GridAI Technologies Corp 8-K, filed Nov 17, 2020
GridAI Technologies Corp. (GRDX)
8-K
2020-11-17
For: 2020-11-17
View Original
Added on
April 11, 2026
About this 8-K
GridAI Technologies Corp filed this 8-K on November 17, 2020.
Items reported
- Item 3.01: Delisting notice or listing transfer
- Item 8.01: Other events
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)
|
|
|
|
|
|
|
Delaware
|
|
021-214723
|
|
46-4993860
|
|
(State or Other Jurisdiction
of Incorporation)
|
|
(Commission
File Number)
|
|
(I.R.S. Employer
Identification No.)
|
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)
[
]
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:
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
|
Common
Stock, par value $0.0001 per share
|
AZRX
|
Nasdaq
Capital Market
|
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
|
Exhibit No.
|
Description
|
|
|
|
|
Press Release issued by the Company, dated November
17, 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.
|
November
17, 2020
|
AzurRx BioPharma, Inc.
By:
/s/ James
Sapirstein
Name:
James Sapirstein
Title:
President and Chief Executive Officer
|
Exhibit 99.1
AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2
Study of MS1819 in Cystic Fibrosis Patients
Potential to add additional study arm utilizing immediate release
capsules
Trial objectives, endpoints and statistical analysis to remain the
same
DELRAY BEACH, Florida, Nov. 17, 2020 (GLOBE NEWSWIRE) -- AzurRx
BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the
“Company”), a company specializing in the development
of non-systemic, recombinant therapies
for gastrointestinal diseases, today announced that it will be
submitting a protocol amendment request to the U.S. Food and Drug
Administration (FDA) for its Phase 2b OPTION 2 trial of MS1819 for
the treatment of exocrine pancreatic insufficiency in patients with
cystic fibrosis. The proposed amendment will add a study arm
that uses an immediate release MS1819 capsule, allowing the Company
to compare data from the existing arm that uses enteric (delayed
release) capsules with data from the new arm, and ultimately select
the optimal delivery method.
“We are pleased to announce that our OPTION 2 trial is well
ahead of schedule and almost fully enrolled without any safety
issues being observed,” said Dr. James Pennington, Chief
Medical Officer of AzurRx. “As this trial progresses, we
believe there may be significant clinical value in adding a study
arm that uses our immediate release capsules. Our intention is to
identify the optimal delivery method and potentially provide
additional scientific support and optionality for
MS1819.”
Dr. Pennington added, “The key objectives of any Phase 2
program are to test for safety and efficacy, but another important
goal is to determine appropriate doses and drug delivery method
prior to entering the Phase 3 portion of the clinical program. If
the amendment is accepted by the FDA, we anticipate enrollment into
the new study arm to begin in December 2020.”
James Sapirstein, CEO of AzurRx commented, “The protocol
amendment represents an opportunity to gain valuable additional
clinical data with no significant increase in overall trial costs
or delays to our timeline projections. We remain on target to
release top line data in the first quarter of 2021, as has been our
guidance to date.”
About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical
company specialized in the research and development of
non-systemic biologics for gastrointestinal disorders. The
Company is focused on the development of its lead
drug candidate, MS1819. AzurRx is currently conducting two
Phase 2 clinical trials of MS1819: the OPTION 2
monotherapy trial, and the Combination therapy
trial, consisting of MS1819 in conjunction with
porcine-derived pancreatic enzyme replacement therapy, the
current standard of care. The Company is headquartered in Delray
Beach, Florida with clinical operations in Hayward, California.
Additional information on the Company can be found
at www.azurrx.com.
Forward-Looking Statements
This press release may contain certain statements relating to
future results which are forward-looking statements. These
statements are not historical facts, but instead represent only the
Company’s belief regarding future events, many of which, by
their nature, are inherently uncertain and outside of the
Company’s control. 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, 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 such as the interim results presented will be
indicative of the final results of the trial. Additional
information concerning the Company and its business, including a
discussion of factors that could materially affect the
Company’s financial results, including those related to the
clinical development of MS1819, the results of its clinical trials,
and the impact of the coronavirus (COVID-19) pandemic on the
Company’s operations and current and planned clinical trials,
including, but not limited to delays in clinical trial recruitment
and participation 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.
760 Parkside Avenue, Suite 327F
Brooklyn, NY 11226
Phone: (646)-699-7855
info@azurrx.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