Lisata Therapeutics (LSTA) risk factors, FY2024 10-K

RISKS RELATED TO OUR FINANCIAL CONDITION AND CAPITAL REQUIREMENTS

1. 01We have incurred substantial losses and negative cash flow from operations in the past and expect to continue to incur losses and negative cash flow for the foreseeable future
2. 02We anticipate that we will need substantial additional financing to continue our operations; if we are unable to raise additional capital, we may be forced to delay, reduce or eliminate one or more of our product development programs, and our business will be materially harmed
3. 03We have never generated any revenue from product sales and our ability to generate revenue from product sales and become profitable depends significantly on our success in a number of factors
4. 04guidelines, we may not generate significant revenue from sales of such products, even if approved. If we are not able to generate sufficient revenue from the sale of any approved products, we may never become profitable
5. 05Our ability to utilize our net operating loss carryforwards and tax credit carryforwards may be subject to limitations

RISKS RELATED TO OUR PRODUCT DEVELOPMENT EFFORTS

1. 06Our future success may be dependent on the timely and successful continued development and commercialization of our product candidates and if we encounter delays or difficulties in the development of these product candidates, our business prospects could be materially harmed
2. 07Even if we are able to successfully complete our clinical development programs for our product candidates and receive regulatory approval to market one or more of the products, if the commercial opportunities are smaller than we anticipate, our future revenues will be adversely affected, and our business may suffer
3. 08We may experience delays in enrolling patients in our clinical trials, which would delay or prevent the receipt of necessary regulatory approvals
4. 09We may not be able to file INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the regulators may not permit us to proceed
5. 10Results from a clinical trial, once completed, may be less clear than expected, which may hinder our efforts to obtain regulatory approval for our product candidates
6. 11We and our partners are conducting clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials
7. 12We may be unable to manage multiple late-stage clinical trials for a variety of product candidates simultaneously
8. 13Any disruption to our access to the reagents, devices, materials or equipment we are using in the clinical development of our product candidates would adversely affect our ability to perform clinical trials and seek future regulatory submissions
9. 14The initiation of pivotal Phase 3 clinical trials for our product candidates requires the validation and establishment of manufacturing controls that may delay product development timelines
10. 15Product candidates that appear promising in research and development may be delayed or may fail to reach later stages of clinical development
11. 16If serious or unacceptable side effects are identified during the development of any of our product candidates, we may need to abandon or limit our development of that product candidate
12. 17A breakthrough therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval
13. 18A Fast Track designation by the FDA and other similar regulatory designations may not lead to a faster development, regulatory review or approval process
14. 19Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization
15. 20industry experiencing significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization
16. 21We presently rely on contract manufacturing organizations to produce our product candidates at development and commercial scale quantities and have not yet qualified an alternate manufacturing supply, which could negatively impact our ability to meet any future demand for the products
17. 22The commercial potential and profitability of our product candidates are unknown and subject to significant risk and uncertainty
18. 23If competitors develop and market products that are more effective, safer, or less expensive than our product candidates or offer other advantages, our commercial prospects will be limited
19. 24We conduct significant operations through our Australian wholly-owned subsidiary. If we lose our ability to operate in Australia, or if the subsidiary is unable to receive the research and development tax credit allowed by Australian regulations, our business and results of operations will suffer
20. 25We may be subject to significant product liability claims and litigation, including potential exposure from the use of our product candidates in human subjects, and our insurance may be inadequate to cover claims that may arise
21. 26We may be unable to retain key officers or employees or hire new key officers or employees needed to implement our business strategy and develop our products and businesses
22. 27Our internal computer systems, or those used by our clinical investigators, clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of development programs for our product candidates
23. 28The increasing use of social media platforms presents new risks and challenges

RISKS RELATED TO MANUFACTURING OUR DEVELOPMENT PRODUCT CANDIDATES

1. 29We will need to improve manufacturing efficiency at our contract manufacturers in order to establish cost of goods levels that will permit approved products to succeed commercially
2. 30We have no internal capacity to manufacture our development product candidates and have no assurance that we will continue to have access to manufacturers in our industry that can effectively make our development products or make them at an affordable, salable or otherwise commercially reasonable price or quantity

RISKS RELATED TO SALES, MARKETING, AND COMPETITION

1. 31We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue
2. 32A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business
3. 33Even if we obtain regulatory approval of our product candidates, our products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community
4. 34If our product candidates are approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medical community, we will not be able to generate significant revenue
5. 35We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
6. 36Product candidates that we successfully develop and commercialize may compete with existing therapies and new therapies that may become available in the future

RISKS RELATED TO GOVERNMENT REGULATION

1. 37Any difficulties or failures that we encounter in securing regulatory approval for our product candidates would likely have a substantial adverse impact on our ability to generate product sales and could make any search for a collaborative partner more difficult
2. 38The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
3. 39We may be unsuccessful in our efforts to comply with applicable federal, state and international laws and regulations, which could result in government enforcement actions or impact our ability to secure regulatory approval of our product candidates
4. 40We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage
5. 41Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
6. 42laws, contractual damages, reputational harm, diminished profits and future earnings, and it may be required to curtail or restructure our operations, any of which could adversely affect our ability to operate our business and our results of operations
7. 43Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that it will be successful in obtaining regulatory approval of our product candidates in other jurisdictions
8. 44Health care companies have been the subject of federal and state investigations, and we could become subject to such investigations in the future
9. 45Similarly, the trend toward managed health care and bundled pricing for health care services in the United States, could significantly influence the purchase of health care services and products, resulting in lower prices and reduced demand for our therapeutic products under development
10. 46Legislation and legislative and regulatory proposals intended to contain health care costs may adversely affect our business
11. 47Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any
12. 48A variety of risks associated with operating our business internationally could materially adversely affect our business

RISKS RELATED TO OUR INTELLECTUAL PROPERTY

1. 49We may be unable to obtain or maintain patent protection for our products and product candidates, which could have a material adverse effect on our business
2. 50Litigation relating to intellectual property is expensive, time-consuming and uncertain, and we may be unsuccessful in our efforts to protect against infringement by third parties or defend ourselves against claims of infringement
3. 51If we are unable to maintain our licenses, patents or other intellectual property we could lose important protections that are material to continuing our operations and our future prospects
4. 52Additionally, our license agreements require us to meet certain diligence obligations in the development of the licensed products. Our failure to meet these diligence obligations could result in the loss of some or all of our rights, which could materially and adversely affect our business and future prospects
5. 53If we fail to comply with our obligations under these license agreements, or we are subject to a bankruptcy, the licensor may have the right to terminate the license, in which event we would not be able to market products covered by the license
6. 54the patent laws in the United States and other countries may diminish the value of patents or narrow the scope of patent protection
7. 55If we fail to comply with our obligations in any future agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with future licensors, we could lose license rights that are important to our business
8. 56We may not be successful in obtaining necessary additional rights to our product candidates through acquisitions and in-licenses
9. 57Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
10. 58We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property
11. 59We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses
12. 60If we do not obtain patent term extension and data exclusivity for any of our current or future product candidates we may develop, our business may be materially harmed
13. 61If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected
14. 62If we are unable to protect the confidentiality of trade secrets, our competitive position could be impaired
15. 63In certain countries, patent holders may be required to grant compulsory licenses, which would likely have a significant and detrimental effect on any future revenues in such country
16. 64Changes to U.S. patent law may have a material adverse effect on our intellectual property rights
17. 65Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts

RISKS RELATED TO OUR RELIANCE ON THIRD PARTIES

1. 66We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances, or licensing arrangements
2. 67Our manufacturing process needs to comply with regulatory authority regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals
3. 68If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages

RISKS RELATED TO MANAGING GROWTH AND EMPLOYEE MATTERS

1. 69We may need to grow the size of our organization, and may experience difficulties in managing this growth
2. 70If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
3. 71If 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
4. 72Data collection is governed by restrictive regulations governing the use, storage, processing and transfer of personal information
5. 73We may be unable to adequately protect our information systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal data, damage our reputation, and subject us to significant financial and legal exposure

RISKS RELATED TO OUR COMMON STOCK

1. 74Our stock price has been, and will likely continue to be, highly volatile
2. 75The market price of our common stock has been, and in the future may continue to be, highly volatile. For example, from January 1, 2024 through February 27, 2025 our common stock traded as low as $2.19 per share and as high as $4.20 per share
3. 76We may fail to comply with the continued listing requirements of the Nasdaq Capital Market, such that 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
4. 77compliance with the Minimum Bid Price Requirement, and while we have regained compliance, there can be no assurance that we will remain compliant with the Minimum Bid Price Requirement or any other Nasdaq continued listing requirements
5. 78In addition to potential dilution associated with potential future fundraising and strategic transactions, we currently have significant numbers of securities outstanding that are exercisable for our common stock, which could result in significant additional dilution and downward pressure on our stock price
6. 79Provisions in our amended and restated certificate of incorporation and by-laws and Delaware law may inhibit a takeover of us, which could limit the price investors might be willing to pay in the future for our common stock and could entrench management
7. 80Failure to maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business and stock price