NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- The following statement is being issued by Levi & Korsinsky, LLP: To: All persons or entities who purchased or otherwise acquired securities of Iovance Biotherapeutics, Inc. (“Iovance” or the “Company”) (NASDAQ: IOVA) between August 8, 2024, to May 8, 2025, both dates inclusive. You are hereby notified that the class action lawsuit Karthik Trichur Sundaram v. Iovance Biotherapeutics, Inc., et al. (Case No. 3:25-cv-04177) has been commenced in the United States Dist ...

Core Viewpoint - Iovance Biotherapeutics is a small-cap biotech company trading below $2 per share, which some analysts believe is undervalued despite recent setbacks in revenue guidance and operational challenges [2][5][7]. Group 1: Company Performance - Iovance received approval for its first product, Amtagvi, for metastatic melanoma, marking a significant regulatory milestone [4]. - The company reported $49.3 million in revenue for the first quarter, a notable increase from the previous year, but revised its annual revenue guidance down to $250 million to $300 million from an earlier estimate of $450 million to $475 million [5][9]. - The decline in revenue guidance was attributed to overestimating the growth of authorized treatment centers (ATCs) necessary for administering TIL-based therapies [6][7]. Group 2: Market Potential - Analysts estimate a consensus price target of $19.58 for Iovance, indicating substantial upside potential from current levels [8]. - If Iovance achieves the midpoint of its revised revenue guidance at $275 million, it would be competitive for a newly launched medicine [9]. - The company is pursuing international approvals for Amtagvi, which could expand its market significantly, with potential annual sales exceeding $2 billion at peak [10]. Group 3: Risks and Challenges - The complexity of manufacturing and administering Amtagvi through specialized ATCs increases operational costs compared to simpler therapies [11]. - Clinical setbacks in ongoing studies could negatively impact the company's stock price, making it a risky investment despite its current low valuation [12].

Group 1 - Iovance Biotherapeutics reported a significant decline in first quarter 2025 product revenue, totaling $49.3 million compared to $73.7 million in the previous quarter [2] - The company revised its full fiscal year 2025 total product revenue guidance from a range of $450 million - $475 million to $250 million - $300 million, indicating a reduction of over 40% at the midpoint [2] - The revenue guidance revision was attributed to recent launch dynamics of the T cell immunotherapy, Amtagvi® (lifileucel), which was launched in the U.S. in the first half of 2024 [2] Group 2 - Following the announcement of the financial results and guidance revision, Iovance's stock experienced a drop on unusually heavy trading volume [2] - Bragar Eagel & Squire, P.C. is investigating potential claims against Iovance on behalf of stockholders regarding possible violations of federal securities laws and unlawful business practices [1]

Core Insights - Iovance Biotherapeutics is under investigation for potential violations of federal securities laws and unlawful business practices [1] - The company reported a significant decline in first quarter 2025 product revenue, totaling $49.3 million, down from $73.7 million in the previous quarter [3] - Iovance has revised its full fiscal year 2025 revenue guidance from a range of $450 million-$475 million to $250 million-$300 million, representing a reduction of over 40% at the midpoint [3] - Following the announcement, Iovance's share price dropped by $1.42, or approximately 44%, closing at $1.75 on May 9, 2025 [3] Company Performance - The first quarter 2025 product revenue of $49.3 million indicates a significant decrease compared to the previous quarter's revenue of $73.7 million [3] - The revision of the full-year 2025 revenue guidance reflects challenges in the launch dynamics of the T cell immunotherapy, Amtagvi (lifileucel), which was launched in the U.S. in the first half of 2024 [3] Market Reaction - The announcement of the revenue decline and guidance revision led to a sharp decline in Iovance's stock price, falling from $3.17 to $1.75 within a day [3]

SAN FRANCISCO, May 12, 2025 (GLOBE NEWSWIRE) -- In a dramatic turn for Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), investors watched the company's shares plunge nearly 44% on May 9, 2025, after the San Carlos-based cell therapy pioneer reported a first-quarter revenue miss that sharply contradicted earlier upbeat assurances from management. Hagens Berman is now investigating whether Iovance violated U.S. securities laws and urges Iovance investors who suffered substantial losses to submit your losses now. ...

Core Insights - Iovance Biotherapeutics experienced a significant stock decline on May 9 following a disappointing first-quarter earnings report, with a loss of $0.36 per share compared to the consensus estimate of a $0.24 loss [1] - The company's revenue for Q1 was reported at $49.3 million, which fell short of the expected $81.53 million [1] Financial Performance - The earnings per share (EPS) loss of $0.36 indicates a larger loss than analysts had anticipated [1] - Revenue of $49.3 million represents a substantial shortfall from the forecasted revenue of $81.53 million, highlighting potential operational challenges [1]

Scientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not re ...

Iovance Biotherapeutics, Inc. (IOVA) incurred a first-quarter 2025 loss of 36 cents per share, wider than the Zacks Consensus Estimate of a loss of 25 cents. In the year-ago quarter, the company reported a loss of 42 cents per share.Quarterly revenues totaled $49.3 million, entirely from the sales of its two marketed drugs. This figure missed the Zacks Consensus Estimate of $80.5 million. In the year-ago quarter, Iovance recorded total revenues of $0.7 million. (Find the latest EPS estimates and surprises o ...

Iovance Biotherapeutics (IOVA) came out with a quarterly loss of $0.36 per share versus the Zacks Consensus Estimate of a loss of $0.25. This compares to loss of $0.42 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -44%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.27 per share when it actually produced a loss of $0.26, delivering a surprise of 3.70%.Over the last four quarters, the c ...

Financial Data and Key Metrics Changes - Total product revenue for Q1 2025 was $49.3 million, including $43.6 million from EMTAGV and $5.7 million from Proleukin, compared to $0.7 million for Proleukin in Q1 2024 [37][38] - Net loss for Q1 2025 was $116.2 million or $0.36 per share, compared to a net loss of $113 million or $0.42 per share for Q1 2024 [37][39] - The average standard gross margin for the first four launch quarters was 32%, with a standard gross margin of 10% for Q1 2025, negatively impacted by lower revenue and higher cost of sales [39][40] Business Line Data and Key Metrics Changes - The U.S. commercial launch of EMTAGV generated over $210 million in revenue in its first year, with nearly 300 patients infused [8][9] - First quarter product revenue was lower due to reduced manufacturing capacity from scheduled maintenance, higher patient drop-off rates, and lower manufacturing success rates [9][10] - The company anticipates between 100 and 110 commercial patient infusions in Q2 2025, indicating a rebound in demand [15][16] Market Data and Key Metrics Changes - The company is preparing for potential approvals for EMTAGV in the UK, Canada, and the EU, with additional regulatory submissions underway in Australia and Switzerland [12][13] - The company expects a peak sales opportunity of over $1 billion in the U.S. and over $2 billion globally for EMTAGV in its current approved indication [14] Company Strategy and Development Direction - The company is focused on expanding its ATC network and improving engagement with medical oncologists to drive earlier patient referrals for EMTAGV [18][24] - The company is also working on international expansion and pipeline developments in lung cancer and other solid tumors [12][13] - The management emphasizes the importance of operational efficiencies and economies of scale to optimize cost of goods and improve gross margin over time [33][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in growth prospects under the new Chief Commercial Officer, who is enhancing commercial operations to drive ATC adoption [12][15] - The company revised its full-year revenue guidance to between $250 million and $300 million for 2025, considering growth trajectories and demand trends [13][42] - Management noted that the macroeconomic environment is favorable, with minimal impact from tariffs on their products [33] Other Important Information - The company has a robust patent portfolio with approximately 280 granted or allowed patents, providing exclusivity through at least 2042 [34] - The company is committed to optimizing spending and reducing expenses throughout the organization, maintaining a cash runway into the second half of 2026 [42] Q&A Session Summary Question: Can you confirm whether you're seeing a spike in patient uptake to support your guidance for Q2? - Management confirmed strong demand and confidence in the projected number of infusions for Q2 [54] Question: What barriers exist for ATCs that have infused fewer than ten patients? - Management indicated that many ATCs are ramping up and that infrastructure improvements are underway to enhance patient treatment capabilities [56][59] Question: How does the revised guidance reflect on the expected number of infusions for 2025? - Management clarified that the guidance implies over 500 patients infused throughout the year, indicating significant growth compared to the previous year [63][65] Question: What drove the higher patient drop-off and lower manufacturing success in Q1? - Management attributed these issues to patient selection and tumor procurement techniques, with confidence in a rebound in Q2 [70][74] Question: Will annual maintenance impact manufacturing capacity in the future? - Management confirmed that while annual maintenance is necessary, future impacts will be minimized as the facility expands [85][90]