Iovance Biotherapeutics (IOVA) came out with a quarterly loss of $0.28 per share versus the Zacks Consensus Estimate of a loss of $0.31. This compares to loss of $0.46 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 9.68%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.37 per share when it actually produced a loss of $0.34, delivering a surprise of 8.11%.Over the last four quarters, the ...

FDA Approval and Product Launch - Amtagvi™ (lifileucel) received FDA approval on February 16, 2024, for treating adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody [182]. - The company plans to launch Amtagvi™ in additional markets, including the EU, UK, Canada, Switzerland, and Australia, with the potential to address over 20,000 advanced melanoma patients annually across these markets [171]. - The company aims to activate approximately 70 authorized treatment centers (ATCs) by the end of 2024 for the commercial launch of Amtagvi™ [177]. - Amtagvi™ revenue recognized upon patient infusion reached $42,038,000 for the three months ended September 30, 2024, representing 100% of the total Amtagvi™ revenue, while Proleukin® revenue was $16,517,000, a 3,422% increase from $469,000 in the same period of 2023 [215]. - The company anticipates generating revenue from the sale of Amtagvi™ in the remaining quarters of 2024 [233]. Clinical Trials and Research - The company is conducting two ongoing registrational trials to support a supplementary BLA for TIL cell therapies in frontline advanced melanoma and advanced non-small cell lung cancer (NSCLC) [174]. - The TILVANCE-301 clinical trial aims to enroll approximately 670 patients to investigate lifileucel in combination with pembrolizumab for frontline advanced melanoma [192]. - The company initiated a clinical trial for lifileucel in endometrial cancer in Q2 2024 to address unmet needs for patients previously treated with anti-PD-1 therapy [194]. - The first genetically modified TIL cell therapy, IOV-4001, is being investigated in a Phase 1/2 clinical trial for patients with previously treated advanced melanoma and NSCLC [195]. - A pre-IND meeting request for IOV-5001, a cytokine-tethered TIL therapy, is planned with the FDA in Q4 2024, with IND submission expected in 2026 [199]. Manufacturing and Capacity - The iCTC manufacturing facility has a capacity to treat several thousand cancer patients annually, with ongoing expansion expected to increase capacity to over 5,000 patients per year [179]. - The Gen 2 TIL manufacturing process reduces manufacturing time to approximately 22 days while producing a cryopreserved TIL product [180]. - The iCTC is the first FDA-approved facility for commercial TIL cell therapy, located in Philadelphia, Pennsylvania, and among the largest cell therapy manufacturing facilities [179]. Financial Performance - Revenue for the three and nine months ended September 30, 2024 increased by $58.1 million, or 12,385%, and $89.7 million, or 12,683%, compared to the same periods in 2023, driven by the acquisition of worldwide rights to Proleukin® and the commercial launch of Amtagvi™ [214]. - Total product revenue for the three months ended September 30, 2024 was $58,555,000, compared to $469,000 in the same period of 2023, marking a significant increase [215]. - Net loss for the three months ended September 30, 2024, was $(83,541) thousand, an increase of $30,219 thousand or 27% compared to the same period in 2023 [231]. - For the nine months ended September 30, 2024, net loss was $(293,618) thousand, reflecting an increase of $34,040 thousand or 10% compared to the same period in 2023 [231]. Expenses and Cash Flow - Research and development expenses are expected to decrease as commercial activities increase following the approval of Amtagvi™ [212]. - Selling, general and administrative expenses are anticipated to rise as the company executes the launch of Amtagvi™ and expands its market presence [214]. - Research and development expense for the three months ended September 30, 2024 decreased by $19.3 million, or 22%, primarily due to a $28.7 million decrease in clinical manufacturing costs [221]. - Selling, general and administrative expenses for the three months ended September 30, 2024 increased by $12.6 million, or 47%, mainly due to an $8.8 million increase in payroll and related expenses [227]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $(279,681) thousand, compared to $(277,850) thousand for the same period in 2023 [243]. Intellectual Property and Market Position - The company owns over 230 granted or allowed patents related to TIL technologies, expected to provide exclusivity into 2042 [202]. - The company has a history of contracting with third parties for clinical development, with costs accrued based on work completed to date [264]. Market Risks and Economic Factors - Inflation has not had a material effect on the company's business or financial condition as of the reporting period [268]. - The company does not have any derivative financial instruments or foreign currency instruments, limiting its exposure to market risk [267].

With a cutting-edge melanoma drug now on the market, the company is positioned for a breakout.Iovance Biotherapeutics (IOVA 7.54%) is going to finish the week strong on the stock market if its Thursday performance is any indication. Investors boosted the company's share price by almost 8%, following the initiation of coverage by an analyst who's bullish on its future. With that rise, Iovance easily eclipsed the S&P 500 index's 0.2% increase.Vast potential with melanoma drugThe analyst launching his Iovance ...

The biotech is making important breakthroughs, but is that enough? These are exciting times to be an Iovance Biotherapeutics (IOVA) shareholder. The biotech has made encouraging clinical and regulatory progress in the past year. Its most important product is helping it generate strong revenue growth, and although it has been a bit of a wild and volatile ride, its shares have performed much better than the broader market over the trailing 12-month period. It might be worth investing in the stock if the compa ...

Thank you for reading my research on Seeking Alpha. If you want to learn even more about my method and how I discover these investment opportunities, please check out my subscription marketplace service, Compounding Healthcare , and sign up for a free trial. In my previous Iovance Biotherapeutics, Inc. (NASDAQ: IOVA ) article, I discussed the company's preparations for the FDA's impending verdict on lifileucel, their tumor-infiltrating lymphocyte ("TIL") therapy for advanced melanoma. I was expecting the ti ...

There's plenty of upside with this stock, but it might take a while to realize. Iovance Biotherapeutics (IOVA 9.30%) is a hot biotech stock for a reason: It's almost certainly going to be growing its top line at a snappy pace over the next few years, and there's no other therapy that's quite like the one it recently started to commercialize. But, like most of the companies in its group, there are a lot of caveats and tidbits of industry knowledge that you'll need to appreciate before you can feel confident ...

Core Viewpoint - Iovance Biotherapeutics has received accelerated approval for its cell therapy treatment, Amtagvi, but investors should be cautious about potential dilution and the company's long path to profitability [1][2][9]. Financial Performance - Iovance generated $31.1 million in sales in its most recent quarter, but reported a net loss of $97.1 million, slightly better than the previous year's loss of $106.5 million [4]. - The company has used $220.7 million in cash for operating activities over the past six months, ending with $235.1 million in cash and $183.9 million in short-term investments [5]. Cash Flow and Dilution Risks - The company faces high dilution risk as it may need to raise funds through equity markets due to insufficient cash flow for operations and expansion [6][8]. - Iovance has a clean balance sheet with total liabilities of $195.8 million against total assets of $964.3 million, indicating a preference for share offerings to raise capital [7]. Market Expansion and Future Outlook - Iovance plans to launch Amtagvi in new markets, including the U.K., Canada, and Australia, which will require additional cash [6][9]. - While the company has growth prospects, the need for cash could lead to significant stock offerings, impacting current investors [9][10].

This company's new cancer therapy is producing remarkable results, but the company is losing money at a frightening pace. It's been a wild roller-coaster ride for Iovance Biotherapeutics (IOVA 0.25%). In February, the stock more than doubled in price, then it fell to a 52-week low in July. The stock has since recovered and at recent prices was up 47% for the year. Can Iovance keep soaring in the years to come, or is its big gain in 2024 more likely to fizzle out? Here's a look at what to expect in the near ...

The biopharma company is proving its recently approved cancer therapy is marketable. After watching its stock fall for weeks on worries of disappointing results, Iovance Biotherapeutics (IOVA 18.64%) has vindicated itself. Shares of the young biopharma company are up 24.2% as of 11:20 a.m. ET today in response to an impressive second-quarter report. This bullish jolt could also mark the beginning of a more prolonged move higher. Iovance's Amtagvi is off to a solid start In simplest terms, caregivers are emb ...

Core Viewpoint - Iovance Biotherapeutics reported better-than-expected earnings and revenue for the second quarter, leading to a significant increase in stock price despite a net loss per share. Financial Performance - Adjusted earnings per share for the second quarter were -34 cents, slightly above the expected -35 cents and an improvement from -47 cents in the same period last year [1] - Revenue for the quarter was reported at $31.11 million, exceeding analysts' expectations of $24.23 million and significantly higher than the $238,000 reported in Q2 2023 [2] Revenue Guidance - The company provided revenue guidance of $53 million to $55 million for Q3, surpassing Wall Street's estimate of $49.04 million [3] - For 2024, Iovance Biotherapeutics expects revenue between $160 million and $165 million, again higher than analysts' estimate of $143.21 million [3] - Revenue expectations for 2025 are projected to be between $450 million and $475 million, exceeding Wall Street's estimate of $403.71 million [4] Stock Market Reaction - Following the earnings report and positive guidance, Iovance Biotherapeutics' stock rose by 18.1% as of Friday afternoon [4]