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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

- **China Sale Boosts Liquidity**: $210 million transaction extends cash runway to 2028, enabling U.S. R&D focus.
- **FG-3246 Clinical Momentum**: Phase I rPFS of 8.7 months; Phase II trial with G-CSF prophylaxis to begin Q3.
- **Roxadustat Regulatory Clarity**: FDA-aligned Phase III design for MDS anemia; protocol submission Q4 2025.
- **Financial Efficiency**: 72% YoY expense reduction; cash flow positive despite $13.7 million net loss.

**【CEO Summary Section】**
- **FibroGen China Sale Update**: Total consideration increased to $210 million, extending cash runway into 2028. Transaction expected to close this quarter.
- **FG-3246 & FG-3180 Programs**: Phase I monotherapy trial showed 8.7-month rPFS in heavily pretreated mCRPC patients. Phase II trial to begin Q3 2025 with G-CSF prophylaxis; companion PET imaging agent (FG-3180) to assess CD46 expression.
- **Roxadustat Progress**: Positive Type-C FDA meeting; Phase III trial design agreed for anemia in lower-risk MDS. Protocol submission expected Q4 2025.

**【CFO Financial Commentary】**
- **Q2 2025 Financials**: Revenue $1.3 million (vs. $1 million in Q2 2024). Net loss $13.7 million, down 72% YoY. Operating expenses reduced 72% YoY to $13.4 million.
- **Cash Position**: $23.5 million in U.S., $142.1 million total. Cash flow positive Q2; expects to remain so until China sale close.
- **Debt Repayment**: Post-China sale, plans to pay off $80 million senior term loan, freeing up cash for U.S. programs.

**【Q&A Highlights】**
- **FG-3246 Phase III Design**: Control arm considerations include docetaxel; Phase II combo trial with enzalutamide to report Q4 2025 rPFS data.
- **Roxadustat Exclusivity**: 7-year Orphan Drug Designation; Phase III placebo-controlled trial with ~200 patients.
- **Clinical Focus**: FG-3246 Phase II targeting 10+ months rPFS; roxadustat trial to leverage MATTERHORN subgroup analysis.

FibroGen, Inc. (FGEN) Q2 2025 Earnings Call Transcript

- **China Deal Boost**: $185M sale extends cash runway to 2027H2, up from initial $160M guidance.
- **FG-3246 Momentum**: 8.7-month rPFS in Phase 1; FDA clears companion PET agent for Phase 2 trial (Q3 start).
- **Roxadustat Pathway**: FDA meeting Q3 to clarify MDS development path; post hoc data shows transfusion benefit.
- **Financial Resilience**: 76% YoY expense reduction; $33.8M U.S. cash + $128.4M total (incl. China).

**【CEO Strategic Update】**
- **China Divestiture**: Total consideration increased to $185M (from $160M), extending cash runway to H2 2027. Expected close in Q3 2025.
- **FG-3246 Progress**: Phase 1 monotherapy study shows 8.7-month rPFS in 40 heavily pretreated mCRPC patients. FDA cleared IND for companion PET imaging agent FG-3180, enabling Phase 2 dose optimization trial (Q3 start).
- **Roxadustat Update**: Filed Type C meeting request with FDA for lower-risk MDS indication. Post hoc analysis of MATTERHORN trial shows promise in reducing transfusion dependence.

**【CFO Financial Highlights】**
- **Q1 2025 Results**: Revenue $2.7M (down 90% YoY), operating expenses $17.7M (down 76% YoY). Net loss $16.8M vs. $49M YoY.
- **Cash Position**: $33.8M in U.S., $128.4M total (incl. China). Q1 cash flow positive ($7.3M). Post-China sale, plans to pay down $80M MSTV term loan.
- **2025 Guidance**: Operating expenses $70-80M (58% YoY reduction). Revenue $4-8M.

**【Q&A Key Takeaways】**
- **Clinical Design**: Phase 2 monotherapy trial will allow Pluvicto-experienced patients but not exclusively target them. FG-3180 will be used for all 75 patients to assess CD46 expression-response correlation.
- **FDA Engagement**: Positive interactions on IND approvals and Type C meeting scheduling. No macro regulatory headwinds noted.
- **Commercial Potential**: FG-3180 could become a $1.5B+ PET imaging agent if diagnostic performance validates. Colorectal cancer expansion on hold to prioritize mCRPC development.


FibroGen (FGEN)-12 May 25-2025 Q1 Earnings call transcript

- **$160M China Sale Transforms Cash Runway**: Closing by mid-2025 extends liquidity to 2027, enabling U.S. pipeline focus.
- **FG-3246 Shows Promise in mCRPC**: 8.7m RPFS in Phase I, with Phase II trial (75 pts) starting mid-2025.
- **Roxadustat MDS Opportunity**: FDA meeting Q2 2025 to discuss Phase III trial for ESA-refractory anemia.
- **Cost Cuts Drive Efficiency**: 51% YoY expense reduction to $180M, positioning for lean operations.
- **Key 2025 Milestones**: FG-3246 combo trial readout, Phase II interim analysis, and MDS regulatory clarity.


**【CEO Strategic Overview】**
- Sold FibroGen China to AstraZeneca for $160M, extending cash runway to 2027 and simplifying operations.
- Focused on U.S. pipeline: FG-3246 (ADC targeting CD46 in mCRPC) and FG-3180 (PET imaging companion).
- FG-3246 Phase I monotherapy trial showed 8.7 months RPFS in 40 heavily pretreated patients, with 20% ORR and 36% PSA >50% reduction.
- Planning Phase II monotherapy trial in post-ARSI, pre-chemo mCRPC patients (75 pts) with G-CSF prophylaxis to mitigate neutropenia.
- Exploring roxadustat for anemia in lower-risk MDS; FDA meeting Q2 2025 to discuss potential Phase III trial design.

**【CFO Financial Update】**
- Q4 2024 revenue: $3.1M (down 14% YoY), FY2024: $29.6M (down 37% YoY) due to China divestiture.
- Operating expenses reduced 51% YoY to $180M, driven by R&D ($95.7M, -64%) and SG&A ($49.3M, -43%).
- Net loss from continuing ops: $153.1M FY2024 vs $323M prior year.
- Cash as of Dec 31, 2024: $51M (US) + $121.1M (China), with $80M term loan payoff post-China sale closure.
- FY2025 guidance: Revenue $4-8M, OPEX $70-80M, cash runway to 2027 post-transaction.

**【Q&A Highlights】**
- FG-3246 Phase II futility analysis will assess safety and early efficacy at 12 pts per dose cohort; no details on thresholds.
- MDS trial likely 200 pts, leveraging roxadustat's safety database but requiring new data for MDS-specific endpoints.
- No plans to acquire new assets; focused on advancing existing pipeline.
- FDA feedback sought on roxadustat dosing (2.5mg/kg) and trial design for ESA-refractory MDS patients.
- FG-3246 Phase II combo trial with enzalutamide expects top-line data H2 2025, alongside CD46 biomarker correlation.

**【Risk Considerations】**
- Regulatory and clinical trial execution risks for FG-3246 and roxadustat.
- Dependence on China sale completion for liquidity improvement.
- Competitive dynamics in mCRPC (e.g., Pluvicto) and MDS anemia markets.
- Need for successful patient enrollment in Phase II trials to meet milestones.


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