Creative Medical Technology Holdings (CELZ) risk factors, FY2025 10-K

Risks Related to our Financial Position and Capital Needs

1. 01We have incurred recent losses and our future profitability is uncertain32% rewritten
2. 02Even with the proceeds from our securities offerings, we will need additional capital to fund our operations as planned33% rewritten
3. 03We expect to continue to incur significant financial losses in the future as we proceed with our Type I Diabetes (CELZ-201 CREATE-1) clinical trial, our AlloStemSpine ® Chronic Lower Back Pain (CELZ-201 ADAPT) clinical trial, and our other planned clinical trials

Risks Related to Product Development, Regulatory Approval and Commercialization

1. 04We may not be successful in our commercialization efforts for our proposed products and therapies, which may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success
2. 05The results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects
3. 06We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals
4. 07Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results
5. 08problems with investigator or patient compliance with the trial protocols
6. 09Our autologous products are currently not eligible for reimbursement from public or private insurers
7. 10The pharmaceutical business is subject to increasing government regulation and reform, including with respect to price controls, reimbursement, and access to therapies, which could adversely affect our future revenues and profitability
8. 11United States federal and state privacy laws, and equivalent laws of other nations, may increase our costs of operation and expose us to civil and criminal sanctions
9. 12Later discovery of previously unknown problems could limit our ability to market or sell our products or therapies and can expose us to product liability claims
10. 13If we do not obtain required approvals in other countries in which we aim to market our products, we will be limited in our ability to export or sell the products in those markets
11. 14We rely in part on third parties for research and clinical trials for our products and therapies
12. 15We rely upon third parties for the manufacture of our CaverStem ® and FemCelz ® disposable kits and are dependent on their quality and effectiveness
13. 16We may be unable to compete effectively with marketed therapies or drugs targeting similar indications to our products and therapies
14. 17Our business and operations would suffer in the event of computer system failures or security breaches
15. 18We are subject to risks arising from the global outbreak of the COVID-19 coronavirus
16. 19We are subject to risks arising from the wars in Ukraine and the Gaza Strip

Risks Related to Our Intellectual Property

1. 20We may not be able to protect our proprietary rights
2. 21We are susceptible to intellectual property suits that could cause us to incur substantial costs or pay substantial damages or prohibit us from selling our product candidates
3. 22We may need to initiate lawsuits to protect or enforce our intellectual property rights, which could be expensive and, if we lose, could cause us to lose some of our intellectual property rights, which would harm our ability to compete in the market

Risks Related to Employee Matters

1. 23We are dependent on our executive officers, and we may not be able to pursue our current business strategy effectively if we lose them
2. 24Our employees, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards

Risks Related To Our Common Stock

1. 25The market price of our common stock is highly volatile, and you could lose all or part of your investment
2. 26general economic or political conditions in the United States or elsewhere
3. 27If our shares of common stock are delisted from The Nasdaq Capital Market and become subject to the penny stock rules, it will be more difficult to trade our shares
4. 28Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our securities
5. 29We will indemnify and hold harmless our officers and directors to the maximum extent permitted by Nevada law
6. 30Because we do not expect to pay dividends for the foreseeable future, investors seeking cash dividends should not purchase shares of common stock