89bio(ETNB) - 2023 Q3 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents the company's unaudited financial statements, management's discussion, market risk, and internal controls Item 1. Financial Statements (Unaudited) This section presents unaudited condensed consolidated financial statements, offering a detailed financial overview for periods ended September 30, 2023 Condensed Consolidated Balance Sheets This section details the company's financial position, assets, liabilities, and equity as of September 30, 2023 Condensed Consolidated Balance Sheets (in thousands) | Metric | Sep 30, 2023 | Dec 31, 2022 | Change | | :------------------------------ | :----------- | :----------- | :----- | | Cash and cash equivalents | $251,926 | $55,255 | +356% | | Short-term AFS securities | $196,378 | $132,905 | +47.8% | | Total current assets | $459,526 | $196,080 | +134% | | Total assets | $460,111 | $196,824 | +134% | | Total current liabilities | $25,212 | $24,614 | +2.4% | | Total liabilities | $49,902 | $44,992 | +10.9% | | Total stockholders' equity | $410,209 | $151,832 | +170% | Condensed Consolidated Statements of Operations and Comprehensive Loss This section presents the company's financial performance, including revenues, expenses, and net loss, for the reported periods Three Months Ended September 30 (in thousands) | Metric | 2023 | 2022 | Change (YoY) | | :----------------------- | :--- | :--- | :----------- | | Research and development | $31,417 | $22,197 | +41.5% | | General and administrative | $7,928 | $4,844 | +63.7% | | Total operating expenses | $39,345 | $27,041 | +45.5% | | Loss from operations | $(39,345) | $(27,041) | +45.5% | | Interest expense | $(959) | $(535) | +79.2% | | Interest income and other, net | $5,579 | $773 | +621.7% | | Net loss | $(34,725) | $(26,805) | +29.5% | | Net loss per share | $(0.45) | $(0.57) | -21.1% | Nine Months Ended September 30 (in thousands) | Metric | 2023 | 2022 | Change (YoY) | | :----------------------- | :--- | :--- | :----------- | | Research and development | $88,638 | $61,732 | +43.6% | | General and administrative | $21,360 | $15,155 | +40.9% | | Total operating expenses | $109,998 | $76,887 | +43.1% | | Loss from operations | $(109,998) | $(76,887) | +43.1% | | Interest expense | $(3,928) | $(1,377) | +185.3% | | Interest income and other, net | $11,972 | $843 | +1319.9% | | Net loss | $(101,954) | $(77,424) | +31.7% | | Net loss per share | $(1.50) | $(2.63) | -42.9% | Condensed Consolidated Statements of Stockholders' Equity This section outlines changes in the company's stockholders' equity, including common stock and accumulated deficit Stockholders' Equity Changes (Nine Months Ended September 30, 2023, in thousands) | Metric | Dec 31, 2022 | Sep 30, 2023 | Change | | :------------------------ | :----------- | :----------- | :----- | | Common Stock (Shares) | 50,560,590 | 75,638,516 | +49.6% | | Common Stock (Amounts) | $51 | $75 | +47.1% | | Additional Paid-in Capital | $467,374 | $827,878 | +77.1% | | Accumulated Deficit | $(315,243) | $(417,197) | +32.3% | | Total Stockholders' Equity | $151,832 | $410,209 | +170% | - Issuance of common stock in public offering, net of issuance costs, contributed $296,817k to additional paid-in capital[15] - Issuance of common stock in at-the-market public offerings, net of issuance costs, contributed $13,422k (Q1 2023) and $23,667k (Q2 2023)[15] Condensed Consolidated Statements of Cash Flows This section summarizes the company's cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary (Nine Months Ended September 30, in thousands) | Activity | 2023 | 2022 | Change (YoY) | | :------------------------ | :--- | :--- | :----------- | | Operating activities | $(94,893) | $(53,994) | +75.7% | | Investing activities | $(59,376) | $(22,882) | +159.5% | | Financing activities | $350,940 | $96,820 | +262.5% | | Net change in cash | $196,671 | $19,944 | +886.1% | | Cash at end of period | $251,926 | $72,401 | +248% | - Net cash provided by financing activities in 2023 was primarily from $296.8 million from a public offering, $37.1 million from at-the-market offerings, and $24.4 million from a new term loan facility[127] Notes to Unaudited Condensed Consolidated Financial Statements This section provides explanatory details and significant accounting policies supporting the unaudited financial statements - 89bio, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and cardio-metabolic diseases, with pegozafermin as its lead product candidate for NASH and SHTG[21][83] - The Company had $448.3 million in cash, cash equivalents, and short-term available-for-sale securities as of September 30, 2023, which is expected to fund operating expenses and capital expenditure requirements for at least one year[23][24][92] Fair Value of Financial Assets (September 30, 2023, in thousands) | Asset Type | Fair Value | | :----------------------------------- | :--------- | | Money market funds | $8,947 | | Commercial paper | $104,101 | | U.S. treasury bills | $115,236 | | U.S. government bonds | $89,633 | | Agency bonds | $32,463 | | Agency discount securities | $2,476 | | Corporate debt securities | $3,125 | | Total cash equivalents and AFS securities | $355,981 | - In January 2023, the Company executed a new $100.0 million term loan agreement, with $25.0 million funded at closing, and repaid the prior $21.4 million loan, resulting in a $1.2 million loss on extinguishment[50][51][112] - Total stock-based compensation expense for the nine months ended September 30, 2023, was $12.1 million, an increase from $7.6 million in the same period of 2022[78][123][124] - In October 2023, a $2.5 million milestone payment became due under the Teva Agreements due to achieving a clinical development milestone related to patient enrollment[80][90][131] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial condition, operational results, liquidity, and capital resources, focusing on pegozafermin's development and financial performance for the periods ended September 30, 2023 Overview This section provides a high-level summary of the company's business, lead product candidate pegozafermin, and key financial highlights - Lead product candidate, pegozafermin, is being developed for nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG)[83] - Phase 2b ENLIVEN trial for NASH met primary histology endpoints with high statistical significance for 44 mg every-two-week and 30 mg weekly dose groups, showing significant fibrosis improvement and NASH resolution[84] - FDA breakthrough therapy designation was granted to pegozafermin in patients with NASH in September 2023[84][212] - Initiated the first of two recommended Phase 3 trials for SHTG in Q2 2023, with topline results expected in 2025[89] - As of September 30, 2023, cash and cash equivalents and short-term available-for-sale securities totaled $448.3 million, expected to fund operations for at least one year[92] - Net losses for the three and nine months ended September 30, 2023, were $34.7 million and $102.0 million, respectively, with an accumulated deficit of $417.2 million[93] Components of Results of Operations This section defines the key expense and income categories that constitute the company's financial performance - Research and development expenses primarily consist of external costs for preclinical and clinical development, including contract manufacturing, clinical trials, regulatory submissions, and personnel costs, and are expensed as incurred[94][95] - General and administrative expenses include personnel costs, professional services (legal, HR, audit, accounting), consulting, and facilities costs[99] - Interest expense includes interest, accretion of final payment fees, and amortization of debt issuance costs related to the term loan facility[100] - Interest income and other, net, primarily consists of interest income from cash equivalents and available-for-sale securities[101] Results of Operations This section analyzes the company's financial performance, detailing changes in operating expenses, interest income, and net loss Operating Expenses (Three Months Ended September 30, in thousands) | Expense Category | 2023 | 2022 | Change (YoY) | | :----------------------- | :--- | :--- | :----------- | | Research and development | $31,417 | $22,197 | +42% | | General and administrative | $7,928 | $4,844 | +64% | - R&D increase was driven by $8.1 million in contract manufacturing and $2.4 million in personnel-related costs, partially offset by a $1.5 million decrease in clinical development costs[104] - G&A increase was mainly due to $1.8 million in professional services and $1.5 million in personnel-related costs[105] Operating Expenses (Nine Months Ended September 30, in thousands) | Expense Category | 2023 | 2022 | Change (YoY) | | :----------------------- | :--- | :--- | :----------- | | Research and development | $88,638 | $61,732 | +44% | | General and administrative | $21,360 | $15,155 | +41% | - R&D increase was driven by $23.8 million in contract manufacturing and $5.4 million in personnel-related costs, partially offset by a $2.5 million decrease in clinical development costs[110] - G&A increase was primarily due to $3.9 million in professional services and $3.0 million in personnel-related costs[111] - Interest income and other, net, increased significantly by $4.8 million (three months) and $11.1 million (nine months) due to higher investment balances and favorable interest rates[107][113] - Interest expense increased by $0.4 million (three months) and $2.6 million (nine months), including a $1.2 million loss on extinguishment of the prior term loan[106][112] Liquidity and Capital Resources This section discusses the company's cash position, capital raising activities, and future funding requirements - As of September 30, 2023, the Company had $448.3 million in cash, cash equivalents, and short-term available-for-sale securities, and an accumulated deficit of $417.2 million[114] - Existing capital is expected to fund anticipated cash requirements for at least one year from the filing date of the 10-Q[119] - Significant capital was raised through a March 2023 public offering ($296.8 million net) and at-the-market offerings ($37.1 million net) during the nine months ended September 30, 2023[116] - A new $100.0 million term loan facility was entered into in January 2023, with $25.0 million funded at closing, and the prior term loan of $21.4 million was repaid[117][129] - Future funding requirements are highly dependent on the progress, timing, scope, and costs of clinical trials for pegozafermin and other product candidates, as well as regulatory approvals and commercialization efforts[118][120][121] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, 89bio, Inc. is not required to provide detailed quantitative and qualitative disclosures about market risk in this report - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[137] Item 4. Controls and Procedures Management, with the participation of the principal executive and financial officers, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2023. No material changes in internal control over financial reporting occurred during the quarter - Management concluded that disclosure controls and procedures were effective as of September 30, 2023, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[138] - No material changes in internal control over financial reporting occurred during the quarter ended September 30, 2023[139] PART II. OTHER INFORMATION This section covers legal proceedings, significant risk factors, equity sales, defaults, and a list of exhibits Item 1. Legal Proceedings The company is not currently a party to any material legal proceedings but acknowledges that litigation can arise in the ordinary course of business and may adversely impact operations due to costs, diversion of resources, and reputational harm - The company is not currently a party to any material legal proceedings[142] - Litigation, if it occurs, can have an adverse impact due to defense and settlement costs, diversion of management resources, and reputational harm[142] Item 1A. Risk Factors Investing in 89bio common stock involves significant risks, including limited operating history, reliance on pegozafermin, substantial capital needs, and uncertain clinical development and regulatory processes - The company is a clinical-stage biopharmaceutical company with a limited operating history, no approved products, and expects to incur significant and increasing operating losses, making investment highly speculative[146][149] - Business success is critically dependent on pegozafermin, its only clinical product candidate; failure to obtain regulatory approval or commercialize it would materially harm the business[150] - Clinical drug development is a lengthy, expensive, and uncertain process, with prior preclinical/clinical trial results not necessarily predictive of future outcomes, and a high failure rate for drugs in clinical trials[151][152] - Substantial additional capital is required to finance operations, and if not available on acceptable terms, could prevent completion of pegozafermin's development and commercialization[153][154][155] - Reliance on third-party manufacturers (sole source BTPH) for pegozafermin production introduces risks of supply disruption, increased costs, and delays in clinical trials or regulatory approvals[161][162][167] - The biopharmaceutical industry is intensely competitive, with numerous companies developing therapies for NASH and SHTG, potentially leading to others commercializing competing products sooner or more successfully[178][180][181] - Regulatory approval processes are lengthy, time-consuming, and unpredictable; even with breakthrough therapy designation, approval is not guaranteed and post-approval requirements or side effects could lead to revocation or costly claims[206][208][211][212][216] - The company relies on licenses from Teva and ratiopharm for glycoPEGylation technology; termination or loss of these rights would materially and adversely affect its ability to develop and commercialize pegozafermin[232][233] - The price of common stock may be volatile due to various factors, and sales of common stock or exercise of warrants could depress the stock price, leading to potential loss of investment[242][243][244] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section states that there were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds to report[259] Item 3. Default Upon Senior Securities The company reported no defaults upon senior securities during the period - No defaults upon senior securities[260] Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable[261] Item 5. Other Information The company reported no other information for this item - No other information to report[262] Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including organizational documents, warrant forms, and certifications - Lists various exhibits filed, including organizational documents, warrant forms, and certifications[265] Signatures This section provides the official certifications and signatures from the company's principal executive and financial officers - The report is signed by Rohan Palekar (Chief Executive Officer) and Ryan Martins (Chief Financial Officer) on November 9, 2023[268]