Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $1.3 million, an increase from $1 million in Q2 2024 [28] - The company raised its full-year revenue guidance to between $6 million and $8 million for 2025 [28] - Total operating costs and expenses decreased to $13.4 million in 2025 from $47.4 million in 2024, a reduction of 72% year over year [29] - R&D expenses were $5.9 million in 2025, down from $32.4 million in 2024, representing an 82% decrease [29] - SG&A expenses decreased to $7.1 million in 2025 from $14.9 million in 2024, a 53% reduction [29] - The net loss from continuing operations was $13.7 million or $3.38 per share in 2025, compared to a net loss of $47.1 million or $11.79 per share in 2024 [29] - Cash and cash equivalents totaled $142.1 million, including balances in China, with the company being cash flow positive in Q2 2025 [30] Business Line Data and Key Metrics Changes - The sale of FibroGen China to AstraZeneca is expected to provide total consideration of approximately $210 million, an increase of $50 million from initial guidance [5][26] - The transaction is anticipated to extend the company's cash runway into 2028 [5][27] Market Data and Key Metrics Changes - The total addressable market for FG3246 in the U.S. is estimated to exceed $5 billion annually, targeting metastatic castration-resistant prostate cancer [9] - The company is focused on addressing the unmet need in late-stage prostate cancer, with a five-year survival rate of approximately 30% for patients [8] Company Strategy and Development Direction - The company is prioritizing the sale of FibroGen China, advancing FG3246 and FG3180 in metastatic castration-resistant prostate cancer, and refining the pathway for roxadustat in treating anemia due to lower-risk myelodysplastic syndromes [4][5] - FG3246 is positioned as a potential first-in-class antibody-drug conjugate targeting CD46, with a companion PET imaging agent FG3180 [10][11] - The company aims to finalize the Phase III trial design for roxadustat and submit the protocol in 2025 [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's refined focus and simplified capital structure, which are expected to create value for patients and shareholders [8] - The company anticipates multiple near-term catalysts, including the initiation of the Phase II monotherapy study for FG3246 and reporting top-line results from the Phase II IST for FG3246 in combination with enzalutamide [33] Other Important Information - The company recorded a significant decrease in operating costs, reflecting a strategic shift and operational efficiency [29] - The FDA provided positive feedback regarding the pivotal Phase III trial for roxadustat, aligning on key design elements [23] Q&A Session Summary Question: Insights on FG3246 and Phase III design considerations - Management acknowledged the evolving nature of the field and the potential inclusion of docetaxel in the control arm for Phase III trials, emphasizing the need for further discussions [36][39] Question: Updates on roxadustat's exclusivity and trial design - Management confirmed a minimum of seven years of exclusivity with orphan drug designation for roxadustat and stated that the Phase III trial will be placebo-controlled [44][48] Question: Feedback from the physician community on FG3246 Phase I data - Management reported positive feedback from clinical sites regarding FG3246, highlighting its potential in the unmet need space for metastatic castration-resistant prostate cancer [56][58]

Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $2.7 million, a significant decrease from $25.4 million in the same period in 2024 [28] - Total operating costs and expenses for Q1 2025 were $17.7 million, down from $74.5 million in Q1 2024, representing a 76% year-over-year decrease [29] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49 million, or $0.49 per share, in Q1 2024 [29] Business Line Data and Key Metrics Changes - R&D expenses for Q1 2025 were $9.2 million, down from $36.5 million in Q1 2024, a decrease of 75% year-over-year [29] - SG&A expenses for Q1 2025 were $8.1 million, compared to $16.7 million in Q1 2024, a decrease of 51% year-over-year [29] Market Data and Key Metrics Changes - The total addressable market for FG3246 in metastatic castration-resistant prostate cancer (mCRPC) is estimated to be over $5 billion in annual sales [10] - Approximately 290,000 men are diagnosed with prostate cancer each year in the U.S., with 65,000 being drug-treatable patients in the metastatic castration-resistant stage [9] Company Strategy and Development Direction - The company is focused on advancing its U.S. pipeline opportunities, particularly FG3246 and FG3180, while divesting FibroGen China to simplify operations and extend cash runway [5][6] - The sale of FibroGen China to AstraZeneca is expected to close in Q3 2025, with total consideration now estimated at approximately $185 million, an increase from the initial guidance [5][6][27] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the refined focus and multiple near-term catalysts across clinical programs, positioning the company well for shareholder value creation [9] - The company anticipates FDA feedback on roxadustat's development for anemia associated with lower-risk myelodysplastic syndromes (MDS) in Q3 2025 [8] Other Important Information - The company reported cash flow positive results in Q1 2025, generating $7.3 million in cash flow on a consolidated basis [30] - Upon closing the China transaction, the company plans to pay off its senior secured term loan, resulting in a cash outflow of approximately $80 million [30] Q&A Session Summary Question: Regarding clinical development on FG3246 and market dynamics after Pluvicto approval - Management confirmed that Pluvicto experienced patients will be allowed in the Phase II monotherapy trial to mitigate enrollment challenges [39][40] Question: Comments on recent FDA correspondence regarding roxadustat - Management reported favorable interactions with the FDA, including timely responses for IND filings and Type C meeting requests [41][42][43] Question: Feasibility studies in colorectal cancer given cash infusion from AstraZeneca - Management indicated that they will hold off on colorectal cancer studies for now, focusing on initiating the Phase II monotherapy trial [44][45] Question: Rate limiting steps ahead of the upcoming Phase II monotherapy study - The close of the China transaction is the primary rate limiter for starting the Phase II monotherapy trial [50] Question: Evolving commercial opportunity for FG3180 - Management highlighted the importance of the Phase II trial in assessing the commercial potential of FG3180 as a diagnostic tool [52][54]

Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $2.7 million, a significant decrease from $25.4 million in Q1 2024 [27] - Total operating costs and expenses for Q1 2025 were $17.7 million, down 76% year-over-year from $74.5 million in Q1 2024 [28] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49 million, or $0.49 per share, in Q1 2024 [28] Business Line Data and Key Metrics Changes - The company is focused on advancing FG3246 and FG3180 in metastatic castration-resistant prostate cancer (mCRPC) [6] - Roxadustat is being developed for anemia associated with lower-risk myelodysplastic syndromes (MDS), with a Type C meeting request filed with the FDA [8][23] Market Data and Key Metrics Changes - There are approximately 290,000 men diagnosed with prostate cancer annually in the U.S., with 65,000 being drug-treatable patients in the mCRPC stage [9] - The total addressable market for FG3246 in mCRPC is estimated to exceed $5 billion in annual sales [10] Company Strategy and Development Direction - The company is divesting FibroGen China to AstraZeneca, with total consideration expected to increase to approximately $185 million, extending the cash runway into the second half of 2027 [5][26] - The strategic focus is on U.S. pipeline opportunities, particularly FG3246 and FG3180, and advancing clinical trials [4][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the refined focus and multiple near-term catalysts across clinical programs to create shareholder value [9] - The company anticipates important feedback from the FDA regarding roxadustat and plans to initiate the Phase II monotherapy study for FG3246 and FG3180 in mCRPC [31] Other Important Information - The company recorded cash flow positive results in Q1 2025, generating $7.3 million in cash flow on a consolidated basis [29] - The IND for FG3180 was cleared, allowing it to be used alongside FG3246 in upcoming trials [7][12] Q&A Session Summary Question: Regarding clinical development on FG3246 and market dynamics after Pluvicto approval - Management confirmed that Pluvicto experienced patients will be allowed in the Phase II monotherapy trial to mitigate enrollment challenges [38][39] Question: Comments on recent FDA communications regarding roxadustat - Management reported favorable interactions with the FDA, including timely responses to IND filings and Type C meeting requests [40][42] Question: Feasibility studies in colorectal cancer due to cash infusion from AstraZeneca - Management indicated that while colorectal cancer is a potential opportunity, the immediate focus is on starting the Phase II monotherapy trial [44][45]

Core Insights - FibroGen reported financial results for Q1 2025, highlighting a significant decrease in total revenue compared to the same period in 2024, with total revenue of $2.7 million versus $25.4 million [14] - The company is focused on advancing its lead asset, FG-3246, with a Phase 2 monotherapy dose optimization study expected to start in Q3 2025 [2][5] - FibroGen is in the process of selling its China operations to AstraZeneca for approximately $185 million, which is expected to close in Q3 2025 [5][6] Financial Performance - Total revenue for Q1 2025 was $2.7 million, a decrease from $25.4 million in Q1 2024 [14] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49.0 million, or $0.49 per share, in the previous year [14][19] - As of March 31, 2025, FibroGen reported $33.8 million in cash and cash equivalents in the U.S. and $128.4 million in total consolidated cash [14] Strategic Developments - The company has filed a Type C meeting request with the FDA to discuss the potential Phase 3 development program for roxadustat in treating anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) [2][7] - The anticipated initiation of the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) is set for Q3 2025 [5][11] - Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected in Q4 2025 [5][6] Transaction Details - The sale of FibroGen China to AstraZeneca is expected to provide a total consideration of approximately $185 million, which includes an enterprise value of $85 million plus estimated net cash of $100 million [5][6] - Upon closing, the transaction will extend FibroGen's cash runway into the second half of 2027 [5][14] Upcoming Milestones - The company anticipates feedback from the FDA regarding the development plan for roxadustat in Q3 2025 [7] - The Phase 2 trial of FG-3246 will also include FG-3180 to assess its diagnostic performance and correlation with CD46 expression [6][11]

Financial Data and Key Metrics Changes - For Q4 2024, total revenue was $3.1 million, down from $3.6 million in Q4 2023, representing a decrease of approximately 14% [38] - For the full year 2024, total revenue was $29.6 million, compared to $46.8 million in 2023, a decline of about 37% [38] - Operating costs and expenses for Q4 2024 were $10.3 million, a significant decrease of 84% from $66.3 million in Q4 2023 [41] - Full year 2024 operating costs were $180 million, down 51% from $369.5 million in 2023 [41] - The net loss from continuing operations for Q4 2024 was $8.7 million, compared to a net loss of $62.5 million in Q4 2023 [42] - For the full year 2024, the net loss was $153.1 million, down from $323 million in 2023 [42] Business Line Data and Key Metrics Changes - Development revenue for Q4 2024 was $0.4 million, down from $2.6 million in Q4 2023 [39] - Drug product revenue for Q4 2024 was $2.7 million, an increase from $1.1 million in Q4 2023 [40] - For the full year 2024, drug product revenue was $27.7 million, compared to $18.8 million in 2023, indicating a growth of approximately 47% [40] Market Data and Key Metrics Changes - The company is focusing on the U.S. market following the divestiture of FibroGen China, which is expected to close by mid-2025 [9][35] - The total addressable market for FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) is estimated to exceed $5 billion annually [13] Company Strategy and Development Direction - The sale of FibroGen China for approximately $160 million is aimed at simplifying operations and extending the cash runway into 2027 [9] - The company is prioritizing the advancement of FG-3246 and FG-3180 in mCRPC, with plans for a Phase 2 monotherapy study [10][12] - Roxadustat is being considered for development in treating anemia associated with lower-risk myelodysplastic syndrome (MDS), with an FDA meeting planned for Q2 2025 [11][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's refined focus and multiple near-term catalysts across its programs [12] - The company aims to create value for shareholders through a leaner organization focused on high-value oncology indications [46] - The upcoming milestones include the initiation of the Phase 2 study for FG-3246 and the FDA meeting regarding roxadustat [47] Other Important Information - The company has implemented significant cost reduction measures, including a 5% reduction in headcount and a shift to a virtual work environment [43] - The anticipated cash runway extends into 2027, with expectations of being cash flow positive in Q1 2025 [44][45] Q&A Session Summary Question: Can you characterize the level of stringency for the futility analysis coming up in mid-2026? - Management indicated that the futility analysis will assess both safety and efficacy parameters, but specific details were not disclosed [56] Question: What are the qualifications for patients regarding radioligand in the trial? - Patients treated with Pluvicto are eligible for the trial as long as they have not been treated within the prior 28 days [55] Question: Will the company consider new assets or indications given the strong cash balance? - Management stated that the focus remains on advancing FG-3246 and FG-3180, with no plans to branch out into new assets at this time [70] Question: What are the expectations going into the upcoming FDA meeting for roxadustat? - The company aims to leverage previous trial data to avoid additional dose-finding work and seeks to conduct a placebo-controlled trial with about 200 patients [72][76]