Phase III Clinical Trial with 22nd Century’s Very Low Nicotine Cigarettes Names Ten Major Research Institutions as Study Locations

CLARENCE, N.Y.–(BUSINESS WIRE)– 22nd Century Group, Inc. (NYSE MKT: XXII),
a plant biotechnology company that is a leader in tobacco harm
reduction, announced today that an update has been issued on the pivotal Phase
III study entitled “Strategies for Reducing Nicotine Content in
Cigarettes.” Funded by the National Institutes of Health (NIH) and
led by Eric C. Donny, Ph.D. of the University of Pittsburgh, this highly
significant clinical trial will determine whether the harm caused by
smoking is most effectively addressed by either 22nd Century’s
proprietary Very Low Nicotine Content tobacco cigarettes (95% less
nicotine than conventional cigarettes), or 22nd Century’s proprietary
SPECTRUM tobacco cigarettes that contain progressively lower nicotine
content. The clinical trial update names 10 nationally recognized
research centers, including the Mayo Clinic, the MD Anderson Cancer
Center, Duke University, Johns Hopkins University, the Moffitt Cancer
Center, and the University of California San Francisco. With an
estimated enrollment of 1,250 patients, the on-going study is expected
to be completed in March 2017. The Company expects the results of this
study to accelerate the governmental approval process of the Company’s
“X-22” smoking cessation product so that millions of lives and billions
in healthcare costs can be saved each year.

“By evaluating 22nd Century’s Very Low Nicotine cigarettes against 22nd
Century’s gradually reduced nicotine cigarettes, the Donny trial
recognizes that reducing smokers’ exposure to nicotine is a vital public
health goal. Contrary to false and misleading information recently
disseminated by short-sellers of 22nd Century stock, we are confident
that our patented technologies will produce multi-billion dollar
products in both the tobacco and the pharmaceutical industries,”
explained Henry Sicignano, III, President and CEO of 22nd Century Group.
“Our Company is recognized by the National Institute of Health, the
World Health Organization, and public health advocates around the world
as absolutely key to reducing smokers’ exposure to nicotine; independent
clinical studies continue to show that our Very Low Nicotine cigarettes
have the potential to greatly impact public health.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology
which allows it to increase or decrease the level of nicotine in tobacco
plants and the level of cannabinoids in cannabis plants through genetic
engineering and plant breeding. The Company’s primary mission is to
reduce the harm caused by smoking. 22nd Century currently owns or
exclusively controls more than 200 issued patents and more than 50
pending patent applications around the world. Visit www.xxiicentury.com
and www.heraclespharma.com
for more information.

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, including but not limited to our future revenue expectations.
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, 2015, filed on February 18,
2016, 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.

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