89bio(ETNB) - 2025 Q1 - Quarterly Results

89bio First Quarter 2025 Financial Results and Corporate Updates Recent Highlights and Anticipated Milestones 89bio advances global Phase 3 MASH trials with data expected by 2028, significantly enhancing its financial position - Topline histology data from ENLIGHTEN-Fibrosis expected 1H 2027, and ENLIGHTEN-Cirrhosis in 2028[2][4] - The Phase 3 ENTRUST trial for SHTG is fully enrolled, with topline data expected in Q1 2026[2][10] - Pegozafermin shows potential for fibrosis improvement and MASH resolution, supported by a Hepatology meta-analysis[3] - The company concluded Q1 2025 with $638.8 million in cash and equivalents following a $287.5 million gross proceeds equity offering[2] Clinical Program Updates Three global Phase 3 trials are actively enrolling, with MASH histology data expected by 2028 and SHTG data by Q1 2026 Metabolic dysfunction-associated steatohepatitis (MASH) ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials are actively enrolling globally, with histology data expected by 2028 - The Phase 3 ENLIGHTEN-Fibrosis (F2-F3 MASH) and ENLIGHTEN-Cirrhosis (F4 MASH) trials are actively enrolling patients globally[3][4] - Topline histology data is anticipated in 1H 2027 for ENLIGHTEN-Fibrosis and in 2028 for ENLIGHTEN-Cirrhosis[4] - Trials are designed with FDA and EMA alignment to support accelerated approval via histology data, while collecting outcomes for full approval[5] Severe Hypertriglyceridemia (SHTG) The global Phase 3 ENTRUST trial for SHTG is fully enrolled, with topline data expected in Q1 2026 - The global Phase 3 ENTRUST trial is fully enrolled[2] - Topline data from the ENTRUST trial is expected in Q1 2026[10] - ENTRUST is a 52-week trial evaluating weekly pegozafermin doses (30 mg and 20 mg) versus placebo[10] Corporate Updates Q1 2025 saw 89bio secure $287.5 million from an equity offering and implement a flexible global manufacturing strategy - A follow-on equity offering in Q1 2025 generated $287.5 million in gross proceeds[10] - The company holds a $150 million credit facility with K2 HealthVentures, with $35 million drawn[10] - A flexible, global manufacturing strategy is implemented with alternative suppliers to mitigate risks[3][10] First Quarter 2025 Financial Results Q1 2025 saw 89bio report a $71.3 million net loss due to increased expenses, while maintaining a $638.8 million cash position - As of March 31, 2025, cash, cash equivalents, and marketable securities totaled approximately $638.8 million[6] Key Financial Metrics | Financial Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change Driver | | :--- | :--- | :--- | :--- | | R&D Expenses | $64.4 | $47.4 | Increased clinical development for Phase 3 MASH trials and higher personnel costs | | G&A Expenses | $11.5 | $9.8 | Increased personnel-related expenses due to higher headcount | | Net Loss | $71.3 | $51.7 | Higher R&D and G&A expenses | Financial Statements Unaudited Q1 2025 financial statements show a $71.3 million net loss, $685.0 million total assets, and $605.5 million stockholders' equity Condensed Consolidated Statement of Operations and Comprehensive Loss The statement details a net loss of $71.3 million for Q1 2025, driven by $75.9 million in total operating expenses | (In thousands, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $64,394 | $47,428 | | General and administrative | $11,515 | $9,849 | | Total operating expenses | $75,909 | $57,277 | | Loss from operations | $(75,909) | $(57,277) | | Interest income and other, net | $6,038 | $6,556 | | Net loss | $(71,275) | $(51,681) | | Net loss per share, basic and diluted | $(0.49) | $(0.54) | | Weighted-average shares outstanding | 146,365,115 | 95,846,740 | Condensed Consolidated Balance Sheet Data The balance sheet shows total assets of $685.0 million as of March 31, 2025, with cash and equivalents at $638.8 million | (In thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $638,780 | $439,955 | | Total assets | $685,031 | $478,685 | | Total current liabilities | $37,884 | $36,129 | | Total liabilities and stockholders' equity | $685,031 | $478,685 |