PetVivo Holdings (PETV) risk factors, FY2025 10-K

Risks Relating to Our Financial Condition

1. 01We have incurred substantial losses to date and could continue to incur such losses
2. 02If we are unable to obtain sufficient funding, we may have to reduce materially or even discontinue our business

Risks Relating to Our Business and Industry

1. 03We have a limited operating history upon which to base an evaluation of our business prospects
2. 04We are substantially dependent upon the success of Spryng® and any failure of Spryng® to achieve market acceptance would harm us significantly
3. 05Our lead product, Spryng®, will face significant competition in our industry, and our failure to compete effectively may prevent us from achieving any significant market penetration
4. 06We will rely on third parties to conduct studies of our current and new products, and if these third parties do not successfully perform their contracted commitments effectively or substantially fail to meet expected study deadlines, we could be delayed from effectively commercializing our future products
5. 07Our operations rely on third parties to produce our raw materials to produce our products
6. 08If we experience the rapid commercial growth of Spryng®, we may not be able to manage such growth effectively
7. 09Our Distribution Agreements with Vedco and Clipper Distributing are important to our business and if we were to lose our Distribution Agreements it would adversely affect our revenues and profitability
8. 10If our current sales and marketing program is insufficient or inadequate to support the current introduction of our Spryng® product, we may not be able to sell this product in quantities to become commercially successful
9. 11Our business will depend significantly on the sufficiency and effectiveness of our marketing and product promotional programs and incentives
10. 12Any damage to our reputation or our brand may materially harm our business
11. 13If we fail to attract and retain qualified management and key scientific personnel, we may be unable to successfully commercialize our current products or develop new products effectively
12. 14Natural disasters and other events beyond our control could materially adversely affect us

Risks relating to Manufacturing

1. 15We may not be able to manage our manufacturing and supply chain effectively, which would harm our results of operations

Risks relating to our Intellectual Property

1. 16Failure to protect our intellectual property could harm our competitive position or cause us to incur significant expenses and personnel resources to enforce our rights
2. 17We may be subject to intellectual property infringement claims, which could result in substantial damages and diversion of the efforts and attention of our management

Risks related to Regulation

1. 18We may be unable to obtain required regulatory approvals for future products timely or at all, and the denial or substantial delay of any such approval could delay materially or even prevent our efforts to commercialize new products, which could adversely impact our ability to generate future revenues

Risks relating to our Information Technology

1. 19A failure of one or more key information technology systems, networks, or processes may harm our ability to conduct our business effectively

Risks Related to our Company

1. 20Ownership and control of our Company is concentrated in our management
2. 21The market price of our common stock has been volatile in the past and the market price of our common stock and our warrants is likely to be highly volatile in the future. You may not be able to resell shares of our common stock following periods of volatility because of the market’s adverse reaction to volatility
3. 22Our common stock has in the past been a “penny stock” under SEC rules, and if our common stock is deemed to be a “penny stock,” it will be more difficult to resell our securities
4. 23We are required to comply with certain provisions of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”) and if we fail to continue to comply, our business could be harmed, and the price of our securities could decline
5. 24The elimination of monetary liability against our directors and executive officers under Nevada law and the existence of indemnification rights held by them granted by our bylaws could result in substantial expenditures by us
6. 25Our Articles of Incorporation, Bylaws, and Nevada law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline