Alaunos Therapeutics (TCRT) risk factors, FY2024 10-K

RISKS RELATED TO OUR STRATEGIC REPRIORITIZATION

1. 01Even if we successfully consummate a transaction from our strategic assessment, we may fail to realize all of the anticipated benefits of the transaction, those benefits may take longer to realize than expected, or we may encounter integration difficulties
2. 02If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks
3. 03Any of the foregoing risks could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects
4. 04Our ability to consummate a strategic transaction depends on our ability to retain our remaining employee and consultants
5. 05Our corporate restructuring and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could significantly disrupt our business
6. 06We may become involved in litigation, including securities class action litigation, that could divert management’s attention and harm the Company’s business, and insurance coverage may not be sufficient to cover all costs and damages

RISKS RELATED TO OUR BUSINESS

1. 07Further, if our common stock is delisted, we would incur additional costs under state blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of our common stock and the ability of our stockholders to sell our common stock in the secondary market
2. 08The development and commercialization of non-viral adoptive TCR-T cell therapies could be considered a new approach to cancer treatment, the successful development of which is subject to significant challenges
3. 09unless we revoke the notice to terminate the Patent License or subsequently acquire substantially similar rights, our inability to use the technology currently licensed to us pursuant to the Patent License
4. 10Any termination of our licenses with MD Anderson or our research and development agreements with MD Anderson could result in the loss of significant rights and could significantly harm our ability to develop and commercialize our product candidates
5. 11the allocation of ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and by us
6. 12We may not be able to retain the rights licensed to us and Precigen by MD Anderson to technologies relating to TCR-T cell therapies and other related technologies
7. 13Should we resume development of our TCR-T product candidates, we may not be able to commercialize them, generate significant revenues, or attain profitability
8. 14Our operating history makes it difficult to evaluate our business and prospects
9. 15Conducting sales and marketing activities
10. 16Our business subjects us to the risk of liability claims associated with the use of hazardous materials and chemicals
11. 17We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits
12. 18A decline in our share price

RISKS RELATED TO THE PRECLINICAL, CLINICAL TESTING, GOVERNMENT REGULATION AND MANUFACTURING OF OUR PRODUCT CANDIDATES

1. 19We may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA must approve any replacement contractor
2. 20Our future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store, and distribute our products
3. 21Our future contract manufacturers may not perform as agreed or may remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our products
4. 22If any third party manufacturer makes improvements in the manufacturing process for our products, we may not own, or may have to share, the intellectual property rights to the innovations
5. 23regulatory determinations to temporarily or permanently cease enrollment for other reasons not related to patient safety
6. 24Each of these risks could delay our clinical trials, the approval, if any, of our product candidates by the FDA or the commercialization of our product candidates or result in higher costs or deprive us of potential product revenues
7. 25The risk that patients enrolled in clinical trials will drop out of the clinical trials before the manufacturing and infusion of our product candidates or clinical trial completion
8. 26Our product candidates are subject to extensive regulation and compliance, which is costly and time consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates, should we resume development
9. 27Such authorities may not accept a submission due to, among other reasons, the content or formatting of the submission
10. 28Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following any potential marketing approval
11. 29Any of the foregoing could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved. Furthermore, any of these occurrences may harm our business, financial condition and prospects significantly
12. 30demand for our product candidates, which could adversely and materially affect our ability to conduct clinical trials, should we resume them, which could significantly harm our business
13. 31We may have difficulty validating our manufacturing process as we manufacture our product candidates from an increasingly diverse patient population for our clinical trials, should we resume these activities
14. 32The gene transfer vectors from our Sleeping Beauty system used to manufacture our TCR-T product candidates may incorrectly modify the genetic material of a patient’s T cells, potentially triggering the development of a new cancer or other adverse events
15. 33Injunctions or the imposition of civil or criminal penalties

RISKS RELATED TO OUR ABILITY TO COMMERCIALIZE OUR PRODUCT CANDIDATES

1. 34Our inability to obtain the necessary U.S. or worldwide regulatory approvals to commercialize any product candidate would cause our business to suffer significantly
2. 35Diminish any competitive advantages that we may otherwise enjoy
3. 36If we are unable either to create sales, marketing and distribution capabilities or enter into agreements with third parties to perform these functions, we will be unable to commercialize our product candidates successfully
4. 37If physicians and patients do not accept and use our product candidates, once approved, our ability to generate revenue from sales of our products will be materially impaired
5. 38The price at which we sell our products
6. 39Our ability to generate product revenues will be diminished if our products do not obtain coverage and adequate reimbursement from payors
7. 40The market opportunities for our TCR-T product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small
8. 41may not be amenable to treatment with our product candidates. Our market opportunities may also be limited by competitor treatments that may enter the market
9. 42In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory enactments in recent years that change the healthcare system in ways that could impact our future ability to sell our product candidates profitably
10. 43If we fail to comply with federal and state healthcare laws, including fraud and abuse and health information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, cash flows and prospects could be materially and adversely affected
11. 44To the extent that any of our product candidates is ultimately sold in a foreign country, we may be subject to similar foreign laws and regulations

RISKS RELATED TO OUR INTELLECTUAL PROPERTY

1. 45If we or our licensors fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish and our ability to successfully develop our product candidates may be materially impaired
2. 46That we will not need to initiate litigation and/or administrative proceedings that may be costly whether we win or lose
3. 47If we are unable to protect the confidentiality of our confidential information, our business and competitive position would be significantly harmed
4. 48Third-party claims of intellectual property infringement would require us to spend significant time and money and could prevent us from developing or commercializing our products
5. 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 noncompliance with these requirements
6. 50In addition, in certain cases, the rights licensed to us are rights of a third party licensed to our licensor. In such instances, if our licensors do not comply with their obligations under such licenses, our rights under our license agreements with our licensor may be adversely affected
7. 51We may be subject to claims by third parties asserting that our employee or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property
8. 52Our stock price has been, and may continue to be, volatile
9. 53Changes in accounting principles
10. 54Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us, which may be beneficial to our stockholders, more difficult
11. 55Because we do not expect to pay dividends, you will not realize any income from an investment in our common stock unless and until you sell your shares at a profit
12. 56Our ability to use net operating loss carryforwards and research tax credits to reduce future tax payments may be limited or restricted
13. 57If securities' and/or industry analysts' recommendations change adversely or if our business, financial condition, results of operations, cash flows or prospects do not meet their expectations, our stock price and trading volume could significantly decline
14. 58Our business could be materially and negatively affected as a result of the actions of activist stockholders
15. 59Our principal stockholders, executive officers and directors have substantial control over the Company, which may prevent you and other stockholders from influencing significant corporate decisions and may significantly harm the market price of our common stock
16. 60Discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us
17. 61We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors