▸ Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.· · · · ● 1 ▸ Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.· · · ● ● 2 rw ▸ The design, development, manufacture, supply and distribution of our products are technically complex and require regulatory compliance.· · · ● ● 2 ▸ Adzenys and Cotemplacontain controlled substances, and their manufacture, use, sale, importation, exportation, prescribing and distribution are subject to regulation by the DEA.· · ● ● ● 3 rw ▸ Certain of our stockholders own a large percentage of our stock and their interests may conflict with yours.· · ● ● ● 3 rw ▸ The expiration or loss of patent protection may adversely affect our future net revenue and operating results.· · ● ● ● 3 rw ▸ We are and may continue to be subject to short selling strategies.· · ● ● ● 3 ▸ We have been and, in the future, may become a defendant in one or more stockholder derivative, class-action, and other litigation, and any such lawsuits may adversely affect our business, financial condition, results of operations and cash flows.· · ● · ● 2 rw ▸ Effecting a reverse stock split, if determined by the Board in its discretion, may not achieve one or more of our objectives.· ● ● ● ● 4 ▸ Our ability to compete may decline if we do not adequately protect or enforce our intellectual property rights.· ● ● ● ● 4 ▸ Our accounts receivable subjects us to credit risk.· ● ● ● ● 4 ▸ Our efforts to expand and transform our businesses may require significant investments; if our strategies are unsuccessful, our business, results of operations and/or financial condition may be materially adversely affected.· ● ● ● ● 4 ▸ We are subject to United Statesand foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.· ● ● ● ● 4 rw ▸ We are subject to various health care fraud and abuse and reimbursement laws pertaining to the marketing of our approved products.· ● ● ● ● 4 ▸ We have incurred losses to date and can give no assurance of profitability.· ● ● ● ● 4 ▸ We have not established sources of ongoing net revenue sufficient to cover operating costs.· ● ● ● ● 4 rw ▸ We may have difficulties integrating acquired businesses or assets and such acquisitions may not result in the anticipated benefits, as a result, our business, results of operations and/or financial condition may be materially adversely affected.· ● ● ● ● 4 rw ▸ Deterioration in general economic conditions in the United States and globally, including the effect of prolonged periods of inflation on our customers and suppliers, could harm our business and results of operations.· · · ● · 1 ▸ Major bank failure or sustained financial market illiquidity, could adversely affect our business, financial condition and results of operations.· · · ● · 1 ▸ See Part I, Item 3, Legal Proceedings for more information on these lawsuits.· · · ● · 1 ▸ Our business could be negatively affected as a result of the actions of activist stockholders.· · ● ● · 2 ▸ The Sabby litigation may result in the issuance of additional shares on the exercise of certain of our warrants and cause dilution to existing shareholders.· · ● · · 1 ▸ Various commercial, regulatory, and manufacturing factors may impact our ability to maintain or grow revenues from sales of our pharmaceutical and consumer health product offerings. Moreover, we have limited· · ● · · 1 ▸ Certain of our products, such as, Adzenys XR-ODT and Cotempla XR-ODT, (collectively, our “Controlled Substance Products”) which are approved by the FDA, are regulated by the DEA as Schedule II controlled substances.· ● · · · 1 ▸ While our pharmaceutical products are approved and generating revenues in the U.S., they may not receive, or continue to receive, physician or hospital acceptance, or they may not maintain adequate reimbursement from third party· ● · · · 1 ▸ Any of these events could prevent us from achieving or maintaining market acceptance of Enzastaurin, if approved, and could significantly harm our business, results of operations and prospects.● · · · · 1 ▸ Any third-party manufacturers we engage are subject to various governmental regulations, and we may incur significant expenses to comply with, and experience delays in, our product commercialization as a result of these regulations.● · · · · 1 ▸ Certain of our products contain, and future other product candidates may contain, controlled substances, the manufacture, use, sale, importation, exportation, prescribing and distribution of which are subject to regulation by the DEA.● ● · · · 2 ▸ Delays, suspensions and terminations in any clinical trial we undertake could result in increased costs to us and delay or prevent our ability to generate revenues.● · · · · 1 ▸ Developments in patent law could have a negative impact on our business.● · · · · 1 ▸ Even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our trials.● · · · · 1 ▸ For our approved products, we compete with companies that design, manufacture and market treatments that compete with our products.● · · · · 1 ▸ From time to time, the U.S. Supreme Court, other federal courts, the U.S. Congress or the USPTO may change the standards of patentability and any such changes could have a negative impact on our business.● · · · · 1 ▸ If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed, and our business will be harmed.● · · · · 1 ▸ If we do not secure collaborations with strategic partners to test, commercialize and manufacture products, we may not be able to successfully develop products and generate meaningful revenues.● ● ● ● · 4 rw ▸ If we fail to achieve announced milestones in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business, prospects and results of operations may be harmed.● · · · · 1 ▸ If we fail to establish and maintain proper internal controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.● ● ● ● · 4 ▸ If we fail to successfully acquire new products, we may lose market position.● · · · · 1 ▸ Legislative or regulatory reform of the health care system in the United States may adversely impact our business, operations or financial results.● · · · · 1 ▸ Our ability to compete may decline if we do not adequately protect our proprietary rights or if we are barred by the patent rights of others.● · · · · 1 ▸ Our approved products may not be accepted by physicians, patients, healthcare payors, health technology assessment bodies or the medical community in general.● · · · · 1 ▸ Our business may be adversely affected by the effects of the COVID-19 pandemic.● ● · · · 2 ▸ Our reverse stock split of 1-for-10 effected on December 8, 2020 may not achieve one or more of our objectives.● · · · · 1 ▸ Pharmaceutical and medical device patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position.● · · · · 1 ▸ group RISKS RELATED TO PRODUCT DEVELOPMENT AND REGULATORY APPROVAL● ● · · · 2 ▸ The design, development, manufacture, supply and distribution of our products are highly regulated processes and technically complex.● ● ● · · 3 rw ▸ The development of Healight faces uncertainties related to testing.● · · · · 1 ▸ The elimination of personal liability against our directors and officers under Delaware law and the existence of indemnification rights held by our directors, officers and employees may result in substantial expenses.● · · · · 1 ▸ The outsourcing of the manufacturing of our ADHD products to third parties, may negatively impact our business.● · · · · 1 ▸ The success of the Company will depend on its ability to obtain, commercialize and grow.● · · · · 1 ▸ These same risks apply to applicable foreign regulatory agencies from which we may seek approval for any of our product candidates.● · · · · 1 ▸ Third parties may assert ownership or commercial rights to inventions we develop.● · · · · 1 ▸ Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.● · · · · 1 ▸ Third-party manufacturing risks and inefficiencies may adversely affect our ability to produce our products.● ● · · · 2 rw ▸ We are subject to various regulations pertaining to the marketing of our approved products.● · · · · 1 ▸ We cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, our product candidates.● · · · · 1 ▸ We do not intend to pay cash dividends on our capital stock in the foreseeable future.● ● ● ● · 4 ▸ We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.● · · · · 1 ▸ We face substantial competition from companies with considerably more resources and experience than we have, which may result in others discovering, developing, receiving approval for, or commercializing products before or more successfully than us.● ● ● · · 3 ▸ We have a limited operating history, have incurred losses, and can give no assurance of profitability.● · · · · 1 ▸ We have and may continue to seek Orphan Drug Designation or other designations for our product candidates, but even if designated we may not ultimately realize the potential benefits of such designations.● ● · · · 2 rw ▸ We intend to acquire, through mergers, asset purchases or in-licensing, businesses or products, or form strategic alliances, in the future, and we may not realize the intended benefits of such acquisitions or alliances.● · · · · 1 ▸ We may fail to realize the anticipated benefits and cost savings of the Neos merger, which could adversely affect the value of shares of our common stock.● · · · · 1 ▸ We may never realize the expected benefits from the divestiture of Natesto.● · · · · 1 ▸ We may renegotiate any of our existing license agreements or other material contracts on terms that might not be viewed by the market as favorable.● · · · · 1 ▸ We must rely on a third party to develop the Healight Technology.● · · · · 1 ▸ We or our strategic partners may choose not to continue an existing product or choose not to develop a product candidate at any time during development, which would reduce or eliminate our potential return on investment for that product.● · · · · 1 ▸ We rely on third parties to conduct our clinical trials and perform data collection and analysis, which may result in costs and delays that prevent us from successfully commercializing product candidates.● · · · · 1 ▸ We will incur increased costs associated with, and our management will need to devote substantial time and effort to, compliance with public company reporting and other requirements.● · · · · 1 ▸ We will need to develop and expand our company, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations.● · · · · 1 ▸ Any of these actions, in combination or alone, could prevent us from marketing, distributing or selling our products, and would likely harm our business.● ● ● · ● 4 ▸ Foreign sales of our products could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs.● ● · ● ● 4 rw ▸ group Risks Related to Our Business and Financial Position● · · ● ● 3 ▸ We may be subject to legal or administrative proceedings and litigation other than product liability lawsuits which may be costly to defend and could materially harm our business, financial condition and operations.● · ● ● ● 4 ▸ A dispute concerning the infringement or misappropriation of our proprietary rights, or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business.● ● ● ● ● 5 rw ▸ Government restrictions on pricing and reimbursement, as well as other healthcare payor cost-containment initiatives, may negatively impact our ability to generate net revenue.● ● ● ● ● 5 rw ▸ If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and any trading volume could decline.● ● ● ● ● 5 ▸ If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.● ● ● ● ● 5 ▸ In fiscal 2025, the great majority of our gross revenue and gross accounts receivable were due to four significant customers, the loss of which could materially and adversely affect our results of operations.● ● ● ● ● 5 rw ▸ Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.● ● ● ● ● 5 ▸ Our business and operations would suffer in the event of system failures, cybersecurity attacks, data leakages or other security breaches.● ● ● ● ● 5 rw ▸ Our failure to meet the continued listing requirements of the Nasdaq could result in a delisting of our common stock.● ● ● ● ● 5 rw ▸ Our financial results will depend on the acceptance among clinicians, third-party payors and the medical community of our products.● ● ● ● ● 5 rw ▸ Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.● ● ● ● ● 5 rw ▸ Our pharmaceutical products may prove to be difficult to effectively commercialize as planned or on the timeframes we announce and expect.● ● ● ● ● 5 rw ▸ Our share price is volatile and may be influenced by numerous factors, some of which are beyond our control.● ● ● ● ● 5 ▸ Product liability and other lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our products.● ● ● ● ● 5 rw ▸ Public concern over the abuse of medications that are controlled substances, including increased legislative, legal and regulatory action, could negatively affect our business.● ● ● ● ● 5 ▸ group Risk Related to Securities Markets and Investment in Our Securities● ● ● ● ● 5 ▸ group Risks Related to Commercialization● ● ● ● ● 5 ▸ group Risks Related to Our Intellectual Property● ● ● ● ● 5 ▸ group Risks Related to Our Organization, Structure and Operation● ● ● ● ● 5 ▸ Some provisions of our charter documents and applicable Delaware law may discourage an acquisition of us by others, even if the acquisition may be beneficial to some of our stockholders.● ● ● ● ● 5 ▸ There is a risk we may be unable to sell and distribute certain of our products if we cannot continue to comply with the serialization requirements of the Drug Quality and Security Act within the necessary time frames.● ● ● ● ● 5 rw ▸ We are dependent on our relationships and license agreements, and we rely on the intellectual property rights granted to us pursuant to the license agreements.● ● ● ● ● 5 ▸ We depend on key personnel and attracting qualified management personnel and our business could be harmed if we lose personnel and cannot attract new personnel.● ● ● ● ● 5 ▸ We may not be able to enforce our intellectual property rights throughout the world.● ● ● ● ● 5 ▸ We may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due.● ● ● ● ● 5 
