Financial Data and Key Metrics Changes - For Q4 2025, total revenue was $1.3 million, down from $3.1 million in Q4 2024, representing a decline of approximately 58.1% [23] - For the full year 2025, total revenue was $6.4 million, compared to $29.6 million in 2024, a decrease of about 78.4% [23] - Total operating costs and expenses for Q4 2025 were $14.8 million, up from $10.3 million in Q4 2024 [23] - For the full year 2025, total operating costs and expenses were $52.3 million, significantly reduced from $180 million in 2024 [23] - The net loss for Q4 2025 was $14.6 million, or $3.61 per share, compared to a net loss of $8.7 million, or $2.15 per share in Q4 2024 [25] - The net loss for the full year 2025 was $58.2 million, or $14.40 per share, down from a net loss of $153.1 million, or $38.26 per share in 2024 [25] - As of December 31, the company reported $109.4 million in cash equivalents, investments, and accounts receivable, with a cash runway expected into 2028 [26] Business Line Data and Key Metrics Changes - The company is advancing the FG-3246 program, a potential first-in-class antibody drug conjugate targeting CD46 in metastatic castration-resistant prostate cancer [4][5] - The FG-3246 program is expected to address a significant unmet need in late-stage prostate cancer, with an estimated total addressable market of over $5 billion annually in the U.S. [8] - Roxadustat is being developed for anemia associated with lower-risk myelodysplastic syndromes (MDS), with a significant opportunity due to the lack of oral treatments currently available [18][22] Market Data and Key Metrics Changes - Approximately 290,000 men are diagnosed with prostate cancer each year in the U.S., with about 65,000 drug-treatable patients with metastatic disease that has become castration-resistant [7] - The incidence of grade 3 or greater neutropenia was substantially reduced with the utilization of GCSF prophylaxis in ongoing trials [12] Company Strategy and Development Direction - The company aims to rebrand from FibroGen to Kyntra Bio to better reflect its focus on oncology and rare diseases [7] - The strategy includes advancing mid and late-stage assets and simplifying the capital structure to create value for shareholders [7] - The company is focused on developing FG-3246 and its companion FG-3180 program, with expected interim analysis from the phase 2 monotherapy trial in the second half of 2026 [27] Management's Comments on Operating Environment and Future Outlook - Management highlighted 2025 as a transformational year, emphasizing the importance of reducing fixed costs to maximize cash runway and invest in U.S. pipeline opportunities [26] - The company remains confident in its positioning to create meaningful therapeutic options for patients and significant value for shareholders [7] Other Important Information - The company has received orphan drug designation for roxadustat, which provides a minimum of 7 years of regulatory exclusivity [22] - The company is exploring opportunities to develop roxadustat internally or with a strategic partner [21] Q&A Session Summary Question: Imaging of CD46 opportunity and commercial potential - Management discussed the potential market for CD46 PET imaging agents and how they would fit into the treatment algorithm alongside existing PSMA agents [30][32] - The company anticipates that patients will need to show positive uptake of CD46 PET imaging to be prescribed FG-3246, similar to the requirements for PSMA agents [34] Question: SUV data and patient selection - Management acknowledged the provocative nature of the SUV data and its potential role in enriching patient selection for treatment [30][40] - The phase 2 trial is designed to define CD46 positivity, which may be based on SUV or other metrics [40] Question: Balance of patients in studies and recruitment - Management clarified that the phase 2 monotherapy trial will focus on patients who have progressed on only one prior ARPI, differentiating it from the IST [46] Question: Updates on roxadustat partnering efforts - Management stated that they are evaluating the opportunity to develop roxadustat internally or through collaboration but did not provide specific updates on the partnering process [49] Question: FDA feedback timeline for roxadustat - Management explained that the FDA indicated a feedback timeline of 60-90 days due to the nature of the protocol submission, which is currently being awaited [53]

Financial Highlights - FibroGen completed the sale of FibroGen China to AstraZeneca for approximately $220 million[3, 50] - The sale included an enterprise value of $85 million and approximately $135 million of FibroGen net cash held in China[50] - The company successfully repaid its term loan to Morgan Stanley Tactical Value[3, 50] - FibroGen extended its cash runway into 2028[3, 50] FG-3246 and FG-3180 Program (Prostate Cancer) - Phase 2 monotherapy trial of FG-3246 and FG-3180 in mCRPC (post-ARPI / pre-chemo setting) has been initiated, with interim results expected in 2H 2026[3, 17, 18] - In a Phase 1 monotherapy study, FG-3246 showed a median rPFS of 8.7 months and a PSA decline of >50% in approximately 36% of patients[15] - In a Phase 1b combination study with enzalutamide, FG-3246 showed a preliminary estimate of median rPFS of 10.2 months and PSA declines in 71% of evaluable patients[15] - Topline results from an investigator-sponsored trial (IST) of FG-3246 in combination with enzalutamide in mCRPC are expected in 1Q 2026[3, 15] Roxadustat (Anemia of LR-MDS) - Roxadustat is being developed as a late-stage development opportunity for anemia due to LR-MDS and high red blood cell transfusion burden[3, 36] - In a post-hoc analysis of the MATTERHORN Phase 3 trial, roxadustat showed promising transfusion independence (TI) benefits compared to placebo in patients with high transfusion burden, with 36% achieving 8-week RBC-TI within 28 weeks compared to 7% for placebo[37, 38] - Phase 3 protocol submission is anticipated in 4Q 2025 for roxadustat in anemia of LR-MDS, with potential Phase 3 initiation in 2026[3, 45]

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]

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]