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Longeveron (LGVN)
NASDAQ:LGVN
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Longeveron (LGVN) AI Stock Analysis

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LGVN

Longeveron

(NASDAQ:LGVN)

Rating:56Neutral
Price Target:
$1.50
▲(18.11% Upside)
Longeveron's overall stock score is primarily influenced by its financial performance challenges and valuation concerns, which are offset by positive corporate developments such as the FDA approval for a new clinical trial. Technical indicators provide a mixed outlook, with some recent positive trends.
Positive Factors
Financial Support
The study is funded by a grant from the National Institute of Health, offsetting study expenses and providing financial support.
Regulatory Designations
Laromestrocel has Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation, which could expedite its approval process.
Regulatory Support
The FDA's ongoing commitment to streamlining approvals for rare diseases, particularly rare pediatric diseases, is expected to support the company's filing on a positive note.
Negative Factors
Financial Performance
Longeveron reported a net loss, and it is expected that the company will require additional capital.
Market Performance
Possible setbacks for Lomecel-B in other indications, notably Alzheimer's Disease, could impact market performance.
Trial Risks
Risks include the potential failure of Lomecel-B in the ELPIS-II trial of HLHS patients and inability to obtain regulatory approval.

Longeveron (LGVN) vs. SPDR S&P 500 ETF (SPY)

Longeveron Business Overview & Revenue Model

Company DescriptionLongeveron Inc. is a biotechnology company focused on developing cellular therapies for aging-related and life-threatening conditions. The company is engaged in the research and development of regenerative medicine, specializing in the use of medicinal signaling cells (MSCs) derived from donor bone marrow. Longeveron aims to harness the potential of these cells to address medical conditions associated with aging, such as frailty, and other severe diseases, thereby improving patient outcomes and enhancing quality of life.
How the Company Makes MoneyLongeveron primarily generates revenue through its clinical development programs, where it conducts clinical trials to evaluate the efficacy and safety of its proprietary cell therapies. The company may receive funding from government grants, research collaborations, and partnerships with other medical institutions to support its research initiatives. Additionally, Longeveron may earn revenue from licensing agreements if its therapies receive regulatory approval and are commercialized. The company's financial performance is significantly influenced by the progress of its clinical trials, regulatory milestones, and strategic partnerships that facilitate the advancement and potential commercialization of its therapies.

Longeveron Earnings Call Summary

Earnings Call Date:May 08, 2025
(Q4-2024)
|
% Change Since: -14.77%|
Next Earnings Date:Aug 13, 2025
Earnings Call Sentiment Neutral
The earnings call presented a balanced view of Longeveron's progress, with strong revenue growth and regulatory advancements highlighted. However, challenges like enrollment delays in clinical trials and anticipated increases in future expenses were also noted. The call reflected cautious optimism about Lomecel-B's potential, supported by robust clinical data and regulatory designations, though future financial and strategic uncertainties remain.
Q4-2024 Updates
Positive Updates
Significant Revenue Growth
Revenues for 2024 were $2.4 million, up $1.7 million or 237% compared to 2023, driven by increased participant demand and new contract manufacturing revenue.
Regulatory Advancement for HLHS Program
The FDA confirmed that the ELPIS II study is pivotal and acceptable for BLA submission for traditional approval, accelerating the potential regulatory path for Lomecel-B.
FDA Designations for Alzheimer's Program
Lomecel-B received both RMAT and fast track designations for the treatment of mild Alzheimer's disease, based on positive Phase IIa data.
Cost Management and Reduced Expenses
Total operating expenses for 2024 declined 13% year-over-year, with G&A expenses decreasing 16% and R&D expenses decreasing 10%.
Strong Cash Position
Cash and cash equivalents as of December 31, 2024, were $19.2 million, providing funding into Q4 2025.
Negative Updates
Enrollment Delays in ELPIS II Study
The ELPIS II study for HLHS has faced delays in enrollment, now expected to complete in the second quarter of 2025, which is behind the initial schedule.
Increased Operating Expenses Expected
Operating expenses and capital expenditure requirements are expected to accelerate in 2025 due to BLA-enabling activities.
Uncertainty in Pediatric Disease Priority Review Voucher
Concerns about the expiration of the pediatric disease priority review voucher program after September 2026, which may impact the potential benefits for Lomecel-B if approved after this date.
Company Guidance
During the Longeveron 2024 Full Year Financial Results Conference Call, the company provided detailed guidance on its clinical and financial progress. Longeveron reported a significant increase in revenue to $2.4 million, up 237% from 2023, mainly driven by participant demand for its frailty and cognitive impairment registry trial in the Bahamas and new contract manufacturing revenue. The company emphasized its dedication to advancing its stem cell therapy, Lomecel-B, highlighting progress in its Phase IIb ELPIS II trial for hypoplastic left heart syndrome (HLHS), which achieved over 90% enrollment and is expected to complete enrollment by the second quarter of 2025. Longeveron also outlined its path to a potential biologics license application (BLA) submission in 2026, contingent on positive results from the ELPIS II trial. Additionally, the company is focusing on its Alzheimer's disease program, having received both regenerative medicine advanced therapy (RMAT) designation and fast track designation from the FDA. Financially, Longeveron decreased its net loss by 25% to approximately $16 million and reported cash and cash equivalents of $19.2 million, providing a runway into the fourth quarter of 2025. The company anticipates accelerated operating expenses in 2025 as it ramps up BLA-enabling activities.

Longeveron Financial Statement Overview

Summary
Longeveron's financial performance is challenged by significant operational and profitability issues. The income statement reflects declining revenue and substantial losses with a negative net profit margin. The balance sheet shows low leverage and a strong equity base, but the negative ROE points to unprofitability. Cash flow issues are evident with negative free and operating cash flows, indicating financial instability despite strong financing inflows.
Income Statement
45
Neutral
The company has been experiencing a decline in revenue with a negative revenue growth rate from $2,392,000 in 2024 to $2,225,000 in TTM. Gross profit margin is relatively strong at 82.3% in TTM, but the net profit margin is highly negative at -760.5%, indicating significant losses. EBIT and EBITDA margins are also negative, reflecting operational challenges. Overall, profitability is a significant concern.
Balance Sheet
55
Neutral
The debt-to-equity ratio is 0.04 in TTM, indicating low leverage, which is a positive aspect. However, the return on equity is negative due to net losses. The equity ratio is 82.3%, indicating a strong equity base. While there are strengths in terms of low debt, the negative ROE points to unprofitability issues.
Cash Flow
50
Neutral
There is a substantial negative free cash flow and operating cash flow, reflecting cash outflow issues. The free cash flow to net income ratio is close to 1, suggesting cash flow challenges are aligned with the company's net losses. Financing inflows have been strong, but sustainability is a concern given ongoing operational losses.
BreakdownDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue2.39M709.00K1.22M1.31M5.63M
Gross Profit1.88M221.00K497.00K590.00K1.83M
EBITDA-16.52M-20.06M-17.15M-16.18M-2.93M
Net Income-15.97M-21.41M-19.63M-17.16M-3.79M
Balance Sheet
Total Assets25.56M12.08M27.41M42.77M9.24M
Cash, Cash Equivalents and Short-Term Investments19.23M5.36M19.66M35.04M815.80K
Total Debt1.45M2.04M2.60M3.14M4.14M
Total Liabilities3.67M5.34M6.91M5.31M7.28M
Stockholders Equity21.89M6.74M20.50M37.45M1.96M
Cash Flow
Free Cash Flow-14.86M-19.70M-14.82M-10.95M-2.63M
Operating Cash Flow-13.87M-19.00M-13.97M-9.64M-2.36M
Investing Cash Flow-640.00K8.19M-677.00K-10.70M-261.50K
Financing Cash Flow28.79M5.26M-509.00K45.17M1.58M

Longeveron Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.27
Price Trends
50DMA
1.40
Negative
100DMA
1.46
Negative
200DMA
1.63
Negative
Market Momentum
MACD
0.02
Positive
RSI
36.49
Neutral
STOCH
9.13
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For LGVN, the sentiment is Negative. The current price of 1.27 is below the 20-day moving average (MA) of 1.57, below the 50-day MA of 1.40, and below the 200-day MA of 1.63, indicating a bearish trend. The MACD of 0.02 indicates Positive momentum. The RSI at 36.49 is Neutral, neither overbought nor oversold. The STOCH value of 9.13 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for LGVN.

Longeveron Risk Analysis

Longeveron disclosed 89 risk factors in its most recent earnings report. Longeveron reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Longeveron Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
56
Neutral
$23.26M-167.57%127.51%71.16%
54
Neutral
$35.29M-36.31%15.73%51.00%
51
Neutral
$7.39B0.36-62.86%2.37%15.48%-2.68%
44
Neutral
$18.13M-83.73%42.39%
42
Neutral
$25.55M-99.84%10.23%
39
Underperform
$41.92M-134.15%95.48%
33
Underperform
$18.49M-112.99%57.93%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
LGVN
Longeveron
1.27
-1.28
-50.20%
NNVC
NanoViricides
1.58
-0.32
-16.84%
OVID
Ovid Therapeutics
0.51
-0.41
-44.57%
CMMB
Chemomab Therapeutics
0.97
-0.04
-3.96%
PASG
Passage Bio
5.61
-9.99
-64.04%
CALC
CalciMedica
2.91
-1.74
-37.42%

Longeveron Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
Longeveron Gains FDA Approval for Laromestrocel Trial
Positive
Jul 9, 2025

On July 8, 2025, Longeveron Inc. announced that the U.S. FDA has approved their Investigational New Drug application for laromestrocel, allowing the company to initiate a Phase 2 pivotal registration clinical trial for treating pediatric dilated cardiomyopathy (DCM). This approval marks a significant milestone in pediatric cardiovascular treatment, as current options are limited and often result in heart transplants or death for nearly 40% of affected children. The trial is expected to begin in the first half of 2026, and laromestrocel’s potential to repair damaged heart tissue could be groundbreaking for pediatric cardiovascular diseases.

The most recent analyst rating on (LGVN) stock is a Buy with a $6.00 price target. To see the full list of analyst forecasts on Longeveron stock, see the LGVN Stock Forecast page.

Executive/Board ChangesShareholder Meetings
Longeveron Elects New Director at Annual Meeting
Neutral
Jun 16, 2025

On June 13, 2025, Longeveron held its annual stockholders’ meeting where three key proposals were voted on. The stockholders elected Rock Soffer as a Class I director for a three-year term, approved an amendment to the 2021 Incentive Award Plan to increase authorized shares, and ratified CBIZ CPAs P.C. as the independent registered public accounting firm for fiscal 2025.

The most recent analyst rating on (LGVN) stock is a Buy with a $6.00 price target. To see the full list of analyst forecasts on Longeveron stock, see the LGVN Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Aug 07, 2025