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Abeona Therapeutics (ABEO)
NASDAQ:ABEO
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Abeona Therapeutics (ABEO) AI Stock Analysis

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ABEO

Abeona Therapeutics

(NASDAQ:ABEO)

Rating:50Neutral
Price Target:
Abeona Therapeutics faces substantial financial challenges with no current revenue and ongoing losses, impacting its overall score. However, the promising potential for FDA approvals and significant revenue opportunities from new therapies provide a positive outlook. Despite bullish technical signals, the high RSI suggests caution. The stock's valuation remains unattractive due to its negative P/E ratio, but strong earnings call projections and adequate cash reserves offer some optimism for future performance.
Positive Factors
Financial Performance
Abeona announced the sale of its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $155M, providing sufficient cash for more than two years of operating expenses.
Market Launch
ZEVASKYN is now officially commercially available in the U.S. after the activation of Ann & Robert H. Lurie Children’s Hospital of Chicago as the first of five qualified treatment centers.
Reimbursement
Reimbursement pressure has been limited, with management noting 100% success on prior authorizations.
Negative Factors
Market Risks
Risks include slower than projected uptake for pz-cel in the United States upon market introduction and setbacks with earlier-stage pipeline programs.
Pricing
The ZEVASKYN list price is $3.1M per treatment, with the potential to generate over $30M in total sales by the end of 2025 if 10-15 patients are treated.

Abeona Therapeutics (ABEO) vs. SPDR S&P 500 ETF (SPY)

Abeona Therapeutics Business Overview & Revenue Model

Company DescriptionAbeona Therapeutics Inc. (ABEO) is a clinical-stage biopharmaceutical company focused on developing cell and gene therapies for serious genetic diseases. Based in the United States, the company's primary areas of focus include rare and life-threatening conditions such as recessive dystrophic epidermolysis bullosa (RDEB) and other genetic disorders. Abeona's core product candidates leverage advanced gene editing and cell therapy technologies aimed at providing transformative treatments for patients with unmet medical needs.
How the Company Makes MoneyAbeona Therapeutics generates revenue primarily through strategic partnerships, grants, and licensing agreements related to its proprietary technologies and product candidates. The company may receive upfront payments, milestone payments, and royalties from these collaborations as their therapeutic products progress through clinical development and towards commercialization. Abeona's focus on rare genetic disorders often attracts funding from non-profit organizations and governmental bodies interested in supporting the advancement of novel treatments for these conditions. Additionally, successful commercialization of their therapies, if achieved, would provide direct revenue from product sales.

Abeona Therapeutics Earnings Call Summary

Earnings Call Date:Aug 14, 2025
(Q2-2025)
|
% Change Since: 6.86%|
Next Earnings Date:Nov 17, 2025
Earnings Call Sentiment Positive
The earnings call conveyed a generally positive sentiment with significant achievements like the FDA approval of ZEVASKYN and strong initial demand. Positive reimbursement trends and financial stability further support a positive outlook. However, logistical challenges in patient treatment and manufacturing scale-up present areas for improvement.
Q2-2025 Updates
Positive Updates
FDA Approval of ZEVASKYN
ZEVASKYN was approved by the FDA in April 2025, marking a significant milestone for Abeona Therapeutics. It is the first and only autologous cell-based gene therapy for RDEB, offering meaningful healing for wounds associated with the condition.
Strong Initial Demand for ZEVASKYN
Within the first three months post-approval, over 50 patients have been identified as candidates for ZEVASKYN, with referrals from both QTCs and other centers.
Positive Reimbursement Trends
ZEVASKYN has achieved positive coverage with multiple national and regional payers, including UnitedHealthcare, and enjoys a 100% prior authorization success rate.
Financial Strength and Profitability Outlook
Abeona reported $225.9 million in cash and anticipates achieving company-wide profitability by early 2026, supported by ZEVASKYN sales.
Community Engagement and Positive Patient Feedback
Engagement with the RDEB community has been positive, with patients from clinical trials reporting durable wound healing lasting several years.
Negative Updates
Complex and Lengthy Administrative Process
The process from patient identification to ZEVASKYN treatment involves significant logistical steps and can take approximately 3 to 4 months.
Challenges in Manufacturing Scale-Up
While capacity to treat 10 patients per month is expected by mid-2026, this requires FDA discussions and potential adjustments to manufacturing processes.
Company Guidance
During Abeona Therapeutics' second-quarter 2025 conference call, significant progress was highlighted with the approval and launch of ZEVASKYN, the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). The company has identified approximately 50 patients for treatment, with plans to treat 10 to 14 patients in 2025. Two qualified treatment centers (QTCs) are operational, and more are planned to ease patient access. The manufacturing capacity is set to increase to treat 10 patients per month by mid-2026. Successful insurance coverage and prior authorization approvals, including a milestone agreement with UnitedHealthcare, support the therapy's market access. Abeona reported a net income of $108.8 million for the second quarter, supported by the sale of a Priority Review Voucher, with cash resources providing over two years of operating capital. Financial guidance will focus on commercialization progress as the company transitions into a revenue-generating phase.

Abeona Therapeutics Financial Statement Overview

Summary
Abeona Therapeutics exhibits significant financial challenges, characterized by consistent losses, lack of revenue growth, and negative cash flows. Despite manageable debt levels, the company's financial health is at risk without a turnaround in operational performance and revenue generation.
Income Statement
15
Very Negative
Abeona Therapeutics shows a concerning trend with no revenue in the latest year, indicating potential challenges in product commercialization. The persistent negative net profit margin and declining EBIT and EBITDA margins reflect ongoing operational struggles and financial losses over recent years.
Balance Sheet
40
Negative
The balance sheet indicates a moderate financial position with a relatively low debt-to-equity ratio, suggesting manageable leverage. However, the shrinking equity base and decreasing return on equity highlight challenges in value creation and financial returns for investors.
Cash Flow
25
Negative
Cash flow analysis reveals negative free cash flow growth and a declining operating cash flow to net income ratio, underscoring liquidity challenges. The reliance on financing activities suggests potential sustainability concerns without generating positive cash flow from operations.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.003.50M1.41M3.00M10.00M
Gross Profit-1.00M-2.91M1.90M964.00K-1.46M-20.14M
EBITDA-36.93M-56.62M-50.57M-34.38M-76.80M-74.52M
Net Income-44.19M-63.73M-54.19M-39.70M-84.94M-84.23M
Balance Sheet
Total Assets99.36M108.93M64.00M64.21M79.59M151.20M
Cash, Cash Equivalents and Short-Term Investments84.16M97.72M52.23M52.15M45.02M95.03M
Total Debt23.98M23.05M5.40M7.63M9.38M8.73M
Total Liabilities57.97M64.90M49.18M37.45M37.22M48.65M
Stockholders Equity41.40M44.03M14.83M26.76M42.37M102.55M
Cash Flow
Free Cash Flow-63.00M-58.46M-37.34M-43.61M-69.82M-36.35M
Operating Cash Flow-59.88M-56.02M-37.01M-43.48M-65.67M-35.02M
Investing Cash Flow-27.21M-39.24M208.00K-23.96M66.06M-83.71M
Financing Cash Flow85.47M104.14M37.06M43.17M24.86M1.94M

Abeona Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price7.01
Price Trends
50DMA
6.33
Positive
100DMA
6.00
Positive
200DMA
5.82
Positive
Market Momentum
MACD
0.21
Negative
RSI
58.60
Neutral
STOCH
67.04
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ABEO, the sentiment is Positive. The current price of 7.01 is above the 20-day moving average (MA) of 6.70, above the 50-day MA of 6.33, and above the 200-day MA of 5.82, indicating a bullish trend. The MACD of 0.21 indicates Negative momentum. The RSI at 58.60 is Neutral, neither overbought nor oversold. The STOCH value of 67.04 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for ABEO.

Abeona Therapeutics Risk Analysis

Abeona Therapeutics disclosed 48 risk factors in its most recent earnings report. Abeona Therapeutics 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

Abeona Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
60
Neutral
$518.15M-51.84%-100.00%-25.75%
51
Neutral
$7.78B-0.06-40.08%2.29%21.32%-1.82%
50
Neutral
$359.46M11.1148.34%
49
Neutral
$447.80M-34.97%-100.00%-61.86%
47
Neutral
$290.45M-32.38%23.24%
44
Neutral
$383.19M-38.49%11.81%
33
Underperform
$313.45M-55.18%60.29%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ABEO
Abeona Therapeutics
7.01
1.41
25.18%
ATXS
Astria Therapeutics
6.67
-5.47
-45.06%
ITOS
iTeos Therapeutics
10.13
-7.23
-41.65%
AVIR
Atea Pharmaceuticals
3.65
-0.19
-4.95%
CMPX
Compass Therapeutics
3.02
1.76
139.68%
CADL
Candel Therapeutics
5.96
0.08
1.36%

Abeona Therapeutics Corporate Events

Regulatory Filings and Compliance
Abeona Therapeutics Hosts Conference Call and Webcast
Neutral
Apr 29, 2025

On April 29, 2025, Abeona Therapeutics Inc. hosted a conference call and webcast, providing a presentation that was furnished as Exhibit 99.1 to a Current Report on Form 8-K. The company clarified that the information shared is not considered ‘filed’ under the Securities Exchange Act of 1934 unless explicitly stated in future filings.

Spark’s Take on ABEO Stock

According to Spark, TipRanks’ AI Analyst, ABEO is a Neutral.

Abeona Therapeutics faces substantial financial hurdles with negative cash flows and no revenue growth. The potential for FDA approval and high revenue from pz-cel offer a positive outlook, yet initial supply constraints and increased expenses present risks. Technical analysis indicates limited momentum, and the negative valuation metrics reflect challenges typical for a biotech at this stage.

To see Spark’s full report on ABEO stock, click here.

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: May 01, 2025