Iovance Biotherapeutics reports record third quarter 2026 revenue

Item 2.02.

Results of Operations and Financial Condition.

On November 5, 2026, Iovance Biotherapeutics,

Inc. (the "Company") issued a press release announcing its financial results for the third quarter ended September 30, 2026, and an update on recent developments. A copy of that press release is furnished as Exhibit 99.1.¹

The information furnished under this Item 2.02, including the accompanying Exhibit 99.1, shall not be deemed to be "filed" for the purposes of Section 18 of the Securities

Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of such section, nor shall such information be deemed to be incorporated by reference in any subsequent filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, regardless of the general incorporation language of such filing, except as specifically stated in such filing.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

99.1

Press Release of Iovance Biotherapeutics, Inc., dated November 5, 2026

104

Cover Page Interactive Data File (embedded as Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 5, 2026

Iovance Biotherapeutics, Inc.

By:

/s/ Frederick G. Vogt

Name:

Frederick G. Vogt, Ph.D., J.D.

Title:

Interim CEO and President, and General Counsel

Iovance Biotherapeutics Reports Record Third

Quarter 2026

Revenue of ~$122M ,

Business Achievements, and Corporate Updates

Total Revenue Increased ~80% and U.S. Amtagvi

Revenue Increased ~77% Year-over-Year, and Gross Margin Increased to ~60%

24.6% Objective Response Rate (ORR) in 69 Patients with Non-Squamous Metastatic Non-Small-Cell Lung Cancer (mNSCLC)⁵

59.1% ORR in Biomarker-Selected mNSCLC Subgroup⁵ with POSITILITY Trial Underway

55.6% ORR in Undifferentiated Pleomorphic Sarcoma⁶

(UPS)⁶

and Dedifferentiated Liposarcoma (DDLPS)⁶ with SARATOGA Registrational Trial Underway

PHILADELPHIA, November 5, 2026 -- Iovance Biotherapeutics,

Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported third quarter 2026 financial results, business achievements, and corporate updates.

"Third quarter revenue reached a new record of ~$122 million with our highest gross margin ever, driven by continued U.S. Amtagvi demand," said Frederick Vogt, Ph.D., J.D., Interim Chief Executive

Officer and President. "We remain on track to achieve our full-year 2026 total revenue guidance of $410 to $420 million and recently marked the tremendous milestone of more than 1,000 commercially treated Amtagvi patients. We released our positive results for Cohorts 1 and 2 of our ongoing IOV-LUN-202 trial with a 24.6% ORR in 69 patients and excellent durability that is much greater than current standard of care. We are completing enrollment in Cohorts 1 and 2 and preparing for a supplemental Biologics License Application (sBLA) submission, while adding the new POSI TIL ITY and OP TIL ISM trials supported by a remarkable 59.1% ORR in biomarker-selected patients.

We also recently presented best-in-class data for lifileucel in chemotherapy-refractory UPS and DDLPS in support of our SARATOGA registrational trial, where our confirmed ORR has now increased to 55.6% in 9 patients with strong durability."

Third Quarter 2026 Financial

Highlights

Second Consecutive Record Quarter in Revenue and High Margin Driven by Volume and Cost Discipline

Total product revenue was ~$122 million, an increase of ~80% from ~$67 million in 3Q25 and ~22% from ~$99 million in 2Q26.²

U.S. Amtagvi revenue was ~$102 million, up ~77% from 3Q25 and ~12% from 2Q26.³

Global Proleukin revenue was ~$20 million in 3Q26.

Gross margin 1 was ~60%, compared to 56% in 2Q26⁴, reflecting higher

Amtagvi sales volume and effective internal cost optimization programs spanning all of product production.

Research and Development (R&D) expenses decreased by ~16% compared to 2Q26, driven by operational efficiencies, marking the fifth straight quarter of improvements, and allowing pipeline growth in additional indications with significant market opportunity.

Full Year 2026 Outlook

Third Quarter Performance and Demand Growth Support Guidance

Iovance remains on track towards achieving its guidance range of $410 to $420 million in total product revenue in 2026.

Improvements in gross margin are expected to continue, excluding occasional one-time items.

Amtagvi Commercial Business

Sustained U.S. Commercial Business Growth and Upcoming Milestones in Global Expansion

Authorized treatment center (ATC) network: The network has grown to more than 100 U.S., Canadian, and Australian

ATCs, with at least 110 ATCs expected to be active by the end of 2026. Community ATCs continue to represent a third of the network and are expected to increase significantly over the next several quarters.

Real-world experience: Numerous real-world studies by Iovance and ATCs using commercial Amtagvi continue to highlight efficacy and safety, with objective response rates (ORRs) of 50% or greater in second-line patients, supporting earlier adoption of Amtagvi with rapid patient referrals and access. In a poster at the European Society for Medical Oncology Congress

2026 (ESMO 2026), an indirect comparison suggested that lifileucel may approximately double four-year overall survival (OS) rates compared with standard-of-care therapies in anti-PD-1-resistant advanced melanoma.

Manufacturing turnaround time: Amtagvi turnaround time for the majority of lots is about 30 days or less⁸ using the only scaled, centralized commercial manufacturing process approved by the U.S. Food and Drug

Administration (FDA) for TIL therapy.

United Kingdom (UK): The Marketing Authorization Application (MAA) was resubmitted and is undergoing expedited review by the Medicines and Healthcare products Regulatory Agency for potential approval by 1Q27.⁸ Advanced melanoma causes more than 2,500 deaths annually in the UK.

Switzerland: A potential MAA approval by Swissmedic is expected in 1Q27, and the process is moving smoothly, opening a second market opportunity in Europe with the added potential for medical tourism.

Switzerland's domestic melanoma burden causes several hundred deaths annually.

Other markets and indications: Iovance is planning to submit an MAA for Amtagvi in advanced melanoma to the Brazilian Health Regulatory Agency (ANVISA) in 2027.^{7 7}An MAA resubmission for Amtagvi to the European⁷

Medicines Agency is on track for 2027.⁷ Other regulatory submissions are planned in international markets with a high prevalence of advanced melanoma, lung cancer,