GridAI Technologies Corp 8-K, filed Aug 11, 2020
GridAI Technologies Corp. (GRDX)
8-K
2020-08-11
For: 2020-08-11
View Original
Added on
April 11, 2026
About this 8-K
GridAI Technologies Corp filed this 8-K on August 11, 2020.
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): 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.
|
Date: August 11, 2020
|
AzurRx BioPharma,
Inc.
By: /s/ James
Sapirstein
Name: James
Sapirstein
Title:
President and Chief Executive Officer
|
Exhibit 99.1
AzurRx BioPharma Announces Positive Interim Data From First Patient
Cohort in Phase 2 Clinical Trial of MS1819 in Combination with PERT
Therapy in the Treatment of Cystic Fibrosis Patients with Severe
Exocrine Pancreatic Insufficiency
●
Data from first five patients demonstrate positive results with
primary efficacy and secondary safety endpoints
achieved
●
Clinically meaningful improvement (>80%) in coefficient of fat
absorption (CFA) for all patients across all dose levels of
MS1819
●
Topline data from full dataset anticipated in 1Q 2021
Management to discuss the interim results on call scheduled for
today, August 11, 2020, at 4:30 p.m. Eastern Time
NEW
YORK, August 11, 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 positive results from the first five
patients in its Phase 2 combination therapy trial of MS1819 for the
treatment of severe exocrine pancreatic insufficiency (EPI) in
patients with cystic fibrosis (CF).
In the
primary efficacy analysis, patients receiving MS1819 in combination
with PERT therapy achieved a clinically meaningful improvement in
the coefficient of fat absorption (CFA) at each of the three dose
levels, with no adverse safety events reported. Additionally,
patients showed improvements in the key secondary endpoints,
including body weight, stool consistency and reductions in the
number of bowel movements and the incidence of
steatorrhea.
Results from the initial five patients in the trial show an
improvement in CFA above 80% (the FDA’s measure for adequate
nutrition) across all dose levels and on all visits. Mean CFA at
the 700mg/day, 1200 mg/day and 2240 mg/day doses of MS1819 plus
standard of care were 88.4%, 87.2% and 86.5% respectively, compared
to baseline level (78.4%). This represents an average increase of 9
points in CFA during the trial.
“We
are thrilled to see such consistently positive responses from these
initial patients in our ongoing Phase 2 combination therapy trial
with MS1819. EPI is a very challenging disease with many CF
patients unable to achieve healthy nutrition even when using the
maximum number of allowed or tolerated PERT capsules, especially
those in the moderate-severe categories,” said James Sapirstein, Chief Executive
Officer of AzurRx. We look forward to completing treatment
of all patients and announcing top line data in 2021.”
Dr. James Pennington, Chief Medical Officer of AzurRx added,
“To see these results in the first five patients is quite
compelling. With its safety and efficacy profile, MS1819 has the
potential to meaningfully improve the quality of life for many
patients with severe EPI. The pill burden of PERT therapy alone is
quite challenging for most patients, and for severe EPI patients
the symptoms of the disease can be debilitating. We believe
that a small daily dose of MS1819, when added to their daily dose
of PERT, has the potential to safely help CF patients meet their
nutritional needs, decrease abdominal pain and alleviate multiple
morbidities caused by severe EPI. We are excited to continue developing
this exciting therapy and are committed to bringing this therapy to
market.”
The
Phase 2 clinical trial of MS1819 in combination with PERT therapy
in the treatment of CF patients with severe exocrine pancreatic
insufficiency is a multi-center study designed to investigate the
safety, tolerability and efficacy of escalating doses of MS1819, in
conjunction with a stable dose of PERTs in order to increase the
patient’s CFA levels and relieve abdominal symptoms. The
study is expected to enroll 24 patients, 12 years of age or older,
with severe EPI, with the goal of having at least 20 patients
completing. Patients enrolled in the study receive escalating doses
of 700mg, 1200mg, and 2240mg of MS1819 once a day for 15 days per
dosing level, in addition to their standard PERT therapy. Baseline
CFA is established by measuring CFA levels while on standard of
care therapy only, before beginning combination therapy.
Eligibility requires a CFA of less than 80%. The primary efficacy
endpoint of the trial is improvement in CFA; secondary endpoints of
the study are improvements in the stool weight, stool consistency,
number of bowel movements, the incidence of steatorrhea, and
increase of body weight.
Additional
information about the ongoing Combination Therapy study can be
found at: https://clinicaltrials.gov/ct2/show/NCT04302662
Conference Call and Webcast Information
The management team will host a conference call to discuss results
from the five patients in the Phase 2 study of MS1819 in
combination with PERT therapy, today, Tuesday, August 11, 2020 at
4:30 pm Eastern Time. To participate in the call, dial
877-407-0784 (domestic) or 201-689-8560 (international) fifteen
minutes before the conference call begins and reference the
conference passcode 13707811. The live conference call can be
accessed via audio webcast at http://public.viavid.com/index.php?id=141064.
A replay of the call will be
available on the “Investor
Relations” section
of the Company’s website
(www.azurrx.com).
About the MS1819 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).
A
combination therapy of PERT and MS1819 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 1Q 2021.
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 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 New York, NY, with scientific operations based in Langlade,
France and 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 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
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
Exhibit
99.2
