Than Powell

Than Powell, CBO, Longeveron

On track for top-line trial results in the third quarter of 2026 from pivotal Phase 2b clinical trial ELPIS II. ELPIS II is evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indication and is fully enrolled.ELPIS II may serve as foundation for a Biologics License Application (BLA) submission for full approval for HLHS, if results demonstrate sufficient evidence of efficacyCompany to host conference call and webcast today at 4:30 p.m. ET MIAMI, Nov. 04, 2025 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today reported financial results for the quarter ended September 30, 2025 and provided a business update. “I am excited to step in to lead Longeveron at this transformational period in both the Company’s history, and our advancement of laromestrocel,” said Than Powell, Interim Chief Executive Officer of Longeveron. “Longeveron has made significant progress advancing three stem cell therapy programs, with each step getting us closer to treating patients with life altering diseases. Our pivotal Phase 2b clinical trial evaluating laromestrocel as a potential treatment for HLHS, a rare pediatric congenital heart defect, is on track to deliver top-line trial results in the third quarter of 2026. If positive, this trial may be the foundation of the Company’s first BLA filing with the U.S. FDA. We believe our research is driving the next wave of medical innovation and Longeveron is well positioned to be an industry leader in stem cell clinical development and commercialization for the benefit of patients and their families.” Development Programs UpdateLongeveron’s investigational therapeutic candidate is laromestrocel (Lomecel-BTM), a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications. Hypoplastic Left Heart Syndrome (HLHS) – a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. Pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct therapy for HLHS achieved full enrollment of 40 pediatric patients in June 2025.Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months.Laromestrocel Biological License Application (BLA) submission for full approval for HLHS, if ELPIS II results demonstrate sufficient evidence of efficacy, now anticipated in 2027 rather than late 2026 based on operational decisions to extend the cash runway for delivery of ELPIS II study results and to optimize manufacturing spend.ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH).ELPIS II builds on the positive clinical results of ELPIS I, in which children in the trial experienced 100% transplant-free survival up to five years of age after receiving laromestrocel compared to approximate 20% mortality rate observed from historical control data.The FDA has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS. Alzheimer’s disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options. Results from the Phase 2a clinical trial (CLEAR MIND), which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development, were published in the peer reviewed journal Nature Medicine in March 2025.Positive Type B meeting with FDA regarding pathway to BLA submission for laromestrocel in Alzheimer’s disease held in March 2025 with alignment reached on proposed trial study design, population and endpoints for a single, pivotal Phase 2/3 clinical trial that, if positive, would be acceptable for BLA submission for Alzheimer’s disease.The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease.The Company is seeking to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing AD. Pediatric Dilated Cardiomyopathy (DCM) – a rare pediatric cardiovascular disease in which the muscles in one or more of the heart chambers become enlarged or stretched (dilated), with nearly 40% of children with DCM requiring a heart transplant or dying within two years of diagnosis. In July 2025, the FDA approved Longeveron’s 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.The Company currently anticipates initiation of the pivotal Phase 2 clinical trial in 2026, subject to obtaining necessary financing. Corporate Updates In July, the Company announced the licensing of a new, composition of matter patent protected, stem cell technology from the University of Miami for unique induced pluripotent derived cardiomyogenic cells that have widespread therapeutic indications for heart diseases.In August, the Company completed a public offering, raising approximately $5.0 million, with up to an additional $12.5 million of potential aggregate gross proceeds upon the exercise in full of short-term warrants.In September, the Company announced key leadership updates with Than Powell being appointed Interim Chief Executive Officer, and Dr. Joshua Hare being appointed Executive Chairman of the Board of Directors.In October, the Company announced that George Paletta, Jr., MD, MBA, has been elected to the Longeveron Board of Directors. Dr. Paletta is a nationally and internationally recognized orthopedic surgeon and the head team doctor for the St. Louis Cardinals. Dr. Paletta is a developer of ambulatory surgical centers (ASCs), and has participated in the selling of two ASCs with deal values totaling almost $1 billion. Third Quarter 2025 Summary Financial Results Revenues: Revenues for the nine months ended September 30, 2025 and 2024 were $0.8 million and $1.8 million, respectively. This represents a decrease of $1.0 million, or 53% in 2025 compared to 2024, driven primarily by a decreased participant demand for our Bahamas Registry Trial and reduced demand for contract manufacturing services from our third-party client. Clinical trial revenue, which is derived from the Bahamas Registry Trial, for the nine months ended September 30, 2025 and 2024 was $0.7 million and $1.0 million, respectively. Clinical trial revenue for the nine months ended September 30, 2025 decreased by $0.3 million, or 36%, when compared to 2024 as a result of decreased participant demand. Contract manufacturing revenue for the nine months ended September 30, 2025 was $0.2 million from our manufacturing services contract, which is a decrease of $0.6 million, or 76% when compared to the $0.8 million in contract manufacturing revenue for the nine months ended September 30, 2024. This decrease was driven by a substantial reduction in activities under the Secretome Agreement; no additional manufacturing or development activities are planned, and the Company is now limited to performing stability testing and other contract testing services.Cost of Revenues and Gross Profit: Cost of revenues was $0.3 million and $0.4 million for the nine months ended September 30, 2025 and 2024, respectively. This resulted in a gross profit of approximately $0.5 million for the nine months ended September 30, 2025, a decrease of $0.9 million, or 60%, when compared with a gross profit of $1.4 million for 2024.General and Administrative Expenses: General and administrative expenses for the nine months ended September 30, 2025 increased to approximately $9.1 million, compared to $7.4 million for the same period in 2024. The increase of approximately $1.7 million, or 22%, was primarily related to an increase in personnel and related costs in 2025, including increased severance and equity-based compensation.Research and Development Expenses: Research and development expenses for the nine months ended September 30, 2025 increased to approximately $9.3 million, from approximately $6.1 million for the same period in 2024. The increase of $3.2 million, or 52%, was primarily driven by a $1.8 million increase in personnel and related costs, including equity-based compensation, $1.2 million increase in supplies and costs associated with technology transfer, including non-clinical manufacturing batches that advance our readiness for future commercial production as part of our BLA-enabling efforts and a $0.2 million increase in amortization expense related to patent costs.Other Income (Expense): Other income for the nine months ended September 30, 2025 was $0.6 million, primarily consisting of $0.3 million received as a recipient of a Milestone 1 Award in the XPRIZE Healthspan competition and $ 0.3 million interest earned on money market funds. Other income for the nine months ended September 30, 2024 was $0.3 million as result of interest earned on money market funds and marketable securities.Net Loss: Net loss increased to approximately $17.3 million for the nine months ended September 30, 2025 from a net loss of $11.9 million for the same period in 2024. The increase in the net loss of $5.4 million, or 45%, was for the reasons outlined above.Cash and cash equivalents as of September 30, 2025 were $9.2 million. 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, the Company currently anticipates its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements late into the first quarter of 2026, based on its current operating budget and cash flow forecast. 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. The Company intends to seek additional financing through capital raises, non-dilutive funding options, including grants and strategic partnerships across all indications. There can be no assurance the Company will be able to attain future financing at terms favorable to the Company or at all. In the event the Company is unable to attain the financing needed, it will need to materially revise its current operational plan. Conference Call and Webcast Details: Conference Call Number:1.877.407.0789Conference ID:13755997  Call me™ Feature:Click HereWebcast:Click Here   An archived replay of the webcast will be available on the “Events & Presentations” section of the Company’s website following the conference. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM) and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program – Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program – Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking StatementsCertain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, statements about the various below-listed factors. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; 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; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor and Media Contact:Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com —tables follow—   Longeveron Inc.Condensed Balance Sheets(In thousands, except share and per share data)         September 30,2025  December 31,2024   (Unaudited)    Assets      Current assets:      Cash and cash equivalents $9,244  $19,232 Prepaid expenses and other current assets  1,044   308 Accounts and grants receivable  52   84 Total current assets  10,340   19,624 Property and equipment, net  2,122   2,449 Intangible assets, net  2,309   2,401 Operating lease asset, net  608   882 Other assets  178   202 Total assets $15,557  $25,558 Liabilities and stockholders’ equity      Current liabilities:      Accounts payable $1,080  $99 Accrued expenses  3,173   1,820 Current portion of lease liability  647   623 Deferred revenue  40   40 Total current liabilities  4,940   2,582 Long-term liabilities:      Lease liability  336   824 Other liabilities  315   265 Total long-term liabilities  651   1,089 Total liabilities  5,591   3,671 Commitments and contingencies (Note 9)      Stockholders’ equity:      Preferred stock, $0.001 par value per share, 5,000,000 shares authorized, no shares issued and outstanding at September 30, 2025, and December 31, 2024  —   — Class A common stock, $0.001 par value per share, 84,295,000 shares authorized, 19,576,924 shares issued and outstanding at September 30, 2025; 13,407,441 issued and outstanding at December 31, 2024  19   13 Class B common stock, $0.001 par value per share, 15,705,000 shares authorized, 1,484,005 shares issued and outstanding at September 30, 2025, and December 31, 2024  1   1 Additional paid-in capital  136,813   131,480 Accumulated deficit  (126,867)  (109,607)Total stockholders’ equity  9,966   21,887 Total liabilities and stockholders’ equity $15,557  $25,558           See accompanying notes to unaudited condensed financial statements.  Longeveron Inc.Condensed Statements of Operations(In thousands, except per share data)(Unaudited)         Three months endedSeptember 30,  Nine months endedSeptember 30,   2025  2024  2025  2024 Revenues            Clinical trial revenue $94  $210  $651  $1,012 Contract manufacturing lease revenue  6   186   18   377 Contract manufacturing revenue  37   377   165   400 Total revenues  137   773   834   1,789 Cost of revenues  12   91   288   435 Gross profit  125   682   546   1,354              Operating expenses            General and administrative  3,583   3,125   9,113   7,447 Research and development  3,852   2,206   9,321   6,148 Total operating expenses  7,435   5,331   18,434   13,595 Loss from operations  (7,310)  (4,649)  (17,888)  (12,241)Other income and (expenses)            Other income, net  89   230   628   349 Total other income, net  89   230   628   349 Net loss $(7,221) $(4,419) $(17,260) $(11,892)Deemed dividend – warrant inducement offers  —   (149)  —   (8,650)Net loss attributable to common stockholders $(7,221) $(4,568) $(17,260) $(20,542)Basic and diluted net loss per share $(0.39) $(0.34) $(1.07) $(2.71)Basic and diluted weighted average common shares outstanding  18,373,198   13,627,793   16,124,871   7,572,601                   See accompanying notes to unaudited condensed financial statements. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/59470556-6cdc-4e00-86da-f80b4621b8da