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]

PART I—FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Unaudited financial statements show discontinued China operations, reduced net loss for continuing operations, and substantial doubt about going concern without the pending sale Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $23,367 | $50,482 | | Total current assets | $162,322 | $196,509 | | Total assets | $178,055 | $214,525 | | **Liabilities & Deficit** | | | | Total current liabilities | $155,895 | $133,306 | | Senior secured term loan facilities, non-current | $0 | $73,092 | | Total liabilities | $359,085 | $398,160 | | Total stockholders' deficit | ($222,997) | ($225,602) | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $1,348 | $998 | $4,088 | $26,363 | | Research and development | $5,865 | $32,360 | $15,040 | $68,848 | | Selling, general and administrative | $7,057 | $14,906 | $15,164 | $31,622 | | Loss from continuing operations | ($13,683) | ($47,095) | ($30,449) | ($96,141) | | Income from discontinued operations, net of tax | $6,080 | $31,551 | $27,485 | $47,664 | | Net loss | ($7,603) | ($15,544) | ($2,964) | ($48,477) | | Net loss per share - basic and diluted | ($1.88) | ($3.89) | ($0.73) | ($12.19) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $15,401 | ($99,157) | | Net cash provided by (used in) investing activities | ($29) | $123,515 | | Net cash used in financing activities | ($97) | ($133) | | Net increase in cash and cash equivalents | $17,663 | $27,026 | - The company has determined there is **substantial doubt about its ability to continue as a going concern** within 12 months, as it may not have sufficient liquidity for U.S. operations or be able to comply with its debt covenant without completing the sale of FibroGen International or raising additional capital[39](index=39&type=chunk) - On February 20, 2025, FibroGen agreed to sell all its roxadustat assets in China (FibroGen International) to AstraZeneca, with this transaction treated as a **discontinued operation** and related assets and liabilities classified as **'held for sale'**[31](index=31&type=chunk)[36](index=36&type=chunk)[47](index=47&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strategic focus on FG-3246 and roxadustat, noting reduced operating expenses and critical dependence on the China business sale for liquidity - The company's strategic focus is on developing **FG-3246**, a first-in-class ADC for metastatic castration-resistant prostate cancer (mCRPC), with a **Phase 2 study anticipated to start in Q3 2025**[137](index=137&type=chunk) - FibroGen had a **positive Type-C meeting with the FDA in July 2025** and reached alignment on key elements for a **proposed Phase 3 study of roxadustat for anemia associated with lower-risk myelodysplastic syndromes (MDS)**[139](index=139&type=chunk)[156](index=156&type=chunk) Operating Costs and Expenses Comparison (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Cost of goods sold | $337 | $21,483 | ($21,146) | (98)% | | Research and development | $15,040 | $68,848 | ($53,808) | (78)% | | Selling, general and administrative | $15,164 | $31,622 | ($16,458) | (52)% | | **Total operating costs and expenses** | **$31,060** | **$121,953** | **($90,893)** | **(75)%** | - The **significant decrease in operating expenses** for H1 2025 compared to H1 2024 was primarily driven by **lower employee-related costs** from a reduction in force, **termination of pamrevlumab programs**, and a **one-time $21.1 million cost of goods sold** in 2024 related to the AstraZeneca U.S./RoW agreement termination[141](index=141&type=chunk)[151](index=151&type=chunk)[206](index=206&type=chunk) - The company's liquidity is **critically dependent on the sale of its China operations**, as without completing the sale or raising additional capital, FibroGen will **not have sufficient funds for U.S. operations for the next 12 months** and will **violate its debt covenant**, raising **substantial doubt about its ability to continue as a going concern**[238](index=238&type=chunk)[414](index=414&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, FibroGen is not required to provide quantitative and qualitative disclosures about market risk - As a **smaller reporting company** defined in Rule 12b-2 of the Exchange Act, FibroGen is **not required to provide the information for this item**[244](index=244&type=chunk) [Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were **effective at the reasonable assurance level** as of June 30, 2025[246](index=246&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[247](index=247&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal actions, with no material accruals as of June 30, 2025, due to unestimable outcomes - The company did not have any **material accruals** for active legal actions as of June 30, 2025, because the outcomes could not be predicted or reasonably estimated[250](index=250&type=chunk) [Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including dependence on lead products, drug development uncertainties, reliance on collaborators, and critical going concern issues tied to the China operations sale - The company is **substantially dependent on the success of its lead products, roxadustat and FG-3246**, and failure in these programs would materially harm the business[255](index=255&type=chunk)[260](index=260&type=chunk) - A **critical risk is the company's ability to continue as a going concern**; failure to complete the sale of FibroGen International, access cash from China, or raise new capital would lead to **insufficient liquidity for U.S. operations** and a **breach of debt covenants**[379](index=379&type=chunk)[414](index=414&type=chunk) - The company faces **significant risks related to its operations in China**, including regulatory changes, geopolitical tensions, intellectual property protection challenges, and restrictions on cash repatriation, pending the sale of these operations[259](index=259&type=chunk)[380](index=380&type=chunk) - FibroGen **relies heavily on third-party collaborations** with partners like Astellas, and termination of these agreements or failure by partners to perform would adversely affect the development and commercialization of roxadustat[254](index=254&type=chunk)[306](index=306&type=chunk)[309](index=309&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=98&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - **None**[478](index=478&type=chunk) [Defaults Upon Senior Securities](index=98&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable - **Not applicable**[479](index=479&type=chunk) [Mine Safety Disclosures](index=98&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - **Not applicable**[480](index=480&type=chunk) [Other Information](index=98&type=section&id=Item%205.%20Other%20Information) There were no Rule 10b5-1 trading arrangements to report for the period - **None**[481](index=481&type=chunk) [Exhibits](index=98&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate amendments, financing agreements, officer certifications, and XBRL data

[Business Update and Highlights](index=1&type=section&id=Business%20Update%20and%20Highlights) FibroGen advanced its clinical pipeline and expects the $210 million FibroGen China sale to extend its cash runway into 2028 [Key Developments in Q2 2025](index=1&type=section&id=Key%20Developments%20in%20Q2%202025) FibroGen increased FibroGen China sale to $210 million, secured FDA agreement for roxadustat Phase 3, and plans FG-3246 Phase 2 - The sale of FibroGen China to AstraZeneca increased by **$50 million** to approximately **$210 million**, expected to close in Q3 2025[5](index=5&type=chunk)[6](index=6&type=chunk) - Upon closing the FibroGen China sale, the company's cash runway is projected to extend into **2028**[5](index=5&type=chunk)[3](index=3&type=chunk) - FibroGen reached an agreement with the U.S. FDA on key design elements for a pivotal Phase 3 trial for roxadustat in lower-risk myelodysplastic syndromes (LR-MDS) patients[5](index=5&type=chunk)[6](index=6&type=chunk)[3](index=3&type=chunk) - Initiation of the Phase 2 monotherapy trial of FG-3246 for metastatic castration-resistant prostate cancer (mCRPC) is expected in **Q3 2025**[5](index=5&type=chunk)[3](index=3&type=chunk) [Upcoming Milestones](index=2&type=section&id=Upcoming%20Milestones) FibroGen anticipates filing roxadustat's Phase 3 protocol in Q4 2025, initiating FG-3246 Phase 2 in Q3 2025, and expecting combination study results in Q4 2025 - The pivotal Phase 3 clinical trial protocol for roxadustat for anemia in LR-MDS patients is planned for submission in **Q4 2025**[7](index=7&type=chunk) - The Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC is expected to start in **Q3 2025**[14](index=14&type=chunk)[5](index=5&type=chunk) - Topline results from the investigator-sponsored Phase 1b/2 study of FG-3246 in combination with enzalutamide are expected in **Q4 2025**[14](index=14&type=chunk)[5](index=5&type=chunk) [Pipeline Overview](index=2&type=section&id=Pipeline%20Overview) FibroGen's pipeline focuses on oncology with FG-3246 (ADC for prostate cancer) and anemia with roxadustat (HIF-PH inhibitor for CKD and LR-MDS) [FG-3246 (CD46 Targeting ADC)](index=2&type=section&id=About%20FG-3246) FG-3246 is a potential first-in-class CD46-targeting ADC for mCRPC, with a Phase 2 monotherapy trial expected in Q3 2025 - FG-3246 is a potential first-in-class fully human ADC targeting the **CD46 receptor**, highly present in prostate cancer[10](index=10&type=chunk) - The ADC is composed of the anti-CD46 antibody YS5 linked to the clinically validated payload **MMAE**[10](index=10&type=chunk) - A Phase 2 monotherapy dose optimization trial for FG-3246 in mCRPC is anticipated to begin in **Q3 2025**[11](index=11&type=chunk)[3](index=3&type=chunk) [Roxadustat](index=2&type=section&id=About%20Roxadustat) Roxadustat is a first-in-class oral HIF-PH inhibitor approved for CKD anemia globally, now advancing towards a U.S. LR-MDS indication - Roxadustat is an oral, first-in-class **HIF-PH inhibitor** that promotes erythropoiesis[12](index=12&type=chunk) - It is approved in China, Europe, Japan, and other countries for the treatment of anemia of **CKD** in adult patients[13](index=13&type=chunk) - FibroGen is advancing roxadustat towards a pivotal Phase 3 trial in the U.S. for anemia in patients with **LR-MDS** and high transfusion burden[3](index=3&type=chunk)[6](index=6&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) FibroGen reported Q2 2025 revenue of **$1.3 million** and a narrowed net loss of **$13.7 million**, with the FibroGen China sale expected to extend cash runway [Statements of Operations Analysis](index=6&type=section&id=Statements%20of%20Operations%20Analysis) Q2 2025 revenue from continuing operations was **$1.3 million**, with net loss significantly reduced to **$13.7 million** due to lower R&D expenses Q2 2025 Statement of Operations Highlights (from Continuing Operations) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $1,348 | $998 | +35.1% | | Research and Development | $5,865 | $32,360 | -81.9% | | Loss from Operations | $(12,052) | $(46,408) | +74.0% | | Loss from Continuing Operations | $(13,683) | $(47,095) | +71.0% | | Loss per Share (basic & diluted) | $(3.38) | $(11.79) | +71.3% | [Balance Sheet Analysis](index=5&type=section&id=Balance%20Sheet%20Analysis) As of June 30, 2025, FibroGen reported total assets of **$178.1 million** and total liabilities of **$359.1 million**, with **$142.1 million** in total consolidated cash and receivables Condensed Balance Sheet Highlights | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $23,367 | $50,482 | | Current assets held for sale | $132,650 | $110,849 | | Total assets | $178,055 | $214,525 | | Total liabilities | $359,085 | $398,160 | | Total stockholders' deficit | $(202,510) | $(205,115) | - On June 30, 2025, FibroGen reported **$142.1 million** in total consolidated cash, cash equivalents, and accounts receivable[14](index=14&type=chunk) [Financial Outlook](index=1&type=section&id=Financial%20Outlook) FibroGen's financial outlook is bolstered by the pending FibroGen China sale, expected to extend cash runway into 2028 upon Q3 2025 close - The company expects its cash runway to be sufficient to fund operating plans into **2028** after the closing of the FibroGen China sale[14](index=14&type=chunk)[5](index=5&type=chunk)[3](index=3&type=chunk)

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].

Group 1 - FibroGen, Inc. will announce its second quarter 2025 financial results on August 11 after market close [1] - A conference call and webcast presentation will be held on the same day at 5:00 PM Eastern Time to discuss financial results and provide a business update [2] - The company is focused on developing novel therapies for cancer biology and anemia, with its drug Roxadustat approved in multiple countries for treating anemia in chronic kidney disease patients [3] Group 2 - FibroGen is also evaluating a development plan for Roxadustat in anemia associated with lower-risk myelodysplastic syndrome in the U.S. [3] - The company is developing FG-3246, a first-in-class antibody-drug conjugate targeting CD46 for metastatic castration-resistant prostate cancer [3] - FG-3180, an associated CD46-targeted PET biomarker, is also in development [4]

Core Viewpoint - FibroGen, Inc. will implement a 1-for-25 reverse stock split to increase the per-share market price and regain compliance with Nasdaq listing requirements [2][3]. Group 1: Reverse Stock Split Details - The reverse stock split will be effective at 5:00 p.m. Eastern Time on June 16, 2025, with trading on a split-adjusted basis starting June 17, 2025 [1]. - The number of issued and outstanding shares will decrease from approximately 101.1 million to about 4.0 million shares [3]. - Stockholders will receive cash payments for any fractional shares instead of receiving fractional shares [3]. Group 2: Approval and Purpose - The reverse stock split was approved by stockholders at the 2025 Annual Meeting held on June 4, 2025 [2]. - The primary goal of the reverse stock split is to increase the market price of FibroGen's common stock to meet Nasdaq's minimum bid price requirement [2]. Group 3: Company Overview - FibroGen is a biopharmaceutical company focused on developing novel therapies for cancer and anemia [5]. - Roxadustat is approved in multiple regions for treating anemia in chronic kidney disease patients [5]. - The company is also developing FG-3246, an antibody-drug conjugate for metastatic castration-resistant prostate cancer [5].

Company Overview - FibroGen, Inc. is a biopharmaceutical company focused on developing novel therapies in cancer biology and anemia [4] - The company has an approved product, Roxadustat (爱瑞卓®, EVRENZO™), for treating anemia in chronic kidney disease (CKD) patients in multiple regions including China, Europe, and Japan [4] - FibroGen is evaluating a development plan for Roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. [4] - The company is also developing FG-3246 (FOR46), a first-in-class antibody-drug conjugate targeting CD46 for metastatic castration-resistant prostate cancer [4] Leadership Appointment - Dr. Michael Kauffman has been appointed to the Board of Directors of FibroGen effective June 4, 2025 [1] - Dr. Kauffman is recognized as a biotech industry veteran with extensive experience in drug development, particularly in oncology [2] - His expertise is expected to be invaluable as FibroGen progresses its pipeline and approaches near-term clinical milestones [2] Dr. Michael Kauffman's Background - Dr. Kauffman has approximately 30 years of experience in the life sciences industry, focusing on oncology therapeutic products [3] - He currently serves as CEO and president of Nereid Therapeutics Inc. and is a board member of several other biotech companies [3] - His previous roles include co-founder and CEO of Karyopharm, CMO of Onyx Pharma, and leadership positions at Millennium Pharmaceuticals and Biogen [3] - Dr. Kauffman holds an MD and PhD from Johns Hopkins Medical School and is board certified in Internal Medicine [3]

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]

Company Performance - FibroGen reported a quarterly loss of $0.16 per share, significantly worse than the Zacks Consensus Estimate of $0.03, representing an earnings surprise of -633.33% [1] - The company posted revenues of $2.74 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 71.19%, but down from $55.9 million in the same quarter last year [2] - Over the last four quarters, FibroGen has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Movement and Outlook - FibroGen shares have declined approximately 41.8% since the beginning of the year, compared to a -3.8% decline in the S&P 500 [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.09 for the coming quarter and -$0.60 for the current fiscal year [4][7] - The current estimate revisions trend for FibroGen is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Drugs industry, to which FibroGen belongs, is currently ranked in the top 27% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact FibroGen's stock performance [5]

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]