GridAI Technologies Corp S-3/A, filed Sep 17, 2020
GridAI Technologies Corp. (GRDX)
S-3/A
2020-09-17
View Original
Added on
October 17, 2026
As
filed with the Securities and Exchange Commission on
September 17, 2020
Registration
No. 333-240129
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)
|
(I.R.S.
Employer
Identification
Number)
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760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(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.
760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855
(Name,
address, including zip code, and telephone number,
including
area code, of agent for service)
Copies to
Michael J. Lerner, Esq.
James O’Grady, 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. ☐
CALCULATION OF REGISTRATION FEE
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Title
of each class of
securities
to be registered
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Amount
to
be
registered(1)
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Proposed
maximum
offering
price
per share
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Proposed
maximum
aggregate
offering
price
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Amount
of
registration
fee
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Common stock, par
value $0.0001 per share
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50,847,320
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(2)
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$
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1.15
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(3)
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$
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58,474,418
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$
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7,589.98
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(4)
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Common stock, par
value $0.0001 per share
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2,628,448
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(5)
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$
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0.73
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(6)
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$
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1,918,767
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$
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249.06
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(1)
Includes an indeterminable number of additional shares of common
stock, pursuant to Rule 416 under the Securities Act of 1933, as
amended, that may be issued to prevent dilution from stock splits,
stock dividends or similar transactions that could affect the
shares to be offered by the selling stockholders.
(2)
The amount to be registered consists of: (i) 31,754,204 shares of
common stock issuable upon the conversion of 2,912.583005 shares of
Series B Convertible Preferred Stock, par value $0.0001 per share,
issued to the selling stockholders in connection with a private
transaction, (ii) 19,894,558 shares of common stock issuable upon
the exercise of warrants to purchase common stock issued to the
selling stockholders in connection with private transactions; and
(iii) 1,827,006 shares of common stock issuable upon exercise of
common stock purchase warrants held by the placement agent and its
designees identified here in connection with such private
transactions.
(3)
Pursuant to Rule 457(c) of the Securities Act of 1933, as amended,
calculated on the basis of the average of the high and low prices
per share of the registrant’s common stock as reported by The
Nasdaq Capital Market on July 24, 2020.
(4) A
filing fee of $7,589.98 was previously paid.
(5) The
amount to be additionally registered consists of 2,628,448 shares
of common stock potentially issuable in respect of paid-in-kind
dividend obligations relating to the Series B Convertible Preferred
Stock.
(6)
Pursuant to Rule 457(c) of the Securities Act of 1933, as amended,
calculated on the basis of the average of the high and low prices
per share of the registrant’s common stock as reported by The
Nasdaq Capital Market on September 14, 2020.
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 SEPTEMBER 17, 2020
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53,475,768 Shares of Common Stock
This
prospectus relates to the resale of up to 53,475,768
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:
●
31,754,204 shares of common stock issuable upon conversion
of Series B Convertible Preferred Stock (the “Series B
Preferred Stock”) issued to the selling stockholders in a
private placement offering (the “Private Placement”),
including the related exchange offering (the
“Exchange”), which closed on July 16, 2020, including
up to 2,628,448 shares of common stock potentially issuable in
respect of paid-in-kind dividend obligations relating to the Series
B Preferred Stock;
●
14,562,826 shares of common stock issuable upon exercise of
warrants (the “Series B Warrants”) issued to the
selling stockholders in connection with the Private
Placement;
●
1,772,937 shares of common stock issuable upon exercise of
warrants (the “Exchange Warrants”) issued to certain
accredited investors (the “Exchange Investors”) in
connection with the Exchange; and
●
1,382,902 shares of common stock issuable upon exercise of
warrants (the “July Placement Agent Warrants”) issued
to Alexander Capital L.P. (together with its designees identified
as selling stockholders herein, as the context may require,
“Alexander”), or its designees, in connection with the
Private Placement.
●
3,558,795 shares of common stock issuable upon exercise of
warrants (the “Note Warrants”) of issued to the selling
stockholders in an offering of Senior Convertible Promissory Notes
which commenced on December 20, 2019 (the “Convertible Notes
Offering”);
●
444,104 shares of common stock issuable upon exercise of
warrants (the “January Placement Agent Warrants” and
together with the July Placement Agent Warrants, the
“Placement Agent Warrants”) issued to Alexander or its
designees, in connection with the Convertible Notes
Offering;
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 $19.7 million from the cash
exercise the Series B Warrants, the Exchange Warrants, the Note
Warrants and the Placement Agent Warrants (together, the
“warrants”) by the selling stockholders, once the
registration statement, of which this prospectus is a part, is
declared effective. 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.
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 13 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 of 1933, as amended, (the
“Securities Act”).
We will
pay the expenses incurred in registering the shares, including
legal and accounting fees. See Plan of Distribution on page 13 of this
prospectus.
Our common stock is
currently listed on The Nasdaq Capital Market under the symbol
“AZRX”. On September 16, 2020, the last reported sale
price of our common stock on The Nasdaq Capital Market was
$0.80.
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
,
2020.
TABLE OF CONTENTS
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1
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5
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6
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8
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10
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12
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13
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15
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19
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19
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19
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20
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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 non-systemic
biologics for the treatment of patients with gastrointestinal
disorders. Non-systemic biologics are non-absorbable drugs that act
locally, i.e. the intestinal lumen, skin or mucosa, without
reaching an individual’s systemic
circulation.
We are
currently focused on developing our lead drug candidate, MS1819,
which 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.
MS1819
– Phase 2 Chronic Pancreatitis Study
In June
2018, we completed an open-label, dose escalation Phase 2a trial of
MS1819 in France, Australia, and New Zealand to investigate both
the safety of escalating doses of MS1819, and the efficacy of
MS1819 through the analysis of each patient’s coefficient of
fat absorption (“CFA”) and its change from baseline. A
total of 11 CP patients with EPI were enrolled in the study and
final data indicated a strong safety and efficacy profile. Although
the study was not powered for efficacy, in a pre-planned analysis,
the highest dose (2.2 grams per day) cohort of MS1819 showed
statistically significant and clinically meaningful increases in
CFA compared to baseline with a mean increase of 21.8% and a
p-value of p=0.002 on a per protocol basis. Maximal absolute CFA
response to treatment was up to 62%.
MS1819 – Phase 2 and Phase 2b Cystic Fibrosis Monotherapy
Studies
In
October 2018, the U.S. Food and Drug Administration
(“FDA”) cleared our Investigational New Drug
(“IND”) application for MS1819 in patients with EPI due
to CF. In connection with the FDA’s clearance of the IND, we
initiated a multi-center Phase 2 OPTION bridging dose safety study
in the fourth quarter of 2018 in the United States and Europe (the
“OPTION Cross-Over Study”). We targeted enrollment of
30 to 35 patients for the OPTION Cross-Over Study and dosed the
first patients in February 2019. In June 2019, we reached our
enrollment target for the study.
On
September 25, 2019, we announced positive results from the OPTION
Cross-Over Study. Results showed that there were no serious adverse
safety events and that the primary efficacy endpoint of CFA was
comparable to the CFA in a prior Phase 2 study in patients with CP,
while using the same dosage of MS1819. The dosage used in the
OPTION CF Study was 2.2 grams per day, which was determined in
agreement with the FDA as a bridging dose from the highest safe
dose used in the Phase 2 CP dose escalation study. Although the
study was not powered for statistical significance, the data
demonstrated meaningful efficacy results, with approximately 50% of
the patients showing CFAs high enough to reach non-inferiority with
standard porcine enzyme replacement therapy (“PERT”).
Additionally, the coefficient of nitrogen absorption
(“CNA”) was comparable between the MS1819 and PERT
arms, 93% vs. 97%, respectively, in the Option Cross-Over Study.
This important finding confirms that protease supplementation is
not likely to be required with MS1819 treatment. A total of 32
patients, ages 18 or older, completed the OPTION Cross-Over
Study.
On
October 17, 2019, we announced that the Cystic Fibrosis Foundation
Data Safety Monitoring Board (the “CFF DSMB”) completed
its review of the 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 our next planned multi-center dose
escalation Phase 2 OPTION clinical trial (the “OPTION 2
Trial”). In December 2019, we submitted the clinical trial
protocol to the existing IND at the FDA. The clinical trial
protocol has been reviewed by the FDA and we have provided
responses to the FDA’s questions. In April 2020, we received
approval to conduct the OPTION 2 Trial in Therapeutics Development
Network (TDN) clinical sites in the U.S. as well as Institutional
Review Board (IRB) approval to commence the OPTION 2
Trial.
The
OPTION 2 Trial is designed to investigate the safety, tolerability
and efficacy of MS1819 (2.2 gram and 4.4 gram doses in enteric
capsules) in a head-to-head manner versus PERTs, the current
standard of care. The OPTION 2 Trial is 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
CFA. Patients will then be crossed over for another three
weeks of the alternative treatment. After three weeks of cross-over
therapy, stools will again be collected for analysis of CFA. A
parallel group of patients will be randomized and studied in the
same fashion, using a 4.4 gram daily dose of MS1819. All
patients will be followed for an additional two weeks after
completing both crossover treatments for post study safety
observation. Patients will be assessed using descriptive
methods for efficacy, comparing CFA between MS1819 and PERT arms,
and for safety.
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On July 22, 2020,
we announced that we initiated the OPTION 2 Trial with the
activation of three clinical sites in the U.S. and initial
screening of the first patient. We expect topline data for the
OPTION 2 Trial in the first quarter of 2021, however, this timeline may be delayed due to the
COVID-19 epidemic.
MS1819 – Phase 2 Combination Therapy Study
In
addition to the OPTION Cross-Over Study, we launched a Phase 2
multi-center clinical trial (the “Combination Trial”)
in Hungary 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, in conjunction with a stable dose of PERTs, in
order to increase CFA and relieve abdominal symptoms in
uncontrolled CF patients.
On October 15, 2019, we announced that we dosed
the first patients in our Combination Trial. This study 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 porcine PERTs,
in order to increase the CFA and relieve abdominal symptoms. 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. 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
Spain, with study completion now anticipated in the first
quarter of 2021, however, this
timeline may be delayed due to the COVID-19 epidemic.
On
August 11, 2020, the Company announced positive interim data on the
first five patients in the Combination Trial. The primary efficacy
endpoint was met, with CFAs greater than 80% for all patients
across all visits. For secondary efficacy endpoints, the Company
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 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 sale.
Recent Developments
Convertible Notes Offering
On
December 20, 2019, we began an offering of (i) Senior Convertible
Promissory Notes (the “Notes”) in the principal amount
of up to $8.0 million to certain accredited investors (the
“Note Investors”), and (ii) warrants to purchase shares
of our common stock, each pursuant to Note Purchase Agreements
entered into by and between us and each of the Note Investors (the
“NPAs”).
Between
December 20, 2019 and January 9, 2020, we issued Notes to the Note
Investors in the aggregate principal amount of $6,904,000. Each
Note matured on September 20, 2020, accrued interest at a rate of
9% per annum, and was convertible, at the option of the holder,
into shares of our common stock at a price of $0.97 per share (the
“Note Conversion Shares”). As additional consideration
for the execution of the NPA, each Note Investor also received Note
Warrants to purchase that number of shares of our common stock
equal to one-half of the Note Conversion Shares issuable upon
conversion of the Notes (the “Note Warrant Shares”).
The Note Warrants have an exercise price of $1.07 per share and
expire five (5) years from the date of issuance. As disclosed in
our Current Report on Form 8-K filed on June 1, 2020, the
conversion price of Mr. Borkowski’s Convertible Note was
subsequently increased to $1.07 per share, to comply with the
requirements of Nasdaq Listing Rule 5635(c).
Pursuant
to a Registration Rights Agreement, executed by us and each Note
Investor, we were required to register the Note Conversion Shares
and Note Warrant Shares. We have filed this registration statement
with the U.S. Securities and Exchange Commission (the
“SEC”) that includes this prospectus to register for
resale under the Securities Act of 1933, up to 3,998,889 shares of
common stock, the Note Warrant Shares and shares of common stock
issuable upon conversion of the January Placement Agent Warrants.
As a result of the Exchange, described below, we are not
registering the Note Conversion Shares.
Placement
agent fees of $553,860 were paid to Alexander, who acted as the
exclusive placement agent for the Convertible Notes Offering, which
cash fees were based on 9% of the aggregate principal amount of the
Notes issued to the Note Investors introduced by Alexander. In
addition, Alexander (i) was issued warrants, containing
substantially the same terms and conditions as the Note Warrants,
to purchase an aggregate of 444,104 shares of common stock,
representing 7% of the Note Conversion Shares issuable upon
conversion of the Notes issued to the Note Investors introduced by
Alexander, (ii) was paid a non-accountable expense allowance of 1%
of the gross proceeds from the Notes Offering introduced by
Alexander, or $61,540, and (iii) was reimbursed $50,000 for its
counsel's fees. 285,867 of the January Placement Agent Warrants
have an exercise price of $1.21 per and 158,237 of these January
Placement Agent Warrants have an exercise price of $1.42 per share.
All of the January Placement Agent Warrants expire five (5) years
from the date of issuance.
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In
connection with the Convertible Notes Offering, ADEC Private Equity
Investments, LLC (“ADEC”), the holder of certain notes
issued under that certain Note Purchase Agreement, dated as of
February 14, 2019, in the aggregate original principal amount of
$2.0 million, consented to the issuance of the Notes in the
Convertible Notes Offering in consideration for the repayment, in
full, of $554,153 remaining due under the terms of the Notes on or
before January 2, 2020, net of the payment to ADEC of $550,000 made
by us on December 23, 2019 and $1.0 million on December 31, 2019
from proceeds from the issuance of the Notes.
See
section captioned “Description of Transactions –
Convertible Notes Offering” below.
Private Placement and Exchange
On
July 16, 2020, we consummated the Private Placement whereby we
entered into a Convertible Preferred Stock and Warrant Securities
Purchase Agreement (the “Purchase Agreement”) with
certain accredited and institutional investors (the “Private
Placement Investors”). Pursuant to the Purchase Agreement, we
issued an aggregate of 2,912.583005 shares of Series B Convertible
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. The amount of the Series B Warrants is
equal to 50% of the shares of common stock into which the Series B
Preferred Stock is initially convertible.
In
connection with the Private Placement, an aggregate of 1,975.578828
shares of Series B Preferred Stock initially convertible into
19,755,748 shares of common stock and related 9,877,835 Series B
Warrants were issued for cash consideration. In addition, the
balance of an aggregate of 937.004177 shares of Series B Preferred
Stock initially convertible into 9,370,008 shares of common stock
and related Series B Warrants to purchase 4,684,991 shares of
common stock was issued to the Exchange Investors in exchange for
consideration consisting of approximately $6.9 million aggregate
outstanding principal amount, together with accrued and unpaid
interest thereon of approximately $0.3 million, of the Notes,
pursuant to an Exchange Addendum (the “Exchange
Addendum”) executed by us and the Exchange Investors. As
additional consideration to the Exchange Investors, we also issued
the Exchange Warrants to purchase an aggregate of 1,772,937 shares
of common stock at an exercise price of $0.85 per share. The amount
of the Exchange Warrants is equal to 25% of the shares of common
stock into which the Notes were originally convertible upon the
initial issuance thereof
Alexander
acted as placement agent for the Private Placement. We paid
Alexander 9.0% of the gross cash proceeds received by us from
Private Placement Investors introduced by Alexander and 4.0% of the
gross cash proceeds received by us from all other Private Placement
Investors, or approximately $1.3 million. We also paid Alexander a
non-accountable cash fee equal to 1.0% of the gross cash proceeds
in the Private Placement and a cash financial advisory fee equal to
3.0% of the outstanding principal balance of the Notes that were
submitted in the Exchange, excluding certain specified holders, or
approximately $0.3 million in additional cash fees in the
aggregate. Also, we reimbursed Alexander $100,000 for legal and
other out-of-pocket expenses.
In
addition, we issued to Alexander, or its designees, the July
Placement Agent Warrants to purchase up to 7.0% of the aggregate
number of shares of common stock underlying the Series B Preferred
Stock sold for cash consideration in the Private Placement, or
1,382,902 shares.
In
connection with the Private Placement, we entered into a
Registration Rights Agreement with the Private Placement Investors
(the “July RRA”), pursuant to which we are required to
register the shares of common stock underlying the Series B
Preferred Stock, the Series B Warrants and the Exchange Warrants.
We have filed this registration statement with the SEC that
includes this prospectus to register for resale under the
Securities Act, the shares of common stock underlying the Series B
Preferred Stock, the Series B Warrants, the Exchange Warrants and
the July Placement Agent Warrants.
See
section captioned “Description of Transactions –
Private Placement and Exchange” below.
Stockholder Approval
On
September 11, 2020, our stockholders voted to approve the full
conversion of the Series B Preferred Stock and the full exercise of
the Series B Warrants and the Exchange Warrants and the July
Placement Agent Warrants issued in the Private Placement and the
Exchange (the “Stockholder Approval”) at our 2020
annual meeting of stockholders.
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The Offering
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Shares of common stock offered by the selling
stockholders
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53,475,768 shares consisting
of:
● up to 31,754,204
shares of common stock, par value $0.0001 per share, issuable upon
conversion of Series B Preferred Stock held by the selling
stockholders, including up to 2,628,448 shares of common stock
potentially issuable in respect of paid-in-kind dividend
obligations relating to the Series B Preferred
Stock.
● 14,562,826 shares
of common stock issuable upon exercise of Series B Warrants held by
the selling stockholders.
● 1,772,937 shares of
common stock issuable upon exercise of the Exchange
Warrants.
● 1,382,902 shares of
common stock issuable upon exercise of the July Placement Agent
Warrants.
● 3,558,795 shares of
common stock issuable upon exercise of the Note Warrants held by
the selling stockholders.
● 444,104 shares of
common stock issuable upon exercise of warrants the January
Placement Agent Warrants.
|
|
|
|
|
|
|
|
|
|
Shares of common stock outstanding before this
offering
|
|
28,502,850 shares of common stock
|
|
|
|
|
|
|
|
|
|
Shares of common stock to be outstanding after giving effect to the
issuance of shares registered hereunder
|
|
81,978,618
shares of common stock
|
|
|
|
|
|
|
|
|
|
Use of proceeds
|
|
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 $19.7 million from the cash exercise the warrants by
the selling stockholders, once the registration statement, of which
this prospectus is a part, is declared effective. 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. See “Use of Proceeds” on page 12
of this
prospectus.
|
|
|
|
|
|
|
|
|
|
Terms of this offering
|
|
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.
|
|
|
|
|
|
|
|
|
|
Nasdaq symbol
|
|
Our
common stock is listed on The Nasdaq Capital Market under the
symbol “AZRX”.
|
|
|
|
|
|
|
|
|
|
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”.
|
|
|
|
|
|
|
|
RISK FACTORS
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;
●
accuracy of our
estimates regarding expense, future revenue and capital
requirements;
●
ability
to continue operating as a going concern;
●
our
plans to develop and commercialize our lead drug candidate,
MS1819;
●
our
ability to initiate and complete our clinical trials and to advance
our principal product candidates into additional clinical trials,
including pivotal clinical trials, and successfully complete such
clinical trials;
●
regulatory
developments in the U.S. and foreign countries;
●
the
performance of our third-party contract manufacturer(s), contract
research organization(s) and other third-party non-clinical and
clinical development collaborators and regulatory service
providers;
●
our
ability to obtain and maintain intellectual property protection for
our core assets;
●
the
size of the potential markets for our product candidates and our
ability to serve those markets;
●
the
rate and degree of market acceptance of our product candidates for
any indication once approved;
●
the
success of competing products and product candidates in development
by others that are or become available for the indications that we
are pursuing;
●
the
loss of key scientific, clinical and nonclinical development,
and/or management personnel, internally or from one of our
third-party collaborators;
●
the
impact of the coronavirus (COVID-19) epidemic on our operations,
and current and planned clinical trials, including, but not limited
to delays in clinical trial recruitment and participation;
and
●
other
risks and uncertainties, including those listed in the
“Risk Factors”
section of this prospectus and the documents incorporated by
reference herein.
These
forward-looking statements are only predictions and we may not
actually achieve the plans, intentions or expectations disclosed in
our forward-looking statements, so you should not place undue
reliance on our forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements we make.
We have based these forward-looking statements largely on our
current expectations and projections about future events and trends
that we believe may affect our business, financial condition and
operating results. We have included important factors in the
cautionary statements included in this prospectus supplement, as
well as certain information incorporated by reference into this
prospectus supplement and the accompanying prospectus, that could
cause actual future results or events to differ materially from the
forward-looking statements that we make. Our forward-looking
statements do not reflect the potential impact of any future
acquisitions, mergers, dispositions, joint ventures or investments
we may make.
You
should read this prospectus supplement and the accompanying
prospectus with the understanding that our actual future results
may be materially different from what we expect. We do not assume
any obligation to update any forward-looking statements whether as
a result of new information, future events or otherwise, except as
required by applicable law.
DESCRIPTION
OF TRANSACTIONS
Convertible Notes Offering
On
December 20, 2019, we began an offering of (i) the Notes in the
principal amount of up to $8.0 million to the Note Investors, and
(ii) warrants to purchase shares of our common stock, each pursuant
to NPAs.
Between December 20, 2019 and January 9, 2020, we
issued Notes to the Note Investors in the aggregate principal
amount of $6,904,000. Each Note matured on September 20, 2020,
accrued interest at a rate of 9% per annum, and was convertible, at
the option of the holder, into the Note Conversion Shares at a
price of $0.97 per share. As additional consideration for the
execution of the NPA, each Note Investor also received Note
Warrants to purchase that number of shares of our common stock
equal to one-half of the Note Warrant Shares. The Note Warrants
have an exercise price of $1.07 per share and expire five (5) years
from the date of issuance. As
disclosed in our Current Report on Form 8-K filed on June 1, 2020,
the conversion price of Mr. Borkowski’s Convertible Note was
subsequently increased to $1.07 per share, to comply with the
requirements of Nasdaq Listing Rule 5635(c).
Pursuant to
the Registration Rights
Agreement executed by us and each Note Investor, we were
required to register the Note
Conversion Shares and Note Warrant Shares. We have filed
this registration statement with the SEC that includes this
prospectus to register for resale under the Securities Act, the
Note Warrant Shares and shares of common stock issuable upon
conversion of the Note Placement Agent Warrant. As a result of the
Exchange, described below, we are not registering the Note
Conversion Shares.
Placement
agent fees of $553,860 were paid to Alexander, who acted as the
exclusive placement agent for the Convertible Notes Offering, which
cash fees were based on 9% of the aggregate principal amount of the
Notes issued to the Investors introduced by Alexander. In addition,
Alexander (i) was issued warrants, containing substantially the
same terms and conditions as the Note Warrants, to purchase an
aggregate of 444,104 shares of common stock, representing 7% of the
Note Conversion Shares issuable upon conversion of the Notes issued
to the Note Investors introduced by Alexander, (ii) was paid a
non-accountable expense allowance of 1% of the gross proceeds from
the Notes Offering introduced by Alexander, or $61,540, and (iii)
was reimbursed $50,000 for its counsel's fees. 285,867 of the
January Placement Agent Warrants have an exercise price of $1.21
per and 158,237 of these January Placement Agent Warrants have an
exercise price of $1.42 per share. All of the January Placement
Agent Warrants expire five (5) years from the date of
issuance.
In connection with the Convertible Notes
Offering, ADEC, the holder of certain Notes issued under
that certain Note Purchase Agreement, dated as of February 14,
2019, in the aggregate original principal amount of $2.0 million,
consented to the issuance of the Notes
in consideration for the repayment, in full, of the
remaining principal balance of $450,000 plus outstanding accrued
interest of $104,153 remaining due
under the terms of the Notes on or before January 2, 2020, net of
the payment to ADEC of $550,000 made by us on December 23, 2019 and
$1.0 million on December 31, 2019 from proceeds from the issuance
of the Notes.
Private Placement and Exchange
On
July 16, 2020, we consummated the Private Placement whereby we
entered into the Purchase Agreement with the Private Placement
Investors. Pursuant to the Purchase Agreement, we issued an
aggregate of 2,912.583005 shares of Series B Convertible 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. The amount of the Series B Warrants is equal to 50% of
the shares of common stock into which the Series B Preferred Stock
is initially convertible.
In
connection with the Private Placement, an aggregate of 1,975.578828
shares of Series B Preferred Stock initially convertible into
19,755,748 shares of common stock and related 9,877,835 Series B
Warrants were issued for cash consideration. In addition, the
balance of an aggregate of 937.004177 shares of Series B Preferred
Stock initially convertible into 9,370,008 shares of common stock
and related Series B Warrants to purchase 4,684,991 shares of
common stock was issued to the Exchange Investors in exchange for
consideration consisting of approximately $6.9 million aggregate
outstanding principal amount, together with accrued and unpaid
interest thereon of approximately $0.3 million, of the Notes,
pursuant to an Exchange Addendum executed by us and the Exchange
Investors. As additional consideration to the Exchange Investors,
we also issued certain the Exchange Warrants to purchase an
aggregate of 1,772,937 shares of common stock at an exercise price
of $0.85 per share. The amount of the Exchange Warrants is equal to
25% of the shares of common stock into which such Notes were
originally convertible upon the initial issuance
thereof.
Alexander
acted as placement agent for the Private Placement. We paid
Alexander 9.0% of the gross cash proceeds received by us from
Private Placement Investors introduced by Alexander and 4.0% of the
gross cash proceeds received by us from all other Private Placement
Investors, or approximately $1.3 million. We also paid Alexander
non-accountable cash fee equal to 1.0% of the gross cash proceeds
in the Private Placement and a cash financial advisory fee equal to
3.0% of the outstanding principal balance of the Notes that were
submitted in the Exchange, excluding certain specified holders, or
approximately $0.3 million in additional cash fees in the
aggregate. Also, we reimbursed Alexander $100,000 for legal and
other out-of-pocket expenses. In addition, we issued to Alexander,
or its designees, the July Placement Agent Warrants to purchase up
to 7.0% of the aggregate number of shares of common stock
underlying the Series B Preferred Stock sold for cash consideration
in the Private Placement, or 1,382,902 shares.
In
connection with the Private Placement, we entered into the July
RRA, pursuant to which we were required to register the shares of
common stock underlying the Series B Preferred Stock, the Series B
Warrants and the Exchange Warrants. We have filed this registration
statement with the SEC that includes this prospectus to register
for resale under the Securities Act, the shares of common stock
underlying each of the Series B Preferred Stock, the Series B
Warrants, Exchange Warrants and the July Placement Agent
Warrants.
SELLING STOCKHOLDERS
This prospectus relates to the sale from
time to time by the selling
stockholders of up to 53,475,768 shares of our common stock, which consists
of up to (i) 31,754,204 shares
of common stock, par value $0.0001 per share, issuable upon
conversion of the Series B Preferred Stock issued in the Private Placement, including up to
2,628,448 shares of common stock potentially issuable in respect of
paid-in-kind dividend obligations relating to the Series B
Preferred Stock, (ii) 14,562,826 shares of common stock
issuable upon exercise of the Series B Warrants issued in the
Private Placement, (iii) 1,772,937 shares of common stock issuable
upon exercise of the Exchange Warrants issued in the Exchange, (iv)
1,382,902 shares of common stock issuable upon exercise of the July
Placement Agent Warrants issued to Alexander as compensation in
connection with the Private Placement and the Exchange, (v)
3,558,795 shares of common stock issuable upon exercise of the Note
Warrants issued in the Convertible
Notes Offering and (vi) 444,104 shares of common stock
issuable upon exercise of the January Placement Agent Warrants
issued to Alexander as compensation in connection with the
Convertible Notes Offering. 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 table is prepared based on
information supplied to us by the selling stockholder and reflects
its holdings as of September 15, 2020. 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
|
Maximum
Number of Shares
Being
Offered Pursuant to this Prospectus
(1) (2)
|
Shares
Beneficially Owned After Completion of the
Offering
(1) (3)
|
|||
|
|
Beneficially Owned
|
Series B
|
|
|
|
|
|
Name of Selling Stockholder
|
Prior to Offering (1) (2)
(3)
|
Preferred Stock
|
Warrants
|
Number
|
Percent (4)
|
|
|
Adam
Cavise
|
127,272
|
(5)
|
-
|
127,272
|
-
|
*
|
|
Alexander
D. Walsh
|
258,661
|
|
145,528
|
113,133
|
-
|
*
|
|
Allen
Whittemore & Mary Walton
|
309,787
|
|
212,385
|
97,402
|
-
|
*
|
|
Amory
Ross
|
627,967
|
(6)
|
125,930
|
123,475
|
378,562
|
1.3%
|
|
Andrew
Amorosi
|
154,893
|
|
106,192
|
48,701
|
-
|
*
|
|
Andrew
Johnston ROTH IRA
|
99,130
|
|
67,962
|
31,168
|
-
|
*
|
|
Andrew
Sanford
|
105,764
|
|
57,703
|
38,061
|
10,000
|
*
|
|
Archero
2020
|
176,870
|
|
108,007
|
68,863
|
-
|
*
|
|
Arthur
Smalley
|
61,957
|
|
42,477
|
19,480
|
-
|
*
|
|
Beatrice
Knox-Johnston
|
165,220
|
|
113,272
|
51,948
|
-
|
*
|
|
Bellis,
Blauvelt-Demarest Foundations, Inc.
|
82,610
|
|
56,636
|
25,974
|
-
|
*
|
|
Bolton
Equities Management USA, LLC
|
1,032,626
|
|
707,951
|
324,675
|
-
|
*
|
|
Boulderwood
LLC
|
449,126
|
|
254,904
|
194,222
|
-
|
*
|
|
Brenda
B. Oakes
|
182,803
|
|
114,724
|
68,079
|
-
|
*
|
|
Brett
Webbe
|
221,036
|
|
130,335
|
90,701
|
-
|
*
|
|
Brio
Capital Master Fund, Ltd.
|
516,314
|
|
353,976
|
162,338
|
-
|
*
|
|
Brody
2016 Family Trust
|
15,902
|
|
10,902
|
5,000
|
-
|
*
|
|
Bruce
Conway
|
601,113
|
|
412,113
|
189,000
|
-
|
*
|
|
Bryan
McShane
|
418,155
|
|
212,385
|
97,402
|
108,368
|
*
|
|
BTR
Partners LP
|
440,127
|
(7)
|
222,230
|
217,897
|
-
|
*
|
|
C.
Erik Young
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
C.
Finnegan Faldi
|
125,238
|
|
72,609
|
52,629
|
-
|
*
|
|
Carl
Martorano
|
1,887
|
(5)
|
-
|
1,887
|
-
|
*
|
|
Carl
T. Rennie
|
72,283
|
|
49,556
|
22,727
|
-
|
*
|
|
Carlos
A. Franceschi
|
154,893
|
|
106,192
|
48,701
|
-
|
*
|
|
Carole
Greenwell
|
726,135
|
|
497,826
|
228,309
|
-
|
*
|
|
Charles
C. Krafczek
|
222,499
|
|
121,691
|
100,808
|
-
|
*
|
|
Chris
Barcless
|
61,830
|
|
31,258
|
30,572
|
-
|
*
|
|
Christopher
Carlin
|
377,257
|
(5)
|
-
|
363,712
|
13,545
|
*
|
|
Christopher
Crain
|
107,392
|
|
73,626
|
33,766
|
-
|
*
|
|
Christopher
D. Lemp
|
94,209
|
|
51,336
|
42,873
|
-
|
*
|
|
Christopher
Karl Mellon
|
603,206
|
|
360,539
|
242,667
|
-
|
*
|
|
Christopher
Laffey
|
1,032,452
|
(5)
|
141,590
|
860,862
|
30,000
|
*
|
|
Curtis
G. Viebranz
|
449,126
|
|
254,904
|
194,222
|
-
|
*
|
|
Dan
Verbic
|
250,226
|
|
145,046
|
105,180
|
-
|
*
|
|
Daniel
J Schultz
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
Daniel
R. Honeker
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
David
Allan Freedman
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
David
B. Campbell
|
61,957
|
|
42,477
|
19,480
|
-
|
*
|
|
David
C. Johnson
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Davina
Lockhart
|
293,418
|
|
148,153
|
145,265
|
-
|
*
|
|
Deborah
C. Mash
|
82,610
|
|
56,636
|
25,974
|
-
|
*
|
|
Delta
Services of North Branch Capital LP
|
522,683
|
|
292,082
|
230,601
|
-
|
*
|
|
Douglas
Jensen
|
220,629
|
|
130,056
|
90,573
|
-
|
*
|
|
Duncan
Lamb
|
216,850
|
|
148,669
|
68,181
|
-
|
*
|
|
EBR
Ventures LLC
|
2,905,370
|
(8)
|
1,112,726
|
1,090,206
|
702,438
|
2.5%
|
|
Edward
J. Borkowski
|
1,414,224
|
(9)
|
502,827
|
307,923
|
603,474
|
2.1%
|
|
Edwin
W. Laffey Jr
|
25,982
|
|
16,990
|
7,792
|
1,200
|
*
|
|
Elisa
H. Allen
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
Eric
Ridder
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Eric
Ridder Jr
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Eric
Workin
|
20,652
|
|
14,159
|
6,493
|
-
|
*
|
|
FirstFire
Global Opportunities Fund, LLC
|
361,418
|
|
247,782
|
113,636
|
-
|
*
|
|
Francis
H Bowen
|
165,385
|
|
113,385
|
52,000
|
-
|
*
|
|
Frank
W Hamilton
|
2,504,812
|
|
1,452,212
|
1,052,600
|
-
|
*
|
|
Gary
and Robin Gibson
|
309,787
|
|
212,385
|
97,402
|
-
|
*
|
|
Gary
L. Brody
|
10,325
|
|
7,079
|
3,246
|
-
|
*
|
|
Gary
Ryan Hart
|
144,567
|
|
99,113
|
45,454
|
-
|
*
|
|
Geoffrey
J. Toman
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Giovanni
Domino
|
6,185
|
(5)
|
-
|
6,185
|
-
|
*
|
|
Girls
Night Out LLC
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
H.
Robert Holmes
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
Harbor
Watch Partners LP
|
293,418
|
|
148,153
|
145,265
|
-
|
*
|
|
Harry
A. Miller IV
|
293,418
|
|
148,153
|
145,265
|
-
|
*
|
|
Harvard
Home Mortgage Inc.
|
809,731
|
|
502,129
|
307,602
|
-
|
*
|
|
Howard
Fuhrman SEP IRA
|
586,836
|
|
296,307
|
290,529
|
-
|
*
|
|
IBS
Holding Corp
|
619,576
|
|
424,771
|
194,805
|
-
|
*
|
|
JABCO
LP
|
500,961
|
(10)
|
290,441
|
210,520
|
-
|
*
|
|
JAC
Family, LLC
|
353,744
|
|
216,016
|
137,728
|
-
|
*
|
|
Jackson
Melnick
|
339,631
|
|
-
|
339,631
|
-
|
*
|
|
Jacob
Anthony Owens
|
20,652
|
|
14,159
|
6,493
|
-
|
*
|
|
Jacqueline
Anne Matera & Gayle Lynne Matera
|
30,978
|
|
21,238
|
9,740
|
-
|
*
|
|
James
Barone
|
82,610
|
|
56,636
|
25,974
|
-
|
*
|
|
James
Bellis
|
104,535
|
|
58,415
|
46,120
|
-
|
*
|
|
James
M. Walton Jr.
|
382,576
|
|
230,482
|
152,094
|
-
|
*
|
|
James
Morizio
|
147,218
|
|
74,425
|
72,793
|
-
|
*
|
|
James
Sapirstein
|
256,525
|
(11)
|
141,590
|
64,935
|
50,000
|
*
|
|
James
Scott Croasdale
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Jameson
Stull
|
271,879
|
|
145,151
|
105,228
|
21,500
|
*
|
|
Jean
Paul Skovronck
|
1,168
|
(5)
|
-
|
1,168
|
-
|
*
|
|
Jeffrey
Craig Link Jr.
|
41,305
|
|
28,318
|
12,987
|
-
|
*
|
|
Jeffrey
M Bertling
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Joe
Stack
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
John
Degrandpre
|
169,023
|
|
102,627
|
66,396
|
-
|
*
|
|
John
H de Neufville
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
John
Hamblin
|
61,957
|
|
42,477
|
19,480
|
-
|
*
|
|
John
J. Maydick Jr.
|
10,325
|
|
7,079
|
3,246
|
-
|
*
|
|
John
L. Kemmerer, Jr. Trust dtd 6/24/57 FBO Constance A.
Kemmerer
|
413,050
|
|
283,180
|
129,870
|
-
|
*
|
|
John
L. Kemmerer, Jr. Trust dtd 6/24/57 FBO Elizabeth K.
Gray
|
413,050
|
|
283,180
|
129,870
|
-
|
*
|
|
John
L. Kemmerer, Jr. Trust dtd 6/24/57 FBO John L. Kemmerer,
III
|
413,050
|
|
283,180
|
129,870
|
-
|
*
|
|
John
McCrossin
|
20,652
|
|
14,159
|
6,493
|
-
|
*
|
|
John
McMichael Cox
|
41,305
|
|
28,318
|
12,987
|
-
|
*
|
|
Jonathan
Gazdak
|
286,746
|
(5)
|
-
|
236,746
|
50,000
|
*
|
|
Jonathan
K. Greenwell
|
20,652
|
|
14,159
|
6,493
|
-
|
*
|
|
Jonathan
Paul Jacobs
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
Jonathan
S. Scarpati
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
Joseph
Amato
|
111,329
|
(5)
|
14,159
|
97,170
|
-
|
*
|
|
Joseph
P. von Meister
|
156,053
|
|
93,735
|
62,318
|
-
|
*
|
|
Joshuah
Melnick
|
339,630
|
|
-
|
339,630
|
-
|
*
|
|
Karolee
Brown
|
120,804
|
|
72,219
|
48,585
|
-
|
*
|
|
Karolee
Herner
|
29,443
|
|
14,885
|
14,558
|
-
|
*
|
|
Kathryn
M. Parsons Rev Trust
|
500,961
|
(12)
|
290,441
|
210,520
|
-
|
*
|
|
KBB
Asset Management
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
Kenneth
D. Hendriksen
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Kevin
McCaffrey
|
123,915
|
|
84,954
|
38,961
|
-
|
*
|
|
Kirsten
Dermer
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
Kyle
Wade Huey
|
56,381
|
|
38,654
|
17,727
|
-
|
*
|
|
Larry
J. Lambert II
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
Laurence
Lytton
|
619,576
|
|
424,771
|
194,805
|
-
|
*
|
|
Laurie
B. Mellon
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Lawrence
F. & Donna B. Michelson
|
415,272
|
|
251,343
|
153,929
|
10,000
|
*
|
|
Lincoln
Park Capital Fund, LLC
|
1,977,975
|
|
816,191
|
799,574
|
362,210
|
1.3%
|
|
Lind
Global Macro Fund, LP
|
619,576
|
|
424,771
|
194,805
|
-
|
*
|
|
Marcel
Arrouet
|
215,993
|
|
106,192
|
48,701
|
61,100
|
*
|
|
Maria
Dunn
|
1,500
|
(5)
|
-
|
1,500
|
-
|
*
|
|
Mark
Bradford
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
Mark
Gaynor
|
176,743
|
|
107,920
|
68,823
|
-
|
*
|
|
Mark
Laue
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
Mark
Swaim
|
268,062
|
|
146,673
|
121,389
|
-
|
*
|
|
Matias
Isreal Escobar
|
82,610
|
|
56,636
|
25,974
|
-
|
*
|
|
Matthew
Balk
|
600,994
|
|
297,179
|
303,815
|
-
|
*
|
|
Matthew
Edward Traber
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Matthew
Kitchen
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
Matthew
P. McMahon
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
Matthew
Weinrich
|
97,065
|
|
66,546
|
30,519
|
-
|
*
|
|
Micah
W. Rothstein
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Michael
Falk
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Michael
J. Atkinson
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
Michele
Misiti
|
5,000
|
(5)
|
-
|
5,000
|
-
|
*
|
|
Molly
and Joseph Walton Tenants in the entireties
|
382,576
|
|
230,482
|
152,094
|
-
|
*
|
|
Neil
M. Metzheiser
|
751,443
|
|
435,663
|
315,780
|
-
|
*
|
|
Nicholas
Devito
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
Nicholas
W. Walsh
|
283,447
|
|
145,133
|
108,314
|
30,000
|
*
|
|
Nishan
Vartanian
|
212,184
|
|
129,567
|
82,617
|
-
|
*
|
|
Nishann,
LLC
|
82,610
|
|
56,636
|
25,974
|
-
|
*
|
|
Noel
Rubin
|
143,097
|
|
72,342
|
70,755
|
-
|
*
|
|
OCI-VB,
LLC
|
413,050
|
|
283,180
|
129,870
|
-
|
*
|
|
Parallax
Biomedical Fund LP
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Paul
Lemp
|
83,933
|
|
44,291
|
39,642
|
-
|
*
|
|
Paul
Messina
|
90,084
|
(5)
|
-
|
90,084
|
-
|
*
|
|
Peter
Carpentier
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Peter
Herner
|
198,848
|
|
109,822
|
89,026
|
-
|
*
|
|
Peter
M Rooney
|
61,630
|
|
35,397
|
16,233
|
10,000
|
*
|
|
Philip
W Smith III
|
353,642
|
|
215,946
|
137,696
|
-
|
*
|
|
PRK
Partners LP
|
293,418
|
(13)
|
148,153
|
145,265
|
-
|
*
|
|
Rachel
Walton
|
382,576
|
|
230,482
|
152,094
|
-
|
*
|
|
Ralph
I. Rugolo Trust dtd 8/20/91
|
18,586
|
|
12,742
|
5,844
|
-
|
*
|
|
Ralph
Worthington
|
309,787
|
|
212,385
|
97,402
|
-
|
*
|
|
Ratherby
Investments, LLC
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Ratherby
Torch LLC
|
154,893
|
|
106,192
|
48,701
|
-
|
*
|
|
Raymond
& Catherine Marzulli
|
142,800
|
|
72,192
|
70,608
|
-
|
*
|
|
Raymond
L. Schettino
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
Richard
G. and Dorothy C. Hyman
|
30,978
|
|
21,238
|
9,740
|
-
|
*
|
|
Richard
Melnick
|
1,006,746
|
|
806,746
|
-
|
200,000
|
*
|
|
Robert
Bailey
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Robert
G. Murphy Jr.
|
413,050
|
|
283,180
|
129,870
|
-
|
*
|
|
Robert
Omohundro
|
11,105
|
(5)
|
-
|
11,105
|
-
|
*
|
|
Robert
Stefanelli
|
2,300
|
(5)
|
-
|
2,300
|
-
|
*
|
|
Robert
W. Holmes IRA
|
293,927
|
|
148,502
|
145,425
|
-
|
*
|
|
Rocco
Guidicipietro
|
90,677
|
(5)
|
-
|
90,677
|
-
|
*
|
|
Roger
H. Kriete
|
147,116
|
|
74,355
|
72,761
|
-
|
*
|
|
RPLLC
|
297,914
|
|
178,429
|
119,485
|
-
|
*
|
|
RRNR
Investments LLC
|
500,452
|
|
290,092
|
210,360
|
-
|
*
|
|
Ryan
N. Johnson
|
495,660
|
|
339,816
|
155,844
|
-
|
*
|
|
S
Clarke Moody
|
1,062,361
|
|
535,885
|
303,753
|
222,723
|
*
|
|
Sean
Flanagan
|
60,421
|
|
36,123
|
24,298
|
-
|
*
|
|
Shawn
T. Pearce IRA
|
61,957
|
|
42,477
|
19,480
|
-
|
*
|
|
Skyler
Ward
|
70,216
|
|
48,139
|
22,077
|
-
|
*
|
|
St.
Health Capital Investment Corp
|
1,467,094
|
|
740,770
|
726,324
|
-
|
*
|
|
Stacy
L. Giunta Revocable Trust
|
147,218
|
(14)
|
74,425
|
72,793
|
-
|
*
|
|
Stefan
D. Powell
|
206,732
|
|
141,732
|
65,000
|
-
|
*
|
|
Steven
Jun Isaki
|
134,240
|
|
92,033
|
42,207
|
-
|
*
|
|
Sunset
Cove Irrevocable Trust
|
1,915,939
|
(15)
|
1,154,508
|
761,431
|
-
|
*
|
|
Target
Capital LLC
|
3,097,881
|
|
2,123,856
|
974,025
|
-
|
*
|
|
Terri
Sanker Taube
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
The
Entrust Group as custodian for the John Cox IRA
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
|
Thomas
de Neufville
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Thoroughbred
Pharma, LLC
|
1,342,414
|
|
920,337
|
422,077
|
-
|
*
|
|
Todd
Bates
|
29,385
|
|
14,845
|
14,540
|
-
|
*
|
|
Toni
Ann Maisano
|
1,921
|
(5)
|
-
|
1,921
|
-
|
*
|
|
Trust
B fbo Amory L. Ross
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
Udai
Tennati
|
41,305
|
|
28,318
|
12,987
|
-
|
*
|
|
Vince
Pereira
|
845
|
(5)
|
-
|
845
|
-
|
*
|
|
Vincent
V. Basile & Lara Coraci Basile
|
206,525
|
|
141,590
|
64,935
|
-
|
*
|
|
William
Benjamin Holmes
|
41,305
|
|
28,318
|
12,987
|
-
|
*
|
|
William
E. Webbe IV
|
73,608
|
|
37,212
|
36,396
|
-
|
*
|
|
William
Edward Webbe V
|
353,744
|
|
216,016
|
137,728
|
-
|
*
|
|
William
H. Combs
|
29,443
|
|
14,885
|
14,558
|
-
|
*
|
|
William
J. May
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
William
M. Cody
|
103,262
|
|
70,795
|
32,467
|
-
|
*
|
|
William
or Andrea Weitzman
|
20,652
|
|
14,159
|
6,493
|
-
|
*
|
|
William
Pyznar
|
375,568
|
|
217,726
|
157,842
|
-
|
*
|
|
William
Stewart
|
51,630
|
|
35,397
|
16,233
|
-
|
*
|
-10-
Table of Contents
*
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 September 15,
2020.
(2)
Includes
shares of common stock issuable upon conversion of the Series B
Preferred Stock and shares of common stock issuable upon exercise
of the warrants issued in connection with the Convertible Notes
Offering, the Private Placement and the
Exchange.
(3)
Includes
shares of common stock owned prior to the Convertible Notes
Offering, the Private Placement and the Exchange, which shares are
not being offered pursuant to this prospectus, including as noted
in greater detail below.
(4)
All
percentage calculations are based on 28,502,850 shares of common
stock outstanding as of September 15, 2020 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 exercise of Placement Agent
Warrants issued in connection with the Private Placement, the
Exchange and the Convertible Notes Offering. The selling
stockholder is affiliated with Alexander Capital LP, which acted as
placement agent in connection with such
transactions.
(6)
Includes
135,890 shares of common stock issuable upon conversion of the
Series B Preferred Stock and 145,265 shares issuable upon exercise
of warrants held by Harbor Watch Partners, LP; and (ii) 64,935
shares of common stock issuable upon conversion of the Series B
Preferred Stock and 32,467 shares 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.
(7)
As
General Partner of BTR Partners, Ben Ross holds sole voting and
dispositive power over the shares held by such
entity.
(8)
Includes
719,545 shares of common stock and 461,597 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
a principal of PRK Partners, LP, Parthenia Ross Kiersted holds sole
voting and dispositive power over the shares held by such
entity.
(14)
As
Trustee of Stacy L. Giunta Revocable Trust, Stacy L. Giunta holds
sole voting and dispositive power over the shares held by such
entity.
(15)
As
Trustee of Sunset Cove Irrevocable Trust, Philip A. Sigel holds
sole voting and dispositive power over the shares held by such
entity.
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.
USE OF
PROCEEDS
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. A portion of the shares covered by this prospectus
may be issued upon exercise of the 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.
PLAN OF DISTRIBUTION
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”.
DESCRIPTION OF
SECURITIES
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 warrants, 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.
Common Stock
As of
September 15, 2020, there were 28,502,850 shares of
our common stock issued and outstanding, which were held by
approximately 95 stockholders of record. As
of September
15, 2020, there were 387,000 shares of restricted
stock units and restricted stock subject to vesting and issuance,
approximately 25,229,846 shares of common stock subject to
outstanding warrants, and 4,312,506 shares of common stock subject
to outstanding stock options. Each holder of common stock is
entitled to one vote for each share of common stock held on all
matters submitted to a vote of the stockholders, including the
election of directors. Our Charter and 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 September
15, 2020, 5,194.805195 shares were designated as
Series B Preferred Stock, of which 2,912.583005 were issued and
outstanding. No other series of preferred stock have been
designated at this time.
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. This leaves
2,282.222190 shares of authorized but unissued Series B Preferred
Stock. We currently have 2,912.583005 shares of preferred stock
issued and outstanding. This leaves 9,997,087.416995 shares of
preferred stock authorized but unissued. The shares of common stock
being offered by the selling stockholders are those issuable to the
selling stockholders upon conversion of the Series B Preferred
Stock.
Under the Certificate of Designations of the
Series B Preferred Stock (the “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 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 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 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 “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 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 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 Certificate of
Designations); or (h) materially modify or change the nature of
our business.
Warrants
Note Warrants
There
are currently 3,558,795 Note Warrants outstanding. The Note
Warrants have an exercise price of $1.07 per share and expire five
years from the date of issuance. Each full Note Investor Warrant
entitles the holder thereof to purchase one share of common stock.
The exercise price and number of shares of common stock issuable
upon exercise of the Note Warrants are subject to appropriate
adjustment in the event of stock splits affecting the common
stock.
In the
event of any reclassification of our capital stock is effected in
such a way that holders of common stock are entitled to receive
stock, securities, or other assets or property, then, as a
condition of such reclassification, we are required to make lawful
and adequate provisions whereby the holders of the Note Warrants
thereafter have the right to purchase and receive (in lieu of the
shares of the common stock immediately theretofore purchasable and
receivable upon the exercise of the rights represented by such Note
Warrants) such shares of stock, securities or other assets or
property as may be issued or payable with respect to or in exchange
for a number of outstanding shares of such common stock equal to
the number of shares of such common stock immediately theretofore
purchasable and receivable upon the exercise of the rights
represented by such Note Warrants.
The
holders of the Note Warrants may exercise the Note Warrants on a
cashless basis, solely to the extent no resale registration
statement is available at the time of exercise.
Certain
of the Note Warrants were not exercisable, including by way of
cashless exercise, until the six-month anniversary of the date of
issuance. In addition, we are prohibited from effecting an exercise
of such Note Warrants to the extent that such exercise would result
in the number of shares of common stock beneficially owned by such
holder and its affiliates exceeding 4.99% of the total number of
shares of common stock outstanding immediately after giving effect
to the exercise, which percentage may be increased or decreased at
the holder’s election not to exceed 9.99%.
January Placement Agent Warrants
There
are currently 444,104 January Placement Agent Warrants outstanding.
The January Placement Agent Warrants have substantially the same
terms as the Note Warrants, except that they have exercise prices
ranging from $1.21 per share to $1.42 per share, were not
exercisable, including by way of cashless exercise, until the
6-month anniversary of the date of
issuance.
Series B Warrants
There
are currently 14,562,826 Series B Warrants outstanding. The Series
B Warrants have an exercise price of $0.85 per share and expire
five years from the date of issuance. Each full Series B Warrant
entitles the holder thereof to purchase one share of common stock.
The exercise price and number of shares of common stock issuable
upon exercise of the Series B Warrants are subject to appropriate
adjustment in the event of stock dividends, distributions, stock
splits, combinations or similar events affecting the common stock
and the exercise price.
If the
common stock is changed to the same or different number of shares
of any class or classes of stock, whether by reclassification,
exchange, substitution or otherwise, then, and in each event, we
are required to make an appropriate revision to the exercise price
of the Series B Warrants so that, upon any subsequent exercise of
the Series B Warrants, the holders thereof have the right to
receive, in lieu of common stock, the kind and amount of shares of
stock and other securities receivable upon reclassification,
exchange, substitution or other change, by holders of the number of
shares of common stock for which such Series B Warrants were
exercisable immediately prior to such reclassification, exchange,
substitution or other change.
If at
any time we effect a capital reorganization or a
merger or consolidation with or into another corporation where the
holders of our outstanding voting securities prior to
such merger or consolidation do not own over 50% of the outstanding
voting securities of the merged or consolidated entity, immediately
after such merger or consolidation, or the sale of all or
substantially all of our properties or assets to any
other person (an “Organic Change”), then as a part of
such Organic Change, we are required to make an appropriate
revision to the exercise price of the Series B Warrants if
necessary and we are required to make provision if necessary (by
adjustments of the exercise price or otherwise) so that, upon any
subsequent exercise of the Series B Warrants, the holders thereof
shall have the right to receive, in lieu of common stock, the kind
and amount of shares of stock and other securities or property
resulting from the Organic Change.
The
holders of the Series B Warrants may exercise the Series B Warrants
on a cashless basis, solely to the extent no resale registration
statement (or applicable exemption from registration) is available
at the time of exercise.
We are
prohibited from effecting an exercise of any Series B Warrants to
the extent that such exercise would result in the number of shares
of common stock 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 exercise,
which percentage may be increased or decreased at the
holder’s election not to exceed 19.99%.
Exchange Warrants
There
are currently 1,772,937 Exchange Warrants outstanding. The Exchange
Warrants have the same terms as the Series B Warrants.
July Placement Agent Warrants
There are currently
1,382,902 July Placement Agent Warrants outstanding. The July
Placement Agent Warrants have substantially the same terms as the
Series B Warrants, except that the they have an exercise price
equal to $1.06 per share, are not be callable and provide for
cashless exercise.
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.
INCORPORATION OF CERTAIN
INFORMATION BY REFERENCE
The
following documents filed with the SEC are incorporated by
reference into this prospectus:
●
our Annual
Report on Form 10-K for the year ended December 31, 2019, filed on
March 30, 2020 , as amended on April 29, 2020;
●
our
Quarterly Report on Form 10-Q for the periods ended March 31, 2020,
and June 30, 2020 filed on May 15, 2020 and August 14, 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 and September 14, 2020;
●
our
definitive proxy statement on Schedule 14A, filed on August 11,
2020; 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.
-20-
53,475,768 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
|
$ 7,840
|
|
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
|
$ 71,840
|
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.
Item 16. Exhibits
|
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).
|
|
|
|
Certificate
of Amendment to Certificate of Incorporation of the Registrant
(Incorporated by reference from Exhibit 3.1 filed with Current
Report on Form 8-K, filed December 30, 2019).
|
|
|
|
Amended
and Restated Bylaws of the Registrant (Incorporated by reference
from Exhibit 3.2 filed with Registration Statement on Form S-1,
filed July 13, 2016).
|
|
|
|
Certificate
of the Designations, Powers, Preferences and Rights of Series B
Convertible Preferred Stock (Incorporated by reference from Exhibit
3.1 filed with Current Report on Form 8-K, filed 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
Warrant for Convertible Notes Offering
|
|
|
|
Form of
Warrant for Private Placement (Incorporated by Reference from
Exhibit 4.1 filed with Current Report on Form 8-K, filed July 20,
2020).
|
|
|
|
Opinion
of Lowenstein Sandler LLP (filed herewith).
|
|
|
|
Form of
Note Purchase Agreement (Incorporated by Reference from
Exhibit 10.1 filed with Current Report on Form 8-K, filed December
30, 2019).
|
|
|
|
Form of
Registration Rights Agreement (Incorporated by Reference from
Exhibit 10.4 filed with Current Report on Form 8-K, filed December
30, 2019).
|
|
|
|
Form of
Purchase Agreement, including the form of Exchange Addendum
(Incorporated by reference from Exhibit 10.1 filed with Current
Report on Form 8-K, filed July 20, 2020).
|
|
|
|
Form of
Registration Rights Agreement (Incorporated by reference from
Exhibit 10.2 filed with Current Report on Form 8-K, filed July 20,
2020).
|
|
|
|
Consent
of Lowenstein Sandler LLP (included in Exhibit 5.1)
(filed
herewith).
|
|
|
|
Consent
of Independent Registered Public Accounting Firm – Mazars USA
LLP (filed herewith).
|
|
|
|
Power
of Attorney (included in signature page).
|
|
*
|
Filed
herewith.
|
|
**
|
Previously
filed.
|
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
Brooklyn, New York on September 17, 2020.
|
|
AZURRX BIOPHARMA, INC.
|
|
September
17, 2020
|
By: /s/
James Sapirstein
Name: James Sapirstein
Title: President and Chief Executive
Officer
(Principal
Executive Officer)
By: /s/
Daniel Schneiderman
Name: Daniel Schneiderman
Title: Chief Financial Officer
(Principal
Accounting Officer)
|
Pursuant to the requirements of the Securities Act of 1933, as
amended, this registration statement has been signed by the
following persons in the capacities and on the dates
indicated.
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
|
|
/s/ James
Sapirstein
|
|
President,
Chief Executive Officer and Director
|
|
September 17,
2020
|
|
James
Sapirstein
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
/s/ Daniel
Schneiderman
|
|
Chief Financial
Officer
|
|
September 17,
2020
|
|
Daniel
Schneiderman
|
|
(Principal Accounting Officer)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Chair of the Board
of Directors
|
|
September 17,
2020
|
|
Edward J.
Borkowski
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
September 17,
2020
|
|
Charles
Casamento
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
September 17,
2020
|
|
Alastair
Riddell
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
September 17,
2020
|
|
Gregory
Oaks
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
September 17,
2020
|
|
Vern Lee
Schramm
|
|
|
|
|
*By:
/s/ James
Sapirstein
James
Sapirstein
Attorney-in-fact
II-5
Exhibit 5.1
September
17, 2020
AzurRx
BioPharma, Inc.
760
Parkside Avenue
Downstate
Biotechnology Incubator, Suite 304
Brooklyn,
New York 11226
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 53,475,768 shares of the Company’s common
stock, par value $0.0001 per share (the “Common
Stock”). Such shares of Common Stock consist of:
(i)
31,754,204
shares of Common Stock (the “Series B Conversion
Shares”) issuable upon conversion of 2,912.583005 of the
Company’s Series B Convertible Preferred Stock (the
“Series B Preferred Stock”), including 2,628,448 shares
of Common Stock potentially issuable in respect of paid-in-kind
dividend obligations relating to the Series B Preferred Stock,
which are currently issued and outstanding;
(ii)
14,562,826
shares of Common Stock (the “Series B Warrant Shares”)
issuable upon exercise of certain warrants to purchase Common Stock
(the “Series B Warrants”) named in the Registration
Statement, which are currently issued and outstanding;
(iii)
1,772,937
shares of Common Stock (the “Exchange Warrant Shares”)
issuable upon exercise of certain warrants to purchase Common Stock
(the “Exchange Warrants”) named in the Registration
Statement, which are currently issued and outstanding;
(iv)
1,382,902
shares of Common Stock (the “July Placement Agent Warrant
Shares”) issuable upon exercise of certain warrants to
purchase Common Stock (the “July Placement Agent
Warrants”) named in the Registration Statement, which are
currently issued and outstanding.
(v)
3,558,795
shares of Common Stock (the “Note Warrant Shares”)
issuable upon exercise of certain warrants to purchase Common Stock
(the “Note Warrants”) named in the Registration
Statement, which are currently issued and outstanding;
and
(vi)
444,104
shares of Common Stock (the “January Placement Agent Warrant
Shares” and together with the Investor Warrant Shares, the
July Placement Agent Warrant Shares, the Series B Warrants Shares,
and the Exchange Warrant Shares, the “Warrant Shares”)
issuable upon exercise of certain warrants to purchase Common Stock
(the “January Placement Agent Warrants” and together
with the Note Warrants, the July Placement Agents Warrants, the
Series B Warrants and the Exchange Warrants, the
“Warrants”) named in the Registration Statement, which
are currently issued and outstanding.
In
connection with rendering this opinion, we have examined the
Certificate of Incorporation and the Bylaws of the Company, the
Certificate of Designation for the Series B Preferred Stock, the
forms of the 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.
____________________________________________________________________________________
NEW YORK PALO ALTO
NEW JERSEY
UTAH WASHINGTON,
D.C.
Lownstein Sandler
LLP
Based
on the foregoing, and subject to the qualifications stated herein,
we are of the opinion that:
1.
when
issued in accordance with the terms of the respective shares of
Series B Preferred Stock, theSeries B Conversion Shares will be
duly authorized, validly issued, fully paid and
non-assessable; and
2.
when
issued in accordance with the terms of the respective Warrants, the
Warrant Shares 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 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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Exhibit
23.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
We
hereby consent to the incorporation by reference in this Form S-3
(Amendment No. 1) to be filed on or about September 17, 2020
constituting part of the Registration Statement on Form S-3 (Amendment No. 1) of our
report dated March 30, 2020, related to the consolidated financial
statements of AzurRx BioPharma, Inc. as of December 31, 2019 and
2018 and for the years then ended, which appears in the Annual
Report on Form 10-K of AzurRx BioPharma, Inc. for the year ended
December 31, 2019. The report for AzurRx BioPharma, Inc. includes
an explanatory paragraph about the existence of substantial doubt
concerning its ability to continue as a going concern. We also
consent to the reference to our Firm under the caption
“Experts” in this Form S-3 (Amendment No.
1).
/s/ Mazars USA LLP
New
York, New York
September
17, 2020