GridAI Technologies Corp 8-K, filed Jan 13, 2020
GridAI Technologies Corp. (GRDX)
8-K
2020-01-13
For: 2020-01-09
View Original
Added on
April 11, 2026
About this 8-K
GridAI Technologies Corp filed this 8-K on January 13, 2020, reporting on events of January 9, 2020.
Items reported
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 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): January 9, 2020
AZURRX BIOPHARMA, INC.
(Exact name of
Registrant as specified in its 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 or
Organization)
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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
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11226
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(Address of
principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code:(646) 699-7855
(Name, address,
including zip code, and telephone number, including area code, of
agent for service of process)
NOT APPLICABLE
(Former Name or
Former Address, if Changes Since Last Report)
Check the
appropriate box below if the Form 8-K 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))
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)
|
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)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR
240.12b-2) ☒
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
8.01. Other Events.
On January 9,
2020, AzurRx BioPharma, Inc. (the “Company”) issued a press
release announcing that it will present new data from five
patients enrolled in its Phase 2 study for its lead development
candidate MS1819-SD at the 2020 Biotech Showcase Conference being
held at the Hilton San Francisco Union Square Hotel (Yosemite C -
Ballroom Level) on Monday, January 13th at 3:00 p.m.
Pacific Time. A copy of the press
release is attached hereto as Exhibit 99.1.
This Current Report
on Form 8-K and the exhibit attached hereto may contain, among
other things, certain forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, including,
without limitation, (i) statements with respect to the Company's
plans, objectives, expectations and intentions; and (ii) other
statements identified by words such as "may", "could", "would",
"should", "believes", "expects", "anticipates", "estimates",
"intends", "plans" or similar expressions. These statements are
based upon the current beliefs and expectations of the Company's
management and are subject to significant risks and
uncertainties.
Item 9.01. Financial Statements and
Exhibits.
(d)
Exhibits
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Exhibit Number
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Description
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Press Release
issued by AzurRx BioPharma, Inc., dated January 9,
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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AzurRx BioPharma, Inc.
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Date: January 10,
2020
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By:
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/s/ James
Sapirstein
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Name: James Sapirstein
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Title: President and Chief Executive Officer
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Exhibit 99.1
AzurRx BioPharma To Present Interim Phase 2 Clinical Study Data for
MS1819-SD, in combination with standard PERT for Cystic Fibrosis
Patients with Severe Exocrine Pancreatic Insufficiency, at Biotech
Showcase 2020 Conference (January 13) in San Francisco
●
Initial
data from the first five patients indicate positive trends for all
primary and secondary safety and efficacy endpoints in
AzurRx’s Phase 2 Clinical Study for MS1819-SD, in combination
with standard PERT for Cystic Fibrosis patients with severe
exocrine pancreatic insufficiency.
●
New
data underscore the potential of MS1819 to provide meaningful
clinical benefits to patients suffering from severe exocrine
pancreatic insufficiency (EPI) as an add-on therapy.
NEW YORK, January 9, 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 it will present
new data from five patients enrolled in its Phase 2 study for its
lead development candidate MS1819-SD at the 2020 Biotech Showcase
Conference being held at the Hilton San Francisco Union Square
Hotel (Yosemite C - Ballroom Level) on Monday, January
13th at 3:00 p.m. Pacific Time.
The Phase 2 clinical trial is designed to investigate the safety,
tolerability and efficacy of escalating doses of MS1819-SD, in
conjunction with a stable dose of PERTs, in order to increase the
coefficient of fat absorption (CFA) and relieve abdominal symptoms
in Cystic Fibrosis (CF) patients suffering from severe exocrine
pancreatic insufficiency (EPI). Patients enrolled in the
study continue to experience clinical symptoms of
fat malabsorption, despite efforts to control their
symptoms with commercially-available PERTs.
Data from the initial five patients showed positive trends
regarding the primary efficacy endpoint of CFA improvement with no
adverse events reported. Trends were also positive in the secondary
endpoints of improvements in body weight and stool consistency and
reductions in the number of bowel movements and the incidence of
steatorrhea. Additionally, multiple patients reported experiencing
less abdominal pain while being on the combination
therapy.
Dr. James Pennington, Chief Medical Officer of AzurRx, will provide
an overview of the new data and the Company’s clinical
development programs during a live presentation scheduled for 3:00
p.m. at the Biotech Showcase Conference. After the presentation,
Dr. Pennington and James Sapirstein, the Company’s Chief
Executive Officer, will be available for one-on-one meetings with
investors registered for the conference.
About the MS1819-SD Combination Therapy Study
The digestive standard of care for both CF and chronic pancreatitis
(CP) patients with EPI are commercially-available PERTs. Ideally, a
stable daily dose of PERT will enable CF patients to eat a normal
to high-fat diet and minimize unpleasant gastrointestinal symptoms.
In practice, however, a substantial number of CF patients do not
achieve normal absorption of fat with PERTs(1,2).
Achieving an optimal nutritional status, including normal fat
absorption levels, in CF patients is important for maintaining
better pulmonary function, physical performance and prolonging
survival. Furthermore, a decline of body mass index around the age
of 18 years predicts a substantial drop in lung
function(3,4).
The Phase 2 multi-center study is designed to investigate the
safety, tolerability and efficacy of escalating doses of MS1819-SD,
in conjunction with a stable dose of PERTs, in order to increase
the patient’s CFA levels and relieve abdominal
symptoms. A combination therapy of PERT and MS1819-SD has the
potential to: (i) correct macronutrient and micronutrient
maldigestion; (ii) eliminate abdominal symptoms attributable to
maldigestion; and (iii) sustain optimal nutritional status on a
normal diet in CF patients with severe EPI. Planned enrollment is
expected to include approximately 24 CF patients with severe EPI,
with study completion anticipated in 2020.
About MS1819-SD
MS1819-SD, supplied as an oral non-systemic biologic capsule, is a
recombinant enzyme that is derived from
the yarrowia
lipolytica lipase, and
unlike the standard of care, does not contain any animal
products.
About Exocrine Pancreatic Insufficiency:
EPI is a condition characterized by deficiency of the
exocrine pancreatic enzymes, resulting in the inability
to digest food properly, or maldigestion. This deficiency can be
responsible for greasy diarrhea, fecal urge and weight
loss.
There are approximately 90,000 patients in the U.S. with EPI caused
by chronic pancreatitis according to the National Pancreas
Foundation, and more than 30,000 patients with EPI caused by cystic
fibrosis according to the Cystic Fibrosis Foundation. Patients are
currently treated with porcine pancreatic enzyme replacement
pills.
About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is engaged in the research and
development of non-systemic biologics for the treatment of patients
with gastrointestinal disorders. MS1819-SD recombinant lipase for
EPI is the Company's lead development program, and additional early
stage research is being conducted for the prevention of
hospital-acquired infections. The Company is headquartered in
Brooklyn, NY, with scientific operations based in Langlade,
France. Additional information on the Company can be found
at www.azurrx.com
Forward-Looking Statements:
This press release contains forward-looking statements within the
meaning of the Private Securities Litigations Reform Act of 1995.
Such statements include, but are not limited to, any statements
relating to our product development programs and any other
statements that are not historical facts. Such statements involve
risks and uncertainties that could negatively affect our business,
operating results, financial condition and stock price. Factors
that could cause actual results to differ materially from
management's current expectations include those risks and
uncertainties relating to the development and testing of our drug
candidates, the regulatory approval process, our ability to secure
additional financing, the protection of our patent and intellectual
property, the success of strategic agreements and relationships,
and the potential commercialization of any product we may
successfully develop. We expressly disclaim any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in our expectations or any changes in events, conditions or
circumstances on which any such statement is based, except as
required by law.
For more information:
AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
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
www.lifesciadvisors.com
hans@lifesciadvisors.com
References
(1) Freedman, S.D., Am. J. Manag.
Care, 2017; 23:
S2220-S228
(2) Littlewood, J. et al, 2006, Pediatric
Pulmonology, 2006,
41:35-49
(3) Engelen, M. et al, 2014, Curr. Opin. Clin. Nutr. Metab.
Care;
17(6):515-520
(4) Vandenbranden, S.L. et al, 2012, Pediatric
Pulmonology, 2012; 47(2):
135-143