▸ Any change to TriNav’s reimbursement status that reduces our level of reimbursement could cause TriNav sales to materially decline and impede market adoption.· ● ● 2 ▸ If our products do not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community, this could materially adversely impact our business, results of operations and financial condition.· ● ● 2 ▸ We have a limited operating history, have incurred significant losses since our inception and anticipate incurring increasing expenses and continuing losses for the foreseeable future.· ● ● 2 ▸ We may not be able to generate sufficient cash to service our indebtedness or borrow additional funds pursuant to our Loan Facility.· ● ● 2 ▸ In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal· ● · 1 ▸ Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.· ● · 1 ▸ We may at times fail (or be perceived to have failed) in our efforts to comply with our data privacy and security obligations. Moreover, despite our efforts, our personnel or third parties on which we rely may fail to comply with such· ● · 1 ▸ Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could harm our business, financial condition, results of operations and prospects.● ● · 2 ▸ Changes in methods of product candidate manufacturing or formulation may result in additional costs or delays.● · · 1 ▸ Changes in tax law and differences in interpretation of tax laws and regulations may adversely impact our financial statements.● ● · 2 ▸ Depending upon the timing, duration and specifics of FDA marketing approval of our product candidates, one or more of our United States patents may be eligible for limited patent term extension, or PTE, under the Drug Price Competition● · · 1 ▸ Even if we receive orphan drug designation for any of our product candidates, we may be unable to maintain the benefits associated with such designation, including the potential for market exclusivity.● · · 1 ▸ If any of our programs or product candidates receive fast track or breakthrough therapy designation by the FDA or similar designations by other regulatory authorities, there is no assurance that we will receive any benefits from such● · · 1 ▸ If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders if we issue equity securities, cause us to incur debt or assume contingent liabilities, and subject us to other risks.● · · 1 ▸ In the past few years, numerous states - including California, Virginia, Colorado, Connecticut, and Utah - have passed comprehensive privacy laws which impose certain obligations on covered businesses, including providing specific● · · 1 ▸ Intellectual property rights do not necessarily address all potential threats to our business.● ● · 2 ▸ Our Warrants are exercisable for Common Stock, the exercise of which would increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.● ● · 2 ▸ Our Warrants may not be exercised at all or may be exercised on a cashless basis and we may not receive any cash proceeds from the exercise of the Warrants.● ● · 2 ▸ Our future capital needs may require us to sell additional equity or debt securities that may dilute our stockholders, adversely affect the market price of our Common Stock or introduce covenants that may restrict our operations.● ● · 2 ▸ group RISKS RELATED TO OUR BUSINESS● ● · 2 ▸ The validity, scope and enforceability of any of our patents can be challenged by third parties and any lawsuits to protect or enforce our patents could be expensive, time consuming and unsuccessful.● · · 1 ▸ We generally do not have long-term contractual commitments with our customers. Our TriNav customers can terminate many of our consignment agreements with or without cause, in some cases subject only to 30 days’ prior notice● · · 1 ▸ We may be unable to effectively manage our growth or achieve anticipated growth.● ● · 2 ▸ We may in the future develop product candidates in combination with other therapies and that may expose us to additional risks● · · 1 ▸ Workforce shortages may continue to negatively impact our operations.● ● · 2 ▸ Clinical trials of our product candidates or potential product candidates may fail to produce results necessary to support regulatory clearance or authorization.● ● ● 3 ▸ Even if we obtain regulatory approval or clearance for nelitolimod or any future product candidates, such product candidates will remain subject to ongoing regulatory oversight.● ● ● 3 ▸ Failure to obtain, adequately protect, maintain or enforce our intellectual property rights could substantially harm our business and results of operations.● ● ● 3 ▸ Healthcare reform and other governmental and private payor initiatives may have an adverse effect upon, and could prevent, the commercial success of our products or product candidates.● ● ● 3 ▸ If our operating and financial performance in any given period does not meet the guidance provided to the public or the expectations of investment analysts, the market price of Common Stock may decline.● ● ● 3 ▸ If our trademarks are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.● ● ● 3 ▸ If we do not obtain protection under the Hatch-Waxman Amendments by extending the patent term, our business may be harmed.● ● ● 3 ▸ If we do not obtain protection under the Hatch-Waxman Amendments by obtaining data exclusivity, our business may be harmed.● ● ● 3 ▸ If we fail to comply with our obligations under any agreements, we may be required to pay damages and could lose intellectual property rights that are necessary or useful for developing and protecting our product candidates.● ● ● 3 ▸ If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired.● ● ● 3 ▸ If we fail to promote, protect, and maintain our brand in a cost-effective manner, we may lose market share and our ability to commercialize our products and revenues will suffer.● ● ● 3 ▸ Increases in costs, disruption of supply or shortage of materials could harm our business.● ● ● 3 ▸ More stringent oversight by the FDA and other agencies in recent years has resulted in increased enforcement activity, which increases our compliance risk.● ● ● 3 ▸ Natural or man-made disasters and other similar events may significantly disrupt our business, and negatively impact our business, financial condition and results of operations.● ● ● 3 ▸ Our ability to use our net operating loss carryforwards and certain other tax attributes is limited.● ● ● 3 ▸ Our business is dependent upon the continued adoption of TriNav by hospitals and physicians.● ● ● 3 ▸ Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.● ● ● 3 ▸ Our risk management processes and procedures may not be effective.● ● ● 3 ▸ Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.● ● ● 3 ▸ Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our securities.● ● ● 3 ▸ group Risks Related to Our Business and Industry● ● ● 3 ▸ group Risks Related to Our Financial Condition● ● ● 3 ▸ group Risks Related to Our Intellectual Property● ● ● 3 ▸ group Risks Related to Our Legal and Regulatory Environment● ● ● 3 ▸ group Risks Related to the Ownership of Our Securities● ● ● 3 rw ▸ Sales of our securities or the perception of such sales, by us or our equity holders, in the public market or otherwise, could cause the market price for our securities to decline.● ● ● 3 rw ▸ The expiration or loss of patent protection may adversely affect our future revenues.● ● ● 3 ▸ The price of our securities has been and may continue to be volatile.● ● ● 3 ▸ There is a risk that we will not be able to conclude, within the prescribed time period or at all, that our internal control over financial reporting is effective as required by Section 404 of the Sarbanes-Oxley Act.● ● ● 3 ▸ These provisions, alone or together, could delay or prevent hostile takeovers and changes in control of us or changes in our Board and our management.● ● ● 3 ▸ Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.● ● ● 3 ▸ We are subject to numerous complex regulatory requirements, and failure to comply with these regulations, or the cost of compliance with these regulations, may harm our business.● ● ● 3 ▸ We could be subject to litigation that could have an adverse effect on our business and operating results.● ● ● 3 ▸ We could be subject to securities class action litigation.● ● ● 3 ▸ We depend on our senior management team and the loss of one or more key employees or an inability to attract and retain highly skilled employees could adversely affect our business.● ● ● 3 ▸ We generally do not have long-term contractual commitments from our customers, and our customers may choose not to enter into new agreements with us.● ● ● 3 ▸ We intend to use the FDA’s expedited drug development programs for nelitolimod but may not be able to achieve expedited development or approval for this product candidate.● ● ● 3 ▸ We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.● ● ● 3 rw ▸ We may be unable to maintain the listing of our securities on Nasdaq in the future.● ● ● 3 ▸ We may not be able to prevent misappropriation of our trade secrets or other proprietary and confidential information, particularly in countries where the laws may not protect those rights as fully as in the U.S.● ● ● 3 rw ▸ We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.● ● ● 3 ▸ We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products and product candidates.● ● ● 3 
