Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 01, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | 89bio, Inc. | ||
Entity Central Index Key | 0001785173 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 165.5 | ||
Entity Common Stock, Shares Outstanding | 20,351,384 | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Title of 12(b) Security | Common stock, par value $0.001 per share | ||
Trading Symbol | ETNB | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-39122 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 36-4946844 | ||
Entity Address, Address Line One | 142 Sansome Street | ||
Entity Address Address Line Two | Second Floor | ||
Entity Address, City or Town | San Francisco | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94104 | ||
City Area Code | 415 | ||
Local Phone Number | 432-9270 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement relating to its 2022 Annual Meeting of Stockholders, to be held on or about June 1, 2022, are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. Such proxy statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates. | ||
Auditor Firm ID | 185 | ||
Auditor Name | KPMG LLP | ||
Auditor Location | San Francisco, California, USA |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 52,432 | $ 98,183 |
Restricted cash | 25 | 25 |
Short-term available-for-sale securities | 98,288 | 106,446 |
Prepaid and other current assets | 11,237 | 5,548 |
Total current assets | 161,982 | 210,202 |
Property and equipment, net | 150 | 166 |
Other assets | 290 | 706 |
Total assets | 162,422 | 211,074 |
Current liabilities: | ||
Accounts payable | 6,843 | 2,065 |
Accrued expenses | 10,194 | 6,048 |
Term loan, current | 2,500 | |
Total current liabilities | 19,537 | 8,113 |
Term loan, non-current, net | 16,898 | |
Other non-current liability | 30 | |
Total liabilities | 36,465 | 8,113 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized as of December 31, 2021 and 2020, respectively, no shares issued and outstanding as of December 31, 2021 and 2020, respectively | ||
Common stock, $0.001 par value, 100,000,000 shares authorized as of December 31, 2021 and 2020, respectively; 20,317,204 and 19,931,660 shares issued and outstanding as of December 31, 2021 and 2020, respectively | 20 | 20 |
Additional paid-in capital | 339,218 | 326,046 |
Accumulated other comprehensive loss | (64) | (10) |
Accumulated deficit | (213,217) | (123,095) |
Total stockholders’ equity | 125,957 | 202,961 |
Total liabilities and stockholders’ equity | $ 162,422 | $ 211,074 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 20,317,204 | 19,931,660 |
Common stock, shares outstanding | 20,317,204 | 19,931,660 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating expenses: | ||
Research and development | $ 70,330 | $ 36,199 |
General and administrative | 19,413 | 13,156 |
Total operating expenses | 89,743 | 49,355 |
Loss from operations | (89,743) | (49,355) |
Other expenses, net | (526) | (203) |
Net loss before income tax | (90,269) | (49,558) |
Income tax benefit | 147 | 59 |
Net loss | (90,122) | (49,499) |
Other comprehensive (loss) income: | ||
Unrealized (loss) gain on available-for-sale securities | (71) | 8 |
Foreign currency translation adjustments | 17 | (18) |
Total other comprehensive loss | (54) | (10) |
Comprehensive loss | $ (90,176) | $ (49,509) |
Net loss per share, basic and diluted | $ (4.48) | $ (3.08) |
Weighted-average shares used to compute net loss per share, basic and diluted | 20,098,340 | 16,087,785 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | A T M Facility | Public Offerings | Common Stock | Common StockA T M Facility | Common StockPublic Offerings | Additional Paid-in Capital | Additional Paid-in CapitalA T M Facility | Additional Paid-in CapitalPublic Offerings | Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive LossA T M Facility | Accumulated Other Comprehensive LossPublic Offerings | Retained Earnings |
Beginning balance at Dec. 31, 2019 | $ 89,944 | $ 14 | $ 163,526 | $ 0 | $ (73,596) | ||||||||
Beginning balance, shares at Dec. 31, 2019 | 13,788,982 | ||||||||||||
Issuance of common stock | $ 157,680 | $ 6 | $ 157,674 | $ 0 | |||||||||
Issuance of common stock, shares | 6,072,040 | ||||||||||||
Issuance of common stock upon exercise of stock options | 271 | 271 | 0 | ||||||||||
Issuance of common stock upon exercise of stock options, shares | 63,366 | ||||||||||||
Issuance of common stock upon ESPP purchase | 134 | 134 | 0 | ||||||||||
Issuance of common stock upon ESPP purchase, Shares | 7,272 | ||||||||||||
Issuance of common stock warrant in connection with term loan facility | 634 | 634 | 0 | ||||||||||
Stock-based compensation | 3,807 | 3,807 | 0 | ||||||||||
Issuance Of Common Stock Warrants In Connection With Debt Financing | 0 | ||||||||||||
Net loss | (49,499) | 0 | (49,499) | ||||||||||
Other comprehensive loss | (10) | (10) | |||||||||||
Ending balance at Dec. 31, 2020 | 202,961 | $ 20 | 326,046 | (10) | (123,095) | ||||||||
Ending balance, shares at Dec. 31, 2020 | 19,931,660 | ||||||||||||
Issuance of common stock | $ 3,289 | $ 3,289 | $ 0 | ||||||||||
Issuance of common stock, shares | 186,546 | ||||||||||||
Issuance of common stock upon exercise of stock options | 487 | 487 | 0 | ||||||||||
Issuance of common stock upon exercise of stock options, shares | 188,286 | ||||||||||||
Issuance of common stock upon ESPP purchase | 144 | 144 | 0 | ||||||||||
Issuance of common stock upon ESPP purchase, Shares | 10,712 | ||||||||||||
Issuance of common stock warrant in connection with term loan facility | 574 | 574 | 0 | ||||||||||
Stock-based compensation | 8,678 | 8,678 | 0 | ||||||||||
Net loss | (90,122) | 0 | (90,122) | ||||||||||
Other comprehensive loss | (54) | (54) | |||||||||||
Ending balance at Dec. 31, 2021 | $ 125,957 | $ 20 | $ 339,218 | $ (64) | $ (213,217) | ||||||||
Ending balance, shares at Dec. 31, 2021 | 20,317,204 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - Convertible Preferred Shares - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
A T M Facility | ||
Temporary equity, issuance costs | $ 165 | |
Public Offerings | ||
Temporary equity, issuance costs | $ 1,208 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows $ in Thousands | 12 Months Ended | |
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | |
Cash flows from operating activities: | ||
Net loss | $ (90,122) | $ (49,499) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 8,678 | 3,807 |
Amortization of premium on available-for-sale securities | 865 | 268 |
Amortization of debt issuance costs and accretion of final payment fee | 617 | 230 |
Depreciation | 79 | 60 |
Deferred tax assets | (150) | (69) |
Changes in operating assets and liabilities: | ||
Prepaid and other current assets | (5,672) | (3,600) |
Accounts payable | 4,778 | 1,131 |
Accrued expenses | 4,146 | 1,428 |
Net cash used in operating activities | (76,781) | (46,244) |
Cash flows from investing activities: | ||
Proceeds from sales and maturities of available-for-sale securities | 148,422 | 12,189 |
Purchases of available-for-sale securities | (141,200) | (118,895) |
Purchases of property and equipment | (63) | (126) |
Net cash provided by (used in) investing activities | 7,159 | (106,832) |
Cash flows from financing activities: | ||
Proceeds from term loan facility, net of issuance costs | 19,951 | |
Proceeds from issuance of common stock upon public offerings,net of issuance costs | 3,289 | 157,680 |
Proceeds from issuance of common stock upon stock option exercises | 487 | 271 |
Payment of debt issuance costs | (161) | |
Net cash provided by financing activities | 23,871 | 157,924 |
Net change in cash and cash equivalents, and restricted cash | (45,751) | 4,848 |
Cash and cash equivalents, and restricted cash at beginning of period | 98,208 | 93,360 |
Cash and cash equivalents, and restricted cash at end of period | 52,457 | 98,208 |
Components of cash and cash equivalents, and restricted cash: | ||
Cash and cash equivalents | 52,432 | 98,183 |
Restricted cash | 25 | 25 |
Total cash and cash equivalents, and restricted cash | 52,457 | 98,208 |
Supplemental disclosures of cash information: | ||
Cash paid for interest | 16 | |
Cash paid for income taxes | 142 | |
Supplemental disclosures of noncash information: | ||
Issuance of common stock warrant in connection with term loan facility | 574 | 634 |
ESPP Purchases | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock upon ESPP purchases | $ 144 | $ 134 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Description of Business 89bio, Inc. (“89bio” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The Company’s lead product candidate, pegozafermin (previously BIO89-100), a specifically engineered glycoPEGylated analog of fibroblast growth factor 21, is currently being developed for the treatment of nonalcoholic steatohepatitis and for the treatment of severe hypertriglyceridemia. 89bio, Inc. was formed as a Delaware corporation in June 2019 Public Offerings In July 2020, the Company completed an underwritten public offering of 3,047,040 shares of its common stock at the public offering price of $27.50 per share. The Company raised a total of $78.2 million in net proceeds after deducting underwriting discounts and commissions of $5.0 million and offering costs of $0.6 million. In September 2020, the Company completed an underwritten public offering of 3,025,000 shares of its common stock, at a public offering price of $28.00 per share. The Company raised a total of $79.5 million in net proceeds after deducting underwriting discounts and commissions of $4.6 million and offering costs of $0.6 million. In March 2021, the Company entered into a sales agreement (the “Sales Agreement”) with SVB Leerink LLC and Cantor Fitzgerald & Co. (the “Sales Agents”) pursuant to which it may offer and sell up to $75.0 million of shares of the Company’s common stock, from time to time, in “at-the-market” offerings (the “ATM Facility”). The Sales Agents are entitled to compensation at a commission equal to 3.0% of the aggregate gross sales price per share sold under the Sales Agreement. During the fourth quarter of 2021, the Company received proceeds of $3.3 million, net of commissions and offering expenses from sales of 186,546 shares of its common stock at a weighted-average price of $17.97 per share pursuant to the ATM Facility. Liquidity The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. To date, the Company has not generated revenues from its activities and has incurred substantial operating losses. Management expects the Company to continue to generate substantial operating losses for the foreseeable future until it completes development of its products and seeks regulatory approvals to market such products. The Company had cash and cash equivalents and short-term available-for-sale securities of $150.7 million as of December 31, 2021. The Company expects that its cash and cash equivalents and short-term available-for-sale securities as of December 31, 2021, together with proceeds available from the Company’s term loan (see Note 6) and its ATM Facility, will be sufficient to fund operating expenses and capital expenditure requirements for a period of at least one year from the date these audited consolidated financial statements are filed with the Securities and Exchange Commission (“SEC”). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”). Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Foreign Currencies Certain transactions during the years ended December 31, 2021 and 2020 were denominated in currencies other than the U.S. dollar. Gains and losses from foreign currency transactions were not material for all periods presented and are reflected in the consolidated statements of operations and comprehensive loss as a component of other expenses, net. The Company’s subsidiary in Lithuania uses the Euro as its functional currency for financial reporting. The re-measurement from Euros to U.S. dollars results in translation gain and loss adjustments, which are reflected as a component of comprehensive loss as foreign currency translation adjustments. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements include but are not limited to accrued research and development expenses and the fair value of stock options. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. Fair Value Measurements Financial assets and liabilities are recorded at fair value on a recurring basis in the consolidated balance sheets. The carrying values of Company’s financial assets and liabilities, including cash and cash equivalents, restricted cash, prepaid and other current assets, accounts payable, and accrued expenses approximate to their fair value due to the short-term nature of these instruments. The fair value of the Company’s term loan approximates its carrying value, or amortized cost, due to the prevailing market rates of interest rates it bears. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. Assets and liabilities recorded at fair value are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels are directly related to the amount of subjectivity with the inputs to the valuation of these assets or liabilities as follows: Level 1 —Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 —Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable inputs for similar assets or liabilities. These include quoted prices for identical or similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active; and Level 3 —Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Concentrations of Credit Risk Financial limits amounts invested in available-for-sale securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company is not exposed to any significant concentrations of credit risk from these financial instruments. Other The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, the Company’s early stages of clinical drug development; the Company’s ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; the Company’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; the Company’s ability to enroll patients in its ongoing and future clinical trials; the Company’s ability to successfully manufacture and supply its product candidates for clinical trials; the Company’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases the Company is targeting; the Company’s ability to obtain, maintain, and protect its intellectual property rights; developments relating to the Company’s competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties. The Company’s product candidates will require approvals from the U.S. Food and Drug Administration and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company was denied approval, approval was delayed or the Company was unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company. The ongoing COVID-19 pandemic has disrupted and may continue to disrupt the Company’s business and delay its preclinical and clinical programs and timelines. The Company does not yet know the full extent of potential delays to clinical trials, which could prevent or delay the Company from obtaining approval for pegozafermin. Segment Reporting The Company has one operating Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market funds and commercial paper that are stated at fair value. Restricted Cash Restricted cash consists of a money market account that serves as collateral for the Company’s operating lease agreement for its facility in Israel. Investments Investments have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its available-for-sale investments in debt securities at the time of purchase. Generally, investments with original maturities beyond three months at the date of purchase are classified as short-term because it is management’s intent to use the investments to fund current operations or to make them available for current operations. Unrealized gains and losses are excluded from earnings and are reported as a component of comprehensive loss. The Company periodically evaluates whether declines in fair values of its available-for-sale securities below their book value are other-than-temporary. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale securities before recovery of its amortized cost basis. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in other expenses, net. The cost of investments sold is based on the specific-identification method. The Company has not experienced material realized gains or losses or other-than-temporary losses in the periods presented. Interest on available-for-sale securities is included in other expenses, net and is not material for all periods presented. Property Property Upon retirement or sale of the assets, the cost and related accumulated depreciation and amortization are removed from the consolidated balance sheets and the resulting gains or losses are recorded in the consolidated statements of operations and comprehensive loss. Impairment The Company periodically Accrued Research and Development Expenses The Company estimates preclinical The Company accrues for these costs based on factors such as estimates of the work completed in accordance with agreements established with its third-party service providers. The Company makes judgments and estimates in determining the accrued expenses balance. As actual costs become known, the Company adjusts its accrued expenses. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status Leases The Company leases Research and Research future Stock-Based Compensation The Company provides equity awards in the form of stock options and restricted stock units. The Company measures The Company estimates The Black-Scholes option pricing model requires a number of assumptions, of which the most significant are expected volatility, expected option term (the time from the grant date until the options are exercised or expire), risk-free rate, and expected divided rate. These assumptions include: • Expected volatility—Since the Company has limited trading history for its common stock, expected volatility is estimated based on weighting the Company’s volatility and the volatility of comparable publicly traded biotechnology companies during the equivalent period of the calculated expected term of the options granted. The comparable companies were chosen based on their similar size, stage in the life cycle or area of specialty. There is a degree of uncertainty in determining a comparable peer group as each of the peers are engaged in varied research and development activities, the timing and progress of which differ within the peer group. • Expected term—The expected term of options granted to employees and directors is determined using the “simplified” method. Under this approach, the expected term is presumed to be the midpoint between the weighted-average vesting term and the contractual term of the option. The simplified method makes the assumption that the employee will exercise share options evenly over the period when the share options are vested and ending on the date when the share options would expire. The expected option term for options granted to non-employees is estimated on a grant-by-grant basis. • Risk-free interest rate—The risk-free interest rate is based on the U.S. Treasury zero coupon bonds in effect on the grant date for periods with an equivalent expected term as the option. • Expected dividend—The Company has never paid dividends and has no foreseeable plans to pay dividends on its shares of common stock. Therefore, an expected dividend of zero is used. The fair value of restricted stock units is based on the fair value of the Company’s common stock on the date of grant. The grant date fair value of restricted stock units with service vesting conditions is recognized over the requisite service period on a straight-line basis. For restricted stock units with performance vesting conditions, the Company evaluates the probability of achieving the performance condition at each reporting date and recognizes expense for such performance awards over the requisite service period using the accelerated attribution method. Income Taxes Income taxable income in the years in which those temporary differences are expected to be realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income or loss in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. Interest and penalties related to unrecognized tax benefits are included within the provision of income tax. Basic and Basic loss per share shares of Comprehensive The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains or losses on available-for-sale securities and foreign currency translation adjustments. Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2016-02— Leases In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326) : Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) , which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. As an emerging growth company, ASU 2016-13 is effective for the Company for the year ending December 31, 2023 and interim periods within that fiscal year and must be adopted using a modified retrospective approach, with certain exceptions. The Company is evaluating the impact of this standard on its consolidated financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The following table presents the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2021 (in thousands): As of December 31, 2021 Valuation Amortized Unrealized Unrealized Hierarchy Cost Gains Losses Fair Value Money market funds Level 1 $ 21,477 $ — $ — $ 21,477 Commercial paper Level 2 59,647 — (10 ) 59,637 U.S. government bonds Level 2 21,662 — (42 ) 21,620 Corporate debt securities Level 2 8,776 1 (1 ) 8,776 Agency bonds Level 2 7,747 1 (7 ) 7,741 Municipal bonds Level 2 4,251 — (4 ) 4,247 Non-U.S. debt securities Level 2 2,506 — (1 ) 2,505 Total cash equivalents and available-for-sale securities $ 126,066 $ 2 $ (65 ) $ 126,003 Classified as: Cash equivalents $ 27,715 Short-term available-for-sale securities 98,288 Total cash equivalents and available-for-sale securities $ 126,003 The following table summarizes the Company’s cash equivalents and available-for-sale securities by contractual maturity as of December 31, 2021 (in thousands): As of December 31, 2021 Within one year $ 120,726 After one year through two years 5,277 Total cash equivalents and available-for-sale securities $ 126,003 The following table presents the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2020 (in thousands): As of December 31, 2020 Valuation Amortized Unrealized Unrealized Hierarchy Cost Gains Losses Fair Value Money market funds Level 1 $ 46,134 $ — $ — $ 46,134 Commercial paper Level 2 76,605 — (2 ) 76,603 Agency bonds Level 2 29,654 15 — 29,669 Corporate debt securities Level 2 11,890 — (6 ) 11,884 U.S. government bonds Level 2 7,093 — — 7,093 Municipal bonds Level 2 5,592 2 (1 ) 5,593 U.S. treasury bills Level 2 4,680 — — 4,680 Agency discount securities Level 2 200 — — 200 Total cash equivalents and available-for-sale securities $ 181,848 $ 17 $ (9 ) $ 181,856 Classified as: Cash equivalents $ 75,410 Short-term available-for-sale securities 106,446 Total cash equivalents and available-for-sale securities $ 181,856 The following table summarizes the Company’s cash equivalents and available-for-sale securities by contractual maturity as of December 31, 2020 (in thousands): As of December 31, 2020 Within one year $ 160,304 After one year through two years 21,552 Total cash equivalents and available-for-sale securities $ 181,856 |
Consolidated Balance Sheet Comp
Consolidated Balance Sheet Components | 12 Months Ended |
Dec. 31, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Consolidated Balance Sheet Components | 4. Consolidated Balance Sheet Components Prepaid and Other Current Assets Prepaid and other current assets consist of the following as of the periods presented (in thousands): As of December 31, 2021 2020 Prepaid research and development $ 7,895 $ 2,534 Prepaid taxes 836 481 Prepaid other 2,506 2,533 Total prepaid and other current assets $ 11,237 $ 5,548 Accrued Expenses Accrued expenses consist of the following as of the periods presented (in thousands): As of December 31, 2021 2020 Accrued research and development expenses $ 6,195 $ 2,884 Accrued employee and related expenses 3,168 2,552 Accrued professional and legal fees 495 453 Accrued other 336 159 Total accrued expenses $ 10,194 $ 6,048 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies Leases In May 2018, the Company entered In December 2019, the Company entered into an operating lease for its headquarters in San Francisco, with a lease term that was due to expire in January 2022. In July 2021, the Company amended the lease agreement to extend the term of the lease to January 2023, with an option to renew the term for one year. Under the lease agreement, monthly lease payments are approximately $18,000. Future minimum 2022 $ 212 2023 7 Total future minimum annual payments $ 219 Rent expense was $290,000 and $273,000 for the years ended December 31, 2021 and 2020, respectively. The Company has security deposit balances of $95,000, a portion of which is included in restricted cash and a portion in other assets in the consolidated balance sheets as of December 31, 2021 and 2020. Asset Transfer and License Agreement with Teva Pharmaceutical Industries Ltd In April 2018, the Company concurrently entered into two Asset Transfer and License Agreements (the “Teva Agreements”) with Teva Pharmaceutical Industries Ltd (“Teva”) under which it acquired certain patents and intellectual property relating to two programs: (1) Teva’s glycoPEGylated FGF21 program, including the compound TEV-47948 (pegozafermin), a glycoPEGylated long-acting FGF21 and (2) Teva’s development program of small molecule inhibitors of fatty acid synthase. Pursuant to the Teva Agreements, the Company paid Teva an initial nonrefundable upfront payment of $6.0 million and the Company could be obligated to pay Teva up to $67.5 million under each program, for a total of $135.0 million, upon the achievement of certain clinical development and commercial milestones. In addition, the Company is obligated to pay Teva tiered royalties at percentages in the low-to-mid single-digits on worldwide net sales on all products containing the Teva compounds. The Teva Agreements can be terminated (i) by the Company without cause upon 120 days’ written notice to Teva, (ii) by either party, if the other party materially breaches any of its obligations under the Teva Agreements and fails to cure such breach within 60 days after receiving notice thereof, or (iii) by either party, if a bankruptcy petition is filed against the other party and is not dismissed within 60 days. In addition, Teva can also terminate the agreement related to the Company’s glycoPEGylated FGF21 program in the event the Company, or any of its affiliates or sublicensees, challenges any of the Teva patents licensed to the Company, and the challenge is not withdrawn within 30 days of written notice from Teva. During the years ended December 31, 2021 and 2020, none of the development and commercial milestones were met and accordingly, there were no milestone payments related to the Teva Agreements. |
Term Loan
Term Loan | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Term Loan | 6. Term Loan Loan and Security Agreement In April 2020, the Company entered into a Loan and Security Agreement, (the “Loan Agreement”) with the lenders referred to therein (the “Lenders”), and Silicon Valley Bank (“SVB”), as collateral agent. The Loan Agreement provided for (i) a secured term A loan facility (the “Term A Loan Facility”) of up to $10.0 million and (ii) a secured term B loan facility (the “Term B Loan Facility”) of up to $5.0 million that became available upon the satisfaction of certain milestones, each of which was available to be drawn through May 31, 2021 pursuant to an amendment executed in April 2021. The term loan is secured by certain assets of the Borrowers (as defined in the Loan Agreement), including substantially all of the assets of the Company, excluding the Company’s intellectual property. The term loan contains customary representations, warranties, affirmative covenants and also certain restrictive covenants. In April 2020, in connection with the execution of the Loan Agreement, the Company issued SVB a warrant to purchase 25,000 shares of the Company’s common stock with a warrant exercise price of $22.06 per share that is immediately exercisable and expires on In May 2021, the parties further amended the Loan Agreement (as amended, the “2021 Loan Agreement”). The 2021 Loan Agreement increased the Term A Loan Facility to up to $20.0 million thereby increasing the total term loan facility from $15.0 million to $25.0 million. The Term B Loan Facility of up to $5.0 million remains available to be drawn upon the achievement of certain additional milestones, and each loan facility is available to be drawn upon on or before September 30, 2022. Concurrent with the closing and as a condition of the 2021 Loan Agreement, the Company drew $ 1.5 million and in December 2021, drew the remaining $18.5 million under the Term Loan A Facility. The 2021 Loan Agreement provides for interest - only payments until October 1, 2022, followed by consecutive monthly payments of principal and interest starting on October 1, 2022 and continuing through September 1, 2024 , the maturity date of the term loan. The interest only period may be extended to April 1, 2023, if on or before September 20, 2022, the Company receives net cash proceeds of at least $ 75.0 million from the sale of its equity securities. The term loan bears interest at the greater of (i) 4.25 % and (ii) the sum of (a) the Prime Rate as reported in The Wall Street Journal plus (b) 1.00 % (or for both amounts drawn 4.25% initially and as of December 3 1 , 2021). In addition, a final payment fee of 5% of the principal amount of the loan is due when the term loan becomes due or upon prepayment of the term loan. If the Company elects to prepay the loan, there is also a prepayment fee of between 1% and 3% of the principal amount of the term loan depending on the timing of prepayment. In May 2021, in connection with the execution of the 2021 Loan Agreement, the Company issued SVB a warrant to purchase 33,923 shares of the Company’s common stock with a warrant exercise price of $19.12 per share that is immediately exercisable and expires on May 28, 2031. The Company determined the fair value of the warrant at the issuance date by using the Black-Scholes option-pricing model with the following assumptions: risk-free interest rate of 1.6%, no dividends, expected volatility of 98.6% and expected term of 10.0 years. Upon issuance, the fair value of the warrant of $0.6 million was recorded as a debt issuance cost and met the requirements for equity classification within additional paid-in capital in the consolidated balance sheets. In addition, closing costs incurred were not material. In connection with Term Loan B Facility, if funded, the Company will issue additional warrant to purchase 11,305 shares of the Company’s common stock with the exercise price at the Company’s stock price at the time of issuance. The 2021 Loan Agreement was accounted for as a modification to a credit facility. The related debt issuance costs incurred in May 2021, including the fair value of the warrant, together with the remaining unamortized debt issuance costs related to the Loan Agreement of $0.4 million were recorded as deferred assets and recognized on a straight-line basis as interest expense over the availability of the draw period. As of December 31, 2021, all amounts were drawn under the Term Loan A Facility such that all debt issuance costs were recorded as a debt discount. The carrying value of the debt discount, together with the final payment fee, are recognized using the effective interest method. Interest expense is recorded within other expenses, net in the consolidated statements of operations and comprehensive loss. The expected repayments of principal amount due on the term loan, excluding the final payment fee, as of December 31, 2021 are as follows (in thousands): 2022 $ 2,500 2023 $ 10,000 2024 $ 7,500 Total principal repayments $ 20,000 Less: unamortized debt discount (602 ) Total term loan, net 19,398 Less: term loan, current (2,500 ) Term loan, non-current, net $ 16,898 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 7. Stock-Based Compensation Equity Incentive Plans The Company’s board of directors approved the 2019 Equity Incentive Plan (the “2019 Plan”), which became effective in September 2019. The Company initially reserved 2,844,193 shares of common stock for issuance under the 2019 Plan. In addition, the number of shares of common stock reserved for issuance under the 2019 Plan will automatically increase on the first day of January for a period of up to ten years, commencing on January 1, 2020, in an amount equal to 4% of the total number of shares of the Company’s capital stock outstanding on the immediately preceding December 31, or a lesser number of shares determined by the Company’s board of directors. As of December 31, 2021, there were 1,428,304 shares of common stock available for issuance as future option grants under the 2019 Plan. The board of directors determines the period over which options become exercisable and options generally vest over a four-year Employee Stock Purchase Plan In October 2019, the Company adopted the 2019 Employee Stock Purchase Plan (“ESPP”), which became effective in November 2019. The Company initially reserved 225,188 shares of common stock for purchase under the ESPP. The number of shares of common stock reserved for issuance under the ESPP will automatically increase on the first day of January for a period of up to ten years, in an amount equal to 1% of the total number of shares of the Company’s common stock outstanding on the immediately preceding December 31, or a lesser number of shares determined by the Company’s board of directors. Purchases will be accomplished through the participation of discrete offering periods and each offering is expected to be 6 months long. For each offering period, ESPP participants will purchase shares of common stock at a price per share equal to of the lesser of the fair market value of the Company’s common stock on (1) the first trading day of the applicable offering period or (2) the last trading day of the applicable offering period As of December 31, 2021, there were 544,410 shares of common stock available for issuance under the ESPP. The Company recorded stock-based compensation for the periods presented as follows (in thousands): Year Ended December 31, 2021 2020 Research and development $ 2,966 $ 1,250 General and administrative 5,712 2,557 Total stock-based compensation $ 8,678 $ 3,807 The fair value of stock options granted for the periods presented was estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions: Year Ended December 31, 2021 2020 Expected term (years) 5.5-6.1 4.0-6.1 Expected volatility 86.9-91.9% 86.4-97.6% Risk-free interest rate 0.7-1.3% 0.2-1.5% Expected dividend — — The following table summarizes stock option activity for the year ended December 31, 2021: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Options Price Term Value (In years) (In thousands) Balance outstanding as of December 31, 2020 1,898,395 $ 12.79 8.6 $ 25,918 Granted 830,013 22.22 Exercised (188,286 ) 2.59 Cancelled and forfeited (133,454 ) 19.55 Balance outstanding as of December 31, 2021 2,406,668 $ 16.46 8.1 $ 9,970 Exercisable as of December 31, 2021 922,104 $ 10.76 7.3 $ 6,800 The estimated grant date fair value of stock options that vested during the year ended December 31, 2021, was $7.0 million. The weighted-average that were 2.3 Restricted Stock Units (“RSUs”) In February 2021, the Company granted 56,545 service-based RSUs to its employees with a total grant date fair value of $1.3 million. The RSUs vest annually over a three-year In February 2021, the Company granted 61,500 performance-based RSUs to certain executives, one-third of which vest on each one-year |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes Tax Rates Applicable to the Income of the Company and its Subsidiaries The Company is taxed according to U.S. federal and state tax laws and Israeli tax laws. The statutory tax rates applicable to the income of the Company and its subsidiaries for the periods presented are as follows: Year Ended December 31, 2021 2020 89bio, Inc. 21 % 21 % 89Bio Ltd. 23 % 23 % 89bio Management, Inc. 21 % 21 % UAB 89bio Lithuania 15 % 15 % The income Year Ended December 31, 2021 2020 Current: Federal $ — $ (11 ) State (2 ) 1 Foreign (1 ) — Total (3 ) (10 ) Deferred: Federal 150 69 Total 150 69 Income tax benefit $ 147 $ 59 Deferred Deferred for the periods presented As of December 31, 2021 2020 U.S. net operating loss carryforwards $ 29,094 $ 11,342 Research and development expenses 6,529 5,392 Israel net operating loss carryforwards 4,262 3,978 Stock-based compensation 1,969 610 Accrued expenses 220 635 Other 191 48 Total deferred tax assets 42,265 22,005 Less: valuation allowance (42,046 ) (21,936 ) Net deferred tax assets $ 219 $ 69 As Available Losses and Credits As of December 31, 2021, the Company had an accumulated tax loss carryforward of approximately $138.5 million and $18.5 million for U.S. and Israeli tax purposes, respectively. As of December 31, 2020, the Company had an accumulated As of December 31, 2021 and 2020, the Company had federal research and development credit carryforwards of approximately $2.1 million and $0.6 million, respectively, which expire beginning in 2040. As of December 31, 2021 and December 31, 2020, the Company has state research and development credit carryforwards of approximately $1.1 million and $0.7 million, respectively, which will carry forward indefinitely. Loss from Operations, Before Income Tax The Company recorded a loss from operations, before income tax for the periods presented as follows (in thousands): Year Ended December 31, 2021 2020 United States $ (91,141 ) $ (58,760 ) Lithuania 10 (73 ) Israel 862 9,275 Net loss before income tax $ (90,269 ) $ (49,558 ) Reconciliation of Income Tax Benefit The reconciliation for the periods presented Year Ended December 31, 2021 2020 Income tax benefit computed at statutory rates $ 18,757 $ 8,285 Change in valuation allowance (20,111 ) (11,914 ) Foreign rate differential (19 ) 1,671 Change in Israel effective tax rate due to the 2019 reorganization (2 ) 647 Research and development credits, net of uncertain tax position 1,331 815 Other 191 555 Income tax benefit $ 147 $ 59 Utilization of U.S. federal and state net operating losses and credit carryforwards may be subject to an annual limitation provided for in Section 382 of the Internal Revenue Code and similar state codes. Any annual limitation could result in a deferral of the utilization of the net operating loss and credit carryforwards. Unrecognized Tax Benefits During the years ended December 31, 2021 and 2020, the amount of gross unrecognized tax benefits increased by $0.5 million and $0.3 million, respectively. If the total amount of unrecognized tax benefits was recognized, it would not have an impact to the effective tax rate as it would be offset by the reversal of related deferred tax assets which are subject to a full valuation allowance. The Company recognizes interest and penalties related to uncertain tax positions as part of the income tax provision. As of December 31, 2021 and 2020, such interest and penalties were not material. The Company is subject to taxation in the United States, California, and several foreign jurisdictions. To date, the Company has not been subject to any federal or state income tax audits. The Company is currently under examination by the Israeli taxing authorities for 2018 and 2019. As of December 31, 2021 all tax years remain open to examination. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 9. Net Loss Per Share The following outstanding potentially dilutive shares, including all outstanding stock options, have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect: As of December 31, 2021 2020 Stock options to purchase common stock 2,406,668 1,898,395 Unvested restricted stock units 106,394 — Warrants to purchase common stock 58,923 — Total 2,571,985 1,898,395 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”). |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Foreign Currencies | Foreign Currencies Certain transactions during the years ended December 31, 2021 and 2020 were denominated in currencies other than the U.S. dollar. Gains and losses from foreign currency transactions were not material for all periods presented and are reflected in the consolidated statements of operations and comprehensive loss as a component of other expenses, net. The Company’s subsidiary in Lithuania uses the Euro as its functional currency for financial reporting. The re-measurement from Euros to U.S. dollars results in translation gain and loss adjustments, which are reflected as a component of comprehensive loss as foreign currency translation adjustments. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements include but are not limited to accrued research and development expenses and the fair value of stock options. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. |
Fair Value Measurements | Fair Value Measurements Financial assets and liabilities are recorded at fair value on a recurring basis in the consolidated balance sheets. The carrying values of Company’s financial assets and liabilities, including cash and cash equivalents, restricted cash, prepaid and other current assets, accounts payable, and accrued expenses approximate to their fair value due to the short-term nature of these instruments. The fair value of the Company’s term loan approximates its carrying value, or amortized cost, due to the prevailing market rates of interest rates it bears. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. Assets and liabilities recorded at fair value are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels are directly related to the amount of subjectivity with the inputs to the valuation of these assets or liabilities as follows: Level 1 —Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 —Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable inputs for similar assets or liabilities. These include quoted prices for identical or similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active; and Level 3 —Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial limits amounts invested in available-for-sale securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company is not exposed to any significant concentrations of credit risk from these financial instruments. |
Other Risks and Uncertainties | Other The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, the Company’s early stages of clinical drug development; the Company’s ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; the Company’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; the Company’s ability to enroll patients in its ongoing and future clinical trials; the Company’s ability to successfully manufacture and supply its product candidates for clinical trials; the Company’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases the Company is targeting; the Company’s ability to obtain, maintain, and protect its intellectual property rights; developments relating to the Company’s competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties. The Company’s product candidates will require approvals from the U.S. Food and Drug Administration and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company was denied approval, approval was delayed or the Company was unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company. The ongoing COVID-19 pandemic has disrupted and may continue to disrupt the Company’s business and delay its preclinical and clinical programs and timelines. The Company does not yet know the full extent of potential delays to clinical trials, which could prevent or delay the Company from obtaining approval for pegozafermin. |
Segment Reporting | Segment Reporting The Company has one operating |
Cash and Cash Equivalents and Restricted Cash | Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market funds and commercial paper that are stated at fair value. Restricted Cash Restricted cash consists of a money market account that serves as collateral for the Company’s operating lease agreement for its facility in Israel. |
Investments | Investments Investments have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its available-for-sale investments in debt securities at the time of purchase. Generally, investments with original maturities beyond three months at the date of purchase are classified as short-term because it is management’s intent to use the investments to fund current operations or to make them available for current operations. Unrealized gains and losses are excluded from earnings and are reported as a component of comprehensive loss. The Company periodically evaluates whether declines in fair values of its available-for-sale securities below their book value are other-than-temporary. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale securities before recovery of its amortized cost basis. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in other expenses, net. The cost of investments sold is based on the specific-identification method. The Company has not experienced material realized gains or losses or other-than-temporary losses in the periods presented. Interest on available-for-sale securities is included in other expenses, net and is not material for all periods presented. |
Property and Equipment, Net | Property Property Upon retirement or sale of the assets, the cost and related accumulated depreciation and amortization are removed from the consolidated balance sheets and the resulting gains or losses are recorded in the consolidated statements of operations and comprehensive loss. |
Impairment of Long-Lived Assets | Impairment The Company periodically |
Accrued Research and Development Expenses | Accrued Research and Development Expenses The Company estimates preclinical The Company accrues for these costs based on factors such as estimates of the work completed in accordance with agreements established with its third-party service providers. The Company makes judgments and estimates in determining the accrued expenses balance. As actual costs become known, the Company adjusts its accrued expenses. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status |
Leases | Leases The Company leases |
Research and Development Expenses | Research and Research future |
Stock-Based Compensation | Stock-Based Compensation The Company provides equity awards in the form of stock options and restricted stock units. The Company measures The Company estimates The Black-Scholes option pricing model requires a number of assumptions, of which the most significant are expected volatility, expected option term (the time from the grant date until the options are exercised or expire), risk-free rate, and expected divided rate. These assumptions include: • Expected volatility—Since the Company has limited trading history for its common stock, expected volatility is estimated based on weighting the Company’s volatility and the volatility of comparable publicly traded biotechnology companies during the equivalent period of the calculated expected term of the options granted. The comparable companies were chosen based on their similar size, stage in the life cycle or area of specialty. There is a degree of uncertainty in determining a comparable peer group as each of the peers are engaged in varied research and development activities, the timing and progress of which differ within the peer group. • Expected term—The expected term of options granted to employees and directors is determined using the “simplified” method. Under this approach, the expected term is presumed to be the midpoint between the weighted-average vesting term and the contractual term of the option. The simplified method makes the assumption that the employee will exercise share options evenly over the period when the share options are vested and ending on the date when the share options would expire. The expected option term for options granted to non-employees is estimated on a grant-by-grant basis. • Risk-free interest rate—The risk-free interest rate is based on the U.S. Treasury zero coupon bonds in effect on the grant date for periods with an equivalent expected term as the option. • Expected dividend—The Company has never paid dividends and has no foreseeable plans to pay dividends on its shares of common stock. Therefore, an expected dividend of zero is used. The fair value of restricted stock units is based on the fair value of the Company’s common stock on the date of grant. The grant date fair value of restricted stock units with service vesting conditions is recognized over the requisite service period on a straight-line basis. For restricted stock units with performance vesting conditions, the Company evaluates the probability of achieving the performance condition at each reporting date and recognizes expense for such performance awards over the requisite service period using the accelerated attribution method. |
Income Taxes | Income Taxes Income taxable income in the years in which those temporary differences are expected to be realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income or loss in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. Interest and penalties related to unrecognized tax benefits are included within the provision of income tax. |
Basic and Diluted Net Loss per Share | Basic and Basic loss per share shares of |
Comprehensive Loss | Comprehensive The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains or losses on available-for-sale securities and foreign currency translation adjustments. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2016-02— Leases In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326) : Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) , which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. As an emerging growth company, ASU 2016-13 is effective for the Company for the year ending December 31, 2023 and interim periods within that fiscal year and must be adopted using a modified retrospective approach, with certain exceptions. The Company is evaluating the impact of this standard on its consolidated financial statements and related disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets Measured at Fair Value on Recurring Basis | The following table presents the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2021 (in thousands): As of December 31, 2021 Valuation Amortized Unrealized Unrealized Hierarchy Cost Gains Losses Fair Value Money market funds Level 1 $ 21,477 $ — $ — $ 21,477 Commercial paper Level 2 59,647 — (10 ) 59,637 U.S. government bonds Level 2 21,662 — (42 ) 21,620 Corporate debt securities Level 2 8,776 1 (1 ) 8,776 Agency bonds Level 2 7,747 1 (7 ) 7,741 Municipal bonds Level 2 4,251 — (4 ) 4,247 Non-U.S. debt securities Level 2 2,506 — (1 ) 2,505 Total cash equivalents and available-for-sale securities $ 126,066 $ 2 $ (65 ) $ 126,003 Classified as: Cash equivalents $ 27,715 Short-term available-for-sale securities 98,288 Total cash equivalents and available-for-sale securities $ 126,003 The following table presents the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2020 (in thousands): As of December 31, 2020 Valuation Amortized Unrealized Unrealized Hierarchy Cost Gains Losses Fair Value Money market funds Level 1 $ 46,134 $ — $ — $ 46,134 Commercial paper Level 2 76,605 — (2 ) 76,603 Agency bonds Level 2 29,654 15 — 29,669 Corporate debt securities Level 2 11,890 — (6 ) 11,884 U.S. government bonds Level 2 7,093 — — 7,093 Municipal bonds Level 2 5,592 2 (1 ) 5,593 U.S. treasury bills Level 2 4,680 — — 4,680 Agency discount securities Level 2 200 — — 200 Total cash equivalents and available-for-sale securities $ 181,848 $ 17 $ (9 ) $ 181,856 Classified as: Cash equivalents $ 75,410 Short-term available-for-sale securities 106,446 Total cash equivalents and available-for-sale securities $ 181,856 |
Schedule of Contractual Maturities of Cash Equivalents and Available-for-Sale Securities | The following table summarizes the Company’s cash equivalents and available-for-sale securities by contractual maturity as of December 31, 2021 (in thousands): As of December 31, 2021 Within one year $ 120,726 After one year through two years 5,277 Total cash equivalents and available-for-sale securities $ 126,003 The following table summarizes the Company’s cash equivalents and available-for-sale securities by contractual maturity as of December 31, 2020 (in thousands): As of December 31, 2020 Within one year $ 160,304 After one year through two years 21,552 Total cash equivalents and available-for-sale securities $ 181,856 |
Consolidated Balance Sheet Co_2
Consolidated Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid and Other Current Assets | Prepaid and other current assets consist of the following as of the periods presented (in thousands): As of December 31, 2021 2020 Prepaid research and development $ 7,895 $ 2,534 Prepaid taxes 836 481 Prepaid other 2,506 2,533 Total prepaid and other current assets $ 11,237 $ 5,548 |
Schedule of Accrued Expenses | Accrued Expenses Accrued expenses consist of the following as of the periods presented (in thousands): As of December 31, 2021 2020 Accrued research and development expenses $ 6,195 $ 2,884 Accrued employee and related expenses 3,168 2,552 Accrued professional and legal fees 495 453 Accrued other 336 159 Total accrued expenses $ 10,194 $ 6,048 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments Under Non-cancellable Operating Lease Obligations | Future minimum 2022 $ 212 2023 7 Total future minimum annual payments $ 219 |
Term Loan (Tables)
Term Loan (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Repayment of Principal Amount | The expected repayments of principal amount due on the term loan, excluding the final payment fee, as of December 31, 2021 are as follows (in thousands): 2022 $ 2,500 2023 $ 10,000 2024 $ 7,500 Total principal repayments $ 20,000 Less: unamortized debt discount (602 ) Total term loan, net 19,398 Less: term loan, current (2,500 ) Term loan, non-current, net $ 16,898 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock-Based Compensation | The Company recorded stock-based compensation for the periods presented as follows (in thousands): Year Ended December 31, 2021 2020 Research and development $ 2,966 $ 1,250 General and administrative 5,712 2,557 Total stock-based compensation $ 8,678 $ 3,807 |
Summary of Estimated Fair Value of Stock Options Granted Using Black-Scholes Option-Pricing Model | The fair value of stock options granted for the periods presented was estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions: Year Ended December 31, 2021 2020 Expected term (years) 5.5-6.1 4.0-6.1 Expected volatility 86.9-91.9% 86.4-97.6% Risk-free interest rate 0.7-1.3% 0.2-1.5% Expected dividend — — |
Summary of Stock Option Activity | The following table summarizes stock option activity for the year ended December 31, 2021: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Options Price Term Value (In years) (In thousands) Balance outstanding as of December 31, 2020 1,898,395 $ 12.79 8.6 $ 25,918 Granted 830,013 22.22 Exercised (188,286 ) 2.59 Cancelled and forfeited (133,454 ) 19.55 Balance outstanding as of December 31, 2021 2,406,668 $ 16.46 8.1 $ 9,970 Exercisable as of December 31, 2021 922,104 $ 10.76 7.3 $ 6,800 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Summary of Statutory Tax Rates Applicable to Income of Company and Subsidiaries | The Company is taxed according to U.S. federal and state tax laws and Israeli tax laws. The statutory tax rates applicable to the income of the Company and its subsidiaries for the periods presented are as follows: Year Ended December 31, 2021 2020 89bio, Inc. 21 % 21 % 89Bio Ltd. 23 % 23 % 89bio Management, Inc. 21 % 21 % UAB 89bio Lithuania 15 % 15 % |
Summary of Income Tax Benefit (Expense) | The income Year Ended December 31, 2021 2020 Current: Federal $ — $ (11 ) State (2 ) 1 Foreign (1 ) — Total (3 ) (10 ) Deferred: Federal 150 69 Total 150 69 Income tax benefit $ 147 $ 59 |
Summary of Components of Deferred Tax Assets | Significant for the periods presented As of December 31, 2021 2020 U.S. net operating loss carryforwards $ 29,094 $ 11,342 Research and development expenses 6,529 5,392 Israel net operating loss carryforwards 4,262 3,978 Stock-based compensation 1,969 610 Accrued expenses 220 635 Other 191 48 Total deferred tax assets 42,265 22,005 Less: valuation allowance (42,046 ) (21,936 ) Net deferred tax assets $ 219 $ 69 |
Summary of Loss from Operations Before Taxes on Income | The Company recorded a loss from operations, before income tax for the periods presented as follows (in thousands): Year Ended December 31, 2021 2020 United States $ (91,141 ) $ (58,760 ) Lithuania 10 (73 ) Israel 862 9,275 Net loss before income tax $ (90,269 ) $ (49,558 ) |
Summary of Reconciliation of Income Tax Benefit (Expense) Statutory Tax Rate to Effective Tax Rate | The reconciliation for the periods presented Year Ended December 31, 2021 2020 Income tax benefit computed at statutory rates $ 18,757 $ 8,285 Change in valuation allowance (20,111 ) (11,914 ) Foreign rate differential (19 ) 1,671 Change in Israel effective tax rate due to the 2019 reorganization (2 ) 647 Research and development credits, net of uncertain tax position 1,331 815 Other 191 555 Income tax benefit $ 147 $ 59 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Outstanding Potentially Dilutive Securities Excluded From Calculation of Diluted Net Loss | The following outstanding potentially dilutive shares, including all outstanding stock options, have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect: As of December 31, 2021 2020 Stock options to purchase common stock 2,406,668 1,898,395 Unvested restricted stock units 106,394 — Warrants to purchase common stock 58,923 — Total 2,571,985 1,898,395 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2021 | Sep. 30, 2020 | Jul. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2021 | |
Subsidiary Sale Of Stock [Line Items] | |||||
Date of incorporation | Jun. 30, 2019 | ||||
Cash and cash equivalents and short term available-for-sale securities | $ 150,700 | $ 150,700 | |||
A T M Facility | |||||
Subsidiary Sale Of Stock [Line Items] | |||||
Issuance of common stock | $ 3,289 | ||||
A T M Facility | Maximum | |||||
Subsidiary Sale Of Stock [Line Items] | |||||
Issuance of common stock | $ 75,000 | ||||
SVB Leerink LLC | |||||
Subsidiary Sale Of Stock [Line Items] | |||||
Shares issued and sold | 186,546 | ||||
Proceeds from issuance of common stock, net of underwriters discount and commissions | $ 3,300 | ||||
Selling commission per shares sold percentage | 3.00% | ||||
Proceeds from issuance of common stock upon ESPP purchases | $ 3,300 | ||||
Issuance of common stock, weighted average price per share | $ 17.97 | ||||
Common Stock | A T M Facility | |||||
Subsidiary Sale Of Stock [Line Items] | |||||
Shares issued and sold | 186,546 | ||||
Underwritten public offering | Common Stock | |||||
Subsidiary Sale Of Stock [Line Items] | |||||
Shares issued and sold | 3,025,000 | 3,047,040 | |||
Proceeds from issuance of common stock, net of underwriters discount and commissions | $ 79,500 | $ 78,200 | |||
IPO price per share | $ 28 | $ 27.50 | |||
Payment of underwriting discounts, commissions | $ 4,600 | $ 5,000 | |||
Other offering expenses | 600 | 600 | |||
Proceeds from issuance of common stock upon ESPP purchases | $ 79,500 | $ 78,200 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2021Segment | |
Summary Of Significant Accounting Policies [Line Items] | |
Number of operating segments | 1 |
Leasehold Improvements | |
Summary Of Significant Accounting Policies [Line Items] | |
Leasehold improvements amortization, description | Leasehold improvements are amortized on a straight-line basis over the shorter of the assets’ estimated useful life or the remaining term of the lease. |
Minimum [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Property and equipment, estimated useful lives | 3 years |
Maximum | |
Summary Of Significant Accounting Policies [Line Items] | |
Property and equipment, estimated useful lives | 7 years |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | $ 126,003 | $ 181,856 |
Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 126,066 | 181,848 |
Short-term investments, Gross Unrealized Holding Gains | 2 | 17 |
Short-term investments, Gross Unrealized Holding Losses | (65) | (9) |
Short-term investments, Aggregated Fair Value | 126,003 | 181,856 |
Recurring | Cash equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | 27,715 | 75,410 |
Recurring | Short-term available for sale securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | 98,288 | 106,446 |
Recurring | Level 1 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 21,477 | 46,134 |
Short-term investments, Aggregated Fair Value | 21,477 | 46,134 |
Recurring | Level 2 | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 59,647 | 76,605 |
Short-term investments, Gross Unrealized Holding Losses | (10) | (2) |
Short-term investments, Aggregated Fair Value | 59,637 | 76,603 |
Recurring | Level 2 | U.S. government bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 21,662 | 7,093 |
Short-term investments, Gross Unrealized Holding Losses | (42) | |
Short-term investments, Aggregated Fair Value | 21,620 | 7,093 |
Recurring | Level 2 | Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 8,776 | 11,890 |
Short-term investments, Gross Unrealized Holding Gains | 1 | |
Short-term investments, Gross Unrealized Holding Losses | (1) | (6) |
Short-term investments, Aggregated Fair Value | 8,776 | 11,884 |
Recurring | Level 2 | Agency bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 7,747 | 29,654 |
Short-term investments, Gross Unrealized Holding Gains | 1 | 15 |
Short-term investments, Gross Unrealized Holding Losses | (7) | |
Short-term investments, Aggregated Fair Value | 7,741 | 29,669 |
Recurring | Level 2 | Municipal Bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 4,251 | 5,592 |
Short-term investments, Gross Unrealized Holding Gains | 2 | |
Short-term investments, Gross Unrealized Holding Losses | (4) | (1) |
Short-term investments, Aggregated Fair Value | 4,247 | 5,593 |
Recurring | Level 2 | Non-US debt securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 2,506 | |
Short-term investments, Gross Unrealized Holding Losses | (1) | |
Short-term investments, Aggregated Fair Value | $ 2,505 | |
Recurring | Level 2 | U.S. treasury bills | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 4,680 | |
Short-term investments, Aggregated Fair Value | 4,680 | |
Recurring | Level 2 | Agency discount securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 200 | |
Short-term investments, Aggregated Fair Value | $ 200 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Contractual Maturities of Cash Equivalents and Available-for-Sale Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value Disclosures [Abstract] | ||
Within one year | $ 120,726 | $ 160,304 |
After one year through two years | 5,277 | 21,552 |
Total cash equivalents and available-for-sale securities | $ 126,003 | $ 181,856 |
Consolidated Balance Sheet Co_3
Consolidated Balance Sheet Components - Schedule of Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Prepaid research and development | $ 7,895 | $ 2,534 |
Prepaid taxes | 836 | 481 |
Prepaid other | 2,506 | 2,533 |
Total prepaid and other current assets | $ 11,237 | $ 5,548 |
Consolidated Balance Sheet Co_4
Consolidated Balance Sheet Components - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued research and development expenses | $ 6,195 | $ 2,884 |
Accrued employee and related expenses | 3,168 | 2,552 |
Accrued professional and legal fees | 495 | 453 |
Accrued other | 336 | 159 |
Total accrued expenses | $ 10,194 | $ 6,048 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2019 | May 31, 2018 | Apr. 30, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | |
Loss Contingencies [Line Items] | |||||
Lessee, operating lease, description | The Company amended the lease term to expire in April 2022, with an option to renew for an additional 12 months. | ||||
Operating lease, payments | $ 4,200 | ||||
Lessee, operating lease term of contract | 12 months | ||||
Operating leases, rent expense | $ 290,000 | $ 273,000 | |||
Teva Agreements | |||||
Loss Contingencies [Line Items] | |||||
Nonrefundable upfront payment | $ 6,000,000 | ||||
Payment upon achievement of certain clinical and commercial milestones | 135,000,000 | ||||
Asset transfer and license agreement, termination period after written notice | 120 days | ||||
Asset transfer and license agreement, termination period notice of breach | 60 days | ||||
Asset transfer and license agreement termination notice period if bankruptcy petition filed | 60 days | ||||
Teva Agreements | Research and Development Expenses | |||||
Loss Contingencies [Line Items] | |||||
Milestone payments | $ 0 | 0 | |||
Teva Agreements | Teva's GlycoPEGylated FGF21 Program | |||||
Loss Contingencies [Line Items] | |||||
Payment upon achievement of certain clinical and commercial milestones | 67,500,000 | ||||
Teva Agreements | Teva's Development Program | |||||
Loss Contingencies [Line Items] | |||||
Payment upon achievement of certain clinical and commercial milestones | $ 67,500,000 | ||||
Restricted Cash And Other Assets Member | |||||
Loss Contingencies [Line Items] | |||||
Security deposit | $ 95,000 | 95,000 | |||
San Francisco Office | |||||
Loss Contingencies [Line Items] | |||||
Lessee, operating lease, description | with a lease term that was due to expire in January 2022. In July 2021, the Company amended the lease agreement to extend the term of the lease to January 2023, with an option to renew the term for one year. | ||||
Operating lease, payments | $ 18,000 | ||||
Lessee,operating lease, renewal term | 1 year |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Lease Payments Under Non-cancellable Operating Lease Obligations (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2022 | $ 212 |
2023 | 7 |
Total future minimum annual payments | $ 219 |
Term Loan - Additional Informat
Term Loan - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
May 31, 2021USD ($)$ / sharesshares | Apr. 30, 2020USD ($)$ / sharesshares | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | |
Debt Instrument [Line Items] | ||||
Risk free interest rate | 0.75% | |||
Expected volatility | 92.30% | |||
Expected terms (years) | 10 years | |||
Percentage of fee on loan | 5.00% | |||
Deferred tax assets | $ 42,265 | $ 22,005 | ||
Maximum | ||||
Debt Instrument [Line Items] | ||||
Expected terms (years) | 6 years 1 month 6 days | 6 years 1 month 6 days | ||
Minimum [Member] | ||||
Debt Instrument [Line Items] | ||||
Expected terms (years) | 5 years 6 months | 4 years | ||
Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Line of Credit Facility, Description | In May 2021, the parties further amended the Loan Agreement (as amended, the “2021 Loan Agreement”). The 2021 Loan Agreement increased the Term A Loan Facility to up to $20.0 million thereby increasing the total term loan facility from $15.0 million to $25.0 million. The Term B Loan Facility of up to $5.0 million remains available to be drawn upon the achievement of certain additional milestones, and each loan facility is available to be drawn upon on or before September 30, 2022. | In April 2020, the Company entered into a Loan and Security Agreement, (the “Loan Agreement”) with the lenders referred to therein (the “Lenders”), and Silicon Valley Bank (“SVB”), as collateral agent. The Loan Agreement provided for (i) a secured term A loan facility (the “Term A Loan Facility”) of up to $10.0 million and (ii) a secured term B loan facility (the “Term B Loan Facility”) of up to $5.0 million that became available upon the satisfaction of certain milestones, each of which was available to be drawn through May 31, 2021 pursuant to an amendment executed in April 2021. The term loan is secured by certain assets of the Borrowers (as defined in the Loan Agreement), including substantially all of the assets of the Company, excluding the Company’s intellectual property. The term loan contains customary representations, warranties, affirmative covenants and also certain restrictive covenants. | ||
Warrants to purchase common stock | shares | 33,923 | |||
Warrant exercise price | $ / shares | $ 19.12 | |||
Warrant expiration date | May 28, 2031 | Jun. 30, 2025 | ||
Debt issuance costs, gross | $ 600 | $ 600 | ||
Line of credit facility increase in borrowing capacity | 15,000 | |||
Proceeds from sale of available-for-sale securities, equity | $ 75,000 | |||
Deferred tax assets | 400 | |||
Loan Agreement | Measurement Input, Expected Dividend Payment | ||||
Debt Instrument [Line Items] | ||||
Fair value of warrant assumptions, dividends | $ 0 | |||
Loan Agreement | Valuation Technique, Option Pricing Model | Measurement Input, Risk Free Interest Rate | ||||
Debt Instrument [Line Items] | ||||
Fair measurement input | 0.016 | |||
Loan Agreement | Valuation Technique, Option Pricing Model | Measurement Input, Price Volatility | ||||
Debt Instrument [Line Items] | ||||
Fair measurement input | 0.986 | |||
Loan Agreement | Valuation Technique, Option Pricing Model | Measurement Input, Expected Term | ||||
Debt Instrument [Line Items] | ||||
Fair measurement input | 10 years | |||
Loan Agreement | Prime Rate | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, basis spread on variable rate | 1.00% | |||
Loan Agreement | Maximum | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 25,000 | |||
Loan Agreement | Minimum [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, interest rate | 4.25% | |||
Loan Agreement | Other Assets | ||||
Debt Instrument [Line Items] | ||||
Debt issuance costs, gross | 200 | |||
Loan Agreement | Term A Loan Facility | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | 20,000 | $ 10,000 | ||
Warrants to purchase common stock | shares | 25,000 | |||
Warrant exercise price | $ / shares | $ 22.06 | |||
Term loan amount drawn | $ 1,500 | |||
Credit facility maturity date | Sep. 1, 2024 | |||
Loan Agreement | Term B Loan Facility | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 5,000 | $ 5,000 | ||
Warrants to purchase common stock | shares | 11,305 |
Term Loan - Schedule of Repayme
Term Loan - Schedule of Repayment of Principal Amount (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Debt Disclosure [Abstract] | |
2022 | $ 2,500 |
2023 | 10,000 |
2024 | 7,500 |
Total principal repayments | 20,000 |
Less: unamortized debt discount | (602) |
Total term loan, net | 19,398 |
Less: term loan, current | (2,500) |
Term loan, non-current, net | $ 16,898 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2021 | Oct. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share base compensation expense | $ 8,678,000 | $ 3,807,000 | ||
Service-based RSUs | Employee | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Shares granted | 56,545 | |||
Total grant date fair value | $ 1,300,000 | |||
Share base compensation expense | $ 300,000 | |||
Restricted Stock Units (RSUs) | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Cancelled shares | 11,651 | |||
Outstanding | 44,894 | |||
Performance RSUs | Executive Officer | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Shares granted | 61,500 | |||
Total grant date fair value | $ 1,400,000 | |||
Share base compensation expense | $ 800,000 | |||
Anniversary period | 1 year | |||
ESPP Purchases | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of common shares issuable under the plan (in shares) | 225,188 | |||
Percentage of increase in number of shares of capital stock issued and outstanding | 1.00% | |||
Percent of purchase shares of common stock | 85.00% | |||
First offering period | 6 months | |||
Commencement date of first six month offering period | Jan. 1, 2020 | |||
Number of shares of common stock available for issuance under ESPP | 544,410 | |||
2019 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of common shares issuable under the plan (in shares) | 2,844,193 | |||
Percentage of increase in number of shares of capital stock issued and outstanding | 4.00% | |||
Common stock reserved and available for issuance as future option grants | 1,428,304 | |||
Vesting period | 4 years | |||
Percentage of option vesting | 25.00% | |||
Terms of award | The board of directors determines the period over which options become exercisable and options generally vest over a four-year period, with 25% of options vesting on the first anniversary of employment, and thereafter, the remaining options vesting quarterly, over the following 36-month period. The options will expire within ten years from the date of grant. | |||
Remaining option vesting period | 36 months | |||
Expiration period | 10 years | |||
Unrecognized stock option granted under plan | $ 17,900,000 | |||
Unrecognized weighted average period | 2 years 3 months 18 days | |||
Shares granted | 830,013 | |||
Cancelled shares | 133,454 | |||
Outstanding | 2,406,668 | 1,898,395 | ||
2020 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Estimated total grant date fair value of options vested | $ 7,000,000 | |||
Weighted average fair value options granted | $ 16.18 | $ 21.88 | ||
Maximum | ESPP Purchases | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Period for increase in number of shares of common stock reserved for issuance | 10 years | |||
Maximum | 2019 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Period for increase in number of shares of common stock reserved for issuance | 10 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-Based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 8,678 | $ 3,807 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | 2,966 | 1,250 |
General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 5,712 | $ 2,557 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Estimated Fair Value of Stock Options Granted Using Black-Scholes Option-Pricing Model (Details) | 1 Months Ended | 12 Months Ended | |
Apr. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected terms (years) | 10 years | ||
Expected volatility, minimum | 86.90% | 86.40% | |
Expected volatility, maximum | 91.90% | 97.60% | |
Risk-free interest rate, minimum | 0.70% | 0.20% | |
Risk-free interest rate, maximum | 1.30% | 1.50% | |
Minimum [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected terms (years) | 5 years 6 months | 4 years | |
Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected terms (years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Activity (Details) - 2019 Plan $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | |
Number of Options | ||
Outstanding, Beginning Balance | shares | 1,898,395 | |
Granted | shares | 830,013 | |
Exercised | shares | (188,286) | |
Cancelled and forfeited | shares | (133,454) | |
Outstanding, Ending Balance | shares | 2,406,668 | 1,898,395 |
Exercisable as of December 31, 2021 | shares | 922,104 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price Outstanding, Beginning Balance | $ / shares | $ 12.79 | |
Issuance of common stock, weighted average price per share | $ / shares | 22.22 | |
Weighted Average Exercise Price, Exercised | $ / shares | 2.59 | |
Weighted Average Exercise Price, Cancelled and forfeited | $ / shares | 19.55 | |
Weighted Average Exercise Price Outstanding, Ending Balance | $ / shares | 16.46 | $ 12.79 |
Weighted Average Exercise Price, Exercisable as of December 31, 2021 | $ / shares | $ 10.76 | |
Weighted Average Remaining Contractual Term (In years) | ||
Weighted Average Remaining Contractual Term (In years), Outstanding | 8 years 1 month 6 days | 8 years 7 months 6 days |
Weighted Average Remaining Contractual Term (In years), Exercisable as of December 31, 2021 | 7 years 3 months 18 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value Outstanding | $ | $ 25,918 | |
Aggregate Intrinsic Value Outstanding | $ | 9,970 | $ 25,918 |
Aggregate Intrinsic Value, Exercisable as of December 31, 2021 | $ | $ 6,800 |
Income Taxes - Summary of Statu
Income Taxes - Summary of Statutory Tax Rates Applicable to Income of Company and Subsidiaries (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Line Items] | ||
Effective income tax rate | 21.00% | 21.00% |
89Bio Ltd | ||
Income Tax Disclosure [Line Items] | ||
Effective income tax rate | 23.00% | 23.00% |
89bio Management, Inc. | ||
Income Tax Disclosure [Line Items] | ||
Effective income tax rate | 21.00% | 21.00% |
UAB 89bio Lithuania | ||
Income Tax Disclosure [Line Items] | ||
Effective income tax rate | 15.00% | 15.00% |
Income Taxes - Summary of Incom
Income Taxes - Summary of Income Tax Benefit (Expense) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Current: | ||
Federal | $ (11) | |
State | $ (2) | 1 |
Foreign | (1) | |
Total | (3) | (10) |
Deferred: | ||
Federal | 150 | 69 |
Total | 150 | 69 |
Income tax benefit | $ 147 | $ 59 |
Income Taxes - Summary of Compo
Income Taxes - Summary of Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Income Tax Disclosure [Line Items] | ||
Research and development expenses | $ 6,529 | $ 5,392 |
Stock-based compensation | 1,969 | 610 |
Accrued expenses | 220 | 635 |
Other | 191 | 48 |
Total deferred tax assets | 42,265 | 22,005 |
Less: valuation allowance | (42,046) | (21,936) |
Net deferred tax assets | 219 | 69 |
United States | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | 29,094 | 11,342 |
Israel | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | $ 4,262 | $ 3,978 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Line Items] | ||
Deferred tax assets, valuation allowance | $ 42,046,000 | $ 21,936,000 |
Deferred tax assets, change in valuation allowance | 20,100,000 | $ 11,900,000 |
Operating loss carryforwards limitations on use | Federal net operating losses generated after 2017 can be carried forward indefinitely but utilization will be limited to 80% of taxable income in the period that net operating losses are being utilized. | |
Taxable income utilization percentage | 80.00% | |
Federal research and development credit carryforwards | 2,100,000 | $ 600,000 |
State research and development credit carryforwards | 1,100,000 | 700,000 |
Increase in unrecognized tax benefits | 500,000 | 300,000 |
Unrecognized Tax Benefits | 0 | |
Israel | ||
Income Tax Disclosure [Line Items] | ||
Deferred tax assets, change in valuation allowance | (69,000) | |
Accumulated tax loss carryforward | 18,500,000 | 17,300,000 |
United States | ||
Income Tax Disclosure [Line Items] | ||
Accumulated tax loss carryforward | $ 138,500,000 | $ 54,100,000 |
Income Taxes - Summary of Loss
Income Taxes - Summary of Loss from Operations Before Taxes on Income (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Line Items] | ||
Net loss before income tax | $ (90,269) | $ (49,558) |
United States | ||
Income Tax Disclosure [Line Items] | ||
Net loss before income tax | (91,141) | (58,760) |
LITHUANIA | ||
Income Tax Disclosure [Line Items] | ||
Net loss before income tax | 10 | (73) |
Israel | ||
Income Tax Disclosure [Line Items] | ||
Net loss before income tax | $ 862 | $ 9,275 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of Income Tax Benefit (Expense) Statutory Tax Rate to Effective Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Income tax benefit computed at statutory rates | $ 18,757 | $ 8,285 |
Change in valuation allowance | (20,111) | (11,914) |
Foreign rate differential | (19) | 1,671 |
Change in Israel effective tax rate due to the 2019 reorganization | (2) | 647 |
Research and development credits, net of uncertain tax position | 1,331 | 815 |
Other | 191 | 555 |
Income tax benefit | $ 147 | $ 59 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Outstanding Potentially Dilutive Securities Excluded From Calculation of Diluted Net Loss (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 2,571,985 | 1,898,395 |
Stock Options to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 2,406,668 | 1,898,395 |
Unvested Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 106,394 | |
Warrants to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 58,923 |