UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31 , 2021
OR
☐ TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 001-37941
SENESTECH, INC.
(Exact name of registrant as specified in its
charter)
Delaware 20-2079805
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
23460 N . 19 th Avenue , Suite 110
Phoenix , AZ 85027
(Address of principal executive offices) (Zip Code)
(928) 779-4143
(Registrant’s telephone number, including
area code)
(Former name, former address and former fiscal
year, if changed since last report)
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class Trading symbol Name of each exchange on
which registered
Common Stock, $0.001 par value SNES The Nasdaq Stock Market LLC (Nasdaq Capital Market)
Securities registered pursuant to Section 12(g)
of the Act:
NONE
Indicate by check mark if the registrant is a well-known seasoned issuer,
as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth
company” in Rule 12b-2 of the Exchange Act.:
Large accelerated
filer ☐ Accelerated
filer ☐ Non-accelerated
filer ☒ Smaller reporting
company ☒ Emerging growth
company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on
and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section
404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
☐
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of the registrant’s common stock held
by non-affiliates on June 30, 2021 (the last business day of the registrant’s most recently completed second fiscal quarter) as
reported by The NASDAQ Capital Market on such date was approximately $ 19,477,004 . There were 12,097,518 shares of the registrant’s
common stock outstanding on June 30, 2021.
The number of shares of common stock outstanding
as of March 29, 2022: 12,212,283
Documents Incorporated by Reference
Portions of the registrant’s definitive proxy
statement for the 2022 Annual Meeting of Stockholders
are incorporated by reference into Part III of
this Form 10-K.
SENESTECH, INC.
ANNUAL REPORT ON FORM 10-K
TABLE OF CONTENTS
Page
PART I
Item 1
Business
1
Item 1A
Risk Factors
9
Item 1B
Unresolved Staff Comments
22
Item 2
Properties
22
Item 3
Legal Proceedings
22
Item 4
Mine Safety Disclosures
22
PART II
Item 5
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
23
Item 6
Reserved
23
Item 7
Management’s Discussion and Analysis of Financial Condition and Results of Operations
24
Item 7A
Quantitative and Qualitative Disclosures About Market Risk
33
Item 8
Financial Statements and Supplementary Data
F-1
Item 9
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
34
Item 9A
Controls and Procedures
34
Item 9B
Other Information
34
Item
9C
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
34
PART III
Item 10
Directors, Executive Officers and Corporate Governance
35
Item 11
Executive Compensation
35
Item 12
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
3 5
Item 13
Certain Relationships and Related Transactions, and Director Independence
35
Item 14
Principal Accounting Fees and Services
35
PART IV
Item 15
Exhibits, Financial Statement Schedules
36
Item 16
Form 10-K Summary
38
Signatures
39
i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
The statements contained in this Annual Report
on Form 10-K that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements
of historical facts contained or incorporated herein by reference in this Annual Report on Form 10-K, including statements regarding our
future operating results, future financial position, business strategy, objectives, goals, plans, prospects, markets, and plans and objectives
for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipates,”
“believes,” “estimates,” “expects,” “intends,” “suggests,” “targets,”
“contemplates,” “projects,” “predicts,” “may,” “might,” “plan,”
“would,” “should,” “could,” “can,” “potential,” “continue,” “objective,”
or the negative of those terms, or similar expressions intended to identify forward-looking statements. However, not all forward-looking
statements contain these identifying words. Specific forward-looking statements in this Annual Report on Form 10-K include statements
regarding:
●
our belief 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 concept;
●
our belief ContraPest can establish a new paradigm in rodent control, making fertility control an essential component of a sustainable IPM program;
●
our belief that the size of the rat control market is sufficient for our near-term focus;
●
our belief that successful field trials with certain influential end-users will help drive significant subsequent sales to other participants in the relevant market;
●
our belief 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 compared to other products;
●
our belief that ContraPest consumption should not cause rats to become ill, change their behavior, or become more susceptible to predation, which reduces risks of non-target species exposure;
●
our belief that a certain non-registered product being sold online that claims to control rodent reproduction humanely may attempt to compete with us;
●
our plan to continue to use promotional efforts to support the value message and to justify our product’s premium price;
●
our plan to attempt 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;
●
the 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;
●
our plan to continue to utilize various forms of stock-based compensation awards to attract and retain qualified employees;
●
our anticipation that stock-based compensation expense will continue to represent a significant portion of our selling, general and administrative expenses for the foreseeable future;
●
our expectation our expenses to continue or increase in connection with our ongoing activities, particularly as we focus on marketing and sales of ContraPest;
●
our expectation to continue to grant stock options and other equity-based awards, such as restricted stock units, in the future and to continue to recognize stock-based compensation expense in future periods
●
our commercialization and promotion strategy and plans, including key elements to our business strategy, how we commercialize, our sales approach, the tools we use, our hiring and retention strategy; our areas and markets of focus, our pricing strategy, our strategic relationships and which geographic markets we target;
●
our seeking, obtaining or maintaining regulatory approvals for our product candidates;
●
our expectations regarding the potential market size for our products and how the market may develop;
ii
●
our estimates or expectations related to our revenue, cash flow, expenses, capital requirements and need for additional financing;
●
our ability, and the time required, to improve our cost structure and gross margins, and limit our cash burn;
●
our plans for our business, including for research and development;
●
our ability to enter into strategic arrangements and to achieve the expected results from such arrangements;
●
the adequacy of our facilities to meet our current needs;
●
the initiation, timing, progress and results of field studies and other studies and trials and our research and development programs;
●
our belief the claims against us do not have merit and our intention to aggressively defend against these accusations;
●
our belief the litigation against us is not likely to have a material effect on our operations;
●
our financial performance, including our ability to fund operations;
●
developments and projections relating to our projects, competitors and our industry, including legislative developments and impacts from those developments; and
●
other risks and uncertainties, including those described or incorporated by reference under the caption “Risk Factors” in this Annual Report on Form 10-K.
These forward-looking statements are not guarantees
of future performance and involve known and unknown risks, uncertainties and situations that are difficult to predict and that may cause
our own, or our industry’s, actual results to be materially different from the future results that are expressed or implied by these
statements. Accordingly, actual results may differ materially from those anticipated or expressed in such statements as a result of a
variety of factors, including those discussed in Item 1A-“Risk Factors” of Part II of in this Annual Report on Form 10-K.
A number of factors could cause our actual results to differ materially from those indicated by the forward-looking statements. Such factors
include, among others, the following:
●
the impacts and implications of the COVID-19 pandemic;
●
the successful commercialization of our products;
●
market acceptance of our products; and
●
regulatory approval and regulation of our products and other factors and risks identified from time to time in our filings with the Securities and Exchange Commission, including this Annual Report on Form 10-K.
All forward-looking statements included herein
are based on information available to us as of the date hereof and speak only as of such date. Except as required by law, we undertake
no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. The forward-looking
statements contained in or incorporated by reference into this Annual Report on Form 10-K reflect our views as of the date of this Annual
Report on Form 10-K about future events and are subject to risks, uncertainties, assumptions, and changes in circumstances that may cause
our actual results, performance, or achievements to differ significantly from those expressed or implied in any forward-looking statement.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future events,
results, performance, or achievements.
We are subject to the information requirements
of the Exchange Act, and we file or furnish reports, proxy statements and other information with the Securities and Exchange Commission,
or the SEC. Such reports and other information we file with the SEC are available free of charge at www.senestech.com as soon as practicable
after such reports are available on the SEC’s website at www.sec.gov. The SEC’s website contains reports, proxy and information
statements, and other information regarding issuers that file electronically with the SEC.
iii
PART I
Item 1. Business.
Overview
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
the world. 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. These
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. In
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. 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
States.
We were formed in July 2004 and incorporated in the state of Nevada.
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.
1
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.
Rats reach sexual maturity at approximately nine weeks of age. Females
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
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
programs. 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.
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
concept. An effective IPM program needs to reduce the existing rat population while preventing the population from rebounding. We believe
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.
2
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.
(source: 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.
3
Business Strategy
Our goal is to be a leader in the pest management industry; utilizing
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; and
●
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.
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. We continue
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
from us. 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.
4
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 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; and
●
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; and
●
public relations and risk reduction advantages when reducing usage of lethal rodenticides and traps.
Raw Materials and Manufacturing Process
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.
5
Scientific Background Regarding our Product
ContraPest is a liquid bait containing the active ingredients VCD and
triptolide. 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. Within the ovary, eggs develop within structures called follicles. 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). 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. The average
duration of infertility 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.
Competition
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 humanely. We
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.
6
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.
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.
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. 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. 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, 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
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 labelling. 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.
Personnel
As of December 31, 2021, we had 26 full-time employees and one part-time
employee. 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
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.
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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. 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.
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.
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. 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.
Data Sets
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.
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Item 1A. Risk Factors
As discussed immediately prior to Item 1 of Part I, “Business”
under “Cautionary Note Regarding Forward-Looking Statements,” our actual results could differ materially from those expressed
in our forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, those discussed
below. Additional risks and uncertainties not presently known to us, or that we currently deem immaterial, may also impair our business
operations. If any of the following risks occur, our business, financial condition, operating results, cash flows and the trading price
of our common stock could be materially adversely affected.
Risks Relating to our Business
The impacts of the coronavirus pandemic could adversely affect
our business, and other similar crises could result in similar or other harms.
The outbreak of the novel coronavirus (COVID-19) pandemic has resulted
in widespread travel and transportation restrictions and closures of commercial spaces, industrial facilities and other spaces and businesses
in and across the United States and the world, including in the locations we operate or target sales. As a result, our business has been
impacted and we could face continued or more adverse effects. In addition, our results and financial condition may be adversely affected
by federal or state legislation, or other similar laws, regulations, orders or other governmental or regulatory actions or best practices,
that would impose new restrictions on our ability to operate our business or customers to operate their businesses. For example, our sales
and technical field forces have been restricted from traveling or limited in travel, which adversely affects our ability to sell our products
and complete field studies. While we have implemented cautionary procedures at our manufacturing facility, there may be disruptions to
our ability to manufacture due to current and additional workplace controls. Our customers may be less inclined or unable to purchase
our products or continue product studies due to restrictions under which they may be operating. Those restrictions have been and are more
severe in some jurisdictions, such as California. If financial markets tighten, we may have more limited ability to raise necessary financing.
The COVID-19 pandemic is also placing a significant budgetary burden on federal, state and local governments, which may impede or delay
their ability to purchase our products. We source some of our critical raw materials from Asia, and the coronavirus has caused supply
chain disruptions, which could limit a timely supply of materials. Each of these could have negative effects on our business, results
of operations, financial condition and cash flows. Even if the coronavirus pandemic passes, another crisis with similar effects could
develop and harm our business, financial results and liquidity. The degree to which the COVID-19 pandemic may impact our results of operations
and financial condition is unknown at this time and will depend on future developments, including the ultimate severity and the duration
of the pandemic, and further actions that may be taken by governmental authorities or businesses or individuals on their own initiatives
in response to the pandemic.
Our success is dependent on the successful commercialization
of ContraPest.
The EPA granted registration approval for ContraPest effective August
2, 2016, and as of July 12, 2018, we have received registration for ContraPest in all 50 states and the District of Columbia. However,
we have not yet had significant sales of ContraPest, which is our only product to date that is available for commercialization and the
generation of revenue.
ContraPest and our other product candidates, if approved, may
not achieve adequate market acceptance necessary for commercial success.
Even following receipt of regulatory approval for ContraPest or future
regulatory approval of our other product candidates, such products may not gain market acceptance. Market acceptance of any of our product
candidates for which we receive approval depends on a number of factors, including the following:
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the potential and perceived advantages of product candidates over alternative or complementary products;
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the effectiveness of our sales and marketing efforts and those of our collaborators;
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the efficacy and safety of such product candidates as demonstrated in trials;
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the uses, indications or limitations for which the product candidate is approved;
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product labeling or product insert requirements of the EPA or other regulatory authorities;
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the timing of market introduction of our products as well as future competitive or alternative products;
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relative convenience and ease of use; and
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unfavorable publicity relating to the product.
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If we cannot successfully commercialize our products, especially
ContraPest, we will not become profitable.
If any of our approved product candidates fail to achieve sufficient
market acceptance, we will not be able to generate significant revenues or become profitable. The commercial success of ContraPest will
depend on a number of factors, including the following:
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the execution of our commercial strategy and the successful expansion of our commercial organization;
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our success in educating end users about the benefits, administration and use of ContraPest;
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the effectiveness of our own or our potential strategic partners’ marketing, sales and distribution strategy and operations;
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convincing PMPs to deploy ContraPest in quantity as an enhancement to, or replacement of, their current strategy of rodenticide use;
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c ontinued refinement of our
pricing strategy;
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our ability to manufacture quantities of ContraPest using commercially acceptable processes and at a scale sufficient to meet anticipated demand and enable us to reduce our cost of manufacturing; and
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a continued acceptable safety profile of ContraPest.
Many of these factors are beyond our control. If we are unable to successfully
commercialize ContraPest, we may not be able to earn sufficient revenues or profits to continue our business.
We will require additional capital to fund our operations. Failure
to obtain this necessary capital if needed may force us to delay, limit, or terminate our product development efforts or other operations.
Commercialization of ContraPest and developing further product candidates,
including conducting experiments and field studies, obtaining and maintaining regulatory approval and commercializing any products approved
for sale, is a time-consuming, expensive and uncertain process that takes years to complete. We expect our expenses to continue and to
increase in connection with our ongoing activities, particularly as we advance our commercialization activities. We may expand our operations,
and as a result of many factors, some of which may be currently unknown to us, our expenses may be higher than expected. Securing additional
financing may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize
our product candidates, including ContraPest. In addition, we cannot guarantee that future financing will be available in sufficient amounts
or on terms acceptable to us, if at all. If we are unable to raise additional capital when required or on acceptable terms, we may be
required to take certain actions, including the following:
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significantly delay, scale back or discontinue the development or commercialization of our product candidates, including ContraPest;
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seek strategic partners for the manufacturing, sales and distribution of ContraPest or any of our other product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; and
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relinquish, or license on unfavorable terms, our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves.
The occurrence of any of the events described above would have a material
adverse effect on our business, operating results and prospects and on our ability to develop our product candidates.
ContraPest is the first product we have marketed, and if we are
unable to establish and maintain an effective sales force and marketing and distribution infrastructures, or enter into and rely upon
acceptable third-party relationships, we may be unable to generate any revenue.
We continue to develop a functional infrastructure for the sales, marketing,
and distribution of our products and the cost of establishing and maintaining such an infrastructure may exceed the cost-effectiveness
of doing so. In order to market ContraPest and any other products that may be approved by the EPA and comparable foreign regulatory authorities,
we must continue to build our sales, marketing, managerial and other non-technical capabilities or make arrangements with third parties
to perform these services for which we would incur substantial costs. If we are unable to establish and maintain adequate sales, marketing,
and distribution capabilities, whether independently or with third parties, we may not be able to generate sufficient product revenue
to become profitable. Without an effective internal commercial organization or the support of a third party to perform sales and marketing
functions, we may be unable to compete successfully.
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Risks Regulations Have on Our Business
Regulatory approval processes of the EPA and comparable foreign
regulatory authorities are lengthy, time-consuming and unpredictable, and if we are ultimately unable to obtain regulatory approval for
our product candidates, our business may fail.
The EPA review process for a product with one or more new active ingredients
typically takes approximately two years to complete and approval is never guaranteed. In addition, we continue to seek approvals to expand
labels and use designations for ContraPest to broaden its market and usability. Our efforts could fail to receive marketing approval from
the EPA or, with respect to ContraPest or our product candidates, from a comparable foreign regulatory authority for many reasons, including
the following:
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disagreement over the design or implementation of our trials;
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failure to demonstrate a product candidate is safe or works according to our claims;
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failure to demonstrate a product candidate’s benefits outweigh its risks;
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disagreement over our interpretation of data;
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disagreement over whether to accept efficacy results from trials;
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the insufficiency of data collected from trials to obtain regulatory approval;
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irreparable or critical compliance issues relating to our manufacturing process; or
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changes in the approval policies or regulations that render our data insufficient for approval.
Any of these factors, some of which are beyond our control, could jeopardize
our ability to obtain regulatory approval for and successfully market any of our product candidates. Any such setback in our pursuit of
regulatory approval could have a material adverse effect on our business and prospects.
Even following receipt of any regulatory approval for ContraPest
and our other product candidates, we will continue to face extensive regulatory requirements and our products may face future development
and regulatory difficulties.
Even following receipt of any regulatory approval for ContraPest or
our product candidates, our products will be subject to ongoing requirements by the EPA and comparable state and foreign regulatory authorities
governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, safety surveillance, import,
export, advertising, promotion, recordkeeping and reporting of safety and other post-market information.
The safety profile of any product will continue to be closely monitored
by the EPA and comparable foreign regulatory authorities after approval. In addition, we may be required, from time to time, to provide
further testing results and certifications to the EPA and state regulatory agencies for ContraPest.
For instance, we have found it challenging to produce applicable stability
test results for certain of our active ingredients, due in part to the small quantities used in the final product and continue to work
with the EPA to develop appropriate biological or chemical measurements of product stability. Because our data continue to demonstrate
the long-term efficacy of ContraPest, we believe that the testing is a matter we will resolve.
If the EPA or comparable foreign regulatory authorities become aware
of new information after approval of ContraPest or any other product candidate, or we are unable to adequately complete required testing
and certification requirements, a number of potentially significant negative consequences could result, including the following:
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we may be forced to suspend marketing of such
product;
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regulatory authorities may withdraw their approvals of such product
after certain procedural requirements have been met;
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regulatory authorities may require additional warnings on the label
that could diminish the usage or otherwise limit the commercial success of such product;
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the EPA or other regulatory bodies may issue safety alerts, press releases or other communications containing warnings about such product;
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the EPA may require the establishment or modification of restricted use, or a comparable foreign regulatory authority may require the establishment or modification of a similar strategy that may, for instance, restrict distribution of our product and impose burdensome implementation requirements on us;
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we may be required to change the way the product is administered or conduct additional trials;
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we could be sued and held liable for harm caused;
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we may be subject to litigation or product liability claims; and
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our reputation may suffer.
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Any of these events could prevent us from achieving or maintaining
market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and
prospects.
Moreover, existing government regulations may change, and additional
government regulations may be enacted that could prevent, limit or delay regulatory approval of ContraPest or any other product candidates.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not
able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and/or be subject to different marketing
requirements or fines or enhanced government oversight and reporting obligations, which would adversely affect our business, prospects,
and ability to achieve or sustain profitability.
Our future success is also dependent on regulatory approval and
commercialization of our other product candidates.
We are actively working on a semi-solid product as well as an alternative
dispenser. We also plan to continue work on a product to control fertility in mice. We cannot commercialize our product candidates in
the United States without first obtaining regulatory approval for each product and each use pattern from the EPA or, if applicable, the
Food and Drug Administration, or FDA, and from any related applicable state authorities. Before obtaining regulatory approvals for the
commercial sale of any product candidate for a target indication, the law requires that applicants demonstrate through laboratory and
field studies and related data showing that the product candidate will perform its intended function without causing unreasonable adverse
effects on the environment. The EPA or a comparable foreign regulatory authority may require more information, including additional data
to support approval that may delay or prevent approval.
Even following receipt of any regulatory approval for ContraPest
and our other product candidates, we will continue to be subject to regulation of our manufacturing processes and advertising practices.
As a manufacturer of pest control products, we are subject to continual
government oversight and periodic inspections by the EPA and other regulatory authorities. If we or a regulatory agency discover problems
with a facility where our products are manufactured, a regulatory agency may impose restrictions on the manufacturing facility, including
requiring recall or withdrawal of the product from the market or suspension of manufacturing until certain procedural requirements have
been met. The occurrence of any such event or penalty could limit our ability to market ContraPest or any other product candidates and
generate revenue.
In addition, the EPA strictly regulates the advertising and promotion
of pest control products, and these pest control products may only be marketed or promoted for their EPA approved uses, consistent with
the product’s approved labeling. Advertising and promotion of any product candidate that obtains approval in the U.S. will be heavily
scrutinized by the EPA, other applicable state regulatory agencies and the public. Violations, including promotion of our products for
unapproved or off-label uses, are subject to enforcement actions, inquiries and investigations, and civil, criminal and/or administrative
sanctions imposed by the EPA.
Failure to obtain regulatory approval in foreign jurisdictions
would prevent ContraPest or any other product candidates from being marketed in those jurisdictions.
To market and sell our products globally, we must obtain separate marketing
approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve
additional testing. Obtaining foreign regulatory approvals and maintaining compliance with foreign regulatory requirements could result
in significant delays, difficulties, and cost for us and could delay or prevent the introduction of our products in certain countries.
Approval by the EPA does not ensure approval by regulatory authorities in other countries or jurisdictions, but EPA approval may influence
decisions by the foreign regulatory authority. If we are unable to obtain approval of ContraPest or for any of our other product candidates
by regulatory authorities in the world market, the commercial prospects of that product candidate may be significantly diminished and
our business prospects could decline.
Risks Related to our Operations and Supply Chain
We depend on key personnel to operate our business. If we are
unable to retain, attract and integrate qualified personnel, our ability to develop and successfully grow our business could be harmed.
We believe that our success is highly dependent on our ability to attract
and retain highly skilled and experienced sales, research and development, and other personnel. If one or more of our executive officers
or key employees terminates employment or becomes disabled or experiences long-term illness, we may not be able to replace their expertise,
fully integrate new personnel or replicate the prior working relationships, and the loss of their services might significantly delay or
prevent the achievement of our research and development and business objectives. Qualified individuals with the breadth of skills and
experience in our industry that we require are in high demand, and we may incur significant costs to attract them. Many of the other companies
that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a more established
history in the industry. They also may provide more diverse opportunities and better chances for career advancement. Our failure to attract
and/or retain key personnel could impede the achievement of our research and development and commercialization objectives.
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We have internal manufacturing capabilities to meet our current
and near term forecasted demand for ContraPest, however, we must develop additional manufacturing capability or rely upon third parties
to manufacture our products to meet future demand and our single location manufacturing operations could be disrupted.
Our existing internal manufacturing platform is adequate for meeting
our current and near term forecasted demand for ContraPest. We may be required to spend significant time and resources to expand these
manufacturing facilities to fully meet future demand. If we are unable to develop full-scale manufacturing capabilities, we may not be
able to meet demand of our products without relying on third party manufacturers, which could adversely affect our operations or financial
condition.
In addition, if our manufacturing operations fail or are disrupted
for any reason, including because of labor, disasters, and/or equipment malfunctions, among others, our ability to timely produce ContraPest
may be adversely affected, which would harm our sales and reputation . We only operate in a single location, which means we do not
have back-up facilities to produce our products during a time when our manufacturing facility becomes unavailable.
We will need to expand our operations and grow the size of our
organization, and we may experience difficulties in managing this growth.
As of December 31, 2021, we had 26 full-time employees. As our development
and commercialization plans and strategies develop, we will need additional managerial, operational, sales, marketing, scientific and
financial headcount and other resources. Our management, personnel, and systems currently in place may not be adequate to support this
future growth. Future growth would impose significant added responsibilities on members of management, including the following:
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identifying, recruiting, maintaining, motivating and integrating additional employees with the expertise and experience we will require;
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managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;
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managing additional relationships with various strategic partners, suppliers and other third parties;
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managing our trials effectively, which we anticipate being conducted at numerous field study sites;
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improving our managerial, development, operational, marketing, production and finance reporting systems and procedures; and
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expanding our facilities.
Our failure to accomplish any of these tasks could prevent us from
successfully growing our business.
Business or supply chain disruptions could seriously harm our
future revenues and financial condition and increase our costs and expenses, particularly because we have limited suppliers and a critical
ingredient is sourced from China.
Our operations could be subject to a variety of potential business
disruptions, including power shortages, telecommunications failures, water shortages, floods, fires, earthquakes, extreme weather conditions,
medical epidemics and other natural or manmade disasters or other interruptions, for which we are predominantly self-insured. We do not
carry insurance for all categories of risk that our business may encounter. The occurrence of any of these business disruptions could
seriously harm our operations and financial condition and increase our costs and expenses. Moreover, we rely on third parties to supply
various ingredients and other items which are critical for producing our product candidates.
We currently use one supplier for each of our two active ingredients,
triptolide and VCD. Our ability to produce our product candidates would be disrupted if the operations of these suppliers are affected
by a man made or natural disaster or other business interruption. Because triptolide is sourced from China and other Asian countries,
we have a greater risk of supply interruption, including as a result of tariff and trade disputes, or disruptive events like the outbreak
of COVID-19. The ultimate impact on our operations from any business interruption impacting us or any of our significant suppliers is
unknown, but our operations and financial condition would likely suffer adverse consequences. Further, any significant uninsured liability
may require us to pay substantial amounts, which would adversely affect our business, results of operations, financial condition and cash
flows from future prospects.
We are dependent on triptolide, a key ingredient for ContraPest,
which has limited sources and must be in a very refined condition.
If we are unable to develop additional sources of or alternatives to
triptolide, a key ingredient for ContraPest, our long-term ability to produce ContraPest at a cost effective price could be in jeopardy.
If market demand for triptolide causes the price to increase beyond our ability to market at a competitive price or causes the quality
of the refined ingredient to be less than needed for our production, our ability to commercialize ContraPest could be limited or delayed,
which would adversely affect our business, results of operations and financial condition.
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A variety of risks associated with marketing our product candidates
internationally could materially adversely affect our business.
We may seek regulatory approval of our product candidates outside of
the U.S. and, in that case, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain
the necessary approvals, including the following:
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differing regulatory requirements in foreign countries;
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unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
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economic weakness, including inflation or political instability in particular foreign economies and markets;
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compliance with tax, employment, immigration and labor laws for employees living or traveling internationally;
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foreign taxes, including withholding of payroll taxes;
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foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
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difficulties staffing and managing foreign operations;
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workforce uncertainty in countries where labor unrest is more common than in the United States;
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potential liability under the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, or comparable foreign regulations;
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challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
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production shortages resulting from any events affecting raw material supply or manufacturing capabilities internationally; and
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business interruptions resulting from geopolitical actions, including war and terrorism.
These and other risks associated with our international operations
may materially adversely affect our ability to attain or maintain profitable operations.
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Risks Relating to Protections of our Intellectual Property and Legal
Actions
If we fail to obtain or protect intellectual property rights,
our competitive position could be harmed.
We depend on our ability to protect our proprietary technology. We
rely on trade secret, patent, copyright and trademark laws, and confidentiality, licensing, and other agreements with employees and third
parties, all of which offer only limited protection. Our commercial success will depend in part on our ability to obtain and maintain
intellectual property protection in the United States and other countries with respect to our proprietary technology and products. Where
we deem appropriate, we seek to protect our proprietary position by filing patent applications in the United States and internationally
related to our novel technologies and products that are important to our business. However, our financial resources constrain us from
seeking protection in every instance, so we may rationalize and selectively pursue expensive patent protection. Patent positions can be
highly uncertain, involve complex legal and factual questions and be the subject of litigation. As a result, the issuance, scope, validity,
enforceability and commercial value of our patents, including those patent rights licensed to us by third parties, are highly uncertain.
The steps we have taken to protect our proprietary rights may not be
adequate to preclude misappropriation of our proprietary information or infringement of our intellectual property rights, both inside
and outside the United States. The rights already granted under any of our currently issued patents and those that may be granted under
future issued patents may not provide us with the proprietary protection or competitive advantages we are seeking. If we are unable to
obtain and maintain protection for our technology and products, or if the scope of the protection obtained is not sufficient, our competitors
could develop and commercialize technology and products similar or superior to ours, and our ability to successfully commercialize our
technology and products may be adversely affected.
With respect to patent rights, we do not know whether any of our pending
patent applications for any of our technologies or products will result in the issuance of patents that protect such technologies or products,
or if our licensed patent will effectively prevent others from commercializing competitive technologies and products. Our pending patent
applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent
issues from such applications. Further, the examination process may require us to narrow the claims for our pending patent applications,
which may limit the scope of patent protection that may be obtained if these applications issue. Because the issuance of a patent is not
conclusive as to its inventorship, scope, validity or enforceability, issued patents that we own or have licensed from third parties may
be challenged in the courts or patent offices in the U.S. and internationally. Such challenges may result in the loss of patent protection,
the narrowing of claims in such patents, or the invalidity or unenforceability of such patents, which could limit our ability to stop
others from using or commercializing similar or identical technology and products or limit the duration of the patent protection for our
technology and products. Protecting against the unauthorized use of our patented technology, trademarks and other intellectual property
rights, is expensive, difficult, and in some cases, may not be possible. In some cases, it may be difficult or impossible to detect third
party infringement or misappropriation of our intellectual property rights, even in relation to issued patent claims, and proving any
such infringement may be even more difficult.
Intellectual property rights do not necessarily address all potential
threats to any competitive advantage we may have.
The degree of future protection afforded by our intellectual property
rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit us to
maintain our competitive advantage. The following examples are illustrative:
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others may be able to make compounds that are the same as or similar to our future products but that are not covered by the claims of the patents that we own or have exclusively licensed;
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we might not have been the first to file patent applications covering certain of our inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing on our intellectual property rights;
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issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors;
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our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
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we may not develop additional proprietary technologies that are patentable or otherwise protectable;
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employees may violate confidentiality and proprietary invention assignment agreements and we may not have the resources to enforce those agreements or otherwise enforce our patent rights; and
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the patents of others may have an adverse effect on our business.
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Our technology may be found to infringe third party intellectual
property rights.
Third parties may in the future assert claims or initiate litigation
related to their patent, copyright, trademark and other intellectual property rights in technology that is important to us. The asserted
claims and/or litigation could include claims against us, our licensors, or our suppliers alleging infringement of intellectual property
rights with respect to our product candidates or components of those products. Regardless of the merit of the claims, they could be time
consuming, resulting in costly litigation and diversion of technical and management personnel, or require us to develop non-infringing
technology or enter into license agreements. We cannot assure you that licenses will be available on acceptable terms, if at all. Furthermore,
because of the potential for significant damage awards, which are not necessarily predictable, it is not unusual to find even arguably
unmeritorious claims resulting in large settlements. If any infringement or other intellectual property claim made against us by any third
party is successful, or if we fail to develop non-infringing technology or license the proprietary rights on commercially reasonable terms
and conditions, our business, operating results and financial condition could be materially adversely affected.
If our product candidates, methods, processes and other technologies
infringe the proprietary rights of other parties, we could incur substantial costs and we may have to take certain actions, including
the following:
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obtain licenses, which may not be available on commercially reasonable terms, if at all;
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redesign our product candidates or processes to avoid infringement;
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stop using the subject matter claimed to be held by others;
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pay damages; or
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defend litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our financial and management resources.
We may need to license intellectual property from third parties,
and such licenses may not be available or may not be available on commercially reasonable terms.
A third party may hold intellectual property, including patent rights
that are important or necessary to the development of our product candidates. It may be necessary for us to use the patented or proprietary
technology of a third party to manufacture or otherwise commercialize our own technology or products, in which case we would be required
to obtain a license from such third party. Licensing such intellectual property may not be available or may not be available on commercially
reasonable terms, which could have a material adverse effect on our business and financial condition.
We may be subject to legal proceedings in the ordinary course
of our business that could result in significant harm to our business, financial condition and operating results.
We could be subject to legal proceedings and claims from time to time
in the ordinary course of our business, including actions arising from tort, contract or other claims. See “Legal Proceedings”
elsewhere in this filing for more information. Litigation is expensive, time consuming, and could divert management’s attention
away from running our business. The outcome of litigation or other proceedings is subject to significant uncertainty, and it is possible
that an adverse resolution of one or more such proceedings could result in reputational harm and/or significant monetary damages, injunctive
relief or settlement costs that could adversely affect our results of operations or financial condition as well as our ability to conduct
our business as it is presently being conducted. Insurance might not cover such claims, might not provide sufficient payments to cover
all the costs to resolve one or more such claims and might not be available on terms acceptable to us. In addition, regardless of merit
or outcome, claims brought against us that are uninsured or underinsured could result in unanticipated costs, which could harm our business,
financial condition and operating results and reduce the trading price of our stock.
For example, we have become aware that we were involved in a transaction
in which an investor of the Company may have resold approximately 175,000 shares of our common stock pursuant to a registration statement
that was not declared effective by the Securities and Exchange Commission (SEC). As a result, it is possible that the SEC brings an action
against us, or we may ultimately be responsible for an action for rescission by purchasers of the securities that were resold. If the
SEC were to bring such an enforcement action against us, or if purchasers were to bring such an action for rescission, it may have a material
adverse effect on our financial position.
16
Product liability lawsuits against us could cause us to incur
substantial liabilities and to limit commercialization of any products that we may develop.
We face an inherent risk of product liability exposure related to the
use of ContraPest and any of our other products. If we cannot successfully defend ourselves against claims from our product users, we
could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in the following:
●
decreased demand for any product that we may develop;
●
termination of field studies or other research and development efforts;
●
injury to our reputation and significant negative media attention;
●
significant costs to defend the related litigation;
●
substantial monetary awards to plaintiffs;
●
loss of revenue;
●
diversion of management and scientific resources from our business operations; and
●
the inability to commercialize our product candidates.
We may be unable to obtain commercially reasonable product liability
insurance for any products approved for marketing. Large judgments have been awarded in class action lawsuits based on products that had
unanticipated side effects, including, without limitation, any potential adverse effects of our products on humans or other species. A
successful product liability claim or series of claims brought against us, particularly if judgments exceed our insurance coverage, could
decrease our cash and adversely affect our business.
Risks Related to our Reporting and Cybersecurity
We have not fully assessed our internal control over financial
reporting. If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls,
we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor
confidence in us and, as a result, the value of our Common Stock.
A material weakness is a deficiency, or combination of deficiencies,
in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our financial
statements will not be prevented or detected on a timely basis.
This Annual Report on Form 10-K for the year ended December 31, 2021
does not include an attestation report of our registered public accounting firm due to a transition period established by rules of the
SEC for smaller reporting companies. As a result, we have not yet fully assessed our internal control over financial reporting and are
unable to assure that the measures we have taken to date, together with any measures we may take in the future, will be sufficient to
remediate the control deficiencies that led to our material weaknesses in our internal control over financial reporting, or to avoid potential
future material weaknesses.
If we are unable to develop and maintain an effective system of internal
control over financial reporting, successfully remediate any existing or future material weaknesses in our internal control over financial
reporting, or identify any additional material weaknesses, the accuracy and timing of our financial reporting may be adversely affected,
we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports and Nasdaq listing
requirements, investors may lose confidence in our financial reporting, and our stock price may decline as a result.
17
Privacy breaches and other cyber security risks related to our
business could negatively affect our reputation, credibility and business.
We are making sales through our new e-Commerce tool, which depends on information
technology systems and networks. We are also responsible for storing data relating to our customers and employees and rely on third party
vendors for the storage, processing and transmission of personal and Company information. Consumers, lawmakers and consumer advocates
alike are increasingly concerned over the security of personal information transmitted over the Internet, consumer identity theft and
privacy. We do not control our third-party service providers and cannot guarantee that they have implemented reasonable security measures
to protect our employees’ and customers’ identity and privacy, or that no electronic or physical computer break-ins or security
breaches will occur in the future. Our systems and technology are vulnerable from time-to-time to damage, disruption or interruption from,
among other things, physical damage, natural disasters, inadequate system capacity, system issues, security breaches, “hackers,”
email blocking lists, computer viruses, power outages and other failures or disruptions outside of our control. A significant breach of
customer, employee or Company data could damage our reputation and our relationship with customers, and could result in lost sales, sizable
fines, significant breach-notification costs and lawsuits, as well as adversely affect our results of operations. We may also incur additional
costs in the future related to the implementation of additional security measures to protect against new or enhanced data security and
privacy threats, or to comply with state, federal and international laws that may be enacted to address those threats.
Risks Related to our Capital Stock, Funding and Trading in our Stock
We have incurred significant operating losses every quarter since
our inception and anticipate that we will continue to incur significant operating losses in the future.
Investment in product development is highly speculative because it
entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to become commercially
viable or gain regulatory approval. To date, we have financed our operations primarily through the sale of equity securities and debt
financings as well as research grants. We have not generated sufficient revenue from product sales to date to achieve profitability .
We continue to incur significant sales, marketing, research, development, and other expenses related to our ongoing operations. As a result,
we are not profitable and have incurred losses in every reporting period since our inception. For the years ended December 31, 2021 and
2020, we reported net losses of $8.3 million and $8.4 million, respectively. As of December 31, 2021, we had an accumulated deficit since
inception of $112.5 million.
Since inception, we have dedicated a majority of our resources to the
discovery and development and marketing of our proprietary product candidates. We expect to continue to incur significant expenses and
operating losses for the foreseeable future. The size of our losses will depend, in part, on the rate of future expenditures and our ability
to generate revenues. In particular, we expect to incur substantial and increased expenses as we perform the following:
●
attempt to achieve market acceptance for our products;
●
continue to establish an infrastructure for the sales, marketing and distribution of ContraPest and any other product candidates for which we may receive regulatory approval;
●
scale up manufacturing processes and quantities for the commercialization of ContraPest and any other product candidates for which we receive regulatory approval;
●
continue the research and development of ContraPest and our other product candidates, including engaging in any necessary field studies;
●
seek regulatory approvals for ContraPest in various jurisdictions and for our other product candidates;
●
expand our research and development activities and advance the discovery and development programs for other product candidates;
●
maintain, expand and protect our intellectual property portfolio; and
●
add operational, financial and management information systems and personnel, including personnel to support our clinical development and commercialization efforts and operations as a public company.
18
We may encounter unforeseen expenses, difficulties, complications,
delays, and other unknown factors that may adversely affect our financial condition. Our prior losses and expected future losses have
had, and will continue to have, an adverse effect on our financial condition. If ContraPest or any other product candidate does not gain
or maintain sufficient regulatory approval, or if approved, fails to achieve market acceptance, we may never become profitable. Even if
we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Our failure to become and remain
profitable would decrease the value of our company and could impair our ability to raise capital, expand our business, diversify our product
offerings or continue our operations. A decline in the value of our company could cause you to lose all or part of your investment.
If we are unable to continue as a going concern, our securities
will have little or no value.
We have incurred operating losses since our inception, and we expect
to continue to incur significant expenses and operating losses for the foreseeable future. Our financial statements as of December 31,
2021 and 2020 have been prepared under the assumption that we will continue as a going concern. Our independent registered public accounting
firm included in its opinion for the years ended December 31, 2021 and 2020 an explanatory paragraph referring to our net loss from operations
and net capital deficiency and expressing substantial doubt in our ability to continue as a going concern without additional capital becoming
available. If we encounter continued issues or delays in the commercialization of ContraPest or greater than anticipated expenses, our
prior losses and expected future losses could have an adverse effect on our financial condition and negatively impact our ability to fund
continued operations, obtain additional financing in the future and continue as a going concern. There are no assurances that such financing,
if necessary, will be available to us at all or will be available in sufficient amounts or on reasonable terms. Our financial statements
do not include any adjustments that may result from the outcome of this uncertainty. If we are unable to generate additional funds in
the future through financings, sales of our products, licensing fees, royalty payments or from other sources or transactions, we will
exhaust our resources and will be unable to continue operations. If we cannot continue as a going concern, our stockholders would likely
lose most or all of their investment in us.
Raising additional capital may cause dilution to our existing
stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
Until such time, if ever, as we can generate sufficient product revenues,
we expect to finance our cash needs primarily through the sale of equity securities and debt financings, and possibly through credit facilities
and government and foundation grants. We may also seek to raise capital through third party collaborations, strategic alliances and similar
arrangements. We currently do not have any committed external source of funds.
Raising funds in the future may present additional challenges and future
financing may not be available in sufficient amounts or on terms acceptable to us, if at all. The terms of any financing arrangements
we enter into may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities by us, or
the possibility of such issuance, may cause the market price of our shares to decline. For example, during 2020, we completed equity financings
that resulted in the issuance of shares of Common Stock and warrants to purchase Common Stock, resulting in substantial dilution to the
existing stockholders. Similarly, in the first quarter of 2021, we again issued shares of Common Stock and warrants to purchase Common
Stock, resulting in additional substantial dilution to the existing stockholders. We generally have raised capital as the opportunity
arises.
Certain of our agreements with investors and our outstanding warrants
contain provisions that impose limitations on our ability to participate in certain variable rate transactions, including at-the-market
transactions, which may limit our opportunities to obtain financing in sufficient amounts or on acceptable terms. The sale of additional
equity or convertible debt securities would dilute all of our stockholders, and if such sales occur at a deemed issuance price that is
lower than the current exercise price of our outstanding warrants sold to investors in November 2017, the exercise price for those warrants
would adjust downward to the deemed issuance price pursuant to price adjustment protection contained within those warrants. Our various
warrants contain other terms that may affect our fundraising.
The incurrence of indebtedness through credit facilities would result
in increased fixed payment obligations and, potentially, the imposition of restrictive covenants. Those covenants may include limitations
on our ability to incur additional debt, making capital expenditures or declaring dividends, and may impose limitations on our ability
to acquire, sell, or license intellectual property rights and other operating restrictions that could adversely impact our ability to
conduct our business.
19
If we raise additional funds through collaborations, strategic alliances,
or licensing arrangements or other marketing or distribution arrangements with third parties, we may have to relinquish valuable rights
to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable
to us. If we are unable to expand our operations or otherwise capitalize on our business opportunities, our business, financial condition
and results of operations could be materially adversely affected.
If we are unable to raise additional funds through equity or debt financings
when needed, we may be required to delay, limit, reduce or terminate our product development or commercialization efforts, or grant others
rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Our share price may be volatile, which could subject us to securities
class action litigation and your investment in our securities could decline in value.
Our stock could be subject to wide fluctuation in response to many
risk factors listed in this section, and others beyond our control, including the following:
●
market acceptance and commercialization of our products;
●
our being able to timely demonstrate achievement of milestones, including those related to revenue generation, cost control, cost effective source supply, and regulatory approvals;
●
our ability to remain listed on Nasdaq;
●
results and timing of our submissions with the regulatory authorities;
●
failure or discontinuation of any of our development programs;
●
regulatory developments or enforcements in the United States and non-U.S. countries with respect to our products or our competitors’ products;
●
failure to achieve pricing acceptable to the market;
●
regulatory actions with respect to our products or our competitors’ products;
●
actual or anticipated fluctuations in our financial condition and operating results or our continuing to sustain operating losses;
●
competition from existing products or new products that may emerge;
●
announcements by us or our competitors of significant acquisitions, strategic arrangements, joint ventures, collaborations or capital commitments;
●
issuance of new or updated research or reports by securities analysts;
●
announcement or expectation of additional financing efforts, particularly if our cash available for operations significantly decreases or if the financing efforts result in a price adjustment to certain outstanding warrants;
●
fluctuations in the valuation of companies perceived by investors to be comparable to us;
●
share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
●
disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
●
entry by us into any material litigation or other proceedings;
●
sales of our Common Stock by us, our insiders, or our other stockholders;
●
exercise of outstanding warrants;
●
market conditions for equity securities; and
●
general economic and market conditions unrelated to our performance.
20
Furthermore,
the capital markets can experience extreme price and volume fluctuations that may affect the market prices of equity securities of many
companies. These broad market and industry fluctuations, as well as general economic, political, and market conditions such as recessions,
interest rate changes, or international currency fluctuations, may negatively impact the market price of shares of our Common Stock.
In addition, such fluctuations could subject us to securities class action litigation, which could result in substantial costs and divert
our management’s attention from other business concerns, which could seriously harm our business. You may not realize any return
on your investment in us and may lose some or all of your investment.
Future
sales, or the possibility of future sales, of a substantial number of our common shares could adversely affect the price of the shares
and dilute stockholders.
Future
sales of a substantial number of shares of our Common Stock, or the perception that such sales will occur, could cause a decline in the
market price of our Common Stock. This is particularly true if we sell our stock at a discount. As of March 29, 2022, we had 121,714
shares of our Common Stock subject to outstanding warrants that contain anti-dilution adjustments that provide for an adjustment to the
exercise price for certain dilutive issuances of securities. If we offer or issue additional securities at a deemed price lower than
the current exercise price of these outstanding warrants, these warrants will adjust pursuant to the price adjustment protection contained
within these warrants. For example, our January 2020 registered direct offering resulted in an additional downward adjustment of the
exercise price of these warrants from $19.00 per share to $7.126 per share and our inducement offering in October 2020 resulted in an
additional downward adjustment of the exercise price of these warrants from $7.126 per share to $1.3659 per share. Any future issuance
of Common Stock or securities convertible or exercisable into our Common Stock could cause a further downward adjustment of the exercise
price of these warrants to the deemed issuance price if the issuance price is less than the exercise price of the warrants at the time
of the new issuance.
Also,
in the future, we may issue additional shares of our Common Stock or other equity or debt securities convertible into Common Stock in
connection with a financing, acquisition, litigation settlement, employee arrangements, or otherwise. Any such issuance could result
in substantial dilution to our existing stockholders and could cause our common share price to decline.
An
active market in the shares may not continue to develop in which investors can resell our Common Stock.
We
cannot predict the extent to which an active market for our Common Stock will continue to develop or be sustained, or how the development
of such a market might affect the market price for our Common Stock. Market conditions in effect at the time you acquire our stock may
not be indicative of the price at which our Common Stock will trade in the future. Investors may not be able to sell their Common Stock
at or above the price they acquired it.
If
securities or industry analysts, or other sources of information, do not publish research, or publish inaccurate or unfavorable
research or other information about our business, our stock price and trading volume could decline.
The
trading market for our Common Stock may depend on the research, reports and other information that securities or industry analysts,
or other third-party sources of information, publish about us or our business. We do not have any control over these analysts or other
third-party sources of information. From time to time inaccurate or unfavorable research or other information about our business,
financial condition, results of operations and stock ownership may be published. We cannot assure that analysts will cover us or
provide favorable coverage. If one or more of the analysts who cover us downgrade our stock or change their opinion of our stock, our
share price could decline. If one or more of these analysts cease coverage of us or fail to regularly publish reports on us, we could
lose visibility in the financial markets, which could cause our stock price or trading volume to decline. If incorrect or misleading
information is disseminated publicly by third parties about us, our stock price could decline.
We
may not be able to comply with all applicable listing requirements or standards of The Nasdaq Capital Market and Nasdaq could delist
our Common Stock.
Our Common Stock is listed on The Nasdaq Capital Market. In order to
maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards. On March 2, 2022, we
received a letter from the listing qualifications staff (the “Staff”) of Nasdaq providing notification that the bid price
for our common stock had closed below $1.00 per share for the previous 30 consecutive business days and our common stock no longer meets
the minimum bid price requirement for continued listing under Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A),
we have an initial period of 180 calendar days, or until August 29, 2022, to regain compliance. To regain compliance, the closing bid
price of our common stock must be $1.00 per share or more for a minimum of 10 consecutive business days at any time before August 29,
2022.
In
the event that we are unable to regain compliance with Rule 5550(a)(2) by August 29, 2022, we may be eligible for an additional 180 calendar
day compliance period. To qualify, we would need to meet the continued listing requirement for market value of publicly held shares and
all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price requirement, and would
need to provide written notice of our intention to cure the deficiency during the second compliance period, by effecting a reverse stock
split, if necessary. Further, the liquidity of the shares of our Common Stock may be affected adversely by a reverse stock split given
the reduced number of shares that are outstanding following a reverse stock split. In addition, a reverse stock split could increase
the number of stockholders who own odd lots (less than 100 shares) of our Common Stock, creating the potential for such stockholders
to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.
21
In
the event that we remain non-compliant with Rule 5550(a)(2), our Common Stock could be delisted from The Nasdaq Capital Market, which
could have a material adverse effect on our financial condition and which could cause the value of our Common Stock to decline. If our
Common Stock is not eligible for listing or quotation on another market or exchange, trading of our Common Stock could be conducted in
the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC
Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our Common Stock,
and there would likely be a reduction in our coverage by security analysts and the news media, which could cause the price of our Common
Stock to decline further. In addition, it may be difficult for us to raise additional capital if we are not listed on a national securities
exchange.
The
reverse stock split may decrease the liquidity of the shares of our Common Stock.
On February 20, 2020, we implemented a 1-for-20 reverse stock split
of our common stock to regain compliance with the minimum bid price requirement of Nasdaq. The liquidity of the shares of our Common Stock
may be affected adversely by the reverse stock split given the reduced number of shares that are outstanding following the reverse stock
split. In addition, the reverse stock split increased the number of stockholders who own odd lots (less than 100 shares) of our Common
Stock, creating the potential for such stockholders to experience an increase in the cost of selling their shares and greater difficulty
effecting such sales.
Our
corporate documents, Delaware law and certain warrants contain provisions that could discourage, delay or prevent a change in control
of our company.
Provisions
in our certificate of incorporation and our bylaws may discourage, delay or prevent a merger or acquisition involving us that our stockholders
may consider favorable. For example, our certificate of incorporation currently provides for a staggered board of directors, whereby
directors serve for three-year terms, with approximately one-third of the directors coming up for reelection each year. Having a staggered
board will make it more difficult for a third party to obtain control of our board of directors through a proxy contest, which may be
a necessary step in an acquisition of us that is not favored by our board of directors. Additionally, most of our warrants provide a
Black Scholes value-based payment to the warrant holders in connection with certain transactions that may discourage, delay or prevent
a merger or acquisition.
We
are also subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law. Under these provisions,
if anyone becomes an “interested stockholder,” we may not enter into a “business combination” with that person
for three years without special approval, which could discourage a third party from making a takeover offer and could delay or prevent
a change of control. For purposes of Section 203, “interested stockholder” means, generally, someone owning 15% or more
of our outstanding voting stock or an affiliate of ours that owned 15% or more of our outstanding voting stock during the past three
years, subject to certain exceptions as described in Section 203.
Item 1B. Unresolved Staff Comments.
Not
applicable.
Item 2. Properties.
As
of December 31, 2021, our corporate headquarters is located in Phoenix, Arizona, where we lease and occupy approximately 5,529 square
feet of office space pursuant to a lease that commenced on December 1, 2019 and expires on November 30, 2024. Also, as of December 31,
2021, our manufacturing facility occupied a separate facility in Phoenix, Arizona, where we lease and occupy approximately 5,105 square
feet of space. The lease for our manufacturing facility commenced on August 1, 2020 and expires on November 30, 2024. We believe that
our existing facilities are adequate and meet our current needs for business, manufacturing and research.
Item 3. Legal Proceedings.
Information
regarding our legal proceedings is discussed in Note 13 to our financial statements, which is incorporated herein by reference.
Item 4. Mine Safety Disclosures.
Not
applicable.
22
PART
II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market
Information
Our
common stock is traded on the Nasdaq Capital Market under the symbol “SNES.” Our common stock was initially listed for trading
on the Nasdaq Capital Market on December 8, 2016.
Holders
As
of March 29, 2022, there were approximately 696 holders of record of our common stock. Because many shares of our common stock are held
by brokers and other institutions on behalf of stockholders, we are unable to determine the total number of beneficial owners represented
by these holders of record.
Dividends
We
have never declared or paid any cash dividends on our common stock. We currently intend to retain all available funds and any future
earnings to support our operations and finance the growth and development of our business. We do not intend to pay cash dividends on
our common stock for the foreseeable future. Any future determination related to our dividend policy will be made at the discretion of
our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements,
contractual restrictions, business prospects and other factors our board of directors may deem relevant.
Recent
Sales of Unregistered Securities
None.
Purchases
of Equity Securities by the Company
We
withhold shares of common stock in connection with the vesting of restricted stock units to satisfy required tax withholding obligations
when they occur. There were no purchases of our equity securities during the 12 months ended December 31, 2021.
Item 6. Reserved.
23
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You
should read the following discussion and analysis of our financial condition and results of operations in conjunction with our financial
statements and the notes thereto included elsewhere in this Annual Report on Form 10-K. In addition to historical financial information,
the following discussion contains forward-looking statements that reflect our plans, estimates, beliefs and expectations that involve
risks and uncertainties. Our actual results and the timing of events could differ materially from those discussed in the forward-looking
statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report
on Form 10-K, particularly in the sections of this report titled “Risk Factors” and “Cautionary Note Regarding Forward-Looking
Statements.”
Overview
Since
our inception, we have sustained significant operating losses in the course of our research and development activities and commercialization
efforts and expect such losses to continue for the near future. We have generated limited revenue to date from product sales, research
grants and licensing fees received under a former license. We have primarily funded our operations to date through the sale of equity
securities, including convertible preferred stock, common stock and warrants to purchase common stock; and debt financing, consisting
primarily of convertible notes.
As
of December 31, 2021, we had received net proceeds of $84.3 million from our sales of common stock, preferred stock and issuance of convertible
and other promissory notes, an aggregate of $1.7 million from research grants and licensing fees and an aggregate of $1.5 million in
product sales. At December 31, 2021, we had an accumulated deficit of $112.5 million and cash and cash equivalents of $9.3 million.
On
April 15, 2020, we also received cash proceeds of $645,700 from the Paycheck Protection Program (or “PPP”) of the Coronavirus
Aid, Relief, and Economic Security Act (“CARES Act”). We used the proceeds from the PPP Loan to retain employees, maintain
payroll and make lease, interest and utility payments. On June 18, 2021, the Company received notification from BMO Harris Bank National
Association as the lender in a promissory note pursuant to the CARES Act, that such loan was forgiven in full under the terms of the
program.
We
have incurred significant operating losses every year since our inception. Our net losses were $8.3 million and $8.4 million for the
years ended December 31, 2021 and 2020, respectively. We expect to continue to incur significant expenses and generate operating losses
for at least the next 12 months.
We
will need additional funding to continue to fund our operations, achieve profitability and become cash flow positive, we will continue
to seek additional financing. If such equity or debt financing is not available at adequate levels or on acceptable terms, we may need
to delay, limit or terminate commercialization and development efforts or discontinue operations.
While
it is difficult to measure the effect and impact of the COVID-19 pandemic on revenue for the years ended December 31, 2021 and December
31, 2020, the travel and other restrictions that started in March 2020 resulted in a significant slowdown in our proof-of-concept field
studies and sales efforts. While we were able to resume field studies in some important projects by mid-year 2020 and initially believed
that we would re-start all our most significant field studies as we obtained limited waivers of certain travel bans, we still have delays
on certain projects that might remain on hold until certain businesses and government entities return to more normal operations. Continued
delays or new restrictions on travel or operations as a result of new outbreaks and variants could impact our results in future quarters.
Initially, we believed that pest control would continue through the COVID-19 pandemic as a necessity and we were and have been able to
maintain our manufacturing with cautionary, best practices put in place. However, we have concerns about distributor, pest control operator
and individual consumer spending as restrictive measures related to the COVID-19 pandemic continue. Extended stay at home orders across
the world, whether imposed by governments or individual businesses, have impeded our ability to communicate with current and prospective
customers, potentially reducing sales until the orders are lifted. In addition, federal, state and municipal budgets continue to be severely
strained as a result of the COVID-19 pandemic. This may delay or impede their ability to make near term purchases of our products. While
we have stocked certain long lead time inventory raw material ingredients, any prolonged impact on the suppliers we rely on for the purchase
of these items by the COVID-19 pandemic could impact future manufacturing operations.
We
have historically utilized, and intend to continue to utilize, various forms of stock-based awards in order to hire, retain and motivate
talented employees, consultants and directors and encourage them to devote their best efforts to our business and financial success.
In addition, we believe that our ability to grant stock-based awards is a valuable and necessary compensation tool that aligns the long-term
financial interests of our employees, consultants and directors with the financial interests of our stockholders. As a result, a significant
portion of our operating expenses includes stock-based compensation expense. Stock-based compensation expense has been, and will continue
to be for the foreseeable future, a significant recurring expense in our business and an important part of our compensation strategy.
Specifically, our stock-based compensation expense for the year ended December 31, 2021 and December 31, 2020 was $0.8 million and $0.6
million, respectively, which represented 8.3% and 8.1%, respectively, of our total operating expenses for those periods.
24
Components
of our Results of Operations
Grant
Revenue
Grant
revenue is comprised entirely of grant funding provided by the City of Phoenix, Arizona for jobs created and new employee training in
the City of Phoenix, Arizona during the years ended December 31, 2021 and December 31, 2020.
Sales
Sales
are comprised primarily of sales, net of discounts and promotions, of ContraPest and related components, to our distributors and customers,
as well as consulting and implementation services provided in conjunction with ContraPest deployments.
Cost
of Sales
Cost
of sales consist primarily of cost of products sold, including scrap and reserves for obsolescence. We continue to focus on improving
our cost structure, with the goals of shifting resources to commercialization, significantly reducing our year-over-year burn rate and
achieving a 50% or greater gross margin. Steps have included relocating to more cost-efficient space, organizational restructuring, improving
our manufacturing and supply processes and reducing staffing.
Operating
Expenses
Research
and Development Expenses
Research
and development expenses consist primarily of costs incurred in connection with the research and development of ContraPest and our other
product candidates, which costs include:
●
employee related
expenses, including salaries, related benefits, travel and stock-based compensation expense for employees engaged in research and
development functions, including that portion of manufacturing not included in cost of goods sold;
●
expenses incurred
in connection with the development of our product candidates including related regulatory and production expenses; and
●
facilities, depreciation and other
expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and supplies.
We
expense research and development costs as incurred.
We
continue to investigate other applications of our core technology to other product candidates and modifications to our existing products
to expand usability, which includes laboratory tests and academic collaborations. We also continue to develop our supply chain, particularly
identifying and improving our sourcing of triptolide, a key active ingredient for our product candidates. At this time, we cannot reasonably
estimate the costs for further development of ContraPest or the cost associated with the development of any of our other product candidates.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel
in executive, finance, sales, marketing and administrative functions. Selling, general and administrative expenses also include direct
and allocated facility-related costs as well as professional fees for legal, consulting, accounting and audit services.
We
plan to continue to utilize various forms of stock-based compensation awards to attract and retain qualified employees. As a result,
we anticipate that stock-based compensation expense will continue to represent a significant portion of our selling, general and administrative
expenses for the foreseeable future.
25
Interest
Income
Interest
income consists primarily of interest income earned on cash and cash equivalents.
Interest
Expense
Interest
expense consists primarily of interest accrued on our finance lease and note commitments.
Other
Income (Expense), Net
Other
income (expense), net, consists primarily of any recognized gains or losses related to the sale of fixed assets. In the year ended December
31, 2021, other income also included the reversal of a payroll benefits accrual from 2019 that was reversed as the liability period had
expired.
Income
Taxes
Deferred
tax assets and liabilities are determined based on differences between the financial statement and tax basis of assets and liabilities,
as well as a consideration of net operating loss and credit carry forwards, using enacted tax rates in effect for the period in which
the differences are expected to impact taxable income. A valuation allowance is established, when necessary, to reduce deferred tax assets
to the amount that is more likely than not to be realized. The Company’s effective tax rate for the years ended December 31, 2021
and December 31, 2020 has been affected by the valuation allowance on the Company’s deferred tax assets.
The
Company has not recorded any U.S. federal or state income tax benefits for our net operating losses incurred since inception or for our
research and development tax credits generated to date, due to the uncertainty regarding our ability to realize a benefit from these
tax attributes in the future. Based on tax return activity through December 31, 2021, the Company has federal and state net operating
loss carryforwards of approximately $77.2 million and $63.7 million, respectively, not considering any potential Internal Revenue Code
of 1986 (“IRC”) Section 382 annual limitation discussed below. The federal loss carryforwards begin to expire in 2029, unless
previously utilized. The state loss carryforwards expire in 2041, unless previously utilized. Included in the $77.2 million of federal
loss carryforwards are approximately $32.7 million of net operating losses that do not expire due to the tax law changes promulgated
in conjunction with the Tax Cuts and Jobs Act of 2017.
Additionally,
the utilization of the net operating loss carryforwards is subject to an annual limitation under Section 382 and 383 of the Internal
Revenue Code od 1986, and similar state tax provisions due to ownership change limitations that have occurred previously or that could
occur in the future. These ownership changes limit the amount of net operating loss carryforwards and other deferred tax assets that
can be utilized to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382 and
383. results from transactions increasing ownership of certain stockholders or public groups in the stock of the corporation by more
than 50 percent points over a three-year period. The Company has not conducted an analysis of an ownership change under section 382.
To the extent that a study is completed and an ownership change is deemed to occur, the Company’s net operating losses could be
limited
During
the quarter ended June 30, 2021, the Company received notification that a loan to the Company under the Paycheck Protection Program (the
“PPP”) in the amount of approximately $646 thousand was forgiven in full pursuant to the PPP program under the Coronavirus
Aid, Relief, and Economic Security Act (the “CARES Act”). Section 1106(i) of the CARES Act specifically requires taxpayers
to exclude canceled indebtedness from PPP loans from gross income, and accordingly, the debt forgiveness amount is nontaxable to the
Company. Subsequent to the passage of the CARES Act, the IRS issued Notice 2020-32, which precludes a deduction for an expense that
would otherwise be deductible if the payment results in the forgiveness of a loan, thereby preventing entities from claiming a double
tax benefit on the qualifying expenses for PPP loans. On December 27, 2020, the Consolidated Appropriations Act (“CAA”) was
signed into law, which reverses existing IRS guidance provided in Notice 2020-32 by allowing taxpayers to fully deduct any business expenses,
regardless of whether the expense was paid for using forgiven PPP loan proceeds. None of the other provisions of the CARES Act or CAA
had a material impact to the Company’s tax accounts.
26
Comparison
of the Years December 31, 2021 to 2020
The
following table summarizes our results of operations for the years ended December 31, 2021 and 2020:
SENESTECH,
INC.
STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
(In
thousands, except shares and per share data)
For the Years
Ended December 31,
2021
2020
Revenue:
Grant revenue
$ 24
$ 24
Sales
576
258
Total revenue
600
282
Cost of sales
356
281
Gross profit
244
1
Operating expenses:
Research and development
1,954
1,494
Selling, general and administrative
7,224
6,440
Total operating expenses
9,178
7,934
Net operating loss
(8,934 )
(7,933 )
Other income (expense):
Interest income
4
3
Interest expense
(11 )
(28 )
Payroll Protection Program loan forgiveness
673
-
Other income
-
21
Total other income
666
(4 )
Net loss and comprehensive loss
(8,268 )
(7,937 )
Deemed dividend-warrant price protection-revaluation adjustment
-
436
Net loss attributable to common shareholders
$ (8,268 )
$ (8,373 )
Weighted average common shares outstanding - basic and fully diluted
11,191,814
3,006,475
Net loss per common share - basic and fully diluted
$ (0.74 )
$ (2.78 )
Grant
Revenue
Grant revenue for the years ended December 31, 2021 and December 31,
2020 was $24,000and was granted for jobs created and related new employee training in the City of Phoenix, Arizona during the 12 months
ended December 31, 2021 and December 31, 2020.
Sales
Sales,
shown net of sales discounts and promotions, were $576,000 for the year ended December 31, 2021, compared to $258,000 for year ended
December 31, 2020. Sales increased by $318,000 in 2021 due, in part, to the continued focus of our internet sales initiatives, augmenting
our existing pull through sales strategy, where demand from the consumer market encourages, or pulls, resellers and pest management professionals
to offer our products, as well as enhanced strategic partnerships and collaborations with key distributors and PMPs. While these initiatives
continue to progress, we believe the benefits of these initiatives continue to be impacted by reduced spending by customers due to the
COVID-19 pandemic.
27
Cost
of Sales
Cost
of sales was $356,000, or 61.8% of sales, exclusive of grant revenue for the year ended December 31, 2021, compared to $281,000, or 108.9%
of sales, exclusive of grant revenue for the year ended December 31, 2020. The increase in cost of sales of $75,000 in 2021 is primarily
due to higher sales volume offset by lower reserves for obsolete product delivery system supplies of $119,000 and higher scrap expense
in 2020. Without the reserve for delivery system supplies, cost of sales for the year ended December 31, 2020 would have been $162,000,
or 62.8% of sales.
Gross
Profit
Gross profit for the year ended December 31, 2021 was $244,000, or 42.4%
of sales, compared to a gross profit of $1,000, or less than 1% of sales, for the year ended December 31, 2020. The increase in gross
profit was primarily due to increased sales and the impact of a reserve for obsolete product delivery system supplies of $119,000 recorded
in the year ended December 31, 2020. Gross profit for the year ended December 31, 2020 would have been $120,000, or 42.6% of sales, without
this reserve.
Research
and Development Expenses
Years Ended
December 31,
Increase
2021
2020
(Decrease)
(in thousands)
Direct research and development expenses:
Personnel related (including stock-based compensation)
$ 847
$ 604
$ 243
Professional fees
371
209
162
Facility related
99
167
(68 )
Other
637
514
123
Total research and development expenses
$ 1, 954
$ 1,494
$ 460
Research
and development expenses were $2.0 million for the year ended December 31, 2021, compared to $1.5 million for the year ended December
31, 2020. The $460,000 increase in research and development expenses was primarily due to an increase in manufacturing personnel-related
costs of $243,000, an increase in professional fees of $162,000, a decrease in facility related expenses of $68,000 and an increase in
other research and development expenses of $123,000.
The
increase in manufacturing personnel-related costs relative to the same period of 2020, which was impacted by the COVID-19 pandemic, in
addition to increases in manufacturing and regulatory headcount to meet current and future demand.
The
increase in professional fees expenses of $162,000 in the year ended December 31, 2021 compared to the same period in 2020 was primarily
due to increased regulatory legal expenses and expenses related to field and regulatory compliance studies.
Facility-related
expenses decreased $68,000 primarily due to the expiration of a facility lease of 7,632 square feet of manufacturing space in Flagstaff,
Arizona at December 31, 2020 as discussed in Note 13 - Commitments and Contingencies to our financial statements included elsewhere in
this Annual Report on Form 10-K.
The
year over year increase in other research and development expenses of $123,000 was primarily due to increased expenses related to field
and regulatory compliance studies and increased shipping expenses due to higher sales volume during the period.
28
Selling,
General and Administrative Expenses
Years Ended
December 31,
Increase
2021
2020
(Decrease)
(in thousands)
Direct selling, general and administrative expenses:
Personnel related (including stock-based compensation)
$ 3,940
$ 3,516
$ 424
Professional fees
1,179
1,318
(139 )
Facility-related
156
173
(17 )
Other
1,949
1,433
516
Total selling, general and administrative expenses
$ 7,224
$ 6,440
$ 784
Selling,
general and administrative expenses were $7.2 million for the year ended December 31, 2021, compared to $6.4 million for the year ended
December 31, 2020. The increase of $784,000 in selling, general and administrative expenses was primarily due to an increase of $424,000
in net salary costs, including stock compensation expenses and an increase in other selling, general and administrative expenses of $516,000,
offset by a $139,000 reduction in professional fees and a reduction in facility related costs of $17,000.
Net
salaries and wages for the year ended December 31, 2021 were $424,000 higher than the same period in 2020, primarily due to recognition
of incentive compensation expense for employees of $362,000 and increased stock compensation due to the issuance of certain common stock
option awards of $125,000 offset by net headcount reductions in selling and marketing positions due to hiring delays.
The
reduction in professional fees was primarily due to reduced legal expenses related to a litigation settlement incurred in the year ended
December 31, 2020 that were not incurred in the same period of 2021, partially offset by an increase in professional services expenses
relating to legal patent registration filings in the year ended December 31, 2021.
The
increase in other selling, general and administrative expenses of $516,000 from $1.4 million for the year ended December 31, 2020 to
$1.9 million for the year ended December 31, 2021 was primarily due to an increase in marketing expenses of $386,000 as a result of costs
associated with rebranding activities to highlight our commercial focus and continued on-line marketing program expansion, an increase
in travel expenses of $84,000 as a direct result of eased COVID-19 travel restrictions in 2021 that were put in place at the end of March
2020, and an increase in director and officer and other insurance premiums of $75,000, offset by reduced depreciation expense due to
certain assets becoming fully depreciated after December 31, 2020.
The
decrease in facilities related expenses of $17,000 to $156,000 for the year ended December 31, 2021 from $173,000 for the year ended
December 31, 2020 is a direct result of the expiration of a facility lease of 7,632 square feet of manufacturing space in Flagstaff,
Arizona at December 31, 2020.
Interest
Income/Expense, Net
We
recorded $7,000 of interest expense, net for the year ended December 31, 2021, as opposed to interest expense, net of $25,000 for the
year ended December 31, 2020. The decrease in interest expense, net of $18,000 was a result of reduced interest expense as a result of
finance leases and promissory notes that expired during the year ended December 31, 2021 and increased interest income for the year ended
December 31, 2021 as a result of higher investments in cash invested in money market accounts.
Paycheck
Protection Program Loan Forgiveness
PPP
loan forgiveness income for the year ended December 31, 2021 represents the forgiveness of a promissory note pursuant to the PPP under
the CARES Act that we secured under this program
Other
Income (Expense), Net
We
recorded $21,000 of other income (expense), net for each of the years ended December 31, 2021 and December 31, 2020. Other income (expense),
net for the year ended December 31, 2021 primarily represented a payroll benefits accrual from 2019 that was reversed as the liability
period had expired. Other income (expense), net for the year ended December 31, 2020 primarily represented income recognized for gains
on sale of certain fixed assets during the year.
29
Liquidity
and Capital Resources
Since
our inception, we have sustained significant operating losses in the course of our research and development activities and commercialization
efforts and expect such losses to continue for the near future. We have generated limited revenue to date from product sales, research
grants and licensing fees received under a former license. We have primarily funded our operations to date through the sale of equity
securities, including convertible preferred stock, common stock and warrants to purchase common stock; and debt financing, consisting
primarily of convertible notes.
Through
December 31, 2021, we had received net proceeds of $84.3 million from our sales of common stock, preferred stock and issuance of convertible
and other promissory notes, an aggregate of $1.7 million from research grants and licensing fees and an aggregate of $1.5 million in
product sales. At December 31, 2021, we had an accumulated deficit of $112.5 million and cash and cash equivalents of $9.3 million.
As
discussed in Note 8 - Borrowings of our Notes to Financial Statements included elsewhere in this Annual Report on Form 10-K, on April
15, 2020, we received cash proceeds of $645,700 from the PPP of the CARES Act. We used the proceeds from the PPP loan to retain employees,
maintain payroll and make lease, interest and utility payments. This loan was fully forgiven under terms of the PPP on June 14, 2021.
Our
ultimate success depends upon the outcome of a combination of factors, including the following: (i) successful commercialization of ContraPest
and maintaining and obtaining regulatory approval of our products and product candidates; (ii) market acceptance, commercial viability
and profitability of ContraPest and other products; (iii) the ability to market our products and establish an effective sales force and
marketing infrastructure to generate significant revenue; (iv) the success of our research and development; (v) the ability to retain
and attract key personnel to develop, operate and grow our business; and (vi) our ability to meet our working capital needs.
Based upon our current operating plan, we expect that cash and cash equivalents
at December 31, 2021, in combination with anticipated revenue and any additional sales of our equity securities, will be sufficient to
fund our current operations for at least the next 12 months. We have evaluated and will continue to evaluate our operating expenses and
will concentrate our resources toward the successful commercialization of ContraPest in the United States. However, if anticipated revenue
targets and margin targets are not achieved or expenses are more than we have budgeted, we may need to raise additional financing before
that time. If we need more financing, including within the next 12 months, and we are unable to raise the necessary capital through the
sale of our securities, we may be required to take other measures that could impair our ability to be successful and operate as a going
concern. In any event, we may require additional capital in order to fund our operating losses and research and development activities
before we become profitable and may opportunistically raise capital. We may never achieve profitability or generate positive cash flows,
and unless and until we do, we will continue to need to raise capital through equity or debt financing. If such equity or debt financing
is not available at adequate levels or on acceptable terms, we may need to delay, limit or terminate commercialization and development
efforts or discontinue operations.
Additional
Funding Requirements
We expect our expenses to continue or increase in connection with our ongoing
activities, particularly as we focus on marketing and sales of ContraPest. Further, the COVID-19 pandemic will likely continue to delay
the completion of field studies and achievement of sales, which will further increase our need for financing. In addition, we will continue
to incur costs associated with operating as a public company.
In
particular, we expect to incur substantial and increased expenses as we:
●
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; and
●
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.
We
believe we will need additional financing to fund these continuing and additional expenses.
30
Cash
Flows
The
following table summarizes our sources and uses of cash for each of the years presented:
Year Ended
December 31,
2021
2020
Cash used in operating activities
$ (7,779 )
$ (7,108 )
Cash used in investing activities
(99 )
(67 )
Cash provided by financing activities
13,561
8,882
Net increase (decrease) in cash and cash equivalents
$ 5,683
$ 1,707
Operating
Activities .
During
the year ended December 31, 2021, operating activities used $7.8 million of cash, primarily resulting from our net loss of $8.3 million,
offset by changes in our operating assets and liabilities of $0.1 million and non-cash charges of $0.4 million. Our net loss was primarily
attributed to research and development activities and our selling, general and administrative expenses, as we generated limited product
sales and grant revenue during the year. Net cash generated by changes in our operating assets and liabilities for the year ended December
31, 2021 consisted primarily of a $215,000 increase in accrued expenses and accounts payable and a decrease in other assets of $12,000,
offset by increases in net inventories of $56,000, prepaid expenses of $52,000 and a net increase in accounts receivable-trade of $52,000.
During
the year ended December 31, 2020, operating activities used $7.1 million of cash, primarily resulting from our net loss of $7.9 million
and changes in our operating assets and liabilities of $0.1 million offset by non-cash charges of $0.9 million. Our net loss was primarily
attributed to research and development activities and our selling, general and administrative expenses, as we generated limited product
sales and no research grant and licensing revenue during the year. Net cash used by changes in our operating assets and liabilities for
the year ended December 31, 2020 consisted primarily of a decrease in accrued expenses and accounts payable of $524,000 offset by a decrease
in prepaid expenses of $79,000, a decrease in inventories of $235,000 and a net increase in accounts receivable and other assets of $127,000.
Investing
Activities
During
the year ended December 31, 2021, we used $99,000 of cash in investing activities, which consisted of $100,000 for the purchases of property
and equipment, offset by $1,000 of cash received on the sales of property and equipment.
During
the year ended December 31, 2020, we used $67,000 of cash in investing activities, which consisted of $114,000 for the purchases of property
and equipment, offset by $47,000 of cash received on the sales of property and equipment.
Financing
Activities
During
the year ended December 31, 2021, net cash provided by financing activities was $13.6 million as a result of $12.4 million in net proceeds
from the issuance of common stock and $1.3 million in proceeds from warrant exercises, partially offset by $135,000 of repayments related
to notes payable and finance lease obligations.
During
the year ended December 31, 2020, net cash provided by financing activities was $8.9 million as a result of $5.7 million in net proceeds
from the issuance of common stock, $2.6 million in proceeds from warrant exercises and $646,000 from the issuance of notes payable, partially
offset by $110,000 of repayments related to notes payable, finance lease obligations and payment of employee withholding taxes related
to share-based awards.
Critical
Accounting Policies and Significant Judgments and Estimates
Our
financial statements are prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The
preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported
amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent assets and liabilities in our financial
statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable
under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may
differ from these estimates under different assumptions or conditions.
While
our significant accounting policies are described in more detail in Note 2 — Summary of Significant Accounting Policies to our
financial statements included elsewhere in this Annual Report on Form 10-K, we believe that the following accounting policies are those
most critical to the judgments and estimates used in the preparation of our financial statements.
31
Revenue
Recognition
Effective
January 1, 2018, we adopted Accounting Standards Codification (“ASC”) 606 — Revenue from Contracts with Customers
(“ASC 606”) . Under ASC 606, we recognize revenue from the commercial sales of products, licensing agreements and
contracts to perform pilot studies by applying the following steps: (1) identify the contract with a customer; (2) identify the performance
obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to each performance obligation in
the contract; and (5) recognize revenue when each performance obligation is satisfied. For the comparative periods, revenue has not been
adjusted and continues to be reported under ASC 605 — Revenue Recognition (“ASC 605”) . Under ASC 605,
revenue is recognized when the following criteria are met: (1) persuasive evidence of an arrangement exists; (2) the performance of service
has been rendered to a customer or delivery has occurred; (3) the amount of the fee to be paid by a customer is fixed and determinable;
and (4) the collectability of the fee is reasonably assured. The performance obligations identified by us under ASC 606 are straightforward
and similar to the unit of account and performance obligation determination under ASC Topic 605, Revenue Recognition .
We
recognize revenue when product is shipped at a fixed selling price on payment terms of 30 to 120 days from invoicing. We recognize other
revenue earned from pilot studies, consulting and implementation services upon the performance of specific services under the respective
service contract.
We
derive revenue primarily from commercial sales of products, net of discounts and promotions, as well as consulting and implementation
services provided in conjunction with our product deployments.
Stock-Based
Compensation
We
recognize compensation costs related to stock options granted to employees based on the estimated fair value of the awards on the date
of grant, net of estimated forfeitures, in accordance with ASC Topic 718 — Stock Compensation . We estimate the
grant date fair value of the awards, and the resulting stock-based compensation expense, using the Black-Scholes option-pricing model.
The grant date fair value of stock-based awards is expensed on a straight-line basis over the vesting period of the respective award.
We
recorded stock-based compensation expense of approximately $765,000 and $645,000 for the years ended December 31, 2021 and 2020, respectively.
We expect to continue to grant stock options and other equity-based awards, such as restricted stock units, in the future and to continue
to recognize stock-based compensation expense in future periods.
The
Black-Scholes option-pricing model requires the use of highly subjective and complex assumptions, which determine the fair value of stock-based
awards. If we had made different assumptions, our stock-based compensation expense, net loss and loss per share of common stock could
have been significantly different. Our assumptions are as follows:
●
Expected term . The expected
term represents the period that the stock-based awards are expected to be outstanding. Our historical share option exercise experience
does not provide a reasonable basis upon which to estimate an expected term because of a lack of sufficient data. Therefore, we estimate
the expected term by using the simplified method, which calculates the expected term as the average of the time-to-vesting and the
contractual life of the options.
●
Expected volatility . Expected
volatility is derived from the average historical volatilities of publicly traded companies within our industry that we consider
to be comparable to our business over a period approximately equal to the expected term. We intend to continue to consistently apply
this process using the same or similar public companies unless circumstances change such that the identified companies are no longer
similar to us, in which case, more suitable companies whose share prices are publicly available would be utilized in the calculation.
●
Risk-free interest rate .
The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes
with maturities approximately equal to the expected term.
●
Expected dividend . The expected
dividend is assumed to be zero as we have never paid dividends and have no current plans to pay any dividends on our common stock.
●
Expected forfeitures . We
use historical data to estimate pre-vesting option forfeitures and record stock-based compensation expense only for those awards
that are expected to vest. To the extent actual forfeitures differ from the estimates, the difference will be recorded as a cumulative
adjustment in the period that the estimates are revised.
32
Significant
Factors, Assumptions and Methodologies Used in Determining Fair Value of Our Common Stock
As
noted above, we are required to estimate the fair value of the common stock underlying our stock-based awards when performing the fair
value calculations using the Black-Scholes option-pricing model.
The
assumptions underlying these valuations represent management’s best estimates, which involve inherent uncertainties and the application
of management’s judgment. If we had made different assumptions than those used, the amount of our stock-based compensation expense,
net income and net income per share amounts could have been significantly different. The fair value per share of our common stock for
purposes of determining stock-based compensation expense is the closing price of our common stock as reported on the applicable grant
date. The compensation cost that has been included in the statements of operations and comprehensive loss for all stock-based compensation
arrangements is as follows:
Years Ended
December 31,
2021
2020
(In thousands)
Selling, general and administrative expenses
$ 762
$ 636
Research and development expense
3
9
Total stock-based compensation expense
$ 765
$ 645
The
intrinsic value of stock options outstanding as of December 31, 2021 is $0.
Off-Balance
Sheet Arrangements
None.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk.
Not
applicable.
33
Item 8. Financial Statements and Supplementary Data.
SENESTECH,
INC.
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID 2738 ) F-2
Balance Sheets as of December 31, 2021 and 2020 F-3
Statements of Operations and Comprehensive Loss for the years ended December 31, 2021 and 2020 F-4
Statements of Changes in Stockholders’ Equity (Deficit) for the years ended December 31, 2021 and 2020 F-5
Statements of Cash Flows for the years ended December 31, 2021 and 2020 F-6
Notes to Financial Statements F-7
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and
Stockholders of SenesTech, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying balance sheets of SenesTech, Inc. (the Company) as of December 31, 2021 and 2020, and the related statements
of operations and comprehensive loss, stockholders’ equity (deficit), and cash flows for each of the years in the two-year period
ended December 31, 2021, and the related notes (collectively referred to as the financial statements). In our opinion, the financial
statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the
results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2021, in conformity with
accounting principles generally accepted in the United States of America.
Going
Concern
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 1 to the financial statements, the Company suffered a net loss from operations and has a net capital deficiency, which raises
substantial doubt about its ability to continue as a going concern. Management’s plans regarding those matters are also described in
Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits,
we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
Critical
Audit Matters
The
critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated
or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial
statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters
does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
As
discussed in Note 1 to the financial statements, the Company had a going concern due to a continual net loss, stockholders’ deficiency
and cash used in operations.
Auditing
management’s evaluation of a going concern can be a significant judgment given the fact that the Company uses management estimates
on future revenues and expenses which are not able to be substantiated.
To
evaluate the appropriateness of the going concern, we examined and evaluate the financial information that was the initial cause along
with management’s plans to mitigate the going concern and management’s disclosure on going concern.
/s/
M&K CPAS, PLLC
We have served as the Company’s auditor since 2017.
Houston, TX
March 29, 2022
F- 2
SENESTECH,
INC.
BALANCE
SHEETS
(In
thousands, except shares and per share data)
December 31,
December 31,
2021
2020
ASSETS
Current assets:
Cash
$ 9,326
$ 3,643
Accounts receivable trade, net
77
25
Prepaid expenses
230
178
Inventory
1,001
945
Deposits
22
28
Total current assets
10,656
4,819
Right to use asset-operating leases
511
665
Property and equipment, net
334
538
Total assets
$ 11,501
$ 6,022
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Short-term debt
$ 32
$ 98
Accounts payable
333
404
Accrued expenses
578
292
Total current liabilities
943
794
Long-term debt, net
-
673
Operating lease liability
523
671
Total liabilities
1,466
2,138
Commitments and contingencies (See note 13)
-
-
Stockholders’ equity:
Common stock, $ 0.001 par value, 100,000,000 shares authorized, 12,207,283 and 5,099,512 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively
12
5
Additional paid-in capital
122,531
108,119
Accumulated deficit
( 112,508 )
( 104,240 )
Total stockholders’ equity
10,035
3,884
Total liabilities and stockholders’ equity
$ 11,501
$ 6,022
The accompanying notes are an integral part of these financial statements.
F- 3
SENESTECH,
INC.
STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
(In
thousands, except shares and per share data)
For the Years
Ended December 31,
2021
2020
Revenue:
Grant revenue
$ 24
$ 24
Sales
576
258
Total revenue
600
282
Cost of sales
356
281
Gross profit
244
1
Operating expenses:
Research and development
1,954
1,494
Selling, general and administrative
7,224
6,440
Total operating expenses
9,178
7,934
Net operating loss
( 8,934 )
( 7,933 )
Other income (expense):
Interest income
4
3
Interest expense
( 11 )
( 28 )
Payroll Protection Program loan forgiveness
673
-
Other income
-
21
Total other income
666
( 4 )
Net loss and comprehensive loss
( 8,268 )
( 7,937 )
Deemed dividend-warrant price protection-revaluation adjustment
-
436
Net loss attributable to common shareholders
$ ( 8,268 )
$ ( 8,373 )
Weighted average common shares outstanding - basic and fully diluted
11,191,814
3,006,475
Net loss per common share - basic and fully diluted
$ ( 0.74 )
$ ( 2.78 )
The
accompanying notes are an integral part of these financial statements.
F- 4
SENESTECH,
INC.
STATEMENTS
OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
(In
thousands, except shares and per share data)
For The Years Ended December 31, 2020 and 2021
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity (Deficit)
Balance, December 31, 2019
1,414,671
$ 1
$ 98,433
$ ( 95,867 )
$ 2,567
Stock based compensation
-
-
645
-
645
Issuance of common stock, sold for cash, net
1,928,180
2
5,739
-
5,741
Issuance of common stock upon exercise of warrants, net
1,700,680
2
2,628
-
2,630
Issuance of common stock upon cashless exercise of warrants
51,414
-
238
-
238
Issuance costs of common stock for services
4,543
-
-
-
-
Issuance of common stock for fractional shares-20-1 reverse split
24
-
-
-
-
Warrant antidilution price protection adjustment
-
-
436
-
436
Net loss for the year ended December 31, 2020
-
-
-
( 8,373 )
( 8,373 )
Balance, December 31, 2020
5,099,512
$ 5
$ 108,119
$ ( 104,240 )
$ 3,884
Stock based compensation
-
-
765
-
765
Issuance costs of common stock for service
20,951
-
-
-
Issuance of common stock, sold for cash, net
6,163,854
6
12,415
-
12,421
Issuance of common stock upon exercise of warrants
922,966
1
1,249
-
1,250
Shares forfeited for payment of employee withholding taxes related to share based awards
-
-
( 17 )
-
( 17 )
Net loss for the year ended December 31, 2021
-
-
-
( 8,268 )
( 8,268 )
Balance, December 31, 2021
12,207,283
$ 12
$ 122,531
$ ( 112,508 )
$ 10,035
The
accompanying notes are an integral part of these financial statements.
F- 5
SENESTECH,
INC.
STATEMENTS
OF CASH FLOWS
(In
thousands)
For the Years
Ended December 31,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 8,268 )
$ ( 7,937 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
303
288
Stock-based compensation
765
645
Paycheck Protection Program loan forgiveness
( 646 )
-
Gain on sale of equipment
-
( 21 )
(Increase) decrease in current assets:
Accounts receivable - trade
( 52 )
1
Accounts receivable - other
-
123
Other assets
12
11
Prepaid expenses
( 52 )
79
Inventory
( 56 )
235
Deposits
( 8 )
Increase (decrease) in current liabilities:
Accounts payable
( 71 )
139
Accrued expenses
286
( 663 )
Net cash used in operating activities
( 7,779 )
( 7,108 )
CASH FLOWS FROM INVESTING ACTIVITIES
Cash received on sale of property and equipment
1
47
Purchase of property and equipment
( 100 )
( 114 )
Net cash provided by (used in) investing activities
( 99 )
( 67 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from the issuance of common stock, net
12,421
5,741
Proceeds from the issuance of notes payable
-
646
Repayments of notes payable
( 39 )
( 73 )
Repayments of finance lease obligations
( 54 )
( 62 )
Proceeds from the exercise of warrants
1,250
2,630
Payment of employee withholding taxes related to share based awards
( 17 )
-
Net cash provided by financing activities
13,561
8,882
NET CHANGE IN CASH
5,683
1,707
CASH AT BEGINNING OF PERIOD
3,643
1,936
CASH AT END OF PERIOD
$ 9,326
$ 3,643
SUPPLEMENTAL INFORMATION:
Interest paid
$ 11
$ 28
Income taxes paid
$ -
$ -
NON-CASH INVESTING AND FINANCING ACTIVITIES:
Forgiveness of accrual in warrant exercise
$ -
$ 238
Deemed dividend
$ -
$ 436
The
accompanying notes are an integral part of these financial statements.
F- 6
SENESTECH,
INC.
NOTES
TO THE FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
1. Organization and Description of Business
SenesTech,
Inc. (referred to in this report as “SenesTech,” the “Company,” “we” or “us”) was formed
in July 2004 and incorporated in the state of Nevada. The Company subsequently reincorporated in the state of Delaware in November 2015.
Our corporate headquarters is in Phoenix, Arizona. We have developed and are commercializing a global, proprietary technology for managing
animal pest populations, initially rat populations, through fertility control.
Although
there are myriad tools available to control rat populations, most rely on some form of lethal method to achieve effectiveness. Each of
these solutions is inherently limited by rat species’ resilience and survival mechanisms as well as their extraordinary rate of
reproduction. ContraPest ® , our initial product, is unique in the pest control industry in attacking the reproductive systems
of both male and female rats, which our field data shows will result in a sustained reduction of the rat population.
Rats
have plagued humanity throughout history. They pose significant threats to the health and food security of many communities. In addition,
rodents cause significant product loss and damage through consumption and contamination. Rats also cause significant damage to critical
infrastructure by burrowing beneath foundations and gnawing on electrical wiring, insulation, fire proofing systems, electronics and
equipment.
The
most prevalent solution to rat infestations is the use of increasingly powerful rodenticides. Although these solutions provide short
term results, there are growing concerns about secondary exposure and bioaccumulation of rodenticides in the environment, as well as
concerns about rodenticides that have no antidotes. The pest management industry and Pest Management Professionals (“PMPs”)
are being asked for new solutions that are both effective and less toxic. Our goal is to provide customers with not only a solution to
combat their most difficult rat problems, but also offer a non-lethal option to serve customers that are looking to decrease or remove
the amount of rodenticide used in their pest control programs.
ContraPest
is a liquid bait containing the active ingredients 4-vinylcyclohexene diepoxide (“VCD”) and triptolide. ContraPest limits
reproduction of male and female rats beginning with the first breeding cycle following consumption. ContraPest is being marketed for
use in controlling Norway and roof rat populations.
SenesTech
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. We
believe ContraPest is the first and only non-lethal, fertility control product approved by the EPA for the management of rodent populations.
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
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.
We
expect to continue to pursue regulatory approvals and amendments to the existing U.S. registration for ContraPest to broaden the marketability
and use of ContraPest, and if ContraPest begins to generate sufficient revenue, regulatory approvals for additional jurisdictions beyond
the United States. In certain cases, our EPA and state registrations require completion of additional testing and certifications even
though we have received approval for the product or its labelling. We continue to seek to comply with these requirements.
The
Company also continues to research and develop enhancements to ContraPest that align with our target verticals and other potential fertility
control options for additional species.
Reverse
Stock Split
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 our 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.
F- 7
SENESTECH,
INC.
NOTES
TO THE FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
1. Organization and Description of Business – (continued)
Going
Concern
Although
our audited financial statements for the years ended December 31, 2021 and December 31, 2020 were prepared under the assumption that
we would continue our operations as a going concern, the report of our independent registered public accounting firm that accompanies
our financial statements for the years ended December 31, 2021 and December 31, 2020 contains a going concern qualification in which
such firm expressed substantial doubt about our ability to continue as a going concern, based on the financial statements at that time.
Specifically, as noted above, we have incurred operating losses since our inception, and we expect to continue to incur significant expenses
and operating losses for the foreseeable future. These prior losses and expected future losses have had, and will continue to have, an
adverse effect on our financial condition. If we encounter continued issues or delays in the commercialization of ContraPest, our prior
losses and expected future losses could have an adverse effect on our financial condition and negatively impact our ability to fund continued
operations, obtain additional financing in the future and continue as a going concern. There are no assurances that such financing, if
necessary, will be available to us at all or will be available in sufficient amounts or on reasonable terms. Our financial statements
do not include any adjustments that may result from the outcome of this uncertainty. If we are unable to generate additional funds in
the future through additional financings, sales of our products, licensing fees, royalty payments or from other sources or transactions,
we will exhaust our resources and will be unable to continue operations.
Need
for Additional Capital
Since
our inception, we have sustained significant operating losses in the course of our research and development and commercialization activities
and expect such losses to continue for the near future. We have generated limited revenue to date from product sales, research grants
and licensing fees received under our former license agreement with Neogen. We have primarily funded our operations to date through the
sale of equity securities, including convertible preferred stock, common stock and warrants to purchase common stock. See Note 9 Common
Stock Warrants and Common Stock Warrant Liability for a description of our public equity sales.
We
have also raised capital through debt financing, consisting primarily of convertible notes and government loan programs, and, to a lesser
extent, payments received in connection with product sales, research grants and licensing fees.
Through
December 31, 2021, we had received net proceeds of $ 84.3 million from our sales of common stock, preferred stock and warrant exercises
and issuance of convertible and other promissory notes, an aggregate of $ 1.7 million from licensing fees and an aggregate of $ 1.5 million
in net product sales. At December 31, 2021, we had an accumulated deficit of $ 112.5 million and cash and cash equivalents of $ 9.3 million.
As
discussed in Note 8 - Borrowings on April 15, 2020, we received cash proceeds of $ 645,700 from the Paycheck Protection Program (“PPP”)
of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). We used the proceeds from the PPP loan to retain employees,
maintain payroll and make lease, interest and utility payments. This loan was fully forgiven, under terms of the PPP, on June 14, 2021.
Our
ultimate success depends upon the outcome of a combination of factors, including the following: (i) successful commercialization of ContraPest
and maintaining and obtaining regulatory approval of our products and product candidates; (ii) market acceptance, commercial viability
and profitability of ContraPest and other products; (iii) the ability to market our products and establish an effective sales force and
marketing infrastructure to generate significant revenue; (iv) the success of our research and development; (v) the ability to retain
and attract key personnel to develop, operate and grow our business; and (vi) our ability to meet our working capital needs.
Based
upon our current operating plan, we expect that cash and cash equivalents at December 31, 2021, in combination with anticipated revenue
and any additional sales of our equity securities, will be sufficient to fund our current operations for at least the next 12 months.
We have evaluated and will continue to evaluate our operating expenses and will concentrate our resources toward the successful commercialization
of ContraPest in the United States. However, if anticipated revenue targets and margin targets are not achieved or expenses are more
than we have budgeted, we may need to raise additional financing before that time. If we need more financing, including within the next
12 months, and we are unable to raise necessary capital through the sale of our securities, we may be required to take other measures
that could impair our ability to be successful and operate as a going concern. In any event, we may require additional capital in order
to fund our operating losses and research and development activities before we become profitable and may opportunistically raise capital.
We may never achieve profitability or generate positive cash flows, and unless and until we do, we will continue to need to raise capital
through equity or debt financing. If such equity or debt financing is not available at adequate levels or on acceptable terms, we may
need to delay, limit or terminate commercialization and development efforts or discontinue operations.
Major
Customer
We
did not have any customers that accounted for 10 % or more of sales for the year ended December 31, 2021. We did have one major customer
that accounted for approximately $ 44 , or 15 % of sales, for the year ended December 31, 2020. We expect to maintain the relationships with
these customers.
F- 8
SENESTECH,
INC.
NOTES
TO THE FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
2. Summary of Significant Accounting Policies
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts and classification of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial
statements and reported amounts of revenues and expenses during the reporting period. The significant estimates in our financial statements
include the valuation of preferred stock, if issued, common stock and related warrants, and other stock-based awards. Actual results
could differ from such estimates.
Reclassifications
Certain
prior year amounts have been reclassified to conform to the current year presentation. These reclassifications had no impact on net earnings,
financial position or cash flows.
Cash
and Cash Equivalents
We
consider money market fund investments to be cash equivalents. We had cash equivalents in the form of money market fund investment of
$ 8,800 and $ 1,500 at December 31, 2021 and December 31, 2020, respectively, included in cash as reported.
Accounts
Receivable-Trade
Accounts
receivable-trade consist primarily of receivables from customers. We provide an allowance for doubtful trade receivables equal to the
estimated uncollectible amounts. That estimate is based on historical collection experience, current economic and market conditions and
a review of the current status of each customer’s trade accounts receivable. We did not have any allowance for doubtful trade receivables
at December 31, 2021 or at December 31, 2020.
Inventories
Inventories
are stated at the lower of cost or market value, using the first-in, first-out convention. Inventories consist of raw materials, work
in progress and finished goods. Raw materials are stocked to reduce the risk of impact on manufacturing for potential supply interruptions
due to the COVID-19 pandemic or long lead times on certain ingredients.
Reserves
for obsolete inventory consist of reserves primarily related to obsolete product containers and delivery systems.
Components
of inventory are:
December 31,
2021
2020
Raw materials
$ 937
$ 950
Work in progress
5
24
Finished goods
88
94
Total inventory
1,030
1,068
Less:
Reserve for obsolete
( 29 )
( 123 )
Total net inventory
$ 1,001
$ 945
F- 9
SENESTECH,
INC.
NOTES
TO THE FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
2. Summary of Significant Accounting Policies – (continued)
Prepaid
Expenses
Prepaid
expenses consist primarily of payments made for director and officer insurance, marketing services, rent, legal and inventory purchase
deposits and seminar/trade show fees to be expensed in the current year.
Property
and Equipment
Property
and equipment are stated at cost less accumulated depreciation. Equipment held under finance leases are stated at the present value of
minimum lease payments less accumulated amortization.
Depreciation
on property and equipment is computed using the straight-line method over the estimated useful lives of the respective assets. The cost
of leasehold improvements is amortized over the life of the improvement or the term of the lease, whichever is shorter. Equipment held
under finance leases are amortized over the shorter of the lease term or estimated useful life of the asset. The Company incurs maintenance
costs on its major equipment. Repair and maintenance costs are expensed as incurred.
Impairment
of Long-Lived Assets
Long-lived
assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying
amount of an asset may not be recoverable. If circumstances require long-lived assets or asset groups to be tested for possible impairment,
the Company compares the undiscounted cash flows expected to be generated from the use of the asset or asset group to its carrying amount.
If the carrying amount of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment charge
is recognized to the extent that the carrying amount exceeds its fair value. Fair value is determined through various valuation techniques,
such as discounted cash flow models and the use of third- party independent appraisals. We have not recorded an impairment of long-lived
assets since our inception.
Revenue
Recognition
Effective
January 1, 2018, we adopted Accounting Standards Codification (“ASC”) 606 — Revenue from Contracts with Customers
(“ASC 606”) . Under ASC 606, we recognize revenue from the commercial sales of products, licensing agreements and
contracts to perform pilot studies by applying the following steps: (1) identify the contract with a customer; (2) identify the performance
obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to each performance obligation in
the contract; and (5) recognize revenue when each performance obligation is satisfied.
We
recognize revenue when product is shipped at a fixed selling price on payment terms of 30 to 120 days from invoicing. We recognize other
revenue earned from pilot studies, consulting and implementation services upon the performance of specific services under the respective
service contract.
We
derive revenue primarily from commercial sales of products, net of discounts and promotions, as well as consulting and implementation
services provided in conjunction with our product deployments.
Research
and Development
Research
and development costs are expensed as incurred. Research and development expenses primarily consist of salaries and benefits for research
and development employees, stock-based compensation, consulting fees, lab supplies, costs incurred related to conducting scientific trials
and field studies, regulatory compliance costs, as well as manufacturing costs associated with process improvement and other research.
Research and development expenses include an allocation of facilities related costs, including depreciation of equipment.
Stock-based
Compensation
Stock-based
awards, consisting of stock options and restricted stock units expected to be settled in shares of our common stock, are recorded as
equity awards. The grant date fair value of these awards is measured using the Black-Scholes option pricing model for stock options and
grant date market value for restricted stock units. We expense the grant date fair value of our stock-based awards on a straight-line
basis over their respective vesting periods.
F- 10
SENESTECH,
INC.
NOTES
TO THE FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
2. Summary of Significant Accounting Policies – (continued)
The
stock-based compensation expense recorded for the 12 months ended December 31, 2021 and 2020, is as follows:
Years Ended
December 31,
2021
2020
Research and development
$ 3
$ 9
General and administrative
762
636
Total stock-based compensation expense
$ 765
$ 645
See
Note 11 – Stock-Based Compensation for additional discussion on stock-based compensation.
Income
Taxes
We
account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities
for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax
assets and liabilities are determined based on the differences between the financial statements and tax bases of assets and liabilities
and net operating loss carryforwards using enacted tax rates in effect for the year in which the differences are expected to reverse.
The effect of a change in tax rates on deferred tax assets and liabilities is recognized in the period that includes the enactment date.
We
record net deferred tax assets to the extent we believe these assets will more likely than not be realized. These deferred tax assets
are subject to periodic assessments as to recoverability and if it is determined that it is more likely than not that the benefits will
not be realized, valuation allowances are recorded which would increase the provision for income taxes. In making such determination,
we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected
future taxable income, tax planning strategies and recent financial operations. We currently maintain a full valuation allowance against
its deferred tax assets.
We
apply a more-likely-than-not recognition threshold for all tax uncertainties. Only those benefits that have a greater than fifty percent
likelihood of being sustained upon examination by the taxing authorities are recognized. Based on our evaluation, we have concluded
there are no significant uncertain tax positions requiring recognition in our financial statements.
We
recognize interest and/or penalties related to uncertain tax positions in income tax expense. There are no uncertain tax positions as
of December 31, 2021 or December 31, 2020 and as such, no interest or penalties were recorded in income tax expense.
Comprehensive
Loss
Net
loss and comprehensive loss were the same for all periods presented; therefore, a separate statement of comprehensive loss is not included
in the accompanying financial statements.
Loss
Per Share Attributable to Common Stockholders
Basic
loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the
weighted average number of common shares outstanding during the period. Diluted loss per share attributable to common stockholders is
computed by dividing the loss attributable to common stockholders by the weighted average number of common shares and potentially dilutive
securities outstanding for the period determined using the treasury stock and if-converted methods. For purposes of the computation of
diluted loss per share attributable to common stockholders, common stock purchase warrants, restricted stock units and common stock options
are considered to be potentially dilutive securities but have been excluded from the calculation of diluted loss per share attributable
to common stockholders because their effect would be anti-dilutive given the net loss reported for the years ended December 31, 2021
and 2020. Therefore, basic and diluted loss per share attributable to common stockholders was the same for all periods presented.
F- 11
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
2. Summary of Significant Accounting Policies – (continued)
The
following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted loss
per share attributable to common stockholders (in common stock equivalent shares):
December 31,
2021
2020
Common stock purchase warrants
4,531,447
2,582,697
Restricted stock unit
667
32,072
Common stock options
1,087,820
496,471
Total
5,619,934
3,111,240
Accounting Standards Issued but Not Yet
Adopted
There have been no new accounting pronouncements not yet effective
or adopted in the current year that we believe have a significant impact, or potential significant impact, to our condensed consolidated
financial statements.
3. Fair Value Measurements
We issued common stock warrants to purchase shares of common stock
in June of 2015 (see Note 9 - Common Stock Warrants and Common Stock Warrant Liability) that expired in June of 2020. These warrants contained
a cash settlement provision that resulted in a common stock warrant liability that was revalued at the end of each reporting period.
We valued these warrant derivatives at fair value. The accounting guidance
for fair value, among other things, establishes a consistent framework for measuring fair value and expands disclosure for each major
asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the price that
would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants
at the reporting date. The framework for measuring fair value consists of a three-level valuation hierarchy that prioritizes the inputs
to valuation techniques used to measure fair value based upon whether such inputs are observable or unobservable. Observable inputs reflect
market data obtained from independent sources, while unobservable inputs reflect market assumptions made by the reporting entity. The
three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows:
Level 1 — Inputs are
unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;
Level 2— Inputs are observable,
unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets
or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the related assets or liabilities; and
Level 3— Unobservable
inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market
data.
An asset’s or liability’s fair value measurement level
within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation
techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs.
Assets and liabilities measured at fair value are based on one or more
of the following three valuation techniques:
A.
Market approach: Prices and other relevant information generated by market transactions involving identical or comparable assets or liabilities.
B.
Cost approach: Amount that would be required to replace the service capacity of an asset (replacement cost).
C.
Income approach: Techniques to convert future amounts to a single present amount based upon market expectations, including present value techniques, option-pricing and excess earnings models.
Our common stock warrant liabilities were classified as Level 3 because
there was limited activity or less transparency around the inputs to valuation.
Financial Instruments Not Carried at Fair Value
The carrying amounts of our financial instruments, including accounts
payable and accrued liabilities, approximate fair value due to their short maturities. The estimated fair value of the long-term debt,
not recorded at fair value, are recorded at cost or amortized cost, which was deemed to estimate fair value.
F- 12
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
4. Credit Risk
We are potentially subject to concentrations of credit risk in our
accounts receivable. Credit risk with respect to receivables is limited due to the number of companies comprising our customer base. However,
we did identify a potentially uncollectable account at December 31, 2019 and maintained a reserve for this receivable balance of $ 123 .
At December 31, 2020, the account was deemed uncollectable and offset against the reserve. At December 31, 2021, we did have two customers
that accounted for 33 % of total receivables. We deemed these accounts fully collectable. We did not have any potentially uncollectable
accounts at December 31, 2021 and therefore, did not record a reserve for uncollectable accounts at December 31, 2021. We do not require
collateral or other securities to support its accounts receivable.
5. Prepaid expenses
Prepaid expenses consisted of the following:
December 31,
2021
2020
Director, officer and other insurance
$ 109
$ 18
Marketing programs and conferences
66
106
Patents
41
-
Legal retainer
-
25
Professional service retainer
-
8
Rent
-
18
Engineering, software licenses and other
14
3
Total prepaid expenses
$ 230
$ 178
6. Property and Equipment
Property and equipment, net consisted of the following:
December 31,
Useful Life
2021
2020
Research and development equipment
5 years
$ 1,425
$ 1,397
Office and computer equipment
3 years
762
733
Autos
5 years
54
54
Furniture and fixtures
7 years
41
41
Leasehold improvements
*
112
283
Construction in progress
45
115
2,439
2,623
Less accumulated depreciation and amortization
2,105
2,085
Total property and equipment
$ 334
$ 538
* Shorter
of lease term or estimated useful life
(1) For
the years ended December 31, 2021 and December 31, 2020, we received net proceeds of $ 1 and $ 47 in the sale of research and development
equipment and office and computer equipment, respectively, resulting in gains on the sale of these assets of $ 0 and $ 21 for the years
ended December 31, 2021 and December 31, 2020, respectively.
Depreciation and amortization expense was approximately $ 303 and $ 288
for the years ended December 31, 2021 and 2020, respectively.
F- 13
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
7. Accrued Expenses
Accrued expenses consisted of the following:
December 31,
2021
2020
Compensation, severance and related benefits
$
524
$
218
Legal services
17
-
Product warranty
18
-
Personal property and franchise tax
5
57
Other
14
17
Total accrued expenses
$
578
$
292
8. Borrowings
A summary of our borrowings, including finance lease obligations, was
as follows:
At December 31,
2021
2020
Short-term debt:
Current portion of long-term debt
$ 32
$ 98
Total short-term debt
$ 32
$ 98
Long-term debt:
Finance lease obligations
$ -
$ 79
Other unsecured promissory notes
-
692
Total
-
771
Less: current portion of long-term debt
32
98
Total long-term debt
$ -
$ 673
Finance Lease Obligations
Finance lease obligations at December 31, 2021
was for manufacturing equipment leased through ENGS Commercial Finance Co. This finance lease expires on April 18, 2022 and carries an
interest rate of 11.4 %.
Other Promissory Notes
Also included in the table above is a note payable
to Fidelity Capital for the financing of a computing fixed asset. This note expires on July 1, 2022 and carries interest rate of 13.3 %.
On June 18, 2021, we received notification from
BMO Harris Bank National Association as the lender in a promissory note pursuant to the PPP under the CARES Act, that a loan to us under
this program in the amount of $ 645,700 was forgiven in full under the terms of the program. The forgiveness of this note and related interest
was recorded as other income on the Statements of Operations and Comprehensive Loss for the year ended December 31, 2021.
F- 14
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
9. Common Stock Warrants and Common Stock Warrant Liability
The table below summarizes common stock warrant activity for the years
ended December 31, 2021and December 31, 2020, by warrant type.l
Issue Date
Warrant Type
Term
Date
Exercise
Price
Balance
December 31,
2019
Issued
Exercised
Expired
Balance
December 31,
2020
Issued
Exercised
Expired
Balance
December 31,
2021
2016 and prior
Various
Various-2020/2021
Various
17,059
-
( 9,375 )
( 7,684 )
-
-
-
-
-
November 21, 2017
Common Stock Offering Warrants
November 21, 2022
$ 1.3659
(1)
143,501
-
-
-
143,501
-
( 21,787 )
-
121,714
November 21, 2017
Dealer Manager Warrants
November 21, 2022
$ 30.00
47,250
-
( 47,250 )
-
-
-
-
-
-
June 20, 2018
Warrant Reissue
December 20, 2023
$ 36.40
56,696
-
-
-
56,696
-
-
-
56,696
August 13, 2018
Rights Offering Warrants
July 25, 2023
$ 23.00
202,943
-
-
-
202,943
-
( 499 )
-
202,444
August 13, 2018
Dealer Manager Warrants
August 13, 2023
$ 34.50
13,393
-
-
-
13,393
-
-
-
13,393
July 16, 2019
Dealer Manager Warrants
July 11, 2024
$ 33.75
8,334
-
-
-
8,334
-
-
-
8,334
January 28, 2020
Registered Direct Offering
July 28, 2025
$ 9.00
-
177,500
-
-
177,500
-
-
-
177,500
January 28, 2020
Dealer Manager Warrants
July 28, 2025
$ 10.00
-
13,315
-
-
13,315
-
-
-
13,315
March 6, 2020
Registered Direct Offering
September 8, 2025
$ 2.88
-
176,372
( 176,372 )
-
-
-
-
-
-
March 6, 2020
Dealer Manager Warrants
March 4, 2025
$ 3.76
-
13,228
-
-
13,228
-
-
-
13,228
April 21, 2020
Dealer Manager Warrants
April 21, 2025
$ 3.97
-
118,073
-
-
118,073
-
-
-
118,073
April 24, 2020
Registered Direct Offering
April 24, 2025
$ 3.05
-
1,574,308
( 1,524,308 )
-
50,000
-
-
-
50,000
October 26, 2020
Private Warrant Inducement
April 27, 2026
$ 1.73
-
1,700,680
1,700,680
-
( 700,680 )
-
1,000,000
October 26, 2020
Dealer Manager Warrants
April 27, 2026
$ 2.16
-
85,034
85,034
-
-
-
85,034
February 2, 2021
Private Placement Agreement
August 2, 2026
$ 2.216
-
-
-
-
-
2,194,427
-
-
2,194,427
February 2, 2021
Dealer Manager Warrants
August 2, 2026
$ 2.848
-
-
-
-
-
329,164
-
-
329,164
March 23, 2021
Dealer Manager Warrants
March 23, 2026
$ 2.50
-
-
-
-
-
148,125
-
-
148,125
489,176
2,582,697
4,531,447
(1) The
initial exercise price of these warrants was $ 30.00 per share. Pursuant to antidilution price adjustment protection contained within
these warrants, the initial exercise price of these warrants was adjusted downward to $ 29.40 on July 24, 2018, the record date of the
Right’s Offering and downward to $ 19.00 per share on August 13, 2018. These warrants were further adjusted downward from $ 19.00
to $ 7.13 and to $ 2.1122 on January 28, 2020 and March 4, 2020, respectively, in connection with separate Registered Direct Offerings. These
warrants were further adjusted downward from $ 2.1122 to $ 1.3659 on October 26, 2020 in connection with a Registered Direct Offering. These
warrants are subject to further adjustment pursuant to antidilution price adjustment protection.
F- 15
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
9. Common Stock Warrants and Common Stock Warrant Liability – (continued)
As of December 31, 2021, we had 4,531,447 shares of common stock issuable
upon exercise of outstanding common stock warrants, at a weighted-average exercise price of $ 4.00 per share.
On November 21, 2017, we issued a total of 232,875 detachable common
stock warrants issued with the second public offering of 293,000 shares of our common stock at $ 20.00 per share. The common stock warrant
is exercisable until five years from the date of grant. Our common stock and detachable warrants exist independently as separate securities.
As such, we estimated the fair value of the common stock warrants, exercisable at $ 30.00 per share, to be $ 661 using a lattice model based
on the following significant inputs: common stock price of $ 20.00 ; comparable company volatility of 73.8 %; remaining term 5 years; dividend
yield of 0 % and risk-free interest rate of 1.87 . The initial exercise price of these warrants was $ 30.00 per share, which adjusted downward
to $ 29.40 on July 24, 2018, the record date of the Right’s Offering, and downward to $ 19.00 per share on August 13, 2018, the date
of the Rights Offering, pursuant to antidilution price adjustment protection contained within these warrants. The exercise price of the
warrants was adjusted downward to $ 7.13 on January 28, 2020 in connection with a private placement of common stock. Per guidance of ASC
260, we recorded a deemed dividend of $ 285 on the 143,501 unexercised warrants that contained this antidilution price adjustment protection
provision and was calculated as the difference between the fair value of the warrants immediately prior to downward exercise price adjustment
and immediately after the adjustment using a Black Scholes model based on the following significant inputs: On January 28, 2020, common
stock price of $ 7.90 ; comparable company volatility of 73.8 %; remaining term 2.82 years; dividend yield of 0 % and risk-free interest rate
of 1.45 %.
The exercise price of the warrants was adjusted downward to $ 2.1122
on March 4, 2020 in connection with a private placement of common stock. Per guidance of ASC 260, we recorded a deemed dividend of $ 129
on the 143,501 unexercised warrants that contained this antidilution price adjustment protection provision and was calculated as the difference
between the fair value of the warrants immediately prior to downward exercise price adjustment and immediately after the adjustment using
a Black Scholes model based on the following significant inputs: On March 4, 2020, common stock price of $ 2.88 ; comparable company volatility
of 74.5 %; remaining term 2.71 years; dividend yield of 0 % and risk-free interest rate of 0.68 %.
The exercise price of the warrants was adjusted downward to $ 1.3659
on October 26, 2020 in connection with an inducement offering of common stock. Per guidance of ASC 260, we recorded a deemed dividend
of $ 22 on the 143,501 unexercised warrants that contained this antidilution price adjustment protection provision and was calculated as
the difference between the fair value of the warrants immediately prior to downward exercise price adjustment and immediately after the
adjustment using a Black Scholes model based on the following significant inputs: On October 26, 2020, common stock price of $ 1.47 ; comparable
company volatility of 96.5 %; remaining term 2.08 years; dividend yield of 0 % and risk-free interest rate of 0.18 %.
On June 20, 2018, we entered into an agreement with a holder of 56,696
of the November 2017 warrants to exercise its original warrant representing 56,696 shares of common stock for cash at the $ 30.00 exercise
price for gross proceeds of $ 1.7 million, and we issued to holder a new warrant to purchase 56,696 shares of common stock at an exercise
price of $ 36.40 per share. The new warrant did not contain the antidilution price adjustment protection that was contained within the
exercised warrants. In June 2018, we recorded stock compensation expense of $ 1,700 representing the fair value of the of 56,696 inducement
warrants issued. We estimated the fair value of the common stock warrants, exercisable at $ 36.40 per share, to be $ 1,700 using a Black
Scholes model based on the following significant inputs: common stock price of $ 42.20 ; comparable company volatility of 72.6 %; remaining
term 5 years; dividend yield of 0 % and risk-free interest rate of 2.8 %. Also, in June 2018, an additional 17,088 of the November 8, 2017
warrants that were in the money at the time of exercise, were exercised for gross proceeds of $ 513 .
On August 13, 2018, in connection with a Rights Offering of 267,853
shares of our common stock, we issued 267,853 warrants to purchase shares of our common stock at an exercise price of $ 23.00 per share.
We estimated the fair value of the common stock warrants, exercisable at $ 23.00 per share, to be $ 3,600 using a Monte Carlo model based
on the following significant inputs: common stock price of $ 18.80 ; comparable company volatility of 159.0 %; remaining term 5 years; dividend
yield of 0 % and risk-free interest rate of 2.77 %.
In connection with the closing of the Rights Offering, we issued a
warrant to purchase 13,393 shares of common stock to Maxim Partners LLC, an affiliate of the dealer-manager of the Rights Offering. We
estimated the fair value of the common stock warrants, exercisable at $ 34.50 per share, to be $ 169 using a using a Monte Carlo model based
on the following significant inputs: common stock price of $ 18.80 ; comparable company volatility of 159.0 %; remaining term 5 years; dividend
yield of 0 % and risk-free interest rate of 2.77 %.
F- 16
SENESTECH,
INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
9. Common Stock Warrants and Common Stock Warrant Liability – (continued)
Common Stock Warrant Issued to Underwriter of Common Stock Offering
In July 2019, we issued to H.C. Wainwright & Co., as placement
agent, a warrant to purchase 8,334 shares of common stock at an exercise price of $ 33.75 per share as consideration for providing services
in connection with a common stock offering in July 2019. The warrant was fully vested and exercisable on the date of issuance. The common
stock warrant is exercisable until five years from the date of grant. We estimated the fair value of the common stock warrants, exercisable
at $ 33.75 per share, to be $ 127 using a lattice model based on the following significant inputs: common stock price of $ 26.80 ; comparable
company volatility of 133.3 %; remaining term 5 years; dividend yield of 0 % and risk-free interest rate of 2.07 %.
Common Stock Warrants Issued in January
and March 2020 Private Placements
In January and March 2020, in separate private placements concurrent
with registered direct offerings (collectively, the “2020 Registered Direct Offerings”) of shares of our common stock, we
also issued warrants to purchase an aggregate of up to 353,872 shares of common stock to certain institutional and accredited investors
that participated in the 2020 Registered Direct Offerings (the “2020 Warrants”). The warrants were issued in reliance on the
exemption from registration provided by Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D promulgated thereunder.
Terms used but not otherwise defined herein will have the meanings given them in the warrants, attached as Exhibit 4.1 to our Current
Report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on January 28, 2020 and our Current
Report on Form 8-K filed with the SEC on March 6, 2020.
The warrants issued in January 2020 to purchase 177,500 shares of common
stock have an exercise price of $ 9.00 per share, are exercisable after July 28, 2020 and will expire July 28, 2025. We estimated
the fair value of the common stock warrants, exercisable at $ 9.00 per share, to be $ 813 using a Black Scholes model based on the following
significant inputs: common stock price of $ 7.90 ; comparable company volatility of 73.8 %; remaining term 5 years; dividend yield of 0 %
and risk-free interest rate of 1.53 %.
The warrants issued in March 2020 to purchase 176,372 shares of common
stock have an exercise price of $ 2.88 per share, are immediately exercisable and will expire September 8, 2025. We estimated the fair
value of the common stock warrants, exercisable at $ 2.88 per share, to be $ 242 using a Black Scholes model based on the following significant
inputs: common stock price of $ 2.35 ; comparable company volatility of 74.8 %; remaining term 5.5 years; dividend yield of 0 % and risk-free
interest rate of 0.39 %.
For so long as the 2020 Warrants remain outstanding, the exercise price
and number of shares of common stock issuable upon exercise of the warrants are subject to adjustment as follows: (a) upon payment
of a stock dividend or other distribution on a class or series of shares common stock, not including shares issued under this warrant;
(b) upon subdivision (by stock spilt, stock dividend, recapitalization, or otherwise) or combination (by reverse stock split or otherwise)
of shares of common stock; or (c) upon the issuance of any shares of capital stock by reclassification of shares of the common stock.
In the event that we declare or make any dividend or other distribution
of our assets to holders of our common stock, each 2020 Warrant holder will be entitled to participate in such distribution to the same
extent that such holder would have participated therein if the holder had held the number of shares of common stock acquirable upon exercise
of the 2020 Warrant.
In the event of a Fundamental Transaction, as described in the 2020
Warrants and generally including the sale, transfer or other disposition of all or substantially all of our properties or assets; our
consolidation or merger with or into another person or reorganization; a recapitalization, reorganization or reclassification in which
our common stock is converted into other securities, cash or property; or any acquisition of our outstanding common stock that results
in any person or group becoming the beneficial owner of 50 % of the voting power represented by our outstanding common stock, then the
holders of the 2020 Warrants will be entitled to receive upon exercise of such warrants the kind and amount of securities, cash, assets
or other property that the holders would have received had they exercised the 2020 Warrants immediately prior to such Fundamental Transaction.
Subject to certain limitations, in the event of a Fundamental Transaction the 2020 Warrant holder may at its option require us or any
Successor Entity to purchase such warrant from the holder by paying to the holder an amount of cash equal to the Black Scholes Value of
the remaining unexercised portion of the 2020 Warrant on the date of the consummation of the Fundamental Transaction.
Any time that we grant, issue, or sell any securities pro rata to all
of the record holders of our common stock (the “2020 Purchase Right”), each holder of 2020 Warrants will be entitled to acquire
the aggregate amount of securities that the holder could have acquired if the holder had held the number of shares of common stock acquirable
upon exercise of the applicable 2020 Warrant. However, to the extent that an exercise of a 2020 Purchase Right would exceed the Beneficial
Ownership Limitation (defined below), then to such extent the 2020 Purchase Right will be held in abeyance until such time, if ever, that
complete exercise of the 2020 Purchase Right would not exceed the Beneficial Ownership Limitation.
F- 17
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
9. Common Stock Warrants and Common Stock Warrant Liability – (continued)
After the Initial Exercisability Date, the 2020 Warrants will be exercisable,
at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full
for the number of shares of our common stock purchased upon such exercise. If, at the time a holder exercises the 2020 Warrant (but not
sooner than six months following the date of such warrant), a registration statement registering the issuance of the shares of common
stock underlying the 2020 Warrants under the Securities Act is not then effective or available, nor is any current prospectus thereto
available, and an exemption from registration under the Securities Act is not available for the issuance of such shares, then in lieu
of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the
holder may elect instead to receive upon such exercise (either in whole or in part) the number of shares of common stock determined according
to a formula set forth in the 2020 Warrant.
Limitations on Exercise . A holder (together with its affiliates)
may not exercise any portion of the 2020 Warrants to the extent that the holder would own more than 4.99% of the outstanding common stock
after exercise (the “Beneficial Ownership Limitation”), except that upon at least 61 days’ prior notice from the holder
to us, the holder may increase the Beneficial Ownership Limitation up to 9.99% of the number of shares of our common stock outstanding
immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the 2020 Warrants.
No fractional shares of common stock will be issued in connection with the exercise of a 2020 Warrant. In lieu of fractional shares, we
will either pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price or round up to the next whole
share.
Except as otherwise provided in the 2020 Warrants or by virtue of such
holder’s ownership of shares of our common stock, the holders of the 2020 Warrants do not have the rights or privileges of holders
of our common stock, including any voting rights, unless and until they exercise such warrants.
Common Stock Warrants Issued in April 2020
Public Offering
On April 24, 2020, in connection with a previously announced public
offering of 145,586 Class A Units and 1,428,722 Class B Units, we issued warrants to purchase 1,574,308 shares of common stock to the
participants in the public offering and have an exercise price of $ 3.05 per share (the “April 2020 Warrants”). These warrants
are immediately exercisable and will expire April 24, 2025 .
The Common Stock, Pre-Funded Warrants and Warrants sold in this Public
Offering were offered and sold pursuant to a registration statement on Form S-1 (File No. 333-236302) initially filed with the SEC on
February 7, 2020, as amended (“Registration Statement”), which was declared effective by the SEC on February 14, 2020. The
Post-Effective Amendment No. 2 to the Registration Statement was declared effective by the SEC on April 21, 2020.
We estimated the fair value of the common stock
warrants, exercisable at $ 3.05 per share, to be $ 2,402 using a Black Scholes model based on the following significant inputs: common stock
price of $ 2.40 ; comparable company volatility of 87.9 %; remaining term 5 years; dividend yield of 0 % and risk-free interest rate of 0.18 %.
Common Stock Warrants Issued to Placement
Agent in 2020 Registered Direct Offerings and Private Placement
In connection with the separate private placements concurrent with
registered direct offerings of shares of our common stock in January and March 2020, we issued to H.C. Wainwright & Co., LLC, as placement
agent, a warrant to purchase 13,228 shares of common stock and a warrant to purchase 13,313 shares of common stock. The warrants were
issued in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation
D promulgated thereunder. These warrants have substantially similar terms as the 2020 Warrants described above, except that the placement
agent warrant issued in January 2020 has an exercise price of $ 10.00 per share, and the placement agent warrant issued in March 2020 has
an exercise price of $ 3.7563 per share.
We estimated the fair value of the common stock warrants issued in
January, with an exercise price of $ 10.00 per share, to be $ 58 using a Black Scholes model based on the following significant inputs:
common stock price of $ 7.90 ; comparable company volatility of 73.8 %; remaining term 5 years; dividend yield of 0 % and risk-free interest
rate of 1.53 %.
F- 18
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
9. Common Stock Warrants and Common Stock Warrant Liability – (continued)
We estimated the fair value of the common stock warrants issued in
March, with an exercise price of $3.7563 per share, to be $ 17 using a Black Scholes model based on the following significant inputs: common
stock price of $ 2.35 ; comparable company volatility of 74.8 %; remaining term 5.5 years; dividend yield of 0 % and risk-free interest rate
of 0.39 %.
In connection with the public offering of 145,586
Class A Units and 1,428,722 Class B Units on April 24, 2020, we issued to H.C. Wainwright & Co., LLC, as placement agent, warrants
to purchase 118,073 shares of common stock. The warrants were issued in reliance on the exemption from registration provided by Section
4(a)(2) of the Securities Act and Rule 506(b) of Regulation D promulgated thereunder. These warrants have substantially similar terms
as the April 2020 Warrants described above, except that the placement agent warrant issued has an exercise price of $ 3.97 per share.
We estimated the fair value of the common stock warrants issued in
April, with an exercise price of $ 3.97 per share, to be $ 167 using a Black Scholes model based on the following significant inputs: common
stock price of $ 2.40 ; comparable company volatility of 87.9 %; remaining term 5.5 years; dividend yield of 0 % and risk-free interest rate
of 0.18 %.
Common Stock Warrants Issued in October
2020 Private Warrant Inducement
In October 2020, in connection with an inducement agreement with an
existing accredited investor to exercise 1,700,680 outstanding warrants to purchase an equal number of shares of our common stock, we
issued new unregistered warrants to purchase up to an aggregate of 1,700,680 shares of common stock at an exercise price of $ 1.725 per
share. The warrants issued were immediately exercisable with an exercise period of five and one-half years from the date of issuance.
The Original Warrants were issued on March 6, 2020 and on April 24, 2020. Pursuant to the Letter Agreement, the per share exercise price
of the Original Warrants were reduced from $ 2.88 and $ 3.05 , respectively, to $ 1.725 . We estimated the fair value of the common stock warrants,
exercisable at $ 1.725 per share, to be $ 1,806 using a Black Scholes model based on the following significant inputs: common stock price
of $ 1.47 ; comparable company volatility of 96.5 %; remaining term 5.5 years; dividend yield of 0 % and risk-free interest rate of 0.18 %.
Common Stock Warrants Issued to Placement
Agent in October 2020 Inducement Offering
In connection with the private warrant inducement in October 2020 of
1,700,680 shares of our common warrants, we issued to H.C. Wainwright & Co., LLC, as placement agent, warrants to purchase 85,034
shares of common stock. These warrants have substantially similar terms as the 2020 Warrants described above, except that the placement
agent warrant issued in October 2020 has an exercise price of $ 2.156 per share.
We estimated the fair value of these common stock warrants, with an
exercise price of $ 2.156 per share, to be $ 86 using a Black Scholes model based on the following significant inputs: common stock price
of $ 1.47 ; comparable company volatility of 96.5 %; remaining term 5.5 years; dividend yield of 0 % and risk-free interest rate of 0.18 %.
F- 19
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
9. Common Stock Warrants and Common Stock Warrant Liability – (continued)
Common Stock Warrants Issued in February 2021 Private Placement
Agreement
In February 2021, in connection with a private
placement agreement with certain institutional and accredited investors, we issued common stock warrants to purchase up to an aggregate
of 2,194,427 shares of common stock at an exercise price of $ 2.216 per share. The warrants were exercisable immediately and have an exercise
period of five and one-half years from the date of issuance. The warrant holder may not exercise any portion of such holder’s warrants
to the extent that the holder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the holder,
9.99%) of our outstanding shares of common stock immediately after exercise, except that upon at least 61 days’ prior notice from
the holder to us, the holder may increase the beneficial ownership limitation to up to 9.99% of the number of shares of common stock outstanding
immediately after giving effect to the exercise. We estimated the fair value of the common stock warrants, exercisable at $ 2.216 per share,
to be $ 3,052 using a Black Scholes model based on the following significant inputs: common stock price of $ 1.93 ; comparable company volatility
of 95.6 %; remaining term 5.5 years; dividend yield of 0 % and risk-free interest rate of 0.18 %.
Common Stock Warrants Issued to Placement
Agent in February 2021 Private Placement Agreement
In connection with the private placement in February
2021, we issued to H.C. Wainwright & Co., LLC, as placement agent, warrants to purchase up to 329,164 shares of common stock with
an exercise price of $ 2.8481 per share. The warrants are exercisable immediately and have an exercise period of five and one-half years
from the date of issuance. We estimated the fair value of these common stock warrants, with an exercise price of $ 2.8481 per share, to
be $ 435 using a Black Scholes model based on the following significant inputs: common stock price of $ 1.93 ; comparable company volatility
of 95.6 %; remaining term 5.5 years; dividend yield of 0 % and risk-free interest rate of 0.18 %.
Common Stock Warrants Issued to Placement
Agent in March 2021 Registered Direct Offering
On March 23, 2021, we consummated a registered
direct offering with certain institutional investors and issued an aggregate of 1,975,000 shares of our common stock, par value $ 0.001
per share at a purchase price of $ 2.00 per share for gross proceeds to us of approximately $ 3.95 million, before deducting fees payable
to the placement agent and other estimated offering expenses payable by us. The 1,975,000 shares of common stock sold in the offering
were offered and sold pursuant to a prospectus, dated August 24, 2018, and a prospectus supplement, dated March 22, 2021, in connection
with a takedown from our shelf registration statement on Form S-3 (File No. 333-225712).
In connection with the registered direct offering in March 2021, we
issued to H.C. Wainwright & Co., LLC, as the placement agent, warrants to purchase up to 148,125 shares of common stock. The placement
agent warrants will be exercisable commencing six months following the date of issuance, expire five years following the date of sale
and have an exercise price per share of $ 2.50 per share. The placement agent warrants, and the shares of common stock issuable upon exercise
thereof, will be issued in reliance on the exemption from registration provided in Section 4(a)(2) under the Securities Act of 1933, as
amended, and Regulation D promulgated thereunder. We estimated the fair value of these common stock warrants, with an exercise price of
$ 2.50 per share, to be $ 181 using a Black Scholes model based on the following significant inputs: common stock price of $ 1.76 ; comparable
company volatility of 100.8 %; remaining term 5 years; dividend yield of 0 % and risk-free interest rate of 0.31 %.
F- 20
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
9. Common Stock Warrants and Common Stock Warrant Liability – (continued)
Deemed Dividend Adjustment-Warrant Modified
Terms Revaluation
On March 3, 2020, we issued an aggregate of 51,414 common shares in
a cashless exercise of 56,625 warrants issued in December 2016 and November 2017. Consideration for the exercise of these warrants was
the full settlement of an outstanding litigation reserve of $ 238 .
On October 26, 2020, in connection with the private warrant inducement
with an existing accredited investor to exercise 1,700,680 outstanding warrants (“Original Warrants”), we agreed to modify
the terms of the original warrants that were originally issued on March 6, 2020 and on April 24, 2020. Pursuant to the agreement, the
per share exercise price of the original warrants were reduced from $ 2.88 and $ 3.05 , respectively, to $ 1.725 .
Per recent proposed guidance of ASC 260, we determined that this was
an exchange of the existing 1,700,680 warrants that were affected and the difference between the fair value of the warrants immediately
prior to modification of terms and immediately after the adjustment was a cost of raising capital and was recorded as a reduction of equity.
The difference between the fair value of the warrants immediately prior to modification of terms and immediately after the adjustment
was calculated as $ 237 , using a Black Scholes model based on the following significant inputs: On October 26, 2020: common stock price
of $ 1.47 ; comparable company volatility of 96.5 %; remaining term 4.5 -4. 8 years; dividend yield of 0 % and risk-free interest rate of 0.18 .
10. Stockholders’ Deficit
Capital Stock
We organized under the laws of the state of Nevada on July 27, 2004
and subsequently reincorporated under the laws of the state of Delaware on November 10, 2015. In connection with the reincorporation,
as approved by the stockholders, we changed our authorized capital stock to consist of (i) 100 million shares of common stock, $0.001
par value, and (ii) 2 million shares of preferred stock, $0.001 par value, designated as Series A convertible preferred stock. In December
2015, we amended our Certificate of Incorporation to change our authorized capital stock to provide for 15 million authorized shares of
preferred stock of which 7,515,000 was designated as Series B convertible preferred stock, par value $.001 per share.
Prior to November 10, 2015, our authorized capital stock consisted
of 100 million shares of common stock, $.001 par value, and 10 million shares of preferred stock, $.001 par value.
Common Stock
We had 12,207,283 and 5,099,512 shares of common stock issued and outstanding
as of December 31, 2021 and December 31, 2020, respectively.
During the year ended December 31, 2021, we issued 7,107,771 shares
of common stock as follows:
● an
aggregate of 4,188,854 shares in connection with a private placement offering and exercise of pre-funded warrants issued in connection
with the offering, generating net proceeds to us in February 2021 of approximately $ 8,898 , as further described below;
● an
aggregate of 1,975,000 shares in connection with a registered direct offering generating net proceeds to us in March 2021 of approximately
$ 3,523 , as further described below;
● an
aggregate of 922,966 shares in connection with the exercise of common stock warrants in March, June, July and October, 2021, generating
net proceeds to us of approximately $ 1,250 , as further described below; and
● an
aggregate of 20,951 shares for service as a result of the vesting of restricted stock units.
F- 21
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
10. Stockholders’
Deficit – (continued)
Public Offerings and Registered Direct Offerings
On February 2, 2021, we consummated a private
placement with certain institutional and accredited investors and issued an aggregate of 3,968,854 shares of our common stock, par value
$ 0.001 per share at a purchase price of $ 2.2785 per share, pre-funded warrants to purchase up to an aggregate of 420,000 shares of common
stock at a purchase price of $ 2.2775 per pre-funded warrant and associated warrants to purchase up to an aggregate of 2,194,427 shares
of common stock, for gross proceeds of approximately $ 10.0 million, prior to deducting placement agent fees and offering expenses. At
March 29, 2021, all 420,000 pre-funded shares had been distributed. In connection with the offering, we issued the placement agent warrants
to purchase up to 329,164 shares of common stock with an exercise price of $2.8481 per share.
On March 23, 2021, we consummated a registered
direct offering with certain institutional investors and issued an aggregate of 1,975,000 shares of our common stock, par value $0.001
per share at a purchase price of $2.00 per share for gross proceeds to us of approximately $3.95 million, pursuant to a prospectus, dated
August 24, 2018, and a prospectus supplement, dated March 22, 2021, in connection with a takedown from our shelf registration statement
on Form S-3 (File No. 333-225712).
In connection with the offering, we issued the
placement agent warrants to purchase up to 148,125 shares of common stock at an exercise price per share of $ 2.50 per share.
On March 19, 2021, June 22, 2021, July 15, 2021
and October 7, 2021, we issued an aggregate of 700, 680, 499, 5,616 and 16,171 shares of commons stock for the exercise of certain warrants,
respectively. The net proceeds to us for these exercises was $1,250.
11. Stock-Based Compensation
On June 12, 2018, our stockholders approved the 2018 Equity Incentive
Plan (the “2018 Plan”) to replace our 2015 Equity Incentive Plan (the “2015 Plan”). On July 8, 2020, our stockholders
approved an amendment to the 2018 Plan to increase the number of shares of common stock available for issuance under the 2018 Plan by
800,000 shares from 50,000 to 850,000. In addition, up to 122,279 shares of our common stock previously reserved for issuance under the
2015 Plan are available for issuance under the 2018 Plan to the extent such shares were available for issuance under the 2015 Plan as
of June 12, 2018 or thereafter cease to be subject to awards outstanding under the 2015 Plan, such as by expiration, cancellation, or
forfeiture of such awards.
On June 24, 2021, our stockholders approved an amendment to the 2018
Plan to increase the number of shares of common stock available for issuance under the 2018 Plan by 3,000,000 shares.
Stock options are generally issued with a per share exercise price
equal to no less than fair market value of our common stock at the date of grant. Options granted under the 2018 Plan generally vest immediately,
or ratably over a two- to 36-month period coinciding with their respective service periods. Options under the 2018 Plan generally have
a term of five years . Certain stock option awards provide for accelerated vesting upon a change in control.
As of December 31, 2021, we had 2,838,100 shares
of common stock available for issuance under the 2018 Plan.
F- 22
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
11. Stock-based Compensation – (continued)
Stock Options
We measure the fair value of stock options with service-based vesting
criteria to employees, directors and consultants on the date of grant using the Black-Scholes option pricing model. The Black-Scholes
valuation model requires us to make certain estimates and assumptions, including assumptions related to the expected price volatility
of our stock, the period during which the options will be outstanding, the rate of return on risk-free investments, and the expected dividend
yield for our stock.
The weighted-average assumptions used in the Black-Scholes option-pricing
model used to calculate the fair value of options granted during the year ended December 31, 2021 were as follows:
Employee
Expected volatility
95.8 %
Expected dividend yield
-
Expected term (in years)
3.01
Risk-free interest rate
0.46 %
The weighted average grant date fair value of options granted during
the year ended December 31, 2021 was $ 0.97 per share, as per the table below.
The weighted-average assumptions used in the Black-Scholes option-pricing
model used to calculate the fair value of options granted during the year ended December 31, 2020, were as follows:
Employee
Expected volatility
92.1 %
Expected dividend yield
-
Expected term (in years)
3.5
Risk-free interest rate
0.17 %
Due to our limited operating history and lack of company-specific historical
or implied volatility, the expected volatility assumption was determined based on historical volatilities from traded options of biotech
companies of comparable size and stability, whose share prices are publicly available. The expected term of options granted to employees
is calculated based on the mid-point between the vesting date and the end of the contractual term according to the simplified method as
described in SEC Staff Accounting Bulletin 110 because we do not have sufficient historical exercise data to provide a reasonable basis
upon which to estimate the expected term due to the limited period of time our awards have been outstanding. For non-employee options,
the expected term of options granted is the contractual term of the options. The risk-free interest rate is determined by reference to
the implied yields of U.S. Treasury securities with a remaining term equal to the expected term assumed at the time of grant. The expected
dividend assumption is based on our history and expectation of dividend payouts. We have not paid and do not intend to pay dividends.
F- 23
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
11. Stock-based Compensation – (continued)
The table summarizes the stock option activity for the periods indicated
as follows:
Number of
Options
Weighted
Average
Exercise
Price Per
Share
Weighted
Average
Remaining
Contractual
Term
(years)
Aggregate
Intrinsic
Value (1)
Outstanding at December 31, 2019
136,489
$ 27.85
3.9
$ -
Granted
370,397
$ 1.37
4.9
$ -
Exercised
-
$ -
-
$ -
Forfeited
( 10,415 )
$ -
-
$ -
Expired
-
$ -
-
$ -
Outstanding at December 31, 2020
496,471
$ 8.63
3.9
$ -
Granted
598,649
$ 0.97
4.6
$ -
Exercised
-
$ -
-
$ -
Forfeited
( 3,300 )
$ -
-
$ -
Expired
( 4,000 )
$ -
-
$ -
Outstanding at December 31, 2021
1,087,820
$ 4.08
3.9
$ -
Exercisable at December 31, 2021
649,153
$ 5.38
1.8
$ -
(1) The
aggregate intrinsic value on the table was calculated based on the difference between the estimated fair value of our stock and the exercise
price of the underlying option. The estimated stock values used in the calculation was $ 0.98 and $ 1.73 per share for each of the years
ended December 31, 2021 and 2020, respectively.
The weighted average grant date fair value of options granted to employees
for the year ended December 31, 2021 was $ 0.97 per share.
At December 31, 2021, the total compensation cost related to non-vested
options not yet recognized was $ 581 , which will be recognized over a weighted average period of 27 months, assuming the grantees complete
their service period required for vesting.
Restricted Stock Units
The following table summarizes restricted stock unit activity for the
years ended December 31, 2021 and 2020:
Number of
Units
Weighted Average
Grant Date Fair Value Per Unit
Outstanding as of December 31, 2019
5,877
$ 30.28
Granted
30,738 (1)
$ 1.97
Vested
( 4,543 )
$ 1.42
Forfeited
-
$ -
Outstanding as of December 31, 2020
32,072
$ 4.13
Granted
-
$ -
Vested
( 31,405 )
$ 4.22
Forfeited
-
$ -
Outstanding as of December 31, 2021
667
$ 1.80
(1) 30,738
restricted stock units were granted on July 23, 2020 with a weighted average grant date fair value of $1.97.
F- 24
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
11. Stock-based Compensation – (continued)
The stock-based compensation expense was recorded as follows:
Years Ended
December 31,
2021
2020
Research and development
$ 3
$ 9
General and administrative
762
636
Total stock-based compensation expense
$ 765
$ 645
The allocation between research and development and general and administrative
expense was based on the department and services performed by the employee or non-employee.
12. Income Taxes
The components of the pretax loss from operations for the years ended
December 31, 2021 and 2020 are as follows (in thousands):
Years Ended
December 31,
2021
2020
U.S. Domestic
$ ( 8,268 )
$ ( 8,373 )
Foreign
-
-
Pretax loss from operations
$ ( 8,268 )
$ ( 8,373 )
The provision for income taxes from continuing operations for the years
ended December 31, 2021 and 2020 are as follows:
Years Ended
December 31,
2021
2020
Current
$
$
Federal
-
-
State
-
-
Foreign
-
-
Total current
-
-
Deferred
Federal
-
-
State
-
-
Foreign
-
-
Total deferred
-
-
Total income tax expense (benefit)
$ -
$ -
F- 25
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
12. Income Taxes – (continued)
Tax Rate Reconciliation
A reconciliation of income taxes to the amount computed by applying
the statutory federal income tax rate to the net loss is summarized as follows :
Years Ended
December 31,
2021
2020
Income tax benefit at statutory rates
$ ( 1,736 )
$ ( 1,758 )
State income tax, net of federal benefit
( 329 )
( 309 )
Permanent items
-
1
Stock-based compensation
118
84
PPP loan forgiveness
( 137 )
-
Change in rate
-
-
Stock compensation DTA adjustment
-
-
Change in valuation allowance
1,976
1,982
RTP and other
109
-
Income tax expense (benefit)
$ -
$ -
Significant components of our deferred tax assets as of December 31,
2021 and 2020 are shown below.
A valuation allowance has been recognized to offset the net deferred
tax assets as realization of such deferred tax assets have not met the more likely than not threshold.
December 31,
2021
2020
Deferred tax assets:
ASC 842 leases
$ 130
$ 167
Federal and state net operating loss carryovers
19,448
17,548
Stock-Based Compensation
333
289
Compensation accruals and other
139
84
Depreciation
-
17
Total deferred tax assets
20,050
18,105
Valuation allowance for deferred tax assets
( 19,916 )
( 17,940 )
Deferred tax assets, net of valuation allowance
134
165
Deferred tax liabilities:
Depreciation
( 7 )
-
ASC 842 assets
( 127 )
( 165
Total deferred tax liabilities
( 134 )
( 165 )
$ -
$ -
At December 31, 2021, we had federal and state net operating loss carryforwards
of approximately $ 77.2 million and $ 63.7 million, respectively, not considering the IRC Section 382 annual limitation discussed below.
The federal loss carryforwards begin to expire in 2029 , unless previously utilized. In addition, we had approximately $ 32.7 million of
the total $ 77.2 million of net operating losses that do not expire, as these losses were generated after the law change introduced as
part of the Tax Cuts and Jobs Act. The state net operating losses expire if not utilized by 2041.
F- 26
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
12. Income Taxes – (continued)
Additionally, the utilization of the net operating loss carryforwards
could be subject to an annual limitation under Section 382 and 383 of the Internal Revenue Code of 1986, and similar state tax provisions
due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes limit the
amount of net operating loss carryforwards and other deferred tax assets that can be utilized to offset future taxable income and tax,
respectively. In general, an ownership change, as defined by Section 382 and 383, results from transactions increasing ownership of certain
stockholders or public groups in the stock of the corporation by more than 50 percentage points over a three-year period. We have not
conducted an analysis of an ownership change under section 382. To the extent that a study is completed and an ownership change is deemed
to occur, our net operating losses could be limited.
The following table summarizes the activity related to our gross unrecognized
tax benefits at the beginning and end of the years ended December 31, 2021 and 2020 (in thousands):
Years Ended
December 31,
2021
2020
Gross unrecognized tax benefits at the beginning of the year
$ -
$ -
Increases related to current year positions
-
-
Increases related to prior year positions
-
-
Decreases related to prior year positions
-
-
Expiration of unrecognized tax benefits
-
-
Gross unrecognized tax benefits at the end of the year
$ -
$ -
None of the unrecognized tax benefits would affect our annual effective
tax rate.
We do not expect a significant change in unrecognized tax benefits
over the next 12 months.
We file income tax returns in the United States and Arizona with general
statutes of limitations of three and four years, respectively. Due to net operating losses incurred, our tax returns from inception to
date are subject to examination by taxing authorities. Our policy is to recognize interest expense and penalties related to income tax
matters as a component of income tax expense. As of December 31, 2021, we had no interest or penalties accrued for uncertain tax positions.
13. Commitments and Contingencies
Legal Proceedings
In July 2020, Kennan E. Kaedar, our former corporate general counsel
(the “Plaintiff”), commenced an action against us in the Superior Court of the State of California, for the County of San
Diego. The complaint alleges, among other things, that we breached the Plaintiff’s employment contract with us, as well as the implied
covenant of good faith and fair dealing, by refusing to issue him the balance of stock options he claims we owe him. In September 2021,
the Plaintiff also named the following individuals as defendants: Loretta Mayer, Cheryl Dyer, Thomas C. Chesterman, Kim Wolin, Grover
Wickersham, Marc Dumont, Bob Ramsey, Matthew Szot, Julia Williams, and Bill Baker. The Plaintiff alleges that such individuals agreed
to knowingly and wrongfully withhold the stock options owed to him and are knowingly in receipt of stolen property. The Plaintiff seeks
compensatory damages in excess of $ 500,000 , treble damages and reasonable attorneys’ fees. We do not believe the claims described
above have merit and intend to aggressively defend against these accusations. We do not believe that this litigation is likely to have
a material effect on our operations.
In addition to the matter described above, we may be subject to other
legal proceedings and claims arising from contracts or other matters from time to time in the ordinary course of business. Management
is not aware of any other pending or threatened litigation where the ultimate disposition or resolution could have a material adverse
effect on our financial position, results of operations or liquidity.
F- 27
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
13. Commitments and Contingencies – (continued)
Lease Commitments
We are obligated under finance leases for certain research and computer
equipment that expire on various dates through July 2023. At December 31, 2021, the gross amount of office and computer equipment, and
research equipment and the related accumulated amortization recorded under the finance leases was $ 478 and $ 442 , respectively.
In February 2012, we entered into an operating lease for our then corporate
headquarters in Flagstaff, Arizona. The lease was originally due to expire in January 2015. In December 2013, we amended our lease to
expand into the remaining area in the building and extended the term to December 31, 2019. In February 2014, we further amended the lease
to expand into an adjacent building. The lease required escalating rental payments over the lease term. Minimum rental payments under
the operating lease were recognized on a straight-line basis over the term of the lease and accordingly, we recorded the difference between
the cash rent payments and the recognition of rent expense as a deferred rent liability. The lease was guaranteed by the former President
of our Company. In December 2019, we extended the current lease for only our manufacturing facilities are located in Flagstaff, Arizona,
occupying a total of 7,632 square feet of space. The lease for our manufacturing facilities expired in December 2020.
On November 16, 2016, we leased an additional 1,954 square feet of
research and development space, also in Flagstaff, Arizona. This lease expired on November 15, 2018 but was extended for an additional
24 months, through November 2020. A subsequent amendment to the lease allows for us to cancel the lease at any time through the lease
term with 30 days notice. We provided a 30-day cancellation notice effective February 2020.
On December 1, 2019, we entered into a lease for our corporate headquarters
in Phoenix, Arizona where we lease and occupy approximately 5,529 square feet of office space. This lease expires in November 2024.
On August 1, 2020, we entered into a lease for our manufacturing and
research facility in Phoenix, Arizona where we occupy approximately 5,105 square feet of manufacturing and warehouse space. This lease
expires on November 30, 2024.
We believe that our existing facilities are adequate and meet our current
needs for business, manufacturing and research.
Rent expense was $ 222 and $ 286 for the years ended December 31, 2021
and 2020, respectively. The future minimum lease payments under non-cancellable operating lease and future minimum finance lease payments
as of December 31, 2021 are follows:
Finance
Leases
Operating
Lease
Years Ending December 31,
2022
$ 28
$ 194
2023
-
198
2024
-
186
Total minimum lease payments
$ 28
$ 578
F- 28
SENESTECH, INC.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except share and per share data)
13. Commitments and Contingencies – (continued)
Finance
Leases
Less: amounts representing interest ( 11.43 %)
$ ( 1 )
Present value of minimum lease payments
27
Less: current installments under finance lease obligations
( 27 )
Total long-term portion
$ -
14. Related Party Transactions
Related party transactions are conducted in the normal course of business
and, unless otherwise noted, are measured at the exchange amount, which is the amount of consideration established and agreed to by the
related parties. In connection with consulting agreements in place, during each of the years ended December 31, 2021 and December 30,
2020, $ 50,400 of cash payments were made to the Kito Impact Foundation of which Dr. Bechtel, the Chair of our board, serves as chief executive
officer.
15. Subsequent Events
COVID-19
The travel and other restrictions that began in March 2020 in response
to the COVID-19 global pandemic have resulted in a significant slowdown in our field studies and sales efforts. We were able to resume
some projects during 2020 and into 2021, however, we still have delays on certain projects that might remain on hold until certain government
restrictions are lifted. These delays have impacted our results of operations and could impact our results in future quarters. In addition,
stay at home orders and other social distancing initiatives continue to limit our ability to communicate with current and potential commercial
customers. Further, new stay at home orders and other social distancing initiatives may be reimplemented at any time. The COVID-19 pandemic
is also placing a significant budgetary burden on federal, state and local governments, which may impede or delay their ability to purchase
our products.
Nasdaq
On March 2, 2022, we received a letter from the
listing qualifications staff (the “Staff”) of The Nasdaq Stock Market (“Nasdaq”) providing notification that the
bid price for our common stock had closed below $1.00 per share for the previous 30 consecutive business days and our common stock no
longer meets the minimum bid price requirement for continued listing under Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing
Rule 5810(c)(3)(A), we have an initial period of 180 calendar days, or until August 29, 2022, to regain compliance. To regain compliance,
the closing bid price of our common stock must be $1.00 per share or more for a minimum of 10 consecutive business days at any time before
August 29, 2022.
If we do not regain compliance with Rule 5550(a)(2)
by August 29, 2022, we may be eligible for an additional 180 calendar day compliance period. To qualify, we would need to meet the continued
listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with
the exception of the minimum bid price requirement, and would need to provide written notice of our intention to cure the deficiency during
the second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to the Staff that we will not be
able to cure the deficiency, or if we are otherwise not eligible, Nasdaq would notify us that our securities would be subject to delisting.
In the event of such notification, we may appeal the Staff’s determination to delist our securities, but there can be no assurance
the Staff would grant our request for continued listing.
The Nasdaq notification has no immediate effect
on the listing of our common stock on the Nasdaq Capital Market. We intend to actively monitor the bid price of our common stock and our
minimum market value of listed securities and will consider options available to us to achieve compliance with the Nasdaq listing rules.
There can be no assurance that we will be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance
with the other listing standards for the Nasdaq Capital Market.
Settlement of Restricted Stock Units
On March 1, 2022, the Company issued 5,000 shares of common stock in
the settlement of restricted stock units that were issued and vested during the period.
Other Subsequent Events
We have evaluated subsequent events from the balance sheet date through
March 29, 2022, the date at which the financial statements were issued, and determined that there were no other items that require adjustment
to or disclosure in the financial statements.
F- 29
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure .
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to
ensure that the information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934 (“Exchange
Act”) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and
that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer,
as appropriate, to allow timely decisions regarding required disclosure.
In connection with the preparation of this Annual Report on Form 10-K,
our management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer and Chief Financial
Officer, as of December 31, 2021, of the effectiveness of the design and operation of our disclosure controls and procedures, as such
term is defined under Rule 13a-15(e) and 15d-15(e) under the Exchange Act. Based upon this evaluation, our Chief Executive Officer and
Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2021.
Management’s Report on Internal Control Over Financial
Reporting
Management is responsible for establishing and maintaining adequate
internal control over financial reporting as defined in Rules 13a-15(f) or 15d-15(f) under the Exchange Act of 1934. Our internal control
over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with U.S. GAAP. All internal control systems, no matter how well
designed, have inherent limitations. Even those systems determined to be effective can provide only reasonable assurance with respect
to financial statement preparation and presentation. Management is committed to continue monitoring our internal controls over financial
reporting and will modify or implement additional controls and procedures that may be required to ensure the ongoing integrity of our
consolidated financial statements.
With the participation of our Chief Executive Officer and Chief Financial
Officer, management conducted an evaluation of the effectiveness of internal control over financial reporting as of December 31, 2021.
In making this assessment, the Company used the framework established in Internal Control—Integrated Framework (2013) issued by
the Committee of Sponsoring Organizations of the Treadway Commission, (COSO). Based on this assessment, management has concluded that
internal control over financial reporting was effective as of December 31, 2021 based on those criteria.
This annual report does not include an attestation report of the
company’s registered public accounting firm due to a transition period established by rules of the Securities and Exchange Commission
for smaller reporting companies.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting
that occurred during the quarter ended December 31, 2021, that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
Item 9B. Other Information.
Not Applicable.
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
34
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The information required by this Item relating to our directors and
corporate governance is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the
Exchange Act for our 2022 Annual Meeting of Stockholders.
Item 11. Executive Compensation.
The information required by this Item relating to our directors and
corporate governance is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the
Exchange Act for our 2022 Annual Meeting of Stockholders.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this Item relating to our directors and
corporate governance is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the
Exchange Act for our 2022 Annual Meeting of Stockholders.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item relating to our directors and
corporate governance is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the
Exchange Act for our 2022 Annual Meeting of Stockholders.
Item 14. Principal Accounting Fees and Services.
The information required by this Item relating to our directors and
corporate governance is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the
Exchange Act for our 2022 Annual Meeting of Stockholders.
35
PART IV
Item 15. Exhibits, Financial Statement Schedules.
(a) Financial Statements and Schedules
1. Consolidated
Financial Statements are listed in the Index to Consolidated Financial Statements on page F-1 of this report.
2. All
schedules for which provision is made in the applicable accounting regulations of the Securities and Exchange Commission have been omitted
because of the absence of the conditions under which they are required or because the information required is shown in the financial
statements or notes above.
(b) Exhibits
36
SENESTECH, INC.
INDEX TO EXHIBITS
Exhibit
Number
Description
3.1
Amended and Restated Certificate of Incorporation, as amended by the Certificate of Amendment to the Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 17, 2020 (File no. 001-37941))
3.2
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.5 to the Registrant’s Registration Statement on Form S- 1, filed with the SEC on September 21, 2016 (File no. 333-213736))
4.1
Description of Securities (incorporated by reference to Exhibit 4.1 to the Registrant’s Annual Report on Form 10-K/A, filed with the SEC on April 21, 2020 (File no. 001-37941))
4.2
Form of the Registrant’s Common Stock certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Amendment No. 1 to Registration Statement on Form S-1, filed with the SEC on October 7, 2016 (File no. 333-213736))
4.3+
Form of Restricted Stock Unit Agreement (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on December 21, 2016 (File no. 001-37941))
4.4
Form of Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Amendment No. 1 to Registration Statement on Form S-1, filed with the SEC on November 16, 2017 (File no. 333-221433))
4.5
Form of Underwriter’s Warrant, as amended (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on November 21, 2017 (File no. 001-37941))
4.6
Form of Restricted Stock Unit Notice and Agreement (incorporated by reference to Exhibit 4.6 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 17, 2020 (File no. 001-37941))
4.7
Form of New Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 20, 2018 (File no. 001-37941))
4.8
Form of Warrant issued to investors in Rights Offering (incorporated by reference to Exhibit 4.1 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 14, 2018 (File no. 001-37941))
4.9
Form of Warrant issued to dealer-manager in Rights Offering (incorporated by reference to Exhibit 4.2 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 14, 2018 (File no. 001-37941))
4.10
Warrant Agency Agreement, dated August 13, 2018, between the Registrant and Transfer Online, Inc. (incorporated by reference to Exhibit 4.3 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 14, 2018 (File no. 001-37941))
4.11
Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on July 17, 2019 (File no. 001-37941))
4.12
Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on January 28, 2020 (File no. 001-37941))
4.13
Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on January 28, 2020 (File no. 001-37941))
4.14
Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on March 6, 2020 (File no. 001-37941))
4.15
Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on March 6, 2020 (File no. 001-37941))
4.16
Form of New Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on October 27, 2020 (File no. 001-37941))
4.17
Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on October 27, 2020 (File no. 001-37941))
4.18
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on February 2, 2021 (File no. 001-37941))
4.19
Form of Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on February 2, 2021 (File no. 001-37941))
4.20
Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K, filed with the SEC on February 2, 2021 (File no. 001-37941))
10.3+
SenesTech, Inc. 2018 Equity Incentive Plan, as amended, and forms of agreement thereunder (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020 (File no. 001-37941))
10.4+
Form of Indemnification Agreement (incorporated by reference to Exhibit 10.6 to the Registrant’s Registration Statement on Form S-1, filed with the SEC on September 21, 2016 (File no. 333-213736))
37
10.7+
Employment Letter Agreement
by and between the Registrant and Kenneth Siegel dated May 16, 2019 (incorporated by reference to Exhibit 10.1 to the Registrant’s
Current Report on Form 8-K, filed with the SEC on May 20, 2019 (File no. 001-37941))
10.8+
Employment Offer Letter
by and between the Registrant and Thomas Chesterman dated November 20, 2015 (incorporated by reference to Exhibit 10.9 to the Registrant’s
Registration Statement on Form S-1, filed with the SEC on September 21, 2016 (File no. 333-213736))
10.9+
Employment Letter Agreement
by and between the Registrant and Kim Wolin dated January 28, 2020 (incorporated by reference to Exhibit 10.7 to the Registrant’s
Registration Statement on Form S-1, filed with the SEC on February 13, 2020 (File no. 333-236302))
10.10+
Employment Letter Agreement
by and between the Registrant and Steven Krause, dated January 12, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s
Annual Report on Form 10-K/A, filed with the SEC on April 21, 2020 (File no. 001-37941))
10.11
Promissory Note, dated
April 15, 2020, by and between the Company and BMO Harris Bank National Association (incorporated by reference to Exhibit 10.1 to
the Registrant’s Current Report on Form 8-K, filed with the SEC on April 21, 2020 (File no. 001-37941))
10.14*
Lease by and between the Registrant and Pinnacle Campus Office-Retail, LLC, dated as of November 18, 2019
10.15
Standard Industrial/Commercial
Multi-Tenant Lease, between the Company and Duke Go PP, LLC, dated as of June 22, 2020 (incorporated by reference to Exhibit 10.4
to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020 (File no. 001-37941))
10.16
Form of Securities Purchase
Agreement (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on
July 17, 2019 (File no. 001-37941))
10.17
Form of Securities Purchase
Agreement (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on
January 28, 2020 (File no. 001-37941))
10.18
Form of Securities Purchase
Agreement (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on
March 6, 2020 (File no. 001-37941))
10.19
Form of Securities Purchase
Agreement (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on
April 24, 2020 (File no. 001-37941))
10.20
Form of Letter Agreement,
dated as of October 23, 2020, between the Company and the purchaser thereto (incorporated by reference to Exhibit 10.1 to the Registrant’s
Current Report on Form 8-K, filed with the SEC on October 27, 2020 (File no. 001-37941))
10.21
Form of Securities Purchase
Agreement, dated as of January 27, 2021 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form
8-K, filed with the SEC on February 2, 2021 (File no. 001-37941))
10.22
Form of Registration Rights
Agreement, dated as of January 27, 2021 (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form
8-K, filed with the SEC on February 2, 2021 (File no. 001-37941))
21.1*
List of Subsidiaries of the Registrant
23.1*
Consent of M&K CPAS, PLLC, independent registered public accounting firm
31.1*
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934
31.2*
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934
32.1*
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS *
Inline XBRL Instance Document
101.SCH *
Inline XBRL Taxonomy Extension Schema Document
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase
Document
101.LAB*
Inline XBRL Taxonomy Extension Labels Linkbase
Document
101.PRE *
Inline XBRL Taxonomy Extension Presentation Linkbase
Document
101.DEF *
Inline XBRL Taxonomy Extension Definition Linkbase
Document
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained
in Exhibit 101)
* Filed
herewith.
+ Indicates
a management contract or compensatory plan.
(c) Financial
Statement Schedules
None
Item 16. Form 10-K Summary.
Not applicable.
38
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SENESTECH, INC.
Date: March 29, 2022
By:
/s/
Kenneth Siegel
Kenneth
Siegel
Chief
Executive Officer
Date: March 29, 2022
By:
/s/
Thomas C. Chesterman
Thomas
C. Chesterman
Chief
Financial Officer and Treasurer
Pursuant to the requirements of the Securities
Exchange Act of 1934, this report has been signed below by the following persons on March 29, 2022, on behalf of the registrant and in
the capacities indicated.
Signature
Title
/s/ Kenneth Siegel
Chief Executive Officer
Kenneth Siegel
(Principal Executive Officer)
/s/ Thomas C. Chesterman
Chief Financial Officer and Treasurer
Thomas C. Chesterman
(Principal Financial and Accounting Officer)
/s/ Jamie Bechtel
Chair of the Board
Jamie Bechtel
/s/ Marc Dumont
Director
Marc Dumont
/s/ Delphine Francois Chiavarini
Director
Delphine Francois Chiavarini
/s/ Phil Grandinetti
Director
Phil Grandinetti
/s/ K.C. Kavanagh
Director
K.C. Kavanagh
/s/ Jake Leach
Director
Jake Leach
/s/ Matthew K. Szot
Director
Matthew K. Szot
39
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