Attached files
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| EX-99.1 - ADDITIONAL EXHIBITS - AzurRx BioPharma, Inc. | ex99-1.htm |
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): November 17,
2020
AzurRx BioPharma, Inc.
(Exact Name of Registrant as Specified in
Charter)
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Delaware
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021-214723
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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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760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(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)
[
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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 3.01 Notice of Delisting or Failure to Satisfy a Continued
Listing Rule or Standard; Transfer of Listing.
As
previously reported, on August 21, 2020, AzurRx BioPharma, Inc.
(the “Company”) received a letter from the Listing
Qualifications Department (the “Staff”) of The Nasdaq
Stock Market LLC, notifying the Company that it was not in
compliance with Listing Rule 5550(b)(1) based on a deficit in
stockholders’ equity reported as of June 30,
2020.
On
November 17, 2020, the Company received a follow up letter from the
Staff, notifying the Company that it has regained compliance with
Nasdaq Listing Rule 5550(b)(1) based on its Form 10-Q filed
November 16, 2020, which reported stockholders’ equity of
approximately $14.1 million as of September 30, 2020.
Accordingly, the
Staff has determined that the matter is now closed.
Item 8.01 Other Events.
On
November 17, 2020, the Company announced that it will be submitting
a protocol amendment request to the U.S. Food and Drug
Administration for its Phase 2b OPTION 2 trial of MS1819 for the
treatment of exocrine pancreatic insufficiency in patients with
cystic fibrosis. A copy of the press release is attached hereto as
Exhibit 99.1 and incorporated by reference herein.
Exhibit
Index
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Exhibit No.
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Description
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Press Release issued by the Company, dated November
17, 2020.
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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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November
17, 2020
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AzurRx BioPharma, Inc.
By:
/s/ James
Sapirstein
Name:
James Sapirstein
Title:
President and Chief Executive Officer
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