▸ Coverage and reimbursement may not be available for our products, which could make it difficult for our licensees to sell our products profitably.· · ● 1 ▸ If revenue from royalties related to sales of our products does not increase, we may be required to seek to raise additional funds, which could have an adverse effect on our business, financial condition, results of operations, and growth prospects.· · ● 1 ▸ Licensing of intellectual property involves complex legal, business, and scientific issues, and disputes could jeopardize our rights under such agreements.· · ● 1 ▸ Our dependence upon third parties for the manufacture and supply of our existing women’s healthcare products may cause delays in, or prevent our licensees from, successfully commercializing and marketing our products.· · ● 1 ▸ Our future success depends on our ability to attract and retain qualified personnel.· · ● 1 ▸ There is substantial doubt about our ability to continue as a going concern.· · ● 1 ▸ Time and costs associated with winding down our general and administrative, commercial, and research and development activities may be significant.· · ● 1 ▸ Unfavorable global economic conditions could harm our business, financial condition or results of operations.· · ● 1 ▸ We have incurred net losses in the past and there are no assurances we will be able to maintain or increase profitability in the future.· · ● 1 ▸ We maintain our cash at financial institutions, often in balances that exceed federally insured limits.· · ● 1 ▸ We must rely on Mayne Pharma to file lawsuits or take other actions to protect or enforce our patents and there can be no assurance they will be take such actions or be successful.· · ● 1 ▸ Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.· ● ● 2 ▸ We have experienced significant turnover in our top executives, and our business could be adversely affected by these and other transitions in our senior management team.· ● ● 2 ▸ Our level of indebtedness and the terms of the Financing Agreement, which matures in June 2022, raises substantial doubt about our ability to continue as a going concern.· ● · 1 ▸ We may not be able to realize the expected savings from our cost savings initiatives.· ● · 1 ▸ Another party could develop competing pharmaceutical products and obtain FDA regulatory exclusivity in the U.S. before we do, potentially preventing our ability to commercialize our pharmaceutical products and other products in development.● ● · 2 ▸ Clinical trials are lengthy and expensive with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.● ● · 2 ▸ Coverage and reimbursement may not be available for our products, which could make it difficult for us to sell our products profitably, or if available, government mandated rebates may be too high and may adversely affect our profitability.● ● · 2 ▸ December 31, 2020, to the lesser of the NOL carryforward or 80 percent of the taxpayer's taxable income (after considering● · · 1 ▸ Delays in clinical trials are common for many reasons, and any such delays could result in increased costs to us and jeopardize or delay our ability to obtain regulatory approval or commence or continue product sales.● ● · 2 ▸ If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.● ● · 2 ▸ If we use hazardous materials in a manner that causes injury or violates applicable law, we may be liable for damages.● ● · 2 ▸ Our operations are concentrated in Boca Raton, Florida and interruptions affecting us or our suppliers due to natural disasters, the COVID-19 pandemic, or other unforeseen events could adversely affect our operations.● ● · 2 ▸ Our success depends on how efficiently we respond to changing consumer preferences and demand.● ● · 2 ▸ We cannot ensure that our compliance controls, policies, and procedures will be sufficient to protect against acts of our employees, business partners or vendors that may violate federal or state fraud and abuse laws or other applicable requirements.● ● · 2 rw ▸ We have incurred significant operating losses since inception and anticipate that we will incur continued losses for the foreseeable future.● ● · 2 ▸ We may be required to file lawsuits or take other actions to protect or enforce our patents or the patents of our licensors, which could be expensive and time-consuming.● ● · 2 ▸ We may be required to suspend or discontinue clinical trials because of adverse side effects or other safety risks that could preclude approval of our pharmaceutical product candidates.● ● · 2 ▸ We may not be able to complete the commercialization of our pharmaceutical products and development of future product candidates if we fail to obtain additional financing.● ● · 2 ▸ We may not recognize any anticipated benefits of the proposed disposition of vitaCare or any other divestitures we may pursue in the future.● ● · 2 rw ▸ We will need to grow our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.● ● · 2 ▸ A failure to maintain optimal inventory levels to meet commercial demand for our products could harm our and out licensees’ reputation and subject us to financial losses.● ● ● 3 rw ▸ Any failure of our licensees to adequately maintain a sales force or adequately promote our products will impede our growth.● ● ● 3 rw ▸ Failure to obtain regulatory approval outside the U.S. will prevent our licensees from marketing our hormone therapy pharmaceutical products in non-U.S. markets.● ● ● 3 ▸ Future legislation or regulations may adversely affect reimbursement from government healthcare programs and third-party payers.● ● ● 3 ▸ Future sales and issuances of equity securities, convertible securities or other securities could result in additional dilution of the percentage ownership of holders of our common stock.● ● ● 3 ▸ group General risks related to our business● ● ● 3 ▸ group General risks related to our intellectual property● ● ● 3 ▸ group General risks related to ownership of our Common Stock● ● ● 3 ▸ If our dietary supplement, hormone therapy pharmaceutical products or patient-controlled, long-acting contraceptive products do not have the effects intended or cause undesirable side effects, our business may suffer.● ● ● 3 ▸ If our efforts to protect the proprietary nature of the intellectual property covering our hormone therapy pharmaceutical products and other products are not adequate, we may not be able to compete effectively in our market.● ● ● 3 ▸ If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.● ● ● 3 ▸ If we are sued for infringing intellectual property rights of third parties, litigation will be costly and time consuming and could prevent or delay us from developing or commercializing our pharmaceutical product candidates.● ● ● 3 ▸ If we are unable to protect the confidentiality of certain information, the value of our products and technology could be adversely affected.● ● ● 3 ▸ If we fail to maintain proper internal controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.● ● ● 3 ▸ Our ability to utilize net operating loss carryforwards may be limited.● ● ● 3 ▸ Our business may be affected by unfavorable publicity or lack of consumer acceptance.● ● ● 3 ▸ Our business may be impacted by new or changing tax laws or regulations and actions by federal, state, and/or local agencies, or how judicial authorities apply tax laws.● ● ● 3 ▸ Our employees and business partners may not appropriately secure and protect confidential information in their possession.● ● ● 3 ▸ Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.● ● ● 3 ▸ Our failure to comply with foreign data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.● ● ● 3 ▸ Our financial condition and results of operations for 2021 and 2022 were, and our financial condition and results of operations for 2023 and beyond may be, adversely affected by the ongoing COVID-19 pandemic and any future pandemics or epidemics.● ● ● 3 rw ▸ Our licensees may initiate product recalls or withdrawals or may be subject to regulatory enforcement actions that could negatively affect our business.● ● ● 3 rw ▸ Our principal stockholder owns a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.● ● ● 3 rw ▸ Our products and our licensees are subject to extensive and costly government regulation.● ● ● 3 rw ▸ Our products face significant competition from branded and generic products, and our operating results will suffer if we fail to compete effectively.● ● ● 3 ▸ Our success is tied to our licensees’ distribution channels.● ● ● 3 rw ▸ Product liability lawsuits could divert our resources, result in substantial liabilities, and reduce the commercial potential of our products.● ● ● 3 rw ▸ Recent government enforcement has targeted pharmaceutical companies for violations of fraud, abuse and other laws.● ● ● 3 ▸ group Risks related to our business● ● ● 3 ▸ group Risks related to our intellectual property● ● ● 3 ▸ group Risks related to ownership of our common stock● ● ● 3 ▸ The availability of generic products at lower prices than branded products may substantially reduce the likelihood of reimbursement for branded products, such as IMVEXXY, BIJUVA, and ANNOVERA.● ● ● 3 ▸ The commercial success of our existing products will depend upon gaining and retaining significant market acceptance of these products among physicians and payers.● ● ● 3 rw ▸ The market price of our common stock may be highly volatile, and you could lose all or part of your investment.● ● ● 3 ▸ We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.● ● ● 3 ▸ We may be subject to claims that our former employees wrongfully used or disclosed alleged trade secrets of their former employers or of other third parties with whom we have obligations of confidentiality.● ● ● 3 rw ▸ We may not be able to maintain effective and efficient information systems or properly safeguard our information systems.● ● ● 3 
