Fibrogen Stock Earnings Reports

Kyntra Bio reported Q1 2026 progress focused on two clinical programs and maintained financial stability. FG-3246 (CD46-targeting ADC) and its companion PET imaging agent FG-3180 are in a Phase II monotherapy dose-optimization trial in post-1 ARPI, pre-chemotherapy metastatic castration-resistant prostate cancer (mCRPC). The Phase II will enroll ~75 patients across three dose levels, uses primary G-CSF prophylaxis to mitigate neutropenia, includes FG-3180 imaging for exploratory biomarker-based patient selection, and has an interim analysis planned for Q4 2026; mature rPFS data expected in 2027. Prior data: Phase I monotherapy showed median rPFS 8.7 months, PSA50 in 36% of patients, and ORR 20%; an investigator-initiated study (IST) combining FG-3246 with enzalutamide showed median rPFS 7.0 months overall and 10.1 months in patients with only one prior ARPI. FG-3180 PET uptake showed a trend associating higher CD46 tumor uptake with greater PSA50 response, supporting its potential as a selection biomarker. Roxadustat (oral HIF prolyl hydroxylase inhibitor) is being advanced for anemia in lower-risk myelodysplastic syndromes (MDS); it received orphan drug designation, showed encouraging post-hoc results in a high-transfusion-burden subgroup (36% achieving ≥8-week transfusion independence vs 7% placebo), and the Phase III protocol (primary endpoint: 8-week transfusion independence; key secondaries: 12- and 16-week) is being finalized after constructive FDA feedback with expected initiation in H2 2026. Financials: Q1 revenue $3.7M; operating expenses roughly flat YoY; net loss from continuing operations $15.1M ($3.74/share). Cash, cash equivalents, investments and accounts receivable totaled $100.3M as of March 31, 2026, with a stated cash runway into 2028. Upcoming catalysts: FG-3246/FG-3180 Phase II interim readout (Q4 2026), roxadustat Phase III initiation (H2 2026), and mature FG-3246 rPFS data in 2027.