22nd Century Group, Inc.

7/22/2019 22nd Century Group, Inc.

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A Biotechnology Company

Focused on Smoking Cessation and

Tobacco Harm Reduction Products

Ticker: XXII Q4 2013

22nd Century Group, Inc.

2013 22nd Century Group, Inc. For Investor Relation Purposes Only


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This document is based on information provided by 22nd Century Group, Inc. (the Company) and other sources that the Company believes arereliable. Nothing in this document is, or may be relied upon as, a promise or representation by the Company as to the past or the future.

This document contains statements that the Company believes to be forward-looking statementswithin the meaning of the safe harborprovisions ofthe Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that is not a statement ofhistorical fact, including, without limitation, statements regarding the Companys business strategy and plans and objectives of management for futureoperations or thatmay predict, forecast, indicate or imply future results, performance or achievements. The words estimate,project,intend,forecast,anticipate,plan,planning,expect,believe,will,will likely,should,could,would,mayor the negative of such words orwords or expressions of similar meaningare intended to identify forward-looking statements. These forward-looking statements are not guarantees offuture performance, and all such forward-looking statements involve risks and uncertainties, many of which are beyond the Companys ability to control.

Actual results may differ materially from those expressed or implied by such forward-looking statements as a result of various factors, including but notlimited to the Risk Factorsset forth below and the Risk Factorsdisclosed in the Companys reports filed with the Securities and Exchange Commission.

Additional information concerning these and other factors is contained in the Companys filings with the Securities and Exchange Commission. All forward-looking statements and other information in this document speak only as of the date of this document. The delivery of this document at any time does not

imply that the information contained herein is correct as of any time subsequent to the date hereof. We do not undertake, and we disclaim, any obligationto update any forward-looking statements or to announce revisions to any of the forward-looking statements.

The risks and uncertainties relating to the forward-looking statements in this presentation are included in those described under Risk Factorsin theCompanys Annual Report filed with the Securities and Exchange Commission on March 18, 2013. The below summary of Risk Factorsis not completeand does not contain all the information that should be considered before investing in our common stock.

We will require additional capital in 2013 for working capital purposes and to complete the FDA authorization process for our Modified Risk Cigarettes andclinical trials for our X-22 smoking cessation product. We may not be able to obtain additional debt or equity financing on favorable terms, if at all. Therecan be no assurance that we will receive FDA authorization to market BRAND Aand BRAND Bas Modified Risk Cigarettes and there can be no assurance ourX-22smoking cessation aid will be approved by the FDA, European Medicines Agency (EMA), or any other governmental body.

We face intense competition in the market for our RED SUN and MAGICcigarettes, and our failure to compete effectively could have a material adverseeffect on our profitability and results of operations. We also face significant governmental action, especially in the U.S. pursuant to the Tobacco Control Act,including but not limited to efforts aimed at reducing the incidence of tobacco use, restricting marketing and advertising, and imposing regulations onproducts and packaging. In addition, there can be no assurance that all necessary regulatory approvals will be granted or sustained for our potentialproducts and commercial products. Regulatory review or actions may involve delays, including those caused by requests for additional information ortesting, that could adversely affect the time to market for our potential products and the continued sale of our products.

Our common stock is an OTC Bulletin Board penny stock,which is likely to limit its liquidity. The market price of our common stock is, and will likelyremain for the foreseeable future, less than $5.00 per share, and therefore will be a penny stockaccording to SEC rules.

Disclaimer, Safe Harbor and Risk Factors

2013 22nd Century Group, Inc. For Investor Relation Purposes Only 2


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Overview

3



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Corporate Structure



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Upcoming Catalysts

5


Purchase manufacturing facility Apply to up-list to national securities exchange, NASDAQ or NYSE, in

Q1 2014

Closing NASCO acquisition; company will become MSA member

National distribution of RED SUNcigarette brand in Q1 2014

Increase in Exports in 2014 including MAGICGOLD in Benelux

Published results from smoking cessation Phase II trials will beavailable in 2014

Applications will be filed in 2014 with the FDA for two types of

proprietary modified risk cigarette candidates

Closing of a pharmaceutical JV to fund Phase III clinical trials forX-22,the companys prescription smoking-cessation aid in development.

Milestone payments from British American Tobacco


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U.S. and Global Markets

U.S. market is $1 billion; Global market is $3+ billion

22 million Americans attempt to quit smoking each year

2-5% quit smoking permanently in a given year

Average number of serious quit attempts before success: 8 to 11

U.S. market is $80 billion; Global market is $610 billion (~6 trillioncigarettes)

45 million Americans are smokers; 1.3 billion smokers worldwide

According to JP Morgan, 90% of smokers would be willing to try anew brand if it were saferthan their usual brand

Smoking Cessation Market

Cigarette Market



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Multiple Value Drivers

Super-premium priced cigarette brands RED SUN MAGIC

X-22

Modified Risk

Cigarettes

CommercialProducts

ResearchCigarettes

New product category regulated by FDA in which the advantages ofcigarettes that reduce risk can be marketed and conveyed to the public

BRAND A95% less nicotine than cigarettes marketed as light BRAND BLowest amount of tar per milligram of nicotine

Very low nicotine (VLN) cigarettes under development as a prescriptionsmoking cessation aid

Six independent trials have demonstrated efficacy No new side effects Very attractive to smokers

7

National Institute on Drug Abuse (NIDA) research cigarettes SPECTRUM Approx. 12 million cigarettes delivered to date Received Order for additional 5.5 million cigarettes



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Proprietary Technology

22nd Centurys114 patents and 36 patent applications relate primarily to decreasing and

increasing the expression of key genes and transcription factors responsible for the

production of nicotine (and other alkaloids) in the tobacco plant (depicted in blue) and the

tobacco and products produced therefrom.

Model of the Nicotine Biosynthetic Pathway



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Extensive Intellectual Property Portfolio

Technology Covered by

12 Patent Families

114 issued patents in 78 countries

36 pending patent applications

2 Plant Variety Protection (PVP) Certificates PVP prevents growing, importing and exporting of the

protected plant variety/tobacco leaf

Various Trademarks



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X-22Smoking Cessation Aid



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Smoking CessationCompetitive Landscape

The limited effectiveness and serious side effects of currently available

FDA-approved smoking cessation aids have resulted in a huge unmet medical need

1990 2000 2010

Gums Patches Inhalers Lozenges

1980 Future

X-22

NicotineReplacement

Therap

y(NRT)

Non-nicotinepills

In 2009, the FDArequired a

Boxed Warningon both Zyban

and Chantix

Nasal

Sprays



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Q4

2006

Q1

2007

Q2 Q3 Q4 Q1

2008

Q2 Q3 Q4 Q1

2009

Q2 Q3 Q4 Q1

2010

Q2 Q3 Q4 Q1

2011

Q2 Q3 Q4 Q1

2012

$50 MM

$100 MM

$150 MM

$200 MMJuly 1, 2009:FDA requires a Boxed Warning,the most serious type of warningin prescription drug labeling

November 20, 2007:FDA issues Early Communication Warning on safety of CHANTIX

February 1, 2008:

FDA issues a Public Health Advisoryon CHANTIX

June 16, 2011:FDA issues a drugsafety communicationthat Chantix use isassociated with anincreased risk ofcertain cardiovascularadverse events

Smoking CessationChantixCase Study

The FDA boxed warning on Chantix has significantly reduced

its market acceptance among patients and physicians

Quarterly ChantixSales



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Patients smoke VLN cigarettes over six-week treatment period to

facilitate quitting smoking by the end of the treatment period

Patients concurrently useX-22with either Chantix or NRT

X-22satisfies smokerscravings for cigarettes while:

Greatly reducing nicotine exposure and nicotine dependence

Separating the act of smoking from the rapid delivery of nicotine

(addresses the behavioral aspects of smoking)

X-22 Smoking Cessation Aid

HowX-22Works



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Six Independent Cessation Trials with VLN Cigarettes

1. Phase II: University of Minnesota Masonic Cancer Center Hatsukami et al. 2010,Addiction105:343-355

2. Phase III: Clinical Trials Research Unit, University of Auckland Walker et al. 2012,Addiction (Epub ahead of print) SRNT Posterof 1,410-patient study presented at SRNT Europe 2011

3. Phase II: Vector Tobacco Becker et al. 2008, Nic Tob Res10:1139-1148

4. Phase II: Roswell Park Cancer Institute Rezaishiraz et al. 2007, Nic Tob Res11:1139-1146

Partial Results disclosed to SRNT conference in Boston in March 2013:

5. Phase II: Queen Mary University NCT01250301 Pfizer Inc. is collaborator in study 22nd Centurys XODUSVLN cigarettes utilized

6. Phase II: University of Minnesota Masonic Cancer Center Follow-up Study

Innovative Interventions for Smoking Cessation: NCT01050569

22nd Century has right to use data and results for its own IND at FDA

22nd Centurys XODUSVLN cigarettes utilized

XODUS

has the same nicotine content as other independent trialsall of which were successful 2013 22nd Century Group, Inc. For Investor Relation Purposes Only 15
http://www.ncbi.nlm.nih.gov/pubmed/20078491http://www.ncbi.nlm.nih.gov/pubmed/22594651http://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/18629723http://www.ncbi.nlm.nih.gov/pubmed/17978987http://clinicaltrials.gov/ct2/show/NCT01250301http://clinicaltrials.gov/ct2/show/NCT01050569?term=NCT01050569&rank=1http://clinicaltrials.gov/ct2/show/NCT01050569?term=NCT01050569&rank=1http://clinicaltrials.gov/ct2/show/NCT01050569?term=NCT01050569&rank=1http://clinicaltrials.gov/ct2/show/NCT01250301http://www.ncbi.nlm.nih.gov/pubmed/17978987http://www.ncbi.nlm.nih.gov/pubmed/17978987http://www.ncbi.nlm.nih.gov/pubmed/17978987http://www.ncbi.nlm.nih.gov/pubmed/18629723http://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/22594651http://www.ncbi.nlm.nih.gov/pubmed/22594651http://www.ncbi.nlm.nih.gov/pubmed/22594651http://www.ncbi.nlm.nih.gov/pubmed/20078491http://www.ncbi.nlm.nih.gov/pubmed/20078491http://www.ncbi.nlm.nih.gov/pubmed/20078491


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VLN Cigarettes Work When Used By Themselves

Hastukami et al. 2010, Addict ion105:343-355

The VLN group used as many VLN cigarettes as needed for 6 weeks.

The 0.05 mg nicotine cigarette was associated with greater relief of

withdrawal from usual brand cigarettes than the FDA-approved nicotine lozenge.

Abstinent Percent Abstinent Percent Abstinent Percent -valueQuit Rate

4-week continuous abstinence (during

weeks 3 to 6 post-treatment)

Quit Rate

7-day point prevalence (at 6 weeks post

treatment)

VLN Cigarette

(0.05 mg)

n = 53

Nicotine Lozenge

(4 mg)

n = 60

Reduced Nicotine

Cigarette (0.30 mg)

n = 52

21% 0.0508

0.035725 47% 22 37% 12 23%

23 43% 21 35% 11

University of Minnesota Masonic Cancer Center - PHASE II TRIAL (ITT)

http://www.ncbi.nlm.nih.gov/pubmed/20078491http://www.ncbi.nlm.nih.gov/pubmed/20078491http://www.ncbi.nlm.nih.gov/pubmed/20078491


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VLN Cigarettes Improve Quit Rates of NRT

Walker et al. 2012, Addict ion (Epub ahead of print)

SRNT Posterof 1,410-patient study presented at SRNT Europe 2011

A clear increase in cessation rates over NRT was found,with a positive impact on time to relapse and high participant acceptability.

There was no evidence of any excess adverse events

in the VLN cigarette + NRT intervention group.

Abstinent Percent Abstinent Percent -value

Quit rate at 6 weeks (7-day point prevalence) 333 47% 232 33% 0.0001

Quitrate at 6 months (7-day point prevalence) 231 33% 195 28% 0.037

Quit rate at 6 months (Continuous abstinence) 160 23% 107 15% 0.0003

VLN cigarettes + NRT

(patches and/or gum

or lozenges)

NRT

(patches and/or gum

or lozenges)

n = 705 n = 705

The University of Auckland - PHASE III TRIAL (ITT)

http://www.ncbi.nlm.nih.gov/pubmed/22594651http://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/22594651


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VLN Cigarettes Improve Quit Rates of CHANTIX& NRT

ClinicalTrials.gov Identifier: NCT012550301

Queen Mary University of London, in collaboration with Pfizer

The use of VLN cigarettes in conjunction with either Chantix or NRT

resulted in higher quit rates at all time points than the use of Chantix or NRT

Chantix or NRT

plus VLNChantix or NRT

n = 100 n = 100

Percent Abstinent Percent Abstinent -valueQuit Rate

70% 53% 0.021 week after stopping all cigarettes

Quit Rate

64% 50% 0.064 weeks continuous abstinence afterstopping all cigarettes

http://clinicaltrials.gov/ct2/show/NCT01250301http://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdfhttp://clinicaltrials.gov/ct2/show/NCT01250301http://nihi.auckland.ac.nz/sites/nihi.auckland.ac.nz/files/pdf/addictions/reliq_poster.pdf


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22nd Century will include results from the following trials in its IND:

Queen Mary University of London clinical trial: NCT01250301

University of Minnesota follow-up Phase II trial: NCT01050569

22nd Century provided its own VLN cigarettes for both these trials;

these VLN cigarettes had the same nicotine content (95% reduced) as VLN

cigarettes in other independent trialsall of which were successful

University of Auckland clinical trial: Walker et al. 2012

Upon identifying a joint venture partner to fund furtherX-22 clinicaltrials, we anticipate the remainder of the FDA approval process to be

approximately 2 years.

Smoking Cessation - Clinical Path to FDA Approval

http://clinicaltrials.gov/ct2/show/NCT01250301http://clinicaltrials.gov/ct2/show/NCT01050569?term=NCT01050569&rank=1http://www.ncbi.nlm.nih.gov/pubmed/22594651http://www.ncbi.nlm.nih.gov/pubmed/22594651http://www.ncbi.nlm.nih.gov/pubmed/22594651http://clinicaltrials.gov/ct2/show/NCT01050569?term=NCT01050569&rank=1http://clinicaltrials.gov/ct2/show/NCT01250301


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Modified Risk Cigarettes

20 2013 22nd Century Group, Inc. For Investor Relation Purposes Only 20


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Banned the terms low tar, light and ultra light on cigarette labeling

and in marketing effective June 2010

Created large void in marketplace (70% of $80 Billion U.S. cigarette market)

Established procedures for less harmful cigarettes to be marketed as

Modified Risk Tobacco Products

FDA issued Modified Risk Tobacco Product Applications Draft Guidance on

March 30, 2012


Cigarettes that reduce exposure to tobacco toxins and are reasonably likely topose lower health risks as compared to conventional cigarettes


The Tobacco Control Act passed in 2009 granted the FDA regulatorycontrol of all tobacco products



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Fewer cigarettes per day and reduced smoke consumption Hatsukami et al. 2010

Donny et al. 2007

Donny & Jones 2009

Becker et al. 2008

22nd Century Phase IIb clinical trial, unpublished

Curtails compensatory smoking of low-tar cigarettes

The lower the ratio, the less smoke exposure

Literature (researchers added nicotine to cigarettes or tobacco)

Russell MAH 2000 Company presentation given to LSRO, Reducing the Adverse

summarizes:

Armitage et al. 1988

Fagerstrom 1982

Woodman et al. 1987


Brand AVery Low Nicotine (VLN) Cigarettes ~ 1 mg/cig (content)

Brand BLow Tar-to-Nicotine Ratio Cigarettes: T/N


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12 147

(TNR) = Tar yield/Nicotine yield

(inversely correlated to nicotine content)

250

Highest TNRSPECTRUM

Lowest TNRSPECTRUM


1255

Tar-to-Nicotine Ratio



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0

2

4

6

8

10

12

14

Marlboro MarlboroGold

MarlboroSilver

NewportMenthol King

Camel Blue BRAND B

Tar-to-NicotineRatio

63%Reduction

Brand BLow Tar-to-Nicotine Ratio Cigarette

The lower the Tar-to-Nicotine Ratio, the less tar and other smoke components

per milligram of nicotine



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Companys Commercial Products

In 2011, 22nd Century introduced 2 super-premium cigarette

brands into the U.S. market: RED SUN& MAGIC



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Appendix



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Name Experience

Joseph Pandolfino, MBAChief Executive Officer

Founded 22nd Century Limited, LLC in 1998 Developed and marketed a number of specialty cigarette

brands during 20 years in tobacco industry

Henry Sicignano, III, MBAPresident

Vice President and Marketing Director of Santa Fe NaturalTobacco Company (SFNTC)

Spearheaded transition of Natural American Spirit

from aniche brand to a recognized national brand and SFNTCssale to RJ Reynolds for $356MM in 2002

Michael R. Moynihan, Ph.D.Vice President of R&D

More than 25 years experience in plant biotechnologyincluding six years as Director of BiotechnologyDevelopment at Fundacin Chile

John T. BrodfuehrerChief Financial Officer

33 years of experience in corporate finance, businessacquisitions and divestitures, and public accounting

Highly skilled CFO with diverse experience in complexcorporate transactions; impeccable reputation over15-year history as CFO of leading consumer productscorporations

Management



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Cap Table


Common shares authorized: 300,000,000

Total shares issued and outstanding: 50,112,180Total shares owned by management and affiliates: ~20 MillionTotal shares in float: ~30 Million

Outstanding Warrants: ~18.5 Million All warrants have a cashless exercise provision

Potential Shares from Options: 680,000


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1998 22nd Century is founded to fund a 5-year R&D project at NORTH CAROLINA STATE UNIVERSITY(NCSU) on nicotine biosynthesis in tobacco

22nd Century obtains exclusive worldwide license from NCSUfor QPTand other technologies

1999 22nd Century sub-licensesQPT to Liggett Group/Vector Tobacco in Reduced Nicotine Field

2005 22nd Century funds 4-year R&D project at NARA INSTITUTE OF SCIENCE & TECHNOLOGY, Japan

22nd Century obtains exclusive worldwide license from NARAfor NBB1, A622and MPO

2005 22nd Century funds two 4-year R&D projects at NCSU

R&D includes multiple field trials on increasing expression of nicotine biosynthesis genes

2006 22nd Century funds 3-year R&D project at NATIONAL RESEARCH COUNCIL, PLANTBIOTECHNOLOGY UNIT, Saskatoon Canada (NRC)

22nd Century obtains exclusive worldwide license from NRCfor MPO and TRANSCRIPTIONFACTOR Technology

2008 Following arbitration with Vector, 22nd Century is awarded: Right of Referenceto Vectors smokingcessation IND and a monetary award; all rights under NCSU sub-license revert back to 22nd Century

2010 NARAassigns all subject patents under exclusive license agreement to 22nd Century

2011 22nd Century receives FDA clearance for X-22Investigational New Drug (IND) Application

Hercules Pharmaceuticals is licensed all rights to X-22

22nd Century enters into a 3-year R&D agreement with UNIVERSITY OF VIRGINIA

2012 22nd Century completes Phase II-B trial for X-22; does not demonstrate statistical significance

2013 22nd Century and British American Tobacco (BAT) enter into a worldwide research license agreement

History of 22nd Centurys R&D



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Worldwide Patent Portfolio Summary


Countries Pending

Assignee Patents are Patent

Granted Applications

1 QPT Expression NCSU 22nd Century WO 1998/056923 7,605,308 73 6

2 Root Cortex (TobRD2) Promoter NCSU 22nd Century WO 1997/005261 5,837,876 15 0

3 PMT Promoter NCSU 22nd Century WO 2002/038588 7,189,570 2 0

4 Molecular Decoys NCSU 22nd Century WO 2002/018607 7,192,771 9 05 Reduced TSNAs NCSU 22nd Century WO 2002/100199 6,907,887 6 0

6 NBB1 & A622 (Down-regulation) 22nd Century 22nd Century WO 2006/109197 20070240728 5 10

7 NBB1 & A622 (Up-regulat ion) 22nd Century 22nd Century WO 2007/072224 20080120737 2 4 including EU

8 N-methylputrescine Oxidase (MPO) 22nd Century 22nd Century N/A 20080292735 0 U.S.

N-methylputrescine Oxidase (MPO) NRC 22nd Century WO 2008/020333 8,410,341 1 US, CA, China

9 Transcription Factors NRC 22nd Century WO 2009/063312 20100192244 1 US, CA, China, HK

10 Reduced Exposure Tobacco Products 22nd Century 22nd Century WO 2005/018307 20070034220 19 7

11 Non-addictive Tobacco Products Berger 22nd Century N/A 5,713,376 1 0

12 Tobacco Biomass 22nd Century 22nd Century WO 2002/098208 N/A 2 Brazil

International

Application

Exclusive

Licensee

U.S. Patent/

ApplicationPATENT FAMILY


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Verfola

A novel high-yield leaf crop for integrated production

of bioproducts with high aggregate value

RubiscoA protein with excellent nutritional quality

Better than Soy in essential amino acid content Tasteless, odorless and colorless when mixed with water

As a plant-based protein, ideal to displace casein

(about 70,000 metric tons imported to the U.S. annually)

BiofuelsFuels that are environmentally sustainable Ethanol, Butanol, Biogas and Bio-oil

Animal FeedSubstitutes for soy and alfalfa protein Ideal for aquaculture

Non-Traditional Application of Nicotine-free Tobacco

22nd Century Group, Inc.

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