Below is a summary of the principal factors that make an investment in our common stock speculative. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with the other information in this Annual Report and our other filings with the Securities and Exchange Commission (the “SEC”), before making investment decisions regarding our common stock.
| · | We need to obtain substantial additional funding to complete the development and any commercialization of AL001 and ALZN002. If we are unable to raise this capital when needed, we may be forced to delay, reduce or eliminate our research and development programs and/or other operations. |
| · | We are at an early stage of clinical development and currently have no source of near-term revenue and may never become profitable. |
| · | We have both operational and financial milestones that must be met to maintain the licensing rights to our current technology and intellectual property from the University of South Florida Research Foundation. |
| · | If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with the University of South Florida Research Foundation, we could lose license rights that are important to our business. |
| · | We are substantially dependent on the success of our product candidates, which may not receive regulatory approval or be successfully commercialized. |
| · | Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of AL001 or ALZN002, or limit the scope of any approved label or market acceptance. |
| · | Development and regulatory approval of our drug candidates present a number of risks, which are delineated in the “Risk Factors” section, below. |
| · | We rely on third parties to conduct our preclinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our medicines and drug candidates and our business could be substantially harmed. |
| · | If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop AL001, ALZN002 or any future product candidates, conduct our in-licensing and development efforts or commercialize AL001, ALZN002 or any of our future product candidates. |
| · | Our intellectual property rights present a number of risks. |
| · | If we are unable to regain compliance with, or thereafter maintain compliance with, the continued listing requirements of The Nasdaq Capital Market, our common stock could be delisted, which would adversely affect our common stock’s market price and liquidity and reduce our ability to raise capital. |
| · | The market price of our common stock is volatile, which could result in substantial losses for investors. |
| · | We have identified a material weakness in our internal control over financial reporting. If our remediation of this material weakness is not effective, or if we experience additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock. |
Part I
