Precigen (PGEN) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Capital Needs

1. 01We have identified conditions that raise substantial doubt about our ability to continue as a going concern and we may need substantial additional capital in the future in order to fund our business
2. 02We have a limited number of shares of common stock available for future issuance which could adversely affect our ability to raise capital or consummate strategic transactions
3. 03Our strategic prioritization and streamlining of resources undertaken to extend our cash runway and focus more of our capital resources on PRGN-2012 might not achieve our intended outcome
4. 04We have a history of net losses, and we may not achieve or maintain profitability
5. 05We expect our future capital requirements will be substantial and will depend on many factors
6. 06Failure 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 risk

Risks Related to the Discovery and Development of Our Product Candidates

1. 07Our business is dependent on our ability to advance our current and future product candidates through clinical trials, obtain marketing approval, and ultimately commercialize them
2. 08The market opportunities for our product candidates may be smaller than we estimate
3. 09The 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. 10We 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. 11Clinical 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. 12We may find it difficult to enroll patients in clinical trials, which could delay or prevent us from proceeding with clinical trials
7. 13We 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. 14Cell and gene therapies are novel, complex, and difficult to manufacture
9. 15Interim 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. 16Our 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. 17Even 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 seek
12. 18We have chosen to prioritize development of certain of our product candidates. We may expend our limited resources on product candidates or indications that do not yield a successful product and fail to capitalize on other opportunities for which there may be a greater likelihood of success or may be more profitable

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

1. 19Even if a current or future product candidate receives marketing approval, it 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. 20Delays in obtaining regulatory approval of manufacturing processes and facilities or disruptions in manufacturing processes may delay or disrupt our commercialization efforts
3. 21Obtaining and maintaining marketing approval of our current and future product candidates in one jurisdiction does not mean that we will be successful in obtaining and maintaining marketing approval of our current and future product candidates in other jurisdictions
4. 22As a company, we have never commercialized a product, we currently have no active sales force and we may lack the necessary expertise, personnel and resources to successfully commercialize our product candidates
5. 23Our business may be adversely affected by current and potential future healthcare reforms
6. 24Defending 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 business
7. 25Contractual Clauses or the U.K. Government-approved International Data Transfer Agreement) to establish or maintain legitimate means for the transfer and receipt of personal data from the European Economic Area and the United Kingdom to the United States
8. 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
9. 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 our Exemplar reporting segment 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 in which we are developing candidate products using our technologies are highly competitive. Competitors and potential competitors may develop products and technologies that make ours obsolete or garner greater market share than ours
5. 32If 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 candidates
6. 33not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience staffing constraints that will adversely affect our ability to support our internal research and development programs or meet other demands
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 position
10. 37We have international operations and assets and may have additional international operations and assets in the future. Our international operations and assets may be subject to various economic, social, and governmental risks
11. 38We may pursue strategic acquisitions and investments that could have an adverse impact on our business if they are unsuccessful
12. 39We 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
13. 40Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited

Risks Related to Our Intellectual Property

1. 41Our 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 proceedings
2. 42Litigation or other proceedings or third-party claims of intellectual property infringement, misappropriation or other violation could require us to spend significant time and money and could prevent us from commercializing our technologies or impact our stock price
3. 43Obtaining 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. 44If 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. 45If 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. 46Enforcing our intellectual property rights may be difficult and unpredictable
7. 47We may not be able to enforce our intellectual property rights throughout the world
8. 48If 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. 49Confidentiality agreements with employees and others may not adequately prevent disclosures of trade secrets and other proprietary information

Risks Related to Our Common Stock

1. 50Deficiency Letter had no immediate effect on the listing or trading of our common stock
2. 51Our 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. 52Our stock price is volatile, and purchasers of our common stock could incur substantial losses
4. 53We do not anticipate paying cash dividends, and accordingly, shareholders will have to rely on any stock appreciation for return on their investment
5. 54If 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. 55We have engaged in transactions with companies in which Randal J. Kirk, our Executive Chairman, and his affiliates have an interest
7. 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 well
8. 57Our articles of incorporation authorize us to issue preferred stock with terms that are preferential to those of our common stock
9. 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