89bio (ETNB -4.85%), a clinical-stage biotech focused on metabolic and liver diseases, released its second quarter 2025 results on August 7, 2025. The company posted GAAP earnings per share of $(0.71), missing the consensus estimate of $(0.50) and falling below $(0.48) in Q2 2024. There was no revenue, as expected for a development-stage company. Expenses (GAAP) increased sharply, especially in research and development, reflecting both the ramp-up of late-stage clinical programs and a significant one-time payment for commercial manufacturing infrastructure. Management judged the quarter as broadly in line with its strategic focus on advancing pegozafermin, its lead candidate, but highlighted that the company remains in a clinical stage with no commercial revenue yet.
Source: Analyst estimates for the quarter provided by FactSet.
89bio develops new medicines for metabolic and liver diseases. Its lead asset, pegozafermin, is a drug candidate designed to treat serious conditions like metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH) and severe hypertriglyceridemia (SHTG).
The company's main priority is progressing pegozafermin through late-stage clinical trials in both MASH and SHTG. Key factors for success include proving clinical efficacy and safety, obtaining regulatory approvals, standing out against rivals, and ensuring manufacturing readiness. The company places special emphasis on unique features like pegozafermin's every-two-week dosing and broad metabolic effects.
89bio increased its GAAP research and development expenses by 131%, climbing to $103.9 million compared to $44.9 million in the prior year. Management attributed this surge to ongoing Phase 3 trials for pegozafermin and a $42.4 million non-recurring payment to build a commercial-scale production facility.
General and administrative expenses (GAAP) rose to $11.9 million, up 38% from $8.6 million in Q2 2024, driven by higher personnel costs and stock-based compensation.
As a result of these increased investments, the net loss (GAAP) widened to $111.5 million, compared with $48.0 million in Q2 2024. The main drivers were the jump in research spending and growing administrative costs tied to scaling operations. Weighted average shares outstanding (GAAP) rose sharply to 157.9 million from 99.8 million a year ago, largely reflecting equity raises to bolster the balance sheet. This helped push cash, cash equivalents, and marketable securities to $561.2 million as of June 30, 2025 (GAAP), up from $440.0 million as of December 31, 2024 (GAAP) -- a strategic move to support funding for lengthy and capital-intensive late-stage studies.
Pegozafermin, a drug belonging to the FGF21 analog class, remained the backbone of the company's product strategy. It is currently in three pivotal Phase 3 studies: ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis for MASH, and ENTRUST for SHTG, a disorder of very high triglycerides. The ENTRUST study measures the percent change in fasting triglyceride levels, a standard marker for SHTG efficacy. No new efficacy or safety results were announced this quarter, but prior studies and regulatory designations (Breakthrough Therapy from the FDA and PRIME from the European Medicines Agency) underpin the ongoing Phase 3 work.
Manufacturing readiness took a leap forward with progress on the new production facility for pegozafermin, scheduled to be online in time for possible commercial launches. The company noted a fixed remaining payment of $13.5 million due in 2026 for this facility, which is meant to support regulatory filings and ensure supply stability. This investment is essential for reliable production if the therapy achieves approval. The company reports that its manufacturing network is diversified, helping minimize risks of supply-chain disruptions.
89bio's management has not provided quantitative financial guidance for future quarters or the full year. The company reiterated timelines for its key clinical trials: topline data for ENTRUST in SHTG is expected in Q1 2026, while results from the ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis studies in MASH are targeted for the first halves of 2027 and 2028, respectively.
Looking forward, investors will be watching key clinical milestones, the pace of trial enrollment, regulatory interactions, and any future capital raises. Near-term catalysts appear limited until the Phase 3 readouts in 2026 and later. Monitoring cash burn, manufacturing readiness, and competition in the MASH and SHTG drug markets will be critical in the months ahead.