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A Biotechnology Company
Focused on Smoking Cessation and
Tobacco Harm Reduction Products
Ticker: XXII Q4 2013
22nd Century Group, Inc.
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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
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Overview
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Corporate Structure
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Upcoming Catalysts
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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
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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)
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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)
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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
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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
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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
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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
Modified Risk Cigarettes
Cigarettes that reduce exposure to tobacco toxins and are reasonably likely topose lower health risks as compared to conventional cigarettes
Modified Risk 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
Modified Risk Cigarettes
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
Modified Risk Cigarettes
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
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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
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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