Kyntra Bio (KYNB) Q4 2025 earnings summary

Executive summary

• Completed sale of FibroGen China to AstraZeneca for ~$220 million, repaid senior secured term loan, and rebranded as Kyntra Bio, extending cash runway into 2028.

• Advanced FG-3246 (CD46-targeted ADC) and companion PET agent FG-3180 in mCRPC, with active phase II enrollment and interim results expected in the second half of 2026.

• Progressed roxadustat for anemia in lower-risk MDS, submitted phase III protocol, received orphan drug designation, and secured FDA agreement on trial design.

• Positive results from FG-3246 combination study with enzalutamide in mCRPC presented at ASCO GU 2026, supporting phase II design.

• Cash, equivalents, investments, and receivables totaled $109.4M at year-end, supporting operations into 2028.

Financial highlights

• Q4 2025 revenue was $1.3M, down from $3.1M in Q4 2024; full year 2025 revenue was $6.4M, down from $29.6M in 2024.

• Q4 2025 net loss from continuing operations was $14.6M ($3.61/share), compared to $8.7M ($2.15/share) in Q4 2024.

• Full year 2025 net loss from continuing operations was $58.2M ($14.40/share), improved from $153.1M ($38.26/share) in 2024.

• R&D expenses for 2025 were $23.5M, down from $95.7M in 2024; SG&A expenses were $27.7M, down from $49.3M.

• Gross margin for Q4 2025 was $1.0M on $1.3M revenue; operating loss for Q4 2025 was $13.5M, full year operating loss was $45.9M.

Outlook and guidance

• Interim results from the phase II FG-3246 monotherapy trial expected in the second half of 2026; mature RPFS data anticipated in 2027.

• Phase III trial for roxadustat in lower-risk MDS targeted to initiate in the second half of 2026, pending FDA feedback.

• Costs for an internally run phase III LR-MDS study are not included in current cash runway projections.

• Continued evaluation of internal development versus strategic partnership for roxadustat.