Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 08, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | EQUILLIUM, INC. | |
Entity Central Index Key | 0001746466 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 34,414,149 | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Trading Symbol | EQ | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-38692 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 82-1554746 | |
Entity Address, Address Line One | 2223 Avenida de la Playa | |
Entity Address, Address Line Two | Suite 105 | |
Entity Address, City or Town | La Jolla | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92037 | |
City Area Code | 858 | |
Local Phone Number | 412-5302 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 24,503 | $ 59,107 |
Estimated Fair Value | 37,489 | 11,916 |
Accounts receivable | 3,424 | 2,838 |
Prepaid expenses and other current assets | 4,804 | 2,874 |
Total current assets | 70,220 | 76,735 |
Operating lease right-of-use assets | 1,114 | 1,191 |
Property and equipment, net | 360 | 391 |
Other assets | 96 | 104 |
Total assets | 71,790 | 78,421 |
Current liabilities: | ||
Accounts payable | 5,692 | 3,977 |
Accrued expenses | 5,443 | 7,239 |
Current portion of deferred revenue | 14,767 | 14,700 |
Current portion of notes payable | 5,714 | 5,714 |
Current portion of operating lease liabilities | 404 | 408 |
Total current liabilities | 32,020 | 32,038 |
Long-term notes payable | 1,841 | 3,239 |
Long-term deferred revenue | 7,941 | 10,378 |
Long-term operating lease liabilities | 719 | 824 |
Total liabilities | 42,521 | 46,479 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.0001 par value; 200,000,000 shares shares authorized as of March 31, 2023 and December 31, 2022; 34,414,149 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | 3 | 3 |
Additional paid-in capital | 205,306 | 204,268 |
Accumulated other comprehensive income | 305 | 76 |
Accumulated deficit | (176,345) | (172,405) |
Total stockholders' equity | 29,269 | 31,942 |
Total liabilities and stockholders' equity | $ 71,790 | $ 78,421 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 34,414,149 | 34,414,149 |
Common stock, shares outstanding | 34,414,149 | 34,414,149 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Statement [Abstract] | ||
Revenue | $ 8,879,000 | |
Operating expenses: | ||
Research and development | 9,272,000 | $ 10,763,000 |
Acquired in-process research and development | 23,049,000 | |
General and administrative | 3,715,000 | 3,517,000 |
Total operating expenses | 12,987,000 | 37,329,000 |
Loss from operations | (4,108,000) | (37,329,000) |
Other income (expense), net: | ||
Interest expense | (232,000) | (255,000) |
Interest income | 639,000 | 25,000 |
Other (expense) income, net | (179,000) | 142,000 |
Total other income (expense), net | 228,000 | (88,000) |
Loss before income taxes | (3,880,000) | (37,417,000) |
Income tax expense | 60,000 | 0 |
Net loss | (3,940,000) | (37,417,000) |
Other comprehensive income (loss), net: | ||
Unrealized gain (loss) on available-for-sale securities, net | 96,000 | (180,000) |
Foreign currency translation gain (loss) | 133,000 | (136,000) |
Total other comprehensive income (loss), net | 229,000 | (316,000) |
Comprehensive loss | $ (3,711,000) | $ (37,733,000) |
Net loss per share, basic | $ (0.11) | $ (1.17) |
Net loss per share, diluted | $ (0.11) | $ (1.17) |
Weighted-average number of common shares outstanding, basic | 34,414,149 | 31,865,783 |
Weighted-average number of common shares outstanding, diluted | 34,414,149 | 31,865,783 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Bioniz | Common Stock | Common Stock Bioniz | Additional Paid-in Capital | Additional Paid-in Capital Bioniz | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 66,505 | $ 2 | $ 176,618 | $ (138) | $ (109,977) | |||
Balance, Shares at Dec. 31, 2021 | 29,455,668 | |||||||
Issuance of common stock | $ 22,542 | $ 1 | $ 22,541 | |||||
Issuance of common stock, Shares | 4,820,230 | |||||||
Vesting of restricted stock liability | 18 | 18 | ||||||
Stock-based compensation expense | 1,298 | 1,298 | ||||||
Comprehensive income (loss) | (316) | (316) | ||||||
Net loss | (37,417) | (37,417) | ||||||
Balance at Mar. 31, 2022 | 52,630 | $ 3 | 200,475 | (454) | (147,394) | |||
Balance, Shares at Mar. 31, 2022 | 34,275,898 | |||||||
Balance at Dec. 31, 2022 | 31,942 | $ 3 | 204,268 | 76 | (172,405) | |||
Balance, Shares at Dec. 31, 2022 | 34,414,149 | |||||||
Stock-based compensation expense | 1,038 | 1,038 | ||||||
Comprehensive income (loss) | 229 | 229 | ||||||
Net loss | (3,940) | (3,940) | ||||||
Balance at Mar. 31, 2023 | $ 29,269 | $ 3 | $ 205,306 | $ 305 | $ (176,345) | |||
Balance, Shares at Mar. 31, 2023 | 34,414,149 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities: | ||
Net loss | $ (3,940) | $ (37,417) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Acquired in-process research and development | 23,049 | |
Depreciation and amortization | 31 | 25 |
Stock-based compensation | 1,038 | 1,298 |
Net unrealized loss (gain) on foreign currency transactions | 159 | (140) |
Amortization of term loan discount and issuance costs | 30 | 48 |
Amortization of investments, net | (296) | 47 |
Deferred revenue | (2,370) | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (586) | |
Prepaid expenses and other current assets | (1,983) | (553) |
Accounts payable | 1,726 | 2,692 |
Accrued expenses | (1,771) | (1,218) |
Right-of-use assets and lease liabilities, net | (33) | 35 |
Net cash used in operating activities | (7,995) | (12,134) |
Investing activities: | ||
Purchases of property and equipment | (223) | |
Purchases of short-term investments | (37,181) | (14,962) |
Maturities of short-term investments | 12,000 | 2,500 |
Cash acquired in Bioniz acquisition | 700 | |
Net cash used in investing activities | (25,181) | (11,985) |
Financing activities: | ||
Principal repayments on notes payable | (1,429) | |
Net cash used in financing activities | (1,429) | |
Effect of exchange rate changes on cash and cash equivalents | 1 | (3) |
Net decrease in cash and cash equivalents | (34,604) | (24,122) |
Cash and cash equivalents at beginning of period | 59,107 | 50,366 |
Cash and cash equivalents at end of period | $ 24,503 | 26,244 |
Supplemental disclosures of non-cash activities: | ||
Fair value of Bioniz assets acquired | 23,049 | |
Issuance of common stock for Bioniz acquisition | (22,542) | |
Bioniz net liabilities assumed | 507 | |
Amounts included in accounts payable for purchases of property and equipment | $ 36 |
Organization and Accounting Pro
Organization and Accounting Pronouncements | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Accounting Pronouncements | 1. Organization and Accounting Pronouncements Description of Business Equillium, Inc. (the Company) was incorporated in the state of Delaware on March 16, 2017 . The Company is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The Company’s strategy is focused on advancing the clinical development of its product candidates, including potentially pursuing additional indications and acquiring new product candidates and platforms to expand its pipeline. The Company intends to commercialize its product candidates either independently or through partnerships or otherwise monetize its pipeline through strategic transactions. From inception through March 31, 2023, the Company has devoted substantially all of its efforts to organizing and staffing the Company, business planning, raising capital, in-licensing rights to itolizumab (EQ001), conducting non-clinical research, filing three Investigational New Drug applications (INDs), conducting clinical development of the Company’s product candidates, conducting business development activities such as the acquisition of Bioniz Therapeutics, Inc. (Bioniz), the Asset Purchase Agreement with Ono Pharmaceutical Co., Ltd. (Ono) and other transactions not completed, and the general and administrative activities associated with operating a public company. In addition, the Company has not generated revenues from product sales, milestone payments, or royalties, and the sales and income potential of its business is unproven. Liquidity and Business Risks As of March 31, 2023, the Company had $ 62.0 million in cash, cash equivalents and short-term investments. The Company has incurred significant operating losses and negative cash flows from operations. The Company expects to use its cash, cash equivalents, and short-term investments to fund research and development of its product candidates, for potentially acquiring and conducting research and development of new products, and for working capital and other general corporate purposes. The Company does not expect to generate any revenues from product sales unless and until the Company successfully completes development and obtains regulatory approval of any of its product candidates, which is unlikely to happen within the next 12 months, if ever. Accordingly, until such time as the Company can generate significant revenue from sales of its product candidates, if ever, the Company expects to finance its cash needs through a combination of equity offerings, debt financings, and collaboration and license agreements, such as its Asset Purchase Agreement with Ono. However, the Company may not be able to secure additional financing or enter into such other arrangements in a timely manner or on favorable terms, if at all. As a result of the conflict between Russia and Ukraine, bank failures, inflationary pressures on the economy and monetary policy responses taken by government agencies and other macroeconomic factors, the global credit and financial markets have experienced extreme volatility, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth and uncertainty about economic stability. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. If equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive. The Company’s failure to raise capital or enter into such other arrangements when needed would have a negative impact on the Company’s financial condition and could force the Company to delay, reduce or terminate its research and development programs or other operations, or grant rights to develop and market product candidates that the Company would otherwise prefer to develop and market itself. Management believes that the Company’s cash, cash equivalents and short-term investments as of March 31, 2023, will be sufficient to fund operations for at least the next 12 months from the date this Quarterly Report on Form 10-Q is filed with the Securities and Exchange Commission (SEC). Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and the rules and regulations of the SEC related to a quarterly report on Form 10-Q. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB). Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The condensed consolidated financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 23, 2023. Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. Foreign Currency Translation The Company’s wholly-owned subsidiary in Australia uses its local currency as its functional currency. Assets and liabilities are translated into U.S. dollars at quarter-end exchange rates and revenues and expenses are translated at average exchange rates during the quarter and year-to-date periods. Foreign currency translation adjustments for the reported periods are included in accumulated other comprehensive income (loss), net in the Company’s condensed consolidated statements of comprehensive loss, and the cumulative effect is included in the stockholders’ equity section of the Company’s condensed consolidated balance sheets. Recently Issued Accounting Pronouncements In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers , which requires an acquirer to recognize and measure contract assets and liabilities acquired in a business combination in accordance with Revenue from Contracts with Customers (Topic 606) rather than adjust them to fair value at the acquisition date. This accounting standards update will be effective for the Company beginning in the first quarter of fiscal 2024. The Company does not expect this accounting standards update to have a material impact on its consolidated financial statements. No other new accounting pronouncements or legislation issued or effective as of March 31, 2023 have had, or are expected to have, a material impact on our consolidated financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The preparation of the Company’s condensed consolidated financial statements requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the condensed consolidated financial statements and accompanying notes. Significant estimates in the Company’s condensed consolidated financial statements relate to accrued research and development expense, revenue recognition and the valuation of equity awards. Management evaluates its estimates on an ongoing basis. Although estimates are based on the Company’s historical experience, knowledge of current events, and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Concentration of Credit Risk and Off-Balance Sheet Risk Financial instruments which potentially subject the Company to significant concentration of credit risk consist of cash and cash equivalents and short-term investments. The Company maintains deposits in federally insured financial institutions in which the majority of deposits are in excess of federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company’s investment policy includes guidelines for the quality of the related institutions and financial instruments and defines allowable investments that the Company may invest in, which the Company believes minimizes the exposure to concentration of credit risk. Comprehensive Loss The Company is required to report all components of comprehensive loss, including net loss, in the consolidated financial statements in the period in which they are recognized. Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses. Other comprehensive income (loss), net includes unrealized gains or losses on short-term investments as well as foreign currency translation gains or losses. Cash and Cash Equivalents Cash and cash equivalents include cash in readily available checking and savings accounts, and money market funds. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. At March 31, 2023 and December 31, 2022, the Company's cash and cash equivalents were primarily comprised of money market funds. Short-Term Investments Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported in comprehensive loss. The amortized cost of available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income or expense. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. Accounts Receivable Accounts receivable includes trade accounts receivables from the Ono Asset Purchase Agreement (see Note 8). Reimbursable costs that have not been invoiced as of the balance sheet date are recorded as unbilled accounts receivable. As of March 31, 2023 and December 31, 2022, the Company had unbilled accounts receivable totaling $ 3.4 million and $ 2.8 million, respectively, classified as accounts receivable on its consolidated balance sheet. The Company makes judgments as to its ability to collect outstanding receivables and provide an allowance for receivables when collection becomes doubtful. Allowance for credit risk for accounts receivable is established based on various factors including credit profiles of the Company’s customers, historical payments and current economic trends. The Company reviews its allowance for accounts receivable by assessing individual accounts receivable over a specific aging and amount. The estimate of expected credit losses is based on information about past events, current economic conditions, and forecasts of future economic conditions that affect the collectability. Accounts receivable is written-off on a case by case basis, net of any amounts that may be collected. As of March 31, 2023 and December 31, 2022, no credit losses have been recorded by the Company. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets primarily represent amounts related to clinical trial and preclinical research agreements, an estimated tax refund from the Australian Tax Office for eligible research and development expenditures, and director and officer insurance. Property and Equipment Property and equipment is stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to five years ). Leases The Company determines if an arrangement is a lease at inception. Lease right-of-use assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. For operating leases with an initial term greater than 12 months, the Company recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease right-of-use assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when we are reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For our operating leases, if the interest rate used to determine the present value of future lease payments is not readily determinable, the Company estimates its incremental borrowing rate as the discount rate for the lease. Our incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in similar economic environments. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has elected the practical expedient to not separate lease and non-lease components. Impairment of Long-Lived Assets Long-lived assets consist primarily of property and equipment. An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, management believes that future cash flows to be received support the carrying value of its long-lived assets and, accordingly, has not recognized any impairment losses since inception. Accrued Research and Development Expense The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, consultants and contract research organizations, in connection with conducting research and development activities. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company reflects research and development expenses in its condensed consolidated financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of the preclinical or clinical study as measured by the timing of various aspects of the study or related activities. The Company determines accrual estimates through review of the underlying contracts along with preparation of financial models taking into account discussions with research and other key personnel as to the progress of studies, or other services being conducted. During the course of a study, the Company adjusts its rate of expense recognition if actual results differ from its estimates. The Company classifies its estimates for accrued research and development expenses as accrued expenses on the accompanying condensed consolidated balance sheet. Australian Research and Development Tax Incentive The Company is eligible under the Australian Research and Development Tax Incentive Program, or the Tax Incentive, to obtain a cash refund from the Australian Taxation Office for eligible research and development expenditures. To be eligible, the filing entity must have revenue of less than AUD $ 20.0 million during the reimbursable period and cannot be controlled by income tax exempt entities. The Tax Incentive is recognized as a reduction to research and development expense when there is reasonable assurance that the Tax Incentive will be received, the relevant expenditure has been incurred, and the amount can be reliably measured. The Company classifies its estimate for the Tax Incentive as prepaid expenses and other current assets on the accompanying consolidated balance sheet. As of March 31, 2023 and December 31, 2022, the Company recorded $ 1.7 million and $ 1.0 million within prepaid and other current assets attributed to the Tax Incentive, respectively. Revenue Recognition The Company recognizes revenue in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration the Company is entitled to receive in exchange for such product or service. In doing so, the Company follows a five-step approach: (i) identify the contract with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service. The Company considers the terms of a contract and all relevant facts and circumstances when applying the revenue recognition standard. The Company applies the revenue recognition standard, including the use of any practical expedients, consistently to contracts with similar characteristics and in similar circumstances. A customer is a party that has entered into a contract with the Company, where the purpose of the contract is to obtain a product or a service that is an output of the Company’s ordinary activities in exchange for consideration. To be considered a contract, (i) the contract must be approved (in writing, orally, or in accordance with other customary business practices), (ii) each party’s rights regarding the product or the service to be transferred can be identified, (iii) the payment terms for the product or the service to be transferred can be identified, (iv) the contract must have commercial substance (that is, the risk, timing or amount of future cash flows is expected to change as a result of the contract), and (v) it is probable that the Company will collect substantially all of the consideration to which it is entitled to receive in exchange for the transfer of the product or the service. A performance obligation is defined as a promise to transfer a product or a service to a customer. The Company identifies each promise to transfer a product or a service (or a bundle of products or services, or a series of products and services that are substantially the same and have the same pattern of transfer) that is distinct. A product or a service is distinct if both (i) the customer can benefit from the product or the service either on its own or together with other resources that are readily available to the customer and (ii) the Company’s promise to transfer the product or the service to the customer is separately identifiable from other promises in the contract. Each distinct promise to transfer a product or a service is a unit of accounting for revenue recognition. If a promise to transfer a product or a service is not separately identifiable from other promises in the contract, such promises should be combined into a single performance obligation. The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to a customer. To determine the transaction price, the Company considers the existence of any significant financing component, the effects of any variable elements, noncash considerations and consideration payable to the customer. If a significant financing component exists, the transaction price is adjusted for the time value of money. If an element of variability exists, the Company must estimate the consideration it expects to receive and uses that amount as the basis for recognizing revenue as the product or the service is transferred to the customer. There are two methods for determining the amount of variable consideration: (i) the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts, and (ii) the mostly likely amount method, which identifies the single most likely amount in a range of possible consideration amounts. If a contract has multiple performance obligations, the Company allocates the transaction price to each distinct performance obligation in an amount that reflects the consideration the Company is entitled to receive in exchange for satisfying each distinct performance obligation. For each distinct performance obligation, revenue is recognized when (or as) the Company transfers control of the product or the service applicable to such performance obligation. In those instances where the Company first receives consideration in advance of satisfying its performance obligation, the Company classifies such consideration as deferred revenue until (or as) the Company satisfies such performance obligation. In those instances where the Company first satisfies its performance obligation prior to its receipt of consideration, the consideration is recorded as accounts receivable. The Company expenses incremental costs of obtaining and fulfilling a contract as and when incurred if the expected amortization period of the asset that would be recognized is one year or less, or if the amount of the asset is immaterial. Otherwise, such costs are capitalized as contract assets if they are incremental to the contract and amortized to expense proportionate to revenue recognition of the underlying contract. Contract Assets The Company does not have material amounts of contract assets since revenue is recognized as control of goods is transferred or as services are performed. There are a small number of research and development services that may occur over a period of time, but that period of time is generally very short in duration. Any contract assets that may arise are recorded in accounts receivable in the Company’s consolidated balance sheet net of an allowance for credit losses. Contract Liabilities The Company’s contract liabilities consist of advance payments and deferred revenue. The Company classifies advance payments and deferred revenue as current or noncurrent based on the timing of when it expects to recognize revenue. Generally, all contract liabilities are expected to be recognized within one year and are included in deferred revenue in the Company’s consolidated balance sheet. The noncurrent portion of deferred revenue is included and separately disclosed in the Company’s consolidated balance sheet. Acquired In-Process Research and Development Expense The Company has acquired, and may continue to acquire, the rights to develop new product candidates. Payments to acquire a new product candidate, as well as future milestone payments associated with asset acquisitions in which contingent payments are resolved are immediately expensed as acquired in-process research and development provided that the product candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. Research and Development Research and development expenses include salaries and related overhead expenses, non-cash stock-based compensation expense, external research and development expenses incurred under arrangements with third parties, costs of services performed by consultants and contract research organizations, and regulatory costs including those related to preparing and filing INDs with the FDA. Research and development costs are expensed as incurred. Patent Costs The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the consolidated statement of operations. Stock-Based Compensation The Company measures employee and non-employee stock-based awards, including stock options and stock purchase rights, at grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the award. The Company uses the Black-Scholes option pricing model to value its stock option awards. Estimating the fair value of stock option awards requires management to apply judgment and make estimates of certain assumptions, including the volatility of the Company’s common stock, the expected term of the Company’s stock options, the expected dividend yield and the fair value of the Company’s common stock on the measurement date. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. Pursuant to the Internal Revenue Code of 1986, as amended (IRC), specifically Sections 382 and 383, the Company’s ability to use tax attribute carryforwards to offset future taxable income is limited if the Company experiences a cumulative change in ownership of more than 50 % within a three-year testing period. The Company has not completed an ownership change analysis pursuant to IRC Section 382. If ownership changes within the meaning of IRC Section 382 are identified as having occurred, the amount of remaining tax attribute carryforwards available to offset future taxable income and income tax expense in future years may be significantly restricted or eliminated, including those acquired through Bioniz. Further, our deferred tax assets associated with such tax attributes could be significantly reduced or eliminated upon realization of an ownership change within the meaning of IRC Section 382. If eliminated, the related asset would be removed from the deferred tax asset schedule, with a corresponding reduction in the valuation allowance. Additionally, as discussed in the following paragraph, limitations on the utilization of our tax attribute carryforwards can increase the amount of taxable income and current income tax expense recognized. Due to the existence of the valuation allowance, ownership change limitations that are not significant may not impact our effective tax rate. The Tax Cuts and Jobs Act of 2017 amended IRC Section 174 to eliminate the immediate expensing of research and experimental (R&E) expenditures for amounts paid or incurred in tax years beginning after December 31, 2021. The rules of IRC Section 174, as amended, require taxpayers to charge their R&E expenditures and software development costs (collectively, R&E expenditures) to a capital account. Capitalized costs are required to be amortized over five or fifteen years for research performed within the United States or foreign jurisdictions, respectively. As a result of these law changes, the Company is forecasting an immaterial amount of federal taxable income after the utilization of its federal tax attribute carryforwards. As noted above, the Company has not yet completed an ownership change analysis pursuant to the rules of IRC Sections 382 and 383, and the conclusions from such an analysis could materially affect our federal tax expense. The Company is in the process of preparing a formal ownership change analysis and will adjust its tax expense forecast accordingly once more information is available regarding IRC Section 382 and 383 limitations. The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more- likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common share equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. The Company’s potentially dilutive securities include outstanding options under the Company’s equity incentive plan and outstanding warrants to purchase common stock, each of which have been excluded from the computation of diluted net loss per share as they would be anti-dilutive to the net loss per share. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows (in common stock equivalent shares): Three Months Ended 2023 2022 Common stock options 7,095,775 5,214,762 Common stock warrants 1,366,141 1,366,141 Total 8,461,916 6,580,903 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments The following tables summarize the Company’s assets that require fair value measurements on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands): Fair Value Measurements Using Quoted Prices in Significant Significant Active Markets Other Unobservable March 31, for Identical Observable Inputs 2023 Assets (Level 1) Inputs (Level 2) (Level 3) Short-term investments: U.S. treasury securities $ 37,489 $ 37,489 $ - $ - Total $ 37,489 $ 37,489 $ - $ - Fair Value Measurements Using Quoted Prices in Significant Significant Active Markets Other Unobservable December 31, for Identical Observable Inputs 2022 Assets (Level 1) Inputs (Level 2) (Level 3) Short-term investments: U.S. treasury securities $ 11,916 $ 11,916 $ - $ - Total $ 11,916 $ 11,916 $ - $ - U.S. treasury securities and certificates of deposit are valued using Level 1 inputs. Level 1 securities are valued at unadjusted quoted prices in active markets that are observable at the measurement date for identical, unrestricted assets or liabilities. Fair values determined by Level 2 inputs, which utilize data points that are observable such as quoted prices, interest rates and yield curves, require the exercise of judgment and use of estimates, that if changed, could significantly affect the Company’s financial position and results of operations. Investments in agency securities are valued using Level 2 inputs. Level 2 securities are initially valued at the transaction price and subsequently valued and reported utilizing inputs other than quoted prices that are observable either directly or indirectly, such as quotes from third-party pricing vendors. The carrying amounts of the Company’s financial instruments, including cash and cash equivalents, prepaid and other current assets, accounts payable, and accrued liabilities, approximate fair value due to their short maturities. The carrying amount of the Company’s notes payable of $ 7.6 million and $ 9.0 million at each of March 31, 2023 and December 31, 2022, respectively, approximated their fair value as the terms of the notes are consistent with the market terms of transactions with similar profiles (Level 2 inputs). None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. The Company did no t hold any Level 1, 2 or 3 financial liabilities that are recorded at fair value on a recurring basis as of March 31, 2023 or December 31, 2022. |
Certain Financial Statement Cap
Certain Financial Statement Caption Information | 3 Months Ended |
Mar. 31, 2023 | |
Certain Financial Statement Caption Information [Abstract] | |
Certain Financial Statement Caption Information | 4. Certain Financial Statement Caption Information Short-Term Investments The following table summarizes the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Unrealized Estimated (in years) Cost Gains Losses Fair Value March 31, 2023 U.S. treasury securities 1 or less $ 37,483 $ 10 $ ( 4 ) $ 37,489 Total $ 37,483 $ 10 $ ( 4 ) $ 37,489 December 31, 2022 U.S. treasury securities 1 or less $ 12,006 - ( 90 ) $ 11,916 Total $ 12,006 $ - $ ( 90 ) $ 11,916 All of the Company’s available-for-sale securities are available to the Company for use in its current operations. As a result, the Company categorizes all of these securities as current assets even though the stated maturity of some individual securities may be one year or more beyond the balance sheet date. All of the Company’s securities have a maturity within two years of the balance sheet date. There were no impairments considered other-than-temporary during the periods presented, as it is management’s intention and ability to hold the securities until a recovery of the cost basis or recovery of fair value. Unrealized gains and losses are included in accumulated other comprehensive loss. Accrued Expenses Accrued expenses consisted of the following (in thousands): March 31, December 31, 2023 2022 Clinical development $ 3,313 $ 3,253 Accrued payroll and other employee benefits 976 2,975 Other accruals 732 472 Non-clinical research 356 465 Accrued interest 66 74 Total accrued expenses $ 5,443 $ 7,239 |
Acquisition
Acquisition | 3 Months Ended |
Mar. 31, 2023 | |
Business Combination and Asset Acquisition [Abstract] | |
Acquisition | 5. Acquisition On February 14, 2022, the Company entered into an Agreement and Plan of Merger with Project JetFuel Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of the Company (Merger Sub), Bioniz and Kevin Green, solely in his capacity as representative of the securityholders of Bioniz (the Securityholders’ Representative). As consideration for the acquisition of Bioniz, the Company agreed to (a) issue up to an aggregate of 5,699,492 shares of the Company’s common stock (Merger Shares), and (b) make contingent payments up to an aggregate of $ 57.5 million based on the achievement of certain regulatory events for the Bioniz product candidates commencing on first U.S. approval, and up to an aggregate of $ 250 million based on the achievement of certain commercialization events for product candidate BNZ-1 (now referred to as EQ101) as set forth in the Merger Agreement. The Merger Shares may be adjusted downward after the closing, pursuant to procedures set forth in the Merger Agreement, including with respect to indemnification claims and in connection with the finalization of transaction expenses, debt, net exercise taxes and working capital amounts at closing. At closing, the Company delivered to the transfer agent 4,820,230 shares of its common stock for issuance to former stockholders of Bioniz per the terms of the Merger Agreement. Up to an additional 879,252 shares of the Company's common stock, pending any adjustments per the terms of the Merger Agreement, will be issued to former stockholders of Bioniz 18 months after closing. The acquisition of Bioniz expanded the Company's pipeline of novel immunomodulatory drug candidates, adding two first-in-class clinical stage assets, BNZ-1 and BNZ-2, now referred to as EQ101 and EQ102, respectively, and a proprietary product discovery platform. The Company determined the acquisition constituted an acquisition of assets instead of a business combination as substantially all of the fair value of the gross assets acquired was concentrated in a group of similar identifiable assets, and therefore, the acquisition was not considered a business. As the Company is recording the transaction as an asset acquisition under ASC 805, the contingent payments will be recognized upon achievement and at that time will be expensed to in-process research and development. Transaction costs of approximately $ 0.4 million associated with the acquisition were included in the Company’s research and development expense during the three months ended March 31, 2022. A summary of the purchase price allocation is as follows (in thousands): Amount Assets acquired: Cash $ 700 Prepaid expenses and other current assets 28 Fixed assets 6 Total assets acquired 734 Liabilities assumed: Accounts payable 265 Accrued expenses 976 Total liabilities assumed 1,241 Net liabilities acquired $ 507 Issuance of common stock for Bioniz acquisition 22,542 Acquired in-process research and development $ 23,049 |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Notes Payable | 6. Notes Payable On September 30, 2019 (the Effective Date), the Company entered into a Loan and Security Agreement (the Loan Agreement) with two lenders (the Lenders) pursuant to which the Company borrowed $ 10.0 million from the Lenders (the Term Loan), which represents the maximum amount the Company is permitted to borrow under the terms of the Loan Agreement. The Term Loan matures on June 1, 2024 (the Maturity Date) and is repaid through interest-only payments, which originally extended through June 30, 2021, followed by 36 equal monthly payments of principal and interest. The Term Loan bears interest at a floating per annum rate equal to the greater of (i) 8.25 % and (ii) the sum of (a) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 3.00 %. On April 23, 2021, the Loan Agreement was amended to (i) change the final payment percentage from 4.5 % to 5.0 % and (ii) extend the interest-only payment period based on achieving the following milestones: (a) the Company achieving positive data in the Company's Phase 1b aGVHD trial of itolizumab (EQ001) supporting a formal decision to advance into Phase 2 or Phase 3 development, and as confirmed by the Company's Board of Directors in written board minutes (the Interest-Only Extension Milestone) and (b) the Company initiating a pivotal Phase 3 aGVHD trial (the Interest-Only Extension II Milestone). In May 2021, the Company achieved the Interest-Only Extension Milestone, and in March 2022, the Company obtained confirmation from the Lenders that the Interest-Only Extension II Milestone had been achieved, which extended the interest-only payments through September 30, 2022, followed by 24 equal monthly principal payments and interest. In February 2022, the Company entered into a Third Amendment to the Loan Agreement (the Third Amendment) which added Bioniz as a secured party to the loan. Under authoritative guidance, the April 2021 amendment did not meet the criteria to be accounted for as a troubled debt restructuring. In addition, the Company performed a quantitative analysis and determined that the terms of the new debt and original debt instrument were not substantially different. Accordingly, the April 2021 amendment was accounted for as a debt modification. A new effective interest rate that equates the revised cash flows to the carrying amount of the original debt was computed and applied prospectively. The effective interest rate as of March 31, 2023 is 12.11 %. The Company will be required to make a final payment of 5.00 % of the original principal amount of the Term Loan drawn payable on the earlier of (i) the Maturity Date, (ii) the acceleration of the Term Loan in the event of a default, or (iii) the prepayment of the Term Loan (the Final Payment). The Company may prepay all, but not less than all, of the Term Loan upon 30 days’ advance written notice to the lender, provided that the Company will be obligated to pay a prepayment fee equal to (i) 3.00 % of the principal amount of the Term Loan prepaid on or before the first anniversary of the applicable funding date, (ii) 2.00 % of the principal amount of the Term Loan prepaid between the first and second anniversary of the funding date, and (iii) 1.00 % of the principal amount of the Term Loan prepaid thereafter, and prior to the Maturity Date (each, a Prepayment Fee). In connection with entering into the Loan Agreement, the Company issued to the Lenders warrants exercisable for 80,428 shares of the Company’s common stock (the Warrants). The Warrants are exercisable in whole or in part, immediately, and have a per share exercise price of $ 3.73 , which was the closing price of the Company’s common stock reported on the Nasdaq Global Market on the day prior to the Effective Date. The Warrants will terminate on the earlier of September 30, 2029 or the closing of certain merger or consolidation transactions. The aggregate carrying amounts of the Term Loans are comprised of the following (in thousands): March 31, December 31, 2023 2022 Principal $ 7,143 $ 8,571 Add: accreted liability for final payment fee 448 430 Less: unamortized discount ( 36 ) ( 48 ) Total $ 7,555 $ 8,953 Upon the occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Loan Agreement, the breach of certain of its other covenants under the Loan Agreement, or the occurrence of a material adverse change, cross defaults to other indebtedness or material agreements, judgment defaults and defaults related to failure to maintain governmental approvals failure of which to maintain could result in a material adverse effect, the Lenders will have the right, among other remedies, to declare all principal and interest immediately due and payable, to exercise secured party remedies, to receive the Final Payment and, if the payment of principal and interest is due prior to the Maturity Date, to receive the applicable Prepayment Fee. At March 31, 2023, the Company was in compliance with the covenants contained in the Loan Agreement. Future maturities of the Term Loans, including the Final Payment fee, as of March 31, 2023 are as follows (in thousands): Remainder of 2023 (nine months) $ 4,286 Year ending December 31, 2024 3,357 7,643 Unaccreted balance for Final Payment fee on Term Loans ( 52 ) Unamortized discounts ( 36 ) 7,555 Less current portion ( 5,714 ) Noncurrent portion $ 1,841 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Leases | 7. Leases The Company’s leases relate primarily to office and laboratory facilities located in La Jolla and previously in South San Francisco, California. The Company’s lease of office space in South San Francisco expired in February 2023 and the Company did not renew that lease. The Company’s lease of laboratory space in La Jolla expires in 2025 , and the Company's leases of office space in La Jolla expire in 2027 . The terms of the Company’s non-cancelable operating lease arrangements typically contain fixed lease payment which increases over the term of the lease at fixed rates, and include rent holidays and provide for additional renewal periods. Lease expense is recognized over the term of the lease on a straight-line basis. All of the Company’s leases are classified as operating leases. The Company has determined that periods covered by options to extend the Company’s leases are excluded from the lease term as the Company is not reasonably certain the Company will exercise such options. Operating lease expense, including expenses related to short-term leases, was $ 0.1 million for each of the three months ended March 31, 2023 and 2022. The Company records its right-of-use (ROU) assets within other assets (long term) and its operating lease liabilities within other current and long-term liabilities. Additional information related to the Company’s leases as of and for the three months ended March 31, 2023, is as follows (in thousands, except lease term and discount rate): March 31, 2023 Balance sheet information Right-of-use assets $ 1,114 Lease liabilities, current $ 404 Lease liabilities, non-current 719 Total lease liabilities $ 1,123 Other information Weighted average remaining lease term 2.89 years Weighted average discount rate 8.25 % Supplemental cash flow information Operating cash flows from operating leases $ 167 Right-of-use assets obtained in exchange for lease obligations $ — Maturities of lease liabilities as of March 31, 2023 were as follows (in thousands): Year ending December 31, 2023 (remaining nine months) 360 2024 492 2025 219 2026 169 2027 28 Total undiscounted lease payments 1,268 Less: imputed interest ( 145 ) Total lease liabilities $ 1,123 As of March 31, 2023, the Company does not have any leases that have not yet commenced that create significant rights and obligations. |
Partnerships
Partnerships | 3 Months Ended |
Mar. 31, 2023 | |
Collaboration And License Agreement [Abstract] | |
Partnerships | 8. Partnerships Asset Purchase Agreement with Ono Pharmaceutical Co., Ltd. On December 5, 2022, the Company and Ono, a Japan kabushiki kaisha, entered into an Asset Purchase Agreement pursuant to which the Company granted Ono the exclusive right, but not the obligation, to acquire the Company’s rights to itolizumab (the Option). These rights include all therapeutic indications and the rights to commercialize itolizumab in the United States, Canada, Australia, and New Zealand. In exchange for the Option, Ono paid the Company a one-time, upfront payment of an amount equal to JPY 3.5 billion, or $ 26.4 million. If Ono exercises the Option, Ono will pay the Company a one-time payment of an amount equal to JPY 5.0 billion, or approximately $ 37.2 million based on the currency exchange rate quoted by MUFG Bank, Ltd. on March 16, 2023. The Company is also eligible to receive up to $ 101.4 million upon the achievement of certain development and commercialization milestones. The Company is responsible for conducting all research and development of itolizumab, which will be funded by Ono on a quarterly basis from July 1, 2022, through the option period. Unless terminated early, the option period will expire three months following the delivery of topline data from the EQUALISE clinical study in lupus nephritis and interim data from the EQUATOR Phase 3 clinical study in acute graft-versus-host disease. The Asset Purchase Agreement can be terminated at any time by Ono upon written notice, provided that in limited circumstances Ono will be obligated to continue to reimburse the Company for research and development costs and expenses of itolizumab for a certain period of time following such termination. If Ono does not timely exercise its Option, the Asset Purchase Agreement and the Option will automatically terminate. The Asset Purchase Agreement also contains customary termination rights for both parties for material breach and an outside date (subject to limited adjustments) that permits either party to terminate the Asset Purchase Agreement if the closing has not occurred by December 31, 2025. The Asset Purchase Agreement contains customary representations and warranties with respect to both the Company and Ono. Additionally, the Company is subject to customary obligations and covenants, including affirmative and negative operating covenants on the Company with respect to its business as it applies to the development and exploitation of itolizumab, exclusivity obligations that prohibit the Company, except in limited circumstances, including in connection with the sale of the Company, from pursuing a direct or indirect sale, license or other disposition of all or any portion of the Company's itolizumab program or any of the assets to be purchased pursuant to the Asset Purchase Agreement and indemnification obligations, which, except in limited circumstances, are subject to customary caps and deductibles. The Company applied ASC 808, Collaborative Arrangements, to the Asset Purchase Agreement and determined that the agreement is applicable to such guidance. The Company concluded that Ono represented a customer and applied relevant guidance from ASC 606, Revenue Recognition , (ASC 606) to evaluate the appropriate accounting for the Asset Purchase Agreement. In accordance with this guidance, the Company identified its performance obligations, including its grant of a license to Ono to certain of its intellectual property subject to certain conditions and the conduct of research and development services. The Company determined that its grant of a license to Ono to certain of its intellectual property subject to certain conditions was not distinct from other performance obligations because such grant is dependent on the conduct and results of the research and development services. Accordingly, the Company determined that all performance obligations should be accounted for as one combined performance obligation, and that the combined performance obligation is transferred over the expected term of the conduct of the research and development services. The Company also assessed, in connection with the upfront and non-creditable payment of JPY 3.5 billion or $ 25.8 million, invoiced on December 5, 2022, that there was not a significant financing component in the Asset Purchase Agreement. The Company received payment of $ 26.4 million related to this upfront payment in December 2022 which included a foreign currency realized gain of $ 0.6 million as the initial invoice for the upfront payment was denominated in JPY. The Company also assessed the effects of any variable elements under the Asset Purchase Agreement. Such assessment evaluated, among other things, the likelihood of receiving (i) option fees and (ii) various clinical, regulatory and commercial milestone payments. Based on its assessment, the Company concluded that, based on the likelihood of these variable components occurring, there was not a significant variable element included in the transaction price. Accordingly, the Company has not assigned a transaction price to any option fees or milestone payments under the Asset Purchase Agreement given the substantial uncertainty related to their achievement. In accordance with ASC 606, the Company determined that the initial transaction price under the Asset Purchase Agreement equals $ 102.6 million, consisting of the upfront and non-creditable payment of $ 25.8 million and the aggregate estimated research and development funding of $ 76.8 million over the estimated option period. The upfront payment of $ 25.8 million was recorded as deferred revenue and is being recognized as revenue over time in conjunction with the Company’s conduct of research and development services as the research and development services are the primary component of the combined performance obligations. Revenue associated with the upfront payment will be recognized based on actual costs incurred as a percentage of the estimated total costs expected to be incurred over the expected term of the research and development services. Reimbursable research and development costs will be recognized as revenue as incurred. The Company recognized revenue of $ 8.9 million under the Asset Purchase Agreement during the three months ended March 31, 2023. Such revenue was comprised of $ 6.7 million associated with development funding and $ 2.2 million associated with the amortization of the upfront payment. As of March 31, 2023, aggregate deferred revenue related to the Asset Purchase Agreement was $ 22.7 million, which consisted of $ 14.8 million classified as current and $ 7.9 million as long-term. As of March 31, 2023, the Company has received $ 18.1 million in cash of aggregate development funding from Ono. Biocon Collaboration and License Agreement In May 2017, the Company entered into a collaboration and license agreement (which was amended in September 2018, April 2019, December 2019, April 2021 and November 2022), clinical supply agreement, investor rights agreement, and common stock purchase agreement (collectively License Agreements) with Biocon SA (subsequently assigned to Biocon Limited, or together, Biocon). Pursuant to the License Agreements, Biocon granted the Company an exclusive license to develop, make, have made, use, sell, have sold, offer for sale, import and otherwise exploit itolizumab and any pharmaceutical composition or preparation containing or comprising itolizumab that uses Biocon technology or Biocon know-how (collectively a Biocon Product) in the United States, Canada, Australia and New Zealand (collectively Equillium Territory). The Company also has the right to sublicense through multiple tiers to third parties, provided such sublicenses comply with the terms of the License Agreements and the Company provides Biocon a copy of each sublicense agreement within 30 days of execution. If the Company grants a third party a sublicense of its rights to develop and commercialize Biocon Products in Australia or New Zealand, the Company will be required to pay Biocon a high double-digit percentage of any upfront payment the Company receives from such sublicensee for such sublicense, as well as a high double-digit percentage of any additional payments the Company receives from such sublicensee for such sublicense, including but not limited to royalty payments on net sales of Biocon Products by such sublicensee. Under the License Agreements, the Company granted back to Biocon a license to use its technology and know-how related to itolizumab and Biocon Products in certain countries outside of the Equillium Territory. Pursuant to the License Agreements, Biocon agreed to be the Company’s exclusive supplier of itolizumab clinical drug product. Biocon will provide clinical drug product at no cost for up to three concurrent orphan indications until the Company’s first U.S. regulatory approval and all other clinical drug product at Biocon’s cost. In addition, we have agreed to co-fund an ongoing Phase 2 clinical study of itolizumab in subjects with ulcerative colitis being conducted by Biocon in India. In consideration of the rights granted to the Company by Biocon, the Company issued Biocon a total of 2,316,134 shares of its common stock. In addition, the Company is obligated to pay Biocon up to an aggregate of $ 30 million in regulatory milestone payments upon the achievement of certain regulatory approvals and up to an aggregate of $ 565 million in sales milestone payments upon the achievement of first commercial sale of product and specified levels of product sales. The Company is also required to pay royalties on tiers of aggregate annual net sales of Biocon Products by the Company, the Company's affiliates and the Company's sublicensees in the United States and Canada at percentages from the mid-single digits to sub-teen double-digits and on tiers of aggregate annual net sales of Biocon Products by the Company and the Company's affiliates (but not the Company's sublicensees) in Australia and New Zealand, in each case, subject to adjustments in certain circumstances. Biocon is also required to pay the Company royalties at comparable percentages for sales of itolizumab (EQ001) outside of the Equillium Territory if the approvals in such geographies included or referenced the Company’s data including data from certain of the Company’s clinical studies, subject to adjustments in certain circumstances. Should Ono exercise its option to acquire our rights to itolizumab (EQ001), as described below, the aforementioned milestone payments and royalties potentially owed to Biocon would become Ono’s responsibility, and the potential royalties on sales of itolizumab outside of the Equillium Territory would be become Ono’s right. Under the License Agreements, net sales are calculated on a country-by-country basis and are subject to adjustments, including whether the Biocon Product is sold in the form of a combination product. As of March 31, 2023, the Company has not made or received payments in connection with the milestones or royalties within the agreement. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | 9. Stockholders’ Equity As of March 31, 2023 , the Company’s authorized capital stock consisted of 200,000,000 shares of common stock, par value $ 0.0001 per share, and 10,000,000 shares of preferred stock, par value $ 0.0001 per share. The Company had 34,414,149 shares of common stock outstanding as of March 31, 2023 and December 31, 2022. Stock Options The following table summarizes stock option activity during the three months ended March 31, 2023: Outstanding Options Weighted- Weighted Aggregate (a) Balances as of December 31, 2022 5,102,501 $ 4.11 Granted 2,034,500 $ 1.05 Exercised - $ - Forfeitures and cancellations ( 41,226 ) $ 5.85 Balances as of March 31, 2023 7,095,775 $ 3.23 8.17 $ 1 Options exercisable as of March 31, 2023 3,035,253 $ 4.15 6.95 $ - (a) Aggregate intrinsic value in this table was calculated as the positive difference, if any, between the closing price per share of the Company’s common stock on March 31, 2023 of $ 0.73 and the price of the underlying options. At March 31, 2023, unamortized stock compensation for stock options was $ 7.2 million, with a weighted-average recognition period of 3.1 years. Stock-Based Compensation Expense The non-cash stock-based compensation expense for all stock awards, net of forfeitures recognized as they occur, that was recognized in the condensed consolidated statements of operations is as follows (in thousands): Three Months Ended 2023 2022 Research and development $ 628 $ 544 General and administrative 410 754 Total $ 1,038 $ 1,298 Common Stock Reserved for Future Issuance Common stock reserved for future issuance at March 31, 2023 is as follows: March 31, December 31, 2023 2022 Stock options issued and outstanding 7,095,775 5,102,501 Warrants for common stock 1,366,141 1,366,141 Awards available under the 2018 Equity Incentive Plan 511,764 784,331 Employee stock purchase plan 1,269,238 925,963 Total 10,242,918 8,178,936 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes The Company is subject to income tax in the United States (U.S.) as well as other tax jurisdictions in which it conducts business. Earnings from non-U.S. activities are subject to local country income tax. The Company does not provide for U.S. deferred income taxes on the undistributed earnings of its foreign subsidiaries as such earnings are reinvested indefinitely. The Company’s tax provision for interim periods is determined using an estimate of its annual effective tax rate, adjusted for discrete items arising in that quarter. In each quarter, the Company updates its estimate of the annual effective tax rate, and if the estimated annual tax rate changes, the Company makes a cumulative adjustment in that quarter. The Company’s quarterly tax provision, and its quarterly estimate of its annual effective tax rate, are subject to significant volatility due to several factors, including the Company’s ability to accurately predict its pre-tax income and loss in multiple jurisdictions. Income tax expense was $ 0.1 million for the three months ended March 31, 2023. The Company's effective tax rate was ( 1.6 %) for the three months ended March 31, 2023. There was no income tax expense for the three months ended March 31, 2022. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers , which requires an acquirer to recognize and measure contract assets and liabilities acquired in a business combination in accordance with Revenue from Contracts with Customers (Topic 606) rather than adjust them to fair value at the acquisition date. This accounting standards update will be effective for the Company beginning in the first quarter of fiscal 2024. The Company does not expect this accounting standards update to have a material impact on its consolidated financial statements. No other new accounting pronouncements or legislation issued or effective as of March 31, 2023 have had, or are expected to have, a material impact on our consolidated financial statements. |
Use of Estimates | Use of Estimates The preparation of the Company’s condensed consolidated financial statements requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the condensed consolidated financial statements and accompanying notes. Significant estimates in the Company’s condensed consolidated financial statements relate to accrued research and development expense, revenue recognition and the valuation of equity awards. Management evaluates its estimates on an ongoing basis. Although estimates are based on the Company’s historical experience, knowledge of current events, and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. |
Concentration of Credit Risk and Off-Balance Sheet Risk | Concentration of Credit Risk and Off-Balance Sheet Risk Financial instruments which potentially subject the Company to significant concentration of credit risk consist of cash and cash equivalents and short-term investments. The Company maintains deposits in federally insured financial institutions in which the majority of deposits are in excess of federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company’s investment policy includes guidelines for the quality of the related institutions and financial instruments and defines allowable investments that the Company may invest in, which the Company believes minimizes the exposure to concentration of credit risk. |
Comprehensive Loss | Comprehensive Loss The Company is required to report all components of comprehensive loss, including net loss, in the consolidated financial statements in the period in which they are recognized. Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses. Other comprehensive income (loss), net includes unrealized gains or losses on short-term investments as well as foreign currency translation gains or losses. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include cash in readily available checking and savings accounts, and money market funds. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. At March 31, 2023 and December 31, 2022, the Company's cash and cash equivalents were primarily comprised of money market funds. |
Short-Term Investments | Short-Term Investments Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported in comprehensive loss. The amortized cost of available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income or expense. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. |
Accounts Receivable | Accounts Receivable Accounts receivable includes trade accounts receivables from the Ono Asset Purchase Agreement (see Note 8). Reimbursable costs that have not been invoiced as of the balance sheet date are recorded as unbilled accounts receivable. As of March 31, 2023 and December 31, 2022, the Company had unbilled accounts receivable totaling $ 3.4 million and $ 2.8 million, respectively, classified as accounts receivable on its consolidated balance sheet. The Company makes judgments as to its ability to collect outstanding receivables and provide an allowance for receivables when collection becomes doubtful. Allowance for credit risk for accounts receivable is established based on various factors including credit profiles of the Company’s customers, historical payments and current economic trends. The Company reviews its allowance for accounts receivable by assessing individual accounts receivable over a specific aging and amount. The estimate of expected credit losses is based on information about past events, current economic conditions, and forecasts of future economic conditions that affect the collectability. Accounts receivable is written-off on a case by case basis, net of any amounts that may be collected. As of March 31, 2023 and December 31, 2022, no credit losses have been recorded by the Company. |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets primarily represent amounts related to clinical trial and preclinical research agreements, an estimated tax refund from the Australian Tax Office for eligible research and development expenditures, and director and officer insurance. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to five years ). |
Leases | Leases The Company determines if an arrangement is a lease at inception. Lease right-of-use assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. For operating leases with an initial term greater than 12 months, the Company recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease right-of-use assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when we are reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For our operating leases, if the interest rate used to determine the present value of future lease payments is not readily determinable, the Company estimates its incremental borrowing rate as the discount rate for the lease. Our incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in similar economic environments. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has elected the practical expedient to not separate lease and non-lease components. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets consist primarily of property and equipment. An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, management believes that future cash flows to be received support the carrying value of its long-lived assets and, accordingly, has not recognized any impairment losses since inception. |
Accrued Research and Development Expense | Accrued Research and Development Expense The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, consultants and contract research organizations, in connection with conducting research and development activities. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company reflects research and development expenses in its condensed consolidated financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of the preclinical or clinical study as measured by the timing of various aspects of the study or related activities. The Company determines accrual estimates through review of the underlying contracts along with preparation of financial models taking into account discussions with research and other key personnel as to the progress of studies, or other services being conducted. During the course of a study, the Company adjusts its rate of expense recognition if actual results differ from its estimates. The Company classifies its estimates for accrued research and development expenses as accrued expenses on the accompanying condensed consolidated balance sheet. |
Australian Research and Development Tax Incentive | Australian Research and Development Tax Incentive The Company is eligible under the Australian Research and Development Tax Incentive Program, or the Tax Incentive, to obtain a cash refund from the Australian Taxation Office for eligible research and development expenditures. To be eligible, the filing entity must have revenue of less than AUD $ 20.0 million during the reimbursable period and cannot be controlled by income tax exempt entities. The Tax Incentive is recognized as a reduction to research and development expense when there is reasonable assurance that the Tax Incentive will be received, the relevant expenditure has been incurred, and the amount can be reliably measured. The Company classifies its estimate for the Tax Incentive as prepaid expenses and other current assets on the accompanying consolidated balance sheet. As of March 31, 2023 and December 31, 2022, the Company recorded $ 1.7 million and $ 1.0 million within prepaid and other current assets attributed to the Tax Incentive, respectively. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration the Company is entitled to receive in exchange for such product or service. In doing so, the Company follows a five-step approach: (i) identify the contract with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service. The Company considers the terms of a contract and all relevant facts and circumstances when applying the revenue recognition standard. The Company applies the revenue recognition standard, including the use of any practical expedients, consistently to contracts with similar characteristics and in similar circumstances. A customer is a party that has entered into a contract with the Company, where the purpose of the contract is to obtain a product or a service that is an output of the Company’s ordinary activities in exchange for consideration. To be considered a contract, (i) the contract must be approved (in writing, orally, or in accordance with other customary business practices), (ii) each party’s rights regarding the product or the service to be transferred can be identified, (iii) the payment terms for the product or the service to be transferred can be identified, (iv) the contract must have commercial substance (that is, the risk, timing or amount of future cash flows is expected to change as a result of the contract), and (v) it is probable that the Company will collect substantially all of the consideration to which it is entitled to receive in exchange for the transfer of the product or the service. A performance obligation is defined as a promise to transfer a product or a service to a customer. The Company identifies each promise to transfer a product or a service (or a bundle of products or services, or a series of products and services that are substantially the same and have the same pattern of transfer) that is distinct. A product or a service is distinct if both (i) the customer can benefit from the product or the service either on its own or together with other resources that are readily available to the customer and (ii) the Company’s promise to transfer the product or the service to the customer is separately identifiable from other promises in the contract. Each distinct promise to transfer a product or a service is a unit of accounting for revenue recognition. If a promise to transfer a product or a service is not separately identifiable from other promises in the contract, such promises should be combined into a single performance obligation. The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to a customer. To determine the transaction price, the Company considers the existence of any significant financing component, the effects of any variable elements, noncash considerations and consideration payable to the customer. If a significant financing component exists, the transaction price is adjusted for the time value of money. If an element of variability exists, the Company must estimate the consideration it expects to receive and uses that amount as the basis for recognizing revenue as the product or the service is transferred to the customer. There are two methods for determining the amount of variable consideration: (i) the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts, and (ii) the mostly likely amount method, which identifies the single most likely amount in a range of possible consideration amounts. If a contract has multiple performance obligations, the Company allocates the transaction price to each distinct performance obligation in an amount that reflects the consideration the Company is entitled to receive in exchange for satisfying each distinct performance obligation. For each distinct performance obligation, revenue is recognized when (or as) the Company transfers control of the product or the service applicable to such performance obligation. In those instances where the Company first receives consideration in advance of satisfying its performance obligation, the Company classifies such consideration as deferred revenue until (or as) the Company satisfies such performance obligation. In those instances where the Company first satisfies its performance obligation prior to its receipt of consideration, the consideration is recorded as accounts receivable. The Company expenses incremental costs of obtaining and fulfilling a contract as and when incurred if the expected amortization period of the asset that would be recognized is one year or less, or if the amount of the asset is immaterial. Otherwise, such costs are capitalized as contract assets if they are incremental to the contract and amortized to expense proportionate to revenue recognition of the underlying contract. |
Contract Assets | Contract Assets The Company does not have material amounts of contract assets since revenue is recognized as control of goods is transferred or as services are performed. There are a small number of research and development services that may occur over a period of time, but that period of time is generally very short in duration. Any contract assets that may arise are recorded in accounts receivable in the Company’s consolidated balance sheet net of an allowance for credit losses. |
Contract liabilities | Contract Liabilities The Company’s contract liabilities consist of advance payments and deferred revenue. The Company classifies advance payments and deferred revenue as current or noncurrent based on the timing of when it expects to recognize revenue. Generally, all contract liabilities are expected to be recognized within one year and are included in deferred revenue in the Company’s consolidated balance sheet. The noncurrent portion of deferred revenue is included and separately disclosed in the Company’s consolidated balance sheet. |
Acquired In-Process Research and Development Expense | Acquired In-Process Research and Development Expense The Company has acquired, and may continue to acquire, the rights to develop new product candidates. Payments to acquire a new product candidate, as well as future milestone payments associated with asset acquisitions in which contingent payments are resolved are immediately expensed as acquired in-process research and development provided that the product candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. |
Research and Development | Research and Development Research and development expenses include salaries and related overhead expenses, non-cash stock-based compensation expense, external research and development expenses incurred under arrangements with third parties, costs of services performed by consultants and contract research organizations, and regulatory costs including those related to preparing and filing INDs with the FDA. Research and development costs are expensed as incurred. |
Patent Costs | Patent Costs The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the consolidated statement of operations. |
Stock-Based Compensation | Stock-Based Compensation The Company measures employee and non-employee stock-based awards, including stock options and stock purchase rights, at grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the award. The Company uses the Black-Scholes option pricing model to value its stock option awards. Estimating the fair value of stock option awards requires management to apply judgment and make estimates of certain assumptions, including the volatility of the Company’s common stock, the expected term of the Company’s stock options, the expected dividend yield and the fair value of the Company’s common stock on the measurement date. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. Pursuant to the Internal Revenue Code of 1986, as amended (IRC), specifically Sections 382 and 383, the Company’s ability to use tax attribute carryforwards to offset future taxable income is limited if the Company experiences a cumulative change in ownership of more than 50 % within a three-year testing period. The Company has not completed an ownership change analysis pursuant to IRC Section 382. If ownership changes within the meaning of IRC Section 382 are identified as having occurred, the amount of remaining tax attribute carryforwards available to offset future taxable income and income tax expense in future years may be significantly restricted or eliminated, including those acquired through Bioniz. Further, our deferred tax assets associated with such tax attributes could be significantly reduced or eliminated upon realization of an ownership change within the meaning of IRC Section 382. If eliminated, the related asset would be removed from the deferred tax asset schedule, with a corresponding reduction in the valuation allowance. Additionally, as discussed in the following paragraph, limitations on the utilization of our tax attribute carryforwards can increase the amount of taxable income and current income tax expense recognized. Due to the existence of the valuation allowance, ownership change limitations that are not significant may not impact our effective tax rate. The Tax Cuts and Jobs Act of 2017 amended IRC Section 174 to eliminate the immediate expensing of research and experimental (R&E) expenditures for amounts paid or incurred in tax years beginning after December 31, 2021. The rules of IRC Section 174, as amended, require taxpayers to charge their R&E expenditures and software development costs (collectively, R&E expenditures) to a capital account. Capitalized costs are required to be amortized over five or fifteen years for research performed within the United States or foreign jurisdictions, respectively. As a result of these law changes, the Company is forecasting an immaterial amount of federal taxable income after the utilization of its federal tax attribute carryforwards. As noted above, the Company has not yet completed an ownership change analysis pursuant to the rules of IRC Sections 382 and 383, and the conclusions from such an analysis could materially affect our federal tax expense. The Company is in the process of preparing a formal ownership change analysis and will adjust its tax expense forecast accordingly once more information is available regarding IRC Section 382 and 383 limitations. The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more- likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common share equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. The Company’s potentially dilutive securities include outstanding options under the Company’s equity incentive plan and outstanding warrants to purchase common stock, each of which have been excluded from the computation of diluted net loss per share as they would be anti-dilutive to the net loss per share. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows (in common stock equivalent shares): Three Months Ended 2023 2022 Common stock options 7,095,775 5,214,762 Common stock warrants 1,366,141 1,366,141 Total 8,461,916 6,580,903 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss Per Share | Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows (in common stock equivalent shares): Three Months Ended 2023 2022 Common stock options 7,095,775 5,214,762 Common stock warrants 1,366,141 1,366,141 Total 8,461,916 6,580,903 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets that Require Fair Value Measurements on Recurring Basis and Their Respective Input Levels Based on Fair Value Hierarchy | The following tables summarize the Company’s assets that require fair value measurements on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands): Fair Value Measurements Using Quoted Prices in Significant Significant Active Markets Other Unobservable March 31, for Identical Observable Inputs 2023 Assets (Level 1) Inputs (Level 2) (Level 3) Short-term investments: U.S. treasury securities $ 37,489 $ 37,489 $ - $ - Total $ 37,489 $ 37,489 $ - $ - Fair Value Measurements Using Quoted Prices in Significant Significant Active Markets Other Unobservable December 31, for Identical Observable Inputs 2022 Assets (Level 1) Inputs (Level 2) (Level 3) Short-term investments: U.S. treasury securities $ 11,916 $ 11,916 $ - $ - Total $ 11,916 $ 11,916 $ - $ - |
Certain Financial Statement C_2
Certain Financial Statement Caption Information (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Certain Financial Statement Caption Information [Abstract] | |
Schedule of Company's Short-Term Investments | The following table summarizes the Company’s short-term investments (in thousands): Maturity Amortized Unrealized Unrealized Estimated (in years) Cost Gains Losses Fair Value March 31, 2023 U.S. treasury securities 1 or less $ 37,483 $ 10 $ ( 4 ) $ 37,489 Total $ 37,483 $ 10 $ ( 4 ) $ 37,489 December 31, 2022 U.S. treasury securities 1 or less $ 12,006 - ( 90 ) $ 11,916 Total $ 12,006 $ - $ ( 90 ) $ 11,916 |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): March 31, December 31, 2023 2022 Clinical development $ 3,313 $ 3,253 Accrued payroll and other employee benefits 976 2,975 Other accruals 732 472 Non-clinical research 356 465 Accrued interest 66 74 Total accrued expenses $ 5,443 $ 7,239 |
Acquisition (Tables)
Acquisition (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Business Combination and Asset Acquisition [Abstract] | |
Summary of Purchase Price Allocation | A summary of the purchase price allocation is as follows (in thousands): Amount Assets acquired: Cash $ 700 Prepaid expenses and other current assets 28 Fixed assets 6 Total assets acquired 734 Liabilities assumed: Accounts payable 265 Accrued expenses 976 Total liabilities assumed 1,241 Net liabilities acquired $ 507 Issuance of common stock for Bioniz acquisition 22,542 Acquired in-process research and development $ 23,049 |
Notes Payable (Tables)
Notes Payable (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Aggregate Carrying Amounts of Term Loans | The aggregate carrying amounts of the Term Loans are comprised of the following (in thousands): March 31, December 31, 2023 2022 Principal $ 7,143 $ 8,571 Add: accreted liability for final payment fee 448 430 Less: unamortized discount ( 36 ) ( 48 ) Total $ 7,555 $ 8,953 |
Schedule of Future Maturities of Term Loans, Including Final Payment Fee | Future maturities of the Term Loans, including the Final Payment fee, as of March 31, 2023 are as follows (in thousands): Remainder of 2023 (nine months) $ 4,286 Year ending December 31, 2024 3,357 7,643 Unaccreted balance for Final Payment fee on Term Loans ( 52 ) Unamortized discounts ( 36 ) 7,555 Less current portion ( 5,714 ) Noncurrent portion $ 1,841 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Summary of Additional Information Related to Leases | Additional information related to the Company’s leases as of and for the three months ended March 31, 2023, is as follows (in thousands, except lease term and discount rate): March 31, 2023 Balance sheet information Right-of-use assets $ 1,114 Lease liabilities, current $ 404 Lease liabilities, non-current 719 Total lease liabilities $ 1,123 Other information Weighted average remaining lease term 2.89 years Weighted average discount rate 8.25 % Supplemental cash flow information Operating cash flows from operating leases $ 167 Right-of-use assets obtained in exchange for lease obligations $ — |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities as of March 31, 2023 were as follows (in thousands): Year ending December 31, 2023 (remaining nine months) 360 2024 492 2025 219 2026 169 2027 28 Total undiscounted lease payments 1,268 Less: imputed interest ( 145 ) Total lease liabilities $ 1,123 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity during the three months ended March 31, 2023: Outstanding Options Weighted- Weighted Aggregate (a) Balances as of December 31, 2022 5,102,501 $ 4.11 Granted 2,034,500 $ 1.05 Exercised - $ - Forfeitures and cancellations ( 41,226 ) $ 5.85 Balances as of March 31, 2023 7,095,775 $ 3.23 8.17 $ 1 Options exercisable as of March 31, 2023 3,035,253 $ 4.15 6.95 $ - (a) Aggregate intrinsic value in this table was calculated as the positive difference, if any, between the closing price per share of the Company’s common stock on March 31, 2023 of $ 0.73 and the price of the underlying options. |
Summary of Non-cash Stock-based Compensation Expense | The non-cash stock-based compensation expense for all stock awards, net of forfeitures recognized as they occur, that was recognized in the condensed consolidated statements of operations is as follows (in thousands): Three Months Ended 2023 2022 Research and development $ 628 $ 544 General and administrative 410 754 Total $ 1,038 $ 1,298 |
Summary of Reserved Shares of Common Stock for Future Issuance | Common stock reserved for future issuance at March 31, 2023 is as follows: March 31, December 31, 2023 2022 Stock options issued and outstanding 7,095,775 5,102,501 Warrants for common stock 1,366,141 1,366,141 Awards available under the 2018 Equity Incentive Plan 511,764 784,331 Employee stock purchase plan 1,269,238 925,963 Total 10,242,918 8,178,936 |
Organization and Accounting P_2
Organization and Accounting Pronouncements - Additional Information (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
State of incorporation | DE |
Date of incorporation | Mar. 16, 2017 |
Cash, Cash equivalents and short-term investments | $ 62 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Summary Of Significant Accounting Policies [Line Items] | ||
Allowance for credit losses | $ 0 | $ 0 |
Prepaid and other current assets tax incentive | 1,700 | 1,000 |
Accounts receivable | $ 3,424 | $ 2,838 |
Cumulative change in ownership percentage | 50% | |
Cumulative change in ownership period | 3 years | |
Research and experimental expenditures capitalized cost amortization period | 5 years | |
Foreign | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Research and experimental expenditures capitalized cost amortization period | 15 years | |
Minimum | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Property and equipment, useful lives | 3 years | |
Percentage of tax benefit to be realized upon ultimate settlement with tax authority | 50% | |
Maximum | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Property and equipment, useful lives | 5 years | |
Maximum | Australian Taxation Office | Australian Research and Development Tax Incentive Program | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Revenue for availability of research and development tax incentive | $ 20,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities not included in calculation of diluted net loss per share | 8,461,916 | 6,580,903 |
Common Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities not included in calculation of diluted net loss per share | 7,095,775 | 5,214,762 |
Common Stock Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities not included in calculation of diluted net loss per share | 1,366,141 | 1,366,141 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Summary of Assets that Require Fair Value Measurements on Recurring Basis and Their Respective Input Levels Based on Fair Value Hierarchy (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | $ 37,489 | $ 11,916 |
U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 37,489 | 11,916 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 37,489 | 11,916 |
Level 1 | U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | $ 37,489 | $ 11,916 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Additional Information (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Carrying amount of notes payable | $ 7,600,000 | $ 9,000,000 |
Financial liabilities | $ 0 | $ 0 |
Certain Financial Statement C_3
Certain Financial Statement Caption Information - Schedule of Company's Short-Term Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 37,483 | $ 12,006 |
Unrealized Gains | 10 | |
Unrealized losses | (4) | (90) |
Estimated Fair Value | 37,489 | 11,916 |
U.S. Treasury Securities Maturing in One Year or Less | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 37,483 | 12,006 |
Unrealized Gains | 10 | |
Unrealized losses | (4) | (90) |
Estimated Fair Value | $ 37,489 | $ 11,916 |
U.S. Treasury Securities Maturing in One Year or Less | Maximum | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 year | 1 year |
Certain Financial Statement C_4
Certain Financial Statement Caption Information - Additional information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Schedule Of Available For Sale Securities [Line Items] | ||
Other than temporary impairment loss investments available for sale securities | $ 0 | $ 0 |
Minimum | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available for sale Securities debt maturities period | 1 year | |
Maximum | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available for sale Securities debt maturities period | 2 years |
Certain Financial Statement C_5
Certain Financial Statement Caption Information - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Clinical development | $ 3,313 | $ 3,253 |
Accrued payroll and other employee benefits | 976 | 2,975 |
Other accruals | 732 | 472 |
Non-clinical research | 356 | 465 |
Accrued interest | 66 | 74 |
Total accrued expenses | $ 5,443 | $ 7,239 |
Acquisition - Additional Inform
Acquisition - Additional Information (Details) - Bioniz - USD ($) $ in Millions | 3 Months Ended | |
Feb. 14, 2022 | Mar. 31, 2022 | |
Business Acquisition [Line Items] | ||
Business acquisition, common stock shares issued | 4,820,230 | |
Business acquisition, term for finalization after the closing | 18 months | |
Transaction costs | $ 0.4 | |
18 Months after Closing | ||
Business Acquisition [Line Items] | ||
Business acquisition, common stock shares issued | 879,252 | |
Achievement of Regulatory Events | ||
Business Acquisition [Line Items] | ||
Contingent payments | $ 57.5 | |
Achievement of Commercialization Events | ||
Business Acquisition [Line Items] | ||
Contingent payments | $ 250 | |
Maximum | ||
Business Acquisition [Line Items] | ||
Business acquisition, common stock shares issued | 5,699,492 |
Acquisition - Summary of Purcha
Acquisition - Summary of Purchase Price Allocation (Details) - Bioniz $ in Thousands | Feb. 14, 2022 USD ($) |
Assets acquired: | |
Cash | $ 700 |
Prepaid expenses and other current assets | 28 |
Fixed assets | 6 |
Total assets acquired | 734 |
Liabilities assumed: | |
Accounts payable | 265 |
Accrued expenses | 976 |
Total liabilities assumed | 1,241 |
Net liabilities acquired | 507 |
Issuance of common stock for Bioniz acquisition | 22,542 |
Acquired in-process research and development | $ 23,049 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | ||
May 31, 2021 Installment | Sep. 30, 2019 USD ($) Installment $ / shares shares | Mar. 31, 2023 | Apr. 23, 2021 | |
Short Term Debt [Line Items] | ||||
Term Loan maturity date | Jun. 01, 2024 | |||
Line of Credit | ||||
Short Term Debt [Line Items] | ||||
Debt instrument, frequency of periodic payment | monthly | |||
Debt instrument, interest rate, basis for effective rate | prime rate | |||
Percentage of final principal payment | 5% | |||
Required notice period for debt prepayment | 30 days | |||
Debt prepayment fee as percent on year one | 3% | |||
Debt prepayment fee as percent on year two | 2% | |||
Debt prepayment fee as percent from year three | 1% | |||
Line of Credit | Prime Rate | ||||
Short Term Debt [Line Items] | ||||
Debt instrument, basis spread on variable rate | 3% | |||
Line of Credit | Minimum | ||||
Short Term Debt [Line Items] | ||||
Debt instrument, interest rate, stated percentage | 8.25% | |||
Loan Agreement | ||||
Short Term Debt [Line Items] | ||||
Line of credit facility frequency of payments principal and interest | 24 | |||
Debt instrument, frequency of periodic payment | monthly | |||
Debt instrument, interest rate, effective percentage | 12.11% | |||
Loan Agreement | Minimum | ||||
Short Term Debt [Line Items] | ||||
Debt instrument, interest rate, effective percentage | 4.50% | |||
Loan Agreement | Maximum | ||||
Short Term Debt [Line Items] | ||||
Debt instrument, interest rate, effective percentage | 5% | |||
Term Loan | ||||
Short Term Debt [Line Items] | ||||
Borrowings under loan agreement | $ | $ 10 | |||
Line of credit facility frequency of payments principal and interest | 36 | |||
Lenders warrants exercisable for shares | shares | 80,428 | |||
Warrants exercisable, per share exercise price | $ / shares | $ 3.73 |
Notes Payable - Schedule of Agg
Notes Payable - Schedule of Aggregate Carrying Amounts of Term Loans (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Less: unamortized discount | $ (36) | |
Total | 7,643 | |
Line of Credit | ||
Debt Instrument [Line Items] | ||
Principal | 7,143 | $ 8,571 |
Add: accreted liability for final payment fee | 448 | 430 |
Less: unamortized discount | (36) | (48) |
Total | $ 7,555 | $ 8,953 |
Notes Payable - Schedule of Fut
Notes Payable - Schedule of Future Maturities of Term Loans, Including Final Payment Fee (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Debt Disclosure [Abstract] | |
Remainder of 2023 (nine months) | $ 4,286 |
Year ending December 31, 2024 | 3,357 |
Debt instrument carrying amount including unaccreted liability for final payment fee | 7,555 |
Unaccreted balance for Final Payment fee on Term Loans | (52) |
Less: unamortized discount | (36) |
Total | 7,643 |
Less current portion | (5,714) |
Noncurrent portion | $ 1,841 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Lessee, Lease, Description [Line Items] | ||
Operating Lease, Expense | $ 0.1 | $ 0.1 |
Office Space | ||
Lessee, Lease, Description [Line Items] | ||
Lease expiration year | 2027 | |
Lease expired date | 2023-02 | |
Laboratory Space | ||
Lessee, Lease, Description [Line Items] | ||
Lease expiration year | 2025 |
Leases - Summary of Additional
Leases - Summary of Additional Information Related to Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Assets and Liabilities, Lessee [Abstract] | ||
Right-of-use assets | $ 1,114 | $ 1,191 |
Lease liabilities, current | 404 | 408 |
Lease liabilities, non-current | 719 | $ 824 |
Total lease liabilities | $ 1,123 | |
Other information | ||
Weighted average remaining lease term | 2 years 10 months 20 days | |
Weighted average discount rate | 8.25% | |
Supplemental cash flow information | ||
Operating cash flows from operating leases | $ 167 | |
Right-of-use assets obtained in exchange for lease obligations | $ 0 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Lessee, Operating Lease, Liability, to be Paid [Abstract] | |
2023 (remaining nine months) | $ 360 |
2024 | 492 |
2025 | 219 |
2026 | 169 |
2027 | 28 |
Total undiscounted lease payments | 1,268 |
Less: imputed interest | 145 |
Total lease liabilities | $ 1,123 |
Partnerships - Additional Infor
Partnerships - Additional Information (Details) ¥ in Billions | 1 Months Ended | 3 Months Ended | 31 Months Ended | |||||
Dec. 31, 2022 USD ($) | May 31, 2017 USD ($) | Mar. 31, 2023 USD ($) | Nov. 30, 2019 shares | Mar. 16, 2023 USD ($) | Mar. 16, 2023 JPY (¥) | Dec. 05, 2022 USD ($) | Dec. 05, 2022 JPY (¥) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Deferred revenue current | $ 14,700,000 | $ 14,767,000 | ||||||
Deferred revenue long term | 10,378,000 | 7,941,000 | ||||||
Recognized revenue | 8,879,000 | |||||||
Ono | Asset Purchase Agreement | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
One-time payment receivable, upon exercises the option | $ 37,200,000 | ¥ 5 | ||||||
Upfront non-refundable and non-creditable payment receivable, upon exchange of option | $ 26,400,000 | ¥ 3.5 | ||||||
Foreign curreny realized gain | 600,000 | |||||||
Upfront payment received | $ 26,400,000 | |||||||
Upfront non-refundable and non-creditable payment invoiced | 25,800,000 | ¥ 3.5 | ||||||
Upfront and non-creditable payment invoiced | 25,800,000 | |||||||
Estimated research and development funding | 76,800,000 | |||||||
Initial transaction price | 102,600,000 | |||||||
Deferred revenue | 22,700,000 | $ 25,800,000 | ||||||
Deferred revenue current | 14,800,000 | |||||||
Deferred revenue long term | 7,900,000 | |||||||
Proceeds from research and development fees | 18,100,000 | |||||||
Recognized revenue | $ 8,900,000 | |||||||
Option period expiry condition | the option period will expire three months following the delivery of topline data from the EQUALISE clinical study in lupus nephritis and interim data from the EQUATOR Phase 3 clinical study in acute graft-versus-host disease. | |||||||
Ono | Asset Purchase Agreement | Maximum | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Eligible to receive payment on achievement of certain development milestones | $ 101,400,000 | |||||||
Biocon | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Common stock shares issued | shares | 2,316,134 | |||||||
Biocon | Collaboration and License Agreement | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Regulatory milestone payments | $ 30,000,000 | |||||||
Sales milestone payments | $ 565,000,000 | |||||||
Research and Development Services | Ono | Asset Purchase Agreement | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Recognized revenue | $ 6,700,000 | |||||||
Upfront Payment Amortization | Ono | Asset Purchase Agreement | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Recognized revenue | $ 2,200,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | ||
Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock, shares authorized | 200,000,000 | 200,000,000 | |
Common stock, par value | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized | 10,000,000 | ||
Preferred stock, par value | $ 0.0001 | ||
Common stock, shares outstanding | 34,414,149 | 34,414,149 | 34,414,149 |
Unamortized stock compensation for stock options | $ 7.2 | ||
Weighted-average recognition period of stock option unamortized | 3 years 1 month 6 days |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Details) - Stock Options $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of Outstanding Options, Beginning Balance | shares | 5,102,501 |
Number of Outstanding Options, Granted | shares | 2,034,500 |
Number of Outstanding Options, Exercised | shares | 0 |
Number of Outstanding Options, Forfeitures and Cancellations | shares | (41,226) |
Number of Outstanding Options, Ending Balance | shares | 7,095,775 |
Number of Outstanding Options, Exercisable | shares | 3,035,253 |
Weighted- Average Exercise Price Per Share, Beginning Balance | $ / shares | $ 4.11 |
Weighted- Average Exercise Price Per Share, Granted | $ / shares | 1.05 |
Weighted- Average Exercise Price Per Share, Exercised | $ / shares | |
Weighted- Average Exercise Price Per Share, Forfeitures and Cancellations | $ / shares | 5.85 |
Weighted- Average Exercise Price Per Share, Ending Balance | $ / shares | 3.23 |
Weighted- Average Exercise Price Per Share, Exercisable | $ / shares | $ 4.15 |
Weighted Average Remaining Contractual Term, Options Outstanding | 8 years 2 months 1 day |
Weighted Average Remaining Contractual Term, Options Exercisable | 6 years 11 months 12 days |
Aggregate Intrinsic Value, Options Outstanding | $ | $ 1 |
Aggregate Intrinsic Value, Options Exercisable | $ | $ 0 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock Option Activity (Parenthetical) (Details) | Mar. 31, 2023 $ / shares |
Stock Options | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Closing stock price per share | $ 0.73 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Total Non-cash Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total non-cash stock-based compensation expense | $ 1,038 | $ 1,298 |
Research and Development Expense | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total non-cash stock-based compensation expense | 628 | 544 |
General and Administrative Expense | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total non-cash stock-based compensation expense | $ 410 | $ 754 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Details) - shares | Mar. 31, 2023 | Dec. 31, 2022 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total common stock reserved for future issuance | 10,242,918 | 8,178,936 |
Stock Options Issued and Outstanding | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total common stock reserved for future issuance | 7,095,775 | 5,102,501 |
Warrants for Common Stock | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total common stock reserved for future issuance | 1,366,141 | 1,366,141 |
Awards Available Under 2018 Equity Incentive Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total common stock reserved for future issuance | 511,764 | 784,331 |
Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total common stock reserved for future issuance | 1,269,238 | 925,963 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense | $ 60,000 | $ 0 |
Effective tax rate | (1.60%) |