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Share Name | Share Symbol | Market | Type |
---|---|---|---|
AzurRx BioPharma Inc | NASDAQ:AZRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 3.45 | 3.41 | 3.51 | 0 | 01:00:00 |
Delaware
|
2834
|
46-4993860
|
(State
or Other Jurisdiction of
Incorporation
or Organization)
|
(Primary
Standard Industrial
Classification
Code Number)
|
(I.R.S.
Employer
Identification
Number)
|
Large accelerated filer
|
[
]
|
Accelerated filer
|
[
]
|
Non-accelerated
filer
|
[X]
|
Smaller reporting company
|
[X]
|
|
Emerging
growth company
|
[X]
|
Title
of each class of
securities
to be registered
|
|
Amount
to
be
registered(1)
|
|
Proposed
maximum
offering
price
per share
|
|
Proposed
maximum
aggregate
offering
price
|
|
Amount
of
registration
fee
|
||||||
Common stock, par
value $0.0001 per share
|
|
50,847,320
|
(2)
|
|
$
|
1.15
|
(3)
|
|
$
|
58,474,418
|
|
$
|
7,589.98
|
(4)
|
Common stock, par
value $0.0001 per share
|
|
2,628,448
|
(5)
|
|
$
|
0.73
|
(6)
|
|
$
|
1,918,767
|
|
$
|
249.06
|
|
PRELIMINARY PROSPECTUS
|
SUBJECT TO COMPLETION
|
DATED SEPTEMBER 17, 2020
|
1
|
|
5
|
|
6
|
|
8
|
|
10
|
|
12
|
|
13
|
|
15
|
|
19
|
|
19
|
|
19
|
|
20
|
|
II-3
|
|
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.
|
|
|
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.
|
|
|
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.
|
|
|
|
|
||
|
The Offering
|
|
||
|
|
|
|
|
|
Shares of common stock offered by the selling
stockholders
|
|
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”.
|
|
|
|
|
|
|
|
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
|
-
|
*
|
|
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
|
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.
|
|
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)
|
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
|
|
|
|
|
1 Year AzurRx BioPharma Chart |
1 Month AzurRx BioPharma Chart |
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