Iovance Biotherapeutics
IOVA
conference date: February 24, 2026 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2025 (fourth quarter, Q4 2025)

Forward-looking
statements
Overview: Announced results from clinical trial for TIL Cell Therapy in soft tissue sarcomas [separate press release]
Basic data (GAAP):
Revenue was $87 million, up 18% from %74 million year-earlier.
Net Income was negative $72 million, up from negative $79 million year-earlier.
EPS (Earnings per Share), diluted, were negative $0.18, up from negative $0.26 year-earlier.
Guidance:
Cash runway to Q3 2027.
Conference Highlights:
Frederick Vogt, Interim President and CEO said, "Iovance delivered approximately 30 percent quarterly revenue growth and achieved our 2025 guidance range in the first full calendar year of launch. Growth was driven by increasing demand for Amtagvi. After ongoing improvements in our operations and gross margin, we are well positioned for future profitability. Iovance is poised to create substantial value for patients and shareholders as we increase revenue while advancing our registrational trial in non-small cell lung cancer and best-in-class TIL pipeline in solid tumors." Demand increase has continued in Q1.
Revenue consisted of $65 million from U.S. sales of Amtagvi plus $22 million from global sales of Proleukin. Amtagvi (lifileucel) treamtent centers grew in numbers, and international launch is underway. In 2026 announced Amtagvi for advanced melanoma trial reported ORR of 44%, improved from the trial data used for FDA accelerated approval.
The lifileucel for previously treated advanced, metastatic nonsquamous NSCLC registrational trial reported positve interim data, with a 26% ORR and 72% disease control rate. Enrollment should complete in 2026 with a launch possible in H2 2027. This is a much larger potential market than melanoma.
In Q1 2026 Iovance announced positive early data for one-time lifileucel treatment for advanced undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy. For six evaluable patients, the confirmed RECIST v1.1 ORR was 50%.
Iovance plans to commence a single arm registrational trial in previously treated advanced UPS and DDLPS in Q2 2026. [note that if 1 less patient had had a response, the ORR would have dropped to 33%]
Lifileucel is in a Phase 2 trial for advanced endometrial cancer.
Lifileucel is in a Phase 2 trial for melanoma.
As of Q1 2026 a Phase 1/2 trial of IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC, is ongoing.
As of Q1 2026 a Phase 1/2 trial of IOV-3001, a second-generation, modified IL-2 analog, is ongoing.
For 1H 2026, An IND submission is planned for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL therapy, for a Phase 1/2 basket trial.
Now able to expand manufacturing for global production without significant futher capital expense. All our manufacturing operations are now in house, at our Philadelphia facility.
Cash and investments ended at $297 million.
Total expenses were $160.2 milllion, consisting of: cost of sales $43.1 million, R&D $71.2 million, SG&A $35.4 million, depreciation and amortization $9.5 million. Other income $1.7 million. Income tax benefit $0.2 million.
For the full year 2025, revenue was $264 million, up from $164 million in 2024. Net income was negative $391 million, down from negative $372 million in 2024. EPS, diluted, was negative $1.09, up from negative $1.28,
Q&A:
First line melanoma pembro combo trial data timeline, expectations? We have an early interim read of ORR, would be in 2027. Benchmark is pembrolizimab monotherapy, where ORR was about 30%. In an earlier cohort we had an ORR around 60%.
Proleukin q/q revenue jump? All 3 distributors ordered in Q4. We are not guiding. We expect further margin improvement. We have already seen a new order in Q1.
2026 guidance delay? Because growth right now is remarkable, we need some time to finalize, it should be released soon.
Q4 new ATCs vs. existing centers? Base book was academic ATCs, community ATCs started coming online, will see more in 2026. Expects continued growth in both segments.
Durability stats tend to very long times, we are seeing scans get better over time.
Fast Track for NSCLC? Timing has not changed, potential launch in 2027. Finishing the trial right now, confident in results.
Other sarcoma types? We are looking at additional subtypes. We see strong activity for TIL in this space, where checkpoint inhibitors don't seem to work.
We did a price increase for Proleukin on February 1. The main source of Proleukin orders is based on Amtagvi demand.
We see a potential of $10 to $12 billion dollars annual sales in the U.S. with Amtagvi if the sarcoma and NSCLC indications are approved.
Currently our prices outside the U.S. are the same as our U.S. price.
We believe the community providers should have the same learning curve as the academic centers. They will want to do one or two patients first, see the reimbursements.
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