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Iovance Biotherapeutics Inc (IOVA)
NASDAQ:IOVA
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Iovance Biotherapeutics (IOVA) AI Stock Analysis

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IOVA

Iovance Biotherapeutics

(NASDAQ:IOVA)

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Neutral 46 (OpenAI - 4o)
Rating:46Neutral
Price Target:
$2.50
▲(23.76% Upside)
Iovance Biotherapeutics faces significant financial challenges, with weak profitability and cash flow issues being the most impactful factors. While the earnings call provided a positive outlook with strategic restructuring and revenue growth, the technical indicators and valuation metrics remain weak. The overall stock score reflects these mixed signals, with financial performance being the most significant concern.
Positive Factors
Revenue Growth
The consistent revenue growth indicates strong market demand and successful product adoption, which is crucial for long-term sustainability and expansion.
Strategic Restructuring
The restructuring plan aims to improve operational efficiency and profitability, enhancing the company's financial health and competitive position.
Manufacturing Improvements
Improved manufacturing efficiency reduces costs and enhances product reliability, supporting long-term operational success and customer satisfaction.
Negative Factors
Profitability Challenges
Persistent profitability issues can hinder reinvestment and growth, posing risks to financial stability and long-term viability.
Cash Flow Constraints
Negative cash flow limits the company's ability to fund operations and invest in growth opportunities, impacting future prospects.
European Regulatory Setback
The withdrawal from the EMA submission affects the company's European expansion plans, limiting potential market reach and revenue growth.

Iovance Biotherapeutics (IOVA) vs. SPDR S&P 500 ETF (SPY)

Iovance Biotherapeutics Business Overview & Revenue Model

Company DescriptionIovance Biotherapeutics, Inc., a clinical-stage biotechnology company, focuses on developing and commercializing cancer immunotherapy products to harness the power of a patient's immune system to eradicate cancer cells. It has six ongoing phase 2 clinical studies, including C-144-01, of its lead product candidate, lifileucel, for the treatment of metastatic melanoma; C-145-04, of its product candidate lifileucel for recurrent, metastatic, or persistent cervical cancer; and C-145-03, of its product candidate LN-145, for recurrent and/or metastatic head and neck squamous cell carcinoma. Iovance Biotherapeutics, Inc. has collaborations and licensing agreements with H. Lee Moffitt Cancer Center; M.D. Anderson Cancer Center; Ohio State University; Centre hospitalier de l'Université de Montreal; Cellectis S.A.; and Novartis Pharma AG. The company was formerly known as Lion Biotechnologies, Inc. and changed its name to Iovance Biotherapeutics, Inc. in June 2017. Iovance Biotherapeutics, Inc. was incorporated in 2007 and is headquartered in San Carlos, California.
How the Company Makes MoneyIovance Biotherapeutics generates revenue primarily through the development and commercialization of its cell therapy products. The company may earn revenue from product sales once its therapies receive regulatory approval and enter the market. Additionally, Iovance may engage in strategic partnerships and collaborations with larger pharmaceutical companies, which can provide upfront payments, milestone payments upon achieving specific development goals, and royalties on future sales of the therapies developed under these agreements. These partnerships not only enhance Iovance's financial resources but also facilitate the advancement of its product candidates through clinical trials and regulatory processes. Research grants and funding from government or non-profit organizations may also contribute to the company's revenue streams, particularly during the development stages of its therapies.

Iovance Biotherapeutics Earnings Call Summary

Earnings Call Date:Aug 07, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 06, 2025
Earnings Call Sentiment Positive
The earnings call presented a strong positive outlook with significant revenue growth, successful adoption of Amtagvi, and strategic restructuring to improve profitability. Despite increased expenses and a setback in European regulatory strategy, the overall momentum and achievements outweigh the challenges.
Q2-2025 Updates
Positive Updates
Strong Revenue Growth
Iovance reported $60 million in total revenue for Q2 2025, representing a 22% growth over the prior quarter, with $54 million from Amtagvi infusions and $6 million from Proleukin.
Amtagvi Adoption and Response Rates
Amtagvi adoption continues to grow, surpassing 100 patients treated in a single quarter for the first time, with a nearly 49% response rate among real-world patients and 61% in certain treatment settings.
Strategic Restructuring for Cost Savings
A strategic restructuring is expected to generate over $100 million in annual cost savings starting in Q4 2025, with a 19% workforce reduction planned for Q3 2025.
Manufacturing Improvements
Manufacturing success rates improved in Q2 2025, with lower patient drop-offs and out-of-spec rates. Turnaround time for manufacturing was reduced to 33 days.
Negative Updates
Increased Operating Expenses
Total operating expenses increased to $117 million in Q2 2025 from $102 million in the prior year period, driven by higher headcount and clinical trial costs.
Withdrawal from EMA Submission
Iovance withdrew its submission from the European Medicines Agency due to lack of alignment during data discussions, impacting its strategy for Amtagvi in Europe.
Company Guidance
During the Iovance Biotherapeutics Second Quarter 2025 Financial Results Conference Call, the company provided several key metrics and updates. They reported total revenue of $60 million for the second quarter, marking a 22% growth over the previous quarter, with $54 million coming from Amtagvi infusions and $6 million from Proleukin. The company treated 102 commercial patients with Amtagvi during the quarter, surpassing 100 patients for the first time in a single quarter. Iovance reiterated its full-year 2025 revenue guidance of $250 million to $300 million and highlighted a gross margin of 31%, excluding noncash items. Operating expenses for the quarter were approximately $117 million, up from $102 million in the prior year, attributed to increased headcount and clinical trial costs. The company announced a strategic restructuring, including a workforce reduction of approximately 19%, expected to save over $100 million annually starting in the fourth quarter. Despite these changes, Iovance plans to maintain its clinical pipeline, aiming for a cash runway into the fourth quarter of 2026. The company also expressed confidence in achieving U.S. peak sales of $1 billion or more for Amtagvi, with opportunities for international expansion.

Iovance Biotherapeutics Financial Statement Overview

Summary
Iovance Biotherapeutics is experiencing significant revenue growth, marking its first substantial revenue generation. However, the company remains unprofitable with a negative net income and negative cash flow, indicating operational and profitability challenges. The balance sheet shows a strong equity position with low leverage, but sustained losses could impact financial stability.
Income Statement
35
Negative
Iovance Biotherapeutics has shown substantial revenue growth with total revenue increasing significantly from $1.18 million in 2023 to $212.68 million in TTM (Trailing-Twelve-Months), marking its first substantial revenue generation. However, despite revenue growth, the company remains unprofitable with a negative net income of $375.36 million in TTM. The gross profit margin is 19.2% in TTM, reflecting that costs are still high relative to revenue. The EBIT and EBITDA margins are negative, indicating ongoing operational inefficiencies and high operating costs.
Balance Sheet
40
Negative
The balance sheet shows a relatively strong equity position, with a debt-to-equity ratio of 0.07, suggesting low leverage. Stockholders' equity stands at $767.87 million, indicating financial stability. However, the negative net income affects the return on equity, which remains negative. The equity ratio is 79.4%, reflecting a strong capital structure with substantial equity financing.
Cash Flow
30
Negative
The company has a negative operating cash flow of $334.39 million in TTM, demonstrating cash outflows from operations. Free cash flow also remains negative at $347.50 million, indicating challenges in generating cash from operations after capital expenditures. However, the firm successfully raised $340.40 million through financing activities, supporting its cash position.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue241.52M164.07M1.19M0.000.000.00
Gross Profit49.75M40.08M-9.57M-21.14M-13.98M-8.71M
EBITDA-361.58M-351.67M-427.43M-374.76M-328.27M-250.87M
Net Income-389.92M-372.18M-444.04M-395.89M-342.25M-259.58M
Balance Sheet
Total Assets907.44M910.43M780.35M663.98M777.33M768.46M
Cash, Cash Equivalents and Short-Term Investments301.18M323.78M279.87M471.85M504.41M629.44M
Total Debt53.17M58.26M75.86M85.45M71.53M51.66M
Total Liabilities208.95M200.02M195.74M164.34M155.67M111.96M
Stockholders Equity698.49M710.40M584.61M499.64M621.66M656.50M
Cash Flow
Free Cash Flow-323.54M-364.05M-384.11M-313.18M-265.51M-251.93M
Operating Cash Flow-303.41M-352.98M-361.82M-292.76M-227.94M-205.13M
Investing Cash Flow4.58M-96.41M-155.24M256.45M132.00K-317.85M
Financing Cash Flow200.81M390.66M462.96M190.15M239.27M576.42M

Iovance Biotherapeutics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price2.02
Price Trends
50DMA
2.48
Negative
100DMA
2.24
Negative
200DMA
3.71
Negative
Market Momentum
MACD
-0.09
Positive
RSI
38.74
Neutral
STOCH
14.68
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For IOVA, the sentiment is Negative. The current price of 2.02 is below the 20-day moving average (MA) of 2.24, below the 50-day MA of 2.48, and below the 200-day MA of 3.71, indicating a bearish trend. The MACD of -0.09 indicates Positive momentum. The RSI at 38.74 is Neutral, neither overbought nor oversold. The STOCH value of 14.68 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for IOVA.

Iovance Biotherapeutics Risk Analysis

Iovance Biotherapeutics disclosed 82 risk factors in its most recent earnings report. Iovance Biotherapeutics 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

Iovance Biotherapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
57
Neutral
1.48B-5.53-183.14%-100.08%-2.45%
49
Neutral
730.70M-1.29-58.07%-75.91%-12.11%
48
Neutral
890.96M-10.08-15.91%83.36%22.27%
46
Neutral
$767.13M-53.16%636.99%27.10%
45
Neutral
653.27M-3.02-13.14%
45
Neutral
1.11B-4.79900.35%70.25%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
IOVA
Iovance Biotherapeutics
2.02
-7.59
-78.98%
KALV
KalVista Pharmaceuticals
12.10
-0.24
-1.94%
VIR
Vir Biotechnology
5.18
-2.35
-31.21%
IMTX
Immatics
7.05
-4.68
-39.90%
NUVB
Nuvation Bio
3.01
0.62
25.94%
AMLX
Amylyx Pharmaceuticals Inc
13.82
10.74
348.70%

Iovance Biotherapeutics Corporate Events

Business Operations and StrategyProduct-Related Announcements
Iovance Biotherapeutics Updates Corporate Presentation
Neutral
Aug 29, 2025

On August 29, 2025, Iovance Biotherapeutics updated its corporate presentation for use at healthcare conferences and with analysts and stockholders. The presentation highlights the company’s progress in TIL therapy, including the commercial launch of products like Amtagvi and Proleukin, and outlines ongoing clinical trials and regulatory submissions, which could impact its market positioning and stakeholder interests.

The most recent analyst rating on (IOVA) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Iovance Biotherapeutics stock, see the IOVA Stock Forecast page.

Business Operations and StrategyPrivate Placements and Financing
Iovance Biotherapeutics Amends Sale Agreement with Jefferies
Positive
Aug 22, 2025

On August 22, 2025, Iovance Biotherapeutics entered into an Amended and Restated Open Market Sale Agreement with Jefferies LLC for an at-the-market offering program. This agreement allows the company to issue and sell up to $350 million of its common stock, with Jefferies acting as the sales agent. The sale of shares will be conducted under a prospectus supplement to the company’s registration statement, and Jefferies will receive a commission of up to 3% on the gross sales proceeds. This strategic move could enhance Iovance’s financial flexibility and strengthen its market position.

The most recent analyst rating on (IOVA) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Iovance Biotherapeutics stock, see the IOVA Stock Forecast page.

Business Operations and StrategyProduct-Related Announcements
Iovance Biotherapeutics Gains Health Canada Approval
Positive
Aug 19, 2025

On August 18, 2025, Iovance Biotherapeutics announced that its product Amtagvi® (lifileucel) received approval from Health Canada for use in advanced melanoma patients who have progressed after anti-PD-1 and targeted therapies. This approval marks Iovance’s first marketing authorization outside the U.S., based on the C-144-01 trial results, and signifies a strategic step in addressing unmet needs in solid tumor cancers, with plans to authorize a Canadian treatment center soon.

The most recent analyst rating on (IOVA) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Iovance Biotherapeutics stock, see the IOVA 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: Sep 13, 2025