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 42 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 AG (“Proteomedix”) acquisitions commensurate with the ownership dilution they have experienced in connection with the transactions. |
| ● | We may fail or elect not to commercialize our products. |
| ● | Disruptions to or significantly increased costs associated with transportation and other distribution channels for ENTADFI and/or Proclarix may adversely affect our margins and profitability. |
| ● | ENTADFI is subject to competition from other benign prostatic hyperplasia (“BPH”) drugs and larger, well-established companies with substantially greater resources than us. |
| ● | 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 ENTADFI in the U.S. market and Proclarix in the European market, or, if authorized, grow sales of either in any other 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 limited number of products. If we do not successfully commercialize one or more of our products or we experience significant delays in doing so, these products 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 products. |
| ● | We expect to rely on third party manufacturers for ENTADFI and Proclarix. |
| ● | Legislation, such as the Inflation Reduction Act, may impact our ability to market and commercialize ENTADFI and reduce our profitability from such asset. |
| ● | 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 products, others could compete against us more directly, which would harm our business, possibly materially. |
| ● | If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected. |
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| ● | Healthcare reform in the United States has been implemented in the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare industry. Violations of healthcare laws can have an adverse impact on our ability to advance ENTADFI and our operating results. |
| ● | 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. |
| ● | The Committee on Foreign Investment in the United States (“CFIUS”) may delay, prevent or impose conditions on the Conversion (as defined below) of newly issued shares of preferred stock of the Company, par value $0.00001 per share (“Series B Preferred Stock”), or may later review the Conversion and impose civil penalties or recommend to the President of the United States that other remedial actions be taken if CFIUS determines there are unresolved national security concerns. |
| ● | There can be no assurance that we will be able to comply with the continued listings of 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 entered into an asset purchase agreement and management services agreement with WraSer LLC, a Mississippi limited liability company (“WraSer”), which we have terminated because we believe that a material adverse event has occurred with respect to the six FDA-pharmaceutical assets across several indications, including cardiology, otic infections, and pain management we acquired from WraSer (the “WraSer Assets”). However, the termination is subject to WraSer’s right to challenge the termination and assert claims against us. |
| ● | 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. |
| ● | As a result of our failure to timely file our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, we are currently ineligible to file new short form registration statements on Form S-3, which may impair our ability to raise capital on terms favorable to us, in a timely manner or at all. |
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