Workflow
FibroGen(FGEN) - 2025 Q2 - Quarterly Results
FibroGenFibroGen(US:FGEN)2025-08-11 20:05

Business Update and Highlights FibroGen advanced its clinical pipeline and expects the $210 million FibroGen China sale to extend its cash runway into 2028 Key Developments in Q2 2025 FibroGen increased FibroGen China sale to $210 million, secured FDA agreement for roxadustat Phase 3, and plans FG-3246 Phase 2 - The sale of FibroGen China to AstraZeneca increased by $50 million to approximately $210 million, expected to close in Q3 202556 - Upon closing the FibroGen China sale, the company's cash runway is projected to extend into 202853 - FibroGen reached an agreement with the U.S. FDA on key design elements for a pivotal Phase 3 trial for roxadustat in lower-risk myelodysplastic syndromes (LR-MDS) patients563 - Initiation of the Phase 2 monotherapy trial of FG-3246 for metastatic castration-resistant prostate cancer (mCRPC) is expected in Q3 202553 Upcoming Milestones FibroGen anticipates filing roxadustat's Phase 3 protocol in Q4 2025, initiating FG-3246 Phase 2 in Q3 2025, and expecting combination study results in Q4 2025 - The pivotal Phase 3 clinical trial protocol for roxadustat for anemia in LR-MDS patients is planned for submission in Q4 20257 - The Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC is expected to start in Q3 2025145 - Topline results from the investigator-sponsored Phase 1b/2 study of FG-3246 in combination with enzalutamide are expected in Q4 2025145 Pipeline Overview FibroGen's pipeline focuses on oncology with FG-3246 (ADC for prostate cancer) and anemia with roxadustat (HIF-PH inhibitor for CKD and LR-MDS) FG-3246 (CD46 Targeting ADC) FG-3246 is a potential first-in-class CD46-targeting ADC for mCRPC, with a Phase 2 monotherapy trial expected in Q3 2025 - FG-3246 is a potential first-in-class fully human ADC targeting the CD46 receptor, highly present in prostate cancer10 - The ADC is composed of the anti-CD46 antibody YS5 linked to the clinically validated payload MMAE10 - A Phase 2 monotherapy dose optimization trial for FG-3246 in mCRPC is anticipated to begin in Q3 2025113 Roxadustat Roxadustat is a first-in-class oral HIF-PH inhibitor approved for CKD anemia globally, now advancing towards a U.S. LR-MDS indication - Roxadustat is an oral, first-in-class HIF-PH inhibitor that promotes erythropoiesis12 - It is approved in China, Europe, Japan, and other countries for the treatment of anemia of CKD in adult patients13 - FibroGen is advancing roxadustat towards a pivotal Phase 3 trial in the U.S. for anemia in patients with LR-MDS and high transfusion burden36 Financial Performance FibroGen reported Q2 2025 revenue of $1.3 million and a narrowed net loss of $13.7 million, with the FibroGen China sale expected to extend cash runway Statements of Operations Analysis Q2 2025 revenue from continuing operations was $1.3 million, with net loss significantly reduced to $13.7 million due to lower R&D expenses Q2 2025 Statement of Operations Highlights (from Continuing Operations) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $1,348 | $998 | +35.1% | | Research and Development | $5,865 | $32,360 | -81.9% | | Loss from Operations | $(12,052) | $(46,408) | +74.0% | | Loss from Continuing Operations | $(13,683) | $(47,095) | +71.0% | | Loss per Share (basic & diluted) | $(3.38) | $(11.79) | +71.3% | Balance Sheet Analysis As of June 30, 2025, FibroGen reported total assets of $178.1 million and total liabilities of $359.1 million, with $142.1 million in total consolidated cash and receivables Condensed Balance Sheet Highlights | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $23,367 | $50,482 | | Current assets held for sale | $132,650 | $110,849 | | Total assets | $178,055 | $214,525 | | Total liabilities | $359,085 | $398,160 | | Total stockholders' deficit | $(202,510) | $(205,115) | - On June 30, 2025, FibroGen reported $142.1 million in total consolidated cash, cash equivalents, and accounts receivable14 Financial Outlook FibroGen's financial outlook is bolstered by the pending FibroGen China sale, expected to extend cash runway into 2028 upon Q3 2025 close - The company expects its cash runway to be sufficient to fund operating plans into 2028 after the closing of the FibroGen China sale1453