Financial Data and Key Metrics Changes - For Q3 2025, total revenue was $1.1 million, a significant increase from $0.1 million in Q3 2024 [22] - Total operating costs and expenses decreased to $6.5 million from $47.8 million year-over-year, representing an 86% reduction [23] - Net loss from continuing operations was $13.1 million, compared to a net loss of $48.3 million in Q3 2024 [23] - Cash, cash equivalents, and investments as of September 30, 2025, totaled $121.1 million, extending the cash runway into 2028 [24] Business Line Data and Key Metrics Changes - The sale of FibroGen China to AstraZeneca was completed for approximately $220 million, providing access to cash and extending the company's runway [5][21] - The company is progressing with FG3246 and FG3180 in metastatic castration-resistant prostate cancer (MCRPC), with a phase two trial initiated [5][10] - Roxadustat is on track for a pivotal phase three trial for lower-risk myelodysplastic syndromes (MDS), with a regulatory path established following a successful FDA meeting [18][19] Market Data and Key Metrics Changes - The total addressable market for FG3246 in MCRPC is estimated to be over $5 billion annually [8] - Approximately 49,000 patients in the US are affected by anemia associated with lower-risk MDS, highlighting a significant market opportunity for Roxadustat [16] Company Strategy and Development Direction - The company aims to advance its mid and late-stage clinical development programs for FG3246 and Roxadustat, focusing on innovative treatment options for cancer and anemia [25] - The strategy includes leveraging the sale of FibroGen China to support US development initiatives and reduce fixed costs [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to advance meaningful therapeutic options and create shareholder value [6] - The company anticipates reporting top-line results from the investigator-sponsored trial of FG3246 in combination with enzalutamide in Q1 2026 [25] Other Important Information - The company has a clear regulatory path for Roxadustat, with plans to submit the phase three trial protocol by the end of 2025 [19][25] - The company has reduced its total operating costs and expenses guidance for 2025 to between $50 million and $60 million, reflecting a 70% reduction from 2024 [24] Q&A Session Summary Question: Congratulations on closing the $220 million deal with AstraZeneca - Management acknowledged the transformative nature of the transaction [26] Question: What proportion of patients might be screened out due to thrombotic risk in the Roxadustat trial? - Management indicated that it is too early to estimate the proportion, as it depends on FDA alignment and trial data [29] Question: What is the estimated cost of the phase three trial for Roxadustat? - The estimated cost is between $50 to $60 million, assuming an enrollment of about 200 patients [29] Question: Can you provide more details on the top-line data expectations from the IST study for FG3246? - Management expects encouraging results consistent with previous efficacy estimates, particularly focusing on patient history with ARPIs [37] Question: Is the $63 million liability related to milestone payments for the ADC asset? - Management clarified that the liability is related to royalties from the royalty financing with NovaQuest Capital Management [39] Question: When will the decision be made regarding the phase three trial for Roxadustat? - Management expects to have clarity on the path forward by the second quarter of next year [44]

November 10, 2025 FibroGen Reports Third Quarter 2025 Financial Results Forward-Looking Statements This release contains forward-looking statements regarding FibroGen's strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, convenience, and potential clinical or commercial success of F ...

Core Insights - FibroGen has initiated a Phase 2 monotherapy, dose-optimization trial for FG-3246, targeting metastatic castration-resistant prostate cancer (mCRPC) [1][2] - The trial will also evaluate FG-3180, a companion PET imaging agent, for its ability to identify mCRPC lesions and predict responses to FG-3246 [1][2] Company Developments - FibroGen has completed its transformation into a U.S.-focused organization and has a cash runway extending into 2028 [2] - The Phase 2 trial will enroll 75 patients who have progressed after androgen receptor signaling inhibitor (ARSI) treatment and have not received chemotherapy [2][6] - Interim analysis results from the Phase 2 study are expected in the second half of 2026 [2][6] Clinical Trial Details - The Phase 2 trial is a randomized, open-label study designed to determine the optimal dose of FG-3246 based on efficacy, safety, and pharmacokinetics [2][5] - Patients will be randomized to receive one of three doses: 1.8, 2.4, or 2.7 mg/kg AJBW of FG-3246 [2] - Secondary endpoints include radiographic progression-free survival (rPFS) and prostate-specific antigen (PSA) response rates [2][6] Product Information - FG-3246 is a first-in-class fully human antibody-drug conjugate (ADC) targeting CD46, which is highly expressed in prostate cancer [4][8] - The drug is linked to the anti-mitotic agent MMAE, which has shown anti-tumor activity in both preclinical and clinical studies [4][8] Market Context - Prostate cancer is the second most common malignancy in men, with approximately 13% of men diagnosed during their lifetime [7] - There are about 65,000 drug-treatable mCRPC cases annually in the U.S., with a 5-year survival rate of approximately 30% [7]

Financial Highlights - FibroGen China sale预计总对价约为2.1亿美元，比最初的指导增加了5000万美元[3] - 通过出售FibroGen China，公司预计可以获得约1.25亿美元的净现金，并将现金流延长至2028年[3] - 公司将偿还Morgan Stanley Tactical Value定期贷款[3] FG-3246 & FG-3180 Program - FG-3246在既往接受大量治疗的转移性去势抵抗性前列腺癌(mCRPC)患者的1期单药治疗研究中，显示出有意义的临床活性，中位rPFS为8.7个月[14, 17] - 在FG-3246联合恩杂鲁胺治疗mCRPC的1b期研究中，观察到有临床意义的疗效信号，初步估计的中位rPFS为10.2个月，71%的可评估患者PSA下降[19] - FG-3246的2期单药治疗试验预计将于2025年第三季度启动，中期结果预计在2026年下半年公布[3, 38] Roxadustat - 在MATTERHORN 3期试验的事后亚组分析中，对于高输血负担的患者，Roxadustat与安慰剂相比显示出输血独立(TI)的益处，在28周内，Roxadustat组有36%的患者达到8周RBC-TI，而安慰剂组只有7%[49, 50] - 计划的关键性3期试验的最终方案预计将于2025年第四季度提交[3, 52]

Core Insights - FibroGen reported financial results for Q2 2025, showing total revenue of $1.3 million, an increase from $1.0 million in Q2 2024, and a net loss of $13.7 million compared to a net loss of $47.1 million in the same period last year [16][21]. Recent Developments - The company is advancing its clinical pipeline, with the Phase 2 monotherapy trial of FG-3246 expected to start in Q3 2025 [2][6]. - FibroGen reached an agreement with the FDA to advance roxadustat towards a pivotal Phase 3 trial for lower-risk myelodysplastic syndromes (LR-MDS) [2][7]. - The sale of FibroGen China to AstraZeneca is expected to close in Q3 2025 for approximately $210 million, which includes $125 million in net cash [6][7]. Financial Overview - As of June 30, 2025, FibroGen reported $23.5 million in cash and cash equivalents in the U.S. and $142.1 million in total consolidated cash [16]. - The company expects its cash runway to extend into 2028 following the sale of FibroGen China [6][16]. Upcoming Milestones - The initiation of the Phase 2 trial for FG-3246 is anticipated in Q3 2025, with topline results from an investigator-sponsored study expected in Q4 2025 [6][8]. - FibroGen plans to file the pivotal Phase 3 clinical trial protocol for roxadustat in Q4 2025 [8]. Product Development - FG-3246 is a potential first-in-class antibody-drug conjugate targeting CD46, currently in a Phase 1b/2 study in combination with enzalutamide for metastatic castration-resistant prostate cancer [11][12]. - Roxadustat is in clinical development for chemotherapy-induced anemia and is already approved in several countries for treating anemia in chronic kidney disease [13][14].

FibroGen Transformation and Financial Outlook - FibroGen China 的出售给阿斯利康的总对价预计约为 1.85 亿美元，比最初的指导增加了 2500 万美元[3] - 出售 FibroGen China 是获得在中国持有的所有净现金（约 1 亿美元）的最有效方式，并将现金流延长至 2027 年下半年[3] - 该公司将偿还摩根士丹利 Tactical Value 定期贷款融资[3] FG-3246 and FG-3180 Program in mCRPC - FG-3246 是一种潜在的同类首创的 CD46 靶向 ADC，在预处理的 mCRPC 中具有临床意义的反应和良好的安全性[3] - FG-3246 单药治疗在 5L+ mCRPC 患者中显示出有意义的单药治疗临床活性，中位 rPFS 为 8.7 个月[13, 14] - 在评估 FG-3246 与恩杂鲁胺联合用药的 mCRPC 研究的 1b 期中期结果中，中位 rPFS 的初步估计值为 10.2 个月[18, 19] - 预计 2025 年第三季度启动 FG-3246 的 2 期单药治疗试验，包括 FG-3180，用于 ARSI 后/化疗前 mCRPC[3] - 预计 2025 年第四季度获得 FG-3246 与恩杂鲁胺联合用药的 mCRPC 研究的 2 期部分的主要结果[3, 20] Roxadustat Development Opportunity - 在较低风险 MDS 引起的贫血症中，Roxadustat 具有完全自主的后期美国开发机会[3] - 在 MATTERHORN III 期试验的亚组结果中，接受 roxadustat 治疗的输血负担较高的患者与安慰剂相比，达到 TI 的患者更多，在 28 周内 TI ≥ 56 天的患者比例为 36.1%，而安慰剂组为 11.5%[43, 44] - 预计 FDA 将在 2025 年第三季度就 roxadustat 治疗 LR-MDS 相关贫血症的潜在途径提供反馈[3]