Iovance Biotherapeutics (NASDAQ:IOVA) reported record third-quarter revenue of approximately $122 million, up 80% from a year earlier, as sales of its melanoma treatment AMTAGVI surpassed $100 million in a quarter for the first time.
The company reaffirmed its 2026 revenue guidance of $410 million to $420 million and said its cash resources are expected to fund operations well into 2029. Iovance also outlined plans to seek approval for its cell therapy lifileucel in previously treated non-small cell lung cancer in 2027, alongside trials targeting other cancers.
AMTAGVI Drives Revenue Growth
AMTAGVI revenue rose 77% year over year and 12% sequentially to approximately $102 million, Chief Financial Officer Corleen Roche said. Proleukin contributed about $20 million, more than double its second-quarter level, as wholesaler ordering patterns realigned with AMTAGVI demand.
Total revenue increased 22% from the second quarter. Margin rose to approximately 60%, up from 56% in the prior quarter, while research and development expenses fell about 16% sequentially to $49 million. Selling, general and administrative expenses were roughly flat at $39 million.
Iovance had approximately $382 million in cash equivalents, short-term investments and restricted cash as of Sept. 30. Revenue for the first nine months of 2026 totaled $292 million.
Asked whether profitability could be achieved before potential launches in lung cancer or sarcoma, Roche said yes but declined to provide a timeline. “If we continue on this path of revenue growth and disciplined investments, we’ll get there,” she said.
Interim CEO and President Fred Vogt said facility maintenance that had previously affected results, primarily in the first quarter, was no longer an issue. He said the company expected quarter-over-quarter growth and was tracking to its recently updated annual guidance.
Treatment Network Expands
Iovance has infused more than 1,000 commercial AMTAGVI patients in the U.S. since launch and now has more than 100 authorized treatment centers. It expects to reach at least 110 centers by year-end.
Chief Commercial Officer Dan Kirby said community-based facilities make up more than a third of the network, although roughly two-thirds of infusions currently occur at academic centers. He expects community centers to account for more than half of infusions in the future.
AMTAGVI is also approved in Canada and Australia for previously treated melanoma. Kirby said the first Canadian treatment centers are ready and Australian centers are being onboarded. They will initially treat private-pay patients while the company pursues public reimbursement.
The company sees potential approvals in the U.K. and Switzerland by the first quarter of 2027. It also plans a Brazilian application and a resubmission in the European Union during 2027.
Lung Cancer Filing Planned for 2027
Iovance is completing enrollment in two cohorts of its IOV-LUN-202 trial, targeting approximately 80 patients for a supplemental biologics license application in previously treated non-squamous metastatic non-small cell lung cancer.
In updated results from 69 patients, the objective response rate was 24.6%. Chief Medical Officer Noah Berkowitz said about half of the patients who responded remained in response in the study. He said the trial’s reduced-dose preconditioning regimen improved safety while maintaining a similar response rate, including durable responses.
Vogt said the company expects to report further data in 2027, though the median duration of response might not yet have been reached. Chief Regulatory Officer Raj Puri said Iovance is confident the U.S. Food and Drug Administration will consider accelerated approval based on the planned submission; approval has not been granted.
The company is also pursuing a biomarker-selected lung cancer population after reporting a 59.1% response rate in a subgroup of current or former smokers without actionable driver mutations. A prospective cohort called POSITILITY is targeting 80 patients and is scheduled to begin enrollment this month. Iovance plans a separate frontline trial, OPTILISM, in 2027.
Additional Pipeline Programs
In a pilot trial involving two types of soft tissue sarcoma, five of nine evaluable patients had a confirmed response to lifileucel. Two responses remained ongoing more than a year after infusion. Iovance is enrolling patients in its SARATOGA trial and plans separate supplemental applications for the two sarcoma types in 2028 or 2029.
For frontline advanced melanoma, Vogt said a phase 2 cohort showed a 62.5% response rate, including complete responses in 29.2% of patients. The company is enrolling a phase 3 trial intended to support frontline approval and serve as the confirmatory trial for full U.S. approval of AMTAGVI.
About Iovance Biotherapeutics (NASDAQ:IOVA)
Iovance Biotherapeutics, Inc (NASDAQ: IOVA) is a biotechnology company focused on developing and commercializing personalized cell therapies for patients with cancer. Its technology is based on tumor-infiltrating lymphocytes (TILs), immune cells collected from a patient’s tumor, expanded outside the body, and reinfused to help attack cancer cells.
The company’s lead product, Amtagvi (lifileucel), is an autologous TIL therapy approved in the United States for certain adults with unresectable or metastatic melanoma that has progressed following prior treatment.
