FibroGen (NasdaqGS:FGEN) FY Conference Transcript

Summary of FibroGen FY Conference Call - September 09, 2025 Company Overview - Company: FibroGen (NasdaqGS:FGEN) - Event: 27th Annual H. C. Wainwright Global Investment Conference Key Points Financial and Operational Highlights - FibroGen completed the sale of its China operations to AstraZeneca for approximately $220 million, extending its cash runway into 2028 and allowing the payoff of a term loan with Morgan Stanley [3][31] - The sale simplified the company's capital structure by eliminating $75 million of debt [31] Product Development and Pipeline - Antibody Drug Conjugate (ADC) targeting CD46 for prostate cancer: - Phase one monotherapy trial showed a median radiographic progression-free survival (RPFS) of 8.7 months and a 36% PSA 50 response [12][19] - Phase two trial expected to initiate soon, with interim results anticipated in 2026 [6][19] - Companion PET imaging agent to assist in patient selection [11][19] - Roxadustat for anemia associated with lower risk myelodysplastic syndrome (MDS): - Approved in over 40 markets for anemia related to chronic kidney disease [20][21] - Phase three trial protocol submission expected in the fourth quarter of this year, with trial initiation planned for 2026 [30][32] - Previous phase three trial showed a 36% transfusion independence rate in patients with high transfusion burden [25][27] Market Opportunity - Significant unmet need in metastatic castration-resistant prostate cancer (mCRPC) and lower risk MDS: - mCRPC has a competitive landscape but still requires novel therapies [6][19] - The market for lower risk MDS projected to exceed $4 billion by 2030 [23][24] Regulatory and Clinical Strategy - Successful Type C meeting with the FDA regarding the design elements for the phase three trial of roxadustat [29][30] - Focus on mitigating thrombotic risks associated with roxadustat [29][30] Future Catalysts - Near-term catalysts include: - Initiation of the phase two monotherapy trial for ADC [18][32] - Top line results from the ongoing investigator-sponsored trial (IST) at UCSF expected by the end of the year [19][32] - Interim analysis from the phase two trial anticipated in the second half of next year [19][32] Additional Insights - The ADC program represents a novel mechanism of action with no current competitors targeting CD46 [19][32] - Roxadustat offers a potential oral treatment option for patients, which is particularly appealing for older patients with advanced health conditions [23][24] This summary encapsulates the critical aspects of FibroGen's conference call, highlighting the company's strategic direction, product pipeline, and market opportunities.