UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 89bio, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 36-4946844 (State or other jurisdiction of incorporation or organization) 655 Montgomery Street, Suite 1500 San F ...

89bio Reports First Quarter 2025 Financial Results and Corporate Updates – Topline histology data from ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 trials are expected in 1H 2027 and in 2028, respectively; each trial is designed to support accelerated approval to treat patients with metabolic dysfunction-associated steatohepatitis (MASH) – – The Phase 3 ENTRUST trial in severe hypertriglyceridemia (SHTG) has been fully enrolled and topline data are expected in 1Q 2026 – – Cash, cash equivalents, and m ...

– Topline histology data from ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 trials are expected in 1H 2027 and in 2028, respectively; each trial is designed to support accelerated approval to treat patients with metabolic dysfunction-associated steatohepatitis (MASH) – – The Phase 3 ENTRUST trial in severe hypertriglyceridemia (SHTG) has been fully enrolled and topline data are expected in 1Q 2026 – – Cash, cash equivalents, and marketable securities totaled $638.8 million as of March 31, 2025; complet ...

We initiate a Buy rating for 89bio, Inc. (NASDAQ: ETNB ), which, in our view, presents a good long-term opportunity, mainly because of its lead candidate, pegozafermin. This drug might be able to help in two challenging indications withAnalyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in ETNB over the next 72 hour ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Has 89BIO (ETNB) been one of those stocks this year? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.89BIO is one of 1012 companies in the Medical group. The Medical group currently sits at #3 within the Zacks Sector Rank. The Zacks Sector Rank considers 16 different sector groups. The aver ...

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 ...

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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]