Filed Pursuant to Rule 424(b)(3)
Registration No. 333-256476
PROSPECTUS
AzurRx BioPharma, Inc.
3,464,664 Shares of Common Stock
This
prospectus relates to the resale of up to 3,464,664 shares of
AzurRx BioPharma, Inc. (the “Company,”
“we,” “our,” or “us”) common
stock, par value $0.0001 per share, by the selling stockholders
listed in this prospectus or their permitted transferees. The
shares of common stock registered for resale pursuant to this
prospectus includes: (i) 75,663 shares of common stock issuable
upon exercise of warrants (the “Selling Agent
Warrants”) issued to Alexander Capital L.P. (together with
its designees identified as selling stockholders herein, as the
context may require, “Alexander”), or its designees, in
connection with the Selling Agent Agreement, dated April 1, 2019,
and the Selling Agent Agreement, dated May 9, 2019, by and between
us and Alexander (collectively, the “Selling Agent
Agreements”), (ii) 3,329,138 shares of common stock converted
from shares of Series C 9.00% Convertible Junior Preferred Stock,
par value $0.0001 per share (the “Series C Preferred
Stock”) issued to First Wave Bio, Inc. (“First
Wave”) pursuant to the securities purchase agreement, dated
January 8, 2021, by and between us and First Wave (the “First
Wave Purchase Agreement”) and (iii) 59,863 shares of common
stock issued to Armistice Capital Master Fund Ltd.
(“Armistice”) as accrued dividends in connection with
the issuance of the Series C Preferred Stock to Armistice pursuant
to a private placement and concurrent registered direct offering
which was completed on January 6, 2021.
We are
not selling any securities under this prospectus and will not
receive any of the proceeds from the sale of shares by the selling
stockholders. However, we may receive proceeds of up to
approximately $203,000 from the cash exercise of the Selling Agent
Warrants by the selling stockholders, once the registration
statement, of which this prospectus is part, is declared effective.
The Selling Agent Warrants may also be exercised and resold
hereunder on a cashless basis, at the option of their holders, and
we will not receive any proceeds upon such cashless
exercise.
The
selling stockholders may sell the shares of common stock described
in this prospectus in a number of different ways and at varying
prices. See “Plan of Distribution” on page 11 of this
prospectus for more information on how the selling stockholders may
sell the shares of common stock being registered pursuant to this
prospectus. The selling stockholders may be an
“underwriter” within the meaning of Section 2(a)(11) of
the Securities Act.
We will
pay the expenses incurred in registering the shares, including
legal and accounting fees. See “Plan of Distribution”
on page 11 of this prospectus.
We are an “emerging growth company” as defined in
Section 2(a) of the Securities Act, and we have elected to
comply with certain reduced public company reporting
requirements.
Our
common stock is listed on the Nasdaq Capital Market under the
symbol “AZRX.” On June 1, 2021, the last reported sale
price of our common stock on the Nasdaq Capital Market was $0.86
per share.
Investing in our securities involves a high degree of risk. See
“Risk Factors” beginning on page 3 of this
prospectus and
the documents incorporated by reference into this
prospectus for
a discussion of the risks that you should consider in connection
with an investment in our securities.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is June 2, 2021.
TABLE OF CONTENTS
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1
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2
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3
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4
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6
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8
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10
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11
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13
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13
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13
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14
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This
summary highlights information contained elsewhere in this
prospectus. This summary does not contain all of the information
that you should consider before deciding to invest in our
securities. You should read this entire
prospectus carefully,
including the “Risk Factors” section in this prospectus
and under similar captions in the documents incorporated by
reference into this prospectus. In this prospectus, unless
otherwise stated or the context otherwise requires, references to
“AzurRx”, “Company”, “we”,
“us”, “our” or similar references mean
AzurRx BioPharma, Inc. and its subsidiaries on a consolidated
basis. References to “AzurRx BioPharma” refer to AzurRx
BioPharma, Inc. on an unconsolidated basis. References to
“AzurRx SAS” refer to AzurRx SAS, AzurRx
BioPharma’s wholly-owned subsidiary through which we conduct
our European operations.
Overview
We are engaged in the research and development of
targeted, non-systemic therapies for the treatment of patients with
gastrointestinal (“GI”) diseases. Non-systemic therapies are
non-absorbable drugs that act locally, i.e. in the intestinal
lumen, skin or mucosa, without reaching an individual’s
systemic circulation. We are focused on
developing our pipeline of gut-restricted GI clinical drug
candidates, including MS1819 and niclosamide.
Our lead drug candidate
is MS1819, a recombinant lipase for the treatment of exocrine
pancreatic insufficiency (“EPI”)
in patients with cystic
fibrosis (“CF”) and chronic pancreatitis
(“CP”), currently in two
Phase 2 CF clinical trials. In March 2021, we announced topline results from
our Phase 2b OPTION 2 monotherapy trial, and in May 2021, we
announced positive interim results from the first 18 patients in
our Phase 2 Combination trial in Europe.
In 2021, we intend to
launch two new clinical programs using proprietary formulations of
niclosamide, a small molecule
with anti-helminthic, anti-viral and anti-inflammatory
properties; FW-1022, for
Severe Acute Respiratory Syndrome Coronavirus 2
(“COVID-19”)
gastrointestinal infections, and FW-420, for Grade 1 and Grade 2
Immune Checkpoint Inhibitor-Associated Colitis
(“ICI-AC”)
and diarrhea in advanced stage oncology patients.
We initiated our Phase 2 RESERVOIR
clinical trial using a proprietary oral immediate-release tablet
formulation of micronized niclosamide (FW-1022) for the treatment
of COVID-19 related GI infections in April 2021, and we are
preparing to initiate our Phase 1b/2a PASSPORT ICI-AC trial using
both an oral immediate-release tablet and a topical rectal enema
foam formulations of niclosamide (FW-420) in the first half of
2021.
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. Our principal
executive offices are located at 1615 South Congress Avenue, Suite
103, Delray Beach, Florida 33445. 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.
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Shares
of common stock offered by the selling stockholders
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3,464,664
shares of common stock consisting of:
●
up to
75,663 shares of common stock issuable upon exercise, for cash, of
the Selling Agent Warrants held by certain selling
stockholders.
●
3,329,138 shares of
common stock issued to First Wave upon conversion of the shares of
Series C Preferred Stock, plus accrued dividends thereon, issued
pursuant to the First Wave Purchase Agreement.
●
59,863
shares of common stock issued to Armistice upon conversion of the
accrued dividends on the shares of Series C Preferred Stock issued
pursuant to the private placement and registered direct offering
which was completed on January 6, 2021.
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Shares
of common stock outstanding before this offering
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78,575,131
shares of common stock
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Shares
of common stock to be outstanding after giving effect to the
issuance of 3,464,664 shares registered hereunder
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82,039,795
shares of common stock
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Use of
proceeds
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We are
not selling any securities under this prospectus and will not
receive any of the proceeds from the sale of shares by the selling
stockholder. However, we may receive proceeds of up to
approximately $203,000 from the cash exercise of the Selling Agent
Warrants by certain selling stockholders, once the registration
statement, of which this prospectus is part, is declared effective.
The Selling Agent Warrants may be exercised and resold hereunder on
a cashless basis, at the option of their holders, and we will not
receive any proceeds upon such cashless exercise.
We
anticipate that the proceeds we receive from the cash exercise of
the Selling Agent Warrants, if any, will be used for general
corporate purposes, which may include funding research, development
and product manufacturing, clinical trials, acquisitions or
investments in businesses, products or technologies that are
complementary to our own, increasing our working capital, reducing
indebtedness, and capital expenditures. Please see “Use of
Proceeds” on page 10.
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Terms
of this offering
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The
selling stockholders, including their transferees, donees,
pledgees, assignees and successors-in-interest, may sell, transfer
or otherwise dispose of any or all of the shares of common stock
offered by this prospectus from time to time on The Nasdaq Capital
Market or any other stock exchange, market or trading facility on
which the shares are traded or in private transactions. The shares
of common stock may be sold at fixed prices, at market prices
prevailing at the time of sale, at prices related to prevailing
market price or at negotiated prices.
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Risk
factors
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Investing
in our common stock involves a high degree of risk. See “Risk
Factors” beginning on page 3 of this prospectus and
under similar headings in the other documents that are filed after
the date hereof and incorporated by reference in this
prospectus for a discussion of factors to consider before
deciding to purchase shares of our common stock.
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Nasdaq
Capital Market symbol
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AZRX
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Before
purchasing any of the securities you should carefully consider the
risk factors incorporated by reference in this prospectus from our
Annual Report on Form 10-K for the fiscal year ended December 31,
2020 and any subsequent updates described in our Quarterly Reports
on Form 10-Q and Current Reports on Form 8-K, as well as the risks,
uncertainties and additional information set forth in our SEC
reports on Forms 10-K, 10-Q and 8-K and in the other documents
incorporated by reference in this prospectus. For a description of
these reports and documents, and information about where you can
find them, see “Where You Can Find More Information”
and “Incorporation of Certain Information By
Reference.” Additional risks not presently known or that we
presently consider to be immaterial could subsequently materially
and adversely affect our financial condition, results of
operations, business and prospects.
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
This
prospectus and any documents we incorporate by reference,
contain certain forward-looking statements that involve substantial
risks and uncertainties. All statements contained in this
prospectus and any documents we incorporate by reference,
other than statements of historical facts, are forward-looking
statements including statements regarding our strategy, future
operations, future financial position, future revenue, projected
costs, prospects, plans, objectives of management and expected
market growth. These statements involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements.
The
words “anticipate”, “believe”,
“estimate”, “expect”, “intend”,
“may”, “plan”, “predict”,
“project”, “target”,
“potential”, “will”, “would”,
“could”, “should”, “continue”
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. These forward-looking statements include,
among other things, statements about:
●
statements
regarding the impact of the COVID-19 pandemic and its effects on
our operations, access to capital, research and development and
clinical trials and potential disruption in the operations and
business of third-party vendors, contract research organizations
(“CROs”),
contract development and manufacturing organizations
(“CDMOs”),
other service providers, and collaborators with whom we conduct
business;
●
availability of
capital to satisfy our working capital requirements;
●
our current and
future capital requirements and our ability to raise additional
funds to satisfy our capital needs;
●
the accuracy of our
estimates regarding expense, future revenue and capital
requirements;
●
ability to continue
operating as a going concern;
●
our plans to
develop and commercialize our drug candidates, including MS1819 and
niclosamide;
●
our ability to
initiate and complete our clinical trials and to advance our
principal drug 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 vendor(s), CROs, CDMOs 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;
●
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, as well as
certain information incorporated by reference into this prospectus,
that could cause actual future results or events to differ
materially from the forward-looking statements that we make. Our
forward-looking statements do not reflect the potential impact of
any future acquisitions, mergers, dispositions, joint ventures or
investments we may make.
Discussions
containing these forward-looking statements may be found, among
other places, in the sections titled “Business,”
“Risk Factors” and “Management’s Discussion
and Analysis of Financial Condition and Results of
Operations” incorporated by reference from our most recent
Annual Report on Form 10-K for the fiscal year ended December 31,
2020 and our most recent Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2021, as well as any amendments
thereto, filed with the SEC. Additional factors are discussed under
the caption “Risk Factors” in this prospectus and any
free writing prospectus and under similar headings in the other
documents that are incorporated by reference into this prospectus.
New risks and uncertainties arise from time to time, and it is
impossible for us to predict these events or how they may affect
us. We disclaim any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as may be required by
law.
You
should read this prospectus with the understanding that our
actual future results may be materially different from what we
expect. We do not assume any obligation to update any
forward-looking statements whether as a result of new information,
future events or otherwise, except as required by applicable
law.
DESCRIPTION OF THE
TRANSACTIONS
April 2019 Selling Agent Agreement
On
April 1, 2019, we entered into a Selling Agent Agreement (the
“April 2019 Selling Agent Agreement”) with Alexander,
pursuant to which Alexander agreed to act as selling agent in
connection with a public offering of shares of our common
stock (the “April 2019 Offering”). Pursuant to the
April 2019 Selling Agent Agreement, we agreed to pay Alexander a
cash fee equal to 7.0% of the aggregate gross proceeds of the April
2019 Offering and to issue Alexander warrants to purchase a number
of shares our common stock equal to 3.0% of the aggregate number of
shares of our common stock sold in the April 2019 Offering. We also
agreed to reimburse Alexander for its expenses in connection with
the April 2019 Offering on a non-accountable basis in an amount
equal to 1.0% of the gross proceeds of the April 2019 Offering and
up to $50,000 for other accountable expenses.
On
April 2, 2019, we offered and sold a total of 1,294,930 shares of
our common stock in connection with the April 2019 Offering at a
public offering price of $2.13 per share. As a result, we received
net proceeds of approximately $2.5 million, after deducting the
selling agent fee payable to Alexander and other April 2019
Offering expenses payable by us. In connection with the closing of
the April 2019 Offering and pursuant to the April 2019 Selling
Agent Agreement, the Company issued warrants to Alexander to
purchase up to 38,848 shares of our common stock (the “April
2019 Selling Agent Warrants”). 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.
May 2019 Selling Agent Agreement
On May
9, 2019, we entered into a Selling Agent Agreement (the
“May 2019 Selling Agent Agreement”) with Alexander,
pursuant to which Alexander agreed to act as selling agent in
connection with a public offering of shares of our common
stock (the “May 2019 Offering” and with the April 2019
Offering, the “Offerings”). Pursuant to the May 2019
Selling Agent Agreement, we agreed to pay Alexander a cash fee
equal to 7.0% of the aggregate gross proceeds of the May 2019
Offering and to issue Alexander warrants to purchase a number of
shares of our common stock equal to 3.0% of the aggregate number of
shares of our common stock sold in the May 2019 Offering. We also
agreed to reimburse Alexander for its expenses in connection with
the May 2019 Offering on a non-accountable basis in an amount equal
to 1.0% of the gross proceeds of the May 2019 Offering and up to
$50,000 for other accountable expenses.
On May
13, 2019, we offered and sold a total of 1,227,167 shares of our
common stock in connection with the May 2019 Offering at a public
offering price of $2.35 per share. As a result, we received net
proceeds of approximately $2.55 million, after deducting the
selling agent fee payable to Alexander and other May 2019 Offering
expenses payable by us. In connection with the closing of the May
2019 Offering and pursuant to the May 2019 Selling Agent Agreement,
the Company issued warrants to Alexander to purchase up to 36,815
shares of our common stock (the “May 2019 Selling Agent
Warrants” and with the April 2019 Selling Agent Warrants, the
“Selling Agent Warrants”). The May 2019 Selling Agent
Warrants will become exercisable one year from the date of
issuance, expire on May 9, 2024 and have an exercise price of $2.82
per share.
The
Offerings were conducted pursuant to our effective shelf
registration statement on Form S-3 (File No. 333-226065),
filed with the Securities and Exchange Commission (the
“SEC”) on July 3, 2018, and declared effective on July
12, 2018. A prospectus supplement and the accompanying base
prospectus relating to the Offerings were filed with the SEC on
April 2, 2019 and May 9, 2019, respectively. The Selling Agent
Warrants were offered and sold without registration under the
Securities Act of 1933, as amended, pursuant to the exemption
provided in Section 4(a)(2) under the Securities Act and
Regulation D promulgated thereunder.
First Wave Purchase Agreement
On
January 8, 2021, pursuant to the license agreement, dated December
31, 2020, by and between us and First Wave, we entered into the
First Wave Purchase Agreement pursuant to which we issued First
Wave 3,290.1960 shares of Series C Preferred Stock, initially
convertible into an aggregate of 3,290,196 shares of our common
stock, at an initial stated value of $750.00 per share and a
conversion price of $0.75 per share. On February 24, 2021, our
stockholders approved certain proposals related to the issuance of
the Series C Preferred Stock, and all outstanding shares of Series
C Preferred Stock issued to First Wave were converted into an
aggregate of 3,329,138 shares of common stock, including the
3,290.1960 shares of Series C Preferred Stock plus accrued
dividends thereon through the conversion date.
Registered Direct Offering and Private Placement
On
December 31, 2020, we entered into a securities purchase agreement
(the “Series C Purchase Agreement”) with Armistice
pursuant to which we agreed to sell in a registered direct offering
(the “Registered Direct Offering”) 5,333.333 shares of
Series C Preferred Stock, at a price of $750 per share, initially
convertible into an aggregate of 5,333,334 shares of our common
stock, at an initial stated value of $750 per share and a
conversion price of $0.75 per share. The Registered Direct Offering
closed on January 6, 2021 and Armistice converted all of its Series
C Preferred Stock issued in the Registered Direct Offering,
effective immediately upon closing. Concurrently with the
Registered Direct Offering, in a private placement (the
“Private Placement”) pursuant to the Series C Purchase
Agreement, we also sold Armistice an additional 5,333.333 shares of
Series C Preferred Stock at the same price as the Series C
Preferred Stock offered in the Registered Direct Offering, which
shares are convertible into an aggregate of 5,333,334 shares of our
common stock, together with warrants to purchase up to an aggregate
of 10,666,668 shares of our common stock, with an exercise price of
$0.80 per share and an expiration term of five and a half years
from the date of issuance. The Private Placement closed on January
6, 2021.
On
February 24, 2021, our stockholders approved certain proposals
related to the issuance of the Series C Preferred Stock and all
outstanding shares of Series C Preferred Stock issued to Armistice
were converted into 5,393,197 shares of our common stock, including
the 5,333.333 shares of Series C Preferred Stock plus accrued
dividends thereon through the conversion date. 5,333,334 shares of
our common stock issued to Armistice upon conversion of the Series
C Preferred Stock was registered for resale on the Registration
Statement on Form S-1 (File No. 333-252087) filed with the SEC on
January 13, 2021 and was declared effective on January 21, 2021. We
are registering the 59,863 shares of common stock issued to
Armistice in respect of accrued dividends on the Series C Preferred
Stock through the conversion date on this registration
statement.
This prospectus relates to the sale from time to time by
the selling stockholders of up to 75,663 shares of our common
stock issuable upon exercise of the Selling Agent Warrants issued
in connection with the Offerings, 3,329,138 shares of our common
stock issued to First Wave upon conversion of the shares of Series
C Preferred Stock, plus accrued dividends thereon, issued pursuant
to the First Wave Purchase Agreement and 59,863 shares of our
common stock issued to Armistice as accrued dividends on the Series
C Preferred Stock issued pursuant to the Private
Placement. When we refer to the “selling
stockholders” in this prospectus, we mean the persons and
entities listed in the table below, and their respective pledgees,
donees, permitted transferees, assignees, successors and others who
later come to hold any of the selling stockholders’ interests
in shares of our common stock other than through a public
sale.
The selling stockholders may sell some, all or none of their
shares. We do not know how long the selling stockholders will hold
the shares before selling them, and we currently have no
agreements, arrangements or understandings with the selling
stockholder regarding the sale of any of the shares.
The following table presents information regarding the selling
stockholders and the shares that they may offer and sell from time
to time under this prospectus. The number of shares common
stock beneficially owned by the selling stockholders is determined
under rules promulgated by the SEC. Except as described above,
there are currently no agreements, arrangements or understandings
with respect to the resale of any of the securities covered by this
prospectus.
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Maximum Number of Shares
Being Offered Pursuant to this Prospectus
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Shares Beneficially Owned After Offering (1)(2)
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Shares
Beneficially
Owned Prior to Offering
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Shares of Common
Stock Underlying Selling Agent
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Name of Selling Stockholder
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(1)(2)(3)
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Armistice
Capital Master Fund Ltd.
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59,863
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59,863
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-
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**%
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Bari
Latterman
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1,000
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(5)
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1,000
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-
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-
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**%
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Christopher
Carlin
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222,873
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(6)
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31,731
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-
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191,142
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**%
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First
Wave Bio, Inc.
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3,329,138
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-
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3,329,138
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-
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**%
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Jonathan
Gazdak
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48,641
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(7)
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24,266
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-
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24,375
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**%
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Joseph
Amato
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48,042
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(8)
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9,333
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-
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38,709
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**%
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Rocco
Guidicipietro
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22,708
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(9)
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9,333
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-
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13,375
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**%
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*
Beneficial
ownership assumes the exercise of any warrants and conversion of
any Series B Preferred Stock held by the selling
stockholder.
(1)
Except
as noted below, beneficial ownership is determined in accordance
with the rules of the SEC and generally includes voting or
investment power with respect to securities. All entries exclude
beneficial ownership of shares issuable pursuant to warrants,
options or other derivative securities that have not vested or that
are not otherwise exercisable as of the date hereof or which will
not become vested or exercisable within 60 days of May 21,
2021.
(2)
Based
upon our internal books and records and public filings only, as of
the date of this prospectus; may not include beneficial ownership
of shares of our common stock, if any, held in “street
name” through unrelated third-party brokers, as of the date
of this prospectus, which are not being offered for resale by this
prospectus.
(3)
Includes
certain shares of our common stock which are not being offered
pursuant to this prospectus.
(4)
All
percentage calculations are based on 78,575,131 shares of our
common stock outstanding as of May 21, 2021 and are rounded to the
nearest tenth of a percent. Warrants, options or other derivative
securities that are presently exercisable or exercisable within 60
days are deemed to be beneficially owned by the person holding such
securities for the purpose of calculating the percentage ownership
of that person, but are not treated as outstanding for the purpose
of calculating the percentage ownership of any other
person.
(5)
Includes
1,000 warrants issued to Alexander Capital L.P. and their assignees
which were designated to the selling stockholder.
(6)
Includes
190,974 warrants issued to Alexander Capital L.P. and their
assignees which were designated to the selling stockholder, and
31,899 shares of common stock.
(7)
Includes
24,266 warrants issued to Alexander Capital L.P. and their
assignees which were designated to the selling stockholder, and
24,375 shares of common stock.
(8)
Includes
48,042 warrants issued to Alexander Capital L.P. and their
assignees which were designated to the selling
stockholder.
(9)
Includes
13,333 warrants issued to Alexander Capital L.P. and their
assignees which were designated to the selling stockholder, and
9,375 shares of common stock.
Issuances
of our common stock to the selling stockholders will not affect the
rights or privileges of our existing stockholders, except that the
economic and voting interests of each of our existing stockholders
will be diluted as a result of any such issuance. Although the
number of shares of common stock that our existing stockholders own
will not decrease, the shares owned by our existing stockholders
will represent a smaller percentage of our total outstanding shares
after any such issuance to the selling stockholders identified
herein.
The
common stock to be offered and sold using this prospectus will be
offered and sold by the selling stockholders named in this
prospectus. Accordingly, we will not receive any proceeds from any
sales of shares of our common stock in this offering. Upon any cash
exercise of the Selling Agent Warrants, certain selling
stockholders will pay us the applicable exercise price. The Selling
Agent Warrants may be exercised and resold hereunder on a cashless
basis, at the option of their holders, and we will not receive any
proceeds upon such cashless exercise. We anticipate that any
proceeds that we receive from the cash exercise of such warrants,
if any, will be used for general corporate purposes, which may
include funding research, development and product manufacturing,
clinical trials, acquisitions or investments in businesses,
products or technologies that are complementary to our own,
increasing our working capital, reducing indebtedness, and capital
expenditures. We will pay all of the fees and expenses incurred by
us in connection with this registration. We will not be responsible
for fees and expenses incurred by the selling stockholders or any
underwriting discounts or agent’s commissions.
Each selling stockholder and any of their pledgees, assignees
and successors-in-interest may, from time to time, sell any or all
of their shares of common stock covered hereby from time to time
directly to one or more purchasers or through brokers, dealers, or
underwriters who may act solely as agents at market prices
prevailing at the time of sale, at prices related to the prevailing
market prices, at negotiated prices, or at fixed prices, which may
be changed. The sale of the common stock offered by this prospectus
could be affected in one or more of the following
methods:
●
ordinary brokers’ transactions;
●
transactions involving cross or block trades;
●
through brokers, dealers, or underwriters who may act solely as
agents;
●
“at the market” into an existing market for the common
stock;
●
in other ways not involving market makers or established business
markets, including direct sales to purchasers or sales effected
through agents;
●
in privately negotiated transactions; or
●
any combination of the foregoing.
The selling stockholders also may resell all or a portion of the
securities in open market transactions in reliance upon Rule 144
under the Securities Act, as permitted by that rule, or
Section 4(1) under the Securities Act, if available, rather
than under this prospectus, provided that they meet the criteria
and conform to the requirements of those
provisions
Broker-dealers engaged by the selling stockholders may arrange for
other brokers-dealers to participate in sales. If the selling
stockholders effect such transactions by selling securities to or
through underwriters, broker-dealers or agents, such underwriters,
broker-dealers or agents may receive commissions in the form of
discounts, concessions or commissions from the selling stockholders
or commissions from purchasers of the securities for whom they may
act as agent or to whom they may sell as principal. Such
commissions will be in amounts to be negotiated, but, except as set
forth in a supplement to this prospectus, in the case of an agency
transaction will not be in excess of a customary brokerage
commission in compliance with NASD Rule 2440; and in the case of a
principal transaction a markup or markdown in compliance with NASD
IM-2440.
In connection with the sale of the common stock or interests
therein, the selling stockholders may enter into hedging
transactions with broker-dealers or other financial institutions,
which may in turn engage in short sales of the common stock in the
course of hedging the positions they assume. The selling
stockholders may also sell shares of the common stock short and
deliver these securities to close out their short positions, or
loan or pledge the shares of common stock to broker-dealers that in
turn may sell these securities. The selling stockholders may also
enter into option or other transactions with broker-dealers or
other financial institutions or create one or more derivative
securities which require the delivery to such broker-dealer or
other financial institution of shares offered by this prospectus,
which shares such broker-dealer or other financial institution may
resell pursuant to this prospectus (as supplemented or amended to
reflect such transaction).
The selling stockholders and any broker-dealers or agents that are
involved in selling the shares may be deemed to be
“underwriters” within the meaning of the Securities Act
in connection with such sales. In such event, any commissions
received by such broker-dealers or agents and any profit on the
resale of the shares purchased by them may be deemed to be
underwriting commissions or discounts under the Securities Act.
Each selling stockholder has informed us that it does not have any
written or oral agreement or understanding, directly or indirectly,
with any person to distribute their shares of common
stock.
We are required to pay certain fees and expenses incurred by us
incident to the registration of the shares. We have agreed to
indemnify the selling stockholders against certain losses, claims,
damages and liabilities, including liabilities under the Securities
Act.
The selling stockholders will be subject to the prospectus delivery
requirements of the Securities Act, including Rule 172 thereunder.
The selling stockholders have advised us that there is no
underwriter or coordinating broker acting in connection with the
proposed sale of the resale shares by the selling
stockholders.
The resale shares will be sold only through registered or licensed
brokers or dealers if required under applicable state securities
laws. In addition, in certain states, the resale shares of common
stock covered hereby may not be sold unless they have been
registered or qualified for sale in the applicable state or an
exemption from the registration or qualification requirement is
available and is complied with.
Under applicable rules and regulations under the Exchange Act, any
person engaged in the distribution of the resale shares may not
simultaneously engage in market making activities with respect to
the common stock for the applicable restricted period, as defined
in Regulation M, prior to the commencement of the distribution. In
addition, the selling stockholders will be subject to applicable
provisions of the Exchange Act, and the rules and regulations
thereunder, including Regulation M, which may limit the timing of
purchases and sales of shares of the common stock by the selling
stockholders or any other person. We will make copies of this
prospectus available to the selling stockholders and have informed
them of the need to deliver a copy of this prospectus to each
purchaser at or prior to the time of the sale (including by
compliance with Rule 172 under the Securities Act).
Our common stock is quoted on The Nasdaq Capital Market under the
symbol “AZRX”.
The
validity of the securities offered hereby will be passed upon for
us by Lowenstein Sandler LLP, New York, New York.
The audited annual consolidated
financial statements of AzurRx BioPharma, Inc. incorporated by
reference in this prospectus and elsewhere in the registration
statement have been incorporated by reference in reliance upon the
report of Mazars USA LLP, independent registered public accounting
firm, upon the authority of said firm as experts in accounting and
auditing. The 2020 and 2019 audited annual consolidated financial
statements of AzurRx BioPharma, Inc., as of and for the years ended
December 31, 2020 and 2019, have been audited by Mazars USA LLP,
independent registered public accounting firm. The audit report
dated March 31, 2021 for the 2020 audited annual consolidated
financial statements includes an explanatory paragraph which states
that certain circumstances raise substantial doubt about our
ability to continue as a going concern.
WHERE YOU CAN 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 SEC. The SEC maintains a website that contains
reports, proxy and information statements and other information
regarding registrants that file electronically with the SEC. The
address of the SEC’S website is www.sec.gov.
We make
available free of charge on or through our website our Annual
Reports on Form 10-K, Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K and amendments to those reports
filed or furnished pursuant to Section 13(a) or 15(d) of the
Securities Exchange Act of 1934, as amended, as soon as reasonably
practicable after we electronically file such material with or
otherwise furnish it to the SEC.
We have
filed with the SEC a registration statement under the Securities
Act, relating to the offering of these securities. The registration
statement, including the attached exhibits, contains additional
relevant information about us and the securities. This prospectus
does not contain all of the information set forth in the
registration statement. You can obtain a copy of the registration
statement for free at www.sec.gov. The registration statement and
the documents referred to below under “Incorporation of
Certain Information By Reference” are also available on our
website, www.azurrx.com/investors/regulatory-filings.
We have
not incorporated by reference into this prospectus the
information on our website, and you should not consider it to be a
part of this prospectus.
INCORPORATION OF CERTAIN INFORMATION BY
REFERENCE
The following documents filed with the SEC are incorporated by
reference into this prospectus:
●
our Annual Report on Form 10-K for the year ended December 31,
2020, filed with the SEC on March 31, 2021;
●
our Quarterly Report on Form 10-Q for the period ended March 31,
2021, filed with the SEC on May 24, 2021;
●
our Current Reports on Form 8-K, filed
with the SEC on January 4, 2021 (as amended on January 13, 2021),
January 5, 2021, January 8, 2021, February 16, 2021, February 25,
2021 and March 10, 2021 (other than any portion thereof deemed
furnished and not filed);
●
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 with the SEC on August 8, 2016, including any
amendment or reports filed for the purposes of updating this
description, including Exhibit 4.1 to our Annual Report on Form
10-K for the year ended December 31, 2020, filed with the SEC on
March 31, 2021.
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.
3,464,664 Shares
Common Stock
AzurRx BioPharma, Inc.
PROSPECTUS
We have
not authorized any dealer, salesperson or other person to give any
information or to make any representations not contained in this
prospectus. You must not rely on any unauthorized information. This
prospectus is not an offer to sell these securities in any
jurisdiction where an offer or sale is not permitted.
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