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Item 1. Business

2023-03-17 compared with 2022-03-29 · 175 added, 318 removed, 31 unchanged (94% of the section changed)

We have developed and are commercializing a global, proprietary technology

for managing animal pest populations, initially rat populations, through fertility control.

Rats pose threats to human and animal health as well as food security around

In addition, rats cause extensive product loss through consumption and contamination, including in the agricultural industry.

Rats also cause significant damage to critical infrastructure by burrowing beneath foundations and gnawing on electrical wiring, insulation,

fire proofing systems, electronics and computer equipment.

The most prevalent response to rat infestations is the use of lethal tools

such as traps and rodenticides, although there are growing concerns about secondary exposure and bioaccumulation of rodenticides.

solutions are limited by the rat’s extraordinary reproduction rate as well as their behavior.

ContraPest ® , our initial product, is unique liquid bait

in the pest control industry.

ContraPest targets the reproductive systems of both male and female Norway and roof rats, which can lead

to sustained reductions of the rat population.

ContraPest is a liquid bait containing the active ingredients 4-vinylcyclohexene

diepoxide (“VCD”) and triptolide.

ContraPest limits the reproduction of male and female rats beginning with the first breeding

cycle following consumption.

Accordingly, it offers an alternative to traditional rodenticides in many environments and also may be used

in coordination with rodenticides as part of integrated pest management.

It is an important option in the increasing number of jurisdictions

that are restricting the use of second-generation anti-coagulant products.

We began the registration process with the United States Environmental

Protection Agency (the “EPA”) for ContraPest on August 23, 2015.

On August 2, 2016, the EPA granted an unconditional registration

for ContraPest as a Restricted Use Product (“RUP”), due to the need for applicator expertise for deployment.

On October 18,

2018, the EPA approved the removal of the RUP designation and was reclassified as a general-use pesticide.

In addition to the EPA , ContraPest

is registered in all 50 states, 48 of which have approved the removal of the RUP designation, as well as the District of Columbia.

certain cases, our registrations are conditional and require completion of testing and we continue to seek to comply with these requirements.

We continue to develop enhancements to ContraPest that align with our

target verticals while pursuing regulatory approvals and amendments to the existing U.S.

We have developed and are commercializing a global, proprietary technology for managing animal pest populations, initially rat populations, through fertility control.

As far back as we can trace, rats have been foe to mankind.

Posing threats to human and animal health, food security, and infrastructure around the world, we have spent centuries trying to solve the problem.

Rats carry or can spread at least 35 diseases, globally posing a dangerous risk to public health and safety and protein production.

Through consumption and contamination, rats destroy at least 20% of the global stored food supply every year.

Additionally, rats cause over $27 billion in damage to public and private infrastructure annually in the United States alone by burrowing beneath foundations and gnawing on electrical wiring, insulation, fire proofing systems, electronics and computer equipment.

Over the centuries, the most prevalent response to rat infestations has been to try to eliminate them through the use of lethal tools such as traps and rodenticides.

However, there are growing concerns about secondary exposure and bioaccumulation of rodenticides through documentation of rats becoming resistant to their lethal effects or learning to avoid them altogether.

While some of these challenges are new, the efficacy of the response to rat infestations has always been limited by the rat’s extraordinary reproduction.

ContraPest®, our initial product, is novel liquid bait in the pest control industry.

ContraPest targets the reproductive systems of both male and female Norway and roof rats, which can lead to sustained reductions of the rat population.

ContraPest is a liquid bait containing the active ingredients 4-vinylcyclohexene diepoxide (“VCD”) and triptolide.

ContraPest limits the reproduction of male and female rats beginning with the first breeding cycle following consumption.

Accordingly, it offers a new tool used in coordination with rodenticides as part of an integrated pest management program, or an alternative to traditional rodenticides altogether.

It is an important option in the increasing number of jurisdictions that are restricting the use of second-generation anti-coagulant products.

The registration process with the United States Environmental Protection Agency (the “EPA”) for ContraPest began on August 23, 2015.

On August 2, 2016, the EPA granted an unconditional registration for ContraPest as a Restricted Use Product (“RUP”), due to the need for applicator expertise for deployment.

On October 18, 2018, the EPA approved the removal of the RUP designation and was reclassified as a general-use pesticide.

ContraPest is registered in all 50 states, 49 of which have approved the removal of the RUP designation, as well as the District of Columbia and five major U.S.

In certain cases, our registrations are conditional and require completion of testing.

We continue to actively seek to comply with these requirements.

On March 10, 2022, the EPA granted a sub-label for ContraPest allowing for an alternative delivery system in a hanging bait station designed to target roof rat habitats and infestations, currently marketed as Elevate Bait™.

We are continuously enhancing ContraPest to align with the unique needs and environments of our customers in our target verticals while simultaneously pursuing regulatory approvals and amendments to the existing U.S.

registration to broaden its use and marketability.

When ContraPest begins to generate sufficient revenue, we will seek regulatory approval for additional jurisdictions beyond the United

We were formed in July 2004 and incorporated in the state of Nevada.

When regulatory and financial conditions permit, we will seek regulatory approval for additional jurisdictions beyond the United States.

We were incorporated in the state of Nevada in July 2004.

On November 12, 2015, we subsequently reincorporated in the state of Delaware.

Our corporate headquarters and manufacturing site are in

Phoenix, Arizona.

On December 8, 2016, we went public and are currently traded on the Nasdaq Capital Market (“Nasdaq”) under

the symbol SNES.

On February 4, 2020, we amended our amended and restated certificate

of incorporation to effect a 1-for-20 reverse split of our issued and outstanding shares of common stock.

The accompanying condensed financial

statements and notes thereto give retrospective effect to the reverse stock split for all periods presented.

All issued and outstanding

common stock, options and warrants exercisable for common stock, restricted stock units, preferred stock conversions to common stock and

per share amounts contained in our condensed financial statements have been retrospectively adjusted.

Our corporate headquarters and manufacturing site are in Phoenix, Arizona.

On December 8, 2016, we went public and are currently traded on the Nasdaq Capital Market (“Nasdaq”) under the symbol SNES.

In November 2022, we amended our amended and restated certificate of incorporation to effect a 1-for-20 reverse split of our issued and outstanding shares of common stock.

The accompanying financial statements and notes thereto give retrospective effect to the reverse stock split for all periods presented.

All issued and outstanding common stock, options and warrants exercisable for common stock, restricted stock units, and per share amounts contained in our financial statements have been retrospectively adjusted.

Current Challenges in Pest Control Methodologies

Lethal control measures such as traps and rodenticides are often at

the forefront of rat control programs but reproduction, behavior, and genetic resistance can negatively impact results of mitigation efforts.

Two base rats, a male and female, can produce 15,000 descendants in approximately 12 months.

Lethal control measures such as traps and rodenticides are often at the forefront of rat control programs, but this reproduction rate, intelligence, and genetic resistance to the active ingredients in rodenticides can negatively impact results of traditional mitigation efforts.

Rats reach sexual maturity at approximately nine weeks of age.

can give birth to six litters per year, with up to five to ten offspring each.

This rapid reproduction rate can cause populations to rebound

quickly after implementing a lethal control program.

Rat behavior, either learned or innate, can negatively affect pest control

Females can give birth to six litters per year, an average of five to ten offspring each.

This rapid reproduction rate can cause populations to rebound quickly after implementing a lethal control program.

Rat behavior, either learned or innate, can negatively affect pest control efforts.

Neophobia, or the fear and avoidance of new objects, is an innate behavior that often impacts control efforts.

Rats avoid bait

stations, loose bait, or traps until they are confident that these new objects pose no danger.

Over time rats will begin to sample new

foods to determine if there are any negative side effects.

If the food or rodenticide causes illness in rats but they do not die, they

will avoid that food or rodenticide in the future.

Genetic resistance also creates challenges for rodent control

Rats can be resistant develop resistance to rodenticides due to genetic through genetic mutations.

This resistance is

passed onto their offspring who will carry this resistant trait to future generations.

Because of the above factors, conventional rodenticide producers are continually

challenged to develop new, more lethal chemicals to control future rat populations.

Rodenticides have significant drawbacks, in that they may affect species

that prey on rats, including birds of prey and large cats, due to the persistence of the rodenticide in the rat tissue.

In addition, there

is growing concern about the adverse effects that rodenticides may have on children and pets due to accidental, direct exposure.

Rats avoid bait stations, loose bait, or traps until they are confident that these new objects pose no danger.

Over time rats will begin to sample new foods to determine if there are any negative side effects.

If the food or rodenticide causes illness in rats but they do not die, they will avoid that food or rodenticide in the future.

Resistance to traditional rodenticides creates challenges for rodent control programs.

Rats are hard-wired to survive and some rats may develop a genetic mutation making them resistant to certain rodenticides.

Studies show that resistance is increasing in rat species.

This resistance is passed onto their offspring who will then carry this resistant trait into future generations.

Because of the above factors, traditional rodenticide producers are continually challenged to develop new, more lethal chemicals to control future rat populations.

Rodenticides may affect other species within the food chain.

It has been reported that animals that prey on rats such as raptors and large cats, have significant levels of rodenticide present in their bodies due to persistence of the rodenticide in the rat tissue.

Additionally, there is growing concern about the rise in reported cases of adverse effects that rodenticides have on children and pets due to accidental, and direct exposure.

In November 2022, the EPA released an update to its Endangered Species Act workplan which intends to expand the mitigation efforts for 90 species potentially affected by rodenticides.

The EPA will perform biological evaluations to analyze the potential effects of the rodenticides on listed species and their designated critical habitats and will identify mitigation measures for these species and critical habitats to avoid or minimize exposure from the rodenticides.

When the plan is described, they will consider it the Rodenticide Strategy.

A portion of the draft plan includes a focus on addressing effects to primary consumers of rodenticide bait (mammals and birds) and to secondary consumers that consume primary consumers (mammals, birds, and reptiles).

These changes to the EPA’s review and registration policies could affect filings with the agency due to expanded test requirements for mammals, birds, reptiles, and critical habitats.

Even though ContraPest is not a traditional rodenticide, these requirements (or a subset) may impact our registration in the future since it is classified in the rodenticide category with the EPA.

We will maintain close contact with the EPA as their final draft of this policy is due November 2023 with an intended final biological evaluation due November 2024.

Integrated Pest Management and Fertility Control

The most effective, long-term way to manage rats is by using a combination

of tools that work together to magnify the efficacy of the pest management protocol;

integrated pest management (IPM) is based upon this

The most effective, long-term way to manage rats is by using a combination of tools that work together to magnify the efficacy of the pest management protocol;

IPM is based upon this concept.

An effective IPM program needs to reduce the existing rat population while preventing the population from rebounding.

ContraPest has established a new paradigm in rodent control, making fertility control an essential component of a sustainable IPM program.

ContraPest is a highly palatable liquid formulation that reduces fertility

in both male and female rats.

Rats require 10% of their body weight in water per day, making ContraPest a great tool to add to IPM programs.

The high-fat content and sweet taste promote sustained consumption even when other sought-after food sources are present.

In both field

and laboratory settings, ContraPest will be consumed by rats even in the presence of abundant water sources and plentiful food choices,

including animal feed, trash and other options.

Consumption of ContraPest does not cause illness in rats, and therefore, it does not change

behavior or result in bait aversion.

Adding ContraPest to an IPM program brings the rodent population down

initially and keeps it at a manageable level by minimizing reproduction and thereby limiting population rebounds.

Continued maintenance

baiting of ContraPest at lower population levels dramatically reduces the risk of future population spikes, allowing customers to be more

focused on eliminating the causes of future invasions through exclusion and sanitation initiatives.

The following graphs illustrate the incremental benefit of adding ContraPest

to IPM programs with conventional rodenticides.

The data is derived from three programs we began in late 2019 to demonstrate the effectiveness

of ContraPest to potential end-users and our study of the results through monitoring rat activity by camera.

The data presented shows

the incremental benefit of ContraPest deployment beyond that achieved through rodenticides.

Ongoing monitoring of the program locations

has indicated that there has been no rebound in the rodent population from the current low levels.

Based on company field research, the addition of ContraPest to an IPM program has demonstrated improved efficacy of more than 90% with sustained population suppression.

Maintaining a ContraPest program reduces the reproduction and therefore the risk of future population spikes, known as the rebound effect.

Ongoing monitoring of the program locations has indicated that there has been no rebound in the rodent population from the current low levels.

ContraPest is a highly palatable liquid formulation that reduces fertility in both male and female rats.

Rats require 10% of their body weight in water per day.The high-fat content and sweet taste of ContraPest promotes sustained consumption even when other sought-after food sources are present.

In both field and laboratory settings, consumption of ContraPest occurs even in the presence of abundant water sources and plentiful food choices, including animal feed, trash and other options.

Additionally, ContraPest does not cause illness in rats, and therefore, it does not change behavior or result in bait aversion.

company studies)

Other Applications

While our proprietary technology is effective on rodent species, our technology

can be applied to other mammalian species.

We are currently developing a fertility control product for mice.

Further, we have developed

preliminary data with feral dogs, feral pigs, wallabies and brushtail possums.

While this preliminary data indicates potential for the

continued development of fertility control technology in general, we are not pursuing these opportunities at this time.

We believe that

the size of the rat control market as well as mice control market are sufficient for our near-term focus.

We remain open to the potential

to license our technology to other strategic partners to explore its applicability to other mammalian species.

While our proprietary technology is effective on rat species, our technology can be applied to other mammalian species.

We have explored and continue to evaluate fertility control in mice, feral dogs, and other species.

This preliminary data indicates potential for the continued development of fertility control technology in general.

We believe that the size of the rat control market is sufficient for our near-term focus.

We remain open to the potential to license our technology to other strategic partners to explore its applicability to other mammalian species.

Business Strategy

Our goal is to be a leader in the pest management industry;

fertility control technologies to limit the adverse effects caused by rodent infestations, educating PMP’s and the general public

on alternatives or enhancements to lethal rodenticides and developing additional product lines to address the needs of our customers.

Key elements of our strategy are as follows:

work to maximize market acceptance for, and generate sales of, our products, including by conducting field demonstrations at potential lead customers;

explore strategic partnerships to enable us to penetrate additional target markets and geographical locations;

manage the infrastructure for sales, marketing and distribution of ContraPest and any other product candidates for which we may receive regulatory approval;

seek additional regulatory approvals for ContraPest, including to more fully expand the market and use for ContraPest and, if we believe there is commercial viability, for our other product candidates;

further develop our manufacturing processes to contain costs while being able to scale to meet future demand of ContraPest and any other product candidates for which we receive regulatory approval;

continue product development of ContraPest and advance our research and development activities and, as our operating budget permits, advance the research and development programs for other product candidates;

maintain and protect our intellectual property portfolio;

add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts and operations as a public company.

Our goal is for ContraPest fertility control to be a standard tool utilized in pest management in IPM programs across all verticals.

We will achieve this through the following:

End User Awareness and Adoption.

Our focus is educating end users on the rapid reproduction rate of rats, drawing attention to the complex issue of gaining control of an infestation if you do not have control of rat fertility.

As more rodenticides come to market to address rat populations, attention will be drawn to the impact other rodenticides may have to other species due to bioaccumulation, and the benefit of ContraPest having a low potential for bioaccumulation.

Tailored Value Propositions.

While the desire to achieve and maintain control of rat populations is universal among end users, each vertical has a specific pain point and therefore inherent value may be achieved through the use of ContraPest.

By working with our existing customers and conducting field research, we are understanding and leveraging these unique opportunities in our sales strategies across verticals.

Our value statements include, but are not limited to the following:

• Product Development.

The needs of customers in each vertical vary due to environment and limitations, requiring ongoing innovation, exploration of additional species, and the pursuit of additional regulatory approvals for ContraPest both in the United States and globally.

• Strategic Partnerships.

Alignment with industry leaders and organizations accelerate awareness, adoption, product innovation and development.

• Efficiencies.

Through securing more reliable, affordable suppliers for our raw materials, and continuous development of our manufacturing process, we will be able to increase profits while scaling to meet rising product demand, and production of additional registered products.

Marketing and Sales Approach

The pest control industry is highly competitive with a number of large

competitors developing and marketing pest control products, particularly rodenticides, and services.

Because fertility control in general,

and ContraPest specifically, may be considered a disruptive technology, we have encountered resistance to initial adoption.

to build a robust set of case studies to demonstrate efficacy and cost efficiency, identify lead users and expand within market segments.

In order to enhance the likelihood of success, we have currently targeted key market segments with the highest likelihood to add ContraPest

into their IPM programs.

These include agribusiness (e.g., egg hen farms, grain and protein production and grain storage, transport and

sales facilities), municipalities and government agencies, e-Commerce, zoos and sanctuaries, and commercial accounts.

In the United States, ContraPest is most commonly deployed and serviced

by a licensed Pest Management Professional (“PMP”), although some customers have in house pest management service personnel.

In some circumstances, customers will request PMPs to use certain products in the provision of their service.

Initially, our marketing

strategy involved sales to and through large distributors of pest control products.

In 2019, we substantially modified this strategy to

create two different sources of pull-through-demand:

sales to PMPs and sales directly to commercial customers.

We believe that by making

end users aware of the existence and benefits of ContraPest, we are more likely to create demand through PMPs that would otherwise simply

continue to use their existing rodenticide-based IPM models.

We currently market ContraPest both to pest management companies and directly

to target segments, using a direct to PMP sales channel;

indirectly through distributor sales;

and through our own direct sales force.

In addition, in the fourth quarter of 2019, we added a new e-Commerce tool to enable customers in each of our target segments to buy directly

Finally, we have been pursuing strategic relationships with large pest management companies and key end-user organizations in

our target segments for the distribution and sale of ContraPest.

In each of our target segments we have identified potential lead customers

with whom we are working on large scale projects to demonstrate the efficacy of ContraPest in real world situations.

We provide significant

product support to these customers to make sure that we are not only achieving desired results, but also obtaining the data to support

sales in the related market vertical.

We believe that successful field trials with these influential end users will help drive significant

subsequent sales to other participants in the relevant market.

We are also focused on expanding regulatory approvals for ContraPest

to make the product more user friendly and available for use in an increased number of applications.

These include alternative delivery

methods and expansion of the label to additional applications and/or species.

Pricing and Value

Our pricing strategy takes into account the cost of goods sold, the

cost of competitive products and the value of our product to the end user.

We believe ContraPest will be perceived as a significant value

as a complement to existing pest control products or as a non-lethal stand-alone solution for managing rat infestations and, as such,

should command a premium price.

Our experience is that once potential customers understand the advantages of ContraPest, they recognize

that the benefits of long-term sustained rodent reduction dramatically offset the cost of the product.

We plan to continue to use promotional

efforts to support the value message and to justify our product’s premium price, built around the following advantages:

ContraPest uses targeted delivery for maximum efficacy;

our proprietary gravity feeding system optimizes consumption;

ContraPest is differentiated in what is otherwise a very crowded rodenticide market.

It is the only product registered with the EPA that restricts fertility in both male and female rats and is designed to be non-lethal.

As first and second generation anti-coagulants come under increased scrutiny for bioaccumulation and impact on non-target species as they travel up the food chain, their use is being restricted or even banned in select areas across the United States and globally.

These increasing restrictions and bans create an opportunity for ContraPest, as industry professionals are looking for effective tools to serve their customers and gain control of rat populations through nontraditional means.

Because the pest industry in the United States has demonstrated a reluctance to adopt new technologies, the marketing of ContraPest has primarily been aimed at end-user awareness, creating pull through demand with Pest Management Providers (“PMP”) by applying pressure for PMPs to use ContraPest as part of their IPM.

Additionally, within our target verticals, agribusiness, commercial, distributors, e-commerce, pest management, municipalities, and zoos and sanctuaries, many large targets employ internal pest management teams as opposed to contracting with service providers.

For these reasons, the end-user is our primary target in order to grow market penetration for ContraPest.

While pain points and benefits are unique to each vertical, they have shared core value propositions.

• ContraPest is effective.

Lab tests and field research demonstrate more than 90% reduction in rat populations when added to an IPM with sustained population suppression;

• Our proprietary, patent-protected formulation and gravity feeding system optimizes consumption and provides targeted delivery for maximum efficacy;

• ContraPest is specifically designed to minimize exposure hazard for handlers and non-targeted species such as wildlife, livestock, and pets;

• ContraPest can be used as an anchor or enhancement for an IPM program, or as a stand-alone solution to decrease reliance on lethal control options.

ContraPest is designed, formulated and dispensed in a manner that minimizes the exposure hazard for handlers and non-targeted species such as wildlife, livestock and pets;

over time, as the pest population decreases, the quantity deployed and consequently, the cost of ContraPest will decrease, bringing the long-term cost of ContraPest in line with other elements of integrated pest management.

We also focus on specific advantages for the individual customer and

expect to position our product as having the following additional general advantages:

savings by reducing loss or contamination of food and product inventories;

savings by reducing damage to infrastructure and major production equipment;

reduction in labor and servicing costs due to dramatically reduced rodent populations;

creation of a more predictable cost model based on prevention versus treatment of spikes in population seen with rebound effect;

reduction in disease vectors;

public relations and risk reduction advantages when reducing usage of lethal rodenticides and traps.

Three core sales channels drive revenue allowing SenesTech to reach a wider customer base and target different segments of the market.

• e-Commerce.

Because ContraPest is not a retail product, e-commerce provides a hub to push end-users for further education as well as providing 24/7 availability for purchasing products and managing subscriptions.

• Field Sales.

Field sales allows for personal interaction, consultation, and development of potential customers.

Field sales representatives, in charge of regional territories across the United States, focus in the larger account segments, attending trade shows and educational opportunities within target verticals.

• Distributors and resellers.

Distributors and resellers serve as an expansion of our sales team, increasing our reach by leveraging the established networks and connections of these third-party businesses.

Additionally, the logistics and marketing support offered through these partners reduces cost and effort required to expand our sales.

Our current focus is successful commercialization of ContraPest in the United States.

Aware of the global need for effective rat fertility control, we evaluate requests and inquiries for licensing and manufacturing ContraPest in other regions on a regular basis.

There is a sustained focus on building strategic partnerships now for future globalization of ContraPest.

Raw Materials and Manufacturing Process

ContraPest contains two active ingredients, VCD, an industrial chemical,

and triptolide, a plant derived chemical.

ContraPest contains two active ingredients, VCD, an industrial chemical, and Triptolide, a plant derived chemical.

ContraPest also contains several other inactive, generally recognized as safe (“GRAS”), ingredients.

Currently, we source VCD from standard industrial chemical supply providers.

Triptolide is derived from the Thunder God Vine, Tripterygium

wilfordii, which is commonly cultivated and harvested wild in southeastern China and other Asian countries.

Triptolide is available from

a variety of sources, but the process to purify triptolide for use in ContraPest is expensive.

Thus, we are investigating other, less

costly sources of triptolide.

Our manufacturing process involves the incorporation of our two active

ingredients, in low concentrations, into several inactive ingredients.

Once incorporated, the entire product goes through a micro-encapsulation

process in order to stabilize the final formulation.

This process allows ContraPest to be delivered to rats in a palatable, non-lethal,

and effective manner.

Currently, we have production scale capability in our facilities in

Arizona to manufacture ContraPest.

Our internal production capabilities allow us to meet our current and anticipated demand through 2023

for ContraPest.

Triptolide is derived from the Thunder god vine, Tripterygium wilfordii, which is commonly cultivated and harvested wild in southeastern China and other Asian countries.

Triptolide is available from a variety of sources, but the process to purify triptolide for use in ContraPest is expensive.

Thus, we are investigating other, less costly sources of triptolide.

Our manufacturing process involves the incorporation of our two active ingredients, in low concentrations, into several inactive ingredients.

Once incorporated, the entire product goes through a proprietary process in order to stabilize the final formulation.

This process allows ContraPest to be delivered to rats in a palatable, effective manner, and it is designed to be non-lethal.

Currently, we have production scale capability in our facilities in Arizona to manufacture ContraPest.

Our internal production capabilities allow us to meet our current and anticipated demand through 2023 for ContraPest.

Scientific Background Regarding our Product

ContraPest is a liquid bait containing the active ingredients VCD and

When consumed, ContraPest targets reproduction, limiting fertility in male and female rats beginning with the first breeding

cycle following consumption.

Female rats are born with a finite number of eggs, or oocytes, and

remain fertile until death.

Female rats are born with a finite number of eggs, or oocytes, and remain fertile until death.

Within the ovary, eggs develop within structures called follicles.

The non-regenerating and least mature follicles

are called primordial.

The non-regenerating and least mature follicles are called primordial.

The primordial follicles mature through primary, secondary and antral stages and ultimately ovulate.

Once the primordial

follicles have become depleted, ovarian failure occurs, which terminates reproductive capability.

VCD causes specific loss of small ovarian

follicles (both primordial and primary).

Once the primordial follicles have become depleted, ovarian failure occurs, which terminates reproductive capability.

VCD causes specific loss of small ovarian follicles (both primordial and primary).

Triptolide causes specific loss of growing follicles (secondary and antral).

In males, triptolide

exerts a significant suppression of male fertility by preventing sperm maturation and impairing the movement of sperm.

The safety and efficacy of VCD, triptolide, and ContraPest are supported

by considerable evidence.

VCD and triptolide are rapidly metabolized by the rat, limiting the possibility of bioaccumulation or effect

on non-target species.

Further, based on our toxicology studies, ContraPest should not cause rats to become ill, change behavior or become

more susceptible to predation.

Furthermore, ContraPest is a contraceptive, not a sterilant.

duration of infertility ranges from 77 to over 180 days.

In males, triptolide exerts a significant suppression of male fertility by preventing sperm maturation and impairing the movement of sperm.

The safety and efficacy of VCD, triptolide, and ContraPest are supported by considerable evidence.

VCD and triptolide are rapidly metabolized by the rat, limiting the possibility of bioaccumulation or effect on non-target species.

Further, based on our toxicology studies, ContraPest should not cause rats to become ill, or change their behavior.

Furthermore, ContraPest is a contraceptive, not a sterilant, limiting fertility in male and female rats beginning with the first breeding cycle following consumption.

The average duration of infertility post consumption ranges from 77 to over 180 days.

Other Potential Products

We have begun work on new formulations of ContraPest – particularly

solid and semi-solid variants.

Although solid bait is not essential to our near-term plans, the non-liquid formulations may expand the

potential uses of ContraPest as well as pave the way for future sales through retail stores.

Our plan is to accelerate the reformulation

process through partnerships with others in the industry that will be able to give us access to proven technologies, thus reducing potential

development time.

we are unaware of any other non-lethal fertility control products targeting rats that are registered by the EPA.

There is a non-registered

product being sold online that claims to control rodent reproduction humanely.

do not believe this is a product that can compete with us.

Our principal competition is the substitution of other tools that PMPs

use in their IPM.

We have begun work on new formulations of ContraPest – particularly solid and semi-solid variants.

Although solid bait is not essential to our near-term plans, the non-liquid formulations may expand the potential uses and applications of ContraPest.

Our plan is to accelerate the reformulation process through partnerships with others in the industry that will be able to give us access to proven technologies, thus reducing potential development time.

Currently, we are unaware of any other non-lethal fertility control products targeting rats that are registered by the EPA.

There is a non-registered product being sold online that claims to control rodent reproduction.

We do not believe this to be a competitive product.

Our principal competition is the substitution of other tools that PMPs use in their IPM.

Government Regulation and Product Approval

Federal, state and local government authorities in the United States

regulate, among other things, the testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, distribution

and marketing of the products we develop.

The process for obtaining regulatory approval and compliance with appropriate federal, state

and local regulations is rigorous and requires the expenditure of substantial time and financial resources.

Federal, state and local government authorities in the United States regulate, among other things, the testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, distribution and marketing of the products we develop.

The process for obtaining regulatory approval and compliance with appropriate federal, state and local regulations is rigorous and requires the expenditure of substantial time and financial resources.

United States Review and Approval Processes

In the United States, the EPA regulates the sale, distribution and

use of any pesticide under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

The EPA’s definition of a pesticide includes

“any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.” FIFRA defines

a pest as “any insect, rodent, nematode, fungus, or weed.” To register a new product with the EPA, all active ingredients

within the product must be registered with the EPA.

In the United States, the EPA regulates the sale, distribution and use of any pesticide under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”).

The EPA’s definition of a pesticide includes “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.” FIFRA defines a pest as “any insect, rodent, nematode, fungus, or weed.” To register a new product with the EPA, all active ingredients within the product must be registered with the EPA.

The EPA granted registration for ContraPest effective August 2, 2016.

This initial EPA approval labeled ContraPest as a restricted-use product, due to the need for applicator expertise for deployment.

October 18, 2018, the EPA removed the Restricted Use designation, meaning that we can sell ContraPest to consumers who do not have applicator

On October 18, 2018, the EPA removed the Restricted Use designation, meaning that we can sell ContraPest to consumers who do not have applicator expertise.

ContraPest is currently limited by EPA requirements to indoor use and to use within one foot of manmade structures.

to diligently pursue additional related regulatory approvals from the EPA to support our product evolution, including seeking approval

for full outdoor use, alternative formulations and for additional rodent species.

This may entail the need to complete and submit to EPA

additional studies, principally related to the effects on other animals and fish if ingested or if the product enters the water supply.

In addition to the EPA registration of ContraPest in the United States,

we must obtain registration from the various state regulatory agencies prior to selling in each state.

To date, we have received registration

for ContraPest in all 50 states and the District of Columbia, 48 of which have approved the removal of the Restricted Use designation.

In addition to product registration, the EPA also approves all labeling

(the container label, instructional inserts, and the Safety Data Sheet (SDS)) of ContraPest.

Generally, states accept the EPA approved

ContraPest’s labeling was submitted to states at initial registration and is resubmitted during state scheduled reregistration

or for any significant labeling change requiring EPA approval.

In certain cases, our EPA and state registrations require completion

of testing and certifications even after we have received approval for the product or its labelling.

We continue to seek to comply with

these requirements.

We intend to diligently pursue additional related regulatory approvals from the EPA to support our product evolution, including

seeking approval for full outdoor use, alternative formulations and for additional rodent species.

This may entail the need to complete and submit to EPA additional studies, principally related to the effects on other animals and fish if ingested or if the product enters the water supply.

In addition to the EPA registration of ContraPest in the United States, we must obtain registration from the various state regulatory agencies prior to selling in each state.

To date, we have received registration for ContraPest in all 50 states and the District of Columbia, 49 of which have approved the removal of the Restricted Use designation.

In addition to product registration, the EPA also approves all labeling (the container label, instructional inserts, and the Safety Data Sheet) of ContraPest.

Generally, states accept the EPA approved label as is.

ContraPest’s labeling was submitted to states at initial registration and is resubmitted during state scheduled reregistration or for any significant labeling change requiring EPA approval.

In certain cases, our EPA and state registrations require completion of testing and certifications even after we have received approval for the product or its labeling.

We continue to seek to comply with these requirements.

International Review and Approval Processes

We are researching potential international markets and will evaluate

the regulatory landscapes of each prospective market.

Country-specific regulatory laws have provisions that include requirements for certain

labeling, safety, efficacy and manufacturers’ quality control procedures to assure the consistency of the product, as well as company

records and reports.

Some specific in-country studies will be required for particular countries, but others will generally accept an EPA

or EU compliant dossier.

As of December 31, 2021, we had 26 full-time employees and one part-time

Within our workforce, seven employees are engaged in research and development and 20 employees are engaged in sales, business

development, finance, regulatory, human resources, facilities, information technology and general management and administration.

None of our employees are represented by labor unions or covered by

collective bargaining agreements.

Intellectual Property and Other Proprietary

Maintaining a strong position in the rodenticide market requires constant

innovation along with a healthy research program to evolve product lines to remain competitive and relevant to the needs of the changing

global marketplace.

We seek to protect our proprietary data and trade secrets with attention to data exchanges among employees, consultants,

collaborators and research and trade partners.

We are researching potential international markets and will evaluate the regulatory landscapes of each prospective market.

Country-specific regulatory laws have provisions that include requirements for certain labeling, safety, efficacy and manufacturers’ quality control procedures to assure the consistency of the product, as well as company records and reports.

Some specific in-country studies will be required for particular countries, but others will generally accept an EPA or EU compliant dossier.

As of December 31, 2022, we had 29 full-time employees and one part-time employee.

Within our workforce, eight employees are engaged in research and development and 21 employees are engaged in sales, business development, finance, regulatory, human resources, facilities, information technology and general management and administration.

None of our employees are represented by labor unions or covered by collective bargaining agreements.

Intellectual Property and Other Proprietary Rights

Maintaining a strong position in the rodenticide market requires constant innovation along with a healthy research program to evolve product lines to remain competitive and relevant to the needs of the changing global marketplace.

We seek to protect our proprietary data and trade secrets with attention to data exchanges among employees, consultants, collaborators and research and trade partners.

Patent Filings

Our intellectual property portfolio supporting ContraPest consists

of nine international patent filings (in the United States, Europe, Canada, Brazil, Russia, Japan, Mexico, South Korea, and Australia)

addressing the ContraPest compound.

Claims directed toward the compound include composition-of-matter involving a diterpenoid epoxide

or salts thereof in combination with an organic diepoxide, use claims for inducing follicle depletion and for reducing the reproductive

capability of a mammalian animal or non-human mammalian population.

Issued claims will have a patent term extending to 2033 or longer

based on patent term determinations in each of the filing countries.

The novelty of ContraPest extends to its method of field distribution

and has required innovation to perfect the dosing of our product to rodents.

Our intellectual property portfolio supporting ContraPest consists of nine international patent filings (in the United States, Europe, Canada, Brazil, Russia, Japan, Mexico, South Korea, and Australia) addressing the ContraPest compound.

Claims directed toward the compound include composition-of-matter involving a diterpenoid epoxide or salts thereof in combination with an organic diepoxide, use claims for inducing follicle depletion and for reducing the reproductive capability of a mammalian animal or non-human mammalian population.

Issued claims will have a patent term extending to 2033 or longer based on patent term determinations in each of the filing countries.

The novelty of ContraPest extends to its method of field distribution and has required innovation to perfect the dosing of our product to rodents.

We have filed U.S.

and international patent applications

covering our novel bait station device to effectively and efficiently deliver our rodent bait at individual bait sites that would, if

issued, offer patent term protection through at least 2036.

and international patent applications covering our novel bait station device to effectively and efficiently deliver our rodent bait at individual bait sites that would, if issued, offer patent term protection through at least 2036.

License Agreements

We have an exclusive patent license with the University of Arizona

for background intellectual property that we plan to employ for future product development in the domestic animal fertility control market.

The patent claims in the United States, Australia and New Zealand cover the use of 4-vinylcyclohexene diepoxide to deplete ovarian follicles

in individual mammals and mammal populations.

The license agreement, signed in 2005, will terminate with the last-to-expire patent claims,

which have a term extending to 2026.

We have an exclusive patent license with the University of Arizona for background intellectual property that we plan to employ for future product development in the domestic animal fertility control market.

The patent claims in the United States, Australia and New Zealand cover the use of 4-vinylcyclohexene diepoxide to deplete ovarian follicles in individual mammals and mammal populations.

The license agreement, signed in 2005, will terminate with the last-to-expire patent claims, which have a term extending to 2026.

Trade Secrets and Trademarks

Beyond our patent right holdings, we broaden our intellectual property

position with trademark, trade secret, know-how and continuous scientific discovery to accompany our product development efforts.

these proprietary assets with a combination of confidentiality terms in all commercial agreements or stand-alone confidentiality agreements

along with rights-ownership agreements and structured information transfer understandings prior to beginning any collaborative projects.

We own and maintain the ContraPest trademark and intend to register new trademarks for products from our evolving rodenticide product

line and for products for mammalian species beyond rodentia.

We have exclusive use status with the EPA for the data sets we have

developed and submitted to the EPA as part of our application for ContraPest.

The exclusive use status applies to new active ingredients

and the final formulation of the ContraPest product for a period of 10 years.

For five years after the 10-year period of exclusivity,

if another applicant or the EPA Administrator chooses to rely on one or more data sets that we submitted in support of an application

submitted by another applicant, the new applicant must make a binding offer to compensate us and certify to the EPA that it has done so.

If we and the offeror cannot reach agreement on the terms of the compensation for the use of such data sets, FIFRA requires resolution

by binding arbitration.

The EPA rules do not describe how the compensation should be determined, and there is publicly available information

about some, but not all, binding arbitration decisions.

Beyond our patent right holdings, we broaden our intellectual property position with trademark, trade secret, know-how and continuous scientific discovery to accompany our product development efforts.

We protect these proprietary assets with a combination of confidentiality terms in all commercial agreements or stand-alone confidentiality agreements along with rights-ownership agreements and structured information transfer understandings prior to beginning any collaborative projects.

We own and maintain the ContraPest trademark and intend to register new trademarks for products from our evolving rodenticide product line and for products for mammalian species beyond rodentia.

We have exclusive use status with the EPA for the data sets we have developed and submitted to the EPA as part of our application for ContraPest.

The exclusive use status applies to new active ingredients and the final formulation of the ContraPest product for a period of 10 years.

For five years after the 10-year period of exclusivity, if another applicant or the EPA Administrator chooses to rely on one or more data sets that we submitted in support of an application submitted by another applicant, the new applicant must make a binding offer to compensate us and certify to the EPA that it has done so.

If we and the offeror cannot reach agreement on the terms of the compensation for the use of such data sets, FIFRA requires resolution by binding arbitration.

The EPA rules do not describe how the compensation should be determined, and there is publicly available information about some, but not all, binding arbitration decisions.

Where You Can Find Additional Information

We electronically file with the SEC our Annual Reports on Form 10-K,

Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a)

or 15(d) of the Securities Exchange Act of 1934.

We make available on our website at www.senestech.com, free of charge, copies of these

reports, as soon as reasonably practicable after electronically filing such reports with, or furnishing them to, the SEC.

The information

contained in, or that can be accessed through, our website is not part of, and is not incorporated into, this Annual Report on Form 10-K.

We electronically file with the SEC our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934.

We make available on our website at www.senestech.com, free of charge, copies of these reports, as soon as reasonably practicable after electronically filing such reports with, or furnishing them to, the SEC.

The information contained in, or that can be accessed through, our website is not part of, and is not incorporated into, this Annual Report on Form 10-K.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business