89bio (ETNB) Q2 R&D Jumps 131%

Core Insights - 89bio reported a GAAP earnings per share of $(0.71) for Q2 2025, missing the consensus estimate of $(0.50) and showing a decline from $(0.48) in Q2 2024 [1][2] - The company had no revenue, consistent with its status as a development-stage biotech firm [1][2] - Significant increases in expenses were noted, particularly in research and development, reflecting the advancement of late-stage clinical programs and a one-time payment for manufacturing infrastructure [1][5] Financial Performance - Research and development expenses surged by 131.4% to $103.9 million compared to $44.9 million in Q2 2024 [2][5] - General and administrative expenses rose by 38.4% to $11.9 million from $8.6 million in Q2 2024, driven by higher personnel costs and stock-based compensation [2][6] - The net loss widened to $111.5 million from $48.0 million in Q2 2024, primarily due to increased research and administrative costs [7] Business Focus - 89bio is focused on developing pegozafermin, a drug candidate for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG) [3][4] - The company is prioritizing late-stage clinical trials for pegozafermin, with key success factors including clinical efficacy, regulatory approvals, and manufacturing readiness [4] Clinical Development - Pegozafermin is currently in three pivotal Phase 3 studies: ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis for MASH, and ENTRUST for SHTG [8] - The ENTRUST study focuses on the percent change in fasting triglyceride levels, a standard marker for SHTG efficacy [8] - No new efficacy or safety results were reported this quarter, but previous studies and regulatory designations support ongoing Phase 3 work [8] Manufacturing and Future Outlook - Progress has been made on a new production facility for pegozafermin, which is expected to be operational for potential commercial launches [9][10] - A fixed payment of $13.5 million is due in 2026 for this facility, which is crucial for regulatory filings and supply stability [10] - Management has not provided quantitative financial guidance but has outlined timelines for key clinical trials, with topline data for ENTRUST expected in Q1 2026 [11][12]