Longeveron (LGVN) risk factors, FY2024 10-K

Risks Related to our Business

1. 01We have a limited operating history and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability
2. 02If the potential of our product candidates to treat diseases is not realized, the value of our technology and our development programs could be significantly reduced
3. 03Our product development programs are based on novel technologies and are inherently risky
4. 04If we are not able to recruit and retain qualified management and scientific personnel, we may fail in developing our technologies and product candidates
5. 05Our product candidates represent new classes of therapy that the marketplace may not understand or accept
6. 06Our dependence upon a limited supply of bone marrow donors and biologic growth media may impact our ability to produce sufficient quantities of our product candidates as needed to complete our clinical trials, and if our trials are successful and our products are approved, to meet product demand
7. 07Mesenchymal stem cells are biological entities derived from human bone marrow and therefore have the potential for disease transmission and can pose risks to the recipient
8. 08If our processing and storage facility or our clinical manufacturing facilities are damaged or destroyed, our business and prospects could be negatively affected
9. 09Ethical and other concerns surrounding the use of stem cell therapy or human tissue may negatively affect public perception of us or our future products or product candidates, or may negatively affect regulatory approval of our future products or product candidates, thereby reducing demand for our future products
10. 10We may eventually compete for product sales with other companies, many of which will have greater resources or capabilities than we have, or may succeed in developing better products or in developing products more quickly than we do, and we may not compete successfully with them
11. 11Sales of our products may involve a lengthy sales cycle
12. 12We have ongoing challenges with respect to our liquidity and access to capital
13. 13We face risks related to health epidemics, pandemics, and outbreaks
14. 14Adverse global conditions, including macroeconomic uncertainty, may negatively impact our financial results
15. 15We have a history of losses and may not be able to achieve profitability going forward, and may not be able to raise additional capital necessary to continue as a going concern
16. 16adjustments that might result from the outcome of this going concern uncertainty and have been prepared under the assumption that we will continue to operate as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business
17. 17We have been funded in part by government and non-profit association grant awards, which is not a guaranteed source of future funding
18. 18The use of our product candidates or future products in individuals may expose us to product liability claims, and we may not be able to obtain adequate product liability insurance coverage
19. 19We face risks with respect to our contract development and manufacturing business

Risks Related to Intellectual Property

1. 20If our trade secret and patent position does not adequately protect our product candidates and their uses, others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition and results of operations
2. 21If certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected
3. 22If we are unable to protect the confidentiality of our proprietary information, trade secrets, and know-how, our competitive position could be impaired and our business, financial condition, results of operations, and prospects could be adversely affected
4. 23Third-party claims of intellectual property infringement may prevent or delay our product development efforts
5. 24We may become involved in lawsuits to protect or enforce our patents or the patents of our collaborators or licensors, which could be expensive and time consuming
6. 25Our industry is highly competitive and subject to significant or rapid technological change
7. 26If all of the Company’s intellectual property has not been properly assigned to the Company, our business, financial condition, results of operation, and prospects could be adversely affected
8. 27Intellectual property rights do not necessarily address all potential threats to our competitive advantage
9. 28Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline
10. 29Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents
11. 30Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
12. 31Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
13. 32If we or our licensors do not obtain patent term extension for our product candidates and/or methods of their use, our business may be materially harmed
14. 33We may not be able to protect our intellectual property rights throughout the world
15. 34Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements

Risks Related to Regulatory Approval and Other Government Regulations

1. 35If we are not able to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals, we may not generate sufficient revenues to continue our business operations
2. 36The FDA or other comparable foreign regulatory authorities may require us to submit additional data such as long-term toxicology studies or may impose other requirements before permitting us to initiate or complete a clinical trial
3. 37We cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals
4. 38If we are not able to conduct our clinical trials properly and on schedule, marketing approval by FDA and other regulatory authorities may be delayed or denied
5. 39Final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues
6. 40There has been very little success in gaining FDA approval for an Alzheimer’s disease drug, and we have not had success to date in developing Alzheimer’s disease therapeutics
7. 41We may not be able to secure and maintain research institutions to conduct our clinical trials
8. 42Our business involves the use of hazardous materials that could expose us to environmental and other liability
9. 43consent decrees or injunctions or the imposition of civil or criminal penalties, or the invocation of the FDA's Application Integrity Policy
10. 44Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations
11. 45Healthcare reform in the U.S. and other countries may materially and adversely affect us
12. 46the level of taxes that we are required to pay
13. 47Prescription Drug Pricing Reduction Act

Risks Related to Our Dependence on Third Parties

1. 48We rely on third parties to serve as local representatives in foreign jurisdictions where we perform our clinical trials
2. 49Use of third-party manufacturers may increase the risk that we will not have adequate quantities of our product candidates
3. 50If we decide to use third-party manufacturers in the future, they will likely be dependent upon their own third-party suppliers, making us vulnerable to supply shortages and price fluctuations, which could harm our business
4. 51fluctuation in delivery by the suppliers due to changes in demand from us, our third-party manufacturers or their other customers
5. 52We will depend on third-party distributors in the future to market and sell our future products which will subject us to a number of risks
6. 53The successful commercialization of our current or future product candidates will depend on obtaining reimbursement from government and third-party payors, and price controls in foreign markets could adversely affect our future profitability
7. 54We may enter into arrangements with third-party collaborators to help us develop our product candidates and commercialize our products, and our ability to commercialize such products may be impaired or delayed if collaborations are unsuccessful
8. 55If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks
9. 56our inability to generate revenue from acquired technology, product candidates and/or approved products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs
10. 57Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading

Risks Related to the Discovery, Development and Commercialization of Our Product Candidates

1. 58Interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data
2. 59We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on other product candidates or indications that may be more profitable or for which there is a greater likelihood of success
3. 60The U.S. FDA, Japanese PMDA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction
4. 61Obtaining and maintaining regulatory approval of a product in one jurisdiction does not mean that we will be successful in obtaining or maintaining regulatory approval in other jurisdictions
5. 62The FDA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses
6. 63We may attempt to secure approval from the FDA or comparable foreign regulatory authorities through an expedited review program, and if we are unable to do so, then we could face increased expense to obtain, and delays in the receipt of, necessary marketing approvals
7. 64We may face difficulties from changes to current regulations and future legislation, both in the U.S. as well as in other foreign jurisdictions where we may be operating
8. 65challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future
9. 66The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel, collection of user fees, and statutory, regulatory, and policy changes
10. 67If 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 our business, financial condition, and results of operations
11. 68We may not be successful in our efforts to identify or discover additional product candidates in the future
12. 69potential product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to receive marketing approval and achieve market acceptance
13. 70Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing

Risks Related to Our Class A Common Stock and the Securities Market

1. 71The price of our Class A common stock has been, and may continue to be, volatile, which could result in substantial or total losses for investors
2. 72general economic, industry and market conditions
3. 73There may not be sufficient liquidity in the market for our securities in order for investors to sell their shares
4. 74We will need to raise substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, scale back or discontinue some of our product candidate development programs or commercialization efforts
5. 75Identifying potential current or future product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve drug sales
6. 76Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our current or future product candidates
7. 77The dual-class structure of our common stock may adversely affect the trading market for our Class A common stock
8. 78Holders of our Class B common stock exert considerable control over the direction of our business and their ownership of our Class B common stock can prevent other stockholders from influencing significant decisions
9. 79If securities or industry analysts do not publish research or reports, or if they publish negative, adverse, or misleading research or reports, regarding us, our business or our market, our Class A common stock price and trading volume could decline
10. 80FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our securities
11. 81Provisions in our Certificate of Incorporation and Bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock
12. 82require a super-majority vote of stockholders to amend some of the provisions described above
13. 83We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our common stock less attractive to investors
14. 84common stock less attractive as a result, there may be a less active trading market for our Class A common stock and our stock price may be more volatile
15. 85The issuance of additional stock in connection with acquisitions or otherwise will dilute all other stockholdings

Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business

1. 86We have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators
2. 87In order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth
3. 88improving our operational, financial and management controls, reporting systems and procedures
4. 89have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities
5. 90Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
6. 91A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business
7. 92The increasing use of social media platforms presents new risks and challenges