▸ Even if we are successful in obtaining regulatory approval to market a drug candidate, we, and our third-party manufacturer(s) will be, subject to extensive regulation by the FDA.· · · ● 1 ▸ If our patent position does not adequately protect our drug candidates, others could compete against us more directly, which would harm our business.· · · ● 1 ▸ If securities or industry analysts do not publish research or reports about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading volume could decline.· · · ● 1 ▸ Our common stock has been delisted from The Nasdaq Capital Market and there is no guarantee that our common stock will be regularly traded on the OTCQB Venture Market or other over-the-counter markets.· · · ● 1 ▸ Our inability to promptly obtain coverage and profitable reimbursement rates from government-funded and private payors for any of our drug candidates that obtain approval could have a material adverse effect on our business and financial condition.· · · ● 1 ▸ Recent and future reverse stock splits may decrease the liquidity of our common stock and result in higher transaction costs.· · · ● 1 ▸ group Risks Related to Intellectual Property· · · ● 1 ▸ We may be subject to claims that our employees and contractors have wrongfully used or disclosed alleged trade secrets of their former employers.· · · ● 1 ▸ Unstable market and economic conditions may have serious adverse effects on our ability to raise funds, which may cause delays, restructuring or cessation of our operations.· · ● ● 2 ▸ Our business and operations have been affected by and could be materially and adversely affected in the future by the effects of health epidemics and pandemics, including the evolving and ongoing effects of the COVID-19 pandemic.· ● ● ● 3 ▸ The report of our independent registered public accounting firm contains an emphasis of a matter regarding substantial doubt about our ability to continue as a going concern.· ● ● ● 3 ▸ Act provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.· ● ● · 2 ▸ Because our research and development of drug candidates incorporates compounds and other information that is the intellectual property of third parties, we depend on continued access to such intellectual property to conduct and complete our● · · · 1 ▸ Identification of previously unknown problems with respect to a drug candidate, manufacturer or facility may result in restrictions on the drug candidate, manufacturer or facility.● ● ● · 3 ▸ Our common stock may be delisted from The Nasdaq Capital Market which could negatively impact the price of our common stock and our ability to access the capital markets.● ● ● · 3 ▸ Patent No. Title Date Issued● · · · 1 ▸ The COVID-19 pandemic could adversely impact our business, including our clinical trials.● · · · 1 ▸ Changes in existing laws and regulations affecting the healthcare industry could increase our costs and otherwise adversely affect our business.● ● ● ● 4 ▸ Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information and may not adequately protect our intellectual property.● ● ● ● 4 ▸ Delays in the commencement of clinical trials of our drug candidates could result in increased costs to us and delay our ability to generate revenues.● ● ● ● 4 ▸ Failure to maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on the price of our common stock.● ● ● ● 4 ▸ Future collaboration arrangements to leverage our capabilities may not be successful.● ● ● ● 4 ▸ If any third-party owners of intellectual property we may license in the future do not properly maintain or enforce the patents underlying such licenses, our competitive position and business prospects will be harmed.● ● ● ● 4 ▸ If our future drugs do not achieve market acceptance, we may be unable to generate significant revenue, if any.● ● ● ● 4 ▸ If third-party payors do not adequately reimburse patients for any of our drug candidates that are approved for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase.● ● ● ● 4 ▸ If we acquire or license technologies, resources or drug candidates, we will incur a variety of costs and may never realize benefits from the transaction.● ● ● ● 4 ▸ If we are unable to attract and retain key management, scientific personnel and advisors, we may not successfully develop our drug candidates or achieve our other business objectives.● ● ● ● 4 ▸ If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our drug candidates, we may not generate product revenue.● ● ● ● 4 ▸ If we are unable to obtain U.S. and/or foreign regulatory approval, we will be unable to commercialize our drug candidates.● ● ● ● 4 ▸ If we are unsuccessful in our collaborative efforts, our ability to develop and market drug candidates could be severely limited.● ● ● ● 4 ▸ If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed.● ● ● ● 4 ▸ Many of these factors that may lead to a delay, suspension or termination of clinical trials of our drug candidates may also ultimately lead to denial of regulatory approval of our drug candidates.● ● ● ● 4 ▸ Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.● ● ● ● 4 ▸ Our certificate of incorporation grants our Board of Directors the power to designate and issue additional shares of common and/or preferred stock.● ● ● ● 4 ▸ Our employees, agents, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with applicable regulatory standards and requirements.● ● ● ● 4 ▸ Our management is required to devote substantial time and incur additional expense to comply with public company regulations.● ● ● ● 4 ▸ Provisions of our charter documents or Delaware law could delay or prevent an acquisition of our company, even if the acquisition would be beneficial to our stockholders, and could make it more difficult to change management.● ● ● ● 4 ▸ group Risks Related to Commercialization● ● ● ● 4 ▸ group Risks Related to Manufacturing Our Drug Candidates● ● ● ● 4 ▸ group Risks Related to Our Business● ● ● ● 4 ▸ group Risks Related to Our Securities● ● ● ● 4 ▸ group Risks Related to the Development of Our Drug Candidates● ● ● ● 4 ▸ The trading price of our common stock has been volatile and is likely to be volatile in the future.● ● ● ● 4 ▸ We do not anticipate paying cash dividends, and accordingly stockholders must rely on stock appreciation for any return on their investment in us.● ● ● ● 4 ▸ We expect to expand our operations, including clinical trials, in the future and may face challenges in managing our growth, which may result in disruptions to our operations.● ● ● ● 4 ▸ We may experience delays in the development of our drug candidates if the third-party manufacturers of our drug candidates cannot meet FDA requirements relating to current Good Manufacturing Practices.● ● ● ● 4 ▸ We may not be able to obtain or maintain orphan drug exclusivity for our product candidates.● ● ● ● 4 ▸ We rely on third parties for manufacturing of our clinical drug supplies; our dependence on these manufacturers may impair the development of our drug candidates.● ● ● ● 4 
