Iovance Reaches About $122 Million In Quarterly Sales While Cutting Its Loss
Amtagvi supplied about $102 million in U.S. revenue as production margins improved and the full-year forecast stayed intact.
Iovance Biotherapeutics, which develops and sells cancer cell therapies, reached about $122 million in third-quarter product sales, a record, while narrowing its net loss to $22.271 million. Results released Thursday alongside an SEC filing put sales growth at about 80% from a year earlier and about 22% from the previous quarter, driven by U.S. demand for Amtagvi.
Amtagvi Volume And Lower Costs
U.S. sales of Amtagvi were about $102 million, increasing about 77% from a year earlier and about 12% from the second quarter. Proleukin contributed about $20 million globally.
Higher Amtagvi volume and production efficiencies lifted gross margin to about 60%, from 56% in the previous quarter. That measure excludes depreciation and amortization and represents the portion of revenue left after production costs.
Research spending fell about 16% from the second quarter as operational efficiencies delivered a fifth consecutive quarterly improvement, the company said. Third-quarter research and development expenses were $49.337 million, versus $75.174 million a year earlier.
The quarterly net loss compared with $91.253 million a year earlier; the per-share loss narrowed to $0.05 from $0.25. For the first nine months, revenue totaled $292.212 million and the net loss was $148.631 million, compared with $176.731 million and $319.074 million, respectively, a year earlier.
IOVA shares rose about 3% to $8.00 in Friday trading.
More Treatment Centers, Same Forecast
Frederick Vogt, Iovance's interim chief executive officer and president, said, "We remain on track to achieve our full-year 2026 total revenue guidance of $410 to $420 million" in the earnings statement. Management also expects further gross-margin improvements, excluding occasional one-time items.
Amtagvi is a one-time treatment for adults with previously treated advanced melanoma, made using each patient's own immune cells. Iovance manufactures these tumor-infiltrating lymphocyte therapies in Philadelphia; Proleukin is used in the Amtagvi regimen and other applications.
More than 1,000 patients have received commercial Amtagvi treatment. The authorized treatment-center network now exceeds 100 centers across the U.S., Canada and Australia, with at least 110 expected to be active by year-end. Community centers account for a third of the network.
Manufacturing turnaround for most Amtagvi lots is about 30 days or less. The company reported about $382 million in cash, cash equivalents, short-term investments and restricted cash as of September 30, and expects its current funding to cover operations well into 2029.
Lung Cancer And European Expansion
Iovance is pursuing additional uses for lifileucel, the therapy sold as Amtagvi. Its ongoing study in non-squamous metastatic non-small-cell lung cancer produced a 24.6% response rate among 69 patients, including two responses that remained unconfirmed. A response means the cancer shrank sufficiently to meet the study's criteria.
The company plans an FDA application in 2027 based on those study groups, targeting approximately 80 patients. A subgroup selected using biological markers had a 59.1% response rate, supporting another study with a target of 80 patients and enrollment scheduled to begin in November. A trial testing earlier treatment in similarly selected lung-cancer patients is planned for 2027.
In heavily pretreated patients with undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, the confirmed response rate reached 55.6% in nine patients. A study designed to support approval is enrolling approximately 40 patients for each cancer type.
European expansion remains pending. Amtagvi's resubmitted U.K. approval application is under expedited review by the Medicines and Healthcare products Regulatory Agency, with potential approval in the first quarter of 2027. Iovance also expects potential Swissmedic approval in Switzerland that quarter.
Iovance plans a Brazilian approval application and a resubmission to the European Medicines Agency in 2027, alongside its planned U.S. lung-cancer application.
Sources
- 8-K Filing — IOVANCE BIOTHERAPEUTICS, INC. (IOVA) — SEC EDGAR
- Exhibit tm2628901d1_ex99-1.htm — IOVANCE BIOTHERAPEUTICS, INC. 8-K exhibit — SEC EDGAR
- Iovance Biotherapeutics Inc (IOVA) (Q3 2026) Earnings Call Highlights: Record $122 Million ... — Yahoo Finance
- Iovance targets $410M-$420M 2026 revenue while planning lung sBLA in 2027 (NASDAQ:IOVA) | Seeking Alpha — seekingalpha.com
- Iovance Biotherapeutics Reports Record Third Quarter 2026 — globenewswire.com
