We are a plant biotechnology company focused on technology that allows us
to increase or decrease the level of nicotine and other nicotinic alkaloids
in tobacco plants and levels of cannabinoids in cannabis plants through genetic
engineering and plant breeding. Our primary mission is to reduce the harm caused
by smoking. We own or exclusively control more than 200 issued patents plus
more than 50 pending patent applications.
We are in the process of transitioning from researching and developing our
proprietary technology and tobaccos to commercializing our technology and products.
According to Euromonitor International annual worldwide tobacco product sales,
including cigarettes and smokeless products, are approximately $800 billion,
most of which are cigarette sales. If we capture a small fraction of this market,
we believe our value will increase tremendously.
We are primarily involved in the following activities:
· The research and development of potentially less harmful or modified
risk tobacco products and novel tobacco plant varieties;
· The pursuit of necessary regulatory approvals and clearances from the
FDA to market BRAND A in the U.S. as an over-the-counter product labeled as
reduced exposure to nicotine as BRAND A has 95% less nicotine than conventional
tobacco cigarettes;
· The development of X-22, a prescription-based smoking cessation aid
consisting of very low nicotine (“VLN”) cigarettes, and the pursuit
of regulatory approvals and clearances from the FDA to market X-22 as a prescription
smoking cessation aid;
· The pursuit of necessary regulatory approvals and clearances from the
FDA to market BRAND B as a modified risk cigarette with an extremely low tar-to-nicotine
ratio;
· The manufacture, marketing and distribution of RED SUN and MAGIC proprietary
cigarettes;
· The production of SPECTRUM research cigarettes for the National Institute
on Drug Abuse (“NIDA”), a part of the National Institutes of Health
(“NIH”);
· The international licensing of our technology, proprietary tobaccos,
and trademarks;
· The international sale of our branded proprietary tobaccos;
· The contract manufacturing of third-party branded tobacco products;
and
· The research and development in Canada of unique plant varieties of
hemp/cannabis, such as (i) plants with low to no amounts of delta-9-tetrahydrocannabinol,
or THC, for the legal hemp industry, and (ii) plants with high levels of cannabidiol,
or CBD, and other non-THC cannabinoids for the legal medical marijuana markets.
Our prospects depend on our ability to generate and sustain revenues from (i)
licensing and/or sale of our proprietary tobacco, technology and products; (ii)
domestic and international sales of our brands, including RED SUN and MAGIC;
(iii) further development of our potential modified risk tobacco products and
our X-22 smoking cessation aid; and (iv) the manufacture of the filtered cigar
and cigarette brands of third-parties at our manufacturing facility in North
Carolina. Our ability to generate meaningful revenue from our potential modified
risk tobacco products in the United States depends on obtaining FDA authorization
to market these products as modified risk or reduced exposure; and our ability
to generate meaningful revenue in the United States from X-22 depends on FDA
approval. If these products are authorized and approved by the FDA, we must
still meet the challenges of successful marketing, distribution and consumer
acceptance.
We believe our products address unmet needs of smokers; for those who desire
to quit, an innovative smoking cessation aid, and for those who are unable or
unwilling to quit smoking, cigarettes that may reduce the level of exposure
to tobacco toxins and/or nicotine.
We believe our proprietary technology, tobaccos and products will generate multiple
significant revenue streams from licensing of our technology and tobacco and
from the sales of our products.
Our intellectual property enables us to decrease or increase the level of nicotine
and other nicotinic alkaloids in tobacco plants by decreasing or increasing
the expression of gene(s) responsible for nicotine production in the tobacco
plant using genetic engineering. The basic techniques include, but are not limited
to, those that are used in the production of genetically modified (“GM”)
varieties of other crops, which are also known as “biotech crops.”
We own or exclusively control more than 200 issued patents plus more than 50
pending patent applications. A “patent family” is a set of patents
granted in various countries to protect a single invention. Our patent coverage
in the United States and China, two of the most valuable smoking cessation and
cigarette markets in the world, consists of 27 issued patents and 21 pending
applications and 6 issued patents and 6 pending patent applications, respectively.
We have exclusive rights to all uses of the following genes responsible for
nicotine content in tobacco plants: NBB, QPT, A622, MPO and several transcription
factor genes.
In September 2014, we entered into a Sublicense Agreement with Anandia Laboratories,
Inc. (the “Anandia Sublicense”). Under the terms of the Anandia
Sublicense, we were granted an exclusive sublicense in the United States and
a co-exclusive sublicense in the remainder of the world, excluding Canada, to
1 U.S. patent and 20 patent applications relating to four genes in the cannabis
plant that are required for the production of cannabinoids, the active ingredients
in the cannabis plant. The Anandia Sublicense continues through the life of
the last-to-expire patent, which is expected to be in 2035. As a plant biotechnology
company, our entry into the legal hemp/cannabis markets is a natural evolution
of our activities in a plant that has important research and commercial value
and applications. We intend to engage in research and development activities
in Canada to create unique plant varieties of hemp/cannabis, such as (i) plants
with low to no amounts of THC for the legal hemp industry, and (ii) plants with
high levels of CBD and other non-THC cannabinoids for the legal medical marijuana
markets.
We own various registered trademarks in the United States. We also have exclusive
plant variety rights in the United States (plant variety protection certificates
are issued by the U.S. Department of Agriculture (“PVP”)) and Canada.
A PVP certificate prevents anyone other than the owner/licensee from planting,
propagating, selling, importing and exporting a plant variety for twenty (20)
years in the U.S. and generally for twenty (20) years in other member countries
of the International Union for the Protection of New Varieties of Plants, known
as UPOV, an international treaty concerning plant breeders’ rights. There
are currently more than 70 countries that are members of UPOV.
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