IOVANCE BIOTHERAPEUTICS (IOVA) Company Report

Iovance Biotherapeutics reported Q3 2025 total product revenue of approximately $68 million, marking a 13% increase over the prior quarter, with Amtagvi sales of approximately $58 million and a gross margin of 43%. The company reiterated its full-year 2025 revenue guidance of $250 million-$300 million.
The company's cash position stood at $307 million as of September 30th, 2025, which is expected to fund operations into the second quarter of 2027. Gross margin is anticipated to improve further with the centralization of all manufacturing at its internal facility in early 2026.
Positive interim clinical data from the IOV-LUN-202 trial for non-squamous non-small cell lung cancer demonstrated an objective response rate of 26% and a median duration of response not reached at over 25 months. Enrollment for this trial is on track to complete for approximately 80 patients in 2026, with a potential launch in the second half of 2027 for an indication that has potential U.S. peak sales of $10 billion.

Nov 6, 2025, 1:30 PM

Transcript

Iovance Biotherapeutics Reports Q3 2025 Results and Pipeline Milestones

IOVA

Earnings

Guidance Update

Product Launch

Iovance Biotherapeutics reported Q3 2025 revenue growth of 13% over the prior quarter, reaching approximately $68 million, and achieved a gross margin of 43%.
As of September 30, 2025, the company's cash, cash equivalents, investments, and restricted cash totaled approximately $307 million, which is expected to fund operations into the second quarter of 2027.
The company reaffirmed its full-year 2025 revenue guidance within the range of $250 million to $300 million.
The U.S. launch of Amtagvi has activated more than 80 authorized treatment centers, and Health Canada granted the first Amtagvi approval outside the U.S. in August 2025, with potential approvals in the UK and Australia anticipated in the first half of 2026.
Positive interim data for lifileucel in previously treated advanced non-small cell lung cancer (NSCLC) demonstrated an objective response rate (ORR) of 26% and a median duration of response (mDOR) not reached after more than 25 months of follow-up. Enrollment for the IOV-LUN-202 trial is expected to complete in 2026, supporting a potential launch in 2027.

Nov 6, 2025, 1:05 PM

8-K

Iovance Biotherapeutics Reports Q3 2025 Results, Highlights Revenue Growth and Pipeline Progress

IOVA

Earnings

Guidance Update

New Projects/Investments

Iovance Biotherapeutics reported Q3 2025 total product revenue of ~$68 million, a 13% increase over the prior quarter, achieving a gross margin of 43%. The company reaffirmed its full-year 2025 revenue guidance of $250 to $300 million.
As of September 30, 2025, the company's cash, cash equivalents, investments, and restricted cash totaled ~$307 million, expected to fund operations into the second quarter of 2027.
The U.S. launch of Amtagvi continues with over 80 authorized treatment centers activated, and Health Canada granted the first Amtagvi approval outside the U.S. in August 2025.
Positive interim data from the IOV-LUN-202 clinical trial for lifileucel in advanced NSCLC showed a 26% objective response rate with median duration of response not reached after more than 25 months, with enrollment expected to complete in 2026 for a potential 2027 launch.

Nov 6, 2025, 1:00 PM

Press Release

Iovance Reports Promising Lung Cancer Trial Results Amid Financial Challenges

IOVA

Product Launch

Profit Warning

New Projects/Investments

Iovance Biotherapeutics announced positive interim Phase 2 trial results for its lifileucel therapy in advanced non-small cell lung cancer, demonstrating a 25.6% objective response rate and a 71.8% disease control rate.
The company aims to submit a biologics license application to the FDA, targeting a potential product launch in the second half of 2027.
Despite these positive clinical developments, Iovance continues to face significant financial challenges, evidenced by a negative net margin of 161.44% and a negative return on equity of 52.87%.

Nov 3, 2025, 1:11 PM

Morningstar

Iovance Biotherapeutics Reports Interim Clinical Data for Lifileucel in NSCLC

IOVA

Product Launch

New Projects/Investments

Iovance Biotherapeutics announced interim data from its registrational Phase 2 IOV-LUN-202 trial of lifileucel monotherapy for previously treated advanced nonsquamous NSCLC.
The trial demonstrated an objective response rate (ORR) of 25.6% and a median duration of response (mDOR) that was not reached after a median follow-up of 25.4 months.
The company expects to progress towards a supplemental Biologics License Application (BLA) in 2026 and anticipates a potential launch of lifileucel in the second half of 2027 for this indication.
The safety profile of the lifileucel treatment regimen was consistent with the underlying disease, with improvements noted after introducing an updated regimen.

Nov 3, 2025, 12:00 PM

Press Release

IOVANCE BIOTHERAPEUTICS, INC. Updates Corporate Presentation with Financial Guidance and Pipeline Progress

IOVA

Guidance Update

New Projects/Investments

Product Launch

Iovance Biotherapeutics, Inc. released an updated corporate presentation on August 29, 2025, providing key financial and pipeline updates.
The company reported a cash position of $307.1 million as of June 30, 2025, with a projected cash runway into Q4 2026 and an anticipated cash burn of less than $245 million from Q3 2025 to Q3 2026.
Iovance provided FY 2025 revenue guidance of $250 million to $300 million and announced a strategic restructuring expected to yield over $100 million in annual cost savings starting in Q4 2025.
The company highlighted its commercial products, Amtagvi and Proleukin, which generated over $240 million in product revenue for the 12 months ending June 30, 2025, and provided updates on its clinical pipeline, including the Phase 3 TILVANCE-301 trial for frontline advanced melanoma.

Aug 29, 2025, 8:06 PM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for IOVANCE BIOTHERAPEUTICS.

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