Core Insights - FibroGen, Inc. announced the publication of a Phase 1 study of FOR46 (FG-3246), an immune-modulating antibody-drug conjugate targeting CD46, in patients with metastatic castration-resistant prostate cancer (mCRPC) [1][2] Group 1: Study Overview - The Phase 1 study was a multi-center, first-in-human, open-label dose escalation and expansion study evaluating safety, tolerability, and anti-tumor activity in 56 heavily pre-treated patients [3][6] - The study showed FG-3246 had an acceptable safety profile with the most frequent adverse events being infusion-related reactions (48.2%), neutropenia (41.1%), and peripheral neuropathy (32.1%) [6][9] - The confirmed objective response rate was 20% with a median duration of response of 7.5 months, and the disease control rate was 80% [6][9] Group 2: Future Development Plans - The company plans to initiate a Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC by mid-2025 [4][5] - Topline results from a combination trial of FG-3246 and enzalutamide are expected in the second half of 2025 [4][11] Group 3: Background on mCRPC - Prostate cancer is the second most common malignancy in men, with approximately 13% of men diagnosed during their lifetime [10] - There are about 65,000 drug-treatable mCRPC cases in the U.S. annually, with a 5-year survival rate of approximately 30% [10] Group 4: About FG-3246 - FG-3246 is a potential first-in-class fully human antibody-drug conjugate targeting CD46, which is present at high levels in prostate cancer and other tumor types [11] - The drug is currently in an ongoing Phase 1/2 study at UCSF, evaluating it in combination with enzalutamide, with topline data expected in the second half of 2025 [11] Group 5: Company Overview - FibroGen, Inc. focuses on developing novel therapies in cancer biology and anemia, with Roxadustat approved in multiple countries for treating anemia in chronic kidney disease [12]

Financial Data and Key Metrics Changes - For Q4 2024, total revenue was $3.1 million, down from $3.6 million in Q4 2023, representing a decrease of approximately 14% [38] - For the full year 2024, total revenue was $29.6 million, compared to $46.8 million in 2023, a decline of about 37% [38] - The company recorded a net loss from continuing operations of $8.7 million in Q4 2024, compared to a net loss of $62.5 million in Q4 2023, indicating a significant improvement [42] - For the full year 2024, the net loss from continuing operations was $153.1 million, down from $323 million in 2023, reflecting a reduction of approximately 52% [42] Business Line Data and Key Metrics Changes - Development revenue for Q4 2024 was $0.4 million, down from $2.6 million in Q4 2023 [39] - Drug product revenue for Q4 2024 was $2.7 million, up from $1.1 million in Q4 2023, showing an increase of approximately 145% [40] - For the full year 2024, drug product revenue was $27.7 million, compared to $18.8 million in 2023, an increase of about 47% [40] Market Data and Key Metrics Changes - The total addressable market for FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) is estimated to exceed $5 billion annually [13] - The unmet need in late-stage prostate cancer is highlighted by the grim five-year survival rate of approximately 30% for patients diagnosed with mCRPC [13] Company Strategy and Development Direction - The company announced the sale of FibroGen China to AstraZeneca for approximately $160 million, which is expected to close by mid-2025 [9] - The focus is on advancing FG-3246 and FG-3180 in mCRPC, with plans for a Phase 2 monotherapy study and a meeting with the FDA regarding roxadustat for anemia associated with lower-risk MDS [11][47] - The company aims to create value for shareholders by refining its focus on high-value oncology indications and extending its cash runway into 2027 [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategic transformation and the potential for significant value creation through its focused pipeline [46] - The upcoming FDA meeting regarding roxadustat is anticipated to provide clarity on the development path for anemia associated with lower-risk MDS [33][47] Other Important Information - The company has implemented a significant cost reduction plan, resulting in a decrease in total operating costs and expenses by 51% year-over-year for 2024 [41] - The company expects total operating costs for 2025 to be between $70 million and $80 million, representing a 58% reduction from 2024 [44] Q&A Session Summary Question: Can you characterize the level of stringency for the futility analysis coming up in mid-2026? - Management indicated that the futility analysis will assess both safety and efficacy parameters, but specific details were not disclosed at this time [56] Question: What are the qualifications for patients who have experienced radioligand treatment in the trial? - Patients treated with Pluvicto previously are eligible for the trial, provided they have not been treated within the prior 28 days [55] Question: Will the cost-saving measures open up possibilities for new assets or indications? - Management stated that there are no plans to branch out into new assets at this time, maintaining a focus on advancing existing programs [70] Question: What are the expectations going into the upcoming FDA meeting regarding roxadustat? - The wish list includes the ability to proceed with a previously established dose without additional dose-finding work and to conduct a placebo-controlled trial [72][76]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-36740 Washington, D.C. 20549 Form 10-K FIBROGEN, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organ ...

Transaction Details - FibroGen entered into a share purchase agreement with AstraZeneca to sell FibroGen International for approximately $160 million, including $85 million in cash and an estimated $75 million in net cash held in China[7]. - The transaction is expected to close by mid-2025, pending regulatory approval from the China State Administration for Market Regulation[7]. - Upon closing, AstraZeneca will acquire all rights to roxadustat in China, Hong Kong, and Macao, while FibroGen retains rights in the United States, Canada, and Mexico[8][9]. - The cash payable by AstraZeneca at closing includes holdbacks of $6 million for final net cash adjustments and $4 million for indemnity claims[10]. - FibroGen will assign its rights to certain patents and trademarks related to roxadustat in the regions acquired by AstraZeneca[12]. - AstraZeneca is a long-time commercialization partner for roxadustat in Greater China and South Korea[8]. Financial Information - As of December 31, 2024, FibroGen estimated it had approximately $121.1 million in cash, cash equivalents, and accounts receivable[15]. - The estimated cash held in China is subject to change before closing, and the total amount payable to Morgan Stanley Tactical Value may also change materially[14]. - The preliminary financial information provided is unaudited and may be subject to adjustments before the year-end audited financial statements are completed[16][17]. Employment Impact - The sale will result in the cessation of employment for Christine L. Chung, Senior Vice President of China Operations, who is entitled to severance benefits[19].

Core Viewpoint - FibroGen, Inc. reported its financial results for Q4 and full year 2024, highlighting a strategic focus on advancing its clinical programs and improving its financial position through cost reduction and the sale of FibroGen China to AstraZeneca for approximately $160 million [1][2][8]. Financial Performance - Total revenue from continuing operations for Q4 2024 was $3.1 million, a decrease from $3.6 million in Q4 2023 [6]. - For the full year 2024, total revenue was $29.6 million, down from $46.8 million in 2023 [14]. - The net loss from continuing operations for Q4 2024 was $8.7 million, or $0.08 per share, compared to a net loss of $62.5 million, or $0.63 per share, in Q4 2023 [14][20]. - The net loss for the full year 2024 was $153.1 million, or $1.53 per share, compared to a net loss of $323.0 million, or $3.32 per share, in 2023 [14][20]. Recent Developments - The company plans to initiate a Phase 2 monotherapy trial of FG-3246, an ADC targeting CD46 for mCRPC, by mid-2025 [2][7]. - The sale of FibroGen China is expected to close by mid-2025, which will extend the company's cash runway into 2027 [8][14]. - FibroGen has completed a cost reduction program, aiming to create a leaner organization with a stronger financial position [2][8]. Upcoming Milestones - The initiation of the Phase 2 monotherapy dose optimization study of FG-3246 is anticipated by mid-2025 [8][11]. - Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected in the second half of 2025 [7][8]. Product Pipeline - FG-3246 is a first-in-class ADC targeting CD46, currently in a Phase 1b/2 study at UCSF [10][11]. - Roxadustat, an oral medication for anemia, is in development for lower-risk myelodysplastic syndrome (LR-MDS) and has a Supplemental New Drug Application accepted in China [5][12].

Financial Results Announcement - FibroGen, Inc. will announce its fourth quarter and full year 2024 financial results on March 17, 2025, after market close [1] - A conference call will be held on the same day at 5:00 PM Eastern Time to discuss the company's corporate and financial performance [1] Conference Call Details - The management team will host a conference call and webcast presentation to discuss financial results and provide a business update, followed by a live Q&A session [2] - Interested parties can access the live audio webcast and register for phone access to receive dial-in details [2] - A replay of the webcast will be available for a limited time on FibroGen's website [2] 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 development plan 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 development for metastatic castration-resistant prostate cancer, along with FG-3180, a CD46-targeted PET biomarker [3]

Core Viewpoint - FibroGen, Inc. has announced the sale of its China subsidiary to AstraZeneca for approximately $160 million, which is expected to strengthen its financial position and extend its cash runway into 2027 [1][2]. Financial Impact - The sale includes an enterprise value of $85 million plus an estimated $75 million in net cash held in China at closing, totaling approximately $160 million [2][7]. - Following the transaction, FibroGen will repay its term loan facility to Morgan Stanley Tactical Value, simplifying its capital structure [2][7]. Strategic Developments - The transaction allows FibroGen to continue advancing its clinical development programs, particularly for FG-3246, a first-in-class CD46 targeting antibody drug conjugate, and FG-3180, a companion PET imaging agent, with a Phase 2 trial for FG-3246 expected to begin in Q2 2025 [2][5]. - FibroGen retains rights to roxadustat in the U.S. and other markets not licensed to Astellas, and is evaluating a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) [4][8]. Market Position - Roxadustat is a leading treatment for anemia in chronic kidney disease in China, with a pending regulatory decision for chemotherapy-induced anemia [3].

Core Viewpoint - FibroGen, Inc. has announced the sale of its China subsidiary to AstraZeneca for approximately $160 million, which is expected to strengthen its financial position and extend its cash runway into 2027 [1][2]. Financial Impact - The sale includes an enterprise value of $85 million plus an estimated $75 million in net cash held in China at closing, totaling around $160 million [2][7]. - Following the transaction, FibroGen plans to repay its term loan facility to Morgan Stanley Tactical Value, simplifying its capital structure [2][7]. Strategic Developments - The transaction allows FibroGen to continue advancing its clinical development programs, particularly for FG-3246, a first-in-class antibody-drug conjugate, and FG-3180, a companion PET imaging agent, with a Phase 2 trial expected to start in Q2 2025 [2][5]. - FibroGen retains rights to roxadustat in the U.S. and other markets not licensed to Astellas, and is evaluating a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) [4][8]. Market Position - Roxadustat is a leading treatment for anemia in chronic kidney disease in China, with a pending regulatory decision for chemotherapy-induced anemia [3][8].

SAN FRANCISCO, Dec. 16, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the appointment of David DeLucia to Chief Financial Officer (CFO), effective December 16, 2024. The company previously announced that Juan Graham would step down on December 15, 2024. Reporting to Chief Executive Officer Thane Wettig, DeLucia will lead and oversee FibroGen’s global finance organization. He has most recently served as FibroGen’s Vice President, Head of Corporate Financial Planning and Analysis, Inv ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was $46.3 million, a 15% increase from $40.1 million in Q3 2023 [37] - Roxadustat net product revenue in China was $46.2 million for Q3 2024, up 57% from $29.4 million in Q3 2023 [37][39] - The company recorded a net loss of $17.1 million or $0.17 per share, compared to a net loss of $63.6 million or $0.65 per share in Q3 2023 [45] Business Line Data and Key Metrics Changes - Roxadustat sales in China totaled $96.6 million in Q3 2024, a 25% increase from $77.1 million in Q3 2023, driven by a 34% increase in volume [28][39] - The company reiterated its full-year net product revenue guidance of $135 million to $150 million, raising the lower end of the guidance for roxadustat net sales in China to $330 million to $350 million [9][41] Market Data and Key Metrics Changes - Roxadustat maintained a 45% brand value share in China as of August 2024 [29] - The company expects an approval decision for chemotherapy-induced anemia in early 2025, which would provide a significant growth opportunity [10][29] Company Strategy and Development Direction - The company is focusing on advancing FG-3246 and FG-3180 in metastatic castration-resistant prostate cancer (mCRPC) as a key priority [8] - The company regained rights to roxadustat in the U.S. and is exploring development opportunities for anemia in patients with lower-risk myelodysplastic syndromes [33][34] - The company aims to enhance roxadustat's value and is actively seeking partnerships for its oncology pipeline [51][52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's refined focus and strong foundation to create shareholder value [12] - The anticipated initiation of the Phase 2 dose optimization study for FG-3246 in Q1 2025 and top-line results from the Phase 2 portion of the combination study are expected in the first half of 2025 [26][53] Other Important Information - The company has reduced its operating costs significantly, with total operating costs and expenses for Q3 2024 at $63.1 million, down 39% year-over-year [42] - Cash, cash equivalents, and accounts receivable stood at $160 million as of September 30, 2024, reflecting an increase of $12.9 million quarter-over-quarter [47] Q&A Session Summary Question: Clarification on Phase II study and data release - Management confirmed that top-line results for the investigator-sponsored trial will include data from both the escalation and expansion cohorts, with expectations for results in the first half of next year [56] Question: Logistics of PET imaging agent - Management indicated that the PET imaging agent will require a longer wait time for imaging compared to current standards, likely around six days post-exposure [59] Question: Guidance on roxadustat sales and deferred revenue - Management explained that the guidance for roxadustat sales considers potential approval of the chemotherapy-induced anemia indication, which may affect revenue recognition [66]