[89bio First Quarter 2025 Financial Results and Corporate Updates](index=1&type=section&id=89bio%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Corporate%20Updates) [Recent Highlights and Anticipated Milestones](index=1&type=section&id=Recent%20Highlights%20and%20Anticipated%20Milestones) 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](index=2&type=chunk)[4](index=4&type=chunk) - The Phase 3 ENTRUST trial for SHTG is **fully enrolled**, with **topline data expected in Q1 2026**[2](index=2&type=chunk)[10](index=10&type=chunk) - Pegozafermin shows potential for **fibrosis improvement and MASH resolution**, supported by a *Hepatology* meta-analysis[3](index=3&type=chunk) - The company concluded Q1 2025 with **$638.8 million in cash and equivalents** following a **$287.5 million gross proceeds equity offering**[2](index=2&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) 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)](index=1&type=section&id=Metabolic%20dysfunction-associated%20steatohepatitis%20(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](index=3&type=chunk)[4](index=4&type=chunk) - **Topline histology data** is anticipated in **1H 2027** for ENLIGHTEN-Fibrosis and in **2028** for ENLIGHTEN-Cirrhosis[4](index=4&type=chunk) - Trials are designed with **FDA and EMA alignment** to support **accelerated approval** via histology data, while collecting outcomes for full approval[5](index=5&type=chunk) [Severe Hypertriglyceridemia (SHTG)](index=2&type=section&id=Severe%20Hypertriglyceridemia%20(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](index=2&type=chunk) - **Topline data** from the ENTRUST trial is expected in **Q1 2026**[10](index=10&type=chunk) - ENTRUST is a **52-week trial** evaluating **weekly pegozafermin doses (30 mg and 20 mg)** versus placebo[10](index=10&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) 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](index=10&type=chunk) - The company holds a **$150 million credit facility** with K2 HealthVentures, with **$35 million drawn**[10](index=10&type=chunk) - A **flexible, global manufacturing strategy** is implemented with alternative suppliers to mitigate risks[3](index=3&type=chunk)[10](index=10&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) 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](index=6&type=chunk) 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](index=5&type=section&id=Financial%20Statements) 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](index=5&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) 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** |

Core Insights - 89bio, Inc. is advancing its clinical-stage biopharmaceutical development, focusing on therapies for liver and cardiometabolic diseases, particularly targeting metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG) [11] Clinical Trials - The Phase 3 ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials are designed to support accelerated approval for treating patients with MASH, with topline data expected in 1H 2027 and 2028, respectively [1][5] - The ENTRUST trial for SHTG has been fully enrolled, with topline data anticipated in 1Q 2026 [1][5] - Pegozafermin has been recognized in a meta-analysis as one of the most effective agents for fibrosis improvement and MASH resolution, highlighting its potential in the market [2] Financial Position - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling approximately $638.8 million, an increase from $439.9 million at the end of 2024 [7][15] - The company completed a follow-on equity offering in 1Q 2025, generating gross proceeds of $287.5 million [4] - A $150 million credit facility with K2 HealthVentures has been established, with $35 million drawn down [4] Expenses and Losses - Research and development expenses for Q1 2025 were $64.4 million, up from $47.4 million in Q1 2024, primarily due to increased clinical development costs [8] - General and administrative expenses rose to $11.5 million in Q1 2025 from $9.8 million in Q1 2024, driven by higher personnel-related costs [9] - The net loss for Q1 2025 was reported at $71.3 million, compared to a net loss of $51.7 million in Q1 2024, attributed to higher R&D and G&A expenses [10]

Core Viewpoint - 89bio, Inc. (NASDAQ: ETNB) is initiated with a Buy rating due to its promising lead candidate, pegozafermin, which has potential in addressing two challenging medical indications [1] Company Summary - 89bio, Inc. is focused on developing pegozafermin, a drug that may provide solutions for difficult medical conditions [1]

Group 1 - Creative Medical Technology Holdings, Inc. (CELZ) is currently outperforming its peers in the Medical sector with a year-to-date performance increase of approximately 14.3%, compared to the sector average gain of 5% [4] - CELZ has a Zacks Rank of 2 (Buy), indicating a positive outlook based on earnings estimates and revisions [3] - The Zacks Consensus Estimate for CELZ's full-year earnings has increased by 9.4% over the past quarter, reflecting improving analyst sentiment [4] Group 2 - CELZ is part of the Medical - Biomedical and Genetics industry, which includes 509 stocks and currently ranks 74 in the Zacks Industry Rank [6] - The Medical - Biomedical and Genetics industry has seen an average gain of 6% year-to-date, indicating that CELZ is performing better than the industry average [6] - Another stock in the same industry, 89BIO (ETNB), has also shown strong performance with a year-to-date increase of 17% and a Zacks Rank of 2 (Buy) [5][6]

Company Performance - 89BIO (ETNB) has returned 10.5% year-to-date, outperforming the average gain of 7.4% for Medical stocks [4] - The Zacks Consensus Estimate for ETNB's full-year earnings has increased by 38% over the past quarter, indicating improving analyst sentiment [3] - Eton Pharmaceuticals, Inc. (ETON) has also shown strong performance with a year-to-date return of 13.9% and a consensus EPS estimate increase of 33.8% over the past three months [4][5] Industry Context - 89BIO is part of the Medical - Biomedical and Genetics industry, which consists of 510 companies and currently ranks 66 in the Zacks Industry Rank [6] - The average gain for the Medical - Biomedical and Genetics industry so far this year is 7.8%, with 89BIO outperforming this average [6] - The Medical group, which includes 1012 companies, is currently ranked 3 within the Zacks Sector Rank [2]

SAN FRANCISCO, March 03, 2025 (GLOBE NEWSWIRE) -- 89bio, Inc. (the “Company” or “89bio”) (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the Company’s Management will participate in a fireside chat at the Leerink Partners Global Healthcare Conference on Monday, March 10, 2025 at 4:20 PM EST and participate in one-on-one investor meetings. The webca ...

Group 1: IPOs and Secondary Offerings - Basel Medical (BMGL) is conducting an IPO priced at $4.00 for 2.205 million shares [1] - Intelligent Living Application Group (ILAG) is executing a spot secondary offering priced at $0.58 for 1.035 million shares [1] - SiriusPoint (SPNT) is also conducting a spot secondary offering priced at $14.00 for 4.107 million shares [1] - Luda Technology (LUD) is launching an IPO priced at $4.00 for 2.5 million shares [3] - LZ Technology (LZMH) is conducting an IPO priced at $4.00 for 1.8 million shares [3] - Webus International (WETO) is executing an IPO priced at $4.00 for 2 million shares [5] Group 2: Large Secondary Offerings - Keurig Dr Pepper (KDP) is conducting a spot secondary offering priced at $32.80 for 73 million shares [5] - CCC Intelligent Solutions (CCCS) is executing a spot secondary offering priced at $10.38 for 42 million shares [6] - Life Time Group (LTH) is also conducting a spot secondary offering priced at $30.40 for 23 million shares [7]

Drug Development and Trials - Pegozafermin is being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG) with positive topline results reported from Phase 1b/2a and Phase 2b trials[19][20]. - In March 2023, the FDA granted Breakthrough Therapy designation to pegozafermin for MASH, and in November 2023, positive topline data from the 48-week blinded extension phase of the ENLIVEN trial were announced[19][20]. - The Phase 3 program (ENLIGHTEN) for MASH includes two trials: ENLIGHTEN-Fibrosis for F2-F3 patients initiated in March 2024 and ENLIGHTEN-Cirrhosis for F4 patients initiated in May 2024[21]. - Topline data from the ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials are expected in the first half of 2027 and 2028, respectively, to support accelerated approval filings in the U.S. and Europe[22]. - The ENTRUST Phase 3 trial for SHTG patients completed enrollment in December 2024 with a total of 369 patients, and topline data is expected in the first quarter of 2026[23]. - The Phase 2b ENLIVEN trial enrolled 219 patients with fibrosis stage 2 or 3 MASH, receiving either pegozafermin or placebo for 24 weeks[55]. - The FDA has agreed to the primary endpoint of reduction in triglycerides from baseline for the ENTRUST trial without the need for a clinical outcome study[77]. - The ENLIGHTEN trials will stratify patients based on GLP-1-based therapy usage to evaluate the incremental benefit of adding Pegozafermin[75]. Market Opportunity and Patient Demographics - Approximately 4 million patients in the U.S. have triglyceride levels ≥ 500 mg/dL, with around 800,000 inadequately treated, representing a significant market opportunity for pegozafermin[34]. - The prevalence of MASH is driven by the obesity epidemic, affecting approximately 25% of the global population, with 20% to 25% of MASLD patients developing MASH[31]. - MASH patients often have significant metabolic co-morbidities, including obesity and Type 2 diabetes, which contribute to cardiovascular disease risk[32]. Efficacy and Safety - Pegozafermin demonstrated a 27% and 26% improvement in fibrosis without worsening of MASH for the 44 mg every-two-week and 30 mg weekly dose groups, respectively, compared to a 7% rate in the placebo group[56]. - MASH resolution without worsening of fibrosis was observed in 26% and 23% of patients in the 44 mg and 30 mg groups, respectively, compared to 2% in the placebo group[57]. - At week 48, both the 44 mg and 30 mg dose groups showed statistically significant improvements in key liver health markers, consistent with results from week 24[62]. - Pegozafermin was well tolerated with the most common adverse events being mild to moderate gastrointestinal issues, with no significant effects on bone mineral density[59]. - Patients on background GLP-1 therapy receiving pegozafermin showed greater benefits in liver health markers compared to those on placebo[66]. - Pegozafermin demonstrated significant improvements in liver fat, with a reduction of 60% in MRI-PDFF for patients dosed with 30mg QW compared to a placebo[70]. - At week 48, ALT levels decreased by 58% and AST levels by 38% in compensated cirrhosis (F4) patients treated with Pegozafermin[74]. - Pegozafermin maintained a favorable safety profile, with no new patients reporting diarrhea or nausea during the extension phase[70]. Manufacturing and Supply Chain - Pegozafermin is manufactured through fermentation of a recombinant strain of E. coli, with the process involving cell disruption and purification to achieve target quality attributes[178][179]. - The company has established supply agreements with Northway Biotechpharma and BiBo Biopharma Engineering for the supply of pegozafermin for ongoing clinical trials[180]. - A collaboration agreement with BiBo was signed in April 2024 to construct a production facility in Shanghai for commercial supply of pegozafermin if approved[182]. - The company relies on third parties for manufacturing and does not plan to develop its own manufacturing operations in the foreseeable future[177]. Financials and Revenue Expectations - The company has incurred net losses since its inception in 2018 and expects significant and increasing operating losses in the coming years[208]. - The company has not generated any revenue from product sales to date and does not expect to receive revenue from pegozafermin for several years, if ever[211]. - The company has $269.9 million in net proceeds from a February 2025 equity offering, which is expected to fund projected operating requirements for at least one year[217]. - The company anticipates that its research and development expenses will increase significantly as it conducts Phase 3 clinical trials for pegozafermin[217]. Regulatory Environment - The company must submit an investigational new drug (IND) application to the FDA before starting any clinical trials in the United States[90]. - The IND becomes effective 30 days after submission unless the FDA raises safety concerns[91]. - The FDA aims to review standard BLA applications within ten months and priority reviews within six months after filing[99]. - A Complete Response letter from the FDA outlines deficiencies in a BLA and may recommend actions for approval[100]. - The FDA may grant approval with specific indications and may require a Risk Evaluation and Mitigation Strategy (REMS) to manage risks[101]. - Expedited programs like Fast Track and Breakthrough Therapy designation can significantly reduce FDA review times for serious conditions[102]. - The company faces significant uncertainty regarding the coverage and reimbursement status of any pharmaceutical or biological product it may obtain regulatory approval for[141]. - Regulatory approval for pegozafermin is uncertain, and the company may encounter difficulties in meeting the requirements set by the FDA and other authorities[213]. Intellectual Property - The FGF21 patent portfolio includes ten families, with granted patent protection in 39 countries for pegozafermin and its compositions[188]. - The U.S. Patent Number 10,407,479 for pegozafermin has a term expiring on September 4, 2038, covering various therapeutic indications[189]. Workforce and Company Culture - As of December 31, 2024, the company had 93 full-time employees, with 70 engaged in research and development activities[197]. - Approximately 62% of the company's employees identify as female, reflecting a commitment to diversity and inclusion[198]. - The company covers 90% of its employees' monthly healthcare premiums and offers competitive benefits, including a 401(k) plan and employee stock purchase plan[200].

Financial Position - As of December 31, 2024, the company expects to report approximately $440 million in cash, cash equivalents, and marketable securities[6] - The financial results for the year ended December 31, 2024, are still pending finalization and auditing[6] - The company emphasizes that the preliminary financial information is subject to change and has not been audited[6] Forward-Looking Statements - Forward-looking statements regarding expected financial results are based on current estimates and assumptions, which may be subject to various risks and uncertainties[7] - The company claims protection under the Safe Harbor provisions for forward-looking statements as per the Private Securities Litigation Reform Act of 1995[7]

Core Insights - 89bio, Inc. is advancing its Phase 3 trials for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG), with topline data expected in 2027 and 2026 respectively [1][2] - The company reported a cash position of $440 million as of December 31, 2024, down from $578.9 million in 2023, following a follow-on offering that raised $287.5 million [7][13] - Significant increases in research and development (R&D) expenses were noted, totaling $345 million for the year ended December 31, 2024, compared to $122.2 million in 2023, primarily due to contract manufacturing costs [8][10] Clinical Trials - The Phase 3 ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials for MASH were initiated in 2024, with topline histology data expected in 2027 and 2028 [6] - The ENTRUST trial for SHTG has completed enrollment with 369 patients, and topline data is now anticipated in the first quarter of 2026 [6][10] - The company aims for accelerated approval in the U.S. and conditional approval in Europe based on the outcomes of these trials [6] Financial Performance - R&D expenses for Q4 2024 were $111.3 million, a significant increase from $33.6 million in Q4 2023, driven by contract manufacturing and clinical development costs [8] - General and administrative (G&A) expenses rose to $39.6 million for the year ended December 31, 2024, compared to $29 million in 2023, attributed to higher personnel-related expenses [9] - The net loss for the year was $367.1 million, up from $142.2 million in 2023, reflecting increased operational costs [10] Corporate Strategy - The company is focused on executing clinical trials and preparing for a potential Biologics License Application (BLA) filing, contingent on positive trial results [2][13] - Pegozafermin, the lead candidate, is positioned as a potentially best-in-class therapy for patients with advanced MASH and SHTG, with a favorable safety profile and convenient dosing [2][11]