5635, unless stockholder approval
is first obtained by the Company.
Warrants issued in the July
2017 Public Offering
The Company issued
warrants in connection with its public offering transaction in July 2017. The common warrants issued in the July 2017 public offering
entitle the registered holder to purchase one five-hundredths of a share of common stock at an exercise price of $212.50 per share. In
addition, the Company issued warrants to the placement agent that have an exercise price of $250.00 per share of common stock. All of
the warrants issued in the July 2017 public offering were immediately exercisable and have a five-year term from the date of issuance.
Warrants issued in the February
2018 Public Offering
The Company issued
warrants in connection with its public offering transaction in February 2018. The common warrants issued in the February 2018 public
offering entitle the registered holder to purchase one-fortieth of a share of common stock at an exercise price of $65.00 per share.
In addition, the Company issued warrants to the placement agent that have an exercise price of $81.25 per share of common stock. All
of the warrants issued in the February 2018 public offering are immediately exercisable and have a five-year term from the date of issuance.
Common Warrants in the October
2019 Offering
The following
is a summary of certain terms and provisions of the common warrants issued by us to purchasers and the placement agent in connection
with our private placement offering of units and pre-funded units in October 2019.
Duration and Exercise Price
Each common warrant
included in the units and the pre-funded units has an initial exercise price per share equal to $2.00. In addition, the Company issued
warrants to the placement agent that have an exercise price of $2.60 per share. The common warrants are immediately exercisable and will
expire on the fifth anniversary of the original issuance date. The exercise price and number of shares of common stock issuable upon
exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting
our common stock and the exercise price. The common warrants were issued separately from the common stock included in the units, or the
pre-funded warrants included in the pre-funded units, as the case may be, and may be transferred separately.
Cashless Exercise
If, at the time
a holder exercises its common warrants, a registration statement registering the issuance of the shares of common stock underlying the
common warrants under the Securities Act is not then effective or available for the issuance of such shares, then in lieu of making the
cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect
instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a
formula set forth in the common warrants.
Exercisability
The common warrants
will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied
by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise
as discussed below). A holder (together with its affiliates) may not exercise any portion of the common warrant to the extent that the
holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days' prior
notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder's common
warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such
percentage ownership is determined in accordance with the terms of the common warrants.
Fractional Shares
No fractional
shares of common stock will be issued upon the exercise of the common warrants. Rather, the number of shares of common stock to be issued
will, at our election, either be rounded up to the nearest whole number or we will pay a cash adjustment in respect of such final fraction
in an amount equal to such fraction multiplied by the exercise price.
Transferability
Subject to applicable
laws, a common warrant may be transferred at the option of the holder upon surrender of the common warrant to us together with the appropriate
instruments of transfer.
Trading Market
There is no trading
market available for the common warrants on any securities exchange or nationally recognized trading system.
Right as a Stockholder
Except as otherwise
provided in the common warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the common
warrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their
common warrants.
Fundamental Transaction
In the event
of a fundamental transaction which is within our control, the holders of the common warrants have the right to require us or a successor
entity to redeem the common warrant for cash in the amount of the Black-Scholes value of the unexercised portion of the common warrant
on the date of the consummation of the fundamental transaction. In the event of a fundamental transaction which not in our control, including
a fundamental transaction that is not approved by our Board, the holders of the common warrants have the right to require us or a successor
entity to redeem the common warrant for the consideration paid in the fundamental transaction in the amount of the Black Scholes value
of the unexercised portion of the common warrant on the date of the consummation of the fundamental transaction.
Common Warrants in February
2021 Offering
The following
is a summary of certain terms and provisions of the common warrants issued by us to purchasers and the placement agent in connection
with our registered direct offering of shares of common stock, common warrants and pre-funded warrants in February 2021.
Duration and Exercise Price
Each common warrant
issued to purchasers has an initial exercise price per share equal to $3.55. In addition, the Company issued warrants to the placement
agent that have an exercise price of $3.90 per share. The common warrants were exercisable on the six month anniversary of their issuance
and will expire on the five-and-a-half year anniversary of the original issuance date. The exercise price and number of shares of common
stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar
events affecting our common stock and the exercise price. The common warrants were issued separately from the common stock or pre-funded
warrants issued in the offering and may be transferred separately.
Cashless Exercise
If, at the time
a holder exercises its common warrants, a registration statement registering the issuance of the shares of common stock underlying such
warrants under the Securities Act is not then effective or available for the issuance of such shares, then in lieu of making the cash
payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead
to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula
set forth in the common warrants.
Exercisability
The common warrants
will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied
by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise
as discussed below). A holder (together with its affiliates) may not exercise any portion of the common warrant to the extent that the
holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days' prior
notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder's common
warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such
percentage ownership is determined in accordance with the terms of the common warrants, as applicable.
Fractional Shares
No fractional
shares of common stock will be issued upon the exercise of the common warrants. Rather, the number of shares of common stock to be issued
will, at our election, either be rounded up to the nearest whole number or we will pay a cash adjustment in respect of such final fraction
in an amount equal to such fraction multiplied by the exercise price.
Transferability
Subject to applicable
laws, a common warrant may be transferred at the option of the holder upon surrender of the warrant to us together with the appropriate
instruments of transfer.
Trading Market
There is no trading
market available for the common warrants on any securities exchange or nationally recognized trading system.
Right as a Stockholder
Except as otherwise
provided in the warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the warrants do
not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their warrants.
Fundamental Transaction
In the event
of a fundamental transaction which is within our control, the holders of the common warrants have the right to require us or a successor
entity to redeem the common warrant for cash in the amount of the Black-Scholes value of the unexercised portion of the common warrant
on the date of the consummation of the fundamental transaction. In the event of a fundamental transaction which not in our control, including
a fundamental transaction that is not approved by our Board, the holders of the common warrants have the right to require us or a successor
entity to redeem the common warrant for the consideration paid in the fundamental transaction in the amount of the Black Scholes value
of the unexercised portion of the common warrant on the date of the consummation of the fundamental transaction.
Common Warrants in March 2021
Warrant Exercise Transaction and November 2020 Placement Agent Warrants
In November 2020,
the Company consummated a private placement transaction of common stock that included the issuance of 4,842,615 common warrants to the
purchaser and 242,130 common warrants to the placement agent. In March 2021, the Company completed a warrant exercise transaction pursuant
to which the purchaser exercised the remaining common warrants in exchange for an aggregate amount of 3,147,700 warrants. The following
is a summary of certain terms and provisions of the common warrants issued by us in connection with our warrant exercise transaction
in March 2021 as well as the common warrants issued to the placement agent in connection with the private placement transaction in November
2020.
Duration and Exercise Price
Each common warrant
issued in the warrant exercise transaction has an initial exercise price per share equal to $3.56. In addition, the common warrants issued
to the placement agent in the November 2020 private placement that have an exercise price of $2.6845 per share. The common warrants were
immediately exercisable and expire on the five year anniversary of the original issuance date. The exercise price and number of shares
of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations
or similar events affecting our common stock and the exercise price.
Cashless Exercise
If, at the time
a holder exercises its common warrants, a registration statement registering the issuance of the shares of common stock underlying such
warrants under the Securities Act is not then effective or available for the issuance of such shares, then in lieu of making the cash
payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead
to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula
set forth in the common warrants.
Exercisability
The common warrants
will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied
by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise
as discussed below). A holder (together with its affiliates) may not exercise any portion of the common warrant to the extent that the
holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days' prior
notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder's common
warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such
percentage ownership is determined in accordance with the terms of the common warrants, as applicable.
Fractional Shares
No fractional
shares of common stock will be issued upon the exercise of the common warrants. Rather, the number of shares of common stock to be issued
will, at our election, either be rounded up to the nearest whole number or we will pay a cash adjustment in respect of such final fraction
in an amount equal to such fraction multiplied by the exercise price.
Transferability
Subject to applicable
laws, a common warrant may be transferred at the option of the holder upon surrender of the warrant to us together with the appropriate
instruments of transfer.
Trading Market
There is no trading
market available for the common warrants on any securities exchange or nationally recognized trading system.
Right as a Stockholder
Except as otherwise
provided in the warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the warrants do
not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their warrants.
Fundamental Transaction
In the event
of a fundamental transaction which is within our control, the holders of the common warrants have the right to require us or a successor
entity to redeem the common warrant for cash in the amount of the Black-Scholes value of the unexercised portion of the common warrant
on the date of the consummation of the fundamental transaction. In the event of a fundamental transaction which not in our control, including
a fundamental transaction that is not approved by our Board, the holders of the common warrants have the right to require us or a successor
entity to redeem the common warrant for the consideration paid in the fundamental transaction in the amount of the Black Scholes value
of the unexercised portion of the common warrant on the date of the consummation of the fundamental transaction.
Units
We may issue
units consisting of one or more warrants, shares of preferred stock, shares of common stock or any combination of such securities. The
applicable prospectus supplement will describe the terms of the units and of the securities comprising the units, including whether and
under what circumstances the securities comprising the units may be traded separately. You should read the particular terms of the documents
pursuant to which the units will be issued, which will be described in more detail in the applicable prospectus supplement.
Registration Rights
Investors’ Rights Agreement
Under the Third
Amended and Restated Investors’ Rights Agreement, dated as of December 18, 2013, among the Company and certain investors, or the
investors’ rights agreement, we granted registration rights to the holders of shares acquired prior to our initial public offering,
or their permitted transferees. These rights are provided under the terms of the investors’ rights agreement, and include demand
registration rights, short-form registration rights and piggyback registration rights. All fees, costs and expenses of underwritten registrations
will be borne by us and all selling expenses, including underwriting discounts and selling commissions, will be borne by the holders
of the shares being registered. As of the date of this prospectus, the holders of 11,619 shares of our common stock have registration
rights under the investors’ rights agreement. The investors’ rights agreement contains customary cross-indemnification provisions,
under which we are obligated to indemnify holders of registrable shares in the event of material misstatements or omissions in the registration
statement attributable to us, and they are obligated to indemnify us for material misstatements or omissions attributable to them. The
registration rights granted under the investors’ rights agreement will terminate at the earlier of the closing of a deemed liquidation
event and when all of the holders of registrable securities are eligible to be sold without restrictions under Rule 144 promulgated under
the Securities Act within any 90-day period.
Bridge Financing Registration
Rights
In connection
with the bridge financing the Company entered into a registration rights agreement with jVen Capital and with MGHIF, pursuant to which
the investors were granted certain demand registration rights and piggyback registration rights in connection with subsequent registered
offerings of the Company’s common stock. The registrable securities include the shares of common stock underlying the warrants
issued to jVen Capital and to MGHIF under the terms of the bridge financing promissory notes.
Anti-Takeover Effects of Our Certificate
of Incorporation, Bylaws and Delaware Law
Our Certificate
of Incorporation and Bylaws include a number of provisions that may have the effect of delaying, deferring or preventing another party
from acquiring control of us and encouraging persons considering unsolicited tender offers or other unilateral takeover proposals to
negotiate with our Board of Directors rather than pursue non-negotiated takeover attempts. These provisions include the items described
below.
Meetings of Stockholders
Our Certificate
of Incorporation and Bylaws provide that only the Chair of the Board, the Chief Executive Officer or a majority of the members of our
Board of Directors then in office may call special meetings of stockholders and only those matters set forth in the notice of the special
meeting may be considered or acted upon at a special meeting of stockholders. Our Bylaws limit the business that may be conducted at
an annual meeting of stockholders to those matters properly brought before the meeting.
Advance Notice Requirements
Our Bylaws establish
advance notice procedures with regard to stockholder proposals relating to the nomination of candidates for election as directors or
new business to be brought before meetings of our stockholders. These procedures provide that notice of stockholder proposals must be
timely given in writing to our corporate secretary prior to the meeting at which the action is to be taken. Generally, to be timely,
notice must be received at our principal executive offices not less than 90 days nor more than 120 days prior to the first
anniversary date of the annual meeting for the preceding year. Our Bylaws specify the requirements as to form and content of all stockholders’
notices. These requirements may preclude stockholders from bringing matters before the stockholders at an annual or special meeting.
Amendment to Certificate of
Incorporation and Bylaws
Any amendment
of our Certificate of Incorporation must first be approved by a majority of our Board of Directors, and if required by law or our Certificate
of Incorporation, must thereafter be approved by a majority of the outstanding shares entitled to vote on the amendment, except that
the amendment of the provisions relating to stockholder action, board composition, limitation of liability and the amendment of our Certificate
of Incorporation must be approved by not less than 66 2/3% of the outstanding shares entitled to vote on the amendment, and not less
than 66 2/3% of the outstanding shares of each class entitled to vote thereon as a class. Our Bylaws may be amended by the affirmative
vote of a majority of the directors then in office, subject to any limitations set forth in the bylaws; and may also be amended by the
affirmative vote of at least 66 2/3% of the outstanding shares entitled to vote on the amendment, or, if our board of directors recommends
that the stockholders approve the amendment, by the affirmative vote of the majority of the outstanding shares entitled to vote on the
amendment, in each case voting together as a single class.
Exclusive Jurisdiction
for Certain Actions
Our Certificate
of Incorporation provides that, once our common stock is a “covered security,” unless we consent in writing to the selection
of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative
action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors,
officers or other employees to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware
General Corporation Law, our certificate of incorporation or our bylaws, or (iv) any action asserting a claim against us governed by
the internal affairs doctrine. Although we believe this provision benefits us by providing increased consistency in the application of
Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging lawsuits against our directors
and officers. The enforceability of similar exclusive forum provisions in other companies’ certificates of incorporation has been
challenged in legal proceedings, and it is possible that a court could rule that this provision in our certificate of incorporation is
inapplicable or unenforceable. In addition, this exclusive forum provision is intended to apply to claims arising under Delaware state
law and would not apply to claims brought pursuant to the Securities Act or the Exchange Act or any other claim for which the federal
courts have exclusive jurisdiction. To the extent the provision could be construed to apply to such claims, there is uncertainty as to
whether a court would enforce the provision in such respect, and our stockholders will not be deemed to have waived compliance with federal
securities laws and the rules and regulations thereunder.
Section 203 of the Delaware
General Corporation Law
We are subject
to the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a publicly held
Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a three-year
period following the time that this stockholder becomes an interested stockholder, unless the business combination is approved in a prescribed
manner. Under Section 203, a business combination between a corporation and an interested stockholder is prohibited unless it satisfies
one of the following conditions:
| · | before
the stockholder became interested, our Board of Directors approved either the business combination
or the transaction which resulted in the stockholder becoming an interested stockholder; |
| · | upon
consummation of the transaction which resulted in the stockholder becoming an interested
stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation
outstanding at the time the transaction commenced, excluding for purposes of determining
the voting stock outstanding, shares owned by persons who are directors and also officers,
and employee stock plans, in some instances, but not the outstanding voting stock owned by
the interested stockholder; or |
| · | at
or after the time the stockholder became interested, the business combination was approved
by our Board of Directors and authorized at an annual or special meeting of the stockholders
by the affirmative vote of at least two-thirds of the outstanding voting stock which is not
owned by the interested stockholder. |
Section 203
defines a business combination to include:
| · | any
merger or consolidation involving the corporation and the interested stockholder; |
| · | any
sale, transfer, lease, pledge or other disposition involving the interested stockholder of
10% or more of the assets of the corporation; |
| · | subject
to exceptions, any transaction that results in the issuance or transfer by the corporation
of any stock of the corporation to the interested stockholder; |
| · | subject
to exceptions, any transaction involving the corporation that has the effect of increasing
the proportionate share of the stock of any class or series of the corporation beneficially
owned by the interested stockholder; and |
| · | the
receipt by the interested stockholder of the benefit of any loans, advances, guarantees,
pledges or other financial benefits provided by or through the corporation. |
In general, Section 203
defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation
and any entity or person affiliated with or controlling or controlled by the entity or person.
Listing
Our common stock
is listed on the Nasdaq Capital Market under the symbol “OPGN.”
Transfer Agent and Registrar
The transfer
agent and registrar for our common stock is Philadelphia Stock Transfer, Inc. The transfer agent’s address is 2320 Haverford Rd.,
Suite 230, Ardmore, PA 19003.
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, 2020 and 2019, 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, 2020 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 ADDITIONAL INFORMATION
We
filed with the SEC a registration statement under the Securities Act of 1933 for the Warrant 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, 2020, filed with the SEC on March 29, 2021; |
· our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021, filed with the SEC on May 14, 2021, and August 13, 2021, respectively; |
· our Current Reports on Form 8-K filed with the SEC on February 10, 2021 (Items 1.01, 3.02, 8.01 and 9.01), March 8, 2021 (Items 5.02 and 8.01), March 9, 2021 (Items 1.01, 3.02 and 9.01), June 9, 2021 (Items 5.07, 8.01 and 9.01), July 7, 2021 (Items 8.01 and 9.01), July 29, 2021 (Item 5.02), August 5, 2021 (Item 8.01 and 9.01), October 4, 2021 (Items 8.01 and 9.01), and October 15, 2021 (Items 1.01, 3.03, 5.02, 5.03, 8.01 and 9.01); |
· our proxy statement for the Annual Meeting of Stockholders held on June 9, 2021, filed with the SEC on April 26, 2021; 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: Oliver Schacht, Chief Executive Officer
9717 Key West Avenue, Suite 100
Rockville, MD 20850
Telephone No.:
(240) 813-1260
5,360,000 Shares of Common
Stock
33,810 Shares of Preferred
Stock
4,300,000 Shares of Common
Stock Underlying Pre-funded Warrants
PROSPECTUS SUPPLEMENT
___________________
H.C. Wainwright
& Co.
___________________
September 30, 2022
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