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What changed in Longeveron Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Longeveron Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+562 added−570 removedSource: 10-K (2026-03-17) vs 10-K (2025-02-28)

Top changes in Longeveron Inc.'s 2025 10-K

562 paragraphs added · 570 removed · 392 edited across 7 sections

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

309 edited+125 added−99 removed270 unchanged
Biggest changeAny potential acquisition or strategic partnership may entail numerous risks, including: • increased operating expenses and cash requirements; • the assumption of additional indebtedness or contingent liabilities; • the issuance of our equity securities; • assimilation of operations, intellectual property and products or product candidates of an acquired company, including difficulties associated with integrating new personnel; • the diversion of our management’s attention from our existing programs and initiatives in pursuing such a strategic merger or acquisition; • retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships; • risks and uncertainties associated with the other party to such a transaction, including the prospects of that party to receive marketing approvals for their existing products or product candidates; and • 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.
Biggest changeAny potential acquisition, sale strategic partnership, or licensing arrangement may entail numerous risks, including: • increased operating expenses and cash requirements; • the assumption of additional indebtedness or contingent liabilities; • the issuance of our equity securities; • assimilation of operations, intellectual property and products or investigational product candidates of an acquired company, including difficulties associated with integrating new personnel; • the diversion of our management’s attention from our existing programs and initiatives in pursuing such a strategic licensing arrangement, merger or acquisition; • in the case of a licensing arrangement, counterparties and partners may not properly or adequately obtain, maintain, enforce, or defend intellectual property or proprietary rights relating to our intellectual property or may use our proprietary information in such a way as to expose us to potential litigation or other intellectual property-related proceedings, including proceedings challenging the scope, ownership, validity, and enforceability of our intellectual property; • retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships; • risks and uncertainties associated with the other party to such a transaction, including the prospects of that party to receive marketing approvals for their existing products or investigational product candidates; and • 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.
Although we do not believe that any recently enacted or presently proposed legislation in any jurisdictions in which we currently operate should impact our business based on our current model, we might be subject to future regulations or other cost-control initiatives that materially restrict the pricing or reimbursement of our products.
Although we do not believe that any recently enacted or presently proposed legislation in any jurisdictions in which we currently operate should impact our business based on our current model, we might be subject to future regulations or other cost-control initiatives that materially restrict the pricing or reimbursement of our future products.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.
It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
For so long as holders of Class B common stock continue to hold their current shares, they will be able to significantly influence the composition of our Board of Directors (the "Board") and the approval of actions requiring stockholder approval through their voting power.
For so long as holders of Class B common stock continue to hold their current shares, they will be able to significantly influence the composition of our Board of Directors and the approval of actions requiring stockholder approval through their voting power.
These provisions, among other things: • establish a classified Board of directors so that not all members of our Board are elected at one time; • permit only the Board of directors to establish the number of directors and fill vacancies on the Board; • provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders; • provide for a dual class common stock structure, which provides certain affiliates of ours, including our co-founder and members of our Board, individually or together, with the ability to significantly influence the outcome of matters requiring stockholder approval, even if they own significantly less than a majority of the shares of our outstanding common stock and Class B common stock; • authorize the issuance of “blank check” preferred stock that our Board could use to implement a stockholder rights plan (also known as a “poison pill”); • eliminate the ability of our stockholders to call special meetings of stockholders; • prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders; • prohibit cumulative voting; • authorize our Board to amend our Bylaws; • establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and • require a super-majority vote of stockholders to amend some of the provisions described above.
These provisions, among other things: • establish a classified Board of Directors so that not all members of our Board are elected at one time; • permit only the Board of Directors to establish the number of directors and fill vacancies on the Board; • provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders; • provide for a dual class common stock structure, which provides certain affiliates of ours, including our co-founder and members of our Board, individually or together, with the ability to significantly influence the outcome of matters requiring stockholder approval, even if they own significantly less than a majority of the shares of our outstanding Class A common stock and Class B common stock; • authorize the issuance of “blank check” preferred stock that our Board could use to implement a stockholder rights plan (also known as a “poison pill”); • eliminate the ability of our stockholders to call special meetings of stockholders; • prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders; • prohibit cumulative voting; • authorize our Board to amend our Bylaws; • establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and • require a super-majority vote of stockholders to amend some of the provisions described above.
Factors that may affect our ability to commercialize our future approved products on our own include recruiting and retaining adequate numbers of effective sales and marketing personnel, obtaining access to or persuading adequate numbers of physicians to prescribe our products and other unforeseen costs associated with creating an independent sales and marketing organization.
Factors that may affect our ability to commercialize our future approved products on our own include recruiting and retaining adequate numbers of effective sales and marketing personnel, obtaining access to or persuading adequate numbers of physicians to prescribe our future approved products and other unforeseen costs associated with creating an independent sales and marketing organization.
The completion of our clinical trials may be delayed or terminated for many reasons, including, but not limited to, if: • the FDA does not grant INDs to test the product candidates in humans; • the FDA does not grant, or suspends, permission to proceed with a clinical trial and places a trial on clinical hold; • we are not able to identify sufficient clinical trial sites and/or clinical trial investigators to begin or complete a trial; • subjects do not enroll in our trials at the rate we expect; 39 • subjects experience an unacceptable rate or severity of adverse side effects; • third-party clinical investigators do not perform our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, Current Good Clinical Practices (cGCPs), cGMPs, Current Good Tissue Practices (cGTPs), and other regulatory requirements, or other third parties do not perform data collection and analysis in a timely or accurate manner; • third-party service providers acting as our local representative in communications with foreign regulatory authorities do not appropriately perform the services required or terminate a service agreement; • inspections by the FDA or IRBs of clinical trial sites at research institutions participating in our clinical trials find regulatory violations that require us to undertake corrective action, suspend, or terminate one or more sites, or prohibit us from using some or all of the data in support of our marketing applications; or • 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.
The completion of our clinical trials may be delayed or terminated for many reasons, including, but not limited to, if: • the FDA does not grant INDs to test the investigational product candidates in humans; • the FDA does not grant, or suspends, permission to proceed with a clinical trial and places a trial on clinical hold; • we are not able to identify sufficient clinical trial sites and/or clinical trial investigators to begin or complete a trial; • subjects do not enroll in our trials at the rate we expect; • subjects experience an unacceptable rate or severity of adverse side effects; • third-party clinical investigators do not perform our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, cGCPs, cGMPs, Current Good Tissue Practices (cGTPs), and other regulatory requirements, or other third parties do not perform data collection and analysis in a timely or accurate manner; • third-party service providers acting as our local representative in communications with foreign regulatory authorities do not appropriately perform the services required or terminate a service agreement; • inspections by the FDA or IRBs of clinical trial sites at research institutions participating in our clinical trials find regulatory violations that require us to undertake corrective action, suspend, or terminate one or more sites, or prohibit us from using some or all of the data in support of our marketing applications; or • 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.
For example: • others may be able to develop products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license; • we or our licensors might not have been the first to make the inventions covered by the issued patents or patent application that we own or license; • we or our licensors might not have been the first to file patent applications covering certain of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • some or all of our licensors’ pending patent applications may not lead to issued patents; • issued patents that we own or license may be held invalid or unenforceable as a result of legal challenges by our competitors; • our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets or in commercial markets where we do not have patent rights; • we may not develop additional proprietary technologies that are patentable; and • the patents of others may have an adverse effect on our business.
For example: • others may be able to develop products that are similar to our investigational product candidates but that are not covered by the claims of the patents that we own or license; • we or our licensors might not have been the first to make the inventions covered by the issued patents or patent application that we own or license; • we or our licensors might not have been the first to file patent applications covering certain of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • some or all of our licensors’ pending patent applications may not lead to issued patents; • issued patents that we own or license may be held invalid or unenforceable as a result of legal challenges by our competitors; • our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets or in commercial markets where we do not have patent rights; • we may not develop additional proprietary technologies that are patentable; and • the patents of others may have an adverse effect on our business.
We will remain an EGC until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial public offering (i.e., December 31, 2026), (b) in which we have total annual gross revenue of at least $1.235 billion or (c) in which we are deemed to be a large accelerated filer, which requires the market value of our common 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.
We will remain an EGC until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial public offering (i.e., December 31, 2026), (b) in which we have total annual gross revenue of at least $1.235 billion or (c) in which we are deemed to be a large accelerated filer, which requires the market value of our common 67 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.
We plan to seek regulatory approval of our product candidates outside of the U.S. and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including: • differing regulatory requirements and reimbursement regimes in foreign countries; • unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; • economic weakness, including inflation, or political instability in particular foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; • difficulties staffing and managing foreign operations; • workforce uncertainty in countries where labor unrest is more common than in the U.S.; • potential liability under the FCPA or comparable foreign regulations; • challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and • business interruptions resulting from geo-political actions, including war and terrorism.
We plan to seek regulatory approval of our investigational product candidates outside of the U.S. and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including: • differing regulatory requirements and reimbursement regimes in foreign countries; • unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; • economic weakness, including inflation, or political instability in particular foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; • difficulties staffing and managing foreign operations; • workforce uncertainty in countries where labor unrest is more common than in the U.S.; • potential liability under the FCPA or comparable foreign regulations; • challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.; 70 • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and • business interruptions resulting from geo-political actions, including war and terrorism.
Future growth would impose significant added responsibilities on members of management, including: • identifying, recruiting, integrating, maintaining and motivating additional employees; • managing our internal development efforts effectively, including preclinical and clinical studies and investigations, as well as FDA, PMDA and other comparable foreign regulatory authorities review process for any current or future product candidates, while complying with any contractual obligations to contractors and other third parties we may have; and • improving our operational, financial and management controls, reporting systems and procedures.
Future growth would impose significant added responsibilities on members of management, including: • identifying, recruiting, integrating, maintaining and motivating additional employees; • managing our internal development efforts effectively, including preclinical and clinical studies and investigations, as well as FDA, PMDA and other comparable foreign regulatory authorities review process for any current or future investigational product candidates, while complying with any contractual obligations to contractors and other third parties we may have; and • improving our operational, financial and management controls, reporting systems and procedures.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other 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.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other 53 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.
In addition to the factors discussed in this “Risk Factors” section and elsewhere in this report, these factors include: • the timing and results, or perception of the results, of preclinical studies and clinical trials of our product candidates or those of our competitors; • the success of competitive products or announcements by potential competitors of their product development efforts; • regulatory actions with respect to our or our competitors’ product candidates or approved products; • actual or anticipated changes in our growth rate relative to our competitors; • regulatory or legal developments in the U.S. and other countries; • developments or disputes concerning patent applications, issued patents or other proprietary rights; • the recruitment or departure of key personnel; • announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, or capital commitments; • actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • market conditions in the pharmaceutical and biotechnology sector; • changes in the structure of healthcare payment systems; • Class A common stock price and volume fluctuations attributable to inconsistent trading volume levels of our Class A common stock; • announcement or expectation of additional financing efforts; • sales of our Class A common stock by us, our insiders, or our other stockholders; • expiration of market stand-off or lock-up agreements; and • general economic, industry and market conditions.
In addition to the factors discussed in this “Risk Factors” section and elsewhere in this report, these factors include: • the timing and results, or perception of the results, of preclinical studies and clinical trials of our investigational product candidates or those of our competitors; • the success of competitive products or announcements by potential competitors of their product development efforts; • regulatory actions with respect to our or our competitors’ investigational product candidates or approved products; • actual or anticipated changes in our growth rate relative to our competitors; • regulatory or legal developments in the U.S. and other countries; • developments or disputes concerning patent applications, issued patents or other proprietary rights; • the recruitment or departure of key personnel; • announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, or capital commitments; • actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • market conditions in the pharmaceutical and biotechnology sector; 61 • changes in the structure of healthcare payment systems; • Class A common stock price and volume fluctuations attributable to inconsistent trading volume levels of our Class A common stock; • announcement or expectation of additional financing efforts; • sales of our Class A common stock by us, our insiders, or our other stockholders; • expiration of market stand-off or lock-up agreements; and • general economic, industry and market conditions.
If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the preclinical or clinical data they obtain is compromised due to the failure to adhere to our protocols or regulatory requirements or for other reasons or if, due to federal or state orders, they are unable to meet their contractual and regulatory obligations, our development timelines, including clinical development timelines, may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates.
If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the preclinical or clinical data they obtain is compromised due to the failure to adhere to our protocols or regulatory requirements or for other reasons or if, due to federal or state orders, they are unable to meet their contractual and regulatory obligations, our development timelines, including clinical development timelines, may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our investigational product candidates.
Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy or patient selection methods, the holders of any such patent may be able to block our ability to develop and commercialize the product candidate unless we obtained a license or until such patent expires or is finally determined to be held not infringed, unpatentable, invalid or unenforceable.
Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy or patient selection methods, the holders of any such patent may be able to block our ability to develop and commercialize the investigational product candidate unless we obtained a license or until such patent expires or is finally determined to be held not infringed, unpatentable, invalid or unenforceable.
Our ability to compete successfully against currently existing and future alternatives to our product candidates and systems and competitors who compete directly with us in the biopharmaceutical industry may depend, in part, on our ability to attract and retain skilled scientific and research personnel, develop technologically superior products, develop competitively priced products, obtain patent or other required regulatory approvals for our products, be an early entrant to the market and manufacture, market, and sell our products, independently or through collaborations.
Our ability to compete successfully against currently existing and future alternatives to our investigational product candidates and systems and competitors who compete directly with us in the biopharmaceutical industry may depend, in part, on our ability to attract and retain skilled scientific and research personnel, develop technologically superior products, develop competitively priced products, obtain patent or other required regulatory approvals for our investigational product candidates, be an early entrant to the market and manufacture, market, and sell products, independently or through collaborations.
Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, or the making of unsupported claims, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program.
Later discovery of previously unknown problems with our investigational product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, or the making of unsupported claims, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program.
If such disclosures occur, there is a risk that trial enrollment may be adversely impacted, that we may fail to monitor and comply with applicable adverse event reporting obligations or that we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our product candidates.
If such disclosures occur, there is a risk that trial enrollment may be adversely impacted, that we may fail to monitor and comply with applicable adverse event reporting obligations or that we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our investigational product candidates.
To the extent that any disruption or security breach were to result in a loss of, or damage to, our data, or inappropriate disclosure of confidential or proprietary information, we could be exposed to litigation and governmental investigations, the further development, approval, and commercialization of our product candidates could be delayed, and we could be subject to significant fines or penalties for any noncompliance with certain state, federal and/or international privacy and security laws.
To the extent that any disruption or security breach were to result in a loss of, or damage to, our data, or inappropriate disclosure of confidential or proprietary information, we could be exposed to litigation and governmental investigations, the further development, approval, and commercialization of our investigational product candidates could be delayed, and we could be subject to significant fines or penalties for any noncompliance with certain state, federal and/or international privacy and security laws.
The Executive Orders direct the Secretary of HHS to: (1) eliminate protection under an AKS safe harbor for certain retrospective price reductions provided by drug manufacturers to sponsors of Medicare Part D plans or pharmacy benefit managers that are not applied at the point-of-sale; (2) allow the importation of certain drugs from other countries through individual waivers, permit the re-importation of insulin products, and prioritize finalization of the proposed rule to permit the importation of drugs from Canada; (3) ensure that payment by the Medicare program for certain Medicare Part B drugs is not higher than the payment by other comparable countries (depending on whether pharmaceutical manufacturers agree to other measures); and (4) require Federally Qualified Health Centers, or FQHCs, participating in the 340B drug program to provide insulin and injectable epinephrine to certain low-income individuals at the discounted price paid by the FQHC, plus a minimal administrative fee.
The Executive Orders directed the Secretary of HHS to: (1) eliminate protection under an AKS safe harbor for certain retrospective price reductions provided by drug manufacturers to sponsors of Medicare Part D plans or pharmacy benefit managers that are not applied at the point-of-sale; (2) allow the importation of certain drugs from other countries through individual waivers, permit the re-importation of insulin products, and prioritize finalization of the proposed rule to permit the importation of drugs from Canada; (3) ensure that payment by the Medicare program for certain Medicare Part B drugs is not higher than the payment by other comparable countries (depending on whether pharmaceutical manufacturers agree to other measures); and (4) require Federally Qualified Health Centers, or FQHCs, participating in the 340B drug program to provide insulin and injectable epinephrine to certain low-income individuals at the discounted price paid by the FQHC, plus a minimal administrative fee.
Reliance on these third-party manufacturers and their suppliers could subject us to a number of risks that could harm our business, including: • interruption of supply resulting from modifications to or discontinuation of a supplier’s operations; • failure of third-party manufacturers or suppliers to comply with their own legal and regulatory requirements; • delays in product shipments resulting from uncorrected defects, reliability issues, or a supplier’s variation in a component; • a lack of long-term supply arrangements for key components with our suppliers; • inability to obtain adequate supply in a timely manner, or to obtain adequate supply on commercially reasonable terms; • difficulty and cost associated with locating and qualifying alternative suppliers for components in a timely manner; 46 • production delays related to the evaluation and testing of products from alternative suppliers, and corresponding regulatory qualifications; • delay in delivery due to suppliers prioritizing other customer orders over ours or those of our third-party manufacturers; • damage to our brand reputation caused by defective components produced by the suppliers; and • fluctuation in delivery by the suppliers due to changes in demand from us, our third-party manufacturers or their other customers.
Reliance on these third-party manufacturers and their suppliers could subject us to a number of risks that could harm our business, including: • interruption of supply resulting from modifications to or discontinuation of a supplier’s operations; • failure of third-party manufacturers or suppliers to comply with their own legal and regulatory requirements; • delays in future product shipments resulting from uncorrected defects, reliability issues, or a supplier’s variation in a component; • a lack of long-term supply arrangements for key components with our suppliers; • inability to obtain adequate supply in a timely manner, or to obtain adequate supply on commercially reasonable terms; • difficulty and cost associated with locating and qualifying alternative suppliers for components in a timely manner; • production delays related to the evaluation and testing of future products from alternative suppliers, and corresponding regulatory qualifications; • delay in delivery due to suppliers prioritizing other customer orders over ours or those of our third-party manufacturers; • damage to our brand reputation caused by defective components produced by the suppliers; and • fluctuation in delivery by the suppliers due to changes in demand from us, our third-party manufacturers or their other customers.
We could also be required to seek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or current or future product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.
We could also be required to seek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or current or future investigational product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.
In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by third party service providers is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain marketing approval of our current and future product candidates or otherwise advance our business.
In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by third party service providers is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain marketing approval of our current and future investigational product candidates or otherwise advance our business.
Although a number of these and other measures may require additional authorization to become effective, Congress and the Trump Administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors.
Although a number of these and other measures may require additional authorization to become effective, Congress and the Trump 45 Administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors.
We are unable to predict what healthcare programs and regulations will ultimately be implemented at any level of government in or outside the U.S., but any changes that decrease reimbursement for our approved products, reduce volumes of medical procedures or impose new cost-containment measures could adversely affect us.
We are unable to predict what healthcare programs and regulations will ultimately be implemented at any level of government in or outside the U.S., but any changes that decrease reimbursement for our future approved products, reduce volumes of medical procedures or impose new cost-containment measures could adversely affect us.
As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed. Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO begins work.
As a result, our financial results and the commercial prospects for our investigational product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed. Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO begins work.
The 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. If we successfully develop and obtain necessary regulatory approvals, we intend to sell our product candidates in countries such as the U.S. and Japan.
The 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. If we successfully develop and obtain necessary regulatory approvals, we intend to sell our investigational product candidates in countries such as the U.S. and Japan.
Moreover, increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates.
Moreover, increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our investigational product candidates.
Any prolonged disruption in the operations of third parties could have a significant negative impact on our ability to produce our product candidates for pre-clinical and clinical trials or sell our future approved products, could harm our reputation and could cause us to seek other third-party contracts, thereby increasing our anticipated development and commercialization costs.
Any prolonged disruption in the operations of third parties could have a significant negative impact on our ability to produce our investigational product candidates for pre-clinical and clinical trials or sell our future approved products, could harm our reputation and could cause us to seek other third-party contracts, thereby increasing our anticipated development and commercialization costs.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights. 50 The U.S.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights. The U.S.
To achieve commercial success for our product candidates, if they are approved, which we may license to others, we will rely on the assistance and guidance of those collaborators. For future approved products for which we retain commercialization rights, we will have to develop our own sales, marketing and supply organization or outsource these activities to a third party.
To achieve commercial success for our investigational product candidates, if they are approved, which we may license to others, we will rely on the assistance and guidance of those collaborators. For future approved products for which we retain commercialization rights, we will have to develop our own sales, marketing and supply organization or outsource these activities to a third party.
As discussed, our ability to obtain one or more types of regulatory exclusivity upon product approval could impact the timing of approval of a competing biosimilar or interchangeable product. If 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.
As discussed, our ability to obtain one or more types of regulatory exclusivity upon future product approval could impact the timing of approval of a competing biosimilar or interchangeable product. If 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.
Since patent applications in the U.S. and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we were the first to either (1) file any patent application related to our product candidates or (2) invent any of the inventions claimed in our patents or patent applications.
Since patent applications in the U.S. and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we were the first to either (1) file any patent application related to our investigational product candidates or (2) invent any of the inventions claimed in our patents or patent applications.
The legislation also caps Medicare beneficiaries’ annual out-of-pocket drug expenses at $2,000. The effect of Inflation Reduction Act of 2022 on our business and the healthcare industry in general is not yet known. Additionally, it is not yet known whether, during the second Trump Administration, the Inflation Reduction Act of 2022 will be repealed or otherwise modified.
The legislation also caps Medicare beneficiaries’ annual out-of-pocket drug expenses at $2,000. The effect of Inflation Reduction Act of 2022 on our business and the healthcare industry in general is not yet known. Additionally, it is not yet known whether, during the second Trump Administration, the Inflation Reduction Act of 2022 will be repealed or otherwise further modified.
MSC therapies may be expensive compared with conventional pharmaceuticals, due to the higher cost and complexity associated with the research, development, and production of product candidates, the small size and large geographic diversity of the target patient population for some indications, and the complexity associated with distribution of signaling cell therapies which require special handling, storage, and shipment procedures and protocols.
MSC therapies may be expensive compared with conventional pharmaceuticals, due to the higher cost and complexity associated with the research, development, and production of investigational product candidates, the small size and large geographic diversity of the target patient population for some indications, and the complexity associated with distribution of signaling cell therapies which require special handling, storage, and shipment procedures and protocols.
Furthermore, we 61 cannot assure you that other stock indices will not take a similar approach to S&P, Dow Jones or FTSE Russell in the future. Exclusion from indices could make our Class A common stock less attractive to investors and, as a result, the market price of our Class A common stock could be adversely affected.
Furthermore, we cannot assure you that other stock indices will not take a similar approach to S&P, Dow Jones or FTSE Russell in the future. Exclusion from indices could make our Class A common stock less attractive to investors and, as a result, the market price of our Class A common stock could be adversely affected.
There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking platform. In addition, we may encounter attacks on social media regarding our company, management, product candidates or future approved products. Finally, social media may aid in the social reform of current drug prices.
There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking platform. In addition, we may encounter attacks on social media regarding our company, management, investigational product candidates or future approved products. Finally, social media may aid in the social reform of current drug prices.
However, the policies of the FDA and of other regulatory authorities may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.
However, the policies of the FDA and of other regulatory authorities may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our investigational product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.
We may in the future seek approval for one or more of our product candidates under one of the FDA’s expedited review programs for serious conditions. These programs are available to sponsors of therapies that address an unmet medical need to treat a serious condition. The qualifying criteria and requirements vary for each expedited program.
We may in the future seek approval for one or more of our investigational product candidates under one of the FDA’s expedited review programs for serious conditions. These programs are available to sponsors of therapies that address an unmet medical need to treat a serious condition. The qualifying criteria and requirements vary for each expedited program.
In addition, our current or future product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of drugs that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to continue to rely on additional funding to achieve our business objectives.
In addition, our current or future investigational product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of drugs that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to continue to rely on additional funding to achieve our business objectives.
Even if patents directed to our product candidates are obtained, once the patent term has expired, we may be open to competition from competitive products. Given the amount of time required for the development, testing and regulatory review of product candidates, patents directed to our product candidates might expire before or shortly after such candidates are commercialized.
Even if patents directed to our investigational product candidates are obtained, once the patent term has expired, we may be open to competition from competitive products. Given the amount of time required for the development, testing and regulatory review of investigational product candidates, patents directed to our investigational product candidates might expire before or shortly after such candidates are commercialized.
For example, in May 2019, 42 Centers for Medicare and Medicaid Services (“CMS”) issued a final rule that would allow Medicare Advantage Plans the option of using step therapy, a type of prior authorization, for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019.
For example, in May 2019, Centers for Medicare and Medicaid Services (“CMS”) issued a final rule that would allow Medicare Advantage Plans the option of using step therapy, a type of prior authorization, for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019.
Any problems experienced by these third parties could result in a delay or interruption in the supply of our product candidates for our clinical trials and future approved products to our customers, which could have a material negative effect on our business. We rely on third parties to provide us with supplies to produce our product candidates.
Any problems experienced by these third parties could result in a delay or interruption in the supply of our investigational product candidates for our clinical trials and future approved products to our customers, which could have a material negative effect on our business. We rely on third parties to provide us with supplies to produce our investigational product candidates.
Any interruption in the supply of components of our product candidates or future products or materials, or our inability to obtain substitute components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demands of our clinical trials or of our future customers, which would have an adverse effect on our business.
Any interruption in the supply of components of our investigational product candidates or future products or materials, or our inability to obtain substitute components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demands of our clinical trials or of our future customers, which would have an adverse effect on our business.
For example, although the FDA has approved several cell therapy products, the FDA has relatively limited experience with regulating these kinds of therapies, and its regulations and policies are still evolving. As a result, the pathway to regulatory approval for our product candidates may be more complex and lengthier.
For example, although the FDA has approved several cell therapy products, the FDA has relatively limited experience with regulating these kinds of therapies, and its regulations and policies are still evolving. As a result, the pathway to regulatory approval for our investigational product candidates may be more complex and lengthier.
Our financial statements do not include any 30 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.
Our financial statements do not include any 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.
Our continued receipt of government and non-profit association funding is also dependent on the ability to adhere to the terms and provisions of the original grant and contract documents and other regulations. We can provide no assurance that we will receive or continue to receive funding for the grants and contracts we have been awarded.
Our continued receipt of government and non-profit association funding is also dependent on the ability to adhere to the terms and provisions of the 31 original grant and contract documents and other regulations. We can provide no assurance that we will receive or continue to receive funding for the grants and contracts we have been awarded.
As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. If 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.
As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. If 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.
These laws, and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.
These laws, and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our investigational product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.
In addition, if one or more of our product candidates is approved for commercial sale, we intend to rely on third parties for their distribution. Proper shipping and distribution require compliance with specific storage and shipment procedures (e.g., prevention of damage to shipping materials and prevention of temperature excursions during shipment).
In addition, if one or more of our investigational product candidates is approved for commercial sale, we intend to rely on third parties for their distribution. Proper shipping and distribution require compliance with specific storage and shipment procedures (e.g., prevention of damage to shipping materials and prevention of temperature excursions during shipment).
Risks Related to the Discovery, Development and Commercialization of Our Product Candidates Interim, “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.
Risks Related to the Discovery, Development and Commercialization of Our Investigational Product Candidates Interim, “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.
If the FDA, PMDA or any applicable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our product candidates not receiving approval for commercialization in the applicable jurisdiction.
If the FDA, PMDA or any applicable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our investigational product candidates not receiving approval for commercialization in the applicable jurisdiction.
It is possible that a broader or more active public 59 trading market for our common stock will not develop or be sustained, or that trading levels will not continue. These factors may materially adversely affect the market price of our Class A common stock, regardless of our performance. We will need to raise substantial additional funding.
It is possible that a broader or more active public trading market for our Class A common stock will not develop or be sustained, or that trading levels will not continue. These factors may materially adversely affect the market price of our Class A common stock, regardless of our performance. We will need to raise substantial additional funding.
If we are not able to effectively expand our organization by hiring new employees and/or engaging additional third-party service providers, we may not be able to successfully implement the tasks necessary to further develop and commercialize our current and future product candidates and, accordingly, may not achieve our research, development and commercialization goals.
If we are not able to effectively expand our organization by hiring new employees and/or engaging additional third-party service providers, we may not be able to successfully implement the tasks necessary to further develop and commercialize our current and future investigational product candidates and, accordingly, may not achieve our research, development and commercialization goals.
Patent term extension may also be available in certain foreign countries upon regulatory approval of our product candidates. However, we or our licensors may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements.
Patent term extension may also be available in certain foreign countries upon regulatory approval of our investigational product candidates. However, we or our licensors may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements.
Our reliance on third parties does not relieve us of our regulatory responsibilities for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards. We and these third parties are required to comply with cGCP requirements, for product candidates in clinical development.
Our reliance on third parties does not relieve us of our regulatory responsibilities for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards. We and these third parties are required to comply with cGCP requirements, for investigational product candidates in clinical development.
Because we have limited financial and managerial resources, we focus on research programs and product candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other therapeutic platforms or product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success.
Because we have limited financial and managerial resources, we focus on research programs and investigational product candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other therapeutic platforms or investigational product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success.
If safe and effective use of any of our product candidates depends on the use of an in vitro diagnostic test that is not otherwise commercially available, then the FDA generally will require approval or clearance of that diagnostic, known as a companion diagnostic, at the same time that the FDA approves our product candidates if at all.
If safe and effective use of any of our investigational product candidates depends on the use of an in vitro diagnostic test that is not otherwise commercially available, then the FDA generally will require approval or clearance of that diagnostic, known as a companion diagnostic, at the same time that the FDA approves our investigational product candidates if at all.
We may also need to raise additional funds sooner if we choose to pursue additional indications and/or geographies for our current product candidates or otherwise expand more rapidly than we presently anticipate. Furthermore, we expect to continue to incur significant costs associated with operating as a public company.
We may also need to raise additional funds sooner if we choose to pursue additional indications and/or geographies for our current investigational product candidates or otherwise expand more rapidly than we presently anticipate. Furthermore, we expect to continue to incur significant costs associated with operating as a public company.
We also may need to transition from a company with a research focus to a company capable of supporting commercial activities. Such a transition may involve substantial additional capital requirements in order to launch and market a product, changes in the use of proceeds, and significant adjustment to personnel, compared to a clinical-stage development company.
We also may need to transition from a company with a research focus to a company capable of supporting commercial activities. Such a transition may involve substantial additional capital requirements in order to launch and market a product, changes in the use of proceeds, and significant adjustment to personnel, 26 compared to a clinical-stage development company.
The Exclusive License Agreement with the University of Miami dated November 20, 2014, as amended on December 11, 2017, and on March 3, 2021, and the additional Exclusive License Agreement with the University of Miami, signed and effective as of July 18, 2024, require the Company to pay fees and royalties and to make commercially reasonable efforts to achieve milestones.
The 33 Exclusive License Agreement with the University of Miami dated November 20, 2014, as amended on December 11, 2017, and on March 3, 2021, and the additional Exclusive License Agreement with the University of Miami, signed and effective as of July 18, 2024, require the Company to pay fees and royalties and to make commercially reasonable efforts to achieve milestones.
In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our product candidates may be impaired or delayed, which could in turn significantly harm our business.
In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our investigational product candidates may be impaired or delayed, which could in turn significantly harm our business.
We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates.
We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of our investigational product candidates.
At the federal level, the first Trump Administration’s budget for fiscal year 2021 included a $135 billion allowance to support legislative proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic and biosimilar drugs.
First Trump Administration At the federal level, the first Trump Administration’s budget for fiscal year 2021 included a $135 billion allowance to support legislative proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic and biosimilar drugs.
The background technologies used in the development of our product candidates are known in the scientific community, and it may be possible to duplicate the methods we use to create our product candidates, which makes us vulnerable to competition, without the ability to exclude others from potentially commercializing a similar product.
The background technologies used in the development of our investigational product candidates are known in the scientific community, and it may be possible to duplicate the methods we use to create our investigational product candidates, which makes us vulnerable to competition, without the ability to exclude others from potentially commercializing a similar product.
Parties making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our product candidates. They might seek an exclusion order from the International Trade Commission to prevent import of our product candidates.
Parties making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our investigational product candidates. They might seek an exclusion order from the International Trade Commission to prevent import of our investigational product candidates.
Our success depends, in large part, on our ability to obtain and maintain intellectual property protection for our product candidates. The patent position of biotechnology companies is generally highly uncertain, involves complex legal and factual questions, and continues to be the subject of much litigation.
Our success depends, in large part, on our ability to obtain and maintain intellectual property protection for our investigational product candidates. The patent position of biotechnology companies is generally highly uncertain, involves complex legal and factual questions, and continues to be the subject of much litigation.
If certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected. We are a party to various agreements that give us rights to use specified technologies applicable to research, development, and commercialization of our product candidates.
If certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected. We are a party to various agreements that give us rights to use specified technologies applicable to research, development, and commercialization of our investigational product candidates.
Changes 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. As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.
Changes 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. As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.
In addition, if the FDA or a comparable foreign regulatory authority approves our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our product candidates will be subject to extensive and ongoing regulatory requirements.
In addition, if the FDA or a comparable foreign regulatory authority approves our investigational product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our investigational product candidates will be subject to extensive and ongoing regulatory requirements.
Our requirements for these items are expected to increase if and when we transition to the manufacture of commercial quantities of our product candidates. In addition, as we proceed with our clinical trial efforts, we must be able to demonstrate to the FDA that we can manufacture our product candidates with consistent characteristics.
Our requirements for these items are expected to increase if and when we transition to the manufacture of commercial quantities of our investigational product candidates. In addition, as we proceed with our clinical trial efforts, we must be able to demonstrate to the FDA that we can manufacture our investigational product candidates with consistent characteristics.
Further, others, including regulatory authorities, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and the value of our company in general.
Further, others, including regulatory authorities, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular investigational product candidate or product and the value of our company in general.
Some state laws require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures.
Further, some state laws require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures.
If we are unable to meet our obligations, or we experience a disruption in our cash flows, it could limit or halt our ability to continue to develop our current product candidate or even to continue operations, either of which occurrence would have a material adverse effect on us.
If we are unable to meet our obligations, or we experience a disruption in our cash flows, it could limit or halt our ability to continue to develop our current investigational product candidate or even to continue operations, either of which occurrence would have a material adverse effect on us.
For example, they could impact the timing and enrollment of our collaborators’ planned or ongoing clinical trials, delaying clinical site initiation, regulatory review and the potential receipt of regulatory approvals, payment of milestones under our license agreements and commercialization of one or more of our product candidates, if approved.
For example, they could impact the timing and enrollment of our collaborators’ planned or ongoing clinical trials, delaying clinical site initiation, regulatory review and the potential receipt of regulatory approvals, payment of milestones under our license agreements and commercialization of one or more of our investigational product candidates, if approved.
If the FDA, PMDA or a comparable regulatory authority requires approval of a companion diagnostic for any of our product candidates, whether before or after it obtains marketing approval, we, and/or future collaborators, may encounter difficulties in developing and obtaining approval for such product candidate.
If the FDA, PMDA or a comparable regulatory authority requires approval of a companion diagnostic for any of our investigational product candidates, whether before or after it obtains marketing approval, we, and/or future collaborators, may encounter difficulties in developing and obtaining approval for such product candidate.
In addition, epidemics, pandemics, and other public health risks could materially and adversely impact our operations due to, among other factors: • a general decline in business activity; 29 • difficulty accessing the capital and credit markets on favorable terms, or at all, and a severe disruption and instability in the global financial markets, or deteriorations in credit and financing conditions which could affect our access to capital necessary to fund business operations; • the potential negative impact on the health of our employees, especially if a significant number of them or any of their family members are impacted or if any of our senior leaders are impacted for an extended period of time; • the potential negative impact on our ability to monitor the investigative sites participating in our clinical studies in person or even remotely, which could result in a deviation from pre-pandemic protocols and/or site monitoring and data management plans, and delays in our ability to perform data-related tasks dependent on communications with personnel at the investigative sites, such as resolution of open data queries, the cumulative effects of which could lead to delayed or missed identification of non-compliance with cGCPs, and/or unrecognized data errors; • potential delays in the preparation and submission of applications for regulatory approval of our products, as well as potential delays in FDA’s or another regulatory authority's ability to review applications in a timely manner consistent with past practices; • potential difficulty in adequately overseeing and/or evaluating the manufacturing process at the facilities that will manufacture future commercial products; and • a deterioration in our ability to ensure business continuity during a disruption.
In addition, epidemics, pandemics, and other public health risks could materially and adversely impact our operations due to, among other factors: • a general decline in business activity; • difficulty accessing the capital and credit markets on favorable terms, or at all, and a severe disruption and instability in the global financial markets, or deteriorations in credit and financing conditions which could affect our access to capital necessary to fund business operations; • the potential negative impact on the health of our employees, especially if a significant number of them or any of their family members are impacted or if any of our senior leaders are impacted for an extended period of time; • the potential negative impact on our ability to monitor the investigative sites participating in our clinical studies in person or even remotely, which could result in a deviation from pre-pandemic protocols and/or site monitoring and data management plans, and delays in our ability to perform data-related tasks dependent on communications with personnel at the investigative sites, such as resolution of open data queries, the cumulative effects of which could lead to delayed or missed identification of non-compliance with cGCPs, and/or unrecognized data errors; • potential delays in the preparation and submission of applications for regulatory approval of our investigational product candidates, as well as potential delays in FDA’s or another regulatory authority's ability to review applications in a timely manner consistent with past practices; • potential difficulty in adequately overseeing and/or evaluating the manufacturing process at the facilities that will manufacture future commercial products; and • a deterioration in our ability to ensure business continuity during a disruption.
If this facility in Miami, Florida or the equipment in the facility were to be significantly damaged or destroyed, we could suffer a loss of some, or all of the stored units of our product candidates and it could force us to halt our clinical trial processes.
If this facility in Miami, Florida or the equipment in the facility were to be significantly damaged or destroyed, we could suffer a loss of some, or all of the stored units of our investigational product candidates and it could force us to halt our clinical trial processes.
We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize our product candidates, which could harm our business significantly.
We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize our investigational product candidates, which could harm our business significantly.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeRisk Management and Strategy As one of the critical elements of the Company’s overall ERM approach, the Company’s cybersecurity program is focused on the following key areas: • Governance: As discussed in more detail under the heading “Governance,” The Board’s oversight of cybersecurity risk management is supported by the Audit Committee of the Board (the “Audit Committee”), which regularly interacts with the Company’s General Counsel ("GC"), Chief Technology Officer ("CTO"), other members of management and relevant management committees, including Company’s Senior Leadership Team (“SLT”), regarding cybersecurity oversight and risk management. • Collaborative Approach: The Company, through its information technology partner , has implemented a comprehensive, cross-functional approach to identifying, preventing, and mitigating cybersecurity threats and incidents, while also implementing controls and procedures that provide for the prompt escalation of certain cybersecurity incidents so that decisions regarding the public disclosure and reporting of such incidents can be made by management in a timely manner. • Technical Safeguards: The Company, through its information technology partner, deploys technical safeguards that are designed to protect the Company’s information systems from cybersecurity threats, including firewalls, intrusion prevention and detection systems, anti- malware functionality and access controls, which are evaluated and improved through vulnerability assessments, penetration testing, and cybersecurity threat intelligence. • Incident Response and Recovery Planning: The Company, with its information technology partner, maintains comprehensive incident response and recovery plans that fully address the Company’s response to a cybersecurity incident. • Education and Awareness: The Company, through its information technology partner, provides regular, mandatory training for personnel regarding cybersecurity threats to equip the Company’s personnel with effective tools to address cybersecurity threats, and to communicate the Company’s evolving information security policies, standards, processes, and practices.
Biggest changeRisk Management and Strategy As one of the critical elements of the Company’s overall ERM approach, the Company’s cybersecurity program is focused on the following key areas: • Governance: As discussed in more detail under the heading “Governance,” The Board’s oversight of cybersecurity risk management is supported by the Audit Committee of the Board (the “Audit Committee”), which regularly interacts with the Company’s General Counsel ("GC"), Chief Technology Officer ("CTO"), Director of Information Technology, and other members of management and relevant management committees, including the Company’s Senior Leadership Team (“SLT”), regarding cybersecurity oversight and risk management. • Collaborative Approach: The Company, through its information technology partner , has implemented a comprehensive, cross-functional approach to identifying, preventing, and mitigating cybersecurity threats and incidents, while also implementing 71 controls and procedures that provide for the prompt escalation of certain cybersecurity incidents so that decisions regarding the public disclosure and reporting of such incidents can be made by management in a timely manner. • Technical Safeguards: The Company, through its information technology partner, deploys technical safeguards that are designed to protect the Company’s information systems from cybersecurity threats, including firewalls, intrusion prevention and detection systems, anti- malware functionality and access controls, which are evaluated and improved through vulnerability assessments, penetration testing, and cybersecurity threat intelligence. • Incident Response and Recovery Planning: The Company, with its information technology partner, maintains comprehensive incident response and recovery plans that fully address the Company’s response to a cybersecurity incident. • Education and Awareness: The Company, through its information technology partner, provides regular, mandatory training for personnel regarding cybersecurity threats to equip the Company’s personnel with effective tools to address cybersecurity threats, and to communicate the Company’s evolving information security policies, standards, processes, and practices. • Third-Party Risk Management: The Company recognizes that cybersecurity risks may arise from third-party service providers, including its information technology partners and other vendors that process, store, or have access to Company information.
The Company’s information technology partner has worked in information technology and information security for over 30 years with over 300 employees with six locations in the United States. A virtual Chief Information Officer (“vCIO”) from the partner works directly with the Company to align business and technical strategies, decisions, and implementations.
The Company’s information technology partner has worked in information technology and information security for over 30 years with over 300 employees with six locations in the United States. A virtual Chief Information Officer from the partner works directly with the Company to align business and technical strategies, decisions, and implementations.
The Company’s Chief Executive Officer, CFO and General Counsel each hold undergraduate and graduate degrees in their respective fields, and each have over 25 years of experience managing risks at similar companies, including risks arising from cybersecurity threats.
The Company’s Chief Executive Officer, CFO and General Counsel each hold undergraduate and graduate degrees in their respective 72 fields, and each have over 25 years of experience managing risks at similar companies, including risks arising from cybersecurity threats.
Cybersecurity threats, including the results of any previous cybersecurity incidents, have not materially affected or are reasonably likely to affect the Company, including its business strategy, results of operations or financial condition.
Cybersecurity threats, including the results of any previous cybersecurity incidents, have not materially affected nor are reasonably likely to affect the Company, including its business strategy, results of operations or financial condition.
The Company engages in the periodic assessment and testing of the Company’s policies, standards, processes, systems, and practices that are designed to address cybersecurity threats and incidents. These efforts include a wide range of activities, including audits, assessments, tabletop exercises, threat modeling, vulnerability and penetration testing and other exercises focused on evaluating the effectiveness of our cybersecurity measures and planning.
These efforts include a wide range of activities, including audits, assessments, tabletop exercises, threat modeling, vulnerability and penetration testing and other exercises focused on evaluating the effectiveness of our cybersecurity measures and planning.
On an annual basis, the Audit Committee and the Board discuss the Company’s approach to cybersecurity risk management with the members of the SLT, which includes the Company’s CTO, GC, and Chief Financial Officer (“CFO”). 67 The CTO, in coordination with the SLT, works collaboratively across the Company to implement a program designed to protect the Company’s information systems from cybersecurity threats and to promptly respond to any cybersecurity incidents in accordance with the Company’s incident response and recovery plans.
The CTO, in coordination with the SLT, works collaboratively across the Company to implement a program designed to protect the Company’s information systems from cybersecurity threats and to promptly respond to any cybersecurity incidents in accordance with the Company’s incident response and recovery plans.
Added
As part of its enterprise risk management program, the Company maintains processes designed to identify, assess, and oversee cybersecurity risks associated with third parties. These processes may include risk-based due diligence prior to engagement, contractual requirements regarding information security controls and incident notification, periodic reassessments, review of independent audit reports and certifications where available, and ongoing monitoring of vendor performance.
Added
Cybersecurity risks associated with third parties are incorporated into the Company’s overall risk management and reporting structure, and material risks or incidents are escalated to senior management and the Audit Committee, as appropriate. The Company engages in the periodic assessment and testing of the Company’s policies, standards, processes, systems, and practices that are designed to address cybersecurity threats and incidents.
Added
On an annual basis, the Audit Committee and the Board discuss the Company’s approach to cybersecurity risk management with the members of the SLT, which includes the Company’s CTO, GC, Chief Executive Officer and Chief Financial Officer (“CFO”).

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Item 4. Mine Safety Disclosures Not Applicable. 68 PART II
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As of December 31, 2025, the Company is not aware of any legal proceedings or material developments requiring disclosure. Item 4. Mine Safety Disclosures Not Applicable. 73 PART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures 68 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 69 Item 6. [Reserved] 69 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 70 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 81 Item 8.
Biggest changeItem 4. Mine Safety Disclosures 73 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 74 Item 6. [Reserved] 74 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 75 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 84 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeRecent Sales of Unregistered Securities; Use of Proceeds from Registered Securities; Repurchases of Securities ISSUER PURCHASES OF EQUITY SECURITIES Period Total Number of Shares (or Units) Purchased (a) Average Price Paid per Share (or Unit) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs Maximum Number or Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs October 1-31, 2024 27,620 $ 1.88 - - November 1-30, 2024 233 1.98 - - December 1-31, 2024 - - - - Total 27,853 $ 1.88 - - (a) Includes shares withheld from employees to satisfy minimum tax withholding obligations associated with the vesting of restricted stock units during the period.
Biggest changeRecent Sales of Unregistered Securities; Use of Proceeds from Registered Securities; Repurchases of Securities ISSUER PURCHASES OF EQUITY SECURITIES Period Total Number of Shares (or Units) Purchased (a) Average Price Paid per Share (or Unit) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs Maximum Number or Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs October 1-31, 2025 77,808 $ 0.75 - - November 1-30, 2025 - - - - December 1-31, 2025 - - - - Total 77,808 $ 0.75 - - (a) Includes shares withheld from employees to satisfy minimum tax withholding obligations associated with the vesting of restricted stock units during the period.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market for Common Stock; Holders Our Class A common stock is traded on The Nasdaq Capital Market under the under the symbol “LGVN.” Our Class B common stock is not listed or traded on any stock exchange or other market.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market for Common Stock; Holders Our Class A common stock is traded on The Nasdaq Capital Market under the symbol “LGVN.” Our Class B common stock is not listed or traded on any stock exchange or other market.
Dividends We have never declared nor paid any cash dividends, and currently intend to retain all our cash and any earnings for use in our business and, therefore, do not anticipate paying any cash dividends in the foreseeable future.
Dividends We have never declared nor paid any cash dividends, and we currently intend to retain all our cash and any earnings for use in our business and, therefore, do not anticipate paying any cash dividends in the foreseeable future.
Holders of Common Stock As of February 17, 2025, there were 19 and 12 holders of record of our Class A and Class B common stock, respectively, based on information provided by our transfer agent, Colonial Stock Transfer Co., Inc.
Holders of Common Stock As of March 9, 2026, there were 18 and 12 holders of record of our Class A and Class B common stock, respectively, based on information provided by our transfer agent, Colonial Stock Transfer Co., Inc.
As of such date, 13,473,898 shares of our Class A common stock and 1,484,005 shares of our Class B common stock were issued and outstanding.
As of such date, 21,783,749 shares of our Class A common stock and 1,484,005 shares of our Class B common stock were issued and outstanding.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeRESULTS OF OPERATIONS 73 COMPARISON OF THE YEARS ENDED DECEMBER 31, 2024 AND 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023, together with the changes in those items in dollars (in thousands): Year Ended December 31, Increase 2024 2023 (Decrease) Revenues $ 2,392 $ 709 $ 1,683 Cost of revenues 508 488 20 Gross profit 1,884 221 1,663 Operating Expenses General and administrative 10,269 12,184 (1,915 ) Research and development 8,137 9,066 (929 ) Total operating expenses 18,406 21,250 (2,844 ) Loss from operations (16,522 ) (21,029 ) (4,507 ) Other income and (expense) Lawsuit expense - (30 ) (30 ) Other tax credits - 23 (23 ) Other income (expense), net 549 (377 ) 926 Total other income (expenses), net 549 (384 ) 933 Net loss $ (15,973 ) $ (21,413 ) $ (5,440 ) Revenues, Cost of Revenues and Gross Profit: Revenues for the years ended December 31, 2024 and 2023 were $2.4 million and $0.7 million, respectively. 2024 revenues increased $1.7 million, or 237%, when compared to 2023 as a result of higher participant demand for our Bahamas Registry Trial and the addition of our manufacturing services contract.
Biggest changeRESULTS OF OPERATIONS COMPARISON OF THE YEARS ENDED DECEMBER 31, 2025 AND 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and 2024, together with the changes in those items in dollars (in thousands): Year Ended December 31, Increase 2025 2024 (Decrease) Revenues $ 1,199 $ 2,392 $ (1,193 ) Cost of revenues 396 508 (112 ) Gross profit 803 1,884 (1,081 ) Operating Expenses General and administrative 12,049 10,269 1,780 Research and development 12,041 8,137 3,904 Total operating expenses 24,090 18,406 5,684 Loss from operations (23,287 ) (16,522 ) 6,765 Other income and (expense) Loss on disposal of assets (97 ) — 97 Other income, net 680 549 131 Total other income, net 583 549 34 Net loss $ (22,704 ) $ (15,973 ) $ 6,731 Revenues, Cost of Revenues and Gross Profit: Revenues for the year ended December 31, 2025 were $1.2 million and consisted of $1.0 million of clinical trial revenue and $0.2 million of contract manufacturing revenue.
General and administrative expenses consist primarily of salaries and other related costs, including equity-based compensation, for personnel in our executive, finance, business development and administrative functions.
General and Administrative Expenses General and administrative expenses consist primarily of salaries and other related costs, including equity-based compensation, for personnel in our executive, finance, business development and administrative functions.
Longeveron Project Funding Agency (1) Total Amount ($) Status of Award Aging-related frailty Phase 2b Trial SBIR (DHHS) NIA 3,957,813 Complete Aging-related frailty Phase 2b Trial SBIR (DHHS) NIA 283,040 Complete Alzheimer’s Disease Phase 1 Trial (2) Alzheimer’s Association 3,000,000 Complete Alzheimer’s Disease Phase 1 Trial Alzheimer’s Association 1,000,000 Complete The Metabolic Syndrome Sub-Study STTR (DHHS) NIA 150,000 Complete The Metabolic Syndrome Sub-Study STTR (DHHS) NIA 901,486 Complete Aging-related frailty Influenza Vaccine Trial (“HERA”) MSCRF - TEDCO 750,000 Complete HLHS Phase 1 Trial MSCRF - TEDCO 750,000 Complete HLHS Phase 2 Trial (3) UG3 (DHHS) NHLBI 477,566 Ongoing ARDS Phase 1 MSCRF - TEDCO 650,000 Complete Total 11,919,905 (1) SBIR=Small Business Innovation Research programs; STTR=Small Business Technology Transfer programs; DHHS=Department of Health and Human Services; NIA = National Institute on Aging; NHLBI=National Heart, Lung, and Blood Institute.
Longeveron Project Funding Agency (1) Total Amount ($) Status of Award Aging-related frailty Phase 2b Trial SBIR (DHHS) NIA 3,957,813 Complete Aging-related frailty Phase 2b Trial SBIR (DHHS) NIA 283,040 Complete Alzheimer’s Disease Phase 1 Trial (2) Alzheimer’s Association 3,000,000 Complete Alzheimer’s Disease Phase 1 Trial Alzheimer’s Association 1,000,000 Complete The Metabolic Syndrome Sub-Study STTR (DHHS) NIA 150,000 Complete The Metabolic Syndrome Sub-Study STTR (DHHS) NIA 901,486 Complete Aging-related frailty Influenza Vaccine Trial (“HERA”) MSCRF - TEDCO 750,000 Complete HLHS Phase 1 Trial MSCRF - TEDCO 750,000 Complete HLHS Phase 2 Trial (3) UG3 (DHHS) NHLBI 477,566 Complete ARDS Phase 1 MSCRF - TEDCO 650,000 Complete Total 11,919,905 (1) SBIR=Small Business Innovation Research programs; STTR=Small Business Technology Transfer programs; DHHS=Department of Health and Human Services; NIA = National Institute on Aging; NHLBI=National Heart, Lung, and Blood Institute.
Based on the timing of amounts invoiced by service providers, we may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered. We currently do not carry any inventory for our product candidates, as we have yet to launch a product for commercial distribution.
Based on the timing of amounts invoiced by service providers, we may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered. We currently do not carry any inventory for our investigational product candidates, as we have yet to launch a product for commercial distribution.
If we raise additional funds through other third-party funding, collaboration agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
If we raise additional funds through other third-party funding, collaboration agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or investigational product candidates or grant licenses on terms that may not be favorable to us.
If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our biologic drug development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our biologic drug development or future commercialization efforts or grant rights to develop and market products or investigational product candidates that we would otherwise prefer to develop and market ourselves.
Net cash provided by financing activities for the year ended December 31, 2024 was $28.8 million consisting primarily of proceeds from the issuance of common stock of $12.9 million and warrants exercised of $16.2 million, which was partially offset by the payment of taxes upon vesting of RSUs.
Net cash provided by financing activities for the year ended 79 December 31, 2024 was $28.8 million consisting primarily of proceeds from the issuance of common stock of $12.9 million and warrants exercised of $16.2 million, which was partially offset by the payment of taxes upon vesting of RSUs.
We expect that our sales, research and development and general and administrative costs will remain substantial in connection with conducting additional preclinical studies and clinical trials for our current and future programs and product candidates, contracting with CROs to support preclinical studies and clinical trials, expanding our intellectual property portfolio, and providing general and administrative support for our operations.
We expect that our sales, research and development and general and administrative costs will remain substantial in connection with conducting additional preclinical studies and clinical trials for our current and future programs and investigational product candidates, contracting with CROs to support preclinical studies and clinical trials, expanding our intellectual property portfolio, and providing general and administrative support for our operations.
Our future funding requirements will depend on many factors, including: • the progress, costs and results of our clinical trials for our programs for our cell-based therapies, and additional research and preclinical studies in other research programs we initiate in the future; • the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs we advance through preclinical and clinical development; • our ability to establish and maintain strategic collaborations, licensing or other agreements and the financial terms of such agreements; • the extent to which we in-license or acquire rights to other products, product candidates or technologies; and • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property-related claims.
Our future funding requirements will depend on many factors, including: • the progress, costs and results of our clinical trials for our programs for our cell-based therapies, and additional research and preclinical studies in other research programs we initiate in the future; 82 • the costs and timing of process development and manufacturing scale-up activities associated with our investigational product candidates and other programs we advance through preclinical and clinical development; • our ability to establish and maintain strategic collaborations, licensing or other agreements and the financial terms of such agreements; • the extent to which we in-license or acquire rights to other products, investigational product candidates or technologies; and • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property-related claims.
Net cash used in investing activities for the year ended December 31, 2024 was $0.6 million consisting primarily of additions to intangible assets of $0.6 million and purchases of equipment of $0.3 million, which was partially offset by proceeds from the sale of marketable securities of $0.3 million.
Net cash used in investing activities for year ended December 31, 2024 was $0.6 million consisting primarily of additions to intangible assets of $0.3 million and purchases of equipment of $0.6 million, which was partially offset by proceeds from the sale of marketable securities of $0.3 million. Financing Activities .
Historically our operations have focused on conducting clinical trials, product research and development efforts, and improving and refining our manufacturing processes, and accordingly, manufactured clinical doses of product candidates were expensed as incurred, consistent with the accounting for all other research and development costs.
Historically our operations have focused on conducting clinical trials, product research and development efforts, and improving and refining our manufacturing processes, and accordingly, manufactured clinical doses of investigational product candidates were expensed as incurred, consistent with the accounting for all other research and development costs.
If we raise additional funds through up-front payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our product candidates or grant licenses on terms that are not favorable to us.
If we raise additional funds through up-front payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our investigational product candidates or grant licenses on terms that are not favorable to us.
When appropriate funding opportunities arise, we routinely apply for grant funding to support our ongoing research and since 2016 we have received approximately $16.0 million in grant awards ($11.5 million of which has been directly awarded to us and is recognized as revenue when the performance obligations are met) from the National Institute on Aging (“NIA”) of the National Institutes of Health (“NIH”), the National Heart Lung and Blood Institute (“NHLBI”) of the NIH, the Alzheimer’s Association, and the Maryland Stem Cell Research Fund (“MSCRF”) of the Maryland Technology Development Corporation, or TEDCO.
When appropriate funding opportunities arise, we routinely apply for grant funding to support our ongoing research and since 2016 we have received approximately $16.3 million in grant awards ($11.5 million of which has been directly awarded to us and is recognized as revenue when the performance obligations are met) from the National Institute on Aging (“NIA”) of the National Institutes of Health (“NIH”), the National Heart Lung and Blood Institute (“NHLBI”) of the NIH, the Alzheimer’s Association, and the Maryland Stem Cell Research Fund (“MSCRF”) of the Maryland Technology Development Corporation, or TEDCO.
Research and development include costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, equity-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs.
Research and development expenses include costs such as clinical trial expenses, contracted research and manufacturing, license agreement fees with no alternative future use, supplies and materials, salaries, equity-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs.
Terms and Conditions of Grant Awards Grant projects are typically divided into periods (e.g., a three-year grant may have three one-year periods), and the total amount awarded is divided according to the number of periods.
Terms and Conditions of Grant Awards Governmental grant projects are typically divided into periods (e.g., a three-year grant may have three one-year periods), and the total amount awarded is divided according to the number of periods.
Grant awards are recognized as revenue, and depending on the funding mechanism, are deposited directly in our accounts as lump sums, which are staggered over a predetermined period or drawn down from a federal payment management system account for reimbursement of expenses incurred. Revenue recognition occurs when the grant related expenses are incurred or supplies and 78 materials are received.
Grant awards are recognized as revenue, and depending on the funding mechanism, are deposited directly in our accounts as lump sums, which are staggered over a predetermined period or drawn down from a federal payment management system account for reimbursement of expenses incurred. Revenue recognition occurs when the grant related expenses are incurred or supplies and 81 materials are received.
As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources. To date, we have financed our operations primarily through our IPO, registered and private placement equity financings, grant awards, and fees generated from the Bahamas Registry Trials and contract manufacturing services.
As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources. To date, we have financed our operations primarily through our IPO, registered and private placement equity financings, grant awards, fees generated from The Bahamas Registry Trial and contract manufacturing services.
We enter into contracts in the normal course of business with third-party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that our non-cancelable obligations under these agreements are not material.
From time to time we may enter into contracts in the normal course of business with third-party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that our non-cancelable obligations under these agreements are not material.
(3) The HLHS Phase 2b clinical trial grant was awarded to Sunjay Kaushal, M.D., Ph.D, Ann and Robert H. Lurie Children’s Hospital of Chicago, and the trial will be conducted under our IND and will test Lomecel-B™. The total award was $4.6 million, and we have received $0.3 million of the approximately $0.5 million apportioned to us.
(3) The HLHS Phase 2b clinical trial grant was awarded to Sunjay Kaushal, M.D., Ph.D, Ann and Robert H. Lurie Children’s Hospital of Chicago, and the trial will be conducted under our IND and will test laromestrocel. The total award was $4.2 million, and we have received $0.3 million of the approximately $0.5 million apportioned to us.
The fee is recognized as revenue and is used to pay for the costs associated with manufacturing and testing of Lomecel-B™, administration, shipping and importation fees, data collection and management, biological sample collection and sample processing for biomarkers and other data, and overall management of the Registry, including personnel costs.
The fee is recognized as revenue and is used to pay for the costs associated with manufacturing and testing of laromestrocel, administration, shipping and importation fees, data collection and management, biological sample collection and sample processing for 76 biomarkers and other data, and overall management of the Registry, including personnel costs.
We accrue for costs incurred by external service providers, including contract research organizations (“CROs”) and clinical investigators, based on estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, subject enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed.
We accrue for costs incurred by external service providers, including clinical investigators, based on estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, subject enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed.
In past years we have been able to fund a large portion of our clinical programs and our administrative overhead with the use of grant funding.
In past years we have been able to fund a large portion of our clinical programs with the use of grant funding.
ASC 730 addresses the proper accounting and reporting for research and development costs. It identifies: 1. Those activities that should be identified as research and development; 2. The elements of costs that should be identified with research and development activities, and the accounting for these costs; and 3. The financial statement disclosures related to them.
It identifies: (1) those activities that should be identified as research and development; (2) the elements of costs that should be identified with research and development activities, and the accounting for these costs; and (3) the financial statement disclosures related to them.
As of December 31, 2024, and 2023, the amount of unused grant funds that were available for us to draw was approximately $0.1 million and $0.1 million, respectively. The following table summarizes the grants awarded.
Grant revenues were $0 in both 2025 and 2024. As of December 31, 2025, and 2024, the amount of unused grant funds that were available for us to draw was approximately $0 and $0.1 million, respectively. The following table summarizes the grants awarded.
In addition, we may 80 seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Contractual Obligations and Commitments As of December 31, 2024, we have $1.4 million in operating lease obligations and no CRO payment obligations.
In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Contractual Obligations and Commitments As of December 31, 2025, we have $0.8 million in operating lease obligations and no CRO payment obligations.
The Company does not yet have a product that has been approved by the FDA, and has only generated revenues from grants, the Bahamas Registry Trials and contract manufacturing. The Company has not yet achieved profitable operations or generated positive cash flows from operations.
We do not yet have a product that has been approved by the FDA, and have only generated revenues from grants, The Bahamas Registry Trial and contract manufacturing. We have not yet achieved profitable operations or generated positive cash flows from operations.
We have incurred losses since inception. Net cash used in operating activities for the year ended December 31, 2024 was $13.9 million, consisting primarily of our net loss of $16.0 million and payments for accounts payable of $0.5 million and a decrease in deferred revenue of $0.5 million.
Net cash used in operating activities for the year ended December 31, 2024 was $13.9 million, consisting primarily of our net loss of $16.0 million and payments towards accounts payable of $0.5 million and a decrease in deferred revenue of $0.5 million.
We expect that our research and development expenses will continue to be significant in the future as we increase our headcount to support increased research and development activities relating to our clinical programs, as well as incur additional expenses related to our clinical trials.
Subject to obtaining necessary financing, we expect that our research and development expenses will continue to be significant in the future as we support increased research and development activities relating to our clinical programs, as well as incur additional expenses related to our clinical trials.
This was partially offset by non-cash expenses of $2.3 million in equity-based compensation expenses and $1.0 million in depreciation and amortization.
This was partially offset by non-cash expenses of $1.7 million in equity-based compensation and $1.2 million in depreciation and amortization, including intangibles.
Emerging Growth Company Status We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, which is a law intended to encourage funding of small businesses in the U.S. by easing many of the country’s securities regulations, and we may take advantage of reduced reporting requirements that are otherwise applicable to public companies.
We have not included milestone or royalty payments or other contractual payment obligations if the timing and amount of such obligations are unknown or uncertain. 83 Emerging Growth Company Status We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, which is a law intended to encourage funding of small businesses in the U.S. by easing many of the country’s securities regulations, and we may take advantage of reduced reporting requirements that are otherwise applicable to public companies.
Research and Development Expenses: Research and development expenses for the year ended December 31, 2024 decreased to approximately $8.1 million from approximately $9.1 million for the same period in 2023.
Research and Development Expenses: Research and development expenses for the year ended December 31, 2025 increased to approximately $12.0 million from approximately $8.1 million for the same period in 2024.
Cash Flows The following table summarizes our sources and uses of cash for the period presented for the (in thousands): Year Ended December 31, 2024 2023 Net cash used in operating activities $ (13,868 ) $ (19,002 ) Net cash (used in) provided by investing activities (640 ) 8,186 Net cash provided by financing activities 28,791 5,262 Net increase (decrease) in cash and cash equivalents $ 14,283 $ (5,554 ) Operating Activities .
Cash Flows The following table summarizes our sources and uses of cash for the period presented for the (in thousands): Year Ended December 31, 2025 2024 Net cash used in operating activities $ (18,645 ) $ (13,868 ) Net cash used in investing activities (595 ) (640 ) Net cash provided by financing activities 4,669 28,791 Net (decrease) increase in cash and cash equivalents $ (14,571 ) $ 14,283 Operating Activities .
Specifically, we will incur expenses to: • advance the clinical development of Lomecel-B™ for the treatment of several disease states and indications; • pursue the preclinical and clinical development of other current and future research programs and product candidates; • in-license or acquire the rights to other products, product candidates or technologies; • maintain, expand and protect our intellectual property portfolio; 79 • hire additional personnel in research, manufacturing and regulatory and clinical development as well as management personnel; • seek regulatory approval for any product candidates that successfully complete clinical development; and • optimize our operational, financial and management systems and increase personnel, including personnel to support our operations as a public company.
Specifically, we will incur expenses to: • advance the clinical development of laromestrocel for the treatment of several disease states and indications; • pursue the preclinical and clinical development of other current and future research programs and investigational product candidates; • in-license or acquire the rights to other products, investigational product candidates or technologies; • maintain, expand and protect our intellectual property portfolio; • hire additional personnel in research, manufacturing and regulatory and clinical development as well as management personnel; • seek regulatory approval for any investigational product candidates that successfully complete clinical development, including a potential BLA filing with the FDA in 2027 for HLHS if the current ELPIS II trial is successful, subject to sufficient resources; • advance CMC activities to support BLA readiness; and • expand our operational, financial and management systems and increase personnel, including personnel to support our operations as a public company.
We will remain an “emerging growth company” until the earliest of (1) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more, (2) the last day of the fiscal year following the fifth anniversary of the completion of our IPO, (3) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC, which generally is when a company has more than $700 million in market value of its reported class of stock held by non-affiliates and has been a public company for at least 12 months and have filed at least one Annual Report on Form 10-K.
December 31, 2026), (3) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC, which generally is when a company has more than $700 million in market value of its reported class of stock held by non-affiliates and has been a public company for at least 12 months and have filed at least one Annual Report on Form 10-K.
For grants we record allocated expenses for research and development costs to a grant as a cost of revenues. For the clinical trial revenue, directly related expenses for that program are allocated and accrued as incurred. These expenses are similar to those described under “Research and Development Expenses” below.
For the clinical trial revenue, directly related expenses for that program are allocated and accrued as incurred. These expenses are similar to those described under “Research and Development Expenses” below. For contract manufacturing revenue, directly related expenses for the services and facilities provided under the contract are recorded as cost of revenues.
General and administrative expenses also include public company related expenses; legal fees relating to corporate matters; insurance costs; professional fees for accounting, auditing, tax and consulting services; travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.
General and administrative expenses also include public company related expenses; legal fees relating to corporate matters; insurance costs; professional fees for accounting, auditing, tax and consulting services; travel expenses; rent and facility-related expenses, direct depreciation costs and other operating costs. 77 Other Income and Expenses We earn interest income on cash equivalents and money market funds.
The Company has incurred recurring losses from operations since its inception, and as of December 31, 2024 the Company had an accumulated deficit of $109.6 million. The Company expects to continue to generate operating losses for the foreseeable future.
We have incurred recurring losses from operations since our inception, and as of December 31, 2025 we had an accumulated deficit of $132.3 million. We expect to continue to generate operating losses for the foreseeable future.
Lomecel-B™ is considered an investigational treatment in The Bahamas and is not licensed for commercial sale. • Contract development and manufacturing services. From time to time, we enter into fee-for-service agreements with third parties for our product development and manufacturing capabilities. These agreements may include research, process development, and manufacturing services tailored to customer needs.
Laromestrocel is considered an investigational treatment in The Bahamas and is not licensed for commercial sale. We refer to revenue generated from The Bahamas Registry Trial as clinical trial revenue in our statements of operations. • Contract development and manufacturing services. From time to time, we enter into fee-for-service agreements with third parties for our product development and manufacturing capabilities.
Operating results are not necessarily indicative of results that may occur in future periods. Introduction and Overview We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™.
Operating results are not necessarily indicative of results that may occur in future periods. Introduction and Overview We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. Our lead investigational product is laromestrocel. We are currently pursuing three potential indications: Hypoplastic Left Heart Syndrome (“HLHS”), Alzheimer’s disease (“AD”) and pediatric Dilated Cardiomyopathy ("pediatric DCM").
In February 2024, we entered into our first manufacturing services contract with a third-party biotechnology company. Revenue from this contract is recognized over time as the services are provided. Additionally, the customer pays a fixed monthly fee per suite to reserve and maintain a dedicated manufacturing suite and storage space.
These agreements may include research, process development, and manufacturing services tailored to customer needs. In February 2024, we entered into our first manufacturing services contract with a third-party biotechnology company. Revenue from this contract is recognized over time as the services are provided.
Since we were formed, we have raised approximately $113.0 million in gross proceeds from the issuance of equity. As of December 31, 2024, the Company had cash and cash equivalents of $19.2 million and working capital of approximately $17.0 million.
Since we were formed, we have raised approximately $119.0 million in gross proceeds from the issuance of equity, including $15.9 million in gross proceeds from the March 2026 private placement. As of December 31, 2025, we had cash and cash equivalents of $4.7 million and working capital of $1.4 million.
The preparation of these financial statements requires that we make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods.
GAAP), which requires our management to make estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting periods.
For contract manufacturing revenue, directly related expenses for the services and facilities provided under the contract are recorded as cost of revenues. Research and Development Expenses Research and development costs are charged to expense when incurred in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 730 Research and Development.
Research and Development Expenses Research and development costs are charged to expense when incurred in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 730 Research and Development. ASC 730 addresses the proper accounting and reporting for research and development costs.
Grant Awards From inception through December 31, 2024, we have been awarded approximately $11.9 million in governmental and non-profit association grants, which have been used to fund our clinical trials, research and development, production and overhead.
See Note 14, Subsequent Events, for a discussion of the March 2026 private placement financing. Grant Awards Since 2016 through December 31, 2025, we have been directly awarded approximately $11.5 million in governmental and non-profit association grants, which have been used to fund our clinical trials, research and development, production and overhead.
Because of the numerous risks and uncertainties associated with research, development and commercialization of our product candidates, it is difficult to estimate with certainty the amount of our working capital requirements.
As such we cannot be sure that we will be awarded grant funds in the future despite our past success in receiving such awards. Funding Requirements Because of the numerous risks and uncertainties associated with research, development and commercialization of our investigational product candidates, it is difficult to estimate with certainty the amount of our working capital requirements.
This resulted in a gross profit of approximately $1.9 million for the year ended December 31, 2024, an increase of $1.7 million, or 752%, when compared with a gross profit of $0.2 million for 2023.
Related cost of revenues was $0.4 million and $0.5 million for the years ended December 31, 2025 and 2024, respectively. This resulted in a gross profit of approximately $0.8 million for the year ended December 31, 2025, a decrease of $1.1 million, or 57%, when compared with a gross profit of $1.9 million for 2024.
We expect to incur significant expenses and operating losses as we advance the preclinical and clinical development of our programs.
LIQUIDITY, CAPITAL RESOURCES, AND GOING CONCERN We have incurred recurring losses and negative cash flows from operations since inception. We expect to incur significant expenses and operating losses as we advance the preclinical and clinical development of our programs.
Additionally, as of December 31, 2024, warrants exercisable for an aggregate of up to 6,802,668 shares of a Company's Class A common stock remain outstanding at exercise prices ranging from $2.35 per share to $175.00 per share.
Additionally, as of December 31, 2025, warrants exercisable for an aggregate of up to 21,920,318 shares of our Class A common stock remain outstanding at exercise prices ranging from $0.85 per share to $175.00 per share. In the third quarter of 2025, we undertook two capital raising transactions.
Participants in The Bahamas Registry Trial pay us a fee to receive Lomecel-B™, imported into The Bahamas, and administered at one of two private medical clinics in Nassau.
Components of Our Results of Operations Revenue We have generated revenue from two sources: • The Bahamas Registry Trial . Participants in The Bahamas Registry Trial pay us a fee to receive laromestrocel, imported into The Bahamas, and administered at Lyford Cay Hospital, a private medical clinic in Nassau.
We intend to seek additional financing/capital raises/non-dilutive funding options to support these activities, and current cash projections may be impacted by these ramped up activities and any financing transactions entered into. There can be no assurance we will be able to attain future financing at terms favorable to us or at all.
We expect that our current operating plan will require increased spending and additional capital investments to support these initiatives and we intend to seek additional financing through capital raises, non-dilutive funding options, and commercial partnering across all indications. There can be no assurance we will be able to attain future financing at terms favorable to us or at all.
Capital Raising Efforts Since the time that we became a publicly traded company in February 2021, we have sold 12,686,240 shares of Class A common stock through our IPO and subsequent follow-on public and private equity offerings and transactions.
Capital Raising Efforts As of December 31, 2025, we have sold 20,328,220 shares of Class A common stock through our IPO and subsequent follow-on public and private equity offerings and transactions.
This was partially offset by non-cash expenses of $2.0 million in equity-based compensation expenses, $0.9 million in depreciation and amortization, and $0.3 million for the write-off of intangible assets, as well as an increase in accrued expenses of $1.5 million. Investing Activities .
This was partially offset by non-cash expenses of $2.3 million in equity-based compensation expenses and $1.0 million in depreciation and amortization. Investing Activities . Net cash used in investing activities for the year ended December 31, 2025 was approximately $0.6 million consisting primarily of additions to intangible assets of $0.3 million and purchases of equipment of $0.2 million.
Additionally, as of December 31, 2024, warrants exercisable for an aggregate of up to 6,802,668 shares of a Company's Class A common stock remain outstanding at exercise prices ranging from $2.35 per share to $175.00 per share.
Additionally, as of December 31, 2025, warrants exercisable for an aggregate of up to 21,920,318 shares of our Class A common stock remain outstanding at exercise prices ranging from $0.85 per share to $175.00 per share. 80 In the third quarter of 2025, we undertook two capital raising transactions.
After funding the initial period, receipt of additional grant funds is contingent upon satisfactory submission of our interim reports to the granting agency. Grant awards arise from submitting detailed research proposals to granting agencies and winning a highly competitive and rigorous application review and process that is judged on the merits of the proposal.
Grant awards arise from submitting detailed research proposals to granting agencies and other organizations and winning a highly competitive and rigorous application review and process that is judged on the merits of the proposal. There are typically multiple applicants applying and competing for a finite amount of funds.
We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025 based on our current operating budget and cash flow forecast. However, as a result of our Type C meeting with the U.S.
We currently anticipate our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2026, based on our current operating budget and cash flow forecast. Our operating costs will continue to be substantial for the foreseeable future in connection with our ongoing activities.
While our significant accounting policies and estimates are described in more detail in the accompanying Notes to the Condensed Financial Statements contained in this Annual Report on Form 10-K, we believe that the following accounting policies are those most critical due to the judgments and estimates used in the preparation of our financial statements. Revenue recognition.
There are items within our financial statements that require estimation but are not deemed critical, as defined pursuant to Item 303(b)(3) of Regulation S-K. Our significant accounting policies and estimates are described in more detail in the accompanying Notes to the Financial Statements contained in this Annual Report on Form 10-K.
General and Administrative Expense: General and administrative expenses for the year ended December 31, 2024 decreased to approximately $10.3 million compared to $12.2 million for the same period in 2023. The decrease of approximately $1.9 million, or 16%, was primarily due to lower personnel expenses as a result of reduced severance in 2024 and lower legal and other administrative expenses.
General and Administrative Expense: General and administrative expenses for the year ended December 31, 2025 increased to approximately $12.0 million compared to $10.3 million for the same period in 2024.
Research and development expenses consisted primarily of the following items (less those expenses allocated to the cost of revenues) (in thousands): 74 Year Ended December 31, 2024 2023 Clinical trial expenses-statistics, monitoring, labs, sites, etc. $ 2,031 $ 4,349 Supplies and costs to manufacture Lomecel-B™ 327 1,214 Employee compensation and benefits 3,554 1,861 Equity-based compensation 825 555 Depreciation 735 722 Amortization 224 224 Travel 173 38 Other activities 268 103 Total $ 8,137 $ 9,066 Other Income (Expense), net: Other income (expense) for the years ended December 31, 2024 and 2023 was an income of $0.6 million and an expense of $0.4 million, respectively.
Research and development expenses consisted primarily of the following items (in thousands): Year Ended December 31, 2025 2024 Clinical trial expenses-statistics, monitoring, labs, sites, etc. $ 1,826 $ 2,031 CMC 1,746 327 Employee compensation and benefits 5,919 3,554 Equity-based compensation 660 825 Depreciation 761 735 Amortization 466 224 Travel 227 173 Other activities 436 268 Total $ 12,041 $ 8,137 Other Income: Other income for the year ended December 31, 2025 was $0.6 million, consisting of $0.4 million of interest earned on money market funds and $0.3 million of cash received as a recipient of a Milestone 1 Award in the XPRIZE Healthspan competition, partially offset by a $0.1 million loss on the disposal of assets.
The gross proceeds to the Company from the July offering were approximately $9.0 million, before deducting placement agent fees and other offering expenses payable by the Company.
The combined public offering price was $0.85 per share of Class A common stock and related Class A common stock warrants and $0.849 per pre-funded warrant and related Class A common stock warrants. The gross proceeds to the Company from the offering were approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
Clinical trial revenue, which is derived from the Bahamas Registry Trial, for the years ended December 31, 2024 and 2023 was $1.4 million and $0.7 million, respectively, reflecting an increase of $0.7 million, or 110%, when compared to 2023 as a result of increased participant demand.
Revenues for the year ended December 31, 2024 were $2.4 million and consisted of $1.4 million of clinical trial revenue, $0.5 million of contract manufacturing lease revenue, and $0.5 million of contract manufacturing revenue. 2025 revenues decreased $1.2 million, or 50%, when compared to 2024, as a result of lower participant demand for our Bahamas Registry Trial and reduced demand for contract manufacturing services from our third-party client.
We may incur income taxes in the future if we have earnings. At this time the Company has not evaluated the impact of any future profits.
Other income and expense also includes items incurred that are not part of our normal operations. Income Taxes No provision for income taxes has been recorded for the years ended December 31, 2025 and 2024. We may incur income taxes in the future if we have earnings. At this time, we have not evaluated the impact of any future profits.
Net Loss: Net loss decreased to approximately $16.0 million for the year ended December 31, 2024 from a net loss of $21.4 million for the same period in 2023. The decrease in the net loss of $5.4 million, or 25%, was for reasons outlined above.
Other income for the year ended December 31, 2024 was $0.5 million, consisting primarily of interest earned on money market funds and marketable securities. Net Loss: Net loss increased to approximately $22.7 million for the year ended December 31, 2025 from a net loss of $16.0 million for the same period in 2024.
As compensation to the placement agent the Company also issued to designees of the placement agent warrants to purchase up to 154,894 shares of Class A common stock, which had substantially the same terms as the Common Warrants, and with an exercise price of $2.9375 per share and a term of five years from the commencement of sales in the offering.
We also issued them warrants to purchase up to 411,765 shares of Class A common stock, which had substantially the same terms as the Class A common stock warrants, except that the exercise price was $1.0625 per share (which represented 125% of the combined public offering price per share and related Class A Common Stock warrants).
Net cash provided by investing activities for year ended December 31, 2023 was $8.2 million consisting primarily of proceeds from the sale of marketable securities of $8.9 million, which was partially offset by additions to intangible assets of $0.4 million and purchases of equipment of $0.3 million. Financing Activities .
Net cash provided by financing activities for the year ended December 31, 2025 was $4.7 million and primarily consists of proceeds from the issuance of common stock of approximately $5.0 million, which was partially offset by the payment of taxes upon vesting of restricted stock units (“RSUs”).
Net cash provided by financing activities for the year ended December 31, 2023 was $5.3 million consisting primarily of $5.4 million of net proceeds received from the October 2023 and December 2023 offerings. 75 LIQUIDITY AND CAPITAL RESOURCES Since our inception, we have incurred significant operating losses.
We have incurred losses since inception. Net cash used in operating activities for the year ended December 31, 2025 was $18.6 million, consisting primarily of our net loss of $22.7 million and the amortization of prepaid expenses and other current assets of $0.4 million and in operating lease asset and liability of $0.3 million.
The warrants to purchase up to 2,399,744 shares of Class A common stock (the “Series C Warrants”) have a term of five (5) years from the issuance date, and 76 the warrants to purchase up to 2,399,744 shares of Class A common stock (the “Series D Warrants”) have a term of twenty-four (24) months from the issuance date, with all of the Series C Warrants and Series D Warrants being immediately exercisable.
The Class A common stock warrants were immediately exercisable, expire twenty-four (24) months from the date of issuance and have an exercise price equal to $0.85 per share of Class A common stock.
The shares and Pre-Funded Warrants were sold together with warrants to purchase up to an aggregate of 2,212,766 shares of Class A common stock (the “Common Warrants”). The combined public offering price was $2.35 per share and related Common Warrant and $2.349 per Pre-Funded Warrant and related Common Warrant.
On August 11, 2025, we closed a public offering of 5,882,354 shares of Class A common stock and pre-funded warrants, which were sold together with Class A common warrants to purchase up to 14,705,885 shares of Class A Common Stock.
We intend to seek additional financing and non-dilutive funding options to support these activities, and the current cash projections may be impacted by these ramped up activities and any financing transactions entered into. There can be no assurance we will be able to attain future financing at terms favorable to us or at all.
There can be no assurance we will be able to attain future financing at terms favorable to us or at all. In the event we are unable to attain the financing needed, we will need to materially revise our current operational plan.
Since the time that we became a publicly traded company in February 2021, we have sold 12,686,240 shares of Class A common stock through our IPO and subsequent follow-on public and private equity offerings and transactions.
Our mission is to continue to advance the development and regulatory approval of laromestrocel in order to make it available for patients who may need it. Financial Overview As of December 31, 2025, we have sold 20,328,220 shares of Class A common stock through our IPO and subsequent follow-on public and private equity offerings and transactions.
The gross proceeds to the Company from the July warrant exercises, inclusive of the payment consideration for such Series C warrants and June Inducement Warrants, were approximately $6.3 million, inclusive of the payment consideration for such warrants, before deducting placement agent fees payable by the Company.
The combined public offering price was $0.85 per share of Class A common stock and related Class A common stock warrants and $0.849 per pre-funded warrant and related Class A common stock warrants. The gross proceeds to the Company from the offering were approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
Removed
Lomecel-B™ has multiple modes of action that include pro-vascular, pro-regenerative, and anti-inflammatory mechanisms, promoting tissue repair and healing with broad potential applications across a spectrum of disease areas. We are currently pursuing three pipeline indications: Hypoplastic Left Heart Syndrome (“HLHS”), Alzheimer’s disease (“AD”) and Aging-related Frailty.
Added
On September 19, 2025, we entered into an At The Market Offering Agreement (the “ATM Agreement”) providing for the sale and issuance by the Company of shares of Class A common stock from time to time, through or to H.C. Wainwright & Co., LLC (“Wainwright") as the Company’s sales agent or principal.
Removed
Our mission is to advance Lomecel-B™ and other cell-based product candidates into pivotal or Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization, and broad use by the healthcare community. Financial Overview. Since inception, the Company has primarily been engaged in organizational activities, including raising capital, and research and development activities.
Added
The aggregate market value of the shares of Class A common stock eligible for sale under the ATM prospectus supplement is currently $10.7 million. See further discussion of these transactions under Capital Raising Efforts in LIQUIDITY AND CAPITAL RESOURCES section below.
Removed
FDA in August 2024 with respect to the HLHS regulatory pathway, we have started to ramp up Biologics License Application (BLA) enabling activities as we currently anticipate a potential filing with the FDA in 2026 if the current ELPIS II trial is successful.
Added
On March 11, 2026, we completed an initial closing of a private placement transaction with certain institutional and accredited investors, pursuant to which an aggregate of 6,013,384 shares of common stock were sold at a purchase price of $0.52 per share and 11,873.04 shares of Series A Preferred Stock convertible into an aggregate of 22,832,770 shares of common stock were sold at a purchase price of $1,000.00 per preferred share.
Removed
Our operating expenses and capital expenditure requirements are expected to accelerate in calendar 2025 as a result of these activities, including CMC (Chemistry, Manufacturing, and Controls) and manufacturing readiness, and there will be a need to increase our current proposed spend and further increase our capital investments.
Added
Additionally, we agreed to sell to the investors an interest in 50% of proceeds received (after deducting necessary, documented third-party fees or charges) from the potential future sale of a Rare Pediatric Disease Priority Review Voucher to the extent received from the U.S. FDA in connection with the Company’s laromestrocel program for Hypoplastic Left Heart Syndrome (HLHS).
Removed
We intend to seek additional financing/capital raises/non-dilutive funding options to support these activities, and current cash projections may be impacted by these ramped up activities and any financing transactions entered into. There can be no assurance we will be able to attain future financing at terms favorable to us or at all. Operational Overview .
Added
The aggregate gross proceeds from the initial closing were approximately $15.9 million, before deducting placement agent fees and other private placement expenses. H.C. Wainwright, who acted as the exclusive placement agent for the private placement, received a cash fee equal to 7.0% and a management fee equal to 1.0%, of the aggregate gross proceeds raised.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeItem 7A. Quantitative and Qualitative Disclosures about Market Risk. We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate sensitivities. We held cash and cash equivalents of approximately $19.2 million as of December 31, 2024. We generally hold our cash in interest-bearing money market accounts.
Biggest changeItem 7A. Quantitative and Qualitative Disclosures about Market Risk. We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate sensitivities. We held cash and cash equivalents of approximately $4.7 million as of December 31, 2025. We generally hold our cash in interest-bearing money market accounts.

Other LGVN 10-K year-over-year comparisons