AZRX S-3
As filed with the Securities and Exchange Commission on June 4,
2019
Registration No. 333-_______
UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
AZURRX BIOPHARMA, INC.
(Exact Name Of Registrant As Specified In Its Charter)
Delaware
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46-4993860
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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AzurRx BioPharma, Inc.
760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855
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Johan M. (Thijs) Spoor
President and Chief Executive Officer
AzurRx BioPharma, Inc.
760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855
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(Address, including zip code, and telephone number,
including area code of Registrant’s principal executive
offices),
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(Name, address, including zip code, and telephone
number,
including area code, of agent for service)
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From time to time after the effective date of this Registration
Statement
(Approximate date of commencement of proposed sale to
public)
Copies of all communications, including all communications sent to
the agent for service, should be sent to:
Johan M. (Thijs) Spoor
President and Chief Executive Officer
AzurRx BioPharma, Inc.
760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855
Daniel W. Rumsey, Esq.
Jessica R. Sudweeks, Esq.
Disclosure Law Group,
a Professional Corporation
655 West Broadway, Suite 870
San Diego, California 92101
Tel: (619) 272-7050
Fax: (619) 330-2101
If the only securities being registered on this form are being
offered pursuant to dividend or interest reinvestment plans, please
check the following box. [ ]
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415
of the Securities Act of 1933, other than securities offered only
in connection with dividend or interest reinvestment plans, check
the following box. [X]
If this form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same offering. [ ]
If this form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [
]
If this Form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that shall
become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, please check the following
box. [ ]
If this Form is a post-effective amendment to a registration
statement filed pursuant to General Instruction I.D. filed to
register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, please check the
following box. [ ]
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company or an emerging growth company. See the
definitions of “large accelerated filer,”
“accelerated filer,” “smaller reporting
company” and “emerging growth company” in
Rule 12b-2 of the Exchange Act.
Large accelerated filer [ ]
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Accelerated filer [ ]
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Non-accelerated filer [
]
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Smaller reporting company [X]
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Emerging growth company [X]
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If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided Section 7(a)(2)(B) of the Securities Act.
[ ]
CALCULATION OF REGISTRATION FEE
Title of each class of securities to
be registered
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Proposed
Maximum
Offering Price Per Unit
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Proposed
Maximum
Aggregate
Offering Price
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Amount of
Registration
Fee(1)
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Common
Stock, par value $0.0001 per share
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(2)
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(3)
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(3)
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$—
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Preferred
Stock, par value $0.0001 per share
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(2)
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(3)
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(3)
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—
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Warrants
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(2)
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(3)
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(3)
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—
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Units
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(2)
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(3)
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(3)
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—
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Total
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(2)
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(3)
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$50,000,000
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$538
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(1)
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Calculated pursuant to Rule 457(o) under the Securities Act
of 1933, as amended (the “Securities
Act”). Pursuant to Rule
415(a)(6) under the Securities Act, securities with a maximum
aggregate price of $44,357,957 registered hereunder are unsold
shares (the “Unsold
Shares”) previously
covered by the registrant’s registration statement on Form
S-3 (File No. 333-226065), initially filed with the Securities and
Exchange Commission on July 3, 2018 (the “Prior Registration
Statement”). In
accordance with Rule 415(a)(6), registration fees of $5,522 that
were previously paid in connection with the Unsold Shares under the
Prior Registration Statement are being carried forward and will
continue to be applied to the Unsold
Shares.
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(2)
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There are being registered hereunder such indeterminate number of
shares of common stock and preferred stock, and such indeterminate
number of warrants and units as shall have an aggregate offering
price not to exceed $50,000,000. Any securities registered
hereunder may be sold separately or together with other securities
registered hereunder. The securities registered also include such
indeterminate number of shares of common stock and preferred stock
as may be issued upon conversion of or exchange for preferred
stock, upon exercise of warrants or pursuant to the anti-dilution
provisions of any such securities. In addition, pursuant to Rule
416 under the Securities Act, the shares being registered hereunder
include such indeterminate number of shares of common stock and
preferred stock as may be issuable with respect to the shares being
registered hereunder as a result of stock splits, stock dividends
or similar transactions.
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(3)
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The proposed maximum aggregate offering price per class of security
will be determined from time to time by the Registrant in
connection with the issuance by the Registrant of the securities
registered hereunder and is not specified as to each class of
security.
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The Registrant hereby amends this registration statement on such
date or dates as may be necessary to delay its effective date until
the registrant shall file a further amendment which specifically
states that this registration statement shall thereafter become
effective in accordance with Section 8(a) of the Securities Act of
1933 or until the registration statement shall become effective on
such date as the Commission, acting pursuant to said section 8(a),
may determine.
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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
jurisdiction where the offer or sale is not permitted.
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PRELIMINARY
PROSPECTUS
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SUBJECT TO COMPLETION
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DATED JUNE 4, 2019
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$50,000,000
COMMON STOCK
PREFERRED STOCK
WARRANTS
UNITS
From time to time, we may offer and sell, in one or more offerings,
up to $50,000,000 of any combination of the securities described in
this prospectus. We may also offer securities as may be issuable
upon conversion, repurchase, exchange or exercise of any securities
registered hereunder, including any applicable anti-dilution
provisions.
This prospectus provides a general description of the securities we
may offer from time to time. Each time we offer securities, we will
provide specific terms of the securities offered in a supplement to
this prospectus. We may also authorize one or more free writing
prospectuses to be provided to you in connection with an offering.
The prospectus supplement and any related free writing prospectus
may also add, update or change information contained in this
prospectus. You should carefully read this prospectus, the
applicable prospectus supplement and any related free writing
prospectus, as well as any documents incorporated by reference,
before you invest in any of the securities being
offered.
Our common stock is listed on the Nasdaq Capital Market under the
ticker symbol “AZRX.” On June 4, 2019, the last
reported sale price per share of our common stock was $2.20 per
share.
We may offer and sell our securities to or through one or more
agents, underwriters, dealers or other third parties or directly to
one or more purchasers on a continuous or delayed basis. If agents,
underwriters or dealers are used to sell our securities, we will
name them and describe their compensation in a prospectus
supplement. The price to the public of our securities and the net
proceeds we expect to receive from the sale of such securities will
also be set forth in a prospectus supplement. For additional
information on the methods of sale, you should refer to the section
entitled “Plan of
Distribution” in this
prospectus.
As of June 4, 2019, the aggregate market value of our outstanding
common stock held by non-affiliates was approximately $53.4
million, which was calculated in accordance with General
Instruction I.B.6 of Form S-3, based on 18,469,076 shares of
outstanding common stock held by non-affiliates, at a price per
share of $2.89, the closing sale price of our common stock reported
on the Nasdaq Capital Market on May 8, 2019.
Pursuant to General Instruction I.B.6 of Form S-3, in no event will
we sell the securities described in this prospectus in a public
primary offering with a value exceeding more than one-third (1/3)
of the aggregate market value of our common stock held
bynon-affiliates in any twelve (12)-month period, so long as the
aggregate market value of our outstanding common stock held by
non-affiliates remains below $75.0 million. During the twelve (12)
calendar months prior to and including the date of this prospectus,
we have offered and sold $5,642,043 of securities pursuant to
General Instruction I.B.6 of Form S-3. As a result, we are
currently eligible to offer and sell up to an aggregate of
approximately $12.17 million of our securities pursuant to General
Instruction I.B.6. of Form S-3.
Our business and investing in our
securities involves significant risks. You should review carefully
the risks and uncertainties referenced under the heading
“Risk
Factors” on page 4 of
this prospectus, as well as those contained in the applicable
prospectus supplement and any related free writing prospectus, and
in the other documents that are incorporated by reference into this
prospectus or the applicable prospectus
supplement.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal
offense.
The date of this prospectus is ,
2019
TABLE OF CONTENTS
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This prospectus is part of a registration statement filed with the
Securities and Exchange Commission
(the “SEC”), using a “shelf” registration
process. Under this shelf registration process, we may sell
the securities described in this prospectus in one or more
offerings. This prospectus provides you with a general
description of the securities which may be offered. Each time
we offer securities for sale, we will provide a prospectus
supplement that contains information about the specific terms of
that offering. Any prospectus supplement may also add or update
information contained in this prospectus. You should read both
this prospectus and any prospectus supplement together with
additional information described below under
“Where You Can Find More
Information” and
“Incorporation of Certain
Information by Reference.”
THIS PROSPECTUS MAY NOT BE USED TO CONSUMMATE A SALE OF SECURITIES UNLESS IT IS ACCOMPANIED BY A PROSPECTUS SUPPLEMENT.
You should rely only on the information contained or incorporated
by reference in this prospectus, and in any prospectus
supplement. We have not authorized any other person to provide
you with different information. If anyone provides you with
different or inconsistent information, you should not rely on
it. We are not making offers to sell or solicitations to buy
the securities described in this prospectus in any jurisdiction in
which an offer or solicitation is not authorized, or in which the
person making that offer or solicitation is not qualified to do so
or to anyone to whom it is unlawful to make an offer or
solicitation. You should not assume that the information in
this prospectus or any prospectus supplement, as well as the
information we file or previously filed with the SEC that we
incorporate by reference in this prospectus or any prospectus
supplement, is accurate as of any date other than its respective
date. Our business, financial condition, results of operations
and prospects may have changed since those dates.
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 actual documents. Copies of
some of the documents referred to herein have been filed, will be
filed or will be incorporated by reference as exhibits to the
registration statement of which this prospectus is a part, and you
may obtain copies of those documents as described below under the
heading “Where You Can Find More
Information.”
This summary highlights information contained elsewhere in this
prospectus. This summary does not contain all the information you
should consider before buying our securities. You should read the
following summary together with the more detailed information
appearing in this prospectus, including the section titled
“Risk Factors” on page 4, before deciding whether to
purchase our securities.
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 non-systemic biologics for the
treatment of patients with gastrointestinal disorders. Non-systemic
biologics are non-absorbable drugs that act locally, i.e. the
intestinal lumen, skin or mucosa, without reaching an
individual’s systemic circulation. The Company’s
current product pipeline consists of two therapeutic proteins under
development:
MS1819-SD
MS1819-SD is a yeast derived recombinant lipase for exocrine
pancreatic insufficiency (“EPI”)
associated with chronic pancreatitis (“CP”)
and cystic fibrosis (“CF”).
A lipase is an enzyme that breaks up fat molecules. MS1819-SD is
considered recombinant because it was created from new combinations
of genetic material in yeast called Yarrowia lipolytica. In June
2018, the Company completed an open-label, dose escalation Phase
IIa trial of MS1819-SD in France, Australia, and New Zealand to
investigate both the safety of escalating doses of MS1819-SD, and
the efficacy of MS1819-SD through the analysis of each
patient’s coefficient of fat absorption (“CFA”)
and its change from baseline. A total of 11 CP patients with EPI
were enrolled in the study and final data showed a strong safety
and efficacy profile. Although the study was not powered for
efficacy, in a pre-planned analysis, the highest dose cohort of
MS1819-SD showed statistically significant and clinically
meaningful increases in CFA compared to baseline with a mean
increase of 21.8% and a p value of p=0.002 on a per protocol basis.
Additionally, maximal absolute CFA response to treatment was up to
57%, with an inverse relationship to baseline CFA. In October 2018,
the U.S. Food and Drug Administration (“FDA”)
cleared the Company’s Investigational New Drug
(“IND”)
application for MS1819-SD in patients with EPI due to CF. In
connection with the FDA’s clearance of the IND, in the fourth
quarter of 2018 the Company initiated the multi-center Phase II
OPTION study in the United States and Europe (the
“OPTION
Study”), which the
Company expects will include approximately 30 patients. The Company
dosed the first patients in the OPTION Study in February 2019 and
reached 50% of its enrollment target for the OPTION Study in April
2019. The Company expects to conclude and announce topline results
from the OPTION Study in the summer of 2019.
b-Lactamase Program
The Company’s b-lactamase program focuses on products with an
enzymatic combination of bacterial origin for the prevention of
hospital-acquired infections and antibiotic-associated diarrhea
(“AAD”)
by resistant bacterial strains induced by parenteral administration
of several antibiotic classes. Currently, the Company has two
compounds in pre-clinical development in this program, AZX1101 and
AZX1103. Both AZX1101 and AZX1103 are composed of several distinct
enzymes that break up individual classes of antibiotic molecules.
AZX1103 is a b-lactamase enzyme combination that has shown positive
pre-clinical activity, with degradation of amoxicillin in the
presence of clavulanic acid in the upper gastrointestinal tract in
the Gottingen minipig model. Currently, the Company is focused on
advancing pre-clinical development of AZX1103. The Company is also
currently assessing its plans for the continuation of the
development of AZX1101.
Risk Factors
Our business is subject to substantial risk. Please carefully
consider the section titled “Risk
Factors” on page 4 of
this prospectus for a discussion of the factors you should
carefully consider before deciding to purchase securities that may
be offered by this prospectus.
Additional risks and uncertainties not presently known to us or
that we currently deem immaterial may also impair our business
operations. You should be able to bear a complete loss of your
investment.
Corporate Information
We were incorporated on January 30, 2014 in the State of Delaware.
In June 2014, we acquired 100% of the issued and outstanding
capital stock of AzurRx SAS (formerly ProteaBio Europe SAS), a
company incorporated in October 2008 under the laws of France. Our
principal executive offices are located at 760 Parkside Avenue,
Downstate Biotechnology Incubator, Suite 304, Brooklyn, NY 11226.
Our telephone number is (646) 699-7855. We maintain a website at
www.azurrx.com. The information contained on our website is not,
and should not be interpreted to be, a part of this
prospectus.
Investing in our securities involves a high degree of risk. Before
deciding whether to purchase any of our securities, you should
carefully consider the risks and uncertainties described under
“Risk
Factors” in our Annual
Report on Form 10-K for the fiscal year ended
December 31, 2018, any subsequent Quarterly Report on
Form 10-Q and our other filings with the SEC, all of which are
incorporated by reference herein. If any of these risks actually
occur, our business, financial condition and results of operations
could be materially and adversely affected and we may not be able
to achieve our goals, the value of our securities could decline and
you could lose some or all of your investment. Additional risks not
presently known to us or that we currently deem immaterial may also
impair our business operations. If any of these risks occur, the
trading price of our common stock could decline materially and you
could lose all or part of your investment.
CAUTIONARY
NOTES REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus and the documents incorporated by reference herein
contain forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statements of
historical facts, contained in this
prospectus and the documents incorporated by reference herein,
including statements regarding our strategy, future operations, future
financial position, future revenue, projected costs, prospects,
plans, objectives of management and expected market growth, are
forward-looking statements. 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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the
availability of capital to satisfy our working capital
requirements;
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the
accuracy of our estimates regarding expenses, future revenues and
capital requirements;
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our
ability to continue operating as a going concern;
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our
plans to develop and commercialize our principal product
candidates, consisting of MS1819-SD, AZX1103 and
AZX1101;
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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;
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the
size of the potential markets for our product candidates and our
ability to serve those markets;
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the
rate and degree of market acceptance of our product candidates for
any indication once approved;
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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; 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, particularly in the “Risk
Factors” section in this
prospectus and the documents incorporated by reference herein, that
we believe could cause actual 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, the documents incorporated by
reference herein and the documents that we have filed as exhibits
to the registration statement of which this prospectus is a part
completely and with the understanding that our actual future
results may be materially different from what we expect. We qualify
all of the forward-looking statements in this prospectus and the
documents incorporated by reference herein by these cautionary
statements. Except as required by law, we undertake no obligation
to publicly update any forward-looking statements, whether as a
result of new information, future events or otherwise.
Unless otherwise provided in the applicable
prospectus supplement, we intend to use the net proceeds from the
sale of the securities under this prospectus primarily
for research and development expenses associated with continuing
clinical development and testing of MS1819-SD, advancing our
preclinical programs for AZX1103 and for other working capital and
capital expenditures.
Pending
other uses, we intend to invest our proceeds from the offering in
short-term investments or hold them as cash. We cannot predict
whether the proceeds invested will yield a favorable return. Our
management will have broad discretion in the use of the net
proceeds from this offering, and investors will be relying on the
judgment of our management regarding the application of the net
proceeds
DESCRIPTION OF OUR CAPITAL STOCK
General
Our amended and restated certificate of incorporation (our
“Charter”) authorizes the issuance of up to
100,000,000 shares of common stock, par value $0.0001 per share,
and 10,000,000 shares of preferred stock, par value $0.0001 per
share.
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.
Common Stock
This section describes the general terms of our common stock that
we may offer from time to time. For more detailed information, a
holder of our common stock should refer to our Charter and our
amended and restated Bylaws, copies of which are filed with the SEC
as exhibits to our Annual Report on Form 10-K for the year ended
December 31, 2018, which is incorporated by reference into the
registration statement of which this prospectus forms a
part.
As of
June 4, 2019, there were 21,060,055 shares of our common stock
issued and outstanding, which were held by approximately 110
stockholders of record, approximately 3,188,378
shares
of common stock subject to outstanding warrants,
994,000 shares of common stock
subject to outstanding stock options under our Amended and Restated
2014 Omnibus Equity Incentive Plan and 816,438 issuable upon
conversion of outstanding senior convertible notes. Each holder of
common stock is entitled to one vote for each share of common stock
held on all matters submitted to a vote of the stockholders,
including the election of directors. Our Charter and Bylaws do not
provide for cumulative voting rights.
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
This section describes the general terms and provisions of our
outstanding shares of preferred stock, as well as preferred stock
that we may offer from time to time. The applicable prospectus
supplement will describe the specific terms of the shares of
preferred stock offered through that prospectus supplement, which
may differ from the terms we describe below. We will file a
copy of the certificate of designation that contains the terms of
each new series of preferred stock with the SEC each time we issue
a new series of preferred stock, and these certificates of
designation will be incorporated by reference into the registration
statement of which this prospectus is a part. Each certificate of
designation will establish the number of shares included in a
designated series and fix the designation, powers, privileges,
preferences and rights of the shares of each series as well as any
applicable qualifications, limitations or restrictions. A holder of
our preferred stock should refer to the applicable certificate of
designation, our Charter and the applicable prospectus supplement
(and any related free writing prospectus that we may authorize to
be provided to you) for more specific information.
Our Board of Directors has the authority, without action by our
stockholders to designate and issue up to 10,000,000 shares of
preferred stock in one or more series and to designate the rights,
preferences and privileges of each series, which may be greater
than the rights of our common stock. Currently, there are no shares
of our preferred stock that are issued or outstanding.
It is not possible to state the actual effect of any future
issuance of shares of our preferred stock upon the rights of
holders of our common stock until our Board of Directors determines
the specific rights of the holders of our preferred stock. However,
the effects might include, among other things:
●
restricting
dividends on our common stock;
●
diluting
the voting power of our common stock;
●
impairing
the liquidation rights of our common stock; or
●
delaying
or preventing a change in control of our Company without further
action by our stockholders.
A prospectus supplement will describe the terms of any series of
preferred stock being offered, including:
●
the
designation of the shares and the number of shares that constitute
the series;
●
the
dividend rate (or the method of calculation thereof), if any, on
the shares of the series and the priority as to payment of
dividends with respect to other classes or series of our capital
stock and the payment date of dividends;
●
the
dividend periods (or the method of calculation
thereof);
●
the
date from which dividends on the preferred stock shall accumulate,
if applicable;
●
the
voting rights of the shares;
●
the
liquidation preference and the priority as to payment of the
liquidation preference with respect to other classes or series of
our capital stock and any other rights of the shares of the series
upon our liquidation or winding-up;
●
whether
the preferred stock will rank senior or junior to or on a parity
with any other class or series of preferred
stock;
●
whether
or not and on what terms the shares of the series will be subject
to redemption or repurchase at our option;
●
whether
and on what terms the shares of the series will be convertible into
or exchangeable for other securities;
●
the
provision of a sinking fund, if any, for the preferred
stock;
●
whether
the shares of the series of preferred stock will be listed on a
securities exchange;
●
whether
interests in the preferred stock will be represented by depositary
shares;
●
the
transfer agent for the series of preferred
stock;
●
any
special United States federal income tax considerations applicable
to the series; and
●
any
other preferences and rights and any qualifications, limitations or
restrictions of the preferences and rights of the
series.
The following description, together with the additional information
we include in any applicable prospectus supplements or free writing
prospectus, summarizes the material terms and provisions of the
warrants that we may offer under this prospectus. Warrants may be
offered independently or together with common stock or preferred
stock offered by any prospectus supplement or free writing
prospectus, and may be attached to or separate from those
securities. While the terms we have summarized below will generally
apply to any future warrants we may offer under this prospectus, we
will describe the particular terms of any warrants that we may
offer in more detail in the applicable prospectus supplement or
free writing prospectus. The terms of any warrants we offer under a
prospectus supplement or free writing prospectus may differ from
the terms we describe below.
In the event that we issue warrants, we will issue the warrants
under a warrant agreement, which we will enter into with a warrant
agent to be selected by us. Forms of these warrant agreements and
forms of the warrant certificates representing the warrants, and
the complete warrant agreements and forms of warrant certificates
containing the terms of the warrants being offered, will be filed
as exhibits to the registration statement of which this prospectus
is a part or will be incorporated by reference from reports that we
file with the SEC. We use the term “warrant agreement”
to refer to any of these warrant agreements. We use the term
“warrant agent” to refer to the warrant agent under any
of these warrant agreements. The warrant agent will act solely as
an agent of ours in connection with the warrants and will not act
as an agent for the holders or beneficial owners of the
warrants.
The following summaries of material provisions of the warrants and
the warrant agreements are subject to, and qualified in their
entirety by reference to, all the provisions of the warrant
agreement applicable to a particular series of warrants. We urge
you to read the applicable prospectus supplements or free writing
prospectus related to the warrants that we sell under this
prospectus, as well as the complete warrant agreements that contain
the terms of the warrants.
General
We will describe in the applicable prospectus supplement or free
writing prospectus the terms relating to a series of warrants. If
warrants for the purchase of common stock or preferred stock are
offered, the prospectus supplement or free writing prospectus will
describe the following terms, to the extent
applicable:
●
the
offering price and the aggregate number of warrants
offered;
●
the
total number of shares that can be purchased if a holder of the
warrants exercises them and, in the case of warrants for preferred
stock, the designation, total number and terms of the series of
preferred stock that can be purchased upon exercise;
●
the
designation and terms of any series of preferred stock with which
the warrants are being offered and the number of warrants being
offered with each share of common stock or preferred
stock;
●
the
date on and after which the holder of the warrants can transfer
them separately from the related common stock;
●
the
number of shares of common stock or preferred stock that can be
purchased if a holder exercises the warrant and the price at which
such common stock or preferred stock may be purchased upon
exercise, including, if applicable, any provisions for changes to
or adjustments in the exercise price and in the securities or other
property receivable upon exercise;
●
the
terms of any rights to redeem or call, or accelerate the expiration
of, the warrants;
●
the
date on which the right to exercise the warrants begins and the
date on which that right expires;
●
federal
income tax consequences of holding or exercising the warrants;
and
●
any
other specific terms, preferences, rights or limitations of, or
restrictions on, the warrants.
Exercise of Warrants
Each holder of a warrant is entitled to purchase the number of
shares of common stock or preferred stock, as the case may be, at
the exercise price described in the applicable prospectus
supplement or free writing prospectus. After the close of business
on the day when the right to exercise terminates (or a later date
if we extend the time for exercise), unexercised warrants will
become void.
A holder of warrants may exercise them by following the general
procedure outlined below:
●
delivering
to the warrant agent the payment required by the applicable
prospectus supplement or free writing prospectus to purchase the
underlying security;
●
properly
completing and signing the reverse side of the warrant certificate
representing the warrants; and
●
delivering
the warrant certificate representing the warrants to the warrant
agent within five business days of the warrant agent receiving
payment of the exercise price.
If you comply with the procedures described above, your warrants
will be considered to have been exercised when the warrant agent
receives payment of the exercise price, subject to the transfer
books for the securities issuable upon exercise of the warrant not
being closed on such date. After you have completed those
procedures and subject to the foregoing, we will, as soon as
practicable, issue and deliver to you the common stock or preferred
stock that you purchased upon exercise. If you exercise fewer than
all of the warrants represented by a warrant certificate, a new
warrant certificate will be issued to you for the unexercised
amount of warrants. Holders of warrants will be required to pay any
tax or governmental charge that may be imposed in connection with
transferring the underlying securities in connection with the
exercise of the warrants.
Amendments and Supplements to the Warrant Agreements
We may amend or supplement a warrant agreement without the consent
of the holders of the applicable warrants to cure ambiguities in
the warrant agreement, to cure or correct a defective provision in
the warrant agreement, or to provide for other matters under the
warrant agreement that we and the warrant agent deem necessary or
desirable, so long as, in each case, such amendments or supplements
do not materially adversely affect the interests of the holders of
the warrants.
Warrant Adjustments
Unless the applicable prospectus supplement or free writing
prospectus states otherwise, the exercise price of, and the number
of securities covered by, a common stock or a preferred stock
warrant will be adjusted proportionately if we subdivide or combine
our common stock or preferred stock, as applicable. In addition,
unless the prospectus supplement or free writing prospectus states
otherwise, if we, without receiving payment:
●
issue
capital stock or other securities convertible into or exchangeable
for common stock or preferred stock, or any rights to subscribe
for, purchase or otherwise acquire any of the foregoing, as a
dividend or distribution to holders of our common stock or
preferred stock;
●
pay
any cash to holders of our common stock or preferred stock other
than a cash dividend paid out of our current or retained earnings
or other than in accordance with the terms of the preferred
stock;
●
issue
any evidence of our indebtedness or rights to subscribe for or
purchase our indebtedness to holders of our common stock or
preferred stock; or
●
issue
common stock or preferred stock or additional stock or other
securities or property to holders of our common stock or preferred
stock by way of spinoff, split-up, reclassification, combination of
shares or similar corporate rearrangement,
then the holders of common stock or preferred stock warrants will
be entitled to receive upon exercise of the warrants, in addition
to the securities otherwise receivable upon exercise of the
warrants and without paying any additional consideration, the
amount of stock and other securities and property such holders
would have been entitled to receive had they held the common stock
or preferred stock, as applicable, issuable under the warrants on
the dates on which holders of those securities received or became
entitled to receive such additional stock and other securities and
property.
Except as stated above or as otherwise set forth in the applicable
prospectus supplement or free writing prospectus, the exercise
price and number of securities covered by a common stock or
preferred stock warrant, and the amounts of other securities or
property to be received, if any, upon exercise of such warrant,
will not be adjusted or provided for if we issue those securities
or any securities convertible into or exchangeable for those
securities, or securities carrying the right to purchase those
securities or securities convertible into or exchangeable for those
securities.
Holders of common stock and preferred stock warrants may have
additional rights under the following circumstances:
●
certain
reclassifications, capital reorganizations or changes of the common
stock or preferred stock, as applicable;
●
certain
share exchanges, mergers, or similar transactions involving us and
which result in changes of the common stock or preferred stock, as
applicable; or
●
certain
sales or dispositions to another entity of all or substantially all
of our property and assets.
If one of the above transactions occurs and holders of our common
stock or preferred stock are entitled to receive stock, securities
or other property with respect to or in exchange for their
securities, the holders of the common stock warrants and preferred
stock warrants then outstanding, as applicable, will be entitled to
receive, upon exercise of their warrants, the kind and amount of
shares of stock and other securities or property that they would
have received upon the applicable transaction if they had exercised
their warrants immediately before the transaction.
This section outlines some of the provisions of the units and the
unit agreements. This information may not be complete in all
respects and is qualified entirely by reference to the unit
agreement with respect to the units of any particular series. The
specific terms of any series of units will be described in the
applicable prospectus supplement or free writing prospectus. If so
described in a particular prospectus supplement or free writing
prospectus, the specific terms of any series of units may differ
from the general description of terms presented below.
As specified in the applicable prospectus supplement, we may issue
units consisting of one or more shares of common stock, shares of
our preferred stock, warrants or any combination of such
securities.
The applicable prospectus supplement will specify the following
terms of any units in respect of which this prospectus is being
delivered:
●
the
terms of the units and of any of the shares of common stock, shares
of preferred stock, or warrants comprising the units, including
whether and under what circumstances the securities comprising the
units may be traded separately;
●
a
description of the terms of any unit agreement governing the
units;
●
if
appropriate, a discussion of material U.S. federal income tax
considerations; and
●
a
description of the provisions for the payment, settlement, transfer
or exchange of the units.
DESCRIPTION OF CERTAIN PROVISIONS OF DELAWARE LAW
AND
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.
We may sell the securities described in this prospectus to or
through underwriters or dealers, through agents, or directly to one
or more purchasers. A prospectus supplement or supplements (and any
related free writing prospectus that we may authorize to be
provided to you) will describe the terms of the offering of the
securities, including, to the extent applicable:
●
the
name or names of any underwriters or agents, if
applicable;
●
the
purchase price of the securities and the proceeds we will receive
from the sale;
●
any
over-allotment options under which underwriters may purchase
additional securities from us;
●
any
agency fees or underwriting discounts and other items constituting
agents’ or underwriters’ compensation;
●
any
public offering price;
●
any
discounts or concessions allowed or reallowed or paid to dealers;
and
●
any
securities exchange or market on which the securities may be
listed.
We may also sell equity securities covered by this registration
statement in an “at the market offering” as defined in
Rule 415 under the Securities Act. Such offering may be made into
an existing trading market for such securities in transactions at
other than a fixed price, either:
●
On
or through the facilities of the Nasdaq Capital Market or any other
securities exchange or quotation or trading service on which such
securities may be listed, quoted or traded at the time of sale;
and/or
●
to
or through a market maker otherwise than on the Nasdaq Capital
Market or such other securities exchanges or quotation or trading
services.
Such at-the-market offerings, if any, may be conducted by
underwriters acting as principal or agent.
Only underwriters named in a prospectus supplement are underwriters
of the securities offered by the prospectus
supplement.
If underwriters are used in the sale, they will acquire the
securities for their own account and may resell the securities from
time to time in one or more transactions at a fixed public offering
price or at varying prices determined at the time of sale. The
obligations of the underwriters to purchase the securities will be
subject to the conditions set forth in the applicable underwriting
agreement. We may offer the securities to the public through
underwriting syndicates represented by managing underwriters or by
underwriters without a syndicate. Subject to certain conditions,
the underwriters will be obligated to purchase all of the
securities offered by the prospectus supplement. Any public
offering price and any discounts or concessions allowed or
reallowed or paid to dealers may change from time to time. We may
use underwriters with whom we have a material relationship. We will
describe in the prospectus supplement that names the underwriter,
the nature of any such relationship.
We may sell securities directly or through agents we designate from
time to time. We will name any agent involved in the offering and
sale of securities, and we will describe any commissions we will
pay the agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, our agent will act on a best-efforts
basis for the period of its appointment.
We may authorize agents or underwriters to solicit offers by
certain types of institutional investors to purchase securities
from us at the public offering price set forth in the prospectus
supplement pursuant to delayed delivery contracts providing for
payment and delivery on a specified date in the future. We will
describe the conditions to these contracts and the commissions we
must pay for solicitation of these contracts in the prospectus
supplement.
We may provide agents and underwriters with indemnification against
civil liabilities related to this offering, including liabilities
under the Securities Act, or contribution with respect to payments
that the agents or underwriters may make with respect to these
liabilities. Agents and underwriters may engage in transactions
with, or perform services for, us in the ordinary course of
business.
Any underwriter may engage in overallotment, stabilizing
transactions, short covering transactions and penalty bids in
accordance with Regulation M under the Securities Exchange Act of
1934, as amended (the “Exchange
Act”). Overallotment
involves sales in excess of the offering size, which create a short
position. Stabilizing transactions permit bids to purchase the
underlying security so long as the stabilizing bids do not exceed a
specified maximum. Short covering transactions involve purchases of
the securities in the open market after the distribution is
completed to cover short positions. Penalty bids permit the
underwriters to reclaim a selling concession from a dealer when the
securities originally sold by the dealer are purchased in a
covering transaction to cover short positions. Those activities may
cause the price of the securities to be higher than it would
otherwise be. If commenced, the underwriters may discontinue any of
the activities at any time.
Any underwriters who are qualified market makers on the Nasdaq
Capital Market may engage in passive market making transactions in
accordance with Rule 103 of Regulation M during the business day
prior to the pricing of the offering, before the commencement of
offers or sales of the securities. Passive market makers must
comply with applicable volume and price limitations and must be
identified as passive market makers. In general, a passive market
maker must display its bid at a price not in excess of the highest
independent bid for such security; if all independent bids are
lowered below the passive market maker’s bid, however, the
passive market maker’s bid must then be lowered when certain
purchase limits are exceeded.
Certain legal matters in connection with this offering will be
passed upon for us by Disclosure Law Group, a Professional
Corporation, of San Diego, California.
Mazars USA LLP, our independent registered public accounting firm,
has audited our consolidated financial statements included in our
Annual Report on Form 10-K for the year ended December 31,
2018, as set forth in their report, which is incorporated by
reference in this prospectus. The report for AzurRx BioPharma, Inc.
includes an explanatory paragraph about the existence of
substantial doubt concerning its ability to continue as a going
concern. Our financial statements are incorporated by reference in
reliance on Mazars USA LLP’s report, given on their authority
as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are a public company and file annual, quarterly and special
reports, proxy statements and other information with the SEC. . Our
SEC filings are available, at no charge, to the public at the
SEC’s website at http://www.sec.gov.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The following documents filed by us with the SEC are incorporated
by reference in this prospectus:
●
our
Annual Report on Form 10-K for the year ended December 31, 2018,
filed on April 1, 2019;
●
our
Amendment No. 1 to our Annual Report on Form 10-K/A for the year
ended December 31, 2018, filed on April 30, 2019;
●
our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2019,
filed on May 15, 2019;
●
our
Current Report on Form 8-K, filed on April 3, 2019;
●
our
Current Report on Form 8-K, filed on April 11, 2019;
●
our
Current Report on Form 8-K, filed on April 24, 2019;
●
our
Current Report on Form 8-K, filed May 7, 2019;
●
our
Current Report on Form 8-K, filed May 14, 2019;
●
our
Current Report on Form 8-K, filed on May 20, 2019;
●
our
Current Report on Form 8-K, filed on May 23, 2019; 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 15 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.
We will provide to each person, including any beneficial owner, to
whom a prospectus is delivered, a copy of any or all of the
information that has been incorporated by reference in the
prospectus but not delivered with the prospectus. You may request a
copy of these filings, excluding the exhibits to such filings which
we have not specifically incorporated by reference in such filings,
at no cost, by writing to or calling us at:
AzurRx Biopharma, Inc.
760 Parkside Avenue
Downtown Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855.
This prospectus is part of a registration statement we filed with
the SEC. You should only rely on the information or representations
contained in this prospectus and any accompanying prospectus
supplement. We have not authorized anyone to provide information
other than that provided in this prospectus and any accompanying
prospectus supplement. We are not making an offer of the securities
in any state where the offer is not permitted. You should not
assume that the information in this prospectus or any accompanying
prospectus supplement is accurate as of any date other than the
date on the front of the document.
PROSPECTUS
$ 50,000,000
COMMON STOCK
PREFERRED STOCK
WARRANTS
UNITS
, 2019
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND
DISTRIBUTION
The following table sets forth an estimate of the fees and
expenses, other than the underwriting discounts and commissions,
payable by us in connection with the issuance and distribution of
the securities being registered. All the amounts shown are
estimates, except for the SEC and FINRA registration
fees.
|
|
SEC
registration fee
|
$538
|
FINRA
registration fee
|
$*
|
Legal
fees and expenses
|
$*
|
Accounting
fees and expenses
|
$*
|
Printing
and miscellaneous fees and expenses
|
$*
|
Total
|
$*
|
* To be included by amendment.
ITEM 15. INDEMNIFICATION OF OFFICERS AND
DIRECTORS
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 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 Charter and 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 16. EXHIBITS
1.1*
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Form of Underwriting Agreement
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1.2*
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Form of Placement Agent Agreement
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4.1*
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Form of any certificate of designation with respect to any
preferred stock issued hereunder and the related form of preferred
stock certificate
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4.2*
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Form of any warrant agreement with respect to each particular
series of warrants issued hereunder
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4.3*
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Form of any warrant agency agreement with respect to each
particular series of warrants issued hereunder
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4.4*
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Form of any unit agreement with respect to any unit issued
hereunder
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5.1*
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Opinion of Disclosure Law Group, a Professional
Corporation
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23.1*
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Consent of Disclosure Law Group, a Professional
Corporation
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Consent of Independent Registered Public Accounting Firm
– Mazars USA LLP, filed herewith
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Power of Attorney (located on signature page)
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*
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To be filed, if necessary, by an amendment to this registration
statement or incorporation by reference pursuant to a Current
Report on Form 8-K in connection with an offering of
securities.
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ITEM 17. UNDERTAKINGS
(a) The undersigned Registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration
statement:
(i) To
include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(ii) To
reflect in the prospectus any facts or events arising after the
effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in the form
of prospectus filed with the Commission pursuant to Rule 424(b) if,
in the aggregate, the changes in volume and price represent no more
than 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 (i),
(ii) and (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 Section 15(d) of the
Exchange Act of 1934 that are incorporated by reference in the
registration statement, or is contained in a form of prospectus
filed pursuant to Rule 424(b) that is part of the registration
statement.
(2) That,
for the purpose of determining any liability under the Securities
Act of 1933, each such post-effective amendment shall be deemed to
be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof.
(3) To
remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the
termination of the offering.
(4) That,
for the purpose of determining liability under the Securities Act
of 1933 to any purchaser:
(i) If
the Registrant is relying on Rule 430B:
(A)
Each prospectus filed by the registrant pursuant to Rule 424(b)(3)
shall be deemed to be part of the registration statement as of the
date the filed prospectus was deemed part of and included in the
registration statement; and
(B)
Each prospectus required to be filed pursuant to Rule 424(b)(2),
(b)(5), or (b)(7) as part of a registration statement in reliance
on Rule 430B relating to an offering made pursuant to Rule
415(a)(1)(i), (vii), or (x) for the purpose of providing the
information required by section 10(a) of the Securities Act of 1933
shall be deemed to be part of and included in the registration
statement as of the earlier of the date such form of prospectus is
first used after effectiveness or the date of the first contract of
sale of securities in the offering described in the prospectus. As
provided in Rule 430B, for liability purposes of the issuer and any
person that is at that date an underwriter, such date shall be
deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which
that prospectus relates, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof. Provided, however, that no statement made in a
registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or
prospectus that is part of the registration statement will, as to a
purchaser with a time of contract of sale prior to such effective
date, supersede or modify any statement that was made in the
registration statement or prospectus that was part of the
registration statement or made in any such document immediately
prior to such effective date; or
(ii) If
the registrant is subject to Rule 430C, each prospectus filed
pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying
on Rule 430B or other than prospectuses filed in reliance on Rule
430A, shall be deemed to be part of and included in the
registration statement as of the date it is first used after
effectiveness. Provided, however, that no statement made in a
registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or
prospectus that is part of the registration statement will, as to a
purchaser with a time of contract of sale prior to such first use,
supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement
or made in any such document immediately prior to such date of
first use.
(5) That,
for the purpose of determining liability of the registrant under
the Securities Act of 1933 to any purchaser in the initial
distribution of the securities: The undersigned registrant
undertakes that in a primary offering of securities of the
undersigned registrant pursuant to this registration statement,
regardless of the underwriting method used to sell the securities
to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the
undersigned registrant will be a seller to the purchaser and will
be considered to offer or sell such securities to such
purchaser:
(i) Any
preliminary prospectus or prospectus of the undersigned registrant
relating to the offering required to be filed pursuant to Rule
424;
(ii) Any
free writing prospectus relating to the offering prepared by or on
behalf of the undersigned registrant or used or referred to by the
undersigned registrant;
(iii) The
portion of any other free writing prospectus relating to the
offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the
undersigned registrant; and
(iv) Any
other communication that is an offer in the offering made by the
undersigned registrant to the purchaser.
(6)
That, for purposes of determining any liability under the
Securities Act, 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.
Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers and
controlling persons of each Registrant pursuant to the foregoing
provisions, or otherwise, each Registrant has been advised that in
the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the
Securities Act of 1933 and is, therefore,
unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by
a Registrant of expenses incurred or paid by a director, officer or
controlling person of a 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, that Registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in
the Securities Act and will be governed by the final adjudication
of such issue.
Pursuant to the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-3 and has
duly caused this Registration Statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the City of
Brooklyn, New York, on June 4, 2019.
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AZURRX BIOPHARMA, INC.
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By:
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/s/ Johan M. (Thijs) Spoor
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Johan M. (Thijs) Spoor
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President and Chief Executive Officer
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KNOW ALL PERSONS BY THESE PRESENTS, that each person whose
signature appears below constitutes and appoints Johan M. (Thijs)
Spoor, and his or her true and lawful attorney-in-fact and agent,
with full power of substitution and resubstitution, for him and in
his or her name, place, and stead, in any and all capacities, to
(i) act on, sign and file with the Securities and Exchange
Commission any and all amendments (including post-effective
amendments) to this registration statement together with all
schedules and exhibits thereto and any subsequent registration
statement filed pursuant to Rule 462(b) under the Securities Act of
1933, as amended, together with all schedules and exhibits thereto,
(ii) act on, sign and file such certificates, instruments,
agreements and other documents as may be necessary or appropriate
in connection therewith, (iii) act on and file any supplement
to any prospectus included in this registration statement or any
such amendment or any subsequent registration statement filed
pursuant to Rule 462(b) under the Securities Act of 1933, as
amended, and (iv) take any and all actions which may be
necessary or appropriate to be done, as fully for all intents and
purposes as he or she might or could do in person, hereby ratifying
and confirming all that said attorney-in-fact and agent, or his or
her substitute or substitutes, may lawfully do or cause to be done
by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in
the capacities indicated on the dates indicated.
Signature
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Title
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Date
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/s/ Johan M. (Thijs) Spoor
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President, Chief Executive Officer and Director
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June
4, 2019
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Johan M. (Thijs) Spoor
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(principal executive officer)
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/s/ Maged Shenouda
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Chief Financial Officer and Director
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Maged Shenouda
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(principal financial and accounting officer)
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/s/ Edward J. Borkowski
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Chairman of the Board of Directors
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June
4,
2019
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Edward J. Borkowski
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/s/ Alastair Riddell
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Director
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Alastair Riddell
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/s/ Charles Casamento
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Director
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Charles Casamento
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/s/ Vern Lee Schramm
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Director
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Vern Lee Schramm
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