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- **$220M China Sale**: Extended cash runway to 2028, reducing debt by $75M and receiving $6.4M of $10M holdback.
- **FG-3246 Milestones**: Phase II trial initiated with G-CSF prophylaxis; IST combo data due Q1 2026, interim Phase II results H2 2026.
- **Roxadustat Path**: FDA-aligned Phase III protocol for lower-risk MDS; $50-60M trial cost, exploring partner funding.
- **Financial Health**: Q3 2025 operating expenses down 86% YoY; $121.1M U.S. cash, no near-term liabilities beyond optional Phase III.

**【CEO Summary Section】**
- Completed sale of FibroGen China to AstraZeneca for $220M, extending cash runway to 2028 and paying off $75M term loan.
- Initiated Phase II monotherapy trial for FG-3246 in mCRPC with 75 patients, targeting optimal dose with G-CSF prophylaxis.
- Expected top-line results from FG-3246/enzalutamide IST in Q1 2026 and interim Phase II data in H2 2026.
- FDA-aligned Phase III protocol for roxadustat in lower-risk MDS with high transfusion burden, aiming for submission by end-2025.

**【CFO Financial Commentary】**
- Q3 2025 cash balance: $121.1M (U.S. only), with total operating costs reduced 86% YoY to $6.5M.
- Full-year 2025 operating expenses guidance: $50-60M, excluding potential Phase III trial costs ($50-60M).
- Received $6.4M of $10M holdback from China sale, with remaining $4M due Q2 2026.

**【Q&A Highlights】**
- Roxadustat Phase III cost: $50-60M, could reduce cash runway to mid-2027 if self-funded; exploring partnerships.
- FG-3246: 10.2-month rPFS in Ib IST combo trial; correlation between CD46/PSMA expression to be assessed in Phase II.
- No additional milestones for FG-3246 beyond $80M Phase III option; no royalty obligations post-approval.
- Decision on roxadustat trial path expected Q2 2026, with potential FDA-exclusivity supporting economic opportunity.

FibroGen, Inc. (FGEN) Q3 2025 Earnings Call Transcript

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KYNB

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