89bio(ETNB) - 2025 Q2 - Quarterly Results

markdown [Executive Summary & Corporate Updates](index=1&type=section&id=Executive%20Summary%20%26%20Corporate%20Updates) [Second Quarter 2025 Highlights](index=1&type=section&id=Second%20Quarter%202025%20Highlights) 89bio reported its Q2 2025 financial results and provided updates on its **Phase 3** clinical trials for pegozafermin in MASH and SHTG, reiterating key data timelines and a strong cash position - ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis **Phase 3** topline histology data expected in **1H 2027** and **2028**, respectively, designed to support accelerated approval for MASH[1](index=1&type=chunk) - ENTRUST **Phase 3** topline data in severe hypertriglyceridemia (SHTG) expected in **1Q 2026**[1](index=1&type=chunk) Cash, Cash Equivalents, and Marketable Securities | Metric | Amount (as of June 30, 2025) | | :----- | :--------------------------- | | Cash, cash equivalents, and marketable securities | $561.2 million | [Clinical Development & Milestones](index=1&type=section&id=Recent%20Highlights%20and%20Anticipated%20Milestones) The company provided detailed updates on the progress and anticipated timelines for its **Phase 3** ENLIGHTEN trials for MASH (**F2-F3** and **F4**) and the ENTRUST trial for SHTG, outlining regulatory strategies for accelerated approval [Metabolic Dysfunction-Associated Steatohepatitis (MASH) Program](index=1&type=section&id=Metabolic%20Dysfunction-Associated%20Steatohepatitis%20(MASH)) The **Phase 3** ENLIGHTEN-Fibrosis (**F2-F3** MASH) and ENLIGHTEN-Cirrhosis (**F4** MASH) trials are actively enrolling patients, with topline histology data expected in **1H 2027** and **2028**, respectively, aiming for accelerated approval based on FDA and EMA alignment - **Phase 3** ENLIGHTEN-Fibrosis (non-cirrhotic **F2-F3** MASH) and ENLIGHTEN-Cirrhosis (compensated cirrhotic **F4** MASH) trials continue to enroll patients[5](index=5&type=chunk) - Topline histology data from ENLIGHTEN-Fibrosis expected in **1H 2027**, and ENLIGHTEN-Cirrhosis in **2028**, supporting accelerated approval filings[3](index=3&type=chunk)[5](index=5&type=chunk) - Both trials will continue for outcomes to potentially support full approval, with pegozafermin aiming for best-in-class relative risk ratio on histology endpoints, favorable safety, and convenient dosing[3](index=3&type=chunk)[5](index=5&type=chunk) [Severe Hypertriglyceridemia (SHTG) Program](index=1&type=section&id=Severe%20Hypertriglyceridemia%20(SHTG)) The **Phase 3** ENTRUST trial for SHTG is evaluating pegozafermin's efficacy, safety, and tolerability, with topline data anticipated in **Q1 2026**, focusing on the percent change from baseline in fasting triglycerides at **Week 26** - ENTRUST is a randomized, double-blind, placebo-controlled global study evaluating pegozafermin (**30 mg**, **20 mg**) or placebo once weekly for **52 weeks** in SHTG patients[5](index=5&type=chunk) - Primary endpoint is the percent change from baseline in fasting triglycerides at **Week 26** compared to placebo[5](index=5&type=chunk) - Topline data from the **Phase 3** ENTRUST trial in SHTG are expected in the **first quarter of 2026**[5](index=5&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) [Second Quarter 2025 Financial Overview](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) 89bio reported a significant increase in R&D and G&A expenses for Q2 2025 compared to Q2 2024, primarily due to advancing **Phase 3** MASH trials, a non-recurring payment for a commercial-scale production facility, and higher personnel costs, leading to an increased net loss Key Financial Metrics | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :----------------------- | :-------------------- | :-------------------- | :----------- | | Cash, cash equivalents, and marketable securities (as of June 30) | $561.2 | N/A | N/A | | R&D Expenses | $103.9 | $44.9 | +131.4% | | G&A Expenses | $11.9 | $8.6 | +38.4% | | Net Loss | $(111.5) | $(48.0) | +132.3% | - Increase in R&D expenses driven by **Phase 3** ENLIGHTEN trials in MASH and a non-recurring **$42.4 million** payment for commercial-scale pegozafermin production facility construction, with a remaining **$13.5 million** obligation in **2026**[7](index=7&type=chunk) - Increase in G&A expenses primarily due to higher personnel-related expenses, including stock-based compensation, driven by increased headcount[8](index=8&type=chunk) - Increased net loss primarily driven by higher R&D expenses (contract manufacturing, MASH programs) and personnel-related expenses[9](index=9&type=chunk) [Condensed Consolidated Statement of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20and%20Comprehensive%20Loss) The condensed consolidated statement of operations shows a significant increase in operating expenses and net loss for both the three and six months ended June 30, 2025, compared to the prior year, primarily due to increased R&D and G&A activities Condensed Consolidated Statement of Operations and Comprehensive Loss | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $103,902 | $44,865 | $168,296 | $92,293 | | General and administrative | $11,922 | $8,571 | $23,437 | $18,420 | | Total operating expenses | $115,824 | $53,436 | $191,733 | $110,713 | | Loss from operations | $(115,824) | $(53,436) | $(191,733) | $(110,713) | | Net loss | $(111,504) | $(47,971) | $(182,779) | $(99,652) | | Net loss per share, basic and diluted | $(0.71) | $(0.48) | $(1.20) | $(1.02) | | Weighted-average shares used to compute net loss per share, basic and diluted | 157,880,203 | 99,831,111 | 152,154,469 | 97,838,926 | [Condensed Consolidated Balance Sheet Data](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, 89bio's cash, cash equivalents, and marketable securities significantly increased to **$561.2 million** from **$439.9 million** at December 31, 2024, contributing to a rise in total assets and stockholders' equity Condensed Consolidated Balance Sheet Data | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash, cash equivalents and marketable securities | $561,164 | $439,955 | | Total assets | $603,485 | $478,685 | | Total current liabilities | $39,611 | $36,129 | | Non current liabilities | $42,141 | $41,767 | | Total stockholders' equity | $521,733 | $400,789 | | Total liabilities and stockholders' equity | $603,485 | $478,685 | [Company Information](index=2&type=section&id=Company%20Information) [About 89bio](index=2&type=section&id=About%2089bio) 89bio is a clinical-stage biopharmaceutical company focused on developing therapies for liver and cardiometabolic diseases, with its lead candidate pegozafermin in **Phase 3** trials for MASH and SHTG, utilizing a unique glycoPEGylated FGF21 analog technology - 89bio is a clinical-stage biopharmaceutical company developing therapies for liver and cardiometabolic diseases[10](index=10&type=chunk) - Lead candidate, pegozafermin, is in **Phase 3** trials for MASH with advanced fibrosis (including compensated cirrhosis) and SHTG[10](index=10&type=chunk) - Pegozafermin is an engineered fibroblast growth factor 21 (FGF21) analog with glycoPEGylated technology for optimized biological activity and extended half-life[10](index=10&type=chunk) [Forward-looking Statements](index=2&type=section&id=Forward-looking%20Statements) This section contains cautionary statements regarding future expectations, including therapeutic potential, trial outcomes, regulatory approvals, and financial resources, emphasizing that actual results may differ due to various risks and uncertainties outlined in SEC filings - Statements regarding therapeutic potential, efficacy, clinical benefits, trial designs, development plans, and timing for pegozafermin, including topline data and accelerated/conditional approval possibilities, are forward-looking[11](index=11&type=chunk) - Undue reliance should not be placed on these statements, which are subject to various risks and uncertainties, including trial outcomes, competition, economic conditions, regulatory changes, and capital sufficiency[12](index=12&type=chunk) - 89bio disclaims any obligation to update or alter these statements, except as required by law, and claims protection under the Safe Harbor of the Private Securities Litigation Reform Act of 1995[12](index=12&type=chunk) [Investor and Media Contacts](index=3&type=section&id=Investor%20Contacts) Contact information for investor relations and media inquiries is provided for 89bio, Inc - Investor contacts: Annie Chang (investors@89bio.com), Eva Bilange (eva.bilange@89bio.com)[13](index=13&type=chunk) - Media contact: Sheryl Seapy, Real Chemistry (sseapy@realchemistry.com)[13](index=13&type=chunk)