Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 12, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
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 | 34,352,084 | |
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 | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 23,808 | $ 50,366 |
Short-term investments | 33,754 | 30,345 |
Prepaid expenses and other current assets | 2,920 | 2,659 |
Total current assets | 60,482 | 83,370 |
Operating lease right-of-use assets | 1,418 | 1,645 |
Property and equipment, net | 451 | 237 |
Other assets | 121 | 153 |
Total assets | 62,472 | 85,405 |
Current liabilities: | ||
Accounts payable | 5,091 | 1,225 |
Accrued expenses | 5,377 | 5,886 |
Current portion of long-term notes payable | 4,286 | 1,428 |
Current portion of operating lease liabilities | 434 | 376 |
Total current liabilities | 15,188 | 8,915 |
Long-term notes payable | 5,992 | 8,750 |
Long-term operating lease liabilities | 1,025 | 1,235 |
Total liabilities | 22,205 | 18,900 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 34,352,084 and 29,455,668 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 3 | 2 |
Additional paid-in capital | 201,936 | 176,618 |
Accumulated other comprehensive loss | (149) | (138) |
Accumulated deficit | (161,523) | (109,977) |
Total stockholders' equity | 40,267 | 66,505 |
Total liabilities and stockholders' equity | $ 62,472 | $ 85,405 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
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 | 34,352,084 | 29,455,668 |
Common stock, shares outstanding | 34,352,084 | 29,455,668 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 9,488 | $ 5,985 | $ 20,251 | $ 11,865 |
Acquired in-process research and development | 23,049 | |||
General and administrative | 4,064 | 2,858 | 7,581 | 5,673 |
Total operating expenses | 13,552 | 8,843 | 50,881 | 17,538 |
Loss from operations | (13,552) | (8,843) | (50,881) | (17,538) |
Other expense, net: | ||||
Interest expense | (259) | (270) | (515) | (541) |
Interest income | 64 | 13 | 90 | 39 |
Other expense, net | (382) | (58) | (240) | (109) |
Total other expense, net | (577) | (315) | (665) | (611) |
Net loss | (14,129) | (9,158) | (51,546) | (18,149) |
Other comprehensive income (loss), net: | ||||
Unrealized loss on available-for-sale securities, net | (54) | (5) | (234) | (8) |
Foreign currency translation gain | 359 | 51 | 223 | 96 |
Total other comprehensive income (loss), net | 305 | 46 | (11) | 88 |
Comprehensive loss | $ (13,824) | $ (9,112) | $ (51,557) | $ (18,061) |
Net loss per share, basic | $ (0.41) | $ (0.31) | $ (1.56) | $ (0.64) |
Net loss per share, diluted | $ (0.41) | $ (0.31) | $ (1.56) | $ (0.64) |
Weighted-average number of common shares outstanding, basic | 34,292,642 | 29,076,562 | 33,085,917 | 28,205,805 |
Weighted-average number of common shares outstanding, diluted | 34,292,642 | 29,076,562 | 33,085,917 | 28,205,805 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Bioniz | Registered Direct Offerings | Common Stock | Common Stock Bioniz | Common Stock Registered Direct Offerings | Additional Paid-in Capital | Additional Paid-in Capital Bioniz | Additional Paid-in Capital Registered Direct Offerings | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Balance at Dec. 31, 2020 | $ 69,854 | $ 2 | $ 141,074 | $ (297) | $ (70,925) | ||||||
Balance, Shares at Dec. 31, 2020 | 24,753,102 | ||||||||||
Issuance of common stock under registered direct offering, net of offering costs | $ 29,909 | $ 29,909 | |||||||||
Issuance of common stock under registered direct offering, net of offering costs, Shares | 4,285,710 | ||||||||||
Exercise of stock options | 4 | 4 | |||||||||
Exercise of stock options, Shares | 1,458 | ||||||||||
Vesting of restricted stock liability | 18 | 18 | |||||||||
Stock-based compensation expense | 1,044 | 1,044 | |||||||||
Other comprehensive income (loss) | 42 | 42 | |||||||||
Net loss | (8,991) | (8,991) | |||||||||
Balance at Mar. 31, 2021 | 91,880 | $ 2 | 172,049 | (255) | (79,916) | ||||||
Balance, Shares at Mar. 31, 2021 | 29,040,270 | ||||||||||
Balance at Dec. 31, 2020 | 69,854 | $ 2 | 141,074 | (297) | (70,925) | ||||||
Balance, Shares at Dec. 31, 2020 | 24,753,102 | ||||||||||
Other comprehensive income (loss) | 88 | ||||||||||
Net loss | (18,149) | ||||||||||
Balance at Jun. 30, 2021 | 84,773 | $ 2 | 174,054 | (209) | (89,074) | ||||||
Balance, Shares at Jun. 30, 2021 | 29,382,806 | ||||||||||
Balance at Mar. 31, 2021 | 91,880 | $ 2 | 172,049 | (255) | (79,916) | ||||||
Balance, Shares at Mar. 31, 2021 | 29,040,270 | ||||||||||
Issuance of common stock under employee stock purchase plan | 127 | 127 | |||||||||
Issuance of common stock under employee stock purchase plan, Shares | 48,966 | ||||||||||
Exercise of stock options | 796 | 796 | |||||||||
Exercise of stock options, Shares | 293,570 | ||||||||||
Vesting of restricted stock liability | 18 | 18 | |||||||||
Stock-based compensation expense | 1,064 | 1,064 | |||||||||
Other comprehensive income (loss) | 46 | 46 | |||||||||
Net loss | (9,158) | (9,158) | |||||||||
Balance at Jun. 30, 2021 | 84,773 | $ 2 | 174,054 | (209) | (89,074) | ||||||
Balance, Shares at Jun. 30, 2021 | 29,382,806 | ||||||||||
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 Bioniz acquisition | $ 22,542 | $ 1 | $ 22,541 | ||||||||
Issuance of common stock, Bioniz acquisition | 4,820,230 | ||||||||||
Vesting of restricted stock liability | 18 | 18 | |||||||||
Stock-based compensation expense | 1,298 | 1,298 | |||||||||
Other 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, 2021 | 66,505 | $ 2 | 176,618 | (138) | (109,977) | ||||||
Balance, Shares at Dec. 31, 2021 | 29,455,668 | ||||||||||
Other comprehensive income (loss) | (11) | ||||||||||
Net loss | (51,546) | ||||||||||
Balance at Jun. 30, 2022 | 40,267 | $ 3 | 201,936 | (149) | (161,523) | ||||||
Balance, Shares at Jun. 30, 2022 | 34,352,084 | ||||||||||
Balance at Mar. 31, 2022 | 52,630 | $ 3 | 200,475 | (454) | (147,394) | ||||||
Balance, Shares at Mar. 31, 2022 | 34,275,898 | ||||||||||
Issuance of common stock under employee stock purchase plan | 141 | 141 | |||||||||
Issuance of common stock under employee stock purchase plan, Shares | 76,186 | ||||||||||
Vesting of restricted stock liability | 18 | 18 | |||||||||
Stock-based compensation expense | 1,302 | 1,302 | |||||||||
Other comprehensive income (loss) | 305 | 305 | |||||||||
Net loss | (14,129) | (14,129) | |||||||||
Balance at Jun. 30, 2022 | $ 40,267 | $ 3 | $ 201,936 | $ (149) | $ (161,523) | ||||||
Balance, Shares at Jun. 30, 2022 | 34,352,084 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating activities: | ||
Net loss | $ (51,546) | $ (18,149) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Acquired in-process research and development | 23,049 | |
Depreciation and amortization | 56 | 34 |
Stock-based compensation | 2,600 | 2,108 |
Net unrealized loss on foreign currency transactions | 245 | 107 |
Amortization of term loan discount and issuance costs | 100 | 126 |
Amortization/accretion of investments, net | 73 | 205 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (220) | 1,252 |
Accounts payable | 3,623 | (971) |
Accrued expenses | (1,447) | 350 |
Right-of-use assets and lease liabilities, net | 74 | |
Net cash used in operating activities | (23,393) | (14,938) |
Investing activities: | ||
Purchases of property and equipment | (277) | (23) |
Purchases of short-term investments | (14,962) | (7,605) |
Maturities of short-term investments | 11,245 | 41,455 |
Net cash (used in) provided by investing activities | (3,294) | 33,827 |
Financing activities: | ||
Proceeds from registered direct offering, net of offering costs | 29,909 | |
Proceeds from exercises of stock options | 626 | |
Proceeds from employee stock purchase plan purchases | 141 | 127 |
Net cash provided by financing activities | 141 | 30,662 |
Effect of exchange rate changes on cash and cash equivalents | (12) | (8) |
Net (decrease) increase in cash and cash equivalents | (26,558) | 49,543 |
Cash and cash equivalents at beginning of period | 50,366 | 23,982 |
Cash and cash equivalents at end of period | 23,808 | 73,525 |
Supplemental cash flow information: | ||
Unsettled stock option exercises | 174 | |
Property and equipment in accounts payable | $ 25 | |
Bioniz | ||
Investing activities: | ||
Cash acquired in Bioniz acquisition | 700 | |
Supplemental cash flow information: | ||
Fair value of Bioniz assets acquired | 23,049 | |
Issuance of common stock for Bioniz acquisition | (22,542) | |
Bioniz net liabilities assumed | $ 507 |
Organization and Accounting Pro
Organization and Accounting Pronouncements | 6 Months Ended |
Jun. 30, 2022 | |
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 deep understanding of immunology to develop novel products 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 June 30, 2022, 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 initial product candidate, itolizumab (EQ001), conducting business development activities such as the acquisition of Bioniz Therapeutics, Inc., (Bioniz) in February 2022, and the general and administrative activities associated with operating a public company. In addition, the Company has not generated revenues from its principal operations, and the sales and income potential of its business is unproven. Liquidity and Business Risks As of June 30, 2022, the Company had $ 57.6 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. 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 ongoing COVID-19 pandemic and actions taken to slow its spread, and more recently with the conflict in Ukraine, the global credit and financial markets have experienced extreme volatility, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates 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 June 30, 2022, together with proceeds that could be generated at the Company's sole discretion from its existing, committed equity line with Lincoln Park Capital Fund, LLC (Lincoln Park), 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). The COVID-19 outbreak in the United States and the rest of the world has caused disruptions to the Company’s business, which may delay results of the Company’s clinical trials and adversely impact the Company’s business. The Company cannot predict how legal and regulatory responses to concerns about COVID-19 or other major public health issues will impact the Company’s business, nor can it predict potential adverse impacts related to the availability of capital to fund the Company’s operations. Additionally, the Company’s workforce and outside consultants may also be affected, which could result in an adverse impact on the Company’s ability to conduct business. Any of these factors, alone or in combination with others, could harm the Company’s business, results of operations, financial condition or liquidity. However, the magnitude, timing, and duration of any such potential financial impacts cannot be reasonably estimated at this time. 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, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 23, 2022. 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 loss 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. Realized and unrealized gains and losses denominated in foreign currencies are recorded in operating expenses in the Company’s condensed consolidated statements of operations. For the three and six months ended June 30, 2022, net unrealized losses totaled $ 0.4 million and $ 0.2 million, respectively. For each of the three and six months ended June 30, 2021, net unrealized losses totaled $ 0.1 million. There were no material realized gains or losses for all periods presented. Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments , which will require a reporting entity to use a new forward-looking impairment model for most financial assets that generally will result in the earlier recognition of allowances for losses. The ASU, along with related amendments, revised the measurement of credit losses for financial assets measured at amortized cost from an incurred loss to an expected loss methodology. The ASU affected receivables, debt securities, net investment in leases, and most other financial assets that represent a right to receive cash. The standard and other related subsequently issued ASUs will be effective for the Company for annual periods beginning after December 15, 2022, with early adoption permitted. The Company is currently evaluating the impact that the adoption of the standard and other related subsequently issued ASUs will have on its consolidated financial statements and accompanying footnotes. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
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 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 gains and losses. Other comprehensive income (loss), net includes unrealized losses or gains on short-term investments as well as foreign currency translation losses or gains. 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. 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. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets primarily represent amounts related to director and officer insurance, preclinical research and clinical trial agreements, equity issuance costs and an estimated tax refund from the Australian Tax Office for eligible research and development expenditures. 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 Company 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 condensed 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. 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): Six Months Ended 2022 2021 Common stock options 5,303,825 3,839,951 Common stock warrants 1,366,141 1,366,141 Total 6,669,966 5,206,092 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, for Identical Observable Inputs 2022 Assets (Level 1) Inputs (Level 2) (Level 3) Short-term investments: U.S. treasury securities $ 32,779 $ 32,779 $ - $ - Certificates of deposit 975 975 - - Total $ 33,754 $ 33,754 $ - $ - Fair Value Measurements Using Quoted Prices in Significant Significant Active Markets Other Unobservable December 31, for Identical Observable Inputs 2021 Assets (Level 1) Inputs (Level 2) (Level 3) Short-term investments: U.S. treasury securities $ 29,121 $ 29,121 $ - $ - Certificates of deposit 1,224 1,224 - - Total $ 30,345 $ 30,345 $ - $ - 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, 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 $ 10.3 million and $ 10.2 million at each of June 30, 2022 and December 31, 2021, 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. At June 30, 2022 and December 31, 2021, the Company had investments in money market funds of $ 16.8 million and $ 45.1 million, respectively, that were measured at fair value using the net asset value per share (or its equivalent) that have not been classified in the fair value hierarchy. The funds invest primarily in U.S. government securities. 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 June 30, 2022 or December 31, 2021. |
Certain Financial Statement Cap
Certain Financial Statement Caption Information | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 U.S. treasury securities 1 or less $ 33,060 $ - $ ( 281 ) $ 32,779 Certificates of deposit 1 or less 980 - ( 5 ) 975 Total $ 34,040 $ - $ ( 286 ) $ 33,754 December 31, 2021 U.S. treasury securities 1 or less $ 17,122 $ - $ ( 7 ) $ 17,115 U.S. treasury securities > 1 and < 5 12,049 - ( 43 ) 12,006 Certificates of deposit 1 or less 1,226 - ( 2 ) 1,224 Total $ 30,397 $ - $ ( 52 ) $ 30,345 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): June 30, December 31, 2022 2021 Accrued payroll and other employee benefits $ 1,887 $ 2,511 Clinical studies 2,835 2,627 Other accruals 252 245 Preclinical studies 334 432 Accrued interest 69 71 Total accrued expenses $ 5,377 $ 5,886 |
Acquisition
Acquisition | 6 Months Ended |
Jun. 30, 2022 | |
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) valued at $ 22.5 million, based on the average share price on the date of close of $ 3.96 , 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 the 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, 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 six months ended June 30, 2022. No transaction costs were included for the three months ended June 30, 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 | 6 Months Ended |
Jun. 30, 2022 | |
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 extends the interest-only payments through September 30, 2022, followed by 24 equal monthly principal payments and interest. In February 2022, the Company entered into another amendment to the Loan Agreement which added Bioniz Therapeutics, Inc. as a secured party to the loan. Under authoritative guidance, the April 2021 amendment does 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 are not substantially different. Accordingly, the April 2021 amendment is 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 is 10.58 %. 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): June 30, December 31, 2022 2021 Principal $ 10,000 $ 10,000 Add: accreted liability for Final Payment fee 369 310 Less: unamortized discount ( 91 ) ( 132 ) Total $ 10,278 $ 10,178 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 June 30, 2022, 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 June 30, 2022 are as follows (in thousands): June 30, 2022 Remainder of 2022 $ 1,429 Year ending December 31, 2023 5,714 Year ending December 31, 2024 3,357 10,500 Unaccreted balance for Final Payment fee on Term Loans ( 131 ) Unamortized discounts ( 91 ) 10,278 Less current portion ( 4,286 ) Noncurrent portion $ 5,992 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | 7. Leases The Company’s leases relate primarily to office facilities that expire on various dates from 2023 through 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 $ 0.2 million and $ 0.3 million for the three and six months ended June 30, 2022, respectively. Operating lease expense, including expenses related to short-term leases, was $ 0.1 million for both the three and six months ended June 30, 2021, respectively. 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 six months ended June 30, 2022, is as follows (in thousands, except lease term and discount rate): June 30, 2022 Balance sheet information ROU assets $ 1,418 Lease liabilities, current $ 434 Lease liabilities, non-current 1,025 Total lease liabilities $ 1,459 Other information Weighted average remaining lease term 3.44 Weighted average discount rate 8.25 % Supplemental cash flow information Operating cash flows from operating leases $ 183 ROU assets obtained in exchange for lease obligations $ — Maturities of lease liabilities as of June 30, 2022 were as follows (in thousands): Remainder of 2022 $ 283 Year ending December 31, 2023 494 Year ending December 31, 2024 492 Year ending December 31, 2025 219 Year ending December 31, 2026 169 Year ending December 31, 2027 28 Total undiscounted lease payments 1,685 Less: imputed interest ( 226 ) Total lease liabilities $ 1,459 As of June 30, 2022, the Company does not have any leases that have not yet commenced that create significant rights and obligations. |
Collaboration and License Agree
Collaboration and License Agreement | 6 Months Ended |
Jun. 30, 2022 | |
Collaboration And License Agreement [Abstract] | |
Collaboration and License Agreement | 8. 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, and April 2021), clinical supply agreement, investor rights agreement, and common stock purchase agreement (collectively License Agreements) with Biocon SA (together with Biocon Limited, 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 Company Territory). However, unless the Company achieves certain regulatory and development milestones within a specific time period, the licensed rights, other than development rights, are limited to the fields of orphan indications and the treatment of conditions related to asthma and lupus. 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 Company 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 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 Company Territory if the approvals in such geographies included or referenced the Company’s data including data from certain of the Company’s clinical trials, subject to adjustments in certain circumstances. 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 June 30, 2022, the Company has not made or received payments in connection with the milestones or royalties within the agreement. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity | 9. Stockholders’ Equity As of June 30, 2022 , 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 34,352,084 and 29,455,668 shares of common stock outstanding as of June 30, 2022 and December 31, 2021, respectively. Registered Direct Offering and related warrants On February 3, 2021, the Company entered into a securities purchase agreement (the Securities Purchase Agreement) with two institutional investors (the Purchasers), relating to the issuance and sale (the Offering) of an aggregate of 4,285,710 shares of common stock and warrants to purchase 1,285,713 shares of common stock (the Warrants) for aggregate gross proceeds to the Company from this Offering of approximately $ 30.0 million, excluding any proceeds the Company may receive upon exercise of the Warrants. No underwriter or placement agent participated in the Offering. The proceeds, net of related issuance costs, were $ 29.9 million. The Warrants are exercisable immediately upon issuance at an initial exercise price of $ 14.00 per share and are exercisable on a cashless basis. The Warrants expire on the earlier of (i) the fifth anniversary of issuance or (ii) the 15 th calendar date following the date on which the Company closes upon an equity financing that results in not less than $ 25 million of gross proceeds to the Company at a price per share of common stock equal to or greater than $ 25.00 , at which time, all remaining Warrants will automatically be exercised on a cashless basis. The exercise price and the number of shares of common stock purchasable upon the exercise of the Warrants are subject to adjustment upon the occurrence of specific events, including stock dividends, stock splits, reclassifications and combinations of the Company’s common stock. All of the warrants are recorded within equity in accordance with authoritative accounting guidance. Pursuant to the terms of the Securities Purchase Agreement, the Company appointed Dr. Yu (Katherine) Xu, Ph.D. to the Board as a nominee of the Purchasers. At-the-Market Offering Program On July 14, 2020, the Company entered into an "at the market" (ATM) equity offering program (2020 ATM Facility) with Jefferies LLC (Jefferies) under which the Company may offer and sell shares of the Company’s common stock having an aggregate price of up to $ 150 million, from time to time, through Jefferies acting as our sales agent. During the three and six months ended June 30, 2022, there was no activity under the 2020 ATM Facility. As of June 30, 2022, the Company sold an aggregate of 788,685 shares of common stock under the 2020 ATM Facility and received gross proceeds of $ 10.4 million. The Company paid commissions on the gross proceeds, plus reimbursement of expenses to Jefferies and other issuance costs in the aggregate amount of approximately $ 0.4 million, resulting in net proceeds of $ 10.0 million. Since June 30, 2022 and through the date of the filing of this Quarterly Report on Form 10-Q, there have been no additional sales of the Company’s stock under the 2020 ATM Facility. Purchase Agreement On March 27, 2020, the Company entered into a purchase agreement (Purchase Agreement), with Lincoln Park, which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company may sell to Lincoln Park up to $ 15.0 million of shares of its common stock from time to time over the 36-month term of the Purchase Agreement. Upon execution of the Purchase Agreement, the Company issued 65,374 shares of its common stock to Lincoln Park as commitment shares in accordance with the closing conditions contained within the Purchase Agreement. The commitment shares were valued using the closing price of the Company’s common stock on the effective date of the Purchase Agreement resulting in a fair market value of approximately $ 0.2 million. The fair market value of the commitment shares as well as other issuance costs associated with the Purchase Agreement totaled $ 0.4 million. These issuance costs are classified as prepaid expenses and other current assets in the accompanying condensed consolidated balance sheet. As shares of common stock are sold to Lincoln Park in accordance with the Purchase Agreement, the issuance costs, including the fair value of the commitment shares, will be reclassified to additional paid-in capital on the Company’s condensed consolidated balance sheet. There have been no sales of the Company’s stock under this Purchase Agreement as of June 30, 2022 and through the date of the filing of this Quarterly Report on Form 10-Q. Stock Options The following table summarizes stock option activity during the six months ended June 30, 2022: Shares Weighted- Weighted Aggregate Options outstanding at December 31, 2021 3,947,025 $ 4.58 Granted 2,094,800 $ 3.67 Exercised - $ - Forfeitures and cancellations ( 738,000 ) $ 5.04 Options outstanding at June 30, 2022 5,303,825 $ 4.16 8.30 $ - Options exercisable at June 30, 2022 2,048,297 $ 4.20 6.62 $ - (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 June 30, 2022 of $ 2.04 and the price of the underlying options. At June 30, 2022, unamortized stock compensation for stock options was $ 9.7 million, with a weighted-average recognition period of 2.8 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 Six Months Ended 2022 2021 2022 2021 Research and development $ 397 $ 462 $ 942 $ 936 General and administrative 905 602 1,658 1,172 Total $ 1,302 $ 1,064 $ 2,600 $ 2,108 Common Stock Reserved for Future Issuance Common stock reserved for future issuance at June 30, 2022 is as follows: June 30, December 31, 2022 2021 Stock options issued and outstanding 5,303,825 3,947,025 Warrants for common stock 1,366,141 1,366,141 Awards available under the 2018 Equity Incentive Plan 583,007 467,024 Employee stock purchase plan 988,028 769,658 Total 8,241,001 6,549,848 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments , which will require a reporting entity to use a new forward-looking impairment model for most financial assets that generally will result in the earlier recognition of allowances for losses. The ASU, along with related amendments, revised the measurement of credit losses for financial assets measured at amortized cost from an incurred loss to an expected loss methodology. The ASU affected receivables, debt securities, net investment in leases, and most other financial assets that represent a right to receive cash. The standard and other related subsequently issued ASUs will be effective for the Company for annual periods beginning after December 15, 2022, with early adoption permitted. The Company is currently evaluating the impact that the adoption of the standard and other related subsequently issued ASUs will have on its consolidated financial statements and accompanying footnotes. |
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 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 gains and losses. Other comprehensive income (loss), net includes unrealized losses or gains on short-term investments as well as foreign currency translation losses or gains. |
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. |
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. |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets primarily represent amounts related to director and officer insurance, preclinical research and clinical trial agreements, equity issuance costs and an estimated tax refund from the Australian Tax Office for eligible research and development expenditures. |
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 Company 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 condensed 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. 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): Six Months Ended 2022 2021 Common stock options 5,303,825 3,839,951 Common stock warrants 1,366,141 1,366,141 Total 6,669,966 5,206,092 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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): Six Months Ended 2022 2021 Common stock options 5,303,825 3,839,951 Common stock warrants 1,366,141 1,366,141 Total 6,669,966 5,206,092 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, for Identical Observable Inputs 2022 Assets (Level 1) Inputs (Level 2) (Level 3) Short-term investments: U.S. treasury securities $ 32,779 $ 32,779 $ - $ - Certificates of deposit 975 975 - - Total $ 33,754 $ 33,754 $ - $ - Fair Value Measurements Using Quoted Prices in Significant Significant Active Markets Other Unobservable December 31, for Identical Observable Inputs 2021 Assets (Level 1) Inputs (Level 2) (Level 3) Short-term investments: U.S. treasury securities $ 29,121 $ 29,121 $ - $ - Certificates of deposit 1,224 1,224 - - Total $ 30,345 $ 30,345 $ - $ - |
Certain Financial Statement C_2
Certain Financial Statement Caption Information (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 U.S. treasury securities 1 or less $ 33,060 $ - $ ( 281 ) $ 32,779 Certificates of deposit 1 or less 980 - ( 5 ) 975 Total $ 34,040 $ - $ ( 286 ) $ 33,754 December 31, 2021 U.S. treasury securities 1 or less $ 17,122 $ - $ ( 7 ) $ 17,115 U.S. treasury securities > 1 and < 5 12,049 - ( 43 ) 12,006 Certificates of deposit 1 or less 1,226 - ( 2 ) 1,224 Total $ 30,397 $ - $ ( 52 ) $ 30,345 |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): June 30, December 31, 2022 2021 Accrued payroll and other employee benefits $ 1,887 $ 2,511 Clinical studies 2,835 2,627 Other accruals 252 245 Preclinical studies 334 432 Accrued interest 69 71 Total accrued expenses $ 5,377 $ 5,886 |
Acquisition (Tables)
Acquisition (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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) | 6 Months Ended |
Jun. 30, 2022 | |
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): June 30, December 31, 2022 2021 Principal $ 10,000 $ 10,000 Add: accreted liability for Final Payment fee 369 310 Less: unamortized discount ( 91 ) ( 132 ) Total $ 10,278 $ 10,178 |
Schedule Future Maturities of Term Loans, Including Final Payment Fee | Future maturities of the Term Loans, including the Final Payment fee, as of June 30, 2022 are as follows (in thousands): June 30, 2022 Remainder of 2022 $ 1,429 Year ending December 31, 2023 5,714 Year ending December 31, 2024 3,357 10,500 Unaccreted balance for Final Payment fee on Term Loans ( 131 ) Unamortized discounts ( 91 ) 10,278 Less current portion ( 4,286 ) Noncurrent portion $ 5,992 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Summary of Additional Information Related to Leases | Additional information related to the Company’s leases as of and for the six months ended June 30, 2022, is as follows (in thousands, except lease term and discount rate): June 30, 2022 Balance sheet information ROU assets $ 1,418 Lease liabilities, current $ 434 Lease liabilities, non-current 1,025 Total lease liabilities $ 1,459 Other information Weighted average remaining lease term 3.44 Weighted average discount rate 8.25 % Supplemental cash flow information Operating cash flows from operating leases $ 183 ROU assets obtained in exchange for lease obligations $ — |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities as of June 30, 2022 were as follows (in thousands): Remainder of 2022 $ 283 Year ending December 31, 2023 494 Year ending December 31, 2024 492 Year ending December 31, 2025 219 Year ending December 31, 2026 169 Year ending December 31, 2027 28 Total undiscounted lease payments 1,685 Less: imputed interest ( 226 ) Total lease liabilities $ 1,459 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity during the six months ended June 30, 2022: Shares Weighted- Weighted Aggregate Options outstanding at December 31, 2021 3,947,025 $ 4.58 Granted 2,094,800 $ 3.67 Exercised - $ - Forfeitures and cancellations ( 738,000 ) $ 5.04 Options outstanding at June 30, 2022 5,303,825 $ 4.16 8.30 $ - Options exercisable at June 30, 2022 2,048,297 $ 4.20 6.62 $ - |
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 Six Months Ended 2022 2021 2022 2021 Research and development $ 397 $ 462 $ 942 $ 936 General and administrative 905 602 1,658 1,172 Total $ 1,302 $ 1,064 $ 2,600 $ 2,108 |
Summary of Reserved Shares of Common Stock for Future Issuance | Common stock reserved for future issuance at June 30, 2022 is as follows: June 30, December 31, 2022 2021 Stock options issued and outstanding 5,303,825 3,947,025 Warrants for common stock 1,366,141 1,366,141 Awards available under the 2018 Equity Incentive Plan 583,007 467,024 Employee stock purchase plan 988,028 769,658 Total 8,241,001 6,549,848 |
Organization and Accounting P_2
Organization and Accounting Pronouncements - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
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 | $ 57,600 | $ 57,600 | ||
Foreign currency transaction net unrealized losses | $ 400 | $ 100 | $ 245 | $ 107 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2022 AUD ($) | |
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 | $ 20,000,000 |
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 | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities not included in calculation of diluted net loss per share | 6,669,966 | 5,206,092 |
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 | 5,303,825 | 3,839,951 |
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 | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | $ 33,754 | $ 30,345 |
U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 32,779 | 29,121 |
Certificates of Deposit | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 975 | 1,224 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 33,754 | 30,345 |
Level 1 | U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 32,779 | 29,121 |
Level 1 | Certificates of Deposit | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | $ 975 | $ 1,224 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Additional Information (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Carrying amount of notes payable | $ 10,300,000 | $ 10,200,000 |
Financial liabilities | 0 | 0 |
Fair Value Measured Using Net Asset Value | Money Market Funds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Investments in money market funds | $ 16,800,000 | $ 45,100,000 |
Certain Financial Statement C_3
Certain Financial Statement Caption Information - Schedule of Company's Short-Term Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 34,040 | $ 30,397 |
Unrealized losses | (286) | (52) |
Short-term investments | 33,754 | 30,345 |
U.S. Treasury Securities Maturing in One Year or Less | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 33,060 | 17,122 |
Unrealized losses | (281) | (7) |
Short-term investments | $ 32,779 | $ 17,115 |
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 |
U.S. Treasury Securities Maturing between One and Five years | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 12,049 | |
Unrealized losses | (43) | |
Short-term investments | $ 12,006 | |
U.S. Treasury Securities Maturing between One and Five years | Minimum | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 year | |
U.S. Treasury Securities Maturing between One and Five years | Maximum | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 5 years | |
Certificates of Deposit Maturing in One Year or Less | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 980 | $ 1,226 |
Unrealized losses | (5) | (2) |
Short-term investments | $ 975 | $ 1,224 |
Certificates of Deposit Maturing in One Year or Less | Maximum | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 year |
Certain Financial Statement C_4
Certain Financial Statement Caption Information - Additional information (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
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 | Jun. 30, 2022 | Dec. 31, 2021 |
Accrued Liabilities, Current [Abstract] | ||
Accrued payroll and other employee benefits | $ 1,887 | $ 2,511 |
Clinical studies | 2,835 | 2,627 |
Other accruals | 252 | 245 |
Preclinical studies | 334 | 432 |
Accrued interest | 69 | 71 |
Total accrued expenses | $ 5,377 | $ 5,886 |
Acquisition - Additional Inform
Acquisition - Additional Information (Details) - Bioniz - USD ($) | 3 Months Ended | 6 Months Ended | |
Feb. 14, 2022 | Jun. 30, 2022 | Jun. 30, 2022 | |
Business Acquisition [Line Items] | |||
Business acquisition, common stock shares issued | 4,820,230 | ||
Common stock value | $ 22,500,000 | $ 22,542,000 | $ 22,542,000 |
Average share price | $ 3.96 | ||
Business acquisition, term for finalization after the closing | 18 months | ||
Transaction costs | $ 0 | $ 400,000 | |
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 | $ 57,500,000 | ||
Achievement of Commercialization Events | |||
Business Acquisition [Line Items] | |||
Contingent payments | $ 250,000,000 | ||
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) - USD ($) $ in Thousands | Jun. 30, 2022 | Feb. 14, 2022 |
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 | |
Acquired in-process research and development | 23,049 | |
Bioniz | ||
Liabilities assumed: | ||
Issuance of common stock for Bioniz acquisition | $ 22,542 | $ 22,500 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | ||
May 31, 2021 Installment | Sep. 30, 2019 USD ($) Installment $ / shares shares | Jun. 30, 2022 | 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, interest rate, stated percentage | 8.25% | |||
Debt instrument, basis spread on variable rate | 3% | |||
Loan Agreement | ||||
Short Term Debt [Line Items] | ||||
Borrowing capacity under loan agreement | $ | $ 10 | |||
Line of credit facility frequency of payments principal and interest | Installment | 24 | |||
Debt instrument, frequency of periodic payment | monthly | |||
Debt instrument, interest rate, effective percentage | 10.58% | |||
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 | Installment | 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 | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Less: unamortized discount | $ (91) | |
Total | 10,278 | |
Line of Credit | ||
Debt Instrument [Line Items] | ||
Principal | 10,000 | $ 10,000 |
Add: accreted liability for Final Payment fee | 369 | 310 |
Less: unamortized discount | (91) | (132) |
Total | $ 10,278 | $ 10,178 |
Notes Payable - Schedule of Fut
Notes Payable - Schedule of Future Maturities of Term Loans, Including Final Payment Fee (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Debt Disclosure [Abstract] | |
Remainder of 2022 | $ 1,429 |
Year ending December 31, 2023 | 5,714 |
Year ending December 31, 2024 | 3,357 |
Debt instrument carrying amount including unaccreted liability for final payment fee | 10,500 |
Unaccreted balance for Final Payment fee on Term Loans | (131) |
Less: unamortized discount | (91) |
Total | 10,278 |
Less current portion | (4,286) |
Noncurrent portion | $ 5,992 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Lessee, Lease, Description [Line Items] | ||||
Operating Lease, Expense | $ 0.2 | $ 0.1 | $ 0.3 | $ 0.1 |
Minimum | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease expiration year | 2023 | |||
Maximum | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease expiration year | 2027 |
Leases - Summary of Additional
Leases - Summary of Additional Information Related to Leases (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | |
Assets and Liabilities, Lessee [Abstract] | ||
ROU assets | $ 1,418 | $ 1,645 |
Lease liabilities, current | 434 | 376 |
Lease liabilities, non-current | 1,025 | $ 1,235 |
Total lease liabilities | $ 1,459 | |
Other information | ||
Weighted average remaining lease term | 3 years 5 months 8 days | |
Weighted average discount rate | 8.25% | |
Supplemental cash flow information | ||
Operating cash flows from operating leases | $ 183 | |
ROU asset obtained in exchange for lease obligations | $ 0 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Lessee, Operating Lease, Liability, to be Paid [Abstract] | |
Remainder of 2022 | $ 283 |
Year ending December 31, 2023 | 494 |
Year ending December 31, 2024 | 492 |
Year ending December 31, 2025 | 219 |
Year ending December 31, 2026 | 169 |
Year ending December 31, 2027 | 28 |
Total undiscounted lease payments | 1,685 |
Less: imputed interest | (226) |
Total lease liabilities | $ 1,459 |
Collaboration And License Agr_2
Collaboration And License Agreements - Additional Information (Details) - Biocon - USD ($) | 1 Months Ended | 31 Months Ended |
May 31, 2017 | Nov. 30, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Common stock shares issued | 2,316,134 | |
Collaboration and License Agreement | Maximum | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Regulatory milestone payments | $ 30,000,000 | |
Sales milestone payments | $ 565,000,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) $ / shares in Units, $ in Millions | 6 Months Ended | ||||
Feb. 03, 2021 USD ($) Investor $ / shares shares | Jul. 14, 2020 USD ($) | Mar. 27, 2020 USD ($) shares | Jun. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2021 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock, shares authorized | shares | 200,000,000 | 200,000,000 | |||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | |||
Preferred stock, shares authorized | shares | 10,000,000 | ||||
Preferred stock, par value | $ / shares | $ 0.0001 | ||||
Common stock, shares outstanding | shares | 34,352,084 | 29,455,668 | |||
Unamortized stock compensation for stock options | $ 9.7 | ||||
Weighted-average recognition period of stock option unamortized | 2 years 9 months 18 days | ||||
Equity Unit Purchase Agreements | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Number of Institutional Investors | Investor | 2 | ||||
Shares upon exercise of warrants | shares | 1,285,713 | ||||
Gross proceeds from issuance of common stock | $ 30 | ||||
Proceeds from issuance of common stock | $ 29.9 | ||||
Common Stock | Purchase Agreement | Lincoln Park | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Issuance of common stock, Shares | shares | 65,374 | 0 | |||
Stock issuance costs | $ 0.4 | ||||
Estimated maximum amount of common stock issuable | $ 15 | ||||
Term of purchase agreement | 36 months | ||||
Fair market value of commitment shares | $ 0.2 | ||||
Common Stock | Equity Unit Purchase Agreements | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Issuance of common stock, Shares | shares | 4,285,710 | ||||
Common Stock | 2020 ATM Facility | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Issuance of common stock, Shares | shares | 0 | ||||
Common Stock | 2020 ATM Facility | Open Market Sales Agreement | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Issuance of common stock, Shares | shares | 788,685 | ||||
Gross proceeds from issuance of common stock | $ 10.4 | ||||
Proceeds from issuance of common stock | 10 | ||||
Common stock shares maximum aggregate offering price | $ 150 | ||||
Stock issuance costs | $ 0.4 | ||||
Common Stock Warrants | Equity Unit Purchase Agreements | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Sale of stock, price per share | $ / shares | $ 25 | ||||
Gross proceeds from issuance of common stock | $ 25 | ||||
Warrants exercisable, per share exercise price | $ / shares | $ 14 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Details) - Stock Options $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of Shares Subject to Options outstanding, Beginning Balance | shares | 3,947,025 |
Number of Shares Subject to Options, Granted | shares | 2,094,800 |
Number of Shares Subject to Options, Exercised | shares | |
Number of Shares Subject to Options, Forfeitures and Cancellations | shares | (738,000) |
Number of Shares Subject to Options outstanding, Ending Balance | shares | 5,303,825 |
Number of Shares Subject to Options, Exercisable | shares | 2,048,297 |
Weighted- Average Exercise Price Per Share, Beginning Balance | $ / shares | $ 4.58 |
Weighted- Average Exercise Price Per Share, Granted | $ / shares | 3.67 |
Weighted- Average Exercise Price Per Share, Exercised | $ / shares | |
Weighted- Average Exercise Price Per Share, Forfeitures and Cancellations | $ / shares | 5.04 |
Weighted- Average Exercise Price Per Share, Ending Balance | $ / shares | 4.16 |
Weighted- Average Exercise Price Per Share, Exercisable | $ / shares | $ 4.20 |
Weighted Average Remaining Contractual Term, Options Outstanding | 8 years 3 months 18 days |
Weighted Average Remaining Contractual Term, Options Exercisable | 6 years 7 months 13 days |
Aggregate Intrinsic Value, Options Outstanding | $ | $ 0 |
Aggregate Intrinsic Value, Options Exercisable | $ | $ 0 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock Option Activity (Parenthetical) (Details) | Jun. 30, 2022 $ / shares |
Stock Options | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Closing stock price per share | $ 2.04 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Non-cash Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Non-cash stock-based compensation expense | $ 1,302 | $ 1,064 | $ 2,600 | $ 2,108 |
Research and Development Expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Non-cash stock-based compensation expense | 397 | 462 | 942 | 936 |
General and Administrative Expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Non-cash stock-based compensation expense | $ 905 | $ 602 | $ 1,658 | $ 1,172 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Details) - shares | Jun. 30, 2022 | Dec. 31, 2021 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total common stock reserved for future issuance | 8,241,001 | 6,549,848 |
Stock Options Issued and Outstanding | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total common stock reserved for future issuance | 5,303,825 | 3,947,025 |
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 | 583,007 | 467,024 |
Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total common stock reserved for future issuance | 988,028 | 769,658 |