As filed with the Securities and Exchange Commission on April 6,
2021
Registration No.
333-252087
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
POST-EFFECTIVE AMENDMENT NO. 1
TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
AzurRx BioPharma, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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2834
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46-4993860
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(State
or other jurisdiction of incorporation or
organization)
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(Primary
Standard Industrial Classification Code Number)
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(I.R.S.
Employer Identification No.)
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1615 South Congress Avenue, Suite 103
Delray Beach, Florida 33445
Telephone: (646)
699-7855
(Address, including zip code, and telephone number,
including area code, of principal executive offices)
James Saperstein
Chief Executive Officer
AzurRx BioPharma, Inc.
1615 South Congress Avenue, Suite 103
Delray Beach, Florida 33445
Telephone: (646)
699-7855
(Address, including zip code, and telephone
number,
including area code, of agent for service)
Copy to:
James O’Grady, Esq.
Michael J. Lerner, Esq.
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, New York 10020
Telephone: (212) 262-6700
Approximate date of commencement of proposed sale to the
public: As soon as practicable after this Registration
Statement is declared effective.
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, check the following box. ☒
If this
Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, check the
following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same
offering. ☐
If this
Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier
effective registration statement for the same offering.
☐
If this
Form is a post-effective amendment filed pursuant to Rule 462(d)
under the Securities Act, check the following box and list the
Securities Act registration number of the earlier effective
registration statement for the same offering. ☐
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See the definitions of “large accelerated
filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 under the Securities
Exchange Act of 1934. (Check one):
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Large
Accelerated Filer
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☐
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Accelerated
Filer
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☐
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Non-accelerated
Filer
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☒
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Smaller
Reporting Company
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☒
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Emerging
Growth Company
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If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 7(a)(2)(B) of the Securities Act. ☒
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 that specifically states that this
registration statement shall thereafter become effective in
accordance with Section 8(a) of the Securities Act of 1933, as
amended, or until the registration statement shall become effective
on such date as the Securities and Exchange Commission, acting
pursuant to said Section 8(a), may determine.
EXPLANATORY
NOTE
On
January 13, 2021, AzurRx BioPharma, Inc. (the
“Company”) filed a registration
statement with the Securities and Exchange Commission (the
“SEC”) on Form S-1 (File No. 333-252087)
(the “Registration Statement”) covering the resale of
up to up to 16,000,002 shares of the Company’s common stock,
par value $0.0001 per share (“Common Stock”), the
selling stockholder identified in the Registration Statement may
acquire upon (i) the conversion of outstanding Series C 9.00%
Convertible Junior Preferred Stock, par value $0.0001 per share
(the “Series C Preferred Stock”), (ii) upon the
exercise of outstanding warrants (“Investor Warrants”)
and (iii) upon the exercise of any pre-funded warrants
(“Pre-funded Warrants”) issued or issuable upon the
conversion of the Series C Preferred
Stock. The Registration Statement was originally declared
effective by the SEC on January 21, 2021.
This
Post-Effective Amendment No. 1 is being filed in order to include
information from the Company’s Annual Report on Form 10-K for
the fiscal year ended December 31, 2020 that was filed with
the SEC on March 31, 2021 and to make certain corresponding
changes in the Registration Statement.
No
additional securities are being registered under this
Post-Effective Amendment. All applicable registration and filing
fees were paid at the time of the original filing of the
Registration Statement.
The information in this prospectus is not complete and may be
changed. We may not sell these securities until the registration
statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities
and it is not soliciting an offer to buy these securities in any
state where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED APRIL 6, 2021
PRELIMINARY
PROSPECTUS
16,000,002 Shares of Common Stock
Issuable upon
Conversion of Outstanding Series C Preferred Stock
and
Exercise of
Outstanding Warrants
This
prospectus relates to the resale from time to time, by the selling
stockholder identified in this prospectus under the caption
“Selling Stockholder,” of up to 16,000,002 shares of
our common stock, par value $0.0001 per share (“Common
Stock”), it may acquire upon (i) the conversion of
outstanding Series C 9.00% Convertible Junior Preferred Stock, par
value $0.0001 per share (the “Series C Preferred
Stock”), (ii) upon the exercise of outstanding warrants
(“Investor Warrants”) and (iii) upon the exercise
of any pre-funded warrants (“Pre-funded Warrants”)
issued or issuable upon the conversion of the Series C Preferred
Stock. Up to 5,333,334 shares of our Common Stock are issuable
upon conversion of the Series C Preferred Stock (or any Pre-funded
Warrants, as applicable), and up to 10,666,668 shares of our Common
Stock are issuable upon exercise of the Investor
Warrants.
We
issued the Series C Preferred Stock and the Investor Warrants to
the selling stockholder in a private placement (the “Private
Placement”) concurrent with a registered direct offering (the
“Registered Direct Offering,” and together with the
Private Placement, the “Offerings”) of additional
shares of Series C Preferred Stock convertible into an additional
5,333,334 shares of Common Stock (or Pre-funded Warrants, as
applicable), which was completed on January 6, 2021.
Pursuant to the
terms of the Series C Preferred Stock and the Investor Warrants,
the foregoing shares of Series C Preferred Stock issued to the
Selling Stockholder were not convertible in excess of certain
specified thresholds, and the related Investor Warrants were not
exercisable at all, until the Company obtained certain stockholder
approvals (the “Stockholder Approvals”). As a result of
obtaining the Stockholder Approvals at a special meeting of
stockholders held on February 24, 2021, all of the foregoing shares
of Series C Preferred Stock, and all of the related Investor
Warrants, have now become convertible or exercisable, as the case
may be, into shares of Common Stock without
limitation.
The
Selling Stockholder previously requested the conversion of shares
of Series C Preferred Stock into the maximum issuable amount of
6,186,966 shares of Common Stock. On February 24, 2021, following
the Stockholder Approvals, we elected to convert the remaining
balance of such shares of Series C Preferred Stock, including
accrued and unpaid dividends thereon, in full into 4,539,863
additional shares of Common Stock for the account of the Selling
Stockholder. Accordingly, the shares of Series C Preferred Stock
issued to the Selling Stockholder are no longer
outstanding.
The
Selling Stockholder may, from time to time, sell, transfer or
otherwise dispose of any or all of their shares of Common Stock or
interests in their shares of Common Stock on any stock exchange,
market or trading facility on which the shares of Common Stock are
traded or in private transactions. These dispositions may be at
fixed prices, at prevailing market prices at the time of sale, at
prices related to the prevailing market price, at varying prices
determined at the time of sale, or at negotiated prices. See
“Plan of Distribution” in this prospectus for more
information. We will not receive any proceeds from the resale or
other disposition of the Common Stock by the selling stockholder.
However, we will receive the proceeds of any cash exercise of the
Investor Warrants. See “Use of Proceeds” beginning on
page [ ] and “Plan of Distribution” beginning on page [
] of this prospectus for more information.
Our
Common Stock is listed on the Nasdaq Capital Market under the
symbol “AZRX.” On April 1, 2021, the last reported sale
price of our Common Stock as reported on the Nasdaq Capital Market
was $1.02 per share.
We
are an “emerging growth company” as that term is used
in the Jumpstart Our Business Startups Act of 2012, and, as such,
we have elected to take advantage of certain reduced public company
reporting requirements for this prospectus and future
filings.
You
should read this prospectus, together with additional information
described under the headings “Information Incorporated by
Reference” and “Where You Can Find More
Information,” carefully before you invest in any of our
securities.
This
prospectus contains or incorporates by reference summaries of
certain provisions contained in some of the documents described
herein, but reference is made to the actual documents for complete
information. All the summaries are qualified in their entirety by
the actual documents. Copies of some of the documents referred to
herein have been filed or have been incorporated by reference as
exhibits to the registration statement of which this prospectus
forms a part, and you may obtain copies of those documents as
described in this prospectus under the heading “Where You Can
Find More Information.
Neither
the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or
determined if this prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
The
date of this Prospectus is , 2021
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Description
of Securities
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ABOUT THIS PROSPECTUS
We
have not authorized anyone to provide you with information that is
different from that contained in this prospectus or in any free
writing prospectus we may authorize to be delivered or made
available to you. When you make a decision about whether to invest
in our securities, you should not rely upon any information other
than the information in this prospectus or in any free writing
prospectus that we may authorize to be delivered or made available
to you. Neither the delivery of this prospectus nor the sale of our
securities means that the information contained in this prospectus
or any free writing prospectus is correct after the date of this
prospectus or such free writing prospectus. This prospectus is not
an offer to sell or the solicitation of an offer to buy our
securities in any circumstances under which the offer or
solicitation is unlawful.
For
investors outside the United States: We have not taken any action
that would permit this offering or possession or distribution of
this prospectus in any jurisdiction where action for that purpose
is required, other than in the United States. Persons outside the
United States who come into possession of this prospectus must
inform themselves about, and observe any restrictions relating to,
the offering of the securities covered hereby and the distribution
of this prospectus outside the United States.
This
prospectus contains summaries of certain provisions contained in
some of the documents described herein, but reference is made to
the actual documents for complete information. All of the summaries
are qualified in their entirety by the full text of the actual
documents, some of which have been filed or will be filed and
incorporated by reference herein. See “Information
Incorporated by Reference” and “Where You Can Find More
Information” in this prospectus. We further note that the
representations, warranties and covenants made by us in any
agreement that is filed as an exhibit to any document that is
incorporated by reference into this prospectus were made solely for
the benefit of the parties to such agreement, including, in some
cases, for the purpose of allocating risk among the parties to such
agreements, and should not be deemed to be a representation,
warranty or covenant to you. Moreover, such representations,
warranties or covenants were accurate only as of the date when
made. Accordingly, such representations, warranties and covenants
should not be relied on as accurately representing the current
state of our affairs.
This
prospectus contains and incorporates by reference certain market
data and industry statistics and forecasts that are based on
studies sponsored by us, independent industry publications and
other publicly available information. Although we believe these
sources are reliable, estimates as they relate to projections
involve numerous assumptions, are subject to risks and
uncertainties, and are subject to change based on various factors,
including those discussed under “Risk Factors” in this
prospectus and under similar headings in the documents incorporated
by reference herein and therein. Accordingly, investors should not
place undue reliance on this information.
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This summary highlights information contained elsewhere in this
prospectus. This summary does not contain all of the information
that you should consider before deciding to invest in our
securities. You should read this entire prospectus carefully,
including the “Risk Factors” section in this prospectus
and under similar captions in the documents incorporated by
reference into this prospectus. In this prospectus, unless
otherwise stated or the context otherwise requires, references to
“AzurRx”, “Company”, “we”,
“us”, “our” or similar references mean
AzurRx BioPharma, Inc. and its subsidiaries on a consolidated
basis. References to “AzurRx BioPharma” refer to AzurRx
BioPharma, Inc. on an unconsolidated basis. References to
“AzurRx SAS” refer to AzurRx SAS, AzurRx
BioPharma’s wholly-owned subsidiary through which we conduct
our European operations.
Overview
We are engaged in the research and development of targeted,
non-systemic therapies for the treatment of patients with
gastrointestinal (“GI”) diseases. Non-systemic
therapies are non-absorbable drugs that act locally, i.e. in the
intestinal lumen, skin or mucosa, without reaching an
individual’s systemic circulation.
We are currently focused on developing our pipeline of
gut-restricted GI clinical drug candidates. Our lead drug candidate
is MS1819, a recombinant lipase for the treatment of exocrine
pancreatic insufficiency (“EPI”) in patients
with cystic fibrosis
(“CF”) and chronic pancreatitis
(“CP”), currently in two
Phase 2 CF clinical trials. In 2021, we plan to launch two
clinical programs using proprietary formulations of niclosamide, a
pro-inflammatory pathway inhibitor; FW-1022, for Severe Acute
Respiratory Syndrome Coronavirus 2 (“SARS-CoV-2,” or “COVID-19”)
gastrointestinal infections, and FW-420, for Grade 1 Immune
Checkpoint Inhibitor-Associated Colitis (“ICI-AC”) and
diarrhea in oncology patients. Each drug candidate is described
below.
MS1819
MS1819, a recombinant lipase enzyme for the treatment of EPI
associated with CF and CP, is supplied as an oral non-systemic
biologic capsule. MS1819 is derived from
the Yarrowia
lipolytica yeast lipase
and breaks up fat molecules in the digestive tract of EPI patients
so that they can be absorbed as nutrients. Unlike the standard of
care, the MS1819 lipase does not contain any animal
products.
EPI is a condition characterized by deficiency of
exocrine pancreatic enzymes, primarily lipase, resulting
in a patient’s inability to digest food properly, or
maldigestion. The deficiency of these enzymes can be responsible
for greasy diarrhea, fecal urge, abdominal pain and weight loss. We
believe that there are two principal therapeutic indications for
EPI compensation by MS1819: (i) children and adults affected by CF,
and (ii) adult patients with CP. There are more than 30,000
patients with EPI caused by CF according to the Cystic Fibrosis
Foundation and there are approximately 90,000 patients in the U.S.
with EPI caused by CP according to the National Pancreas
Foundation. Patients are currently treated with porcine pancreatic
enzyme replacement (“PERT”) pills.
We have determined to initially pursue the indication for adults in
CF.
Corporate History
We were incorporated on January 30, 2014 in the
State of Delaware. In May
2014, we entered into a stock purchase agreement with Protea
Biosciences Group, Inc. (“Protea Group”) and its
wholly-owned subsidiary, Protea Biosciences, Inc. (“Protea
Sub” and, together with Protea Group, “Protea”),
to acquire 100% of the outstanding capital stock of AzurRx SAS
(formerly ProteaBio Europe SAS), a wholly-owned subsidiary of
Protea Sub. In June 2014, we completed the acquisition in exchange
for the payment of $600,000 and the issuance of shares of our
Series A Convertible Preferred Stock (“Series A
Preferred”) convertible into 33% of our outstanding Common
Stock and agreed to make certain milestone and royalty payments to
Protea in connection with MS1819. In October 2016, we completed an
initial public offering (“IPO”), which allowed us to
list our shares of Common Stock on the Nasdaq Capital
Market.
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THE OFFERING
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Securities
to be Offered by the Selling Stockholder
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Up to
16,000,002 shares of Common Stock issuable upon conversion of the
Series C Preferred Stock (or Pre-funded Warrants, as applicable)
and exercise of the Investor Warrants.
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Use of
Proceeds
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The
Common Stock to be offered and sold using this prospectus will be
offered and sold by the Selling Stockholder named in this
prospectus. Accordingly, we will not receive any proceeds from any
sale of shares of our Common Stock in this offering. A portion
of the shares covered by this prospectus may be issued upon
exercise of the Investor Warrants. Upon any cash exercise of
the Investor Warrants, the Selling Stockholder will pay us the
applicable exercise price. We anticipate that proceeds that we
receive from the cash exercise of such warrants, if any, will be
used for working capital and general corporate purposes, including,
without limitation, development of our product candidates, and
general and administrative expenses. It is possible that, pending
their use, we may invest the net proceeds in a way that does not
yield a favorable, or any, return for us. See the section entitled
“Use of Proceeds” in this prospectus.
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Risk
Factors
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An
investment in our securities involves a high degree of risk. Before
deciding whether to invest in our securities, you should consider
carefully the risks and uncertainties described in the section
captioned “Risk Factors” contained in our Annual Report
on Form 10-K for the fiscal year ended December 31, 2020 filed with
the Securities and Exchange Commission on March 31, 2021, and other
filings we make with the Securities and Exchange Commission from
time to time, which are incorporated by reference herein in their
entirety, together with other information in this prospectus and
the information incorporated by reference
herein.
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Nasdaq
Capital Market Symbol
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Our
Common Stock is listed on the Nasdaq Capital Market under the
symbol “AZRX.”
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An investment in our securities involves a high degree of
risk. Before deciding whether to invest in our securities, you
should consider carefully the risks and uncertainties described in
the section captioned “Risk Factors” contained in our
Annual Report on Form 10-K for the fiscal year ended December 31,
2020 filed with the Securities and Exchange Commission on March 31,
2021 and other filings we make with the Securities and Exchange
Commission from time to time, which are incorporated by reference
herein in their entirety, together with other information in this
prospectus and the information incorporated by reference herein. If
any of these risks actually occurs, our business, financial
condition, results of operations or cash flow could suffer
materially. In such event, the trading price of our common stock
could decline, and you might lose all or part of your
investment.
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
This
prospectus, and any documents we incorporate by reference, contain
certain forward-looking statements that involve substantial risks
and uncertainties. All statements contained in this prospectus and
any documents we incorporate by reference, other than statements of
historical facts, are forward-looking statements including
statements regarding our strategy, future operations, future
financial position, future revenue, projected costs, prospects,
plans, objectives of management and expected market growth. These
statements involve known and unknown risks, uncertainties and other
important factors that may cause our actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements.
The
words “anticipate”, “believe”,
“estimate”, “expect”, “intend”,
“may”, “plan”, “predict”,
“project”, “target”,
“potential”, “will”, “would”,
“could”, “should”, “continue”
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. These forward-looking statements include,
among other things, statements about:
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availability
of capital to satisfy our working capital
requirements;
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our
current and future capital requirements and our ability to raise
additional funds to satisfy our capital needs;
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accuracy
of our estimates regarding expense, future revenue and capital
requirements;
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ability
to continue operating as a going concern;
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our
plans to develop and commercialize our lead drug candidate,
MS1819;
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our
ability to initiate and complete our clinical trials and to advance
our principal product candidates into additional clinical trials,
including pivotal clinical trials, and successfully complete such
clinical trials;
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regulatory
developments in the U.S. and foreign countries;
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the
performance of our third-party contract manufacturer(s), contract
research organization(s) and other third-party non-clinical and
clinical development collaborators and regulatory service
providers;
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our
ability to obtain and maintain intellectual property protection for
our core assets;
●
the
size of the potential markets for our product candidates and our
ability to serve those markets;
●
the
rate and degree of market acceptance of our product candidates for
any indication once approved;
●
the
success of competing products and product candidates in development
by others that are or become available for the indications that we
are pursuing;
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the
loss of key scientific, clinical and nonclinical development,
and/or management personnel, internally or from one of our
third-party collaborators;
●
the
impact of the coronavirus (COVID-19) epidemic on our operations,
and current and planned clinical trials, including, but not limited
to delays in clinical trial recruitment and participation;
and
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other risks and uncertainties, including those
listed in the “ Risk
Factors” section of this
prospectus and the documents incorporated by reference
herein.
These
forward-looking statements are only predictions and we may not
actually achieve the plans, intentions or expectations disclosed in
our forward-looking statements, so you should not place undue
reliance on our forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements we make.
We have based these forward-looking statements largely on our
current expectations and projections about future events and trends
that we believe may affect our business, financial condition and
operating results. We have included important factors in the
cautionary statements included in this prospectus that could cause
actual future results or events to differ materially from the
forward-looking statements that we make. Our forward-looking
statements do not reflect the potential impact of any future
acquisitions, mergers, dispositions, joint ventures or investments
we may make.
You
should read this prospectus with the understanding that our actual
future results may be materially different from what we expect. We
do not assume any obligation to update any forward-looking
statements whether as a result of new information, future events or
otherwise, except as required by applicable law.
The
common stock to be offered and sold using this prospectus will be
offered and sold by the selling stockholders named in this
prospectus. Accordingly, we will not receive any proceeds from any
sale of shares of our Common Stock in this offering. A portion
of the shares covered by this prospectus may be issued upon
exercise of the warrants. Upon any cash exercise of the
warrants, the selling stockholders will pay us the applicable
exercise price. We anticipate that proceeds that we receive from
the cash exercise of such warrants, if any, will be used for
working capital and general corporate purposes, including, without
limitation, development of our product candidates, and general and
administrative expenses. We will pay all of the fees and expenses
incurred by us in connection with this registration. We will not be
responsible for fees and expenses incurred by the selling
stockholders or any underwriting discounts or agent’s
commissions.
DESCRIPTION OF CAPITAL STOCK
The following is a
summary of information concerning capital stock of AzurRx
BioPharma, Inc. (“us,” “our,”
“we” or the “Company”) and certain
provisions of our certificate of incorporation, as amended and
restated, and amended and restated bylaws currently in effect. This
summary does not purport to be complete and is qualified in its
entirety by the provisions of our amended and restated certificate
of incorporation, as amended (the “Charter”) and
amended and restated bylaws (the “Bylaws”), each
previously filed with the Securities and Exchange Commission
(“SEC”) and incorporated by reference as an
exhibit to our Form 10-K for the year
ended December 31, 2020, filed with the SEC on March 31,
2021, as well
as to the applicable provisions of the Delaware General Corporation
Law (the “DGCL”). We encourage you to read our
Certificate of Incorporation, Bylaws and the applicable portions of
the DGCL carefully.
General
Our
authorized capital stock consists of:
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250,000,000
shares of common stock, par value $0.0001 per share;
and
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10,000,000
shares of preferred stock, par value $0.0001 per
share.
Common Stock
Holders of our common stock are entitled to one
vote for each share held of record on all matters on which the
holders are entitled to vote (or consent pursuant to written
consent). Directors are elected by a plurality of the votes present
in person or represented by proxy and entitled to
vote. Our Charter and Bylaws
do not provide for cumulative voting rights.
Holders
of our common stock are entitled to receive, ratably, dividends
only if, when and as declared by our board of directors out of
funds legally available therefor and after provision is made for
each class of capital stock having preference over the common
stock.
In
the event of our liquidation, dissolution or winding-up, the
holders of common stock are entitled to share, ratably, in all
assets remaining available for distribution after payment of all
liabilities and after provision is made for each class of capital
stock having preference over the common stock.
Holders of our common stock have no preemptive, conversion or
subscription rights, and there are no redemption or sinking fund
provisions applicable to the common stock. The rights, preferences
and privileges of the holders of common stock are subject to, and
may be adversely affected by, the rights of the holders of shares
of any series of our preferred stock that we may designate and
issue in the future.
Preferred Stock
We currently have up to
10,000,000 shares of preferred stock, par value $0.0001 per share,
authorized and available for issuance in one or more series. Our
board of directors is authorized to divide the preferred stock into
any number of series, fix the designation and number of each such
series, and determine or change the designation, relative rights,
preferences, and limitations of any series of preferred stock. The
board of directors may increase or decrease the number of shares
initially fixed for any series, but no decrease may reduce the
number below the shares then outstanding and duly reserved for
issuance. Currently, 5,194.805195 shares have been initially
designated as Series B Convertible Preferred Stock, par value
$0.0001 per share (the “Series B Preferred
Stock”), and 75,000 have been
initially designated as Series C 9.00% Convertible Junior Preferred
Stock, par value $0.0001 per share (the “Series C Preferred
Stock”), of which none are issued and outstanding. This
leaves 9,994,805.1948 shares of preferred stock
authorized but unissued.
The
shares of Common Stock being offered by the Selling Stockholder are
those issuable to the selling stockholder upon conversion of the
Series C Preferred Stock, exercise of the Investor Warrants, and to
the extent any are issued to the selling stockholder upon
conversion of the Series C Preferred Stock, the Pre-funded
Warrants. On January 6, 2021, the
Offerings closed and the investor converted all of its Series C
Preferred Stock issued in the Registered Direct Offering, effective
immediately upon the closing. Upon such conversion, the investor
received an aggregate of 3,400,000 shares of Common Stock and
Pre-funded Warrants to purchase up to 1,933,334 shares of Common
Stock.
Series C Preferred Stock
Under
the Series C Certificate of Designations, each share of Series C
Preferred Stock will be convertible, at either the holder’s
option or at our option at any time, into common stock at a
conversion rate equal to the quotient of (i) the Series C Stated
Value of $750 plus all accrued and accumulated and unpaid dividends
on such share of Series C Preferred Stock divided by (ii) the
initial conversion price of $0.75, subject to specified adjustments
for stock splits, cash or stock dividends, reorganizations,
reclassifications other similar events as set forth in the Series
C Certificate of Designations.
The
Series C Preferred Stock contains limitations that prevent the
holders thereof from acquiring shares of our common stock upon
conversion that would result in the number of shares beneficially
owned by any such holder and its affiliates exceeding 9.99% of the
total number of shares of our common stock outstanding immediately
after giving effect to the conversion. As a result, the Series C
Certificate of Designations provides for the issuance of pre-funded
warrants to purchase shares of our common stock, with an exercise
price of $0.001 per share and with no expiration date, if necessary
to comply with this limitation.
Each
holder of shares of Series C Preferred Stock, subject to the
preference and priority to the holders of our Series B Preferred
Stock, is entitled to receive dividends, commencing from the date
of issuance of the Series C Preferred Stock. Such dividends may be
paid only when, as and if declared by our board of directors, out
of assets legally available therefore, quarterly in arrears on the
last day of March, June, September and December in each year,
commencing on the date of issuance, at the dividend rate of 9.0%
per year. Such dividends are cumulative and continue to accrue on a
daily basis whether or not declared and whether or not we have
assets legally available therefore.
Under
the Series C Certificate of Designations, each share of Series C
Preferred Stock carries a liquidation preference equal to the
Series C Stated Value plus accrued and unpaid dividends thereon and
any other fees or liquidated damages then due and owing
thereon.
The holders of the Series C Preferred Stock have
no voting rights. We may not take the following actions without the
prior consent of the holders of at least a majority of the Series C
Preferred Stock then outstanding: (a) alter or change adversely the
powers, preferences or rights given to the Series C Preferred Stock
or alter or amend the Series C Certificate of Designations, (b)
authorize or create any class of stock ranking as to dividends,
redemption or distribution of assets upon a Liquidation (as defined
in the Series C Certificate of Designations) senior to, or
otherwise pari passu with,
the Series C Preferred Stock, (c) amend our certificate of
incorporation or other charter documents in any manner that
adversely affects any rights of the holders of the Series C
Preferred Stock, (d) increase the number of authorized shares of
Series C Preferred Stock, or (e) enter into any agreement with
respect to any of the foregoing.
Pursuant
to the terms of the Series C Preferred Stock, the Series C
Preferred Stock were not convertible in excess of certain specified
thresholds until we obtained certain stockholder approvals. As a
result of obtaining the Stockholder Approvals at the Special
Meeting, all of the Series C Preferred Stock are convertible into
shares of Common Stock without limitation.
Series B Preferred Stock
Under
the Series B Certificate of Designations, each share of Series
B Preferred Stock will be convertible, at the holder’s option
at any time, into our common stock at a conversion rate equal to
the quotient of (i) the $7,700 stated value (the “Series B
Stated Value”) divided by (ii) the initial conversion price
of $0.77, subject to specified adjustments for stock splits, cash
or stock dividends, reorganizations, reclassifications other
similar events as set forth in the Series B Certificate of
Designations. In addition, if at any time after January 16,
2021, the six month anniversary of the date of the closing of our
private placement transaction on July 16, 2020, the closing sale
price per share of our common stock exceeds 250% of the initial
conversion price, or $1.925, for 20 consecutive trading days, then
all of the outstanding shares of Series B Preferred Stock will
automatically convert (the “Automatic Conversion”) into
such number of shares of our common stock as is obtained by
multiplying the number of shares of Series B Preferred Stock to be
so converted, plus the amount of any accrued and unpaid dividends
thereon, by the Series B Stated Value per share and dividing the
result by the then applicable conversion price.
The
Series B Preferred Stock contains limitations that prevent the
holder thereof from acquiring shares of our common stock upon
conversion (including pursuant to the Automatic Conversion) that
would result in the number of shares beneficially owned by such
holder and its affiliates exceeding 9.99% of the total number of
shares of our common stock outstanding immediately after giving
effect to the conversion, which percentage may be increased or
decreased at the holder’s election not to
exceed 19.99%.
Each
holder of shares of Series B Preferred Stock, in preference and
priority to the holders of all other classes or series of our
stock, is entitled to receive dividends, commencing from the date
of issuance. Such dividends may be paid by us only when, as and if
declared by our board of directors, out of assets legally available
therefore, semiannually in arrears on the last day of June and
December in each year, commencing December 31, 2020, at the
dividend rate of 9.0% per year, which is cumulative and continues
to accrue on a daily basis whether or not declared and whether or
not we have assets legally available therefore. We may pay such
dividends at our sole option either in cash or in kind in
additional shares of Series B Preferred Stock (rounded down to the
nearest whole share), provided we must pay in cash the fair value
of any such fractional shares in excess of $100.00. Under the
Series B Certificate of Designations, to the extent that applicable
law or any of our existing contractual restrictions prohibit any
required issuance of additional shares of Series B Preferred Stock
as in-kind dividends or otherwise (“Additional
Shares”), then appropriate adjustment to the conversion price
of the Series B Preferred Stock shall be made so that the resulting
number of conversion shares includes the aggregate number of shares
of our common stock into which such Additional Shares would
otherwise be convertible.
Under
the Series B Certificate of Designations, each share of Series
B Preferred Stock carries a liquidation preference equal to the
Series B Stated Value (as adjusted thereunder) plus accrued and
unpaid dividends thereon (the “Series B Liquidation
Preference”).
In
the event we effect any issuance of common stock or common stock
equivalents for cash consideration, or a combination of units
thereof (a “Subsequent Financing”), each holder of the
Series B Preferred Stock has the right, subject to certain
exceptions set forth in the Series B Certificate of Designations,
at its option, to exchange (in lieu of cash subscription payments)
all or some of the Series B Preferred Stock then held (with a value
per share of Series B Preferred Stock equal to the Series B
Liquidation Preference) for any securities or units issued in a
Subsequent Financing on dollar-for-dollar basis. As a result, we
may currently be required to issue additional shares of Series C
Preferred Stock to any holders of Series B Preferred Stock who
elect to exercise this right. Any shares of Series C Preferred
Stock to be issued pursuant to this right would, upon issuance, be
immediately converted into underlying shares of our common
stock.
The
holders of the Series B Preferred Stock, voting as a separate
class, will have customary consent rights with respect to certain
corporate actions by us. We may not take the following actions
without the prior consent of the holders of at least a majority of
the Series B Preferred Stock then outstanding: (a) authorize,
create, designate, establish, issue or sell an increased number of
shares of Series B Preferred Stock or any other class or series of
capital stock ranking senior to or on parity with the Series B
Preferred Stock as to dividends or upon liquidation; (b) reclassify
any shares of common stock or any other class or series of capital
stock into shares having any preference or priority as to dividends
or upon liquidation superior to or on parity with any such
preference or priority of Series B Preferred Stock; (c) amend,
alter or repeal our Charter or Bylaws and the powers, preferences,
privileges, relative, participating, optional and other special
rights and qualifications, limitations and restrictions thereof,
which would adversely affect any right, preference, privilege or
voting power of the Series B Preferred Stock; (d) issue any
indebtedness or debt security, other than trade accounts payable,
insurance premium financings and/or letters of credit, performance
bonds or other similar credit support incurred in the ordinary
course of business, or amend, renew, increase, or otherwise alter
in any material respect the terms of any such indebtedness existing
as of the date of first issuance of shares of Series B Preferred
Stock; (e) redeem, purchase, or otherwise acquire or pay or declare
any dividend or other distribution on (or pay into or set aside for
a sinking fund for any such purpose) any of our capital stock; (f)
declare bankruptcy, dissolve, liquidate, or wind up our affairs;
(g) effect, or enter into any agreement to effect, a Change of
Control (as defined in the Series B Certificate of Designations);
or (h) materially modify or change the nature of our
business.
Warrants
Investor Warrants
The
following is a summary of the material terms and provisions of the
Investor Warrants that were offered in the concurrent Private
Placement. This summary is subject to and qualified in its entirety
by the form of Investor Warrant.
The Investor
Warrants have an exercise price of $0.80 per share. The Investor
Warrants have a term of five and one-half years. The exercise price
and number of shares of Common Stock issuable upon exercise are
subject to appropriate adjustment in the event of share dividends,
share splits, reorganizations or similar events affecting our
shares of Common Stock. Investor Warrants will be issued in
certificated form only.
The Investor
Warrants are exercisable, at the option of each holder, in whole or
in part, by delivering to us a duly executed exercise notice
accompanied by payment in full for the number of shares of Common
Stock purchased upon such exercise (except in the case of a
cashless exercise as discussed below). A holder (together with its
affiliates) may not exercise any portion of such holder’s
Investor Warrants to the extent that the holder would own more than
4.99% (or, at the election of the purchaser, 9.99%) of our
outstanding shares of Common Stock immediately after exercise,
except that upon at least 61 days’ prior notice from the
holder to us, the holder may increase the amount of ownership of
outstanding shares of Common Stock after exercising the
holder’s Investor Warrants up to 9.99% of the number of
shares of Common Stock outstanding immediately after giving effect
to the exercise, as such percentage ownership is determined in
accordance with the terms of the Investor
Warrants.
If at the time of exercise of the Investor Warrant
there is no effective registration statement registering, or the
prospectus contained therein is not available for the resale of the
shares of Common Stock issuable upon exercise of the Investor
Warrant, then the Investor Warrants will also be exercisable on a
“cashless exercise” basis under which the holder will
receive upon such exercise a net number of common shares determined
according to a formula set forth in the Investor
Warrants.
In
the event of any fundamental transaction, as described in the
Investor Warrants and generally including any merger with or into
another entity, sale of all or substantially all of our assets,
tender offer or exchange offer, or reclassification of our shares
of Common Stock, then upon any subsequent exercise of an Investor
Warrant, the holder will have the right to receive as alternative
consideration, for each share of Common Stock that would have been
issuable upon such exercise immediately prior to the occurrence of
such fundamental transaction, the number of shares of Common Stock
of the successor or acquiring corporation or of our company, if it
is the surviving corporation, and any additional consideration
receivable upon or as a result of such transaction by a holder of
the number of shares of Common Stock for which the Investor Warrant
is exercisable immediately prior to such event. In addition, in the
event of a fundamental transaction which is approved by our board
of directors, the holder has the right to require us or a successor
entity to redeem the Investor Warrant for cash in the amount of the
Black-Scholes value of the unexercised portion of the Investor
Warrant on the date of the consummation of the fundamental
transaction. In the event of a fundamental transaction which is not
approved by our Board, the holders of the Investor Warrants have
the right to require us or a successor entity to redeem the
Investor Warrant for the consideration paid in the fundamental
transaction in the amount of the Black Scholes value of
the unexercised portion of the Investor Warrant on the date of the
consummation of the fundamental transaction.
In
accordance with its terms and subject to applicable laws, an
Investor Warrant may be transferred at the option of the holder
upon surrender of the Investor Warrant to us together with the
appropriate instruments of transfer and payment of funds sufficient
to pay any transfer taxes (if applicable).
No
fractional shares of Common Stock will be issued upon the exercise
of the Investor Warrants. Rather, the number of shares of Common
Stock to be issued will, at our election, either be rounded up to
the nearest whole number or we will pay a cash adjustment in
respect of such final fraction in an amount equal to such fraction
multiplied by the exercise price.
There
is no established trading market for the Investor Warrants, and we
do not expect a market to develop. We do not intend to apply for a
listing for the Investor Warrants on any securities exchange or
other nationally recognized trading system. Without an active
trading market, the liquidity of the Investor Warrants will be
limited.
Except
as otherwise provided in the Investor Warrants or by virtue of the
holders’ ownership of shares of Common Stock, the holders of
Investor Warrants do not have the rights or privileges of holders
of our shares of Common Stock, including any voting rights, until
such Investor Warrant holders exercise their warrants.
An
Investor Warrant may be modified or amended or the provisions
thereof waived with the written consent of our company and the
holder of the Investor Warrant.
Pre-funded Warrants
The
following is a summary of the material terms and provisions of the
Pre-funded Warrants. This summary is subject to and qualified in
its entirety by the form of Pre-funded Warrant.
The
Series C Certificate of Designations provides for the issuance of
Pre-funded Warrants if necessary to comply with the Beneficial
Ownership Limitation. The Pre-funded Warrants are exercisable at a
price of $0.001 per share and are not subject to expiration. We are
prohibited from effecting an exercise of any Pre-funded Warrants to
the extent that such exercise would result in the number of shares
of Common Stock beneficially owned by such holder and its
affiliates exceeding 4.99% of the total number of shares of Common
Stock outstanding immediately after giving effect to the exercise,
which percentage may be increased or decreased at the
holder’s election not to exceed 9.99%.
Registration Rights
Within
30 calendar days of the closing of the Offerings, pursuant to the
Registration Rights Agreement we entered into with the Selling
Stockholder named herein, we are required to file a registration
statement to register the shares of Common Stock issuable upon: (i)
the conversion of the Series C Preferred Stock sold in the Private
Placement, (ii) the exercise of the Investor Warrants and (iii) the
exercise of any Pre-funded Warrants issued upon the conversion of
the Series C Preferred Stock sold in the Private Placement; and to
cause such and to cause such registration statement to be declared
effective under the Securities Act as promptly as possible after
the filing thereof, but in any event no later than 120 days
following the closing date of the Offering, and shall use our best
efforts to keep such registration statement continuously effective
under the Securities Act until the date that all Registrable
Securities covered by such registration statement have been sold or
are otherwise able to be sold pursuant to Rule 144. We are filing
the registration statement of which this prospectus forms a part to
register the resale of the Registerable Securities by the selling
stockholder named herein in compliance with our obligations under
the Registration Rights Agreement.
Listing
Our
Common Stock is listed on The Nasdaq Capital Market under the
symbol “AZRX”.
Transfer Agent
The
transfer agent and registrar for our Common Stock is Colonial Stock
Transfer, 66 Exchange Place, 1st Floor, Salt Lake City, Utah 84111,
Tel: (801) 355-5740.
Anti-Takeover Effects of Certain Provisions of Delaware Law and of
Our Certificate of Incorporation and Bylaws
Certain
provisions of Delaware law, our Charter and Bylaws discussed below
may have the effect of making more difficult or discouraging a
tender offer, proxy contest or other takeover attempt. These
provisions are expected to encourage persons seeking to acquire
control of our company to first negotiate with our Board of
Directors. We believe that the benefits of increasing our ability
to negotiate with the proponent of an unfriendly or unsolicited
proposal to acquire or restructure our company outweigh the
disadvantages of discouraging these proposals because negotiation
of these proposals could result in an improvement of their
terms.
Delaware Anti-Takeover Law.
We are
subject to Section 203 of the Delaware General Corporation
Law. Section 203 generally prohibits a public Delaware
corporation from engaging in a “business combination”
with an “interested stockholder” for a period of three
years after the date of the transaction in which the person became
an interested stockholder, unless:
●
prior
to the date of the transaction, the Board of Directors of the
corporation approved either the business combination or the
transaction which resulted in the stockholder becoming an
interested stockholder;
●
upon
consummation of the transaction that resulted in the stockholder
becoming an interested stockholder, the interested stockholder
owned at least 85% of the voting stock of the corporation
outstanding at the time the transaction commenced, excluding
specified shares; or
●
at or
subsequent to the date of the transaction, the business combination
is approved by the Board of Directors and authorized at an annual
or special meeting of stockholders, and not by written consent, by
the affirmative vote of at least 66 2/3% of the outstanding voting
stock which is not owned by the interested
stockholder.
Section 203
defines a “business combination” to
include:
●
any
merger or consolidation involving the corporation and the
interested stockholder;
●
any
sale, lease, exchange, mortgage, pledge, transfer or other
disposition of 10% or more of the assets of the corporation to or
with the interested stockholder;
●
subject
to exceptions, any transaction that results in the issuance or
transfer by the corporation of any stock of the corporation to the
interested stockholder;
●
subject
to exceptions, any transaction involving the corporation that has
the effect of increasing the proportionate share of the stock of
any class or series of the corporation beneficially owned by the
interested stockholder; or
●
the
receipt by the interested stockholder of the benefit of any loans,
advances, guarantees, pledges or other financial benefits provided
by or through the corporation.
In
general, Section 203 defines an “interested
stockholder” as any person that is:
●
the
owner of 15% or more of the outstanding voting stock of the
corporation;
●
an
affiliate or associate of the corporation who was the owner of 15%
or more of the outstanding voting stock of the corporation at any
time within three years immediately prior to the relevant date;
or
●
the
affiliates and associates of the above.
Under
specific circumstances, Section 203 makes it more difficult
for an “interested stockholder” to effect various
business combinations with a corporation for a three-year period,
although the stockholders may, by adopting an amendment to the
corporation’s certificate of incorporation or bylaws, elect
not to be governed by this section, effective 12 months after
adoption.
Our
Charter and Bylaws do not exclude us from the restrictions of
Section 203. We anticipate that the provisions of
Section 203 might encourage companies interested in acquiring
us to negotiate in advance with our Board of Directors since the
stockholder approval requirement would be avoided if a majority of
the directors then in office approve either the business
combination or the transaction that resulted in the stockholder
becoming an interested stockholder.
Charter and Bylaws.
Provisions of our
Charter and Bylaws may delay or discourage transactions involving
an actual or potential change of control or change in our
management, including transactions in which stockholders might
otherwise receive a premium for their shares, or transactions that
our stockholders might otherwise deem to be in their best
interests. Therefore, these provisions could adversely affect the
price of our Common Stock.
The Common Stock being offered by the selling
stockholder are those previously issued to the selling stockholder,
and those issuable to the selling stockholder, upon conversion of
the Series C preferred stock or exercise of the warrants. For
additional information regarding the issuances of those shares of
Common Stock and warrants, see “Prospectus Summary—
Registered Direct Offering and Private Placement” above. We are registering the shares of
Common Stock in order to permit the selling stockholder to offer
the shares for resale from time to time. Except for the ownership
of the shares of Common Stock and the warrants, the selling
stockholder has not had any material relationship with us within
the past three years.
The
table below lists the selling stockholder and other information
regarding the beneficial ownership of the shares of Common Stock by
the selling stockholder. The second column lists the number of
shares of Common Stock beneficially owned by the selling
stockholder, based on its ownership of the shares of Common Stock,
shares of Series C preferred Stock, Pre-funded Warrants and
Investor Warrants, as of March 31, 2021, assuming exercise of the
warrants held by the selling stockholder on that date, without
regard to any limitations on exercises.
The
third column lists the shares of Common Stock being offered by this
prospectus by the selling stockholder.
In accordance with the terms of the Registration
Rights Agreement with the selling stockholder, this prospectus
generally covers the resale of the sum of the maximum number of
shares of Common Stock issued or issuable to the selling
stockholder upon conversion of the Series C Preferred Stock or
exercise of the Pre-funded warrants, the Investor Warrants, in each
case as described in the “Prospectus Summary—
Registered Direct Offering and Private Placement” above, determined as if such securities
were converted or exercised in full, each as of the trading day
immediately preceding the applicable date of determination, and all
subject to adjustment as provided in the Registration Rights
Agreement, without regard to any limitations on the conversion or
exercise thereof. The fourth column assumes the sale of all of the
shares offered by the selling stockholder pursuant to this
prospectus.
The terms of the Series C Preferred Stock prevent
the holder thereof from acquiring shares of Common Stock upon
conversion that would result in the number of shares beneficially
owned by such holder and its affiliates exceeding 9.99% of the
total number of shares of Common Stock outstanding immediately
after giving effect to the conversion. Further, holders of the
Investor Warrants may not exercise any portion of such
holder’s Investor Warrants to the extent that the holder
would own more than 4.99% (or, at the election of the holder,
9.99%) of our outstanding shares of Common Stock immediately after
giving effect to the exercise. The numbers of shares reported below
do not reflect these limitations. The selling stockholder may sell
all, some or none of its shares in this offering. See
"Plan of
Distribution."
|
|
Number of Shares of Common Stock Owned Prior to
Offering
|
Maximum Number of shares of Common Stock to be Sold Pursuant to
this Prospectus
|
Number Shares of Common Stock Owned After
Offering
|
|
Name of Selling Stockholder
|
|
|
|
|
Armistice Capital
Master Fund Ltd. (1)
|
14,655,805
|
10,666,668
|
3,989,137
|
|
(1)
|
Consists of (i) 10,666,668 shares of Common Stock issuable
upon exercise of Investor Warrants (the exercise of the Investor
Warrants is subject to certain beneficial ownership limitations set
forth in the Investor Warrants), the resale of which is registered
hereby, (ii) 59,863 shares of restricted Common Stock previously
issued in respect of accrued dividends on the Series C Preferred
Stock, which accrued prior to the Stockholder Approvals, and (iii)
3,929,274 shares of Common Stock issuable upon the exercise of
warrants unrelated to the Offerings (the exercise of these warrants
is subject to certain beneficial ownership limitations set forth in
the warrants). The Selling Stockholder has previously resold
pursuant to this registration statement an aggregate of 5,333,334
shares of Common Stock, which were previously issued upon
conversion of shares of Series C Preferred stock (including any
Pre-funded Warrants) originally purchased in the Private Placement.
Armistice Capital, LLC, the investment manager of Armistice and
Steven Boyd, the managing member of Armistice Capital, LLC, hold
shared voting and dispositive power over the shares held by
Armistice. Each of Armistice Capital, LLC and Steven Boyd disclaims
beneficial ownership of the securities listed except to the extent
of their pecuniary interest therein. The address of Armistice
Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison
Avenue, 7th Floor, New York, NY 10022.
|
The
selling stockholders of the securities and any of their pledgees,
assignees and successors-in-interest may, from time to time, sell
any or all of their securities covered hereby on The Nasdaq Capital
Market or any other stock exchange, market or trading facility on
which the securities are traded or in private transactions. These
sales may be at fixed or negotiated prices. A selling stockholder
may use any one or more of the following methods when selling
securities:
●
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
●
block
trades in which the broker-dealer will attempt to sell the
securities 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;
●
settlement
of short sales;
●
in
transactions through broker-dealers that agree with the selling
stockholders to sell a specified number of such securities at a
stipulated price per security;
●
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
●
a
combination of any such methods of sale; or
●
any
other method permitted pursuant to applicable law.
The
selling stockholders may also sell securities under Rule 144 or any
other exemption from registration under the Securities Act, if
available, rather than under this prospectus.
Broker-dealers
engaged by the selling stockholders may arrange for other
brokers-dealers to participate in sales. Broker-dealers may receive
commissions or discounts from the selling stockholders (or, if any
broker-dealer acts as agent for the purchaser of securities, from
the purchaser) in amounts to be negotiated, but, except as set
forth in a supplement to this Prospectus, in the case of an agency
transaction not in excess of a customary brokerage commission in
compliance with FINRA Rule 2440; and in the case of a principal
transaction a markup or markdown in compliance with FINRA
IM-2440.
In
connection with the sale of the securities or interests therein,
the selling stockholders may enter into hedging transactions with
broker-dealers or other financial institutions, which may in turn
engage in short sales of the securities in the course of hedging
the positions they assume. The selling stockholders may also sell
securities short and deliver these securities to close out their
short positions, or loan or pledge the securities to broker-dealers
that in turn may sell these securities. The selling stockholders
may also enter into option or other transactions with
broker-dealers or other financial institutions or create one or
more derivative securities which require the delivery to such
broker-dealer or other financial institution of securities offered
by this prospectus, which securities such broker-dealer or other
financial institution may resell pursuant to this prospectus (as
supplemented or amended to reflect such
transaction).
The
selling stockholders and any broker-dealers or agents that are
involved in selling the securities may be deemed to be
“underwriters” within the meaning of the Securities Act
in connection with such sales. In such event, any commissions
received by such broker-dealers or agents and any profit on the
resale of the securities purchased by them may be deemed to be
underwriting commissions or discounts under the Securities Act.
Each Selling Stockholder has informed us that it does not have any
written or oral agreement or understanding, directly or indirectly,
with any person to distribute the securities.
We
are required to pay certain fees and expenses incurred by us
incident to the registration of the securities. We have agreed to
indemnify the selling stockholders against certain losses, claims,
damages and liabilities, including liabilities under the Securities
Act.
We
agreed to keep this prospectus effective until the earlier of (i)
the date on which the securities may be resold by the selling
stockholders without registration and without regard to any volume
or manner-of-sale limitations by reason of Rule 144, without the
requirement for us to be in compliance with the current public
information under Rule 144 under the Securities Act or any other
rule of similar effect or (ii) all of the securities have been sold
pursuant to this prospectus or Rule 144 under the Securities Act or
any other rule of similar effect. The resale securities will be
sold only through registered or licensed brokers or dealers if
required under applicable state securities laws. In addition, in
certain states, the resale securities covered hereby may not be
sold unless they have been registered or qualified for sale in the
applicable state or an exemption from the registration or
qualification requirement is available and is complied
with.
Under
applicable rules and regulations under the Exchange Act, any person
engaged in the distribution of the resale securities may not
simultaneously engage in market making activities with respect to
the common stock for the applicable restricted period, as defined
in Regulation M, prior to the commencement of the distribution. In
addition, the selling stockholders will be subject to applicable
provisions of the Exchange Act and the rules and regulations
thereunder, including Regulation M, which may limit the timing of
purchases and sales of the common stock by the selling stockholders
or any other person. We will make copies of this prospectus
available to the selling stockholders and have informed them of the
need to deliver a copy of this prospectus to each purchaser at or
prior to the time of the sale (including by compliance with Rule
172 under the Securities Act).
The
validity of the securities offered hereby will be passed upon for
us by Lowenstein Sandler LLP, New York, New York.
EXPERTS
The
audited financial statements incorporated by reference in this
prospectus and elsewhere in the registration statement have been
incorporated by reference in reliance upon the report of Mazars USA
LLP, independent registered public accounting firm, upon the
authority of said firm as experts in accounting and auditing. The
2020 and 2019 audited annual consolidated financial statements of
AzurRx BioPharma, Inc., as of and for the years ended December 31,
2020 and 2019, have been audited by Mazars USA LLP, independent
registered public accounting firm. The audit report dated March 31,
2021 for the 2020 audited annual consolidated financial statements
includes an explanatory paragraph which states that certain
circumstances raise substantial doubt about our ability to continue
as a going concern.
INFORMATION
INCORPORATED BY REFERENCE
The SEC allows us to “incorporate by reference”
information that we file with it into this prospectus, which means
that we can disclose important information to you by referring you
to those documents. The information incorporated by reference is an
important part of this prospectus. The information incorporated by
reference is considered to be a part of this prospectus, and
information that we file later with the SEC will automatically
update and supersede information contained in this
prospectus.
We incorporate by reference the documents listed below that we have
previously filed with the SEC:
●
our Annual Report on Form 10-K for the year ended December 31,
2020, filed on March 31, 2021;
●
our Current Report on Form 8-K, filed January 4, 2021; January 5,
2021; January 8, 2021, as amended on January 13, 2021; February 16,
2021; February 25, 2021; and March 10, 2021;
●
our definitive proxy statements on Schedule 14A, filed on August
11, 2020 and January 19, 2021 (as supplemented by the Definitive
Additional Materials filed on January 20, 2021); and
●
the description of our common stock which is registered under
Section 12 of the Exchange Act, in our registration statement on
Form 8-A, filed on August 8, 2016, including any amendment or
reports filed for the purposes of updating this
description.
We also incorporate by reference all documents we file pursuant to
Section 13(a), 13(c), 14 or 15d of the Exchange Act (other than any
portions of filings that are furnished rather than filed pursuant
to Items 2.02 and 7.01 of a Current Report on Form 8-K) after the
date of the initial registration statement of which this prospectus
is a part and prior to effectiveness of such registration
statement. All documents we file in the future pursuant to Section
13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of
this prospectus and prior to the termination of the offering are
also incorporated by reference and are an important part of this
prospectus.
Any statement contained in a document incorporated or deemed to be
incorporated by reference herein shall be deemed to be modified or
superseded for the purposes of this registration statement to the
extent that a statement contained herein or in any other
subsequently filed document which also is or deemed to be
incorporated by reference herein modifies or supersedes such
statement. Any statement so modified or superseded shall not be
deemed, except as so modified or superseded, to constitute a part
of this registration statement.
WHERE YOU CAN FIND MORE
INFORMATION
We have
filed a registration statement on Form S-1 with the SEC under
the Securities Act of 1933, as amended. This prospectus is part of
the registration statement, but the registration statement includes
additional information and exhibits. We file annual, quarterly and
current reports, proxy statements and other information with the
SEC. The SEC maintains a web site that contains reports, proxy and
information statements and other information regarding companies,
such as ours, that file documents electronically with the SEC. The
website address is www.sec.gov. The information on
the SEC’s website is not part of this prospectus, and any
references to this website or any other website are inactive
textual references only. Additionally, you may access our filings
with the SEC through our website at http://azurrx.com/. The information on
our website is not part of this prospectus.
PART
II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
The
following table sets forth the costs and expenses, other than
placement agent fees, paid or payable by the Registrant, in
connection with the sale and distribution of the securities being
registered. All amounts are estimated except the SEC registration
fee.
|
Item
|
|
|
SEC registration
fee
|
$1,427.02
|
|
Legal fees and
expenses
|
274,000
|
|
Accounting fees and
expenses
|
15,000
|
|
Printing and
engraving expenses
|
2,000
|
|
Transfer agent and
registrar fees and expenses
|
2,000
|
|
Miscellaneous fees
and expenses
|
5,572.98
|
|
Total
|
$300,000
|
Item 14. Indemnification of Directors and Officers
Amended and Restated Bylaws
Pursuant to our
bylaws, our directors and officers will be indemnified to the
fullest extent allowed under the laws of the State of Delaware for
their actions in their capacity as our directors and
officers.
We must
indemnify any person made a party to any threatened, pending, or
completed action, suit, or proceeding, whether civil, criminal,
administrative, or investigative (“Proceeding”) by
reason of the fact that he is or was a director, against judgments,
penalties, fines, settlements and reasonable expenses (including
attorney’s fees) (“Expenses”) actually and
reasonably incurred by him in connection with such Proceeding if:
(a) he conducted himself in good faith, and: (i) in the case of
conduct in his own official capacity with us, he reasonably
believed his conduct to be in our best interests, or (ii) in all
other cases, he reasonably believes his conduct to be at least not
opposed to our best interests; and (b) in the case of any criminal
Proceeding, he had no reasonable cause to believe his conduct was
unlawful.
We must
indemnify any person made a party to any Proceeding by or in the
right of us, by reason of the fact that he is or was a director,
against reasonable expenses actually incurred by him in connection
with such proceeding if he conducted himself in good faith, and:
(a) in the case of conduct in his official capacity with us, he
reasonably believed his conduct to be in our best interests; or (b)
in all other cases, he reasonably believed his conduct to be at
least not opposed to our best interests; provided that no such
indemnification may be made in respect of any proceeding in which
such person shall have been adjudged to be liable to
us.
No
indemnification will be made by unless authorized in the specific
case after a determination that indemnification of the director is
permissible in the circumstances because he has met the applicable
standard of conduct.
Reasonable expenses
incurred by a director who is party to a proceeding may be paid or
reimbursed by us in advance of the final disposition of such
Proceeding in certain cases.
We have
the power to purchase and maintain insurance on behalf of any
person who is or was our director, officer, employee, or agent or
is or was serving at our request as an officer, employee or agent
of another corporation, partnership, joint venture, trust, other
enterprise, or employee benefit plan against any liability asserted
against him and incurred by him in any such capacity or arising out
of his status as such, whether or not we would have the power to
indemnify him against such liability under the provisions of the
amended and restated bylaws.
Delaware Law
We are
incorporated under the laws of the State of Delaware. Section 145
of the Delaware General Corporation Law provides that a Delaware
corporation may indemnify any persons who are, or are threatened to
be made, parties to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by or in the right of such
corporation), by reason of the fact that such person was an
officer, director, employee or agent of such corporation, or is or
was serving at the request of such person as an officer, director,
employee or agent of another corporation or enterprise. The
indemnity may include expenses (including attorneys’ fees),
judgments, fines and amounts paid in settlement actually and
reasonably incurred by such person in connection with such action,
suit or proceeding, provided that such person acted in good faith
and in a manner he or she reasonably believed to be in or not
opposed to the corporation’s best interests and, with respect
to any criminal action or proceeding, had no reasonable cause to
believe that his or her conduct was illegal. A Delaware corporation
may indemnify any persons who are, or are threatened to be made, a
party to any threatened, pending or completed action or suit by or
in the right of the corporation by reason of the fact that such
person was a director, officer, employee or agent of such
corporation, or is or was serving at the request of such
corporation as a director, officer, employee or agent of another
corporation or enterprise. The indemnity may include expenses
(including attorneys’ fees) actually and reasonably incurred
by such person in connection with the defense or settlement of such
action or suit provided such person acted in good faith and in a
manner he or she reasonably believed to be in or not opposed to the
corporation’s best interests except that no indemnification
is permitted without judicial approval if the officer or director
is adjudged to be liable to the corporation. Where an officer or
director is successful on the merits or otherwise in the defense of
any action referred to above, the corporation must indemnify him or
her against the expenses which such officer or director has
actually and reasonably incurred. Our amended and restated
certificate of incorporation and amended and restated bylaws
provide for the indemnification of our directors and officers to
the fullest extent permitted under the Delaware General Corporation
Law.
Section
102(b)(7) of the Delaware General Corporation Law permits a
corporation to provide in its certificate of incorporation that a
director of the corporation shall not be personally liable to the
corporation or its stockholders for monetary damages for breach of
fiduciary duties as a director, except for liability for
any:
●
transaction
from which the director derives an improper personal
benefit;
●
act or
omission not in good faith or that involves intentional misconduct
or a knowing violation of law;
●
unlawful
payment of dividends or redemption of shares; or
●
breach
of a director’s duty of loyalty to the corporation or its
stockholders.
Our
amended and restated certificate of incorporation and amended and
restated bylaws include such a provision. Expenses incurred by any
officer or director in defending any such action, suit or
proceeding in advance of its final disposition shall be paid by us
upon delivery to us of an undertaking, by or on behalf of such
director or officer, to repay all amounts so advanced if it shall
ultimately be determined that such director or officer is not
entitled to be indemnified by us.
Section
174 of the Delaware General Corporation Law provides, among other
things, that a director who willfully or negligently approves of an
unlawful payment of dividends or an unlawful stock purchase or
redemption may be held liable for such actions. A director who was
either absent when the unlawful actions were approved, or dissented
at the time, may avoid liability by causing his or her dissent to
such actions to be entered in the books containing minutes of the
meetings of the board of directors at the time such action occurred
or immediately after such absent director receives notice of the
unlawful acts.
Indemnification Agreements
As
permitted by the Delaware General Corporation Law, we have entered,
and intend to continue to enter, into separate indemnification
agreements with each of our directors and executive officers, that
require us to indemnify such persons against any and all expenses
(including attorneys’ fees), witness fees, damages,
judgments, fines, settlements and other amounts incurred (including
expenses of a derivative action) in connection with any action,
suit or proceeding, whether actual or threatened, to which any such
person may be made a party by reason of the fact that such person
is or was a director, an officer or an employee of us or any of our
affiliated enterprises, provided that such person acted in good
faith and in a manner such person reasonably believed to be in or
not opposed to our best interests and, with respect to any criminal
proceeding, had no reasonable cause to believe his or her conduct
was unlawful. The indemnification agreements also set forth certain
procedures that will apply in the event of a claim for
indemnification thereunder.
At
present, there is no pending litigation or proceeding involving any
of our directors or executive officers as to which indemnification
is required or permitted, and we are not aware of any threatened
litigation or preceding that may result in a claim for
indemnification.
We have
an insurance policy covering our officers and directors with
respect to certain liabilities, including liabilities arising under
the Securities Act or otherwise.
Insofar
as indemnification for liabilities arising under the Securities Act
may be permitted to our directors, officers or controlling persons,
we have been advised that in the opinion of the SEC this
indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable.
Item 15. Recent Resales of Unregistered Securities
On
December 7, 2018, we entered into an asset sale and purchase
agreement (the “Protea Purchase Agreement”) with Protea
Biosciences Group, Inc. and its wholly owned subsidiary, Protea
Biosciences, Inc. (“Protea”), pursuant to which we
agreed to purchase the rights to any milestone payments, royalty
payments, and transaction value consideration due from us to the
Protea now or in the future. Pursuant to the Protea Purchase
Agreement, the purchase price was $1,550,000, of which $250,000 was
paid by us in cash and the remaining $1,300,000 was paid by the
issuance of restricted shares of Common Stock at a price of $1.77
per share. The issuance of the shares of Common Stock to Protea was
exempt from registration under the Securities Act of 1933, as
amended, in reliance upon Section 4(a)(2) (or Regulation D
promulgated thereunder).
On
February 14, 2019, we entered into a Note Purchase Agreement (the
“NPA”), with ADEC Private Equity Investments, LLC
(“ADEC”), pursuant to which we issued to ADEC two
Senior Convertible Promissory Notes in the principal amount of $1.0
million per note, resulting in gross proceeds to us of $2.0
million.
On
April 2, 2019, in connection with a public offering of our Common
Stock and pursuant to a Selling Agent Agreement, we issued warrants
to the selling agent to purchase up to 38,848 shares of Common
Stock. The warrants expire on April 2, 2024 and have an exercise
price of $2.55 per share. The sale of the warrants was exempt from
registration under the Securities Act of 1933, as amended, in
reliance upon Section 4(a)(2) (or Regulation D promulgated
thereunder).
On May
13, 2019, in connection with a public offering of our Common Stock
and pursuant to a Selling Agent Agreement, we issued warrants to
the selling agent to purchase up to 36,815 shares of Common Stock.
The warrants expire on May 9, 2024 and have an exercise price of
$2.82 per share. The sale of the warrants was exempt from
registration under the Securities Act of 1933, as amended, in
reliance upon Section 4(a)(2) (or Regulation D promulgated
thereunder).
On July
22, 2019, in connection with a public offering of our Common Stock
and pursuant to an Underwriting Agreement, issued unregistered
warrants to the underwriter to purchase up to 200,000 shares of
common stock. The warrants expire on July 17, 2024 and have an
exercise price of $1.25 per share. The sale of the warrants was
exempt from registration under the Securities Act of 1933, as
amended, in reliance upon Section 4(a)(2) (or Regulation D
promulgated thereunder).
On
November 13, 2019, we issued to an investor 487,168
shares of Common Stock as commitment shares in consideration for
entering into an equity line agreement with us.
Between
December 20, 2019 and January 9, 2020, we sold senior convertible
promissory notes to investors in the aggregate principal amount of
$2,942,700 and warrants to purchase an aggregate of up to 1,516,888
shares of Common Stock. We issued to the placement agent in the
offering warrants to purchase an aggregate of 498,229 shares of
Common Stock. The sale of the warrants was exempt from registration
under the Securities Act of 1933, as amended, in reliance upon
Section 4(a)(2) (or Regulation D promulgated
thereunder).
On July
16, 2020, we issued an aggregate of 2,912.583124 shares of Series B
Convertible Preferred Stock, at a price of $7,700.00 per share,
initially convertible into an aggregate of 29,125,833 shares of our
Common Stock at $0.77 per share, together with Series B Warrants to
purchase an aggregate of 14,562,957 shares of Common Stock at an
exercise price of $0.85 per share. An aggregate of 1,975.578900
shares of Series B Preferred Stock initially convertible into
19,755,795 shares of Common Stock and related 7,379,790 Series B
Warrants were issued for cash consideration, resulting in aggregate
gross proceeds to us of approximately $15.2 million. In addition,
the balance of an aggregate of 937.004221 shares of Series B
Preferred Stock initially convertible into 9,370,039 shares of
Common Stock and related Series B Warrants to purchase 4,685,040
shares of Common Stock was issued to certain investors in exchange
for consideration consisting of approximately $6.9 million
aggregate outstanding principal amount, together with accrued and
unpaid interest thereon of approximately $0.3 million, of certain
Senior Convertible Promissory Notes issued between December 20,
2019 and January 9, 2020. As additional consideration to the
Exchange Investors, we also issued certain additional warrants to
purchase an aggregate of 1,772,972 shares of Common Stock at an
exercise price of $0.85 per share. We issued to the placement agent
in the offerings warrants to purchase up to 7.0% of the aggregate
number of shares of Common Stock underlying the Series B Preferred
Stock sold for cash consideration in the Private Placement, or
1,377,458 shares. The issuance of these securities was made
pursuant to Section 4(2) of the Securities Act, and the rules
promulgated thereunder, to accredited investors.
During
the period from April 6, 2020 through May 22, 2020, we sold an
aggregate of 1,345,199 shares of Common Stock pursuant to an equity
line agreement, from which we derived approximately $869,000 in net
proceeds. The sales of these shares under the equity line agreement
was exempt from registration under the Securities Act of 1933, as
amended, in reliance upon Section 4(a)(2) (or Regulation D
promulgated thereunder).
On
January 5, 2021, in a private placement offering we sold to an
investor 5,333.3333 shares of Series C Preferred Stock, which
shares are convertible into an aggregate of 5,333,334 shares of
Common Stock, together with warrants to purchase up to an aggregate
of 10,666,668 shares of Common Stock, with an exercise price of
$0.80 per share and an expiration term of five and one-half years
from the date of issuance. The aggregate gross proceeds from the
offering, excluding the net proceeds, if any, from the exercise of
the Private Placement Warrants will be approximately $8.0 million.
The issuance of these securities was made pursuant to Section 4(2)
of the Securities Act, and the rules promulgated thereunder, to
accredited investors.
On
January 8, 2021, in connection with entering into a license
agreement with a third party, we entered into a securities purchase
agreement where we issued 3,290.1960 shares of Series C Preferred
Stock, initially convertible into an aggregate of 3,290,196 shares
of Common Stock, at an initial stated value of $750.00 per share
and a conversion price of $0.75 per share. The Series C
Preferred Stock issued, together with any Common Stock issuable
upon conversion, were issued without registration under the
Securities Act in reliance on the exemptions provided by Section
4(a)(2) of the Securities Act as transactions not involving a
public offering.
Item 16. Exhibits and Financial Statement Schedules.
See the
Exhibit Index attached to this Registration Statement, which is
incorporated by reference herein.
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(b)
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Financial Statement Schedules
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No
financial statement schedules are provided because the information
called for is not required or is shown either in the financial
statements or the notes thereto.
Item 17. Undertakings
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 Securities and Exchange Commission
pursuant to Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than 20% change in the maximum
aggregate offering price set forth in the “Calculation of
Registration Fee” table in the effective registration
statement.
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 Exchange Act that are
incorporated by reference in 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, 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, 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 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 registrant relating to
the offering filed pursuant to Rule 424;
(ii)
any
free writing prospectus relating to the offering prepared by or on
behalf of the registrant or used or referred to by the
registrant;
(iii)
the
portion of any other free writing prospectus relating to the
offering containing material information about the registrant or
its securities provided by or on behalf of the registrant;
and
(iv)
any
other communication that is an offer in the offering made by the
registrant to the purchaser.
6. That, for purposes of determining any liability under the
Securities Act of 1933, each filing of the registrant’s
annual report pursuant to Section 13(a) or 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.
7. 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 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 Act and will be governed by the final adjudication of such
issue.
EXHIBITS
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Exhibit
No.
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Description
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Amended
and Restated Certificate of Incorporation of the Registrant
(incorporated by reference to Exhibit 3.1 of the Company's
Registration Statement on Form S-1, filed July 13,
2016).
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Amended
and Restated Bylaws of the Registrant (incorporated by reference to
Exhibit 3.2 of the Company's Registration Statement on Form S-1,
filed with the SEC July 13, 2016).
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Certificate
of Amendment to Certificate of Incorporation of the Registrant
(incorporated by reference to Exhibit 3.1 of the Company's Current
Report on Form 8-K, filed with the SEC December 30,
2019).
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Certificate
of the Designations, Powers, Preferences and Rights of Series B
Convertible Preferred Stock (incorporated by reference to Exhibit
3.1 of the Company's Current Report on Form 8-K filed with the SEC
on July 20, 2020.)
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Amended
and Restated Bylaws (incorporated by reference to Exhibit 3.1 of
the Company's Current Report on Form 8-K filed with the SEC on
August 5, 2020.)
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Certificate
of the Designations, Powers, Preferences and Rights of Series C
9.00% Convertible Junior Preferred Stock (incorporated by reference
to Exhibit 3.1 of the Company’s Current Report on Form 8-K
filed with the SEC on January 8, 2021).
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Certificate
of Amendment to the Certificate of Incorporation of the Registrant
(incorporated by reference to the Company’s Current Report on
Form 8-K filed with the SEC on February 25, 2021).
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Form of
Common Stock Certificate (incorporated by reference to Exhibit 4.1
of the Company's Registration Statement on Form S-1, filed with the
SEC on July 29, 2016).
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Form of
Investor Warrant (incorporated by reference to Exhibit 4.2 of the
Company’s Registration Statement on Form S-1 filed with the
SEC on July 13, 2016).
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Form of
Underwriter Warrant (incorporated by reference to Exhibit 4.3 to
the Company's Registration Statement on Form S-1, filed with the
SEC on July 29, 2016).
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Form of
Series A Warrant, dated April 11, 2017 between the Company and
Lincoln Park Capital Fund, LLC (incorporated by reference to
Exhibit 10.3 filed with the Company’s Current Report on Form
8-K filed with the SEC on April 12, 2017).
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Form of
Series A Warrant, dated June 5, 2017 (incorporated by reference to
Exhibit 10.3 filed with the Company’s Current Report on Form
8-K filed with the SEC on June 9, 2017).
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Form of
Series A-1 Warrant, dated June 5, 2017 (incorporated by reference
to Exhibit 10.4 filed with the Company’s Current Report on
Form 8-K filed with the SEC on June 9, 2017).
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Form of
Underwriter Warrant (incorporated by reference to Exhibit 4.1 of
the Company’s Current Report on Form 8-K filed with the SEC
on May 4, 2018).
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Form of
Selling Agent Warrant (incorporated by reference to Exhibit 4.1 of
the Company’s Current Report on Form 8-K filed with the SEC
on April 3, 2019).
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Form of
Selling Agent Warrant (incorporated by reference to Exhibit 4.1 of
the Company’s Current Report on Form 8-K filed with the SEC
on May 14, 2019).
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Form of
Wainwright Warrant (incorporated by reference to Exhibit 4.1 of the
Company’s Current Report on Form 8-K filed with the SEC on
July 22, 2019).
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Form of Warrant (incorporated by reference to Exhibit 4.1 of the
Company’s Current Report on Form 8-K filed with the SEC on
July 20, 2020).
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Form of Warrant for Convertible Notes Offering (incorporated by
reference to Exhibit 4.2 of the Company’s Registration
Statement on Form S-3 filed with the SEC on July 27,
2020).
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Form of Pre-funded Warrant (incorporated by reference to Exhibit
4.1 of the Company’s Current Report on Form 8-K filed with
the SEC on January 4, 2021).
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Form of Private Placement Warrant (incorporated by reference to
Exhibit 4.2 of the Company’s Current Report on Form 8-K filed
with the SEC on January 4, 2021).
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Form of Wainwright Warrant (incorporated by reference to Exhibit
4.1 of the Company’s Current Report on Form 8-K filed with
the SEC on January 8, 2021).
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Form of Pre-Funded Warrant (incorporated by reference to Exhibit
4.1 of the Company’s Current Report on Form 8-K filed with
the SEC on March 10, 2021).
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Form of Warrant (incorporated by reference to Exhibit 4.2 of the
Company’s Current Report on Form 8-K filed with the SEC on
March 10, 2021).
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Form of Wainwright Warrant (incorporated by reference to Exhibit
4.3 of the Company’s Current Report on Form 8-K filed with
the SEC on March 10, 2021).
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Description of Capital Stock (incorporated by reference to Exhibit
4.19 of the Company’s Annual Report on Form 10-K filed with
the SEC on March 31, 2021).
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5.1**
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Opinion of Lowenstein Sandler LLP
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Stock Purchase Agreement dated May 21, 2014 between the Registrant,
Protea Biosciences Group, Inc. and its wholly-owned subsidiary,
Protea Biosciences, Inc (incorporated by reference to Exhibit 10.1
of the Company’s Registration Statement on Form S-1 filed
with the SEC on July 13, 2016).
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Amended and Restated AzurRx BioPharma, Inc. 2014 Omnibus
Equity Incentive Plan (incorporated by reference to Exhibit 10.3 of
the Company’s Registration Statement on Form S-1 filed with
the SEC on July 13, 2016).
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Securities Purchase Agreement dated April 11, 2017 between the
Registrant and Lincoln Park Capital Fund, LLC (incorporated by
reference to Exhibit 10.1 of the Company’s Current Report on
Form 8-K filed with the SEC on April 12, 2017).
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Registration Rights Agreement dated April 11, 2017 between the
Registrant and Lincoln Park Capital Fund, LLC (incorporated by
reference to Exhibit 10.4 of the Company’s Current Report on
Form 8-K filed with the SEC on April 12, 2017).
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Form of Securities Purchase Agreement dated June 5, 2017
(incorporated by reference to Exhibit 10.1 of the Company’s
Current Report on Form 8-K filed with the SEC on June 9,
2017).
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Form of Registration Rights Agreement dated June 5, 2017
(incorporated by reference to Exhibit 10.2 of the Company’s
Current Report on Form 8-K filed with the SEC on April 12,
2017).
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Sublicense Agreement dated August 7, 2017 by and between the
Registrant and TransChem, Inc. (incorporated by reference to
Exhibit 10.1 of the Company’s Current Report on Form 8-K
filed with the SEC on August 11, 2017).
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Asset Sale and Purchase Agreement, dated December 7, 2018, by and
between Protea Biosciences Group, Inc., Protea Biosciences, Inc.
and AzurRx Biopharma, Inc. (incorporated by reference to Exhibit
10.1 of the Company’s Current Report on Form 8-K filed with
the SEC on December 13, 2018).
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|
Registration Rights Agreement, dated February 14, 2019
(incorporated by reference to Exhibit 10.6 of the Company’s
Current Report on Form 8-K filed with the SEC on February 20,
2019).
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Asset Purchase Agreement, by and
between AzurRx BioPharma,
Inc., AzurRx BioPharma SAS
and Laboratoires Mayoly Spindler SAS, dated March
27, 2019 (incorporated by reference to Exhibit 10.25 of the
Company’s Annual Report on Form 10-K filed with the SEC on
April 1, 2019).
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Patent License Agreement, by and
between AzurRx BioPharma, Inc.
and Laboratoires Mayoly Spindler SAS, dated March
27, 2019 (incorporated by reference to Exhibit 10.26 of the
Company’s Annual Report on Form 10-K filed with the SEC on
April 1, 2019).
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Employment Agreement by and between AzurRx BioPharma, Inc. and
James Sapirstein, dated October 8, 2019 (incorporated by reference
to Exhibit 10.1 of the Company’s Current Report on Form 8-K
filed with the SEC on October 11, 2019).
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Securities Purchase Agreement, dated November 13, 2019
(incorporated by reference to Exhibit 10.1 of the Company’s
Current Report on Form 8-K filed with the SEC on November 14,
2019).
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Registration Rights Agreement, dated November 13, 2019
(incorporated by reference to Exhibit 10.2 of the Company’s
Current Report on Form 8-K filed with the SEC on November 14,
2019).
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|
Form of Note Purchase Agreement (incorporated by reference to
Exhibit 10.1 of the Company’s Current Report on Form 8-K
filed with the SEC on December 30, 2019).
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|
Form of Warrant (incorporated by reference to Exhibit 10.3 of the
Company’s Current Report on Form 8-K filed with the SEC on
December 30, 2019).
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Form of Registration Rights Agreement (incorporated by reference to
Exhibit 10.4 of the Company’s Current Report on Form 8-K
filed with the SEC on December 30, 2019).
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Employment Agreement by and between AzurRx BioPharma, Inc. and
Daniel Schneiderman, dated January 1, 2020 (incorporated by
reference to Exhibit 10.1 of the Company’s Current Report on
Form 8-K filed with the SEC on January 6, 2020).
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Form of Purchase Agreement, by and among the Company and the
investors set forth on the signature pages thereto, including the
form of Exchange Addendum (incorporated by reference to Exhibit
10.1 of the Company’s Current Report on Form 8-K filed with
the SEC on July 20, 2020).
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Form of Registration Rights Agreement, by and among the Company and
the investors set forth on the signature page thereto (incorporated
by reference to Exhibit 10.2 of the Company’s Current Report
on Form 8-K filed with the SEC on July 20, 2020).
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First Amendment to 2014 Omnibus Equity Incentive Plan (incorporated
by reference as Exhibit 10.3 of the Company’s Current Report
on Form 8-K filed with the SEC on July 20, 2020).
|
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|
2020 Omnibus Equity Incentive Plan (incorporated by reference to
Exhibit 10.4 of the Company’s Quarterly Report on Form 10-Q
filed with the SEC on November 16, 2020).
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|
|
|
Form of Purchase Agreement (incorporated by reference to Exhibit
10.1 of the Company’s Current Report on Form 8-K filed with
the SEC on January 4, 2021).
|
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|
|
Form of Registration Rights Agreement (incorporated by reference to
Exhibit 10.2 of the Company’s Current Report on Form 8-K
filed with the SEC on January 4, 2021).
|
|
|
|
First Wave Purchase Agreement (incorporated by reference to Exhibit
10.1 of the Company’s Current Report on Form 8-K filed with
the SEC on January 8, 2021).
|
|
|
|
First Wave License Agreement (incorporated by reference to Exhibit
10.1 filed with the Company’s Current Report on Form 8-K
filed with the SEC on January 13, 2021).
|
|
|
|
Form of Purchase Agreement (incorporated by reference to Exhibit
10.1 filed with the Company’s Current Report on Form 8-K
filed with the SEC on March 10, 2021).
|
|
|
|
Subsidiaries of the Registrant (incorporated by reference to
Exhibit 21.1 filed with the Company’s Registration Statement
on Form S-1 filed with the SEC on July 13, 2016).
|
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|
|
Consent of Mazars USA LLP.
|
|
23.2
|
|
Consent of Lowenstein Sandler LLP (included in Exhibit
5.1)
|
|
24.1
|
|
Power
of Attorney (included on signature page)
|
|
101.SCH*
|
|
XBRL Taxonomy Extension Schema
|
|
101.CAL*
|
|
XBRL Taxonomy Extension Calculation Linkbase
|
|
101.DEF*
|
|
XBRL Taxonomy Extension Definition Linkbase
|
|
101.LAB*
|
|
XBRL Taxonomy Extension Label Linkbase
|
|
101.PRE*
|
|
XBRL Taxonomy Extension Presentation Linkbase
|
* Filed
as an exhibit to the Form 10-K filed with the SEC on March 31,
2021.
**
Previously Filed.
***
Filed herewith.
#
Certain portions of this exhibit (indicated by
“[*****]”) have been omitted as we have determined (1)
it is not material and (2) is the type that the Company treats
as private or confidential.
Pursuant to the
requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing on Form S-1 and has duly caused
this registration statement thereto to be signed on its behalf by
the undersigned, thereunto duly authorized, in the City of Del
Ray Beach, Florida on this 6th day of April, 2021.
|
|
AZURRX BIOPHARMA, INC.
|
|
|
By: /s/
James Sapirstein
Name: James Sapirstein
Title: President and Chief Executive
Officer
(Principal Executive
Officer)
|
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in
the capacities and on the dates indicated.
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
|
|
/s/
James Sapirstein
|
|
President,
Chief Executive Officer and Director
|
|
April
6, 2021
|
|
James
Sapirstein
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
/s/
Daniel Schneiderman
|
|
Chief
Financial Officer
|
|
April
6, 2021
|
|
Daniel
Schneiderman
|
|
(Principal Financial Officer and Principal Accounting
Officer)
|
|
|
|
|
|
|
|
|
|
*
|
|
Chair
of the Board of Directors
|
|
April
6, 2021
|
|
Edward
J. Borkowski
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
April
6, 2021
|
|
Charles
Casamento
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
April
6, 2021
|
|
Alastair
Riddell
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
April
6, 2021
|
|
Gregory
Oaks
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
April
6, 2021
|
|
Vern
Lee Schramm
|
|
|
|
|
|
By:
/s/ James
Sapirstein
|
|
Attorney-in-Fact
|
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