As
filed with the U.S. Securities and Exchange Commission on June 5,
2020
Registration
No. 333-238631
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
Amendment
No. 1
to
FORM
S-3
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Akers
Biosciences, Inc.
(Exact
name of registrant as specified in its charter)
New
Jersey |
|
22-2983783 |
(State
or other jurisdiction of
incorporation
or organization)
|
|
(I.R.S.
Employer
Identification
Number)
|
201
Grove Road
Thorofare,
NJ 08086
(856)
848-8698
(Address,
including zip code, and telephone number, including area code, of
registrant’s principal executive offices)
Christopher
C. Schreiber
Executive
Chairman
Akers
Biosciences, Inc.
201
Grove Road
Thorofare,
New Jersey USA 08086
(856)
848-8698
(Name,
address, including zip code, and telephone number, including area
code, of agent for service)
Copies of all communications, including communications sent to
agent for service, should be sent to:
Rick
A. Werner, Esq.
Jayun
Koo, Esq.
Haynes
and Boone, LLP
30
Rockefeller Plaza, 26th Floor
New
York, New York 10112
Tel.
(212) 659-7300
Fax
(212) 884-8234
Approximate
date of commencement of proposed sale to the public: From time
to time after the effective date of this Registration
Statement.
If
the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check
the following box: [ ]
If
any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the
following box: [X]
If
this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same offering. [ ]
If
this Form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier
effective registration statement for the same offering.
[ ]
If
this Form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that shall
become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following box.
[ ]
If
this Form is a post-effective amendment to a registration statement
filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant
to Rule 413(b) under the Securities Act, check the following box.
[ ]
Indicate
by check mark whether the Registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the
Exchange Act.
Large
accelerated filer |
[ ] |
Accelerated
filer |
[ ] |
|
|
|
|
Non-accelerated
filer |
[X] |
Smaller
reporting company |
[X] |
|
|
|
|
|
|
Emerging
growth company |
[ ] |
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided to
Section 7(a)(2)(B) of the Securities Act. [ ]
CALCULATION
OF REGISTRATION FEE
Title of Each Class of
Securities to be Registered |
|
Amount
to be
Registered
(1) (2)
|
|
|
Proposed Maximum Aggregate Offering Price per Share (3) |
|
|
Proposed Maximum Aggregate Offering Price (3) |
|
|
Amount of Registration Fee (4) |
|
Common Stock, no par value |
|
|
793,437 |
|
|
$ |
3.37 |
|
|
$ |
2,673,882.69 |
|
|
$ |
347.07 |
(5)
|
(1) |
Pursuant
to Rule 416 under the Securities Act of 1933, as amended (the
“Securities Act”), the shares of common stock offered by this
registration statement shall be deemed to cover such additional
securities as may be issued as a result of share splits, share
dividends or similar transactions |
(2) |
Comprised
of (i) 411,403 shares of common stock issued pursuant to a certain
Membership Interest Purchase Agreement by and between members of
Cystron Biotech, LLC and Akers Biosciences, Inc., dated as of March
23, 2020, as amended (the “MIPA”), (ii) 211,353 shares of common
stock issuable upon conversion of the Series D Convertible
Preferred Stock issued pursuant to the MIPA, (iii) 61,333 shares of
common stock issuable upon exercise of warrants issued to the
placement agent designees on April 8, 2020 and (iv) 109,348 shares
of common stock issuable upon exercise of warrants issued to the
placement agent designees on May 18, 2020. |
(3) |
Estimated
solely for the purpose of calculating the registration fee pursuant
to Rule 457(c) under the Securities Act and based upon the average
of the high and low sale prices of our shares of common stock on
the Nasdaq Capital Market on May 29, 2020. |
(4) |
Calculated
in accordance with Rule 457(c) under the Securities
Act. |
(5) |
$330.08 of which has been previously paid.
|
The
Registrant hereby amends this Registration Statement on such date
or dates as may be necessary to delay its effective date until the
Registrant shall file a further amendment which specifically states
that this Registration Statement shall thereafter become effective
in accordance with Section 8(a) of the Securities Act of 1933 or
until this Registration Statement shall become effective on such
date as the Commission, acting pursuant to said Section 8(a), may
determine.
The
information in this prospectus is not complete and may be changed.
The selling stockholders named in this prospectus may not sell
these securities until the Registration Statement filed with the
Securities and Exchange Commission, of which this prospectus is a
part, is effective. This prospectus is not an offer to sell these
securities and the selling stockholders named in this prospectus
are not soliciting an offer to buy these securities in any state
where the offer or sale is not permitted.
SUBJECT
TO COMPLETION, DATED JUNE 5, 2020
Prospectus

793,437
Shares
COMMON
STOCK
The
selling stockholders named in this prospectus may use this
prospectus to offer and resell from time to time up to 793,437
shares of our common stock, which are comprised of (i) 411,403
shares of our common stock (the “MIPA Common Stock Shares”) issued
pursuant to a certain Membership Interest Purchase Agreement by and
between members of Cystron Biotech, LLC (individually, each a
“Seller,” and collectively, the “Sellers”) and Akers Biosciences,
Inc., dated as of March 23, 2020 (the “Original MIPA”), as amended
by Amendment No. 1, dated as of May 14, 2020 (as amended, the
“MIPA”), (ii) 211,353 shares of our common stock (the “Series D
Shares” and, together with the MIPA Common Stock Shares, the “MIPA
Shares”) issuable upon conversion of the Series D Convertible
Preferred Stock (the “Preferred Stock”) issued pursuant to the
MIPA, (iii) 61,333 shares of our common stock (the “April Warrant
Shares”) issuable upon exercise of the warrants issued on April 8,
2020 (the “April Warrants”) to the designees of H.C. Wainwright
& Co., LLC, who served as our placement agent in connection
with a registered direct offering closed on April 8, 2020, and (iv)
109,348 shares of our common stock (the “May Warrant Shares” and,
together with the April Warrant Shares, the “Warrant Shares”)
issuable upon exercise of the warrants issued on May 18, 2020 (the
“May Warrants” and together with April Warrants, the “Warrants”) to
the designees of H.C. Wainwright & Co., LLC, who served as our
placement agent in connection with a registered direct offering
closed on May 18, 2020.
The
MIPA Common Stock Shares and the Preferred Stock were issued to the
Sellers pursuant to the MIPA in reliance upon the exemption from
the registration requirements in Section 4(a)(2) of the Securities
Act of 1933, as amended (the “Securities Act”) and Regulation D
(Rule 506) under the Securities Act. Each Seller represented that
it was an “accredited investor” (as defined by Rule 501 under the
Securities Act). We are registering the offer and resale of the
MIPA Shares to satisfy a provision in a registration rights
agreement, dated as of March 23, 2020 (the “Registration Rights
Agreement”), pursuant to which we agreed to register the resale of
the MIPA Shares.
In
addition, the Warrants were issued to the placement agent’s
designees in reliance upon the exemption from the registration
requirements in Section 4(a)(2) of the Securities Act and
Regulation D under the Securities Act.
We
will not receive any of the proceeds from the sale of our common
stock by the selling stockholders.
Any
shares of common stock subject to resale hereunder will have been
issued by us and acquired by the selling stockholders prior to any
resale of such shares pursuant to this prospectus.
The
selling stockholders named in this prospectus, or their donees,
pledgees, transferees or other successors-in-interest, may offer or
resell the shares from time to time through public or private
transactions at prevailing market prices, at prices related to
prevailing market prices or at privately negotiated prices. The
selling stockholders will bear all commissions and discounts, if
any, attributable to the sale of shares, and all selling and other
expenses incurred by the selling stockholders. We will bear all
costs, expenses and fees in connection with the registration of the
shares. For additional information on the methods of sale that may
be used by the selling stockholders, see “Plan of Distribution”
beginning on page 14 of this prospectus.
Our
common stock is listed on the Nasdaq Capital Market (the “NASDAQ”)
under the symbol “AKER.” On June 4, 2020, the last reported sale
price of our common stock as reported on the NASDAQ was $3.68 per
share.
Investing
in our securities involves a high degree of risk. These risks are
discussed in this prospectus under “Risk Factors” beginning on page
4 and in our most recent Annual Report on Form 10-K, which
is incorporated by reference in this prospectus, as well as in any
other recently filed quarterly or current reports and, if any, in
any applicable prospectus supplement.
Neither
the Securities and Exchange Commission (the “SEC”) nor any state
securities commission has approved or disapproved of these
securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal
offense.
The
date of this prospectus is
,
2020
TABLE OF
CONTENTS
ABOUT THIS
PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we
filed with the SEC using a “shelf” registration process. The
selling stockholders named in this prospectus may resell, from time
to time, in one or more offerings, the common stock offered by this
prospectus. Information about the selling stockholders may change
over time. When the selling stockholders sells shares of common
stock under this prospectus, we will, if necessary and required by
law, provide a prospectus supplement that will contain specific
information about the terms of that offering. Any prospectus
supplement may also add to, update, modify or replace information
contained in this prospectus. If a prospectus supplement is
provided and the description of the offering in the prospectus
supplement varies from the information in this prospectus, you
should rely on the information in the prospectus supplement. You
should carefully read this prospectus and the accompanying
prospectus supplement, if any, along with all of the information
incorporated by reference herein and therein, before making an
investment decision.
You
should rely only on the information contained or incorporated by
reference in this prospectus or any applicable prospectus
supplement. We have not, and the selling stockholders have not,
authorized any other person to provide you with different or
additional information. If anyone provides you with different or
additional information, you should not rely on it. This prospectus
is not an offer to sell, nor are the selling stockholders seeking
an offer to buy, the shares offered by this prospectus in any
jurisdiction where the offer or sale is not permitted. No offers or
sales of any of the shares of common stock are to be made in any
jurisdiction in which such an offer or sale is not permitted. You
should assume that the information contained in this prospectus or
in any applicable prospectus supplement is accurate only as of the
date on the front cover thereof or the date of the document
incorporated by reference, regardless of the time of delivery of
this prospectus or any applicable prospectus supplement or any
sales of the shares of common stock offered hereby or
thereby.
You
should read the entire prospectus and any prospectus supplement and
any related issuer free writing prospectus, as well as the
documents incorporated by reference into this prospectus or any
prospectus supplement or any related issuer free writing
prospectus, before making an investment decision. Neither the
delivery of this prospectus or any prospectus supplement or any
issuer free writing prospectus nor any sale made hereunder shall
under any circumstances imply that the information contained or
incorporated by reference herein or in any prospectus supplement or
issuer free writing prospectus is correct as of any date subsequent
to the date hereof or of such prospectus supplement or issuer free
writing prospectus, as applicable. You should assume that the
information appearing in this prospectus, any prospectus supplement
or any document incorporated by reference is accurate only as of
the date of the applicable documents, regardless of the time of
delivery of this prospectus or any sale of securities. Our
business, financial condition, results of operations and prospects
may have changed since that date.
CAUTIONARY
STATEMENT REGARDING FORWARD LOOKING STATEMENTS
This
prospectus and any accompanying prospectus supplement and the
documents we have filed or will file with the SEC that are or will
be incorporated by reference into this prospectus and the
accompanying prospectus supplement contain forward-looking
statements, within the meaning of Section 27A of the Securities Act
and Section 21E of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), that involve risks and uncertainties. Any
statements contained, or incorporated by reference, in this
prospectus and any accompanying prospectus that are not statements
of historical fact may be forward-looking statements. When we use
the words “anticipate,” “believe,” “could,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “will” and other
similar terms and phrases, including references to assumptions, we
are identifying forward-looking statements. Forward-looking
statements involve risks and uncertainties which may cause our
actual results, performance or achievements to be materially
different from those expressed or implied by forward-looking
statements.
A
variety of factors, some of which are outside our control, may
cause our operating results to fluctuate significantly. They
include:
|
● |
changes
in the market acceptance of our products and services; |
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|
● |
challenges
we may face in identifying, acquiring and operating new business
opportunities; |
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|
● |
the
outcome of litigation or other proceedings to which we are subject
as described in the “Legal Proceedings” sections of the Annual
Report on Form 10-K and our subsequent filings with the SEC that
are incorporated by reference to this prospectus or which we may
become subject to in the future; |
|
|
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|
● |
increased
levels of competition; |
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|
● |
changes
in political, economic or regulatory conditions generally and in
the markets in which we operate; |
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|
● |
our
relationships with our key customers; |
|
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|
● |
adverse
conditions in the industries in which our customers
operate; |
|
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|
● |
our
ability to retain and attract senior management and other key
employees; |
|
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● |
our
ability to quickly and effectively respond to new technological
developments; |
|
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● |
delisting
of our common stock from the NASDAQ; |
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|
● |
our
ability to protect our trade secrets or other proprietary rights,
operate without infringing upon the proprietary rights of others
and prevent others from infringing on our proprietary
rights; |
|
|
|
|
● |
our
ability to achieve the expected benefits and costs of the
transactions related to the acquisition of Cystron Biotech, LLC
(“Cystron”), including: |
|
○ |
the
timing of, and our ability to, obtain and maintain regulatory
approvals for clinical trials of our vaccine product
candidate; |
|
○ |
the
timing and results of our planned clinical trials for our vaccine
product candidate; |
|
○ |
the
amount of funds we require for our vaccine product candidate;
and |
|
○ |
our
ability to maintain our existing license with Premas Biotech PVT
Ltd; and |
|
● |
the
impact of the recent COVID-19 outbreak on our results of
operations, business plan and the global economy. |
The
foregoing does not represent an exhaustive list of risks that may
impact upon the forward-looking statements used herein or in the
documents incorporated by reference herein. Please see “Risk
Factors” in our reports filed with the SEC or in a prospectus
supplement related to this prospectus for additional risks which
could adversely impact our business and financial performance.
Moreover, new risks regularly emerge and it is not possible for our
management to predict all risks, nor can we assess the impact of
all risks on our business or the extent to which any risk, or
combination of risks, may cause actual results to differ from those
contained in any forward-looking statements. All forward-looking
statements included in this prospectus and any accompanying
prospectus supplement are based on information available to us on
the date hereof or thereof. Except to the extent required by
applicable laws or rules, we undertake no obligation to publicly
update or revise any forward-looking statement, whether as a result
of new information, future events or otherwise. All subsequent
written and oral forward-looking statements attributable to us or
persons acting on our behalf are expressly qualified in their
entirety by the cautionary statements contained throughout (or
incorporated by reference in) this prospectus, any accompanying
prospectus and the documents we have filed with the SEC.
PROSPECTUS SUMMARY
This
summary highlights selected information contained elsewhere or
incorporated by reference in this prospectus. This summary does not
contain all the information that you should consider before
investing in our Company. You should carefully read the entire
prospectus, including all documents incorporated by reference
herein. In particular, attention should be directed to our “Risk
Factors,” “Information With Respect to the Company,” “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” and the financial statements and related notes thereto
contained herein or otherwise incorporated by reference hereto,
before making an investment decision.
As
used herein, and any amendment or supplement hereto, unless
otherwise indicated, “we,” “us,” “our,” the “Company,” “Akers” or
similar terminology means Akers Biosciences, Inc.
Overview
We
are pursuing the development of a newly acquired license to a
coronavirus vaccine candidate. On March 23, 2020, we entered into
the Original MIPA with the Sellers, pursuant to which we acquired
100% of the membership interests (the “Membership Interests”) of
Cystron. On May 14, 2020, we and the Sellers entered into an
Amendment No. 1 to the Original MIPA (as amended, the “MIPA”),
which provided that any Equity Offering Payments in respect of an
equity offering that is consummated prior to September 23, 2020,
shall be accrued, but shall not be due and payable until September
24, 2020. Cystron is a party to a license agreement with Premas
Biotech PVT Ltd (“Premas”) whereby Premas granted Cystron, among
other things, an exclusive license with respect to Premas’ vaccine
platform for the development of a vaccine against COVID-19 and
other coronavirus infections. Premas is primarily responsible for
the development of the vaccine candidate through proof of concept
and is entitled to receive milestone payments upon achievement of
certain development milestones through proof of concept.
On
May 14, 2020, we issued a press release announcing that Premas has
successfully completed its vaccine prototype. Though the prototype
is complete, the vaccine candidate is still in early stages of
development, and, accordingly, must undergo preclinical testing and
all phases of clinical trials before a marketing application (in
this case, a biologics license application, or “BLA”) may be
submitted to the U.S. Food and Drug Administration (“FDA”) (which
must be approved before any biological product, including (without
limitation) vaccines, may be lawfully marketed in the United
States). We believe the most pivotal, yet difficult, stage in our
anticipated development of the contemplated vaccine candidate is
the requisite conduct of extensive clinical trials to demonstrate
the safety and efficacy of the product candidate. Additionally,
after we complete the necessary preclinical testing, but before we
may begin any clinical studies in the United States, we must submit
an Investigational New Drug (“IND”) application to the FDA, as this
is required before any clinical studies may be conducted in the
United States. In some cases, clinical studies may be conducted in
other countries; however, the FDA may not accept data from foreign
clinical studies in connection with a BLA (or other marketing
application) submission. In early May 2020, Premas obtained
transmission electron microscopic (TEM) images of the recombinant
virus like particle (VLP) assembled in yeast. Premas continues to
collate data at this time and, collectively with us, is moving
forward with conversations with regulatory authorities
in India and continuing to develop a regulatory strategy
in the United States. A manufacturing protocol has also been
established and large-scale production studies have been initiated
for the vaccine candidate. Clinical testing is expensive, time
consuming, and uncertain as to outcome. We cannot guarantee that
any clinical trials will be conducted as planned or completed in a
timely manner, or at all. Failures in connection with one or more
clinical trials can occur at any stage of testing.
Premas owns, and has exclusively licensed rights to us, two
provisional Indian patent applications filed in January and March
2020. The scope of these Indian provisional patent applications are
directed, respectively, to (i) a platform for the expression of
difficult to express proteins (DTE-Ps), which might provide
coverage for a method of making the to-be-developed vaccine; and
(ii) an expression platform for SARS-CoV-2-like virus proteins,
methods relevant thereto, and a relevant vaccine. If
non-provisional patent rights are pursued claiming priority to each
of these two provisional applications, any resulting patent rights
that issue might not expire until approximately January 20, 2041
and March 4, 2041, if all annuities and maintenance fees are timely
paid. The expiration dates may be extendable beyond these dates
depending on the jurisdiction and the vaccine development process.
As we do not own the patents or patent applications that we
license, we may need to rely upon Premas to properly prosecute and
maintain those patent applications and prevent infringement of
those patents.
With
regard to our existing product line, we continue to sell our
rapid, point-of-care screening and testing products, but at
continued reduced volumes compared to prior years. As a result, we
continue to experience low sales revenue from our screening and
testing products. We are also experiencing a production backlog for
some of our screening and testing products, which will further
reduce our sales revenue. In addition, as we previously reported,
we eliminated our sales force for our screening and testing
products. In light of these facts and the progress that we have
made in our partnership with Premas for the development of a
vaccine candidate for COVID-19, as previously announced, we
recently initiated a strategic review of the screening and testing
products business. As part of this review, we are exploring
potential strategic and alternative transactions, which may include
the disposition or winddown of our current commercial screening and
testing products business. As a result, the makeup of our lines of
business is subject to change.
Corporate
Information
We
were incorporated in 1989 in the state of New Jersey. Our principal
executive offices are located at 201 Grove Road, Thorofare, New
Jersey USA 08086 and our telephone number is (856) 848-8698. Our
corporate website address is www.akersbio.com. The
information contained on or accessible through our website is not a
part of this prospectus, and the inclusion of our website address
in this prospectus is an inactive textual reference
only.
THE
OFFERING
Securities
offered by the selling stockholders |
Up to
793,437 shares of our common stock, which are comprised of (i)
411,403 shares of common stock issued pursuant to the MIPA, (ii)
211,353 shares of common stock issuable upon conversion of the
Preferred Stock issued pursuant to the MIPA, (iii) 61,333 shares of
our common stock issuable upon exercise of the April Warrants and
(iv) 109,348 shares of our common stock issuable upon exercise of
the May Warrants. |
|
|
Selling
stockholders |
All
of the shares of common stock are being offered by the selling
stockholders named herein. See “Selling Stockholders” on page 8 of
this prospectus for more information on the selling
stockholders. |
|
|
Use
of proceeds |
We
will not receive any proceeds from the sale of the shares in this
offering. See “Use of Proceeds” beginning on page 7 of this
prospectus for additional information. |
|
|
Registration
Rights |
Under
the terms of the Registration Rights Agreement, we have agreed to
file this registration statement with respect to the registration
of the resale by the selling stockholders of the MIPA Shares. We
have agreed that, upon this registration statement being declared
effective, we will use our reasonable best efforts to maintain the
effectiveness of this registration statement until the earlier of
the selling shareholders have sold all of the MIPA Shares or the
MIPA Shares may be resold by the selling stockholders pursuant to
Rule 144 of the Securities Act, without the requirement for us to
be in compliance with the current public information required under
such Rule and without volume or manner-of-sale
restriction.
The selling
stockholders do not have any registration rights in connection with
the Warrants.
See
“Selling Stockholders” on page 8 of this prospectus for additional
information.
|
|
|
Plan
of Distribution |
The
selling stockholders named in this prospectus, or their pledgees,
donees, transferees, distributees, beneficiaries or other
successors-in-interest, may offer or sell the shares from time to
time through public or private transactions at prevailing market
prices, at prices related to prevailing market prices or at
privately negotiated prices. The selling stockholders may also
resell the shares of common stock to or through underwriters,
broker-dealers or agents, who may receive compensation in the form
of discounts, concessions or commissions. See “Plan of
Distribution” beginning on page 14 of this prospectus for
additional information on the methods of sale that may be used by
the selling stockholders. |
|
|
Risk
factors |
Investing
in our common stock involves a high degree of risk. You should
carefully read and consider the information beginning on page 4 of
this prospectus set forth under the heading “Risk Factors” and all
other information set forth in this prospectus, and the documents
incorporated herein and therein by reference before deciding to
invest in our common stock. |
|
|
NASDAQ
trading symbol for common stock |
“AKER” |
RISK FACTORS
An
investment in our securities involves a high degree of risk. Before
deciding whether to invest in our securities, you should consider
carefully the risk factors described below and specific risk
factors discussed under the heading “Risk Factors” in the
applicable prospectus supplement, together with all of the other
information contained or incorporated by reference in the
prospectus supplement or appearing or incorporated by reference in
this prospectus. You should also consider the risks, uncertainties
and assumptions discussed under Item 1A, “Risk Factors,” in our
Annual Report on Form 10-K for the fiscal year ended December 31,
2019, which is incorporated herein by reference, as updated or
superseded by the risks and uncertainties described under similar
headings in the other documents that are filed after the date
hereof and incorporated by reference into this prospectus and any
prospectus supplement related to a particular offering. The risks
and uncertainties we have described are not the only ones we face.
Additional risks and uncertainties not presently known to us or
that we currently deem immaterial may also affect our operations.
Past financial performance may not be a reliable indicator of
future performance, and historical trends should not be used to
anticipate results or trends in future periods. If any of these
risks actually occurs, our business, business prospects, financial
condition or results of operations could be seriously harmed. This
could cause the trading price of our common stock to decline,
resulting in a loss of all or part of your investment. Please also
read carefully the section below entitled “Cautionary Statement
Regarding Forward-Looking Statements.”
With regard to our contemplated coronavirus vaccine candidate, we
must conduct preclinical testing, prepare and submit an IND to the
FDA, and conduct all phases of clinical studies (which may include
postmarket or “Phase 4” studies), which will likely take several
years and substantial expenses to complete, before we can submit an
application for marketing approval to the FDA, and there is no
guarantee that we will complete such clinical development in a
timely manner or at all or that our BLA will be approved, if
submitted.
We
expect that a substantial portion of our efforts and expenditures
over the next few years will be devoted to our contemplated vaccine
candidate for coronavirus. Accordingly, our business currently
depends heavily on the successful development, FDA approval, and
commercialization of such candidate, which may never receive FDA
approval or be successfully commercialized even if FDA approval is
received. The research, testing, manufacturing, labeling, approval,
sale, marketing, and distribution of our contemplated vaccine
candidate are, and will remain, subject to extensive regulation by
the FDA and other regulatory authorities in the United States and
other countries, as applicable. We are not permitted to market our
tablet vaccines in the United States until we receive FDA approval
of our applicable BLA. To date, we have not-yet begun any
preclinical studies for the COVID-19 vaccine candidate, nor have we
prepared or submitted an IND. Accordingly, we have not submitted a
BLA to the FDA or comparable applications to other regulatory
authorities and do not expect to be in a position to do so for the
foreseeable future, as there are numerous developmental steps that
must be completed before we can prepare and submit a
BLA.
In
the United States, the FDA regulates pharmaceutical and biological
products (including vaccines and vaccine candidates, such as the
COVID-19 vaccine candidate currently in early stages of
development) under the Federal Food, Drug and Cosmetic Act and the
Public Health Service Act, as well as their respective implementing
regulations. Such products and product candidates are also subject
to other federal, state, and local statutes and regulations. The
process of obtaining regulatory approvals and the subsequent
compliance with appropriate federal, state, local, and foreign
statutes and regulations requires the expenditure of substantial
time and financial resources. The process required by the FDA
before a drug or biological product may be marketed in the United
States generally involves the following:
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completion
of preclinical laboratory tests and animal studies in accordance
with FDA’s good laboratory practices (“GLPs”) and applicable
requirements for the humane use of laboratory animals or other
applicable regulations; |
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submission
to the FDA of an IND, which must become effective before human
clinical trials in the United States may begin; |
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performance
of adequate and well-controlled human clinical trials in accordance
with FDA’s IND regulations, good clinical practices (“GCPs”), and
any additional requirements for the protection of human research
subjects and their health information, to establish the safety and
efficacy of the proposed biological product for its intended
use; |
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submission
to the FDA of a BLA for marketing approval that meets applicable
requirements to ensure the continued safety, purity, and potency of
the product that is the subject of the BLA based on results of
preclinical testing and clinical trials; |
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satisfactory
completion of an FDA inspection of the manufacturing facility or
facilities where the biological product is produced, to assess
compliance with current good manufacturing processes (“cGMPs”) and
assure that the facilities, methods and controls are adequate to
preserve the biological product’s identity, strength, quality and
purity; |
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potential
FDA audit of the nonclinical study and clinical trial sites that
generated the data in support of the BLA; and |
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FDA
review and approval, or denial, of the BLA. |
Before
testing any biological vaccine candidate, including our
contemplated vaccine candidate, in humans, the vaccine candidate
enters the preclinical testing stage. Preclinical tests include
laboratory evaluations of product chemistry, toxicity and
formulation, as well as animal studies to assess the potential
safety and activity of the vaccine candidate. The conduct of the
preclinical tests must comply with federal regulations and
requirements including GLPs. The clinical trial sponsor must submit
the results of the preclinical tests, together with manufacturing
information, analytical data, any available clinical data or
literature and a proposed clinical protocol, to the FDA as part of
the IND. Some preclinical testing may continue even after the IND
is submitted. The IND automatically becomes effective 30 days after
receipt by the FDA, unless the FDA raises concerns or questions
regarding the proposed clinical trials and places the trial on a
clinical hold within that 30-day time period. In such a case, the
IND sponsor and the FDA must resolve any outstanding concerns
before the clinical trial can begin. The FDA may also impose
clinical holds on a biological product candidate at any time before
or during clinical trials due to safety concerns or non-compliance.
If the FDA imposes a clinical hold, trials may not recommence
without FDA authorization and then only under terms authorized by
the FDA. Accordingly, we cannot be sure that submission of an IND
will result in the FDA allowing clinical trials to begin, or that,
once begun, issues will not arise that suspend or terminate such
trials.
Clinical
trials involve the administration of the biological product
candidate to healthy volunteers or patients under the supervision
of qualified investigators, generally physicians not employed by or
under the trial sponsor’s control. Clinical trials are conducted
under protocols detailing, among other things, the objectives of
the clinical trial, dosing procedures, subject selection and
exclusion criteria, and the parameters to be used to monitor
subject safety, including stopping rules that assure a clinical
trial will be stopped if certain adverse events should occur. Each
protocol and any amendments to the protocol must be submitted to
the FDA as part of the IND. Clinical trials must be conducted and
monitored in accordance with the FDA’s regulations composing the
GCP requirements, including the requirement that all research
subjects provide informed consent. Further, each clinical trial
must be reviewed and approved by an independent institutional
review board, or IRB, at or servicing each institution at which the
clinical trial will be conducted. An IRB is charged with protecting
the welfare and rights of trial participants and considers such
items as whether the risks to individuals participating in the
clinical trials are minimized and are reasonable in relation to
anticipated benefits. The IRB also approves the form and content of
the informed consent that must be signed by each clinical trial
subject or his or her legal representative and must monitor the
clinical trial until completed. Human clinical trials are typically
conducted in three sequential phases that may overlap or be
combined:
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Phase
1. The biological product is initially introduced into healthy
human subjects and tested for safety. In the case of some products
for severe or life-threatening diseases, especially when the
product may be too inherently toxic to ethically administer to
healthy volunteers, the initial human testing is often conducted in
subjects. |
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Phase
2. The biological product is evaluated in a limited patient
population to identify possible adverse effects and safety risks,
to preliminarily evaluate the efficacy of the product for specific
targeted diseases and to determine dosage tolerance, optimal dosage
and dosing schedule. |
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Phase
3. Clinical trials are undertaken to further evaluate dosage,
clinical efficacy, potency, and safety in an expanded patient
population at geographically dispersed clinical trial sites. These
clinical trials are intended to establish the overall risk to
benefit ratio of the product and provide an adequate basis for
product labeling. |
Post-approval
clinical trials, sometimes referred to as Phase 4 clinical trials,
may be conducted after initial marketing approval. These clinical
trials are used to gain additional experience from the treatment of
patients in the intended therapeutic indication, particularly for
long-term safety follow-up.
After
the completion of clinical trials of a biological product, FDA
approval of a BLA must be obtained before commercial marketing of
the biological product. The BLA must include results of product
development, laboratory and animal studies, human trials,
information on the manufacture and composition of the product,
proposed labeling and other relevant information. The FDA may grant
deferrals for submission of data, or full or partial waivers. The
testing and approval processes require substantial time and effort
and there can be no assurance that the FDA will accept the BLA for
filing and, even if filed, that any approval will be granted on a
timely basis, if at all. Before approving a BLA, the FDA will
inspect the facilities at which the product is manufactured. The
FDA will not approve the product unless it determines that the
manufacturing processes and facilities are in compliance with cGMP
requirements and adequate to assure consistent production of the
product within required specifications. Additionally, before
approving a BLA, the FDA will typically inspect one or more
clinical sites to assure that the clinical trials were conducted in
compliance with IND trial requirements and GCP requirements. To
assure cGMP and GCP compliance, an applicant must incur significant
expenditure of time, money and effort in the areas of training,
record keeping, production, and quality control.
Notwithstanding
the submission of relevant data and information, the FDA may
ultimately decide that the BLA does not satisfy its regulatory
criteria for approval and deny approval. Data obtained from
clinical trials are not always conclusive and the FDA may interpret
data differently than we interpret the same data. Our vaccine
candidate is in the earliest stages of clinical development and,
therefore, a long way from BLA submission. We cannot predict with
any certainty if or when we might submit a BLA for regulatory
approval for our vaccine candidate or whether any such BLA will be
approved by the FDA. Human clinical trials are very expensive and
difficult to design and implement, in part because they are subject
to rigorous regulatory requirements. For example, the FDA may not
agree with our proposed endpoints for any clinical trial we
propose, which may delay the commencement of our clinical trials.
The clinical trial process is also lengthy and requires substantial
time and effort. We estimate that the clinical trials we need to
conduct to be in a position to submit a BLA for our vaccine
candidate for coronavirus will take several years to complete.
Furthermore, failure can occur at any stage of the trials, and we
could encounter problems that cause us to abandon or repeat
clinical trials. Also, the results of early preclinical and
clinical testing of the COVID-19 vaccine candidate may not be
predictive of the results of subsequent clinical trials. A number
of companies in the biopharmaceutical industry have suffered
significant setbacks in advanced clinical trials due to lack of
efficacy or adverse safety profiles, notwithstanding promising
results in earlier studies. Moreover, preclinical and clinical data
are often susceptible to multiple interpretations and analyses.
Many companies that have believed their vaccine candidates
performed satisfactorily in preclinical studies and clinical trials
have, nonetheless, failed to obtain marketing approval of their
products. Success in preclinical testing and early clinical trials
does not ensure that later clinical trials, which involve many more
subjects, and the results of later clinical trials may not
replicate the results of prior clinical trials and preclinical
testing. Any failure or substantial delay in our vaccine
development plans may have a material adverse effect on our
business.
We may opt to conduct future clinical studies for our contemplated
vaccine candidate outside the United States, which could heighten
the risk of delay and/or failure, as the FDA may not accept data
from such studies in support of any BLA we may submit after
completing the applicable developmental and regulatory
prerequisites, if ever.
We
are still in the earliest stages of development with respect to our
contemplated coronavirus vaccine candidate and may ultimately
decide to conduct preclinical and/or clinical studies in one or
more countries outside the United States. Although the FDA may
accept data from clinical trials conducted outside the United
States that are not conducted under an IND, the FDA’s acceptance of
such data is subject to certain conditions. For example, the
clinical trial must be well designed and conducted and performed by
qualified investigators in accordance with ethical principles and
all applicable FDA regulations. The trial population must also
adequately represent the intended U.S. population, and the data
must be applicable to the U.S. population and U.S. medical practice
in ways that the FDA deems clinically meaningful. In general, the
patient population for any clinical trials conducted outside of the
United States must be representative of the population for whom we
intend to market the vaccine candidate in the United States, if
approved. In addition, while these clinical trials are subject to
the applicable local laws, FDA acceptance of the data will be
dependent upon its ability to verify the data and its determination
that the trials also complied with all applicable U.S. laws and
regulations. We cannot guarantee that the FDA will accept data from
trials we conduct outside of the United States, if any. If the FDA
does not accept the data from such clinical trials, it would likely
result in the need for additional trials and the completion of
additional regulatory steps, which would be costly and
time-consuming and could delay or permanently halt our development
of the contemplated candidate.
USE OF PROCEEDS
We
will not receive any proceeds from the sale of shares of our common
stock by the selling stockholders. However, we will receive
proceeds from the exercise of the Warrants if such warrants are
exercised for cash. We intend to use those proceeds, if any, for
working capital and general corporate purposes.
SELLING STOCKHOLDERS
Up to
793,437 shares of our common stock are currently being offered by
the selling stockholders.
Cystron
Acquisition
Membership
Interest Purchase Agreement
On
March 23, 2020, the Company entered into the Original MIPA with the
Sellers, pursuant to which the Company acquired the Membership
Interests of Cystron. As consideration for the Membership
Interests, we delivered to the Sellers: (1) that number of newly
issued shares of our common stock equal to 19.9% of the issued and
outstanding shares of our common stock and pre-funded warrants as
of the date of the Original MIPA, but, to the extent that the
issuance of our common stock would have resulted in any Seller
owning in excess of 4.9% of our outstanding common stock, then, at
such Seller’s election, such Seller received “common stock
equivalent” preferred shares with a customary 4.9% beneficial
ownership blocker (with such common stock and preferred stock
collectively referred to as “Common Stock Consideration”), and (2)
$1,000,000 in cash. On March 24, 2020, we delivered 411,403 shares
of common stock and 211,353 shares of Preferred Stock with a
customary 4.9% blocker. On April 22, 2020, Premas, one of the
sellers of Cystron, returned to us $299,074, representing its
portion of the cash purchase price to acquire Cystron. Premas has
advised us that these funds were returned temporarily in order for
Premas to meet certain regulatory requirements in India.
Additionally,
we are required to (A) make an initial payment to the Sellers of up
to $1,000,000 upon our receipt of cumulative gross proceeds from
the consummation of an initial equity offering after the date of
the Original MIPA of $8,000,000, and (B) pay to Sellers an amount
in cash equal to 10% of the gross proceeds in excess of $8,000,000
raised from future equity offerings after the date of the Original
MIPA until the Sellers have received an aggregate additional cash
consideration equal to $10,000,000 (collectively, the “Equity
Offering Payments”). On May 14, 2020, we and the Sellers entered
into an Amendment No. 1 to the Original MIPA (as amended, the
“MIPA”), which provided that any Equity Offering Payments in
respect of an equity offering that is consummated prior to
September 23, 2020, shall be accrued, but shall not be due and
payable until September 24, 2020. The other provisions of the
Original MIPA remain unmodified and in full force and effect. Upon
the achievement of certain milestones, including the completion of
a Phase 2 study for a COVID-19 vaccine that meets its primary
endpoints, Sellers will be entitled to receive an additional
750,000 shares of our common stock or, in the event we are unable
to obtain stockholder approval for the issuance of such shares,
750,000 shares of non-voting preferred stock that are valued
following the achievement of such milestones and shall bear a 10%
annual dividend (the “Milestone Shares”). Sellers will also be
entitled to contingent payments from us of up to $20,750,000 upon
the achievement of certain milestones, including the approval of a
new drug application by the FDA. Pursuant to the Original MIPA,
upon the Company’s consummation of the registered direct equity
offering closed on April 8, 2020 (as discussed further below, the
“April 2020 Offering”), we paid the Sellers $250,000 on April 20,
2020. On April 30, 2020, Premas, one of the Sellers, returned to us
$83,334, representing their portion of the $250,000 amount paid to
the Sellers on April 20, 2020. Premas has advised us that these
funds were returned temporarily in order for Premas to meet certain
regulatory requirements in India. In addition, the Company’s
consummation of the registered direct equity offering closed on May
18, 2020 (as discussed further below, the “May 2020 Offering”)
triggered an accrued payment to the Sellers of approximately
$892,500 pursuant to the MIPA, which will be due and payable on
September 24, 2020.
We
shall also make quarterly royalty payments to Sellers equal to 5%
of the net sales of a COVID-19 vaccine or combination product by
the Company (the “COVID-19 Vaccine”) for a period of five (5) years
following the first commercial sale of the COVID-19 Vaccine,
provided that such payment shall be reduced to 3% for any net sales
of the COVID-19 Vaccine above $500 million.
In
addition, Sellers shall be entitled to receive 12.5% of the
transaction value, as defined in the MIPA, of any change of control
transaction, as defined in the MIPA, that occurs prior to the fifth
(5th) anniversary of the closing date of the MIPA, provided that
the Company is still developing the COVID-19 Vaccine at that time.
Following the consummation of any change of control transaction,
the Sellers shall not be entitled to any payments as described
above under the MIPA.
Support
Agreement
On
March 23, 2020, as an inducement to enter into the MIPA, and as one
of the conditions to the consummation of the transactions
contemplated by the MIPA, the Sellers entered into a shareholder
voting agreement with us, pursuant to which each Seller agreed to
vote their shares of our common stock or preferred stock in favor
of each matter proposed and recommended for approval by our
management at every meeting of the stockholders and on any action
or approval by written consent of the stockholders.
License
Agreement
Cystron
is a party to a License and Development Agreement (the “Initial
License Agreement”) with Premas. As a condition to the Company’s
entry into the MIPA, Cystron amended and restated the Initial
License Agreement on March 19, 2020 (as amended and restated, the
“License Agreement”). Pursuant to the License Agreement, Premas
granted Cystron, among other things, an exclusive license with
respect to Premas’ vaccine platform for the development of a
vaccine against COVID-19 and other coronavirus
infections.
Upon
the achievement of certain developmental milestones by Cystron,
Cystron shall pay to Premas a total of up to $2,000,000. On April
16, 2020, we paid Premas $500,000 for the achievement of the first
two development milestones, of which $250,000 was accrued as
research and development expense for the three months ended March
31, 2020. On May 14, 2020, we and Premas agreed that the third
milestone under the License Agreement has been satisfied. Due to
the achievement of this milestone, Premas is entitled to receive a
payment of $500,000 from us.
Registration
Rights Agreement
To
induce the Sellers to enter into the MIPA, we also entered into the
Registration Rights Agreement with the Sellers, pursuant to which
we agreed to prepare and file with the SEC a registration statement
covering all of the shares of our common stock issued and shares of
our common stock issuable upon conversion of the Preferred Stock
issued as Common Stock Consideration pursuant to the MIPA and use
reasonable best efforts to have such registration statement and any
amendments thereof declared effective by the SEC at the earliest
possible date.
We
have also agreed to use reasonable best efforts to keep such
registration statement effective until earlier of the selling
shareholders have sold all of the share of common stock offered
hereby or the shares of common stock covered thereby may be resold
by the selling stockholders pursuant to Rule 144 of the Securities
Act without any public information requirements or volume or manner
of sale limitations.
Pursuant
to the Registration Rights Agreement, we are registering the shares
of common stock in order to permit the selling stockholders to
offer the shares for resale from time to time pursuant to this
prospectus. The selling stockholders may also sell, transfer or
otherwise dispose of all or a portion of their shares in
transactions exempt from the registration requirements of the
Securities Act, or pursuant to another effective registration
statement covering those shares.
Terms
of the Series D Convertible Preferred Stock
On
March 24, 2020, we filed the Certificate of Designation of
Preferences, Rights and Limitations of Series D Convertible
Preferred Stock (the “Certificate of Designation”) with the
Secretary of State of the State of New Jersey. Pursuant to the
Certificate of Designation, in the event of the Company’s
liquidation or winding up of its affairs, the holders of our
Preferred Stock will be entitled to receive the same amount that a
holder of our common stock would receive if the Preferred Stock
were fully converted (disregarding for such purposes any conversion
limitations set forth in the Certificate of Designation) to common
stock which amounts shall be paid pari passu with all holders of
the Company’s common stock. Each share of Preferred Stock has a
stated value equal to $0.01 (the “Stated Value”), subject to
increase as set forth in Section 7 of the Certificate of
Designation.
A
holder of Preferred Stock is entitled at any time to convert any
whole or partial number of shares of Preferred Stock into shares of
our common stock determined by dividing the Stated Value of the
Preferred Stock being converted by the conversion price of $0.01
per share.
A holder of
Preferred Stock will be prohibited from converting Preferred Stock
into shares of our common stock if, as a result of such conversion,
the holder, together with its affiliates, would own more than 4.99%
of the total number of shares of our common stock then issued and
outstanding (with such ownership restriction referred to as the
“Beneficial Ownership Limitation”). However, any holder may
increase or decrease such percentage to any other percentage not in
excess of 9.99%, provided that any increase in such percentage
shall not be effective until 61 days after such notice to us. In
addition, a holder of Preferred Stock will be prohibited from
converting any portion of the Preferred Stock if, as a result of
such conversion, the holder, together with its affiliates, would
exceed the aggregate number shares of our common stock which we may
issue under the MIPA without breaching our obligations under the
rules or regulations of NASDAQ (the number of shares which may be
issued without violating such rules and regulations, the “Exchange
Cap”).
Subject
to the Beneficial Ownership Limitation, on any matter presented to
our stockholders for their action or consideration at any meeting
of our stockholders (or by written consent of stockholders in lieu
of a meeting), each holder of Preferred Stock will be entitled to
cast the number of votes equal to the number of whole shares of our
common stock into which the shares of Preferred Stock beneficially
owned by such holder are convertible as of the record date for
determining stockholders entitled to vote on or consent to such
matter (taking into account all Preferred Stock beneficially owned
by such holder). Except as otherwise required by law or by the
other provisions of our certificate of incorporation, the holders
of Preferred Stock will vote together with the holders of our
common stock and any other class or series of stock entitled to
vote thereon as a single class.
A
holder of Preferred Stock shall be entitled to receive dividends as
and when paid to the holders of our common stock on an as-converted
basis.
Terms
of the Warrants
April
2020 Offering and the April Warrants
In
the April 2020 Offering, pursuant to a securities purchase
agreement with certain institutional and accredited investors,
dated April 7, 2020, we issued and sold an aggregate of 766,667
shares of our common stock at an offering price of $6.00 per share,
for gross and net proceeds of $4,600,002 and $4,146,102,
respectively. Upon closing of the offering as partial compensation
to our placement agent, we issued to the placement agent’s
designees the April Warrants to purchase up to 61,333 shares of
common stock at an exercise price of $7.50, subject to certain
adjustments as set forth in the April Warrants. The April Warrants
are exercisable at any time and from time to time, in whole or in
part, following the date of issuance and expire on April 7,
2025.
Each
holder of the April Warrants is prohibited from exercising the
April Warrants if, as a result of such conversion, any such holder,
together with its affiliates, would own more than 4.99% of the
total number of shares of our common stock then issued and
outstanding. This limitation may be increased or decreased, but in
no event exceed 9.99%, with respect to a holder upon such holder’s
provision of not less than 61 days’ prior written notice to us. If
at any time of exercise of the April Warrants, there is no
effective registration statement under the Securities Act
registering the resale of the common stock underlying the April
Warrants by the selling stockholders, then the April Warrants may
also be exercised, in whole or in part, by means of a cashless
exercise.
Pursuant
to Rule 5110(g) of the Financial Industry Regulatory Authority, or
FINRA, the warrants issued to the placement agent (or its
designees) and any shares issued upon exercise thereof will not be
sold, transferred, assigned, pledged or hypothecated, or be the
subject of any hedging, short sale, derivative, put or call
transaction that would result in the effective economic disposition
of the securities by any person, for a period of 180 days
immediately following the date of effectiveness or commencement of
sales in the offering, except: (i) the transfer of any security by
operation of law or by reason of our reorganization; (ii) the
transfer of any security to any FINRA member firm participating in
the offering and the officers or partners thereof, if all
securities so transferred remain subject to the lock-up restriction
set forth above for the remainder of the time period; (iii) the
transfer of any security if the aggregate amount of our securities
held by the placement agent or related persons do not exceed 1% of
the securities being offered; (iv) the transfer of any security
that is beneficially owned on a pro-rata basis by all equity owners
of an investment fund, provided that no participating member
manages or otherwise directs investments by the fund and the
participating members in the aggregate do not own more than 10% of
the equity in the fund; or (v) the exercise or conversion of any
security, if all securities remain subject to the lock-up
restriction set forth above for the remainder of the time
period.
May 2020
Offering and the May Warrants
In
the May 2020 Offering, pursuant to a securities purchase agreement
with certain institutional and accredited investors, dated May 14,
2020, we issued and sold an aggregate of 1,366,856 shares of our
common stock at an offering price of $3.53 per share, for gross and
net proceeds of $4.825 million and $4.3 million, respectively,
which closed on May 18, 2020. Upon closing of the offering as
partial compensation to our placement agent, we issued to the
placement agent’s designees the May Warrants to purchase up to
109,348 shares of common stock at an exercise price of $4.4125,
subject to certain adjustments as set forth in the May Warrants.
The May Warrants are exercisable at any time and from time to time,
in whole or in part, following the date of issuance and expires on
May 14, 2025.
Each
holder of the May Warrants is prohibited from exercising the May
Warrants if, as a result of such conversion, any such holder,
together with its affiliates, would own more than 4.99% of the
total number of shares of our common stock then issued and
outstanding. This limitation may be increased or decreased, but in
no event exceed 9.99%, with respect to a holder upon such holder’s
provision of not less than 61 days’ prior written notice to us. If
at any time of exercise of the May Warrants, there is no effective
registration statement under the Securities Act registering the
resale of the common stock underlying the May Warrants by the
selling stockholders, then the warrants may also be exercised, in
whole or in part, by means of a cashless exercise.
Pursuant
to Rule 5110(g) of the Financial Industry Regulatory Authority, or
FINRA, the warrants issued to the placement agent (or its
designees) and any shares issued upon exercise thereof will not be
sold, transferred, assigned, pledged or hypothecated, or be the
subject of any hedging, short sale, derivative, put or call
transaction that would result in the effective economic disposition
of the securities by any person, for a period of 180 days
immediately following the date of effectiveness or commencement of
sales in the offering, except: (i) the transfer of any security by
operation of law or by reason of our reorganization; (ii) the
transfer of any security to any FINRA member firm participating in
the offering and the officers or partners thereof, if all
securities so transferred remain subject to the lock-up restriction
set forth above for the remainder of the time period; (iii) the
transfer of any security if the aggregate amount of our securities
held by the placement agent or related persons do not exceed 1% of
the securities being offered; (iv) the transfer of any security
that is beneficially owned on a pro-rata basis by all equity owners
of an investment fund, provided that no participating member
manages or otherwise directs investments by the fund and the
participating members in the aggregate do not own more than 10% of
the equity in the fund; or (v) the exercise or conversion of any
security, if all securities remain subject to the lock-up
restriction set forth above for the remainder of the time
period.
Relationship
with the Selling Stockholders
Each
of Noam Rubinstein, Charles Worthman, Michael Vasinkevich and Craig
Schwabe are affiliated with H.C. Wainwright & Co., LLC, which
served as our placement agent for our public offering we
consummated in December 2019 (the “December 2019 Offering”), the
April 2020 Offering and the May 2020 Offering for which it received
compensation.
In
addition, approximately one-third of Cystron was owned by two
entities, each of which is controlled by an associated person of
H.C. Wainwright & Co., LLC (the “Associated Persons”). Pursuant
to the MIPA, as consideration for the Membership Interests
purchased from the Associated Persons, the Associated Persons were
paid approximately one-third of the consideration paid at closing
and are entitled to the same percentage of any future consideration
under the MIPA. Upon closing of the acquisition of Cystron, we
delivered to the Associated Persons, collectively: (x) 142,259
shares of our common stock and 65,369 shares of Preferred Stock,
and (y) approximately $333,333. In connection with the April 2020
Offering, the Associated Persons received approximately $83,333
pursuant to the Original MIPA. The closing of the May 2020 Offering
triggered an accrued payment to the Associated Persons of
approximately $297,500 pursuant to the MIPA, which will be due and
payable on September 24, 2020.
The
selling stockholders have not had any material relationship with us
within the past three years other than as described
above.
Information About
Selling Stockholder Offering
The
following table sets forth the number and percentage of our common
stock beneficially owned by the selling stockholders as of June 4,
2020, taking into account number of shares that may be offered
under this prospectus and the number and percentage of our common
stock beneficially owned by the selling stockholders assuming all
of the shares covered hereby are sold. Beneficial ownership is
determined in accordance with the rules of the SEC and includes
voting or investment power with respect to our common stock.
Generally, a person “beneficially owns” shares of our common stock
if the person has or shares with others the right to vote those
shares or to dispose of them, or if the person has the right to
acquire voting or disposition rights within 60 days.
The
information in the table below and the footnotes thereto regarding
shares of common stock to be beneficially owned after the offering
assumes that the selling stockholders have, as applicable, (i)
converted the Preferred Stock in full, without giving effect to the
4.99% beneficial ownership limitation and the Exchange Cap as
applicable for the conversion of the Preferred Stock into common
stock as set forth in Certificate of Designation and (ii) exercised
the Warrants in full for cash, without giving effect to the 4.99%
beneficial ownership limitation as set forth in the Warrants. The
information in the table below and the footnotes thereto further
assumes the sale of all shares being offered by the selling
stockholders under this prospectus.
The
percentage of shares owned prior to and after the offering is based
on 6,122,263 shares of common stock outstanding as of June 4, 2020,
and, with respect to the percentage of shares owned after the
offering, on the assumption that the selling stockholder has, as
applicable, (i) converted such selling stockholder’s Preferred
Stock in full, and therefore that all shares of common stock
issuable upon conversion of such selling stockholder’s Preferred
Stock were outstanding as of that date or (ii) exercised such
selling stockholder’s Warrants in full, and therefore that all
shares of common stock issuable upon exercise of such selling
stockholder’s Warrants were outstanding as of that date. Unless
otherwise indicated in the footnotes to this table, we believe that
the selling stockholders have sole voting and investment power with
respect to the shares of common stock indicated as beneficially
owned.
As
used in this prospectus, the term “selling stockholders” includes
the selling stockholders set forth below and any donees, pledgees,
transferees or other successors-in-interest selling shares of
common stock received after the date of this prospectus from the
selling stockholders as a gift, pledge, or other non-sale related
transfer.
The
number of shares in the column “Number of Shares Offered”
represents all of the shares of common stock that a selling
stockholder may offer under this prospectus. Under the terms of the
Preferred Stock, a selling stockholder may not convert the
Preferred Stock to the extent such conversion would cause such
selling stockholder, together with its affiliates, to beneficially
own a number of shares of common stock which would exceed 4.99% of
our then outstanding shares of common stock following such
conversion. However, any holder may increase or decrease such
percentage to any other percentage not in excess of 9.99%, provided
that any increase in such percentage shall not be effective until
61 days after such notice to the Company. The number of shares in
the second column does not reflect these limitations nor the
Exchange Cap. Under the terms of the Warrants, a selling
stockholder may not exercise the Warrant to the extent such
exercise would cause such selling stockholder, together with its
affiliates, to beneficially own a number of shares of common stock
which would exceed 4.99% of our then outstanding and issued shares
of common stock following such exercise. However, any holder may
increase or decrease such percentage to any other percentage not in
excess of 9.99%, provided that any increase in such percentage
shall not be effective until 61 days after such notice to the
Company. The number of shares in the second column does not reflect
these limitations. The third and fourth column assumes the sale of
all of the shares offered by each selling stockholder pursuant to
this prospectus and that the selling stockholder does not acquire
any additional shares of common stock before the completion of this
offering. However, because the selling stockholders may sell all or
some of its shares under this prospectus from time to time, or in
another permitted manner, we cannot assure you as to the actual
number of shares that will be sold by the selling stockholders or
that will be held by the selling stockholders after completion of
any sales. The selling stockholders may sell some, all or none of
their shares in this offering. We do not know how long the selling
stockholders will hold the shares before selling them, and we
currently have no agreements, arrangements or understandings with
the selling stockholders regarding the sale of any of the
shares.
|
|
Ownership Before Offering |
|
|
Ownership After Offering |
|
Selling Stockholders |
|
Number of shares of common stock beneficially owned |
|
|
Number of shares offered |
|
|
Number of shares of common stock beneficially owned |
|
|
Percentage of common stock beneficially owned |
|
Nadav Kidron |
|
|
207,564 |
(1) |
|
|
207,564 |
(1) |
|
|
— |
|
|
|
— |
|
Premas Biotech PVT Ltd. (2) |
|
|
207,564 |
(3) |
|
|
207,564 |
(3) |
|
|
— |
|
|
|
— |
|
Noam Rubinstein |
|
|
103,913 |
(4) |
|
|
53,765 |
(5) |
|
|
50,148 |
|
|
|
* |
|
Charles Worthman |
|
|
3,298 |
(6) |
|
|
1,706 |
(7) |
|
|
1,592 |
|
|
|
* |
|
Michael Vasinkevich |
|
|
409,299 |
(8) |
|
|
306,615 |
(9) |
|
|
102,684 |
|
|
|
1.61 |
% |
Craig Schwabe |
|
|
16,223 |
(10) |
|
|
16,223 |
(10) |
|
|
— |
|
|
|
— |
|
*
Less than 1%
(1)
Includes 72,992 shares of common stock issuable upon conversion of
Series D Preferred Stock.
(2)
Prabuddha Kundu has sole voting and dispositive power over the
securities held for the account of this selling
stockholder.
(3)
Includes 72,992 shares of common stock issuable upon conversion of
Series D Preferred Stock.
(4)
Represents (i) 50,148 shares of common stock issuable upon exercise
of warrants issued as the placement agent’s designee in connection
with the December 2019 Offering, (ii) 19,320 shares of common stock
issuable upon exercise of the April Warrants and (iii) 34,445
shares of common stock issuable upon exercise of the May
Warrants.
(5)
Consists of 19,320 shares of common stock issuable upon exercise of
the April Warrants and 34,445 shares of common stock issuable upon
exercise of the May Warrants.
(6)
Represents (i) 1,592 shares of common stock issuable upon exercise
of warrants issued in connection with the December 2019 Offering,
(ii) 613 shares of common stock issuable upon exercise of the April
Warrants and (iii) 1,093 shares of common stock issuable upon
exercise of the May Warrants.
(7)
Consists of 613 shares of common stock issuable upon exercise of
the April Warrants and 1,093 shares of common stock issuable upon
exercise of the May Warrants.
(8)
Represents (i) 102,684 shares of common stock issuable upon
exercise of warrants issued in connection with the December 2019
Offering, (ii) 39,330 shares of common stock issuable upon exercise
of the April Warrants, (iii) 70,120 shares of common stock issuable
upon exercise of the May Warrants and (iv) 134,572 shares of common
stock and 62,593 shares of common stock issuable upon conversion of
Series D Preferred Stock issued to Cutter Mill Capital LLC pursuant
to the MIPA. Mr. Vasinkevich has sole voting and dispositive power
over the securities held by Cutter Mill Capital LLC and is deemed
to have beneficial ownership of the shares held by Cutter Mill
Capital LLC.
(9)
Consists of 39,330 shares of common stock issuable upon exercise of
the April Warrants, 70,120 shares of common stock issuable upon
exercise of the May Warrants and 134,572 shares of common stock and
62,593 shares of common stock issuable upon conversion of Series D
Preferred Stock issued to Cutter Mill Capital LLC pursuant to the
MIPA.
(10)
Represents (i) 2,070 shares of common stock issuable upon exercise
of the April Warrants, (ii) 3,690 shares of common stock issuable
upon exercise of the May Warrants and (iii) 7,687 shares of common
stock and 2,776 shares of common stock issuable upon conversion of
Series D Preferred Stock issued to Run Ridge LLC. Mr. Schwabe has
sole voting and dispositive power over the securities held by Run
Ridge LLC and is deemed to have beneficial ownership of the shares
held by Run Ridge LLC.
PLAN OF
DISTRIBUTION
We
are registering the shares of common stock to permit the resale of
these shares of common stock by the selling shareholders from time
to time after the date of this prospectus. We will not receive any
of the proceeds from the sale by the selling shareholders of the
shares of common stock. We will bear all fees and expenses incident
to our obligation to register the shares of common
stock.
The
selling shareholders may sell all or a portion of the shares of
common stock beneficially owned by them and offered hereby from
time to time directly or through one or more underwriters,
broker-dealers or agents. If the shares of common stock are sold
through underwriters or broker-dealers, the selling shareholders
will be responsible for underwriting discounts or commissions or
agent’s commissions. The shares of common stock may be sold in one
or more transactions at fixed prices, at prevailing market prices
at the time of the sale, at varying prices determined at the time
of sale, or at negotiated prices. These sales may be effected in
transactions, which may involve crosses or block
transactions,
● |
on
any national securities exchange or quotation service on which the
securities may be listed or quoted at the time of sale; |
|
|
● |
in
the over-the-counter market; |
|
|
● |
in
transactions otherwise than on these exchanges or systems or in the
over-the-counter market; |
|
|
● |
through
the writing of options, whether such options are listed on an
options exchange or otherwise; |
|
|
● |
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers; |
|
|
● |
block
trades in which the broker-dealer will attempt to sell the shares
as agent but may position and resell a portion of the block as
principal to facilitate the transaction; |
|
|
● |
purchases
by a broker-dealer as principal and resale by the broker-dealer for
its account; |
|
|
● |
an
exchange distribution in accordance with the rules of the
applicable exchange; |
|
|
● |
privately
negotiated transactions; |
|
|
● |
short
sales; |
|
|
● |
sales
pursuant to Rule 144; |
|
|
● |
broker-dealers
may agree with the selling security holders to sell a specified
number of such shares at a stipulated price per share; |
|
|
● |
a
combination of any such methods of sale; and |
|
|
● |
any
other method permitted pursuant to applicable law. |
If
the selling shareholders effect such transactions by selling shares
of common stock to or through underwriters, broker-dealers or
agents, such underwriters, broker-dealers or agents may receive
commissions in the form of discounts, concessions or commissions
from the selling shareholders or commissions from purchasers of the
shares of common stock for whom they may act as agent or to whom
they may sell as principal (which discounts, concessions or
commissions as to particular underwriters, broker-dealers or agents
may be in excess of those customary in the types of transactions
involved). In connection with sales of the shares of common stock
or otherwise, the selling shareholders may enter into hedging
transactions with broker-dealers, which may in turn engage in short
sales of the shares of common stock in the course of hedging in
positions they assume. The selling shareholders may also sell
shares common stock short and deliver shares of common stock
covered by this prospectus to close out short positions and to
return borrowed shares in connection with such short sales. The
selling shareholders may also loan or pledge shares of common stock
to broker-dealers that in turn may sell such shares.
The
selling shareholders may pledge or grant a security interest in
some or all of the shares of common stock owned by them and, if
they default in the performance of their secured obligations, the
pledgees or secured parties may offer and sell the shares of common
stock from time to time pursuant to this prospectus or any
amendment to this prospectus under Rule 424(b)(3) or other
applicable provision of the Securities Act, amending, if necessary,
the list of selling shareholders to include the pledgee, transferee
or other successors in interest as selling shareholders under this
prospectus. The selling shareholders also may transfer and donate
the shares of common stock in other circumstances in which case the
transferees, donees, pledgees or other successors in interest will
be the selling beneficial owners for purposes of this
prospectus.
The
selling shareholders and any broker-dealer participating in the
distribution of the shares of common stock may be deemed to be
“underwriters” within the meaning of the Securities Act, and any
commission paid, or any discounts or concessions allowed to, any
such broker-dealer may be deemed to be underwriting commissions or
discounts under the Securities Act. At the time a particular
offering of the shares of common stock is made, a prospectus
supplement, if required, will be distributed which will set forth
the aggregate amount of shares of common stock being offered and
the terms of the offering, including the name or names of any
broker-dealers or agents, any discounts, commissions and other
terms constituting compensation from the selling shareholders and
any discounts, commissions or concessions allowed or reallowed or
paid to broker-dealers.
Under the
securities laws of some states, the shares of common stock may be
sold in such states only through registered or licensed brokers or
dealers. In addition, in some states the shares of common stock may
not be sold unless such shares have been registered or qualified
for sale in such state or an exemption from registration or
qualification is available and is complied with.
There
can be no assurance that any selling shareholder will sell any or
all of the shares of common stock registered pursuant to the shelf
registration statement, of which this prospectus forms a
part.
The
selling shareholders and any other person participating in such
distribution will be subject to applicable provisions of the
Exchange Act, and the rules and regulations thereunder, including,
without limitation, Regulation M of the Exchange Act, which may
limit the timing of purchases and sales of any of the shares of
common stock by the selling shareholders and any other
participating person. Regulation M may also restrict the ability of
any person engaged in the distribution of the shares of common
stock to engage in market-making activities with respect to the
shares of common stock. All of the foregoing may affect the
marketability of the shares of common stock and the ability of any
person or entity to engage in market-making activities with respect
to the shares of common stock.
We
will pay all expenses of the registration of the shares of common
stock pursuant to the registration rights agreement, estimated to
be $10,000 in total, including, without limitation, SEC filing fees
and expenses of compliance with state securities or “blue sky”
laws; provided, however, that a selling shareholder will pay all
underwriting discounts and selling commissions, if any. We will
indemnify the selling shareholders against liabilities, including
some liabilities under the Securities Act, in accordance with the
registration rights agreements, or the selling shareholders will be
entitled to contribution. We may be indemnified by the selling
shareholders against civil liabilities, including liabilities under
the Securities Act, that may arise from any written information
furnished to us by the selling shareholder specifically for use in
this prospectus, in accordance with the related registration rights
agreement, or we may be entitled to contribution.
Once
sold under the shelf registration statement, of which this
prospectus forms a part, the shares of common stock will be freely
tradable in the hands of persons other than our
affiliates.
LEGAL
MATTERS
The
validity of the securities offered by this prospectus will be
passed upon for us by Haynes and Boone, LLP, New York, New
York.
EXPERTS
Morison
Cogen LLP, independent registered public accounting firm, has
audited our consolidated financial statements included in our
Annual Report on Form 10-K for the year ended December 31, 2019, as
filed on March 24, 2020, as set forth in their report which is
incorporated by reference in this prospectus and elsewhere in the
registration statement. Our consolidated financial statements are
incorporated by reference in reliance on Morison Cogen LLP’s
report, given on their authority as experts in accounting and
auditing.
WHERE YOU CAN FIND ADDITIONAL
INFORMATION
We
are subject to the informational requirements of the Exchange Act,
and in accordance therewith file annual, quarterly and current
reports, proxy statements and other information with the SEC. 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 SEC’s
website is www.sec.gov.
We
make available free of charge on or through our website at
www.akersbio.com, 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 Exchange Act, as soon as reasonably practicable after we
electronically file such material with or otherwise furnish it to
the SEC.
We
have filed with the SEC a registration statement under the
Securities Act of 1933, as amended, relating to the offering of
these securities. The registration statement, including the
attached exhibits, contains additional relevant information about
us and the securities. This prospectus does not contain all of the
information set forth in the registration statement. You can obtain
a copy of the registration statement for free at www.sec.gov. The
registration statement and the documents referred to below under
“Incorporation of Documents By Reference” are also available on our
website, www.akersbio.com.
We
have not incorporated by reference into this prospectus the
information on our website, and you should not consider it to be a
part of this prospectus.
INCORPORATION OF DOCUMENTS BY
REFERENCE
We
are “incorporating by reference” in this prospectus certain
documents we file with the SEC, which means that we can disclose
important information to you by referring you to those documents.
The information in the documents incorporated by reference is
considered to be part of this prospectus. Statements contained in
documents that we file with the SEC and that are incorporated by
reference in this prospectus will automatically update and
supersede information contained in this prospectus, including
information in previously filed documents or reports that have been
incorporated by reference in this prospectus, to the extent the new
information differs from or is inconsistent with the old
information. We have filed or may file the following documents with
the SEC and they are incorporated herein by reference as of their
respective dates of filing.
|
1. |
Our
Annual Report on Form 10-K for the year ended December 31, 2019,
filed with the SEC on March 24, 2020; |
|
2. |
Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2020,
filed with the SEC on May 15, 2020; and |
|
3. |
Our
Current Reports on Form 8-K filed with the SEC on January 6, 2020,
January 31, 2020, March 24, 2020, April 7, 2020, April 8, 2020,
April 14, 2020, April 17, 2020, May 14, 2020, May 15, 2020, May 18
and May 19, 2020 (other than any portions thereof deemed furnished
and not filed); and |
|
4. |
The
description of our common stock contained in our Registration
Statement on Form 8-A, filed on January 17, 2014 pursuant to
Section 12(b) of the Exchange Act, which incorporates by reference
the description of the shares of our common stock contained in the
section entitled “Description of Securities” in our Registration
Statement on Form S-1 (File No. 333-190456), as initially filed
with the SEC on August 7, 2013, as amended, and any amendment or
report filed with the SEC for purposes of updating such
description. |
All
documents that we filed with the SEC pursuant to Sections 13(a),
13(c), 14, and 15(d) of the Exchange Act subsequent to the date of
this registration statement and prior to the filing of a
post-effective amendment to this registration statement that
indicates that all securities offered under this prospectus have
been sold, or that deregisters all securities then remaining
unsold, will be deemed to be incorporated in this registration
statement by reference and to be a part hereof from the date of
filing of such documents.
Any
statement contained in a document incorporated or deemed to be
incorporated by reference in this prospectus shall be deemed
modified, superseded or replaced for purposes of this prospectus to
the extent that a statement contained in this prospectus, or in any
subsequently filed document that also is deemed to be incorporated
by reference in this prospectus, modifies, supersedes or replaces
such statement. Any statement so modified, superseded or replaced
shall not be deemed, except as so modified, superseded or replaced,
to constitute a part of this prospectus. None of the information
that we disclose under Items 2.02 or 7.01 of any Current Report on
Form 8-K or any corresponding information, either furnished under
Item 9.01 or included as an exhibit therein, that we may from time
to time furnish to the SEC will be incorporated by reference into,
or otherwise included in, this prospectus, except as otherwise
expressly set forth in the relevant document. Subject to the
foregoing, all information appearing in this prospectus is
qualified in its entirety by the information appearing in the
documents incorporated by reference.
You
may requests, orally or in writing, a copy of these documents,
which will be provided to you at no cost (other than exhibits,
unless such exhibits are specifically incorporate by reference), by
contacting Akers Biosciences, Inc., at 201 Grove Road, Thorofare,
New Jersey 08086. Our telephone number is (856) 848-8698.
Information about us is also available at our website at
http://www.akersbio.com. However, the information in our
website is not a part of this prospectus and is not incorporated by
reference.

793,437
Shares
COMMON
STOCK
PROSPECTUS
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses of Issuance and Distribution.
The
Company is paying all expenses of the offering. The following table
sets forth all expenses to be paid by the registrant. All amounts
shown are estimates except for the registration fee.
SEC registration fee |
|
$ |
350 |
|
Legal fees and expenses |
|
$ |
15,000 |
|
Accounting fees and expenses |
|
$ |
2,500 |
|
Printing Fees and Expenses |
|
$ |
— |
|
Transfer Agent Fees and Expenses |
|
$ |
— |
|
Miscellaneous |
|
$ |
— |
|
Total |
|
$ |
17,850 |
|
Item
15. Indemnification of Directors and Officers.
Section
14A:2-7(3) of the New Jersey Business Corporation Act permits a
corporation to provide in its certificate of incorporation that a
director or officer shall not be personally liable, or shall be
liable only to the extent therein provided, to the corporation or
its shareholders for damages for breach of any duty owed to the
corporation or its shareholders, except that such provision shall
not relieve a director or officer from liability for any breach of
duty based upon an act or omission (a) in breach of such person’s
duty of loyalty to the corporation or its shareholders, (b) not in
good faith or involving a knowing violation of law or (c) resulting
in receipt by such person of an improper personal benefit. Akers
Biosciences, Inc.’s certificate of incorporation provides for such
limitation of liability.
Section
14A:3-5 of the New Jersey Business Corporation Act empowers a
corporation to indemnify any current or former director or officer
made a party to a proceeding because he or she is or was a director
or officer against liability incurred in the proceeding; provided
that such director or officer acted in good faith and in a manner
he reasonably believed to be in or not opposed to the best
interests of the corporation and, with respect to any criminal
proceeding, such director or officer had no reasonable cause to
believe his conduct was unlawful.
Akers
Biosciences, Inc.’s certificate of incorporation provides that the
corporation must indemnify its directors and officers to the
fullest extent authorized by law. Akers Biosciences, Inc. is also
expressly required to advance certain expenses to its directors and
officers. Akers Biosciences, Inc. believes that these
indemnification provisions are useful to attract and retain
qualified directors and executive officers.
Insofar
as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers or persons
controlling us pursuant to the foregoing provisions, we have been
informed that, in the opinion of the SEC, this indemnification is
against public policy as expressed in the Securities Act and is
therefore unenforceable.
Item
16. Exhibits.
The
following exhibits are filed with this Registration
Statement.
The
agreements included or incorporated by reference as exhibits to
this registration statement contain representations and warranties
by each of the parties to the applicable agreement. These
representations and warranties were made solely for the benefit of
the other parties to the applicable agreement and (i) were not
intended to be treated as categorical statements of fact, but
rather as a way of allocating the risk to one of the parties if
those statements prove to be inaccurate; (ii) may have been
qualified in such agreement by disclosures that were made to the
other party in connection with the negotiation of the applicable
agreement; (iii) may apply contract standards of “materiality” that
are different from “materiality” under the applicable securities
laws; and (iv) were made only as of the date of the applicable
agreement or such other date or dates as may be specified in the
agreement.
The
undersigned registrant acknowledges that, notwithstanding the
inclusion of the foregoing cautionary statements, it is responsible
for considering whether additional specific disclosures of material
information regarding material contractual provisions are required
to make the statements in this registration statement not
misleading.
* |
Filed
herewith. |
** |
Previously filed. |
Item
17. Undertakings.
(a)
The undersigned Registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made,
a post-effective amendment to this registration
statement:
(i)
to include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(ii)
to reflect in the prospectus any facts or events arising after the
effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in the form
of prospectus filed with the Commission pursuant to Rule 424(b) if,
in the aggregate, the changes in volume and price represent no more
than a 20% change in the maximum aggregate offering price set forth
in the “Calculation of Registration Fee” table in the effective
registration statement; and
(iii)
to include any material information with respect to the plan of
distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement;
provided
, however , that paragraphs (1)(i), (1)(ii) and (1)(iii) do
not apply if the information required to be included in a
post-effective amendment by those paragraphs is contained in
reports filed with or furnished to the Commission by the registrant
pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934 that are incorporated by reference in the registration
statement, or is contained in a form of prospectus filed pursuant
to Rule 424(b) that is part of the registration
statement.
(2)
That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof.
(3)
To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the
termination of the offering.
(4)
That, for the purpose of determining liability under the Securities
Act of 1933 to any purchaser:
(i)
If the registrant is relying on Rule 430B (§230.430B of this
chapter):
(A)
Each prospectus filed by the registrant pursuant to Rule 424(b)(3)
shall be deemed to be part of the registration statement as of the
date the filed prospectus was deemed part of and included in the
registration statement; and
(B)
Each prospectus required to be filed pursuant to Rule 424(b)(2),
(b)(5), or (b)(7) as part of a registration statement in reliance
on Rule 430B relating to an offering made pursuant to Rule
415(a)(1)(i), (vii), or (x) for the purpose of providing the
information required by Section 10(a) of the Securities Act of 1933
shall be deemed to be part of and included in the registration
statement as of the earlier of the date such form of prospectus is
first used after effectiveness or the date of the first contract of
sale of securities in the offering described in the prospectus. As
provided in Rule 430B, for liability purposes of the issuer and any
person that is at that date an underwriter, such date shall be
deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which
that prospectus relates, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof. Provided, however, that no statement made in a
registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or
prospectus that is part of the registration statement will, as to a
purchaser with a time of contract of sale prior to such effective
date, supersede or modify any statement that was made in the
registration statement or prospectus that was part of the
registration statement or made in any such document immediately
prior to such effective date.
(ii)
If the registrant is subject to Rule 430C, each prospectus filed
pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying
on Rule 430B or other than prospectuses filed in reliance on Rule
430A, shall be deemed to be part of and included in the
registration statement as of the date it is first used after
effectiveness. Provided, however, that no statement made in a
registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or
prospectus that is part of the registration statement will, as to a
purchaser with a time of contract of sale prior to such first use,
supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement
or made in any such document immediately prior to such date of
first use.
(5)
That, for the purpose of determining liability of the registrant
under the Securities Act of 1933 to any purchaser in the initial
distribution of the securities, the undersigned registrant
undertakes that in a primary offering of securities of the
undersigned registrant pursuant to this registration statement,
regardless of the underwriting method used to sell the securities
to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the
undersigned registrant will be a seller to the purchaser and will
be considered to offer or sell such securities to such
purchaser:
(i)
Any preliminary prospectus or prospectus of the undersigned
registrant relating to the offering required to be filed pursuant
to Rule 424;
(ii)
Any free writing prospectus relating to the offering prepared by or
on behalf of the undersigned registrant or used or referred to by
the undersigned registrant;
(iii)
The portion of any other free writing prospectus relating to the
offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the
undersigned registrant; and
(iv)
Any other communication that is an offer in the offering made by
the undersigned registrant to the purchaser.
(b)
The undersigned registrant hereby undertakes that, for purposes of
determining any liability of the registrant under the Securities
Act of 1933, each filing of the registrant’s annual report pursuant
to Section 13(a) or Section 15(d) of the Securities Exchange Act of
1934 (and, where applicable, each filing of an employee benefit
plan’s annual report pursuant to section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
(c)
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the registrant pursuant to the foregoing
provisions, or otherwise, the registrant has been advised that in
the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event that
a claim for indemnification against such liabilities (other than
the payment by the registrant of expenses incurred or paid by a
director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted
by such director, officer or controlling person in connection with
the securities being registered, the registrant will, unless in the
opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public
policy as expressed in the Securities Act of 1933 and will be
governed by the final adjudication of such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the
Registrant certifies that it has reasonable grounds to believe that
it meets all the requirements for filing on Form S-3 and has duly
caused this Amendment No. 1 to the Registration Statement to be
signed on its behalf by the undersigned, thereunto duly authorized,
in the State of New Jersey, on this June 5, 2020.
|
AKERS
BIOSCIENCES, INC. |
|
|
|
By: |
/s/
Christopher C. Schreiber |
|
|
Christopher
C. Schreiber |
|
|
Executive
Chairman of the Board and Director
(Principal
Executive Officer) and Director
|
Pursuant
to the requirements of the Securities Act of 1933, as amended, this
Amendment No. 1 to the Registration Statement has been signed by
the following persons in the capacities and on the dates
indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/
Christopher C. Schreiber |
|
Executive
Chairman of the Board and Director |
|
June
5, 2020 |
Christopher
C. Schreiber |
|
(Principal Executive Officer) |
|
|
|
|
|
|
|
/s/
Howard R. Yeaton |
|
Interim
Chief Financial Officer |
|
June
5, 2020 |
Howard
R. Yeaton |
|
(Principal
Financial Officer and Principal Accounting Officer) |
|
|
|
|
|
|
|
* |
|
Director |
|
June
5, 2020 |
Joshua
Silverman |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
June
5, 2020 |
Bill
J. White |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
June
5, 2020 |
Robert
C. Schroeder |
|
|
|
|
*By: |
/s/
Christopher C. Schreiber |
|
|
Christopher
C. Schreiber |
|
|
Attorney-in-Fact |
|
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