22nd Century Group, Inc. (NYSE MKT:XXII) today announced that
the Company filed a Form S-3 shelf registration statement on April
18th with the U.S. Securities and Exchange Commission (“SEC”). Upon
SEC approval, the universal shelf registration will allow, but not
compel, 22nd Century Group to raise up to $45 million of capital
over a three-year period through a wide array of securities at
amounts and at increments to be determined by the Company.
The universal shelf registration will facilitate potential
acquisition opportunities, research and development initiatives,
including studies for our modified risk tobacco products in
development, and allow the Company to be on solid footing when
negotiating agreements. Upon SEC approval of the universal shelf
registration statement, raising capital will be greatly simplified
and expedited since potential future equity or debt securities will
be pre-registered with the SEC.
Joseph Pandolfino, Founder and CEO of 22nd Century Group,
stated, “As our track record demonstrates, my management team and I
have been and always will be conservative with the Company’s
resources. We raise capital only when we strongly believe doing so
will enhance shareholder value. As management’s beneficial
ownership of the Company is approximately 27 percent, the interests
of management are clearly and fully aligned with all the Company’s
other shareholders.”
OTHER BUSINESS UPDATES
Investor Awareness
22nd Century Group has traded on the NYSE MKT exchange for just
over 5 weeks. To commemorate the Company’s uplisting, 22nd Century
Group has been invited to ring the opening bell at the New York
Stock Exchange on Tuesday, July 15, 2014. This new date replaces
the previously announced date of June 17th.
Beginning in early June 2014, Joseph Pandolfino, CEO, and Henry
Sicignano, President, will embark on a non-deal road show in cities
across the United States introducing 22nd Century Group to
institutional investors, retail brokers, and the business press.
Though the Company has increased its shareholder base from fewer
than 100 shareholders in early 2011 to more than 2,000 shareholders
today, it is clear that 22nd Century remains “well under the radar”
of most of Wall Street. It is management’s intention that the June
road show increases awareness of 22nd Century Group’s technology
and investment potential.
NASCO Acquisition
The Company continues to cooperate fully with the National
Association of Attorneys General (“NAAG”) to close its acquisition
of NASCO Products, LLC (“NASCO”). As previously reported, 22nd
Century Group entered into an agreement to purchase all of the
issued and outstanding membership interests of NASCO (the “NASCO
Acquisition”), a federally licensed tobacco product manufacturer
and participating member of the tobacco Master Settlement Agreement
(“MSA”), an agreement among 46 U.S. states and the tobacco industry
administered by NAAG. The NASCO Acquisition will close immediately
upon the settling states of the MSA consenting to the transaction
and a modified Adherence Agreement for NASCO. The Company believes
that NASCO’s modified Adherence Agreement, as negotiated among
NAAG, NASCO and 22nd Century Group, is close to being finalized.
Upon the closing of the NASCO Acquisition, NASCO will become a
wholly-owned subsidiary of 22nd Century Group and the national
distribution of 22nd Century’s super-premium cigarettes will
commence. NASCO has already begun producing its own tobacco
products at the Company’s factory in Mocksville, North
Carolina.
International Sales
22nd Century Group continues to work with its European partner
on preparations to launch the Company’s products in The
Netherlands, Belgium and Luxemburg. Laboratory testing and European
labeling requirements are expected to be completed soon, and
shortly thereafter distribution of the Company’s products will
commence. 22nd Century Group is also evaluating the sale and
distribution of its products in other European countries.
Separately, 22nd Century Group President, Henry Sicignano, and
Vice President of R&D, Dr. Michael Moynihan, are departing this
week for a 10-day trip to meet with potential joint venture
partners in Asia. The Company intends to distribute its brands
containing 22nd Century’s proprietary tobacco in markets where
there is interest in potentially less harmful tobacco products.
Modified Risk Tobacco Products
The Company intends to seek U.S. Food and Drug Administration
(“FDA”) authorization to market two products in development, BRAND
A and BRAND B, as modified risk cigarettes. 22nd Century is
engaging a consulting company specializing in regulatory filings
and in designing exposure studies to facilitate the submission of
the Company’s applications to the FDA for our two modified risk
cigarette candidates. The Company expects to submit these
applications to the FDA in 2014. Among various novel tobacco lines
being field tested this spring, is a novel tobacco plant line that
the Company believes may be ideal for BRAND B, a very low
tar-to-nicotine ratio cigarette.
SPECTRUM Research Cigarettes and X-22
Goodrich Tobacco Company, our wholly-owned subsidiary, delivered
an additional 5.5 million SPECTRUM® government research cigarettes
in February 2014. SPECTRUM was developed by 22nd Century for NIDA,
a department of the U.S. National Institutes of Health (NIH).
Including this shipment, Goodrich Tobacco has thus far delivered
more than 17 million SPECTRUM cigarettes, equating to 850,000 packs
of 20 cigarettes. NIDA distributes SPECTRUM free of charge to
researchers carrying out independent studies.
The main SPECTRUM product line consists of a series of cigarette
styles that have a fixed “tar” yield but varying nicotine yields
over a 50-fold range – from very low to high. Altogether, SPECTRUM
features 24 styles, 11 regular and 13 menthol versions, with 8
different levels of nicotine content. SPECTRUM is strictly for
research purposes and will not be sold as a commercial cigarette.
The results and data from the dozens of independent SPECTRUM
studies expected will assist 22nd Century with our two modified
risk applications at the FDA.
Hercules Pharmaceuticals, our wholly-owned subsidiary, is
currently in the process of identifying potential joint venture
partners or licensees to fund the remaining X-22 clinical trials.
Upon identifying a suitable joint venture partner or licensee,
Hercules will request a meeting with the FDA to discuss moving the
Company’s active X-22 Investigational New Drug Application
forward.
For additional information, please visit:
www.xxiicentury.com
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company whose proprietary
technology allows for the levels of nicotine and other nicotinic
alkaloids (e.g., nornicotine, anatabine and anabasine) in the
tobacco plant to be decreased or increased through genetic
engineering and plant breeding. 22nd Century owns or is the
exclusive licensee of 116 issued patents in 78 countries plus an
additional 36 pending patent applications. Goodrich Tobacco
Company, LLC and Hercules Pharmaceuticals, LLC are wholly-owned
subsidiaries of 22nd Century. Goodrich Tobacco is focused on
commercial tobacco products and potentially less harmful
cigarettes. Hercules Pharmaceuticals is focused on X-22, a
prescription smoking cessation aid in development.
Cautionary Note Regarding Forward-Looking Statements: This press
release contains forward-looking information, including all
statements that are not statements of historical fact regarding the
intent, belief or current expectations of 22nd Century Group, Inc.,
its directors or its officers with respect to the contents of this
press release. The words “may,” “would,” “will,” “expect,”
“estimate,” “anticipate,” “believe,” “intend” and similar
expressions and variations thereof are intended to identify
forward-looking statements. We cannot guarantee future results,
levels of activity or performance. You should not place undue
reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should
be considered with any written or oral forward-looking statements
that we may issue in the future. Except as required by applicable
law, including the securities laws of the United States, we do not
intend to update any of the forward-looking statements to conform
these statements to reflect actual results, later events or
circumstances, or to reflect the occurrence of unanticipated
events. You should carefully review and consider the various
disclosures made by us in our annual report on Form 10-K for the
fiscal year ended December 31, 2013, filed on January 30, 2014,
including the section entitled “Risk Factors,” and our other
reports filed with the U.S. Securities and Exchange Commission
which attempt to advise interested parties of the risks and factors
that may affect our business, financial condition, results of
operation and cash flows. If one or more of these risks or
uncertainties materialize, or if the underlying assumptions prove
incorrect, our actual results may vary materially from those
expected or projected.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy securities, nor shall there be any
sale of these securities in any state or jurisdiction in which such
offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of any such
state or jurisdiction.
Redington, Inc.Tom Redington, 203-222-7399
22nd Century (AMEX:XXII)
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