52% Amtagvi Response Rate with Two or Fewer Prior Lines of Therapy 73% Overall Disease Control RateSAN CARLOS, Calif., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced data demonstrating a best-in-class profile for commercial Amtagvi® (lifileucel) with unprecedented response rates in a real ...

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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].

Core Points - The article discusses the annual "Turkey of the Year" award, which is given to the worst-performing stock teaser pitch over the past year, focusing on overhyped or misleading stock recommendations [3][4][5] - This year, two main candidates for the award are Iovance (IOVA) and Sable Offshore (SOC), both of which have seen significant declines in stock value [6][13] Summary of Iovance (IOVA) - Iovance was pitched as a takeover target and had some scientific achievements, including an FDA-approved treatment for solid tumors, but has struggled with scalability and profitability [6][9] - The stock was initially teased at $10.44 and closed at $2.25, representing a loss of approximately 78%, and a relative loss of about 95% compared to the S&P 500, which gained roughly 20% during the same period [9][10] - The company projected $1 billion in annual sales for its treatment but is now expected to generate closer to $250 million this year, with declining gross profit margins [10][12] Summary of Sable Offshore (SOC) - Sable Offshore was promoted based on CEO James Flores' connections to the Trump administration, which were expected to facilitate permits for oil production at the Santa Ynez oil field [13][14] - The stock was pitched at $24.19 and closed at $4.47, marking an approximate 80% drop, with a relative loss of about 98% compared to the S&P 500 [19][20] - The company has faced ongoing legal and permitting challenges, despite announcing a restart of production in May 2025, and is currently in a financially precarious position [15][21] Lessons Learned - The article emphasizes the importance of understanding the scalability and business viability of biotech companies, as well as the risks associated with politically motivated investments in energy projects [10][23] - It highlights the need for a solid rationale beyond political connections when investing in stocks, especially in sectors facing local opposition [23][25]

Core Insights - Iovance Biotherapeutics (IOVA) has shown improvement in its Q2'25 earnings, indicating a positive step forward for the company [1] - Despite the progress, there are concerns regarding the previous challenges faced during the launch of Amtagvi, leading to a cautious stance on recommending the stock as a buy [1] Company Analysis - The company is involved in the biotech sector, focusing on trading around significant events such as trial results and NDA/BLA approvals [1] - There is a recognition of the regulatory environment, particularly the influence of the FDA on the company's operations and market performance [1]