ImmunityBio (IBRX) risk factors, FY2025 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01Our payment obligations under the RIPA may adversely affect our financial position and results of operations and our ability to raise additional capital, which in turn may increase our vulnerability to adverse regulatory developments or economic or business downturns
2. 02The RIPA and our payment obligations to Oberland could have important negative consequences to holders of our securities. For example, a portion of our cash flow from operations will be needed to make required payments to Oberland and will not be available to fund future operations
3. 03Our debt and revenue interest liability could adversely affect our cash flows and limit our flexibility to raise additional capital21% rewritten
4. 04The occurrence of any of the foregoing factors could have a material adverse effect on our business, results of operations and financial condition35% rewritten
5. 05Changes in the fair value of our convertible promissory note could have a material effect on our reported financial resultsNew
6. 06We invest our cash on hand in various financial instruments which are subject to risks that could adversely affect our business, results of operations, liquidity and financial condition
7. 07Our ability to use NOLs and research and development credits to offset future taxable income may be subject to certain limitations20% rewritten
8. 08Our transfer pricing policies may be subject to challenge by the Internal Revenue Service or other taxing authorities
9. 09Unanticipated changes in effective tax rates or adverse outcomes resulting from new tax statutes or regulations, examination of our income or other tax returns could expose us to greater than anticipated tax liabilities51% rewritten
10. 10Risks Related to the Discovery, Development and Commercialization of our Approved Product and our Other Product Candidates36% rewritten
11. 11We have limited experience as a commercial company and the sales, marketing, and distribution of our approved product or any future approved products may be unsuccessful or less successful than anticipated
12. 12We have developed an approved product and are developing other product candidates in combination with other therapies, which expose us to additional risks
13. 13Our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization of other product candidates
14. 14The ongoing shortage of TICE BCG in the U.S. may adversely impact market uptake of our approved product, ANKTIVA, and it may also delay our ability to execute our clinical trials or seek new approvals47% rewritten
15. 15We may choose to expend our limited resources on programs that do not yield successful product candidates or additional indications and may fail to capitalize on other indications and product candidates that may ultimately have been more profitable or had a greater likelihood of success
16. 16Our projections regarding the market opportunities for our approved product and our other product candidates may not be accurate, and the actual market for our approved product and other product candidates, may be smaller than we estimate
17. 17There can be no assurance that we will complete strategic partnerships on acceptable terms, or at all62% rewritten
18. 18Interim, initial, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
19. 19If we are required by the FDA or any equivalent foreign regulatory authority to perform clinical trials or studies in addition to those we currently expect to conduct, or if there are any delays in completing the clinical trials of our other product candidates, our expenses could increase substantiallyNew
20. 20Even if more of our product candidates are approved and commercialized, we may not become profitable
21. 21If we encounter delays or difficulties enrolling and/or maintaining patients in our clinical trials, our clinical development activities, and receipt of necessary marketing approvals could be delayed or otherwise adversely affected
22. 22We are also required to register certain clinical trials and post the results of certain completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within specified timeframes. Failure to do so could result in enforcement actions and adverse publicity
23. 23We may not be successful in managing the build-out of our manufacturing facilities and associated costs or satisfying manufacturing-related regulatory requirements50% rewritten
24. 24We also may not successfully realize the anticipated benefits from the capital expenditures at such facilities based on factors such as delays and uncertainties regarding development, regulatory approval, and commercialization of our product candidates, as well as the potential to lose access to the leased facilities
25. 25If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our approved product or other product candidates
26. 26We will face significant competition from other biotechnology and pharmaceutical companies and from non-profit institutions
27. 27As a condition of approval, the FDA may require that we implement various post-marketing requirements and conduct post-marketing studies, any of which would require a substantial investment of time, effort, and money, and which may limit our commercial prospects
28. 28If our approved product or any of our other product candidates do not achieve broad market acceptance, the revenues that we generate from their sales will be limited
29. 29Our approved product and our product candidates may face competition sooner than anticipated
30. 30We will need to obtain FDA approval of any proposed branded product names, and any failure or delay associated with such approval may adversely affect our business24% rewritten
31. 31A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, or the perception of its effects, may materially and adversely affect our business, operations and financial condition

Risks Related to Reliance on Third Parties

1. 32Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services
2. 33If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies
3. 34Our use of joint ventures, strategic partnerships, and alliances may expose us to risks associated with jointly owned investments
4. 35We are heavily dependent on our senior management, particularly Dr. Soon-Shiong, our Founder, Executive Chairman and Global Chief Scientific and Medical Officer, and a loss of a member of our senior management team in the future, even if only temporary, could harm our business
5. 36We will need to grow the size and capabilities of our organization, and we may experience difficulties in achieving and managing this growth
6. 37If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks
7. 38A variety of risks associated with marketing our approved product and other product candidates internationally could materially adversely affect our business63% rewritten
8. 39We are party to a public-private partnership regarding our manufacturing facility in Dunkirk, New York, and our failure to meet the obligations of those agreements could materially impact our development, operations and prospects57% rewritten
9. 40Our contractors and subcontractors may place liens on our projects, and if they then successfully foreclose on such projects, we may not be able to use such assets for our business

Risks Related to Healthcare and Other Government Regulations

1. 41Obtaining and maintaining regulatory approval of our approved product or other product candidates in one jurisdiction does not mean that we will be successful in obtaining or maintaining regulatory approval in other jurisdictions
2. 42Failure to obtain regulatory approval in any targeted jurisdiction would prevent us from marketing our products to a larger patient population and reduce our commercial opportunities
3. 43If we are unable to establish sales, marketing and distribution capabilities, we may not be successful commercializing our approved product or our other product candidates, including in international markets, if and when they are approved32% rewritten
4. 44Problems related to large-scale commercial manufacturing could cause delays in product launches, an increase in product costs, product recalls or product shortages
5. 45If any of these events were to occur, it would have a material and adverse effect on our business, financial condition and results of operations
6. 46Inappropriate assumptions may be drawn based on results for patients who receive access to any of our non-approved product candidates through compassionate use, EAPs, or right to try access, which should not be viewed as representative of how the product candidate will perform in a well-controlled clinical trial56% rewritten
7. 47Recent and further changes in the tariff and trade policies of the U.S. or of other countries could increase manufacturing and sourcing costs, decrease demand for our offerings, disrupt supply chains, or otherwise adversely affect our business and financial conditionNew
8. 48Our failure to comply with state, national and/or international privacy and security laws and regulations could lead to government enforcement actions and significant penalties against us and adversely impact our operating results20% rewritten
9. 49We and our third-party contractors must comply with environmental, health and safety laws and regulations. A failure to comply with these laws and regulations could expose us to significant costs or liabilities
10. 50Coverage and reimbursement may be limited or unavailable in certain market segments for our approved product or other product candidates, which could make it difficult for us to sell our approved product or other product candidates profitably
11. 51We may face difficulties from changes to current regulations and future legislation
12. 52Governments outside the U.S. tend to impose strict price controls, which may adversely affect our revenues, if any
13. 53Our employees, independent contractors, consultants, commercial partners, principal investigators, CROs, CMOs, suppliers and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements

Risks Related to Intellectual Property

1. 54If any of our owned or in-licensed patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively
2. 55Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our approved product and other product candidates
3. 56Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
4. 57Our rights to develop and commercialize our product candidates and technologies are subject, in part, to the terms and conditions of licenses granted to us by others
5. 58If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we may be required to pay damages and we could lose license rights that are important to our business
6. 59We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights in various jurisdictions throughout the world
7. 60We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed trade secrets or other confidential information of third parties or claims asserting ownership of what we regard as our own intellectual property
8. 61We may not be able to license or acquire new or necessary intellectual property rights or technology from third parties
9. 62If we do not obtain patent term extension and data exclusivity for our approved product or any other product candidates we may develop, our business may be materially harmed
10. 63We may be subject to claims challenging rights in our patents and other intellectual property
11. 64If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
12. 65If our trademarks and trade names 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
13. 66Intellectual property rights do not necessarily address all potential threats

Risks Related to Our Common Stock

1. 67Dr. Soon-Shiong, our Founder, Executive Chairman, Global Chief Scientific and Medical Officer and principal stockholder, has significant interests in other companies which may conflict with our interests
2. 68Dr. Soon-Shiong, through his voting control of the company, has the ability to control actions that require stockholder approval28% rewritten
3. 69The market price of our common stock has been and may continue to be volatile, and investors may have difficulty selling their shares31% rewritten
4. 70Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plan, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall37% rewritten
5. 71We have incurred and will continue to incur costs as a result of operating as a public company and our management has been and will be required to devote substantial time to compliance initiatives and corporate governance practices, including maintaining an effective system of internal control over financial reporting81% rewritten
6. 72regulatory authorities may initiate legal proceedings against us, and our business may be harmed. As of June 30, 2025, we are a large accelerated filerNew
7. 73If a restatement of our consolidated financial statements were to occur, our stockholders’ confidence in the company’s financial reporting in the future may be affected, which could in turn have a material adverse effect on our business and stock price
8. 74We have not paid cash dividends in the past and do not expect to pay dividends in the future. Any return on investment may be limited to the value of our common stock
9. 75Because we are relying on the exemptions from corporate governance requirements as a result of being a “controlled company” within the meaning of the Nasdaq listing standards, you do not have the same protections afforded to stockholders of companies that are subject to such requirements
10. 76If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline
11. 77Holders of our CVRs that are payable contingent upon us achieving certain milestones may not receive any further consideration
12. 78We are not subject to the provisions of Section 203 of the DGCL, which could negatively affect your investment
13. 79Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management
14. 80Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us
15. 81Our Bylaws provide that the Delaware Court of Chancery is the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees