This prospectus contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Exchange Act. Forward-looking statements can be identified by words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” “project,” “goal,” “strategy,” “future,” “likely,” “may,” “should,” “will” and variations of these words and similar references to future periods, although not all forward-looking statements contain these identifying words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties, and changes in circumstances, including but not limited to risk factors included in this prospectus and other factors described elsewhere in this prospectus or in our current and future filings with the Securities and Exchange Commission (the “SEC”). As a result, our actual results may differ materially from those expressed or forecasted in the forward-looking statements, and you should not rely on such forward-looking statements. You should carefully read this prospectus completely and with the understanding that our actual future results may be materially different from what we expect. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Forward-looking statements include, but are not limited to, statements about:
| ● | our lack of significant revenue to date, our history of recurring operating losses and our expectation of future operating losses; |
| ● | our need for substantial additional capital and our need to delay, reduce or eliminate our drug development and commercialization efforts if we are unable to raise additional capital; |
| ● | the highly-competitive nature of the pharmaceutical and biotechnology industry and our ability to compete effectively; |
| ● | the success of our plans to use collaboration arrangements to leverage our capabilities; |
| ● | our ability to retain and attract key personnel; |
| ● | the risk of misconduct of our employees, agents, consultants and commercial partners; |
| ● | disruptions to our operations due to expansions of our operations; |
| ● | the costs we would incur if we acquire or license technologies, resources or drug candidates; |
| ● | risks associated with product liability claims; |
| ● | our reliance on information technology systems and the liability or interruption associated with cyber-attacks or other breaches of our systems; |
| ● | our ability to use net operating loss carryforwards; |
| ● | provisions in our charter documents and state law that may prevent a change in control; |
| ● | work slowdown or stoppage at government agencies could negatively impact our business; |
| ● | the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith; |
| ● | our need to complete extensive clinical trials and the risk that we may not be able to demonstrate the safety and efficacy of our drug candidates; |
| ● | risks that that our clinical trials may be delayed or terminated; |
| ● | our ability to obtain domestic and/or foreign regulatory approval for our drug candidates; |
| ● | changes in existing laws and regulations affecting the healthcare industry; |
| ● | our reliance on third parties to conduct clinical trials for our drug candidates; |
| ● | our ability to maintain orphan drug exclusivity for our drug candidates; |
| ● | our reliance on third parties for manufacturing our clinical drug supplies; |
| ● | risks associated with the manufacture of our drug candidates; |
| ● | our ability to establish sales and marketing capabilities relating to our drug candidates; |
| ● | market acceptance of our drug candidates; |
| ● | third-party payor reimbursement practices; |
| ● | our ability to adequately protect the intellectual property of our drug candidates; |
| ● | infringement on the intellectual property rights of third parties; |
| ● | costs and time relating to litigation regarding intellectual property rights; |
| ● | our ability to adequately prevent disclosure by our employees or others of trade secrets and other proprietary information; |
| ● | our need to raise additional capital; |
| ● | our common stock being thinly traded; |
| ● | our ability to issue shares of common or preferred stock without approval from our stockholders; |
| ● | our ability to pay cash dividends; |
| ● | costs and expenses associated with being a public company; |
| ● | our ability to maintain effective internal controls over financial reporting; and |
| ● | our ability to regain and maintain compliance with the listing standards of the Nasdaq Capital Market. |
Any forward-looking statement made by us in this prospectus is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise. However, you should carefully review the risk factors set forth in other reports or documents we file from time to time with the SEC.
