FibroGen (FGEN) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of $0.03. This compares to loss of $0.33 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -633.33%. A quarter ago, it was expected that this biotech drug developer would post a loss of $0.08 per share when it actually produced a loss of $0.08, delivering no surprise.Over the last four quarters, the company has surpassed consens ...

FibroGen (FGEN) Q1 2025 Earnings Call May 12, 2025 05:00 PM ET Speaker0 Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Joanne Greller. Please go ahead. Speaker1 Thank you, operator. Good afternoon, everyone. Thank you for joining today to discuss FibroGen's first quarter twenty twenty five financial and business results. I'm Joanne Greller from LifeFi Advisors. Joining me on today's call are Thane Wedig, our Chief Executive Officer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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 FIBROGEN, INC. (Exact name of registrant as specified in its charter) Delaware 77-0357827 (State or Other Jurisdiction of ...

Exhibit 99.1 FibroGen Reports First Quarter 2025 Financial Results and Provides Business Update SAN FRANCISCO, May 12, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter 2025 and provided an update on the company's recent developments. "We continue to focus on our most important strategic priority of advancing our lead asset, FG-3246, with the initiation of the Phase 2 monotherapy dose optimization study in mCRPC, expected to start in the third quar ...

Total consideration for the sale of FibroGen China to AstraZeneca now expected to be approximately $185 million, a $25 million increase from initial guidance Net cash held in China at closing now estimated to be approximately $100 millionTransaction expected to close in 3Q 2025 Upon close of sale of FibroGen China, cash runway extended into 2H 2027 Initiation of the Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46 in metastatic castration-resista ...

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SAN FRANCISCO, May 05, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) will announce first quarter 2025 financial results on Monday, May 12 after the markets close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further detail the company's corporate and financial performance. Conference Call and Webcast PresentationThe FibroGen management team will host a conference call and webcast presentation to discuss the financial results and p ...

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]

FibroGen, Inc. (NASDAQ:FGEN) Q4 2024 Earnings Conference Call March 17, 2025 5:00 PM ET Company Participants Joanne Greller - LifeSci Advisors Thane Wettig - CEO David DeLucia - CFO Conference Call Participants Andy Sieh - William Blair Matthew Keller - H.C. Wainwright Operator Hello everyone, and welcome to the FibroGen Fourth Quarter and Full Year 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer s ...