▸ Reductions in staffing and funding at FDA and other federal agencies could cause delays in the development and approval of our products.· · · ● ● 2 ▸ Approval may be delayed or denied because we cannot satisfy FDA’s Chemistry, Manufacturing and Control Requirements.· · ● ● ● 3 ▸ Changes in product candidate manufacturing or formulation may result in additional costs or delay.· · ● ● ● 3 ▸ If we fail to maintain effective internal controls, we may not be able to report financial results accurately or on a timely basis, or to detect fraud, which could have a material adverse effect on our business or share price.· · ● ● ● 3 ▸ Our product candidates may cause undesirable side effects or have other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in post-approval regulatory action.· · ● ● ● 3 ▸ Adverse global conditions, including economic uncertainty, may negatively impact our financial results.· ● ● ● ● 4 ▸ Changes in geopolitical conditions, U.S.-China trade relations and other factors beyond our control may adversely impact our business and operating results.· ● ● ● ● 4 ▸ Changes in geopolitical conditions, U.S.-China trade relations and other factors beyond our control may adversely impact our business and operating results;· ● ● ● ● 4 ▸ Clinical trials are very expensive, time-consuming, difficult to design and implement and involve an uncertain outcome;· ● ● ● ● 4 ▸ Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations.· ● ● ● ● 4 ▸ Global conditions, dislocations in the financial markets, any negative financial impacts affecting U.S. as a result of tax reform or changes to existing trade agreements or tax conventions, may adversely impact our business.· ● ● ● ● 4 rw ▸ group Summary of Risks Associated with Our Business· ● ● ● ● 4 ▸ We do not have our own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of our product candidates;· ● ● ● ● 4 ▸ We have in-licensed a portion of our intellectual property, and if we fail to comply with our obligations under these arrangements, we could lose such intellectual property rights or owe damages to the licensor of such intellectual property; and· ● ● ● ● 4 ▸ We will need substantial additional funding, and certain terms included in our financing transactions may restrict our ability to raise such capital at the times and in the manner we may require;· ● ● ● ● 4 ▸ Our Loan Agreement with K2HV for up to $50,000,000 is secured by a lien covering substantially all of our personal property, excluding intellectual property.● · · · · 1 ▸ Our Loan and Security Agreement contains restrictive and financial covenants that may limit our operating flexibility.● ● ● · · 3 ▸ Our affiliates may control our company for the foreseeable future, including the outcome of matters requiring stockholder approval.● · · · · 1 ▸ The coronavirus COVID-19 pandemic or the widespread outbreak of any other communicable disease could materially and adversely affect our business, financial condition and results of operations.● · · · · 1 ▸ There may be limitations on the effectiveness of our internal controls, and a failure of our control systems to prevent error or fraud may materially harm our company.● ● · · · 2 ▸ We believe that the Complaint and Venn’s preliminary injunction motion are without merit and intend to vigorously defend the Company against these claims; however, there can be no assurance that we will prevail in such proceedings.● · · · · 1 ▸ We expect the cash, cash equivalents, and investments of approximately $59.2 million at December 31, 2022 to be sufficient to meet our operating and capital requirements through the second quarter of 2024, based on planned expenditures.● ● · · · 2 rw ▸ An active, liquid trading market for our common stock may not be sustained.● ● ● ● ● 5 ▸ Drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.● ● ● ● ● 5 ▸ Even if we receive regulatory approval for our drug candidates, we still may not be able to successfully commercialize any of our products, and the revenue that we generate from sales, if any, may be limited.● ● ● ● ● 5 ▸ Future capital raises may dilute our existing stockholders’ ownership and/or have other adverse effects on our operations.● ● ● ● ● 5 ▸ Future sales of shares by existing stockholders could cause our stock price to decline.● ● ● ● ● 5 ▸ If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our drug candidates.● ● ● ● ● 5 ▸ If we are not able to obtain any required regulatory approvals for our drug candidates, we will not be able to commercialize our product candidates and our ability to generate revenue will be limited.● ● ● ● ● 5 ▸ If we cannot successfully execute any one of the foregoing, our business may not succeed, and your investment will be adversely affected.● ● ● ● ● 5 rw ▸ If we market our drug candidates in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal penalties.● ● ● ● ● 5 ▸ It is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights.● ● ● ● ● 5 ▸ Legislation or other changes in U.S. tax law could adversely affect our business and financial condition.● ● ● ● ● 5 ▸ Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.● ● ● ● ● 5 ▸ Our cash, cash equivalents, or investments will only fund our operations for a limited time, and we will need to raise additional capital to support our development and commercialization efforts.● ● ● ● ● 5 rw ▸ Our certificate of incorporation, as amended, allows for our board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.● ● ● ● ● 5 ▸ Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.● ● ● ● ● 5 rw ▸ Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and commercialization efforts.● ● ● ● ● 5 ▸ Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and affect the prices we may obtain.● ● ● ● ● 5 ▸ group Risk Related to our Company and our Business● ● ● ● ● 5 ▸ group Risks Related to Our Business, Financial Position and Need for Capital● ● ● ● ● 5 rw ▸ Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization● ● ● ● ● 5 ▸ group Risks Related to our Common Stock● ● ● ● ● 5 ▸ group Risks Relating to Our Intellectual Property Rights● ● ● ● ● 5 ▸ Significant disruptions of information technology systems or breaches of data security could materially adversely affect our business, results of operations and financial condition.● ● ● ● ● 5 ▸ Third-party coverage and reimbursement and health-care cost containment initiatives and treatment guidelines may constrain our future revenues.● ● ● ● ● 5 rw ▸ Upon dissolution of our company, you may not recoup all or any portion of your investment.● ● ● ● ● 5 ▸ We are a biopharmaceutical company with a limited operating history.● ● ● ● ● 5 ▸ We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.● ● ● ● ● 5 ▸ We face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.● ● ● ● ● 5 ▸ We have in-licensed a portion of our intellectual property, and if we fail to comply with our obligations under these arrangements, we could lose such intellectual property rights or owe damages to the licensor of such intellectual property.● ● ● ● ● 5 ▸ We may acquire businesses, assets, or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.● ● ● ● ● 5 rw ▸ We may be subject to claims challenging the inventorship of our patents and other intellectual property.● ● ● ● ● 5 ▸ We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.● ● ● ● ● 5 ▸ We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.● ● ● ● ● 5 ▸ We will need to grow the size of our organization, and we may experience difficulties in managing this growth.● ● ● ● ● 5 
