Group 1 - 89bio, Inc. is advancing Pegozafermin, a long-acting FGF21 analog, through Phase 3 trials [1] - Pegozafermin targets large Total Addressable Markets (TAMs) with unmet needs in Metabolic Associated Steatotic Liver Disease (MASH) with and without cirrhosis, and severe hypertriglyceridemia (SHTG) [1] - The company is pursuing a dual-path approval strategy for Pegozafermin [1]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents 89bio's unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents 89bio's unaudited condensed consolidated financial statements, covering balance sheets, operations, equity, cash flows, and notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (In thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $129,076 | $126,060 | | Marketable securities | $432,088 | $313,895 | | Total current assets | $601,520 | $476,450 | | Total assets | $603,485 | $478,685 | | **Liabilities** | | | | Total current liabilities | $39,611 | $36,129 | | Warrant liability | $— | $516 | | Term loan, noncurrent, net | $36,156 | $35,732 | | Total liabilities | $81,752 | $77,896 | | **Stockholders' Equity** | | | | Total stockholders' equity | $521,733 | $400,789 | | Total liabilities and stockholders' equity | $603,485 | $478,685 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance, including revenues, expenses, and net loss over specific periods Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share amounts) | Metric | 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) | | Interest expense | $(1,137) | $(874) | $(2,404) | $(1,737) | | Interest income and other, net | $6,210 | $6,473 | $12,248 | $13,029 | | Net loss | $(111,504) | $(47,971) | $(182,779) | $(99,652) | | Comprehensive loss | $(111,767) | $(48,135) | $(183,220) | $(100,525) | | Net loss per share, basic and diluted | $(0.71) | $(0.48) | $(1.20) | $(1.02) | | Weighted-average shares (basic and diluted) | 157,880,203 | 99,831,111 | 152,154,469 | 97,838,926 | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in the company's equity, reflecting stock issuances, net losses, and stock-based compensation - Total stockholders' equity increased from **$400,789 thousand** as of December 31, 2024, to **$521,733 thousand** as of June 30, 2025, primarily driven by **$269,903 thousand** from a public offering and stock-based compensation of **$7,216 thousand** and **$7,315 thousand**, partially offset by net losses of **$(71,275) thousand** and **$(111,504) thousand**[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (In thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(172,162) | $(100,884) | | Net cash used in investing activities | $(114,455) | $(52,049) | | Net cash provided by financing activities | $289,633 | $48,990 | | Net change in cash and cash equivalents | $3,016 | $(103,943) | | Cash and cash equivalents at end of period | $129,076 | $212,218 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the unaudited condensed consolidated financial statements [1. Organization and Liquidity](index=8&type=section&id=1.%20Organization%20and%20Liquidity) 89bio, a clinical-stage biopharmaceutical company, has an accumulated deficit of **$1,007.3 million** but sufficient liquidity for at least one year - 89bio, Inc. is a clinical-stage biopharmaceutical company developing pegozafermin for MASH and SHTG[24](index=24&type=chunk) - The company has an accumulated deficit of **$1,007.3 million** as of June 30, 2025, and expects continued operating losses[26](index=26&type=chunk) - Existing cash, cash equivalents, and marketable securities (**$561.2 million** as of June 30, 2025) are projected to fund operations for at least one year[27](index=27&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines 89bio's accounting principles, including U.S. GAAP conformity, fair value measurements, and new FASB ASUs - Financial statements are prepared in conformity with U.S. GAAP and SEC rules for interim reporting, reflecting normal recurring adjustments[28](index=28&type=chunk)[29](index=29&type=chunk) - The company manages its business as a single reportable segment, with the CEO as the Chief Operating Decision Maker (CODM)[43](index=43&type=chunk) - New FASB ASUs (2023-09 on Income Tax Disclosures and 2024-03 on Expense Disaggregation) are expected to result in expanded disclosures upon adoption in 2025 and 2027/2028, respectively[45](index=45&type=chunk)[46](index=46&type=chunk)[47](index=47&type=chunk)[48](index=48&type=chunk) [3. Fair Value Measurements](index=14&type=section&id=3.%20Fair%20Value%20Measurements) This section details fair value measurements for financial assets and liabilities, including cash equivalents, marketable securities, and warrant liability Fair Value of Cash Equivalents and Marketable Securities (In thousands) | Asset Category | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :-------------------------- | :----------------------- | :------------------------- | | Money market funds (Level 1) | $5,535 | $22,645 | | Commercial paper (Level 2) | $101,633 | $51,991 | | U.S. government bonds (Level 2) | $212,381 | $170,270 | | Agency bonds (Level 2) | $56,724 | $63,859 | | Corporate debt securities (Level 2) | $9,103 | $6,166 | | U.S. Treasury securities (Level 2) | $111,149 | $44,509 | | Agency discount securities (Level 2) | $— | $18,942 | | **Total** | **$496,525** | **$378,382** | | Classified as: Cash equivalents | $64,437 | $64,487 | | Classified as: Marketable securities | $432,088 | $313,895 | - The warrant liability, previously **$516 thousand** as of December 31, 2024, was reduced to zero as of June 30, 2025, due to the expiration of Tranche 1 and the remote probability of exercise for Tranches 2 and 3 of the Term Loan Facility[53](index=53&type=chunk)[54](index=54&type=chunk) [4. Balance Sheet Components](index=15&type=section&id=4.%20Balance%20Sheet%20Components) This section breaks down prepaid and other current assets, and accrued expenses, reflecting increased clinical trial activity Prepaid and Other Current Assets (In thousands) | Asset Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Prepaid research and development | $37,802 | $32,550 | | Prepaid taxes | $52 | $368 | | Prepaid other | $2,502 | $3,577 | | **Total** | **$40,356** | **$36,495** | Accrued Expenses (In thousands) | Expense Category | June 30, 2025 | December 31, 2024 | | :------------------------------- | :------------ | :---------------- | | Accrued research and development expenses | $17,363 | $11,426 | | Accrued employee and related expenses | $5,016 | $6,872 | | Accrued professional and legal fees | $1,749 | $1,680 | | Accrued other expenses | $42 | $42 | | **Total** | **$24,170** | **$20,020** | [5. Commitments and Contingencies](index=17&type=section&id=5.%20Commitments%20and%20Contingencies) This section details commitments under the Teva agreement and BiBo collaboration, plus an Israeli Tax Authority assessment - Under the FGF21 Agreement with Teva, 89bio is obligated to make up to **$65.0 million** in commercial milestone payments and tiered royalties on net sales of pegozafermin[57](index=57&type=chunk) - The BiBo Collaboration Agreement for a commercial manufacturing facility was amended in June 2025, increasing the total contractual obligation to **$175.0 million** (exclusive of VAT), with an additional **$40.0 million** paid in June 2025 and a final **$13.5 million** milestone payment due upon facility completion[61](index=61&type=chunk)[62](index=62&type=chunk) - The Israeli Tax Authority (ITA) issued a formal assessment seeking to recharacterize an intercompany IP transfer as a taxable sale, leading to a recorded liability of **$5.3 million** for unrecognized tax benefit, which 89bio is appealing[64](index=64&type=chunk)[65](index=65&type=chunk)[67](index=67&type=chunk) [6. Term Loan Facility](index=19&type=section&id=6.%20Term%20Loan%20Facility) This section describes the **$150.0 million** Term Loan Facility, its tranches, maturity, interest rate, and warrant reclassification - The Term Loan Facility provides for a maximum aggregate principal amount of **$150.0 million**, secured by substantially all assets excluding intellectual property[69](index=69&type=chunk) - Tranche 1's remaining **$35.0 million** commitment expired undrawn on June 30, 2025; Tranche 2's **$30.0 million** is not expected to be achieved by the December 31, 2025, milestone due to revised ENTRUST data reporting in Q1 2026; Tranche 3 is available at lenders' sole discretion[73](index=73&type=chunk) - The loan matures on October 1, 2028, with interest-only payments until January 1, 2027, and the stated interest rate was **9.25%** as of June 30, 2025[70](index=70&type=chunk) [7. Stockholders' Equity](index=20&type=section&id=7.%20Stockholders'%20Equity) This section details changes in stockholders' equity, including public offerings, ATM program activity, and warrant issuances Common Stock Reserved for Issuance (As of June 30, 2025) | Category | Shares Reserved | | :------------------------------------------ | :-------------- | | Stock options outstanding | 11,698,226 | | RSUs and PSUs outstanding | 2,508,289 | | Shares available for future grants | 1,996,052 | | Shares available for ESPP | 3,246,812 | | Warrants to purchase common stock outstanding | 397,123 | | Pre-funded warrants to purchase common stock outstanding | 11,231,081 | | Conversion feature related to outstanding term loan | 1,112,546 | | **Total available for future issuance** | **32,190,129** | - In January 2025, an underwritten public offering of common stock and pre-funded warrants generated approximately **$269.9 million** in net proceeds[76](index=76&type=chunk)[128](index=128&type=chunk) - Under the 2023 ATM Facility, **$21.0 million** in net proceeds were raised from the sale of **2,160,484 shares** during the six months ended June 30, 2025, with approximately **$82.8 million** remaining available under this facility[78](index=78&type=chunk)[79](index=79&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk) - As of June 30, 2025, **11,628,204 warrants** were outstanding, including **11,231,081 pre-funded warrants** with a nominal exercise price of **$0.001** per share[82](index=82&type=chunk) [8. Stock-Based Compensation](index=22&type=section&id=8.%20Stock-Based%20Compensation) Stock-based compensation expense increased due to headcount growth, with significant unrecognized expense for options and RSUs/PSUs Stock-Based Compensation Expense (In thousands) | Category | 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 | $3,184 | $2,342 | $6,586 | $4,657 | | General and administrative | $4,131 | $2,827 | $7,945 | $5,510 | | **Total** | **$7,315** | **$5,169** | **$14,531** | **$10,167** | - Total unrecognized stock-based compensation expense for unvested stock options was **$47.9 million** as of June 30, 2025, to be recognized over a weighted-average period of **2.9 years**[83](index=83&type=chunk) - Total unrecognized stock-based compensation expense for RSUs and PSUs was **$18.0 million** as of June 30, 2025, to be recognized over a weighted-average period of **1.8 years**, with a reassessment of PSU performance conditions reducing unrecognized expense by **$7.8 million**[84](index=84&type=chunk) [9. Net Loss Per Share](index=23&type=section&id=9.%20Net%20Loss%20Per%20Share) Basic and diluted net loss per share were **$(0.71)** and **$(1.20)**, with increased weighted-average shares due to issuances Weighted-Average Shares Outstanding for Net Loss Per Share | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Common stock | 146,649,122 | 98,495,085 | 142,028,913 | 96,230,372 | | Pre-funded warrants | 11,231,081 | 1,336,026 | 10,125,556 | 1,608,554 | | **Total** | **157,880,203** | **99,831,111** | **152,154,469** | **97,838,926** | - Potentially dilutive common stock equivalents, including stock options, RSUs, PSUs, warrants, and term loan conversion features, were excluded from diluted net loss per share calculations due to their anti-dilutive effect during periods of net loss[86](index=86&type=chunk) [10. Segment Information](index=24&type=section&id=10.%20Segment%20Information) 89bio operates as a single segment, with the CEO reviewing consolidated net loss and key expense categories for performance - 89bio operates as a single reportable segment, with the CEO serving as the Chief Operating Decision Maker (CODM)[87](index=87&type=chunk) Significant Expense Categories (In thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Contract manufacturing | $58,084 | $17,018 | $77,141 | $38,369 | | Clinical development | $35,299 | $18,949 | $69,094 | $36,873 | | Research and development personnel-related | $9,608 | $7,847 | $20,281 | $15,580 | | General and administrative | $11,922 | $8,571 | $23,437 | $18,420 | | Interest expense | $1,137 | $874 | $2,404 | $1,737 | | Interest income and other, net | $(6,210) | $(6,473) | $(12,248) | $(13,029) | | Income tax expense | $753 | $134 | $890 | $231 | | **Net loss** | **$(111,504)** | **$(47,971)** | **$(182,779)** | **$(99,652)** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on 89bio's financial condition, operational results, and future funding needs [Overview](index=25&type=section&id=Overview) 89bio is a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardio-metabolic diseases - 89bio is a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardio-metabolic diseases[92](index=92&type=chunk) - Pegozafermin, the lead product candidate, is being developed for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG)[92](index=92&type=chunk) [Pegozafermin MASH Program](index=25&type=section&id=Pegozafermin%20MASH%20Program) Pegozafermin is in Phase 3 clinical development for MASH, with topline data anticipated in H1 2027 and 2028 - Pegozafermin is in Phase 3 clinical development for MASH, following positive Phase 1b/2a and Phase 2b ENLIVEN trial results[93](index=93&type=chunk) - The FDA granted Breakthrough Therapy Designation and the EMA granted Priority Medicines Designation (PRIME) for pegozafermin in MASH[94](index=94&type=chunk) - The Phase 3 ENLIGHTEN program includes two global trials: ENLIGHTEN-Fibrosis (F2-F3 MASH, topline data anticipated H1 2027) and ENLIGHTEN-Cirrhosis (compensated F4 MASH, topline data anticipated 2028)[94](index=94&type=chunk)[96](index=96&type=chunk) [Pegozafermin SHTG Program](index=25&type=section&id=Pegozafermin%20SHTG%20Program) Pegozafermin is advancing for SHTG treatment, with Phase 3 ENTRUST trial topline data expected in Q1 2026 - Pegozafermin is also advancing for SHTG treatment, based on positive Phase 2 ENTRIGUE trial results[95](index=95&type=chunk) - Enrollment in the Phase 3 ENTRUST trial for SHTG was completed in December 2024 (**369 patients**), with topline data expected in Q1 2026 after study completion at Week 52[95](index=95&type=chunk)[97](index=97&type=chunk) [Manufacturing and Commercial Supply Preparedness](index=27&type=section&id=Manufacturing%20and%20Commercial%20Supply%20Preparedness) A collaboration with BiBo Biopharma Engineering is in place for a Commercial Facility to produce pegozafermin's bulk active ingredient - A collaboration agreement with BiBo Biopharma Engineering Co., Ltd. is in place for the construction of a Commercial Facility in China to produce pegozafermin's bulk active ingredient[98](index=98&type=chunk) - The manufacturing platform is designed to provide sufficient capacity for projected commercial needs and is part of a broader global manufacturing strategy to enhance resilience and flexibility[98](index=98&type=chunk) [Components of Results of Operations](index=27&type=section&id=Components%20of%20Results%20of%20Operations) This section defines key components of operations, including R&D, G&A, interest expense, interest income, and income tax expense - Research and development expenses include costs for preclinical and clinical development, intellectual property, license agreements, contract research organizations, manufacturing, and personnel[99](index=99&type=chunk) - General and administrative expenses primarily consist of personnel costs, professional services (legal, HR, audit), consulting, and allocated facilities costs[103](index=103&type=chunk) - Interest expense includes cash interest, accretion of end of term loan fees, and amortization of deferred debt issuance costs, while interest income is mainly from marketable securities[105](index=105&type=chunk)[106](index=106&type=chunk) [Results of Operations (Three Months Ended June 30, 2025 and 2024)](index=29&type=section&id=Results%20of%20Operations%20(Three%20Months%20Ended%20June%2030%2C%202025%20and%202024)) Net loss significantly increased to **$(111.5) million**, driven by higher R&D expenses, including a **$40.0 million** BiBo payment Summary of Results of Operations (Three Months Ended June 30, In thousands) | Metric | 2025 | 2024 | Change | | :-------------------------- | :----- | :----- | :----- | | Research and development | $103,902 | $44,865 | $59,037 | | General and administrative | $11,922 | $8,571 | $3,351 | | Total operating expenses | $115,824 | $53,436 | $62,388 | | Loss from operations | $(115,824) | $(53,436) | $(62,388) | | Interest expense | $(1,137) | $(874) | $(263) | | Interest income and other, net | $6,210 | $6,473 | $(263) | | Net loss before tax | $(110,751) | $(47,837) | $(62,914) | - Research and development expenses increased by **$59.0 million**, primarily due to a **$40.0 million** non-recurring payment to BiBo for the Commercial Facility and a **$16.4 million** increase in clinical development costs for Phase 3 trials[110](index=110&type=chunk)[111](index=111&type=chunk) - General and administrative expenses increased by **$3.4 million**, mainly due to higher personnel-related expenses, including stock-based compensation, driven by increased headcount[112](index=112&type=chunk) [Results of Operations (Six Months Ended June 30, 2025 and 2024)](index=31&type=section&id=Results%20of%20Operations%20(Six%20Months%20Ended%20June%2030%2C%202025%20and%202024)) Net loss increased to **$(182.8) million**, primarily due to higher R&D expenses, including the **$40.0 million** BiBo payment Summary of Results of Operations (Six Months Ended June 30, In thousands) | Metric | 2025 | 2024 | Change | | :-------------------------- | :----- | :----- | :----- | | Research and development | $168,296 | $92,293 | $76,003 | | General and administrative | $23,437 | $18,420 | $5,017 | | Total operating expenses | $191,733 | $110,713 | $81,020 | | Loss from operations | $(191,733) | $(110,713) | $(81,020) | | Interest expense | $(2,404) | $(1,737) | $(667) | | Interest income and other, net | $12,248 | $13,029 | $(781) | | Net loss before tax | $(181,889) | $(99,421) | $(82,468) | - Research and development expenses increased by **$76.0 million**, primarily from a **$38.8 million** increase in contract manufacturing (including the **$40.0 million** BiBo payment) and a **$32.2 million** increase in clinical development costs for Phase 3 trials[117](index=117&type=chunk)[118](index=118&type=chunk) - General and administrative expenses increased by **$5.0 million**, driven by higher personnel-related costs, including a **$2.4 million** increase in stock-based compensation and a **$1.7 million** increase in payroll and benefits[119](index=119&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) 89bio had **$561.2 million** in liquidity, sufficient for one year, but will require substantial additional capital for operations - As of June 30, 2025, the company had **$561.2 million** in cash, cash equivalents, and marketable securities, and an accumulated deficit of **$1,007.3 million**[123](index=123&type=chunk) - Existing financial resources are expected to fund operations for at least one year from the filing date of the 10-Q[134](index=134&type=chunk) - Key sources of liquidity include **$269.9 million** net proceeds from a January 2025 public offering and **$21.0 million** from the 2023 ATM Facility (with **$82.8 million** remaining)[125](index=125&type=chunk)[126](index=126&type=chunk)[128](index=128&type=chunk) - The Term Loan Facility's Tranche 1 expired undrawn, and Tranche 2 is not expected to be achieved by its milestone date, limiting future debt funding from these tranches[133](index=133&type=chunk) - Future funding requirements are substantial and depend on clinical trial progress, manufacturing costs, regulatory approvals, and potential in-licensing activities[135](index=135&type=chunk) [Cash Flows](index=37&type=section&id=Cash%20Flows) Net cash used in operating activities increased, while financing activities provided **$289.6 million**, resulting in a **$3.0 million** net cash increase Summary of Cash Flows (Six Months Ended June 30, In thousands) | Cash Flow Activity | 2025 | 2024 | | :-------------------------------- | :----- | :----- | | Net cash used in operating activities | $(172,162) | $(100,884) | | Net cash used in investing activities | $(114,455) | $(52,049) | | Net cash provided by financing activities | $289,633 | $48,990 | | Net change in cash and cash equivalents | $3,016 | $(103,943) | - Net cash used in operating activities increased by **$71.3 million**, primarily due to a higher net loss and a **$4.2 million** increase in prepaid expenses and other assets[139](index=139&type=chunk) - Net cash provided by financing activities increased by **$240.6 million**, mainly from **$269.9 million** in net proceeds from the public offering and **$21.0 million** from the ATM program[143](index=143&type=chunk) [Contractual Obligations and Commitments](index=38&type=section&id=Contractual%20Obligations%20and%20Commitments) This section details debt obligations, Teva license commitments, BiBo facility payments, and the Israeli Tax Authority assessment - Outstanding principal of **$35.0 million** under the Loan Agreement matures on October 1, 2028, with interest-only payments until January 1, 2027[145](index=145&type=chunk) - Obligations under the Teva license agreement include up to **$65.0 million** in commercial milestones and tiered royalties on net sales of pegozafermin[146](index=146&type=chunk) - The BiBo collaboration for the commercial facility has a total contractual obligation of **$175.0 million** (excluding VAT), with **$161.5 million** paid as of June 30, 2025, and a remaining **$13.5 million** milestone payment due upon facility completion (estimated 2026)[148](index=148&type=chunk)[149](index=149&type=chunk) - The Israeli Tax Authority issued a formal assessment for approximately **$26.0 million** in tax liability and **$3.9 million** in penalties, which the company is appealing, having recorded a **$5.3 million** liability for unrecognized tax benefit[150](index=150&type=chunk)[152](index=152&type=chunk) [Critical Accounting Estimates](index=38&type=section&id=Critical%20Accounting%20Estimates) No significant changes in critical accounting estimates compared to the Annual Report on Form 10-K for December 31, 2024 - There have been no significant changes in critical accounting estimates compared to the Annual Report on Form 10-K for the year ended December 31, 2024[153](index=153&type=chunk) [Recent Accounting Pronouncements](index=39&type=section&id=Recent%20Accounting%20Pronouncements) Refer to Note 2, 'Summary of Significant Accounting Policies,' for information on recent accounting pronouncements - Refer to Note 2, 'Summary of Significant Accounting Policies,' for information on recent accounting pronouncements[154](index=154&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes in market risk from the information provided in the Annual Report on Form 10-K for December 31, 2024 - No material changes in market risk from the information provided in the Annual Report on Form 10-K for the year ended December 31, 2024[155](index=155&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Disclosure controls and procedures were effective as of June 30, 2025, providing reasonable assurance for timely and accurate financial reporting[156](index=156&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[157](index=157&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though litigation could adversely impact operations - The company is not currently a party to any material legal proceedings[160](index=160&type=chunk) - Litigation, even if not material, can adversely impact the company through costs, diversion of resources, and reputational harm[160](index=160&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, including dependence on pegozafermin, funding needs, manufacturing reliance, and regulatory complexities - The company is a clinical-stage biopharmaceutical company with a limited operating history, no approved products, and expects significant and increasing operating losses, making its stock a highly speculative investment[162](index=162&type=chunk)[163](index=163&type=chunk)[166](index=166&type=chunk) - Business success is highly dependent on pegozafermin, its only product candidate under clinical development, which has not completed a pivotal trial, and clinical drug development is lengthy, expensive, and uncertain, with no guarantee of regulatory approval or commercialization[162](index=162&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk) - The company will require substantial additional capital to finance operations, which may not be available on acceptable terms, potentially delaying or preventing the development and commercialization of pegozafermin[162](index=162&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) - Significant risks include reliance on third-party manufacturers (e.g., BiBo in China, subject to geopolitical risks like the BIOSECURE Act), potential undesirable side effects of pegozafermin, and the complex, evolving regulatory landscape for MASH and SHTG[162](index=162&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk)[185](index=185&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk) - The biopharmaceutical industry is intensely competitive, with many companies developing competing products, some with greater resources, and unstable market and economic conditions, including inflation and geopolitical events, pose serious adverse consequences[195](index=195&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk)[200](index=200&type=chunk) - Success depends on obtaining and maintaining intellectual property protection, which is uncertain and subject to challenges, and reliance on licenses (e.g., from Teva) and potential limitations on net operating loss carryforwards (e.g., due to Israeli Tax Authority assessment) are also significant risks[165](index=165&type=chunk)[240](index=240&type=chunk)[245](index=245&type=chunk)[249](index=249&type=chunk)[274](index=274&type=chunk)[275](index=275&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=79&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report during the period - None[278](index=278&type=chunk) [Item 3. Default Upon Senior Securities](index=79&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report during the period - None[279](index=279&type=chunk) [Item 4. Mine Safety Disclosures](index=79&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[280](index=280&type=chunk) [Item 5. Other Information](index=79&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - No directors or executive officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three months ended June 30, 2025[281](index=281&type=chunk) [Item 6. Exhibits](index=80&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including organizational documents and key agreements - The exhibits include various corporate documents such as the Second Amended and Restated Certificate of Incorporation, Third Amended and Restated Bylaws, and specimen common stock certificates[285](index=285&type=chunk) - Forms of warrants to purchase common stock for Silicon Valley Bank and K2 HealthVentures LLC, as well as pre-funded warrants, are included[285](index=285&type=chunk) - Key agreements include an Amendment to Executive Employment Offer Letter and an Amendment to Collaboration Agreement with BiBo Biopharma Engineering Co., Ltd[285](index=285&type=chunk) [SIGNATURES](index=81&type=section&id=SIGNATURES) The report is signed by Rohan Palekar, Chief Executive Officer, and Ryan Martins, Chief Financial Officer, on August 8, 2025 - The report is signed by Rohan Palekar, Chief Executive Officer, and Ryan Martins, Chief Financial Officer, on August 8, 2025[289](index=289&type=chunk)

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). 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 $ ...

```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) ```

Financial Data and Key Metrics Changes - The company is experiencing significant excitement in the NASH space, particularly with the approval of Resdiffera, which has validated the potential for effective treatments in this large market [3][4] - The company anticipates that the market for NASH will expand significantly due to increased awareness and screening, particularly as new mechanisms come into play [5][6] Business Line Data and Key Metrics Changes - The company is focused on both pre-cirrhotic and cirrhotic patient populations, with ongoing studies that are expected to yield significant data in the coming years [8][33] - Pegazifirman is positioned to differentiate itself from competitors based on efficacy, safety, tolerability, and dosing convenience [10][12] Market Data and Key Metrics Changes - The FGF21 class is expected to dominate the advanced fibrosis market, with the company projecting to capture over 50% of this market due to its better safety and tolerability profile [68][71] - The company believes that there is a large market opportunity in advanced fibrosis patients, which includes millions of patients who are at risk of progressing to cirrhosis [69][70] Company Strategy and Development Direction - The company is developing pegazifirman with a focus on advanced fibrosis patients, aiming to prevent progression to cirrhosis while also considering the potential for combination therapies with GLP-1s [67][71] - The company is exploring co-formulation opportunities with GLP-1s, which could enhance its market position and provide additional benefits to patients [72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of pegazifirman to deliver significant benefits in the treatment of cirrhosis and advanced fibrosis, citing strong data from ongoing studies [36][64] - The company is optimistic about the regulatory environment, having received positive feedback from the FDA regarding its study designs and endpoints [63][66] Other Important Information - The company is actively managing enrollment in its clinical trials, with no significant impact from the approval of ResDiffera reported to date [41][42] - Management highlighted the importance of patient tolerability in clinical trials, as it directly affects patient compliance and study outcomes [39][40] Q&A Session Summary Question: How does pegazifirman differentiate from others in the FGF21 class? - The company highlighted differences in efficacy, safety, tolerability, and dosing convenience as key differentiators for pegazifirman compared to other FGF21 drugs [10][12] Question: What gives the company confidence regarding bone mineral density loss? - Management stated that data through week 48 showed no clinically meaningful changes in bone mineral density or biomarkers, providing confidence in the drug's safety profile [24][25] Question: How has enrollment been impacted by the availability of ResDiffera? - Management reported no significant impact on enrollment due to ResDiffera, with many patients still opting to participate in clinical studies [41][42] Question: What is the company's strategy for the phase three program? - The company is focused on powering its studies based on historical placebo responses and aims for a robust design to ensure statistically significant outcomes [48][50] Question: How does the company view the commercial opportunity for pegazifirman? - Management believes pegazifirman will have a dominant position in the advanced fibrosis market, particularly among compensated cirrhotic patients [67][68]

Company Overview - 89bio, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardiometabolic diseases [3] - The company is headquartered in San Francisco and aims to provide best-in-class treatment options for patients lacking optimal therapies [3] Key Developments - The company will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025, at 11:20 AM EDT [1] - Management will also engage in one-on-one investor meetings during the conference [1] Product Focus - 89bio is advancing its lead candidate, pegozafermin, through Phase 3 clinical development for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG) [3] - Pegozafermin is a fibroblast growth factor 21 (FGF21) analog utilizing glycoPEGylated technology to enhance biological activity and extend half-life [3]

Summary of 89Bio (ETNB) Conference Call Company Overview - **Company**: 89Bio - **Focus**: Development of FGF21 analogs for treating NASH (Non-Alcoholic Steatohepatitis) and related liver disorders Key Industry Insights - **NASH as a Metabolic Disorder**: NASH is primarily a metabolic dysregulation affecting the liver, leading to inflammation, fibrosis, and potentially cirrhosis [6][12] - **FGF21 Mechanism**: FGF21 is an endogenous metabolic hormone that regulates energy and lipid metabolism, with direct effects on the liver, distinguishing it from other treatments like GLP-1 [7][8] Clinical Development Highlights - **Pivotal Study Results**: The phase 2b study of pegosafirmin (FGF21 analog) involved 220 patients, showing significant improvements in liver histology markers, including fibrosis reduction and NASH resolution [8][9] - **Comparison with Competitors**: Recent data from competitors like efruxifirman supports the potential of FGF21 in severe patient populations (F4) with high unmet needs [10][12] - **Cirrhosis Reversal**: Over 45% of patients in a small dataset showed cirrhosis reversal without worsening NASH, indicating the potential of FGF21 analogs [12][13] Regulatory Pathway - **Accelerated Approval Potential**: 89Bio has received written confirmation from the FDA that demonstrating fibrosis reversal could lead to accelerated approval in the US and conditional approval in Europe [15][16] - **Study Design**: The ongoing phase 3 study will include a repeat biopsy after 24 months to assess liver healing, crucial for patients with dense fibrotic matrices [14][15] Study Enrollment and Design - **F4 Study Enrollment**: The F4 study aims to enroll approximately 750 compensated cirrhotic patients, with a focus on histology and outcomes [20][21] - **Outcome Measures**: The study will track decompensation events, mortality, and liver transplant rates, with a modified definition of decompensation to allow for earlier event detection [21][22] Manufacturing and Supply Chain - **Manufacturing Locations**: Currently, clinical products are manufactured in Europe, with commercial scaling in China. The company is exploring options to mitigate tariff impacts by transforming the API in Europe [33][35][36] Conclusion - **Market Need**: The FGF21 analogs represent a promising therapeutic avenue for patients with NASH and cirrhosis, with ongoing studies expected to provide critical data for regulatory approval and market entry [19][22]

Summary of 89Bio (ETNB) Conference Call Company Overview - **Company**: 89Bio - **Focus**: Development of picocefermin, an FGF21 analog for treating NASH (Non-Alcoholic Steatohepatitis) and severe hypertriglyceridemia (SHTG) [3][52] Key Points on FGF21 and NASH - **Mechanism of Action**: FGF21 is a unique FGF21 analog that addresses metabolic dysregulation, liver fat reduction, and fibrosis directly [3][4][6] - **Clinical Efficacy**: FGF21 shows benefits in fibrosis improvement as early as 24 weeks, compared to other drugs that may take longer [6][10] - **Market Dynamics**: Recent successful drug approvals in the NASH space have increased confidence in the market, with a shift towards more potent second-generation products [7][10] Competitive Landscape - **Recent Deals**: GSK's acquisition of Boston Pharmaceuticals' efemulsipherman for $800 million validates interest in the NASH market and the FGF21 mechanism [11][12] - **Market Potential**: The F4 cirrhotic population represents the highest unmet need and pricing power in the NASH market [13][14] Differentiating Characteristics of Pegosafirman - **Dosing and Administration**: Pegosafirman can be dosed once a week or every two weeks, with a favorable tolerability profile compared to competitors [18][21][23] - **Efficacy Data**: In phase 2 studies, pegosafirman showed a 20% placebo-adjusted delta in fibrosis improvement, with a relative risk benefit of 3.5 [18][19][20] - **Tolerability**: Lower rates of gastrointestinal adverse events compared to other FGF21 agents, which is crucial for patient compliance [21][22] Physician and Patient Perspectives - **Physician Preferences**: Key criteria include fibrosis benefit, tolerability, and the ability to address steatohepatitis [27][28][30] - **Patient Preferences**: Patients prioritize dosing convenience, adverse event profiles, and affordability [32][33] Market Strategy and Future Outlook - **Targeting Endocrinologists**: As the market evolves, endocrinologists are expected to play a significant role in treating NASH, especially with the approval of GLP-1s [34][35] - **Market Size**: The F4 space alone could exceed $5 billion, indicating significant potential for multiple successful players [38] Combination Therapies - **Potential Combinations**: The combination of FGF21 with GLP-1s could yield synergistic benefits, but safety and tolerability will be critical factors [49][50] Severe Hypertriglyceridemia (SHTG) Strategy - **Target Population**: Patients with triglycerides above 500 mg/dL, often with metabolic dysfunction, represent a significant market opportunity [52][53] - **Efficacy in SHTG**: Phase 2 studies showed a 57% to 63% reduction in triglycerides, positioning pegosafirman as a second-line therapy for refractory patients [54][55] Conclusion - **Overall Outlook**: 89Bio is well-positioned in the NASH and SHTG markets with a differentiated product profile and a strong focus on patient and physician needs, supported by promising clinical data and market validation through recent industry deals [56]

Company Overview - 89bio, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardiometabolic diseases [3] - The company is headquartered in San Francisco and is dedicated to creating best-in-class treatments for patients lacking optimal options [3] Product Development - 89bio is currently in Phase 3 trials for its lead candidate, pegozafermin, targeting metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis and severe hypertriglyceridemia (SHTG) [3] - Pegozafermin is a fibroblast growth factor 21 (FGF21) analog utilizing glycoPEGylated technology to enhance biological activity through an extended half-life [3] Investor Engagement - The company will participate in the BofA Securities 2025 Health Care Conference on May 14, 2025, at 1:40 PM ET [1] - Additionally, 89bio will be present at the RBC Capital Markets Global Healthcare Conference on May 20, 2025, at 9:30 AM ET [2] - Webcasts of these fireside chats will be available on the investor section of 89bio's website, with replays accessible for approximately 30 days post-conference [2]

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for Q1 2025 show total assets increased to $685.0 million due to a public offering, while net loss rose to $71.3 million from increased R&D expenses [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $685.0 million by March 31, 2025, primarily due to a rise in cash and cash equivalents, significantly boosting stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $315,396 | $126,060 | | Marketable securities | $323,384 | $313,895 | | Total current assets | $682,944 | $476,450 | | **Total assets** | **$685,031** | **$478,685** | | **Liabilities & Equity** | | | | Total current liabilities | $37,884 | $36,129 | | Total liabilities | $79,573 | $77,896 | | Total stockholders' equity | $605,458 | $400,789 | | **Total liabilities and stockholders' equity** | **$685,031** | **$478,685** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for Q1 2025 increased to $71.3 million due to higher R&D expenses, though net loss per share decreased to $0.49 due to more shares outstanding Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | P&L Item | 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) | $(57,277) | | **Net loss** | **$(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 Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity significantly increased to $605.5 million by March 31, 2025, primarily driven by $269.9 million from a public offering, partially offset by net loss - In Q1 2025, the company issued common stock and pre-funded warrants in a public offering, raising net proceeds of **$269.9 million**[16](index=16&type=chunk) - The increase in equity was offset by a net loss of **$71.3 million** and other comprehensive loss of **$0.2 million** for the quarter[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to $71.7 million in Q1 2025, but a $268.9 million inflow from financing activities led to a net increase in cash to $315.4 million Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(71,737) | $(39,720) | | Net cash used in investing activities | $(7,833) | $(79,898) | | Net cash provided by financing activities | $268,906 | $21,030 | | **Net change in cash and cash equivalents** | **$189,336** | **$(98,588)** | | **Cash and cash equivalents at end of period** | **$315,396** | **$217,573** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes confirm the company's clinical-stage focus on pegozafermin, an accumulated deficit of $895.8 million, and sufficient cash of $638.8 million for at least one year, alongside key financial commitments - The company is a clinical-stage biopharmaceutical company developing pegozafermin for MASH and SHTG[21](index=21&type=chunk) - As of March 31, 2025, the company had an accumulated deficit of **$895.8 million** but believes its cash, cash equivalents, and marketable securities of **$638.8 million** are sufficient to fund operations for at least one year[23](index=23&type=chunk)[24](index=24&type=chunk) - In February 2025, the company raised net proceeds of approximately **$269.9 million** from an underwritten public offering[62](index=62&type=chunk) - The company has a term loan facility for up to **$150.0 million**, with **$35.0 million** drawn as of March 31, 2025; access to the **$30.0 million** Tranche 2 is not anticipated[56](index=56&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the advancement of pegozafermin in Phase 3 trials, a $17.0 million increase in R&D expenses, and $638.8 million in cash, which is deemed sufficient for at least one year of operations [Overview](index=20&type=section&id=Overview) The company is a clinical-stage biopharmaceutical firm developing pegozafermin, with Phase 3 trials for MASH and SHTG progressing and commercial supply preparations underway - Lead product candidate, pegozafermin, is in Phase 3 development for MASH and SHTG[76](index=76&type=chunk) - The Phase 3 ENLIGHTEN program for MASH is enrolling patients, with topline data for the F2-F3 cohort expected in **H1 2027** and the F4 cohort in **2028**[78](index=78&type=chunk)[80](index=80&type=chunk) - The Phase 3 ENTRUST trial for SHTG has completed enrollment, with topline data expected in **Q1 2026**[79](index=79&type=chunk)[81](index=81&type=chunk) - A collaboration with BiBo is in place to construct a production facility for pegozafermin's commercial supply[82](index=82&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q1 2025 R&D expenses increased by $17.0 million to $64.4 million, driven by Phase 3 MASH trials, while G&A expenses also rose Change in Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Research and development** | **$64,394** | **$47,428** | **$16,966** | | Clinical development | $33,795 | $17,924 | $15,871 | | Contract manufacturing | $19,057 | $21,351 | $(2,294) | | Personnel-related expenses | $10,673 | $7,733 | $2,940 | | **General and administrative** | **$11,515** | **$9,849** | **$1,666** | [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held $638.8 million in cash and equivalents, bolstered by a $269.9 million public offering, sufficient to fund operations for at least one year - The company had cash, cash equivalents, and marketable securities of **$638.8 million** as of March 31, 2025[96](index=96&type=chunk) - In February 2025, a public offering raised net proceeds of **$269.9 million**[100](index=100&type=chunk) - Existing cash is expected to fund operations for at least one year from the filing date of the 10-Q[105](index=105&type=chunk) - The company does not anticipate meeting the condition to access Tranche 2 (**$30.0 million**) of its Term Loan Facility[106](index=106&type=chunk) [Contractual Obligations and Commitments](index=30&type=section&id=Contractual%20Obligations%20and%20Commitments) The company has significant future financial commitments, including $35.0 million in outstanding debt, potential $65.0 million milestone payments to Teva, and a $13.5 million payment to BiBo for a production facility - Obligated to pay Teva up to **$65.0 million** upon achievement of specified commercial milestones for pegozafermin[118](index=118&type=chunk) - A remaining **$13.5 million** is payable to BiBo for a production facility upon achieving a certain milestone[119](index=119&type=chunk) - The outstanding principal of **$35.0 million** under the Loan Agreement matures on October 1, 2028[117](index=117&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes in its market risk from the information provided in its Annual Report on Form 10-K for the year ended December 31, 2024 - There have been no material changes in market risk since the last Annual Report on Form 10-K[122](index=122&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2025 - Management concluded that disclosure controls and procedures were effective as of March 31, 2025[124](index=124&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[125](index=125&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[128](index=128&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including dependence on pegozafermin's success, clinical and regulatory uncertainties, capital needs, reliance on third-party manufacturers, competition, and intellectual property disputes [Risks Related to Business and Industry](index=34&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) Risks include the company's dependence on pegozafermin, the uncertain and costly nature of clinical trials, the need for additional capital, reliance on third-party manufacturers, and intense competition - The company is a clinical-stage biopharmaceutical company with a history of net losses and its business depends entirely on the success of pegozafermin[131](index=131&type=chunk)[136](index=136&type=chunk) - The company will require substantial additional capital to finance operations, which may not be available on acceptable terms[140](index=140&type=chunk) - Reliance on third-party manufacturers, including BiBo in China, exposes the company to supply chain, geopolitical, and regulatory risks like the proposed BIOSECURE Act[147](index=147&type=chunk)[148](index=148&type=chunk)[154](index=154&type=chunk) - The company faces substantial competition from other companies developing therapies for MASH and SHTG, some with greater resources[163](index=163&type=chunk) [Risks Related to Regulatory Approvals](index=54&type=section&id=Risks%20Related%20to%20Regulatory%20Approvals) Significant regulatory risks include the uncertainty of pegozafermin's approval, potential post-market issues, and the limitations of expedited designations, compounded by FDA disruptions and evolving requirements - Pegozafermin has not received regulatory approval, and the process is lengthy, expensive, and uncertain[189](index=189&type=chunk)[193](index=193&type=chunk) - Even if approved, pegozafermin could face post-market difficulties, including potential revocation of approval if harmful side effects are discovered[192](index=192&type=chunk) - Breakthrough Therapy and PRIME designations do not guarantee a faster review or ultimate approval[195](index=195&type=chunk)[196](index=196&type=chunk) - Disruptions at the FDA and other government agencies, including policy changes and budget constraints, could negatively affect the review of regulatory submissions[199](index=199&type=chunk) [Risks Related to Intellectual Property](index=61&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Intellectual property risks include the uncertainty of patent protection, reliance on a critical license from Teva, and the potential for costly litigation to defend or enforce IP rights - Success depends on the ability to obtain and maintain intellectual property protection for products and technologies, which is highly uncertain[209](index=209&type=chunk)[213](index=213&type=chunk) - The company relies on a license from Teva for the glycoPEGylation technology essential for pegozafermin; termination of this license would materially harm the business[217](index=217&type=chunk) - The company may become involved in expensive and unsuccessful lawsuits to protect its intellectual property or defend against infringement claims from third parties[220](index=220&type=chunk)[223](index=223&type=chunk) [Risks Related to Ownership of Our Common Stock](index=67&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) Risks to common stock ownership include significant price volatility, potential depression from substantial share sales, and dilution from future equity offerings - The price of the company's common stock may be volatile and fluctuate significantly due to clinical developments, competitor news, and market trends[225](index=225&type=chunk) - Sales of a substantial number of shares, or the perception of such sales, could depress the stock price[226](index=226&type=chunk) - Raising additional capital through equity offerings may cause significant dilution to existing stockholders[229](index=229&type=chunk) [General Risk Factors](index=69&type=section&id=General%20Risk%20Factors) General risks include substantial control by insiders, inherent limitations of internal controls, and exclusive forum provisions that may limit stockholders' judicial options - Directors, executive officers, and holders of **5%** or more of the stock have substantial control over the company[232](index=232&type=chunk) - The company's disclosure and internal controls have inherent limitations and may not prevent all errors or fraud; failure to maintain effective controls could harm investor confidence[233](index=233&type=chunk)[235](index=235&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards may be limited, and a potential tax assessment from Israeli authorities could impact NOLs and financial condition[239](index=239&type=chunk)[240](index=240&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=72&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[242](index=242&type=chunk) [Other Information](index=72&type=section&id=Item%205.%20Other%20Information) The company states that none of its directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the first quarter of 2025 - No directors or executive officers adopted or terminated a Rule 10b5-1 trading plan during the three months ended March 31, 2025[245](index=245&type=chunk) [Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, forms of warrants, and officer certifications - The report includes a list of all exhibits filed, such as the Certificate of Incorporation, Bylaws, forms of warrants, and officer certifications required by the SEC[247](index=247&type=chunk)