▸ Currently, our neuroscience pipeline includes five clinical-stage intranasal pherine product candidates and AV-101. We seek to maintain a process of prioritization and optimal capital allocation to maintain an appropriate balance between the· · · · ● 1 ▸ If any of our product candidates are regulated as controlled substances, depending on the DEA controlled substance schedule in which the product candidates are placed or that of its foreign counterpart, we, our CDMOs, and any future· · · · ● 1 ▸ Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to management, recorded, processed,· · · · ● 1 ▸ Our success depends, and will likely continue to depend, upon our ability to retain the services of our executive officers, key senior managerial and other key senior personnel within our organization. Our executive officers and other senior· · · · ● 1 ▸ We may not realize the expected benefits from our workforce reduction and we may incur additional costs implementing it or other difficulties.· · · · ● 1 ▸ Additional laws and regulations governing international operations could negatively impact or restrict our operations.· · ● ● ● 3 ▸ Any failure by one or more of our product candidates that obtains regulatory approval to achieve market acceptance or commercial success would adversely affect our business prospects.· · ● ● ● 3 ▸ Because of potential volatility in our trading price and trading volume, we may incur significant costs from litigation, including class action securities litigation.· · ● ● ● 3 rw ▸ Because we have no current plans to pay cash dividends on our common stock, you may not receive any return on investment unless you sell your common stock for a price greater than that which you paid for it.· · ● ● ● 3 ▸ Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.· · ● ● ● 3 ▸ Changes in tax law could adversely affect our business and financial condition.· · ● ● ● 3 ▸ Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, if approved, which could make it difficult for us to sell any product candidates profitably.· · ● ● ● 3 ▸ Failure of any third-party CDMO to comply with cGMP requirements for applicable drug/device combination products could significantly affect supplies of our product candidates.· · ● ● ● 3 rw ▸ Future offerings of debt or equity securities by us may adversely affect the market price of our common stock.· · ● ● ● 3 ▸ Healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.· · ● ● ● 3 rw ▸ If our clinical trials fail to replicate results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidates.· · ● ● ● 3 ▸ If we are unable to develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing our product candidates.· · ● ● ● 3 ▸ If we are unsuccessful in identifying and developing additional product candidates, either through internal development or licensing or acquisition from third parties, our potential for growth and achieving our strategic objectives may be impaired.· · ● ● ● 3 ▸ If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.· · ● ● ● 3 ▸ If we fail to achieve announced milestones in the timeframes we expect, the development and commercialization of our product candidates may be delayed, and our business and results of operations may be significantly harmed.· · ● ● ● 3 rw ▸ If we fail to develop and commercialize other product candidates, we may be unable to grow our business and our ability to achieve our strategic objectives would be impaired.· · ● ● ● 3 ▸ Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.· · ● ● ● 3 ▸ Off-label use or misuse of our product candidates may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits.· · ● ● ● 3 ▸ Our clinical development activities could be materially delayed or otherwise adversely affected by difficulties enrolling and randomizing patients in our clinical trials.· · ● ● ● 3 rw ▸ Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.· · ● ● ● 3 ▸ Our issuance of additional capital stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will significantly dilute all other stockholders.· · ● ● ● 3 rw ▸ Product liability lawsuits against us or any of our future collaborators could divert our resources and attention, cause us to incur substantial liabilities and limit commercialization of our product candidates.· · ● ● ● 3 ▸ Raising additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish significant rights to our technologies or product candidates.· · ● ● ● 3 rw ▸ Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common stock.· · ● ● ● 3 ▸ group Risks Related to Government Regulation· · ● ● ● 3 ▸ group Risks Related to Managing Our Business and Operations· · ● ● ● 3 ▸ group Risks Related to Our Business· · ● ● ● 3 ▸ group Risks Related to Our Dependence on Third Parties· · ● ● ● 3 ▸ The FDA or comparable foreign regulatory authorities may disagree with our regulatory plan for the development and potential approval of our product candidates.· · ● ● ● 3 rw ▸ The successful development of pharmaceutical products is highly uncertain.· · ● ● ● 3 ▸ We are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical studies and clinical trials that were previously conducted for our product candidates.· · ● ● ● 3 ▸ We have concentrated a significant portion of our research and development efforts on the treatment of neuropsychiatric disorders, a field that faces certain challenges in drug development.· · ● ● ● 3 rw ▸ We have never generated revenue from product sales and may never be profitable.· · ● ● ● 3 ▸ We may incur unexpected costs or experience material delays in completing, or ultimately be unable to complete, the contract manufacturing, nonclinical and clinical development and commercialization of our product candidates.· · ● ● ● 3 rw ▸ We may need to maintain licenses for APIs from third parties to develop and commercialize some of our product candidates, which could increase our development costs and delay our ability to commercialize those product candidates.· · ● ● ● 3 ▸ We may not be able to hire and/or retain a sufficient number of employees or employees with the required expertise to develop our product candidates or operate our business successfully.· · ● ● ● 3 ▸ Although we are currently in compliance with all applicable Nasdaq continued listing standards, there can be no assurance that we will be able to continue to comply with such Nasdaq continued listing standards in the future.· · · ● · 1 ▸ Biopharmaceutical product development entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory· · · ● · 1 ▸ Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.· · · ● · 1 ▸ Our industry has experienced a high rate of turnover of management personnel in recent years. Replacing executive officers or other key employees may be difficult and may take an extended period of time because of the limited number of· · · ● · 1 ▸ Although we maintain workers’ compensation insurance to cover us for costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against· · ● · · 1 ▸ Any product candidate we develop and the activities associated with its development and commercialization, including its design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, and· · ● · · 1 ▸ Business interruptions resulting from the COVID-19 pandemic, the post-COVID environment and other public health crises could disrupt the development of our product candidates and adversely impact our business.· · ● · · 1 ▸ Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our product candidates.· · ● ● · 2 ▸ There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.· · ● · · 1 ▸ We expect to expand our organization, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.· · ● ● · 2 ▸ Failures of our current and/or future clinical studies of our product candidates could result in increased costs to us and could delay, prevent or limit our ability to generate revenue and continue our business.· ● · · · 1 ▸ If serious adverse events or other undesirable side effects or safety concerns attributable to our product candidates occur, the clinical development of our product candidates may be delayed or adversely affected.· ● · · · 1 ▸ If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.· ● · · · 1 ▸ Any changes in planned timing or nature of clinical trials compared to completed clinical trials could impede our ability to meet our clinical development objectives for our product candidates.● ● · · · 2 ▸ Competing therapies could emerge adversely affecting our opportunity to generate revenue from the sale of our CNS product candidates.● ● · · · 2 ▸ Current volatile and/or recessionary economic conditions in the U.S. or abroad could adversely affect our business or our access to capital markets in a material manner.● ● · · · 2 ▸ Even if approved, reimbursement policies could limit our ability to sell our CNS product candidates.● ● · · · 2 ▸ Even if we receive marketing approval for any of our CNS product candidate in the U.S., we may never receive regulatory approval to market the same CNS product candidate outside of the U.S.● ● · · · 2 rw ▸ Even if we receive marketing approval for our CNS product candidates, our product candidates may not achieve broad market acceptance, which would limit the revenue that we generate from their sales.● ● · · · 2 ▸ Even if we receive marketing approval for our CNS product candidates, we may still face future development and regulatory difficulties.● ● · · · 2 ▸ Future sales and issuances of our common stock may cause our stock price to decline.● ● · · · 2 ▸ If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.● ● · · · 2 ▸ If equity research analysts do not publish research or reports about our business or if they issue unfavorable commentary or downgrade our common stock, the price of our common stock could decline.● ● · · · 2 ▸ If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.● ● · · · 2 ▸ If we are unable to establish broad sales and marketing capabilities on our own or enter into agreements with third parties to market and sell our CNS product candidates, we may not be able to generate any revenue from product sales.● ● · · · 2 rw ▸ If we fail to retain and attract senior management and key scientific personnel, we may be unable to successfully produce and develop our product candidates.● ● · · · 2 rw ▸ In the event we apply for additional U.S. government funding, and we discover compounds or drug candidates as a result of such funding, intellectual property rights to such discoveries may be subject to the applicable provisions of the Bayh-Dole Act.● · · · · 1 ▸ Results of earlier clinical trials may not be predictive of the results of later-stage clinical trials.● ● · · · 2 ▸ group Risks Related to Our Financial Position● ● · · · 2 ▸ The COVID-19 pandemic has adversely impacted and may continue to adversely impact our business.● ● · · · 2 rw ▸ We are subject to healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.● ● · · · 2 ▸ We do not intend to pay dividends on our common stock and, consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common stock.● ● · · · 2 ▸ We may acquire businesses or product candidates, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.● ● · · · 2 ▸ We may be required to raise additional financing by issuing new securities with terms or rights superior to those of our existing securityholders, which could adversely affect the market price of shares of our common stock and our business.● ● · · · 2 ▸ We require additional financing to execute our long-term business plan.● ● · · · 2 ▸ Should any of these events occur, they could significantly harm our business and results of operations.● ● · ● ● 4 ▸ Any of these risks coming to fruition could have a material adverse effect on our business, results of operations, financial condition and prospects.● ● ● ● ● 5 ▸ Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.● ● ● ● ● 5 ▸ Current politics in the U.S. could diminish the value of the pharmaceutical industry, thereby diminishing the value of our securities.● ● ● ● ● 5 ▸ If we do not obtain additional protection under the Hatch-Waxman Amendments and similar foreign legislation by extending the patent terms or obtaining regulatory and data exclusivity for our product candidates, our business may be materially harmed.● ● ● ● ● 5 rw ▸ If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.● ● ● ● ● 5 ▸ Market volatility may affect our stock price and the value of your investment.● ● ● ● ● 5 ▸ Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.● ● ● ● ● 5 ▸ Our ability to use our net operating losses and research and development tax credits to offset future taxable income may be subject to certain limitations.● ● ● ● ● 5 rw ▸ Our future growth may depend, in part, on our ability to penetrate markets outside of the U.S., where we would be subject to additional regulatory burdens and other risks and uncertainties.● ● ● ● ● 5 rw ▸ Remote working arrangements could significantly increase our digital and cybersecurity risks.● ● ● ● ● 5 rw ▸ group Risks Related to Our Intellectual Property Rights● ● ● ● ● 5 ▸ group Risks Related to Product Development, Regulatory Approval● ● ● ● ● 5 rw ▸ group Risks Related to our Securities● ● ● ● ● 5 ▸ Sales of our product candidates outside of the U.S. could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs.● ● ● ● ● 5 rw ▸ There may be issuances of shares of preferred stock in the future.● ● ● ● ● 5 rw ▸ Unfavorable domestic or global economic or political conditions could adversely affect our business, financial condition or results of operations.● ● ● ● ● 5 rw ▸ We depend heavily on the success of one or more of our current product candidates and we cannot be certain that we will be able to obtain regulatory approval for or commercialize any of our product candidates.● ● ● ● ● 5 rw ▸ We do not seek to protect our intellectual property rights in all jurisdictions throughout the world, and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.● ● ● ● ● 5 rw ▸ We incur significant costs to ensure compliance with corporate governance, federal securities law and accounting requirements.● ● ● ● ● 5 ▸ We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.● ● ● ● ● 5 ▸ We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.● ● ● ● ● 5 ▸ We may seek to establish collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.● ● ● ● ● 5 ▸ We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.● ● ● ● ● 5 
