Blueprint
As filed with the Securities and Exchange Commission on April 25,
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
600 West Broadway, Suite 700
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 post-effective amendment filed pursuant to Rule
462(d) 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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(Do not check if a smaller reporting company)
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided 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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Amount
to be registered
(1)
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Proposed
maximum offering price per unit
(2)
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Proposed
maximum aggregate offering price
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Amount
of registration fee
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Common stock, par value $0.0001 per
share
(3)
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1,647,042
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$2.56
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$4,216,428
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$512.00
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(1)
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In the
event of a stock split, stock dividend or similar transaction
involving our common stock, the number of shares registered shall
automatically be adjusted to cover the additional shares of common
stock pursuant to Rule 416 under the Securities Act of 1933, as
amended.
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(2)
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Estimated
solely for the purpose of calculating the amount of the
registration fee, based upon the average of the high and low prices
of the common stock, as reported by the Nasdaq Capital Market on
April 22, 2019, in accordance
with Rule 457(c) promulgated under the Securities Act of 1933, as
amended.
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(3)
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The Registrant is hereby registering for resale: (i) 871,111 shares
of common stock issuable upon conversion of principal and accrued
but unpaid interest on certain outstanding senior convertible notes
(the “Notes”)
issued pursuant to a Note Purchase Agreement executed by the
Registrant and ADEC Private
Equity Investments, LLC (“ADEC”)
on February 14, 2019 (the “NPA”),
which notes are convertible into shares of the Registrant’s
common stock at an initial conversion price of $2.50, subject to
certain limitations set forth in the NPA (the
“Note
Conversion Shares”); (ii) 400,481
shares of our outstanding common stock issued to
Laboratoires Mayoly Spindler
SAS (“Mayoly”)
as partial consideration for the purchase of certain assets
pursuant to a Asset Purchase Agreement entered into by the
Registrant and Mayoly on March 27, 2019 (the
“Mayoly
APA”); and (iii) an
additional 375,450 shares of our common stock currently held in
escrow, but issuable to Mayoly on future dates in accordance with
the Mayoly APA (the “Mayoly
Escrow Shares”).
The actual number of Note Conversion Shares issuable to ADEC, if
any, could be materially more or less than 871,111 shares of common
stock depending on the amount of accrued but unpaid interest
that is converted into Note Conversion Shares. The number of Note
Conversion Shares registered by the Registrant represents a good
faith estimate, assuming for purposes hereof, the Notes will accrue
interest through December 31, 2019 at a rate of 10% per annum.
This
presentation is not intended to constitute an indication or
prediction of the date on which ADEC will convert the Notes into
Note Conversion Shares, if at all.
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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. The selling stockholders 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.
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SUBJECT TO COMPLETION
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DATED APRIL 25, 2019
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1,647,042 SHARES OF COMMON STOCK
This prospectus relates
to the possible resale from time to time of up to 1,647,042 shares
of our common stock, par value $0.0001 per share, which are held
by, or may be issued to, the selling
stockholders identified in
this prospectus. We will not receive any proceeds from the sale of
any shares offered by this prospectus.
Certain of
the selling stockholders acquired or will
acquire certain of these shares in connection with: (i) the
conversion of outstanding senior convertible notes (the
“Notes”) issued
to ADEC Private Equity Investments,
LLC (“ADEC”) pursuant to the terms and conditions of
the Note Purchase Agreement we executed with ADEC on February 14,
2019 (the “NPA”); and (ii) our acquisition of certain
assets from Laboratoires Mayoly
Spindler SAS (“Mayoly”) pursuant to the terms and conditions of
the Asset Purchase Agreement we entered into with Mayoly on March
27, 2019 (the “Mayoly APA”).
The number of shares of
common stock being registered hereunder is comprised of: (i)
871,111 shares of common stock issuable upon conversion of the
Notes, which Notes are convertible into shares of our common stock
at an initial conversion price of $2.50, subject to certain
beneficial ownership limitations (the “Note
Conversion Shares”); (ii) 400,481
shares of our outstanding common stock issued to Mayoly on March
27, 2019 as partial consideration for the purchase of certain
assets pursuant to the Mayoly APA (the “Mayoly
Shares”); and (iii) an
additional 375,450 shares of our common stock currently held in
escrow, but, in accordance with the Mayoly APA, will be issued to
Mayoly in the following installments: (y) 200,240 shares will be
issued to Mayoly on December 31, 2019 and (z) the remaining 175,210
shares will be issued to Mayoly on December 31, 2020 (collectively,
the “Mayoly
Escrow Shares”).
See the section entitled
“Prospectus
Summary—Recent Developments” beginning on page 3 of this prospectus for
more information with respect to the NPA and the Mayoly
APA.
The actual number of
Note Conversion Shares issuable to ADEC, if any, could be
materially more or less than 871,111 shares of common stock
depending on the amount of accrued but unpaid interest that
is converted into Note Conversion Shares. The number of Note
Conversion Shares registered by the Registrant represents a good
faith estimate, assuming for purposes hereof, the Notes will accrue
interest through December 31, 2019 at a rate of 10% per annum.
This
presentation is not intended to constitute an indication or
prediction of the date on which ADEC will convert the Notes into
Note Conversion Shares, if at all.
In addition, the
registration of shares of our common stock covered by this
prospectus does not mean that the selling
stockholders will offer or
sell any of such shares of our common stock.
The selling stockholders may resell or
dispose of the shares of our common stock, or interests therein, at
fixed prices, at prevailing market prices at the time of sale or at
prices negotiated with purchasers, to or through one or more
underwriters, dealers or agents, or through any other means
described in this prospectus under “Plan
of Distribution” beginning on
page 15 of this prospectus. The selling
stockholders will bear all
commissions and discounts, if any, attributable to the sale or
disposition of the shares of common stock, or interests therein. We
will bear all costs, expenses and fees in connection with the
registration of the shares of common stock.
Our
common stock is listed on the Nasdaq Capital Market under the
symbol “AZRX.” On April 24, 2019, the last reported
sale price of our common stock on the Nasdaq Capital Market was
$2.55 per share.
We
are an “emerging growth company” under the federal
securities laws and, as such, are subject to reduced public company
reporting requirements.
Investing in these securities involves a high degree of risk. See
“Risk
Factors” on page 6 of
this prospectus and in the documents incorporated by reference
herein for a discussion of the factors you should carefully
consider before deciding to invest in our
securities.
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
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PAGE
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About
This Prospectus
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1
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Prospectus
Summary
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2
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Risk
Factors
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6
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Cautionary
Notes Regarding Forward-Looking Statements
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7
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Description
of Transactions with the Selling Stockholders
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Use of
Proceeds
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9
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Selling
Stockholders
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10
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Description
of our Common Stock
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11
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Description
of Certain Provisions of Delaware Law and Our Certificate of
Incorporation and Bylaws
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12
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Plan of
Distribution
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14
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Legal
Matters
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16
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Experts
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16
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Where
You Can Find More Information
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16
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Incorporation
of Certain Information by Reference
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16
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You should rely only on the information contained in or
incorporated by reference into this prospectus or any free writing
prospectuses prepared by or on behalf of us or to which we have
referred you. We have not authorized any person to give any
information or to make any representations other than those
contained or incorporated by reference in this prospectus, any
accompanying prospectus supplement, or any free writing
prospectuses prepared by or on behalf of us or to which we have
referred you, and, if given or made, you must not rely upon the
information or representations as having been authorized. This
prospectus, any accompanying prospectus supplement, and any free
writing prospectuses prepared by or on behalf of us or to which we
have referred you, do not constitute an offer to sell or the
solicitation of an offer to buy securities, nor do this prospectus
or any accompanying supplement to this prospectus constitute an
offer to sell or the solicitation of an offer to buy securities in
any jurisdiction to any person to whom it is unlawful to make such
offer or solicitation. The information contained in this
prospectus, any accompanying prospectus supplement, and any free
writing prospectuses prepared by or on behalf of us or to which we
have referred you, speaks only as of the date set forth on the
cover page and may not reflect subsequent changes in our business,
financial condition, results of operations and prospects even
though this prospectus, any accompanying prospectus supplement, and
any free writing prospectuses prepared by or on behalf of us or to
which we have referred you, is delivered or securities are sold on
a later date.
We will not receive any proceeds from the sale of
any shares offered by this prospectus. This prospectus does not
contain all of the information included in the registration
statement. Before making an investment decision, it is important
for you to read and consider the information contained in this
prospectus, any accompanying prospectus supplement, and any free
writing prospectuses prepared by or on behalf of us or to which we
have referred you, together with the additional information
described under the heading “Where You Can Find More
Information” and
“Incorporation of Certain
Information by Reference”
below.
You
may only rely on the information contained in this prospectus or
incorporated herein by reference. We have not authorized anyone to
provide you with information that differs from what is contained or
incorporated by reference in this prospectus. This prospectus does
not constitute an offer to sell or a solicitation of an offer to
buy any securities other than the common stock offered by this
prospectus. This prospectus does not constitute an offer to sell or
a solicitation of an offer to buy any common stock in any
circumstances in which such offer or solicitation is unlawful.
Neither the delivery of this prospectus nor any sale made in
connection with this prospectus shall, under any circumstances,
create any implication that there has been no change in our affairs
since the date of this prospectus or that the information contained
by reference to this prospectus is correct as of any time after its
date.
Unless otherwise indicated herein, references in this prospectus 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.
This summary highlights certain information about this offering and
selected information contained elsewhere in or incorporated by
reference into this prospectus. This summary is not complete and
does not contain all of the information that you should consider
before deciding whether to invest in shares of our common stock.
You should read this entire prospectus carefully, including the
“Risk Factors” section contained in this prospectus and
the other documents incorporated by reference into this
prospectus.
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. Our current
product pipeline consists of two therapeutic programs under
development, each of which are described below:
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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, we
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. Favorable
trends were also observed on other evaluated endpoints, including
the Bristol stool scale, number of daily evacuations and stool
weight, which were consistent with the CFA results. 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 our 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 we initiated the
multi-center Phase II study that was subject to the IND in the
United States and Europe, which we expect will include
approximately 30 patients and conclude in 2019. On April 24,
2019, we announced that we surpassed 50% enrollment in our Phase II
study to investigate MS1819-SD in CF patients with exocrine
pancreatic insufficiency.
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B-Lactamase Program
Our 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,
we have 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,
we are focused on advancing pre-clinical development of AZX1103. At
this time, the Company is currently assessing its plans for the
continuation of the development of AZX1101.
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Recent Developments
Issuance of Senior Convertible Notes
On February 14, 2019, we entered into the NPA with
ADEC, pursuant to which we issued to ADEC two Notes in the
principal amount of $1.0 million each (which Notes are individually
referred to herein as “Note A” and “Note B”), resulting in gross proceeds us of $2.0
million. The Notes accrue interest at a rate of 10% per
annum; provided,
however, that in the event we
elect to repay the full balance due under both Notes prior to
December 31, 2019, the interest rate will be reduced to 6% per
annum. The Notes will mature on the earlier to occur of (i) 10
business day following the receipt by us or AzurRx SAS of certain
expected tax credits prior to July 2019 in the case of Note A (the
“2019
Tax Credit”) and July
2020 in the case of Note B (the “2020 Tax
Credit”), or (ii)
December 31, 2019 in the case of Note A and December 31, 2020 in
the Case of Note B. As a condition to entering into the NPA, AzurRx
SAS and ADEC also entered into a Pledge Agreement, pursuant to
which AzurRx SAS agreed to pledge an interest in the 2019 Tax
Credit and the 2020 Tax Credit to ADEC in order to guarantee
payment of all amounts due under the terms of the
Notes.
Prior to their respective Maturity Dates, each of
the Notes is convertible, at ADEC’s option, into Note
Conversion Shares at an initial conversion price equal to the
principal and accrued interest due under the terms of the Notes
divided by $2.50; provided,
however, ADEC may not convert
any a portion of the Notes if such conversion would result in ADEC
and/or entities or persons affiliated with ADEC beneficially owning
in excess of 19.99% of our common stock issued and outstanding
immediately after giving effect to the issuance of the Note
Conversion Shares.
Asset Purchase Agreement with Mayoly
On March 27, 2019, we entered into an Asset
Purchase Agreement with Mayoly (the “Mayoly APA”), pursuant to which we purchased all
rights, title and interest in and to MS1819-SD. Upon execution of
the Mayoly APA, the Joint Development and License Agreement (the
“JDLA”) previously executed by AzurRx SAS and
Mayoly was terminated. In addition, we granted to Mayoly an
exclusive, royalty-bearing right to revenue received from
commercialization of MS1819-SD within certain
territories.
In
accordance with the Mayoly APA, we provided to Mayoly the following
consideration for the purchase of MS1819-SD:
(i)
we
assumed certain of Mayoly’s liabilities with respect to
MS1819-SD;
(ii)
we
forgave all amounts currently owed to AzurRx SAS by Mayoly under
the JDLA;
(iii)
we
agreed to pay, within 30 days after the execution of the Mayoly
APA, all amounts incurred by Mayoly for the maintenance of patents
related to MS1819-SD from January 1, 2019 through the date of the
Mayoly APA;
(iv)
we
made an initial payment to Mayoly of €800,000, which amount
was paid by the issuance of the Mayoly Shares; and
(v)
we agreed to pay to Mayoly an additional
€1,500,000, payable in a mix of cash and shares of our common
stock as follows (the “Milestone
Payments”): (y) on
December 31, 2019, a cash payment of €400,000 and 200,240 of
the Mayoly Escrow Shares and (z) on December 31, 2020, a cash
payment of €350,000 and the remaining 175,210 Mayoly Escrow
Shares.
The Mayoly Shares and the Mayoly Escrow Shares
were all issued upon execution of the Mayoly
APA; provided, however, per the terms of the Mayoly APA, the Mayoly
Escrow Shares will be held in escrow until the applicable Milestone
Payment date, at which time the respective Mayoly Escrow Shares
will be released to Mayoly.
Risk Factors
Our business is subject to substantial risk.
Please carefully consider the section titled
“Risk
Factors” on page 6 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, the Company acquired 100% of
the issued and outstanding capital stock of AzurRx 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.
THE OFFERING
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Shares of common stock offered by selling
stockholders(1)
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1,647,042
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Use of Proceeds
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We will not receive any proceeds from the sale of our common stock
offered by the selling stockholders under this
prospectus. See “Use of
Proceeds” beginning on
page 9 of this prospectus.
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Risk Factors
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See “Risk
Factors” beginning on
page 6 of this prospectus and in the documents incorporated by
reference herein for a discussion of factors you should consider
carefully before investing in our common stock.
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Nasdaq Symbol
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“AZRX”
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(1)
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The number of shares of common stock being
registered hereunder is comprised of: (i) 871,111 Note
Conversion Shares issuable upon conversion of the Notes; (ii)
400,481 Mayoly Shares issued to Mayoly on March 27, 2019 as partial
consideration for the purchase of certain assets pursuant to the
Mayoly APA; and (iii) 375,450 Escrow Shares which, in accordance
with the Mayoly APA, will be issued to Mayoly in the following
installments: (y) 200,240 shares will be issued to Mayoly on
December 31, 2019 and (z) the remaining 175,210 shares will be
issued to Mayoly on December 31, 2020.
The actual number of
Note Conversion Shares issuable to ADEC, if any, could be
materially more or less than 871,111 shares of common stock
depending on the amount of accrued but unpaid interest that
is converted into Note Conversion Shares. The number of Note
Conversion Shares registered by the Registrant represents a good
faith estimate, assuming for purposes hereof, the Notes will accrue
interest through December 31, 2019 at a rate of 10% per annum.
This
presentation is not intended to constitute an indication or
prediction of the date on which ADEC will convert the Notes into
Note Conversion Shares, if at all.
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RISK FACTORS
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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●
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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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●
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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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●
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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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●
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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.
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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.
We will not receive any proceeds from any sale of
the shares of our common stock offered by this prospectus.
The selling stockholders will receive all of the proceeds
from any sale of the shares of our common stock offered by this
prospectus. For information about the selling stockholders,
see “Selling
Stockholders” on page 10
of this prospectus.
The selling
stockholders will pay any underwriting discounts and
commissions and expenses incurred by the selling
stockholders for brokerage, accounting, tax or legal services
or any other expenses incurred by the selling
stockholders in disposing of the shares. We will bear all
other costs, fees and expenses incurred in effecting the
registration of the shares of common stock covered by this
prospectus, including all registration and filing fees and fees and
expenses of our counsel and accountants.
This prospectus relates to the sale or other
disposition of up to 1,647,042 shares of our common stock
previously issued to the selling stockholders, some of which
remain subject to the terms of the Notes and escrow arrangement
described in the footnotes to the table below including 871,111 of
the shares of common stock are issuable upon conversion of Notes
held by ADEC and 375,450 Mayoly Escrow Shares which, in accordance
with the Mayoly APA, will be issued to Mayoly in the following
installments: (y) 200,240 shares will be issued to Mayoly on
December 31, 2019 and (z) the remaining 175,210 shares will be
issued to Mayoly on December 31, 2020. See the section entitled
“Prospectus
Summary—Recent Developments” beginning on page 3 of this prospectus for
more information.
The
table below sets forth, to our knowledge, information as of the
date of this prospectus for the selling stockholders and
other information regarding the beneficial ownership of the shares
of common stock held by the selling stockholders. The second
column lists the number of shares and percentage of common stock
beneficially owned by the selling stockholders as of
April 25, 2019. The third column lists the maximum number of shares
of common stock that may be sold or otherwise disposed of by
the selling stockholders pursuant to the registration
statement of which this prospectus forms a part. The fourth column
lists the number of shares and percentage of common stock
beneficially owned by the selling stockholders upon completion
of the offering contemplated hereby, assuming the sale of all
shares of common stock that may be sold or otherwise disposed of by
the selling stockholders pursuant to the registration
statement of which this prospectus forms a part. Notwithstanding,
the selling stockholders may sell or otherwise dispose of
some, all or none of their shares.
Pursuant to the rules and regulations of the
Securities and Exchange Commission (the “SEC”), beneficial ownership includes any shares
of common stock as to which a selling stockholder has sole or
shared voting power or investment power and any shares of common
stock that the selling stockholder has the right to acquire within
60 days of April 25, 2019. The percent of beneficial ownership for
the selling stockholders is based on 19,832,888 shares of
our stock outstanding as of April 25, 2019. Except as described
below, to our knowledge, none of the selling
stockholders has been an officer or director of ours or of our
affiliates within the past three years or had any material
relationship with us or our affiliates within the past three years.
Our knowledge is based on information provided by the selling
stockholders questionnaires in connection with the filing of
this prospectus. The selling stockholders have
contractual rights to require us to file the registration statement
of which this prospectus is a part.
The shares of common stock being covered hereby
may be sold or otherwise disposed of from time to time during the
period the registration statement of which this prospectus is a
part remains effective, by or for the account of the selling
stockholders. After the date of effectiveness, the selling
stockholders may have sold or transferred, in transactions
covered by this prospectus or in transactions exempt from the
registration requirements of the Securities Act, some or all of
their common stock. See the section entitled
“Plan
of Distribution”
beginning on page 15 of this prospectus.
Information
about the selling stockholders may change over time. Any
changed information will be set forth in an amendment to the
registration statement or supplement to this prospectus, to the
extent required by law.
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Shares
Beneficially Owned Prior to
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Shares
Beneficially Owned After Offering
(1)
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Selling
Stockholder
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|
|
|
|
|
|
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ADEC Private Equity
Investments, LLC
|
2,476,009(2)
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871,111(3)
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1,676,009
|
8.2%
|
Laboratoires
Mayoly Spindler SAS
|
775,931
|
775,931(4)
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-
|
-%
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(1)
Assumes that
the selling stockholders will sell all shares of common
stock registered under this prospectus directly held by
such selling stockholders.
(2)
Includes
1,031,268 shares of common stock, 644,741 shares of common stock
issuable upon exercise of warrants and 800,000 shares of common
stock issuable upon conversion of the outstanding principal amount
of the Convertible Notes. As manager of ADEC Private Equity
Investments, Edmond Burke Ross, Jr. holds sole voting and
dispositive power over the shares held by the entity. The address
of ADEC Private Equity Investments, LLC and Mr. Ross entities is
c/o JDJ Family Office Services, P.O. Box 962049, Boston, MA
02196.
(3)
Amount
offered for resale pursuant to this prospectus consists of a total
of 800,000 shares of common stock issuable upon conversion of the
outstanding principal amount of the Convertible Notes and 71,111
shares of common stock that may be issued as payment of accrued but
unpaid dividends on the Convertible Notes through December 31,
2019, assuming the Convertible Notes accrue interest at a rate of
10% per annum.
(4)
Includes 375,450 shares of common stock currently
held in escrow, which, in accordance with the
Mayoly APA, will be issued to Mayoly in the following installments:
(y) 200,240 shares will be issued to Mayoly on December 31, 2019
and (z) the remaining 175,210 shares will be issued to Mayoly on
December 31, 2020. Christophe Hamon, Chief Financial Officer
of Mayoly may be deemed to have
investment and voting power over the shares held by Mayoly.
Mayoly’s address is 6 Avenue de'l Europe 78400 Chatou,
France.
DESCRIPTION OF
OUR COMMON 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
As
of April 25, 2019, there were 19,832,888 shares of our common
stock issued and outstanding, which were held by approximately 110
stockholders of record, approximately 3,151,563 shares of common
stock subject to outstanding warrants and 994,000 shares of common
stock subject to outstanding stock options under our Amended and
Restated 2014 Omnibus Equity Incentive Plan. 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.
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;
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●
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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
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●
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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.
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Section 203
defines a “business combination” to
include:
●
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any merger or consolidation involving the corporation and the
interested stockholder;
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●
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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;
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●
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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;
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●
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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
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●
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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:
●
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the owner of 15% or more of the outstanding voting stock of the
corporation;
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●
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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
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●
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the affiliates and associates of the above.
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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.
ADEC
and/or Mayoly (the “Selling
Stockholders”) 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 or exclusion from registration under the Securities
Act of 1933, as amended (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 the Company that it does not
have any written or oral agreement or understanding, directly or
indirectly, with any person to distribute the
securities.
The
Company is required to pay certain fees and expenses incurred by
the Company incident to the registration of the securities. The
Company has 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 the Company 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 Securities Exchange Act
of 1934, as amended (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).
LEGAL MATTERS
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.
EXPERTS
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;
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●
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our Current Reports on Form 8-K, filed on February 20, 2019, March
28, 2019, April 3, 2019 and April 24, 2019; and
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●
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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.
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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
1,647,042
SHARES
COMMON STOCK
,
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
|
$512
|
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;
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●
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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
|
●
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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
5.1*
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Opinion of Disclosure Law Group, a Professional
Corporation
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Note Purchase Agreement, dated February 14, 2019 (incorporated by
reference to Exhibit 10.1 to the Current Report on Form 8-K filed
on February 20, 2019).
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Senior Convertible Note A, dated February 14, 2019 (incorporated by
reference to Exhibit 10.2 to the Current Report on Form 8-K filed
on February 20, 2019).
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Senior Convertible Note B, dated February 14, 2019 (incorporated by
reference to Exhibit 10.3 to the Current Report on Form 8-K filed
on February 20, 2019).
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Form of Pledge Agreement, dated February 14, 2019 (incorporated by
reference to Exhibit 10.4 to the Current Report on Form 8-K filed
on February 20, 2019).
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Warrant Amendment Agreement, dated February 14, 2019 (incorporated
by reference to Exhibit 10.5 to the Current Report on Form 8-K
filed on February 20, 2019).
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Registration Rights Agreement, dated February 14, 2019
(incorporated by reference to Exhibit 10.6 to the Current Report on
Form 8-K filed on February 20, 2019).
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Asset Purchase Agreement, by and
between AzurRx BioPharma, Inc., AzurRx SAS
and Laboratoires Mayoly Spindler SAS, dated March
27, 2019 (incorporated by reference to Exhibit 10.25 to the Annual
Report on Form 10-K, filed on April 1, 2019).
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Consent of Independent Registered Public Accounting Firm
– Mazars USA LLP, filed herewith.
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23.2*
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Consent of Disclosure Law Group, a Professional
Corporation
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24
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Power of Attorney (located on signature page)
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*
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To be filed by amendment.
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#
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Certain portions of this exhibit (indicated by
“[*****]”) have been omitted as the Company has
determined (i) the omitted information is not material and (ii) the
omitted information would likely cause harm to the Company if
publicly disclosed.
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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.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing on Form S-3 and has duly caused
this Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of Brooklyn,
New York, on April 25, 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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POWER OF ATTORNEY
KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Johan M. (Thijs) Spoor, and
his true and lawful attorney-in-fact and agent, with full power of
substitution and resubstitution, for him and in his 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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April 25, 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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April 25, 2019
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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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April 25, 2019
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Edward J. Borkowski
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/s/
Alastair Riddell
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Director
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April 25, 2019
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Alastair Riddell
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/s/
Charles Casamento
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Director
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April 25, 2019
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Charles Casamento
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/s/
Vern Lee Schramm
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Director
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April 25, 2019
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Vern Lee Schramm
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