SenesTech (SNES) FY2025 10-K Risk Factors: 3 New, 8 Dropped

What the changes say

New risks cover indirect-tax liabilities, uninsured disruptions, third-party ingredients, and competitors using similar or superior technology.

What changed since the prior 10-K

New

NewRisks Related to our Business
We could be required to collect additional sales, value added or similar taxes or be subject to other tax liabilities that may increase the costs our clients would have to pay for our products and adversely affect our results of operations
States or foreign jurisdictions could require additional indirect-tax collection, including taxes on past sales, penalties, and interest, raising client costs and reducing sales.
NewRisks Related to our Operations and Supply Chain
Business or supply chain disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses
Power, weather, epidemics, disasters, or supplier failures could disrupt operations; the company is predominantly self-insured and relies on third parties for critical ingredients.
NewRisks Related to Our Intellectual Property and Legal Actions
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
Competitors could commercialize similar or superior products, while challenged, narrowed, or invalid patents may limit the company’s ability to block them.

Dropped

DroppedRisks Related to our Operations and Supply Chain
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
DroppedRisks Related to our Operations and Supply Chain
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 for ContraPest is currently sourced from China
DroppedRisks Related to our Operations and Supply Chain
We are dependent on triptolide, a key ingredient for ContraPest, which has limited sources and must be in a very refined condition
DroppedRisks Related to our Reporting and Cybersecurity
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
DroppedRisks Related to our Capital Stock, Funding and Trading in our Stock
If we are unable to continue as a going concern, our securities will have little or no value
DroppedRisks Related to our Capital Stock, Funding and Trading in our Stock
per share or more for a minimum of 10 consecutive business days at any time before the expiration of the second compliance period
DroppedRisks Related to our Capital Stock, Funding and Trading in our Stock
Our reverse stock splits may decrease the liquidity of the shares of our common stock
DroppedRisks Related to our Capital Stock, Funding and Trading in our Stock
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

Reworded

97% rewrittenRisks Related to our Capital Stock, Funding, and Trading in our Stock
We may not be able to comply with all applicable listing requirements or standards of Nasdaq, and Nasdaq could delist our common stock
The risk now emphasizes that failing Nasdaq requirements could cause delisting, over-the-counter trading, and a decline in common-stock value.
Was: We may not be able to comply with all applicable listing requirements or standards of The Nasdaq, and Nasdaq could delist our common stock
79% rewrittenRisks Related to our Reporting and Cybersecurity
Privacy breaches and other cybersecurity risks related to our business and vulnerabilities through the use of evolving tools such as Artificial Intelligence could negatively affect our reputation, credibility, and business
The risk expands from e-commerce customer data to business, customer, and employee information, including confidential data and third-party processing.
Was: Privacy breaches and other cyber security risks related to our business and vulnerabilities through the use of evolving tools such as Artificial Intelligence could negatively affect our reputation, credibility and business
64% rewrittenRisks Related to our Business
Our success is dependent on the successful commercialization of ContraPest and Evolve
Evolve Rat is authorized in 48 states and territories, while Evolve Mouse is authorized in 37; international commercialization remains limited by low sales.
53% rewrittenRisks Related to Our Intellectual Property and Legal Actions
If we fail to obtain or protect intellectual property rights, our competitive position could be harmed
No substantive change is apparent; the risk still concerns limited protection from patents, trade secrets, copyrights, trademarks, and related agreements.
52% rewrittenRisks 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
No substantive change is apparent; the risk still concerns losing key managerial, sales, research, development, or other personnel.
44% rewrittenRisks Related to our Business
We are currently operating in a period of economic uncertainty, which has been significantly impacted by geopolitical instability, inflation, increases in interest rates, and other disruptions in credit and financial markets
The risk now highlights military conflicts and geopolitical tensions and specifically states that foreign-sourced materials may face U.S. tariffs.
Was: We are currently operating in a period of economic uncertainty, which has been significantly impacted by geopolitical instability, inflation, increases in interest rates, and other disruptions in credit and financial marktets
40% rewrittenRisks Related to our Operations and Supply Chain
A variety of risks associated with marketing our products and product candidates internationally could materially adversely affect our business
The company has begun marketing Evolve internationally through distributors, making foreign regulatory, tariff, tax, currency, and operating risks more immediate.
Was: A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business
39% rewrittenRisks Related to Regulatory Matters
Regulatory approval processes of the EPA, state 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 wording removes the approximate two-year EPA review reference and broadens the risk to regulatory authorities generally, while retaining approval uncertainties.
Was: 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
38% rewrittenRisks Related to our Business
ContraPest, Evolve, and our other product candidates may not achieve adequate market acceptance necessary for commercial success
34% rewrittenRisks Related to Our Intellectual Property and Legal Actions
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
30% rewrittenRisks Related to Regulatory Matters
Even following receipt of any regulatory approval for ContraPest, Evolve, and our other product candidates, requiring regulatory approval, we will continue to face extensive regulatory requirements and our products may face future development and regulatory difficulties
30% rewrittenRisks Related to our Capital Stock, Funding, and Trading in our Stock
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
27% rewrittenRisks Related to Regulatory Matters
Failure to obtain regulatory approval in foreign jurisdictions would prevent our products or product candidates from being marketed in those jurisdictions
27% rewrittenRisks 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
26% rewrittenRisks Related to our Reporting and Cybersecurity
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
22% rewrittenRisks Related to our Capital Stock, Funding, and Trading in our Stock
Our corporate documents, Delaware law and certain warrants contain provisions that could discourage, delay or prevent a change in control of our company
21% rewrittenRisks Related to our Business
If we cannot successfully commercialize our products, especially ContraPest and Evolve, we will not become profitable

All 33 risk factors

Headings as the filing states them, in filing order.

Risks Related to our Business

01Our success is dependent on the successful commercialization of ContraPest and Evolve64% rewritten
02ContraPest, Evolve, and our other product candidates may not achieve adequate market acceptance necessary for commercial success38% rewritten
03If we cannot successfully commercialize our products, especially ContraPest and Evolve, we will not become profitable21% rewritten
04We 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
05If 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 sufficient revenues to become profitable
06The misuse of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business
07We are currently operating in a period of economic uncertainty, which has been significantly impacted by geopolitical instability, inflation, increases in interest rates, and other disruptions in credit and financial markets44% rewritten
08We could be required to collect additional sales, value added or similar taxes or be subject to other tax liabilities that may increase the costs our clients would have to pay for our products and adversely affect our results of operationsNew

Risks Related to Regulatory Matters

09Regulatory approval processes of the EPA, state 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 fail39% rewritten
10Even following receipt of any regulatory approval for ContraPest, Evolve, and our other product candidates, requiring regulatory approval, we will continue to face extensive regulatory requirements and our products may face future development and regulatory difficulties30% rewritten
11Any of these events could prevent us from achieving or maintaining market acceptance of the particular product or product candidate, if approved, and could significantly harm our business, results of operations and prospects
12Even after receiving any regulatory approval or introducing products or product candidates, we will continue to be subject to regulation of our manufacturing processes and advertising practices
13Failure to obtain regulatory approval in foreign jurisdictions would prevent our products or product candidates from being marketed in those jurisdictions27% rewritten

Risks Related to our Operations and Supply Chain

14We 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 harmed52% rewritten
15We will need to expand our operations and grow our organization, and we may experience difficulties in managing this growth
16Business or supply chain disruptions could seriously harm our future revenues and financial condition and increase our costs and expensesNew
17A variety of risks associated with marketing our products and product candidates internationally could materially adversely affect our business40% rewritten

Risks Related to Our Intellectual Property and Legal Actions

18If we fail to obtain or protect intellectual property rights, our competitive position could be harmed53% rewritten
19competitors 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 affectedNew
20Intellectual property rights do not necessarily address all potential threats to any competitive advantage we may have
21Our technology may be found to infringe third-party intellectual property rights
22We 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
23We 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 results34% rewritten
24Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop

Risks Related to our Reporting and Cybersecurity

25A 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 basis26% rewritten
26Privacy breaches and other cybersecurity risks related to our business and vulnerabilities through the use of evolving tools such as Artificial Intelligence could negatively affect our reputation, credibility, and business79% rewritten

Risks Related to our Capital Stock, Funding, and Trading in our Stock

27We have incurred significant operating losses every quarter since our inception and anticipate that we will continue to incur significant operating losses in the future27% rewritten
28We may not be able to comply with all applicable listing requirements or standards of Nasdaq, and Nasdaq could delist our common stock97% rewritten
29Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates30% rewritten
30Our stock price is volatile, which could subject us to securities class action litigation, and your investment in our securities could decline in value
31An active market for our shares of common stock may not continue to develop
32If 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
33Our corporate documents, Delaware law and certain warrants contain provisions that could discourage, delay or prevent a change in control of our company22% rewritten

Other SenesTech 10-Ks

FY2024 10-K risk factors
38 risks
SenesTech faces heavy going concern risks, relying on ongoing external capital raises to commercialize ContraPest and Evolve. The company depends heavily on single-source triptolide from China and maintains limited internal manufacturing capacity. Nasdaq listing compliance and historical operating losses dominate the financial risk profile.
Filed Mar 13, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.