PROSPECTUS
SUPPLEMENT
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(To the Prospectus Dated June 25, 2019)
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Filed Pursuant to Rule 424(b)(5)
Registration No. 333-231954
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5,800,000
Shares of Common Stock
Prefunded
Warrants to Purchase up to 2,058,548 Shares of Common
Stock
Series
A Warrants to Purchase up to 3,929,274 Shares of Common
Stock
Placement
Agent Warrants to Purchase up to 550,099 Shares of Common
Stock
We are offering (i)
5,800,000 shares of our common stock and (ii) Series A
Warrants to purchase up to an aggregate
of 3,929,274 shares of our common stock (“Series A
Warrants”). Each share of common stock is being sold together
with one half of one warrant to purchase one share of our common
stock for the combined purchase price of $1.2725. The Series A
Warrants are exercisable for five years from the date of issuance
at an exercise price of $1.21 per share. The shares of common
stock and Series A Warrants will be issued separately. This
prospectus also registers the shares of common stock issuable upon
the exercise of the warrants being offered.
We are also
offering prefunded warrants (the
“Prefunded Warrants”) to purchase up to an
aggregate of 2,058,548 shares of common stock to investors whose
purchase of shares of common stock in this offering would otherwise
result in such purchasers, together with their affiliates and
certain related parties, beneficially owning more than 4.99% (or,
at the election of the purchasers, 9.99%) of our outstanding shares
of common stock immediately following the closing of this offering.
Subject to limited exceptions, a holder of Prefunded
Warrants will not have the right to exercise any portion of
its Prefunded Warrants if the holder, together with its
affiliates, would beneficially own in excess of 4.99% (or, at the
election of the purchasers, 9.99%) of the number of shares of
common stock outstanding immediately after giving effect to such
exercise. This offering also relates to the shares of common stock
issuable upon exercise of
any Prefunded Warrants sold in this offering.
Each Prefunded Warrant is being sold at a price of
$1.2625. Each Prefunded Warrant will have an
exercise price per share of common stock equal to $0.01 and is
exercisable at any time after its original issuance until exercised
in full. The Series A Warrants and the Prefunded Warrants are
referred to collectively as the warrants.
Our common stock is
listed on The Nasdaq Capital Market under the symbol
“AZRX.” There is no established trading market for any
of the warrants, and we do not expect a market to develop. We
do not intend to apply for a listing for any of
the warrants on any securities exchange or other
nationally recognized trading system. Without an active trading
market, the liquidity of the warrants will be
limited.
The last reported
sale price of our common stock on March 5, 2021, was $1.21 per
share.
Investing
in our securities involves a high degree of risk. See “Risk
Factors” beginning on page S-7 of this prospectus
supplement.
We engaged H.C.
Wainwright & Co., LLC to act as our exclusive placement agent
in connection with this offering. The placement agent is not
purchasing the securities offered by us in this offering and is not
required to arrange the purchase or sale of any specific number or
dollar amount of securities, but will use its reasonable best
efforts to arrange for the sale of the securities
offered.
We expect that
delivery of the securities being offered pursuant to this
prospectus supplement and the accompanying prospectus will be made
on or about March 10, 2021, subject to the satisfaction of certain
customary closing conditions.
Neither
the Securities and Exchange Commission (the “SEC”) nor
any state securities commission has approved or disapproved of
these securities or determined if this prospectus supplement and
the accompanying prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
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Per
Share and Related Warrant
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Offering
Price
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$1.2725
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$1.2625
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$9,979,416
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Placement Agent
Fees (1)
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$0.0678
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$0.0678
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$800,000
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Proceeds to us,
before expenses (2)
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$1.2047
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$1.1947
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$9,179,416
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(1)
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Includes a cash fee
of 8.0% of the gross proceeds of this offering. We have also agreed
to issue to the placement agent (or its designees) warrants to
purchase shares of common stock to the placement agent as described
under “Plan of Distribution” on page S-20 of this
prospectus supplement and pay the placement agent a reimbursement
for non-accountable expenses equal to $35,000, a reimbursement for
legal fees and expenses of the placement agent in the amount of
$50,000 and $15,950 for clearing fees. For additional information
about the compensation paid to the placement agent, see “Plan
of Distribution.”
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(2)
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The amount of the
offering proceeds to us presented in this table does not give
effect to any exercise of the warrants being issued in this
offering.
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H.C.
Wainwright & Co.
The date of this
prospectus is March 7, 2021.
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-7
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S-8
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S-9
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S-10
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S-13
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S-15
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S-15
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S-15
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S-16
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Prospectus
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ABOUT
THIS PROSPECTUS
SUPPLEMENT
In this prospectus
supplement, “AzurRx,” “we,”
“us,” “our” or “ours” refer to
AzurRx BioPharma, Inc., a Delaware corporation, collectively with
our direct wholly-owned subsidiary AzurRx SAS, a company organized
under the laws of France.
All trademarks or
trade names referred to in this prospectus supplement are the
property of their respective owners. Solely for convenience, the
trademarks and trade names in this prospectus supplement are
referred to without the ® and ™ symbols, but such
references should not be construed as any indicator that their
respective owners will not assert, to the fullest extent under
applicable law, their rights thereto. We do not intend the use or
display of other companies’ trademarks and trade names to
imply a relationship with, or endorsement or sponsorship of us by,
any other companies.
This document is in
two parts. The first part is this prospectus supplement, which adds
to and updates information contained in the accompanying
prospectus. The second part, the prospectus, provides more general
information, some of which may not apply to this offering.
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, you should rely on the information in this prospectus
supplement.
This prospectus
supplement and the accompanying prospectus relate to the offering
of shares of our common stock and warrants to purchase shares of
our common stock. Before buying the shares of common stock and
warrants to buy shares of common stock offered hereby, we urge you
to carefully read this prospectus supplement and the accompanying
prospectus, together with the information incorporated herein by
reference as described under the headings “Where You Can Find More
Information” and “Incorporation of Certain Information by
Reference.” These documents contain important
information that you should consider when making your investment
decision. This prospectus supplement contains information about the
common stock and warrants offered hereby and may add, update or
change information in the accompanying prospectus.
You should rely
only on the information that we have provided or incorporated by
reference in this prospectus supplement and the accompanying
prospectus. Neither we nor the placement agent (or any of our or
its respective affiliates) have 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 and the
placement agent are not making offers to sell or solicitations to
buy our securities 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
assume that the information in this prospectus supplement and the
accompanying prospectus or any related free writing prospectus is
accurate only as of the date on the front of the document and that
any information that we have incorporated by reference is accurate
only as of the date of the document incorporated by reference,
regardless of the time of delivery of this prospectus supplement,
the accompanying prospectus or any related free writing prospectus,
or any sale of a security.
This prospectus
supplement and the accompanying prospectus contain 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 or will be filed as exhibits to the
registration statement of which this prospectus is a part or as
exhibits to documents incorporated by reference herein, and you may
obtain copies of those documents as described below under the
headings “Where You Can Find
More Information” and “Incorporation of Certain Information by
Reference.”
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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. the
intestinal lumen, skin or mucosa, without reaching an
individual’s systemic circulation.
We are currently focused on developing our pipeline of three
gut-restricted GI clinical drug candidates. The lead therapeutic
candidate is MS1819, a recombinant lipase for the treatment of
exocrine pancreatic insufficiency (“EPI”) in patients
with cystic fibrosis and chronic pancreatitis, currently in
two Phase 2 clinical trials. We plan to launch two clinical
programs using proprietary formulations of niclosamide, a
pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune
Checkpoint Inhibitor-Associated Colitis (“ICI-AC”) and
diarrhea in oncology patients and FW-1022, for Severe Acute
Respiratory Syndrome Coronavirus 2 (“COVID-19” or
“COVID”) gastrointestinal infections. Each drug
candidate is described below:
MS1819
MS1819 is a recombinant
lipase enzyme for the treatment of exocrine pancreatic
insufficiency (“EPI”) associated with cystic fibrosis
(“CF”) and chronic pancreatitis (“CP”).
MS1819, supplied as an oral non-systemic biologic capsule, is
derived from the Yarrowia
lipolytica yeast lipase and
breaks up fat molecules in the digestive tract of EPI patients so
that they can be absorbed as nutrients. Unlike the standard of
care, the MS1819 synthetic lipase does not contain any animal
products.
EPI is a condition characterized by deficiency of the
exocrine pancreatic enzymes, resulting in a
patient’s inability to digest food properly, or maldigestion.
The deficiency in this enzyme can be responsible for greasy
diarrhea, fecal urge and weight loss. There are more than 30,000
patients with EPI caused by CF according to the Cystic Fibrosis
Foundation approximately and approximately 90,000 patients in the
U.S. with EPI caused by CP according to the National Pancreas
Foundation. Patients are currently treated with porcine pancreatic
enzyme replacement pills (“PERT”).
MS1819 – Phase 2b OPTION 2 Cystic Fibrosis Monotherapy
Studies
On October 17, 2019, we
announced that the Cystic Fibrosis Foundation Data Safety
Monitoring Board (the “CFF DSMB”) completed its review
of our final results of the OPTION Cross-Over Study and had found
no safety concerns for MS1819, and that the CFF DSMB supported our
plan to proceed to a higher 4.4 gram dose of MS1819 with enteric
capsules in the multi-center dose escalation Phase 2b OPTION
clinical trial (the “OPTION 2 Trial”). In December
2019, the Company submitted the clinical trial protocol to the
existing IND at the FDA. The clinical trial protocol has been
reviewed by the FDA with no comments. In April 2020, the Company
received approval to conduct the OPTION 2 Trial in Therapeutics
Development Network (“TDN”) clinical
sites in the U.S. as well as Institutional Review
Board (“IRB”) approval
to commence the OPTION 2 Trial.
The OPTION 2 Trial is
designed to investigate the safety, tolerability and efficacy of
MS1819 (2.2 gram and 4.4 gram doses in enteric capsules) in a
head-to-head manner versus the current standard of care, porcine
pancreatic enzyme replacement therapy (“PERT”)
pills. The OPTION 2 Trial will be an open-label, crossover study,
conducted in 15 sites in the U.S. and Europe. A total
of 30 CF patients 18 years or older will be enrolled.
MS1819 will be administered in enteric capsules to provide
gastric protection and allow optimal delivery of enzyme to the
duodenum. Patients will first be randomized into two cohorts:
to either the MS1819 arm, where they receive a 2.2 gram daily oral
dose of MS1819 for three weeks; or to the PERT arm, where they
receive their pre-study dose of PERT pills for three weeks. After
three weeks, stools will be collected for analysis of coefficient
of fat absorption (“CFA”). Patients
will then be crossed over for another three weeks of the
alternative treatment. After three weeks of cross-over therapy,
stools will again be collected for analysis of CFA. A parallel
group of patients will be randomized and studied in the same
fashion, using a 4.4 gram daily dose of MS1819. All patients
will be followed for an additional two weeks after completing both
crossover treatments for post study safety
observation. Patients will be assessed using descriptive
methods for efficacy, comparing CFA between MS1819 and PERT arms,
and for safety.
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We initiated the OPTION 2 Trial in July 2020 with the first
patient screened and three clinical trial sites activated in the
U.S. In August 2020, the Company dosed the first patients and
initiated the European arm of the OPTION 2 Trial. Topline data is
anticipated in the first quarter of 2021; however, this timeline
may be further delayed due to
the COVID-19 pandemic.
In November 2020, we submitted a protocol amendment for the OPTION
2 Trial to add a study arm that uses an immediate release MS1819
capsule to compare data from the existing arm, that uses
delayed-release enteric capsules with data from the new arm, that
uses immediate release capsules, in order to determine the optimal
dose and delivery method. We initiated the OPTION 2 study extension
in early first quarter 2021.
MS1819 – Phase 2 Combination Therapy Study
In addition to the monotherapy studies, we launched a Phase 2
multi-center clinical trial (the “Combination Trial”)
in Europe to investigate MS1819 in combination with PERT, for CF
patients who suffer from severe EPI but continue to experience
clinical symptoms of fat malabsorption despite taking the maximum
daily dose of PERTs. The Combination Trial is designed to
investigate the safety, tolerability and efficacy of escalating
doses of MS1819 (700 mg, 1120 mg and 2240 mg per day,
respectively), in conjunction with a stable dose of PERTs, in order
to increase CFA and relieve abdominal symptoms in uncontrolled CF
patients. A combination therapy of PERT and MS1819 has the
potential to: (i) correct macronutrient and micronutrient
maldigestion; (ii) eliminate abdominal symptoms attributable to
maldigestion; and (iii) sustain optimal nutritional status on a
normal diet in CF patients with severe EPI.
We dosed the first patients in its Combination Trial in Hungary in
October 2019. Planned enrollment is expected to include
approximately 24 CF patients with severe EPI, at clinical trial
sites in Hungary and additional countries in Europe, including
Turkey. Topline data is currently expected in the first half of
2021; however, this timeline may be further delayed due to the
COVID-19 pandemic.
We announced positive interim data on the first five patients in
the Combination Trial in August 2020. The primary efficacy endpoint
was met, with CFAs greater than 80% for all patients across all
visits. For secondary efficacy endpoints, we observed that stool
weight decreased, the number of stools per day decreased,
steatorrhea improved, and body weight increased. Additionally, no
serious adverse events were reported.
We opened a total of five clinical sites for the Combination
Trial in Turkey in October 2020 and announced that its first
patients were dosed in November 2020. We currently have a
total of nine of the expected ten sites in Europe active and
recruiting patients.
License Agreement with First Wave Bio, Inc.
On December 31, 2020, we entered into a license agreement (the
“First Wave License Agreement”) with First Wave Bio,
Inc. (“First Wave”). Pursuant to the First Wave License
Agreement, First Wave granted us a worldwide, exclusive right to
develop, manufacture, and commercialize First Wave’s
proprietary immediate release and enema formulations of niclosamide
for the fields of treating Immune Checkpoint Inhibitor-Associated
Colitis (“ICI-AC”) and Severe Acute Respiratory
Syndrome Coronavirus 2 (“COVID”) in humans (the
“Product”). The Product uses First Wave’s
proprietary formulations of niclosamide, a pro-inflammatory pathway
inhibitor. We plan to commence in 2021 both a Phase 2 trial of the
Product for COVID in GI and a Phase 1b/2a trial for
ICI-AC.
In consideration of the license and other rights granted by First
Wave, we paid First Wave a $9.0 million upfront cash payment and
are obligated to make an additional payment of $1.25 million due on
June 30, 2021. In addition, we are obligated to pay potential
milestone payments to First Wave totaling up to $37.0 million for
each indication, based upon the achievement of specified
development and regulatory milestones. Under the First Wave License
Agreement we are obligated to pay First Wave royalties as a
mid-single digit percentage of net sales of the Product, subject to
specified reductions.
On January 8, 2021, pursuant to the First Wave License Agreement,
we entered into a securities purchase agreement with First Wave
(the “First Wave Purchase Agreement”) pursuant to which
we issued to First Wave, on that same day, 3,290.1960 shares of our
Series C Preferred Stock, initially convertible into an aggregate
of 3,290,196 shares of common stock, at an initial stated value of
$750.00 per share and a conversion price of $0.75 per share. The
amount of common stock into which such shares of Series C Preferred
Stock were initially convertible is the equivalent of $3.0 million
worth of Common Stock, based upon the volume weighted average price
of our Common Stock for the five-day period immediately preceding
the date of the First Wave License Agreement, or $0.9118 per share.
The First Wave Purchase Agreement contains demand and piggyback
registration rights with respect to the common stock issuable upon
conversion of the shares of Series C Preferred Stock issued
thereby. All of the Series C Preferred Stock issued to First Wave
has been converted into shares of our common stock.
We do not expect to generate revenue from drug candidates that we
develop until we obtain approval for one or more of such drug
candidates and commercialize our product or enter into a
collaborative agreement with a third party. We do not have any
products approved for sale at the present and have never generated
revenue from product sales.
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 supplement.
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Shares
of Common Stock offered by us
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5,800,000 shares of
common stock
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Series
A Warrants offered by us
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Series A Warrants
to purchase 3,929,274 shares of our common stock. Each Series
A Warrant will have an exercise price of $1.21 per share, will be
immediately exercisable and will expire on the fifth anniversary of
the original issuance date. The shares of common stock and Series A
Warrants will be issued separately but will be purchased together
in this offering. This prospectus supplement also registers the
shares of common stock issuable upon the exercise of the Series A
Warrants being offered.
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Prefunded
Warrants offered by us
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We are also
offering Prefunded Warrants to purchase up to an aggregate
of 2,058,548 shares of common stock. We are offering the
Prefunded Warrants to institutional investors whose purchase of
shares of common stock in this offering would otherwise result in
such purchasers, together with their affiliates and certain related
parties, beneficially owning more than 4.99% (or, at the election
of the purchasers, 9.99%) of our outstanding shares of common stock
immediately following the closing of this offering. Each Series B
Prefunded Warrant is exercisable for one share of common stock and
is being sold at a price of $1.2625. Each Series B Prefunded will
have an exercise price per share of common stock of $0.01, and will
be immediately exercisable and may be exercised at any time until
exercised in full. This prospectus supplement also relates to the
offering of the shares of common stock issuable upon exercise of
the Prefunded Warrants. The exercise price and number of shares of
common stock issuable upon exercise will be subject to certain
further adjustments as described herein.
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Placement
Agent Warrants offered by us
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Pursuant to this
prospectus supplement and the accompanying prospectus, we will
issue the placement agent or its designees warrants to purchase up
to 550,099 shares of common stock as part of the compensation
payable to the placement agent in connection with this offering
(the “Placement Agent Warrants”). See “Plan of
Distribution”. This prospectus supplement also relates to the
offering of the shares of common stock issuable upon exercise of
the Placement Agent Warrants.
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Shares
of common stock outstanding before this offering
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65,206,854 shares of common
stock.
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Shares
of common stock to be outstanding after this offering
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71,006,854 shares of common
stock.
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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-12 of this
prospectus.
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Nasdaq
symbol
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Our common stock is
listed on The Nasdaq Capital Market under the symbol
“AZRX”.
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Risk
Factors
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Investing in our
securities involves significant risks. Before making a decision
whether to invest in our securities, please read the information
contained in or incorporated by reference under the heading
“Risk Factors”
in this prospectus, the documents we have incorporated by reference
herein, and under similar headings in other documents filed after
the date hereof and incorporated by reference into this prospectus.
See “Incorporation of
Certain Information by Reference” and
“Where You Can Find More
Information”.
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Listing
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There is no
established public trading market for the warrants and we do not
expect a market to develop. In addition, we do not intend to apply
for listing of the warrants on the Nasdaq Capital Market or on any
national securities or other national recognized trading
system.
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The
above discussion is based on 65,206,854 shares of our common stock
outstanding as of March 5, 2021 and excludes up to:
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3,932,506 shares of
common stock issuable upon exercise of stock options, with a
weighted average exercise price of $1.20 per share, under our
Amended and Restated 2014 Omnibus Equity Incentive Plan (the
“2014 Plan”);
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387,000 shares of
awarded but unissued restricted stock and restricted stock units
under our 2014 Plan;
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316,185 shares of
common stock issuable upon exercise of stock options, with a
weighted average exercise price of $0.95 per share, under our
Amended and Restated 2020 Omnibus Equity Incentive Plan (the
“2020 Plan”);
●
9,683,815 shares of
common stock available for future issuance under our 2020
Plan;
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44,389,841 shares
of common stock issuable upon exercise of outstanding warrants,
with a weighted average exercise price of $1.03 per
share;
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12,951,294 shares
of common stock issuable upon conversion of Series B Preferred
Stock, including in respect of accrued and unpaid dividends of
approximately $153,246;
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3,628 shares of
common stock issuable upon conversion of Series C Preferred
Stock;
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345,372 shares of
common stock issued upon conversion of Series C Preferred Stock
that was issued pursuant to an exchange right, in excess of amounts
currently underlying Series B Preferred Stock;
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13,296,666 shares
of common stock issuable upon exercise of warrants that may be
issued pursuant to an exchange right;
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5,987,822 shares of
common stock issuable upon exercise of the warrants issued in this
offering;
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550,099
shares of common stock issuable upon exercise of warrants being
issued to the placement agent or its designees as compensation for
its services in this offering (the “Placement Agent
Warrants”).
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An investment in our securities involves a high degree of risk.
Before deciding whether to purchase our securities offered by this
prospectus, 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, 2019, 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 believe are immaterial
may also significantly impair our business operations. If any of
these risks occur, our business, results of operations or financial
condition and prospects could be harmed. In that event, the market
price of our common stock and the value of the warrants could
decline, and you could lose all or part of your
investment.
Risks
Related to this Offering
Investors in this offering will suffer immediate and substantial
dilution as a result of this offering.
Because the
effective offering price per common share and warrant is higher
than the as adjusted net tangible book value per share of common
stock after giving effect to this offering, you will suffer
substantial dilution in the net tangible book value of the
securities you purchase in this offering. For a further description
of the dilution that investors in this offering will experience,
see “Dilution.”
Investors in this offering will also be subject to increased
dilution upon the exercise of outstanding stock options and
warrants.
If we sell shares of our
common stock in future financings, stockholders may experience
immediate dilution and, as a result, our stock price may
decline.
To raise additional
capital, we may in the future offer additional shares of our common
stock or other securities convertible into or exchangeable for our
common stock at prices that may not be the same as the effective
offering price per share of common stock in this offering. We may
sell shares or other securities in any other offering at a price
per share that is less than the effective offering price per share
paid by investors in this offering, and investors purchasing shares
or other securities in the future could have rights superior to
existing stockholders. The price per share at which we sell
additional shares of our common stock, or securities convertible or
exchangeable into common stock, in future transactions may be
higher or lower than the price per share paid by investors in this
offering (on a fully-converted basis). Furthermore, sales of a
substantial number of shares of our common stock in the public
markets, or the perception that such sales could occur, could
depress the market price of our common stock.
There is no established public trading market for the warrants
being offered in this offering.
There is no
established public trading market for the warrants being offered in
this offering, and we do not expect a market to develop. In
addition, we do not intend to apply to list such warrants on any
national securities exchange or other nationally recognized trading
system, including the Nasdaq Capital Market. Without an active
market, the liquidity of the warrants will be limited.
The Series A Warrants being offered may not have
value.
The Series A
Warrants being offered by us in this offering have an exercise
price of $1.21 per share and expire five years from the date of
issuance. In the event that the market price of our common stock
does not exceed the exercise price of the Series A Warrants during
the period when they are exercisable, the Series A Warrants may not
have any value.
Holders of our warrants will have no rights as shareholders until
they acquire shares of our common stock, if ever.
If you acquire
warrants to purchase shares of our common stock in this offering,
you will have no rights with respect to our common stock until you
acquire shares of such common stock upon exercise of your warrants.
Upon exercise of your warrants, you will be entitled to exercise
the rights of a common shareholder only as to matters for which the
record date occurs after the exercise date.
We will have broad discretion in how we use the net proceeds of
this offering. We may not use these proceeds effectively, which
could affect our results of operations and cause our stock price to
decline.
We will have
considerable discretion in the application of the net proceeds of
this offering, including for any of the purposes described in the
section entitled “Use of Proceeds.” We intend to use
the net proceeds received by us from this offering to fund development of our product candidates and for
other general corporate purposes. As a result, investors
will be relying upon management’s judgment with only limited
information about our specific intentions for the use of the
balance of the net proceeds of this offering. We may use the net
proceeds for purposes that do not yield a significant return or any
return at all for our stockholders. In addition, pending their use,
we may invest the net proceeds from this offering in a manner that
does not produce income or that loses value.
The market price of our common stock may be volatile which could
subject us to securities class action litigation and prevent you
from being able to sell your shares at or above the offering
price.
You may be unable
to sell your shares of common stock at or above the offering price.
The market price for our common stock has been and may continue to
be volatile and subject to wide fluctuations in response to factors
including the following:
●
sales or potential
sales of substantial amounts of our common stock;
●
delay or failure in
initiating or completing pre-clinical or clinical trials or
unsatisfactory results of these trials;
●
announcements about
us or about our competitors, including clinical trial results,
regulatory approvals or new product introductions;
●
developments
concerning our licensors or product manufacturers;
●
litigation and
other developments relating to our patents or other proprietary
rights or those of our competitors;
●
conditions in the
pharmaceutical or biotechnology industries;
●
governmental
regulation and legislation;
●
variations in our
anticipated or actual operating results;
●
change in
securities analysts’ estimates of our performance, or our
failure to meet analysts’ expectations; foreign currency
values and fluctuations; and
●
overall economic
conditions.
Many of these
factors are beyond our control. The stock markets in general, and
the market for pharmaceutical and biotechnological companies in
particular, have historically experienced extreme price and volume
fluctuations. These fluctuations often have been unrelated or
disproportionate to the operating performance of these companies.
These broad market and industry factors could reduce the market
price of our common stock, regardless of our actual operating
performance.
We will need substantial additional funding and certain terms
included in our financing transactions may prohibit us from raising
capital when needed, which would force us to delay, curtail or
eliminate one or more of our research and development programs or
commercialization efforts.
Our operations have
consumed substantial amounts of cash since inception. During the
years ended December 31, 2019 and 2018, we incurred research and
development expense of approximately $8.7 million and $5.8 million,
respectively. We expect to continue to spend substantial amounts on
product development, including conducting clinical trials for
MS1819 and our other product candidates and purchasing clinical
trial materials from our suppliers. We will require substantial
additional funds to support our continued research and development
activities, as well as the anticipated costs of preclinical studies
and clinical trials, regulatory approvals and potential
commercialization. We could spend our available financial resources
much faster than we currently expect.
Until such time, if
ever, as we can generate a sufficient amount of product revenue and
achieve profitability, we expect to seek to finance future cash
needs through equity and/or debt financings or corporate
collaboration and licensing arrangements. We currently have no
other commitments or agreements relating to any of these types of
transactions and we cannot be certain that additional funding will
be available on acceptable terms, or at all. If we are unable to
raise additional capital, we will have to delay, curtail or
eliminate one or more of our research and development programs. If
we are able to raise additional capital, our stockholders may
experience additional dilution, and as a result, our stock price
may decline.
Shareholders will
experience dilution by exercises of outstanding warrants and
options.
As of March 5,
2021, there were 44,389,841 shares of our common stock issuable
upon the exercise of outstanding warrants, with a weighted average
exercise price of $1.03 per share, and options to purchase an
aggregate of up to 4,248,691 shares of our common stock, with a
weighted average exercise price of $1.19 per share.
The exercise of
such warrants and options will result in dilution of your
investment. As a result of this dilution, you may receive
significantly less than the full purchase price you paid for our
securities in the event of liquidation.
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:
●
availability of
capital to satisfy our working capital requirements;
●
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 lead drug candidate,
MS1819;
●
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;
●
the impact of the
coronavirus (COVID-19) epidemic on our operations, and current and
planned clinical trials, including, but not limited to delays in
clinical trial recruitment and participation; and
●
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 supplement, as
well as certain information incorporated by reference into this
prospectus supplement and the accompanying prospectus, that could
cause actual future results or events to differ materially from the
forward-looking statements that we make. Our forward-looking
statements do not reflect the potential impact of any future
acquisitions, mergers, dispositions, joint ventures or investments
we may make.
You should read
this prospectus supplement and the accompanying prospectus with the
understanding that our actual future results may be materially
different from what we expect. We do not assume any obligation to
update any forward-looking statements whether as a result of new
information, future events or otherwise, except as required by
applicable law.
The
gross proceeds to us in this offering will be approximately $10.0
million. We estimate that the net proceeds to us from this
offering, after deducting placement agent fees and paying estimated
offering expenses payable by us, will be approximately $9.1
million.
We
intend to use the net proceeds from this offering to initiate our
two niclosamide clinical programs in the first half of 2021, a
Phase 2 clinical trial for COVID-19 GI infections and a Phase 1b/2a
trial for immune checkpoint inhibitor induced colitis,
respectively, and for other general corporate
purposes.
If you invest in
our securities in this offering, your ownership interest will be
immediately diluted to the extent of the difference between the
price per share you pay in this offering and the as adjusted net
tangible book value per share of our common stock immediately after
this offering.
Our historical net
tangible book value is the amount of our total tangible assets less
our total liabilities. Net historical tangible book value per share
is our historical net tangible book value divided by the number of
shares of common stock outstanding as of September 30, 2020. Our
historical net tangible book value as of September 30, 2020 was
$9.0 million, or $0.31 per share of common stock.
As adjusted net
book value is our net tangible book value, plus the effect of the
sale of the shares of Common Stock and Series A at a purchase price
of $1.2725 and Prefunded Warrants to purchase 2,058,548 shares of common stock in this
offering at a price of $1.2625 per Prefunded Warrant, and after
deducting placement agent fees and estimated expenses payable by
us. Our as adjusted net book value as of September 30, 2020 would
have been approximately $18.1 million, or $0.49 per share. This
amount represents an immediate increase in as adjusted net tangible
book value of $0.18 per share to our existing stockholders, and an
immediate dilution of $0.78 per share to new investors
participating in this offering. Dilution per share to new investors
is determined by subtracting as adjusted net tangible book value
per share after this offering from the effective offering price per
share paid by new investors.
The following table
illustrates this dilution on a per share basis:
|
Effective offering
price per share and accompanying Series A Warrant
|
|
$1.2725
|
|
Historical net
tangible book value per share as of September 30, 2020
|
$0.31
|
|
|
Increase in net
tangible book value per share as of September 30, 2020,
attributable to new investor
|
$0.18
|
|
|
As adjusted net
tangible book value per share as of September 30, 2020, after
giving effect to this offering and the concurrent Private
Placement
|
|
$0.49
|
|
Dilution of as
adjusted net tangible book value per share to new
investor
|
|
$0.78
|
The
above discussion and table are based on 28,881,984 shares of common
stock outstanding on September 30, 2020 and excludes up
to:
●
4,312,506 shares of
common stock issuable upon exercise of stock options, with a
weighted average exercise price of $1.38 per share, under our
Amended and Restated 2014 Omnibus Equity Incentive Plan (the
“2014 Plan”);
●
387,000 shares of
awarded but unissued restricted stock and restricted stock units
under our 2014 Plan;
●
10,000,000 shares
of common stock available for future issuance under our 2020
Plan;
●
25,200,168 shares
of common stock issuable upon exercise of outstanding warrants,
with a weighted average exercise price of $1.22 per
share;
●
27,830,424 shares
of common stock issuable upon conversion of Series B Preferred
Stock, including in respect of accrued and unpaid dividends of
approximately $408,043;
●
5,987,822 shares of
common stock issuable upon exercise of the warrants issued in this
offering; and
●
550,099 shares of
common stock issuable upon exercise of the Placement Agent
Warrants.
To the
extent that options or warrants are exercised, new options are
issued under our equity incentive plan, or we issue additional
shares of common stock in the future, there may be further dilution
to investors participating in this offering. In addition, we may
choose to raise additional capital because of market conditionsor
strategic considerations, even if we believe that we have
sufficient funds for our current or future operating plans. If we
raise additional capital through the sale of equity or convertible
debt securities, the issuance of these securities could result in
further dilution to our stockholders.
DESCRIPTION OF THE SECURITIES WE ARE
OFFERING
In
this offering, we are offering shares of our common stock, warrants
to purchase shares of our common stock, and pre-funded warrants to
purchase shares of common stock (and the shares of common stock
issuable from time to time upon exercise of the warrants). No
fractional warrants will be issued.
Common Stock
The material terms and provisions of our common
stock and each other class of our securities that qualifies or
limits our common stock are described under the caption
“Description of Our Capital
Stock” in the
accompanying prospectus. Our common stock is listed on the Nasdaq
Capital market under the symbol “AZRX.” Our transfer
agent is Colonial Stock Transfer.
Series
A Warrants
The
following is a summary of the material terms and provisions of
the Series A Warrants that are being offered hereby. This
summary is subject to and qualified in its entirety by the form
of Series A Warrant, which has been provided to the investors
in this offering and which will be filed with the SEC as an exhibit
to a Current Report on Form 8-K in connection with this
offering and incorporated by reference into the registration
statement of which this prospectus supplement forms a part.
Prospective investors should carefully review the terms and
provisions of the form of the Prefunded Warrant for a complete
description of the terms and conditions of the Prefunded
Warrant.
Duration and Exercise Price
The Series
A Warrants offered hereby will have an exercise price of $1.21 per
share. The Series A Warrants will be immediately exercisable
and may be exercised at any time after their original issuance
until such warrants are exercised in full. The exercise price
and number of shares of common stock issuable upon exercise are
subject to appropriate adjustment in the event of share dividends,
share splits, reorganizations or similar events affecting our
shares of common stock. Series A Warrants will be issued in
certificated form only.
Exercisability
The Series
A Warrants will be exercisable, at the option of each holder, in
whole or in part, by delivering to us a duly executed exercise
notice accompanied by payment in full for the number of shares of
common stock purchased upon such exercise (except in the case of a
cashless exercise as discussed below). A holder (together with its
affiliates) may not exercise any portion of such holder’s
warrants to the extent that the holder would own more than 4.99%
(or, at the election of the purchaser, 9.99%) of our outstanding
shares of common stock immediately after exercise, except that upon
at least 61 days’ prior notice from the holder to us, the
holder may increase the amount of ownership of outstanding shares
of common stock after exercising the holder’s Series A
Warrants up to 9.99% of the number of shares of common stock
outstanding immediately after giving effect to the exercise, as
such percentage ownership is determined in accordance with the
terms of the Series A Warrants. Purchasers in this offering
may also elect prior to the issuance of Series A Warrants to
have the initial exercise limitation set at 9.99% of our
outstanding shares of common stock.
Cashless Exercise
If at the time of exercise of the Series A Warrant
there is no effective registration statement registering, or the
prospectus contained therein is not available for the resale of the
shares of common stock issuable upon exercise of the Series A
Warrant, then the Series A Warrants will also be
exercisable on a “cashless exercise” basis under which
the holder will receive upon such exercise a net number of common
shares determined according to a formula set forth in the Series
A Warrants.
Fundamental Transactions
In
the event of any fundamental transaction, as described in
the Series A Warrants and generally including any merger with
or into another entity, sale of all or substantially all of our
assets, tender offer or exchange offer, or reclassification of our
shares of common stock, then upon any subsequent exercise of
a Prefunded Warrant, the holder will have the right to receive
as alternative consideration, for each share of common stock that
would have been issuable upon such exercise immediately prior to
the occurrence of such fundamental transaction, the number of
shares of common stock of the successor or acquiring corporation or
of our company, if it is the surviving corporation, and any
additional consideration receivable upon or as a result of such
transaction by a holder of the number of shares of common stock for
which the Prefunded Warrant is exercisable immediately prior
to such event.
Transferability
In
accordance with its terms and subject to applicable laws,
a Series A Warrant may be transferred at the option of the
holder upon surrender of the Series A Warrant to us together
with the appropriate instruments of transfer and payment of funds
sufficient to pay any transfer taxes (if
applicable).
Fractional
Shares
No
fractional shares of common stock will be issued upon the exercise
of the Series A Warrants. Rather, the number of shares of
common stock to be issued will, at our election, either be rounded
up to the nearest whole number or we will pay a cash adjustment in
respect of such final fraction in an amount equal to such fraction
multiplied by the exercise price.
Trading
Market
There
is no established trading market for the Series A Warrants,
and we do not expect a market to develop. We do not intend to apply
for a listing for the Series A Warrants on any securities exchange
or other nationally recognized trading system. Without an active
trading market, the liquidity of the Series A Warrants will be
limited.
Rights as a
Shareholder
Except
as otherwise provided in the Series A Warrants or by virtue of
the holders’ ownership of shares of common stock, the holders
of Series A Warrants do not have the rights or privileges of
holders of our shares of common stock, including any voting rights,
until such Series A Warrant holders exercise their
warrants.
Prefunded
Warrants
The
following is a summary of the material terms and provisions of
the Prefunded Warrants that are being offered hereby. This
summary is subject to and qualified in its entirety by the form
of Series B Prefunded Warrant, which has been provided to the
investors in this offering and which will be filed with the SEC as
an exhibit to a Current Report on Form 8-K in connection
with this offering and incorporated by reference into the
registration statement of which this prospectus supplement forms a
part. Prospective investors should carefully review the terms and
provisions of the form of the Prefunded Warrant for a complete
description of the terms and conditions of the Prefunded
Warrant.
Duration and Exercise Price
The Prefunded
Warrants offered hereby will have an exercise price of $0.01 per
share. The Prefunded Warrants will be immediately exercisable
and may be exercised at any time after their original issuance
until such Prefunded Warrants are exercised in full. The
exercise price and number of shares of common stock issuable upon
exercise are subject to appropriate adjustment in the event of
share dividends, share splits, reorganizations or similar events
affecting our shares of common stock. Prefunded Warrants will
be issued in certificated form only.
Exercisability
The Prefunded
Warrants will be exercisable, at the option of each holder, in
whole or in part, by delivering to us a duly executed exercise
notice accompanied by payment in full for the number of shares of
common stock purchased upon such exercise (except in the case of a
cashless exercise as discussed below). A holder (together with its
affiliates) may not exercise any portion of such holder’s
warrants to the extent that the holder would own more than 4.99%
(or, at the election of the purchaser, 9.99%) of our outstanding
shares of common stock immediately after exercise, except that upon
at least 61 days’ prior notice from the holder to us, the
holder may increase the amount of ownership of outstanding shares
of common stock after exercising the holder’s Prefunded
Warrants up to 9.99% of the number of shares of common stock
outstanding immediately after giving effect to the exercise, as
such percentage ownership is determined in accordance with the
terms of the Prefunded Warrants. Purchasers in this offering
may also elect prior to the issuance of Prefunded Warrants to
have the initial exercise limitation set at 9.99% of our
outstanding shares of common stock.
Cashless Exercise
The
holder may elect to receive upon exercise (either in whole or in
part) the net number of shares of common stock determined according
to a formula set forth in the Prefunded
Warrants.
Fundamental Transactions
In
the event of any fundamental transaction, as described in
the Prefunded Warrants and generally including any merger with
or into another entity, sale of all or substantially all of our
assets, tender offer or exchange offer, or reclassification of our
shares of common stock, then upon any subsequent exercise of
a Prefunded Warrant, the holder will have the right to receive
as alternative consideration, for each share of common stock that
would have been issuable upon such exercise immediately prior to
the occurrence of such fundamental transaction, the number of
shares of common stock of the successor or acquiring corporation or
of our company, if it is the surviving corporation, and any
additional consideration receivable upon or as a result of such
transaction by a holder of the number of shares of common stock for
which the Prefunded Warrant is exercisable immediately prior
to such event.
Transferability
In
accordance with its terms and subject to applicable laws,
a Prefunded Warrant may be transferred at the option of the
holder upon surrender of the Prefunded Warrant to us together
with the appropriate instruments of transfer and payment of funds
sufficient to pay any transfer taxes (if
applicable).
Fractional
Shares
No
fractional shares of common stock will be issued upon the exercise
of the Prefunded Warrants. Rather, the number of shares of
common stock to be issued will, at our election, either be rounded
up to the nearest whole number or we will pay a cash adjustment in
respect of such final fraction in an amount equal to such fraction
multiplied by the exercise price.
Trading
Market
There
is no established trading market for the Prefunded Warrants,
and we do not expect a market to develop. We do not intend to apply
for a listing for the Prefunded Warrants on any securities exchange
or other nationally recognized trading system. Without an active
trading market, the liquidity of the Prefunded Warrants will
be limited.
Rights as a
Shareholder
Except
as otherwise provided in the Prefunded Warrants or by virtue
of the holders’ ownership of shares of common stock, the
holders of Prefunded Warrants do not have the rights or
privileges of holders of our shares of common stock, including any
voting rights, until such Prefunded Warrant holders exercise
their warrants.
Placement Agent Warrants
The Placement Agent Warrants will have substantially the same terms
as the other warrants issued in this offering, except with an
exercise price of $1.5906, or 125% of the effective purchase price
per share of common stock and Series A Warrant issued in the
offering.
Listing
on the Nasdaq Capital Market
Our common stock is
listed on the Nasdaq Capital Market under the symbol
“AZRX.” There is no established public trading market
for the warrants, and we do not expect a market to develop. We do
not plan on making an application to list the warrants on the
Nasdaq Capital Market, any securities exchange or any recognized
trading system.
Pursuant to a
letter agreement dated as of October 13, 2020, we have retained
H.C. Wainwright & Co., LLC (“Wainwright”), to act
as our exclusive placement agent in connection with this offering.
Under the terms of the engagement letter, Wainwright is not
purchasing or selling any of the securities offered by us in this
offering, and is not required to arrange for the sale of any
specific number or dollar amount of securities, other than to use
its reasonable best efforts to arrange for the sale of such
securities by us. The terms of this offering were subject to market
conditions and negotiations between us, Wainwright and the
prospective investor.
We are entering
into a securities purchase agreement, dated March 7, 2021, directly
with a single institutional investor in connection with this
offering of common stock and warrants pursuant to this prospectus
supplement and accompanying prospectus, and we will only sell to
the investor who has entered into the securities purchase agreement
with us.
Wainwright will
have no authority to bind us by virtue of the engagement letter.
Further, Wainwright does not guarantee that it will be able to
raise new capital in any prospective offering.
Delivery of the
securities offered hereby is expected to occur on or about March
10, 2021, subject to satisfaction or waiver of customary closing
conditions.
We have agreed to
pay Wainwright a cash fee equal to 8.0% of the gross proceeds
received from the investor who purchased securities in the offering
and will issue to Wainwright or its designees Placement Agent
Warrants to purchase up to 550,099 shares of common stock on
substantially the same terms as the Warrants except with an
exercise price of $1.5906 and the expiration date of March 7, 2026.
We have also agreed to reimburse Wainwright $35,000 for
non-accountable expenses, up to $50,000 for legal fees and expenses
and other out-of-pocket expenses and $15,950 for clearing fees. We
estimate the total offering expenses of this offering that will be
payable by us, excluding the placement agent’s fees and
expenses, will be approximately $53,000.
We have agreed to
indemnify Wainwright and specified other persons against certain
liabilities, including liabilities arising under the Securities
Act, relating to or arising out of Wainwright’s activities
under the engagement letter and to contribute to payments that
Wainwright may be required to make in respect of such
liabilities.
We have also
granted Wainwright a right of first refusal for a period of nine
months following the closing of this offering to act as sole
book-running manager, sole underwriter, sole placement agent or
sole agent for each and every future public or private offering or
any other capital raising financing of equity or equity-linked
securities by us or any of our subsidiaries.
Pursuant to
the securities purchase agreement with the single institutional
investor in connection with this offering, from the date of the
securities purchase agreement until fifty (50) days after the
closing of this offering, neither we nor any subsidiary shall (i)
issue, enter into any agreement to issue or announce the issuance
or proposed issuance of any shares of common stock or common stock
equivalents, or (ii) file any registration statement or prospectus,
or any amendment or supplement thereto
We have also
agreed, subject to certain exceptions, until the one-year
anniversary of the signing of the securities purchase agreement in
connection with this offering, not to (i) issue or sell any debt or
equity securities that are convertible into, exchangeable or
exercisable for, or include the right to receive, additional shares
of common stock either (A) at a conversion price, exercise price or
exchange rate or other price that is based upon, and/or varies
with, the trading prices of or quotations for the shares of common
stock at any time after the initial issuance of such debt or equity
securities or (B) with a conversion, exercise or exchange price
that is subject to being reset at some future date after the
initial issuance of such debt or equity security or upon the
occurrence of specified or contingent events directly or indirectly
related to our business or the market for our common stock or (ii)
enter into, or effect a transaction under, any agreement,
including, but not limited to, an equity line of credit, whereby we
may issue securities at a future determined price.
Wainwright may be
deemed to be an underwriter within the meaning of Section 2(a)(11)
of the Securities Act, and any commissions received by it and any
profit realized on the resale of the securities sold by it while
acting as principal might be deemed to be underwriting discounts or
commissions under the Securities Act. As an underwriter, Wainwright
would be required to comply with the requirements of the Securities
Act and the Exchange Act, including, without limitation, Rule
415(a)(4) under the Securities Act and Rule 10b-5 and Regulation M
under the Exchange Act. These rules and regulations may limit the
timing of purchases and sales of common shares by Wainwright acting
as principal. Under these rules and regulations,
Wainwright:
●
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
Exchange Act, until it has completed its participation in the
distribution.
The securities
purchase agreement is included as an exhibit to a Current Report on
Form 8-K that we have filed with the SEC and that is incorporated
by reference into the registration statement of which this
prospectus supplement forms a part.
In connection with
an offering on January 6, 2021, we paid Wainwright a cash fee equal
to 8.0% and a management fee equal to 1.0% of the aggregate gross
proceeds received by us in the offering, or approximately $0.7
million. We also issued to Wainwright and its designees certain
warrants to purchase up to 746,667 shares of common stock, at an
exercise price of $0.9375 per share, as compensation for services
as placement agent in that offerings. Wainwright also received a
reimbursement for non-accountable expenses equal to $35,000, a
reimbursement for legal fees and expenses in the amount of $125,000
and $12,900 for clearing fees.
Pursuant to a
separate advisory engagement letter with Wainwright, also dated as
of October 13, 2020, as amended, we have previously paid Wainwright
a $150,000 cash retainer fee for services related to exploring
certain potential acquisition transactions with First Wave Bio, Inc., and the Company
became obligated to pay an additional $150,000 fee upon entry into
a license agreement with First Wave Bio, Inc., in each case as
advisory fees.
From time to time,
Wainwright may provide in the future various advisory, investment
and commercial banking and other services to us in the ordinary
course of business, for which they have received and may continue
to receive customary fees and commissions. However, except as
disclosed in this prospectus supplement, we have no present
arrangements with Wainwright for any further services.
The validity of the
securities offered hereby will be passed upon for us by Lowenstein
Sandler LLP, New York, New York. Haynes and Boone, LLP, New York,
New York has acted as counsel for the placement agent in connection
with certain legal matters relating to this offering.
The audited
financial statements incorporated by reference in this prospectus
and elsewhere in the registration statement have been incorporated
by reference in reliance upon the report of Mazars USA LLP,
independent registered public accounting firm, upon the authority
of said firm as experts in accounting and auditing. The 2019 and
2018 audited annual consolidated financial statements of AzurRx
BioPharma, Inc., as of and for the years ended December 31, 2019
and 2018, have been audited by Mazars USA LLP, independent
registered public accounting firm. The audit report dated March 30,
2020 for the 2019 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 Exchange Act and in
accordance therewith we file annual, quarterly, and other reports,
proxy statements and other information with the SEC under the
Exchange Act. Such reports, proxy statements and other information,
including the Registration Statement, and exhibits and schedules
thereto, are available to the public through the SEC’s
website at 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, at
prescribed rates, from the SEC at the address listed above, or 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 supplement the
information on our website, and you should not consider it to be a
part of this prospectus supplement.
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, 2019, filed on March
30, 2020, as amended on April 29, 2020;
●
our Quarterly
Report on Form 10-Q for the periods ended March 31, 2020, June 30,
2020 and September 30, 2020 filed on May 15, 2020, August 14, 2020
and November 16, 2020, respectively;
●
our Current Report
on Form 8-K, filed on January 6, 2020, January 13, 2020, January
14, 2020, January 22, 2020, March 2, 2020, March 27, 2020, April
14, 2020, April 21, 2020, May 1, 2020, June 1, 2020, June 12, 2020,
July 15, 2020, July 20, 2020, July 27, 2020, August 5, 2020, August
21, 2020; September 14, 2020; November 17, 2020; December 7, 2020;
January 4, 2021; January 5, 2021; January 8, 2021; January 13, 2021
(as amended); February 16, 2021; and February 25,
2021;
●
our definitive
proxy statements on Schedule 14A, filed on August 11, 2020 and
January 19, 2021 (as supplemented by the Definitive Additional
Materials filed on January 20, 2021); and
●
the description of
our common stock which is registered under Section 12 of the
Exchange Act, in our registration statement on Form 8-A, filed on
August 8, 2016, including any amendment or reports filed for the
purposes of updating this description.
We also incorporate
by reference all documents we file pursuant to Section 13(a),
13(c), 14 or 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 this
prospectus and prior to the termination of the offering, which 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.
BASE
PROSPECTUS
$50,000,000
COMMON STOCK
PREFERRED STOCK
WARRANTS
UNITS
From
time to time, we may offer and sell, in one or more offerings, up
to $50,000,000 of any combination of the securities described in
this prospectus. We may also offer securities as may be issuable
upon conversion, repurchase, exchange or exercise of any securities
registered hereunder, including any applicable anti-dilution
provisions.
This prospectus provides a general description of the securities we
may offer from time to time. Each time we offer securities, we will
provide specific terms of the securities offered in a supplement to
this prospectus. We may also authorize one or more free writing
prospectuses to be provided to you in connection with an offering.
The prospectus supplement and any related free writing prospectus
may also add, update or change information contained in this
prospectus. You should carefully read this prospectus, the
applicable prospectus supplement and any related free writing
prospectus, as well as any documents incorporated by reference,
before you invest in any of the securities being
offered.
Our
common stock is listed on the Nasdaq Capital Market under the
ticker symbol “AZRX.” On June 4, 2019, the last
reported sale price per share of our common stock was $2.20 per
share.
We may offer and sell our securities to or through
one or more agents, underwriters, dealers or other third parties or
directly to one or more purchasers on a continuous or delayed
basis. If agents, underwriters or dealers are used to sell our
securities, we will name them and describe their compensation in a
prospectus supplement. The price to the public of our securities
and the net proceeds we expect to receive from the sale of such
securities will also be set forth in a prospectus supplement. For
additional information on the methods of sale, you should refer to
the section entitled “Plan of
Distribution” in this
prospectus.
As
of June 4, 2019, the aggregate market value of our outstanding
common stock held by non-affiliates was approximately $53.4
million, which was calculated in accordance with General
Instruction I.B.6 of Form S-3, based on 18,469,076 shares of
outstanding common stock held by non-affiliates, at a price per
share of $2.89, the closing sale price of our common stock reported
on the Nasdaq Capital Market on May 8, 2019.
Pursuant
to General Instruction I.B.6 of Form S-3, in no event will we sell
the securities described in this prospectus in a public primary
offering with a value exceeding more than one-third (1/3) of the
aggregate market value of our common stock held bynon-affiliates in
any twelve (12)-month period, so long as the aggregate market value
of our outstanding common stock held by non-affiliates remains
below $75.0 million. During the twelve (12) calendar months prior
to and including the date of this prospectus, we have offered and
sold $5,642,043 of securities pursuant to General Instruction I.B.6
of Form S-3. As a result, we are currently eligible to offer and
sell up to an aggregate of approximately $12.17 million of our
securities pursuant to General Instruction I.B.6. of Form
S-3.
Our business and investing in our securities involves significant
risks. You should review carefully the risks and uncertainties
referenced under the heading “Risk
Factors” on page 4 of
this prospectus, as well as those contained in the applicable
prospectus supplement and any related free writing prospectus, and
in the other documents that are incorporated by reference into this
prospectus or the applicable prospectus
supplement.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal
offense.
The date of this prospectus is June 4, 2019
TABLE OF CONTENTS
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This prospectus is part of a registration
statement filed with the Securities and Exchange Commission
(the “SEC”), using a “shelf” registration
process. Under this shelf registration process, we may sell
the securities described in this prospectus in one or more
offerings. This prospectus provides you with a general
description of the securities which may be offered. Each time
we offer securities for sale, we will provide a prospectus
supplement that contains information about the specific terms of
that offering. Any prospectus supplement may also add or update
information contained in this prospectus. You should read both
this prospectus and any prospectus supplement together with
additional information described below under
“Where You Can Find More
Information” and
“Incorporation of Certain
Information by Reference.”
THIS PROSPECTUS MAY NOT BE USED TO CONSUMMATE A SALE OF SECURITIES
UNLESS IT IS ACCOMPANIED BY A PROSPECTUS
SUPPLEMENT.
You
should rely only on the information contained or incorporated by
reference in this prospectus, and in any prospectus
supplement. We have not authorized any other person to provide
you with different information. If anyone provides you with
different or inconsistent information, you should not rely on
it. We are not making offers to sell or solicitations to buy
the securities described in this prospectus in any jurisdiction in
which an offer or solicitation is not authorized, or in which the
person making that offer or solicitation is not qualified to do so
or to anyone to whom it is unlawful to make an offer or
solicitation. You should not assume that the information in
this prospectus or any prospectus supplement, as well as the
information we file or previously filed with the SEC that we
incorporate by reference in this prospectus or any prospectus
supplement, is accurate as of any date other than its respective
date. Our business, financial condition, results of operations
and prospects may have changed since those dates.
This prospectus contains summaries of certain
provisions contained in some of the documents described herein, but
reference is made to the actual documents for complete information.
All of the summaries are qualified in their entirety by the actual
documents. Copies of some of the documents referred to herein have
been filed, will be filed or will be incorporated by reference as
exhibits to the registration statement of which this prospectus is
a part, and you may obtain copies of those documents as described
below under the heading “Where You Can Find More
Information.”
This summary highlights information contained elsewhere in this
prospectus. This summary does not contain all the information you
should consider before buying our securities. You should read the
following summary together with the more detailed information
appearing in this prospectus, including the section titled
“Risk Factors” on page 4, before deciding whether to
purchase our securities.
In this prospectus, unless otherwise stated or the context
otherwise requires, references to “AzurRx,”
“Company,” “we,” “us,”
“our,” or similar references mean AzurRx BioPharma,
Inc. and its subsidiaries on a consolidated basis. References to
“AzurRx BioPharma” refer to AzurRx BioPharma, Inc. on
an unconsolidated basis. References to “AzurRx SAS”
refer to AzurRx SAS, AzurRx BioPharma’s wholly-owned
subsidiary through which we conduct our European
operations.
Overview
We are engaged in the research and development of non-systemic
biologics for the treatment of patients with gastrointestinal
disorders. Non-systemic biologics are non-absorbable drugs that act
locally, i.e. the intestinal lumen, skin or mucosa, without
reaching an individual’s systemic circulation. The
Company’s current product pipeline consists of two
therapeutic proteins under development:
MS1819-SD
MS1819-SD is a yeast derived recombinant lipase
for exocrine pancreatic insufficiency (“EPI”)
associated with chronic pancreatitis (“CP”)
and cystic fibrosis (“CF”).
A lipase is an enzyme that breaks up fat molecules. MS1819-SD is
considered recombinant because it was created from new combinations
of genetic material in yeast called Yarrowia lipolytica. In June
2018, the Company completed an open-label, dose escalation Phase
IIa trial of MS1819-SD in France, Australia, and New Zealand to
investigate both the safety of escalating doses of MS1819-SD, and
the efficacy of MS1819-SD through the analysis of each
patient’s coefficient of fat absorption (“CFA”)
and its change from baseline. A total of 11 CP patients with EPI
were enrolled in the study and final data showed a strong safety
and efficacy profile. Although the study was not powered for
efficacy, in a pre-planned analysis, the highest dose cohort of
MS1819-SD showed statistically significant and clinically
meaningful increases in CFA compared to baseline with a mean
increase of 21.8% and a p value of p=0.002 on a per protocol basis.
Additionally, maximal absolute CFA response to treatment was up to
57%, with an inverse relationship to baseline CFA. In October 2018,
the U.S. Food and Drug Administration (“FDA”)
cleared the Company’s Investigational New Drug
(“IND”)
application for MS1819-SD in patients with EPI due to CF. In
connection with the FDA’s clearance of the IND, in the fourth
quarter of 2018 the Company initiated the multi-center Phase II
OPTION study in the United States and Europe (the
“OPTION
Study”), which the
Company expects will include approximately 30 patients. The Company
dosed the first patients in the OPTION Study in February 2019 and
reached 50% of its enrollment target for the OPTION Study in April
2019. The Company expects to conclude and announce topline results
from the OPTION Study in the summer of 2019.
b-Lactamase Program
The Company’s b-lactamase program focuses on
products with an enzymatic combination of bacterial origin for the
prevention of hospital-acquired infections and
antibiotic-associated diarrhea (“AAD”)
by resistant bacterial strains induced by parenteral administration
of several antibiotic classes. Currently, the Company has two
compounds in pre-clinical development in this program, AZX1101 and
AZX1103. Both AZX1101 and AZX1103 are composed of several distinct
enzymes that break up individual classes of antibiotic molecules.
AZX1103 is a b-lactamase enzyme combination that has shown positive
pre-clinical activity, with degradation of amoxicillin in the
presence of clavulanic acid in the upper gastrointestinal tract in
the Gottingen minipig model. Currently, the Company is focused on
advancing pre-clinical development of AZX1103. The Company is also
currently assessing its plans for the continuation of the
development of AZX1101.
Risk Factors
Our business is subject to substantial risk.
Please carefully consider the section titled
“Risk
Factors” on page 4 of
this prospectus for a discussion of the factors you should
carefully consider before deciding to purchase securities that may
be offered by this prospectus.
Additional risks and uncertainties not presently known to us or
that we currently deem immaterial may also impair our business
operations. You should be able to bear a complete loss of your
investment.
Corporate Information
We were incorporated on January 30, 2014 in the State of Delaware.
In June 2014, we acquired 100% of the issued and outstanding
capital stock of AzurRx SAS (formerly ProteaBio Europe SAS), a
company incorporated in October 2008 under the laws of France. Our
principal executive offices are located at 760 Parkside Avenue,
Downstate Biotechnology Incubator, Suite 304, Brooklyn, NY 11226.
Our telephone number is (646) 699-7855. We maintain a website at
www.azurrx.com. The information contained on our website is not,
and should not be interpreted to be, a part of this
prospectus.
Investing in our securities involves a high degree
of risk. Before deciding whether to purchase any of our securities,
you should carefully consider the risks and uncertainties described
under “Risk
Factors” in our Annual
Report on Form 10-K for the fiscal year ended
December 31, 2018, any subsequent Quarterly Report on
Form 10-Q and our other filings with the SEC, all of which are
incorporated by reference herein. If any of these risks actually
occur, our business, financial condition and results of operations
could be materially and adversely affected and we may not be able
to achieve our goals, the value of our securities could decline and
you could lose some or all of your investment. Additional risks not
presently known to us or that we currently deem immaterial may also
impair our business operations. If any of these risks occur, the
trading price of our common stock could decline materially and you
could lose all or part of your investment.
CAUTIONARY NOTES REGARDING
FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by
reference herein contain forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this
prospectus and the documents incorporated by reference herein,
including statements regarding our strategy, future operations, future
financial position, future revenue, projected costs, prospects,
plans, objectives of management and expected market growth, are
forward-looking statements. These statements involve known and
unknown risks, uncertainties and other important factors that may
cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements.
The
words “anticipate,” “believe,”
“estimate,” “expect,” “intend,”
“may,” “plan,” “predict,”
“project,” “target,”
“potential,” “will,” “would,”
“could,” “should,” “continue,”
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. These forward-looking statements include,
among other things, statements about:
●
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 research and development expenses associated with continuing
clinical development and testing of MS1819-SD, advancing our
preclinical programs for AZX1103 and for other working capital and
capital expenditures.
Pending
other uses, we intend to invest our proceeds from the offering in
short-term investments or hold them as cash. We cannot predict
whether the proceeds invested will yield a favorable return. Our
management will have broad discretion in the use of the net
proceeds from this offering, and investors will be relying on the
judgment of our management regarding the application of the net
proceeds
DESCRIPTION OF OUR CAPITAL
STOCK
General
Our amended and restated certificate of
incorporation (our “Charter”) authorizes the issuance of up to
100,000,000 shares of common stock, par value $0.0001 per share,
and 10,000,000 shares of preferred stock, par value $0.0001 per
share.
Transfer Agent
The
transfer agent and registrar for our common stock is Colonial Stock
Transfer, 66 Exchange Place, 1st Floor, Salt Lake City, Utah 84111,
Tel: (801) 355-5740.
Common Stock
This section describes the general terms of our common stock that
we may offer from time to time. For more detailed information, a
holder of our common stock should refer to our Charter and our
amended and restated Bylaws, copies of which are filed with the SEC
as exhibits to our Annual Report on Form 10-K for the year ended
December 31, 2018, which is incorporated by reference into the
registration statement of which this prospectus forms a
part.
As of June 4, 2019,
there were 21,060,055 shares of our common stock issued and
outstanding, which were held by approximately 110 stockholders of
record, approximately 3,188,378 shares of common stock
subject to outstanding warrants, 994,000
shares of common stock subject to
outstanding stock options under our Amended and Restated 2014
Omnibus Equity Incentive Plan and 816,438 issuable upon conversion
of outstanding senior convertible notes. Each holder of common
stock is entitled to one vote for each share of common stock held
on all matters submitted to a vote of the stockholders, including
the election of directors. Our Charter and Bylaws do not provide
for cumulative voting rights.
Holders
of our common stock have no preemptive, conversion or subscription
rights, and there are no redemption or sinking fund provisions
applicable to the common stock. The rights, preferences and
privileges of the holders of common stock are subject to, and may
be adversely affected by, the rights of the holders of shares of
any series of our preferred stock that we may designate and issue
in the future.
Preferred Stock
This section describes the general terms and provisions of our
outstanding shares of preferred stock, as well as preferred stock
that we may offer from time to time. The applicable prospectus
supplement will describe the specific terms of the shares of
preferred stock offered through that prospectus supplement, which
may differ from the terms we describe below. We will file a
copy of the certificate of designation that contains the terms of
each new series of preferred stock with the SEC each time we issue
a new series of preferred stock, and these certificates of
designation will be incorporated by reference into the registration
statement of which this prospectus is a part. Each certificate of
designation will establish the number of shares included in a
designated series and fix the designation, powers, privileges,
preferences and rights of the shares of each series as well as any
applicable qualifications, limitations or restrictions. A holder of
our preferred stock should refer to the applicable certificate of
designation, our Charter and the applicable prospectus supplement
(and any related free writing prospectus that we may authorize to
be provided to you) for more specific information.
Our
Board of Directors has the authority, without action by our
stockholders to designate and issue up to 10,000,000 shares of
preferred stock in one or more series and to designate the rights,
preferences and privileges of each series, which may be greater
than the rights of our common stock. Currently, there are no shares
of our preferred stock that are issued or outstanding.
It
is not possible to state the actual effect of any future issuance
of shares of our preferred stock upon the rights of holders of our
common stock until our Board of Directors determines the specific
rights of the holders of our preferred stock. However, the effects
might include, among other things:
●
restricting
dividends on our common stock;
●
diluting
the voting power of our common stock;
●
impairing
the liquidation rights of our common stock; or
●
delaying
or preventing a change in control of our Company without further
action by our stockholders.
A
prospectus supplement will describe the terms of any series of
preferred stock being offered, including:
●
the
designation of the shares and the number of shares that constitute
the series;
●
the
dividend rate (or the method of calculation thereof), if any, on
the shares of the series and the priority as to payment of
dividends with respect to other classes or series of our capital
stock and the payment date of dividends;
●
the
dividend periods (or the method of calculation
thereof);
●
the
date from which dividends on the preferred stock shall accumulate,
if applicable;
●
the
voting rights of the shares;
●
the
liquidation preference and the priority as to payment of the
liquidation preference with respect to other classes or series of
our capital stock and any other rights of the shares of the series
upon our liquidation or winding-up;
●
whether
the preferred stock will rank senior or junior to or on a parity
with any other class or series of preferred
stock;
●
whether
or not and on what terms the shares of the series will be subject
to redemption or repurchase at our option;
●
whether
and on what terms the shares of the series will be convertible into
or exchangeable for other securities;
●
the
provision of a sinking fund, if any, for the preferred
stock;
●
whether
the shares of the series of preferred stock will be listed on a
securities exchange;
●
whether
interests in the preferred stock will be represented by depositary
shares;
●
the
transfer agent for the series of preferred
stock;
●
any
special United States federal income tax considerations applicable
to the series; and
●
any
other preferences and rights and any qualifications, limitations or
restrictions of the preferences and rights of the
series.
The following description, together with the additional information
we include in any applicable prospectus supplements or free writing
prospectus, summarizes the material terms and provisions of the
warrants that we may offer under this prospectus. Warrants may be
offered independently or together with common stock or preferred
stock offered by any prospectus supplement or free writing
prospectus, and may be attached to or separate from those
securities. While the terms we have summarized below will generally
apply to any future warrants we may offer under this prospectus, we
will describe the particular terms of any warrants that we may
offer in more detail in the applicable prospectus supplement or
free writing prospectus. The terms of any warrants we offer under a
prospectus supplement or free writing prospectus may differ from
the terms we describe below.
In
the event that we issue warrants, we will issue the warrants under
a warrant agreement, which we will enter into with a warrant agent
to be selected by us. Forms of these warrant agreements and forms
of the warrant certificates representing the warrants, and the
complete warrant agreements and forms of warrant certificates
containing the terms of the warrants being offered, will be filed
as exhibits to the registration statement of which this prospectus
is a part or will be incorporated by reference from reports that we
file with the SEC. We use the term “warrant agreement”
to refer to any of these warrant agreements. We use the term
“warrant agent” to refer to the warrant agent under any
of these warrant agreements. The warrant agent will act solely as
an agent of ours in connection with the warrants and will not act
as an agent for the holders or beneficial owners of the
warrants.
The
following summaries of material provisions of the warrants and the
warrant agreements are subject to, and qualified in their entirety
by reference to, all the provisions of the warrant agreement
applicable to a particular series of warrants. We urge you to read
the applicable prospectus supplements or free writing prospectus
related to the warrants that we sell under this prospectus, as well
as the complete warrant agreements that contain the terms of the
warrants.
General
We
will describe in the applicable prospectus supplement or free
writing prospectus the terms relating to a series of warrants. If
warrants for the purchase of common stock or preferred stock are
offered, the prospectus supplement or free writing prospectus will
describe the following terms, to the extent
applicable:
●
the
offering price and the aggregate number of warrants
offered;
●
the
total number of shares that can be purchased if a holder of the
warrants exercises them and, in the case of warrants for preferred
stock, the designation, total number and terms of the series of
preferred stock that can be purchased upon exercise;
●
the
designation and terms of any series of preferred stock with which
the warrants are being offered and the number of warrants being
offered with each share of common stock or preferred
stock;
●
the
date on and after which the holder of the warrants can transfer
them separately from the related common stock;
●
the
number of shares of common stock or preferred stock that can be
purchased if a holder exercises the warrant and the price at which
such common stock or preferred stock may be purchased upon
exercise, including, if applicable, any provisions for changes to
or adjustments in the exercise price and in the securities or other
property receivable upon exercise;
●
the
terms of any rights to redeem or call, or accelerate the expiration
of, the warrants;
●
the
date on which the right to exercise the warrants begins and the
date on which that right expires;
●
federal
income tax consequences of holding or exercising the warrants;
and
●
any
other specific terms, preferences, rights or limitations of, or
restrictions on, the warrants.
Exercise of Warrants
Each
holder of a warrant is entitled to purchase the number of shares of
common stock or preferred stock, as the case may be, at the
exercise price described in the applicable prospectus supplement or
free writing prospectus. After the close of business on the day
when the right to exercise terminates (or a later date if we extend
the time for exercise), unexercised warrants will become
void.
A
holder of warrants may exercise them by following the general
procedure outlined below:
●
delivering
to the warrant agent the payment required by the applicable
prospectus supplement or free writing prospectus to purchase the
underlying security;
●
properly
completing and signing the reverse side of the warrant certificate
representing the warrants; and
●
delivering
the warrant certificate representing the warrants to the warrant
agent within five business days of the warrant agent receiving
payment of the exercise price.
If
you comply with the procedures described above, your warrants will
be considered to have been exercised when the warrant agent
receives payment of the exercise price, subject to the transfer
books for the securities issuable upon exercise of the warrant not
being closed on such date. After you have completed those
procedures and subject to the foregoing, we will, as soon as
practicable, issue and deliver to you the common stock or preferred
stock that you purchased upon exercise. If you exercise fewer than
all of the warrants represented by a warrant certificate, a new
warrant certificate will be issued to you for the unexercised
amount of warrants. Holders of warrants will be required to pay any
tax or governmental charge that may be imposed in connection with
transferring the underlying securities in connection with the
exercise of the warrants.
Amendments and Supplements to the Warrant Agreements
We
may amend or supplement a warrant agreement without the consent of
the holders of the applicable warrants to cure ambiguities in the
warrant agreement, to cure or correct a defective provision in the
warrant agreement, or to provide for other matters under the
warrant agreement that we and the warrant agent deem necessary or
desirable, so long as, in each case, such amendments or supplements
do not materially adversely affect the interests of the holders of
the warrants.
Warrant Adjustments
Unless
the applicable prospectus supplement or free writing prospectus
states otherwise, the exercise price of, and the number of
securities covered by, a common stock or a preferred stock warrant
will be adjusted proportionately if we subdivide or combine our
common stock or preferred stock, as applicable. In addition, unless
the prospectus supplement or free writing prospectus states
otherwise, if we, without receiving payment:
●
issue
capital stock or other securities convertible into or exchangeable
for common stock or preferred stock, or any rights to subscribe
for, purchase or otherwise acquire any of the foregoing, as a
dividend or distribution to holders of our common stock or
preferred stock;
●
pay
any cash to holders of our common stock or preferred stock other
than a cash dividend paid out of our current or retained earnings
or other than in accordance with the terms of the preferred
stock;
●
issue
any evidence of our indebtedness or rights to subscribe for or
purchase our indebtedness to holders of our common stock or
preferred stock; or
●
issue
common stock or preferred stock or additional stock or other
securities or property to holders of our common stock or preferred
stock by way of spinoff, split-up, reclassification, combination of
shares or similar corporate rearrangement,
then
the holders of common stock or preferred stock warrants will be
entitled to receive upon exercise of the warrants, in addition to
the securities otherwise receivable upon exercise of the warrants
and without paying any additional consideration, the amount of
stock and other securities and property such holders would have
been entitled to receive had they held the common stock or
preferred stock, as applicable, issuable under the warrants on the
dates on which holders of those securities received or became
entitled to receive such additional stock and other securities and
property.
Except
as stated above or as otherwise set forth in the applicable
prospectus supplement or free writing prospectus, the exercise
price and number of securities covered by a common stock or
preferred stock warrant, and the amounts of other securities or
property to be received, if any, upon exercise of such warrant,
will not be adjusted or provided for if we issue those securities
or any securities convertible into or exchangeable for those
securities, or securities carrying the right to purchase those
securities or securities convertible into or exchangeable for those
securities.
Holders
of common stock and preferred stock warrants may have additional
rights under the following circumstances:
●
certain
reclassifications, capital reorganizations or changes of the common
stock or preferred stock, as applicable;
●
certain
share exchanges, mergers, or similar transactions involving us and
which result in changes of the common stock or preferred stock, as
applicable; or
●
certain
sales or dispositions to another entity of all or substantially all
of our property and assets.
If
one of the above transactions occurs and holders of our common
stock or preferred stock are entitled to receive stock, securities
or other property with respect to or in exchange for their
securities, the holders of the common stock warrants and preferred
stock warrants then outstanding, as applicable, will be entitled to
receive, upon exercise of their warrants, the kind and amount of
shares of stock and other securities or property that they would
have received upon the applicable transaction if they had exercised
their warrants immediately before the transaction.
This section outlines some of the provisions of the units and the
unit agreements. This information may not be complete in all
respects and is qualified entirely by reference to the unit
agreement with respect to the units of any particular series. The
specific terms of any series of units will be described in the
applicable prospectus supplement or free writing prospectus. If so
described in a particular prospectus supplement or free writing
prospectus, the specific terms of any series of units may differ
from the general description of terms presented below.
As
specified in the applicable prospectus supplement, we may issue
units consisting of one or more shares of common stock, shares of
our preferred stock, warrants or any combination of such
securities.
The
applicable prospectus supplement will specify the following terms
of any units in respect of which this prospectus is being
delivered:
●
the
terms of the units and of any of the shares of common stock, shares
of preferred stock, or warrants comprising the units, including
whether and under what circumstances the securities comprising the
units may be traded separately;
●
a
description of the terms of any unit agreement governing the
units;
●
if
appropriate, a discussion of material U.S. federal income tax
considerations; and
●
a
description of the provisions for the payment, settlement, transfer
or exchange of the units.
DESCRIPTION OF
CERTAIN PROVISIONS OF DELAWARE
LAW AND
OUR CERTIFICATE OF INCORPORATION AND BYLAWS
Certain
provisions of Delaware law, our Charter and Bylaws discussed below
may have the effect of making more difficult or discouraging a
tender offer, proxy contest or other takeover attempt. These
provisions are expected to encourage persons seeking to acquire
control of our company to first negotiate with our Board of
Directors. We believe that the benefits of increasing our ability
to negotiate with the proponent of an unfriendly or unsolicited
proposal to acquire or restructure our company outweigh the
disadvantages of discouraging these proposals because negotiation
of these proposals could result in an improvement of their
terms.
Delaware Anti-Takeover
Law.
We
are subject to Section 203 of the Delaware General Corporation
Law. Section 203 generally prohibits a public Delaware
corporation from engaging in a “business combination”
with an “interested stockholder” for a period of three
years after the date of the transaction in which the person became
an interested stockholder, unless:
●
prior
to the date of the transaction, the Board of Directors of the
corporation approved either the business combination or the
transaction which resulted in the stockholder becoming an
interested stockholder;
●
upon
consummation of the transaction that resulted in the stockholder
becoming an interested stockholder, the interested stockholder
owned at least 85% of the voting stock of the corporation
outstanding at the time the transaction commenced, excluding
specified shares; or
●
at
or subsequent to the date of the transaction, the business
combination is approved by the Board of Directors and authorized at
an annual or special meeting of stockholders, and not by written
consent, by the affirmative vote of at least 66 2/3% of the
outstanding voting stock which is not owned by the interested
stockholder.
Section 203
defines a “business combination” to
include:
●
any
merger or consolidation involving the corporation and the
interested stockholder;
●
any
sale, lease, exchange, mortgage, pledge, transfer or other
disposition of 10% or more of the assets of the corporation to or
with the interested stockholder;
●
subject
to exceptions, any transaction that results in the issuance or
transfer by the corporation of any stock of the corporation to the
interested stockholder;
●
subject
to exceptions, any transaction involving the corporation that has
the effect of increasing the proportionate share of the stock of
any class or series of the corporation beneficially owned by the
interested stockholder; or
●
the
receipt by the interested stockholder of the benefit of any loans,
advances, guarantees, pledges or other financial benefits provided
by or through the corporation.
In
general, Section 203 defines an “interested
stockholder” as any person that is:
●
the
owner of 15% or more of the outstanding voting stock of the
corporation;
●
an
affiliate or associate of the corporation who was the owner of 15%
or more of the outstanding voting stock of the corporation at any
time within three years immediately prior to the relevant date;
or
●
the
affiliates and associates of the above.
Under
specific circumstances, Section 203 makes it more difficult
for an “interested stockholder” to effect various
business combinations with a corporation for a three-year period,
although the stockholders may, by adopting an amendment to the
corporation’s certificate of incorporation or bylaws, elect
not to be governed by this section, effective 12 months after
adoption.
Our
Charter and Bylaws do not exclude us from the restrictions of
Section 203. We anticipate that the provisions of
Section 203 might encourage companies interested in acquiring
us to negotiate in advance with our Board of Directors since the
stockholder approval requirement would be avoided if a majority of
the directors then in office approve either the business
combination or the transaction that resulted in the stockholder
becoming an interested stockholder.
Charter and Bylaws.
Provisions
of our Charter and Bylaws may delay or discourage transactions
involving an actual or potential change of control or change in our
management, including transactions in which stockholders might
otherwise receive a premium for their shares, or transactions that
our stockholders might otherwise deem to be in their best
interests. Therefore, these provisions could adversely affect the
price of our common stock.
We
may sell the securities described in this prospectus to or through
underwriters or dealers, through agents, or directly to one or more
purchasers. A prospectus supplement or supplements (and any related
free writing prospectus that we may authorize to be provided to
you) will describe the terms of the offering of the securities,
including, to the extent applicable:
●
the
name or names of any underwriters or agents, if
applicable;
●
the
purchase price of the securities and the proceeds we will receive
from the sale;
●
any
over-allotment options under which underwriters may purchase
additional securities from us;
●
any
agency fees or underwriting discounts and other items constituting
agents’ or underwriters’ compensation;
●
any
public offering price;
●
any
discounts or concessions allowed or reallowed or paid to dealers;
and
●
any
securities exchange or market on which the securities may be
listed.
We
may also sell equity securities covered by this registration
statement in an “at the market offering” as defined in
Rule 415 under the Securities Act. Such offering may be made into
an existing trading market for such securities in transactions at
other than a fixed price, either:
●
On
or through the facilities of the Nasdaq Capital Market or any other
securities exchange or quotation or trading service on which such
securities may be listed, quoted or traded at the time of sale;
and/or
●
to
or through a market maker otherwise than on the Nasdaq Capital
Market or such other securities exchanges or quotation or trading
services.
Such
at-the-market offerings, if any, may be conducted by underwriters
acting as principal or agent.
Only
underwriters named in a prospectus supplement are underwriters of
the securities offered by the prospectus supplement.
If
underwriters are used in the sale, they will acquire the securities
for their own account and may resell the securities from time to
time in one or more transactions at a fixed public offering price
or at varying prices determined at the time of sale. The
obligations of the underwriters to purchase the securities will be
subject to the conditions set forth in the applicable underwriting
agreement. We may offer the securities to the public through
underwriting syndicates represented by managing underwriters or by
underwriters without a syndicate. Subject to certain conditions,
the underwriters will be obligated to purchase all of the
securities offered by the prospectus supplement. Any public
offering price and any discounts or concessions allowed or
reallowed or paid to dealers may change from time to time. We may
use underwriters with whom we have a material relationship. We will
describe in the prospectus supplement that names the underwriter,
the nature of any such relationship.
We
may sell securities directly or through agents we designate from
time to time. We will name any agent involved in the offering and
sale of securities, and we will describe any commissions we will
pay the agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, our agent will act on a best-efforts
basis for the period of its appointment.
We
may authorize agents or underwriters to solicit offers by certain
types of institutional investors to purchase securities from us at
the public offering price set forth in the prospectus supplement
pursuant to delayed delivery contracts providing for payment and
delivery on a specified date in the future. We will describe the
conditions to these contracts and the commissions we must pay for
solicitation of these contracts in the prospectus
supplement.
We
may provide agents and underwriters with indemnification against
civil liabilities related to this offering, including liabilities
under the Securities Act, or contribution with respect to payments
that the agents or underwriters may make with respect to these
liabilities. Agents and underwriters may engage in transactions
with, or perform services for, us in the ordinary course of
business.
Any underwriter may engage in overallotment,
stabilizing transactions, short covering transactions and penalty
bids in accordance with Regulation M under the Securities Exchange
Act of 1934, as amended (the “Exchange
Act”). Overallotment
involves sales in excess of the offering size, which create a short
position. Stabilizing transactions permit bids to purchase the
underlying security so long as the stabilizing bids do not exceed a
specified maximum. Short covering transactions involve purchases of
the securities in the open market after the distribution is
completed to cover short positions. Penalty bids permit the
underwriters to reclaim a selling concession from a dealer when the
securities originally sold by the dealer are purchased in a
covering transaction to cover short positions. Those activities may
cause the price of the securities to be higher than it would
otherwise be. If commenced, the underwriters may discontinue any of
the activities at any time.
Any
underwriters who are qualified market makers on the Nasdaq Capital
Market may engage in passive market making transactions in
accordance with Rule 103 of Regulation M during the business day
prior to the pricing of the offering, before the commencement of
offers or sales of the securities. Passive market makers must
comply with applicable volume and price limitations and must be
identified as passive market makers. In general, a passive market
maker must display its bid at a price not in excess of the highest
independent bid for such security; if all independent bids are
lowered below the passive market maker’s bid, however, the
passive market maker’s bid must then be lowered when certain
purchase limits are exceeded.
Certain
legal matters in connection with this offering will be passed upon
for us by Disclosure Law Group, a Professional Corporation, of San
Diego, California.
Mazars
USA LLP, our independent registered public accounting firm, has
audited our consolidated financial statements included in our
Annual Report on Form 10-K for the year ended December 31,
2018, as set forth in their report, which is incorporated by
reference in this prospectus. The report for AzurRx BioPharma, Inc.
includes an explanatory paragraph about the existence of
substantial doubt concerning its ability to continue as a going
concern. Our financial statements are incorporated by reference in
reliance on Mazars USA LLP’s report, given on their authority
as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We
are a public company and file annual, quarterly and special
reports, proxy statements and other information with the SEC. . Our
SEC filings are available, at no charge, to the public at the
SEC’s website at http://www.sec.gov.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The
following documents filed by us with the SEC are incorporated by
reference in this prospectus:
●
our
Annual Report on Form 10-K for the year ended December 31, 2018,
filed on April 1, 2019;
●
our
Amendment No. 1 to our Annual Report on Form 10-K/A for the year
ended December 31, 2018, filed on April 30, 2019;
●
our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2019,
filed on May 15, 2019;
●
our
Current Report on Form 8-K, filed on April 3, 2019;
●
our
Current Report on Form 8-K, filed on April 11, 2019;
●
our
Current Report on Form 8-K, filed on April 24, 2019;
●
our
Current Report on Form 8-K, filed May 7, 2019;
●
our
Current Report on Form 8-K, filed May 14, 2019;
●
our
Current Report on Form 8-K, filed on May 20, 2019;
●
our
Current Report on Form 8-K, filed on May 23, 2019; and
●
the
description of our common stock which is registered under Section
12 of the Exchange Act, in our registration statement on Form 8-A,
filed on August 8, 2016, including any amendment or reports filed
for the purposes of updating this description.
We
also incorporate by reference all documents we file pursuant to
Section 13(a), 13(c), 14 or 15 of the Exchange Act (other than any
portions of filings that are furnished rather than filed pursuant
to Items 2.02 and 7.01 of a Current Report on Form 8-K) after the
date of the initial registration statement of which this prospectus
is a part and prior to effectiveness of such registration
statement. All documents we file in the future pursuant to Section
13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of
this prospectus and prior to the termination of the offering are
also incorporated by reference and are an important part of this
prospectus.
Any
statement contained in a document incorporated or deemed to be
incorporated by reference herein shall be deemed to be modified or
superseded for the purposes of this registration statement to the
extent that a statement contained herein or in any other
subsequently filed document which also is or deemed to be
incorporated by reference herein modifies or supersedes such
statement. Any statement so modified or superseded shall not be
deemed, except as so modified or superseded, to constitute a part
of this registration statement.
We
will provide to each person, including any beneficial owner, to
whom a prospectus is delivered, a copy of any or all of the
information that has been incorporated by reference in the
prospectus but not delivered with the prospectus. You may request a
copy of these filings, excluding the exhibits to such filings which
we have not specifically incorporated by reference in such filings,
at no cost, by writing to or calling us at:
AzurRx
Biopharma, Inc.
760
Parkside Avenue
Downtown
Biotechnology Incubator, Suite 304
Brooklyn,
New York 11226
(646) 699-7855.
This
prospectus is part of a registration statement we filed with the
SEC. You should only rely on the information or representations
contained in this prospectus and any accompanying prospectus
supplement. We have not authorized anyone to provide information
other than that provided in this prospectus and any accompanying
prospectus supplement. We are not making an offer of the securities
in any state where the offer is not permitted. You should not
assume that the information in this prospectus or any accompanying
prospectus supplement is accurate as of any date other than the
date on the front of the document.
5,800,000 Shares of Common Stock
Prefunded Warrants to Purchase up to 2,058,548 Shares of Common
Stock
Series A Warrants to Purchase up to 3,929,274 Shares of Common
Stock
Placement Agent Warrants to Purchase up to 550,099 Shares of Common
Stock
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.
H.C.
Wainwright & Co.
March 7, 2021
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