SAN CARLOS, Calif. — May 07, 2026 — Leads & Copy — Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) reported its first quarter 2026 financial results, business achievements, and corporate updates today.
The commercial biotechnology company, focused on tumor infiltrating lymphocyte (TIL) therapies for cancer patients, reported total revenue of ~$71 million for the first quarter of 2026, representing approximately 45% year-over-year growth. The company projects revenue of $86 million to $88 million for the second quarter of 2026 and $350 million to $370 million for the full year 2026.
Iovance is also reporting a 40% confirmed objective response rate in metastatic serous endometrial cancer.
According to Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, the company is experiencing high demand for Amtagvi and is positioned for long-term revenue growth through 2026. Vogt noted the company is advancing multiple ongoing and new clinical trials, including a registrational trial in advanced sarcomas and encouraging initial data for lifileucel in metastatic serous endometrial cancer. Internal manufacturing efficiencies, operational improvements, and cost reductions are expected to benefit gross margin and propel future profitability.
First Quarter 2026 Financial Highlights:
Total product revenue of ~$71 million, an increase of ~45% over 1Q25.
U.S. Amtagvi revenue was ~$60 million.
Global Proleukin revenue was ~$11 million.
Gross margin of 41% absorbed one-time costs for the annual maintenance period and the recent internal facility expansion.
Research and Development (R&D) expenses decreased by 12% compared to 4Q25.
Guidance for 2Q26 includes total product revenue of $86 million to $88 million and for FY26 is $350 million to $370 million.
U.S. Amtagvi revenue for 2Q26 is expected to be $79 million to $81 million, reflecting an expected ~23% increase over 4Q25.
Amtagvi demand is driven by adoption and referrals toward earlier treatment, with recently published real world objective response rates of 52% in patients with two or fewer prior lines of therapy. Five-year follow-up clinical data demonstrated deep and durable responses in heavily pretreated patients, with a median duration of response of 3 years.
The company expects to activate at least 110 authorized treatment centers (ATCs) by year-end 2026.
Decisions on marketing authorization application (MAA) approvals are expected in Australia in the first half of 2026 and in Switzerland in the first half of 2027.
Iovance withdrew its initial MAA for lifileucel in the United Kingdom in May 2026 for procedural reasons and will promptly resubmit the MAA with updated information for an expedited review by the MHRA. Iovance is also working to resubmit an MAA to the European Medicines Agency (EMA) in 2026.
Iovance submitted an Investigational New Drug (IND) application to FDA for a Phase 1/2 basket trial of IOV-5001, a second-generation IL-12 tethered TIL therapy, to begin enrolling in 2H 2026.
Dr. Friedrich Graf Finckenstein, Chief Medical Officer, will retire from Iovance in June 2026.
Iovance’s cash position was ~$319 million on March 31, 2026 and is expected to fund operations well into 2028.
Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register at https://edge.media-server.com/mmc/p/wmx3s4fc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer.
Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication.
Source: Iovance Biotherapeutics, Inc.
