▸ Regulatory legislative reform measures may have a material adverse effect on our business.· · · · ● 1 ▸ Risks Related to Research, Development and Regulatory Approval of Our Product Candidates· · · · ● 1 ▸ Conflicts, military actions, terrorist attacks, natural disasters. public health crises, including the occurrence of a contagious disease or illness, cyber-attacks and general instability could adversely affect our business.· · · ● ● 2 ▸ The biopharmaceutical industry is subject to extensive regulatory obligations and policies that are subject to change, including to judicial challenges.· · · ● ● 2 rw ▸ We have engaged AtomVie and SpectronRx as sources to supply drug product for our ongoing research and clinical studies.· · · ● ● 2 ▸ We identified certain misstatements to our previously issued financial statements and have restated the financial statements described below, which has exposed us to additional risks and uncertainties.· · · ● ● 2 ▸ We rely on a collaborative outsourced business model, and disruptions with our third-party collaborators may impede our ability to gain FDA approval and delay or impair commercialization of any products.· · · ● · 1 ▸ Due to continued changes in marketing, sales and distribution, we may be unsuccessful in our efforts to sell our proposed products, develop a direct sales organization, or enter into relationships with third parties.● ● · · · 2 ▸ Failure to maintain effective internal controls could adversely affect our ability to meet our reporting requirements.● ● ● ● · 4 ▸ group Risks Related to Research and Development and the FDA● ● ● ● · 4 ▸ The COVID-19 pandemic continues to rapidly evolve. While the extent of the impact of the COVID-19 pandemic on our business and financial results is uncertain, a continued and prolonged public health crisis could have a material negative impact on our● · · · · 1 ▸ The COVID-19 pandemic could materially and adversely affect our business.● ● ● · · 3 ▸ We and our third-party collaborators are subject to federal, state and local laws and regulations governing the storage, use and disposal of hazardous materials and waste products. Current or future regulations may impair our research, development,● · · · · 1 ▸ We cannot assure the successful development and commercialization of our compounds in development.● ● ● ● · 4 ▸ Acceptance of our products in the marketplace is uncertain and failure to achieve market acceptance will prevent or delay our ability to generate revenues.● ● ● ● ● 5 ▸ Clinical studies involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.● ● ● ● ● 5 ▸ Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete.● ● ● ● ● 5 ▸ Controls we or our third-party collaborators have in place to ensure compliance with all applicable laws and regulations may not be effective.● ● ● ● ● 5 ▸ Enacted and future legislation may increase the difficulty and cost for us to commercialize our product candidates and may affect the prices we may set.● ● ● ● ● 5 ▸ Failure to meet Nasdaq’s continued listing requirements could result in the delisting of our common stock, negatively impact the price of our common stock and negatively impact our ability to raise additional capital.● ● ● ● ● 5 ▸ Failure to meet investor and stakeholder expectations regarding environmental, social and corporate governance, or “ESG” matters may damage our reputation.● ● ● ● ● 5 ▸ Fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure FDA approval of our product candidates.● ● ● ● ● 5 ▸ If manufacturers obtain approval for generic versions of our products, once approved, or of products with which we compete, our business may be harmed.● ● ● ● ● 5 ▸ If our products are unable to obtain adequate reimbursement from third-party payors, or if additional healthcare reform measures are adopted, it could hinder or prevent the commercial success of our product candidates.● ● ● ● ● 5 rw ▸ If we are unable to convince physicians of the benefits of our intended products, we may incur delays or additional expense in our attempt to establish market acceptance.● ● ● ● ● 5 ▸ Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.● ● ● ● ● 5 ▸ Our business and operations may be materially adversely affected in the event of computer system failures or security breaches.● ● ● ● ● 5 ▸ Our clinical studies may not demonstrate sufficient levels of efficacy necessary to obtain the requisite regulatory approvals for our drugs, and our proposed drugs may not be approved for marketing.● ● ● ● ● 5 ▸ Our common stock could be further diluted as the result of the issuance of additional shares of common stock, convertible securities, warrants or options.● ● ● ● ● 5 ▸ Our stock price has experienced, and may continue to experience, price fluctuations.● ● ● ● ● 5 rw ▸ Provisions of our certificate of incorporation, by-laws, and Delaware law may make an acquisition of us or a change in our management more difficult.● ● ● ● ● 5 ▸ group Risks Related to Capital and Our Operations● ● ● ● ● 5 ▸ group Risks Related to Commercialization of our Products● ● ● ● ● 5 ▸ group Risks Related to Intellectual Property● ● ● ● ● 5 ▸ group Risks Related to Internal Controls● ● ● ● ● 5 ▸ group Risks Related to Legal Compliance and Litigation● ● ● ● ● 5 ▸ group Risks Related to Manufacturing and Supply● ● ● ● ● 5 ▸ group Risks Related to Our Employees● ● ● ● ● 5 ▸ group Risks Related to Our Equity Securities● ● ● ● ● 5 ▸ The FDA has granted rare pediatric disease designation, RPDD, to iopofosine for treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma; however, we may not be able to realize any value from such designation.● ● ● ● ● 5 ▸ The market for our proposed products is rapidly changing and competitive, and new therapeutics, drugs and treatments that may be developed by others could impair our ability to develop our business or become competitive.● ● ● ● ● 5 ▸ The timeframe necessary to achieve these developmental milestones may be long and uncertain, and we may not successfully complete these milestones for any of our intended products in development.● ● ● ● ● 5 ▸ War, terrorism, other acts of violence, or natural or manmade disasters may affect the markets in which we operate, our patients and resources required in our research and development activities.● ● ● ● ● 5 ▸ We are exposed to product, clinical and preclinical liability risks that could create a substantial financial burden should we be sued.● ● ● ● ● 5 ▸ We may be required to suspend or discontinue clinical studies because of unexpected side effects or other safety risks that could preclude approval of our product candidates.● ● ● ● ● 5 rw ▸ We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their current or former employers.● ● ● ● ● 5 ▸ We may face litigation from third parties claiming our products infringe on their intellectual property rights, particularly because there is often substantial uncertainty about the validity and breadth of medical patents.● ● ● ● ● 5 ▸ We rely on a small number of key personnel who may terminate their employment with us at any time, and our success will depend on our ability to hire additional qualified personnel.● ● ● ● ● 5 ▸ We will require additional capital in order to continue our operations and may have difficulty raising additional capital.● ● ● ● ● 5 
