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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:44Neutral
Price Target:
$1.00
▲(21.95% Upside)
Longeveron's overall stock score is primarily impacted by its financial performance, which shows significant challenges with declining revenues and persistent losses. Technical analysis further indicates bearish momentum. While the earnings call highlighted strategic progress, financial uncertainties and increased expenses weigh heavily on the score.
Positive Factors
Financial Support
Grant funding from the National Institute of Health offsets the expenses of the study, providing financial support for the research.
Partnership Opportunities
Longeveron has gained FDA alignment on an adaptive single P2/3 pivotal trial design for Alzheimer's disease, which should make the program more attractive for partnering with a larger company.
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
Capital Requirements
Longeveron reported a net loss, and it is expected that the company will require additional capital.
Financial Performance
The company's recent equity financing has led to dilution, which has contributed to a lowered 12-month price target from $6.00 to $4.00.
Regulatory 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:Aug 13, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 07, 2025
Earnings Call Sentiment Neutral
The call highlighted significant progress in clinical trials and pipeline expansion, alongside strategic moves in manufacturing readiness and financial planning. However, these were tempered by declines in revenue and increased expenses, alongside some regulatory and financial uncertainties.
Q2-2025 Updates
Positive Updates
Completion of ELPIS II Phase 2b Enrollment
Longeveron completed enrollment for the pivotal ELPIS II Phase 2b study, evaluating laromestrocel as a treatment for HLHS, a significant step towards regulatory approval.
Positive Regulatory Progress
The FDA's determination that ELPIS II is pivotal accelerates the regulatory path for laromestrocel, with a potential rolling BLA submission in late 2026.
Strong Pipeline Expansion
Introduction of pediatric dilated cardiomyopathy to the pipeline, with an IND approval from the FDA for a Phase 2 pivotal trial, showing confidence in the program.
Strategic Manufacturing Partner
Decision to use a third-party CDMO for commercial manufacturing to leverage scale and experience, facilitating the strategic plan for BLA readiness.
Positive Financial Outlook
Completion of a public offering raising approximately $5 million with potential for an additional $12.5 million, ensuring funding into the first quarter of 2026.
Negative Updates
Decreased Revenue
Revenues decreased by 31% to $0.7 million in the first half of 2025 compared to 2024, due to decreased participant demand and reduced contract manufacturing services.
Increased Operational Expenses
General and administrative expenses increased by 28%, and research and development expenses rose by 39%, contributing to a net loss increase to $10 million.
Regulatory and Financial Uncertainty
Potential sunset of the PRV program in 2026 could impact benefits, and uncertainty remains around securing future financing and partnerships for the Alzheimer's program.
Company Guidance
During the Longeveron 2025 Q2 Financial Results and Business Update Call, significant guidance was provided on the company's strategic focus and financial status. The company is targeting three main operational goals for 2025: advancing the ELPIS II pivotal Phase 2b study for Hypoplastic Left Heart Syndrome (HLHS), preparing for the Biologics License Application (BLA) submission, and pursuing strategic collaborations for their Alzheimer’s disease program. The HLHS program is prioritized due to its high probability of success and shorter regulatory path. Longeveron has completed enrollment for the ELPIS II Phase 2b study with 40 patients, anticipating top-line results by Q3 2026. Financially, the company reported a decrease in revenue to $0.7 million for the first half of 2025, down from $1 million in 2024, and a net loss of $10 million compared to $7.5 million the previous year. This is attributed to increased general and administrative expenses and research and development costs, primarily due to personnel and manufacturing readiness activities. With cash and cash equivalents of $10.3 million as of June 30, 2025, and a recent public offering raising approximately $5 million, Longeveron expects to fund operations into Q1 2026, contingent on securing additional financing.

Longeveron Financial Statement Overview

Summary
Longeveron faces significant financial challenges with declining revenues and persistent losses impacting profitability. Despite a high gross profit margin and low leverage, negative cash flows and return on equity highlight ongoing operational and financial difficulties.
Income Statement
25
Negative
Longeveron shows a declining revenue trend with a negative revenue growth rate of -6.83% in the TTM. The company has consistently negative net profit margins, indicating ongoing losses. Gross profit margins are relatively high at 78.77%, but the negative EBIT and EBITDA margins highlight significant operational challenges.
Balance Sheet
40
Negative
The company's debt-to-equity ratio is low at 0.05, indicating minimal leverage, which is a positive aspect. However, the return on equity is significantly negative at -95.90%, reflecting poor profitability relative to shareholder equity. The equity ratio stands at 75.57%, suggesting a strong equity base relative to total assets.
Cash Flow
30
Negative
Longeveron has negative operating cash flow and free cash flow, with a declining free cash flow growth rate of -8.43% in the TTM. The operating cash flow to net income ratio is negative, indicating cash flow challenges. The free cash flow to net income ratio is close to 1, suggesting that cash flow is closely aligned with net income, albeit negative.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue2.07M2.39M709.00K1.22M1.31M5.63M
Gross Profit1.63M1.88M221.00K497.00K590.00K1.83M
EBITDA-18.61M-15.56M-20.06M-17.15M-16.18M-2.93M
Net Income-18.54M-15.97M-21.41M-18.84M-17.05M-3.72M
Balance Sheet
Total Assets16.75M25.56M12.08M27.41M42.77M9.24M
Cash, Cash Equivalents and Short-Term Investments10.33M19.23M5.36M19.66M35.04M815.80K
Total Debt639.00K1.45M2.04M2.60M3.14M4.14M
Total Liabilities4.09M3.67M5.34M6.91M5.31M7.28M
Stockholders Equity12.66M21.89M6.74M20.50M37.45M1.96M
Cash Flow
Free Cash Flow-14.27M-14.86M-19.70M-14.82M-10.95M-2.63M
Operating Cash Flow-14.51M-13.87M-19.00M-13.97M-9.64M-2.36M
Investing Cash Flow-1.01M-640.00K8.19M-677.00K-10.70M-261.50K
Financing Cash Flow13.48M28.79M5.26M-509.00K45.17M1.58M

Longeveron Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.82
Price Trends
50DMA
1.27
Negative
100DMA
1.34
Negative
200DMA
1.54
Negative
Market Momentum
MACD
-0.17
Negative
RSI
35.59
Neutral
STOCH
55.98
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 0.82 is below the 20-day moving average (MA) of 1.01, below the 50-day MA of 1.27, and below the 200-day MA of 1.54, indicating a bearish trend. The MACD of -0.17 indicates Negative momentum. The RSI at 35.59 is Neutral, neither overbought nor oversold. The STOCH value of 55.98 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 (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
54
Neutral
$86.75M-52.77%1071.91%-27.61%
51
Neutral
$7.83B-0.18-40.10%2.29%21.46%-2.03%
44
Neutral
$17.01M-134.50%68.67%85.44%
44
Neutral
$21.97M-88.27%32.57%
42
Neutral
$22.98M-99.84%13.83%
39
Underperform
$40.10M-209.36%15.19%
33
Underperform
$70.35M-120.76%47.86%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
LGVN
Longeveron
0.82
-1.27
-60.77%
NNVC
NanoViricides
1.42
-0.46
-24.47%
OVID
Ovid Therapeutics
1.26
0.06
5.00%
CMMB
Chemomab Therapeutics
3.48
-4.36
-55.61%
PASG
Passage Bio
7.04
-7.86
-52.75%
CALC
CalciMedica
2.90
-1.40
-32.56%

Longeveron Corporate Events

Private Placements and Financing
Longeveron Closes $5 Million Public Stock Offering
Neutral
Aug 11, 2025

On August 8, 2025, Longeveron announced the pricing of a public offering of its Class A common stock, which closed on August 11, 2025. The offering, managed by H.C. Wainwright & Co., is expected to generate approximately $5 million upfront, with an additional potential $12.5 million from short-term warrants. The proceeds will support the development of laromestrocel for various conditions and regulatory activities.

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.

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.

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 19, 2025