Iovance Biotherapeutics Inc

Latest Results (02.12.2025):

Iovance Biotherapeutics Inc's second quarter of 2025 (2Q25) results show accelerating commercial traction for Amtagvi with $60.0M in total product revenue (up 93% year‑over‑year), continued investment in R&D and commercialization, and a strategic restructuring intended to extend the company’s cash runway into the fourth quarter of 2026.

Revenue and Commercial Performance

2Q25 total product revenue was $60.0M (Amtagvi $54.1M; Proleukin $5.9M). Revenue rose 93% versus 2Q24 and 22% versus 1Q25; first half 2025 product revenue totaled $109.3M (up 243% y/y). Amtagvi commercial use in 2Q25 represented 102 treated commercial patients.

Guidance and Outlook

Iovance reiterated full‑year 2025 total product revenue guidance of $250–$300M and expects continued revenue growth into 2026. Management expects gross margins to improve with manufacturing capacity optimization.

Profitability and Expenses

Net loss for 2Q25 was $111.7M, or $0.33 per share (2Q24 net loss $97.1M). Cost of sales was $56.7M in 2Q25 (includes patient drop‑off, manufacturing success rates and non‑cash items). R&D was $79.4M and SG&A $37.7M for the quarter.

Cash, Runway and Restructuring

Cash, cash equivalents, investments and restricted cash were ~$307.1M at June 30, 2025. A strategic restructuring (including ~19% workforce reduction) targets >$100M in annual savings beginning Q4 2025 and, together with anticipated product revenue, is expected to fund operations into Q4 2026. Net cash burn for the next four quarters through Q2 2026 is expected to be less than $245M (ex‑one‑time restructuring charges).

Commercial Footprint & Operations

The Amtagvi network includes >80 Authorized Treatment Centers across 35 states, with 95% of addressable U.S. patients within 200 miles of an ATC. Commercial manufacturing turnaround time improved to 33 days (inbound to return shipment).

Clinical, Real‑World Data and Pipeline Milestones

A physician‑assessed real‑world ORR for commercial Amtagvi was 48.8% (20/41); higher in earlier lines (60.9% in third‑line or earlier). Key registrational and registrational‑supporting programs remain active: TILVANCE‑301 (frontline combo) ongoing, IOV‑LUN‑202 (NSCLC) and other Phase 2 trials expect additional data in H2 2025, and next‑gen programs (IOV‑4001, IOV‑3001, IOV‑5001) advancing toward readouts or IND.

Regulatory and Market Expansion

Iovance expects imminent Health Canada approval and is preparing for a Canadian commercial launch. EMA MAA was withdrawn and a new EU strategy is being developed; UK, Australia and Switzerland regulatory reviews are in progress with potential approval timelines into early 2026 for some markets.

Intellectual Property

Iovance reports ~280 granted/allowed U.S. and international patents and patent rights covering Amtagvi and TIL technologies, with exclusivity positions described through at least 2038–2042 across various claims.