Raising capital is a key concern for most businesses, but it's a particularly acute issue for biotechs approaching the commercialization of their first few products, and especially for those expecting to have substantial manufacturing expenses. Remember these two categories, as they're the groups that could soon pick up a new tailwind. As we all know, debt can have consequences, even if the tax shield is handy. If a biotech has no taxable income, there's nothing to offset the cost of interest payments. So u ...

Core Insights - Iovance Biotherapeutics has the potential for significant growth, but the likelihood of it becoming a "millionaire-maker" stock is low due to the challenges in the biotech industry [1][11][9] Company Overview - Iovance currently has a market cap of approximately $2.4 billion and is in the early stages of launching its first medicine, with trailing-12-month (TTM) sales of only $1.9 million [11][12] - The company is involved in seven phase 3 clinical trials related to cancer treatments, with additional programs in planning stages [13] Market Potential - For Iovance to reach a market cap of $86.1 billion, an investment of $25,000 would need to grow by 4,000% to become $1 million, which is highly unlikely in the near term [8][9] - The company would need to successfully commercialize all its current programs and develop additional medicines to significantly increase revenue [10] Competitive Landscape - The oncology market is highly competitive, with high failure rates for drug development, particularly for new cancer treatments [14] - Iovance is speculated to be targeting non-small cell lung cancer (NSCLC) and melanoma, which are popular but competitive areas in the biopharma sector [14]

SAN CARLOS, Calif., June 28, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, a TIL cell therapy, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a P ...

Core Viewpoint - Iovance Biotherapeutics, Inc. has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, a TIL cell therapy aimed at treating adult patients with unresectable or metastatic melanoma previously treated with PD-1 blocking antibodies [1][4] Group 1: Company Developments - The MAA submission for lifileucel is backed by positive clinical data from the C-144-01 clinical trial involving patients with advanced post-anti-PD1 melanoma [4] - If validated, the MAA is expected to receive a scientific opinion from the Committee for Medicinal Products for Human Use (CHMP) in the third quarter of 2024, with potential adoption by the European Commission in 2025 [4] - Additional marketing submissions for lifileucel are planned for Canada and the United Kingdom in the second half of 2024, and for Australia in 2025 [4] Group 2: Market Opportunity - Each year, over 20,000 people die from advanced melanoma in the U.S., EU, United Kingdom, Canada, and Australia, indicating a significant unmet medical need [4] - The submission of lifileucel represents a strategic step in addressing this unmet need and expanding the company's market presence in regions with high prevalence of advanced melanoma [7] Group 3: Innovation and Strategy - Iovance Biotherapeutics aims to be a global leader in TIL therapies, focusing on harnessing the human immune system to target diverse cancer cells [4] - The company is committed to continuous innovation in cell therapy, including gene-edited cell therapy, to improve patient outcomes [4]

Earlier this year, share prices of Iovance Biotherapeutics (IOVA -1.23%) were soaring after one of its therapies obtained approval from regulators. Iovance stock would go on to reach share price highs of more than $18. Today, however, the stock trades at less than half that price. And in just three months, it has fallen by more than 40% as the hype surrounding the business appears to have evaporated. On Feb. 16, the Food and Drug Administration (FDA) granted accelerated approval for Iovance's cell therapy t ...

Core Insights - Iovance Biotherapeutics has made significant progress with its cell therapy, Amtagvi, which was approved in February 2024 for treating unresectable or metastatic melanoma, and is expected to generate revenue soon as over 100 patients are already enrolled for treatment [3][11] - The company is conducting mid-stage clinical trials for Amtagvi in various cancers, including cervical cancer and non-small-cell lung cancer, with promising data indicating potential expansion of its addressable market [4][12] - Recent data from a phase 2 trial shows that the combination of Amtagvi and Keytruda has led to a high response rate among patients, suggesting that the therapy could be used for patients with less advanced disease, which may lower manufacturing costs and increase market potential [5][6][10] Company Developments - Iovance is currently testing Amtagvi in combination with Keytruda, with 15 out of 23 patients responding positively to the treatment, including 7 achieving complete responses [6][15] - The combination therapy could shift the treatment paradigm, allowing for earlier intervention in patients, which may enhance the therapy's efficacy and reduce costs associated with manufacturing [7][10] - The company is also preparing for a phase 3 trial that aims to establish the combination of Amtagvi and Keytruda as a first-line treatment for melanoma, indicating a strategic move to broaden its market reach [15] Market Context - The approval of Amtagvi and its ongoing trials position Iovance favorably within the competitive landscape of cancer therapies, particularly in the context of immunotherapy [3][14] - The potential for expanded indications for Amtagvi could significantly increase the patient population eligible for treatment, thereby driving revenue growth for the company [7][12] - Investors are optimistic about Iovance's future, although there remains uncertainty regarding the profitability of manufacturing Amtagvi, especially as the company navigates the complexities of scaling production [11][18]

SAN CARLOS, Calif., May 24, 2024 (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, today announced that senior leadership plans to present at the following conferences and events: The live and archived webcasts will be available at https://ir.iovance.com/news-events/events-presentations. About Iovance Biotherapeutics, Inc. Iovance ...

SAN CARLOS, Calif., May 24, 2024 (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, today announced that senior leadership plans to present at the following conferences and events: The live and archived webcasts will be available at https://ir.iovance.com/news-events/events-presentations. About Iovance Biotherapeutics, Inc. Iovance ...

Core Insights - Iovance Biotherapeutics announced updated clinical results from the phase II IOV-COM-202 study, showcasing the efficacy of the Amtagvi and Keytruda combination in treating frontline advanced melanoma [1][3] Clinical Results - The Amtagvi/Keytruda combination achieved a confirmed objective response rate (ORR) of 65.2%, with a complete response (CR) rate of 30.4% based on data from 23 patients [2] - Nearly all responses remained ongoing at a median follow-up of 21.7 months, and all evaluable patients showed regression of their target lesions [2] Strategic Implications - The deep and durable response rates support the ongoing phase III TILVANCE-301 study, which aims to evaluate the Amtagvi-Keytruda combo as a potential treatment for frontline advanced melanoma [3] - Analysts noted significant improvement in response rates compared to current standard treatments like Keytruda monotherapy or the combination of Bristol Myers drugs Opdivo and Yervoy [3] Market Reaction - Following the announcement, Iovance's shares increased by over 5% in after-market trading on May 23, with a year-to-date stock increase of 26.2% compared to the industry's 6.0% decline [4] Regulatory and Commercial Developments - Iovance received accelerated FDA approval for Amtagvi for adult patients with advanced melanoma, which progressed after prior anti-PD-1/L1 and targeted therapy [5] - Amtagvi is the first one-time T-cell therapy approved by the FDA for solid tumor cancer and is now a preferred second-line therapy in NCCN guidelines for cutaneous melanoma [6] Enrollment and Demand - Over 100 patients have enrolled for Amtagvi across more than 40 authorized treatment centers (ATCs), with demand for the therapy growing monthly since approval [7] - The company aims to onboard nearly 50 ATCs by the end of the month and expects to close the year with at least 70 ATCs [8] Future Plans - Regulatory applications for Amtagvi in melanoma indications in Europe and Canada are expected to be filed later this year, with additional filings planned for Australia and other countries next year [10]

SAN CARLOS, Calif., May 17, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the "Company"), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte ("TIL") therapies for patients with cancer, today announced that on May 16, 2024 (the "Date of Grant"), the Company approved the grant of inducement stock options covering an aggregate of 153,930 shares of Iovance's common stock to thirty new, non-executive emplo ...