We have developed and are seeking to commercialize globally a proprietary technology
for managing animal pest populations through fertility control. We believe our
innovative non-lethal approach, targeting reproduction, is more humane, less
harmful to the environment, and more effective in providing a sustainable solution
to pest infestations than traditional lethal pest management methods. Our approach
is designed to promote food security and reduce infrastructure damage, disease
outbreaks, environmental contamination and other costs associated with rodent
infestations. Our first fertility control product, ContraPest®, will be
marketed for use in controlling rat populations.
We are pursuing regulatory approvals and amendments to existing registration
in the US for ContraPest in various jurisdictions, including the U.S., India,
Argentina and the EU. We submitted ContraPest for registration with the EPA
on August 23, 2015, and the EPA granted registration approval for ContraPest
effective August 2, 2016. We believe ContraPest is the first non-lethal fertility
control product approved by the EPA for the management of rodent populations.
However, before we can begin selling ContraPest in the U.S., we must obtain
registration from the various state regulatory agencies. To date, we have received
registration for ContraPest in 45 states and the District of Columbia, with
additional applications pending. Other business initiatives include expanding
our technology to other species and applications, and developing bio-synthetic
sources of triptolide, an active ingredient in ContraPest that also has pharmaceutical
applications. This initiative may produce a less expensive source of triptolide
for our own use, and provide us with the potential opportunity to earn revenue
from the sale of such product to other potential consumers of triptolide.
ContraPest, when used as directed, causes rodent populations to remain at a
sustained low level. A third-party laboratory study in partnership with the
United States Department of Agriculture National Wildlife Research Center, or
NWRC, completed in December 2014 observed that 50 wild-caught rats treated with
ContraPest in the presence of regular food and water resulted in a 95% reduction
in litter sizes. A follow-up USDA study completed in June 2015 involving 50
wild-caught rats demonstrated a 96% reduction in litter size in female and male
rats treated with ContraPest in an open arena study. We have also conducted
open population studies, including in trash rooms in the New York City subway
completed August 2013 and with the largest hog producer in the United States
completed in March 2015, in which we have observed decreases in wild rodent
populations of more than 40% over a 12-week period. We believe this decrease
in population will continue and, based on studies conducted by third parties,
will stabilize at an approximately 70% reduction in 12 months without rebound
(based on an initial population of approximately 10,000 rats). Also, we have
observed that the contraceptive effect of ContraPest in reducing rat population
is present regardless of the amount consumed by any particular rat in that population.
Consequently, rat populations treated with ContraPest do not experience the
same “population rebound” effect as those treated with rodenticides
because the non-reproductive rodents continue to defend their territory from
invasion by other rodents. Further, this low level of rodents contain a mixed
gene pool that does not favor the development of resistance to the active ingredients.
As a result, property owners and pest management operators may be able to substantially
decrease the amount of ContraPest used over time, thus reducing the total cost
of rodent population control in the long term. The following chart, which is
based on data derived from our population models and field studies, predicts
that as the use of ContraPest sustainably reduces rat populations over time
and on an ongoing basis, the cost of ContraPest would be lower in the long term
as compared to rodenticides.
Our solution involves a targeted delivery
Our proprietary formulation appears to be attractive to rodents. To maintain
proper hydration, rats drink 10% of their body weight in water each day; our
product is a liquid bait and comprised mostly of water. Moreover, studies show
that rats prefer and develop an addiction to eating sweet and fatty foods. ContraPest
incorporates these elements, and our studies demonstrate that rats prefer ContraPest
even when other familiar food and water sources were abundant, such as in indoor
garbage collection areas of urban, industrial facilities. Once consumed, our
product is designed to avoid a first pass through the liver effect and to deliver
active ingredients directly to targeted reproductive organs, thus increasing
its effectiveness and minimizing harm to the animal.
In addition, our solution utilizes a unique delivery system in the field that
not only allows us to evaluate the effectiveness of our fertility control products,
but also enables us to observe rodent pest behavior and determine the optimal
locations for our proprietary bait stations. We also are able to customize the
specific concentration to address the target pest.
Our solution is safe
Studies of ContraPest have demonstrated that doses of ContraPest are not lethal
to rodents or harmful to people or other animals. The active ingredients in
ContraPest are included at very low concentrations (together totaling less than
0.1% of the formulation) and have short half-lives of less than 20 minutes in
the blood of rodents. Therefore, the active ingredients in ContraPest do not
accumulate in tissues or organs of the rat (as poisons do) and thus do not sicken
or kill predators or scavengers that eat a rat that has consumed ContraPest.
In addition, at the concentrations of active ingredients in our product, there
is no potential for reproductive disruption in humans. A human would have to
consume impossibly large amounts of the active ingredients in our product to
have any effect. Further, the man-made chemical that is one of our active ingredients
(4-vinylcyclohexene diepoxide, or VCD) has been used in manufacturing settings,
and no toxic effects have been demonstrated in humans. The other active ingredient
(triptolide) is a plant-derived ingredient used in traditional Chinese medicine
to treat symptoms of rheumatoid arthritis.
Moreover, ContraPest is delivered in a ready-to-use and pre-packaged plastic
container which is inserted into a tamper-resistant rodent bait station. As
the container is inserted into the station, a spike punctures the foil-covered
opening, allowing the liquid bait to flow into a tray within the bait station.
The tank is a non-refillable container, which is recapped and disposed of when
empty. Thus, as a “closed system,” there is little opportunity for
handler exposure and virtually no opportunity for bystander exposure.
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