GridAI Technologies Corp 8-K, filed Apr 1, 2021
GridAI Technologies Corp. (GRDX)
8-K
2021-04-01
For: 2021-03-31
View Original
Added on
April 11, 2026
About this 8-K
GridAI Technologies Corp filed this 8-K on April 1, 2021, reporting on events of March 31, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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): March 31,
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 7.01 Regulation FD Disclosure
On
March 31, 2021, AzurRx BioPharma, Inc. (the “Company”)
issued a press release summarizing certain matters discussed on an
investor call reporting topline results from its Phase 2b OPTION 2
clinical trial investigating MS1819 in cystic fibrosis patients
with exocrine pancreatic insufficiency. A copy of the press release
is furnished as Exhibit 99.1 to this Form
8-K.
Item 9.01. Financial Statements and Exhibits.
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(d)
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Exhibits.
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Exhibit
No.
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Description
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Press
Release dated March 31, 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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April
1, 2021
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AzurRx BioPharma, Inc.
By:
/s/
James Sapirstein
Name:
James Sapirstein
Title:
President, Chief Executive Officer and Chairman
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Exhibit 99.1
AzurRx BioPharma Provides Key Takeaways from Phase 2b OPTION 2
Clinical Trial Topline Results Conference Call
DELRAY
BEACH, Fla., March 31, 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, today provided key takeaways from its conference call
reporting on the topline results from its Phase 2b OPTION 2
clinical trial investigating MS1819 in cystic fibrosis (CF)
patients with exocrine pancreatic insufficiency (EPI). The
conference call, held on March 31, 2021, at 4:30 p.m. ET, featured
James Sapirstein, President, CEO and Chairman of AzurRx, and Dr.
James Pennington, Chief Medical Officer, discussing the recently
completed OPTION 2 study, and the company’s plans to develop
an optimized formulation of MS1819 for ongoing clinical
investigation.
OPTION
2 was designed as a Phase 2b multi-center study to investigate the
safety, tolerability and efficacy of MS1819 (in enteric capsules)
in a head-to-head comparison against the current porcine enzyme
replacement therapy (PERT) standard of care for the treatment of
exocrine pancreatic insufficiency (EPI) in patients with cystic
fibrosis. The primary efficacy endpoint was the coefficient of fat
absorption (CFA), with secondary endpoints of stool weight, signs
and symptoms of malabsorption and coefficient of nitrogen
absorption (CNA). The trial also included an extension arm that
used 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.
Discussing
the topline results of OPTION 2 during the conference call, Mr.
Sapirstein commented, “To summarize, the best word to
describe the OPTION 2 topline results is mixed. MS1819 demonstrated
itself to be safe and well-tolerated and data from OPTION 2, and
other Phase 2 clinical trials, clearly demonstrate drug activity.
However, OPTION 2 did not consistently meet the primary efficacy
endpoint. Some patients were able to achieve CFA at levels beyond
what is required to demonstrate non-inferiority with PERT
therapies, but the majority did not, and as such, we did not meet
our trial goal.”
Mr.
Sapirstein continued, “The underlying cause of the
drug’s uneven efficacy performance in OPTION 2, we believe,
lies with the enteric capsule formulation. While the enteric
coating protects the capsule from breaking down in the stomach
acid, it also appears to dissolve too slowly in the small intestine
to release the lipase enzyme in time to aid with proper digestion
and nutrient absorption.”
“To
that end, we are planning to pursue a new formulation for MS1819,
this one a capsule filled with acid-resistant granules, or
microbeads, similar to what is used in CREON®, ZENPEP®
and other PERT therapies. Such a capsule would dissolve in the
stomach, disperse the beads, and then pass through to the small
intestine where the beads would break down and release the lipase
enzyme so that it thoroughly mixes with food as it is being
digested.”
Mr.
Sapirstein concluded, “We are moving full force with
developing the optimal formulation technology for MS1819 and have
already initiated discussions with contract manufacturers to
accelerate the process. This will require additional time and
resources. Yet we are fortunate, through financing efforts
that have raised an aggregate of approximately $22.5 million
in the first quarter of 2021, to have sufficient
capital currently on hand to fund this development and, within
the next year or so, initiate a further Phase 2 study to evaluate
efficacy, without substantially delaying our clinical
development initiatives in other areas.
We
firmly believe the cost-benefit ratio with MS1819 is clearly in our
favor. The drug’s mechanism of action is known and proven, it
offers numerous therapeutic, safety and compliance advantages over
today’s standard of care, and remains less cumbersome to
manufacture. Based on these factors, we believe that should this
optimized formulation prove successful in the clinic – and we
have every reason to believe it will – MS1819 could
eventually become the gold standard treatment for EPI in patients
with cystic fibrosis and chronic pancreatitis.”
An
audio webcast of the conference call will be accessible via the
Investors section of the AzurRx website at www.azurrx.com. An
archive of the webcast will remain available for approximately 90
days.
Phase 2 OPTION 2 Trial Design
The
Phase 2b OPTION 2 multi-center trial was designed to investigate
the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram
doses in enteric capsules) in a head-to-head comparison versus the
current standard of care, porcine pancreatic enzyme replacement
therapy pills. The OPTION 2 trial was 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 were enrolled. MS1819 was
administered in enteric capsules to provide gastric protection and
allow optimal delivery of enzyme to the duodenum. Patients were
first randomized into two cohorts: to either the MS1819 arm, where
they received a 2.2 gram daily oral dose of MS1819 for three weeks;
or to the PERT arm, where they received their pre-study dose of
PERT pills for three weeks. After three weeks, stools were
collected for analysis of coefficient of fat absorption. Patients
were then crossed over for another three weeks of the alternative
treatment. After three weeks of cross-over therapy, stools were
again collected for analysis of CFA. A parallel group of patients
were randomized and studied in the same fashion, using a 4.4 gram
daily dose of MS1819. All patients were followed for an additional
two weeks after completing both crossover treatments for post study
safety observation. Patients were assessed using descriptive
methods for efficacy, comparing CFA between MS1819 and PERT arms,
and for safety.
About MS1819
MS1819
is a recombinant lipase enzyme for the treatment of exocrine
pancreatic insufficiency associated with cystic fibrosis and
chronic pancreatitis. 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.
About Exocrine Pancreatic Insufficiency
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 in the U.S. with EPI caused by cystic
fibrosis according to the Cystic Fibrosis Foundation and
approximately 90,000 patients in the U.S with EPI caused by chronic
pancreatitis according to the National Pancreas Foundation.
Patients are currently treated with porcine pancreatic enzyme
replacement pills.
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 CF clinical trials. AzurRx is launching
two clinical programs using proprietary formulations of
niclosamide, a pro-inflammatory pathway inhibitor; FW-1022, for
COVID-19 gastrointestinal infections, and FW-420, for grade 1
Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in
oncology patients. 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