Financial Performance - Total revenue from continuing operations for Q3 2025 was $1.1 million, compared to $0.1 million in Q3 2024, representing a 1000% increase[15] - Net loss from continuing operations for Q3 2025 was $13.1 million, or $3.25 loss per share, compared to a loss of $48.3 million, or $12.01 loss per share, one year ago[15] - Total revenue for the three months ended September 2025 was $1,076,000, compared to $123,000 for the same period in 2024, representing a significant increase[19] - The net income for the three months ended September 2025 was $200,636,000, compared to a net loss of $17,084,000 in the same period of 2024[19] - Loss from continuing operations per share for the three months ended September 2025 was $(3.25), compared to $(12.01) in 2024[19] - Income from discontinued operations per share for the three months ended September 2025 was $52.86, up from $7.76 in 2024[19] Cash and Assets - Cash, cash equivalents, accounts receivable, and investments totaled $121.1 million as of September 30, 2025, providing a cash runway into 2028[15] - Total current assets as of September 30, 2025, were $133.4 million, down from $196.5 million at the end of 2024[18] Liabilities - Total liabilities as of September 30, 2025, were $119.5 million, a significant decrease from $398.2 million at the end of 2024[18] Research and Development - The company initiated the Phase 2 monotherapy trial of FG-3246, targeting metastatic castration-resistant prostate cancer, with interim results expected in the second half of 2026[3] - FibroGen is on track to submit the Phase 3 protocol for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes in Q4 2025[5] - Topline results from the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected to be presented at a medical conference in Q1 2026[6] Expenses - Research and development expenses for the three months ended September 2025 were $1,209,000, a decrease from $19,974,000 in the same period of 2024[19] - Selling, general and administrative expenses for the three months ended September 2025 were $5,295,000, down from $9,362,000 in 2024[19] - Total operating costs and expenses for the three months ended September 2025 were $6,487,000, compared to $47,815,000 in 2024[19] - Loss from operations for the three months ended September 2025 was $(5,411,000), a decrease from $(47,692,000) in 2024[19] Business Transactions - The sale of FibroGen China to AstraZeneca was completed for approximately $220 million, consisting of $85 million in enterprise value and $135 million in net cash held in China[6] - The company maintains rights to roxadustat in the U.S. and all markets outside of China, South Korea, and those licensed to Astellas[7]

Core Insights - FibroGen has completed the sale of its China operations to AstraZeneca for approximately $220 million, simplifying its capital structure and extending its cash runway into 2028 [2][5][6] - The company has initiated a Phase 2 monotherapy trial for FG-3246, a potential first-in-class antibody-drug conjugate targeting CD46 in metastatic castration-resistant prostate cancer, with interim results expected in the second half of 2026 [2][5][6] - FibroGen is on track to submit the Phase 3 protocol for roxadustat for the treatment of anemia in lower-risk myelodysplastic syndromes in the fourth quarter of 2025 [2][7] Recent Developments - The sale of FibroGen China included $85 million in enterprise value and approximately $135 million in net cash held in China [5][6] - The company has successfully repaid its term loan to Morgan Stanley Tactical Value, further simplifying its capital structure [6] - FibroGen maintains rights to roxadustat in the U.S. and other markets outside of China, South Korea, and those licensed to Astellas [6] Financial Performance - Total revenue for Q3 2025 was $1.1 million, compared to $0.1 million in Q3 2024 [15] - The net loss from continuing operations for Q3 2025 was $13.1 million, or $3.25 loss per share, a significant improvement from a loss of $48.3 million, or $12.01 loss per share, in the same quarter last year [15] - As of September 30, 2025, the company reported cash, cash equivalents, accounts receivable, and investments totaling $121.1 million, sufficient to fund operations into 2028 [15] Upcoming Milestones - Topline results from the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected to be presented at a medical conference in Q1 2026 [5][6] - The interim analysis for the Phase 2 monotherapy trial of FG-3246 is anticipated in the second half of 2026 [2][6] - The final protocol submission for the pivotal Phase 3 trial of roxadustat is expected in Q4 2025 [7]

Core Insights - FibroGen, Inc. will announce its third quarter 2025 financial results on November 10, 2025, after market close, followed by a conference call at 5:00 PM Eastern Time to discuss corporate and financial performance [1] Group 1: Financial Results Announcement - The financial results for the third quarter of 2025 will be disclosed on November 10, 2025, after market close [1] - A conference call will be held on the same day at 5:00 PM Eastern Time to provide further details on the company's performance [1] Group 2: Conference Call and Webcast - The FibroGen management team will host a conference call and webcast presentation to discuss financial results and provide a business update [2] - A live Q&A session will follow the presentation, and interested parties can access the live audio webcast [2] Group 3: Company Overview - FibroGen, Inc. is a biopharmaceutical company focused on developing novel therapies in cancer biology and anemia [3] - Roxadustat is approved in multiple regions, including China, Europe, and Japan, for treating anemia in chronic kidney disease patients [3] - The company is evaluating a Phase 3 trial for roxadustat in anemia associated with lower-risk myelodysplastic syndrome in the U.S. [3] - FG-3246, a first-in-class antibody-drug conjugate targeting CD46, is in Phase 2 development for metastatic castration-resistant prostate cancer [3]

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]

Summary of FibroGen FY Conference Call - September 09, 2025 Company Overview - **Company**: FibroGen (NasdaqGS:FGEN) - **Event**: 27th Annual H. C. Wainwright Global Investment Conference Key Points Financial and Operational Highlights - FibroGen completed the sale of its China operations to AstraZeneca for approximately **$220 million**, extending its cash runway into **2028** and allowing the payoff of a term loan with Morgan Stanley [3][31] - The sale simplified the company's capital structure by eliminating **$75 million** of debt [31] Product Development and Pipeline - **Antibody Drug Conjugate (ADC)** targeting CD46 for prostate cancer: - Phase one monotherapy trial showed a median **radiographic progression-free survival (RPFS)** of **8.7 months** and a **36% PSA 50 response** [12][19] - Phase two trial expected to initiate soon, with interim results anticipated in **2026** [6][19] - Companion PET imaging agent to assist in patient selection [11][19] - **Roxadustat** for anemia associated with lower risk myelodysplastic syndrome (MDS): - Approved in over **40 markets** for anemia related to chronic kidney disease [20][21] - Phase three trial protocol submission expected in the **fourth quarter of this year**, with trial initiation planned for **2026** [30][32] - Previous phase three trial showed a **36% transfusion independence** rate in patients with high transfusion burden [25][27] Market Opportunity - Significant unmet need in metastatic castration-resistant prostate cancer (mCRPC) and lower risk MDS: - mCRPC has a competitive landscape but still requires novel therapies [6][19] - The market for lower risk MDS projected to exceed **$4 billion** by **2030** [23][24] Regulatory and Clinical Strategy - Successful Type C meeting with the FDA regarding the design elements for the phase three trial of roxadustat [29][30] - Focus on mitigating thrombotic risks associated with roxadustat [29][30] Future Catalysts - Near-term catalysts include: - Initiation of the phase two monotherapy trial for ADC [18][32] - Top line results from the ongoing investigator-sponsored trial (IST) at UCSF expected by the end of the year [19][32] - Interim analysis from the phase two trial anticipated in the second half of next year [19][32] Additional Insights - The ADC program represents a novel mechanism of action with no current competitors targeting CD46 [19][32] - Roxadustat offers a potential oral treatment option for patients, which is particularly appealing for older patients with advanced health conditions [23][24] This summary encapsulates the critical aspects of FibroGen's conference call, highlighting the company's strategic direction, product pipeline, and market opportunities.

Core Viewpoint - FibroGen, Inc. has successfully completed the sale of its China subsidiary to AstraZeneca for approximately $220 million, significantly enhancing its financial position and extending its cash runway into 2028 [1][2][7] Financial Impact - The total consideration for the sale includes $85 million in enterprise value and about $135 million in net cash held in China, marking a $60 million increase from initial guidance [1][7] - Following the sale, FibroGen repaid its term loan facility to Morgan Stanley Tactical Value for approximately $81 million, simplifying its capital structure [2][7] Clinical Development Plans - The company is on track to initiate the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) in the third quarter of 2025 [2][4][7] - FibroGen intends to submit the Phase 3 protocol for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the fourth quarter of 2025, following a positive meeting with the U.S. FDA [3][4] Product Rights and Development - FibroGen retains rights to roxadustat in the U.S. and all markets not licensed to Astellas, excluding China and South Korea [3] - The company continues to advance the clinical development of FG-3246 and its companion diagnostic FG-3180 [4][5]

Company Announcement - FibroGen, Inc. will attend and present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York, NY [1] - CEO Thane Wettig will deliver a presentation on September 9 at 12:00 PM ET at the Lotte New York Palace Hotel, with a live webcast available [1] Investor Engagement - The management team will be available for one-on-one meetings during the conference, and interested investors should contact their representative at H.C. Wainwright [2] - A replay of the presentation will be posted on the FibroGen website for 90 days after the event [2] Company Overview - FibroGen is a biopharmaceutical company focused on developing novel therapies in cancer biology and anemia [3] - Roxadustat (EVRENZO™) is approved in multiple regions, including China, Europe, and Japan, for treating anemia in chronic kidney disease patients [3] - The company is evaluating a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome in the U.S. [3] - FG-3246 (FOR46), a first-in-class antibody-drug conjugate targeting CD46, is in development for metastatic castration-resistant prostate cancer, along with FG-3180, a CD46-targeted PET biomarker [3]

Core Viewpoint - The sale of FibroGen International (Hong Kong) Ltd. to AstraZeneca Treasury Limited has been approved by the China State Administration for Market Regulation and is expected to close in the third quarter of 2025 [1][2]. Company Overview - FibroGen, Inc. is a biopharmaceutical company focused on developing novel therapies for cancer biology and anemia [3]. - Roxadustat (EVRENZO™) is approved in multiple regions, including China, Europe, and Japan, for treating anemia in chronic kidney disease (CKD) patients [3]. - The company is evaluating a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. [3]. - FG-3246 (FOR46), a first-in-class antibody-drug conjugate targeting CD46, is in development for metastatic castration-resistant prostate cancer, along with FG-3180, a CD46-targeted PET biomarker [3].

Company Performance - FibroGen reported a quarterly loss of $3.38 per share, which was worse than the Zacks Consensus Estimate of a loss of $2.25, and an improvement from a loss of $4 per share a year ago, indicating a surprise of -50.22% [1] - The company posted revenues of $1.35 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 53.52%, and a significant decline from year-ago revenues of $50.64 million [2] - Over the last four quarters, FibroGen has surpassed consensus EPS estimates only once and has topped consensus revenue estimates two times [2] Stock Performance - FibroGen shares have declined approximately 34.2% since the beginning of the year, contrasting with the S&P 500's gain of 8.6% [3] - The current Zacks Rank for FibroGen is 4 (Sell), indicating expectations for the stock to underperform the market in the near future [6] Future Outlook - The consensus EPS estimate for the upcoming quarter is -$2.38 on revenues of $2.9 million, and for the current fiscal year, it is -$3.25 on revenues of $12.7 million [7] - The earnings outlook and estimate revisions trend for FibroGen were unfavorable prior to the earnings release, which may impact future stock movements [6][5] Industry Context - The Medical - Drugs industry, to which FibroGen belongs, is currently in the top 35% of over 250 Zacks industries, suggesting a relatively strong industry performance [8] - Another company in the same industry, AIM ImmunoTech Inc., is expected to report a quarterly loss of $8.00 per share, reflecting a year-over-year change of -166.7% [9]

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]