Lisata Therapeutics (LSTA) risk factors, FY2025 10-K

RISKS RELATED TO THE PROPOSED ACQUISITION BY KUVA

1. 01The proposed acquisition by Kuva is subject to a number of conditions beyond our control. Failure to complete the proposed acquisition within the expected time frame, or at all, could have a material adverse effect on our business, operating results, financial condition and our stock priceNew

RISKS RELATED TO OUR FINANCIAL CONDITION AND CAPITAL REQUIREMENTS

1. 02We 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 future38% rewritten
2. 03We 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 some or all of our product development programs, and our business will be materially harmed
3. 04There is substantial doubt regarding our ability to continue as a going concernNew
4. 05We 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 factors44% rewritten
5. 06Our ability to utilize our net operating loss carryforwards and tax credit carryforwards may be subject to limitations77% rewritten

RISKS RELATED TO OUR PRODUCT DEVELOPMENT EFFORTS

1. 07Our 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. 08Even 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. 09We may experience delays in enrolling patients in our clinical trials, which would delay or prevent the receipt of necessary regulatory approvals
4. 10We 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. 11Results 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. 12We and our partners are conducting clinical trials for product candidates in many countries outside of the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials where the preponderance of data are generated in a foreign jurisdiction
7. 13We may be unable to manage multiple late-stage clinical trials for a variety of product candidates simultaneously
8. 14Any 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. 15The 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. 16Product candidates that appear promising in research and development may be delayed or may fail to reach later stages of clinical development
11. 17If 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. 18A breakthrough therapy designation by the FDA, even if granted for any of our product candidates, is no guarantee of 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. 19A Fast Track designation by the FDA and other similar regulatory designations is no guarantee of a faster development, regulatory review or approval process62% rewritten
14. 20Accelerated or provisional approval by the FDA or other relevant regulatory authority, even if granted for certepetide or future product candidates, is no guarantee of faster market introduction and it does not increase the likelihood that our product candidates will receive full marketing approvalNew
15. 21Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization
16. 22industry 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
17. 23We 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
18. 24The commercial potential and profitability of our product candidates are unknown and subject to significant risk and uncertainty
19. 25If competitors develop and market products that are more effective, safer, and/or less expensive than our product candidates or offer other advantages, our commercial prospects will be limited or eliminated
20. 26We conduct significant operations through our wholly-owned Australian 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
21. 27We 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 arise49% rewritten
22. 28Whether or not we are ultimately successful in any product liability litigation that may arise, such litigation could consume substantial amounts of our financial and managerial resources, decrease demand for our products and injure our reputationNew
23. 29We 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
24. 30Our 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
25. 31The increasing use of social media platforms presents new risks and challenges including but not limited to the dissemination of disinformation, false or misleading accusations, incorrect statements and/or inaccurate statements or data generated by individuals or through use of artificial intelligenceNew

RISKS RELATED TO MANUFACTURING OUR DEVELOPMENT PRODUCT CANDIDATES

1. 32Contract development and manufacturing organizations have a finite manufacturing capacity, which could inhibit the long-term growth prospects of our businessNew
2. 33We 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
3. 34We 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. 35We 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. 36A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business
3. 37Even 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. 38If 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. 39We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
6. 40Product 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. 41Any 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. 42The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
3. 43We 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. 44We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage
5. 45Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements21% rewritten
6. 46Obtaining 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
7. 47Healthcare companies have been the subject of federal and state investigations, and we could become subject to such investigations in the future
8. 48Similarly, the trend toward managed healthcare and bundled pricing for healthcare services in the United States, could significantly influence the purchase of healthcare services and products, resulting in lower prices and reduced demand for our therapeutic products under development
9. 49Legislation and legislative and regulatory proposals intended to contain healthcare costs may adversely affect our business24% rewritten
10. 50Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any42% rewritten
11. 51A variety of risks associated with operating our business internationally could materially adversely affect our business

RISKS RELATED TO OUR INTELLECTUAL PROPERTY

1. 52We 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. 53Litigation 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. 54If 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. 55Additionally, 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. 56If 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 license52% rewritten
6. 57If 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
7. 58We may not be successful in obtaining necessary additional rights to our product candidates through acquisitions and in-licenses
8. 59Obtaining 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
9. 60We 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
10. 61We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses
11. 62If 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
12. 63If 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
13. 64If we are unable to protect the confidentiality of trade secrets, our competitive position could be impaired
14. 65In 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
15. 66Changes to U.S. patent law may have a material adverse effect on our intellectual property rights
16. 67Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts

RISKS RELATED TO OUR RELIANCE ON THIRD PARTIES

1. 68We 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. 69Our 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. 70If 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. 71We may need to grow the size or change the structure of our organization, and may experience difficulties in managing this growth or change
2. 72If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
3. 73If 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. 74Data collection is governed by restrictive regulations governing the use, storage, processing and transfer of personal information
5. 75We 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 exposure51% rewritten
6. 76state (e.g., state breach notification laws), federal (e.g., HIPAA, as amended by HITECH), and international law (e.g., the GDPR) and may cause a material adverse impact to our reputation, affect our ability to conduct new studies and potentially disrupt our businessNew

RISKS RELATED TO OUR COMMON STOCK

1. 77Our stock price has been, and will likely continue to be, highly volatile
2. 78The market price of our common stock has been, and in the future may continue to be, highly volatile. For example, from January 1, 2025 through March 12, 2026 our common stock traded as low as $1.81 per share and as high as $5.07 per share
3. 79We 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 impacted65% rewritten
4. 80In addition to potential dilution associated with potential future fundraising and strategic transactions, we currently have securities outstanding that are exercisable for our common stock, which could result in significant additional dilution and downward pressure on our stock price22% rewritten
5. 81Provisions 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
6. 82Failure 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