Core Insights - Longeveron Inc. has received a patent from the USPTO for its proprietary Mesenchymal Stem Cells (MSCs) aimed at treating aging-related frailty, valid until 2038 [1][2] - The patent covers methods of administering MSCs to patients suffering from aging-related frailty, a condition characterized by weakness, low physical activity, and other debilitating symptoms [3][8] - The company has conducted Phase 1 and 2 clinical trials demonstrating positive results in improving physical functioning in patients with aging-related frailty [4][8] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with its lead product being laromestrocel (Lomecel-B), derived from young healthy adult donors [6] - Laromestrocel is designed to have multiple mechanisms of action, including anti-inflammatory and pro-vascular effects, with potential applications across various diseases [5][6] - The company is pursuing three main pipeline indications: hypoplastic left heart syndrome, Alzheimer's disease, and pediatric dilated cardiomyopathy, and has received several FDA designations for its programs [6]

Financial Data and Key Metrics Changes - Revenues for the nine months ended September 30, 2025, were $0.8 million, a decrease of $1.0 million or 53% compared to $1.8 million in 2024, primarily due to decreased participant demand for the Bahamas registry trial and reduced demand for contract manufacturing services [22][24] - 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, representing an increase of $5.4 million or 45% [26][27] - Cash and cash equivalents as of September 30, 2025, were $9.2 million, with the company anticipating this will fund operating expenses into late Q1 2026 [26][27] Business Line Data and Key Metrics Changes - Clinical trial revenue for the nine months ended September 30, 2025, was $0.7 million, a decrease of $0.3 million or 36% compared to $1.0 million in 2024, driven by decreased participant demand [23] - Contract manufacturing revenue for the same period was $0.2 million, a decrease of $0.6 million or 76% compared to $0.8 million in 2024, also due to reduced demand [24] Company Strategy and Development Direction - The company is focused on three key areas: delivering clinical trial results from ELPASO-2, securing necessary financial resources, and HLHS BLA preparedness [10][12] - The company aims to attract partners for the continued development and potential commercialization of Lomecel-B, particularly in HLHS and other indications [12][30] - The company has made operational decisions to extend its cash runway into late Q1 2026, pushing the potential full BLA filing from late 2026 into 2027 [27][28] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of establishing safety and efficacy through FDA-supported clinical studies as critical for building belief in the potential life-saving qualities of their therapies [7][9] - The company is optimistic about the potential for pivotal clinical data for HLHS and the first BLA submission, viewing this as an exciting time for both the company and its stakeholders [28][30] Other Important Information - The company has received five distinct FDA designations for its development programs, including orphan drug and fast track designations for HLHS [29][30] - The company is exploring opportunities for new contract manufacturing services clients to utilize excess capacity in its Miami cGMP facility [22][24] Q&A Session Summary Question: Business advisability of identifying potential partners for commercialization in rare conditions - Management indicated that they are exploring partnerships outside the US and are prepared to commercialize the product, recognizing the value of being close to pivotal study readouts [34][36] Question: Clarification on the primary endpoint for ELPASO-2 - Management discussed the importance of the composite endpoint, which includes all-cause mortality, transplant-free survival, and overall hospitalization, and emphasized the use of prior positive data to design meaningful endpoints [47][50] Question: Reasons for postponing the BLA submission timeline - Management explained that the full submission by the end of 2026 is unlikely due to operational decisions aimed at optimizing spending, but they remain committed to the database lock and trial conduct [52][55] Question: Impact of early success in similar therapies on Longeveron's value - Management acknowledged the significance of the HLHS program and the potential for high-value outcomes, while also recognizing the success of other cell therapies as a positive case study [65][67] Question: Importance of long-term follow-up data for payer conversations - Management highlighted the value of survival endpoints and long-term data from ELPASO-1 as important for future reimbursement discussions, although they could not predict its exact impact [68][70] Question: Exploration of expedited BLA pathways - Management confirmed ongoing discussions with the FDA regarding potential expedited pathways and emphasized the importance of the priority review voucher system for rare diseases [71][75]

Financial Performance - Revenues for the nine months ended September 30, 2025, were $0.8 million, a decrease of $1.0 million, or 53%, compared to $1.8 million in 2024, primarily due to decreased participant demand for the Bahamas Registry Trial and reduced contract manufacturing services[13] - Clinical trial revenue from the Bahamas Registry Trial decreased by $0.3 million, or 36%, to $0.7 million for the nine months ended September 30, 2025, compared to $1.0 million in 2024[13] - Net loss increased to approximately $17.3 million for the nine months ended September 30, 2025, up $5.4 million, or 45%, from a net loss of $11.9 million in the same period in 2024[13] - Total revenues for the three months ended September 30, 2025, were $137,000, a decrease of 82.3% compared to $773,000 for the same period in 2024[21] - The net loss for the three months ended September 30, 2025, was $7,221,000, compared to a net loss of $4,419,000 in the same period of 2024, indicating a 63.5% increase in losses[21] - Basic and diluted net loss per share for the three months ended September 30, 2025, was $(0.39), compared to $(0.34) for the same period in 2024[21] Expenses - Research and development expenses rose to approximately $9.3 million for the nine months ended September 30, 2025, an increase of $3.2 million, or 52%, compared to $6.1 million in 2024[13] - General and administrative expenses increased to approximately $9.1 million for the nine months ended September 30, 2025, up $1.7 million, or 22%, from $7.4 million in 2024[13] - Operating expenses increased to $7,435,000 for the three months ended September 30, 2025, compared to $5,331,000 for the same period in 2024, representing a 39.5% increase[21] Cash and Assets - Cash and cash equivalents as of September 30, 2025, were $9.2 million, expected to fund operations into the first quarter of 2026[13] - Cash and cash equivalents decreased to $9,244,000 as of September 30, 2025, from $19,232,000 as of December 31, 2024, a decline of 52.1%[19] - Total assets decreased to $15,557,000 as of September 30, 2025, down from $25,558,000 as of December 31, 2024, representing a 39.1% reduction[19] Liabilities and Deficit - Total current liabilities increased to $4,940,000 as of September 30, 2025, compared to $2,582,000 as of December 31, 2024, a rise of 91.3%[19] - The accumulated deficit increased to $(126,867,000) as of September 30, 2025, from $(109,607,000) as of December 31, 2024[19] Clinical Trials and Future Plans - The pivotal Phase 2b clinical trial (ELPIS II) for laromestrocel is fully enrolled with 40 pediatric patients, and top-line results are expected in the third quarter of 2026[6] - Laromestrocel has received multiple FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for the treatment of HLHS[6] - The company plans to initiate a pivotal Phase 2 clinical trial for pediatric dilated cardiomyopathy (DCM) in 2026, subject to financing[10] Funding Activities - The company completed a public offering in August 2025, raising approximately $5.0 million, with potential additional proceeds of up to $12.5 million from short-term warrants[10] Share Information - The number of basic and diluted weighted average common shares outstanding increased to 18,373,198 as of September 30, 2025, from 13,627,793 in the same period of 2024[21]

Core Viewpoint - Longeveron Inc. is advancing its clinical programs, particularly laromestrocel, with significant progress in treating life-threatening pediatric and chronic conditions, aiming for pivotal trial results in 2026 and potential FDA approval thereafter [2][10]. Development Programs Update - Longeveron's lead investigational product, laromestrocel (Lomecel-B), is being evaluated for multiple indications, including Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's disease, and Pediatric Dilated Cardiomyopathy (DCM) [3][4][5]. - The pivotal Phase 2b clinical trial (ELPIS II) for HLHS is fully enrolled with 40 pediatric patients, and top-line results are expected in Q3 2026 [9][10]. - Laromestrocel has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA for HLHS, and RMAT and Fast Track designations for Alzheimer's disease [10][15]. Financial Results Summary - For the nine months ended September 30, 2025, revenues decreased by 53% to $0.8 million compared to $1.8 million in 2024, primarily due to reduced demand for clinical trials and contract manufacturing services [14]. - General and administrative expenses increased by 22% to approximately $9.1 million, while research and development expenses rose by 52% to approximately $9.3 million [14]. - The net loss for the nine months ended September 30, 2025, increased to approximately $17.3 million, up from $11.9 million in the same period in 2024 [14][22]. Corporate Updates - The company appointed Than Powell as Interim CEO and announced key leadership changes, including Dr. Joshua Hare as Executive Chairman [14]. - Longeveron completed a public offering in August 2025, raising approximately $5.0 million, with potential additional proceeds of up to $12.5 million [14]. - The company is seeking strategic collaborations and partnerships to advance laromestrocel in treating Alzheimer's disease [10][14].

Financial Performance - As of September 30, 2025, the company had an accumulated deficit of $126.9 million and expects to continue generating operating losses for the foreseeable future[127]. - Revenues for the three months ended September 30, 2025, were $0.1 million, a decrease of $0.7 million, or 82%, compared to $0.8 million in 2024, primarily due to reduced demand for contract manufacturing services[155]. - For the nine months ended September 30, 2025, revenues were $0.8 million, a decrease of $1.0 million, or 53%, compared to $1.8 million in 2024, driven by decreased participant demand for the Bahamas Registry Trial[162]. - Net loss for the three months ended September 30, 2025, increased to approximately $7.2 million, up $2.8 million, or 63%, from a net loss of $4.4 million in 2024[161]. - General and administrative expenses increased to approximately $3.6 million for the three months ended September 30, 2025, up $0.5 million, or 15%, from $3.1 million in 2024[158]. - Research and development expenses rose to approximately $3.9 million for the three months ended September 30, 2025, an increase of $1.7 million, or 75%, compared to $2.2 million in 2024[159]. - General and administrative expenses for the nine months ended September 30, 2025, increased to approximately $9.1 million, up $1.7 million, or 22%, from $7.4 million in 2024[165]. - Research and development expenses for the nine months ended September 30, 2025, increased to approximately $9.3 million, an increase of $3.2 million, or 52%, compared to $6.1 million in 2024[166]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $13.3 million, compared to $10.5 million in 2024[169]. - Cash and cash equivalents as of September 30, 2025, were $9.2 million, with working capital of approximately $5.4 million[173]. - The company anticipates that existing cash and cash equivalents will fund operating expenses into the first quarter of 2026 based on current forecasts[174]. Funding and Financing - The company raised approximately $5.0 million from a public offering of 5,882,354 shares of Class A common stock at a price of $0.85 per share on August 11, 2025[125]. - The company has access to an At The Market Offering Agreement with an aggregate market value of $10.7 million for the sale of Class A common stock[125]. - The company plans to seek additional financing through capital raises and non-dilutive funding options to support its operational needs[127]. - The company has been awarded approximately $11.5 million in governmental and non-profit association grants since 2016, which have funded clinical trials and research[183]. - The company has entered into an At The Market Offering Agreement with a market value of $10.7 million for the sale of Class A common stock[180]. - The company has no credit facility or committed sources of capital, which may limit its operational flexibility[188]. - The company may need to raise additional funds through equity offerings or other means to meet operational needs and capital requirements[187]. Clinical Trials and Research - The company is currently conducting a Phase 2b clinical trial (ELPIS II) for laromestrocel, targeting Hypoplastic Left Heart Syndrome (HLHS) with a total of 40 subjects enrolled[132]. - The ELPIS II trial is ongoing, with full enrollment achieved, and top-line results expected in Q3 2026, potentially leading to a BLA filing in 2027 if successful[145]. - The CLEAR MIND trial for mild Alzheimer's disease (AD) showed laromestrocel's safety profile was well tolerated, with significant results in secondary efficacy endpoints, including a 48% reduction in whole brain volume loss and a 62% reduction in hippocampal volume loss compared to placebo[137]. - The FDA granted RMAT and Fast Track designations to laromestrocel for mild AD in July 2024, marking it as a unique investigational product candidate[138]. - The FDA approved the IND application for laromestrocel as a potential treatment for pediatric Dilated Cardiomyopathy (DCM) in July 2025, allowing for a Phase 2 pivotal trial in 2026[144]. - The company has discontinued its clinical trial in Japan for aging-related frailty to focus on HLHS and AD, reflecting a strategic shift in clinical priorities[145]. - The company has initiated enhancements to its Chemistry, Manufacturing and Controls (CMC) infrastructure to support future Biologics License Application (BLA) submissions[121]. - The company has filed patent applications for laromestrocel in multiple countries, including the U.S., Canada, and Japan, to protect its intellectual property[135][140]. Operational Strategy - The company has not yet achieved profitable operations and relies on grants and contract manufacturing for revenue generation[127]. - Research and development expenses are expected to remain significant as the company increases headcount and clinical trial activities[151]. - The company plans to expand manufacturing capabilities to achieve cost-effective production for clinical trials and CDMO obligations[145]. - General and administrative expenses primarily consist of salaries, equity-based compensation, and professional fees, indicating a focus on operational efficiency[152]. - The ongoing U.S. federal government shutdown may delay regulatory communications and affect the company's clinical development programs[122]. - The company intends to pursue regulatory approval for product candidates, including a potential BLA filing with the FDA in 2027 for HLHS[178].

Core Viewpoint - Longeveron Inc. is set to report its third quarter 2025 financial results and provide a business update on November 4, 2025, after market close, followed by a conference call and webcast [1]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to meet unmet medical needs [3]. - The company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [3]. - Laromestrocel has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [3]. - Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [3]. Regulatory Designations - Laromestrocel development programs have received five significant FDA designations: - For the HLHS program: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation - For the Alzheimer's disease program: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [3].

Core Insights - Longeveron Inc. is advancing its clinical-stage cellular therapy, laromestrocel, aimed at treating hypoplastic left heart syndrome (HLHS), a severe congenital heart defect [1][2][4] - The pivotal Phase 2b clinical trial, ELPIS II, has completed enrollment, with top-line results expected in Q3 2026 [2][7] - Laromestrocel has shown promising results in previous trials, achieving 100% transplant-free survival up to five years of age compared to a historical mortality rate of approximately 20% [4] Company Overview - Longeveron Inc. focuses on developing regenerative medicines for unmet medical needs, with laromestrocel as its lead investigational product [5] - The company is pursuing multiple indications, including HLHS, Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [5] - Laromestrocel has received several FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, and RMAT designation for Alzheimer's disease [5] Clinical Trial Details - ELPIS II is a pivotal trial conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) and supported by NIH grants [4] - The trial aims to evaluate laromestrocel's efficacy as an adjunct treatment for HLHS, a rare pediatric disease [7] - The FDA has confirmed that successful results from ELPIS II could lead to a Biologics License Application (BLA) submission for full approval [4]

Core Insights - Longeveron Inc. is participating in the 4th Annual ROTH Healthcare Opportunities Conference on October 9, 2025, in New York, where management will hold one-on-one meetings with investors [1] Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to meet unmet medical needs [2] - The company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [2] - Laromestrocel has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [2] - Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [2] - The development programs for laromestrocel have received five important FDA designations: - For the HLHS program: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation - For the Alzheimer's disease program: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [2]

Core Insights - Longeveron Inc. has elected Dr. George Paletta, Jr. to its Board of Directors, bringing extensive experience in medicine and entrepreneurship to the company [2][3] - The company is focused on developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, with a promising pipeline of stem cell therapies [2][6] Company Overview - Longeveron is a clinical stage biotechnology company that develops regenerative medicines to address unmet medical needs, with its lead product being laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy [6] - The company is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [6] - Laromestrocel has received five important FDA designations, including Orphan Drug designation and Fast Track designation for the HLHS program [6] Leadership and Expertise - Dr. Paletta is a recognized orthopedic surgeon and has significant experience in developing ambulatory surgical centers, having participated in the sale of two ASCs valued at nearly $1 billion [2][3] - He holds multiple patents in orthopedic and cardiovascular fields and has been involved in various start-up ventures, providing advisory roles [3][4] - Dr. Paletta's educational background includes a Doctor of Medicine from Johns Hopkins University and an MBA from Washington University in St. Louis [4]

Core Insights - Longeveron Inc. is participating in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa from October 6-8, 2025, to explore partnerships for its Alzheimer's disease stem cell therapy program [1][2] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions [1][5] - The lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [5] - The company is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [5] Alzheimer's Disease Program - Laromestrocel has shown promising results in a completed Phase 2a clinical trial (CLEAR MIND) for mild Alzheimer's disease, demonstrating an overall slowing of disease progression compared to placebo [3][6] - The trial met primary safety and secondary efficacy endpoints, with statistically significant improvements in clinical and biomarker outcomes for specific laromestrocel groups [3][7] - Full results from the CLEAR MIND study were presented at the 2024 Alzheimer's Association International Conference [4] Regulatory Designations - Laromestrocel has received multiple FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the HLHS program; and Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the Alzheimer's disease program [5][6] Clinical Development Pathway - A positive Type B meeting with the FDA in March 2025 established a clear regulatory pathway for a Biologics License Application (BLA) submission for laromestrocel in Alzheimer's disease [7] - The FDA has granted laromestrocel both RMAT and Fast Track designations, facilitating its development [6][7]