Longeveron Inc.
For the period ended Sep 30, 2025. Filed Nov 4, 2025.
View on SEC.govAbout this filing
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.
Sep 30, 2025 · Filed Nov 4, 2025
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 2025-06-30; filed 2025-08-13.
0000950170-25-107983
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 171 previous paragraphs and 161 current paragraphs.
87 unchanged; 59 reworded; 14 added; 25 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 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 (14)
Current report
the potential disruptive impact of the ongoing U.S. federal government shutdown upon our operations, clinical development programs, and capital raising efforts;
Current report
Recent Developments – Government Shutdown
Current 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.
Current 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.
Current report
Financial Overview
Current 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.
Current report
Operational Overview
Current report
Hypoplastic Left Heart Syndrome (HLHS)
Current report
Alzheimer’s disease (AD)
Current report
COMPARISON OF THE NINE MONTHS ENDED SEPTEMBER 30, 2025 AND 2024
Current 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).
Current report
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. Pursuant to the ATM Agreement, Wainwright has agreed to use its commercially reasonable efforts to sell the shares of Class A common stock from time to time. The Company will designate the parameters for the sale of shares of Class A common stock, including the number of shares to be issued, the time period during which sales are requested to be made, limitations on the number of shares that may be sold on any trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the ATM Agreement, Wainwright may sell the shares by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, including without limitation, sales made directly on Nasdaq or on any other existing trading market for the Class A common stock or to or through a market maker. In addition, with the Company’s prior written approval, Wainwright may also sell shares in privately negotiated transactions or block transactions. The gross sales price of the shares of Class A common stock sold by Wainwright under the ATM Agreement as sales agent shall be the market price for the shares of Class A common stock on Nasdaq at the time of sale.
Current report
The Company has no obligation to sell any shares of Class A common stock under the ATM Agreement and the Company or Wainwright may at any time suspend offers under the ATM Agreement, pursuant to the terms therein. Wainwright is not obligated to purchase any shares of Class A common stock on a principal basis pursuant to the ATM Agreement, except as otherwise specifically agreed by Wainwright and the Company in a separate agreement. No assurance can be given that the Company will sell any shares of Class A common stock under the ATM Agreement, or if such sales occur, no assurance can be given as to the price or number of shares that will be sold, or the dates on which any such sales will take place.
Current report
The ATM Agreement provides that the Company will pay Wainwright a sales commission equal to 3.0% of the gross sales price of the shares of Class A common stock sold by Wainwright pursuant to the ATM Agreement, and provide reimbursement for reasonable fees and expenses incurred by its legal counsel in connection with the ATM Agreement. During the three months ended September 30, 2025, we did not sell any shares of Class A common stock under the ATM Agreement. The ATM Offering will terminate upon the earlier of (i) the sale of the Company’s Class A common stock pursuant to the ATM Prospectus Supplement having an aggregate sales price of $10.7 million or (ii) termination of the ATM Agreement by the Company or Wainwright as permitted therein.
Removed paragraphs (25)
Previous report
Cash and cash equivalents as of June 30, 2025 were $10.3 million. As a result of the recently completed financing referenced in Note 13, Subsequent Events, we currently anticipate our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2026 based on our current operating budget and cash flow forecast. We have been and will remain focused on prudent and efficient capital allocation strategies to advance our development programs, which we believe are highly cost efficient, both intrinsically and relative to other development programs. Following a successful Type C meeting with the FDA in August 2024 with respect to the HLHS regulatory pathway, we have begun ramping up our BLA enabling activities. We currently anticipate a potential BLA filing with the FDA in late 2026 if the current ELPIS II trial in HLHS is successful. With the significant opportunity presented with a potential BLA filing, our operating expenses and capital expenditure requirements are currently expected to increase throughout the remainder of calendar 2025 and in 2026 in large part to address CMC (Chemistry, Manufacturing, and Controls) and manufacturing readiness. 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 U.S. FDA in March 2025 with respect to the Alzheimer's disease regulatory pathway, we are focused on seeking partnership opportunities and/or non-dilutive funding for the Alzheimer’s disease program. 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 report
Operational Overview. With respect to HLHS, 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. The standard of care in HLHS is a series of three heart surgeries (staged surgical palliation) that reconfigures the single right ventricle to support system circulation. Despite these life-saving surgical interventions, it is estimated that only 50 to 60 percent of affected individuals survive until adolescence. The pro-vascular, pro-regenerative and anti-inflammatory properties of laromestrocel may improve the function of the right ventricle in these infants. A previous Longeveron Phase 1 open-label study ("ELPIS I") indicated that such a benefit may exist when outcomes were compared to historical controls. Longeveron is currently conducting a controlled study ("ELPIS II") to determine the actual benefit of laromestrocel in these patients.
Previous report
HLHS
Previous report
Our HLHS program is focused on the potential clinical benefits of laromestrocel as an adjunct therapeutic to standard-of-care HLHS surgery. HLHS is a rare and devastating congenital heart defect in which the left ventricle is severely underdeveloped. As such, babies born with this condition die shortly after birth without undergoing a complex series of reconstructive heart surgeries. Despite the availability of life-saving surgical interventions, clinical studies show that only 50 to 60 percent of affected individuals survive to adolescence. Early clinical study data shows the potential survival benefit of laromestrocel for HLHS patients and supports Longeveron’s belief that these data show the potential to alter the treatment landscape for patients with HLHS. We have completed a Phase 1 open-label study (“ELPIS I”)1 that supported the safety and tolerability of laromestrocel for HLHS, when directly injected into the functional right ventricle ("RV") during the second-stage standard-of-care surgery (adding minimal additional time to the surgical procedure). Preliminary data revealed that several indices of right ventricular function show suggestions of either improvement or prevention of deterioration over one year following surgery. Heart transplant-free survival for patients who received laromestrocel intracardiac injection is favorable as compared to historical controls for survival. The ELPIS I trial showed 100 percent transplant-free survival in children up to 5 years after receiving laromestrocel, compared to a 20 percent mortality rate observed from historical control data. The improvement in HLHS survival following the Phase 1 ELPIS I clinical trial resulted in scientific presentations at the American Heart Association (“AHA”) in November 2023 and Congenital Heart Surgeons' Society's 51st Annual Meeting in October 2024.
Previous report
Sunjay Kaushal, M.D., Ph.D, Joshua M Hare, M.D., Jessica R Hoffman, Ph.D, Riley M Boyd, BA, Kevin N Ramdas, M.D., MPH, Nicholas Pietris, M.D., Shelby Kutty, M.D., Ph.D, MS, James S Tweddell, M.D., S Adil Husain, M.D., Shaji C Menon, MBBS, M.D., MS, Linda M Lambert, MSN-cFNP, David A Danford, M.D., Seth J Kligerman, M.D., Narutoshi Hibino, M.D., Ph.D, Laxminarayana Korutla, Ph.D, Prashanth Vallabhajosyula, M.D., MS, Michael J Campbell, M.D., Aisha Khan, Ph.D, Eric Naioti, MSPH, Keyvan Yousefi, PharmD, Ph.D, Danial Mehranfard, PharmD, MBA, Lisa McClain-Moss, Anthony A Oliva, Ph.D, Michael E Davis, Ph.D, Intramyocardial cell-based therapy with Lomecel-B™ during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: The ELPIS phase I trial, European Heart Journal Open, 2023.
Previous report
Based on these findings, the U.S. Food and Drug Administration (the “FDA”) granted laromestrocel Rare Pediatric Disease (“RPD”) Designation, Orphan Drug Designation (“ODD”), and Fast Track Designation for treatment of infants with HLHS. On September 3, 2024, Longeveron announced a positive Type C meeting with the FDA supporting the advancement of laromestrocel. Longeveron is currently conducting a controlled Phase 2b trial (“ELPIS II”) to compare the effects of laromestrocel as an adjunct therapeutic versus standard-of-care (HLHS surgery alone). We announced full enrollment of ELPIS II on June 24, 2025. While it is hard to predict study outcome due to the inherent risk associated with clinical trials, our plans are centered on a successful outcome, which could add to the clinical data suggesting the clinical benefit of laromestrocel as part of standard-of-care treatment in HLHS patients.
Previous report
As a result of the Type C meeting with the FDA, we reached foundational alignment on the registrational path to pursue traditional approval for laromestrocel for treatment of HLHS, based on the proposed clinical development program, which includes the ongoing Phase 2b ELPIS II study as the pivotal study to provide primary evidence of effectiveness. 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 late 2026 if the current ELPIS II trial in HLHS is successful.
Previous report
Alzheimer’s Disease
Previous report
The results of the CLEAR MIND trial were presented in the Featured Research Session at the 2024 Alzheimer’s Association International Conference (“AAIC”) in July 2024. The brain volume results measured by MRI results from this trial also were presented at the poster presentation at AAIC. These findings support both the safety and potential therapeutic benefit of laromestrocel in managing mild AD, and we believe lay the groundwork for subsequent trials in this indication. Based on these results, the FDA granted Regenerative Medicine Advanced Therapeutics (RMAT) Designation on July 9, 2024, and Fast Track designation on July 17, 2024, to laromestrocel for the treatment of mild AD.
Previous report
Additional data from the CLEAR MIND trial was presented as a late breaking poster presentation at the Clinical Trials on Alzheimer's Disease Conference (“CTAD24”) in October 2024 in Madrid, Spain.
Previous report
On March 10, 2025, the results of the CLEAR MIND trial were published in Nature Medicine, a premier peer-reviewed medical and scientific journal.
Previous report
DCM occurs when the muscles in one of more of the heart chambers become enlarged or stretched (dilated). The other chambers of the heart need to work harder to compensate for the affected chambers, and may also become dilated and enlarged. As the condition progresses, the heart becomes weaker, and it becomes more difficult to pump blood through the body. This can lead to congestive heart failure causing a build-up of fluid in the lungs, liver, abdomen, and lower legs. In the majority of cases, the exact cause of DCM cannot be determined (idiopathic cardiomyopathy).
Previous report
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. According to the Pediatric Cardiomyopathy Registry, DCM is reportedly more common in boys than girls. Although all age groups are affected, studies show that DCM is more common in infants (before age 1) than in older children. Current treatment for DCM focuses on managing symptoms, improving heart function, and preventing complications rather than addressing the underlying cause or causes. Many therapeutic agents with known efficacy in adults lack the same evidence in children.
Previous report
Aging-related Frailty
Previous report
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 health span – 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. We are currently not active with Aging-related Frailty following our decision to discontinue clinical trial activities in Japan in 2024.
Previous report
Clinical Development Pipeline in 2025
Previous report
All ELPIS I patients had completed long-term follow-up, and 100% 5-years post-Glenn survival data were presented by Principal Investigator Dr. Sunjay Kaushal, Cardiovascular and Thoracic Surgery, University of Nevada, Las Vegas at American Heart Association (“AHA”) in November 2023 and Congenital Heart Surgeons' Society's 51st Annual Meeting in October 2024.
Previous report
[2] Mark Brody, Marc Agronin, Brad J. Herskowitz, Susan Y. Bookheimer, Gary W. Small, Benjamin Hitchinson, Kevin Ramdas, Tyler Wishard, Katalina Fernández McInerney, Bruno Vellas, Felipe Sierra, Zhijie Jiang, Lisa McClain-Moss, Carmen Perez, Ana Fuquay, Savannah Rodriguez, Joshua M. Hare, Anthony A. Oliva Jr., Bernard Baumel. “Results and insights from a phase I clinical trial of Lomecel-B™ for Alzheimer’s disease” (2023) Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association 19:261-273.
Previous report
Aging-related Frailty. Aging-related Frailty is a life-threatening geriatric condition that disproportionately increases risks for poor clinical outcomes from disease and injury. While the definition of Aging-related Frailty lacks consensus, would be a new indication from a regulatory standpoint, and has no approved pharmaceutical or biologic treatments, there are a number of companies now working to develop potential therapeutics for this unmet medical need.
Previous report
We have previously completed two U.S. clinical trials under FDA IND 16644. One is a multi-center, randomized, placebo-controlled Phase 2b trial which showed that a single infusion of laromestrocel significantly improved 6-Minute Walk Test (“6MWT”) distance 9 months after infusion (although results were inconclusive at six months after infusion), and also showed a dose-dependent increase in 6MWT distance 6 months after infusion. The second is a multi-center, randomized, placebo-controlled Phase 1/2 trial (“HERA Trial”) intended primarily to evaluate safety, and explore the effect laromestrocel may have on specific biomarkers of immune system function in older, frail individuals receiving the high dose influenza vaccine, as well as to evaluate the potential effects of laromestrocel on signs and symptoms of Aging Frailty. Results from this study showed that laromestrocel was generally safe and well tolerated in patients with Aging-related Frailty. Additionally, hemagglutinin inhibition (“HAI”) assay results in the laromestrocel and placebo groups to influenza were not statistically different, indicating laromestrocel does not suppress the immune system.
Previous report
We have filed patent applications relating to the administration of laromestrocel for Aging-related Frailty in Australia, Canada, China, the European Patent Office, Hong Kong, Israel, Japan, Singapore, South Korea, New Zealand, South Africa, Taiwan, the Bahamas and the United States.
Previous report
Given the unmet medical need in DCM, accrued acceptable safety profile of laromestrocel in prior human experience, and literature review evidence suggesting a potential benefit in DCM, the Sponsor considers it is appropriate to assess the safety and efficacy of laromestrocel in clinical trial setting in pediatric participants with DCM aged from 6 months and beyond.
Previous report
We are planning to initiate a Phase 2 pivotal registrational clinical trial for DCM in the first half of 2026, subject to obtaining necessary financing.
Previous report
COMPARISON OF THE SIX MONTHS ENDED JUNE 30, 2025 AND 2024
Previous report
As indicated above, based on our current operating budget, cash flow forecast, and ramp up of BLA enabling activities, our operating expenses and capital expenditure requirements are expected to increase throughout the remainder of calendar 2025 and in 2026 in large part to address CMC and manufacturing readiness. We intend to seek additional financing opportunities, capital raises, as well as non-dilutive funding options to support our operating plans. There can be no assurance we will be able to attain future financing at terms favorable to us or at all.
Reworded paragraphs (59)
Previous wording
the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;
Current wording
the ability of our clinical trials to demonstrate safety and efficacy of our investigational product candidates, and other positive results;
Previous wording
the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;
Current wording
the size of the market opportunity for certain of our investigational product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;
Previous wording
our ability to scale production and commercialize the product candidate for certain indications;
Current wording
our ability to scale production and commercialize the investigational product candidate for certain indications;
Previous wording
the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;
Current wording
the beneficial characteristics, safety, efficacy and therapeutic effects of our investigational product candidates;
Previous wording
our ability to obtain and maintain regulatory approval of our product candidates in the U.S., and other jurisdictions;
Current wording
our ability to obtain and maintain regulatory approval of our investigational product candidates in the U.S., and other jurisdictions;
Previous wording
our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue;
Current wording
our plans relating to the further development of our investigational product candidates, including additional disease states or indications we may pursue;
Previous wording
We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. Our lead investigational product is laromestrocel. Longeveron received notice from the World Health Organization (“WHO”) on February 13, 2025 that the name “laromestrocel” for our Lomecel-B™ product has been adopted by the WHO and published in the International Nonproprietary Names (INN) list 132. Following that notice, we adopted referring to the investigational product as laromestrocel, and will continue to refer to the investigational product formerly referred to as Lomecel-B™ as laromestrocel on an ongoing basis.
Current 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™.
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, promoting tissue repair and healing with broad potential applications across a spectrum of disease areas. We are currently pursuing four pipeline indications: Hypoplastic Left Heart Syndrome (“HLHS”), Alzheimer’s disease (“AD”), pediatric Dilated Cardiomyopathy (“DCM”) and Aging-related Frailty. Our mission is to continue to advance the development and regulatory approval of laromestrocel and make it available to all the patients who may need it.
Current 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.
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.
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 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.
Previous wording
We manufacture our own 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 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 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 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.
Previous wording
Since the time that we became a publicly traded company in February 2021, we have sold 12,686,240 shares of Class A common stock through our IPO and subsequent follow-on public and private equity offerings and transactions. Additionally, as of June 30, 2025, warrants exercisable for an aggregate of up to 6,802,668 shares of a Company's Class A common stock remain outstanding at exercise prices ranging from $2.35 per share to $175.00 per share.
Current wording
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.
Previous wording
Financial Overview. Since inception, we have primarily been engaged in organizational activities, including raising capital, and research and development activities. 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 June 30, 2025 we had an accumulated deficit of $119.6 million. We expect to continue to generate operating losses for the foreseeable future.
Current wording
We do not yet have a product that has been approved by the FDA, and have only generated revenues from grants, the Bahamas Registry 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.
Previous wording
We are currently in clinical development of a single product, laromestrocel for three potential indications:
Current 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.
Previous wording
As of August 8, 2025, we have completed five U.S. clinical studies of laromestrocel: Phase 1 AD, Phase 1 HLHS, Phase 1/2 Aging-related Frailty (“HERA Trial”), Phase 2a AD ("CLEAR MIND Trial”), and Phase 2b Aging-related Frailty. We currently have one fully enrolled, ongoing clinical trial: Phase 2b HLHS (“ELPIS II” trial). Additionally, we sponsor a registry in The Bahamas under the approval and authority of the National Stem Cell Ethics Committee. The Bahamas Registry Trials may administer 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 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.
Previous wording
Hypoplastic Left Heart Syndrome (HLHS). 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). 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.
Current 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.
Previous wording
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 (38 subjects total: 19 per arm). This trial has reached full enrollment and is funded in part by the NHLBI/NIH. We anticipate top-line trial results in the third quarter of 2026.
Current 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).
Previous wording
In September 2023, we completed our Phase 2a AD clinical trial, known as the CLEAR MIND trial. This trial enrolled patients with mild AD and was designed as a randomized, double-blind, placebo-controlled study across ten U.S. centers. Our primary objective was to assess safety, and we tested three distinct laromestrocel dosing regimens against placebo.
Current wording
AD, a devastating neurologic disease leading to cognitive decline, currently has very limited therapeutic options. An estimated 6.7 million Americans aged 65 and older have AD, and this number is projected to more than double by 2060. In September 2023, we completed our Phase 2a AD clinical trial, known as the CLEAR MIND trial. This trial enrolled patients with mild AD and was designed as a randomized, double-blind, placebo-controlled study across ten U.S. centers. Our primary objective was to assess safety, and preliminary efficacy for three distinct laromestrocel dosing regimens against placebo.
Previous wording
The study demonstrated positive results. The established safety profile of laromestrocel for single and multiple dosing regimens was demonstrated in study data that showed no incidence of hypersensitivity or infusion-related reactions, there were no cases of amyloid-related imaging abnormalities (ARIA), and all laromestrocel treatment groups met the safety primary endpoint and showed slowing/prevention of disease worsening relative to placebo. There were statistically significant improvements in the secondary efficacy endpoint, composite AD score (“CADS”) for both the low-dose laromestrocel group and the pooled treatment groups compared to placebo. Other doses also indicated promising results in slowing/prevention of disease worsening. Additionally, a statistically significant 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”). 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 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).
Previous wording
Alzheimer’s disease. AD, a devastating neurologic disease leading to cognitive decline, currently has very limited therapeutic options. An estimated 6.7 million Americans aged 65 and older have AD, and this number is projected to more than double by 2060. Laromestrocel treated patients showed an overall slowing/prevention of disease worsening compared to placebo in the completed Phase 2a study (CLEAR MIND) as previously detailed in this report and met its primary endpoint of safety. These results are consistent with those of our earlier Phase I study 2. Based on these results, in July 2024, the FDA granted RMAT designation and Fast Track designation to laromestrocel for the treatment of mild AD. We believe laromestrocel is the only product candidate to be granted RMAT designation for mild AD to date. We intend to forge strategic collaborations, and/or partnerships for the advancement of laromestrocel in addressing AD.
Current 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.
Previous wording
Based on the totality of the evidence, the FDA granted our request for a Type B meeting. On March 20, 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 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.
Previous wording
We have filed patent applications relating to the treatment of AD using laromestrocel in Australia, the Bahamas, Canada, China, the European Patent Office, Hong Kong, Israel, Japan, New Zealand, South Korea, Singapore, South Africa, and the United States. We have also filed another family of patent applications relating to improving Brain Architecture in Alzheimer’s disease using laromestrocel in the Bahamas, Taiwan, in addition to a PCT application.
Current wording
We have filed patent applications relating to the treatment of AD using laromestrocel in Australia, the Bahamas, Canada, China, the European Patent Office, Hong Kong, Israel, Japan, New Zealand, South Korea, Singapore, South Africa, and the United States. We have also filed another family of patent applications relating to improving Brain Architecture in Alzheimer’s disease using laromestrocel in the Bahamas, Taiwan, in addition to an application under the Patent Cooperation Treaty (PCT).
Previous wording
Pediatric Dilated Cardiomyopathy. DCM is a rare and life-threatening cardiovascular condition with unmet medical needs. 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 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.
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 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.
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
Previous wording
On July 8, 2025, the company announced that the FDA approved the Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for pediatric Dilated Cardiomyopathy (DCM). The accepted IND application provides for moving directly to a single Phase 2 pivotal registration clinical trial in the first half of 2026, subject to obtaining necessary financing.
Current wording
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 wording
Our core strategy is to become a world-leading regenerative medicine company through the development, approval, and commercialization of novel cell therapy products for unmet medical needs, with a focus on HLHS. Key elements are as follows.
Current wording
Our core strategy is to become a world-leading regenerative medicine company through the development, approval, and commercialization of novel cell therapy products for unmet medical needs, with a near-term focus on HLHS. Key elements are as follows.
Previous wording
Execution of ELPIS II, a Phase 2b randomized controlled trial set forth in greater detail below, 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 the third quarter of 2026. We currently anticipate a potential BLA filing with the FDA in late 2026 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 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.
Previous wording
Continue to pursue the therapeutic potential of laromestrocel in mild AD. We completed a Phase 2a trial, the (“CLEAR MIND Trial”), which demonstrated the potential benefits of laromestrocel over placebo to maintain cognitive function and slow deterioration of brain structure atrophy, with no safety issues observed. Specifically, the safety primary endpoint was met across all study groups and the trial demonstrated a statistical significance in the second CADS endpoint. Overall, in laromestrocel groups, brain MRI demonstrated whole brain volume loss slowed accompanied by significant preservation of multiple brain regions, including left hippocampal volume relative to placebo. We plan to continue to analyze the data in order to further develop our clinical development strategy. Our objective is to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing AD.
Current 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.
Previous wording
Preparation and initiation of a Phase 2 pivotal registrational clinical trial for DCM in the first half of 2026, subject to obtaining necessary financing. As announced on July 8, 2025, the FDA approved the Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for pediatric Dilated Cardiomyopathy (DCM).
Current wording
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 wording
Expand our manufacturing capabilities to commercial-scale production. 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 future commercial demand for potential laromestrocel commercialization. As part of these efforts, we have made a strategic decision to pursue commercial manufacturing through a third-party CDMO, rather than renovating our existing facility for commercial-scale production. Our existing Miami facility will continue to support clinical development, research and early-phase manufacturing for our current and future clinical trials.
Current 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.
Previous wording
Product candidate development pipeline through internal research and development, and in-licensing. Through our research and development program, and through strategic in-licensing agreements, or other business development arrangements, we intend to actively explore promising potential additions to our pipeline.
Current wording
Investigational product candidate development pipeline through internal research and development, and in-licensing. Through our research and development program, and through strategic in-licensing agreements, or other business development arrangements, we intend to actively explore promising potential additions to our pipeline.
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 one of two private medical clinics in Nassau. While laromestrocel is considered an investigational product in The Bahamas, under the approval terms received from the National Stem Cell Ethics Committee, we are permitted to charge a fee for participation in the Registry Trial. The fee is recognized as revenue and is used to pay for the costs associated with manufacturing and testing of 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 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.
Previous wording
Contract development and manufacturing services. From time to time, we enter into fee-for-service agreements with third parties for our product development and manufacturing capabilities. These agreements may include research, process development, and manufacturing services tailored to customer needs. In February 2024, we entered into our first manufacturing services contract with a third-party biotechnology company. Revenue from this contract is recognized over time as the services are provided. Additionally, the customer pays a fixed monthly fee per suite to reserve and maintain a dedicated manufacturing suite and storage space. Additional suites may also be secured based on capacity needs, which are billed at a fixed fee per suite per month.
Current wording
Contract development and manufacturing services. From time to time, we enter into fee-for-service agreements with third parties for our product development and manufacturing capabilities. These agreements may include research, process development, and manufacturing services tailored to customer needs. In February 2024, we entered into our first manufacturing services contract with a third-party biotechnology company, 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.
Previous wording
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. In past years they have primarily been a result of either a higher balance of cash compared to a previous year or tax refunds received for social security taxes as part of a research and development tax credit program.
Current wording
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 wording
No provision for income taxes has been recorded for the three and six months ended June 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 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.
Previous wording
Revenues, Cost of Revenues and Gross Profit: Revenues for the three months ended June 30, 2025 and 2024 were 0.3 million and $0.5 million, respectively. 2025 revenues decreased 0.2 million, or 32%, when compared to 2024 driven primarily by a reduced demand for contract manufacturing services.
Current wording
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 wording
Clinical trial revenue, which is derived from the Bahamas Registry Trial, for each of the three months ended June 30, 2025 and 2024 was $0.3 million. Contract manufacturing revenue for the three months ended June 30, 2025 was $18,000 from our manufacturing services contract, which is a decrease of close to $0.2 million or 90%, when compared to the $0.2 million in contract manufacturing revenue for the three months ended June 30, 2024. This decrease was driven by reduced demand for contract manufacturing services from our third-party client.
Current wording
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 wording
Related cost of revenues were $0.2 million and $0.1 million for the three months ended June 30, 2025 and 2024, respectively. This resulted in a gross profit of approximately $0.1 million for the three months ended June 30, 2025, a decrease of $0.2 million, or 58%, when compared with a gross profit of $0.3 million for 2024.
Current 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.
Previous wording
General and Administrative Expense: General and administrative expenses for the three months ended June 30, 2025 increased to approximately $2.6 million, compared to 2.1 million for the same period in 2024. The increase of approximately $0.5 million, or 22% was primarily related to an increase of $0.3 million in personnel and related costs in 2025, including equity-based compensation, and $0.2 million in legal expenses.
Current wording
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 wording
Research and Development Expenses: Research and development expenses for the three months ended June 30, 2025 increased to approximately $3.0 million, from approximately $1.7 million for the same period in 2024. The increase of $1.2 million, or 72% was primarily driven by a $0.9 million increase in personnel and related costs, including equity-based compensation, and a $0.2 million increase in clinical trial expense, both primarily in support of ongoing CMC and manufacturing readiness activities as part of our BLA enabling efforts.
Current wording
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 wording
Other Income (Expense): Other income for the three months ended June 30, 2025 was $0.4 million, primarily consisting of $0.3 million 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. Other income for the three months ended June 30, 2024 was less than $0.1 million as a result of interest earned on money market funds.
Current wording
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.
Showing the first 40 of 59 pairs. Open the source sections for the rest.
Rearranged current paragraphs (1)
Current report — wording carried from 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.