Longeveron Inc.
For the period ended Dec 31, 2025. Filed Mar 17, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 17, 2026
LGVN$1.81+5.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-02-28.
0000950170-25-029968
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-17.
0001193125-26-110664
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 120 previous paragraphs and 98 current paragraphs.
31 unchanged; 41 reworded; 24 added; 44 removed; 4 previous and 2 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (24)
Current report
We are currently pursuing three potential indications: Hypoplastic Left Heart Syndrome (“HLHS”), Alzheimer’s disease (“AD”) and pediatric Dilated Cardiomyopathy ("pediatric DCM"). 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.
Current report
Financial Overview
Current report
In the third quarter of 2025, we undertook two capital raising transactions. 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. 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. 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. 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.
Current report
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.
Current report
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). 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.
Current report
Subject to satisfaction or waiver of certain conditions discussed below, we also agreed to issue and sell to the investors additional shares of common stock and Series A Preferred Stock, respectively, in a second closing, for additional gross proceeds of approximately $15.0 million, before deducting placement agent fees and other private placement expenses. The second closing would occur upon satisfaction or waiver (by Investors holding at least a majority in interest of the Securities then held by the Investors, on an as-converted basis) of the closing conditions set forth under the Purchase Agreement, including (i) the Company’s achievement of Phase 2b study results for HLHS demonstrating statistical significance of the primary endpoint(s) as agreed between the Company and the U.S. FDA (the “Milestone”) and (ii) achievement of a volume weighted average price per share of common stock equal to or greater than $1.85 with aggregate trading volume of at least 25,000,000 shares (in each case, subject to appropriate, proportional adjustment for any stock splits or combinations of the common stock occurring after the date of the Purchase Agreement) during any ten consecutive trading days prior to expiration of the 30 trading days following the date of the Company’s first announcement via press release or a Current Report on Form 8-K of the occurrence of the Milestone.
Current report
On May 12, 2025, we announced our selection as a semi-finalist team and recipient of a $250,000 Milestone 1 Award in the XPRIZE Healthspan competition from the XPRIZE Foundation, Inc., a seven-year, $101 million global competition to identify therapeutic approaches to increase human health span.
Current report
We have prepared a cash flow forecast which indicates that we do not have sufficient cash to meet our minimum expenditure commitments for one year from the date these financial statements are available to be issued and therefore we need to raise additional funds to continue as a going concern. As a result, there is substantial doubt about our ability to continue as a going concern.
Current report
General and Administrative Expenses
Current report
We earn interest income on cash equivalents and money market funds. Other income and expense also includes items incurred that are not part of our normal operations.
Current report
Income Taxes
Current report
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. The increase of approximately $1.8 million, or 17%, was primarily related to an increase in personnel and related costs in 2025 as we increased headcount year over year and accrued severance costs for our former CEO Wa'el Hashad.
Current report
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. This increase of $3.9 million, or 48%, was primarily driven by a $2.2 million increase in personnel and related costs, including equity-based compensation, a $1.4 million increase in CMC costs associated with technology transfer, including non-clinical manufacturing batches that advance our readiness for future commercial production as part of our BLA-enabling efforts, and a $0.2 million increase in amortization expense related to patent costs.
Current report
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. 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.
Current report
LIQUIDITY, CAPITAL RESOURCES, AND GOING CONCERN
Current report
advance CMC activities to support BLA readiness; and
Current report
We intend to seek additional financing opportunities, capital raises, as well as non-dilutive funding options to support our operating plans. Additionally, following a positive Type B meeting with the FDA in March 2025 with respect to the AD regulatory pathway, we are focused on seeking partnership opportunities and/or non-dilutive funding for the AD program, including a proposed single, pivotal seamless adaptive Phase 2/3 clinical trial. 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. We do not have sufficient cash to meet our minimum expenditure commitments for one year from the date these financial statements are available to be issued and therefore we need to raise additional funds to continue as a going concern. As a result, there is substantial doubt about our ability to continue as a going concern.
Current report
In the third quarter of 2025, we undertook two capital raising transactions. 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. 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. 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. As compensation to the placement agent, we paid a cash fee equal to 7.0% of the aggregate gross proceeds raised in the offering, plus a management fee equal to 1.0% of the aggregate gross proceeds raised and certain expenses incurred. 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).
Current report
On September 19, 2025, we entered into an 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 Wainwright as the Company’s sales agent or principal. 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. Pursuant to the ATM Agreement, Wainwright has agreed to use its commercially reasonable efforts to sell the shares of Class A common stock from time to time. The Company will designate the parameters for the sale of shares of Class A common stock, including the number of shares to be issued, the time period during which sales are requested to be made, limitations on the number of shares that may be sold on any trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the ATM Agreement, Wainwright may sell the shares by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, including without limitation, sales made directly on Nasdaq or on any other existing trading market for the Class A common stock or to or through a market maker. In addition, with the Company’s prior written approval, Wainwright may also sell shares in privately negotiated transactions or block transactions. The gross sales price of the shares of Class A common stock sold by Wainwright under the ATM Agreement as sales agent shall be the market price for the shares of Class A common stock on Nasdaq at the time of sale.
Current report
The Company has no obligation to sell any shares of Class A common stock under the ATM Agreement and the Company or Wainwright may at any time suspend offers under the ATM Agreement, pursuant to the terms therein. Wainwright is not obligated to purchase any shares of Class A common stock on a principal basis pursuant to the ATM Agreement, except as otherwise specifically agreed by Wainwright and the Company in a separate agreement. No assurance can be given that the Company will sell any shares of Class A common stock under the ATM Agreement, or if such sales occur, no assurance can be given as to the price or number of shares that will be sold, or the dates on which any such sales will take place.
Current report
The ATM Agreement provides that the Company will pay Wainwright a sales commission equal to 3.0% of the gross sales price of the shares of Class A common stock sold by Wainwright pursuant to the ATM Agreement, and provide reimbursement for reasonable fees and expenses incurred by its legal counsel in connection with the ATM Agreement. As of December 31, 2025, we have sold 1,759,626 shares of Class A common stock under the ATM Agreement at a weighted average share price of $0.67 per share, resulting in net proceeds of approximately $0.9 million to the Company after deducting certain offering expenses, including approximately $50,000 in compensation to Wainwright.
Current report
The ATM Offering will terminate upon the earlier of (i) the sale of the Company’s Class A common stock pursuant to the ATM Prospectus Supplement having an aggregate sales price of $10.7 million or (ii) termination of the ATM Agreement by the Company or Wainwright as permitted therein.
Current report
See Note 14, Subsequent Events, for a discussion of the March 2026 private placement financing.
Current report
In addition to governmental grants, the Company also receives awards from non-profit foundations through competitive application processes, where funding is typically distributed in stages as specific milestones are met.
Removed paragraphs (44)
Previous report
We are currently pursuing three pipeline indications: Hypoplastic Left Heart Syndrome (“HLHS”), Alzheimer’s disease (“AD”) and Aging-related Frailty. 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.
Previous report
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. 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. 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. 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.
Previous report
Operational Overview. With respect to HLHS, we are exploring the possibility that Lomecel-B™ when administered directly to the myocardium of affected infants, can improve outcomes in this devastating rare pediatric disease. The standard of care in HLHS is a series of three heart surgeries (staged surgical palliation) that reconfigures the single right ventricle to support system circulation. Despite these life-saving surgical interventions, it is estimated that only 50 to 60 percent of affected individuals survive until adolescence. The pro-vascular, pro-regenerative and anti-inflammatory properties of Lomecel-B™ may improve the function of the right ventricle in these infants. A previous Longeveron Phase 1 open-label study indicated that such a benefit may exist when outcomes were compared to historical controls. Longeveron is currently conducting a controlled study to determine the actual benefit of Lomecel-B™ in these patients.
Previous report
As of February 17, 2025, we have completed five U.S. clinical studies of Lomecel-B™: Phase 1 AD, Phase 1 HLHS, Phase 1/2 Aging-related Frailty (“HERA Trial”), Phase 2a AD (CLEAR MIND Trial”), and Phase 2b Aging-related Frailty. We currently have one clinical trial actively enrolling patients: Phase 2b HLHS (“ELPIS II” trial). Additionally, we sponsor a registry in The Bahamas under the approval and authority of the National Stem Cell Ethics Committee. The Bahamas Registry Trials may administer Lomecel-B™ to eligible participants at private clinics in Nassau for a variety of indications. While Lomecel-B™ is considered an investigational product in The Bahamas, under the approval terms from the National Stem Cell Ethics Committee, we are permitted to charge a fee to participate in the Registry Trial.
Previous report
Since our founding in 2014, we have focused the majority of our time and resources on the following: organizing and staffing our company, building, staffing and equipping a cGMP manufacturing facility with research and development labs, business planning, raising capital, establishing our intellectual property portfolio, generating clinical safety and efficacy data in our selected disease conditions and indications, and developing and expanding our manufacturing processes and capabilities.
Previous report
We manufacture all of our own product candidates for clinical trials. In 2017 we opened a manufacturing facility comprised of eight clean rooms, two research and development laboratories, and warehouse and storage space. We have supply contracts with multiple third parties for fresh bone marrow, which we use to produce our product candidate for clinical testing and research and development. From time to time, we enter into contract development and manufacturing contracts or arrangements with third parties who seek to utilize our product development capabilities.
Previous report
Revenue recognition.
Previous report
We recognize revenue associated with our contract manufacturing services, which may require us to exercise considerable judgment in estimating revenue to be recognized, including judgments made on day one accounting and judgments associated with the amount of revenue to be recognized over time as performance obligations are satisfied.
Previous report
Significant judgment is required to apply the authoritative accounting guidance at the outset of our contract manufacturing services agreement, and over time, as detailed below:
Previous report
Determining whether products and services are considered distinct performance obligations that should be accounted for separately versus together may require judgment. For our contract manufacturing services revenue, the contract generally includes the terms of the contract manufacturing services and related ancillary services or procedures to comply with regulatory requirements. We have determined, our performance obligations vary per contract and are accounted for as separate performance obligations when a product or services is delivered. If a product or service is determined not to be delivered as in the case of an initial down payment that amount is deferred and combined with another related performance obligation. If a contract contains a single performance obligation, we allocate the entire transaction price to the single performance obligation. If a contract contains multiple performance obligations, we allocate consideration to each performance obligation using the “relative standalone selling price”. Generally, we utilize observable standalone selling prices in our allocations of consideration. If observable standalone selling prices are not available, we estimate the applicable standalone selling price using a cost-plus-margin approach or an adjusted market assessment approach, in each case, representing the amount that we believe the market is willing to pay for the applicable service or product. Revenue is recognized over time using an appropriate method of measuring progress towards fulfilling our performance obligation for the respective arrangement. Determining the measure of progress that consistently depicts our satisfaction of performance obligations within each of our revenue streams across similar arrangements requires judgment.
Previous report
The identified performance obligations will impact most significantly the timing of revenue recognition, and is either at a point in time or an over-time mainly based transfer of control assessment performed at the outset of the arrangement.
Previous report
For revenue recognized over time, this is based on an underlying measure deemed to approximate the progress towards satisfaction of performance obligations for the respective arrangement. These underlying measures, such as costs incurred to date compared with total forecasted costs for a service, may include inherent estimates, which in turn can impact the timing of revenue recognition. For revenue recognized at a point in time, revenue is recognized once the performance obligation is satisfied, meaning the product is delivered or the service is completed, signifying the transfer of control at a specific point in time, The satisfaction of performance obligations assessment is performed at each reporting period. To date, there have been no material true ups to revenue as a result of changes in the satisfaction of performance obligations.
Previous report
Going Concern Assessment
Previous report
The Company has recently faced significant losses over the previous years and expects to incur losses for the foreseeable future. As a result, the company’s management has conducted an assessment of its financial condition, including cash flow projections for the next twelve months from the date the financial statements will be issued. Based on this assessment, management has identified potential material uncertainties that could cast substantial doubt on the company’s ability to continue as a going concern. This assessment includes significant assumptions and estimation of uses and forecasts of cash flows in future periods.
Previous report
To address these uncertainties, management has developed a plan that includes among other things the potential for securing additional financing and non-dilutive funding such as grants. Cost reductions would also be evaluated if needed. The successful execution of these plans is contingent upon various factors some of which may be outside the Company’s control.
Previous report
Given the significant judgment and subjectivity of these estimates involved in assessing the feasibility of these plans and their potential impact on future cash flows, management considers the going concern assessment to be a critical accounting estimate. The financial statements include a disclosure outlining the nature of these uncertainties, the assumptions made by management, and the potential impact on the company’s financial position and performance.
Previous report
Grant awards. Extramural grant award funding, which is non-dilutive, has been a core strategy for supporting our ongoing clinical research. Since 2016 our clinical programs have received over $16.0 million in competitive extramural grant awards ($11.5 million which has been directly awarded to us and which are recognized as revenue when the performance obligations are met) from the NIH, Alzheimer’s Association, and MSCRF.
Previous report
Interest income consists of interest earned on cash equivalents and marketable securities. The increase in interest income for the current year was primarily driven by a higher balance of cash compared to the prior year.
Previous report
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.
Previous report
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. This decrease of $1.0 million, or 10%, was primarily driven by a reduction of $2.3 million in expenses related to the completed CLEAR MIND Alzheimer’s disease clinical trial, reduced costs for the Aging-related Frailty clinical trial following our decision to discontinue trial activities in Japan, and a $0.9 million decrease in supply costs. These reductions were partially offset by $1.7 million in higher compensation and benefit costs and a $0.3 million increase in equity-based compensation expenses allocated to research and development.
Previous report
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. Net other income for 2024 was driven by a higher interest income, compared to net other expense for 2023 driven by realized losses on sales of marketable securities of $0.3 million, write-offs of intangible assets of $0.3 million and reduced benefit of tax credits of $0.3 million.
Previous report
LIQUIDITY AND CAPITAL RESOURCES
Previous report
We currently believe that our cash and cash equivalents as of December 31, 2024 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 successful Type C meeting with the U.S. 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. 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. 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.
Previous report
On April 8, 2024, the Company commenced a public offering of up to 639,872 shares of the Company’s Class A common stock, along with pre-funded warrants to purchase up to an aggregate 1,572,894 shares of Class A common stock (the “Pre-Funded Warrants”). 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. Subject to certain limitations, the Pre-Funded Warrants were immediately exercisable and could be exercised at a nominal consideration of $0.001 per share of Class A common stock at any time until all of the Pre-Funded Warrants were exercised in full. The Common Warrants were immediately exercisable and expire on April 10, 2029.
Previous report
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.
Previous report
In connection with the offering, the Company also entered into an agreement with a holder of existing warrants to amend the holder’s existing Series A warrants and Series B warrants that were issued in a private placement as part of the Company's October 2023 registered direct offering to reduce the exercise price to $2.35 per share and (ii) amend the expiration date of the Series A Warrants to five and one-half (5.5) years following the closing of the public offering and the Series B warrants to eighteen (18) months following the closing of the public offering, in each case for a payment to the Company of $0.125 per amended warrant.
Previous report
On April 16, 2024, the Company entered into inducement letter agreements with certain holders of its existing Series A warrants and Series B warrants, and Common Warrants issued on April 10, 2024, whereby the holders agreed to exercise the warrants for cash at the exercise price of $2.35 per share in consideration for payment of $0.125 per new warrant and for the Company’s agreement to issue new unregistered Class A common stock warrants to purchase up to 4,799,488 shares of Class A common stock at an exercise price of $2.35 per share, and which were immediately exercisable upon issuance. 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 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. All of the Series D Warrants were exercised in June 2024, pursuant to ordinary course exercise as well as a subsequent inducement transaction.
Previous report
Additionally, the Company issued to the placement agent or its designees as compensation, warrants to purchase up to 167,982 shares of Class A common stock, equal to 7.0% of the aggregate number of shares of Class A common stock issued upon exercise of the warrants pursuant to the inducement transaction, which had the same terms as the Series C Warrants, except that the placement agent warrants have an exercise price of $3.25 per share.
Previous report
Furthermore, upon exercise, if any, of the Series D Warrants for cash, the Company agreed to issue the placement agent or its designees, within five (5) business days of the Company’s receipt of the exercise price, warrants to purchase the number of shares of Class A common stock equal to 7.0% of the aggregate number of shares underlying such Series D Warrants that have been exercised, with such warrants to be in the same form and terms as the prior placement agent warrants.
Previous report
On April 18, 2024, the Company filed a registration statement with the SEC on Form S-1 (File No. 333-278995) registering the resale of an aggregate of 4,967,470 shares of Class A common stock issuable upon exercise of certain warrants, including (i) up to 2,399,744 shares issuable upon the exercise of the Series C Warrants issued in the April 2024 warrant inducement transaction; (ii) up to 2,399,744 shares issuable upon the exercise of the Series D Warrants issued in the April 2024 warrant inducement transaction; and (iii) up to 167,982 shares issuable upon exercise of the warrants issued to the placement agent or its designees in the April 2024 warrant inducement transaction. The Form S-1 was subsequently amended by the Company and declared effective by the SEC on May 21, 2024.
Previous report
On June 17, 2024, the Company entered into additional inducement letter agreements with the holders of its existing Series D Warrants to exercise the remaining 1,697,891 shares of Class A common stock underlying Series D Warrants that remained outstanding for cash at the exercise price of $2.35 per share in consideration for the Company’s agreement to issue new unregistered Class A common stock warrants (the "June Inducement Warrants"), for payment of $0.125 per new warrant, to purchase up to an aggregate of 3,395,782 shares of Class A common stock at an exercise price of $2.50 per share and which were immediately exercisable upon issuance and have a term of twenty-four (24) months from the issuance date.
Previous report
The Company also issued to the placement agent or its designees as compensation, (i) warrants to purchase up to 118,852 shares of Class A common stock, equal to 7.0% of the aggregate number of shares of Class A common stock issued upon exercise of the warrants pursuant to the June inducement transaction and (ii) warrants to purchase up to an aggregate of 49,130 shares of Class A common stock, equal to 7.0% of the aggregate number of shares of Common Stock issued upon exercise of certain Series D warrants prior to the inducement transaction, which had substantially the same terms as the June Inducement Warrants, except that the warrants exercisable for 118,852 shares had an exercise price of $3.25 per share and the warrants exercisable for 49,130 shares had an exercise price $2.9375 per share, respectively (collectively, the "June placement agent warrants").
Previous report
Upon exercise, if any, of the June Inducement Warrants for cash, the Company agreed to issue within five (5) business days to the placement agent or its designees, warrants to purchase the number of shares of Class A common stock equal to 7.0% of the aggregate number of shares of Class A common stock underlying such June Inducement Warrants that have been exercised, with such warrants to be in the same form and terms as the June placement agent warrants.
Previous report
The issuance under the inducement offers represented $8.5 million in additional value provided to the investors, which was recorded as a deemed dividend to common stockholders. The June Inducement Warrants expire on June 18, 2026.
Previous report
On June 28, 2024, the Company filed a registration statement with the SEC on Form S-1 (File No. 333-280577) registering the resale of an aggregate of 3,563,764 shares of Class A common stock issuable upon exercise of certain warrants, including (i) up to 3,395,782 shares issuable upon the exercise of the June Inducement Warrants and (ii) up to 167,982 shares issuable upon the exercise of the June placement agent warrants. The Form S-1 was subsequently declared effective by the SEC on July 9, 2024.
Previous report
On July 10, 2024, a holder exercised Series C warrants for 50,000 shares of Class A common stock for cash (the “July Series C warrant exercise”).
Previous report
On July 10, 2024, certain holders of warrants issued in June of 2024 exercised warrants to purchase an aggregate of 150,000 shares of Class A common stock for cash (the “July 10 warrant exercise”). In addition, on July 17, 2024, we issued to the placement agent warrants to purchase up to 10,500 shares of Class A common stock, equal to 7.0% of the aggregate number of shares of Class A common stock issued in the July 10 warrant exercise (the “first tranche July ordinary course placement agent warrants”). The first tranche July ordinary course placement agent warrants have substantially the same terms as the June placement agent warrants, except that the first tranche July ordinary course placement agent warrants (i) have an exercise price of $3.125 per share and (ii) expire July 17, 2026.
Previous report
On July 17, 2024, a holder of the June Inducement Warrants exercised the same to purchase 2,319,186 shares of Class A common stock for cash (the “July 17 warrant exercise” and together with the July 10 warrant exercise and the July Series C warrant exercise, collectively, the “July warrant exercises”). Accordingly, on July 24, 2024, we issued to the placement agent warrants to purchase up to 162,344 shares of Class A common stock, equal to 7.0% of the aggregate number of shares of Class A common stock issued in the July 17 warrant exercise (the “second tranche July ordinary course placement agent warrants”, and together with the first tranche July ordinary course placement agent warrants, the “July ordinary course placement agent warrants”, and collectively with the July offering placement agent warrants, the “July placement agent warrants”). The second tranche July ordinary course placement agent warrants have substantially the same terms as the first tranche July ordinary course placement agent warrants, except that the second tranche July ordinary course placement agent warrants expire July 24, 2026.
Previous report
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.
Previous report
On July 18, 2024, we entered into a securities purchase agreement with institutional and accredited investors relating to the registered direct offering and sale of an aggregate of 2,236,026 shares of our Class A common stock at a purchase price of $4.025 per share of Class A common stock and associated warrant (the “July registered direct offering”). The securities issued in the July registered direct offering were offered pursuant to a prospectus supplement, dated July 18, 2024, and accompanying prospectus, in connection with a takedown from our shelf registration statement on Form S-3 (File No. 333-264142), which was declared effective by the SEC on April 14, 2022.
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Reworded paragraphs (41)
Previous wording
We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™. 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.
Current wording
We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. Our lead investigational product is laromestrocel.
Previous wording
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. 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.
Current wording
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. 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.
Previous wording
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.
Current wording
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.
Previous wording
Financial Overview. Since inception, the Company has primarily been engaged in organizational activities, including raising capital, and research and development activities. 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. 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.
Current wording
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 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. As a result of the recently completed private placement financing referenced in Note 14, Subsequent Events, and based on current operating plans, the Company expects that its cash and cash equivalents as of December 31, 2025 plus the $15.9 million in gross proceeds from the private placement will fund operations into the fourth quarter of 2026. As discussed above, the Company also has access to an ATM equity financing vehicle for sale of up to $10.7 million aggregate market value of shares of the Company’s Class A common stock. 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. In the event we are unable to attain the financing needed, we will need to materially revise our current operational plans.
Previous wording
The discussion and analysis of our financial condition and results of operations is based upon our condensed financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, (U.S. GAAP). 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. We base our estimates on historical experience, anticipated results and trends and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily available from other sources. By their nature, these estimates, judgments and assumptions are subject to an inherent degree of uncertainty, and management evaluates them on an ongoing basis for changes in facts and circumstances. Changes in estimates are recorded in the period in which they become known. Actual results may differ from our estimates under different assumptions or conditions. 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.
Current wording
We prepare our financial statements in accordance with U.S. generally accepted accounting principles, (U.S. 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. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis. We consider an accounting estimate to be critical if: (i) the accounting estimate involves a significant level of estimation uncertainty by requiring us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from period to period or use of different estimates that we reasonably could have used in the current period, had or are reasonably likely to have a material impact on our financial condition or results of operations. 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.
Previous wording
We have generated revenue from three sources:
Current wording
We have generated revenue from two sources:
Previous wording
The Bahamas Registry Trials. 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. While Lomecel-B™ is considered an investigational product in The Bahamas, under the approval terms received from the National Stem Cell Ethics Committee, we are permitted to charge a fee for participation in the Registry Trial. 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. Lomecel-B™ is considered an investigational treatment in The Bahamas and is not licensed for commercial sale.
Current wording
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. 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 biomarkers and other data, and overall management of the Registry, including personnel costs. 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.
Previous wording
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. 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. Additional suites may also be secured based on capacity needs, which are billed at a fixed fee per suite per month.
Current wording
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. 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. Additional suites may also be secured based on capacity needs, which are billed at a fixed fee per suite per month. We refer to revenue generated from these services as contract manufacturing revenue in our statements of operations. During 2025, activities under the contract development and manufacturing service agreement with our customer substantially decreased. No additional manufacturing or development activities are planned and we do not anticipate significant future revenue under this agreement.
Previous wording
We record cost of revenues based on expenses directly related to revenue. 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 contract manufacturing revenue, directly related expenses for the services and facilities provided under the contract are recorded as cost of revenues.
Current wording
We record cost of revenues based on expenses directly related to revenue. 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.
Previous wording
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. It identifies:
Current wording
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. 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.
Previous wording
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. 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. 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.
Current wording
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. 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. 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.
Previous wording
We currently do not carry any inventory for our product candidates, as we have yet to launch a product for commercial distribution. 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. Once we begin commercial distribution, all newly manufactured approved products will be allocated either for use in commercial distribution, which will be carried as inventory and not expensed, or for research and development efforts, which will continue to be expensed as incurred.
Current wording
We currently do not carry any inventory for our investigational product candidates, as we have yet to launch a product for commercial distribution. 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. Once we begin commercial distribution, all newly manufactured approved products will be allocated either for use in commercial distribution, which will be carried as inventory and not expensed, or for research and development efforts, which will continue to be expensed as incurred.
Previous wording
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.
Current wording
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.
Previous wording
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 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.
Current wording
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 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.
Previous wording
No provision for income taxes has been recorded for the years ended December 31, 2024 and 2023. 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.
Current wording
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.
Previous wording
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. 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. Contract manufacturing revenue for the year ended December 31, 2024 was $1.0 million, consisting of $0.5 million from our manufacturing lease services and $0.5 million from our manufacturing services contract.
Current wording
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. 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.
Previous wording
Related cost of revenues was $0.5 million and $0.5 million for the years ended December 31, 2024 and 2023, respectively. 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.
Current wording
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.
Previous wording
Research and development expenses consisted primarily of the following items (less those expenses allocated to the cost of revenues) (in thousands):
Current wording
Research and development expenses consisted primarily of the following items (in thousands):
Previous wording
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.
Current wording
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. The increase in the net loss of $6.7 million, or 41%, was for reasons outlined above.
Previous wording
Operating Activities. 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. 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. Net cash used in operating activities for the year ended December 31, 2023 was $19.0 million, consisting primarily of our net loss of $21.4 million and payments for accounts payable of $1.1 million and payment of the non-operating lawsuit of $1.4 million. 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.
Current wording
Operating Activities. 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. 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. 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. 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.
Previous wording
Investing Activities. 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 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.
Current wording
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. 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.
Previous wording
Financing Activities. 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 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.
Current wording
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
Previous wording
Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses as we advance the preclinical and clinical development of our programs. 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. 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.
Current wording
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. 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. 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.
Previous wording
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. 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.
Current wording
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. 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. 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. In past years we have been able to fund a large portion of our clinical programs with the use of grant funding.
Previous wording
advance the clinical development of Lomecel-B™ for the treatment of several disease states and indications;
Current wording
advance the clinical development of laromestrocel for the treatment of several disease states and indications;
Previous wording
pursue the preclinical and clinical development of other current and future research programs and product candidates;
Current wording
pursue the preclinical and clinical development of other current and future research programs and investigational product candidates;
Previous wording
in-license or acquire the rights to other products, product candidates or technologies;
Current wording
in-license or acquire the rights to other products, investigational product candidates or technologies;
Previous wording
seek regulatory approval for any product candidates that successfully complete clinical development; and
Current wording
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;
Previous wording
optimize our operational, financial and management systems and increase personnel, including personnel to support our operations as a public company.
Current wording
expand our operational, financial and management systems and increase personnel, including personnel to support our operations as a public company.
Previous wording
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. 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.
Current wording
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. 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.
Previous wording
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. 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 materials are received. 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.
Current wording
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. 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 materials are received. 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.
Previous wording
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.
Current wording
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.
Previous wording
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. At pre-specified time points, which are detailed in the grant award notifications, we are required to submit interim financial and scientific reports to the granting agency totaling funds spent, and in some cases, detailing use of proceeds and progress made during the reporting period. After funding the initial period, receipt of additional grant funds is contingent upon satisfactory submission of our interim reports to the granting agency.
Current wording
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. At pre-specified time points, which are detailed in the grant award notifications, we are required to submit interim financial and scientific reports to the granting agency totaling funds spent, and in some cases, detailing use of proceeds and progress made during the reporting period. After funding the initial period, receipt of additional grant funds is contingent upon satisfactory submission of our interim reports to the granting agency.
Previous wording
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. There are typically multiple applicants applying and competing for a finite amount of funds. As such we cannot be sure that we will be awarded grant funds in the future despite our past success in receiving such awards.
Current wording
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. As such we cannot be sure that we will be awarded grant funds in the future despite our past success in receiving such awards.
Previous wording
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. Our future funding requirements will depend on many factors, including:
Current wording
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. Our future funding requirements will depend on many factors, including:
Previous wording
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;
Current wording
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;
Previous wording
the extent to which we in-license or acquire rights to other products, product candidates or technologies; and
Current wording
the extent to which we in-license or acquire rights to other products, investigational product candidates or technologies; and
Previous wording
We currently have no credit facility or committed sources of capital. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. 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 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.
Current wording
We currently have no credit facility or committed sources of capital. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. 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 investigational product candidates that we would otherwise prefer to develop and market ourselves.
Previous wording
In order to meet our operational goals, we will need to obtain additional capital, which we will likely obtain through a variety of means, including through public or private equity, debt financings or other sources, including up-front payments and milestone payments from strategic collaborations. To the extent that we raise additional capital through the sale of convertible debt or equity securities, current stockholder ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect stockholder rights. Such financing will likely result in dilution to stockholders, and may result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect our business. 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. 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.
Current wording
In order to meet our operational goals, we will need to obtain additional capital, which we will likely obtain through a variety of means, including through public or private equity, debt financings or other sources, including up-front payments and milestone payments from strategic collaborations. To the extent that we raise additional capital through the sale of convertible debt or equity securities, current stockholder ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect stockholder rights. Such financing will likely result in dilution to stockholders, and may result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect our business. 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. 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.
Previous wording
As of December 31, 2024, we have $1.4 million in operating lease obligations and no CRO payment obligations. 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.
Current wording
As of December 31, 2025, we have $0.8 million in operating lease obligations and no CRO payment obligations. 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.
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Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
The following table summarizes the grants awarded.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
Those activities that should be identified as research and development;
Previous report — wording carried elsewhere
The elements of costs that should be identified with research and development activities, and the accounting for these costs; and
Previous report — wording carried elsewhere
The financial statement disclosures related to them.
Previous report — wording carried elsewhere
Our operating costs will continue to be substantial for the foreseeable future in connection with our ongoing activities. 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.