Revenue Performance - Revenue for the three months ended June 30, 2024, was $50.6 million, a 14.5% increase from $44.3 million in the same period of 2023[123]. - Roxadustat commercial sales in China contributed $49.6 million for the three months ended June 30, 2024, compared to $23.9 million in the same period of 2023, representing a 74.1% increase[124]. - Net product revenue for Q2 2024 was $49.6 million, a 108% increase from $23.9 million in Q2 2023[160]. - Total revenue for the six months ended June 30, 2024, was $106.5 million, up 32% from $80.5 million in the same period last year[163]. - Sales to Falikang generated net revenue of $46.0 million for Q2 2024, a 124% increase from $20.5 million in Q2 2023[169]. - Total product revenue, net increased by $25.8 million, or 108%, for Q2 2024 compared to Q2 2023[170]. - Revenue from sales to Falikang increased by $25.5 million, or 124%, for the three months ended June 30, 2024, and by $31.2 million, or 75%, for the six months ended June 30, 2024, compared to the same periods a year ago[173]. Financial Losses and Expenses - Net loss for the six months ended June 30, 2024, was $48.5 million, a significant reduction from a net loss of $164.4 million for the same period in 2023[128]. - Operating costs and expenses for the three months ended June 30, 2024, were $61.6 million, down from $132.4 million in the same period of 2023, reflecting a decrease of 53.5%[123]. - Operating expenses decreased due to a $24.6 million one-time charge in the prior year and lower clinical trial expenses by $17.7 million for the three months ended June 30, 2024[126]. - Total operating costs and expenses decreased by $70.8 million, or 53%, for the three months ended June 30, 2024, and by $96.1 million, or 39%, for the six months ended June 30, 2024, compared to the same periods a year ago[183]. - Selling, general and administrative (SG&A) expenses decreased by $8.9 million, or 29%, for the three months ended June 30, 2024, and decreased by $20.4 million, or 31%, for the six months ended June 30, 2024, compared to the same periods a year ago[190]. Research and Development - FG-3246 demonstrated a median radiographic progression-free survival of 8.7 months in a Phase 1 clinical study for metastatic castration-resistant prostate cancer[137]. - The company plans to initiate a Phase 2 monotherapy dose optimization study of FG-3246 in the first quarter of 2025[137]. - FG-3246 in combination with enzalutamide showed a median radiographic progression-free survival of 10.2 months in a Phase 1b/2 study with 17 patients[138]. - The maximally tolerated dose of FG-3246 was established at 2.1 mg/kg adjusted body weight, combined with enzalutamide 160 mg/day[138]. - Research and development expenses decreased by $61.4 million, or 64%, for the three months ended June 30, 2024, and by $97.5 million, or 57%, for the six months ended June 30, 2024, compared to the same periods a year ago[183]. - The company has implemented efforts to streamline operations, which may continue to decrease research and development expenses over time[186]. Cash and Financing - Cash and cash equivalents totaled $140.7 million as of June 30, 2024, a decrease of $101.0 million from December 31, 2023[128]. - Net cash used in operating activities was $99.2 million for the six months ended June 30, 2024, compared to $212.2 million for the same period in 2023[203]. - Total net cash provided by investing activities was $123.5 million for the six months ended June 30, 2024, compared to $89.2 million for the same period in 2023[204]. - The company anticipates continued losses despite expected revenue increases from commercial sales of roxadustat in China, Japan, and Europe[208]. - The company expects to need substantial additional funding to support ongoing operations and research and development efforts[209]. Collaborations and Agreements - The collaboration agreements with Astellas and AstraZeneca have generated a total of $790.1 million in consideration through June 30, 2024[152]. - The AstraZeneca U.S./RoW Agreement generated $439 million in milestone and upfront payments before its termination in February 2024[155]. - Future milestone payments under license agreements could total approximately $697.9 million, contingent upon achieving specific developmental and regulatory milestones[213]. Clinical Trials and Pipeline - Pamrevlumab did not meet the primary endpoint of overall survival in the PanCAN's Precision Promise trial, with a median overall survival of 17.3 months compared to 17.9 months in the control arm[143]. - The Phase 3 LAPIS trial for pamrevlumab included 284 patients, randomized 1:1 to receive either pamrevlumab or placebo[144]. - The preclinical pipeline includes FG-3165 and FG-3175, both targeted antibodies for immuno-oncology, with FG-3165 receiving FDA clearance for investigational new drug application[144][145]. - FibroGen made four quarterly payments totaling $5.4 million to Fortis for development obligations related to FG-3246[147]. - If the option to acquire Fortis is exercised, FibroGen will pay $80 million, with potential contingent payments of up to $200 million for regulatory approvals[147].

Core Insights - FibroGen's stock is experiencing a significant decline due to the failure of clinical trials for pamrevlumab, a treatment for pancreatic cancer [1][2] - The trials did not meet their primary endpoint of overall survival, which is a critical measure in clinical research [1][2] - The company plans to terminate the pamrevlumab program and reduce its workforce by 75% as part of a cost-saving strategy [3] Clinical Trial Results - The first clinical trial aimed at treating metastatic pancreatic cancer with pamrevlumab failed to meet its primary endpoint [1] - The second trial involved pamrevlumab in combination with gemcitabine and nab-paclitaxel for unresectable pancreatic cancer, which also did not achieve the primary endpoint [2] - Both trials were advanced studies, with the metastatic pancreatic cancer trial in Phase 2/3 and the unresectable pancreatic cancer trial in Phase 3 [2] Company Response - CEO Thane Wettig expressed disappointment over the trial results, highlighting the hope for pamrevlumab to provide innovative treatment options for pancreatic cancer patients [3] - The company is shifting to a cost-saving mode following the trial failures, indicating a significant restructuring effort [3] Stock Market Impact - Following the announcement of the trial failures, FibroGen's stock price dropped by 44.4% [4]

Conference Call and Webcast Toll-free: 1-877-300-8521 International investors: 1-412-317-6026 Webcast: Click here About FibroGen For Investor Inquiries: David DeLucia, CFA Vice President of Corporate FP&A / Investor Relations InvestorRelations@fibrogen.com SAN FRANCISCO, July 30, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) will announce second quarter 2024 financial results on Tuesday, August 6 after the market close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Tim ...

SAN FRANCISCO, June 18, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced it will host the second part of its virtual KOL investor event series on Wednesday, June 26, 2024 at 10:00 AM ET. To register, click here. A live question and answer session will follow the formal presentation. Rahul Aggarwal, MD is a Professor of Medicine and Thomas Perkins Distinguished Professor of Cancer Research at the University of California San Francisco. He is the Associate Director for Clinical Research i ...

Core Insights - FibroGen is collaborating with Regeneron Pharmaceuticals to evaluate two monoclonal antibodies, FG-3165 and FG-3175, in combination with Regeneron's anti-PD-1 therapy, LIBTAYO®, for treating select solid tumors [1][2] - FG-3165 targets Galectin-9 (Gal9), which suppresses T and NK cell activation, while FG-3175 targets CCR8, a receptor over-expressed on T regulatory cells in solid tumors [2][5][6] - The FDA has cleared the Investigational New Drug (IND) application for FG-3165, with an IND submission for FG-3175 anticipated in 2025 [4][6] Company Overview - FibroGen, Inc. is focused on developing novel therapies in cancer biology, with other products in development including Pamrevlumab for pancreatic cancer and Roxadustat for anemia in chronic kidney disease [7] - The company is expanding its research portfolio to include immuno-oncology product candidates for solid tumors [7]

Core Insights - FibroGen is collaborating with Regeneron Pharmaceuticals to evaluate two monoclonal antibodies, FG-3165 and FG-3175, in combination with Regeneron's anti-PD-1 therapy, LIBTAYO®, for treating select solid tumors [1][2][3] Group 1: Clinical Trials and Collaborations - FG-3165 targets Galectin-9 (Gal9), which suppresses T and NK cell activation, while FG-3175 targets CCR8, a receptor over-expressed on T regulatory cells in solid tumors [2][5][6] - Both FG-3165 and FG-3175 have shown complementary mechanisms of action with PD-1 inhibitors in preclinical studies, suggesting potential for improved clinical outcomes when combined with LIBTAYO® [1][2][5] - FibroGen will sponsor Phase 1 trials for both monotherapy and combination treatments, with Regeneron providing the drug supply [3] Group 2: Regulatory Developments - The FDA has cleared the Investigational New Drug (IND) application for FG-3165, with plans to initiate a Phase 1 trial in select solid tumors in the second half of 2024 [4][5] - An IND submission for FG-3175 is anticipated in 2025 [4][6] Group 3: Company Overview - FibroGen is focused on developing novel therapies in cancer biology, with other products in development including Pamrevlumab for pancreatic cancer and Roxadustat for anemia in chronic kidney disease [7] - The company is expanding its research portfolio to include immuno-oncology candidates targeting solid tumors [7]

The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors Plan to begin enrollment in 2H 2024 SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. "The FDA's IND clearan ...

The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors Plan to begin enrollment in 2H 2024 SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. "The FDA's IND clearan ...

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 transition period from to Commission file number: 001-36740 FIBROGEN, INC. (Exact name of registrant as specified in its charter) For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 San Francisco, CA 94158 (Address of Principal Execu ...

[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) FibroGen reported a strong start to 2024, highlighted by compelling Phase 1 data for FG-3246 and robust growth of its roxadustat business in China - CEO Thane Wettig highlighted a strong start to 2024, driven by compelling Phase 1 data for FG-3246 and continued robust growth of roxadustat in China[3](index=3&type=chunk) - The company reaffirms its cash runway into **2026**, supported by a cash, cash equivalents, investments, and accounts receivable balance of **$214.7 million**[3](index=3&type=chunk)[6](index=6&type=chunk)[12](index=12&type=chunk) - First quarter net revenue grew **55% year-over-year**, driven by roxadustat performance in China and a one-time drug product revenue recognition from the termination of the US/RoW AstraZeneca agreement[6](index=6&type=chunk)[12](index=12&type=chunk) [Key Milestones and Pipeline Developments](index=1&type=section&id=Key%20Milestones%20and%20Pipeline%20Developments) FibroGen outlined key upcoming milestones, including topline data for two pamrevlumab Phase 3 studies in pancreatic cancer and an approval decision for roxadustat in China [Pamrevlumab](index=1&type=section&id=Pamrevlumab) Topline data from two late-stage pamrevlumab trials in pancreatic cancer are expected in mid-2024 and Q3 2024 - Topline data from the PanCAN Precision Promise Phase 2/3 study in metastatic pancreatic cancer is anticipated in **mid-2024**[6](index=6&type=chunk)[7](index=7&type=chunk) - Topline data from the LAPIS Phase 3 study in locally advanced unresectable pancreatic cancer is expected in **Q3 2024**[6](index=6&type=chunk)[7](index=7&type=chunk) - Pamrevlumab has received Orphan Drug Designation and Fast Track designation from the U.S. FDA for the treatment of LAPC[14](index=14&type=chunk) [Roxadustat](index=1&type=section&id=Roxadustat) Roxadustat sales in China showed robust growth, with an approval decision for chemotherapy-induced anemia (CIA) expected in H2 2024 - An approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China is expected in the **second half of 2024**[4](index=4&type=chunk) - If approved for CIA, FibroGen is set to receive a **$10 million milestone payment** from AstraZeneca[4](index=4&type=chunk) - Roxadustat volume in China grew **39% year-over-year** in the first quarter[6](index=6&type=chunk)[12](index=12&type=chunk) [Oncology Pipeline](index=1&type=section&id=Oncology%20Pipeline) Compelling Phase 1 data for FG-3246 in mCRPC led to a planned Phase 2 study in H2 2024, alongside IND submissions for FG-3165 and FG-3175 - Phase 1 data for FG-3246 in mCRPC showed a median radiographic progression-free survival (rPFS) of **8.7 months** and a **36% rate of PSA reduction (≥ 50%)**[12](index=12&type=chunk) - A Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC is anticipated to start in the **second half of 2024**[7](index=7&type=chunk) - An IND was submitted for FG-3165 (Galectin-9 targeting mAb) in **April 2024**, and an IND filing for FG-3175 (anti-CCR8 mAb) is expected in **2025**[7](index=7&type=chunk)[12](index=12&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) FibroGen reported total revenues of **$55.9 million** for Q1 2024, a **55% increase year-over-year**, with net loss significantly narrowed to **$32.9 million** [Q1 2024 Financial Highlights](index=2&type=section&id=Q1%202024%20Financial%20Highlights) Total revenue increased **55% year-over-year** to **$55.9 million**, with net loss significantly reduced to **$32.9 million** or **$0.33 per share** Q1 2024 vs Q1 2023 Key Financials | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $55.9M | $36.2M | +55% | | Net Loss | ($32.9M) | ($76.7M) | +57% | | Net Loss per Share | ($0.33) | ($0.81) | +59% | Roxadustat China Sales Performance (Q1 2024 vs Q1 2023) | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | FibroGen Net Product Revenue (U.S. GAAP) | $30.5M | $24.2M | +26% | | Total Roxadustat Net Sales in China (incl. JDE) | $79.4M | $64.1M | +24% | - The company reaffirms its full-year 2024 net product revenue guidance under U.S. GAAP to range between **$120 million to $135 million**[12](index=12&type=chunk) - Cash, cash equivalents, investments, and accounts receivable totaled **$214.7 million** at March 31, 2024, supporting operations into **2026**[12](index=12&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Total revenue increased to **$55.9 million** in Q1 2024, driven by product and one-time drug product revenue, resulting in a reduced net loss of **$32.9 million** Condensed Consolidated Statements of Operations | (In thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | **Total revenue** | **$55,902** | **$36,161** | | Product revenue, net | $30,538 | $24,161 | | Drug product revenue, net | $24,486 | $2,109 | | **Total operating costs and expenses** | **$86,965** | **$112,252** | | Research and development | $38,392 | $74,486 | | Selling, general and administrative | $22,820 | $34,275 | | **Loss from operations** | **($31,063)** | **($76,091)** | | **Net loss** | **($32,933)** | **($76,705)** | | **Net loss per share - basic and diluted** | **($0.33)** | **($0.81)** | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$365.9 million** as of March 31, 2024, with total liabilities also decreasing to **$552.0 million** Condensed Consolidated Balance Sheet Highlights | (In thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $105,734 | $113,688 | | Short-term investments | $71,865 | $121,898 | | **Total current assets** | **$278,167** | **$331,559** | | **Total assets** | **$365,868** | **$423,529** | | **Liabilities and Stockholders' Deficit** | | | | **Total current liabilities** | **$196,733** | **$217,668** | | **Total liabilities** | **$552,023** | **$585,728** | | **Total stockholders' deficit** | **($207,635)** | **($183,679)** | [Corporate Information](index=2&type=section&id=Corporate%20Information) FibroGen appointed Deyaa Adib, MD as Chief Medical Officer and provided details for its Q1 2024 conference call and webcast - Appointed Deyaa Adib, MD as the new Chief Medical Officer[9](index=9&type=chunk) - The company is focused on accelerating the development of novel therapies in cancer biology, with key assets including pamrevlumab, roxadustat, and FG-3246[17](index=17&type=chunk)