Cryo Cell International (CCEL) risk factors, FY2024 10-K

Risk Related to our Business

1. 01There is uncertainty with regard to whether we will be able to maximize shareholder value through the completion of a strategic transaction or successfully spinoff Celle Corp
2. 02If we fail to meet any of the continued listing standards of the NYSE, our common stock could be delisted from the exchange. These continued listing standards include specifically enumerated criteria, including compliance with the NYSE's corporate governance requirements
3. 03We may need to raise additional capital
4. 04We may not be able to successfully grow or operate our business
5. 05The Company’s operations and performance depend significantly on global and regional economic conditions
6. 06Because our industry is subject to rapid technological and therapeutic changes and new developments, our future success will depend on the continued viability of the use of stem cells
7. 07If our umbilical cord blood stem cell storage services do not achieve continued market acceptance, we will not be able to generate revenue necessary to support our business
8. 08We may fail to successfully manufacture MSCs
9. 09Clinical development is lengthy and uncertain
10. 10Our product candidates are subject to substantial government regulation, including the regulation of nonclinical testing and clinical trials. If we are unable to obtain regulatory approval for our product candidates, our ability to generate revenues related to such product candidate will be negatively impacted
11. 11lack of adequate funding to continue the clinical trial
12. 12The stem cell preservation market is increasingly competitive
13. 13A failure in the performance of our cryopreservation storage facility or systems, or those of Duke could harm our business and reputation
14. 14Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel
15. 15There is uncertainty with regard to the outcome of the Duke Arbitration Demand
16. 16There is uncertainty with regard to whether we will be able to maximize shareholder value through the Duke License Agreement
17. 17We are not assured of recouping our damages related to the Arbitration Demand against Duke nor our investment in the Duke License Agreement
18. 18From time to time, the Company is subject to proceedings, lawsuits, contract disputes and other claims in the normal course of its business

Risk Related to Government Regulation

1. 19If we do not obtain and maintain necessary domestic regulatory registrations, approvals and comply with ongoing regulations, we may not be able to market our services in the United States
2. 20The final rule allows the FDA to inspect cord blood laboratories to determine compliance with the provisions of 21 CFR Part 1271. As part of this oversight authority, the FDA conducts unannounced inspections of cord blood banks
3. 21Evolving legislation and regulations governing private cord blood banking in various jurisdictions throughout the world may impact the Company’s international licensees
4. 22We may be required to spend substantial amounts to comply with legislative and regulatory initiatives relating to patient privacy
5. 23Our failure to comply with laws related to hazardous materials could materially harm us

Risks Related to International Operations

1. 24Our international operations are subject to risk and we may not be able to successfully protect our intellectual property
2. 25We are subject to the Foreign Corrupt Practices Act
3. 26The Company’s business may be impacted by political events, international trade disputes, war, terrorism, natural disasters, public health issues, industrial accidents and other business interruptions

Risks Related to Information Technology

1. 27Our information systems are critical to our business, and a failure of those systems could materially harm us
2. 28If we experience a significant breach of data security or disruption in our information systems, our business could be adversely affected
3. 29or any significant breach of our data security could have an adverse effect on our business and may materially adversely affect our operating results and financial condition
4. 30Increasing use of social media could give rise to liability, breaches of data security, or reputational damage
5. 31Some of our products contain open source software, which may pose particular risks to our proprietary software, technologies, products and services in a manner that could harm our business

Risks Related to Intellectual Property

1. 32We may not be able to protect our intellectual property rights throughout the world
2. 33We may become subject to third parties’ claims alleging infringement of their patents and proprietary rights, which could be costly, time consuming, and prevent the use of our technology solution

Risks Related to being a Public Company

1. 34We incur significant costs and demands as a result of operating as a public company
2. 35If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock
3. 36Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
4. 37Increasing scrutiny and changing expectations from investors, customers, and governments with respect to Environmental, Social and Governance (“ESG”) policies and practices may cause us to incur additional costs or expose us to additional risks
5. 38significant control over matters subject to stockholder approval
6. 39We may become subject to securities class action litigation, which can be expensive, divert management attention, and, if resolved unfavorably, expose us to significant liabilities
7. 40We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors
8. 41We are responsible for the indemnification of our officers and directors
9. 42Certain provision of our charter, bylaws and Delaware law may delay, defer or prevent a tender offer or takeover attempt that public stockholders might consider in their best interest