Precigen (PGEN) risk factors, FY2025 10-K

Risks Related to Our Financial Position and Capital Needs

1. 01We are substantially dependent on the commercial success of PapzimeosNew
2. 02We have a history of net losses, and we may not achieve or maintain profitability46% rewritten
3. 03We expect our future capital requirements will be substantial and will depend on many factors21% rewritten
4. 04Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operationsNew
5. 05Failure of the U.S. federal government to manage its fiscal matters or to raise or further suspend the debt ceiling may expose us to increased financial and operational risk35% rewritten

Risks Related to the Discovery and Development of Our Product Candidates

1. 06We are heavily dependent on the successful commercialization of Papzimeos in the U.S. and other jurisdictions, where we may obtain regulatory approval, and our ability to advance our current and future product candidates through clinical trials, obtain marketing approval, and ultimately commercialize them
2. 07The market opportunities for our product and product candidates may be smaller than we estimate27% rewritten
3. 08The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be materially harmed
4. 09We may be unable to obtain FDA approval of our product candidates under applicable regulatory requirements. The denial or delay of any such approval would prevent or delay commercialization of our product candidates and adversely impact on our potential to generate revenue, our business, and our results of operations
5. 10Clinical development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and experience delays in developing and commercializing or be unable to develop or commercialize our current and future product candidates
6. 11We may find it difficult to enroll patients in clinical trials, which could delay or prevent us from proceeding with clinical trials
7. 12We may be required to suspend, repeat, or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, or the trials are not well designed
8. 13Papzimeos and our product candidates are novel, complex, and difficult to manufactureNew
9. 14Interim and preliminary results 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, validation, and verification procedures that could result in material changes in the final data
10. 15Our product and our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences
11. 16Even if we complete the necessary clinical trials, we cannot be certain when, or if, we will obtain regulatory approval to commercialize a product candidate, and the approval may be for a narrower indication than we seek55% rewritten
12. 17We may seek designation for our AdenoVerse platform technology as a designated platform technology, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval processNew

Risks Related to the Commercialization of our Product and Product Candidates and Other Legal Compliance Matters

1. 18Our product and product candidates may fail to achieve the degree of market acceptance by physicians, patients, third-party payers, and others in the medical community necessary for commercial success
2. 19Failure by us to maintain a manufacturing supply chain to appropriately and adequately supply Papzimeos for commercial and future clinical uses would adversely affect our ability to commercialize Papzimeos and our business and business prospects could be severely harmedNew
3. 20Delays in obtaining regulatory approval of manufacturing processes and facilities or disruptions in manufacturing processes may delay or disrupt our commercialization efforts
4. 21Obtaining and maintaining marketing approval of our product and current and future product candidates in one jurisdiction does not mean that we will be successful in obtaining and maintaining marketing approval of our product and current and future product candidates in other jurisdictions
5. 22We have limited experience as a commercial company and the sales, marketing, and distribution of Papzimeos or any future approved products may be unsuccessful or less successful than anticipated.New
6. 23future approved products, we may require significant additional capital and financial resources, we may not achieve or maintain profitability, and we may not be able to compete against more established companies in our industryNew
7. 24Our business may be adversely affected by current and potential future healthcare reforms38% rewritten
8. 25Defending against actions or investigations for violations of these laws and regulations, even if ultimately successful, will incur significant legal expenses and divert management's attention from the operation of our business34% rewritten
9. 26We may incur significant costs complying with environmental, health, and safety laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities
10. 27We are subject to certain United States and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations

Risks Related to Our Business Operations and Strategy

1. 28We may be sued for product liability
2. 29Our insurance policies are expensive and protect only from some business risks, which leaves us exposed to significant uninsured liabilities
3. 30The livestock products of Exemplar are subject to disease outbreaks that can increase the cost of production and/or reduce production harvests, and the loss of existing livestock would result in the loss of commercial technology
4. 31The markets for our product and product candidates are highly competitive. Competitors and potential competitors may develop products and technologies that make ours obsolete or garner greater market share than ours65% rewritten
5. 32In the area of infectious diseases, we have Papzimeos, which is based on our AdenoVerse immunotherapy platform, for the treatment of RRP. We believe there are competitors in this area, including INOVIO Pharmaceuticals with their investigational DNA vaccine INO-3107 targeting HPV6 and HPV11 antigensNew
6. 33If we lose key personnel, including key management personnel, or are unable to attract and retain additional personnel, it could delay our product development programs, harm our research and development efforts, and we may be unable to continue to commercialize our product and product candidates40% rewritten
7. 34We depend on sophisticated information technology and infrastructure
8. 35If we experience a significant breach of data security or disruption in our information systems, our business could be adversely affected
9. 36The effects of health epidemics, including the COVID-19 pandemic, could adversely affect our business operations, which could have a material adverse effect on our results of operations, cash flows, and financial position88% rewritten
10. 37aspects of our business, including developing some of our product candidates. These third parties may experience similar disruptions or negative impacts to their businesses due to epidemics, which may result in additional delays or otherwise adversely impact our operationsNew
11. 38We have international assets and may have international operations and additional international assets in the future. Our international operations and assets may be subject to various economic, social, and governmental risks
12. 39We may pursue strategic acquisitions and investments that could have an adverse impact on our business if they are unsuccessful
13. 40We cannot be certain that any acquisition will be successful or that we will realize the anticipated benefits of the acquisition. In particular, we may not be able to realize the strategic and operational benefits and objectives we had anticipated
14. 41Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited34% rewritten

Risks Related to Our Intellectual Property

1. 42Our ability to compete may decline if we do not adequately protect our proprietary technologies or if we lose some of our intellectual property rights through costly litigation or administrative proceedings23% rewritten
2. 43violation could require us to spend significant time and money and could prevent us from commercializing our technologies or impact our stock price
3. 44Obtaining 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
4. 45If we do not obtain additional protection under the Hatch-Waxman Amendments, other United States legislation, and similar foreign legislation by extending the patent terms and obtaining regulatory exclusivity for our technologies, our business may be materially harmed
5. 46If 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 could lose license rights that are important to our business
6. 47Enforcing our intellectual property rights may be difficult and unpredictable
7. 48We may not be able to enforce our intellectual property rights throughout the world
8. 49If our technologies or products using our technologies are stolen, misappropriated, or reverse engineered, others could use the technologies to produce competing technologies or products
9. 50Confidentiality agreements with employees and others may not adequately prevent disclosures of trade secrets and other proprietary information69% rewritten

Risks Related to Our Common Stock

1. 51Deficiency Letter had no immediate effect on the listing or trading of our common stock
2. 52Our quarterly and annual operating results may fluctuate in the future. As a result, we may fail to meet or exceed the expectations of research analysts or investors, which could cause our stock price to decline
3. 53Our stock price is volatile, and purchasers of our common stock could incur substantial losses
4. 54We do not anticipate paying cash dividends, and accordingly, shareholders will have to rely on any stock appreciation for return on their investment
5. 55If securities or industry analysts do not publish research or reports, or publish inaccurate or unfavorable research or reports about our business, our share price and trading volume could decline
6. 56Sales of a substantial number of shares of our common stock in the public market could occur at any time. This could cause the market price of our common stock to drop significantly, even if our business is doing well22% rewritten
7. 57Our articles of incorporation authorize us to issue preferred stock with terms that are preferential to those of our common stock
8. 58We are subject to anti-takeover provisions in our articles of incorporation and bylaws and under Virginia law that could delay or prevent an acquisition of our Company, even if the acquisition would be beneficial to our shareholders