Longeveron Inc.
For the period ended Jun 30, 2026. Filed Aug 12, 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.
Jun 30, 2026 · Filed Aug 12, 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 2026-03-31; filed 2026-05-13.
0001193125-26-221559
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-12.
0001193125-26-346794
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 160 previous paragraphs and 172 current paragraphs.
129 unchanged; 24 reworded; 16 added; 7 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 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 (16)
Current report
On March 11, 2026, the Company completed the initial closing of the Private Placement previously described in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, resulting in gross proceeds of approximately $15.9 million, before deducting placement agent fees and offering expenses. The initial closing included the issuance of Class A common stock, Series A preferred stock convertible into Class A common stock, placement agent warrants, and the sale of an interest in a portion of the potential future proceeds from the sale of a Rare Pediatric Disease Priority Review Voucher ("PRV"). The Private Placement also contemplated a second closing, subject to the satisfaction or waiver of certain closing conditions. See "Liquidity, Capital Resources, and Going Concern—Capital Raising Efforts" below for additional information regarding the Private Placement.
Current report
In June 2026, we announced that the Company has been granted Small or Medium-sized Enterprise (SME) status by the European Medicines Agency (EMA). The SME program is an initiative by the EMA to address the particular needs of small and medium size companies developing medicinal products in Europe. Companies that are granted SME designation are able to seek scientific advice, protocol assistance, and other information and training from dedicated EMA personnel during the clinical development process. Companies with this designation can engage in early dialogue with the EMA multidisciplinary team and discuss regulatory strategy with the goal of mitigating delay and accelerating patient access to lifesaving treatments. In addition, SME designation gives companies reduced administrative fees throughout the development process.
Current report
In May 2026, we announced that the independent Data Monitoring Committee (DMC) completed its final pre-specified data review for ELPIS II. The DMC performed a risk-benefit assessment, indicated no safety concerns, and approved the study to continue as designed to completion.
Current report
Laromestrocel data from its Phase 2b clinical trial in Aging-related Frailty were published in Cell Stem Cell in February 2026. The Phase 2b results indicated that intravenous laromestrocel improved the physical condition of patients with age-related clinical frailty after nine months, compared to placebo.
Current report
Revenues, Cost of Revenues and Gross Profit: Revenues for each of the three-month periods ended June 30, 2026 and June 30, 2025 was $0.3 million. 2026 revenues decreased by $29,000, or 10%, when compared to 2025, primarily due to the absence of contract manufacturing revenue.
Current report
Clinical trial revenue, which is derived from The Bahamas Registry Trial, for each of the three-month periods ended June 30, 2026 and June 30, 2025 was $0.3 million. Contract manufacturing revenues for the three months ended June 30, 2026 and 2025, were $0 and $18,000, respectively. This decrease of $18,000, or 100%, when compared to the same period in 2025, was driven by the absence of any additional contract manufacturing services from our third-party client.
Current report
Related cost of revenues were $0.1 million and $0.2 million for the three months ended June 30, 2026 and 2025, respectively. This resulted in a gross profit of approximately $0.2 million for the three months ended June 30, 2026, an increase of $36,000, or 25%, when compared to 2025.
Current report
General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2026 were $3.2 million, compared to $2.6 million for the same period in 2025. The increase of $0.6 million, or 23%, was primarily due to a $0.4 million increase in legal spend and a $0.2 million increase in personnel-related costs.
Current report
Research and Development Expenses: Research and development expenses were $3.2 million for the three months ended June 30, 2026, compared to $3.0 million for the same period in 2025. The increase of $0.2 million, or 7%, was due to higher clinical trial expenses to support the ELPIS II top-line results expected in September 2026.
Current report
Other Income: Other income for the three months ended June 30, 2026 was $0.1 million, primarily consisting of interest earned on money market funds. Other income for the three months ended June 30, 2025, was $0.4 million, primarily consisting of $250,000 received as a recipient of a Milestone 1 Award in the XPRIZE Healthspan competition and $0.1 million of interest earned on money market funds.
Current report
COMPARISON OF THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025
Current report
Revenues, Cost of Revenues and Gross Profit: Revenues for each of the six-month periods ended June 30, 2026 and June 30, 2025, was $0.7 million. 2026 revenues decreased by $12,000, or 2%, due to lower contract manufacturing revenue offset by increased participant demand for our Bahamas Registry Trial.
Current report
Other Income: Other income was $0.1 million for the six months ended June 30, 2026, primarily consisting of interest earned on money market funds. Other income for the six months ended June 30, 2025, was $0.5 million, primarily consisting of $250,000 received as a recipient of a Milestone 1 Award in the XPRIZE Healthspan competition and $0.2 million of interest earned on money market funds.
Current report
Net Loss: Net loss was $10.8 million for the six months ended June 30, 2026, compared to $10.0 million for the six months ended June 30, 2025. The increase of $0.8 million, or 8%, was due to the factors outlined above.
Current report
On March 10, 2026, the Company entered into a Securities Purchase Agreement with certain institutional and accredited investors providing for a private placement of Class A common stock, Series A preferred stock and certain related rights in up to two closings (the "Private Placement"). The initial closing occurred on March 11, 2026 and resulted in gross proceeds of approximately $15.9 million, before deducting placement agent fees and other offering expenses. Additional information regarding the Private Placement, including the securities issued, the related interest in potential proceeds from the sale of a Rare Pediatric Disease Priority Review Voucher ("PRV"), the placement agent warrants and compensation arrangements, and the terms of the Series A preferred stock, is included in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.
Current report
Pursuant to the Purchase Agreement, subject to the satisfaction or waiver of specified closing conditions, the Company may complete a second closing for additional gross proceeds of approximately $15.0 million, before deducting placement agent fees and other offering expenses. The second closing is contingent upon the achievement (or waiver) of certain clinical and market-based milestones, as set forth in the Purchase Agreement, including specified Phase 2b HLHS study results and a minimum trading price and volume threshold. Investors holding a majority in interest of the Private Placement Securities may waive these conditions and elect to proceed with the second closing.
Removed paragraphs (7)
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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
Previous 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.
Reworded paragraphs (24)
Previous 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.
Current wording
As of June 30, 2026, we have sold 28,230,871 shares of Class A Common Stock, par value $0.001 per share (the "Class A common stock") and 11,873.04 shares of Series A Non-Voting Convertible Preferred Stock, par value $0.001 per share (the "Series A preferred stock") through our IPO and subsequent follow-on public and private equity offerings and transactions. Additionally, as of June 30, 2026, warrants exercisable for an aggregate of up to 21,238,731 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
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 wording
In connection with a review of our 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.
Previous wording
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 wording
Following the initial closing of the March 2026 private placement financing discussed below (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.
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 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.
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 June 30, 2026 we had an accumulated deficit of $143.1 million. We expect to continue to generate operating losses for the foreseeable future. As a result of the March 2026 Private Placement financing, and based on current operating plans, we expect that our cash and cash equivalents as of June 30, 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, of which $9.3 million remains available; however, the ATM facility was 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 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).
Current wording
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
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 wording
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. In June 2026, the Company submitted 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.
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 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.
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 tentative 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 potential 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
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 wording
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, subject to financing, 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.
Previous wording
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 wording
Preparation and initiation of a single Phase 2 registrational clinical trial for pediatric DCM, subject to financing. 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.
Previous 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.
Current wording
No provision for income taxes has been recorded for the three and six months ended June 30, 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
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.
Current wording
Net Loss: Net loss was $6.1 million for the three months ended June 30, 2026, compared to $5.0 million for the three months ended June 30, 2025. The increase of $1.1 million, or 22%, was due to the factors outlined above.
Previous wording
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 wording
Clinical trial revenues for the six months ended June 30, 2026 increased $0.1 million, or 19%, 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 six months ended June 30, 2026 decreased $0.1 million, or 85%, when compared to the same period in 2025, driven by the absence of additional contract manufacturing services from our third-party client.
Previous 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.
Current wording
Related cost of revenues were $0.2 million and $0.3 million for the six months ended June 30, 2026 and 2025, respectively. This resulted in a gross profit of $0.4 million in each of the six months ended June 30, 2026 and 2025.
Previous wording
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 wording
General and Administrative Expense: General and administrative expenses for the six months ended June 30, 2026 were $5.9 million, compared to $5.5 million for the same period in 2025. The increase of $0.4 million, or 7%, was primarily due to higher legal and accounting costs of $0.7 million, partially offset by a decrease in personnel-related costs of $0.3 million.
Previous wording
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 wording
Research and Development Expenses: Research and development expenses were $5.5 million for each of the six month periods ended June 30, 2026 and June 30, 2025. The increase of $44,000, or 1%, was due to higher clinical trial expenses of $0.3 million to support the ELPIS II top-line results expected in September 2026, partially offset by a non-recurring charge for amortization expense related to patent costs recorded in the 2025 period of $0.2 million.
Previous 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.
Current wording
Operating Activities. We have incurred losses since inception. Net cash used in operating activities for the six months ended June 30, 2026 was $10.0 million, consisting primarily of our net loss of $10.8 million, payments of $0.3 million in prepaid expenses and other assets, and $0.3 million in other liabilities. This was partially offset by non-cash expenses of $0.8 million for equity-based compensation expenses, $0.5 million for depreciation and amortization and $0.3 million for accounts payable and accrued expenses. Net cash used in operating activities for the six months ended June 30, 2025 was $8.3 million, consisting primarily of our net loss of $10.0 million and payments of $0.6 million in prepaid expenses and other assets. This was partially offset by non-cash expenses of $0.9 million for equity-based compensation, $0.7 million for depreciation and amortization, and $0.8 million for accounts payable and accrued expenses.
Previous 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.
Current wording
Investing Activities. Net cash used in investing activities consisted of purchases of property and equipment and intangible assets of $0.1 million and $0.4 million for the six months ended June 30, 2026 and 2025, respectively.
Previous wording
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 wording
Financing Activities. Net cash provided by financing activities for the six months ended June 30, 2026 was $15.6 million and consisted primarily of $13.5 million of net proceeds from the issuance of stock in the March 2026 Private Placement financing and the ATM facility as well as $1.4 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 six months ended June 30, 2025 was less than $0.2 million for the payment of taxes upon vesting of RSUs.
Previous wording
To date, we have financed our operations primarily through our IPO, registered and private placement equity financings, grant awards, fees generated from The Bahamas Registry Trial and contract manufacturing services. Since we were formed, we have raised approximately $136.0 million in gross proceeds from the issuance of equity, including $15.9 million in gross proceeds from the Private Placement in March 2026. At March 31, 2026, we had cash and cash equivalents of $15.8 million and working capital of $12.5 million.
Current wording
To date, we have financed our operations primarily through our IPO, registered and private placement equity financings, grant awards, fees generated from The Bahamas Registry Trial and contract manufacturing services. Since we were formed, we have raised approximately $136.0 million in gross proceeds from the issuance of equity, including $15.9 million in gross proceeds from the Private Placement in March 2026. At June 30, 2026, we had cash and cash equivalents of $10.1 million and working capital of $7.0 million.
Previous wording
We intend to seek additional financing opportunities, capital raises, as well as non-dilutive funding options to support our operating plans. Additionally, following a positive Type B meeting with the FDA in March 2025 with respect to the AD regulatory pathway, we are focused on seeking partnership opportunities and/or non-dilutive funding for the AD program, including a proposed single, seamless adaptive Phase 2/3 clinical trial. There can be no assurance we will be able to attain future financing at terms favorable to us or at all. In the event we are unable to attain the financing needed, we will need to materially revise our current operational plan. We do not have sufficient cash to meet our minimum expenditure commitments for one year from the date these unaudited condensed financial statements are available to be issued, and therefore we need to raise additional funds to continue as a going concern. As a result, there is substantial doubt about our ability to continue as a going concern.
Current wording
We intend to seek additional financing opportunities, capital raises, as well as non-dilutive funding options to support our operating plans. Additionally, following a positive Type B meeting with the FDA in March 2025 with respect to the Alzheimer's disease (AD) regulatory pathway, we are focused on seeking partnership opportunities and/or non-dilutive funding for the AD program, including a proposed single, seamless adaptive Phase 2/3 clinical trial. There can be no assurance we will be able to attain future financing at terms favorable to us or at all. In the event we are unable to attain the financing needed, we will need to materially revise our current operational plan. We do not have sufficient cash to meet our minimum expenditure commitments for one year from the date these unaudited condensed 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
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.
Current wording
As of June 30, 2026, we have sold 28,230,871 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 June 30, 2026, warrants exercisable for an aggregate of up to 21,238,731 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
Pursuant to an agreement with Wainwright dated September 19, 2025 (the “ATM Agreement”), the Company also has access to an At-The-Market (ATM) equity financing vehicle, providing for the sale and issuance by the Company of shares of Class A common stock from time to time, through or to Wainwright as the Company’s sales agent or principal. The gross sales price of the shares of Class A common stock sold by Wainwright under the ATM Agreement as sales agent shall be the market price for the shares of Class A common stock on Nasdaq at the time of sale. 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. 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.
Current wording
Pursuant to an agreement with Wainwright dated September 19, 2025 (as amended, the “ATM Agreement”), the Company also has access to an At-The-Market (ATM) equity financing vehicle, providing for the sale and issuance by the Company of shares of Class A common stock from time to time, through or to Wainwright as the Company’s sales agent or principal. The gross sales price of the shares of Class A common stock sold by Wainwright under the ATM Agreement as sales agent shall be the market price for the shares of Class A common stock on Nasdaq at the time of sale. 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. 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.
Previous wording
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 wording
During the three months ended June 30, 2026, we sold 120,689 shares of Class A common stock under the ATM Agreement at a weighted average share price of $0.83 per share, resulting in net proceeds of approximately $42,000 to the Company after deducting certain offering expenses, including approximately $7,100 in compensation to Wainwright. As of June 30, 2026, an aggregate market value of approximately $9.3 million of shares of Class A common stock remains available for future sale under the ATM prospectus supplement.
Previous wording
As of March 31, 2026, we have $0.8 million in operating lease obligations and no CRO payment obligations. From time to time we may enter into contracts in the normal course of business with third-party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that our non-cancelable obligations under these agreements are not material.
Current wording
As of June 30, 2026, we have $0.6 million in operating lease obligations and no CRO payment obligations. From time-to-time we may enter into contracts in the normal course of business with third-party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that our non-cancelable obligations under these agreements are not material.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
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
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025, together with the changes in those items in dollars (in thousands):
Current report — wording carried from elsewhere
Research and development expenses consisted primarily of the following items (in thousands):