SenesTech (SNES) risk factors, FY2024 10-K

Risks Related to our Business

1. 01Our success is dependent on the successful commercialization of ContraPest and Evolve
2. 02ContraPest, Evolve, and our other product candidates may not achieve adequate market acceptance necessary for commercial success
3. 03If we cannot successfully commercialize our products, especially ContraPest and Evolve, we will not become profitable
4. 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
5. 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 any revenue
6. 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
7. 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 marktets

Risks Related to Regulatory Matters

1. 08Regulatory 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
2. 09Even 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
3. 10Any 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
4. 11Even following receipt of any regulatory approval or introduction of products or product candidates, we will continue to be subject to regulation of our manufacturing processes and advertising practices
5. 12Failure to obtain regulatory approval in foreign jurisdictions would prevent our products or product candidates from being marketed in those jurisdictions

Risks Related to our Operations and Supply Chain

1. 13We 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
2. 14We 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
3. 15We will need to expand our operations and grow the size of our organization, and we may experience difficulties in managing this growth
4. 16Business 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
5. 17We are dependent on triptolide, a key ingredient for ContraPest, which has limited sources and must be in a very refined condition
6. 18A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business

Risks Related to Our Intellectual Property and Legal Actions

1. 19If we fail to obtain or protect intellectual property rights, our competitive position could be harmed
2. 20Intellectual property rights do not necessarily address all potential threats to any competitive advantage we may have
3. 21Our technology may be found to infringe third party intellectual property rights
4. 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
5. 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 results
6. 24Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop

Risks Related to our Reporting and Cybersecurity

1. 25report 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
2. 26A 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
3. 27Privacy 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

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

1. 28We have incurred significant operating losses every quarter since our inception and anticipate that we will continue to incur significant operating losses in the future
2. 29If we are unable to continue as a going concern, our securities will have little or no value
3. 30We may not be able to comply with all applicable listing requirements or standards of The Nasdaq, and Nasdaq could delist our common stock
4. 31per share or more for a minimum of 10 consecutive business days at any time before the expiration of the second compliance period
5. 32Our reverse stock splits may decrease the liquidity of the shares of our common stock
6. 33Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
7. 34Our share price is volatile, which could subject us to securities class action litigation and your investment in our securities could decline in value
8. 35Future 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
9. 36An active market in the shares may not continue to develop in which investors can resell our common stock
10. 37If 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
11. 38Our corporate documents, Delaware law and certain warrants contain provisions that could discourage, delay or prevent a change in control of our company