26% Objective Response Rate Median Duration of Response Not Reached after 25 Months Follow Up Lifileucel Launch in Previously Treated Advanced NSCLC Expected in Second Half of 2027 SAN CARLOS, Calif., Nov. 03, 2025 (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 interim data from its registrational Ph ...

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Iovance Biotherapeutics, Inc. due to a class action complaint alleging breaches of fiduciary duties by the company's board of directors during the specified class period from May 9, 2024, to May 8, 2025 [1][6]. Company Summary - Iovance Biotherapeutics, Inc. is facing scrutiny following a class action complaint filed on May 15, 2025, which claims that the company provided misleading statements regarding its growth potential and was not adequately prepared to meet demand for its treatments [1][6]. - The company announced its financial results for Q2 of fiscal 2024 on July 25, 2024, and subsequently lowered its revenue guidance for the full fiscal year 2024 due to several factors, including maintenance issues and lower-than-expected sales [6]. - Following the announcement of reduced guidance, Iovance's stock price experienced a significant decline, dropping from $3.17 per share on May 8, 2025, to $1.75 per share on May 9, 2025, marking a decrease of approximately 44.8% in just one day [6].

Core Insights - Iovance Biotherapeutics, Inc. will report its third quarter 2025 financial results and corporate updates on November 6, 2025 [1] - A conference call and live audio webcast will be held on the same day at 8:30 a.m. ET to discuss these results [2] Company Overview - Iovance Biotherapeutics focuses on innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for cancer patients [3] - The company aims to be a global leader in TIL therapies, utilizing the human immune system to target diverse cancer cells [3] - Iovance's Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication, showcasing the company's commitment to continuous innovation in cell therapy [3]

Core Insights - The article discusses two underperforming healthcare companies, Iovance Biotherapeutics and Teladoc Health, and evaluates their potential as contrarian investment opportunities [2][13]. Group 1: Iovance Biotherapeutics - Iovance Biotherapeutics is a small-cap biotech company known for its advanced melanoma treatment, Amtagvi, which was approved in February 2024 [3][4]. - Revenue from Amtagvi reached $109.3 million in the first half of 2025, more than tripling from the previous year [3]. - The company projects annual revenue of $250 million to $300 million, with a current market cap of $773 million [4]. - Iovance has received approval for Amtagvi in Canada and plans to expand into other countries, targeting a significant market due to the high mortality rate from melanoma in the U.S. [4][5]. - Amtagvi is also being investigated for treating other cancers, which could further enhance sales if clinical progress is made [6]. - The complexity of manufacturing and administering Amtagvi poses challenges, as it requires 34 days to prepare and can only be administered in specialized centers [6][7]. Group 2: Teladoc Health - Teladoc Health has experienced a decline in traction but maintains a large ecosystem with 102.4 million members in its integrated care segment, an 11% increase year-over-year [8]. - The company is addressing subscriber losses in its BetterHelp virtual therapy segment through acquisitions, including UpLift, which has insurance agreements covering 100 million potential patients [9][10]. - Teladoc's second-quarter revenue fell by 2% year-over-year to $631.9 million, but its established presence in telemedicine and international expansion efforts may support a recovery [11][12]. - Despite the risks, Teladoc is viewed as a more attractive investment option due to higher revenue and lower net losses compared to Iovance [13][15].

Core Insights - Iovance Biotherapeutics has developed a promising tumor-infiltrating lymphocyte (TIL) therapy called Amtagvi, which is the first approved treatment of its kind for solid tumors, achieving a 61% response rate in patients who had limited prior treatment options [2][10] - Despite the potential of Amtagvi and ongoing clinical trials, the company's stock is underperforming, attributed to market skepticism and the high cost of treatment, which exceeds $500,000 per patient [6][12] - Analysts remain optimistic about Iovance's future, with a consensus target price of $9.10, suggesting significant upside potential compared to the current market cap of $830 million [15] Company Overview - Iovance Biotherapeutics is focused on innovative cancer treatments, particularly through its TIL technology, which is currently being tested in multiple clinical trials beyond Amtagvi [14] - The company anticipates that annual revenue from Amtagvi could reach between $1 billion and $1.5 billion, indicating strong market potential [12][14] - The biopharmaceutical industry is characterized by high risk and uncertainty, with marketability of new drugs often influenced by factors such as pricing, competition, and safety [4][6] Market Dynamics - The biotechnology sector is known for investor speculation, which can lead to volatility in stock prices as traders react to perceived breakthroughs [7][8] - Iovance's stock performance has been affected by previous investor enthusiasm that waned due to delays in drug approval and external factors like the COVID-19 pandemic [8][9] - The company is positioned to capitalize on its lead in TIL technology, with several ongoing trials that could expand its treatment portfolio [14]

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 designed for both novice and experienced biotech investors, offering insights on catalysts, buy and sell ratings, product sales forecasts, and integrated financial statements [1] - Edmund Ingham, a biotech consultant with over 5 years of experience, leads the investing group Haggerston BioHealth and has compiled detailed reports on more than 1,000 companies [1]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Iovance Biotherapeutics, Inc. due to a class action complaint alleging breaches of fiduciary duties by the company's board of directors during the specified class period from May 9, 2024, to May 8, 2025 [1][6]. Company Overview - Iovance Biotherapeutics, Inc. is facing scrutiny following a class action complaint filed on May 15, 2025, which claims that the company misled investors about its growth potential and operational capabilities [1][6]. - The complaint alleges that Iovance provided overly positive statements while concealing material adverse facts regarding its ability to generate demand for its treatments [6]. Financial Performance - On July 25, 2024, Iovance announced its second-quarter financial results for fiscal 2024, which included a reduction in revenue guidance for the full fiscal year 2024 [6]. - The company attributed its disappointing results and lowered guidance to several factors: scheduled maintenance of the iCTC, lower-than-expected Proleukin sales, and the variable pace of treatment initiation by approved treatment centers [6]. Stock Price Impact - Following the announcement of the reduced revenue guidance, Iovance's stock price experienced a significant decline, dropping from $3.17 per share on May 8, 2025, to $1.75 per share on May 9, 2025, representing a decrease of approximately 44.8% in just one day [6].

Core Insights - Iovance Biotherapeutics, Inc. is recognized as a promising healthcare penny stock, focusing on growth and cost-cutting initiatives [1] Group 1: Commercial Strategy - The company aims to expand the commercial application of its drug Amtagvi (lifileucel) for advanced melanoma, with plans to extend its indications to non-small cell lung cancer and endometrial cancer, targeting $1 billion in sales [2] - A positive Phase 3 study for melanoma has shown a 65% response rate, providing momentum for the drug's market expansion [2] Group 2: Cost Management - Iovance plans to reduce its operating costs by over $100 million in the next four quarters, focusing on operational efficiency and higher manufacturing volume to improve margins [3] Group 3: Product Development - The company specializes in individualized T-cell therapies for solid tumor cancers, utilizing Tumor-Infiltrating Lymphocyte (TIL) therapy, which involves extracting T-cells from a patient's tumor, expanding them, and reinfusing them to combat cancer [4]

Group 1 - Iovance Biotherapeutics achieved a significant milestone with the approval of Amtagvi, the first medicine of its kind for advanced melanoma, but its stock has declined 69% this year [1] - The company's market cap is $832 million, with expected revenues between $250 million and $300 million for the year, resulting in a forward price-to-sales ratio of approximately 2.8, which is reasonable for a small-cap, unprofitable biotech [2] - Amtagvi has recently gained approval in Canada and has the potential for growth in the U.S. market, where there are 8,000 annual melanoma deaths, and the therapy has treated over 100 patients per quarter [3] Group 2 - The administration of Amtagvi is complex, as it is made from patients' own tumor-infiltrating lymphocytes, with a manufacturing process that takes 34 days, raising concerns about the company's profitability [5] - Earlier this year, Iovance revised its guidance due to an error in estimating the activation timing of authorized treatment centers, indicating potential ongoing challenges for the company [6] - Despite decent sales growth for Amtagvi, the company faces significant challenges that may hinder its ability to achieve profitability, making its prospects appear risky [7]

Group 1: Company Overview - Sana Biotechnology (SANA) is valued at $837.6 million and focuses on creating modified cells and gene therapies to repair or replace damaged cells and control gene expression [4] - The company has significantly expanded its financial runway, ending Q2 with $72.7 million in cash, which increased to a pro forma $177.2 million after capital raises, expected to fund operations until the second half of 2026 [1] Group 2: Product Development and Clinical Trials - Sana is developing a functional treatment for diabetes that does not require lifelong immunosuppression, which is considered a promising initiative [1] - The company is also working on allogeneic CAR T therapies, including SC291 for autoimmune diseases and SC262 for relapsed/refractory B-cell malignancies, with results from Phase 1 trials expected by 2025 [2] - The UP421 trial, using hypoimmune-modified pancreatic islet cells for type 1 diabetes, has shown success, leading to a 100% increase in stock price year-to-date [3] Group 3: Market Sentiment and Analyst Ratings - Wall Street rates SANA stock as a "Strong Buy," with seven out of nine analysts recommending it, and an average target price of $9.17, indicating a potential upside of 169.7% [6] - The highest estimate for the stock is $15, suggesting a possible increase of 341.2% in the next 12 months [6]