SAN CARLOS, Calif., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will host a conference call and live audio webcast on Tuesday, February 24, 2026 at 8:30 a.m. ET to report its fourth quarter and full year 2025 financial results and corporate updates. To listen to the live or archived audio webcast, please registe ...

Group 1 - Iovance Biotherapeutics Inc. expects to achieve full-year 2025 revenue guidance of $250 to $300 million in the first full calendar year of Amtagvi sales [1][2] - Amtagvi, the treatment regimen for advanced melanoma, is projected to have peak sales potential of up to $1 billion [1] - The company has $307 million in cash and cash equivalents, which will fund operations through the second quarter of 2027 [2] Group 2 - Lifileucel, an in-development treatment for lung cancer, has a commercial opportunity that could be up to 7 times larger than the current melanoma treatment market [2] - Enrollment and data updates for Lifileucel are expected to be completed this year, with a launch anticipated in the second half of 2027 [2] - Iovance Biotherapeutics specializes in developing and commercializing cell therapies as novel cancer immunotherapy products [2]

Core Insights - Iovance Biotherapeutics, Inc. announced best-in-class data for its commercial TIL therapy, Amtagvi (lifileucel), showing unprecedented response rates in advanced melanoma patients [1][3] Group 1: Clinical Data - In a real-world study, 41 evaluable patients with advanced melanoma treated with Amtagvi showed a confirmed objective response rate (ORR) of 44% and a disease control rate of 73% [3] - The ORR was significantly higher at 52% for patients who had received two or fewer prior lines of therapy, compared to 33% for those with three or more lines [3] - These real-world response rates surpass the 31% ORR observed in the C-144-01 clinical trial that led to the FDA's accelerated approval of Amtagvi [3] Group 2: Expert Commentary - Dr. Lilit Karapetyan emphasized the importance of early treatment with lifileucel, noting the potential for more patients to benefit as TIL therapy adoption increases [4] - Daniel Kirby, Chief Commercial Officer of Iovance, highlighted the impressive response rates and five-year durability data, reinforcing Amtagvi's best-in-class profile [4] Group 3: Market Context - Advanced melanoma represents a significant unmet medical need, with over 8,000 annual deaths in the U.S. and more than half of first-line treatment patients progressing within 12 months [4] - The FDA granted accelerated approval for Amtagvi in February 2024 based on its ORR and duration of response from the C-144-01 trial [4] Group 4: Ongoing Research - Iovance is conducting the TILVANCE-301 Phase 3 clinical trial in frontline advanced melanoma to further confirm the clinical benefits of Amtagvi [4]

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] Investment Opportunity - A specific company, largely overlooked by AI investors, is positioned to benefit from the increasing demand for energy due to AI data centers, making it a critical player in the upcoming AI energy spike [3][6] - This company is not a chipmaker or cloud platform but owns essential energy infrastructure assets that are vital for the future of AI [3][7] Energy Demand and Infrastructure - AI technology is extremely energy-intensive, with data centers consuming as much energy as small cities, leading to concerns about power grid strain and rising electricity prices [2][4] - The company is involved in nuclear energy infrastructure, which is crucial for America's next-generation power strategy, and is capable of executing large-scale engineering, procurement, and construction projects across various energy sectors [7][8] Financial Position - The company is debt-free and has a significant cash reserve, amounting to nearly one-third of its market capitalization, which positions it favorably compared to other energy firms burdened with debt [8][10] - It also holds a substantial equity stake in another AI-related company, providing investors with indirect exposure to multiple growth engines without the associated premium [9][10] Market Trends - The current market environment is characterized by a surge in U.S. LNG exports and a focus on onshoring due to tariffs, which the company is well-positioned to capitalize on [5][14] - The influx of talent into the AI sector ensures continuous innovation and advancements, reinforcing the importance of investing in AI-related companies [12][13] Conclusion - The company represents a unique investment opportunity in the intersection of AI and energy, with potential for significant returns as the demand for energy in AI applications continues to grow [10][15]

Core Thesis - Iovance Biotherapeutics, Inc. (IOVA) is pursuing a high-risk strategy by opting for equity dilution to fund operations rather than selling at a distressed valuation around $2.50 per share, indicating management's confidence in the long-term potential of its Tumor Infiltrating Lymphocyte platform, especially in lung cancer, which could represent a multibillion-dollar opportunity [2][4] Valuation and Market Perception - The stock trades as if it is a failed biotech, with control held by insiders like Wayne Rothbaum, whose cost basis is approximately $9.00, creating a disconnect between market perception and internal expectations [3] - The valuation gap has stalled acquisition activity, as a typical pharmaceutical buyout premium would still result in significant losses for long-term holders, incentivizing insiders to block offers that do not meet their higher internal valuation [4] Operational Insights - Iovance operates with a unique asset, Amtagvi, but faces economic challenges, with gross margins between 24% to 43%, significantly lower than the 80% to 95% margins typical for commercial oncology drugs, making the standalone model cash-intensive [5] - For a potential acquirer, the success of the thesis depends on whether manufacturing scale can improve margins to 70% or higher; if not, Amtagvi may become a source of profitless revenue [6] Comparative Analysis - The bullish thesis on IOVA shares similarities with a previous analysis of Bio-Techne Corporation (TECH), which highlighted strong growth potential; however, IOVA's profile is characterized by higher risk and reward, with acquisition potential and internal conviction as key drivers [7]

Core Insights - Iovance Biotherapeutics Inc. is identified as a promising biotech penny stock, with Barclays raising its price target to $10 from $9 while maintaining an Overweight rating [1] - The company reported a total product revenue of $68 million in Q3 2025, marking a 13% sequential increase, primarily driven by Amtagvi sales of $58 million [2] - Iovance plans to centralize all Amtagvi and clinical manufacturing at its internal facility by early 2026 to enhance capacity and gross margins [3] Financial Performance - Iovance's Q3 2025 product revenue was $68 million, a 13% increase from the previous quarter [2] - The company reaffirmed its full-year 2025 revenue guidance of $250 to $300 million [2] - Management projects peak US sales for Amtagvi in advanced melanoma to exceed $1 billion, supported by over 80 Authorized Treatment Centers across approximately 40 states [2] Strategic Developments - A major operational shift is planned for early 2026, centralizing manufacturing to eliminate reliance on contract manufacturers and maximize capacity [3] - Iovance is pursuing a larger market in non-small cell lung cancer (NSCLC), with interim data from the IOV-LUN-202 trial showing a 26% objective response rate [4] - Enrollment for the IOV-LUN-202 trial is expected to finish in 2026, supporting a potential supplemental BLA and commercial launch in H2 2027 [4] Company Overview - Iovance Biotherapeutics is a commercial-stage biopharmaceutical company focused on developing and commercializing cell therapies for metastatic melanoma and other solid tumors in the US [5]

Core Viewpoint - Intellia Therapeutics faces uncertainty regarding its gene editing candidate nex-z, which is under clinical hold due to a patient death, impacting its stock performance and future prospects [3][2]. Group 1: Intellia Therapeutics Overview - Intellia Therapeutics specializes in gene editing and is developing nex-z as a treatment for transthyretin amyloidosis, a rare disease affecting protein buildup in organs [3]. - The hereditary form of transthyretin amyloidosis affects approximately 50,000 individuals, while the wild type could impact between 200,000 to 500,000 patients, indicating a potentially large market for Intellia [1]. - The stock has declined by 19% this year, reflecting market concerns over the clinical hold and the uncertainty surrounding nex-z's role in the patient death [4]. Group 2: Market Analysis and Predictions - Analysts suggest that Intellia's stock is undervalued, with an average price target of $22.43, indicating a potential upside of 139% from current levels [4]. - If it is confirmed that nex-z is not responsible for the patient death, the stock could see a significant rise, although the timeline for FDA clearance remains uncertain [2][6]. - Despite the potential for stock recovery, challenges such as achieving clinical and regulatory milestones and securing treatment coverage remain significant hurdles for Intellia [5]. Group 3: Comparison with Iovance Biotherapeutics - Iovance Biotherapeutics has an approved product, Amtagvi, which has generated $176.7 million in revenue over the first nine months of 2025, nearly doubling from the previous year [7]. - Iovance is also seeking regulatory approvals in additional markets, which could expand its addressable market beyond the current estimate of 30,000 patients [8][9]. - However, Iovance's stock has also faced challenges, with a 61% decline this year, primarily due to the complex and costly manufacturing process of Amtagvi, making profitability difficult [10][11].

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - The newsletter is led by a biotech consultant with over 5 years of experience, who has compiled detailed reports on more than 1,000 companies [1] - The investing group, Haggerston BioHealth, caters to both novice and experienced investors, providing insights on product sales, forecasts for major pharmaceutical companies, and various financial analyses [1]

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - Edmund Ingham, a biotech consultant with over 5 years of experience, leads the Haggerston BioHealth investing group, which caters to both novice and experienced investors [1] - The investing group provides insights such as buy and sell ratings, product sales forecasts for major pharmaceutical companies, integrated financial statements, discounted cash flow analysis, and market-specific analyses [1]

Core Insights - The biotech industry presents significant growth potential for investors, particularly through companies like CRISPR Therapeutics and Iovance Biotherapeutics, which have substantial upside based on Wall Street price targets [2][16]. CRISPR Therapeutics - CRISPR Therapeutics specializes in gene-editing medicines using the CRISPR technique and has received regulatory approval for its product Casgevy, which targets blood-related disorders [4][16]. - The company is developing CTX310, a therapy aimed at lowering LDL cholesterol and triglycerides, with a potential market of 40 million patients in the U.S. alone [7][8]. - CTX310 is an in vivo therapy, which simplifies administration compared to Casgevy, potentially leading to significant share price increases if clinical progress continues [8][17]. - The company has a meaningful addressable market for Casgevy, estimated at 60,000 patients, with a high price point of $2.2 million in the U.S. [16][17]. Iovance Biotherapeutics - Iovance Biotherapeutics has an approved therapy, Amtagvi, for advanced melanoma, generating $67.5 million in revenue, reflecting a 13% year-over-year increase [9][13]. - The company estimates that around 8,000 patients die from melanoma annually in the U.S., indicating a significant need for effective treatments [10]. - Iovance is pursuing international approvals for Amtagvi, having already succeeded in Canada, and is targeting markets in Australia, the UK, and the EU [11]. - Despite the potential for label expansions, the complex administration process of Amtagvi limits its market potential, and the company lacks a strong commercial partner [14][15].