Kyntra Bio (NasdaqGS:FGEN) 2026 Conference Transcript

Kyntra Bio Conference Call Summary Company Overview - Company Name: Kyntra Bio (formerly FibroGen) - Ticker: NasdaqGS:FGEN - Event: 2026 Conference on March 11, 2026 Key Highlights Company Transformation - Kyntra Bio transitioned from FibroGen to enhance impact for patients and shareholders [2] Financial Developments - Completed the sale of FibroGen China to AstraZeneca for approximately $220 million, including $135 million in cash [3] - Paid off a $75 million term loan facility and extended cash runway into 2028 [3] Product Pipeline FG-3246 and FG-3180 - FG-3246 is a potential first-in-class therapy targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC) [4] - FG-3180 is a PET imaging agent in clinical development for patient selection [4] - Phase II trial for FG-3246 has commenced, focusing on mCRPC patients [5] Roxadustat - Roxadustat is a phase III-ready treatment for anemia associated with lower risk myelodysplastic syndrome (MDS) [5] - Approved in over 40 countries for anemia related to chronic kidney disease [5] - Kyntra Bio owns Roxadustat in North America, South America, and Australia [5] Clinical Trials and Data FG-3246 Phase 1 Results - Phase 1 trial showed an rPFS of 8.7 months and a 36% PSA50 response rate in heavily pretreated mCRPC patients [17] - Notable adverse events included 36% grade three or above neutropenia and 34% peripheral neuropathy [18] FG-3246 and Enzalutamide Combination - Phase 1B/2 trial showed 7 months rPFS across the entire cohort and 10.1 months for patients who progressed on one prior ARPI [21] - Strong correlation between CD46 tumor uptake and PSA50 response [23] Regulatory and Market Opportunities - Received orphan drug designation from the FDA for myelodysplastic syndrome, providing seven years of regulatory exclusivity upon approval [6] - Roxadustat aims to address unmet needs in lower risk MDS, with a focus on patients requiring 4 or more RBC units [31][36] - The worldwide MDS market is projected to exceed $4 billion in the next five years, presenting a significant commercial opportunity [38] Strategic Focus - Kyntra Bio is exploring multiple lines of therapy in prostate cancer and aims to leverage the unique properties of FG-3246 and FG-3180 [29] - The company is committed to developing Roxadustat as an oral alternative for elderly patients with MDS, addressing convenience and efficacy across different patient populations [37] Conclusion Kyntra Bio is positioned to capitalize on significant opportunities in oncology and hematology, with a robust pipeline and strategic focus on addressing unmet medical needs in mCRPC and lower risk MDS. The company is actively advancing its clinical trials and regulatory strategies to enhance its market presence and shareholder value.