▸ Changes in U.S. government policy, regulation, enforcement priorities, and funding decisions could adversely affect our business, financial condition and results of operations.· · · · ● 1 ▸ Our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or third parties’ cybersecurity.· · · · ● 1 ▸ The delisting of our common stock from the Nasdaq Capital Market may continue to adversely affect the liquidity and trading price of our common stock and our ability to raise additional capital.· · · · ● 1 ▸ The implementation of any of the cost containment measures or other healthcare reforms discussed above may prevent us from being able to generate revenue, attain profitability or commercialize our products.· · · · ● 1 ▸ We face substantial competition from other pharmaceutical and biotechnology companies, many of which have significantly greater resources than we do.· · · · ● 1 ▸ Any products for which we receive approval may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, which could harm our business.· · · ● ● 2 ▸ Our common stock may be considered a “penny stock” and, therefore, may be subject to certain rules that make it difficult for brokers, dealers, or investors to sell the shares.· · · ● ● 2 ▸ The market for penny stocks has experienced numerous frauds and abuses, which could adversely impact investors in our common stock.· · · ● ● 2 ▸ The use of artificial intelligence in the healthcare industry and challenges with properly managing its use could adversely affect our business.· · · ● ● 2 ▸ TheOTCPink Open Market is a thinly traded market lacking in liquidity, which could make it difficult for our stockholders to sell their shares of common stock and/or for us to raise additional funding.· · · ● ● 2 ▸ Volatility in our common stock price may subject us to securities litigation.· · · ● ● 2 ▸ Changes in tax laws or regulations that are applied adversely to us may have a material adverse effect on our business, cash flow, financial condition, or results of operations.· · ● ● ● 3 ▸ Fortress’ current or future financial obligations and arrangements, or an event of default thereon, may change the ownership dynamic of us by Fortress.· · ● ● ● 3 ▸ If we experience delays or difficulties in the enrollment of patients in any future clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.· · ● ● ● 3 ▸ The making, use, sale, importation, exportation, and distribution of controlled substances are subject to regulation by state, federal, and foreign law enforcement and other regulatory agencies.· · ● ● ● 3 ▸ Even if one or more of our current or future product candidates receives regulatory approval, which may not occur, it will remain subject to substantial regulatory scrutiny.· ● ● ● ● 4 rw ▸ Fortress has the right to receive a significant grant of shares of our common stock annually, which would result in the dilution of your holdings of common stock upon each grant, which could reduce their value.· ● ● ● ● 4 ▸ If none of our current or future product candidates, if approved, achieves broad market acceptance, the potential revenues that we generate from sales will be limited.· ● ● ● ● 4 rw ▸ We are currently not compliant with certain applicable listing standards of The Nasdaq Capital Market, which could result in our common stock being delisted from The Nasdaq Capital Market.· · ● · · 1 ▸ BAER-101 competitors in the GABA-A space are in the clinic and include Cerevel Therapeutics (darigabat), RespireRx Pharmaceuticals (KRM-II-81), Saniona AB (SAN711), and Engrail Therapeutics (ENX101).· ● · · · 1 ▸ FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.· ● · · · 1 ▸ There is no assurance that we will be able to successfully integrate Baergic or develop BAER-101 or AJ201.· ● · · · 1 ▸ We are subject to new legislation, regulatory proposals, and managed care initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators, and raise capital.· ● ● · · 2 rw ▸ We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.· ● · · · 1 ▸ We have in the past failed to satisfy applicable listing standards of the Nasdaq Capital Market and could fail to satisfy those requirements again in the future, which could result in our common stock being delisted from the Nasdaq Capital Market.· ● · · · 1 ▸ Current and future legislation and regulation may increase the difficulty and cost for us to obtain marketing approval of, and to commercialize, our product candidate and may affect the prices we are able to obtain.● · · · · 1 ▸ Even if IV Tramadol receives regulatory approval, which may not occur, it and any other products we may market will remain subject to substantial regulatory scrutiny.● · · · · 1 ▸ If IV Tramadol does not achieve broad market acceptance, the potential revenues that we generate from its sales will be limited.● · · · · 1 ▸ If we are unable to establish sales, and marketing capabilities or to enter into agreements with third parties to market and sell our product candidate, we may not be successful in commercializing our product candidates if and when they are approved.● ● · · · 2 rw ▸ If we breach the agreement under which we license rights to IV Tramadol, we could lose the ability to continue to develop and potentially commercialize this product candidate.● · · · · 1 ▸ If we fail to satisfy applicable listing standards, including compliance with the minimum market value of listed securities requirement, our common stock may be delisted from the NASDAQ Capital Market.● · · · · 1 ▸ Our business and operations could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic.● ● · · · 2 ▸ Our business and operations would suffer in the event of system failures.● ● ● ● · 4 ▸ Our results of operations and liquidity needs could be materially negatively affected by market fluctuations and economic downturn.● ● ● ● · 4 ▸ Risks Pertaining to Our Stockholders Agreement with InvaGen Pharmaceuticals● · · · · 1 ▸ We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for our current or future product candidates and may have to limit their commercialization, if approved.● · · · ● 2 rw ▸ Fortress controls a voting majority of our common stock.● ● ● ● ● 5 ▸ If serious adverse or unacceptable side effects are identified during the development of our current or future product candidates, we may need to abandon or limit our development of some of our current or future product candidates.● ● ● ● ● 5 rw ▸ If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in any litigation would harm our business.● ● ● ● ● 5 ▸ If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.● ● ● ● ● 5 ▸ 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 harm our business.● ● ● ● ● 5 rw ▸ If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.● ● ● ● ● 5 ▸ Our inability to raise capital when needed would harm our business, financial condition, and results of operations, and could cause our stock value to decline or require that we wind down our operations altogether.● ● ● ● ● 5 rw ▸ Our operating history makes it difficult to evaluate our business and prospects.● ● ● ● ● 5 rw ▸ Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish proprietary rights.● ● ● ● ● 5 rw ▸ Regulatory approval for any approved product is limited by the FDA to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.● ● ● ● ● 5 ▸ Risks Pertaining to Intellectual Property and Potential Disputes Thereof● ● ● ● ● 5 ▸ group Risks Pertaining to Our Business and Industry● ● ● ● ● 5 ▸ group Risks Pertaining to Our Finances● ● ● ● ● 5 ▸ group Risks Pertaining to Regulatory Approval Process● ● ● ● ● 5 ▸ group Risks Pertaining to Reliance on Third Parties● ● ● ● ● 5 ▸ Risks Pertaining to the Commercialization of Product Candidates, if Approved● ● ● ● ● 5 rw ▸ group Risks Pertaining to the Influence of Fortress● ● ● ● ● 5 ▸ The DEA restricts the importation of a controlled substance finished drug product when the same substance is commercially available in the United States, which could reduce the number of potential alternative manufacturers for IV tramadol.● ● ● ● ● 5 ▸ The occurrence of a catastrophic disaster could damage our facilities beyond insurance limits or we could lose key data which could cause us to curtail or cease operations.● ● ● ● ● 5 ▸ The ownership by our executive officers and some of our directors of equity securities of Fortress and/or rights to acquire equity securities of Fortress might create, or appear to create, conflicts of interest.● ● ● ● ● 5 ▸ There is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.● ● ● ● ● 5 ▸ To the extent we operate in foreign jurisdictions, we may be exposed to increased risk associated with the potential theft of technology and intellectual property.● ● ● ● ● 5 ▸ We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.● ● ● ● ● 5 rw ▸ We do not have any products that are approved for commercial sale and therefore do not expect to generate any revenues from product sales in the foreseeable future, if ever.● ● ● ● ● 5 ▸ We expect intense competition for our current or future product candidates, and new products may emerge that provide different or better therapeutic alternatives for our targeted indications.● ● ● ● ● 5 rw ▸ We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.● ● ● ● ● 5 ▸ We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming, and unsuccessful.● ● ● ● ● 5 rw ▸ We may become involved in other types of legal proceedings related to our intellectual property that could result in the invalidation or unenforceability of our patents and could be expensive and time consuming, regardless of the outcome.● ● ● ● ● 5 ▸ We may become involved in securities class action litigation that could divert management’s attention and harm our business.● ● ● ● ● 5 ▸ We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.● ● ● ● ● 5 ▸ We may not be able to manage our business effectively if we are unable to attract and retain key personnel.● ● ● ● ● 5 ▸ We may not receive regulatory approval for IV tramadol, or our approval may be significantly delayed due to scientific or regulatory reasons.● ● ● ● ● 5 ▸ We may not receive regulatory approval for our current or future product candidates, or their approvals may be delayed, which would have a material adverse effect on our business and financial condition.● ● ● ● ● 5 rw ▸ We might have received better terms from unaffiliated third parties than the terms we receive in our agreements with Fortress.● ● ● ● ● 5 ▸ We rely on clinical data and results obtained by third parties that could ultimately prove to be inaccurate, unreliable, or unacceptable to regulatory authorities.● ● ● ● ● 5 rw ▸ We will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.● ● ● ● ● 5 ▸ We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.● ● ● ● ● 5 
