Revenue Growth
Total revenue of $3.7M in Q1 2026 vs $2.7M in Q1 2025, an increase of approximately 37% year-over-year.
Improved Loss and Expense Control
Net loss from continuing operations improved to $15.1M (-$3.74 per share) from $16.8M (-$4.15) a year ago, a ~10% reduction in net loss. Total operating costs were essentially flat at $17.6M vs $17.7M prior year; R&D decreased ~17% to $7.6M and SG&A decreased ~27% to $5.9M.
Strong Cash Position and Runway
Cash, cash equivalents, investments and accounts receivable totaled $100.3M as of March 31, 2026, with management expecting a cash runway into 2028 to fund U.S. pipeline activities.
FG-3246 Phase I Monotherapy Efficacy Signal
Phase I monotherapy topline: median rPFS of 8.7 months in heavily pretreated mCRPC patients; PSA reductions >50% in 36% of patients; overall response rate (ORR) 20% of evaluable patients with median duration of response 7.5 months. All ORRs observed at the 2.7 mg/kg dose, suggesting a dose response.
Encouraging Combination Data (FG-3246 + Enzalutamide)
Investigator-initiated study (n=44) showed median rPFS of 7.0 months in an all-comer cohort and a clinically notable 10.1 months median rPFS in patients who had progressed on only 1 prior ARPI; PSA50 response 40% in that subgroup.
CD46 PET (FG-3180) as a Potential Biomarker
IST data showed higher FG-3180 tumor uptake trended with greater PSA50 response to FG-3246; this represents the first demonstrated association between CD46 expression and response and supports FG-3180 as a potential companion diagnostic to enrich Phase III populations.
Neutropenia Management Strategy Validated
IST showed substantial reduction in grade ≥3 neutropenia when using G-CSF prophylaxis versus Phase I monotherapy, leading to incorporation of primary G-CSF prophylaxis in the ongoing Phase II to reduce dose interruptions and maintain exposure.
Roxadustat Clinical Opportunity and Positive Subgroup Data
Roxadustat received orphan drug designation for lower-risk MDS. Post-hoc MATTERHORN subgroup with high transfusion burden: 36% achieved ≥8-week transfusion independence vs 7% for placebo (nominal p=0.041), supporting targeted Phase III plans.
Clear Development Milestones and Timeline
Active Phase II monotherapy dose-optimization trial for FG-3246 (75 patients) with interim analysis planned in Q4 2026 and mature rPFS data anticipated in 2027; Phase III for roxadustat targeted to initiate in H2 2026.