UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): February 24,
2021
AzurRx BioPharma, Inc.
(Exact Name of Registrant as Specified in
Charter)
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Delaware
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001-37853
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46-4993860
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(State or Other Jurisdiction
of Incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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1615 South Congress Avenue, Suite 103
Delray Beach, Florida 33445
(Address of Principal Executive Offices, and Zip Code)
(646) 699-7855
Registrant’s Telephone Number, Including Area
Code
Not Applicable
(Former Name or Former Address, if Changed Since Last
Report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
[
] Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
[
] Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
[
] Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
[
] Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common
Stock, par value $0.0001 per share
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AZRX
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Nasdaq
Capital Market
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Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (17
CFR §230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR §240.12b-2 of this
chapter).
Emerging growth company [X]
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. ☐
Item 3.02 Unregistered Sales of Equity
Securities.
January 2021 Offerings
As
previously reported in the Prior 8-Ks (as defined below), on
January 6, 2021, AzurRx BioPharma, Inc. (the “Company”)
consummated the sale and issuance, in a concurrent registered
direct offering and private placement (the “Offerings”)
to a single accredited investor (the “Investor”), of
(i) an aggregate of 10,666.6666 shares of its Series C 9.00%
Convertible Junior Preferred stock, par value $0.0001 per share
(the “Series C Preferred Stock”), which were initially
convertible into an aggregate of 10,666,668 shares of its common
stock, par value $0.0001 per share (the “Common
Stock”), at an initial stated value of $750.00 per share and
an initial conversion price of $0.75 per share, together with (ii)
warrants to purchase up to an aggregate of 10,666,668 shares of
Common Stock (the “Investor Warrants”), at an initial
exercise price of $0.80 per share and an expiration term through
July 6, 2026. The aggregate purchase price in such offerings was
$750.00 per share of Series C Preferred Stock and related Investor
Warrants. In the Offerings, 5,333.3333 shares of Series C
Preferred Stock were issued in the registered direct offering, and
5,333.3333 shares of Series C Preferred Stock and all of the
Investor Warrants were issued in the concurrent private
placement.
In
addition, on January 8, 2021, the Company issued to First Wave Bio,
Inc. (“First Wave”) 3,290.1960 shares of Series C
Preferred Stock, which were initially convertible into an aggregate
of 3,290,196 shares of Common Stock, as part of the consideration
for entering into the License Agreement, dated as of December 31,
2020, between First Wave and the Company.
Pursuant to the
terms of the Series C Preferred Stock and the Investor Warrants,
the foregoing shares of Series C Preferred Stock issued to the
Investor and to First Wave were not convertible in excess of
certain specified thresholds, and the related Investor Warrants
were not exercisable at all, until the Company obtained certain
stockholder approvals. As a result of the approval of Proposals 1
and 2 (the “Stockholder Approvals”) reported in Item
5.07 below, all of the foregoing shares of Series C Preferred
Stock, and all of the related Investor Warrants, have now become
convertible or exercisable, as the case may be, into shares of
Common Stock without limitation.
The
Investor previously requested the conversion of shares of Series C
Preferred Stock into the maximum issuable amount of 6,186,966
shares of Common Stock. On February 24, 2021, the Company elected
to convert the remaining balance of such shares of Series C
Preferred Stock, including accrued and unpaid dividends thereon, in
full into 4,539,863 additional shares of Common Stock for the
account of the Investor and 3,329,138 shares of Common Stock for
the account of First Wave. Accordingly, the shares of Series C
Preferred Stock issued to the Investor and to First Wave are no
longer outstanding.
The
terms and conditions of the Offerings and of the Series C Preferred
Stock and the Investor Warrants were previously disclosed in the
Company’s Current Reports on Form 8-K filed January 5, 2021
and January 8, 2021 (the “Prior 8-Ks”), which are
incorporated herein by reference.
Series B Exchange Rights
As
previously reported in the Prior 8-Ks, the Company previously
issued certain shares of Series B Convertible Preferred Stock, par
value $0.0001 per share (the “Series B Preferred
Stock”), which carry a right to exchange the stated value,
plus accrued and unpaid dividends thereon, of the Series B
Preferred Stock (the “Exchange Amount”) 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 (the
“Series B Exchange Rights”). As a result of the
Offerings, pursuant to the Series B Exchange Rights, the Company
became obligated to issue additional shares of Series C Preferred
Stock and additional Investor Warrants to any holders of Series B
Preferred Stock who elect to exercise their Series B Exchange
Rights.
Pursuant to the
terms of the Series C Preferred Stock and the Investor Warrants,
the foregoing shares of Series C Preferred Stock were not to be
convertible in excess of certain previously approved thresholds,
and the related Investor Warrants were not to be exercisable at
all, until the Company obtained certain stockholder approvals. As a
result of the Stockholder Approvals reported in Item 5.07 below,
all of the foregoing shares of Series C Preferred Stock, and all of
the related Investor Warrants, issued or issuable in respect of the
Series B Exchange Right have now become, or upon issuance will be,
convertible or exercisable, as the case may be, into shares of
Common Stock without limitation.
As of February 24,
2021, holders of 1,055.554085 shares
of Series B Preferred Stock with an aggregate Exchange Amount of
approximately $8.2 million had
previously elected to exercise their Series B Exchange Rights into
Series C Preferred Stock, convertible into an aggregate of
10,905,306 shares of
Common Stock (which conversion the Company has elected to make in
full), and additional Investor Warrants exercisable for up to an
aggregate of 10,903,168 shares of
Common Stock. In addition, as of February 24, 2021, 1,466.753351 shares
of Series B Preferred Stock with an aggregate Exchange Amount of
approximately $11.4 million
currently remain outstanding, which are currently exchangeable for
Series C Preferred Stock convertible into an aggregate of up to
15,244,628 shares of
Common Stock and additional Investor Warrants exercisable for up to
an aggregate of 15,244,628 shares of
Common Stock.
The
further terms and conditions applicable to the Series B Exchange
Rights were previously disclosed in the Prior 8-Ks, which are
incorporated herein by reference.
Placement Agent Warrants
As
previously reported in the Prior 8-Ks, as part of its compensation
to in connection with the Offerings described above, the Company
previously issued to the placement agent or its designees certain
warrants to purchase up to 746,667 shares of Common Stock at an
initial exercise price of $0.9375 per share. Other than the
exercise price, the terms of the Placement Agent Warrants were
substantially the same as the Investor Warrants. As a result of the
Stockholder Approval reported in Item 5.07 below, all of the
Placement Agent Warrants have now become exercisable into shares of
Common Stock without limitation.
Item 5.03 Amendments to the Articles of Incorporation or
Bylaws; Change in Fiscal Year.
On
February 24, 2021, following the approval of Proposal 2 reported in
Item 5.07 below, the Company filed with the Secretary of State of
the State of Delaware a Certificate of Amendment (the
“Certificate of Amendment”) to its Certificate of
Incorporation (the “Charter”), increasing the total
number of authorized shares of Common Stock to 250,000,000. A copy
of the Certificate of Amendment is attached hereto as Exhibit 3.1
and incorporated by reference herein.
Item 5.07 Submission of Matters to a Vote of Security
Holders.
On
February 24, 2021, the Company held a Special Meeting of
Stockholders (the “Special Meeting”). The matters voted
on at the Special Meeting were the following proposals: (1) the
approval, pursuant to Nasdaq Listing Rule 5635, of the issuance of
Common Stock upon conversion of the Company’s Series C 9.00%
Convertible Junior Preferred Stock (the “Series C Preferred
Stock”) and other securities in excess of 20% of the Common
Stock outstanding, (2) the approval to amend the Charter to
increase the total number of authorized shares of Common Stock by
100,000,000 shares to 250,000,000 shares, (3) the approval to amend
the Charter to authorize the Board of Directors of the Company (the
“Board”) to effect a reverse stock split of both the
issued and outstanding and authorized shares of Common Stock, at a
specific ratio, ranging from one-for-five (1:5) to one-for-ten
(1:10), at any time prior to the one-year anniversary date of the
Special Meeting, with the exact ratio to be determined by the Board
(the “Reverse Split”) and (4) the approval of the
adjournment of the Special Meeting to the extent there are
insufficient proxies at the Special Meeting to approve any one or
more of the foregoing proposals
At the
Special Meeting, all four of the foregoing stockholder proposals
were approved, based upon an aggregate of 31,250,382 shares of
Common Stock outstanding as of January 4, 2021, which was the
record date for the Special Meeting. The final voting results were
as follows:
1.
The proposal to
approve, pursuant to Nasdaq Listing Rule 5635, the issuance of
Common Stock upon conversion of the Series C Preferred Stock and
other securities in excess of 20% of the Common Stock outstanding
was approved by a majority of votes cast, based upon the following
votes:
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Votes
For
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Votes
Against
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Abstentions
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Broker
Non-Votes
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16,594,085
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1,334,458
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202,045
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4,734,037
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2.
The proposal to
approve the amendment of the Charter to increase the total number
of authorized shares of Common Stock by 100,000,000 shares to
250,000,000 shares was approved by a majority of shares
outstanding, based upon the following votes:
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Votes
For
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Votes
Against
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Abstentions
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Broker
Non-Votes
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15,962,929
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2,038,383
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129,276
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4,734,037
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3.
The proposal to
approve the amendment to the Charter to authorize the Board to
effect the Reverse Stock Split at any time prior to the one-year
anniversary date of the Special Meeting was approved by a majority
of shares outstanding, based upon the following votes:
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Votes
For
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Votes
Against
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Abstentions
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20,603,965
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2,127,947
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132,713
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4.
The proposal to
approve the adjournment of the Special Meeting to the extent that
there are insufficient proxies at the Special Meeting to approve
any one or more of the foregoing proposals was approved by a
majority of votes cast, based upon the following
votes:
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Votes
For
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Votes
Against
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Abstentions
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21,044,013
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1,721,449
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99,163
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Item 7.01. Regulation FD Disclosure
On
February 24, 2021, the Company issued a press release announcing
that James Sapirstein was appointed as chairman of the
Company’s Board. A copy of the press release is furnished as
Exhibit 99.1.
Item
9.01. Financial Statements and Exhibits.
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Exhibit
No.
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Description
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Certificate
of Amendment to the Certificate of Incorporation of AzurRx
BioPharma, Inc.
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Press
Release dated February 24, 2021
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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February
25, 2021
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AzurRx BioPharma, Inc.
By:
/s/
James Sapirstein
Name:
James Sapirstein
Title:
President and Chief Executive Officer
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Exhibit 3.1
CERTIFICATE OF AMENDMENT TO THE
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
AZURRX BIOPHARMA, INC.
AzurRx BioPharma, Inc. (the “Corporation”), a corporation organized and existing
under and by virtue of the General Corporation Law of the State of
Delaware, does hereby certify as follows:
FIRST: That a resolution
was duly adopted on December 31, 2020, by the Board of Directors of
the Corporation pursuant to Section 242 of the General Corporation
Law of the State of Delaware setting forth an amendment to the
Certificate of Incorporation of the Corporation and declaring said
amendment to be advisable. The stockholders of the Corporation duly
approved said proposed amendment at a special meeting of
stockholders held on February 24, 2021 in accordance with Section
242 of the General Corporation Law of the State of Delaware. The
proposed amendment set forth as follows:
Article FOURTH of the Amended and Restated Certificate of
Incorporation of the Corporation, as amended to date, be and hereby
is amended by deleting the following sentence in the first
paragraph of Article FOURTH:
The total number of shares which the Corporation shall have
authority to issue is one hundred sixty million (160,000,000)
shares, of which one hundred and fifty million (150,000,000) shares
shall be common stock, par value $0.0001 per share, and ten million
(10,000,000) shares shall be preferred stock, par value $0.0001 per
share.
The sentence reflected above under the first paragraph of
Article FOURTH will be replaced by the
following:
The total number of shares which the Corporation shall have
authority to issue is two hundred and sixty million (260,000,000)
shares, of which two hundred and fifty million (250,000,000) shares
shall be common stock, par value $0.0001 per share, and ten million
(10,000,000) shares shall be preferred stock, par value $0.0001 per
share.
SECOND: That said
amendment will have an Effective Time of February 24, 2021 at 5:00
P.M., Eastern Time, on the filing date of this Certificate of
Amendment to the Amended and Restated Certificate of
Incorporation
IN WITNESS WHEREOF, the Corporation has caused this Certificate of
Amendment to be signed by its President and Chief Executive Officer
this 24th
day of February,
2021.
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/s/ James
Sapirstein
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James
Sapirstein
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President and Chief Executive Officer
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Exhibit 99.1
AzurRx BioPharma Appoints President and CEO James Sapirstein as New
Chairman of the Board of Directors
Former Chairman Edward J. Borkowski to continue as the lead
independent director on the board
DELRAY
BEACH, FL., February 24, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma,
Inc. (NASDAQ: AZRX), (“AzurRx” or the
“Company”), a clinical stage biopharmaceutical company
specializing in the development of targeted, non-systemic therapies
for gastrointestinal (GI) diseases, announced today the
appointment of James Sapirstein, President and CEO, as chairman of
the company’s board of directors, effective immediately. Mr.
Sapirstein succeeds Mr. Edward J. Borkowski, who joined the AzurRx
board in May 2015 and has served as chairman since April 2016. Mr.
Borkowski will remain as lead independent director of the board of
directors.
“AzurRx
is on the verge of several important inflection points, and I am
pleased to take on additional responsibilities at this exciting
stage in the company's evolution,” said Mr. Sapirstein.
“I look forward to working with Ed and the other Board
members to propel a business and clinical strategy that, I believe,
has the potential to transform AzurRx and generate substantial
value for the company and our shareholders. I look forward to
advancing the clinical programs for our lead investigational
candidate, MS1819, and our novel niclosamide therapies to rapidly
deliver safe and efficacious product candidates to patients who
need them the most.”
Mr.
Sapirstein added, “On behalf of the Board, I want to express
my appreciation to Ed for his years of service to AzurRx. Under his
dedicated stewardship, AzurRx has advanced its mission to develop
world-class medicines that address serious disease-related GI
complications. I am grateful for all that Ed has contributed to
AzurRx and look forward to his ongoing input as a member of the
Board and our lead independent director.”
“Having
served on AzurRx’s Board since 2015, I am committed to
ensuring a prosperous future for the company,” stated Mr.
Borkowski. “Under James’ leadership, AzurRx has
strategically expanded its existing pipeline to pursue new
opportunities in the treatment of gastrointestinal conditions. The
recent licensing agreement with First Wave Bio represents an
exciting new chapter in the company’s growth with the
potential to generate both near-term and long-range returns for
AzurRx shareholders. James has been instrumental in implementing
this strategy, and he is ideally suited to lead the company as both
Chairman and CEO as we seek to maximize the full potential of
AzurRx’s pipeline and advance our clinical development
programs.”
About James Sapirstein
James
Sapirstein was named President and Chief Executive Officer of
AzurRx Therapeutics in October 2019 Mr. Sapirstein arrived at
AzurRx from ContraVir Pharmaceuticals, Inc. (now known as Hepion
Pharmaceuticals, Inc.), where he served as chief executive officer
and board member. His career in the pharmaceutical industry has
spanned nearly 37 years with extensive expertise in drug
development and commercialization. Mr. Sapirstein has participated
in 23 product launches, including six global launches that he led,
and headed numerous business development transactions. Prior to
ContraVir, Mr. Sapirstein served as CEO of Alliqua Therapeutics, as
the founding CEO of Tobira Therapeutics, and as Executive Vice
President, Metabolic and Endocrinology for Serono Laboratories. Mr.
Sapirstein has also held senior level positions at Gilead, Bristol
Myers Squibb and Hoffmann-LaRoche. Mr. Sapirstein currently sits on
the boards of Marizyme, Leading Biosciences and Enochian
Biosciences. He also sits on the board on the Biotechnology
Innovation Organization’s (BIO) Emerging Companies Board and
serves as Chairman Emeritus of BioNJ. Mr. Sapirstein earned a B.S.
in Pharmacy from Rutgers University and received an MBA in
Management from Fairleigh Dickinson University.
About AzurRx BioPharma, Inc.
AzurRx
BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage
biopharmaceutical company specializing in the development
of targeted, non-systemic therapies for gastrointestinal (GI)
diseases. The Company has a pipeline of three gut-restricted GI
assets. 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.
AzurRx is launching two clinical programs using proprietary
formulations of niclosamide, a pro-inflammatory pathway
inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor
Colitis and diarrhea in oncology patients and FW-1022, for
COVID-19 gastrointestinal infections. The Company is headquartered
in Delray Beach, Florida with clinical operations in Hayward,
California. For more information, visit www.azurrx.com.
Forward-Looking Statement
This press release may contain certain statements relating to
future results which are forward-looking statements. It is possible
that the Company’s actual results and financial condition may
differ, possibly materially, from the anticipated results and
financial condition indicated in these forward-looking statements,
depending on factors including whether results obtained in
preclinical and nonclinical studies and clinical trials will be
indicative of results obtained in future clinical trials; whether
preliminary or interim results from a clinical trial will be
indicative of the final results of the trial; and the impact of the
coronavirus (COVID-19) pandemic on the Company’s operations
and current and planned clinical trials, including potential delays
in clinical trial recruitment and participation. Additional
information concerning the Company and its business, including a
discussion of factors that could materially affect the
Company’s financial results are contained in the
Company’s Annual Report on Form 10-K for the year ended
December 31, 2019 under the heading “Risk
Factors,” as well as the Company’s subsequent
filings with the Securities and Exchange Commission. All
forward-looking statements included in this press release are made
only as of the date of this press release, and we do not undertake
any obligation to publicly update or correct any forward-looking
statements to reflect events or circumstances that subsequently
occur or of which we hereafter become aware.
For more information:
AzurRx
BioPharma, Inc.
1615
South Congress Avenue
Suite
103
Delray
Beach, Florida 33445
Phone:
(646) 699-7855
info@azurrx.com
Media contact:
Tiberend Strategic Advisors,
Inc.
Johanna
Bennett/Ingrid Mezo
(212)
375-2665/(646) 604-5150
jbennett@tiberend.com/imezo@tiberend.com
Investor Relations contact:
LifeSci
Advisors, LLC.
Hans
Vitzthum, Managing Director
1
International Place, Suite 1480
Boston,
MA 02110
Phone:
(617) 430-7578
hans@lifesciadvisors.com