Current Report Filing (8-k)
August 11 2020 - 5:23PM
Edgar (US Regulatory)
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): August 11, 2020
Commission
File Number: 021-214723
AzurRx BioPharma, Inc.
(Exact
name of registrant as specified in its charter.)
Delaware
(State
or other jurisdiction of incorporation or
organization)
46-4993860
(IRS
Employer Identification No.)
760 Parkside Ave., Suite 304, Brooklyn, New York 11226
(Address
of principal executive offices)
646-699-7855
(Registrant's
Telephone number)
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:
[ ]
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))
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) or Rule 12b-2 of the Securities Exchange Act of 1934 (17
CFR 240.12b-2)
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. [ ]
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class
Common
Stock, par value $0.0001 per share
Trading Symbol(s)
AZRX
Name of exchange on which registered
Nasdaq
Capital Market
Item 7.01. Regulation FD Disclosure.
On August 11, 2020, AzurRx BioPharma, Inc. (the
“Company”) issued a press release announcing
positive interim data from the first patient cohort in its Phase 2
clinical trial of MS1819 in combination with PERT therapy for the
treatment of severe exocrine pancreatic insufficiency in patients
with cystic fibrosis (the “Phase 2
Trial”). A copy of the
press release is attached hereto as Exhibit
99.1.
The
Company’s management also hosted a conference call on August
11, 2020 to discuss the interim data results of the Phase 2 Trial.
A copy of the presentation utilized during the conference call is
attached hereto as Exhibit 99.2.
The information in this Item 7.01 of this
Current Report on Form 8-K, including the
information set forth in Exhibits 99.1 and 99.2, is being
furnished and shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as
amended (the “Exchange
Act”), nor shall Exhibits
99.1 or 99.2 filed herewith be deemed incorporated by reference in
any filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific
reference in such a filing.
In addition, statements in this Current Report on
Form 8-K and the exhibit(s) attached hereto about Company’s
future expectations, plans and prospects, as well as any other
statements regarding matters that are not historical facts, may
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. These statements
include, but are not limited to, statements about the
Company’s strategy and clinical development plans. The words
“anticipate,” “believe,”
“continue,” “could,”
“estimate,” “expect,” “intend,”
“may,” “plan,” “potential,”
“predict,” “project,” “should,”
“target,” “would” and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Actual results, performance
or achievements of the company and its clinical
trials may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including whether the Company’s cash resources will
be sufficient to fund its continuing operations for the periods
and/or trials anticipated; 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 such as the interim results
presented will be indicative of the final results of the trial;
whether Company’s product candidates will advance through the
clinical trial process on a timely basis, or at all; whether the
results of such trials will warrant submission for approval from
the United States Food and Drug Administration or equivalent
foreign regulatory agencies; whether Company’s product
candidates will receive approval from regulatory agencies on a
timely basis or at all; whether, if product candidates obtain
approval, they will be successfully distributed and marketed;
whether the coronavirus pandemic will have an impact on the timing
of our clinical development, clinical supply and our operations;
and other factors discussed in the “Risk Factors”
section of the Company’s annual report on
Form 10-K for the period ended December 31, 2019, and
risks described in other filings that the Company may make with the
Securities and Exchange Commission. Any forward-looking statements
contained in this report and the exhibit(s) attached speak only as
of the date hereof, and the Company specifically disclaims any
obligation to update any forward-looking statement, whether because
of new information, future events or otherwise.
Item 9.01. Financial Statements
and Exhibits.
Exhibit No.
|
Description
|
|
Press
Release dated August 11, 2020.
|
|
Corporate Presentation, dated August 11, 2020.
|
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.
|
AzurRx BioPharma,
Inc.
By: /s/ James
Sapirstein
Name: James
Sapirstein
Title:
President and Chief Executive Officer
|
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