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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
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2834
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46-4993860
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(State or Other Jurisdiction of
Incorporation or Organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer
Identification Number)
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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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PRELIMINARY PROSPECTUS
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SUBJECT TO COMPLETION
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DATED FEBRUARY 11, 2021
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PROSPECTUS SUMMARY
This summary highlights information contained elsewhere in this
prospectus. This summary does not contain all of the information
that you should consider before deciding to invest in our
securities. You should read this entire prospectus carefully,
including the “Risk Factors” section in this prospectus
and under similar captions in the documents incorporated by
reference into this prospectus. In this prospectus, unless
otherwise stated or the context otherwise requires, references to
“AzurRx”, “Company”, “we”,
“us”, “our” or similar references mean
AzurRx BioPharma, Inc. and its subsidiaries on a consolidated
basis. References to “AzurRx BioPharma” refer to AzurRx
BioPharma, Inc. on an unconsolidated basis. References to
“AzurRx SAS” refer to AzurRx SAS, AzurRx
BioPharma’s wholly-owned subsidiary through which we conduct
our European operations.
Overview
We are engaged in the research and development of targeted,
non-systemic therapies for the treatment of patients with
gastrointestinal (“GI”) diseases. Non-systemic
therapies are non-absorbable drugs that act locally, i.e. the
intestinal lumen, skin or mucosa, without reaching an
individual’s systemic circulation.
We are currently focused on developing our pipeline of three
gut-restricted GI clinical drug candidates. The lead therapeutic
candidate is MS1819, a recombinant lipase for the treatment of
exocrine pancreatic insufficiency (“EPI”) in patients
with cystic fibrosis and chronic pancreatitis, currently in
two Phase 2 clinical trials. We plan to launch two clinical
programs using proprietary formulations of niclosamide, a
pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune
Checkpoint Inhibitor-Associated Colitis (“ICI-AC”) and
diarrhea in oncology patients and FW-1022, for Severe Acute
Respiratory Syndrome Coronavirus 2 (“COVID-19” or
“COVID”) gastrointestinal infections. Each drug
candidate is described below:
MS1819
MS1819
is a recombinant lipase enzyme for the treatment of exocrine
pancreatic insufficiency (“EPI”) associated with cystic
fibrosis (“CF”) and chronic pancreatitis
(“CP”). MS1819, supplied as an oral non-systemic
biologic capsule, is derived from the Yarrowia
lipolytica yeast
lipase and breaks up fat molecules in the digestive tract of EPI
patients so that they can be absorbed as nutrients. Unlike the
standard of care, the MS1819 synthetic lipase does not contain any
animal products.
EPI is a condition characterized by deficiency of the
exocrine pancreatic enzymes, resulting in a
patient’s inability to digest food properly, or maldigestion.
The deficiency in this enzyme can be responsible for greasy
diarrhea, fecal urge and weight loss. There are more than 30,000
patients with EPI caused by CF according to the Cystic Fibrosis
Foundation approximately and approximately 90,000 patients in the
U.S. with EPI caused by CP according to the National Pancreas
Foundation. Patients are currently treated with porcine pancreatic
enzyme replacement pills (“PERT”).
MS1819 – Phase 2b OPTION 2 Cystic Fibrosis Monotherapy
Studies
On
October 17, 2019, we announced that the Cystic Fibrosis Foundation
Data Safety Monitoring Board (the “CFF DSMB”) completed
its review of our final results of the OPTION Cross-Over Study and
had found no safety concerns for MS1819, and that the CFF DSMB
supported our plan to proceed to a higher 4.4 gram dose of MS1819
with enteric capsules in the multi-center dose escalation Phase 2b
OPTION clinical trial (the “OPTION 2 Trial”). In
December 2019, the Company submitted the clinical trial protocol to
the existing IND at the FDA. The clinical trial protocol has been
reviewed by the FDA with no comments. In April 2020, the Company
received approval to conduct the OPTION 2 Trial in Therapeutics
Development Network (“TDN”) clinical
sites in the U.S. as well as Institutional Review
Board (“IRB”) approval
to commence the OPTION 2 Trial.
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The
OPTION 2 Trial is designed to investigate the safety, tolerability
and efficacy of MS1819 (2.2 gram and 4.4 gram doses in enteric
capsules) in a head-to-head manner versus the current standard of
care, porcine pancreatic enzyme replacement therapy
(“PERT”)
pills. The OPTION 2 Trial will be an open-label, crossover study,
conducted in 15 sites in the U.S. and Europe. A total
of 30 CF patients 18 years or older will be enrolled.
MS1819 will be administered in enteric capsules to provide
gastric protection and allow optimal delivery of enzyme to the
duodenum. Patients will first be randomized into two cohorts:
to either the MS1819 arm, where they receive a 2.2 gram daily oral
dose of MS1819 for three weeks; or to the PERT arm, where they
receive their pre-study dose of PERT pills for three weeks. After
three weeks, stools will be collected for analysis of coefficient
of fat absorption (“CFA”). Patients
will then be crossed over for another three weeks of the
alternative treatment. After three weeks of cross-over therapy,
stools will again be collected for analysis of CFA. A parallel
group of patients will be randomized and studied in the same
fashion, using a 4.4 gram daily dose of MS1819. All patients
will be followed for an additional two weeks after completing both
crossover treatments for post study safety
observation. Patients will be assessed using descriptive
methods for efficacy, comparing CFA between MS1819 and PERT arms,
and for safety.
We initiated the OPTION 2 Trial in July 2020 with the first
patient screened and three clinical trial sites activated in the
U.S. In August 2020, the Company dosed the first patients and
initiated the European arm of the OPTION 2 Trial. Topline data is
anticipated in the first quarter of 2021; however, this timeline
may be further delayed due to
the COVID-19 pandemic.
In November 2020, we submitted a protocol amendment for the OPTION
2 Trial to add a study arm that uses an immediate release MS1819
capsule to compare data from the existing arm, that uses
delayed-release enteric capsules with data from the new arm, that
uses immediate release capsules, in order to determine the optimal
dose and delivery method. We plan to initiate the OPTION 2 study
extension in early first quarter 2021.
MS1819 – Phase 2 Combination Therapy
Study
In addition to the monotherapy studies, we launched a Phase 2
multi-center clinical trial (the “Combination Trial”)
in Europe to investigate MS1819 in combination with PERT, for CF
patients who suffer from severe EPI but continue to experience
clinical symptoms of fat malabsorption despite taking the maximum
daily dose of PERTs. The Combination Trial is designed to
investigate the safety, tolerability and efficacy of escalating
doses of MS1819 (700 mg, 1120 mg and 2240 mg per day,
respectively), in conjunction with a stable dose of PERTs, in order
to increase CFA and relieve abdominal symptoms in uncontrolled CF
patients. A combination therapy of PERT and MS1819 has the
potential to: (i) correct macronutrient and micronutrient
maldigestion; (ii) eliminate abdominal symptoms attributable to
maldigestion; and (iii) sustain optimal nutritional status on a
normal diet in CF patients with severe EPI.
We dosed the first patients in its Combination Trial in Hungary in
October 2019. Planned enrollment is expected to include
approximately 24 CF patients with severe EPI, at clinical trial
sites in Hungary and additional countries in Europe, including
Turkey. Topline data is currently expected in the first half of
2021; however, this timeline may be further delayed due to the
COVID-19 pandemic.
We announced positive interim data on the first five patients in
the Combination Trial in August 2020. The primary efficacy endpoint
was met, with CFAs greater than 80% for all patients across all
visits. For secondary efficacy endpoints, we observed that stool
weight decreased, the number of stools per day decreased,
steatorrhea improved, and body weight increased. Additionally, no
serious adverse events were reported.
We opened a total of five clinical sites for the Combination
Trial in Turkey in October 2020 and announced that its first
patients were dosed in November 2020. We currently have a
total of nine of the expected ten sites in Europe active and
recruiting patients.
License Agreement with First Wave Bio, Inc.
On December 31, 2020, we entered into a License Agreement (the
“First Wave License Agreement”) with First Wave Bio,
Inc. (“First Wave”). Pursuant to the First Wave License
Agreement, First Wave granted us a worldwide, exclusive right to
develop, manufacture, and commercialize First Wave’s
proprietary immediate release and enema formulations of niclosamide
for the fields of treating ICI-AC and COVID in humans (the
“Product”). The Product uses First Wave’s
proprietary formulations of niclosamide, a pro-inflammatory pathway
inhibitor. We plan to commence in 2021 both a Phase 2 trial of the
Product for COVID in GI and a Phase 1b/2a trial for
ICI-AC.
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In consideration of the license and other rights granted by First
Wave, we paid First Wave a $9.0 million upfront cash payment and an
additional payment of $1.25 million due on June 30, 2021. In
addition, we are obligated to pay potential milestone payments to
First Wave totaling up to $37.0 million for each indication, based
upon the achievement of specified development and regulatory
milestones. We are also obligated to pay First Wave royalties as a
mid-single digit percentage of net sales of the Product, subject to
specified reductions.
We are now solely responsible, and have agreed to use commercially
reasonable efforts, for all development, regulatory and commercial
activities related to the Products in the ICI-AC and COVID fields.
We may sublicense our rights under the First Wave License Agreement
and, if we do so, we will be obligated to pay milestone payments
and royalties to First Wave based on the sublicensee’s
development and commercialization of the
Products.
As of February 10,
2021, 9,441.4960 shares of Series C Preferred Stock, convertible
into an aggregate of up to 9,441,496 shares of Common Stock, have
been issued in relation to the Series B Exchange Rights at a
conversion price of $0.75 per share, subject to certain
limitations. Further, as of February 10, 2021, 9,441,496 Series B
Exchange Warrants have been issued, exercisable for up to an
aggregate of 9,441,496 additional shares of Common Stock, at an
exercise price of $0.80 per share.
Pursuant to the First Wave License Agreement, First Wave retains
rights to develop and commercialize the licensed niclosamide
formulations outside the ICI-AC and COVID fields, and to develop
and commercialize other niclosamide formulations that are not
licensed to us. However, if prior to April 30, 2021, First Wave
seeks to outlicense, sell to or otherwise grant rights to a third
party related to any products containing niclosamide for use
outside the ICI-AC or COVID fields to develop or commercialize a
product containing niclosamide for use outside of the field then
First Wave shall provide to us written notice of such proposal, in
reasonable detail and we shall have the right and option to
negotiate with First Wave with respect to a definitive agreement
for the acquisition of First Wave. Pursuant to the First Wave
License Agreement, we grant First Wave a worldwide, non-exclusive,
royalty-free, perpetual, irrevocable license for use outside the
ICI-AC and COVID fields, with the right to grant sublicenses, under
any program IP and other intellectual property owned by us and
incorporated into the Product.
The First Wave License Agreement terminates on a country-by-country
basis and product-by-product basis upon the expiration of the
royalty term for such product in such country. Each royalty term
begins on the date of the first commercial sale of the licensed
product in the applicable country and ends on date of expiration of
the last to expire royalty term with respect to the country. The
First Wave License Agreement may be terminated earlier in specified
situations, including termination for uncured material breach of
the First Wave License Agreement by either party, termination by us
in specified circumstances, termination by First Wave in specified
circumstances, termination by us for convenience with advance
notice, and termination upon a party’s insolvency or
bankruptcy. After expiration of the royalty term, we shall have a
non-exclusive, fully-paid, perpetual, royalty-free right and
irrevocable license with respect to any Product in any country
within the territory.
The First Wave License Agreement also contains customary
representations, warranties and covenants by both parties, as well
as customary provisions relating to indemnification,
confidentiality and other matters.
We do not expect to generate revenue from drug candidates that we
develop until we obtain approval for one or more of such drug
candidates and commercialize our product or enter into a
collaborative agreement with a third party. We do not have any
products approved for sale at the present and have never generated
revenue from product sales.
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Recent Developments
Series B Exchange Right
On July 16, 2020, we consummated an offering of shares of our
Series B Preferred Stock (the “Series B Offering”) in
which we issued an aggregate of 2,912.583005 shares of Series B
Preferred Stock, at a price of $7,700.00 per share, initially
convertible into an aggregate of 29,125,756 shares of Common Stock
at $0.77 per share, together with warrants (the “Series B
Warrants”) to purchase an aggregate of 14,562,826 shares of
Common Stock at an exercise price of $0.85 per
share.
Under the Series B Certificate of Designations, in the event we
effect any issuance of Common Stock or common stock equivalents for
cash consideration, or a combination of units thereof, each holder
of the Series B Preferred Stock has the right to exchange the
stated value, plus accrued and unpaid dividends, of the Series B
Preferred Stock for any securities issued in a Subsequent Financing
(as defined in the Series B Certificate of Designations), on a
dollar-for-dollar basis, in lieu of any cash subscription payments
therefor, which we refer to as the Series B Exchange Rights. The
terms and conditions of the Series B Preferred Stock and the Series
B Offering were reported in our Current Report on Form 8-K filed
July 20, 2020, which is incorporated herein by
reference.
On December 31, 2020, we entered into a securities purchase
agreement (the “Series C Purchase Agreement”) with a
certain accredited investor, pursuant to which we agreed to sell in
a registered direct offering (the “Series C Registered Direct
Offering”) 5,333.333 shares of our Series C 9.00% Convertible
Junior Preferred Stock, par value $0.0001 per share (the
“Series C Preferred Stock”), at a price of $750 per
share, which shares were initially convertible into an aggregate of
5,333,334 shares of Common Stock, at an initial stated value of
$750.00 per share and a conversion price of $0.75 per share. The
Series C Registered Direct Offering closed on January 6,
2021.
Concurrently with the Series C Registered Direct Offering, in a
private placement (the “Series C Private Placement,”
and together with the Series C Registered Direct Offering, the
“Series C Offerings”), we also sold to the investor, an
additional 5,333.333 shares of Series C Preferred Stock at the same
price as the Series C Preferred Stock offered in the Series C
Registered Direct Offering, which shares were initially convertible
into an aggregate of 5,333,334 shares of our Common stock, together
with warrants to purchase up to an aggregate of 10,666,668 shares
of Common Stock, with an exercise price of $0.80 per share and an
expiration term through July 6, 2026. The Series C Private
Placement closed on January 6, 2021. The terms of the Series C
Offerings were reported in our Current Reports on Form 8-K filed
January 4, 2021, January 8, 2021 and January 13, 2021, which are
incorporated herein by reference.
As a result of the
Series C Offerings, pursuant to the Series B Certificate of
Designation and the Series B Exchange Right, we are required to
issue (in addition to shares of Series C Preferred Stock) Series B
Exchange Warrants to purchase up to an
additional 26,112,721 shares
of Common Stock to any holders of Series B Preferred Stock who
elect to exercise their Exchange Rights. As of February 10,
2021, the shares of Series C Preferred Stock potentially issuable
in relation to the Series B Exchange Rights would have been
convertible into an aggregate of up to 678,082 incremental shares
of Common Stock (beyond the 25,427,643 shares of Common Stock
into which the underlying shares of Series B Preferred Stock,
including accrued and unpaid dividends thereon, were convertible as
of such date) at a conversion price of $0.75 per share, subject to
certain limitations. In addition, as of February 10, 2021, the
Series B Exchange Warrants potentially issuable in relation to the
Series B Exchange Rights would have been exercisable for up to an
aggregate of 26,105,725 additional shares of Common Stock, at an
exercise price of $0.80 per share. In addition, this prospectus registers
for resale the shares of Common Stock underlying warrants
potentially issuable pursuant to the Series B Exchange Right in
respect of accrued or paid-in-kind dividend obligations relating to
the Series B Preferred Stock. In accordance with applicable
Commission guidance (Securities Act
Forms Compliance and Disclosure Interpretations
116.13), this
prospectus registers for resale, on behalf of the selling
stockholders named herein, the shares of Common Stock issuable upon
exercise of the Series B Exchange
Warrants.
As of February 10,
2021, 9,441.4960 shares of Series C Preferred Stock, convertible
into an aggregate of up to 9,441,496 shares of Common Stock, have
been issued in relation to the Series B Exchange Rights at a
conversion price of $0.75 per share, subject to certain
limitations. Further, as of February 10, 2021, 9,441,496 Series B
Exchange Warrants have been issued, exercisable for up to an
aggregate of 9,441,496 additional shares of Common Stock, at an
exercise price of $0.80 per share.
Pursuant to the Series C Purchase Agreement, we must hold a meeting
of our stockholders not later than March 31, 2021 to seek such
approval as may be required from our stockholders (the
“Stockholder Approval”), in accordance with applicable
law, the applicable rules and regulations of the Nasdaq Stock
Market, our certificate of incorporation and bylaws and the General
Corporate Law of the State of Delaware. Until the Stockholder
Approval has been obtained, the Series B Exchange Warrants held by
the selling stockholders named herein may not be exercised for any
shares of our Common Stock. We have scheduled a special meeting of
our stockholders to be held on February 24, 2021, for the purpose
of obtaining the Stockholder Approval. Please see our Definitive
Proxy Statement filed on January 19, 2021.
The terms of the offerings described above were previously reported
in our Current Reports on Form 8-K filed on July 20, 2020, January
4, 2021, January 8, 2021 and January 13, 2021, which are
incorporated herein by reference.
Corporate Information
We were incorporated on January 30, 2014 in the State of
Delaware. In June 2014, we acquired 100% of the issued
and outstanding capital stock of AzurRx SAS. Our principal
executive offices are located at 1615 South Congress Avenue, Suite
103, Delray Beach, Florida 33445. Our telephone number is (646)
699-7855. We maintain a website at www.azurrx.com. The information
contained on our website is not, and should not be interpreted to
be, a part of this prospectus.
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The Offering
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Shares of common stock offered by the selling
stockholders
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26,112,721
shares of common stock issuable upon exercise, for cash, of Series
B Exchange Warrants held by the selling
stockholders.
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Shares of common stock outstanding before this
offering
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53,418,712 shares of common stock
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Shares of common stock to be outstanding after giving effect to the
issuance of shares registered hereunder
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79,531,433 shares of common stock
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Use of proceeds
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We are not selling any securities under this prospectus and will
not receive any of the proceeds from the sale of shares by the
selling stockholder. However, we may receive proceeds of up to
approximately $20.9 million from the cash exercise of the warrants
by the selling stockholders, once the registration statement, of
which this prospectus is a part, is declared
effective.
We
anticipate that proceeds that we receive from the cash exercise of
such warrants, if any, will be used for working capital and general
corporate purposes, including, without limitation,
development of our product candidates, and general and
administrative expenses. See “Use of
Proceeds” on page 12 of this
prospectus.
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Terms of this offering
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The selling stockholders, including their transferees, donees,
pledgees, assignees and successors-in-interest, may sell, transfer
or otherwise dispose of any or all of the shares of common stock
offered by this prospectus from time to time on The Nasdaq Capital
Market or any other stock exchange, market or trading facility on
which the shares are traded or in private transactions. The shares
of common stock may be sold at fixed prices, at market prices
prevailing at the time of sale, at prices related to prevailing
market price or at negotiated prices.
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Nasdaq symbol
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Our common stock is listed on The Nasdaq Capital Market under the
symbol “AZRX”.
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Risk Factors
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Investing in our securities involves significant risks. Before
making a decision whether to invest in our securities, please read
the information contained in or incorporated by reference under the
heading “Risk
Factors” in this prospectus, the documents we have
incorporated by reference herein, and under similar headings in
other documents filed after the date hereof and incorporated by
reference into this prospectus. See “Incorporation
of Certain Information by Reference” and
“Where
You Can Find More Information”.
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Shares of Common Stock Beneficially Owned
Prior to
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Shares of Common Stock Offered Underlying Series B
Exchange
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Shares of Common Stock Beneficially Owned After this Offering(3) |
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Name of Selling Stockholder
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Offering(1)(2)(3)
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Warrants
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Number(3)
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Percent(4)
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Alexander
D. Walsh
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401,595
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144,231
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257,364
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*
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Allen
Whittemore & Mary Walton
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518,386
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210,492
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307,894
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*
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Amory
Ross (5)
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751,653
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124,808
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626,845
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1.3
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Andrew
Amorosi
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259,193
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105,246
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153,947
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*
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Andrew
Johnston ROTH IRA
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165,290
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67,061
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98,229
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*
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Andrew
Sanford
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162,441
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57,190
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105,251
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*
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Archero
2020
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282,953
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107,045
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175,908
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*
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Arthur
Smalley
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103,676
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42,098
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61,578
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*
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Beatrice
Knox-Johnston
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276,472
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112,262
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164,210
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*
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Bellis,
Blauvelt-Demarest Foundations, Inc.
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138,236
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56,131
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82,105
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*
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Bolton
Equities Management USA, LLC
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1,727,953
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701,639
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1,026,314
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2.1
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Boulderwood
LLC
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697,268
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251,523
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445,745
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*
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Brenda
B. Oakes
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295,483
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113,702
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181,781
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*
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Brett
Webbe
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349,049
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129,174
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219,875
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*
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Brio
Capital Master Fund, Ltd.
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860,212
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348,937
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511,275
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*
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Brody
2016 Family Trust
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26,552
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10,776
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15,776
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*
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Bruce
Conway
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1,005,876
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408,438
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597,438
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1.2
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Bryan
McShane
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626,754
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210,492
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416,262
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*
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BTR
Partners LP (6)
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658,395
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220,249
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438,146
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*
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C.
Erik Young
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345,591
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140,328
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205,263
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*
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C.
Finnegan Faldi
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195,923
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71,647
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124,276
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*
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Carl
T. Rennie
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120,525
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48,899
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71,626
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*
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Carlos
A. Franceschi
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258,269
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104,784
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153,485
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*
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Carole
Greenwell
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1,215,083
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493,387
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721,696
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1.4
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Charles
C. Krafczek
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340,964
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120,078
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220,886
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*
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Chris
Barcless
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92,170
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30,799
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61,371
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*
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Christopher
Crain
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179,066
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72,650
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106,416
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*
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Christopher
D. Lemp
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144,631
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50,879
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93,752
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*
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Christopher
Karl Mellon
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599,294
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356,627
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242,667
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*
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Christopher
Laffey (7)
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205,263
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140,328
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64,935
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*
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Curtis
G. Viebranz
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699,486
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252,632
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446,854
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*
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Dan
Verbic
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391,634
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143,227
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248,407
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*
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Daniel
J Schultz
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86,397
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35,082
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51,315
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*
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Daniel
R. Honeker
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345,591
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140,328
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205,263
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*
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David
Allan Freedman
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86,209
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34,988
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51,221
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*
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David
B. Campbell
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103,306
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41,913
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61,393
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*
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David
C. Johnson
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172,795
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70,164
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102,631
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*
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Davina
Lockhart
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437,641
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146,188
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291,453
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*
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Deborah
C. Mash
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137,770
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55,898
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81,872
|
*
|
Delta
Services of North Branch Capital LP
|
809,559
|
289,479
|
520,080
|
*
|
Douglas
Jensen
|
348,367
|
128,897
|
219,470
|
*
|
Duncan
Lamb
|
362,869
|
147,344
|
215,525
|
*
|
EBR
Ventures LLC (8)
|
2,215,580
|
1,096,883
|
1,118,697
|
2.1
|
Edward
J. Borkowski (9)
|
1,908,087
|
498,345
|
1,409,742
|
2.6
|
Edwin
W. Laffey Jr
|
42,670
|
16,839
|
25,831
|
*
|
Elisa
H. Allen
|
86,089
|
34,928
|
51,161
|
*
|
Eric
Ridder
|
172,179
|
69,856
|
102,323
|
*
|
Eric
Ridder Jr
|
172,795
|
70,164
|
102,631
|
*
|
Eric
Workin
|
34,443
|
13,975
|
20,468
|
*
|
FirstFire
Global Opportunities Fund, LLC
|
526,312
|
206,338
|
319,974
|
*
|
Francis
H Bowen
|
275,762
|
111,881
|
163,881
|
*
|
Frank
W Hamilton
|
3,931,128
|
1,439,264
|
2,491,864
|
4.7
|
Gary
and Robin Gibson
|
516,536
|
209,567
|
306,969
|
*
|
Gary
L. Brody
|
17,242
|
6,998
|
10,244
|
*
|
Gary
Ryan Hart
|
241,912
|
98,229
|
143,683
|
*
|
Geoffrey
J. Toman
|
172,179
|
69,856
|
102,323
|
*
|
Girls
Night Out LLC
|
345,591
|
140,328
|
205,263
|
*
|
H.
Robert Holmes
|
345,591
|
140,328
|
205,263
|
*
|
Harbor
Watch Partners LP
|
438,931
|
146,833
|
292,098
|
*
|
Harry
A. Miller IV
|
437,425
|
146,080
|
291,345
|
*
|
Harvard
Home Mortgage Inc.
|
1,302,908
|
497,653
|
805,255
|
1.5
|
Howard
Fuhrman SEP IRA
|
875,281
|
292,376
|
582,905
|
1.1
|
JABCO
LP (10)
|
786,226
|
287,853
|
498,373
|
1.0
|
JAC
Family, LLC
|
564,028
|
213,150
|
350,878
|
*
|
Jacob
Anthony Owens
|
34,559
|
14,033
|
20,526
|
*
|
Jacqueline
Anne Matera & Gayle Lynne Matera
|
51,838
|
21,049
|
30,789
|
*
|
James
Barone
|
137,744
|
55,885
|
81,859
|
*
|
James
Bellis
|
161,912
|
57,896
|
104,016
|
*
|
James
Morizio
|
219,489
|
73,348
|
146,141
|
*
|
James
Sapirstein (11)
|
395,591
|
140,328
|
255,263
|
*
|
James
Scott Croasdale
|
172,179
|
69,856
|
102,323
|
*
|
Jameson
Stull
|
414,442
|
143,857
|
270,585
|
*
|
Jeffrey
Craig Link Jr.
|
69,119
|
28,066
|
41,053
|
*
|
Jeffrey
M Bertling
|
172,795
|
70,164
|
102,631
|
*
|
Joe
Stack
|
172,179
|
69,856
|
102,323
|
*
|
John
Degrandpre
|
269,822
|
101,713
|
168,109
|
*
|
John
H de Neufville
|
345,591
|
140,328
|
205,263
|
*
|
John
Hamblin
|
103,676
|
42,098
|
61,578
|
*
|
John
J. Maydick Jr.
|
17,196
|
6,975
|
10,221
|
*
|
John
L. Kemmerer, Jr. Trust dtd 6/24/57 FBO Constance A.
Kemmerer
|
691,182
|
280,656
|
410,526
|
*
|
John
L. Kemmerer, Jr. Trust dtd 6/24/57 FBO Elizabeth K.
Gray
|
691,182
|
280,656
|
410,526
|
*
|
John
L. Kemmerer, Jr. Trust dtd 6/24/57 FBO John L. Kemmerer,
III
|
691,182
|
280,656
|
410,526
|
*
|
John
McCrossin
|
34,559
|
14,033
|
20,526
|
*
|
John
McMichael Cox
|
69,119
|
28,066
|
41,053
|
*
|
Jonathan
K. Greenwell
|
34,559
|
14,033
|
20,526
|
*
|
Jonathan
Paul Jacobs
|
345,591
|
140,328
|
205,263
|
*
|
Jonathan
S. Scarpati
|
345,591
|
140,328
|
205,263
|
*
|
Joseph
P. von Meister
|
248,118
|
92,900
|
155,218
|
*
|
Karolee
Brown
|
191,737
|
71,576
|
120,161
|
*
|
Karolee
Herner
|
43,934
|
14,688
|
29,246
|
*
|
Kathryn
M. Parsons Rev Trust (12)
|
786,226
|
287,853
|
498,373
|
1.0
|
Kenneth
D. Hendriksen
|
172,795
|
70,164
|
102,631
|
*
|
Kevin
McCaffrey
|
206,615
|
83,827
|
122,788
|
*
|
Kirsten
Dermer
|
86,089
|
34,928
|
51,161
|
*
|
Kyle
Wade Huey
|
94,349
|
38,311
|
56,038
|
*
|
Larry
J. Lambert II
|
86,397
|
35,082
|
51,315
|
*
|
Laurence
Lytton
|
829,313
|
317,254
|
512,059
|
1.0
|
Laurie
B. Mellon
|
172,521
|
70,027
|
102,494
|
*
|
Lawrence
F. & Donna B. Michelson
|
660,797
|
248,434
|
412,363
|
*
|
Lincoln Park Capital Fund, LLC
(16)
|
1,129,572
|
804,373
|
325,199
|
*
|
Lind
Global Macro Fund, LP
|
629,445
|
217,320
|
412,125
|
*
|
Marcel
Arrouet
|
320,293
|
105,246
|
215,047
|
*
|
Mark
Bradford
|
86,089
|
34,928
|
51,161
|
*
|
Mark
Gaynor
|
282,741
|
106,959
|
175,782
|
*
|
Mark
Laue
|
86,089
|
34,928
|
51,161
|
*
|
Mark
Swaim
|
412,121
|
145,366
|
266,755
|
*
|
Matias
Isreal Escobar
|
138,236
|
56,131
|
82,105
|
*
|
Matthew
Balk
|
679,165
|
187,675
|
491,490
|
*
|
Matthew
Edward Traber
|
172,179
|
69,856
|
102,323
|
*
|
Matthew
Kitchen
|
86,089
|
34,928
|
51,161
|
*
|
Matthew
P. McMahon
|
344,357
|
139,711
|
204,646
|
*
|
Matthew
Weinrich
|
162,427
|
65,954
|
96,473
|
*
|
Micah
W. Rothstein
|
172,795
|
70,164
|
102,631
|
*
|
Michael
Falk
|
172,795
|
70,164
|
102,631
|
*
|
Michael
J. Atkinson
|
86,397
|
35,082
|
51,315
|
*
|
Molly
and Joseph Walton Tenants in the entireties
|
606,274
|
227,090
|
379,184
|
*
|
Neil
M. Metzheiser
|
1,175,544
|
429,882
|
745,662
|
1.4
|
Nicholas
Devito
|
86,397
|
35,082
|
51,315
|
*
|
Nicholas
W. Walsh
|
425,996
|
143,841
|
282,155
|
*
|
Nishan
Vartanian
|
338,315
|
127,849
|
210,466
|
*
|
Nishann,
LLC
|
137,744
|
55,885
|
81,859
|
*
|
Noel
Rubin
|
213,309
|
71,277
|
142,032
|
*
|
OCI-VB,
LLC
|
691,182
|
280,656
|
410,526
|
*
|
Parallax
Biomedical Fund LP
|
172,007
|
69,770
|
102,237
|
*
|
Paul
Lemp
|
127,438
|
43,898
|
83,540
|
*
|
Peter
Carpentier
|
172,795
|
70,164
|
102,631
|
*
|
Peter
Herner
|
306,714
|
108,844
|
197,870
|
*
|
Peter
M Rooney
|
96,345
|
35,056
|
61,289
|
*
|
Philip
A. Sigel Sunset Cove Irrevocable Trust (13)
|
3,043,715
|
1,141,142
|
1,902,573
|
3.6
|
Philip
W Smith III
|
565,738
|
214,021
|
351,717
|
*
|
PRK
Partners LP (14)
|
438,931
|
146,833
|
292,098
|
*
|
Ralph
I. Rugolo Trust dtd 8/20/91
|
31,036
|
12,596
|
18,440
|
*
|
Ralph
Worthington
|
518,386
|
210,492
|
307,894
|
*
|
Ratherby
Investments, LLC
|
172,453
|
69,993
|
102,460
|
*
|
Ratherby
Torch LLC
|
258,679
|
104,989
|
153,690
|
*
|
Raymond
& Catherine Marzulli
|
212,870
|
71,131
|
141,739
|
*
|
Raymond
L. Schettino
|
344,357
|
139,711
|
204,646
|
*
|
Richard
G. and Dorothy C. Hyman
|
51,838
|
21,049
|
30,789
|
*
|
Richard
Melnick
|
1,788,772
|
794,386
|
994,386
|
1.9
|
Robert
Bailey
|
172,795
|
70,164
|
102,631
|
*
|
Robert
G. Murphy Jr.
|
688,716
|
279,423
|
409,293
|
*
|
Robert
W. Holmes IRA
|
439,783
|
147,179
|
292,604
|
*
|
RPLLC
|
473,165
|
176,840
|
296,325
|
*
|
RRNR
Investments LLC
|
785,374
|
287,507
|
497,867
|
1.0
|
Ryan
N. Johnson
|
829,418
|
336,787
|
492,631
|
*
|
S
Clarke Moody
|
1,588,692
|
531,108
|
1,057,584
|
2.0
|
Sean
Flanagan
|
95,902
|
35,802
|
60,100
|
*
|
Shawn
T. Pearce IRA
|
103,676
|
42,098
|
61,578
|
*
|
Skyler
Ward
|
117,081
|
47,502
|
69,579
|
*
|
Stacy
L. Giunta Revocable Trust (15)
|
219,453
|
73,330
|
146,123
|
*
|
Stefan
D. Powell
|
345,936
|
140,468
|
205,468
|
*
|
Steven
Jun Isaki
|
223,831
|
90,812
|
133,019
|
*
|
Terri
Sanker Taube
|
172,179
|
69,856
|
102,323
|
*
|
The
Entrust Group as custodian for the John Cox IRA
|
86,397
|
35,082
|
51,315
|
*
|
Thomas
de Neufville
|
172,795
|
70,164
|
102,631
|
*
|
Todd
Bates
|
43,968
|
14,714
|
29,254
|
*
|
Trust
B fbo Amory L. Ross
|
172,795
|
70,164
|
102,631
|
*
|
Udai
Tennati
|
69,119
|
28,066
|
41,053
|
*
|
Vincent
V. Basile & Lara Coraci Basile
|
344,357
|
139,711
|
204,646
|
*
|
William
Benjamin Holmes
|
69,119
|
28,066
|
41,053
|
*
|
William
E. Webbe IV
|
109,834
|
36,719
|
73,115
|
*
|
William
Edward Webbe V
|
564,028
|
213,150
|
350,878
|
*
|
William
H. Combs
|
44,062
|
14,752
|
29,310
|
*
|
William
J. May
|
172,179
|
69,856
|
102,323
|
*
|
William
M. Cody
|
172,795
|
70,164
|
102,631
|
*
|
William
or Andrea Weitzman
|
34,559
|
14,033
|
20,526
|
*
|
William
Pyznar
|
587,518
|
214,838
|
372,680
|
*
|
William
Stewart
|
86,089
|
34,928
|
51,161
|
*
|
(1)
|
Except
as noted below, beneficial ownership is determined in accordance
with the rules of the SEC and generally includes voting or
investment power with respect to securities. All entries exclude
beneficial ownership of shares issuable pursuant to warrants,
options or other derivative securities that have not vested or that
are not otherwise exercisable as of the date hereof or which will
not become vested or exercisable within 60 days of February 10,
2021.
|
(2)
|
Based
upon the internal books and records of the Company. Assumes full
conversion of Series B Preferred Stock, pursuant to the Series B
Exchange Right, into shares of Series C Preferred Stock and Series
B Exchange Warrants. May not include purchases and sales of Common
Stock, following the consummation of the Series B Offering, which
have not been recorded directly in the share register maintained by
the Company’s transfer agent. Assumes that the Stockholder
Approval has been obtained, such that any shares of Series C
Preferred Stock and Series B Exchange Warrants issuable pursuant to
the Series B Exchange Right are fully convertible or exercisable
into shares of Common Stock. Includes (i) shares of Common Stock
issuable upon conversion of Series C Preferred Stock; (ii) shares
of Common Stock issuable upon exercise of the Series B Exchange
Warrants; and (iii) shares of Common Stock issuable upon exercise
of other outstanding warrants.
|
(3)
|
Includes
shares of Common Stock which are not being offered pursuant to this
prospectus.
|
(4)
|
All
percentage calculations are based on 53,418,712 shares of Common
Stock outstanding as of February 10, 2021 and are rounded to the
nearest tenth of a percent. Warrants, options or other derivative
securities that are presently exercisable or exercisable within 60
days are deemed to be beneficially owned by the person holding such
securities for the purpose of calculating the percentage ownership
of that person, but are not treated as outstanding for the purpose
of calculating the percentage ownership of any other
person.
|
(5)
|
Includes shares of
Common Stock issuable upon conversion of Series B Preferred Stock
and shares issuable upon exercise of warrants held by Harbor Watch
Partners, LP; and (ii) shares of Common Stock issuable upon
conversion of the Series B Preferred Stock and shares of Common
Stock issuable upon exercise of warrants held by Trust B fbo Amory
L. Ross. As General Partner of Harbor Watch Partners, LP, Amory
Ross holds sole voting and dispositive power over the shares held
by such entity. As Trustee of Trust B fbo Amory L. Ross, Amory Ross
holds sole voting and dispositive power over the shares held by
such entity.
|
(6)
|
As General Partner
of BTR Partners, Ben Ross holds sole voting and dispositive power
over the shares held by such entity.
|
(7)
|
Includes shares of
Common Stock issuable upon exercise of warrants issued in
connection with certain previous transactions. The selling
stockholder is affiliated with Alexander Capital LP, which acted as
placement agent in connection with such
transactions.
|
(8)
|
Includes shares of
Common Stock held directly by the selling stockholder and shares of
Common Stock issuable upon exercise of warrants held by EBR
Ventures, LLC. Edmund Burke Ross, Jr. is the Manager of EBR
Ventures, LLC and has voting and dispositive power over the shares
held by such entity. The address of Mr. Ross, Jr. is c/o JDJ Family
Office Services, P.O. Box 962049, Boston, MA
02196.
|
(9)
|
Includes (i)
409,773 shares of Common Stock; (ii) 80,021 shares of Common Stock
issuable upon the exercise of warrants; (iii) 100,000 shares of
Common Stock issuable upon exercise of vested options; and (iv)
13,680 shares of Common Stock held by Mr. Borkowski’s spouse.
Excludes 40,000 shares of Common Stock issuable upon exercise of
unvested options.
|
(10)
|
As General Partner
of JABCO LP, J. Geddes Parsons holds sole voting and dispositive
power over the shares held by such entity.
|
(11)
|
Includes 50,000
shares of Common Stock issuable upon exercise of vested options.
Excludes 1,450,000 shares of Common Stock issuable upon exercise of
unvested options.
|
(12)
|
As Trustee of
Kathryn M. Parsons Rev. Trust, Kathryn M. Parsons holds sole voting
and dispositive power over the shares held by such
entity.
|
(13)
|
As Trustee of
Philip A. Sigel Sunset Cove Irrevocable Trust, Philip A. Sigel
holds sole voting and dispositive power over the shares held by
such entity.
|
(14)
|
As a principal of
PRK Partners, LP, Parthenia Ross Kiersted holds sole voting and
dispositive power over the shares held by such
entity.
|
(15)
|
As Trustee of Stacy
L. Giunta Revocable Trust, Stacy L. Giunta holds sole voting and
dispositive power over the shares held by such
entity.
|
(16)
|
Joshua Scheinfeld
and Jonathan Cope, the principals of Lincoln Park Capital Fund,
LLC, are deemed to be the beneficial owners of all shares of Common
Stock owned by Lincoln Park Capital Fund, LLC. Messrs. Scheinfeld
and Cope have shared voting power.
|
|
Amount
|
SEC Registration
Fee
|
$4,160
|
Legal Fees and
Expenses
|
50,000
|
Accounting Fees and
Expenses
|
10,000
|
Transfer Agent and
Registrar fees and expenses
|
2,000
|
Miscellaneous
Expenses
|
2,000
|
|
|
Total expenses
|
$68,160
|
Exhibit No.
|
|
Description
|
|
|
|
|
Amended and Restated Certificate of Incorporation of the Registrant
(Incorporated by reference from Exhibit 3.1 filed with Registration
Statement on Form S-1, filed July 13, 2016).
|
|
|
Amended and Restated Bylaws (incorporated by reference to Exhibit
3.1 of the Company’s Current Report on Form 8-K filed with
the SEC on August 5, 2020).
|
|
|
Certificate of Amendment to Certificate of Incorporation of the
Registrant (incorporated by reference to Exhibit 3.1 of the
Company’s Current Report on Form 8-K filed with the SEC on
December 30, 2019).
|
|
|
Certificate of the Designations, Powers, Preferences and Rights of
Series B Convertible Preferred Stock (incorporated by reference to
Exhibit 3.1 of the Company’s Current Report on Form 8-K filed
with the SEC on July 20, 2020).
|
|
|
Form of common stock Certificate (Incorporated by reference from
Exhibit 4.1 filed with Amendment No 1. to Registration Statement on
Form S-1, filed July 29, 2016).
|
|
|
Form of Series B Exchange Warrant (incorporated by reference to
Exhibit 4.2 of the Company’s Current Report on Form 8-K filed
with the SEC on January 4, 2021).
|
|
|
Opinion of Lowenstein Sandler LLP (filed
herewith).
|
|
|
Consent of Lowenstein Sandler LLP (included in Exhibit 5.1) (filed
herewith).
|
|
|
Consent of Independent Registered Public Accounting Firm –
Mazars USA LLP (previously filed).
|
|
|
Power of Attorney (included in signature page).
|
*
|
Filed herewith.
|
|
AZURRX BIOPHARMA, INC.
|
|
By: /s/
James Sapirstein
Name: James
Sapirstein
Title:
President and Chief Executive Officer
(Principal Executive
Officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ James Sapirstein
|
|
President, Chief Executive Officer and
Director
|
|
February 11, 2021
|
James Sapirstein
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Daniel Schneiderman
|
|
Chief Financial Officer
|
|
February 11, 2021
|
Daniel Schneiderman
|
|
(Principal
Financial Officer and
Principal
Accounting Officer)
|
|
|
|
|
|
|
|
*
|
|
Chair of the Board of Directors
|
|
February 11, 2021
|
Edward J. Borkowski
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
February 11, 2021
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Charles Casamento
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Director
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February 11, 2021
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Alastair Riddell
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Director
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February 11, 2021
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Gregory Oaks
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Director
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February 11, 2021
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Vern Lee Schramm
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By: /s/ James Sapirstein
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Attorney-in-Fact
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1 Year AzurRx BioPharma Chart |
1 Month AzurRx BioPharma Chart |
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