Palisade Bio (PALI) risk factors, FY2025 10-K

Risks Related to Our Development, Commercialization and Regulatory Approval of Our Product Candidates

1. 01Our business depends on the successful clinical development, regulatory approval, and commercialization of our lead asset PALI-210833% rewritten
2. 02our ability and our applicable collaboration and licensing partners’ ability to establish and enforce intellectual property rights related to our product candidates and technologies48% rewritten
3. 03There are substantial risks in drug development, and, as a result, we may not be able to successfully develop any product candidate, including our lead clinical product candidate, PALI-2108
4. 04Clinical drug development is expensive, time-consuming and uncertain
5. 05We are currently conducting a Phase 1 clinical trial of PALI-2108 in Canada, and the FDA or applicable foreign regulatory authorities may not accept data from such trials, or any other trial we conduct outside of the U.S
6. 06the FDA’s consideration of the risk-benefit ratio for continuing clinical development in the U.S., particularly based on data from a non-U.S. population36% rewritten
7. 07Identifying and qualifying subjects to participate in our current and anticipated future clinical trials is critical to our success. Our inability to enroll patients in our clinical trials on a timely basis could result in the trials being delayed or never completedNew
8. 08ability to monitor patients adequately during and after treatment51% rewritten
9. 09We expect that our operations and development of PALI-2108 will require more capital than we currently have, and we cannot guarantee when or if we will be able to secure such additional funding69% rewritten
10. 10Our product candidates, including our lead clinical product candidate, PALI-2108, may cause undesirable side effects or have other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in post-approval regulatory action
11. 11There can be no assurance that our product candidates will obtain regulatory approval
12. 12adherence to cGMP regulations during production and storage23% rewritten
13. 13If clinical studies of PALI-2108 do not yield successful results, we may discontinue the development of PALI-2108
14. 14It may take us longer than we estimate to complete clinical trials, and we may not be able to complete them at all
15. 15Even if PALI-2108 is approved for commercialization, future regulatory reviews or inspections may result in its suspension or withdrawal, closure of a facility or substantial fines
16. 16The successful commercialization of PALI-2108, if approved, will depend in part on the extent to which government authorities and health insurers establish adequate reimbursement levels and pricing policies
17. 17We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product candidate and we may need to limit our commercialization
18. 18Even if a product candidate obtains regulatory approval, it may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success
19. 19potential product liability claims or other product-related litigation

Risks Related to Healthcare Laws and Other Legal Compliance Matters

1. 20Recent and future changes in healthcare legislation and regulations may increase the difficulty and cost to obtain marketing approval for a drug candidate, increase the costs to commercialize an approved product, and adversely affect the price set for such productNew
2. 21governments will pay for healthcare products and services, which could result in reduced demand or lower pricing for our product candidates, or additional pricing pressuresNew
3. 22Our business operations and current and future relationships with contractors, investigators, healthcare professionals, consultants, third-party payors, patient organizations, customers, and others will be subject to applicable healthcare regulatory laws, which could expose us to penaltiesNew
4. 23We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activitiesNew

Risks Related to Our Business

1. 24We have a limited operating history and have never generated any revenues from product sales31% rewritten
2. 25Our success depends on attracting and retaining senior management and scientists with relevant expertise
3. 26We may choose to discontinue the development or commercialization any of our product candidates, or may choose not to commercialize product candidates in approved indications, at any time during development or after approval, which could adversely affect us and our operations
4. 27Our inability to successfully in-license, acquire, develop and market additional product candidates or approved products could impair our ability to grow our business21% rewritten
5. 28including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictableNew

Risks Related to Our Dependence on Third Parties

1. 29We expect to rely on collaborations with third parties for the successful development and commercialization of our product candidates
2. 30We currently rely on third-party contractors to supply, manufacture and distribute clinical drug supplies for our product candidates

Risks Related to Our Financial Operations

1. 31We have a history of net operating losses, and we expect to continue to incur net operating losses and may never achieve profitability32% rewritten
2. 32Failure to remediate a material weakness in internal controls over financial reporting could result in material misstatements in our consolidated financial statements

Risks Related to Our Intellectual Property

1. 33We may not be able to obtain, maintain or enforce global patent rights or other intellectual property rights that cover our product candidates and technologies that are of sufficient breadth to prevent third parties from competing against us
2. 34We may not be able to protect our intellectual property rights throughout the world
3. 35Obtaining 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. 36If we fail to comply with our obligations under our intellectual property license agreements, we could lose license rights that are important to our business
5. 37We may be subject to patent infringement claims, which could result in substantial costs and liabilities, and could prevent us from commercializing our potential products
6. 38We may be subject to claims that our officers, directors, employees, consultants or independent contractors have wrongfully used or disclosed to us alleged trade secrets of their former employers or their former or current customers
7. 39We will need to raise additional financing in the future to fund our operations, which may not be available to us on favorable terms or at all
8. 40Our common stock price may be highly volatile
9. 41the loss of key personnel
10. 42Our common stock could be delisted from the Nasdaq Stock Market if we are unable to maintain compliance with the Nasdaq Stock Market’s continued listing standards71% rewritten
11. 43minimum bid price compliance letter from Nasdaq confirming that we regained compliance with Listing Rule 5550(a)(2), and that the matter is now closedNew
12. 44We take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our common stock being less attractive to investors
13. 45We do not anticipate paying any dividends in the foreseeable future
14. 46If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline
15. 47Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our management
16. 48If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired
17. 49Our Board has broad discretion to issue additional securities, which might dilute the net tangible book value per share of our common stock for existing stockholders
18. 50Our business could be adversely affected by the effects of health pandemics or epidemics, such as the COVID-19 pandemic, which could cause significant disruptions in our operations and those of our current or future CMOs, CROs, and other third parties upon whom we rely
19. 51Global economic conditions may have an adverse effect on our businessNew
20. 52Furthermore, our remote workforce poses increased risks to our information technology systems and data, as most of our employees work from home, utilizing network connections outside our premises
21. 53Our business and operations would suffer in the event of system failures, cyber-attacks or a deficiency in our cybersecurity