The following is a summary of certain risks, uncertainties and other factors related to our company. These do not represent all of the risks we face. You should carefully consider all of the risk factors presented in “Item 1A. Risk Factors” and all other information contained in this Report including the financial statements in order to provide a more complete picture of the risk factors we face.
Our business is subject to a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial condition, results of operations, cash flows and prospects that you should consider before making a decision to invest in our common stock. These risks are discussed more fully in “Risk Factors” beginning on page 28 of this Report. These risks include, but are not limited to, the following:
| ● | Company shareholders may not realize a benefit from the ENTADFI or Proteomedix (“Proteomedix”) acquisitions commensurate with the ownership dilution they have experienced in connection with the transactions. |
| ● | We may fail or elect not to commercialize our product. |
| ● | Disruptions to or significantly increased costs associated with transportation and other distribution channels for Proclarix may adversely affect our margins and profitability. |
| ● | Proclarix is subject to competition from other prostate cancer diagnostics and larger, well-established companies with substantially greater resources than us. |
| ● | We may not be able to successfully implement our strategy to grow sales of Proclarix in the European market or other markets, if authorized, grow sales in the United States market. |
| ● | We have a limited operating history, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability. |
| ● | We have incurred significant net losses since inception, have only generated minimal revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve or maintain profitability. Our stock is a highly speculative investment. |
| ● | We depend entirely on the success of a single product. If we do not successfully commercialize our product or we experience significant delays in doing so, this product may not be profitable. |
| ● | There is substantial doubt about our ability to continue as a “going concern,” and we will require significant additional capital to make the investments we need to execute our business plan. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate commercialization efforts or certain operations, and we may be unable to continue as a going concern in the long term. If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in us. |
| ● | We may not be able to gain and retain market acceptance for our product. |
| ● | We expect to rely on third party manufacturers for Proclarix. |
| ● | It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position does not adequately protect our product, others could compete against us more directly, which would harm our business, possibly materially. |
| ● | The market price of our common stock has been extremely volatile and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their investment. |
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| ● | There can be no assurance that we will be able to comply with the continued listing requirements of, and remain trading on, the Nasdaq Stock Market, LLC (“Nasdaq”). |
| ● | We are an “emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors. |
| ● | Our amended and restated certificate of incorporation (“Amended and Restated Certificate of Incorporation”) and our amended and restated bylaws (“Amended and Restated Bylaws”), and Delaware law may have anti-takeover effects that could discourage, delay, or prevent a change in control, which may cause our stock price to decline. |
| ● | A possible “short squeeze” due to a sudden increase in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock. |
| ● | We may have violated Section 13(k) of the Exchange Act of 1934, as amended (“Exchange Act”) (implementing Section 402 of the Sarbanes-Oxley Act of 2002) and may be subject to sanctions as a result. |
| ● | Misconduct and errors by our current and former employees and our third-party service providers could cause a material adverse effect on our business and reputation. |
| ● | We may consider strategic alternatives in order to maximize stockholder value, including financing, strategic alliances, licensing arrangements, acquisitions or the possible sale of our business. We may not be able to identify or consummate any suitable strategic alternatives and any consummated strategic alternatives may not be successful. |
| ● | If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired. We have identified weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated, or that additional material weaknesses will not occur in the future. |
| ● | The issuance or conversion of securities would result in significant dilution in the equity interest of existing shareholders and adversely affect the marketplace of the securities. |
| ● | If completed, the Ocuvex Business Combination may not achieve its intended results and may result in us assuming unanticipated liabilities. |
| ● | The transactions contemplated by the Ocuvex LOI are subject to conditions that may not be satisfied on a timely basis or at all. Failure to complete the transactions contemplated by the Ocuvex LOI could have material and adverse effects on us. |
| ● | We will be subject to business uncertainties while the Ocuvex Business Combination is pending, which could adversely affect our business. |
| ● | We expect to incur significant transaction costs in connection with the Ocuvex Business Combination. |
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