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]

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