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SAN CARLOS, Calif. - Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology firm specializing in cancer treatments currently trading near its 52-week low at $1.75, has shared five-year results from their Phase 2 clinical trial of Amtagvi, a T cell therapy for advanced melanoma. According to InvestingPro analysis, the company’s stock has experienced significant pressure, declining over 83% in the past year, though current metrics suggest the stock may be undervalued. The study showed a 20% overall survival rate at five years, a notable outcome for patients previously treated with immune checkpoint inhibitors.
The trial, named C-144-01, included 153 patients with advanced melanoma who had undergone prior treatments. With a median follow-up of 57.8 months, the median overall survival (OS) was recorded at 13.9 months. While the company maintains a strong liquidity position with a current ratio of 4.18 and more cash than debt on its balance sheet, InvestingPro data indicates the company is rapidly burning through its cash reserves. At the five-year benchmark, 19.7% of participants were alive, highlighting the durable response of the therapy. The objective response rate stood at 31.4%, with 5.9% achieving complete responses and 25.5% partial responses. For those who responded, the median duration of response was an impressive 36.5 months, and 31.3% maintained their response at the five-year follow-up.
Amtagvi’s safety profile was consistent with expectations, with no new or late-onset adverse events reported. The therapy is particularly significant as it is the first one-time cell therapy approved for a solid tumor cancer, marking a potential shift in advanced melanoma care.
The U.S. Food and Drug Administration granted accelerated approval to Amtagvi in February 2024 based on response rate and duration from the C-144-01 trial. This positioned Amtagvi as a first-line treatment option for patients with advanced melanoma who have exhausted other therapies. Despite this milestone, eight analysts have recently revised their earnings expectations downward, with consensus forecasts showing continued losses for the fiscal year. For deeper insights into biotech sector valuations and comprehensive analysis, consider accessing the full research report available on InvestingPro, which covers over 1,400 US stocks with detailed metrics and expert analysis.
Iovance’s Chief Medical Officer, Friedrich Graf Finckenstein, M.D., expressed confidence in the therapy’s potential to transform care for solid tumor cancers, which represent a significant portion of cancer diagnoses.
The detailed findings will be presented at the upcoming 2025 American Society of Clinical Oncology Annual Meeting. Additionally, Iovance is conducting a Phase 3 trial, TILVANCE-301, to confirm Amtagvi’s clinical benefit in frontline advanced melanoma.
This report is based on a press release statement from Iovance Biotherapeutics, Inc.
In other recent news, Iovance Biotherapeutics has faced significant challenges following its first-quarter 2025 earnings report, which revealed a revenue miss and a reduction in full-year guidance. The company reported a loss per share of $0.36, falling short of the analyst consensus estimate of a $0.24 loss per share, with revenue coming in at $49.3 million against an expected $83.27 million. This led to a downward revision of its FY25 total product revenue guidance to a range of $250 million to $300 million. As a result, several analysts have adjusted their ratings and price targets for Iovance. UBS downgraded the stock from "Buy" to "Neutral," slashing the price target from $17.00 to $2.00, citing issues with the implementation process and patient dropout rates. Truist Securities also downgraded Iovance from "Buy" to "Hold," highlighting market challenges and performance inconsistencies. Baird followed suit, lowering its rating from "Outperform" to "Neutral" and reducing the price target to $3.00 from $20.00, due to the company’s financial struggles and high cash burn rate. Despite these downgrades, H.C. Wainwright maintained a "Buy" rating, albeit with a reduced price target of $20.00, expressing optimism about Iovance’s long-term prospects.
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