Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) reported a narrower loss for the third quarter of 2026, with a loss of 5 cents per share, which was better than the anticipated loss of 9 cents per share according to the Zacks Consensus Estimate. This compares favorably to the 25 cents per share loss reported in the same quarter last year.
The company’s revenue saw a significant increase of 80.1% year-over-year, reaching $121.5 million, surpassing the expected $117.7 million. This growth was primarily driven by strong demand for Amtagvi, a melanoma cell therapy, which achieved U.S. sales exceeding $100 million for the first time in a single quarter.
Despite these positive results, Iovance’s stock fell by 11% on Thursday, potentially influenced by broader market trends and investor uncertainty following the outcomes of the U.S. midterm elections. However, the stock has experienced a substantial increase of approximately 184% year-to-date, compared to the industry’s average growth of nearly 12%.
Amtagvi’s Sales Performance
Amtagvi, a tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma, recorded U.S. sales of approximately $102 million, marking a 77% increase from the previous year and a 12% rise from the previous quarter. These figures exceeded both the Zacks Consensus Estimate and internal projections of $95 million.
Proleukin, an IL-2 therapy used in conjunction with Amtagvi, generated around $20 million in global sales. Although this was below the projected $22 million, it represented more than a twofold sequential increase as wholesalers adjusted their purchasing to align with Amtagvi demand. According to management, Proleukin’s sales now better reflect expected patient use.
Financial and Operational Highlights
Iovance’s gross margin, excluding depreciation and amortization, improved to approximately 60% from 56% in the previous quarter, marking a record for the second consecutive quarter. This improvement was attributed to increased product volume, manufacturing efficiencies, and cost optimization efforts.
Research and development expenses decreased by 34.4% year-over-year to $49.3 million, continuing a trend of five consecutive quarterly declines. In contrast, selling, general, and administrative expenses rose by 11.6% year-over-year to $38.6 million, though they remained stable compared to the previous quarter.
Future Outlook and Developments
Iovance reaffirmed its full-year 2026 revenue guidance of $410 million to $420 million, having already achieved $292.2 million in revenue during the first nine months. The company expects further sequential growth in the fourth quarter. Management anticipates continued improvement in gross margins, excluding occasional one-time items. As of September 30, 2026, Iovance held approximately $382 million in cash and equivalents, projected to support operations well into 2029.
Since its launch, over 1,000 patients have received commercial Amtagvi treatment. The therapy is available at more than 100 authorized treatment centers across the United States, Canada, and Australia, with plans to have at least 110 centers active by year-end. The manufacturing process for most lots is completed within 30 days. Amtagvi has received approval in Canada and Australia, with reimbursement discussions ongoing. Iovance is also seeking potential approvals in the U.K. and Switzerland in early 2027, and plans to file for regulatory approval in Brazil and the European Union later that year.
Advancements in Lung Cancer Treatment
Iovance is advancing Amtagvi for non-small cell lung cancer (NSCLC), reporting encouraging results from the phase II IOV-LUN-202 study. The study showed an objective response rate (ORR) of 24.6% among 69 patients with previously treated non-squamous metastatic NSCLC, compared to a 12.8% response rate for the chemotherapy drug docetaxel in a separate study. Management noted the durability of responses, with about half of the responding patients maintaining their responses. A reduced-dose lymphodepletion regimen improved the safety profile without affecting efficacy. Iovance plans to file for expanded approval through a supplemental biologics license application (sBLA) in 2027.
Additionally, Iovance identified a biomarker-selected subgroup of lung cancer patients with a significantly higher ORR of 59.1%. This finding led to the launch of POSITILITY, a new registrational-intent cohort targeting 80 patients, with enrollment set to begin in November 2026. The company also plans to initiate OPTILISM in 2027 to evaluate lifileucel in biomarker-selected patients with previously untreated metastatic NSCLC, potentially expanding its use to the frontline setting.
Beyond lung cancer, Iovance is testing Amtagvi in mid-stage studies for endometrial cancer and soft tissue sarcomas, with plans to submit an sBLA for endometrial cancer between 2028 and 2029. The company is also exploring Amtagvi in combination with Merck’s Keytruda in the phase III TILVANCE-301 study as a potential frontline treatment for advanced melanoma, which will also serve as a confirmatory study for its current indication.
Footnotes:
- Iovance Biotherapeutics reported a narrower loss per share than expected for Q3 2026. Source.
- Amtagvi sales in the U.S. surpassed $100 million for the first time in a quarter. Source.
- Iovance’s gross margin improved to approximately 60% in Q3 2026. Source.
- Iovance is advancing Amtagvi in non-small cell lung cancer with promising study results. Source.
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