Transformational Corporate Actions and Strengthened Balance Sheet
Completed sale of FibroGen China to AstraZeneca, paid off senior secured term loan, and extended cash runway into 2028. Reported cash, cash equivalents, investments, and accounts receivable of $109.4M as of 12/31/2025.
Significant Full-Year Cost Reductions
Total operating costs and expenses for FY2025 were $52.3M versus $180.0M in FY2024, a decline of approximately 71.0%. R&D expenses declined to $23.5M from $95.7M (-75.4%) and SG&A declined to $27.7M from $49.3M (-43.8%).
Improved Full-Year Net Loss
Net loss from continuing operations for FY2025 was $58.2M, or $14.40 per share, versus $153.1M, or $38.26 per share in FY2024 — an improvement of ~61.9% in absolute net loss and ~62.4% improvement in loss per share.
FG-3246/FG-3180 Clinical Progress — Encouraging Early Efficacy Signals
Investigator-sponsored trial (IST) of FG-3246 + enzalutamide (n=44) showed median radiographic PFS of 7.0 months in biomarker-unselected patients and 10.1 months in patients who progressed on one prior ARPI; PSA50 response was 40% in the one-prior-ARPI subgroup. Phase 1 monotherapy showed median rPFS of 8.7 months and PSA50 in 36% of heavily pretreated, unselected patients.
Biomarker & Companion Diagnostic Potential
Higher tumor uptake of FG-3180 PET correlated with PSA50 response (trend), supporting the prospect of FG-3180 as a companion diagnostic to select CD46-positive patients. Company cites a potential U.S. FG-3246 addressable market >$5B and notes PSMA PET agents generated nearly $2B in 2025 as a commercial precedent.
Phase 2 Monotherapy Trial and Near-Term Catalysts
Initiated FG-3246 phase 2 monotherapy dose-optimization trial (enrolling 75 patients in post-ARPI, pre-chemo setting across three dose levels) with an interim analysis planned in 2026 (PSA50, ORR, safety, PK) and mature rPFS expected in 2027.
Safety Optimization — Neutropenia Mitigation
Use of primary G-CSF prophylaxis in the IST substantially reduced incidence of grade ≥3 neutropenia versus the phase 1 monotherapy trial, informing design elements of the ongoing phase 2 study to maintain ADC exposure and reduce dose interruptions.
Roxadustat Progress and Orphan Designation in MDS
Roxadustat granted Orphan Drug Designation for anemia associated with lower-risk MDS. Post-hoc analysis in high transfusion burden subgroup showed 36% transfusion independence ≥8 weeks vs 7% for placebo (nominal p=0.041), supporting potential efficacy. Final phase 3 protocol submitted to FDA with feedback expected in coming weeks and target initiation in H2 2026.