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LGVN on Nasdaq

Longeveron Inc.

Longeveron Inc. is an American pharmaceutical preparations company based in Miami.1 Its shares trade on Nasdaq under the symbol LGVN.1

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Last updated Oct 21, 2026.

Overview

$1.2MRevenue, fiscal 20252
-$22.7MNet income, fiscal 20252

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  • TickerLGVN on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersMiami, Florida1
  • Incorporated inDE3
  • Business address1951 Nw 7Th Avenue, Suite 520, Miami, Fl 331363
  • Filer category, Emerging growth company3
  • Legal formCorporation

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Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

67.0%Gross margin2
-1942.2%Operating margin2
-1893.6%Net margin2
-49.9%Revenue growth, 20252
-400.1%Return on equity2
-$18.9MFree cash flow2

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Clinical Trial Revenue brought in 80% of the revenue Longeveron Inc. broke down this way in fiscal 2025.

  1. Clinical Trial Revenue$954.0K280%down 32% from 2024
  2. Contract manufacturing revenues$222.0K219%down 54% from 2024
  3. Contract Manufacturing Lease Revenue$23.0K22%down 95% from 2024
Products and services by year
Products and services20242025
Clinical Trial Revenue$1.4M$954.0K
Contract manufacturing revenues$487.0K$222.0K
Contract Manufacturing Lease Revenue$503.0K$23.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue3¢$396.0K
  • Research and development97¢$12.0M

Out of $1.2M in revenue.2 The company lost money this year.

Financial statements

Revenue45672$1.2M in 2025−79% since 2020
0$2.0M$4.0M$6.0M2020: $5.6M$5.6M20202021: $1.3M$1.3M2021−77%2022: $1.2M$1.2M2022−6%2023: $709.0K$709.0K2023−42%2024: $2.4M$2.4M2024+237%2025: $1.2M$1.2M2025−50%
Gross profit45672$803.0K in 2025−56% since 2020
0$500.0K$1.0M$1.5M$2.0M2020: $1.8M$1.8M20202021: $590.0K$590.0K2021−68%2022: $497.0K$497.0K2022−16%2023: $221.0K$221.0K2023−56%2024: $1.9M$1.9M2024+752%2025: $803.0K$803.0K2025−57%
Operating income45672-$23.3M in 2025+516% since 2020
-$30.0M-$20.0M-$10.0M02020: -$3.8M-$3.8M20202021: -$17.5M-$17.5M2021+362%2022: -$18.0M-$18.0M2022+3%2023: -$21.0M-$21.0M2023+17%2024: -$16.5M-$16.5M2024−21%2025: -$23.3M-$23.3M2025+41%
Net income45672-$22.7M in 2025+510% since 2020
-$30.0M-$20.0M-$10.0M02020: -$3.7M-$3.7M20202021: -$17.0M-$17.0M2021+358%2022: -$18.8M-$18.8M2022+11%2023: -$21.4M-$21.4M2023+14%2024: -$16.0M-$16.0M2024−25%2025: -$22.7M-$22.7M2025+42%

Every line of the income statement as filed: the last 2 fiscal years, latest first.2

Period ending2025-12-312024-12-31
Total revenues$1.2M$2.4M
Cost of revenues$396.0K$508.0K
Gross profit$803.0K$1.9M
General and administrative$12.0M$10.3M
Research and development$12.0M$8.1M
Total operating expenses$24.1M$18.4M
Loss from operations-$23.3M-$16.5M
Loss on disposal of assets-$97.0K
Other income (expense), net$680.0K$549.0K
Total other income (expenses), net$583.0K$549.0K
Net loss-$22.7M-$16.0M
Deemed dividend - warrant inducement offers$0-$8.7M
Net loss attributable to common stockholders-$22.7M-$24.6M
Basic net loss per share-$1.29-$2.62
Diluted net loss per share-$1.29-$2.62
Basic weighted average common shares outstanding17.6B shares9.4B shares
Diluted weighted average common shares outstanding17.6B shares9.4B shares

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Corporate structure

Longeveron Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Longeveron Inc.

  • Longeveron Inc. Miami, Florida

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Longeveron Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$7.7M2 Dec 31, 2025$7.6M2 Dec 31, 2024+0.5%
Property and equipment, net$1.8M2 Dec 31, 2025$2.4M2 Dec 31, 2024−25.0%
Operating-lease assets (leased space)$513.0K2 Dec 31, 2025$882.0K2 Dec 31, 2024−41.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$4.7M2 Dec 31, 2025$19.2M2 Dec 31, 2024−75.8%
Marketable securities, current$07 Dec 31, 2024$412.0K7 Dec 31, 2023−100.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$2.3M2 Dec 31, 2025$2.4M2 Dec 31, 2024−4.8%
Finite-lived intangibles, gross$3.9M2 Dec 31, 2025$3.5M2 Dec 31, 2024+9.9%
Accumulated amortization$1.6M2 Dec 31, 2025$1.1M2 Dec 31, 2024+41.2%
Finite-lived intangibles, net$2.1M2 Dec 31, 2025$911.0K7 Dec 31, 2024+125.6%

Properties, in its own words

Our principal executive offices are located at 1951 NW 7th Avenue, Suite 520, Miami, Florida 33136. We rent approximately 15,000 ft2 of space, which includes our executive offices and cGMP manufacturing facility, and research and development operations. This property is used by the Company’s single operating segment focused on developing regenerative medicines to address unmet medical needs. See “Manufacturing” on page 5 of this 10-K for additional details regarding our facilities.

Item 2 of the 10-K filed Mar 17, 2026.12

Leadership

Who has led Longeveron Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Geoff Green2021–2022
  2. Mohamed Wa'El Ahmed Hashad2023–2026
  3. Stephen H. Willard2026–now

Chair

  1. Joshua Hare2021

Chief financial officer

  1. James Clavijo2021–2023
  2. Lisa Locklear2023–2026
  3. Marie Washburn2026
  4. Nirav S. Jhaveri2026–now
2025
Board members and other officers (20)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerPaul A. Lehr named Dec 13, 2021 to Mar 25, 202640
  • Executive Officer, DirectorWa'el Hashad named Oct 24, 2023 to Jul 23, 202441
  • DirectorCathy E. Ross named Dec 13, 2021 to Apr 25, 202442
  • DirectorDonald Soffer named Dec 13, 202143

Former names

  • LONGEVERON LLCNov 6, 2017 to Feb 10, 20213

Timeline

  1. Oct 14, 20268-K Executive or director change44
  2. Sep 23, 20268-K Other events45
  3. Sep 14, 20268-K Other events46
  4. Aug 24, 20268-K Bylaws or fiscal year changed; Regulation FD disclosure47
  5. Aug 19, 20268-K Executive or director change48
  6. Aug 12, 20268-K Results of operations49
  7. Jul 29, 20268-K Other events50
  8. Jul 14, 20268-K Executive or director change51
  9. Jul 8, 20268-K Executive or director change52
  10. Jul 6, 20268-K Executive or director change; Bylaws or fiscal year changed; Shareholder vote53
  11. Jun 5, 20268-K Executive or director change54
  12. May 13, 20268-K Results of operations55
  13. Mar 13, 2026New chief executive Stephen H. Willard becomes CEO13
  14. Mar 2, 2023New chief executive Mohamed Wa'El Ahmed Hashad becomes CEO14
  15. Feb 11, 2021New chief executive Geoff Green becomes CEO15

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($3.90) a share, on Nov 4, 2025.56

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results49
  2. May 13, 2026Reported quarterly or annual results55
  3. Nov 4, 2025Reported quarterly or annual results57
  4. Aug 13, 2025Reported quarterly or annual results58
  5. May 8, 2025Reported quarterly or annual results59
  6. Feb 28, 2025Reported quarterly or annual results60
  7. Nov 12, 2024Reported quarterly or annual results61
  8. Aug 14, 2024Reported quarterly or annual results62

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

451 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 85 major events, 217 insider forms, 14 large holders, 7 private raises, 107 other. The latest 20:

  1. Oct 14, 20268-K CURRENT REPORT EDGAR
  2. Oct 5, 20264 PRIMARY DOCUMENT EDGAR
  3. Oct 5, 20264 PRIMARY DOCUMENT EDGAR
  4. Oct 5, 20264 PRIMARY DOCUMENT EDGAR
  5. Oct 5, 20264 PRIMARY DOCUMENT EDGAR
  6. Oct 5, 20264 PRIMARY DOCUMENT EDGAR
  7. Sep 23, 20268-K CURRENT REPORT EDGAR
  8. Sep 14, 20268-K CURRENT REPORT EDGAR
  9. Sep 10, 2026SCHEDULE 13G EDGAR
  10. Aug 25, 20264 PRIMARY DOCUMENT EDGAR
  11. Aug 25, 20263 PRIMARY DOCUMENT EDGAR
  12. Aug 24, 20268-K CURRENT REPORT EDGAR
  13. Aug 21, 20264 PRIMARY DOCUMENT EDGAR
  14. Aug 21, 20264 PRIMARY DOCUMENT EDGAR
  15. Aug 21, 20264 PRIMARY DOCUMENT EDGAR
  16. Aug 21, 20264 PRIMARY DOCUMENT EDGAR
  17. Aug 21, 20264 PRIMARY DOCUMENT EDGAR
  18. Aug 21, 20264 PRIMARY DOCUMENT EDGAR
  19. Aug 21, 20264 PRIMARY DOCUMENT EDGAR
  20. Aug 21, 20264 PRIMARY DOCUMENT EDGAR

The 451 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

37 open-market trades by officers, directors and large owners since October 2021: 20 buys and 17 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 11, 2025Locklear LisaChief Financial OfficerBuy11,766Form 4
Aug 11, 2025Baluch KhosoDirectorBuy11,766Form 4
May 30, 2025Soffer RockDirectorSale11,000$1.25$13.8KForm 4
May 29, 2025Soffer RockDirectorSale10,000$1.30$13.0KForm 4
May 22, 2025Soffer RockDirectorSale2,000$1.32$2.6KForm 4
May 16, 2025Hare JoshuaChief Scientific OfficerSale5,250$1.40$7.3KForm 4
Dec 2, 2024Baluch KhosoDirectorSale1,250$2.07$2.6KForm 4
Apr 11, 2024Hare JoshuaChief Scientific OfficerBuy42,553$2.35$100.0KForm 4
Apr 11, 2024Hashad Mohamed Wa'el AhmedChief Executive OfficerBuy10,638$2.35$25.0KForm 4
Apr 11, 2024Soffer RockDirectorBuy31,915$2.35$75.0KForm 4
Apr 10, 2024Hare JoshuaChief Scientific OfficerBuy106,383$2.35$250.0KForm 4
Apr 10, 2024Soffer RockDirectorBuy106,383$2.35$250.0KForm 4
Jan 10, 2024Ross CathyDirectorBuy5,000$1.31$6.5KForm 4
Dec 29, 2023Baluch KhosoDirectorBuy8,322$1.43$11.9KForm 4
Dec 28, 2023Baluch KhosoDirectorBuy1,678$1.40$2.3KForm 4
Dec 28, 2023PFEFFER JEFFREYDirectorBuy10,000$1.35$13.5KForm 4
Jun 29, 2023Clavijo JamesCFO and TreasurerSale5,000$3.51$17.6KForm 4
Jun 28, 2023Clavijo JamesCFO and TreasurerSale10,000$3.43$34.3KForm 4
Jun 27, 2023Clavijo JamesCFO and TreasurerSale8,532$3.48$29.7KForm 4
Jan 27, 2023Hare JoshuaChief Scientific OfficerSale20,000$4.28$85.6KForm 4

All 37 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Wa’el Hashad$482.2K$1.3M71
2025Paul Lehr,59$420.0K$1.0M71
2025Lisa A. Locklear,65$431.7K$862.1K71
2025J. Nathaniel Powell$194.4K$475.8K71
2024Former ChiefExecutive Officer$571.0K$1.8M71
2024General Counsel and Corporate Secretary$420.1K$1.2M71
2024Chief Financial Officer and Treasurer$430.9K$1.1M71

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Mar 11, 2026Raised $15.9 million in a private offering of equity Form D: $33.5 million offered in all Form D
  2. Jul 19, 2024Filed a private offering of securities Form D: $9.5 million offered in all Form D
  3. Jun 18, 2024Filed a private offering of securities Form D: $9.4 million offered in all Form D
  4. Apr 18, 2024Filed a private offering of securities Form D: $12.4 million offered in all Form D
  5. Dec 22, 2023Filed a private offering of securities Form D: $2.6 million offered in all Form D
  6. Oct 13, 2023Filed a private offering of securities Form D: $8.4 million offered in all Form D
  7. Dec 3, 2021Raised $20.5 million in a private offering of equity Form D: 20 investors so far Form D

SEC filer profile

How Longeveron Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARLongeveron Inc.1
  • CIK0001721484
  • Employer ID (EIN)47-217414612
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company12
  • Incorporated inDelaware12
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1951 Nw 7Th Avenue, Suite 520, Miami, FL 331361
  • Phone305-302-71581
  • Shares outstanding21,783,749 Common Class A shares; 1,484,005 Common Class B shares as of Mar 9, 202612
  • Public float$16.5M as of Jun 30, 202512
  • AuditorCBIZ CPAs P.C, Hartford, CT PCAOB ID 199; no auditor attestation of internal control over financial reporting12
  • On EDGAR sinceNov 6, 20171
  • Filings529 in all: 4 (211), 8-K (98), 3 (31), CORRESP (21), 10-Q (17), UPLOAD (16), EFFECT (13), S-1 (11)1
    All 39 form types

    S-1/A (10), 424B3 (9), D (9), DEF 14A (7), 10-K (6), DEFA14A (6), S-8 (5), SCHEDULE 13G (5), 424B4 (4), 424B5 (4), ARS (4), PRE 14A (4), SC 13D/A (4), 144 (3), 4/A (3), FWP (3), SC 13G (3), 10-K/A (2), 8-A12B (2), CERT (2), D/A (2), DRS (2), S-3 (2), SC 13D (2), SCHEDULE 13G/A (2), 25-NSE (1), 5 (1), DRS/A (1), DRSLTR (1), S-1MEF (1), SC 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 17, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) May 20, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Class A common stock, par value $0.001 per shareLGVNNasdaq

From the cover page of the 10-K filed Mar 17, 2026 (Section 12(b) of the Exchange Act).12

Risk factors and legal proceedings

The risks Longeveron Inc. names in Item 1A of its 10-K filed Mar 17, 2026: 72 risks under these headings, as written.12

  • factors, including the risks and uncertainties described below. For a summary of these risk factors, please see “Risk Factors Summary” beginning on page 24 of this 10-K.
  • Risks Related to our Business
  • We have a history of losses and may not be able to achieve profitability going forward, and may not be able to raise additional capital necessary to continue as a going concern.
  • We have a limited operating history and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability.
  • We have ongoing challenges with respect to our liquidity and access to capital.
  • If the potential of our investigational product candidates to treat diseases is not realized, the value of our technology and our development programs could be significantly reduced.
  • Our product development programs are based on novel technologies and are inherently risky.
  • There are no FDA-approved allogeneic, cell-based therapies for Aging-related Frailty, Alzheimer’s disease (AD), or other aging-related conditions, nor HLHS, pediatric DCM or other cardiac-related indications. This could complicate and delay FDA approval of our investigational product candidate for these indications, or other indications we study or will study.
  • According to the FDA, “Aging-related Frailty” does not have a definition that is acceptable for characterizing the conditions for regulatory purposes, and there are no precedents for regulatory approvals of this indication. This could prevent, complicate and/or delay regulatory approval of our investigational product candidate for these indications to the extent that the Company may continue to pursue this indication.
  • If we are not able to recruit and retain qualified management and scientific personnel, we may fail in developing our technologies and investigational product candidates.
  • Our investigational product candidates represent new classes of therapy that the marketplace may not understand or accept.
  • Our dependence upon a limited supply of bone marrow donors and biologic growth media may impact our ability to produce sufficient quantities of our investigational product candidates as needed to complete our clinical trials, and if our trials are successful and our investigational product candidates are approved, to meet product demand.
The other 61 risks
  • Mesenchymal stem cells are biological entities derived from human bone marrow and therefore have the potential for disease transmission and can pose risks to the recipient.
  • If our processing and storage facility or our clinical manufacturing facilities are damaged or destroyed, our business and prospects could be negatively affected.
  • Ethical and other concerns surrounding the use of stem cell therapy or human tissue may negatively affect public perception of us or our future products or investigational product candidates, or may negatively affect regulatory approval of our future products or investigational product candidates, thereby reducing demand for our future products.
  • We may eventually compete for product sales with other companies, many of which will have greater resources or capabilities than we have, or may succeed in developing better products or in developing products more quickly than we do, and we may not compete successfully with them.
  • Sales of our future products may involve a lengthy sales cycle.
  • We face risks related to health epidemics, pandemics, and outbreaks.
  • Adverse global conditions, including macroeconomic uncertainty, may negatively impact our financial results.
  • We have been funded in part by government and non-profit association grant awards, which is not a guaranteed source of future funding.
  • The use of our investigational product candidates or future products in individuals may expose us to product liability claims, and we may not be able to obtain adequate product liability insurance coverage.
  • We face risks with respect to our contract development and manufacturing business.
  • Risks Related to Intellectual Property
  • If our trade secret and patent position does not adequately protect our investigational product candidates and their uses, others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition and results of operations.
  • If certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected.
  • If we are unable to protect the confidentiality of our proprietary information, trade secrets, and know-how, our competitive position could be impaired and our business, financial condition, results of operations, and prospects could be adversely affected.
  • Third-party claims of intellectual property infringement may prevent or delay our product development efforts.
  • We may become involved in lawsuits to protect or enforce our patents or the patents of our collaborators or licensors, which could be expensive and time-consuming.
  • Our industry is highly competitive and subject to significant or rapid technological change.
  • 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.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
  • Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued 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.
  • Patent terms may be inadequate to protect our competitive position on our investigational product candidates for an adequate amount of time.
  • 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.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Regulatory Approval and Other Government Regulations
  • We are substantially dependent on the successful development, regulatory approval and commercialization of laromestrocel, and we cannot assure you that we will obtain regulatory approval or successfully commercialize this investigational therapy.
  • If we are not able to successfully develop and commercialize our investigational product candidates and obtain the necessary regulatory approvals, we may not generate sufficient revenues to continue our business operations.
  • We cannot market and sell our investigational product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals, which are subject to significant uncertainty and may be delayed or never obtained.
  • If we are not able to conduct our clinical trials properly and on schedule, marketing approval by the FDA and other regulatory authorities may be delayed or denied.
  • Even if we complete clinical development, regulatory approval may be delayed, limited, or subject to burdensome conditions, which could materially affect our commercial prospects.
  • Alzheimer’s disease drug development has historically had a high rate of failure, and we may not be successful in developing an effective therapy for this indication.
  • Our business involves the use of hazardous materials that could expose us to environmental and other liability.
  • Our CMC readiness and ability to manufacture laromestrocel for commercialization and any future product candidates for clinical or commercialization may require significant additional investment, be delayed or be unsuccessful.
  • Even if we receive regulatory approval of laromestrocel or any of our other investigational product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense. We may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our investigational product candidates.
  • Our potency assay strategy may not be accepted by regulatory authorities or may require further development which could delay or prevent approval
  • Ongoing healthcare legislative and regulatory reform measures in the U.S. and other countries may have a material adverse effect on our business and results of operations.
  • First Trump Administration
  • Biden Administration
  • Inflation Reduction Act
  • Second Trump Administration
  • Risks Related to Our Dependence on Third Parties
  • We rely on third parties to serve as local representatives in foreign jurisdictions where we perform our clinical trials.
  • We rely on third parties to provide us with supplies to produce our investigational 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 currently depend upon third parties for services and raw materials needed for the manufacture of our investigational product candidates, and if these products are successfully commercialized, we may become dependent upon third parties for product distribution. If any of these third parties fail or are unable to perform in a timely manner, our ability to manufacture and deliver could be compromised.
  • Our reliance on third-party manufacturers and technology transfer activities introduces additional CMC and regulatory risk.
  • Regulatory inspections of our facilities or those of our third-party manufacturers could result in findings that delay or prevent approval.
  • Use of third-party manufacturers may increase the risk that we will not have adequate quantities of our investigational product candidates.
  • We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential investigational product candidates.
  • Because we have made a strategic decision to use third-party manufacturers in the future, they will likely be dependent upon their own third-party suppliers, making us vulnerable to supply shortages and price fluctuations, which could harm our business.
  • We will depend on third-party distributors in the future to market and sell our future products which will subject us to a number of risks.
  • We may engage in future acquisitions, strategic partnerships, mergers, or the sale and/or licensing of our intellectual property, which could disrupt our business, increase our capital requirements, dilute our stockholders, harm our financial condition and operating results, and subject us to other risks.
  • 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.
  • We may enter into arrangements with third-party collaborators to help us develop our investigational product candidates and commercialize our future products, and our ability to commercialize such products may be impaired or delayed if collaborations are unsuccessful.
  • Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • 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.
  • We may expend our limited resources to pursue a particular investigational product candidate or indication and fail to capitalize on other investigational product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • The U.S. FDA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
  • Obtaining and maintaining regulatory approval of a product in one jurisdiction does not mean that we will be successful in obtaining or maintaining regulatory approval in other jurisdictions.
  • The FDA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • If we are required by the FDA to obtain approval of a companion diagnostic test in connection with approval of any of our investigational product candidates, and we do not obtain or face delays in obtaining FDA approval of a diagnostic test, we will not be able to commercialize such future approved product and our ability to generate revenue will be materially impaired.
  • We may attempt to secure approval from the FDA or comparable foreign regulatory authorities through an expedited review program, and if we are unable to do so, then we could face increased expense to obtain, and delays in the receipt of, necessary marketing approvals.
  • The FDA’s Rare Pediatric Disease Designation for laromestrocel for HLHS does not guarantee that we will receive a priority review voucher if the product is approved for this indication, nor does the receipt of Orphan Drug Designation for laromestrocel for HLHS guarantee that we will receive seven years of market exclusivity if the product is approved for this indication.
  • The FDA’s RMAT and Fast Track designations for laromestrocel for mild AD does not guarantee that laromestrocel will be developed or approved faster, or more successfully, than if these designations were not granted, and FDA could rescind these designations if the qualifying criteria are no longer met.
  • We may face difficulties from changes to current regulations and future legislation, both in the U.S. as well as in other foreign jurisdictions where we may be operating.
  • Our relationships with healthcare professionals, clinical investigators, CROs and payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws, which could expose us to, among other things, criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings.
  • A variety of factors, including inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

Legal proceedings

From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. While management does not currently believe that the ultimate disposition of these matters will have a material adverse impact on the Company’s results of operations, cash flows, or financial position, litigation is inherently unpredictable, and depending on the nature and timing of these proceedings, an unfavorable resolution could materially affect the Company’s future results of operations, cash flows or financial condition in a particular period. As of December 31, 2025, the Company is not aware of any legal proceedings or material developments requiring disclosure.

The opening of Item 3, Legal Proceedings.12

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