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EX-10.1 - AMENDMENT NO. 1 TO SECURED PROMISSORY NOTE AND SECURITY AGREEMENT - Charlie's Holdings, Inc. | ex10-1.htm |
8-K - FORM 8-K - Charlie's Holdings, Inc. | chuc_8k.htm |
Exhibit
99.1
Charlie’s Holdings Files Initial PMTA Submission
for FDA Approval
Responsible And Regulated E-Cigarette Manufacturing And Rigorous
Industry Standards Are Vital To Creating A Long-Term Product
Portfolio
Costa Mesa, CA – Accesswire - August 31, 2020 –
Charlie’s Holdings, Inc.
(OTC Pink: CHUC)
(“Charlie’s” or the “Company”), an
industry leader in both the premium, nicotine-only, e-cigarette
space and the hemp-derived, CBD wellness space, is pleased to
announce the filing of its initial Premarket Tobacco Application
(“PMTA”) submission with the Food and Drug
Administration (“FDA”), as it remains committed to
being a leader in responsible manufacturing and promoting the
highest standards of regulatory compliance.
Today’s
submission marks the first of multiple applications that
Charlie’s Chalk Dust (“CCD”) intends to take
through FDA’s approval process as it seeks to create a
long-term, robust product portfolio.
“This
is a day we’ve long awaited for in our industry,”
stated, Charlie’s Holdings’ Chief Operating Officer
Ryan Stump. “After spending nearly $5 million over the past
two years on our PMTA preparation and submission, we are extremely
excited about the application we filed with the FDA. Today is a
great achievement for our Company and will greatly benefit our
customers, our partners, and our shareholders.”
Mr.
Stump, continued, “We strongly believe our commitment to
maintaining the highest standards of regulatory compliance is a
huge differentiating factor for our Company. We feel that a
significant amount of our competitors will not have the resources,
desire, and/or expertise to complete the extensive and costly PMTA
process and that once complete, we will be able to benefit from
being one of only a select group of companies responsibly operating
in the flavored nicotine product space.”
All manufacturers of any newly deemed tobacco products, including
e-liquid derived from tobacco, must seek authorization approval to
sell such products in the United States. In an effort to
satisfy the FDA’s requirements, CCD chose to partner with
Blackbriar Regulatory Services (“BRS”), experts in the
tobacco products regulatory space, to create the roadmap for its
PMTA submissions. Mr. Stump, expressed, “It made perfect
sense for us to partner with such a reputable company in BRS,
having worked so closely over the years with their leadership team
and FDA registered manufacturing facility.”
The FDA PMTA guidance asked brands to gain a deep understanding of
public perceptions of Electronic Nicotine Delivery Systems
(“ENDS”) products and the behavior of ENDS users. BRS
developed a novel research program consisting of a suite of
interrelated studies designed to approach FDA’s questions
from multiple angles. When combined, the results provide a
comprehensive picture of perceptions and behaviors around
CCD’s products and ENDS in general.
As a further measure to demonstrate the quality of our application,
we are excited to say that we are also performing human clinical
trials on our products to help detect the biomarkers of exposure
associated with smoking combustible cigarettes and determine the
nicotine delivery efficiency of the product via pharmacokinetic
studies. A large team of doctors, scientists, biostatisticians, and
data analysts are conducting these time intensive clinical trials.
We believe that this kind of study will significantly set our
application apart from those that are relying solely on the
literature-based approach to this critical "in human" assessment of
product performance.
“Charlie’s was clear with us about their long-term
strategy when we first started working with them several years
ago,” said, Russ Rogers, Chief Executive Officer at
Blackbriar Regulatory Services. “They emphasized the
importance of BRS having its manufacturing facilities and quality
system exceed all FDA standards and fully appreciate the benefits
they get from manufacturing in an FDA registered medical products
facility. When we started discussing PMTA strategy options
with Charlie’s, they specifically wanted an approach tailored
around quantifying what makes them unique in a highly competitive
market space. AVAIL Vapor’s recent announcement on the
status of their PMTA submission by BRS must give Charlie’s
great confidence in the PMTA strategy that they chose to invest
in.” On August 11, 2020 AVAIL Vapor announced their initial
application had been moved to the substantive scientific review
phase of FDA’s approval process. This further distinguishes
the roadmap BRS has put together as superior to the others that
have and will be submitted to the FDA.
“We are thrilled to see that Charlie’s has remained so
strongly committed to the regulatory process,” said, James
Xu, Chairman of AVAIL Vapor. “And we couldn’t be
more excited to continue our long-term partnership and shared
passions with them as we all move forward in this new highly
regulated industry.”
About AVAIL Vapor
Richmond, Virginia-based AVAIL Vapor is a premium retailer that
offers a broad array of products online and in its 99 stores across
12 states. The company delivers on the promise of quality and
transparency. Information on AVAIL products is available through
retail stores and on the web at www.availvapor.com.
About Blackbriar Regulatory Services
Richmond, Virginia-based Blackbriar Regulatory Services specializes
in helping small to mid-sized domestic and international companies
navigate the United States regulatory landscape to bring their
FDA-regulated products to market. BRS provides regulatory and
analytical laboratory services, good manufacturing processes (GMP)
and regulatory audits, as well as contract manufacturing and
distribution for a range of markets regulated by the FDA.
Information on BRS services can be found at www.bb-rs.com.
About Charlie’s Holdings, Inc.
Charlie’s Holdings, Inc. (OTC Pink: CHUC)
is an
industry leader in both the premium, nicotine-only, e-cigarette
space and the hemp-derived, CBD wellness space through its
subsidiary companies Charlie's Chalk Dust, LLC and Don Polly,
LLC. Charlie's Chalk Dust produces high quality vapor products
currently distributed in over 90 countries around the world.
Charlie's Chalk Dust has developed an extensive portfolio of brand
styles, flavor profiles and innovative product formats. Launched in
June of 2019, Don Polly, LLC formulates innovative
hemp-derived CBD wellness products. Don
Polly's high-quality CBD products derive from
single-strain-sourced hemp extract and high purity CBD isolate
crystals.
For additional information, please visit our corporate website
at: CharliesHoldings.com
and our branded online
websites: CharliesChalkDust.com
and EnjoyPachamama.com.
Safe Harbor Statement
This press release contains "forward-looking statements" within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995, including but not limited to
statements regarding the Company's overall business, existing and
anticipated markets and expectations regarding future sales and
expenses. Words such as "expect," "anticipate," "should,"
"believe," "target," "project," "goals," "estimate," "potential,"
"predict," "may," "will," "could," "intend," variations of these
terms or the negative of these terms and similar expressions are
intended to identify these forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, many of which involve factors or circumstances that
are beyond the Company's control. The Company's actual results
could differ materially from those stated or implied in
forward-looking statements due to a number of factors, including
but not limited to: the Company's ability to successful increase
sales and enter new markets; the Company's ability to manufacture
and produce product for its customers; the Company's ability to
formulate new products; the acceptance of existing and future
products; the complexity, expense and time associated with
compliance with government rules and regulations affecting nicotine
and products containing cannabidiol; litigation risks from the use
of the Company's products; risks of government regulations; the
impact of competitive products; and the Company's ability to
maintain and enhance its brand, as well as other risk factors
included in the Company's most recent quarterly report on Form
10-K, Form 10-Q and other SEC filings. These forward-looking
statements are made as of the date of this press release and were
based on current expectations, estimates, forecasts and projections
as well as the beliefs and assumptions of management. Except as
required by law, the Company undertakes no duty or obligation to
update any forward-looking statements contained in this release as
a result of new information, future events or changes in its
expectations.
Investors Contact:
IR@charliesholdings.com
p949-418-4020