U.S. Approval and Strong Launch Momentum for IBTROZI
Received full U.S. FDA approval on June 11, 2025 for IBTROZI in advanced ROS1-positive NSCLC; 432 new patients started IBTROZI in 2025 (216 in Q4) and IQVIA shows prescriptions ~6x faster than the two prior ROS1 TKI launches over their first two full quarters.
Clinical Efficacy and Durability
Pooled analysis in TKI‑naive patients reported a median duration of response (DOR) of 50 months and previously demonstrated an 89% confirmed overall response rate (ORR); strong intracranial activity noted (example: 66% intracranial response in a second-line setting referenced).
Favorable Tolerability Enabling Broader Development
Clinical database of 337 advanced ROS1 patients showed only 1 discontinuation due to the six most common adverse events (≈0.3%); tolerability supported dosing first patient in TRUST‑IV adjuvant Phase III study and enabled global regulatory filings/approvals.
Global Regulatory and Commercial Partnerships
Approvals obtained in China and Japan; partnership with Eisai for Europe and select ex‑U.S. territories (upfront ≈$60M, $30M upon European approval, up to $140M in sales milestones, double‑digit to high‑teens royalties); combined out‑licensing and partner deal values (excluding Latin America) approach ~$520M.
Q4 and Full‑Year 2025 Revenue Highlights
Total revenue in Q4 2025 was $41.9M and total revenue for 2025 was $62.9M, which includes milestone and collaboration revenue; IBTROZI net U.S. product revenue was $15.7M in Q4 and $24.7M for full year 2025.
Strong Cash Position and Path to Profitability
Ended 2025 with $529.2M in cash, cash equivalents and marketable securities (increased by ≈$60M following Eisai upfront); management does not anticipate the need for additional external financing to reach profitability under current operating plans.
Progress on Safusidenib Clinical Program
Safusidenib Phase II in low‑grade IDH1‑mutant glioma: median PFS not reached, 12% progression at 24 months, confirmed ORR 44% (n=27); Phase I in high‑grade showed 17% ORR with durable complete responses in some patients; initiated pivotal SIGMA Phase III (300 patients, PFS primary endpoint, readout expected 2029) and a non‑pivotal grade 3 oligodendroglioma cohort (~40 patients) with a potential 2027 readout for ORR.
Operational Launch Execution and Market Access
Engaged all top‑tier target accounts; IBTROZI prescriptions written across 100% of 47 sales territories with multiple repeat prescribers; achieved broad payer coverage to label across the U.S.; specialty partners holding ~2–4 weeks of inventory, consistent with demand.