Filed
Pursuant to Rule 424(b)(5)
Registration
No. 333-226065
PROSPECTUS
SUPPLEMENT NO. 2
(To
Prospectus dated July 11, 2018)
1,227,167 Shares
Common Stock
We are
offering 1,227,167 shares of our common stock, $0.0001 par value
per share, at a public offering price of $2.35 per share pursuant
to this prospectus supplement and the accompanying
prospectus.
Our
common stock is listed on the NASDAQ Capital Market under the
ticker symbol “AZRX.” On May 8, 2019, the last reported
sale price per share of our common stock was $2.89 per
share.
We have retained
Alexander Capital, L.P. to act as our exclusive selling agent
(“
Selling
Agent
”) in connection with the shares of common stock
offered by this prospectus supplement. The Selling Agent has agreed
to use its reasonable best efforts to arrange for the sale of the
common stock offered by this prospectus supplement. The Selling
Agent is not purchasing or selling any of the shares of common
stock we are offering and the Selling Agent is not required to
arrange the purchase or sale of any specific number of shares or
dollar amount. We have agreed to pay to the Selling Agent the
Selling Agent fees set forth in the table below, which assumes that
we sell all of the common stock offered by this prospectus
supplement. See “
Plan of
Distribution
” on page S-12 of this prospectus
supplement for more information regarding these
arrangements.
Investing
in our common stock involves a high degree of risk. See
“
Risk Factors
”
beginning on page S-5 of this prospectus supplement and page 4 of
the accompanying prospectus.
Neither
the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or
determined if this prospectus supplement or the accompanying
prospectus is truthful or complete. Any representation to the
contrary is a criminal offense.
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Offering
price
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$
2.35
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$
2,883,842
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Selling
Agent’s fees
(1)
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$
0.1645
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$
201,869
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Proceeds, before
expenses, to us
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$
2.1855
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$
2,681,973
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________________________
(1)
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In addition, we
have agreed to reimburse the Selling Agent for certain
offering-related expenses, and to issue the Selling Agent or its
designees warrants to purchase a number of shares of common stock
equal to 3% of the shares of common stock sold in this offering.
See “
Plan of
Distribution
” on page S-12 for more
information.
|
Delivery of the
shares of common stock is expected to be made on or about May 13,
2019, subject to customary closing conditions.
We have agreed to
pay the Selling Agent a Selling Agent fee in an amount equal to 7%
of the aggregate gross proceeds in this offering. Because there is
no minimum offering amount required as a condition to closing in
this offering, the actual public offering amount, Selling Agent
fees, and proceeds to us, if any, are not presently determinable
and may be substantially less than the total maximum offering
amounts set forth above. See “
Plan of Distribution
” on page
S-12 for more information on this offering and the Selling Agent
arrangements.
As of May 8, 2019,
the aggregate market value of our outstanding common stock held by
non-affiliates was $49,829,117, based on 19,832,888 shares of our
common stock outstanding on May 8, 2019, of which 17,241,909 shares
were held by non-affiliates, and a price of $2.89 per share, the
closing price of our common stock on May 8, 2019. During the 12
calendar months prior to and including the date of this prospectus
supplement (excluding this offering), we have sold approximately
$13.15 million worth of securities pursuant to General Instruction
I.B.6 of Form S-3.
Prospectus Supplement dated May 9, 2019
TABLE OF
CONTENTS
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PAGE
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PROSPECTUS
SUPPLEMENT
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S-1
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S-2
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S-4
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S-5
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S-6
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S-7
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S-8
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S-9
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S-11
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S-12
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S-13
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S-13
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S-13
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S-13
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PROSPECTUS
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1
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2
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4
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5
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6
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7
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9
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12
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13
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15
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A
B
OUT THIS PROSPECTUS SUPPLEMENT
This prospectus
supplement and the accompanying prospectus are part of a
registration statement that we filed with the U.S. Securities and
Exchange Commission utilizing a “shelf” registration
process. This document is in two parts. The first part is this
prospectus supplement, which describes the specific terms of this
offering and also adds to and updates information contained in the
accompanying prospectus and the documents incorporated by reference
herein. The second part, the accompanying prospectus, provides more
general information. Generally, when we refer to this prospectus,
we are referring to both parts of this document combined. To the
extent there is a conflict between the information contained in
this prospectus supplement and the information contained in the
accompanying prospectus or any document incorporated by reference
therein filed prior to the date of this prospectus supplement, you
should rely on the information in this prospectus supplement;
provided that if any statement in one of these documents is
inconsistent with a statement in another document having a later
date—for example, a document incorporated by reference in the
accompanying prospectus—the statement in the document having
the later date modifies or supersedes the earlier
statement.
We further note
that the representations, warranties and covenants made by us in
any agreement that is filed as an exhibit to any document that is
incorporated by reference herein were made solely for the benefit
of the parties to such agreement, including, in some cases, for the
purpose of allocating risk among the parties to such agreements,
and should not be deemed to be a representation, warranty or
covenant to you. Moreover, such representations, warranties or
covenants were accurate only as of the date when made. Accordingly,
such representations, warranties and covenants should not be relied
on as accurately representing the current state of our
affairs.
You should rely
only on the information contained in this prospectus supplement or
the accompanying prospectus, or incorporated by reference herein.
We have not authorized, and the Selling Agent has not authorized,
anyone to provide you with information that is different. The
information contained in this prospectus supplement or the
accompanying prospectus, or incorporated by reference herein or
therein is accurate only as of the respective dates thereof,
regardless of the time of delivery of this prospectus supplement
and the accompanying prospectus or of any sale of our common stock.
It is important for you to read and consider all information
contained in this prospectus supplement and the accompanying
prospectus, including the documents incorporated by reference
herein and therein, in making your investment decision. You should
also read and consider the information in the documents to which we
have referred you in the sections entitled “Where you can
find more information” and “Incorporation of certain
information by reference” in this prospectus supplement and
in the accompanying prospectus, respectively.
We are offering to
sell, and seeking offers to buy, the securities offered by this
prospectus supplement only in jurisdictions where offers and sales
are permitted. The distribution of this prospectus supplement and
the accompanying prospectus and the offering of the securities
offered by this prospectus supplement in certain jurisdictions may
be restricted by law. Persons outside the United States who come
into possession of this prospectus supplement and the accompanying
prospectus must inform themselves about, and observe any
restrictions relating to, the offering of the common stock and the
distribution of this prospectus supplement and the accompanying
prospectus outside the United States. This prospectus supplement
and the accompanying prospectus do not constitute, and may not be
used in connection with, an offer to sell, or a solicitation of an
offer to buy, any securities offered by this prospectus supplement
and the accompanying prospectus by any person in any jurisdiction
in which it is unlawful for such person to make such an offer or
solicitation.
PROSP
E
CTUS
SUPPLEMENT SUMMARY
This summary highlights information appearing elsewhere in this
prospectus supplement, in the accompanying prospectus and in the
documents incorporated by reference herein and therein. This
summary does not contain all the information you should consider
before investing in our securities pursuant to this prospectus
supplement and the accompanying prospectus. Before making an
investment decision, to fully understand this offering and its
consequences to you, you should carefully read this entire
prospectus supplement and the accompanying prospectus, including
“Risk Factors,” the financial statements, and related
notes, and the other information incorporated by reference herein
and therein.
In this
this prospectus
supplement and the accompanying 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 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.
Our current
product pipeline consists of two therapeutic programs 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, 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 OPTION study that was subject to the IND in
the United States and Europe (the “
OPTION
Study
”), which we expect
will include approximately 30 patients. We dosed the first patients
in the OPTION Study in February 2019 and reached 50% of our
enrollment target for the OPTION Study in April 2019. We expect to
conclude and announce topline results from the OPTION Study in the
summer of 2019.
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 and
expect to file an IND for AZX1103 with the FDA in 2019. At this
time, the Company is currently assessing its plans for the
continuation of the development of AZX1101. We are also currently
assesing our plans for the continuation of the development of
AZX1101.
Recent Developments
Issuance of Senior Convertible Notes
On February 14, 2019, we entered into a Note
Purchase Agreement (the “
NPA
”) with one of our current stockholders,
ADEC Private Equity Investment, LLC (“
ADEC
”), pursuant to which we issued to ADEC
two
senior convertible notes (the “
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, all
outstanding principal and accrued but unpaid interest under each of
the Notes is convertible, at ADEC’s option, into
shares of
our common stock at a conversion price of $2.50, (the
“
Note
Conversion Shares
”)
;
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.
As additional consideration for entering into the
NPA, we reduced the exercise price of all outstanding warrants
previously issued by us to ADEC and its affiliates (the
“ADEC
Warrants”
) to $1.50 per
share. None of the other terms of the ADEC Warrants were modified
in connection with the NPA and the issuance of the
Notes.
In connection with
the above transaction, we also entered into a registration rights
agreement with ADEC, pursuant to which we agreed to file a
registration statement with the Securities and Exchange Commission
no later than 45 days after the closing date of February 14, 2019
in order to register, on behalf of ADEC, the Conversion Shares.
ADEC subsequently agreed to extend the date to file a registration
statement to April 30, 2019, and we filed a registration statement
on Form S-3 with the Securities and Exchange Commission on April
26, 2019 to register the Conversion Shares and the Escrow Shares
(defined below).
Execution of 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 400,481 shares of
our common stock at a price of $2.29 per share (the
“
Closing Payment
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
shares of common stock at a price of $2.29 per share (the
“
2019
Escrow Shares
”) and (z)
on December 31, 2020, a cash payment of € 350,000 and 175,210
shares of common stock at a price of $2.29 per share (the
“
2020
Escrow Shares
” and,
together with the 2019 Escrow Shares, the
“
Escrow
Shares
”).
The Closing Payment Shares and the Escrow Shares
were all issued upon execution of the Mayoly APA;
provided
,
however
, per the terms of the Mayoly APA, the Escrow
Shares will be held in escrow until the applicable Milestone
Payment date, at which time the respective Escrow Shares will be
released to Mayoly.
April 2019 Public Offering of Common Stock
In April 2019, we completed a public offering of
1,294,930 shares of its common stock at a public offering price of
$2.13 per share, resulting net proceeds of approximately $2.5
million, after deducting the selling agent fee paid to Alexander
Capital, L.P. and other offering expenses payable by the Company
(the “
April 2019 Public
Offering
”). The April
2019 Public Offering was completed pursuant to our effective shelf
registration statement on Form S-3 (File No. 333-225935) and the
prospectus supplement filed on April 2, 2019.
In connection with the April 2019 Public Offering,
we entered into a Selling Agent Agreement with Alexander Capital,
L.P., pursuant to which we paid to Alexander Capital, L.P. (i) a
cash fee equal to 7% of the aggregate gross proceeds of the April
2019 Public Offering, and (ii) issued to Alexander Capital, L.P.
warrants to purchase 38,848 shares of our common stock (the
“
April 2019
Selling Agent
Warrants
”), an amount
equal to 3% of the aggregate number of shares of common stock sold
in the April 2019 Public Offering. We also reimbursed Alexander
Capital, L.P. for its expenses on a non-accountable basis in an
amount equal to 1% of the gross proceeds of the April 2019 Public
Offering and $50,000 for other accountable expenses. The April 2019
Selling Agent Warrants will become exercisable one year from the
date of issuance, expire on April 2, 2024 and have an exercise
price of $2.55 per share.
Risk Factors
Our business is subject to substantial risk.
Please carefully consider the section titled
“
Risk
Factors
” beginning on
page S-5 of this prospectus supplement, as well as risk factors
referenced in the accompanying prospectus, for a discussion of the
factors you should carefully consider before deciding to purchase
securities that may be offered by this prospectus supplement and
the accompanying 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.
Issuer
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AzurRx BioPharma, Inc.
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Securities
offered by us in this offering
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1,227,167
shares of common stock.
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Public
Offering price
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$2.35
per share
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Common
stock outstanding immediately before this offering
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19,832,888
shares
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Common
stock outstanding immediately after this offering
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21,060,055
shares (assuming the sale of all shares covered
by this prospectus supplement).
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Use of
proceeds
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We intend to use all of the net proceeds from this offering for
working capital and general corporate purposes, including, without
limitation, development of our product candidates, and general and
administrative expenses.
See
“
Use
of Proceeds
” on page
S-7.
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Risk
factors
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Investing in our securities involves significant risks. Please read
the information contained in or incorporated by reference under the
heading “
Risk
Factors
” beginning on
page S-5 of this prospectus supplement, and under similar headings
in other documents filed after the date hereof and incorporated by
reference into this prospectus supplement and the accompanying
prospectus.
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NASDAQ Capital Market symbol
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“
AZRX
”
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The number of
shares of common stock to be outstanding immediately after this
offering is based on 19,832,888 shares of our common stock
outstanding as of
May 8, 2019
.
Unless we specifically state
otherwise, the share information in this prospectus supplement
excludes:
●
994,000
shares of common stock issuable
upon the exercise of stock options as of
May 8
, 2019 at a weighted average exercise
price of $3.58 per share;
●
416,000
shares of granted, but unissued,
shares of restricted stock;
●
3,112,715
shares of common stock issuable
upon exercise of outstanding warrants, with a weighted average
exercise price of $4.83 per share;
●
635,067
shares of common stock reserved for
future issuance under the Amended and Restated 2014 Omnibus Equity
Incentive Plan as of
May 8
,
2019;
●
816,438
shares of common stock issuable
upon conversion of the Notes as of
May
8
, 2019; and
●
36,815 shares of common stock issuable upon
exercise of the warrants to be issued to the Selling Agent, which
equals 3% of the shares of common stock to be offered and sold in
this offering.
An
investment in our securities involves a high degree of risk. You
should consider the risks, uncertainties and assumptions discussed
below, together with all of the other information contained or
incorporated by reference in this prospectus supplement and the
accompanying prospectus, including our Annual Report on Form 10-K
for the fiscal year ended December 31, 2018, filed with the
Securities and Exchange Commission on April 1, 2019.
It is not possible to predict or
identify all such risks. Consequently, we could also be affected by
additional factors that are not presently known to us or that we
currently consider to be immaterial to our
operations.
The occurrence of any
of these known or unknown risks might cause you to lose all or part
of your investment in the offered securities.
Risks Related to this Offering
Our management team may invest or spend the proceeds of this
offering in ways with which you may not agree or in ways which may
not yield a significant return
.
Our management will have broad
discretion over the use of proceeds from this offering. We
currently intend to use the net proceeds from the sale of
securities offered by this prospectus
for general corporate
purposes, including research and development, working capital and
capital expenditures.
We may use a portion of
the net proceeds to continue clinical development and testing of
MS1819-SD, advance our preclinical program
AZX1103 and other
products in our b-lactamase program. We may also use the net
proceeds from the sale of the securities under this prospectus to
in-license, acquire or invest in complementary businesses,
technologies, products or assets.
However, our management will have broad discretion
in the application of the net proceeds from this offering and could
spend the proceeds in ways that do not improve our results of
operations or enhance the value of our common stock. The failure by
management to apply these funds effectively could result in
financial losses that could have a material adverse effect on our
business, cause the price of our common stock to decline and delay
the development of our product
candidates.
Purchasers in this offering will experience immediate and
substantial dilution in the book value of their
investment.
Because the public offering price per share is
substantially higher than the book value per share of our common
stock, you will suffer substantial dilution in the net tangible
book value of the common stock you purchase in this offering. After
giving effect to the sale by us of shares of our common stock at a
public offering price of $2.35 per share, and after deducting the
Selling Agent fees and estimated offering expenses payable by us,
you will suffer immediate and substantial dilution of $1.82 per
share in the net tangible book value of the common stock you
purchase in this offering.
To
the extent outstanding options, warrants or other derivative
securities are ultimately exercised or converted, or if we issue
equity-based awards to our employees under our Amended and Restated
2014 Omnibus Equity Incentive Plan, there will be further dilution
to investors who purchase shares in this offering. In addition, if
we issue additional equity securities or derivative securities,
investors purchasing shares in this offering will experience
additional dilution. For a further description of the dilution that
you will experience immediately after this offering, see
“
Dilution
” on page
S-11.
Sales of a substantial number of shares of our common stock, or the
perception that such sales may occur, may adversely impact the
price of our common stock
.
Sales of a substantial number of shares of our
common stock in the public market could occur at any time. These
sales, or the perception that such sales may occur, may adversely
impact the price of our common stock, even if there is no
relationship between such sales and the performance of our
business. As of May 8, 2019, we had 19,832,888 shares of common
stock outstanding, as well as stock options to purchase an
aggregate of
994,000
shares of
our common stock at a weighted average exercise price of $3.58 per
share, 416,000 shares of granted, but unissued restricted stock,
outstanding warrants to purchase up to an aggregate of
3,112,715
shares of our common stock
at a weighted average exercise price of $4.83 per share, and up to
816,438 shares of our common stock issuable upon conversion of the
Notes. The exercise of such outstanding derivative securities may
result in further dilution of your investment.
CAU
T
IONARY REGARDING
FORWARD-LOOKING STATEMENTS
This prospectus supplement and the accompanying
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:
●
the
availability of capital to satisfy our working capital
requirements;
●
the
accuracy of our estimates regarding expenses, future revenues and
capital requirements;
●
our
ability to continue operating as a going concern;
●
our
plans to develop and commercialize our principal product
candidates, consisting of MS1819-SD, AZX1103 and
AZX1101;
●
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;
●
regulatory
developments in the U.S. and foreign countries;
●
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;
●
our
ability to obtain and maintain intellectual property protection for
our core assets;
●
the
size of the potential markets for our product candidates and our
ability to serve those markets;
●
the
rate and degree of market acceptance of our product candidates for
any indication once approved;
●
the
success of competing products and product candidates in development
by others that are or become available for the indications that we
are pursuing;
●
the
loss of key scientific, clinical and nonclinical development,
and/or management personnel, internally or from one of our
third-party collaborators; and
●
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 supplement beginning on page S-5 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 supplement and the accompanying
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 estimate that
the net proceeds from the sale of shares of our common stock
offered under this prospectus supplement, after deducting estimated
Selling Agent fees and estimated offering expenses payable by us,
will be approximately $2,553,000 if we sell the maximum amount of
common stock offered hereby. However, this is a best efforts
offering with no minimum, and we may not sell all or any of these
shares; as a result, we may receive significantly less in net
proceeds.
We currently intend
to use the net proceeds from the sale of the securities offered by
this prospectus supplement and accompanying 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.
PRI
C
E RANGE OF OUR COMMON
STOCK
Our
common stock is listed on the NASDAQ Capital Market under the
ticker symbol “AZRX.” On May 8, 2019, the last reported
sale price per share of our common stock was $2.89 per
share.
The following table sets forth high and low sales
prices for our Common Stock for the calendar quarter and year
indicated as reported by NASDAQ. These prices represent quotations
between dealers without adjustment for retail markup, markdown, or
commission and may not represent actual
transactions.
Fiscal
Year Ending December 31, 2019
|
|
|
First
quarter ending March 31, 2019
|
$
2.52
|
$
1.25
|
Second
quarter ending June 30, 2019 (as of May 8, 2019)
|
2.89
|
2.43
|
|
|
|
Fiscal Year Ending December 31, 2018
|
|
|
First
quarter ending March 31, 2018
|
4.08
|
2.31
|
Second
quarter ending June 30, 2018
|
3.74
|
2.25
|
Third
quarter ending September 30, 2018
|
3.75
|
2.20
|
Fourth
quarter ending December 31, 2018
|
2.83
|
1.00
|
|
|
|
Fiscal Year Ending December 31, 2017
|
|
|
First
quarter ending March 31, 2017
|
5.00
|
3.44
|
Second
quarter ending June 30, 2017
|
4.20
|
3.25
|
Third
quarter ending September 30, 2017
|
5.25
|
3.07
|
Fourth
quarter ending December 31, 2017
|
3.98
|
2.40
|
Holders
At
May 8, 2019, there were 19,832,888 shares of our Common Stock
outstanding and 110 shareholders of record.
We
have never paid or declared any cash dividends on our common stock,
and we do not anticipate paying any cash dividends on our
common stock in the foreseeable future. Instead, we
plan to retain any earnings to finance the development and
expansion of our business. The declaration, payment and amount
of any future dividends will be made at the discretion of our board
of directors, and will depend upon, among other things, the results
of our operations, cash flows and financial condition, operating
and capital requirements, and other factors as the board of
directors considers relevant. There is no assurance that future
dividends will be paid, and if dividends are paid, there is no
assurance with respect to the amount of any such
dividend.
The
following table sets forth our cash and cash equivalents and
capitalization as of December 31, 2018:
●
on
a
pro
forma basis giving effect to (i) net proceeds of $2,000,000 we
received from the issuance of the Notes to ADEC in February 2019;
(ii) the issuance of an aggregate total of 775,931 shares of or
common stock as the Closing Payment Shares and the Escrow Shares to
Mayoly on March 27, 2019; and (iii) receipt of net proceeds from
the April 2019 Public Offering of $2,438,000;
and
●
on
a pro forma, as adjusted basis giving effect to the sale and
issuance by us of 1,227,167 shares of common stock in this
offering, at a public offering price of $2.35 per share, and after
deducting the Selling Agent’s fee and estimated offering
expenses payable by us.
As of December 31, 2018
(amounts in dollars and in thousands, except share and per share
amounts)
|
|
|
|
Cash
and cash equivalents
|
$
1,114,343
|
$
5,551,888
|
$
8,105,023
|
|
|
|
|
Stockholders’
equity:
|
|
|
|
Convertible
preferred stock - Par value $0.0001 per share; 10,000,000 shares
authorized and 0 shares issued and outstanding, actual, pro forma
and pro forma as adjusted
|
0
|
0
|
0
|
Common stock - Par value $0.0001 per share;
100,000,000 shares authorized; 17,704,925 shares issued and
outstanding, actual; 20,592,224 shares issued and outstanding, pro
forma; 21,819,391
shares issued
and outstanding pro forma, as adjusted
|
$
1,771
|
2,059
|
2,183
|
Additional
paid-in capital
|
53,139,259
|
59,378,093
|
61,947,543
|
Accumulated
deficit and other comprehensive loss
|
(48,667,158
)
|
(48,873,544
)
|
(48,889,982
)
|
Total
stockholders’ equity
|
$
4,473,872
|
$
10,506,608
|
$
13,059,744
|
Common
stock outstanding in the table above excludes the following
shares as of December 31, 2018:
●
994,000
shares of common stock issuable
upon the exercise of stock options as of
December 31, 2018
at a weighted average
exercise price of $3.58 per share;
●
416,000
shares of granted, but unissued,
shares of restricted stock;
●
3,112,715
shares of common stock issuable
upon exercise of outstanding warrants, with a weighted average
exercise price of $4.83 per share;
●
471,764
shares of common stock reserved for
future issuance under the Amended and Restated 2014 Omnibus Equity
Incentive Plan as of
December 31,
2018; and
●
36,815
shares of common stock issuable upon
exercise of the warrants to be issued to the Selling Agent, which
equals 3% of the shares of common stock to be offered and sold in
this offering.
If
you purchase shares of our common stock in this offering, you will
experience dilution to the extent of the difference between the
public offering price per share and our as adjusted net tangible
book value per share immediately after this offering.
Net
tangible book value is total assets minus the sum of liabilities
and intangible assets. Net tangible book value per share is net
tangible book value divided by the total number of shares of common
stock outstanding. As of December 31, 2018, our net tangible book
value was approximately $1,979,000, or approximately $0.11 per
share.
Our
pro forma net tangible book value as of December 31, 2018 was
approximately $8,983,000, or approximately $0.44 per share. Pro
forma net tangible book value per share represents our total
tangible assets less our total liabilities, divided by the number
of shares of common stock outstanding as of December 31, 2018,
after giving effect to (i) net proceeds of $2,000,000 we received
from the issuance of the Notes to ADEC in February 2019, (ii) the
issuance of an aggregate total of 775,931 shares of or common stock
as the Closing Payment Shares and the Escrow Shares to Mayoly on
March 29, 2019 and (iii) receipt of net proceeds from the April
2019 Public Offering of $2,438,000.
After
further giving effect to (i) the pro forma adjustment described
above, and (ii) our receipt of approximately $2,553,000 of
estimated net proceeds, after deducting the Selling Agent’s
fee and estimated offering expenses payable by us, from our sale of
1,227,167 shares of common stock in this offering at a public
offering price of $2.35 per share, our pro forma, as
adjusted net tangible book value as of December 31, 2018, would
have been approximately $11,536,000, or $0.53 per share. This
amount represents an immediate increase in net tangible book value
of $0.09 per share of our common stock to existing
stockholders and an immediate dilution in net tangible book value
of $1.82 per share of our common stock to new investors
purchasing shares of common stock and warrants in this
offering.
The following table illustrates this dilution on a per share basis
to new investors:
Public
offering price per share:
|
|
$
2.35
|
Net
tangible book value per share as of December 31, 2018
|
$
0.11
|
|
Pro
forma increase in net tangible book value per share attributable
to the transactions described above
|
0.33
|
|
Pro
forma net tangible book value per share as of December 31,
2018
|
$
0.44
|
|
Increase
in pro forma, as adjusted, net tangible book value per share after
this offering
|
$
0.09
|
|
|
|
|
Pro
forma, as adjusted net tangible book value per share after this
offering
|
|
$
0.53
|
|
|
|
Dilution
in pro forma as adjusted net tangible book value per share to new
investors in this offering
|
|
$
1.82
|
The
foregoing discussion and table do not take into account further
dilution to new investors that could occur upon the exercise of
outstanding options or warrants having a per share exercise price
less than the combined public offering price in this offering. To
the extent that we raise additional capital through the sale of
equity or convertible debt securities after this offering, the
issuance of those securities could result in further dilution to
our stockholders.
The
table and discussion above are based on 17,704,925 shares of our
common stock outstanding as of December 31, 2018 (actual), and
excludes as of that date the following:
●
994,000
shares of common stock issuable
upon the exercise of stock options as of
December 31, 2018
at a weighted average
exercise price of $3.58 per share;
●
416,000
shares of granted, but unissued,
shares of restricted stock;
●
3,112,715
shares of common stock issuable
upon exercise of outstanding warrants, with a weighted average
exercise price of $4.83 per share;
●
471,764
shares of common stock reserved for
future issuance under the Amended and Restated 2014 Omnibus Equity
Incentive Plan as of
December 31,
2018; and
●
36,815
shares of common stock issuable upon
exercise of the warrants to be issued to the Selling Agent, which
equals 3% of the shares of common stock to be offered and sold in
this offering.
Pursuant to an engagement agreement, we have
engaged Alexander Capital, L.P. as exclusive Selling Agent, to
solicit offers to purchase the common stock
and pursuant to
this prospectus supplement and accompanying prospectus
. The Selling Agent is not purchasing any common
stock for its own account in this offering, and is not required to
arrange the purchase or sale of any additional specific number or
dollar amount of the securities. The Selling Agent may engage
sub-agents or selected dealers in connection with this
offering.
The
Selling Agent has agreed to use its reasonable best efforts to
arrange for the sale of all of the securities in this offering.
There is no requirement that any minimum number of shares of common
stock or dollar amount of common stock be sold in this offering and
there can be no assurance that we will sell all or any of the
common stock being offered. We will enter into securities purchase
agreements directly with investors who purchase securities in this
offering.
We
currently anticipate that the closing of this offering will occur
on or about May 13, 2019, subject to customary closing conditions.
On the closing date, the following will occur:
●
we
will receive funds in the amount of the aggregate purchase
price;
●
the
Selling Agent will receive the Selling Agent fees in accordance
with the terms of the engagement agreement; and
we
will
deliver
the shares of common stock to the investors.
We have agreed to pay the Selling Agent a Selling
Agent fee equal to 7% of the aggregate gross proceeds in this
offering. We have also agreed to provide Alexander Capital, L.P. a
non-accountable expense allowance equal to 1% of the gross proceeds
from the offering and to reimburse Alexander Capital, L.P. up to
$50,000 for its expenses in connection with this offering. As a
result, we may pay to Alexander Capital, L.P. up to approximately
$78,800 for expenses incurred in connection with the
offering.
We have also agreed
to issue to the Selling Agent warrants to purchase up to a total of
3% of the shares of common stock sold in this offering. The
warrants are exercisable at $2.82 per share (120% of the public
offering price) commencing on a date which is one year from the
effective date of the offering under this prospectus supplement and
expiring on a date which is no more than five (5) years from the
effective date of the offering in compliance with FINRA Rule
5110(f)(2)(G). The warrants have been deemed compensation by FINRA
and are therefore subject to a 180-day lock-up pursuant to Rule
5110(g)(1) of FINRA. The Selling Agent (or its permitted assignees
under the Rule) will not sell, transfer, assign, pledge, or
hypothecate these warrants or the securities underlying these
warrants, nor will it engage in any hedging, short sale,
derivative, put, or call transaction that would result in the
effective economic disposition of the warrants or the underlying
securities for a period of 180 days from effectiveness. In
addition, the warrants provide for registration rights upon
request, in certain cases. We will bear all fees and expenses
attendant to registering the securities issuable on exercise of the
warrants other than underwriting commissions incurred and payable
by the holders. The exercise price and number of shares issuable
upon exercise of the warrants may be adjusted in certain
circumstances including in the event of a stock dividend,
extraordinary cash dividend or our recapitalization,
reorganization, merger or consolidation. However, the warrant
exercise price or underlying shares will not be adjusted for
issuances of shares of common stock at a price below the warrant
exercise price.
The
following table shows the Selling Agent fees per share and total
Selling Agent fees we will pay in connection with the sale of the
common stock, assuming the purchase of all of the common stock we
are offering.
Selling Agent fees
|
|
Per
share
|
$
0.1645
|
Total
|
$
201,869
|
We
estimate the total expenses of this offering which will be payable
by us, excluding the Selling Agent fees, will be approximately
$78,800
.
After deducting the fees due to the Selling Agent and our estimated
offering expenses, we expect the net proceeds from this offering to
be approximately $2,553,000 (assuming the sale of all shares
covered by this prospectus supplement).
We
have agreed to indemnify the Selling Agent and certain other
persons against certain liabilities relating to or arising out of
the Selling Agent’s activities under the engagement
agreement. We have also agreed to contribute to payments that the
Selling Agent may be required to make in respect of such
liabilities. Alexander Capital, L.P. may be deemed to be
an underwriter within the meaning of Section 2(a)(11) of the
Securities Act of 1933, as amended, and any commissions received by
it and any profit realized on the resale of the common stock sold
by it while acting as principal might be deemed to be underwriting
discounts or commissions under the Securities Act of 1933, as
amended. As an underwriter, Alexander Capital, L.P. would be
required to comply with the requirements of the Securities Act of
1933, as amended, and the Securities Exchange Act of 1934, as
amended, including, without limitation, Rule 415(a)(4) under the
Securities Act of 1933, as amended, and Rule 10b-5 and Regulation M
under the Securities Exchange Act of 1934, as amended. These rules
and regulations may limit the timing of purchases and sales of
shares of common stock by Alexander Capital, L.P. acting as
principal. Under these rules and regulations, Alexander Capital,
L.P.:
●
may
not engage in any stabilization activity in connection with our
securities; and
●
may
not bid for or purchase any of our securities or attempt to induce
any person to purchase any of our securities, other than as
permitted under the Securities Exchange Act of 1934, as amended,
until it has completed its participation in the
distribution.
The validity of the
shares of common stock offered by this prospectus supplement
will be passed upon for us by
Disclosure Law Group, a Professional Corporation, of San Diego,
California.
Cozen
O’Connor of Minneapolis, Minnesota is acting as counsel for
the Selling Agent in connection with the shares of common stock
offered hereby.
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 herein by
reference. 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
C
AN FIND
MORE INFORMATION
We are subject to
the informational requirements of the Securities Exchange Act of
1934, as amended, and in accordance therewith file annual,
quarterly and current reports, proxy statements and other
information with the Securities and Exchange Commission. The
Securities and Exchange Commission maintains a website that
contains reports, proxy and information statements and other
information regarding registrants that file electronically with the
Securities and Exchange Commission. The address of the Securities
and Exchange Commission’s website is
www.sec.gov.
We have filed with
the Securities and Exchange Commission a registration statement
under the Securities Act of 1933, as amended, relating to the
offering of these securities. The registration statement, including
the attached exhibits, contains additional relevant information
about us and the securities. This prospectus does not contain all
of the information set forth in the registration statement. You can
view a copy of the registration statement at
www.sec.gov.
INCORPORATION OF CE
R
TAIN I
NFORMATION BY REFERENCE
In this prospectus
supplement, we “incorporate by reference” certain
information that we file with the SEC, which means that we can
disclose important information to you by referring you to that
information. The information we incorporate by reference is an
important part of this prospectus supplement, and later information
that we file with the SEC will automatically update and supersede
this information. The following documents have been filed by us
with the SEC and are incorporated by reference into this prospectus
supplement:
●
our
Annual Report on Form 10-K for the year ended December 31, 2018,
filed with the SEC 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 with the SEC on April 30,
2019;
●
our
Current Reports on Form 8-K, filed with the SEC on February 20,
2019, March 28, 2019, April 3, 2019 and April 24, 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.
All documents and
reports that we file with the SEC (other than any portion of such
filings that are furnished under applicable SEC rules rather than
filed) under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act
from the date of this prospectus until the completion of the
offering under this prospectus shall be deemed to be incorporated
in this prospectus by reference.
We will furnish
without charge to you, upon written or oral request, a copy of any
or all of the documents incorporated by reference, including
exhibits to these documents. You should direct any requests for
documents to:
AzurRx
Biopharma, Inc.
760
Parkside Avenue
Downtown
Biotechnology Incubator, Suite 304
Brooklyn,
New York 11226
(646) 699-7855
This
prospectus supplement and accompanying 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.
You should rely
only on the information contained or incorporated by reference in
the prospectus, this prospectus supplement, any free writing
prospectus that we authorize and any pricing supplement. We have
not authorized any person, including any salesman or broker, to
provide information other than that provided in the prospectus,
this or any applicable prospectus supplement, any free writing
prospectus that we authorize or any pricing supplement. We have not
authorized anyone to provide you with different information. We do
not take responsibility for, and can provide no assurance as to the
reliability of, any information that others may give you. We are
not making an offer of the securities in any jurisdiction where the
offer is not permitted. You should not assume that the information
in the prospectus, this or any applicable prospectus supplement,
any free writing prospectus that we authorize and any pricing
supplement or any document incorporated by reference is accurate as
of any date other than the date of the applicable
document.
Any statement
contained in a document incorporated or deemed to be incorporated
by reference into this prospectus supplement will be deemed to be
modified or superseded for purposes of this prospectus supplement
to the extent that a statement contained in the prospectus, this or
any prospectus supplement, or any other subsequently filed document
that is deemed to be incorporated by reference into this prospectus
supplement modifies or supersedes the statement. Any statement so
modified or superseded will not be deemed, except as so modified or
superseded, to constitute a part of this prospectus
supplement.
$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 July 3, 2018, the last
reported sale price per share of our common stock was $3.17
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 July 3, 2018, the aggregate market value of our outstanding
common stock held by non-affiliates was approximately $50.0
million, which was calculated in accordance with General
Instruction I.B.6 of Form S-3, based on 14,464,544 shares of
outstanding common stock held by non-affiliates, at a price per
share of $3.46, the closing sale price of our common stock reported
on the NASDAQ Capital Market on June 22, 2018.
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 by non-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 $10.4 million 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
$6.28 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 July 12, 2018
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
.”
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 BioPharma 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. Our
current product pipeline consists of two therapeutic programs 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
. We recently
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 does 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 patients with EPI were enrolled in the study, and initial data
shows a strong safety and efficacy profile. Both clinical activity
and a clear dose response were observed, with the highest MS1819-SD
dose cohort showing greater than 21% improvement in CFA in
evaluable patients. Additionally, maximal absolute CFA response to
treatment was up to 57%, with an inverse relationship to baseline
CFA. Favorable trends were also observed on other evaluated
endpoints, including Bristol stool scale, number of daily
evacuations and weight of stool, and these were consistent with the
CFA results.
We
expect to provide formal data from the Phase IIa study in the fall
of 2018, and we expect to begin a planned Phase IIb study focused
on enrolling patients with CF in the second half of 2018.
●
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,
and expect to file an Investigational New Drug application (an
“
IND
”) for AZX1103 with the U.S. Food and Drug
Administration (“
FDA
”) by the end of 2018. At this time, we do
not have immediate plans to continue 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
BioPharma SAS (formerly ProteaBio Europe SAS), a company
incorporated in October 2008 under the laws of France that had been
a wholly-owned subsidiary of Protea Biosciences, Inc., or Protea
Sub, in turn a wholly-owned subsidiary of Protea Biosciences Group,
Inc., a publicly-traded company. 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, 2017, 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
REGARDIN
G
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:
●
the
availability of capital to satisfy our working capital
requirements;
●
the
accuracy of our estimates regarding expenses, future revenues and
capital requirements;
●
our
ability to continue operating as a going concern;
●
our
plans to develop and commercialize our principal product
candidates, consisting of MS1819-SD, AZX1103 and
AZX1101;
●
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;
●
regulatory
developments in the U.S. and foreign countries;
●
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;
●
our
ability to obtain and maintain intellectual property protection for
our core assets;
●
the
size of the potential markets for our product candidates and our
ability to serve those markets;
●
the
rate and degree of market acceptance of our product candidates for
any indication once approved;
●
the
success of competing products and product candidates in development
by others that are or become available for the indications that we
are pursuing;
●
the
loss of key scientific, clinical and nonclinical development,
and/or management personnel, internally or from one of our
third-party collaborators; and
●
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 general corporate purposes,
including research and development, working capital and
capital expenditures. We may use a portion of the net proceeds to
continue clinical development and testing of MS1819-SD and/or to
advance our preclinical programs for AZX1103. However, we have no
current commitments or obligations to do so. We may set forth
additional information on the use of proceeds from the sale or
the securities we offer under this prospectus in a prospectus
supplement relating to the specific offering. We
cannot currently allocate specific percentages of the net
proceeds that we may use for the purposes specified above. As a
result, our management will have broad discretion in the
allocation of the net proceeds. Pending the application of the net
proceeds, we intend to invest the net proceeds in short- and
intermediate-term, interest-bearing obligations, investment-grade
instruments, certificates of deposit or direct or guaranteed
obligations of the U.S. government.
DESCRIPT
ION
O
F 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 the registration statement of which this prospectus
is a part.
As
of July 3, 2018, there were 16,792,395 shares of our common
stock issued and outstanding, which were held by approximately 115
stockholders of record, approximately 3.11 million shares of common
stock subject to outstanding warrants, 545,000 shares of common
stock subject to outstanding stock options under our Amended and
Restated 2014 Omnibus Equity Incentive Plan, and approximately
74,000 shares subject to certain outstanding convertible
debentures. 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.
DESCRIP
T
I
ON OF
WARRANTS
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.
DESCRIP
T
I
ON OF OUR
UNITS
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 O
F
CERT
AIN 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.
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 of 1933, as amended
(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,
2017, 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 FI
ND
MORE INFORMATION
We
are a public company and file annual, quarterly and special
reports, proxy statements and other information with the SEC. You
may read and copy any document we file at the SEC’s public
reference room at 100 F Street, NE, Washington, D.C. 20549. You can
request copies of these documents by writing to the SEC and paying
a fee for the copying cost. Please call the SEC at 1-800-SEC-0330
for more information about the operation of the public reference
room. Our SEC filings are also available, at no charge, to the
public at the SEC’s website at
http://www.sec.gov.
INCORPORATION O
F CERTAIN I
N
FORMATION 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, 2017,
filed on March 16, 2018;
●
our
Amendment No. 1 to our Annual Report on Form 10-K/A for the year
ended December 31, 2017, filed on April 27, 2018;
●
our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2018,
filed on May 14, 2018;
●
our
Current Report on Form 8-K, filed on January 5, 2018;
●
our
Current Report on Form 8-K, filed on January 17, 2018;
●
our
Current Report on Form 8-K, filed on February 13,
2018;
●
our
Current Report on Form 8-K, filed April 23, 2018;
●
our
Current Report on Form 8-K, filed April 23, 2018;
●
our
Current Report on Form 8-K, filed on May 4, 2018;
●
our
Current Report on Form 8-K, filed on June 1, 2018;
●
our
Current Report on Form 8-K, filed on July 3, 2018; 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.
1,227,167 Shares of Common
Stock
AZURRX
BIOPHARMA, INC.
_______________________________
Prospectus
Supplement
_______________________________
Alexander
Capital, L.P.
May
9, 2019
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