Longeveron Inc.
For the period ended Mar 31, 2026. Filed May 13, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 13, 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-Q
Period ended 2025-09-30; filed 2025-11-04.
0001193125-25-264604
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-13.
0001193125-26-221559
Item 2. 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 161 previous paragraphs and 160 current paragraphs.
66 unchanged; 60 reworded; 31 added; 29 removed; 6 previous and 3 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 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 (31)
Current report
our ability to successfully transition toward a more capital-efficient, asset-light operating model;
Current report
our ability to secure one or more strategic licensing partnerships for our investigational product candidates in our development programs;
Current report
the receipt of results from our clinical trials and other available evidence sufficient to support filings for regulatory approval of our investigational product candidates, including a potential future Biologics License Application with the FDA in the U.S. following the readout of top-line results of the ELPIS II data;
Current report
the willingness of regulatory authorities, including the FDA in the U.S., to deem any of our clinical trials (including ELPIS II) as pivotal or to otherwise reach alignment with us on a potential path toward regulatory approval of our investigational product candidates;
Current report
Our stem cell therapy development programs address life-threatening conditions in the most vulnerable populations - children and the elderly: Hypoplastic Left Heart Syndrome; Alzheimer’s disease; Pediatric Dilated Cardiomyopathy and Aging-related Frailty. We plan to pursue a robust partnering and commercial licensing strategy across our development programs to accelerate potential time to market, increase capital use efficiency and leverage the greater resources of larger organizations.
Current report
In connection with a review of its cash runway and cost structure and following approval from the Board of Directors (the "Board"), the Company implemented a temporary reduction in the compensation or fees payable, as applicable, of its executive officers and Board, effective on or about February 16, 2026, at rates ranging from 25% to 50%. The Company further indicated that it intended to restore compensation and fees to the amounts in effect immediately prior to such reductions at such time as the Company secured sufficient financing or other sources of capital.
Current report
Following the initial closing of the Private Placement, and its good-faith determination of its financial ability to do so, the Company repaid the members of its executive leadership team an amount equal to the difference between such executive’s base salary or fee structure in effect immediately prior to the reduction and the reduced salary or fees paid during the applicable reduction period. The Company undertook the same determination with respect to Board fees and restored Board compensation to its previously established levels. Concerning the Board, because both the temporary reduction in fees and the reinstatement of such fees occurred prior to the first payment of such fees due for 2026, no repayment of any temporarily reduced fees was necessary by the Company.
Current report
On March 11, 2026, we issued and sold an aggregate of 6,013,384 shares of Class A common stock 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 Class A common stock, at a purchase price of $1,000.00 per Preferred Share, in the initial closing of a private placement transaction. Each share of Series A preferred stock is convertible into Class A common stock at a conversion price equal to $0.52 per share. The Company also issued to designees (or their assignees) of H.C. Wainwright & Co., LLC ("Wainwright"), our exclusive placement agent in the transaction, unregistered warrants to purchase up to 2,019,231 shares of Class A common stock which have an exercise price of $0.65 per share, which became immediately exercisable upon issuance and have a term of five years from the date of issuance. In addition, we sold 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 ("PRV") to the extent received from the United States Food and Drug Administration ("FDA") in connection with the Company’s laromestrocel program for HLHS. The aggregate gross proceeds from the initial closing were approximately $15.9 million, before deducting placement agent fees and other private placement expenses. 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. See “Capital Raising Efforts” in the LIQUIDITY, CAPITAL RESOURCES, AND GOING CONCERN section below for further discussion of the private placement transaction.
Current report
** Not currently active
Current report
*** We plan to conduct a single Phase 2 registrational clinical trial in accordance with the Investigational New Drug (“IND”) application which became effective in July 2025.
Current report
On May 8, 2026, the Company announced that a constructive Type C meeting with the FDA was held in late March 2026, with the FDA providing their meeting summary in late April to discuss the ongoing development of laromestrocel.
Current report
In the Type C meeting, the FDA acknowledged that HLHS is a rare disease associated with significant morbidity and mortality with a high unmet medical need for safe and effective therapies, but also asserted that the primary endpoint of right ventricle ejection fraction (RVEF) in the ELPIS II trial is not an appropriate endpoint to demonstrate efficacy. While Longeveron agreed with the FDA regarding the insufficiency of RVEF as the primary endpoint, and was prepared to discuss other potentially appropriate endpoints sufficient to demonstrate efficacy, the FDA indicated that given the interim analysis mandated and conducted by the National Institute of Health (NIH) during the trial (to which the Company was and remains blinded), a new primary endpoint could not be agreed to while the trial is still ongoing. Without an agreed upon primary endpoint sufficient for efficacy, the FDA no longer refers to the ELPIS II trial as pivotal, as had been specifically discussed in the Company’s Type C meeting in 2024. Nevertheless, the FDA expressly agreed that it is willing to meet with Longeveron again when the ongoing ELPIS II study is completed to discuss the study results and align on a potential path forward. The FDA further indicated that only the most objective measures, including, all-cause mortality, cardiac transplant-free survival, event of cardiac transplantation, and well-defined major adverse cardiac events (MACE), could be informative of efficacy in ELPIS II, and in that regard, the Company is capturing all of these measures in ELPIS II along with some additional key measures to support an efficacy determination. The Company intends to submit to the FDA a Sponsor Statistical Analysis Plan (SAP) for ELPIS II with a composite primary endpoint and secondary endpoints for the FDA’s review and approval, and remains optimistic that the trial results and other available evidence will be sufficient to support filing a BLA following the readout of top-line results of the ELPIS II data.
Current report
Aging-related Frailty
Current report
Improvement of the quality of life for the aging population is one of the strategic directions of the Company. Life expectancy has substantially increased over the past century due to medical and public health advancements. However, this longevity increase has not been paralleled by healthspan – the period of time one can expect to live in relatively good health and independence. For many developed and developing countries, health span lags life expectancy by over a decade. This has placed tremendous strain on healthcare systems in the management of aging-related ailments and presents additional socioeconomic consequences due to patient decreased independence and quality-of-life. Since these strains continue to increase with demographic shifts towards an increasingly older population, improving health span has become a priority for health agencies, such as the National Institute on Aging (“NIA”) of the National Institutes of Health (“NIH”), the Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”), and the European Medicines Agency (“EMA”). As we age, we experience a decline in our own stem cells, a decrease in immune system function (known as “immunosenescence”), diminished blood vessel functioning, chronic inflammation (known as “inflammaging”), and other aging-related alterations that affect biological functioning. In April 2024, we discontinued our clinical trial in Japan to evaluate laromestrocel for Aging-related Frailty. We plan to continue enrolling patients on the Frailty and Cognitive Impairment registry trials in The Bahamas and also plan to launch an Osteoarthritis registry trial.
Current report
Our IND application for laromestrocel as a potential treatment for pediatric DCM became effective in July 2025. This IND provides for moving directly to a single Phase 2 registrational clinical trial currently targeted for 2027, with planning and preparation beginning in 2026. If this trial is successful, we would then seek to partner the program for further development and potential commercialization.
Current report
Preparation and initiation of a single Phase 2 registrational clinical trial for pediatric DCM. Our IND application for laromestrocel as a potential treatment for pediatric DCM became effective in July 2025. If this trial is successful, we would then seek to partner the program for further development and potential commercialization.
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
Revenues, Cost of Revenues and Gross Profit: Revenues for the three months ended March 31, 2026 were $0.4 million and consisted of $0.4 million of clinical trial revenues and $20,000 of contract manufacturing revenues. Revenues for the three months ended March 31, 2025 were $0.4 million and consisted of $0.3 million of clinical trial revenues and $0.1 million of contract manufacturing revenues. Clinical trial revenues for the three months ended March 31, 2026 increased $0.1 million, or 46%, when compared to the same period in 2025, as a result of greater participant demand for our Bahamas Registry Trial. Contract manufacturing revenues for the three months ended March 31, 2026 decreased $0.1 million, or 84%, when compared to the same period in 2025, driven by reduced demand for these services from our third-party client.
Current report
General and Administrative Expense: General and administrative expenses for the three months ended March 31, 2026 were $2.7 million, compared to $2.9 million for the same period in 2025. The $0.2 million, or 7%, decrease was primarily due to a $0.4 million reduction in personnel and related costs, reflecting lower performance achievement relating to 2025 annual cash incentive bonuses, partially offset by higher legal, accounting and consulting fees.
Current report
Research and Development Expenses: Research and development expenses were $2.3 million for the three months ended March 31, 2026, compared to $2.5 million for the same period in 2025. The $0.2 million, or 8%, decrease was due to lower performance achievement relating to 2025 annual cash incentive bonuses and a $0.2 million non-recurring charge for amortization expense related to patent costs recorded in the 2025 period, partially offset by a year over year increase in personnel and higher clinical spend as we prepare for ELPIS II study results in August.
Current report
Other Income: Other income was $39,000 and $0.2 million for the three months ended March 31, 2026 and 2025, respectively, and consisted of interest earned on money market funds. The decrease in other income of $0.2 million, or 77%, was due to declining cash balance.
Current report
Financing Activities. Net cash provided by financing activities for the three months ended March 31, 2026 was $15.5 million and consisted primarily of $13.4 million of net proceeds from the issuance of Class A common stock, and Series A Preferred Stock in the March 2026 private placement financing and $1.3 million from the exercise of warrants. The Company also received approximately $0.9 million in cash from a sale to the investors in the Private Placement of an interest in 50% of the future proceeds 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 HLHS. Net cash used in financing activities for the three months ended March 31, 2025 was less than $0.1 million for the payment of taxes upon vesting of RSUs.
Current report
LIQUIDITY, CAPITAL RESOURCES, AND GOING CONCERN
Current report
ATM Agreement
Current report
During the three months ended March 31, 2026, we sold 166,385 shares of Class A common stock under the ATM Agreement at a weighted average share price of $0.60 per share, resulting in net proceeds of approximately $0.1 million to the Company after deducting certain offering expenses, including approximately $4,000 in compensation to Wainwright. As of March 31, 2026, an aggregate market value of approximately $9.4 million of shares of Class A common stock remains available for future sale under the ATM prospectus supplement.
Current report
Private Placement Transaction
Current report
On March 10, 2026, we entered into a Purchase Agreement with certain institutional and accredited investors (each, an “Investor” and collectively, the “Investors”), pursuant to which we agreed to issue and sell shares of the Company’s Class A common stock and Series A preferred stock (the “Series A preferred stock,” and together with the Class A common stock, the “Private Placement Securities”) to the Investors in up to two closings in a private placement (the “Private Placement”). At initial closing on March 11, 2026 we issued and sold an aggregate of 6,013,384 shares of Class A common stock 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 Class A common stock, at a purchase price of $1,000.00 per share of Series A preferred stock. Each share of Series A preferred stock is convertible into Class A common stock at a conversion price equal to $0.52 per share. The powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series A preferred stock are set forth in the Company’s Certificate of Designation filed on March 10, 2026.
Current report
Additionally, the Company 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 HLHS.
Current report
Pursuant to the Purchase Agreement, subject to the occurrence of a Second Closing Trigger Date (as defined below), we agreed to issue and sell to the Investors additional shares of Class A common stock and Series A preferred stock, respectively, for additional gross proceeds of approximately $15.0 million, before deducting placement agent fees and other expenses. The Second Closing Trigger Date shall occur upon satisfaction or waiver of the closing conditions set forth under the Purchase Agreement, including (i) the Company’s achievement, during the period from March 11, 2026 and ending on the announcement 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 Class A 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 occurring after the date of the Purchase Agreement) (the “Price Threshold”) measured during any ten consecutive trading days prior to expiration of the 30 trading days following the date of our first announcement via press release or a Current Report on Form 8-K of the occurrence of the Milestone. Investors holding at least a majority in interest of the Private Placement Securities may choose to waive achievement of the Milestone and Price Threshold and proceed with the second closing.
Current report
The aggregate gross proceeds from the Initial Closing were approximately $15.9 million, before deducting placement agent fees and other expenses. Wainwright acted as the exclusive placement agent for the Private Placement, for which it received a cash fee equal to
Current report
7.0% of the aggregate gross proceeds raised in the Private Placement, plus a management fee equal to 1.0% of the aggregate gross proceeds raised in the Private Placement and reimbursement for certain expenses. We also issued to designees of Wainwright (or their assignees) unregistered warrants to purchase up to 2,019,231 shares of Class A common stock which have an exercise price of $0.65 per share, which became immediately exercisable upon issuance and have a term of five years from the date of issuance.
Removed paragraphs (29)
Previous report
the potential disruptive impact of the ongoing U.S. federal government shutdown upon our operations, clinical development programs, and capital raising efforts;
Previous report
Recent Developments – Government Shutdown
Previous report
In September 2025, the U.S. federal government entered a partial shutdown due to a lapse in appropriations, which remains ongoing as of the date of this Quarterly Report on Form 10-Q. During this period, certain regulatory agencies, including the FDA and the SEC, have operated with limited staffing and reduced capacity. These limitations may delay regulatory communications, guidance, or review activities related to our laromestrocel INDs, clinical-trial amendments and activities, and Chemistry, Manufacturing and Controls (CMC) submissions, and may also affect the timing of SEC or FDA review of company filings, financing-related documentation, and federal grant or funding applications.
Previous report
To date, we have not experienced a material disruption to our operations or clinical-development programs; however, the duration and impact of the shutdown remains uncertain. We continue to monitor potential impacts on planned interactions with the FDA, including any future meetings related to laromestrocel for HLHS and other clinical development programs. A further prolonged federal government shutdown could delay regulatory feedback, clinical-site activation, or data-submission schedules; postpone the review or award of grant funding; and affect the timing or completion of public or private financing transactions, any of which could adversely impact our ability to fund continuing operations and clinical development activities.
Previous report
In the third quarter of 2025, we undertook two capital raising transactions. First, 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.
Previous report
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, the Maryland Stem Cell Research Fund (“MSCRF”) of the Maryland Technology Development Corporation, or TEDCO, and the XPRIZE Foundation, Inc. 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, a seven-year, $101 million global competition to identify therapeutic approaches to increase human health span.
Previous report
** Not currently active for 2025
Previous report
*** IND approved by FDA in late June 2025; The accepted IND application provides for moving directly to a single Phase 2 pivotal registrational clinical trial
Previous report
In July 2025, we announced that the FDA approved the Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for pediatric DCM. The accepted IND application provides for moving directly to a single Phase 2 pivotal registration clinical trial in 2026, subject to obtaining necessary financing.
Previous report
Preparation and initiation of a Phase 2 pivotal registrational clinical trial for DCM in 2026, subject to obtaining necessary financing. As announced on July 8, 2025, the FDA approved the Investigational New Drug (IND) application for our stem cell therapy laromestrocel as a potential treatment for pediatric Dilated Cardiomyopathy (DCM).
Previous report
Limited focus on our international program. In line with the Company’s strategic direction for 2025 and moving forward to focus on HLHS and AD as set forth previously, in April 2024, the Company discontinued its clinical trial in Japan to evaluate laromestrocel for Aging-related Frailty. The Company will continue to enroll patients on the Frailty and Cognitive Impairment registry trials in The Bahamas and plans to also launch an Osteoarthritis registry trial.
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 $16.3 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 National Institutes of Health, Alzheimer’s Association, Maryland Stem Cell Research Fund and XPRIZE Foundation, Inc.
Previous report
Interest income consists of interest earned on cash equivalents and marketable securities. We expect our interest income to vary in conjunction with changes in our monthly cash and marketable securities balances. Other income consists of funds earned that are not part of our normal operations.
Previous report
Revenues, Cost of Revenues and Gross Profit: Revenues for the three months ended September 30, 2025 and 2024 were $0.1 million and $0.8 million, respectively. Revenues decreased $0.7 million, or 82%, for the three months ended September 30, 2025, compared to the same period in 2024 primarily due to reduced demand for contract manufacturing services.
Previous report
Clinical trial revenue, which is derived from the Bahamas Registry Trial, for each of the three months ended September 30, 2025 and 2024 was $0.1 million and $0.2 million, respectively. Contract manufacturing revenue for the three months ended September 30, 2025 was $43,000 from our manufacturing services contract, which is a decrease of $0.5 million, or 92%, when compared to the $0.6 million in contract manufacturing revenue for the three months ended September 30, 2024. This decrease was driven by a substantial reduction in activities under the Secretome Agreement; no additional manufacturing or development activities are planned, and the Company is now limited to performing stability testing and other contract testing services.
Previous report
General and Administrative Expense: General and administrative expenses for the three months ended September 30, 2025 increased to approximately $3.6 million, compared to $3.1 million for the same period in 2024. The increase of approximately $0.5 million, or 15%, was primarily related to an increase of $0.3 million in personnel and related costs in 2025, including increased severance and equity-based compensation, $0.1 million in legal expenses and $0.1 million in other operating costs.
Previous report
Research and Development Expenses: Research and development expenses for the three months ended September 30, 2025 increased to approximately $3.9 million, from approximately $2.2 million for the same period in 2024. The increase of $1.7 million, or 75%, was primarily driven by a $1.1 million increase in supplies and costs associated with technology transfer, including non-clinical manufacturing batches and a $0.4 million increase in personnel and related costs, including equity-based compensation, both primarily in support of advancing our readiness for future commercial production as part of our BLA-enabling efforts.
Previous report
Other Income (Expense): Other income for the three months ended September 30, 2025 was $0.1 million, primarily consisting of $0.1 million of interest earned on money market funds. Other income for the three months ended September 30, 2024 was $0.2 million as a result of interest earned on money market funds.
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COMPARISON OF THE NINE MONTHS ENDED SEPTEMBER 30, 2025 AND 2024
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Revenues, Cost of Revenues and Gross Profit: Revenues for the nine months ended September 30, 2025 and 2024 were $0.8 million and $1.8 million, respectively. This represents a decrease of $1.0 million, or 53%, in 2025 compared to 2024, driven primarily by a decreased participant demand for our Bahamas Registry Trial and reduced demand for contract manufacturing services from our third-party client.
Previous report
Clinical trial revenue, which is derived from the Bahamas Registry Trial, for the nine months ended September 30, 2025 and 2024 was $0.7 million and $1.0 million, respectively. Clinical trial revenue for the nine months ended September 30, 2025 decreased by $0.3 million, or 36%, when compared to 2024 as a result of decreased participant demand. Contract manufacturing revenue for the nine months ended September 30, 2025 was $0.2 million from our manufacturing services contract, which is a decrease of $0.6 million, or 76%, when compared to the $0.8 million in contract manufacturing revenue for the nine months ended September 30, 2024. This decrease was driven by a substantial reduction in activities under the Secretome Agreement; no additional manufacturing or development activities are planned, and the Company is now limited to performing stability testing and other contract testing services.
Previous report
Related cost of revenues was $0.3 million and $0.4 million for the nine months ended September 30, 2025 and 2024, respectively. This resulted in a gross profit of approximately $0.5 million for the nine months ended September 30, 2025, a decrease of $0.9 million, or 60%, when compared with a gross profit of $1.4 million for 2024.
Previous report
General and Administrative Expense: General and administrative expenses for the nine months ended September 30, 2025 increased to approximately $9.1 million, compared to $7.4 million for the same period in 2024. The increase of approximately $1.7 million, or 22%, was primarily related to an increase in personnel and related costs in 2025, including increased severance and equity-based compensation.
Previous report
Research and Development Expenses: Research and development expenses for the nine months ended September 30, 2025 increased to approximately $9.3 million, from approximately $6.1 million for the same period in 2024. The increase of $3.2 million, or 52%, was primarily driven by a $1.8 million increase in personnel and related costs, including equity-based compensation, $1.2 million increase in supplies and 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.
Previous report
Other Income (Expense): Other income for the nine months ended September 30, 2025 was $0.6 million, primarily consisting of $0.3 million received as a recipient of a Milestone 1 Award in the XPRIZE Healthspan competition and $0.3 million interest earned on money market funds. Other income for the nine months ended September 30, 2024 was $0.3 million as result of interest earned on money market funds and marketable securities.
Previous report
Net Loss: Net loss increased to approximately $17.3 million for the nine months ended September 30, 2025 from a net loss of $11.9 million for the same period in 2024. The increase in the net loss of $5.4 million, or 45%, was for the reasons outlined above.
Previous report
Financing Activities. Net cash provided by financing activities for the nine months ended September 30, 2025 was $3.9 million for proceeds from the issuance of common stock of $4.1 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 nine months ended September 30, 2024 was approximately $28.8 million for 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.
Previous report
LIQUIDITY AND CAPITAL RESOURCES
Previous report
In the third quarter of 2025, we undertook two capital raising transactions. First, 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).
Reworded paragraphs (60)
Previous wording
This Quarterly Report on Form 10-Q (this “10-Q”) contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that reflect our current expectations about our future results, performance, prospects and opportunities. This 10-Q contains forward-looking statements that can involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this 10-Q, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, future revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products and prospects, plans and objectives of management are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Current wording
This Quarterly Report on Form 10-Q (this “10-Q”) contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that reflect our current expectations about our future results, performance, prospects and opportunities. Such forward-looking statements can involve substantial risks and uncertainties. All statements other than statements of historical facts contained herein, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, future revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products and prospects, plans and objectives of management are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Previous wording
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements contained in this report include, but are not limited to, statements about:
Current wording
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements contained in this 10-Q include, but are not limited to, statements about:
Previous wording
The forward-looking statements contained in this 10-Q are made on the basis of the views and assumptions of management regarding future events and business performance as of the date this 10-Q is filed with the Securities and Exchange Commission (the “SEC”). We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We operate in a highly competitive and rapidly changing environment; therefore, new risk factors can arise, and it is not possible for management to predict all such risk factors, nor to assess the impact of all such risk factors on our business or the extent to which any individual risk factor, or combination of risk factors, may cause results to differ materially from those contained in any forward-looking statement. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements. We do not undertake any obligation to update these statements to reflect events or circumstances occurring after the date this 10-Q is filed. In addition, this discussion and analysis should be read in conjunction with our unaudited condensed financial statements and notes thereto included in this 10-Q and the audited condensed financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 28, 2025 (the “2024 Form 10-K”). Operating results are not necessarily indicative of results that may occur in future periods.
Current wording
The forward-looking statements contained in this 10-Q are made on the basis of the views and assumptions of management regarding future events and business performance as of the date this 10-Q is filed with the Securities and Exchange Commission (the “SEC”). We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this 10-Q. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for management to predict all risk factors, nor can we assess the impact of all risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, circumstances or otherwise occurring after the date this 10-Q is filed.
Previous wording
We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. Our lead investigational product candidate is laromestrocel, formerly referred to as Lomecel-B™.
Current wording
We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. Our lead investigational product candidate is laromestrocel, also referred to as Lomecel-B®.
Previous wording
Laromestrocel is a proprietary, scalable, allogeneic cellular therapy that has multiple modes of action that include pro-vascular, pro-regenerative, and anti-inflammatory mechanisms, that collectively promote tissue repair and healing. Laromestrocel possesses broad potential applications across a spectrum of disease areas. 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 wording
Laromestrocel is a proprietary, scalable, allogeneic cellular therapy that has multiple potential modes of action that include pro-vascular, pro-regenerative, and anti-inflammatory mechanisms that collectively appear to promote tissue repair and healing. Laromestrocel possesses broad potential applications across a spectrum of disease areas. 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.
Previous wording
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 to support both internal and external development programs.
Current wording
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 current good manufacturing practice (“cGMP”) manufacturing facility with research and development labs, business planning, raising capital, establishing and maintaining 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 to support both internal and external development programs.
Previous wording
We manufacture our own investigational product candidates for early-phase clinical trials and have initiated enhancements to our Chemistry, Manufacturing and Controls (CMC) infrastructure to support future Biologics License Application (BLA) submissions. These efforts include planning for process and analytical method validation as well as commercial production readiness. As part of our ongoing preparations for a potential BLA submission for our lead investigational product candidate for Hypoplastic Left Heart Syndrome (HLHS), we have made a strategic decision to pursue commercial manufacturing through a third-party contract development and manufacturing organization (CDMO), rather than renovating our existing Miami facility for commercial-scale production. This decision was based on a comprehensive evaluation of multiple factors, including cost, timeline feasibility, and scalability. We believe this approach offers a more cost-effective and timely path to support our BLA submission and potential commercial launch. Our Miami manufacturing facility includes eight clean rooms, two research and development laboratories, and warehouse and storage space. This facility will continue to support clinical development, research and early-phase manufacturing for our current and future clinical trials. We have supply contracts with multiple third parties for fresh bone marrow, which we use to produce our investigational 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.
Current wording
We manufacture our own investigational product candidates for early-phase clinical trials and have augmented our Chemistry, Manufacturing and Controls ("CMC") infrastructure to support potential future Biologics License Application ("BLA") submissions. These efforts include planning for process and analytical method validation as well as planning for commercial production readiness. As part of our ongoing preparations for a potential BLA submission for our lead investigational product candidate for Hypoplastic Left Heart Syndrome ("HLHS"), we made a strategic decision to pursue commercial manufacturing through a third-party contract development and manufacturing organization ("CDMO") at the appropriate time, rather than renovating our existing Miami facility for commercial-scale production. This decision was based on a comprehensive evaluation of multiple factors, including cost, timeline feasibility, and scalability. We believe this approach offers a more cost-effective and timely path to support our potential BLA submission and commercial launch. Our Miami manufacturing facility, which includes eight clean rooms, two research and development laboratories, and warehouse and storage space, will continue to support clinical development, research and early-phase manufacturing for our current and future clinical trials. We have supply contracts with multiple third parties for fresh bone marrow, which we use to produce our investigational 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, manufacturing, and testing capabilities.
Previous wording
Since the time that we became a publicly traded company in February 2021, we have sold 18,568,594 shares of Class A common stock through our IPO and subsequent follow-on public and private equity offerings and transactions. Additionally, as of September 30, 2025, warrants exercisable for an aggregate of up to 21,920,318 shares of a Company's Class A common stock remain outstanding at exercise prices ranging from $0.85 per share to $175.00 per share.
Current wording
As of March 31, 2026, we have sold 28,007,242 shares of Class A common stock and 11,873.04 shares of Series A preferred stock through our IPO and subsequent follow-on public and private equity offerings and transactions. Additionally, as of March 31, 2026, warrants exercisable for an aggregate of up to 22,434,760 shares of our Class A common stock remain outstanding at exercise prices ranging from $0.65 per share to $175.00 per share.
Previous 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 Trials 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 September 30, 2025 we had an accumulated deficit of $126.9 million. We expect to continue to generate operating losses for the foreseeable future. As a result of the recently completed financing in August of 2025, and continued focus on disciplined and efficient capital allocation focused on first to market indications, we currently anticipate our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements late into the first 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.
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 March 31, 2026 we had an accumulated deficit of $137.0 million. We expect to continue to generate operating losses for the foreseeable future. As a result of the recently completed Private Placement financing, and based on current operating plans, we expect that our cash and cash equivalents as of March 31, 2026, which include proceeds from the initial closing of the Private Placement, will be adequate to fund operations into the fourth quarter of 2026. The Company also has access to an At-The-Market (ATM) equity financing vehicle for the sale of up to $10.7 million aggregate market value of shares of the Company’s Class A common stock; however, the ATM facility is under a standstill restriction until June 9, 2026, and thereafter we have restrictions in place regarding our ability to use the ATM facility unless our Class A common stock is trading above $0.80 per share until September 7, 2026. 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 Company has prepared a cash flow forecast which indicates that it does not have sufficient cash to meet its minimum expenditure commitments for one year from the date these financial statements are available to be issued and therefore needs to raise additional funds to continue as a going concern. As a result, there is substantial doubt about the Company’s ability to continue as a going concern.
Current wording
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.
Previous wording
We are currently in clinical development of a single investigational product candidate, laromestrocel, for three potential indications: HLHS, Alzheimer’s disease (“AD”), and pediatric Dilated Cardiomyopathy (“DCM”). We are not currently active with a fourth indication, Aging-related Frailty, following our decision to discontinue clinical trial activities in Japan in 2024.
Current wording
We are currently in clinical development of a single investigational product candidate, laromestrocel, for four potential indications: HLHS, Alzheimer’s disease (“AD”), Pediatric Dilated Cardiomyopathy (“pediatric DCM”), and Aging-related Frailty.
Previous wording
Pivotal Phase 2b ELPIS II study; enrollment completed June 24, 2025
Current wording
*Phase 2b ELPIS II study; enrollment completed June 24, 2025
Previous wording
As of November 2025, we have completed five U.S. clinical studies of laromestrocel: ELPIS I Phase 1 (HLHS), Phase 1 and "CLEAR MIND Trial", Phase 2a (AD), Phase 1/2 and Phase 2b Aging-related Frailty. We currently have one fully enrolled, ongoing clinical trial: ELPIS II Phase 2b (HLHS). 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 laromestrocel to eligible participants at private clinics in Nassau for a variety of indications. While laromestrocel 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.
Current wording
As of March 2026, we have completed five U.S. clinical studies of laromestrocel: ELPIS I Phase 1 (HLHS), Phase 1 and Phase 2a “CLEAR MIND Trial” (AD), Phase 1/2 and Phase 2b Aging-related Frailty. We currently have one fully enrolled, ongoing clinical trial: ELPIS II Phase 2b (HLHS). Additionally, we sponsor a registry in The Bahamas under the approval and authority of the National Stem Cell Ethics Committee, now known as the National Longevity and Regenerative Therapy Ethics Review Committee ("The Bahamas Registry Trial"). The Bahamas Registry Trial may administer laromestrocel to eligible participants at private clinics in Nassau, The Bahamas for a variety of indications. While laromestrocel 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 Bahamas Registry Trial.
Previous wording
HLHS is a rare congenital heart condition affecting approximately 1,000 newborns in the US annually. HLHS is a birth defect that affects normal blood flow through the heart. As the baby develops during pregnancy, the left side of the heart does not form correctly so that babies are born with an underdeveloped or absent left ventricle. It is one type of congenital heart defect present at birth. Because a baby with this defect needs surgery or other procedures soon after birth, HLHS is considered a critical congenital heart defect. To prevent certain death shortly after birth, these babies undergo a series of three heart surgeries (staged surgical palliation) that reconfigures the single right ventricle to support systemic circulation. Despite these life-saving surgeries, HLHS patients nevertheless still have high early mortality and morbidity rates due primarily to heart failure. We are exploring the possibility that laromestrocel, when administered directly to the myocardium of affected infants, can improve outcomes in this devastating rare pediatric disease.
Current wording
HLHS is a rare congenital heart condition affecting approximately 1,000 newborns in the U.S. annually. HLHS is a birth defect that affects normal blood flow through the heart. As the baby develops during pregnancy, the left side of the heart does not form correctly so that babies are born with an underdeveloped or absent left ventricle. It is one type of congenital heart defect present at birth. Because a baby with this defect needs surgery or other procedures soon after birth, HLHS is considered a critical congenital heart defect. To prevent certain death shortly after birth, these babies undergo a series of three heart surgeries (staged surgical palliation) that reconfigures the single right ventricle to support systemic circulation. Despite these life-saving surgeries, HLHS patients nevertheless still have high early mortality and morbidity rates due primarily to heart failure. We are exploring the possibility that laromestrocel, when administered directly to the myocardium of affected infants, can improve outcomes in this devastating rare pediatric disease.
Previous wording
The FDA granted laromestrocel for the treatment of HLHS a Rare Pediatric Disease (“RPD”) Designation (on November 8, 2021), Orphan Drug Designation (“ODD”) (on December 2, 2021), and Fast Track Designation (on August 24, 2022). We are currently conducting an ongoing Phase 2b clinical trial (ELPIS II) under FDA IND 17677. ELPIS II is a multi-center, randomized, double-blind, controlled clinical trial designed to evaluate laromestrocel as an adjunct therapy to the standard-of-care second-stage HLHS heart reconstructive surgery which is typically performed at 4-6 months after birth. The primary objective is to evaluate change in right ventricular ejection fraction after laromestrocel treatment versus standard-of-care surgery alone (40 subjects total: 20 per arm).
Current wording
The FDA granted Rare Pediatric Disease Designation (“RPD”) for laromestrocel for the treatment of HLHS (November 8, 2021), Orphan Drug Designation (“ODD”) (December 2, 2021), and Fast Track Designation (August 24, 2022). We are currently conducting an ongoing Phase 2b clinical trial (ELPIS II) under FDA IND 17677. ELPIS II is a multi-center, randomized, double-blind, controlled clinical trial designed to evaluate laromestrocel as an adjunct therapy to the standard-of-care second-stage HLHS heart reconstructive surgery which is typically performed at 4-6 months after birth. The current primary objective is to evaluate change in right ventricular ejection fraction after laromestrocel treatment versus standard-of-care surgery alone (40 subjects total: 20 per arm).
Previous wording
ELPIS II is a next-step trial to our completed 10-patient open-label Phase 1 trial (ELPIS I) under the same IND. This Phase 1 trial was designed to evaluate the safety and tolerability of laromestrocel as an adjunct to the second-stage HLHS surgery, and to obtain preliminary evidence of laromestrocel effect to support a next-phase trial. The primary safety endpoint was met: no major adverse cardiac events (“MACE”) or treatment-related infections during the first month post-treatment, and no triggering of stopping rules. Furthermore, fluid-based and imaging biomarker data supported multiple potentially relevant mechanisms-of-action of laromestrocel, and the potential to improve post-surgical heart function.
Current wording
ELPIS II is a next-step trial to our completed 10-patient open-label Phase 1 trial (ELPIS I) under the same IND. The ELPIS I trial was designed to evaluate the safety and tolerability of laromestrocel as an adjunct to the second-stage HLHS surgery, and to obtain preliminary evidence of laromestrocel effect to support a next-phase trial. The primary safety endpoint was met: no major adverse cardiac events (“MACE”) or treatment-related infections during the first month post-treatment, and no triggering of stopping rules. Furthermore, fluid-based and imaging biomarker data supported multiple potentially relevant mechanisms-of-action of laromestrocel, and the potential to improve post-surgical heart function. We currently anticipate top-line results from ELPIS II in August 2026.
Previous wording
The study demonstrated positive results. The established safety profile of laromestrocel was safe and well tolerated when administered as single or multiple doses, with no incidence of hypersensitivity or infusion-related reactions. In addition, there were no cases of amyloid-related imaging abnormalities (ARIA). With regard to efficacy, laromestrocel showed slowing/prevention of disease worsening relative to placebo. The unadjusted p-values for a several secondary efficacy endpoint composite AD score (“CADS”) for both the low-dose laromestrocel group and the pooled treatment groups compared to placebo suggested significance, indicating potential signals of efficacy. Other doses also indicated promising results in slowing/prevention of disease worsening. Additionally, an improvement versus placebo was observed in the Montreal cognitive assessment (“MoCA”) and in the activity of daily living observed by a caregiver and measured by Alzheimer’s disease Cooperative Study Activities of Daily Living (“ADCS-ADL”) with unadjusted p-values suggestive of significance. The study indicated potential preservation of the brain volumes in some but not all AD related areas of the brain 39 weeks after treatment commenced. Brain magnetic resonance imaging (“MRI”) results demonstrated a 48% reduction in whole brain volume loss, 62% reduction in hippocampal volume loss, and potential improvement in neuroinflammation in some but not all brain regions via diffusion tensor imaging (DTI).
Current wording
The study demonstrated positive results. The safety profile of laromestrocel was safe and well tolerated when administered as single or multiple doses, with no incidence of hypersensitivity or infusion-related reactions. In addition, there were no cases of amyloid-related imaging abnormalities (ARIA). With regard to efficacy, laromestrocel showed slowing/prevention of disease worsening relative to placebo. The unadjusted p-values for a several secondary efficacy endpoint composite AD score (“CADS”) for both the low-dose laromestrocel group and the pooled treatment groups compared to placebo suggested significance, indicating potential signals of efficacy. Other doses also indicated promising results in slowing/prevention of disease worsening. Additionally, an improvement versus placebo was observed in the Montreal Cognitive Assessment (“MoCA”) and in the activity of daily living observed by a caregiver and measured by Alzheimer’s disease Cooperative Study Activities of Daily Living (“ADCS-ADL”) with unadjusted p-values suggestive of significance. The study indicated potential preservation of the brain volumes in some but not all AD related areas of the brain 39 weeks after treatment commenced. Brain magnetic resonance imaging (“MRI”) results demonstrated a 48% reduction in whole brain volume loss, 62% reduction in hippocampal volume loss, and potential improvement in neuroinflammation in some but not all brain regions via diffusion tensor imaging (DTI).
Previous wording
Based on these results, in July 2024, the FDA granted Regenerative Medicine Advanced Therapeutics (RMAT) Designation and Fast Track designation to laromestrocel for the treatment of mild AD.
Current wording
Based on these results, in July 2024, the FDA granted Regenerative Medicine Advanced Therapy (“RMAT”) Designation and Fast Track designation to laromestrocel for the treatment of mild AD.
Previous wording
We believe laromestrocel is the only investigational product candidate to be granted RMAT designation for mild AD to date. In March 2025, Longeveron announced a positive Type B Meeting with the FDA supporting the advancement of laromestrocel as a potential treatment for mild AD. As a result of the Type B meeting, we reached foundational alignment with the FDA on the overall study design for a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trial, including proposed AD patient population, proposed placebo control, laromestrocel dose selection and frequency, trial duration, and trial endpoints. To accelerate the pathway to potential approval of laromestrocel for the treatment of mild AD, the FDA agreed to consider a BLA based on positive interim trial results from the planned single study. Our objective is to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing AD.
Current wording
We believe laromestrocel is the only investigational product candidate to be granted RMAT designation for mild AD to date. In March 2025, Longeveron announced a productive Type B Meeting with the FDA supporting the advancement of laromestrocel as a potential treatment for mild AD. As a result of the Type B meeting, we reached foundational alignment with the FDA on the overall study design for a proposed single, seamless adaptive Phase 2/3 clinical trial, including proposed AD patient population, proposed placebo control, laromestrocel dose selection and frequency, trial duration, and trial endpoints that, if positive, could be acceptable for BLA submission for Alzheimer’s disease. We are actively seeking to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing mild AD.
Previous wording
DCM is a rare and life-threatening cardiovascular condition with unmet medical needs. Pediatric cardiomyopathies affect at least 100,000 children worldwide. DCM is the most common form of cardiomyopathy in children. About 50 to 60 percent of all pediatric cardiomyopathy cases are diagnosed as dilated. DCM is characterized by dilation and impaired systolic function of the left ventricle or both ventricles, typically in the absence of ischemia, abnormal loading conditions, or physiologic insult (e.g., sepsis). Diagnostic criteria for DCM includes reduced measures of ventricular function combined with increased ventricular volumes adjusted for body size on cardiac imaging (left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) z-scores > 2). Treatments for DCM aim to ameliorate symptoms, reduce progression of disease, and prevent life-threatening arrhythmias. Treatment for DCM remains a complex challenge, marked by several limitations.
Current wording
DCM is a rare and life-threatening cardiovascular condition with unmet medical needs. Pediatric cardiomyopathies affect at least 100,000 children worldwide. DCM is the most common form of cardiomyopathy in children. About 50 to 60 percent of all pediatric cardiomyopathy cases are diagnosed as dilated. DCM is characterized by dilation and impaired systolic function of the left ventricle or both ventricles, typically in the absence of ischemia, abnormal loading conditions, or physiologic insult (e.g., sepsis). Diagnostic criteria for DCM include reduced measures of ventricular function combined with increased ventricular volumes adjusted for body size on cardiac imaging (left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) z-scores > 2). Treatments for DCM aim to ameliorate symptoms, reduce progression of disease, and prevent life-threatening arrhythmias. Treatment for DCM remains a complex challenge, marked by several limitations.
Previous wording
Clinical data to date with laromestrocel (a MSC therapy) indicates an acceptable safety profile in various disease indications administered via either IV or intramyocardial injection. Additionally, the safety profile from MSC therapies in general has been acceptable, supported by the literature review showing that MSC therapy has been evaluated in over one thousand clinical trials globally, with a favorable safety profile across numerous disease indications. DCM is associated with the loss of cardiomyocytes and with the replacement of lost cardiomyocytes by noncontractile fibrous tissue. Results from preclinical and clinical trials highlight the potential of MSC therapy to promote cardiomyogenesis, reduce inflammation and fibrosis, and support neovascularization. In adults with both ischemic cardiomyopathy and nonischemic dilated cardiomyopathy (DCM), MSC therapies have demonstrated improved
Current wording
Clinical data to date with laromestrocel (a MSC therapy) indicates an acceptable safety profile in various disease indications administered via either IV or intramyocardial injection. Additionally, the safety profile from MSC therapies in general has been acceptable, supported by the literature review showing that MSC therapy has been evaluated in over one thousand clinical trials globally, with a favorable safety profile across numerous disease indications. DCM is associated with the loss of cardiomyocytes and with the replacement of lost cardiomyocytes by noncontractile fibrous tissue. Results from preclinical and clinical trials highlight the potential of MSC therapy to promote cardiomyogenesis, reduce inflammation and fibrosis, and support neovascularization. In adults with both ischemic cardiomyopathy and nonischemic dilated cardiomyopathy (DCM), MSC therapies have demonstrated improved LV function, functional status, and quality of life (QoL). Pediatric patients with DCM may be ideal candidates for MSC therapy because their hearts, including cardiomyocytes and progenitor cells, are more responsive to the signals from transplanted stem cells. Cell therapies have shown positive outcomes in DCM and other conditions, but further research is needed to confirm long-term safety and efficacy.
Previous wording
Execution of ELPIS II to measure the efficacy of laromestrocel in HLHS. This trial is ongoing and is being conducted in collaboration with the NHLBI through grants from the NIH. As announced on June 24, 2025, the trial has reached full enrollment and we anticipate top-line trial results for ELPIS II in the third quarter of 2026. We currently anticipate a potential BLA filing with the FDA in 2027 if the current ELPIS II trial in HLHS is successful.
Current wording
Execution of ELPIS II to measure the efficacy of laromestrocel in HLHS. This trial is ongoing and is being conducted in collaboration with the National Heart, Lung, and Blood Institute (“NHLBI”) through grants from the NIH. As announced on June 24, 2025, the trial has reached full enrollment and we anticipate top-line trial results for ELPIS II in August 2026. If the current ELPIS II trial in HLHS is successful, and the trial results and other available evidence are deemed sufficient by the FDA to support filing a BLA following the readout of top-line results of the ELPIS II data, then we would intend to pursue a potential BLA filing with the FDA and a commercialization partner.
Previous wording
Continue to pursue the therapeutic potential of laromestrocel in mild AD. Our Phase 2a trial CLEAR MIND Trial met its primary safety endpoint across all treatment groups, with no safety concerns identified. The trial demonstrated nominal statistical significance on the secondary CADS composite endpoint, suggesting a potential benefit of laromestrocel compared with placebo in maintaining cognitive function and slowing brain structural decline. Specifically, MRI analyses indicated that patients treated with laromestrocel experienced a slowing of whole-brain volume loss and preservation of key brain regions, including left hippocampal volume, relative to placebo. These findings are hypothesis-generating and support further investigation of laromestrocel in mild AD. We plan to continue in-depth analyses of the data to refine our clinical development strategy. Our overarching objective is to advance laromestrocel through strategic collaborations and partnerships, with the goal of addressing the significant unmet medical need in AD.
Current wording
Continue to pursue the therapeutic potential of laromestrocel in mild AD. Our Phase 2a trial, the CLEAR MIND Trial, met its primary safety endpoint across all treatment groups, with no safety concerns identified. The trial demonstrated nominal statistical significance on the secondary CADS composite endpoint, suggesting a potential benefit of laromestrocel compared with placebo in maintaining cognitive function and slowing brain structural decline. Specifically, MRI analyses indicated that patients treated with laromestrocel experienced a slowing of whole-brain volume loss and preservation of key brain regions, including left hippocampal volume, relative to placebo. These findings are hypothesis-generating and support further investigation of laromestrocel in mild AD. We plan to continue in-depth analyses of the data to refine our clinical development strategy. Our overarching objective is to advance laromestrocel through strategic collaborations and partnerships, with the goal of addressing the significant unmet medical need in AD.
Previous wording
Expand our manufacturing capabilities. We operate a current good manufacturing practice (“cGMP”)-compliant manufacturing facility and produce our own product candidates for early-phase testing. We continue to improve and expand our capabilities with the goal of achieving cost-effective manufacturing that may potentially satisfy supply for clinical trials product and certain CDMO contractual obligations.
Current wording
Expand our manufacturing capabilities. We operate a cGMP-compliant manufacturing facility and produce our own investigational product candidates for early-phase testing. As part of our HLHS commercialization strategy, we presently plan to utilize a CDMO for commercial-scale production, while continuing to leverage our Miami GMP facility for early-phase clinical supply, process development, other supporting manufacturing activities for our early-phase clinical trials, as well as providing our own CDMO services for potential clients. We intend to continue to improve and expand our capabilities with the goal of achieving cost-effective manufacturing that may potentially satisfy supply for clinical trials product and certain CDMO contractual obligations.
Previous wording
Advance BLA-enabling CMC activities, including process and analytical method validation planning and commercial production planning.
Current wording
Advance BLA-enabling CMC activities, including process and analytical method validation planning and commercial production planning including technology transfer and commercial production readiness activities in support of third-party manufacturing.
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 Trials 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.
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 condensed 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, under which activity has since wound down and is now limited to stability and other contract testing. 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. We may enter into fee-for-service agreements with third parties for our product development and manufacturing capabilities and we may supply mesenchymal stem cells to third parties under a fee-for-product arrangement. Additionally, excess clean room capacity may also be secured by potential customers, which will be billed at a fixed fee per suite per month. These agreements may include research, process development, and manufacturing services tailored to customer needs. In February 2024, we entered into a manufacturing services contract with a customer. Revenue from this contract is recognized over time as the services are provided. Additionally, the customer paid a fixed monthly fee per suite to reserve and maintain a dedicated manufacturing suite and storage space. We refer to revenue generated from these services as contract manufacturing revenue in our condensed 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 expenses 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 three and nine months ended September 30, 2025 and 2024. 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 three months ended March 31, 2026 and 2025. 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
Related cost of revenues were $12,000 and $0.1 million for the three months ended September 30, 2025 and 2024, respectively. This resulted in a gross profit of approximately $0.1 million for the three months ended September 30, 2025, a decrease of $0.6 million, or 82%, when compared with a gross profit of $0.7 million for 2024.
Current wording
Related cost of revenues were $0.1 million in each of the three months ended March 31, 2026 and 2025. This resulted in a gross profit of $0.3 million in each of the three months ended March 31, 2026 and 2025.
Previous wording
Net Loss: Net loss increased to approximately $7.2 million for the three months ended September 30, 2025 from a net loss of $4.4 million for the same period in 2024. This increase of $2.8 million, or 63%,was due to the factors outlined above.
Current wording
Net Loss: Net loss was $4.7 million for the three months ended March 31, 2026, compared to $5.0 million for the three months ended March 31, 2025. The decrease of $0.3 million, or 6%, was due to the factors outlined above.
Previous wording
Operating Activities. We have incurred losses since inception. Net cash used in operating activities for the nine months ended September 30, 2025 was $13.3 million, consisting primarily of our net loss of $17.3 million and payments of $0.7 million in prepaid expenses and other assets. This was partially offset by non-cash expenses of $1.3 million for equity-based compensation expenses, $0.9 million for depreciation and amortization and $2.5 million for accounts payable and accrued expenses. Net cash used in operating activities for the nine months ended September 30, 2024 was $10.5 million, consisting primarily of our net loss of $11.9 million and payments of $0.2 million in prepaid expenses and other assets, and $0.7 million for accrued expenses. This was partially offset by non-cash expenses of $1.9 million for equity-based compensation and $0.7 million for depreciation and amortization.
Current wording
Operating Activities. We have incurred losses since inception. Net cash used in operating activities for the three months ended March 31, 2026 was $4.4 million, consisting primarily of our net loss of $4.7 million and payments of $0.2 million in prepaid expenses and other assets. This was partially offset by non-cash expenses of $0.4 million for equity-based compensation expenses, $0.3 million for depreciation and amortization and $0.2 million for accounts payable and accrued expenses. Net cash used in operating activities for the three months ended March 31, 2025 was $4.7 million, consisting primarily of our net loss of $5.0 million and payments of $0.6 million in prepaid expenses and other assets, and $0.2 million for accrued expenses. This was partially offset by non-cash expenses of $0.3 million for equity-based compensation and $0.4 million for depreciation and amortization.
Previous wording
Investing Activities. Net cash used in investing activities for the nine months ended September 30, 2025 was $0.5 million consisting primarily of purchases of property and equipment and intangible assets. Net cash used in investing activities for the nine months ended September 30, 2024 was $0.5 million consisting primarily of purchases of property and equipment and intangible assets which was partially offset by the redemption of marketable securities.
Current wording
Investing Activities. Net cash used in investing activities for the three months ended March 31, 2026 was $20,000 for the purchase of intangible assets. Net cash used in investing activities for the three months ended March 31, 2025 was $0.2 million consisting primarily of purchases of property and equipment and intangible assets which was partially offset by the redemption of marketable securities.
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.
Showing the first 40 of 60 pairs. Open the source sections for the rest.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.
Current report — wording carried from elsewhere
This discussion and analysis should be read in conjunction with our unaudited condensed financial statements and notes thereto included in this 10-Q and the audited condensed financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 17, 2026 (the “2025 Form 10-K”). Operating results are not necessarily indicative of results that may occur in future periods.
Current report — wording carried from elsewhere
Our current objective is to license or otherwise forge strategic collaborations and/or partnerships for the advancement of laromestrocel in all four potential indications.
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
LV function, functional status, and quality of life (QoL). Pediatric patients with DCM may be ideal candidates for MSC therapy because their hearts, including cardiomyocytes and progenitor cells, are more responsive to the signals from transplanted stem cells. Cell therapies have shown positive outcomes in DCM and other conditions, but further research is needed to confirm long-term safety and efficacy.
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
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024, together with the changes in those items in dollars (in thousands):
Previous report — wording carried elsewhere
Research and development expenses consisted primarily of the following items (in thousands):