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Longeveron® Announces First Quarter 2025 Financial Results and Provides Business Update

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Longeveron (NASDAQ: LGVN) reported its Q1 2025 financial results and provided updates on its laromestrocel stem cell therapy development. The company's pivotal Phase 2b ELPIS II trial for Hypoplastic Left Heart Syndrome (HLHS) has reached 95% enrollment and is expected to complete in Q2 2025, with potential BLA submission in 2026. Results from the Phase 2a CLEAR MIND trial for Alzheimer's disease were published in Nature Medicine, and the FDA has approved a single, pivotal Phase 2/3 adaptive design trial pathway.

Financial highlights include: revenues of $0.4M (down 30% YoY), net loss of $5.0M (up 23% YoY), and cash position of $14.3M, expected to fund operations into Q3 2025. The company plans to seek additional financing to support BLA enabling activities and is pursuing partnership opportunities for its Alzheimer's program.

Longeveron (NASDAQ: LGVN) ha comunicato i risultati finanziari del primo trimestre 2025 e fornito aggiornamenti sullo sviluppo della sua terapia con cellule staminali laromestrocel. Lo studio cardine Phase 2b ELPIS II per la Sindrome del Cuore Sinistro Ipoplastico (HLHS) ha raggiunto il 95% di arruolamento e si prevede che si concluda nel secondo trimestre 2025, con possibile presentazione della BLA nel 2026. I risultati dello studio Phase 2a CLEAR MIND per l'Alzheimer sono stati pubblicati su Nature Medicine, e la FDA ha approvato un singolo studio pivotale di fase 2/3 con disegno adattativo.

Tra i dati finanziari principali si segnalano: ricavi pari a 0,4 milioni di dollari (in calo del 30% su base annua), perdita netta di 5,0 milioni di dollari (in aumento del 23% su base annua) e una posizione di cassa di 14,3 milioni di dollari, sufficiente per finanziare le operazioni fino al terzo trimestre 2025. L'azienda intende cercare ulteriori finanziamenti per supportare le attività necessarie alla presentazione della BLA e sta esplorando opportunità di partnership per il suo programma sull'Alzheimer.

Longeveron (NASDAQ: LGVN) informó sus resultados financieros del primer trimestre de 2025 y proporcionó actualizaciones sobre el desarrollo de su terapia con células madre laromestrocel. El ensayo pivotal Fase 2b ELPIS II para el Síndrome del Corazón Izquierdo Hipoplásico (HLHS) ha alcanzado un 95% de inscripción y se espera que finalice en el segundo trimestre de 2025, con posible presentación de la BLA en 2026. Los resultados del ensayo Fase 2a CLEAR MIND para la enfermedad de Alzheimer fueron publicados en Nature Medicine, y la FDA aprobó un único ensayo pivotal adaptativo de fase 2/3.

Los aspectos financieros destacados incluyen: ingresos de 0,4 millones de dólares (una caída del 30% interanual), una pérdida neta de 5,0 millones de dólares (un aumento del 23% interanual) y una posición de efectivo de 14,3 millones de dólares, que se espera financie las operaciones hasta el tercer trimestre de 2025. La compañía planea buscar financiamiento adicional para apoyar las actividades necesarias para la BLA y está explorando oportunidades de asociación para su programa de Alzheimer.

Longeveron (NASDAQ: LGVN)은 2025년 1분기 재무 결과를 발표하고 라로메스트로셀 줄기세포 치료제 개발 현황을 업데이트했습니다. 저형성 좌심증후군(HLHS)을 위한 중추 임상시험인 2b상 ELPIS II 시험은 95% 등록률을 달성했으며 2025년 2분기에 완료될 예정이며, 2026년 BLA 제출 가능성이 있습니다. 알츠하이머병을 위한 2a상 CLEAR MIND 시험 결과는 Nature Medicine에 발표되었고, FDA는 단일 중추 2/3상 적응 설계 시험 경로를 승인했습니다.

재무 주요 내용으로는: 매출 40만 달러(전년 대비 30% 감소), 순손실 500만 달러(전년 대비 23% 증가), 현금 보유액 1,430만 달러로 2025년 3분기까지 운영 자금이 확보될 것으로 예상됩니다. 회사는 BLA 지원 활동을 위해 추가 자금 조달을 계획하고 있으며, 알츠하이머 프로그램에 대한 파트너십 기회도 모색 중입니다.

Longeveron (NASDAQ : LGVN) a publié ses résultats financiers du premier trimestre 2025 et a fourni des mises à jour sur le développement de sa thérapie par cellules souches laromestrocel. L'essai pivot Phase 2b ELPIS II pour le syndrome de l'hypoplasie du cœur gauche (HLHS) a atteint 95 % d'inclusion et devrait se terminer au deuxième trimestre 2025, avec une possible soumission de la BLA en 2026. Les résultats de l'essai Phase 2a CLEAR MIND pour la maladie d'Alzheimer ont été publiés dans Nature Medicine, et la FDA a approuvé une voie d'essai adaptatif pivot unique de phase 2/3.

Les points financiers clés comprennent : des revenus de 0,4 million de dollars (en baisse de 30 % sur un an), une perte nette de 5,0 millions de dollars (en hausse de 23 % sur un an), et une trésorerie de 14,3 millions de dollars, suffisante pour financer les opérations jusqu'au troisième trimestre 2025. La société prévoit de rechercher un financement supplémentaire pour soutenir les activités liées à la BLA et explore des opportunités de partenariat pour son programme Alzheimer.

Longeveron (NASDAQ: LGVN) veröffentlichte seine Finanzergebnisse für das erste Quartal 2025 und gab Updates zur Entwicklung der laromestrocel-Stammzelltherapie bekannt. Die entscheidende Phase 2b ELPIS II Studie zur Hypoplastischen Linksherzsyndrom (HLHS) hat eine Einschreibungsrate von 95 % erreicht und soll im zweiten Quartal 2025 abgeschlossen werden, mit einer möglichen BLA-Einreichung im Jahr 2026. Ergebnisse der Phase 2a CLEAR MIND Studie zur Alzheimer-Krankheit wurden in Nature Medicine veröffentlicht, und die FDA hat einen einzigen, adaptiven Phase 2/3 Studienpfad genehmigt.

Finanzielle Highlights umfassen: Einnahmen von 0,4 Mio. USD (Rückgang um 30 % im Jahresvergleich), Nettoverlust von 5,0 Mio. USD (Anstieg um 23 % im Jahresvergleich) und eine Liquiditätsposition von 14,3 Mio. USD, die voraussichtlich die Betriebskosten bis zum dritten Quartal 2025 decken wird. Das Unternehmen plant, zusätzliche Finanzierung zur Unterstützung der BLA-relevanten Aktivitäten zu suchen und verfolgt Partnerschaftsmöglichkeiten für sein Alzheimer-Programm.

Positive
  • ELPIS II trial has reached 95% enrollment, with completion expected in Q2 2025
  • FDA confirmed ELPIS II as pivotal trial, potentially supporting BLA submission for HLHS in 2026
  • Previous ELPIS I trial showed 100% transplant-free survival vs 20% mortality in historical control
  • FDA granted multiple designations including Orphan Drug, Fast Track, and Rare Pediatric Disease for HLHS
  • Positive FDA meeting regarding Alzheimer's disease pathway with agreement on Phase 2/3 trial design
Negative
  • Revenue decreased 30% YoY to $0.4M in Q1 2025
  • Net loss increased 23% to $5.0M in Q1 2025
  • Current cash runway only extends to late Q3 2025, requiring additional financing
  • Operating expenses expected to increase throughout 2025

Insights

Longeveron's laromestrocel advancing in two promising indications with supportive FDA pathways, but faces funding challenges ahead of pivotal HLHS data.

Longeveron has achieved remarkable progress with laromestrocel (formerly Lomecel-B), their allogeneic stem cell therapy. The ELPIS II trial for Hypoplastic Left Heart Syndrome (HLHS) has reached 95% enrollment, positioning it for completion in Q2 2025. What's particularly significant is the FDA's confirmation that this single trial could support a Biologics License Application (BLA) submission in 2026 if successful - a streamlined regulatory path that's rare for cell therapies.

The historical data from ELPIS I showing 100% transplant-free survival compared to 20% historical mortality provides a compelling efficacy signal for this devastating pediatric condition. The multiple regulatory designations (Orphan, Fast Track, Rare Pediatric Disease) further support the unmet need.

For Alzheimer's disease, the publication in Nature Medicine represents external validation of their Phase 2a CLEAR MIND data. The FDA agreement on a single, pivotal Phase 2/3 adaptive design is noteworthy, as CNS indications typically require multiple Phase 3 trials. Both RMAT and Fast Track designations demonstrate regulatory recognition of potential benefit.

However, the company faces critical execution challenges. With only $14.3 million in cash providing runway into Q3 2025, Longeveron will require additional funding before potential BLA submission in 2026. Their strategy to seek partners for the Alzheimer's program while internally advancing HLHS appears prudent given limited resources, but introduces partnership dependency risks.

The transition from clinical to commercial readiness with CMC and manufacturing preparations represents a complex operational challenge that shouldn't be underestimated, especially for a cell therapy product.

  • Pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel in HLHS, a rare pediatric disease and orphan-designated indication, has reached approximately 95% enrollment and is expected to complete enrollment in the second quarter of 2025
  • Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II is successful
  • Results from the Phase 2a clinical trial (CLEAR MIND) evaluating laromestrocel as a potential treatment for Alzheimer’s disease were published in Nature Medicine
  • Positive FDA meeting regarding development pathway for laromestrocel in mild Alzheimer’s disease; single, pivotal Phase 2/3 adaptive design clinical trial to support potential BLA submission
  • Company to host conference call and webcast today at 4:30 p.m. ET

MIAMI, May 08, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today reported financial results for the quarter ended March 31, 2025 and provided a business update.

“In the first quarter, we made notable progress advancing the development of our stem cell therapy, laromestrocel,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We have three critical organizational priorities in 2025. First, supporting the completion of ELPIS II, our pivotal Phase 2b clinical trial evaluating laromestrocel as a potential treatment for HLHS. Second, following FDA confirmation that ELPIS II is pivotal, we are focused on organizational readiness for a potential BLA filing for HLHS in 2026. Our goal is to substantially advance our BLA readiness this year ahead of data readout to potentially shorten the timeline to BLA submission. Lastly, we plan to leverage the strength of our Phase 2 data and clarity on the clinical pathway to a potential BLA for Alzheimer’s disease to engage with potential partners that could fund and accelerate the development of laromestrocel in this indication. Our success executing on our strategic plan in an efficient, high-quality manner continues to position Longeveron as a leader in stem cell therapy research and, potentially, commercialization of cellular therapeutics.”

Development Programs Update
Longeveron’s investigational therapeutic candidate is laromestrocel (Lomecel-B™), a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications.

In February 2025, the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved “laromestrocel” as the non-proprietary name of Lomecel-B™.

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 is currently enrolling 38 pediatric patients at twelve premiere infant and children’s treatment institutions across the country. ELPIS II has reached approximately 95% enrollment and is currently anticipated to complete enrollment in the second quarter of 2025.
  • In August 2024, the U.S. Food and Drug Administration (FDA) confirmed that ELPIS II is a pivotal trial and, if it demonstrates sufficient evidence of efficacy, it would be acceptable for a Biologics License Application (BLA) submission for full traditional approval for HLHS.
  • 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.

First Quarter 2025 Summary Financial Results

  • Revenues: Revenues for the three months ended March 31, 2025 and 2024 were $0.4 million and $0.5 million, respectively. This represents a decrease of $0.1 million, or 30%, in 2025 compared to 2024, driven primarily by a decreased participant demand for our Bahamas Registry Trial, partially offset by an increase of our manufacturing services contract revenue. Clinical trial revenue from the Bahamas Registry Trial for the three months ended March 31, 2025 and 2024 was $0.3 million and $0.5 million, respectively, reflecting a decrease of $0.2 million, or 50%, due to decreased participant demand. Contract manufacturing revenue for the three months ended March 31, 2025 and 2024 was $0.1 million and $33,000, reflecting an increase of approximately $0.1 million, or 270%, due to increased activity from our manufacturing services contract.
  • Cost of Revenues and Gross Profit: Cost of revenues was $0.1 million and $0.2 million for the three months ended March 31, 2025 and 2024. This resulted in a Gross Profit of approximately $0.3 million for each of the three months ended March 31, 2025 and 2024, reflecting a flat year-over-year comparison.
  • General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2025 increased to approximately $2.9 million compared to $2.2 million for the same period in 2024. The increase of approximately $0.7 million, or 34%, was primarily related to an increase in personnel and related costs, including equity-based compensation.
  • Research and Development Expenses: Research and development expenses for the three months ended March 31, 2025 increased to approximately $2.5 million from approximately $2.2 million for the same period in 2024. The increase of $0.3 million, or 13%, was primarily driven by a $0.4 million increase in personnel and related costs, including equity-based compensation, a $0.2 million increase in amortization expense related to patent costs and a $0.1 million increase in supplies costs, partially offset by a $0.4 million decrease in clinical trial expense, primarily driven by the absence of costs related to the now-completed CLEAR MIND Alzheimer’s disease clinical trial, as well as the discontinuation of activities related to the Aging-related frailty clinical trial following our decision to discontinue trial activities in Japan.
  • Other Income, net: Other income for the three months ended March 31, 2025 was $0.2 million, primarily consisting of interest earned on money market funds. Other income for the three months ended March 31, 2024 was less than $0.1 million.
  • Net Loss: Net loss increased to approximately $5.0 million for the three months ended March 31, 2025 from $4.0 million for the same period in 2024. This increase of $1.0 million, or 23%, was due to the factors outlined above.
  • Cash and cash equivalents as of March 31, 2025 were $14.3 million. 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 third quarter of 2025 based on its current operating budget and cash flow forecast. Following a successful Type C meeting with the FDA in August 2024 with respect to the HLHS regulatory pathway, the Company has begun ramping up its BLA enabling activities. The Company currently anticipates a potential BLA filing with the FDA in 2026 if the current ELPIS II trial in HLHS is successful. The Company's operating expenses and capital expenditure requirements will increase throughout calendar 2025 as a result of these activities, including CMC (Chemistry, Manufacturing, and Controls) and manufacturing readiness. The Company expects that its current operating plan will require increased spending and additional capital investments to support these initiatives and intends to seek additional financing/capital raises/non-dilutive funding options to support them. Additionally, following a positive Type B meeting with the U.S. FDA in March 2025 with respect to the Alzheimer's disease regulatory pathway, the Company is focused on seeking partnership opportunities and/or non-dilutive funding for the Alzheimer’s disease program, including a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trial.

Conference Call and Webcast Details:

Conference Call Number:1.877.407.0789
Conference ID:13752361
  
Call me™ Feature:Click Here
Webcast: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 (Lomecel-B™) 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 currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, 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 Statements
Certain 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 Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com

---tables follow--- 

 
Longeveron Inc.
Condensed Balance Sheets
(In thousands, except share and per share data)
 
  March 31,
2025
  December 31,
2024
 
  (Unaudited)    
Assets      
Current assets:      
Cash and cash equivalents $14,327  $19,232 
Prepaid expenses and other current assets  919   308 
Accounts and grants receivable  29   84 
Total current assets  15,275   19,624 
Property and equipment, net  2,288   2,449 
Intangible assets, net  2,291   2,401 
Operating lease asset  793   882 
Other assets  201   202 
Total assets $20,848  $25,558 
Liabilities and stockholders’ equity      
Current liabilities:      
Accounts payable $367  $99 
Accrued expenses  1,647   1,820 
Current portion of lease liability  631   623 
Deferred revenue  79   40 
Total current liabilities  2,724   2,582 
Long-term liabilities:      
Lease liability  664   824 
Other liabilities  302   265 
Total long-term liabilities  966   1,089 
Total liabilities  3,690   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 March 31, 2025, and December 31, 2024
      
Class A common stock, $0.001 par value per share, 84,295,000 shares authorized,
13,473,898 shares issued and outstanding at March 31, 2025; 13,407,441 issued and
outstanding at December 31, 2024
  13   13 
Class B common stock, $0.001 par value per share, 15,705,000 shares authorized, 1,484,005 shares issued and outstanding at March 31, 2025, and December 31, 2024  1   1 
Additional paid-in capital  131,762   131,480 
Accumulated deficit  (114,618)  (109,607)
Total stockholders’ equity  17,158   21,887 
Total liabilities and stockholders’ equity $20,848  $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 ended
March 31,
 
  2025  2024 
Revenues      
Clinical trial revenue $259  $515 
Contract manufacturing lease revenue  6   32 
Contract manufacturing revenue  116   1 
Total revenues  381   548 
Cost of revenues  106   219 
Gross profit  275   329 
       
Operating expenses      
General and administrative  2,941   2,200 
Research and development  2,515   2,219 
Total operating expenses  5,456   4,419 
Loss from operations  (5,181)  (4,090)
Other income and (expenses)      
Other income, net  170   32 
Total other income, net  170   32 
Net loss $(5,011) $(4,058)
Basic and diluted net loss per share $(0.34) $(1.61)
Basic and diluted weighted average common shares outstanding  14,950,734   2,513,587 

See accompanying notes to unaudited condensed financial statements.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cfb4911d-2b0b-4c52-b2fa-b6982947155d


FAQ

What were the key financial results for Longeveron (LGVN) in Q1 2025?

Longeveron reported Q1 2025 revenues of $0.4M (down 30% YoY), net loss of $5.0M (up 23% YoY), and cash position of $14.3M expected to fund operations into Q3 2025.

What is the status of Longeveron's ELPIS II trial for HLHS treatment?

The ELPIS II Phase 2b trial has reached 95% enrollment and is expected to complete enrollment in Q2 2025, with potential BLA submission in 2026 if successful.

What progress has Longeveron made in Alzheimer's disease treatment?

Longeveron published Phase 2a CLEAR MIND trial results in Nature Medicine and received FDA approval for a single, pivotal Phase 2/3 adaptive design trial pathway for mild Alzheimer's disease.

What regulatory designations has Longeveron's laromestrocel received?

For HLHS: Orphan Drug, Fast Track, and Rare Pediatric Disease designations. For Alzheimer's disease: Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations.

How long can Longeveron fund its operations with current cash?

Longeveron's current cash position of $14.3M is expected to fund operations late into the third quarter of 2025, after which additional financing will be needed.
Longeveron Inc

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Biotechnology
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