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FibroGen Reports First Quarter 2025 Financial Results and Provides Business Update
FGENFibroGen(FGEN) GlobeNewswire·2025-05-12 20:02

Core Insights - FibroGen reported financial results for Q1 2025, highlighting a significant decrease in total revenue compared to the same period in 2024, with total revenue of 2.7millionversus2.7 million versus 25.4 million [14] - The company is focused on advancing its lead asset, FG-3246, with a Phase 2 monotherapy dose optimization study expected to start in Q3 2025 [2][5] - FibroGen is in the process of selling its China operations to AstraZeneca for approximately 185million,whichisexpectedtocloseinQ32025[5][6]FinancialPerformance−TotalrevenueforQ12025was185 million, which is expected to close in Q3 2025 [5][6] Financial Performance - Total revenue for Q1 2025 was 2.7 million, a decrease from 25.4millioninQ12024[14]−ThenetlossfromcontinuingoperationsforQ12025was25.4 million in Q1 2024 [14] - The net loss from continuing operations for Q1 2025 was 16.8 million, or 0.16pershare,comparedtoanetlossof0.16 per share, compared to a net loss of 49.0 million, or 0.49pershare,inthepreviousyear[14][19]−AsofMarch31,2025,FibroGenreported0.49 per share, in the previous year [14][19] - As of March 31, 2025, FibroGen reported 33.8 million in cash and cash equivalents in the U.S. and 128.4millionintotalconsolidatedcash[14]StrategicDevelopments−ThecompanyhasfiledaTypeCmeetingrequestwiththeFDAtodiscussthepotentialPhase3developmentprogramforroxadustatintreatinganemiaassociatedwithlower−riskmyelodysplasticsyndromes(LR−MDS)[2][7]−TheanticipatedinitiationofthePhase2monotherapytrialofFG−3246inmetastaticcastration−resistantprostatecancer(mCRPC)issetforQ32025[5][11]−ToplineresultsfromthePhase2portionoftheinvestigator−sponsoredstudyofFG−3246incombinationwithenzalutamideareexpectedinQ42025[5][6]TransactionDetails−ThesaleofFibroGenChinatoAstraZenecaisexpectedtoprovideatotalconsiderationofapproximately128.4 million in total consolidated cash [14] Strategic Developments - The company has filed a Type C meeting request with the FDA to discuss the potential Phase 3 development program for roxadustat in treating anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) [2][7] - The anticipated initiation of the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) is set for Q3 2025 [5][11] - Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected in Q4 2025 [5][6] Transaction Details - The sale of FibroGen China to AstraZeneca is expected to provide a total consideration of approximately 185 million, which includes an enterprise value of 85millionplusestimatednetcashof85 million plus estimated net cash of 100 million [5][6] - Upon closing, the transaction will extend FibroGen's cash runway into the second half of 2027 [5][14] Upcoming Milestones - The company anticipates feedback from the FDA regarding the development plan for roxadustat in Q3 2025 [7] - The Phase 2 trial of FG-3246 will also include FG-3180 to assess its diagnostic performance and correlation with CD46 expression [6][11]