Longeveron (LGVN) FY2025 10-K Risk Factors: 21 New, 17 Dropped

What the changes say

Longeveron faces concentrated risks around its lead bone marrow-derived cell therapy, laromestrocel, and Alzheimer's disease development.
Supply limits on bone marrow donors and biologic media threaten production scale for clinical and commercial demands.
Complex manufacturing validation and regulatory hurdles under Trump administration policies create significant uncertainties.

What changed since the prior 10-K

New

NewRisks Related to our Business
If the healthcare community does not accept our investigational product candidates or future approved products for any of the foregoing reasons, or for any other reason, it could affect our sales or have a material adverse effect on our business, financial condition, results of operations, and prospects
Bone marrow donor limits of ages 18 to 45 and max six lifetime donations restrict our manufacturing supply for laromestrocel.
NewRisks Related to Regulatory Approval and Other Government Regulations
We are substantially dependent on the successful development, regulatory approval and commercialization of laromestrocel, and we cannot assure you that we will obtain regulatory approval or successfully commercialize this investigational therapy
Our business is substantially dependent on the success of our lead mesenchymal stem cell therapy, laromestrocel, for Alzheimer's and other indications.
NewRisks Related to Regulatory Approval and Other Government Regulations
one or more IRBs suspends or terminates the trial at an investigational site, precludes enrollment of additional subjects, or withdraws its approval of the trial
Institutional Review Board suspensions or terminations of clinical trials at trial sites could increase our development costs.
NewRisks Related to Regulatory Approval and Other Government Regulations
Even if we complete clinical development, regulatory approval may be delayed, limited, or subject to burdensome conditions, which could materially affect our commercial prospects
Regulatory approvals may be delayed or subject to restrictive labeling, post-marketing requirements, or Complete Response Letters from the FDA.
NewRisks Related to Regulatory Approval and Other Government Regulations
Alzheimer’s disease drug development has historically had a high rate of failure, and we may not be successful in developing an effective therapy for this indication
Alzheimer's disease drug development has a high historical failure rate due to lack of efficacy and safety concerns.
NewRisks Related to Regulatory Approval and Other Government Regulations
Our CMC readiness and ability to manufacture laromestrocel for commercialization and any future product candidates for clinical or commercialization may require significant additional investment, be delayed or be unsuccessful
Chemistry, manufacturing, and controls (CMC) readiness and BLA-enabling activities require significant investment and face complex regulatory review.
NewRisks Related to Regulatory Approval and Other Government Regulations
First Trump Administration
Prior federal budget proposals under the first Trump Administration sought to reduce drug prices and cap Medicare Part D out-of-pocket expenses.
NewRisks Related to Regulatory Approval and Other Government Regulations
Second Trump Administration
Recent executive orders from the second Trump Administration target federal agency operations, drug cost regulations, and domestic medicine production.
NewRisks Related to Regulatory Approval and Other Government Regulations
evaluating the effectiveness of the Food Safety Modernization Act
State-level pricing constraints and hospital bidding procedures could reduce ultimate commercial demand for our approved products.
NewRisks Related to Our Dependence on Third Parties
Our reliance on third-party manufacturers and technology transfer activities introduces additional CMC and regulatory risk
We rely on third-party CDMOs whose technology transfer complexities and cGMP compliance issues could delay our programs.
NewRisks Related to Our Dependence on Third Parties
Regulatory inspections of our facilities or those of our third-party manufacturers could result in findings that delay or prevent approval
Pre-approval and routine regulatory inspections of our manufacturing facilities could result in warning letters or enforcement actions.
NewRisks Related to Our Dependence on Third Parties
We may engage in future acquisitions, strategic partnerships, mergers, or the sale and/or licensing of our intellectual property, which could disrupt our business, increase our capital requirements, dilute our stockholders, harm our financial condition and operating results, and subject us to other risks
Future acquisitions, strategic partnerships, or licensing of intellectual property could disrupt our business and increase capital requirements.
NewRisks Related to Our Dependence on Third Parties
federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations
NewRisks Related to the Discovery, Development and Commercialization of Our Investigational Product Candidates
The FDA’s RMAT and Fast Track designations for laromestrocel for mild AD does not guarantee that laromestrocel will be developed or approved faster, or more successfully, than if these designations were not granted, and FDA could rescind these designations if the qualifying criteria are no longer met
NewRisks Related to the Discovery, Development and Commercialization of Our Investigational Product Candidates
impaired. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs
NewRisks Related to Our Class A Common Stock and the Securities Market
the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our current or future investigational product candidates
NewRisks Related to Our Class A Common Stock and the Securities Market
Minimum Bid Price Requirement
NewRisks Related to Our Class A Common Stock and the Securities Market
Audit Committee Composition
NewRisks Related to Our Class A Common Stock and the Securities Market
Non-Voting Convertible Preferred Stock with the Secretary of State of the State of Delaware (the “Certificate of Designation”) in connection with the Private Placement. The Certificate of Designation provides for the issuance of up to 26,975 authorized shares of the Company’s Series A Preferred Stock
NewRisks Related to Our Class A Common Stock and the Securities Market
stock that is held by non-affiliates to exceed $700.0 million as of the prior June 30th, and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period
NewRisks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business
We may be required to implement employee furloughs or other workforce reductions, which could adversely affect our business, financial condition, and results of operations

Dropped

DroppedRisks Related to our Business
Our 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
DroppedRisks Related to our Business
Ethical 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
DroppedRisks Related to our Business
adjustments 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
DroppedRisks Related to Regulatory Approval and Other Government Regulations
The 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
DroppedRisks Related to Regulatory Approval and Other Government Regulations
Final 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
DroppedRisks Related to Regulatory Approval and Other Government Regulations
There 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
Limited supply of bone marrow donors and biologic growth media.
DroppedRisks Related to Regulatory Approval and Other Government Regulations
We may not be able to secure and maintain research institutions to conduct our clinical trials
DroppedRisks Related to Regulatory Approval and Other Government Regulations
Healthcare reform in the U.S. and other countries may materially and adversely affect us
DroppedRisks Related to Regulatory Approval and Other Government Regulations
Prescription Drug Pricing Reduction Act
Ethical concerns and public perception regarding stem cell therapy.
DroppedRisks Related to Our Dependence on Third Parties
If 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
DroppedRisks Related to the Discovery, Development and Commercialization of Our Product Candidates
challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future
DroppedRisks Related to the Discovery, Development and Commercialization of Our Product Candidates
The 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
DroppedRisks Related to the Discovery, Development and Commercialization of Our Product Candidates
Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing
DroppedRisks Related to Our Class A Common Stock and the Securities Market
Identifying 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
DroppedRisks Related to Our Class A Common Stock and the Securities Market
Holders 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
DroppedRisks Related to Our Class A Common Stock and the Securities Market
common 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
Going concern uncertainty and potential asset liquidation values.
DroppedRisks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business
have 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

Reworded

100% rewrittenRisks Related to Regulatory Approval and Other Government Regulations
the level of taxes that we are required to pay
Updated to detail the Budget Control Act of 2011 and automatic 2% Medicare payment reductions through 2030.
99% rewrittenRisks Related to Regulatory Approval and Other Government Regulations
We cannot market and sell our investigational product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals, which are subject to significant uncertainty and may be delayed or never obtained
Added specific references to commercializing laromestrocel, rigorous CMC requirements, and potential FDA study design disagreements.
Was: We cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals
97% rewrittenRisks Related to Regulatory Approval and Other Government Regulations
Ongoing healthcare legislative and regulatory reform measures in the U.S. and other countries may have a material adverse effect on our business and results of operations
Refined language regarding evolving legislative landscapes, healthcare spending policies, and future product labeling.
Was: Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations
96% rewrittenRisks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business
improving our operational, financial and management controls, reporting systems and procedures
Added discussion on management distraction from growth activities and reliance on independent consultants for clinical development.
94% rewrittenRisks Related to the Discovery, Development and Commercialization of Our Investigational Product Candidates
potential investigational 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
Added explicit compliance risks under the U.S. Foreign Corrupt Practices Act (FCPA) and international trade sanctions.
Was: potential 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
89% rewrittenRisks Related to the Discovery, Development and Commercialization of Our Investigational Product Candidates
We 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
Integrated cross-references to changing regulatory policies and administrative actions impacting marketing approvals.
86% rewrittenRisks Related to Regulatory Approval and Other Government Regulations
If we are not able to successfully develop and commercialize our investigational product candidates and obtain the necessary regulatory approvals, we may not generate sufficient revenues to continue our business operations
Streamlined language regarding the necessity of clinical trials and regulatory approvals to prevent cessation of business operations.
Was: If 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
80% rewrittenRisks Related to Regulatory Approval and Other Government Regulations
Our business involves the use of hazardous materials that could expose us to environmental and other liability
Maintained existing hazard disclosure regarding contract facilities in Florida subject to OSHA and environmental laws.
80% rewrittenRisks Related to Our Dependence on Third Parties
our inability to generate revenue from acquired technology, investigational 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
Was: our 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
75% rewrittenRisks Related to our Business
We face risks with respect to our contract development and manufacturing business
73% rewrittenRisks Related to our Business
We 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
69% rewrittenRisks Related to Our Dependence on Third Parties
Our 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
61% rewrittenRisks Related to Our Class A Common Stock and the Securities Market
The dual-class structure of our common stock may adversely affect the trading market for our Class A common stock
61% rewrittenRisks Related to Our Class A Common Stock and the Securities Market
We 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 investigational product candidate development programs or commercialization efforts
Was: We 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
58% rewrittenRisks Related to Our Class A Common Stock and the Securities Market
Any 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 investigational product candidates
Was: Any 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
58% rewrittenRisks Related to our Business
If our processing and storage facility or our clinical manufacturing facilities are damaged or destroyed, our business and prospects could be negatively affected
46% rewrittenRisks Related to Regulatory Approval and Other Government Regulations
consent decrees or injunctions or the imposition of civil or criminal penalties, or the invocation of the FDA's Application Integrity Policy
44% rewrittenRisks Related to the Discovery, Development and Commercialization of Our Investigational Product Candidates
We 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
40% rewrittenRisks Related to Intellectual Property
Obtaining 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
39% rewrittenRisks Related to the Discovery, Development and Commercialization of Our Investigational Product Candidates
We may not be successful in our efforts to identify or discover additional investigational product candidates in the future
Was: We may not be successful in our efforts to identify or discover additional product candidates in the future
38% rewrittenRisks Related to our Business
Our investigational product candidates represent new classes of therapy that the marketplace may not understand or accept
Was: Our product candidates represent new classes of therapy that the marketplace may not understand or accept
35% rewrittenRisks Related to our Business
If the potential of our investigational product candidates to treat diseases is not realized, the value of our technology and our development programs could be significantly reduced
Was: If 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
31% rewrittenRisks Related to Regulatory Approval and Other Government Regulations
If we are not able to conduct our clinical trials properly and on schedule, marketing approval by the FDA and other regulatory authorities may be delayed or denied
Was: If 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
30% rewrittenRisks Related to our Business
Sales of our future products may involve a lengthy sales cycle
Was: Sales of our products may involve a lengthy sales cycle
30% rewrittenRisks Related to our Business
Adverse global conditions, including macroeconomic uncertainty, may negatively impact our financial results
30% rewrittenRisks Related to Our Class A Common Stock and the Securities Market
We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our Class A common stock less attractive to investors
Was: We 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
27% rewrittenRisks Related to our Business
The use of our investigational 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
Was: The 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
24% rewrittenRisks Related to Our Class A Common Stock and the Securities Market
The issuance of additional stock in connection with acquisitions or otherwise will dilute all other stockholdings
22% rewrittenRisks Related to Intellectual Property
Our industry is highly competitive and subject to significant or rapid technological change
21% rewrittenRisks Related to Intellectual Property
Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline

All 96 risk factors

Headings as the filing states them, in filing order.

Risks Related to our Business

01We 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 concern73% rewritten
02We 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
03We have ongoing challenges with respect to our liquidity and access to capital
04If the potential of our investigational product candidates to treat diseases is not realized, the value of our technology and our development programs could be significantly reduced35% rewritten
05Our product development programs are based on novel technologies and are inherently risky
06If we are not able to recruit and retain qualified management and scientific personnel, we may fail in developing our technologies and investigational product candidates
07Our investigational product candidates represent new classes of therapy that the marketplace may not understand or accept38% rewritten
08If the healthcare community does not accept our investigational product candidates or future approved products for any of the foregoing reasons, or for any other reason, it could affect our sales or have a material adverse effect on our business, financial condition, results of operations, and prospectsNew
09Mesenchymal 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
10If our processing and storage facility or our clinical manufacturing facilities are damaged or destroyed, our business and prospects could be negatively affected58% rewritten
11We 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
12Sales of our future products may involve a lengthy sales cycle30% rewritten
13We face risks related to health epidemics, pandemics, and outbreaks
14Adverse global conditions, including macroeconomic uncertainty, may negatively impact our financial results30% rewritten
15We have been funded in part by government and non-profit association grant awards, which is not a guaranteed source of future funding
16The use of our investigational 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 coverage27% rewritten
17We face risks with respect to our contract development and manufacturing business75% rewritten

Risks Related to Intellectual Property

18If our trade secret and patent position does not adequately protect our investigational 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
19If certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected
20If 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
21Third-party claims of intellectual property infringement may prevent or delay our product development efforts
22We 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
23Our industry is highly competitive and subject to significant or rapid technological change22% rewritten
24If 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
25Intellectual property rights do not necessarily address all potential threats to our competitive advantage
26Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline21% rewritten
27Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents
28Changes 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 investigational product candidates
29Patent terms may be inadequate to protect our competitive position on our investigational product candidates for an adequate amount of time
30If we or our licensors do not obtain patent term extension for our investigational product candidates and/or methods of their use, our business may be materially harmed
31We may not be able to protect our intellectual property rights throughout the world
32Obtaining 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 requirements40% rewritten

Risks Related to Regulatory Approval and Other Government Regulations

33We are substantially dependent on the successful development, regulatory approval and commercialization of laromestrocel, and we cannot assure you that we will obtain regulatory approval or successfully commercialize this investigational therapyNew
34If we are not able to successfully develop and commercialize our investigational product candidates and obtain the necessary regulatory approvals, we may not generate sufficient revenues to continue our business operations86% rewritten
35We cannot market and sell our investigational product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals, which are subject to significant uncertainty and may be delayed or never obtained99% rewritten
36If we are not able to conduct our clinical trials properly and on schedule, marketing approval by the FDA and other regulatory authorities may be delayed or denied31% rewritten
37one or more IRBs suspends or terminates the trial at an investigational site, precludes enrollment of additional subjects, or withdraws its approval of the trialNew
38Even if we complete clinical development, regulatory approval may be delayed, limited, or subject to burdensome conditions, which could materially affect our commercial prospectsNew
39Alzheimer’s disease drug development has historically had a high rate of failure, and we may not be successful in developing an effective therapy for this indicationNew
40Our business involves the use of hazardous materials that could expose us to environmental and other liability80% rewritten
41Our CMC readiness and ability to manufacture laromestrocel for commercialization and any future product candidates for clinical or commercialization may require significant additional investment, be delayed or be unsuccessfulNew
42consent decrees or injunctions or the imposition of civil or criminal penalties, or the invocation of the FDA's Application Integrity Policy46% rewritten
43Ongoing healthcare legislative and regulatory reform measures in the U.S. and other countries may have a material adverse effect on our business and results of operations97% rewritten
44the level of taxes that we are required to pay100% rewritten
45First Trump AdministrationNew
46Second Trump AdministrationNew
47evaluating the effectiveness of the Food Safety Modernization ActNew

Risks Related to Our Dependence on Third Parties

48We rely on third parties to serve as local representatives in foreign jurisdictions where we perform our clinical trials
49Our reliance on third-party manufacturers and technology transfer activities introduces additional CMC and regulatory riskNew
50Regulatory inspections of our facilities or those of our third-party manufacturers could result in findings that delay or prevent approvalNew
51Use of third-party manufacturers may increase the risk that we will not have adequate quantities of our investigational product candidates
52Because we have made a strategic decision 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
53fluctuation in delivery by the suppliers due to changes in demand from us, our third-party manufacturers or their other customers
54We 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
55We may engage in future acquisitions, strategic partnerships, mergers, or the sale and/or licensing of our intellectual property, which could disrupt our business, increase our capital requirements, dilute our stockholders, harm our financial condition and operating results, and subject us to other risksNew
56our inability to generate revenue from acquired technology, investigational product candidates and/or approved products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs80% rewritten
57The successful commercialization of our current or future investigational 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
58We may enter into arrangements with third-party collaborators to help us develop our investigational product candidates and commercialize our future products, and our ability to commercialize such products may be impaired or delayed if collaborations are unsuccessful
59Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading69% rewritten
60federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operationsNew

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

61Interim, “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
62We may expend our limited resources to pursue a particular investigational product candidate or indication and fail to capitalize on other investigational product candidates or indications that may be more profitable or for which there is a greater likelihood of success
63The U.S. FDA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction
64Obtaining 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
65The FDA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses
66We 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 approvals44% rewritten
67The FDA’s RMAT and Fast Track designations for laromestrocel for mild AD does not guarantee that laromestrocel will be developed or approved faster, or more successfully, than if these designations were not granted, and FDA could rescind these designations if the qualifying criteria are no longer metNew
68We 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 operating89% rewritten
69impaired. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programsNew
70If 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
71We may not be successful in our efforts to identify or discover additional investigational product candidates in the future39% rewritten
72potential investigational 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 acceptance94% rewritten

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

73The 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
74general economic, industry and market conditions
75There may not be sufficient liquidity in the market for our securities in order for investors to sell their shares
76We 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 investigational product candidate development programs or commercialization efforts61% rewritten
77the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our current or future investigational product candidatesNew
78Any 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 investigational product candidates58% rewritten
79Minimum Bid Price RequirementNew
80Audit Committee CompositionNew
81The dual-class structure of our common stock may adversely affect the trading market for our Class A common stock61% rewritten
82Non-Voting Convertible Preferred Stock with the Secretary of State of the State of Delaware (the “Certificate of Designation”) in connection with the Private Placement. The Certificate of Designation provides for the issuance of up to 26,975 authorized shares of the Company’s Series A Preferred StockNew
83If 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
84FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our securities
85Provisions 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
86require a super-majority vote of stockholders to amend some of the provisions described above
87We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our Class A common stock less attractive to investors30% rewritten
88stock that is held by non-affiliates to exceed $700.0 million as of the prior June 30th, and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year periodNew
89The issuance of additional stock in connection with acquisitions or otherwise will dilute all other stockholdings24% rewritten

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

90We have never commercialized an investigational 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
91We may be required to implement employee furloughs or other workforce reductions, which could adversely affect our business, financial condition, and results of operationsNew
92In order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth
93improving our operational, financial and management controls, reporting systems and procedures96% rewritten
94Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
95A variety of risks associated with marketing our investigational product candidates internationally could materially adversely affect our business
96The increasing use of social media platforms presents new risks and challenges

Other Longeveron 10-Ks

FY2024 10-K risk factors
92 risks
Longeveron relies on unproven stem cell technologies with no approved products and ongoing going concern uncertainty.
Filed Feb 28, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.