Iovance Biotherapeutics Inc

Latest Results (15.01.2026):

Iovance Biotherapeutics, Inc. — third quarter of 2025: The company reported Q3 2025 product revenue of roughly $68 million (13% sequential growth), improved gross margin to 43%, and a net loss of about $91.3 million (−$0.25 per share). Cash, cash equivalents, investments and restricted cash totaled approximately $307 million as of September 30, 2025, and management reaffirmed full-year 2025 revenue guidance of $250–$300 million while projecting cash to fund operations into Q2 2027.

Topline and margins

Product revenue was ~$68M in Q3 2025 (U.S. Amtagvi ≈ $58M; global Proleukin ≈ $10M), a 13% increase from the prior quarter; gross margin improved to 43% with cost of sales of ~ $39M, attributed to better execution and initial cost-optimization benefits.

Profitability and expense detail

Q3 operating results: total costs and expenses of $162.4M, including cost of sales $38.5M, R&D $75.2M, and SG&A $34.6M. Loss from operations was $94.9M and net loss was $91.3M (basic and diluted loss per share $0.25). Non-cash stock-based compensation included in costs and expenses was $11.9M for the quarter.

Cash, guidance and runway

Cash, cash equivalents, investments and restricted cash were ~$307M at 9/30/2025. Management expects current cash plus expense reductions to fund operations into Q2 2027 and reiterated full‑year 2025 revenue guidance of $250–$300M (first full calendar year of Amtagvi sales).

Commercial execution — Amtagvi U.S. launch

More than 80 U.S. authorized treatment centers activated across nearly 40 states (reaching ~95% of patients within a two‑hour drive). Community ATCs have begun treating patients; manufacturing turnaround averaged ~32 days from inbound to return shipment. A specialty pharmacy agreement with InspiroGene by McKesson was announced to broaden access.

Manufacturing and cost initiatives

Iovance plans to centralize manufacturing at the Iovance Cell Therapy Center (iCTC) in early 2026 to reduce external manufacturing expenses and further improve gross margins; additional operational‑excellence initiatives and cost optimizations are underway.

Global regulatory progress

Health Canada approved Amtagvi in August 2025 (first approval outside the U.S.). Potential approvals are anticipated in the U.K. and Australia in H1 2026 and in Switzerland in 2027; strategy with the EMA is being finalized for EU marketing authorization.

Pipeline and clinical milestones

Lifileucel: interim IOV‑LUN‑202 data in previously treated nonsquamous NSCLC showed ORR 26% and median duration of response not reached after >25 months follow‑up; enrollment expected to complete in 2026 and may support a supplemental BLA with potential launch in 2027. Additional readouts: IOV‑END‑201 initial results expected early 2026; TILVANCE‑301 (frontline advanced melanoma combo) active and accruing; new IOV‑MEL 202 trial planned outside the U.S. Next‑gen programs (IOV‑4001, IOV‑3001, IOV‑5001) have key milestones and IND/phase transitions expected in 2026.