GTHP Guided Therapeutics Dashboard

Risks

• Although we will be required to raise additional funds in 2021, there is no assurance that such funds can be raised on terms that we would find acceptable, on a timely basis, or at all.
• If we cannot obtain additional funds when needed, we will not be able to implement our business plan.
• We do not have a long operating history, especially in the cancer detection field, which makes it difficult to evaluate our business.
• We have a history of losses, and we expect losses to continue.
• We file federal taxes that may be subject to audit and adjustments from time to time.
• We are currently delinquent with some of our federal payroll and unemployment taxes and applicable state payroll and unemployment tax filings
• We have received Paycheck Protection Program (PPP) loans and must retain PPP loan documentation
• Our ability to sell our products is controlled by government regulations, and we may not be able to obtain any necessary clearances or approvals.
• In foreign countries, including European countries, we are subject to government regulation, which could delay or prevent our ability to sell our products in those jurisdictions.
• In the United States, we are subject to regulation by the U.S. FDA, which could prevent us from selling our products domestically.
• Even if we obtain clearance or approval to sell our products, we are subject to ongoing requirements and inspections that could lead to the restriction, suspension or revocation of our clearance.
• We depend on a limited number of distributors and any reduction, delay or cancellation of an order from these distributors or the loss of any of these distributors could cause our revenue to decline.
• To successfully market and sell our products internationally, we must address many issues with which we have limited experience.
• To market and sell LuViva internationally, we depend on distributors and they may not be successful.
• The coronavirus outbreak could adversely impact our business.
• Our success largely depends on our ability to maintain and protect the proprietary information on which we base our products.
• We may be unable to commercialize our products if we are unable to protect our proprietary rights, and we may be liable for significant costs and damages if we face a claim of intellectual property infringement by a third party.
• We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming.
• We may not be able to generate sufficient sales revenues to sustain our growth and strategy plans.
• Because our products, which use different technology or apply technology in different ways than other medical devices, are or will be new to the market, we may not be successful in launching our products and our operations and growth would be adversely affected.
• If we are unable to compete effectively in the highly competitive medical device industry, our future growth and operating results will suffer.
• We have limited manufacturing experience, which could limit our growth.
• Since we rely on sole source suppliers for several of the components used in our products, any failure of those suppliers to perform would hurt our operations.
• Because we operate in an industry with significant product liability risk, and we have not specifically insured against this risk, we may be subject to substantial claims against our products.
• The availability of third party reimbursement for our products is uncertain, which may limit consumer use and the market for our products.
• We have a substantial amount of indebtedness, which may adversely affect our cash flow and our ability to operate our business.
• We have outstanding debt that is collateralized by a general security interest in all of our assets, including our intellectual property. If we were to fail to repay the debt when due, the holders would have the right to foreclose on these assets.
• We are subject to restrictive covenants under the terms of our outstanding secured debt. If we were to default under the terms of these covenants, the holders would have the right to foreclose on the assets that secure the debt.
• Our success depends on our ability to attract and retain scientific, technical, managerial and finance personnel.
• Certain provisions of our certificate of incorporation that authorize the issuance of additional shares of preferred stock may make it more difficult for a third party to effect a change in control.
• On March 29, 2019, a 1:800 reverse stock split of all of our issued and outstanding common stock was implemented. There are risks associated with a reverse stock split.
• The reverse stock split may decrease the liquidity of the shares of our common stock.
• Following the reverse stock split, the resulting market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.
• The number of shares of our common stock issuable upon the conversion of our outstanding convertible debt and preferred stock or exercise of outstanding warrants and options is substantial.
• Adjustments to the conversion price of our convertible debt and preferred stock, and the exercise price for certain of our warrants, will dilute the ownership interests of our existing stockholders.
• Our stock is thinly traded, so you may be unable to sell at or near ask prices or at all.
• Trading in our common stock is subject to special sales practices and may be difficult to sell.
• Our need to raise additional capital in the near future or to use our equity securities for payments could have a dilutive effect on your investment.