GridAI Technologies Corp S-3/A, filed Feb 11, 2021
GridAI Technologies Corp. (GRDX)
S-3/A
2021-02-11
View Original
Added on
October 17, 2026
As filed with the Securities and Exchange Commission on February
11, 2021
Registration No. 333-252623
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
AZURRX BIOPHARMA, INC.
(Exact name of registrant as specified in its
charter)
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Delaware
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2834
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46-4993860
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(State or Other Jurisdiction of
Incorporation or Organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer
Identification Number)
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1615 South Congress Avenue, Suite 103
Delray Beach, Florida 33445
(646) 699-7855
(Address, including zip code, and telephone
number,
including area code, of registrant’s principal executive
offices)
James Sapirstein, President and Chief Executive
Officer
AzurRx BioPharma, Inc.
1615 South Congress Avenue, Suite 103
Delray Beach, Florida 33445
(646) 699-7855
(Name, address, including zip code, and telephone
number,
including area code, of agent for service)
Copies to
James O’Grady, Esq.
Michael J. Lerner, Esq.
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, New York 10020
Telephone: (212) 262-6700
Approximate
date of commencement of proposed sale to the public: As soon
as practicable after this registration statement becomes
effective.
If the only securities being registered on this form are being
offered pursuant to dividend or interest reinvestment plans, please
check the following box. ☐
If any of the securities being registered on this form are to be
offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the
following box. ☒
If this form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act of 1933,
please check the following box and list the Securities Act
registration statement number of the earlier effective registration
statement for the same
offering. ☐
If this form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier
effective registration statement for the same
offering. ☐
If this form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that shall
become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following
box. ☐
If this form is a post-effective amendment to a registration
statement filed pursuant to General Instruction I.D. filed to
register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check the
following box. ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,”
“accelerated filer,” “smaller reporting
company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer
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[ ]
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Accelerated filer
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[ ]
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Non-accelerated filer
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[X]
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Smaller reporting company
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[X]
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Emerging growth company
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[X]
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If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
☐
The Registrant hereby amends this Registration Statement on such
date or dates as may be necessary to delay its effective date until
the registrant shall file a further amendment which specifically
states that this Registration Statement shall thereafter become
effective in accordance with Section 8(a) of the Securities Act of
1933, as amended, or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said
Section 8(a), may determine.
The information in this preliminary prospectus is not complete and
may be changed. The selling stockholders may not resell these
securities until the registration statement filed with the
Securities and Exchange Commission is effective. This preliminary
prospectus is not an offer to sell these securities, nor is it a
solicitation of offers to buy these securities, in any state where
the offer or sale is not permitted.
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PRELIMINARY PROSPECTUS
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SUBJECT TO COMPLETION
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DATED FEBRUARY 11, 2021
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26,112,721
Shares of Common Stock
This prospectus relates to the resale of up to
26,112,721 shares of AzurRx BioPharma, Inc. (the
“Company,” “we,” “our” or
“us”) common stock, par value $0.0001 per share, by the
selling stockholders listed in this prospectus or their permitted
transferees. The shares of common stock registered for resale
pursuant to this prospectus include 26,112,721 shares
of common stock issuable upon exercise, for cash, of warrants (the
“Series B Exchange Warrants”) issued or issuable to the
selling stockholders pursuant to an exchange right (the
“Series B Exchange Right”) under the Certificate of
Designations (the “Series B Certificate of
Designations”) for our Series B Convertible Preferred Stock,
par value $0.0001 per share (the “Series B Preferred
Stock”), as further described below. In addition, this
prospectus registers for resale, on behalf of the selling
stockholders named herein, the shares of Common Stock underlying
warrants potentially issuable
pursuant to the Series B Exchange Right in respect of
accrued or paid-in-kind dividend obligations relating to the Series
B Preferred Stock. Any issuances of Series B Exchange Warrants will
be made pursuant to the exemption provided by
Section 3(a)(9) of the Securities Act of 1933, as amended (the
“Securities Act”). In accordance with applicable U.S.
Securities and Exchange Commission guidance (Securities
Act Forms Compliance and Disclosure Interpretations 116.13),
this prospectus registers for resale, on behalf of the selling
stockholders named herein, the shares of Common Stock issuable upon
exercise of the Series B Exchange Warrants.
We are not selling any securities under this prospectus and will
not receive any of the proceeds from the sale of shares by the
selling stockholder. However,
we may receive proceeds of up to approximately $20.9 million
from
the cash exercise the Series B Exchange Warrants by the selling
stockholders, once the registration statement, of which this
prospectus is a part, is declared
effective.
The selling stockholder may sell the shares of common stock
described in this prospectus in a number of different ways and at
varying prices. See Plan of
Distribution on page 11 of this prospectus for more
information about how the selling stockholder may sell the shares
of common stock being registered pursuant to this prospectus. The
selling stockholder may be an “underwriter” within the
meaning of Section 2(a)(11) of the Securities
Act.
We will pay the expenses incurred in registering the shares,
including legal and accounting fees. See Plan of
Distribution on page 11 of this
prospectus.
Our common stock is currently listed on The Nasdaq Capital Market
under the symbol “AZRX”. On February 10,
2021, the last reported sale price of our common stock on The
Nasdaq Capital Market was $1.89.
We are an “emerging growth company” as defined in
Section 2(a) of the Securities Act of 1933, as amended, and we
have elected to comply with certain reduced public company
reporting requirements.
Investing in our securities involves risks. See “Risk
Factors” beginning on page 5 of this prospectus for a
discussion of the risks that you should consider in connection with
an investment in our securities.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is
,
2021.
TABLE OF CONTENTS
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II-3
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PROSPECTUS SUMMARY
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.
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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.
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 plan to initiate 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 ICI-AC and 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.
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In consideration of the license and other rights granted by First
Wave, we paid First Wave a $9.0 million upfront cash payment and 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. We are also obligated to pay First Wave royalties as a
mid-single digit percentage of net sales of the Product, subject to
specified reductions.
We are now solely responsible, and have agreed to use commercially
reasonable efforts, for all development, regulatory and commercial
activities related to the Products in the ICI-AC and COVID fields.
We may sublicense our rights under the First Wave License Agreement
and, if we do so, we will be obligated to pay milestone payments
and royalties to First Wave based on the sublicensee’s
development and commercialization of the
Products.
As of February 10,
2021, 9,441.4960 shares of Series C Preferred Stock, convertible
into an aggregate of up to 9,441,496 shares of Common Stock, have
been issued in relation to the Series B Exchange Rights at a
conversion price of $0.75 per share, subject to certain
limitations. Further, as of February 10, 2021, 9,441,496 Series B
Exchange Warrants have been issued, exercisable for up to an
aggregate of 9,441,496 additional shares of Common Stock, at an
exercise price of $0.80 per share.
Pursuant to the First Wave License Agreement, First Wave retains
rights to develop and commercialize the licensed niclosamide
formulations outside the ICI-AC and COVID fields, and to develop
and commercialize other niclosamide formulations that are not
licensed to us. However, if prior to April 30, 2021, First Wave
seeks to outlicense, sell to or otherwise grant rights to a third
party related to any products containing niclosamide for use
outside the ICI-AC or COVID fields to develop or commercialize a
product containing niclosamide for use outside of the field then
First Wave shall provide to us written notice of such proposal, in
reasonable detail and we shall have the right and option to
negotiate with First Wave with respect to a definitive agreement
for the acquisition of First Wave. Pursuant to the First Wave
License Agreement, we grant First Wave a worldwide, non-exclusive,
royalty-free, perpetual, irrevocable license for use outside the
ICI-AC and COVID fields, with the right to grant sublicenses, under
any program IP and other intellectual property owned by us and
incorporated into the Product.
The First Wave License Agreement terminates on a country-by-country
basis and product-by-product basis upon the expiration of the
royalty term for such product in such country. Each royalty term
begins on the date of the first commercial sale of the licensed
product in the applicable country and ends on date of expiration of
the last to expire royalty term with respect to the country. The
First Wave License Agreement may be terminated earlier in specified
situations, including termination for uncured material breach of
the First Wave License Agreement by either party, termination by us
in specified circumstances, termination by First Wave in specified
circumstances, termination by us for convenience with advance
notice, and termination upon a party’s insolvency or
bankruptcy. After expiration of the royalty term, we shall have a
non-exclusive, fully-paid, perpetual, royalty-free right and
irrevocable license with respect to any Product in any country
within the territory.
The First Wave License Agreement also contains customary
representations, warranties and covenants by both parties, as well
as customary provisions relating to indemnification,
confidentiality and other matters.
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.
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Recent Developments
Series B Exchange Right
On July 16, 2020, we consummated an offering of shares of our
Series B Preferred Stock (the “Series B Offering”) in
which we issued an aggregate of 2,912.583005 shares of Series B
Preferred Stock, at a price of $7,700.00 per share, initially
convertible into an aggregate of 29,125,756 shares of Common Stock
at $0.77 per share, together with warrants (the “Series B
Warrants”) to purchase an aggregate of 14,562,826 shares of
Common Stock at an exercise price of $0.85 per
share.
Under the Series B Certificate of Designations, in the event we
effect any issuance of Common Stock or common stock equivalents for
cash consideration, or a combination of units thereof, each holder
of the Series B Preferred Stock has the right to exchange the
stated value, plus accrued and unpaid dividends, of the Series B
Preferred Stock for any securities issued in a Subsequent Financing
(as defined in the Series B Certificate of Designations), on a
dollar-for-dollar basis, in lieu of any cash subscription payments
therefor, which we refer to as the Series B Exchange Rights. The
terms and conditions of the Series B Preferred Stock and the Series
B Offering were reported in our Current Report on Form 8-K filed
July 20, 2020, which is incorporated herein by
reference.
On December 31, 2020, we entered into a securities purchase
agreement (the “Series C Purchase Agreement”) with a
certain accredited investor, pursuant to which we agreed to sell in
a registered direct offering (the “Series C Registered Direct
Offering”) 5,333.333 shares of our Series C 9.00% Convertible
Junior Preferred Stock, par value $0.0001 per share (the
“Series C Preferred Stock”), at a price of $750 per
share, which shares were initially convertible into an aggregate of
5,333,334 shares of Common Stock, at an initial stated value of
$750.00 per share and a conversion price of $0.75 per share. The
Series C Registered Direct Offering closed on January 6,
2021.
Concurrently with the Series C Registered Direct Offering, in a
private placement (the “Series C Private Placement,”
and together with the Series C Registered Direct Offering, the
“Series C Offerings”), we also sold to the investor, an
additional 5,333.333 shares of Series C Preferred Stock at the same
price as the Series C Preferred Stock offered in the Series C
Registered Direct Offering, which shares were initially convertible
into an aggregate of 5,333,334 shares of our Common stock, together
with warrants to purchase up to an aggregate of 10,666,668 shares
of Common Stock, with an exercise price of $0.80 per share and an
expiration term through July 6, 2026. The Series C Private
Placement closed on January 6, 2021. The terms of the Series C
Offerings were reported in our Current Reports on Form 8-K filed
January 4, 2021, January 8, 2021 and January 13, 2021, which are
incorporated herein by reference.
As a result of the
Series C Offerings, pursuant to the Series B Certificate of
Designation and the Series B Exchange Right, we are required to
issue (in addition to shares of Series C Preferred Stock) Series B
Exchange Warrants to purchase up to an
additional 26,112,721 shares
of Common Stock to any holders of Series B Preferred Stock who
elect to exercise their Exchange Rights. As of February 10,
2021, the shares of Series C Preferred Stock potentially issuable
in relation to the Series B Exchange Rights would have been
convertible into an aggregate of up to 678,082 incremental shares
of Common Stock (beyond the 25,427,643 shares of Common Stock
into which the underlying shares of Series B Preferred Stock,
including accrued and unpaid dividends thereon, were convertible as
of such date) at a conversion price of $0.75 per share, subject to
certain limitations. In addition, as of February 10, 2021, the
Series B Exchange Warrants potentially issuable in relation to the
Series B Exchange Rights would have been exercisable for up to an
aggregate of 26,105,725 additional shares of Common Stock, at an
exercise price of $0.80 per share. In addition, this prospectus registers
for resale the shares of Common Stock underlying warrants
potentially issuable pursuant to the Series B Exchange Right in
respect of accrued or paid-in-kind dividend obligations relating to
the Series B Preferred Stock. In accordance with applicable
Commission guidance (Securities Act
Forms Compliance and Disclosure Interpretations
116.13), this
prospectus registers for resale, on behalf of the selling
stockholders named herein, the shares of Common Stock issuable upon
exercise of the Series B Exchange
Warrants.
As of February 10,
2021, 9,441.4960 shares of Series C Preferred Stock, convertible
into an aggregate of up to 9,441,496 shares of Common Stock, have
been issued in relation to the Series B Exchange Rights at a
conversion price of $0.75 per share, subject to certain
limitations. Further, as of February 10, 2021, 9,441,496 Series B
Exchange Warrants have been issued, exercisable for up to an
aggregate of 9,441,496 additional shares of Common Stock, at an
exercise price of $0.80 per share.
Pursuant to the Series C Purchase Agreement, we must hold a meeting
of our stockholders not later than March 31, 2021 to seek such
approval as may be required from our stockholders (the
“Stockholder Approval”), in accordance with applicable
law, the applicable rules and regulations of the Nasdaq Stock
Market, our certificate of incorporation and bylaws and the General
Corporate Law of the State of Delaware. Until the Stockholder
Approval has been obtained, the Series B Exchange Warrants held by
the selling stockholders named herein may not be exercised for any
shares of our Common Stock. We have scheduled a special meeting of
our stockholders to be held on February 24, 2021, for the purpose
of obtaining the Stockholder Approval. Please see our Definitive
Proxy Statement filed on January 19, 2021.
The terms of the offerings described above were previously reported
in our Current Reports on Form 8-K filed on July 20, 2020, January
4, 2021, January 8, 2021 and January 13, 2021, which are
incorporated herein by reference.
Corporate Information
We were incorporated on January 30, 2014 in the State of
Delaware. In June 2014, we acquired 100% of the issued
and outstanding capital stock of AzurRx SAS. Our principal
executive offices are located at 1615 South Congress Avenue, Suite
103, Delray Beach, Florida 33445. Our telephone number is (646)
699-7855. We maintain a website at www.azurrx.com. The information
contained on our website is not, and should not be interpreted to
be, a part of this prospectus.
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The Offering
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Shares of common stock offered by the selling
stockholders
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26,112,721
shares of common stock issuable upon exercise, for cash, of Series
B Exchange Warrants held by the selling
stockholders.
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Shares of common stock outstanding before this
offering
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53,418,712 shares of common stock
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Shares of common stock to be outstanding after giving effect to the
issuance of shares registered hereunder
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79,531,433 shares of common stock
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Use of proceeds
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We are not selling any securities under this prospectus and will
not receive any of the proceeds from the sale of shares by the
selling stockholder. However, we may receive proceeds of up to
approximately $20.9 million from the cash exercise of the warrants
by the selling stockholders, once the registration statement, of
which this prospectus is a part, is declared
effective.
We
anticipate that proceeds that we receive from the cash exercise of
such warrants, if any, will be used 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 12 of this
prospectus.
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Terms of this offering
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The selling stockholders, including their transferees, donees,
pledgees, assignees and successors-in-interest, may sell, transfer
or otherwise dispose of any or all of the shares of common stock
offered by this prospectus from time to time on The Nasdaq Capital
Market or any other stock exchange, market or trading facility on
which the shares are traded or in private transactions. The shares
of common stock may be sold at fixed prices, at market prices
prevailing at the time of sale, at prices related to prevailing
market price or at negotiated prices.
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|
Nasdaq symbol
|
|
Our common stock is listed on The Nasdaq Capital Market under the
symbol “AZRX”.
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Risk Factors
|
|
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”.
|
|
|
|
|
|
|
|
Investing in our common stock involves a high degree of risk.
Before deciding whether to purchase our securities, including the
shares of common stock and warrants 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.
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;
●
our current and future capital requirements and our ability to
raise additional funds to satisfy our capital needs;
●
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 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 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.
Series B Exchange Right
On July 16, 2020, we
consummated the Series B Offering in which we issued an aggregate
of 2,912.583005 shares of Series B Preferred Stock, at a price of
$7,700.00 per share, initially convertible into an aggregate of
29,125,756 shares of Common Stock at $0.77 per share, together with
the Series B Warrants to purchase an aggregate of 14,562,826 shares
of Common Stock at an exercise price of $0.85 per
share.
Under the Series B Certificate of Designations, in the event we
effect any issuance of Common Stock or common stock equivalents for
cash consideration, or a combination of units thereof, each holder
of the Series B Preferred Stock has the right to exchange the
stated value, plus accrued and unpaid dividends, of the Series B
Preferred Stock for any securities issued in a Subsequent Financing
(as defined in the Series B Certificate of Designations), on a
dollar-for-dollar basis, in lieu of any cash subscription payments
therefor, which we refer to as the Series B Exchange Rights. The
terms and conditions of the Series B Preferred Stock and the Series
B Offering were reported in our Current Report on Form 8-K filed
July 20, 2020, which is incorporated herein by
reference.
On December 31, 2020, we entered into the Series C Purchase
Agreement with a certain accredited investor, pursuant to which we
agreed to sell in the Series C Registered Direct Offering 5,333.333
shares of our Series C Preferred Stock, at a price of $750 per
share, which shares were initially convertible into an aggregate of
5,333,334 shares of Common Stock, at an initial stated value of
$750.00 per share and a conversion price of $0.75 per share. The
Series C Registered Direct Offering closed on January 6,
2021.
Concurrently with the Series C Registered Direct Offering, in the
Series C Private Placement we also sold to the investor, an
additional 5,333.333 shares of Series C Preferred Stock at the same
price as the Series C Preferred Stock offered in the Series C
Registered Direct Offering, which shares were initially convertible
into an aggregate of 5,333,334 shares of our Common stock, together
with warrants to purchase up to an aggregate of 10,666,668 shares
of Common Stock, with an exercise price of $0.80 per share and an
expiration term through July 6, 2026. The Series C Private
Placement closed on January 6, 2021. The terms of the Series C
Offerings were reported in our Current Reports on Form 8-K filed
January 4, 2021, January 8, 2021 and January 13, 2021, which are
incorporated herein by reference.
As a result of the
Series C Offerings, pursuant to the Series B Certificate of
Designation and the Series B Exchange Right, we are required to
issue (in addition to shares of Series C Preferred Stock) Series B
Exchange Warrants to purchase up to an additional
26,112,721 shares of Common Stock
to any holders of Series B Preferred Stock who elect to exercise
their Exchange Rights. As of February 10,
2021, the shares of Series C Preferred Stock potentially issuable
in relation to the Series B Exchange Rights would have been
convertible into an aggregate of up to 678,082 incremental shares
of Common Stock (beyond the 25,427,643 shares of Common Stock
into which the underlying shares of Series B Preferred Stock,
including accrued and unpaid dividends thereon, were convertible as
of such date) at a conversion price of $0.75 per share, subject to
certain limitations. In addition, as of February 10, 2021, the
Series B Exchange Warrants potentially issuable in relation to the
Series B Exchange Rights would have been exercisable for up to an
aggregate of 26,105,725 additional shares of Common Stock, at an
exercise price of $0.80 per share. In addition, this prospectus registers
for resale, on behalf of the selling stockholders named herein, the
shares of Common Stock underlying warrants potentially
issuable pursuant to the Series
B Exchange Right in
respect of accrued or paid-in-kind dividend obligations relating to
the Series B Preferred Stock. In accordance with applicable
Commission guidance (Securities Act
Forms Compliance and Disclosure Interpretations
116.13), this
prospectus registers for resale, on behalf of the selling
stockholders named herein, the shares of Common Stock issuable upon
exercise of the Series B Exchange Warrants
only.
Pursuant to the Series C Purchase Agreement, we must hold a meeting
of our stockholders not later than March 31, 2021 to seek such
approval as may be required from our stockholders (the
“Stockholder Approval”), in accordance with applicable
law, the applicable rules and regulations of the Nasdaq Stock
Market, our certificate of incorporation and bylaws and the General
Corporate Law of the State of Delaware. Until the Stockholder
Approval has been obtained, the Series B Exchange Warrants held by
the selling stockholders named herein may not be exercised for any
shares of our Common Stock. We have scheduled a special meeting of
our stockholders to be held on February 24, 2021, for the purpose
of obtaining the Stockholder Approval. Please see our Definitive
Proxy Statement filed on January 19, 2021.
This
prospectus relates to the sale from time to time
by the selling stockholders of up to 26,112,721
shares
of our common stock, which consists of
26,112,721 shares of common stock issuable upon
exercise of the Series B Exchange Warrants issued or issuable in
connection with the Series C Offerings and the Series B Exchange
Rights through February 12, 2021. When
we refer to the “selling stockholders” in this
prospectus, we mean the persons and entities listed in the table
below, and their respective pledgees, donees, permitted
transferees, assignees, successors and others who later come to
hold any of the selling stockholders’ interests in shares of
our common stock other than through a public
sale.
The selling stockholder may sell some, all or none of its shares.
We do not know how long the selling stockholder will hold the
shares before selling them, and we currently have no agreements,
arrangements or understandings with the selling stockholder
regarding the sale of any of the shares.
The following table presents information regarding the selling
stockholder and the shares that it may offer and sell from time to
time under this prospectus. The
number of shares common stock beneficially owned by the selling
stockholders is determined under rules promulgated by the SEC.
Except as described above, there are currently no agreements,
arrangements or understandings with respect to the resale of any of
the securities covered by this
prospectus.
|
|
Shares of Common Stock Beneficially Owned
Prior to
|
Shares of Common Stock Offered Underlying Series B
Exchange
|
Shares of Common Stock Beneficially Owned After this Offering(3) |
|
|
Name of Selling Stockholder
|
Offering(1)(2)(3)
|
Warrants
|
Number(3)
|
Percent(4)
|
|
Alexander
D. Walsh
|
401,595
|
144,231
|
257,364
|
*
|
|
Allen
Whittemore & Mary Walton
|
518,386
|
210,492
|
307,894
|
*
|
|
Amory
Ross (5)
|
751,653
|
124,808
|
626,845
|
1.3
|
|
Andrew
Amorosi
|
259,193
|
105,246
|
153,947
|
*
|
|
Andrew
Johnston ROTH IRA
|
165,290
|
67,061
|
98,229
|
*
|
|
Andrew
Sanford
|
162,441
|
57,190
|
105,251
|
*
|
|
Archero
2020
|
282,953
|
107,045
|
175,908
|
*
|
|
Arthur
Smalley
|
103,676
|
42,098
|
61,578
|
*
|
|
Beatrice
Knox-Johnston
|
276,472
|
112,262
|
164,210
|
*
|
|
Bellis,
Blauvelt-Demarest Foundations, Inc.
|
138,236
|
56,131
|
82,105
|
*
|
|
Bolton
Equities Management USA, LLC
|
1,727,953
|
701,639
|
1,026,314
|
2.1
|
|
Boulderwood
LLC
|
697,268
|
251,523
|
445,745
|
*
|
|
Brenda
B. Oakes
|
295,483
|
113,702
|
181,781
|
*
|
|
Brett
Webbe
|
349,049
|
129,174
|
219,875
|
*
|
|
Brio
Capital Master Fund, Ltd.
|
860,212
|
348,937
|
511,275
|
*
|
|
Brody
2016 Family Trust
|
26,552
|
10,776
|
15,776
|
*
|
|
Bruce
Conway
|
1,005,876
|
408,438
|
597,438
|
1.2
|
|
Bryan
McShane
|
626,754
|
210,492
|
416,262
|
*
|
|
BTR
Partners LP (6)
|
658,395
|
220,249
|
438,146
|
*
|
|
C.
Erik Young
|
345,591
|
140,328
|
205,263
|
*
|
|
C.
Finnegan Faldi
|
195,923
|
71,647
|
124,276
|
*
|
|
Carl
T. Rennie
|
120,525
|
48,899
|
71,626
|
*
|
|
Carlos
A. Franceschi
|
258,269
|
104,784
|
153,485
|
*
|
|
Carole
Greenwell
|
1,215,083
|
493,387
|
721,696
|
1.4
|
|
Charles
C. Krafczek
|
340,964
|
120,078
|
220,886
|
*
|
|
Chris
Barcless
|
92,170
|
30,799
|
61,371
|
*
|
|
Christopher
Crain
|
179,066
|
72,650
|
106,416
|
*
|
|
Christopher
D. Lemp
|
144,631
|
50,879
|
93,752
|
*
|
|
Christopher
Karl Mellon
|
599,294
|
356,627
|
242,667
|
*
|
|
Christopher
Laffey (7)
|
205,263
|
140,328
|
64,935
|
*
|
|
Curtis
G. Viebranz
|
699,486
|
252,632
|
446,854
|
*
|
|
Dan
Verbic
|
391,634
|
143,227
|
248,407
|
*
|
|
Daniel
J Schultz
|
86,397
|
35,082
|
51,315
|
*
|
|
Daniel
R. Honeker
|
345,591
|
140,328
|
205,263
|
*
|
|
David
Allan Freedman
|
86,209
|
34,988
|
51,221
|
*
|
|
David
B. Campbell
|
103,306
|
41,913
|
61,393
|
*
|
|
David
C. Johnson
|
172,795
|
70,164
|
102,631
|
*
|
|
Davina
Lockhart
|
437,641
|
146,188
|
291,453
|
*
|
|
Deborah
C. Mash
|
137,770
|
55,898
|
81,872
|
*
|
|
Delta
Services of North Branch Capital LP
|
809,559
|
289,479
|
520,080
|
*
|
|
Douglas
Jensen
|
348,367
|
128,897
|
219,470
|
*
|
|
Duncan
Lamb
|
362,869
|
147,344
|
215,525
|
*
|
|
EBR
Ventures LLC (8)
|
2,215,580
|
1,096,883
|
1,118,697
|
2.1
|
|
Edward
J. Borkowski (9)
|
1,908,087
|
498,345
|
1,409,742
|
2.6
|
|
Edwin
W. Laffey Jr
|
42,670
|
16,839
|
25,831
|
*
|
|
Elisa
H. Allen
|
86,089
|
34,928
|
51,161
|
*
|
|
Eric
Ridder
|
172,179
|
69,856
|
102,323
|
*
|
|
Eric
Ridder Jr
|
172,795
|
70,164
|
102,631
|
*
|
|
Eric
Workin
|
34,443
|
13,975
|
20,468
|
*
|
|
FirstFire
Global Opportunities Fund, LLC
|
526,312
|
206,338
|
319,974
|
*
|
|
Francis
H Bowen
|
275,762
|
111,881
|
163,881
|
*
|
|
Frank
W Hamilton
|
3,931,128
|
1,439,264
|
2,491,864
|
4.7
|
|
Gary
and Robin Gibson
|
516,536
|
209,567
|
306,969
|
*
|
|
Gary
L. Brody
|
17,242
|
6,998
|
10,244
|
*
|
|
Gary
Ryan Hart
|
241,912
|
98,229
|
143,683
|
*
|
|
Geoffrey
J. Toman
|
172,179
|
69,856
|
102,323
|
*
|
|
Girls
Night Out LLC
|
345,591
|
140,328
|
205,263
|
*
|
|
H.
Robert Holmes
|
345,591
|
140,328
|
205,263
|
*
|
|
Harbor
Watch Partners LP
|
438,931
|
146,833
|
292,098
|
*
|
|
Harry
A. Miller IV
|
437,425
|
146,080
|
291,345
|
*
|
|
Harvard
Home Mortgage Inc.
|
1,302,908
|
497,653
|
805,255
|
1.5
|
|
Howard
Fuhrman SEP IRA
|
875,281
|
292,376
|
582,905
|
1.1
|
|
JABCO
LP (10)
|
786,226
|
287,853
|
498,373
|
1.0
|
|
JAC
Family, LLC
|
564,028
|
213,150
|
350,878
|
*
|
|
Jacob
Anthony Owens
|
34,559
|
14,033
|
20,526
|
*
|
|
Jacqueline
Anne Matera & Gayle Lynne Matera
|
51,838
|
21,049
|
30,789
|
*
|
|
James
Barone
|
137,744
|
55,885
|
81,859
|
*
|
|
James
Bellis
|
161,912
|
57,896
|
104,016
|
*
|
|
James
Morizio
|
219,489
|
73,348
|
146,141
|
*
|
|
James
Sapirstein (11)
|
395,591
|
140,328
|
255,263
|
*
|
|
James
Scott Croasdale
|
172,179
|
69,856
|
102,323
|
*
|
|
Jameson
Stull
|
414,442
|
143,857
|
270,585
|
*
|
|
Jeffrey
Craig Link Jr.
|
69,119
|
28,066
|
41,053
|
*
|
|
Jeffrey
M Bertling
|
172,795
|
70,164
|
102,631
|
*
|
|
Joe
Stack
|
172,179
|
69,856
|
102,323
|
*
|
|
John
Degrandpre
|
269,822
|
101,713
|
168,109
|
*
|
|
John
H de Neufville
|
345,591
|
140,328
|
205,263
|
*
|
|
John
Hamblin
|
103,676
|
42,098
|
61,578
|
*
|
|
John
J. Maydick Jr.
|
17,196
|
6,975
|
10,221
|
*
|
|
John
L. Kemmerer, Jr. Trust dtd 6/24/57 FBO Constance A.
Kemmerer
|
691,182
|
280,656
|
410,526
|
*
|
|
John
L. Kemmerer, Jr. Trust dtd 6/24/57 FBO Elizabeth K.
Gray
|
691,182
|
280,656
|
410,526
|
*
|
|
John
L. Kemmerer, Jr. Trust dtd 6/24/57 FBO John L. Kemmerer,
III
|
691,182
|
280,656
|
410,526
|
*
|
|
John
McCrossin
|
34,559
|
14,033
|
20,526
|
*
|
|
John
McMichael Cox
|
69,119
|
28,066
|
41,053
|
*
|
|
Jonathan
K. Greenwell
|
34,559
|
14,033
|
20,526
|
*
|
|
Jonathan
Paul Jacobs
|
345,591
|
140,328
|
205,263
|
*
|
|
Jonathan
S. Scarpati
|
345,591
|
140,328
|
205,263
|
*
|
|
Joseph
P. von Meister
|
248,118
|
92,900
|
155,218
|
*
|
|
Karolee
Brown
|
191,737
|
71,576
|
120,161
|
*
|
|
Karolee
Herner
|
43,934
|
14,688
|
29,246
|
*
|
|
Kathryn
M. Parsons Rev Trust (12)
|
786,226
|
287,853
|
498,373
|
1.0
|
|
Kenneth
D. Hendriksen
|
172,795
|
70,164
|
102,631
|
*
|
|
Kevin
McCaffrey
|
206,615
|
83,827
|
122,788
|
*
|
|
Kirsten
Dermer
|
86,089
|
34,928
|
51,161
|
*
|
|
Kyle
Wade Huey
|
94,349
|
38,311
|
56,038
|
*
|
|
Larry
J. Lambert II
|
86,397
|
35,082
|
51,315
|
*
|
|
Laurence
Lytton
|
829,313
|
317,254
|
512,059
|
1.0
|
|
Laurie
B. Mellon
|
172,521
|
70,027
|
102,494
|
*
|
|
Lawrence
F. & Donna B. Michelson
|
660,797
|
248,434
|
412,363
|
*
|
|
Lincoln Park Capital Fund, LLC
(16)
|
1,129,572
|
804,373
|
325,199
|
*
|
|
Lind
Global Macro Fund, LP
|
629,445
|
217,320
|
412,125
|
*
|
|
Marcel
Arrouet
|
320,293
|
105,246
|
215,047
|
*
|
|
Mark
Bradford
|
86,089
|
34,928
|
51,161
|
*
|
|
Mark
Gaynor
|
282,741
|
106,959
|
175,782
|
*
|
|
Mark
Laue
|
86,089
|
34,928
|
51,161
|
*
|
|
Mark
Swaim
|
412,121
|
145,366
|
266,755
|
*
|
|
Matias
Isreal Escobar
|
138,236
|
56,131
|
82,105
|
*
|
|
Matthew
Balk
|
679,165
|
187,675
|
491,490
|
*
|
|
Matthew
Edward Traber
|
172,179
|
69,856
|
102,323
|
*
|
|
Matthew
Kitchen
|
86,089
|
34,928
|
51,161
|
*
|
|
Matthew
P. McMahon
|
344,357
|
139,711
|
204,646
|
*
|
|
Matthew
Weinrich
|
162,427
|
65,954
|
96,473
|
*
|
|
Micah
W. Rothstein
|
172,795
|
70,164
|
102,631
|
*
|
|
Michael
Falk
|
172,795
|
70,164
|
102,631
|
*
|
|
Michael
J. Atkinson
|
86,397
|
35,082
|
51,315
|
*
|
|
Molly
and Joseph Walton Tenants in the entireties
|
606,274
|
227,090
|
379,184
|
*
|
|
Neil
M. Metzheiser
|
1,175,544
|
429,882
|
745,662
|
1.4
|
|
Nicholas
Devito
|
86,397
|
35,082
|
51,315
|
*
|
|
Nicholas
W. Walsh
|
425,996
|
143,841
|
282,155
|
*
|
|
Nishan
Vartanian
|
338,315
|
127,849
|
210,466
|
*
|
|
Nishann,
LLC
|
137,744
|
55,885
|
81,859
|
*
|
|
Noel
Rubin
|
213,309
|
71,277
|
142,032
|
*
|
|
OCI-VB,
LLC
|
691,182
|
280,656
|
410,526
|
*
|
|
Parallax
Biomedical Fund LP
|
172,007
|
69,770
|
102,237
|
*
|
|
Paul
Lemp
|
127,438
|
43,898
|
83,540
|
*
|
|
Peter
Carpentier
|
172,795
|
70,164
|
102,631
|
*
|
|
Peter
Herner
|
306,714
|
108,844
|
197,870
|
*
|
|
Peter
M Rooney
|
96,345
|
35,056
|
61,289
|
*
|
|
Philip
A. Sigel Sunset Cove Irrevocable Trust (13)
|
3,043,715
|
1,141,142
|
1,902,573
|
3.6
|
|
Philip
W Smith III
|
565,738
|
214,021
|
351,717
|
*
|
|
PRK
Partners LP (14)
|
438,931
|
146,833
|
292,098
|
*
|
|
Ralph
I. Rugolo Trust dtd 8/20/91
|
31,036
|
12,596
|
18,440
|
*
|
|
Ralph
Worthington
|
518,386
|
210,492
|
307,894
|
*
|
|
Ratherby
Investments, LLC
|
172,453
|
69,993
|
102,460
|
*
|
|
Ratherby
Torch LLC
|
258,679
|
104,989
|
153,690
|
*
|
|
Raymond
& Catherine Marzulli
|
212,870
|
71,131
|
141,739
|
*
|
|
Raymond
L. Schettino
|
344,357
|
139,711
|
204,646
|
*
|
|
Richard
G. and Dorothy C. Hyman
|
51,838
|
21,049
|
30,789
|
*
|
|
Richard
Melnick
|
1,788,772
|
794,386
|
994,386
|
1.9
|
|
Robert
Bailey
|
172,795
|
70,164
|
102,631
|
*
|
|
Robert
G. Murphy Jr.
|
688,716
|
279,423
|
409,293
|
*
|
|
Robert
W. Holmes IRA
|
439,783
|
147,179
|
292,604
|
*
|
|
RPLLC
|
473,165
|
176,840
|
296,325
|
*
|
|
RRNR
Investments LLC
|
785,374
|
287,507
|
497,867
|
1.0
|
|
Ryan
N. Johnson
|
829,418
|
336,787
|
492,631
|
*
|
|
S
Clarke Moody
|
1,588,692
|
531,108
|
1,057,584
|
2.0
|
|
Sean
Flanagan
|
95,902
|
35,802
|
60,100
|
*
|
|
Shawn
T. Pearce IRA
|
103,676
|
42,098
|
61,578
|
*
|
|
Skyler
Ward
|
117,081
|
47,502
|
69,579
|
*
|
|
Stacy
L. Giunta Revocable Trust (15)
|
219,453
|
73,330
|
146,123
|
*
|
|
Stefan
D. Powell
|
345,936
|
140,468
|
205,468
|
*
|
|
Steven
Jun Isaki
|
223,831
|
90,812
|
133,019
|
*
|
|
Terri
Sanker Taube
|
172,179
|
69,856
|
102,323
|
*
|
|
The
Entrust Group as custodian for the John Cox IRA
|
86,397
|
35,082
|
51,315
|
*
|
|
Thomas
de Neufville
|
172,795
|
70,164
|
102,631
|
*
|
|
Todd
Bates
|
43,968
|
14,714
|
29,254
|
*
|
|
Trust
B fbo Amory L. Ross
|
172,795
|
70,164
|
102,631
|
*
|
|
Udai
Tennati
|
69,119
|
28,066
|
41,053
|
*
|
|
Vincent
V. Basile & Lara Coraci Basile
|
344,357
|
139,711
|
204,646
|
*
|
|
William
Benjamin Holmes
|
69,119
|
28,066
|
41,053
|
*
|
|
William
E. Webbe IV
|
109,834
|
36,719
|
73,115
|
*
|
|
William
Edward Webbe V
|
564,028
|
213,150
|
350,878
|
*
|
|
William
H. Combs
|
44,062
|
14,752
|
29,310
|
*
|
|
William
J. May
|
172,179
|
69,856
|
102,323
|
*
|
|
William
M. Cody
|
172,795
|
70,164
|
102,631
|
*
|
|
William
or Andrea Weitzman
|
34,559
|
14,033
|
20,526
|
*
|
|
William
Pyznar
|
587,518
|
214,838
|
372,680
|
*
|
|
William
Stewart
|
86,089
|
34,928
|
51,161
|
*
|
* Less
than 1%.
|
(1)
|
Except
as noted below, beneficial ownership is determined in accordance
with the rules of the SEC and generally includes voting or
investment power with respect to securities. All entries exclude
beneficial ownership of shares issuable pursuant to warrants,
options or other derivative securities that have not vested or that
are not otherwise exercisable as of the date hereof or which will
not become vested or exercisable within 60 days of February 10,
2021.
|
|
(2)
|
Based
upon the internal books and records of the Company. Assumes full
conversion of Series B Preferred Stock, pursuant to the Series B
Exchange Right, into shares of Series C Preferred Stock and Series
B Exchange Warrants. May not include purchases and sales of Common
Stock, following the consummation of the Series B Offering, which
have not been recorded directly in the share register maintained by
the Company’s transfer agent. Assumes that the Stockholder
Approval has been obtained, such that any shares of Series C
Preferred Stock and Series B Exchange Warrants issuable pursuant to
the Series B Exchange Right are fully convertible or exercisable
into shares of Common Stock. Includes (i) shares of Common Stock
issuable upon conversion of Series C Preferred Stock; (ii) shares
of Common Stock issuable upon exercise of the Series B Exchange
Warrants; and (iii) shares of Common Stock issuable upon exercise
of other outstanding warrants.
|
|
(3)
|
Includes
shares of Common Stock which are not being offered pursuant to this
prospectus.
|
|
(4)
|
All
percentage calculations are based on 53,418,712 shares of Common
Stock outstanding as of February 10, 2021 and are rounded to the
nearest tenth of a percent. Warrants, options or other derivative
securities that are presently exercisable or exercisable within 60
days are deemed to be beneficially owned by the person holding such
securities for the purpose of calculating the percentage ownership
of that person, but are not treated as outstanding for the purpose
of calculating the percentage ownership of any other
person.
|
|
(5)
|
Includes shares of
Common Stock issuable upon conversion of Series B Preferred Stock
and shares issuable upon exercise of warrants held by Harbor Watch
Partners, LP; and (ii) shares of Common Stock issuable upon
conversion of the Series B Preferred Stock and shares of Common
Stock issuable upon exercise of warrants held by Trust B fbo Amory
L. Ross. As General Partner of Harbor Watch Partners, LP, Amory
Ross holds sole voting and dispositive power over the shares held
by such entity. As Trustee of Trust B fbo Amory L. Ross, Amory Ross
holds sole voting and dispositive power over the shares held by
such entity.
|
|
(6)
|
As General Partner
of BTR Partners, Ben Ross holds sole voting and dispositive power
over the shares held by such entity.
|
|
(7)
|
Includes shares of
Common Stock issuable upon exercise of warrants issued in
connection with certain previous transactions. The selling
stockholder is affiliated with Alexander Capital LP, which acted as
placement agent in connection with such
transactions.
|
|
(8)
|
Includes shares of
Common Stock held directly by the selling stockholder and shares of
Common Stock issuable upon exercise of warrants held by EBR
Ventures, LLC. Edmund Burke Ross, Jr. is the Manager of EBR
Ventures, LLC and has voting and dispositive power over the shares
held by such entity. The address of Mr. Ross, Jr. is c/o JDJ Family
Office Services, P.O. Box 962049, Boston, MA
02196.
|
|
(9)
|
Includes (i)
409,773 shares of Common Stock; (ii) 80,021 shares of Common Stock
issuable upon the exercise of warrants; (iii) 100,000 shares of
Common Stock issuable upon exercise of vested options; and (iv)
13,680 shares of Common Stock held by Mr. Borkowski’s spouse.
Excludes 40,000 shares of Common Stock issuable upon exercise of
unvested options.
|
|
(10)
|
As General Partner
of JABCO LP, J. Geddes Parsons holds sole voting and dispositive
power over the shares held by such entity.
|
|
(11)
|
Includes 50,000
shares of Common Stock issuable upon exercise of vested options.
Excludes 1,450,000 shares of Common Stock issuable upon exercise of
unvested options.
|
|
(12)
|
As Trustee of
Kathryn M. Parsons Rev. Trust, Kathryn M. Parsons holds sole voting
and dispositive power over the shares held by such
entity.
|
|
(13)
|
As Trustee of
Philip A. Sigel Sunset Cove Irrevocable Trust, Philip A. Sigel
holds sole voting and dispositive power over the shares held by
such entity.
|
|
(14)
|
As a principal of
PRK Partners, LP, Parthenia Ross Kiersted holds sole voting and
dispositive power over the shares held by such
entity.
|
|
(15)
|
As Trustee of Stacy
L. Giunta Revocable Trust, Stacy L. Giunta holds sole voting and
dispositive power over the shares held by such
entity.
|
|
(16)
|
Joshua Scheinfeld
and Jonathan Cope, the principals of Lincoln Park Capital Fund,
LLC, are deemed to be the beneficial owners of all shares of Common
Stock owned by Lincoln Park Capital Fund, LLC. Messrs. Scheinfeld
and Cope have shared voting power.
|
Issuances of our common stock to the selling stockholders will not
affect the rights or privileges of our existing stockholders,
except that the economic and voting interests of each of our
existing stockholders will be diluted as a result of any such
issuance. Although the number of shares of common stock that our
existing stockholders own will not decrease, the shares owned by
our existing stockholders will represent a smaller percentage of
our total outstanding shares after any such issuance to the selling
stockholders identified herein.
The
Common Stock to be offered and sold using this prospectus will be
offered and sold by the selling stockholders named in this
prospectus. Accordingly, we will not receive any proceeds from any
sale of shares of our Common Stock in this offering. The
shares of Common Stock covered by this prospectus may be issued
upon exercise of the Series B Exchange Warrants. Upon any cash
exercise of the warrants, the selling stockholders will pay us the
applicable exercise price. The Placement Agent Warrants may be
exercised and resold hereunder on a cashless basis, at the option
of their holders, and we will not receive any proceeds upon such
cashless exercise. We anticipate that proceeds that we receive from
the cash exercise of such warrants, if any, will be used for
working capital and general corporate purposes, including,
without limitation, development of our product candidates, and
general and administrative expenses. We
will pay all of the fees and expenses incurred by us in connection
with this registration. We will not be responsible for fees and
expenses incurred by the selling stockholders or any underwriting
discounts or agent’s
commissions.
Each selling stockholder and any of their pledgees, assignees
and successors-in-interest may, from time to time, sell any or all
of their shares of common stock covered hereby from time to time
directly to one or more purchasers or through brokers, dealers, or
underwriters who may act solely as agents at market prices
prevailing at the time of sale, at prices related to the prevailing
market prices, at negotiated prices, or at fixed prices, which may
be changed. The sale of the common stock offered by this prospectus
could be affected in one or more of the following
methods:
●
ordinary brokers’ transactions;
●
transactions involving cross or block trades;
●
through brokers, dealers, or underwriters who may act solely as
agents;
●
“at the market” into an existing market for the common
stock;
●
in other ways not involving market makers or established business
markets, including direct sales to purchasers or sales effected
through agents;
●
in privately negotiated transactions; or
●
any combination of the foregoing.
The
selling stockholders also may resell all or a portion of the
securities in open market transactions in reliance upon Rule 144
under the Securities Act, as permitted by that rule, or
Section 4(1) under the Securities Act, if available, rather
than under this prospectus, provided that they meet the criteria
and conform to the requirements of those
provisions
Broker-dealers engaged by the selling stockholders may arrange for
other brokers-dealers to participate in sales. If the
selling stockholders effect such transactions by selling securities
to or through underwriters, broker-dealers or agents, such
underwriters, broker-dealers or agents may receive commissions in
the form of discounts, concessions or commissions from the selling
stockholders or commissions from purchasers of the securities for
whom they may act as agent or to whom they may sell as principal.
Such commissions will be in amounts to be negotiated, but, except
as set forth in a supplement to this prospectus, in the case of an
agency transaction will not be in excess of a customary brokerage
commission in compliance with NASD Rule 2440; and in the case of a
principal transaction a markup or markdown in compliance with NASD
IM-2440.
In connection with the sale of the common stock or interests
therein, the selling stockholders may enter into hedging
transactions with broker-dealers or other financial institutions,
which may in turn engage in short sales of the common stock in the
course of hedging the positions they assume. The selling
stockholders may also sell shares of the common stock short and
deliver these securities to close out their short positions, or
loan or pledge the shares of common stock to broker-dealers that in
turn may sell these securities. The selling stockholders may also
enter into option or other transactions with broker-dealers or
other financial institutions or create one or more derivative
securities which require the delivery to such broker-dealer or
other financial institution of shares offered by this prospectus,
which shares such broker-dealer or other financial institution may
resell pursuant to this prospectus (as supplemented or amended to
reflect such transaction).
The selling stockholders and any broker-dealers or agents that are
involved in selling the shares may be deemed to be
“underwriters” within the meaning of the Securities Act
in connection with such sales. In such event, any commissions
received by such broker-dealers or agents and any profit on the
resale of the shares purchased by them may be deemed to be
underwriting commissions or discounts under the Securities Act.
Each selling stockholder has informed us that it does not have any
written or oral agreement or understanding, directly or indirectly,
with any person to distribute their shares of common
stock.
We are required to pay certain fees and expenses incurred by us
incident to the registration of the shares. We have agreed to
indemnify the selling stockholders against certain losses, claims,
damages and liabilities, including liabilities under the Securities
Act.
The selling stockholders will be subject to the prospectus delivery
requirements of the Securities Act, including Rule 172 thereunder.
The selling stockholders have advised us that there is no
underwriter or coordinating broker acting in connection with the
proposed sale of the resale shares by the selling
stockholders.
We agreed to keep this prospectus effective until the earlier of
(i) the date on which the shares may be resold by the selling
stockholders without registration and without regard to any volume
or manner-of-sale limitations by reason of Rule 144, without the
requirement to be in compliance with the current public information
under Rule 144 under the Securities Act, or any other rule of
similar effect (assuming that the shares were at no time held by
any affiliate of ours, and all warrants are exercised by
“cashless exercise” as provided in each of the
warrants) or (ii) all of the shares have been sold pursuant to this
prospectus or Rule 144 under the Securities Act, or any other rule
of similar effect. The resale shares will be sold only through
registered or licensed brokers or dealers if required under
applicable state securities laws. In addition, in certain states,
the resale shares of common stock covered hereby may not be sold
unless they have been registered or qualified for sale in the
applicable state or an exemption from the registration or
qualification requirement is available and is complied
with.
Under applicable rules and regulations under the Exchange Act, any
person engaged in the distribution of the resale shares may not
simultaneously engage in market making activities with respect to
the common stock for the applicable restricted period, as defined
in Regulation M, prior to the commencement of the distribution. In
addition, the selling stockholders will be subject to applicable
provisions of the Exchange Act, and the rules and regulations
thereunder, including Regulation M, which may limit the timing of
purchases and sales of shares of the common stock by the selling
stockholders or any other person. We will make copies of this
prospectus available to the selling stockholders and have informed
them of the need to deliver a copy of this prospectus to each
purchaser at or prior to the time of the sale (including by
compliance with Rule 172 under the Securities
Act).
Our common stock is quoted on The Nasdaq Capital Market under the
symbol “AZRX”.
The
following summary of the rights of our capital stock is not
complete and is subject to and qualified in its entirety by
reference to our certificate of incorporation and bylaws, copies of
which are filed as exhibits to our Annual Report on Form 10-K for
the year ended December 31, 2019, filed with the SEC on March 30,
2020, as amended on April 29, 2020, and the Certificate of
Designations and forms of securities, copies of which are filed as
exhibits to the registration statement of which this prospectus
forms a part , which are incorporated by reference
herein.
General
Our certificate of incorporation, as amended and restated on
December 20, 2019 (our “Charter”) authorizes the
issuance of up to 150,000,000 shares of Common Stock, par value
$0.0001 per share, and 10,000,000 shares of preferred stock, par
value $0.0001 per share (the “Preferred Stock”), of
which a series of 5,194.805195 shares of Series B Preferred Stock
and a series of 75,000 shares of Series C Preferred Stock are
designated.
Common Stock
As of February 10, 2021, there were 150,000,000 shares
of Common Stock, par value $0.0001 per share, and 10,000,000 shares
of preferred stock, par value $0.0001 per share (the
“Preferred Stock”), of which a series of 5,194.805195
shares of Series B Preferred Stock and a series of 75,000 shares of
Series C Preferred Stock have been designated.
As of February 10, 2021, there were
53,418,712 shares of Common Stock outstanding,
1,608 shares of Series B Preferred Stock and
8,015 of Series C Preferred Stock
outstanding.
Our Charter and Amended and Restated Bylaws (our
“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
We currently have up to 10,000,000 shares of preferred stock, par
value $0.0001 per share, authorized and available for issuance in
one or more series. Our board of directors is authorized to divide
the preferred stock into any number of series, fix the designation
and number of each such series, and determine or change the
designation, relative rights, preferences, and limitations of any
series of preferred stock. The board of may increase or decrease
the number of shares initially fixed for any series, but no
decrease may reduce the number below the shares then outstanding
and duly reserved for issuance. As of February 10,
2021, 5,194.805195 shares were designated as Series B Preferred
Stock, of which 1,941 were issued and outstanding, and 75,000 were
designated as Series C Preferred Stock, of which 7,926 were issued
and outstanding. This leaves 9,991,928.022833
shares of preferred stock authorized but
unissued.
Series B Preferred Stock
On July 16, 2020, we designated 5,194.805195 shares as Series B
Preferred Stock and issued 2,912.583005 of such
shares.
Under the Series B Certificate of Designations, each share of
Series B Preferred Stock will be convertible, at the holder’s
option at any time, into Common Stock at a conversion rate equal to
the quotient of (i) the $7,700 stated value (the “Series B
Stated Value”) divided by (ii) the initial conversion price
of $0.77, subject to specified adjustments for stock splits, cash
or stock dividends, reorganizations, reclassifications other
similar events as set forth in the Series B Certificate of
Designations. In addition, if at any time after the six month
anniversary of the date of the Private Placement, the closing sale
price per share of Common Stock exceeds 250% of the initial
conversion price, or $1.925, for 20 consecutive trading days, then
all of the outstanding shares of Series B Preferred Stock will
automatically convert (the “Automatic Conversion”) into
such number of shares of Common Stock as is obtained by multiplying
the number of shares of Series B Preferred Stock to be so
converted, plus the amount of any accrued and unpaid dividends
thereon, by the Series B Stated Value per share and dividing the
result by the then applicable conversion price.
The Series B Preferred Stock contains limitations that prevent the
holder thereof from acquiring shares of Common Stock upon
conversion (including pursuant to the Automatic Conversion) that
would result in the number of shares beneficially owned by such
holder and its affiliates exceeding 9.99% of the total number of
shares of Common Stock outstanding immediately after giving effect
to the conversion, which percentage may be increased or decreased
at the holder’s election not to
exceed 19.99%.
Each holder of shares of Series B Preferred Stock, in preference
and priority to the holders of all other classes or series of our
stock, is entitled to receive dividends, commencing from the date
of issuance. Such dividends may be paid by us only when, as and if
declared by the Board, out of assets legally available therefore,
semiannually in arrears on the last day of June and December in
each year, commencing December 31, 2020, at the dividend rate of
9.0% per year, which is cumulative and continues to accrue on a
daily basis whether or not declared and whether or not we have
assets legally available therefore. We may pay such dividends at
our sole option either in cash or in kind in additional shares of
Series B Preferred Stock (rounded down to the nearest whole share),
provided we must pay in cash the fair value of any such fractional
shares in excess of $100.00. Under the Series B Certificate of
Designations, to the extent that applicable law or any of our
existing contractual restrictions prohibit any required issuance of
additional shares of Series B Convertible Preferred Stock as
in-kind dividends or otherwise (“Additional Shares”),
then appropriate adjustment to the conversion price of the Series B
Convertible Preferred Stock shall be made so that the resulting
number of conversion shares includes the aggregate number of shares
of Common Stock into which such Additional Shares would otherwise
be convertible.
Under the Series B Certificate of Designations, each share of
Series B Preferred Stock carries a liquidation preference equal to
the Series B Stated Value (as adjusted thereunder) plus accrued and
unpaid dividends thereon (the “Series B Liquidation
Preference”).
In the event we effect any issuance of common stock or common stock
equivalents for cash consideration, or a combination of units
thereof (a “Subsequent Financing”), each holder of the
Series B Preferred Stock has the right, subject to certain
exceptions set forth in the Series B Certificate of Designations,
at its option, to exchange (in lieu of cash subscription payments)
all or some of the Series B Preferred Stock then held (with a value
per share of Series B Preferred Stock equal to the Series B
Liquidation Preference) for any securities or units issued in a
Subsequent Financing on dollar-for-dollar
basis.
The holders of the Series B Preferred Stock, voting as a separate
class, will have customary consent rights with respect to certain
corporate actions by us. We may not take the following actions
without the prior consent of the holders of at least a majority of
the Series B Preferred Stock then outstanding: (a) authorize,
create, designate, establish, issue or sell an increased number of
shares of Series B Preferred Stock or any other class or series of
capital stock ranking senior to or on parity with the Series B
Preferred Stock as to dividends or upon liquidation; (b) reclassify
any shares of common stock or any other class or series of capital
stock into shares having any preference or priority as to dividends
or upon liquidation superior to or on parity with any such
preference or priority of Series B Preferred Stock; (c) amend,
alter or repeal our Certificate of Incorporation or Bylaws and the
powers, preferences, privileges, relative, participating, optional
and other special rights and qualifications, limitations and
restrictions thereof, which would adversely affect any right,
preference, privilege or voting power of the Series B Preferred
Stock; (d) issue any indebtedness or debt security, other than
trade accounts payable, insurance premium financings and/or letters
of credit, performance bonds or other similar credit support
incurred in the ordinary course of business, or amend, renew,
increase, or otherwise alter in any material respect the terms of
any such indebtedness existing as of the date of first issuance of
shares of Series B Preferred Stock; (e) redeem, purchase, or
otherwise acquire or pay or declare any dividend or other
distribution on (or pay into or set aside for a sinking fund for
any such purpose) any of our capital stock; (f) declare bankruptcy,
dissolve, liquidate, or wind up our affairs; (g) effect, or enter
into any agreement to effect, a Change of Control (as defined in
the Series B Certificate of Designations); or (h) materially modify
or change the nature of our business.
Warrants
Series B Exchange Warrants
The following is a summary of the material terms and provisions of
the Series B Exchange Warrants. This summary is subject to and
qualified in its entirety by the form of Series B Exchange
Warrant.
The Series B Exchange Warrants will have an exercise price of
$0.80 per share. The Series B Exchange Warrants will have a term of
five and one-half years. 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 B Exchange Warrants will be issued in certificated
form only.
Until the Stockholder Approval is obtained, the Company may not
issue any shares of Common Stock upon exercise of the Series B
Exchange Warrants.
Following the Stockholder Approval, the Series B Exchange
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
Series B Exchange 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 B Exchange 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 B Exchange
Warrants.
If at
the time of exercise of the Series B Exchange 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 B Exchange
Warrant, then the Series B Exchange 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 B
Exchange Warrants.
In the event of any fundamental transaction, as described in
the Series B Exchange 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 an Series B Exchange 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 Series B Exchange Warrant is exercisable
immediately prior to such event. In addition, in the event of a
fundamental transaction which is approved by our board of
directors, the holder has the right to require us or a successor
entity to redeem the Series B Exchange Warrant for cash in the
amount of the Black-Scholes value of the unexercised portion
of the Series B Exchange Warrant on the date of the consummation of
the fundamental transaction. In the event of a fundamental
transaction which is not approved by our Board, the holders of the
Series B Exchange Warrants have the right to require us or a
successor entity to redeem the Series B Exchange Warrant for the
consideration paid in the fundamental transaction in the amount of
the Black Scholes value of the unexercised portion of the
Series B Exchange Warrant on the date of the consummation of the
fundamental transaction.
In accordance with its terms and subject to applicable laws, an
Series B Exchange Warrant may be transferred at the option of the
holder upon surrender of the Series B Exchange Warrant to us
together with the appropriate instruments of transfer and payment
of funds sufficient to pay any transfer taxes (if
applicable).
No fractional shares of Common Stock will be issued upon the
exercise of the Series B Exchange 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.
There is no established trading market for the Series B Exchange
Warrants, and we do not expect a market to develop. We do not
intend to apply for a listing for the Series B Exchange Warrants on
any securities exchange or other nationally recognized trading
system. Without an active trading market, the liquidity of the
Series B Exchange Warrants will be
limited.
Except as otherwise provided in the Series B Exchange Warrants or
by virtue of the holders’ ownership of shares of Common
Stock, the holders of Series B Exchange Warrants do not have the
rights or privileges of holders of our shares of Common Stock,
including any voting rights, until such Series B Exchange Warrant
holders exercise their warrants.
An Series B Exchange Warrant may be modified or amended or the
provisions thereof waived with the written consent of our company
and the holder of the Series B Exchange
Warrant.
Listing
Our Common Stock is listed on The Nasdaq Capital Market under the
symbol “AZRX”.
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.
Anti-Takeover Effects of Certain Provisions of Delaware Law and of
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.
LEGAL
MATTERS
The validity of the securities offered hereby will be passed upon
for us by Lowenstein Sandler LLP, New York, New
York.
EXPERTS
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
Commission 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 Commission’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 Commission.
We have filed with the Commission a registration statement under
the Securities Act of 1933, as amended, relating to the offering of
these securities. The registration statement, including the
attached exhibits, contains additional relevant information about
us and the securities. This prospectus does not contain all of the
information set forth in the registration statement. You can obtain
a copy of the registration statement, at prescribed rates, from the
Commission 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.
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; and January 13, 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 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.
-17-
26,112,721 Shares
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.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and
Distribution.
The following table indicates the expenses to be incurred in
connection with the offering described in this registration
statement, other than underwriting discounts and commissions, all
of which will be paid by us. All amounts are estimated except the
Securities and Exchange Commission registration
fee.
|
|
Amount
|
|
SEC Registration
Fee
|
$4,160
|
|
Legal Fees and
Expenses
|
50,000
|
|
Accounting Fees and
Expenses
|
10,000
|
|
Transfer Agent and
Registrar fees and expenses
|
2,000
|
|
Miscellaneous
Expenses
|
2,000
|
|
|
|
|
Total expenses
|
$68,160
|
Item 15. Indemnification of Directors and
Officers.
Amended and Restated Bylaws
Pursuant to our bylaws, our directors and officers will be
indemnified to the fullest extent allowed under the laws of the
State of Delaware for their actions in their capacity as our
directors and officers.
We must indemnify any person made a party to any threatened,
pending, or completed action, suit, or proceeding, whether civil,
criminal, administrative, or investigative
(“Proceeding”) by reason of the fact that he is or was
a director, against judgments, penalties, fines, settlements and
reasonable expenses (including attorney’s fees)
(“Expenses”) actually and reasonably incurred by him in
connection with such Proceeding if: (a) he conducted himself in
good faith, and: (i) in the case of conduct in his own official
capacity with us, he reasonably believed his conduct to be in our
best interests, or (ii) in all other cases, he reasonably believes
his conduct to be at least not opposed to our best interests; and
(b) in the case of any criminal Proceeding, he had no reasonable
cause to believe his conduct was unlawful.
We must indemnify any person made a party to any Proceeding by or
in the right of us, by reason of the fact that he is or was a
director, against reasonable expenses actually incurred by him in
connection with such proceeding if he conducted himself in good
faith, and: (a) in the case of conduct in his official capacity
with us, he reasonably believed his conduct to be in our best
interests; or (b) in all other cases, he reasonably believed his
conduct to be at least not opposed to our best interests; provided
that no such indemnification may be made in respect of any
proceeding in which such person shall have been adjudged to be
liable to us.
No indemnification will be made by unless authorized in the
specific case after a determination that indemnification of the
director is permissible in the circumstances because he has met the
applicable standard of conduct.
Reasonable expenses incurred by a director who is party to a
proceeding may be paid or reimbursed by us in advance of the final
disposition of such Proceeding in certain
cases.
We have the power to purchase and maintain insurance on behalf of
any person who is or was our director, officer, employee, or agent
or is or was serving at our request as an officer, employee or
agent of another corporation, partnership, joint venture, trust,
other enterprise, or employee benefit plan against any liability
asserted against him and incurred by him in any such capacity or
arising out of his status as such, whether or not we would have the
power to indemnify him against such liability under the provisions
of the amended and restated bylaws.
Delaware Law
We are incorporated under the laws of the State of Delaware.
Section 145 of the Delaware General Corporation Law provides that a
Delaware corporation may indemnify any persons who are, or are
threatened to be made, parties to any threatened, pending or
completed action, suit or proceeding, whether civil, criminal,
administrative or investigative (other than an action by or in the
right of such corporation), by reason of the fact that such person
was an officer, director, employee or agent of such corporation, or
is or was serving at the request of such person as an officer,
director, employee or agent of another corporation or enterprise.
The indemnity may include expenses (including attorneys’
fees), judgments, fines and amounts paid in settlement actually and
reasonably incurred by such person in connection with such action,
suit or proceeding, provided that such person acted in good faith
and in a manner he or she reasonably believed to be in or not
opposed to the corporation’s best interests and, with respect
to any criminal action or proceeding, had no reasonable cause to
believe that his or her conduct was illegal. A Delaware corporation
may indemnify any persons who are, or are threatened to be made, a
party to any threatened, pending or completed action or suit by or
in the right of the corporation by reason of the fact that such
person was a director, officer, employee or agent of such
corporation, or is or was serving at the request of such
corporation as a director, officer, employee or agent of another
corporation or enterprise. The indemnity may include expenses
(including attorneys’ fees) actually and reasonably incurred
by such person in connection with the defense or settlement of such
action or suit provided such person acted in good faith and in a
manner he or she reasonably believed to be in or not opposed to the
corporation’s best interests except that no indemnification
is permitted without judicial approval if the officer or director
is adjudged to be liable to the corporation. Where an officer or
director is successful on the merits or otherwise in the defense of
any action referred to above, the corporation must indemnify him or
her against the expenses which such officer or director has
actually and reasonably incurred. Our amended and restated
certificate of incorporation and amended and restated bylaws
provide for the indemnification of our directors and officers to
the fullest extent permitted under the Delaware General Corporation
Law.
Section 102(b)(7) of the Delaware General Corporation Law permits a
corporation to provide in its certificate of incorporation that a
director of the corporation shall not be personally liable to the
corporation or its stockholders for monetary damages for breach of
fiduciary duties as a director, except for liability for
any:
●
transaction from which the director derives an improper personal
benefit;
●
act or omission not in good faith or that involves intentional
misconduct or a knowing violation of law;
●
unlawful payment of dividends or redemption of shares;
or
●
breach of a director’s duty of loyalty to the corporation or
its stockholders.
Our amended and restated certificate of incorporation and amended
and restated bylaws include such a provision. Expenses incurred by
any officer or director in defending any such action, suit or
proceeding in advance of its final disposition shall be paid by us
upon delivery to us of an undertaking, by or on behalf of such
director or officer, to repay all amounts so advanced if it shall
ultimately be determined that such director or officer is not
entitled to be indemnified by us.
Section 174 of the Delaware General Corporation Law provides, among
other things, that a director who willfully or negligently approves
of an unlawful payment of dividends or an unlawful stock purchase
or redemption may be held liable for such actions. A director who
was either absent when the unlawful actions were approved, or
dissented at the time, may avoid liability by causing his or her
dissent to such actions to be entered in the books containing
minutes of the meetings of the board of directors at the time such
action occurred or immediately after such absent director receives
notice of the unlawful acts.
Indemnification Agreements
As permitted by the Delaware General Corporation Law, we have
entered, and intend to continue to enter, into separate
indemnification agreements with each of our directors and executive
officers, that require us to indemnify such persons against any and
all expenses (including attorneys’ fees), witness fees,
damages, judgments, fines, settlements and other amounts incurred
(including expenses of a derivative action) in connection with any
action, suit or proceeding, whether actual or threatened, to which
any such person may be made a party by reason of the fact that such
person is or was a director, an officer or an employee of us or any
of our affiliated enterprises, provided that such person acted in
good faith and in a manner such person reasonably believed to be in
or not opposed to our best interests and, with respect to any
criminal proceeding, had no reasonable cause to believe his or her
conduct was unlawful. The indemnification agreements also set forth
certain procedures that will apply in the event of a claim for
indemnification thereunder.
At present, there is no pending litigation or proceeding involving
any of our directors or executive officers as to which
indemnification is required or permitted, and we are not aware of
any threatened litigation or preceding that may result in a claim
for indemnification.
We have an insurance policy covering our officers and directors
with respect to certain liabilities, including liabilities arising
under the Securities Act or otherwise.
Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to our directors, officers or
controlling persons, we have been advised that in the opinion of
the SEC this indemnification is against public policy as expressed
in the Securities Act and is, therefore,
unenforceable.
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
|
Amended and Restated Certificate of Incorporation of the Registrant
(Incorporated by reference from Exhibit 3.1 filed with Registration
Statement on Form S-1, filed July 13, 2016).
|
|
|
|
Amended and Restated Bylaws (incorporated by reference to Exhibit
3.1 of the Company’s Current Report on Form 8-K filed with
the SEC on August 5, 2020).
|
|
|
|
Certificate of Amendment to Certificate of Incorporation of the
Registrant (incorporated by reference to Exhibit 3.1 of the
Company’s Current Report on Form 8-K filed with the SEC on
December 30, 2019).
|
|
|
|
Certificate of the Designations, Powers, Preferences and Rights of
Series B Convertible Preferred Stock (incorporated by reference to
Exhibit 3.1 of the Company’s Current Report on Form 8-K filed
with the SEC on July 20, 2020).
|
|
|
|
Form of common stock Certificate (Incorporated by reference from
Exhibit 4.1 filed with Amendment No 1. to Registration Statement on
Form S-1, filed July 29, 2016).
|
|
|
|
Form of Series B Exchange Warrant (incorporated by reference to
Exhibit 4.2 of the Company’s Current Report on Form 8-K filed
with the SEC on January 4, 2021).
|
|
|
|
Opinion of Lowenstein Sandler LLP (filed
herewith).
|
|
|
|
Consent of Lowenstein Sandler LLP (included in Exhibit 5.1) (filed
herewith).
|
|
|
|
Consent of Independent Registered Public Accounting Firm –
Mazars USA LLP (previously filed).
|
|
|
|
Power of Attorney (included in signature page).
|
|
*
|
Filed herewith.
|
Item 17. Undertakings
The undersigned registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration
statement:
(a) To
include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933,
(b) To
reflect in the prospectus any facts or events arising after the
effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in the form
of prospectus filed with the Commission pursuant to Rule 424(b) if,
in the aggregate, the changes in volume and price represent no more
than a 20 percent change in the maximum aggregate offering price
set forth in the “Calculation of Registration Fee”
table in the effective registration statement,
(c) To
include any material information with respect to the plan of
distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement.
Provided, however,
that paragraphs (1)(a), (1)(b) and (1)(c) above do not
apply if the information required to be included in a
post-effective amendment by those paragraphs is contained in
periodic reports filed with or furnished to the Commission by the
registrant pursuant to Section 13 or Section 15(d) of the
Securities Exchange Act of 1934 that are incorporated by reference
in the registration statement, or is contained in a form of
prospectus filed pursuant to Rule 424(b) that is part of the
registration statement.
(2) That,
for the purpose of determining any liability under the Securities
Act of 1933, each such post-effective amendment shall be deemed to
be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering
thereof.
(3) To
remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the
termination of the offering.
(4) That,
for the purpose of determining liability under the Securities Act
of 1933 to any purchaser:
(a) If
the registrant is relying on Rule 430B:
(i) Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall
be deemed to be part of the registration statement as of the date
the filed prospectus was deemed part of and included in the
registration statement; and
(ii) Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5),
or (b)(7) as part of a registration statement in reliance on Rule
430B relating to an offering made pursuant to Rule 415(a)(1)(i),
(vii), or (x) for the purpose of providing the information required
by section 10(a) of the Securities Act of 1933 shall be deemed to
be part of and included in the registration statement as of the
earlier of the date such form of prospectus is first used after
effectiveness or the date of the first contract of sale of
securities in the offering described in the prospectus. As provided
in Rule 430B, for liability purposes of the issuer and any person
that is at that date an underwriter, such date shall be deemed to
be a new effective date of the registration statement relating to
the securities in the registration statement to which that
prospectus relates, and the offering of such securities at that
time shall be deemed to be the initial bona fide offering thereof.
Provided,
however, that no statement made in a registration statement
or prospectus that is part of the registration statement or made in
a document incorporated or deemed incorporated by reference into
the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of
contract of sale prior to such effective date, supersede or modify
any statement that was made in the registration statement or
prospectus that was part of the registration statement or made in
any such document immediately prior to such effective
date.
(b) If
the registrant is subject to Rule 430C, each prospectus filed
pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying
on Rule 430B or other than prospectuses filed in reliance on
Rule 430A, shall be deemed to be a part of and included in the
registration statement as of the date it is first used after
effectiveness. Provided,
however,
that no statement made in a registration statement or prospectus
that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the
registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of
contract of sale prior to such first use, supersede or modify any
statement that was made in the registration statement or prospectus
that was part of the registration statement or made in any such
document immediately prior to such date of first
use.
(5) That,
for the purpose of determining liability of the registrant under
the Securities Act of 1933 to any purchaser in the initial
distribution of the securities, the registrant undertakes that in a
primary offering of securities of the registrant pursuant to this
registration statement, regardless of the underwriting method used
to sell the securities to the purchaser, if the securities are
offered or sold to such purchaser by means of any of the following
communications, the registrant will be a seller to the purchaser
and will be considered to offer or sell such securities to such
purchaser:
(a) Any
preliminary prospectus or prospectus of the registrant relating to
the offering required to be filed pursuant to Rule
424;
(b) Any
free writing prospectus relating to the offering prepared by or on
behalf of the registrant or used or referred to by the
registrant;
(c) The
portion of any other free writing prospectus relating to the
offering containing material information about the registrant or
its securities provided by or on behalf of the registrant;
and
(d) Any
other communication that is an offer in the offering made by a
registrant to the purchaser.
(6) That,
for purposes of determining any liability under the Securities Act
of 1933, each filing of the registrant’s annual report
pursuant to Section 13(a) or 15(d) of the Securities Exchange Act
of 1934 (and, where applicable, each filing of an employee benefit
plan’s annual report pursuant to Section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference
in the registration statement shall be deemed to be a new
registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to
be the initial bona fide offering thereof.
(7) Insofar
as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the forgoing provisions, or
otherwise, the registrant has been advised that in the opinion of
the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Act and is, therefore,
unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the registrant
of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in
the Act and will be governed by the final adjudication of such
issue.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-3 and has
duly caused this registration statement thereto to be signed on its
behalf by the undersigned, thereunto duly authorized, in the
City of Del Ray Beach, Florida on this 11th day of
February, 2021.
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AZURRX BIOPHARMA, INC.
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By: /s/
James Sapirstein
Name: James
Sapirstein
Title:
President and Chief Executive Officer
(Principal Executive
Officer)
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Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in
the capacities and on the dates indicated.
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Signature
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Title
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Date
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/s/ James Sapirstein
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President, Chief Executive Officer and
Director
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February 11, 2021
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James Sapirstein
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(Principal Executive Officer)
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/s/ Daniel Schneiderman
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Chief Financial Officer
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February 11, 2021
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Daniel Schneiderman
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(Principal
Financial Officer and
Principal
Accounting Officer)
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*
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Chair of the Board of Directors
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February 11, 2021
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Edward J. Borkowski
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*
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Director
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February 11, 2021
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Charles Casamento
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*
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Director
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February 11, 2021
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Alastair Riddell
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*
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Director
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February 11, 2021
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Gregory Oaks
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*
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Director
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February 11, 2021
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Vern Lee Schramm
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By: /s/ James Sapirstein
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Attorney-in-Fact
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II-6
Exhibit
5.1
February 11, 2021
AzurRx BioPharma, Inc.
1615 South Congress Avenue, Suite 103
Delray Beach, Florida 33445
Ladies and Gentlemen:
We have acted as counsel to AzurRx BioPharma, Inc., a Delaware
corporation (the “Company”), in connection with the
Company’s Registration Statement
on Form S-3 (the “Registration
Statement”) under the Securities Act of 1933, as amended (the
“Securities Act”). The Registration Statement relates
to the offer and sale by the selling stockholders identified
therein of up to 26,112,721 shares of the Company’s common
stock, par value $0.0001 per share (the “Common Stock”)
issuable upon exercise, for cash, of warrants (the “Series B
Exchange Warrants”) issued or issuable to the selling
stockholders pursuant to an exchange right (the “Series B
Exchange Right”) under the Certificate of Designations (the
“Series B Certificate of Designations”) for the
Company’s Series B Preferred Convertible Stock par value
$0.0001 per share (the “Series B Preferred
Stock”).
In connection with rendering this opinion, we have examined the
Certificate of Incorporation and the Bylaws of the Company, the
Series B Certificate of Designations, the forms of the Series B
Exchange Warrants, and such other corporate records, agreements,
documents and instruments, and such certificates or comparable
documents of public officials and of officers and representatives
of the Company, and we have made such inquiries of such officers
and representatives, as we have deemed necessary or appropriate for
the purposes of this opinion.
In such examination, we have assumed the genuineness of all
signatures, the legal capacity of all natural persons, the
authenticity of all documents submitted to us as originals, the
conformity of original documents of all documents submitted to us
as certified, conformed or photostatic copies and the authenticity
of the originals of such latter documents. As to all questions of
fact material to these opinions that have not been independently
established, we have relied upon certificates or comparable
documents of officers and representatives of the
Company.
When issued in accordance with the terms of the respective Series B
Exchange Warrants, the shares of Common Stock will be duly
authorized, validly issued, fully paid and
non-assessable.
The opinions expressed herein are limited to the corporate laws of
the State of Delaware, and we express no opinion as to the effect
on the matters covered by this letter of the laws of any other
jurisdiction.
We hereby consent to the filing of a copy of this opinion letter as
an exhibit to the Registration Statement. In giving such consent,
we do not thereby admit that we are in the category of persons
whose consent is required under Section 7 of the Securities
Act.
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Very
truly yours,
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/s/ Lowenstein
Sandler LLP
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Lowenstein
Sandler LLP
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____________________________________________________________________________________
NEW YORK PALO ALTO
NEW JERSEY
UTAH WASHINGTON,
D.C.
Lowenstein Sandler
LLP