Inovio Pharmaceuticals (INO) risk factors, FY2025 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concernNew
2. 02We will need substantial additional capital to develop our DNA medicines and proprietary device technology, which may prove difficult or costly to obtain
3. 03We have incurred significant losses in recent years, expect to incur significant net losses in the foreseeable future and may never become profitable45% rewritten
4. 04We have limited sources of revenue and our success is dependent on our ability to develop our DNA medicines and proprietary device technology
5. 05A small number of licensing partners and government contracts have accounted for a substantial portion of our revenue

Risks Related to Product Development, Manufacturing and Regulatory Approval

1. 06products. If we do not obtain marketing authorization for both the device and biologic constituent parts of our products, we will be unable to sell our products, which will significantly impair our ability to generate any revenuesNew
2. 07Pursuing accelerated approval for INO-3107 or any of our other product candidates may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval62% rewritten
3. 08treatment landscape can change quickly as the FDA converts accelerated approvals to full approvals on the basis of successful confirmatory trialsNew
4. 09Even if our products receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States, and the same risk applies for products approved outside the United States, with respect to regulatory approval in the United States
5. 10Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results
6. 11Delays in the commencement, conduct or completion of clinical testing could result in increased costs to us and delay or limit our ability to generate revenues
7. 12None of our DNA medicine candidates have been approved for sale, and we may never develop commercially successful DNA medicine products81% rewritten
8. 13obligations to us or with stringent regulations, we may face delays in the development and commercialization of our proprietary device and DNA medicine candidatesNew
9. 14We are dependent on single-source suppliers for some of the components and materials used in, and the processes required to develop, our proprietary device and DNA medicine candidates
10. 15If any of these risks materialize, costs could significantly increase and our ability to meet demand for our products could be impacted
11. 16As part of our business strategy, we may seek Orphan Drug Designation for our DNA medicine candidates, and we may be unsuccessful in obtaining new designations or may be unable to obtain or maintain the benefits associated with Orphan Drug Designation, including the potential for orphan drug exclusivityNew
12. 17A breakthrough therapy designation or fast track designation by the FDA for a drug may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that the drug will receive marketing approval

Risks Related to Reliance on Third Parties

1. 18If we lose or are unable to secure collaborators or partners, or if our collaborators or partners do not apply adequate resources to their relationships with us, our product development and potential for profitability will suffer89% rewritten
2. 19If any of our current or future collaborators breaches or terminates our agreements, or fails to conduct our collaborative activities in a timely manner, our commercialization of products could be diminished or blocked completelyNew
3. 20We and our collaborators rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we and our collaborators may not be able to obtain regulatory approval for or commercialize our DNA medicine candidates
4. 21We enter into various contracts in the normal course of our business in which we agree to indemnify the other party to the contract. In the event we have to perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition and results of operations

Risks Related to Commercialization of Our DNA Medicine Candidates

1. 22We currently have only a small marketing and sales organization. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, if approved, we may not be able to generate product revenues
2. 23If products for which we receive regulatory approval do not achieve broad market acceptance, the revenues that we generate from their sales will be limited
3. 24We are subject to uncertainty relating to coverage and reimbursement policies which, if not favorable to our DNA medicine candidates, could hinder or prevent our products' commercial success

Risks Related to Employee and Operational Matters

1. 25We face intense and increasing competition and steps taken by our competitors, such as the approval of PAPZIMEOS for the treatment of RRP or the introduction of other new, disruptive technology, may impede our ability to develop and commercialize our DNA medicines
2. 26We also compete more specifically with companies seeking to utilize antigen-encoding DNA delivered with electroporation or other delivery technologies such as viral vectors or lipid vectors to induce in vivo generated antigen production and immune responses to prevent or treat various diseases22% rewritten
3. 27We are currently subject to litigation and may become subject to additional litigation, which could harm our business, financial condition and reputation78% rewritten
4. 28We depend upon key personnel who may terminate their employment with us at any time and we may need to hire additional qualified personnel in order to obtain financing, pursue collaborations or develop or market our DNA medicine candidates
5. 29Our business could be adversely affected by the effects of health epidemics
6. 30We may acquire, in-license, develop and/or market additional products and product candidates. The success of these actions depends partly upon our ability to identify, select and acquire promising product candidates and products
7. 31Changes in funding for the FDA and other government agencies could prevent new products from being developed or commercialized in a timely manner, which could negatively impact our business78% rewritten
8. 32If our information technology systems, or those of third parties with whom we work, or our data, are or were to be compromised, we could experience material adverse consequences resulting from such compromiseNew
9. 33We face potential product liability exposure and, if successful claims are brought against us, we may incur substantial liability
10. 34Healthcare reform measures could hinder or prevent our products' commercial success92% rewritten
11. 35In addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and will remain in effect until 2032 unless additional Congressional action is takenNew
12. 36If we fail to comply with applicable healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected
13. 37The shifting regulatory environment, along with the requirement to comply with multiple jurisdictions with different compliance and/or reporting requirements, increases the possibility that a company may run afoul of one or more laws
14. 38Our business involves the use of hazardous materials and we and our third-party manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business87% rewritten
15. 39International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospectsNew
16. 40Our employees, principal investigators, and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
17. 41Employee litigation and unfavorable publicity could negatively affect our future business

Risks Related to Our Intellectual Property

1. 42It is difficult and costly to generate and protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection
2. 43Our commercial success will depend in part on obtaining and maintaining patent, trademark, trade secret, and other intellectual property protection relating to our proprietary device and DNA medicine candidates, as well as successfully defending these intellectual property rights against third-party challenges
3. 44If we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business
4. 45We have not yet registered our trademarks in all of our potential markets, and failure to secure those registrations could adversely affect our business

Risks Related to an Investment in Our Common Stock

1. 46An active trading market for our common stock may not be sustained
2. 47The price of our common stock has been and may continue to be volatile, and an investment in our common stock could decline substantially in value
3. 48We have broad discretion in the use of our cash, cash equivalents, and investments, and may not use them effectively
4. 49Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock
5. 50We have never paid cash dividends on our common stock and we do not anticipate paying dividends in the foreseeable future
6. 51Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited48% rewritten
7. 52Our data processing activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security33% rewritten
8. 53Our quarterly operating results may fluctuate significantly
9. 54Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions
10. 55Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, could adversely impact our business, financial condition and results of operations
11. 56If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline
12. 57The issuance of additional stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders47% rewritten
13. 58We incur significant costs and demands upon management as a result of being a public company
14. 59Changes in tax laws could adversely affect our business and financial condition91% rewritten
15. 60The increasing use of social media platforms presents new risks and challenges38% rewritten