Iovance Biotherapeutics, Inc. (IOVA)

Key figures

The last twelve months reported, with the latest price and balance sheet.

Revenue, last twelve months

$325.0M

Revenue growth

34.5%

Net income, last twelve months

-$289.5M

Earnings per share

-$0.73

Operating margin

-92.7%

Net margin

-89.1%

Free cash flow

-$296.4M

Return on equity

-39.3%

Market value

$6.7B

Cash

$110.8M

Debt

$0

Debt to equity

0.00

Shares outstanding

453.0M

Financial statements

Revenue, profit and cash flow by fiscal year, each year linked to its annual report.

By quarter

What the company said with its results

From the second quarter 2026 results, filed 6 August 2026.

• Product revenue rose to $99.3 million. Total product revenue reached $99.3 million, up 66% from $60 million in the second quarter of 2025 and 39% from $71 million in the first quarter of 2026.
• Gross margin rose to 56%. Gross margin was 56%, excluding depreciation and amortization, compared with 41% in the first quarter. Management cited higher Amtagvi volume, cost optimization and manufacturing efficiencies.
• FY26 revenue range under review. The company is reviewing its FY26 revenue range of $350 million to $370 million. The prior release had also set second-quarter product revenue guidance of $86 million to $88 million.
• Net loss narrowed to $47.3 million. Net loss was $47.3 million, or $0.11 per share, against $111.7 million, or $0.33 per share, in the second quarter of 2025. Weighted shares were 450.2 million.
• U.S. Amtagvi revenue reached $91 million. U.S. Amtagvi revenue was about $91 million, up 40% from the fourth quarter of 2025. Global Proleukin revenue was about $9 million.
• Australia approval adds third market. The Therapeutic Goods Administration approved Amtagvi in Australia. Australian centers are moving through authorization in parallel with national reimbursement discussions.
• UK review on expedited path. The UK application was resubmitted in early July after a May withdrawal for procedural reasons. The company describes approval as potential later in 2026.
• Switzerland approval expected 1H27. Potential Swiss approval is expected in the first half of 2027, which management describes as a second European market with possible medical tourism.
• European resubmission now on track for 2027. The European Medicines Agency resubmission for advanced melanoma is on track for 2027. The prior release had said the resubmission would occur in 2026.
• SARATOGA earns Fast Track Designation. FDA granted Fast Track Designation for undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. The company cited early data from the registrational trial.
• Early SARATOGA response rate 50%. The trial is underway. Early objective response rate by RECIST v1.1 was 50% in the first six evaluable patients.
• Lung cancer pivotal cohorts nearly enrolled. Pivotal cohorts in previously treated metastatic non-squamous NSCLC are nearly fully enrolled. Management said the U.S. market is about seven times the size of advanced melanoma.
• Endometrial cancer moves to histology-based path. Positive initial data in previously treated serous endometrial cancer used a histology-based biomarker strategy. The protocol is being amended to focus on this population.
• Frontline melanoma Phase 3 interim analysis planned. The TILVANCE-301 Phase 3 trial of lifileucel plus pembrolizumab includes an early interim analysis on objective response rate. It also serves as the confirmatory study for second-line accelerated approval.

Revenue by segment

As the company reports it in the segment note of its annual report.

By product, FY2025

By region, FY2025

Company events

The newest 8-K filings of 256 held.

Every filing

The newest filings with the SEC of 550 held.

Large holders

Schedule 13D and 13G filings by holders of more than 5% of the voting shares.

Short interest

Shares sold short and not yet bought back, on each FINRA settlement date.

Funds that hold it

From each fund's latest Form 13F.

328 funds held it at 30 Jun 2026: 166 added and 64 trimmed in the quarter. The largest:

Peers

Companies in the same industry.

• Amgen Inc. (AMGN): revenue $38.1B, market value $244.4B
• Gilead Sciences, Inc. (GILD): revenue $30.5B, market value $197.6B
• Moderna, Inc. (MRNA): revenue $2.2B, market value $85.4B
• argenx SE (ARGX): revenue $4.2B, market value $55.2B
• Biogen Inc. (BIIB): revenue $10.3B, market value $36.1B
• BioNTech SE (BNTX): revenue $3.2B, market value $22.1B
• Exelixis, Inc. (EXEL): revenue $2.4B, market value $16.5B
• Halozyme Therapeutics, Inc. (HALO): revenue $1.7B, market value $14.8B
• Neurocrine Biosciences Inc. (NBIX): revenue $3.4B, market value $14.8B
• Bio-Techne Corp. (TECH): revenue $1.2B, market value $11.3B

What the company does

Iovance Biotherapeutics is a commercial-stage biopharmaceutical company that develops tumor infiltrating lymphocyte, or TIL, cell therapies for patients with solid tumor cancers. The company has two commercial products, Amtagvi (lifileucel) and Proleukin (aldesleukin). Amtagvi is approved in the United States and Canada.

What it sells

Amtagvi is a one-time, individualized T cell therapy for adults with advanced melanoma who were previously treated with a PD-1 blocking antibody and, if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. It is given as part of a regimen that includes lymphodepletion and a short course of Proleukin. The company says Amtagvi has the potential to address more than 30,000 previously treated advanced melanoma patients each year.

The filing lists approvals as pending in the United Kingdom and Australia, and in Switzerland. In the European Union, the company withdrew its initial marketing authorization application in July 2025 and says it is working with the European Medicines Agency to resubmit.

It is approved in the United States, and licensed in multiple international markets, for adults with metastatic renal cell carcinoma and/or metastatic melanoma. Iovance acquired the worldwide rights from Clinigen in May 2023. It sells Proleukin to three main distributors in the United States, to distributors outside the United States, and to numerous third-party clients. These sales fall into three channels: use in the Amtagvi regimen or other approved oncology uses, use in manufacturing Amtagvi and other cell therapies, and use in clinical and research settings.

Amtagvi revenue is recognized when the patient is infused. Proleukin revenue is recognized on shipment or delivery.

How treatment reaches patients and where it is made

After a surgical biopsy collects the patient's tumor tissue, the cells are processed at the Iovance Cell Therapy Center. Under the Gen 2 process, the cells multiply during a slow growth phase for the first 11 days and a rapid expansion phase from days 11 to 22. They are then cryopreserved, tested and shipped to the treatment center.

The company says the center has the potential capacity to supply TIL cell therapies for more than 5,000 cancer patients annually, and that more than 1,500 patients have been treated with therapies made using Iovance processes. It delivers to treatment centers in North America, Europe and Asia Pacific.

A contract manufacturer, Minaris Advanced Therapies, supplemented internal capacity until its agreement ended in the first quarter of 2026. All Amtagvi and lifileucel manufacturing is moving to the Philadelphia center. Contract manufacturing organizations still support certain trials of next-generation therapies. Proleukin is made and supplied by Boehringer Ingelheim Biopharmaceuticals GmbH, and Iovance must buy a minimum number of vials each calendar year through 31 December 2028.

What it is developing

Iovance is running two registrational trials. The company says it plans to start a registrational trial in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma in the second quarter of 2026. A Phase 2 trial in advanced endometrial cancer, IOV-END-201, is also under way.

Next-generation programs include IOV-3001, a modified interleukin-2 analog now in a Phase 1/2 trial. IOV-4001 uses TALEN technology licensed from Cellectis to inactivate the gene coding for PD-1. IOV-5001 is engineered to induce IL-12 expression, and the company says it plans an investigational new drug submission in the first half of 2026.

Patents and licences

The company says it owns more than 330 granted or allowed patents and patent applications for Amtagvi and other TIL technologies, which it expects to provide Amtagvi with exclusivity into 2042. More than 90 are United States patents related to TIL cell therapy.

Iovance also licenses technology from third parties. It holds a patent license with the National Institutes of Health and a Cooperative Research and Development Agreement with the National Cancer Institute, which runs to August 2029. It has agreements with Cellectis and Novartis Pharma AG. The FDA has granted Orphan Drug Designation for lifileucel in melanoma and in cervical cancer, which would give seven years of market exclusivity in the United States if approved.

Who it competes with

The filing says many competitors have substantially greater research, manufacturing and marketing resources. For melanoma, lung and other solid tumors, it names companies including Bristol-Myers Squibb, Merck, Pfizer and Regeneron Pharmaceuticals. In engineered T cell and TIL products it names companies including Immatics and Obsidian Therapeutics. For new interleukin-2 treatments it names Alkermes, Nektar Therapeutics and Sanofi, among others. Sales also depend on coverage and reimbursement from payors such as Medicare, Medicaid and private insurers.

Its people

Of the 975 employees at 31 December 2025, 775 worked in research and development and commercial manufacturing, and 200 in general and administrative support. None are covered by a collective bargaining agreement.

*From Iovance's annual report on Form 10-K for the year ended 31 December 2025. [The filing](https://www.sec.gov/Archives/edgar/data/1425205/000110465926018899/iova-20251231x10k.htm)*

From the company's 10-K.