Genprex (GNPX) risk factors, FY2024 10-K

Risks Related to Our Operations and Need for Additional Capital

1. 01We will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations
2. 02the economic and other terms, timing of and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future
3. 03Our recurring losses from operations have raised substantial doubt regarding our ability to continue as a going concern
4. 04We have never been profitable, we have no products approved for commercial sale, and to date we have not generated any revenue from product sales. As a result, our ability to reduce our losses and reach profitability is unproven, and we may never achieve or sustain profitability
5. 05We have a limited operating history and we expect a number of factors to cause our operating results to fluctuate on an annual basis, which may make it difficult to predict our future performance
6. 06Our ability to utilize our net operating loss carryforwards may be limited, resulting in income taxes sooner than currently anticipated

Risks Related to Development and Commercialization of Our Current and Future Product Candidates

1. 07Our success depends greatly on the success of our development of REQORSA for the treatment of NSCLC and SCLC, and our other product candidates, including GPX-002 for the treatment of diabetes
2. 08The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to change, including due to judicial challenges
3. 09If we are unable to secure contract manufacturers with capabilities to produce the products that we require, we could experience delays in conducting our planned clinical trials
4. 10Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may damage public perception of our current and potential product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our current and potential product candidates
5. 11Conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit
6. 12Delays in the commencement, enrollment and completion of clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for REQORSA and other current or future product candidates
7. 13Fast track designation of our products by FDA and designation under any other FDA expedited development program may not actually lead to a faster development or regulatory review or approval process, nor will it assure FDA approval of our product candidates
8. 14We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates
9. 15A product candidate can fail at any stage of preclinical and clinical development
10. 16unfavorable FDA or other regulatory agency inspection and review of a clinical trial site or vendor
11. 17Even if we obtain regulatory approval of our current and future product candidates, the products may not gain market acceptance among physicians, patients, hospitals, treatment centers, third-party payors and others in the medical community
12. 18REQORSA®, GPX-002, and other current or future product candidates may have undesirable side effects that may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales
13. 19If a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage, we could be forced to pay substantial damage awards that could materially harm our business
14. 20Security breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation to suffer
15. 21We face competition from other biotechnology and pharmaceutical companies, particularly those that are gene therapy companies, and our operating results will suffer if we fail to compete effectively
16. 22We cannot provide assurance that REQORSA, GPX-002, or any of our other current or future product candidates will receive regulatory approval, and without regulatory approval we will not be able to market them
17. 23may change approval policies or adopt new regulations
18. 24Even if we obtain regulatory approval for our product candidates, our products will remain subject to regulatory oversight
19. 25refuse to allow us to enter into supply contracts, including government contracts
20. 26If the FDA does not find the manufacturing facilities of our current or future contract manufacturers acceptable for commercial production, we may not be able to commercialize REQORSA, GPX-002, or any of our other current or future product candidates
21. 27the possibility of termination or nonrenewal of any manufacturing agreement we may enter into
22. 28state and foreign equivalents of each of the healthcare laws described above, among others, some of which may be broader in scope and may apply regardless of the payor
23. 29Coverage and reimbursement may be limited or unavailable in certain market segments for REQORSA, GPX-002, and our other current or future product candidates, if approved, which could make it difficult for us to sell REQORSA, GPX-002, and our other current or future product candidates profitably
24. 30neither experimental nor investigational
25. 31Concerns about gene therapy, genetic testing, and genetic research could result in new and/or additional government regulations and requirements that restrict or prohibit the processes we use or delay or prevent the regulatory approval of our current and potential product candidates
26. 32Healthcare legislative reform measures may have a material adverse effect on our business and results of operations
27. 33We are subject to a variety of risks associated with international operations which could materially adversely affect our business
28. 34If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business

Risks Related to Our Dependence on Third Parties

1. 35We may not be successful in establishing and maintaining development and commercialization collaborations, which could adversely affect our ability to develop our current and future product candidates and our financial condition and operating results could be adversely affected
2. 36When we collaborate with a third party for development and commercialization of a product candidate, we can expect to relinquish some or all of the control over the timing and future success of that product candidate to such third party
3. 37We rely, in part, and expect to continue to rely, in part, on third parties to conduct, supervise and monitor our clinical trials, and if these third parties perform in an unsatisfactory manner, it may harm our business
4. 38Changes in the U.S. political and regulatory environment could affect availability of government funding that we or our third party collaborators may rely on, which could negatively impact the development of our product candidates
5. 39We have completed and may in the future complete related party transactions that were not and may not be conducted on an arm’s length basis
6. 40Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations

Risks Related to Our Intellectual Property

1. 41the priority of invention of patented technology
2. 42The intellectual property rights we have licensed from MD Anderson and the University of Pittsburgh are subject to the rights of the U.S. government
3. 43If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate for our technology and product candidates, our competitive position could be harmed
4. 44Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts
5. 45We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses
6. 46Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information and may not adequately protect our intellectual property
7. 47Our reliance on third parties may require us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed
8. 48We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful
9. 49Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
10. 50Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court
11. 51We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
12. 52We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
13. 53Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
14. 54We may not be able to protect our intellectual property rights throughout the world

Risks Related to Employee Matters and Managing Growth

1. 55We have no sales, marketing or distribution experience and we will have to invest significant resources to develop those capabilities or enter into acceptable third-party sales and marketing arrangements
2. 56We may not be able to manage our business effectively if we are unable to attract and retain key personnel and consultants
3. 57We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success
4. 58If 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
5. 59our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs

Risks Related to our Securities

1. 60The market price of our common stock may be highly volatile, and you may lose all or part of your investment
2. 61General economic conditions in the United States and abroad; and other events or factors, many of which may be out of our control, including, but not limited to, pandemics, war, or other acts of God
3. 62An active, liquid and orderly market for our common stock may not be sustained, and you may not be able to sell your common stock
4. 63We are currently listed on The Nasdaq Capital Market. If we fail to regain compliance with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
5. 64Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price
6. 65Failure to maintain effective internal control over our financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley Act”) could cause our financial reports to be inaccurate
7. 66We have no intention of declaring dividends in the foreseeable future
8. 67We will likely continue to incur increased costs and devote additional management time to public company reporting and compliance obligations as a result of exiting “emerging growth company” status
9. 68Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall
10. 69Future sales and issuances of our securities could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall
11. 70If securities or industry analysts do not publish research or reports about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading volume could decline
12. 71Certain provisions in our organizational documents could enable our board of directors to prevent or delay a change of control
13. 72providing that special meetings of our stockholders may be called only by the Chairman of the board, our Chief Executive Officer or by the board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors
14. 73Obligations associated with being a public company in the United States are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters
15. 74Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
16. 75We may be at risk of securities class action litigation