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Longeveron (LGVN)
NASDAQ:LGVN
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Longeveron
(NASDAQ:LGVN)
51Neutral
Positive Factors
Clinical Trial Success
Longeveron has previously completed two positive clinical trials studying patients with mild Alzheimer's disease, showing a favorable safety profile and several domains of potential clinical efficacy.
Financial Performance
Top-line revenue exceeded expectations, driven by higher participant demand and the addition of a third-party manufacturing services contract.
Regulatory Progress
The FDA agreed to consider a Biologics License Application based on positive interim trial results from the planned single study, which is considered a particularly positive sign.
Negative Factors
Operational Risks
The ELPIS II trial in hypoplastic left heart syndrome has achieved over 80% enrollment, indicating progress towards completion.
Regulatory Challenges
Risks include failure of Lomecel-B in the ELPIS-II trial of hypoplastic left heart syndrome patients and inability to obtain regulatory approval.
Regulatory Risks
Risks include failure of Lomecel-B in the ELPIS-II trial of HLHS patients and the inability to obtain regulatory approval for Lomecel-B in HLHS.
Longeveron (LGVN) vs. S&P 500 (SPY)
Market Cap
$23.33M
Dividend YieldN/A
Average Volume (3M)139.10K
Price to Earnings (P/E)―
Beta (1Y)1.89
Revenue Growth237.38%
EPS Growth60.32%
CountryUS
Employees25
SectorHealthcare
Sector Strength58
IndustryBiotechnology
Share Statistics
EPS (TTM)-4.05
Shares Outstanding13,473,898
10 Day Avg. Volume104,064
30 Day Avg. Volume139,102
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)0.00
Price to Cash Flow (P/CF)0.00
P/FCF Ratio0.00
Enterprise Value/Market Cap0.23
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit2.79
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$8.67Price Target Upside455.77% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering3
Longeveron Business Overview & Revenue Model
Company DescriptionLongeveron Inc., a clinical stage biotechnology company, develops cellular therapies for aging-related and life-threatening conditions. The company's lead investigational product is the LOMECEL-B, a cell-based therapy product that is derived from culture-expanded medicinal signaling cells that are sourced from bone marrow of young healthy adult donors. It is conducting Phase 1 and 2 clinical trials in various indications, such as aging frailty, alzheimer's disease, metabolic syndrome, acute respiratory distress syndrome, and hypoplastic left heart syndrome. The company was incorporated in 2014 and is based in Miami, Florida.
How the Company Makes MoneyLongeveron Inc. makes money primarily through the development and commercialization of its proprietary cellular therapies. The company's revenue model includes generating income from clinical trials, research grants, and potential partnerships or licensing agreements with healthcare institutions and pharmaceutical companies. Longeveron's business model involves advancing its therapeutic candidates through clinical trials, with the goal of achieving regulatory approval for their commercial use. Significant partnerships or collaborations with research organizations and healthcare providers may also contribute to its revenue streams, facilitating the further development and distribution of its therapies.
Longeveron Financial Statement Overview
Summary
Longeveron shows potential growth in revenue and equity financing, yet faces significant profitability and cash flow challenges. The company must address operational inefficiencies and improve cash management to enhance financial stability.Income Statement
Longeveron has experienced fluctuating revenue with recent growth from $709,000 to $2,392,000 in 2024. However, consistent net losses and negative profit margins indicate ongoing profitability challenges. The net profit margin remains negative, and EBIT and EBITDA margins indicate operational inefficiencies.45
Neutral
Balance Sheet
The company's balance sheet shows a relatively low debt-to-equity ratio due to strong equity levels. Stockholders' equity has improved, suggesting strong equity financing. However, the company needs to improve its overall asset utilization and manage liabilities more effectively.55
Neutral
Cash Flow
Free cash flow remains negative, though there has been a reduction in operating cash outflows. The company has increased its financing activities, which temporarily supports liquidity but suggests reliance on external funding. Cash flow to net income ratios are not favorable, indicating cash management issues relative to earnings.50
Neutral
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 2.39M | 709.00K | 1.22M | 1.31M | 5.63M | Gross Profit |
| 1.88M | 221.00K | 497.00K | 590.00K | 1.83M | EBIT |
| -16.52M | -21.03M | -18.04M | -17.46M | -3.78M | EBITDA |
| -16.52M | -20.06M | -17.15M | -16.18M | -2.93M | Net Income Common Stockholders |
| -15.97M | -21.41M | -19.63M | -17.16M | -3.79M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 19.23M | 5.36M | 19.66M | 35.04M | 815.80K | Total Assets |
| 25.56M | 12.08M | 27.41M | 42.77M | 9.24M | Total Debt |
| 1.45M | 2.04M | 2.60M | 3.14M | 4.14M | Net Debt |
| -17.79M | -2.91M | -7.90M | -22.52M | 3.33M | Total Liabilities |
| 3.67M | 5.34M | 6.91M | 5.31M | 7.28M | Stockholders Equity |
| 21.89M | 6.74M | 20.50M | 37.45M | 1.96M |
| Cash Flow | Free Cash Flow | |||
| -13.87M | -19.70M | -14.82M | -10.95M | -2.63M | Operating Cash Flow |
| -13.87M | -19.00M | -13.97M | -9.64M | -2.36M | Investing Cash Flow |
| -640.00K | 8.19M | -677.00K | -10.70M | -261.50K | Financing Cash Flow |
| 28.79M | 5.26M | -509.00K | 45.17M | 1.58M |
Longeveron Technical Analysis
Negative
1.56
Price Trends
1.55
Positive
1.64
Negative
1.95
Negative
Market Momentum
0.02
Negative
49.88
Neutral
41.76
Neutral
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 1.56 is above the 20-day moving average (MA) of 1.51, above the 50-day MA of 1.55, and below the 200-day MA of 1.95, indicating a neutral trend. The MACD of 0.02 indicates Negative momentum. The RSI at 49.88 is Neutral, neither overbought nor oversold. The STOCH value of 41.76 is Neutral, 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 (52)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
52 Neutral | $5.36B | 3.88 | -42.93% | 2.87% | 17.85% | 1.45% | |
51 Neutral | $23.33M | ― | -111.19% | ― | 237.38% | 60.32% | |
44 Neutral | $23.01M | ― | -33.88% | ― | 44.50% | 49.72% | |
44 Neutral | $20.83M | ― | -75.07% | ― | ― | 42.39% | |
42 Neutral | $20.33M | ― | -82.01% | ― | ― | 10.23% | |
39 Underperform | $20.90M | ― | -121.42% | ― | ― | 95.48% | |
33 Underperform | $26.78M | ― | -91.76% | ― | ― | 57.93% |
* Healthcare Sector Average
Performance Comparison
LGVN
Longeveron
1.56
-0.19
-10.86%
NNVC
NanoViricides
1.30
0.17
15.04%
OVID
Ovid Therapeutics
0.32
-2.74
-89.54%
CMMB
Chemomab Therapeutics
1.42
0.68
91.89%
PASG
Passage Bio
0.40
-0.91
-69.47%
CALC
CalciMedica
1.75
-3.99
-69.51%
Longeveron Earnings Call Summary
Earnings Call Date:Feb 28, 2025
(Q4-2024)
| % Change Since: 2.63%|
Next Earnings Date:May 09, 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 Corporate Events
Executive/Board ChangesBusiness Operations and Strategy
Longeveron Re-approves Cash-to-Equity Program Strategy
Positive
May 1, 2025
On April 24, 2025, Longeveron Inc.’s Board of Directors confirmed the ongoing approval of its Cash-to-Equity Program, initially launched in May 2024. This program allows executive officers and directors to receive up to 80% of their cash compensation as restricted stock units or stock options, with a premium value ranging from 125% to 200% of the cash compensation. The re-approval signifies a strategic move to enhance compensation flexibility and align management interests with shareholder value, potentially impacting the company’s financial management and stakeholder relations.
Spark’s Take on LGVN Stock
According to Spark, TipRanks’ AI Analyst, LGVN is a Neutral.
Longeveron’s stock score reflects a mix of both promise and challenge. The company has shown significant revenue growth and regulatory progress, particularly with its Lomecel-B program, but faces ongoing profitability and cash flow issues. Technical indicators suggest bearish momentum, and valuation concerns persist due to negative earnings. The earnings call provided cautious optimism, but strategic uncertainties and increased expenses in future years pose risks.
To see Spark’s full report on LGVN stock, click here.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
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.