Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 21, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-39452 | ||
Entity Registrant Name | INHIBRX, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 82-4257312 | ||
Entity Address, Address Line One | 11025 N. Torrey Pines Road | ||
Entity Address, Address Line Two | Suite 200 | ||
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 | 795-4220 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 | ||
Trading Symbol | INBX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 764.3 | ||
Entity Common Stock, Shares Outstanding (in shares) | 39,025,644 | ||
Documents Incorporated by Reference | The following documents (or parts thereof) are incorporated by reference into the following parts of this Form 10-K: Certain information required in Part III of this Annual Report on Form 10-K is incorporated from the Registrant’s Proxy Statement for the 2022 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission. | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001739614 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Audit Information [Abstract] | |
Auditor Firm ID | 243 |
Auditor Name | BDO USA, LLP |
Auditor Location | San Diego, California |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 131,301 | $ 128,664 |
Accounts receivable | 373 | 82 |
Receivables from related parties | 505 | 533 |
Prepaid expenses and other current assets | 6,933 | 2,893 |
Total current assets | 139,112 | 132,172 |
Property and equipment, net | 3,153 | 3,492 |
Right-of-use asset | 6,338 | 7,831 |
Other non-current assets | 1,847 | 245 |
Total assets | 150,450 | 143,740 |
Current liabilities: | ||
Accounts payable | 9,125 | 13,458 |
Accrued expenses | 9,621 | 13,357 |
Current portion of deferred revenue | 2,034 | 3,081 |
Current portion of lease liability | 1,674 | 1,503 |
Total current liabilities | 22,454 | 31,399 |
Long-term debt, net of current portion and including final payment fee | 70,470 | 29,244 |
Non-current portion of lease liability | 5,033 | 6,707 |
Non-current portion of deferred revenue | 110 | 737 |
Other non-current liabilities | 0 | 180 |
Total liabilities | 98,067 | 68,267 |
Commitments and contingencies (Note 11) | ||
Stockholders’ equity | ||
Preferred stock, $0.0001 par value, 15,000,000 shares authorized and no shares outstanding as of December 31, 2021 and 2020 | 0 | 0 |
Common stock, $0.0001 par value, 120,000,000 shares authorized as of December 31, 2021 and 2020; 38,991,307 and 37,712,390 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively | 4 | 4 |
Additional paid-in-capital | 279,526 | 220,848 |
Accumulated deficit | (227,147) | (145,379) |
Total stockholders’ equity | 52,383 | 75,473 |
Total liabilities, convertible preferred stock and stockholders’ equity | $ 150,450 | $ 143,740 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 15,000,000 | 15,000,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 |
Common stock, shares issued (in shares) | 38,991,307 | 37,712,390 |
Common stock, shares outstanding (in shares) | 38,991,307 | 37,712,390 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue: | ||
Total revenue | $ 7,231 | $ 12,888 |
Operating expenses: | ||
Research and development | 71,440 | 73,495 |
General and administrative | 12,355 | 6,836 |
Total operating expenses | 83,795 | 80,331 |
Loss from operations | (76,564) | (67,443) |
Other income (expense): | ||
Interest expense, net | (5,216) | (10,816) |
Other income (expense), net | 14 | (2) |
Change in fair value of warrant liabilities | 0 | (24) |
Change in fair value of derivative liabilities | 0 | 2,651 |
Total other expense | (5,202) | (8,191) |
Loss before provision for income taxes | (81,766) | (75,634) |
Provision for income taxes | 2 | 3 |
Loss from equity method investment | 0 | 487 |
Net loss | $ (81,768) | $ (76,124) |
Net loss per share, basic (in dollars per share) | $ (2.15) | $ (3.01) |
Net loss per share, diluted (in dollars per share) | $ (2.15) | $ (3.01) |
Weighted-average shares of common stock outstanding, basic (in shares) | 38,010,000 | 25,261,000 |
Weighted-average shares of common stock outstanding, diluted (in shares) | 38,010,000 | 25,261,000 |
License fee revenue | ||
Revenue: | ||
Total revenue | $ 7,125 | $ 12,808 |
Grant revenue | ||
Revenue: | ||
Total revenue | $ 106 | $ 80 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Deficit - USD ($) $ in Thousands | Total | IPO | Convertible Preferred Stock | 2019 and 2020 Notes | 2019 Convertible Note | 2020 Convertible Note | COMMON STOCK | COMMON STOCKIPO | COMMON STOCKConvertible Preferred Stock | COMMON STOCK2019 and 2020 Notes | Additional Paid-In Capital | Additional Paid-In CapitalIPO | Additional Paid-In CapitalConvertible Preferred Stock | Additional Paid-In Capital2019 and 2020 Notes | Additional Paid-In Capital2019 Convertible Note | Additional Paid-In Capital2020 Convertible Note | Accumulated Deficit |
Beginning balance, preferred stock (in shares) at Dec. 31, 2019 | 12,534,000 | ||||||||||||||||
Beginning balance, preferred stock at Dec. 31, 2019 | $ 59,507 | ||||||||||||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||||||||||||
Issuance of shares in conversion of preferred shares (in shares) | (12,534,000) | ||||||||||||||||
Issuance of shares in conversion of preferred shares | $ (59,507) | ||||||||||||||||
Ending balance, preferred stock (in shares) at Dec. 31, 2020 | 0 | ||||||||||||||||
Ending balance, preferred stock at Dec. 31, 2020 | $ 0 | ||||||||||||||||
Beginning balance (in shares) at Dec. 31, 2019 | 18,154,000 | ||||||||||||||||
Beginning balance at Dec. 31, 2019 | (93,569) | $ 2 | $ (24,316) | $ (69,255) | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||
Stock-based compensation expense | 5,023 | 5,023 | |||||||||||||||
Beneficial conversion feature | $ 2,656 | $ 2,656 | |||||||||||||||
Issuance of shares upon exercise of stock options (in shares) | 2,000 | ||||||||||||||||
Issuance of shares upon exercise of stock options | 27 | 27 | |||||||||||||||
Issuance of shares in IPO (in shares) | 8,050,000 | ||||||||||||||||
Issuance of shares in IPO, net of issuance costs | $ 125,860 | $ 1 | $ 125,859 | ||||||||||||||
Issuance of shares in conversion of convertible securities (in shares) | 7,211,000 | 4,295,000 | |||||||||||||||
Issuance of shares in conversion of convertible securities | $ 59,507 | $ 59,393 | $ 1 | $ 59,506 | $ 59,393 | ||||||||||||
Reversal of unamortized BCF | $ (5,332) | $ (2,107) | $ (5,332) | $ (2,107) | |||||||||||||
Reclassification of warrant liabilities into equity | 139 | 139 | |||||||||||||||
Net loss | $ (76,124) | (76,124) | |||||||||||||||
Ending balance (in shares) at Dec. 31, 2020 | 37,712,390 | 37,712,000 | |||||||||||||||
Ending balance at Dec. 31, 2020 | $ 75,473 | $ 4 | 220,848 | (145,379) | |||||||||||||
Ending balance, preferred stock (in shares) at Dec. 31, 2021 | 0 | ||||||||||||||||
Ending balance, preferred stock at Dec. 31, 2021 | $ 0 | ||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||
Stock-based compensation expense | $ 15,048 | 15,048 | |||||||||||||||
Issuance of shares upon exercise of stock options (in shares) | 358,000 | 358,000 | |||||||||||||||
Issuance of shares upon exercise of stock options | $ 3,956 | 3,956 | |||||||||||||||
Issuance of shares in IPO (in shares) | 921,000 | ||||||||||||||||
Issuance of shares in IPO, net of issuance costs | 39,674 | 39,674 | |||||||||||||||
Net loss | $ (81,768) | (81,768) | |||||||||||||||
Ending balance (in shares) at Dec. 31, 2021 | 38,991,307 | 38,991,000 | |||||||||||||||
Ending balance at Dec. 31, 2021 | $ 52,383 | $ 4 | $ 279,526 | $ (227,147) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (81,768) | $ (76,124) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,195 | 1,019 |
Accretion of debt discount and non-cash interest expense | 1,234 | 10,189 |
Stock-based compensation expense | 15,048 | 5,023 |
Non-cash lease expense | 1,493 | 1,374 |
Gain on disposal of fixed assets | (9) | 0 |
Change in fair value of derivative liabilities | 0 | (2,651) |
Change in fair value of warrant liabilities | 0 | 24 |
Loss from equity method investment | 0 | 487 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (167) | 117 |
Receivables from related parties | 28 | (294) |
Prepaid expenses and other current assets | (4,040) | 690 |
Other non-current assets | (1,602) | 0 |
Accounts payable | (4,642) | 10,426 |
Accrued expenses and other current liabilities | (3,736) | 8,525 |
Operating lease liability | (1,503) | (1,345) |
Deferred revenue, current portion | (1,047) | (5,345) |
Deferred revenue, non-current portion | (627) | (263) |
Other non-current liabilities | (180) | 180 |
Net cash used in operating activities | (80,323) | (47,968) |
Cash flows from investing activities | ||
Purchase of fixed assets | (864) | (1,364) |
Proceeds from the sale of fixed assets | 55 | 0 |
Net cash used in investing activities | (809) | (1,364) |
Cash flows from financing activities | ||
Proceeds from the issuance of debt | 39,992 | 29,938 |
Payment of fees associated with debt | 0 | (786) |
Proceeds from exercise of stock options | 3,956 | 27 |
Proceeds from the issuance of convertible notes | 0 | 15,000 |
Repayment of principal on debt | 0 | (2,183) |
Final payment on debt | 0 | (1,400) |
Proceeds from the Paycheck Protection Program loan | 0 | 1,875 |
Repayment of principal on the Paycheck Protection Program loan | 0 | (1,875) |
Net cash provided by financing activities | 83,769 | 166,456 |
Net increase in cash | 2,637 | 117,124 |
Cash and cash equivalents at beginning of period | 128,664 | 11,540 |
Cash and cash equivalents at end of period | 131,301 | 128,664 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 3,889 | 504 |
Cash paid for income taxes | 2 | 3 |
Supplemental schedule of non-cash investing and financing activities | ||
ATM offering costs included in accounts payable | 271 | 0 |
ATM offering costs reimbursable in accounts receivable | 124 | 0 |
Payable for purchase of fixed assets | 38 | 83 |
Conversion of preferred stock to common stock | 0 | 59,507 |
Conversion of the 2019 Note and the 2020 Notes to common stock | 0 | 59,393 |
Debt discount arising from convertible note beneficial conversion features and reversal of beneficial conversion features | 0 | 4,783 |
Operating lease liabilities arising from obtaining right-of-use assets | 0 | 1,752 |
Derivative liabilities arising from the issuance of the 2019 Note and the 2020 Notes | 0 | 735 |
Non-cash equity method investment | 0 | 487 |
Reclassification of warrant liabilities to equity | 0 | 139 |
Warrant liabilities issued to lender in conjunction with 2020 Loan Agreement | 0 | 115 |
ATM Offering | ||
Cash flows from financing activities | ||
Proceeds from equity offering | 40,203 | 0 |
Costs associated with offering | (382) | 0 |
IPO | ||
Cash flows from financing activities | ||
Proceeds from equity offering | 0 | 136,850 |
Costs associated with offering | $ 0 | $ (10,990) |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization Inhibrx, Inc., or the Company, or Inhibrx, is a clinical-stage biotechnology company focused on developing a broad pipeline of novel biologic therapeutic candidates. The Company combines target biology with protein engineering, technologies, and research and development to design therapeutic candidates. The Company’s current pipeline is focused on oncology and orphan diseases. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, risks associated with preclinical studies, clinical trials and regulatory applications, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. The Company’s therapeutic candidates currently under development will require significant additional research and development efforts, including clinical and preclinical testing and marketing approval prior to commercialization. These efforts require significant amounts of capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. Initial Public Offering On August 21, 2020, the Company completed its initial public offering, or IPO, in which it sold 8,050,000 shares of common stock at an offering price of $17.00 per share. Net proceeds from the IPO were $125.9 million, net of underwriting discounts, commissions, and offering costs. In addition, each of the following occurred in connection with the completion of the IPO: • the conversion of the 2019 Note and the 2020 Notes (each as defined below) into 4,294,603 shares of the Company’s common stock; • the conversion of all outstanding convertible preferred stock into 7,211,086 shares of the Company’s common stock; • the adjustment of an outstanding warrant to purchase convertible preferred stock into a warrant to purchase 7,354 shares of the Company’s common stock; and • the amendment and restatement of the Company’s certificate of incorporation, authorizing 120.0 million shares of common stock and 15.0 million shares of preferred stock. Reverse Stock Split On August 11, 2020 the Company effected a one-for-1.7382 reverse stock split of the Company’s common stock, or the Reverse Stock Split. The par value and the authorized shares of the common stock were not adjusted as a result of the Reverse Stock Split. All issued and outstanding common stock and the conversion prices of the convertible preferred stock and convertible notes have been retroactively adjusted to reflect this Reverse Stock Split for all periods presented. Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or the SEC, related to an annual report on the Form 10-K. Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary and have been prepared in conformity with GAAP. All intercompany accounts and transactions have been eliminated in consolidation. Liquidity As of December 31, 2021, the Company had an accumulated deficit of $227.1 million and cash and cash equivalents of $131.3 million. From its inception and through December 31, 2021, the Company has devoted substantially all of its efforts to therapeutic drug discovery and development, conducting preclinical studies and clinical trials, enabling manufacturing activities in support of its therapeutic candidates, organizing and staffing the Company, establishing its intellectual property portfolio and raising capital to support and expand these activities. The Company believes that its existing cash and cash equivalents will be sufficient to fund the Company’s operations for at least 12 months from the date these consolidated financial statements are issued. The Company plans to finance its future cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements. As discussed in Note 5, the Company entered into the Open Market Sale Agreement, or the Sales Agreement, with Jefferies LLC, or the Sales Agent, under which it may, from time to time, sell shares of its common stock having an aggregate offering price of up to $200.0 million through the Sales Agent, or the ATM Offering. As of December 31, 2021, 921,042 shares have been sold pursuant to the Sales Agreement for net proceeds of $40.2 million, after deducting commissions. If the Company does raise additional capital through public or private equity or convertible debt offerings, the ownership interests of its existing stockholders will be diluted, and the terms of those securities may include liquidation or other preferences that adversely affect its stockholders’ rights. If the Company raises capital through additional debt financings, it may be subject to covenants limiting or restricting its ability to take specific actions, such as incurring additional debt or making certain capital expenditures. To the extent that the Company raises additional capital through strategic licensing, collaboration or other similar agreement, it may have to relinquish valuable rights to its therapeutic candidates, future revenue streams or research programs at an earlier stage of development or on less favorable terms than it would otherwise choose, or to grant licenses on terms that may not be favorable to the Company. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future. If the Company is unable to secure adequate additional funding, it will need to reevaluate its operating plan and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of its development programs, or relinquish rights to its technology on less favorable terms than it would otherwise choose. These actions could materially impact its business, financial condition, results of operations and prospects. The rules and regulations of the SEC or any other regulatory agencies may restrict the Company’s ability to conduct certain types of financing activities, or may affect the timing of and amounts it can raise by undertaking such activities. Impact of COVID-19 Pandemic In response to the global outbreak of COVID-19 and the World Health Organization’s classification of the outbreak as a pandemic, the Company continues to take the necessary precautions to ensure the safety of its employees and to minimize interruptions to its operations. The full impact of the COVID-19 outbreak continues to evolve as of the date of these financial statements. While the pandemic has not yet had a material effect on the Company’s financial results, it is uncertain as to the full magnitude of impact the pandemic will have on the Company’s financial condition, liquidity and future results of operations. Management is actively monitoring the risks to public health and the impact of overall global business activity on its financial condition, liquidity, operations, suppliers, industry, and workforce. The U.S. federal government enacted the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. The CARES Act includes a provision for a Paycheck Protection Program, or PPP, administered by the U.S. Small Business Administration, or SBA, and further amended by the Paycheck Protection Program Flexibility Act of 2020, or PPP Flexibility Act, which was enacted on June 5, 2020. The Company was approved for a loan pursuant to the PPP, or the PPP Loan, in the amount of $1.9 million and received the funds on May 11, 2020. On October 2, 2020, the Company repaid the loan in full plus all interest accrued during the period outstanding. The CARES Act also permits employers to defer the payment of the employer share of social security taxes due for the period beginning March 27, 2020 and ending December 31, 2020. Of the amounts deferred, 50% was required to be paid by December 31, 2021 and the remaining 50% is required to be paid by December 31, 2022. The Company began deferring payment of the employer share of social security taxes in April 2020 and deferred a total of $0.4 million of such taxes during the period. The Company paid $0.3 million of deferred taxes during December 2021. As of December 31, 2021, the Company has a remaining deferred payment of $0.1 million of such taxes which are classified as accrued expenses in the Company’s consolidated balance sheets. The Company will continue to examine and evaluate any impacts the CARES Act and associated subsequent legislation may have on its business and taxes. Use of Estimates The preparation of these consolidated financial statements in conformity with GAAP requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expense and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. The Company’s most significant estimates relate to evaluation of embedded derivative instruments and beneficial conversion features, or BCFs, within its previously issued and outstanding convertible notes, whether revenue recognition criteria have been met, accounting for development work and preclinical studies and clinical trials, determining the assumptions used in measuring stock-based compensation, the incremental borrowing rate estimated in relation to the Company’s operating lease, and valuation allowances for the Company’s deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. The Company’s actual results may differ from these estimates under different assumptions or conditions. Fair Value of Financial Instruments The Company’s financial instruments consist principally of accounts receivable, accounts payable, accrued expense, its long-term debt, convertible notes, warrants, and derivative instruments as applicable. The carrying amounts of financial instruments such as accounts receivable, accounts payable, accrued expense, and convertible notes approximate their related fair values due to the short-term nature of these instruments. The carrying value of the Company’s debt approximates fair value due to its interest being reflective of current market rates for debt with similar terms and conditions. The Company’s derivative instruments and warrants are carried at fair value based on unobservable market inputs. Cash and Cash Equivalents Cash and cash equivalents are comprised of cash held in financial institutions including readily available checking and money market accounts. Concentrations of Credit Risk The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial condition of the depository institutions in which those deposits are held. The Company continually evaluates its accounts receivable for all outstanding third-party balances to determine the potential exposure to a concentration of credit risk. The Company’s major third-party contracting parties, some of which account for significant balances in both accounts receivable and revenue, are generally large, credit-worthy biotechnology companies and government bodies. The Company assesses the collectability of accounts receivable through a review of its current aging, as well as an analysis of its historical collection rate, general economic conditions, and credit status of these third parties. As of December 31, 2021 and 2020, all outstanding accounts receivable were deemed to be fully collectible, and therefore, no allowance for doubtful accounts was recorded. The Company currently depends on third-party suppliers for key materials and services used in its research and development, as well as manufacturing processes, and is subject to certain risks related to the loss of these third-party suppliers or their inability to supply the Company with adequate materials and services. In August 2018, the Company entered into a strategic alliance with WuXi Biologics (Hong Kong), Limited, or WuXi Biologics, pursuant to which the Company agreed, for three years and subject to certain conditions, to exclusively use WuXi Biologics to manufacture its therapeutic candidates on a project-by-project basis. In August 2021, the exclusivity provisions of the Wuxi Agreement expired, and the Company may use manufacturers other than Wuxi to manufacture its therapeutic candidates. The Company does not control the manufacturing processes of the contract development and manufacturing organizations, or CDMOs, with whom it contracts, including WuXi Biologics, and is dependent on these third parties for the production of its therapeutic candidates in accordance with relevant regulations such as current Good Manufacturing Practices, or cGMP, which includes, among other things, quality control, quality assurance and the maintenance of records and documentation. Dividends As of December 31, 2021, the Company has never declared or paid any dividends on its common stock. Additionally, the Amended 2020 Loan Agreement limits, among other things, the Company’s ability to pay dividends and make certain other payments. Any future determination to pay dividends on the Company’s common stock will be at the discretion of the Company’s board of directors and will depend upon, among other factors, the results of operations, financial condition, capital requirements, contract restrictions, business prospects and other factors the Company’s board of directors may deem relevant. Property and Equipment, Net Property and equipment are stated at cost less accumulated depreciation. Depreciation is provided on a straight-line basis over the estimated useful lives of the assets. The Company estimates useful lives as follows: • machinery and equipment: three • furniture and fixtures: three • computer software: four Amortization of leasehold improvements is provided on a straight-line basis over the shorter of their estimated useful lives or the lease term. The costs of additions and betterments are capitalized, and repairs and maintenance costs are expensed in the periods incurred. Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss is recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. If such assets are considered impaired, the amount of the impairment loss recognized is measured as the amount by which the carrying value of the asset exceeds the fair value of the asset, fair value being determined based upon future cash flows or appraised values, depending on the nature of the asset. The Company recognized no impairment losses during any of the periods presented within its consolidated financial statements. Leases The Company has two existing leases for its corporate headquarters in La Jolla, California. Its first lease commenced in June 2018. In May 2019, the Company signed an amendment to its lease agreement to expand the Company’s facilities, which commenced in January 2020 and is accounted for as a separate lease. The Company’s two existing leases are classified as operating leases. For the long-term operating lease of its corporate headquarters, the Company recognized a right-of-use asset and lease liability on its consolidated balance sheet. The lease liability is determined as the present value of future lease payments using an estimated incremental borrowing rate that the Company would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The right-of-use asset is based on the liability adjusted for any prepaid or deferred rent. The lease term at the commencement date is determined by considering whether renewal options and termination options are reasonably assured of exercise. Agreements are reviewed at inception to determine if they contain a lease. Leases are reviewed and classified as operating or financing leases at commencement. The Company has elected to exclude from its consolidated balance sheets recognition of leases having a term of 12 months or less (short-term leases) and has elected not to separate lease components and non-lease components for its long-term operating leases. Rent expense for the operating leases are recognized on a straight-line basis over the lease term and is included in operating expense in the consolidated statements of operations for all periods presented. Equity Method Investment The Company uses the equity method of accounting for equity investments in companies if the investment provides the ability to exercise significant influence, but not control, over operating and financial policies of the investee. As discussed in Note 7, the Company received an equity investment in the form of a 10% equity interest as consideration in a series of agreements with Phylaxis (as defined below), which is accounted for as an equity method investment. The Company's proportionate share of the net income or loss of these companies is included as loss in equity method investment in the consolidated statement of operations. Judgment regarding the level of influence over each equity method investment includes considering key factors such as the Company’s ownership interest, representation on the board of directors, legal form of the investee (e.g. limited liability corporation), participation in policy-making decisions, and material purchase and sale transactions. During the third quarter of 2020, the Company’s equity method investment was written down to zero as a result of the allocation of the Company’s share of losses of the investee. As of December 31, 2021 and 2020, the equity method investment remains at zero. Derivative Liabilities As discussed in Note 4, the convertible promissory note, or the 2019 Note, issued in May 2019 to DRAGSA 50 LLC, an entity affiliated with Viking Global Investors LP, or Viking, and the convertible promissory notes, or the 2020 Notes, issued in April 2020 to Viking and certain other investors contained embedded features that provided multiple settlement alternatives. Certain of these settlement features provided the noteholders with a right to a fixed number of the Company’s shares upon conversion of the note. Other settlement features provided the noteholders the right or the obligation to receive cash or a variable number of shares upon the completion of a capital raising transaction, change of control, qualified IPO (as defined in the 2019 Note and the 2020 Notes), or default of the Company. The Company evaluated each settlement alternative within the 2019 Note and the 2020 Notes under the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 815-15, Embedded Derivatives and ASC Topic 815-40, Contracts in Entity’s Own Equity and determined certain of the settlement features would be accounted for as redemption features meeting the requirements for separate accounting as a single, compound derivative instrument. This single, compound derivative instrument was accounted for as a liability at its estimated fair value as of the date of issuance, and then subsequently remeasured to fair value as of each balance sheet date, with the related remeasurement adjustment being recognized as a component of change in fair value of derivative liabilities in the consolidated statements of operations. During August 2020, the Company consummated its IPO, resulting in the conversion of the 2019 Note and the 2020 Notes into shares of the Company’s common stock. As of December 31, 2021 and 2020, the derivative liabilities no longer exist. Warrant Liabilities As discussed in Note 3, in conjunction with the 2020 Loan Agreement with Oxford, the Company issued warrants for the purchase of: 1) its preferred stock if the Company remained privately-held or 2) common stock upon the successful completion of an IPO prior to December 31, 2020. Upon the issuance of the warrants in July 2020, pursuant to ASC Topic 480, the warrants were accounted for as liabilities and measured at their estimated fair value as of the date of issuance, based on the potential conversion into preferred stock. During August 2020, upon consummation of the Company’s IPO, the warrants were deemed to be issued for the purchase of common stock and were no longer accounted for as liabilities. The change in fair value was recognized as a component of change in fair value of warrant liabilities in the consolidated statements of operations during the year ended December 31, 2020. Fair Value Measurements The Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established by accounting guidance and prioritizes the inputs used in measuring fair value. These tiers include: • Level 1 - Quoted prices in active markets for identical assets or liabilities. • Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the level in the fair value hierarchy within which the fair value measurement in its entirety falls has been determined based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The 2019 Note and the 2020 Notes contained embedded derivative liabilities (see Note 4). The 2020 Loan Agreement contained warrant liabilities (see Note 3). Prior to the completion of the IPO in August 2020, these were classified within Level 3 of the hierarchy, since they were valued by using inputs that were unobservable in the market. Upon the consummation of the IPO in August 2020, the derivative liabilities and warrant liabilities no longer existed. As of December 31, 2021 and 2020, the Company had no financial liabilities measured at fair value. Prior to the completion of the IPO in August 2020, the Company’s liabilities that were measured at fair value on a recurring basis using significant unobservable inputs (Level 3) included the derivative liabilities related to the 2019 Note and the 2020 Notes and the warrants issued with the 2020 Loan Agreement. The following table provides a reconciliation of financial instruments measured at fair value using Level 3 unobservable inputs for the year ended December 31, 2020 (in thousands): Balance as of December 31, 2019 $ 1,916 Establishment of derivative liability on the 2020 Notes 735 Establishment of warrant liabilities on the 2020 Loan Agreement 115 Change in fair value of derivative liabilities on the 2019 and 2020 Notes (2,651) Change in fair value of warrant liabilities 24 Reclassification of warrant liabilities into equity (139) Balance as of December 31, 2020 $ — The fair value of the Company’s derivative liabilities categorized in Level 3 of the fair value hierarchy during the year ended December 31, 2020 was determined, with the assistance of an independent third-party valuation specialist, using a lattice model. The valuation utilized unobservable inputs, including the discount rate, management’s assessment of the probability of various underlying events triggering the conversion of the Company’s 2019 Note and the 2020 Notes (as discussed in Note 4), such as an IPO, financing, or extraordinary event, and the current valuation of the Company determined with the assistance of an independent third-party valuation specialist. The warrant liabilities were valued using a Black-Scholes model upon issuance. As of December 31, 2020, the derivative liabilities no longer exist as a result of the conversion of the 2019 Note and the 2020 Notes upon the IPO. Additionally, as of December 31, 2020 the warrant liabilities have been reclassified into equity after the Oxford warrants became exercisable for common stock subsequent to the Company’s IPO. There were no financial instruments measured at fair value during the year ended December 31, 2021. Deferred Financing Costs and Other Debt-Related Costs Deferred financing costs are capitalized, recorded as an offset to the Company’s debt balances and amortized as interest expense over the term of the associated debt instrument using the effective interest method, pursuant to ASC Topic 835-30, Imputation of Interest . If the maturity of the debt is accelerated as a result of default or early debt repayment, the amortization would then be accelerated. Amounts paid related to debt financing activities are presented on the consolidated balance sheet as a direct deduction from the debt liability. Deferred Offering Costs The Company capitalizes costs that are directly associated with equity financings until such financings are consummated at which time such costs are recorded against the gross proceeds of the offering. Legal, accounting, and filing fees related directly to the Company’s IPO were capitalized as deferred offering costs to be offset against proceeds upon the consummation of the IPO within stockholders’ equity (deficit). In August 2020, the Company completed its IPO and offset $11.0 million of IPO costs against the proceeds. No deferred offering costs were capitalized on the Company’s consolidated balance sheets as of December 31, 2020. Legal, accounting, and filing fees related directly to the Company’s Shelf Registration are capitalized as deferred offering costs. Deferred offering costs associated with the Shelf Registration are reclassified to additional paid-in capital when the Company completes offerings under the Shelf Registration. In November 2021, the Company completed an offering under the Shelf Registration and offset $1.7 million of offering costs against the proceeds. Revenue Recognition The Company has generated revenue from its license and collaboration agreements with partners, as well as from grants from government agencies and private not-for-profit organizations. Payments received from customers are included in deferred revenue, allocated between current and non-current on the consolidated balance sheet until all revenue recognition criteria are met. In accordance with ASC Topic 606, Revenue from Contracts with Customers, or ASC Topic 606, the Company recognizes revenue when, or as, the promised goods or services are transferred to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those services. To determine revenue recognition for arrangements the Company concludes are within the scope of ASC Topic 606, the Company performs the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligation(s) in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligation(s) in the contract; and (5) recognize revenue when (or as) the performance obligation(s) are satisfied. At contract inception, the Company assesses the goods or services promised within each contract, assesses whether each promised good or service is distinct and identifies those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. Collaborative Research, Development, and License Agreements The Company enters into collaborative agreements with partners that typically include one or more of the following: (1) license fees; (2) nonrefundable up-front fees; (3) payments for reimbursement of research costs; (4) payments associated with achieving specific development, regulatory, or commercial milestones; and (5) royalties based on specified percentages of net product sales, if any. At the initiation of an agreement, the Company analyzes whether each unit of account results in a contract with a customer under ASC Topic 606 or in an arrangement with a collaborator subject to guidance under ASC Topic 808, Collaborative Arrangements , or ASC Topic 808. The Company’s licensing arrangements are typically for functional intellectual property as it exists at a point in time, being the time that the license agreement is executed. The Company typically does not have an ongoing performance obligation to support or maintain the licensed intellectual property. The Company considers a variety of factors in determining the appropriate estimates and assumptions under these arrangements, such as whether the elements are distinct performance obligations, whether there are observable stand-alone prices, and whether any licenses are functional or symbolic. The Company evaluates each performance obligation to determine if it can be satisfied and recognized as revenue at a point in time or over time. Typically, license fees, non-refundable upfront fees, and funding of research activities are considered fixed, while milestone payments are identified as variable consideration which must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. The Company estimates the amount of variable consideration using the most likely amount, as milestone payments typically only have two possible outcomes. The Company recognizes revenue for sales-based royalty promised in exchange for the license of intellectual property only when the subsequent sale occurs. In the case of an agreement which provides the partner with an option to license a therapeutic or therapeutic candidate in the future, the Company evaluates whether this option represents a material right at the inception of the agreement. If determined to be a material right, the Company will consider the option a separate performance obligation. The Company has historically concluded that the option to grant a license in the future are not material rights as they are contingent upon future events which may not occur. When an option is exercised, the Company will identify any separate performance obligations. The Company may allocate transaction price using a number of methods including estimating standalone selling price of performance obligations and using the residual approach when the standalone selling price of the license is highly variable or uncertain, and observable standalone selling prices exist for the other goods or services promised in the contract. Grant Revenue The Company has been awarded grants from the Congressionally Directed Medical Research Program, or CDMRP, funded through the DoD. With respect to revenue derived from reimbursement of direct, out-of-pocket expenses for research and development costs associated with these grants, where the Company acts as a principal with discretion to choose su |
OTHER FINANCIAL INFORMATION
OTHER FINANCIAL INFORMATION | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
OTHER FINANCIAL INFORMATION | OTHER FINANCIAL INFORMATION Prepaid Expense and Other Current Assets Prepaid expense and other current assets were comprised of the following (in thousands): AS OF DECEMBER 31, 2021 2020 Outside research and development services $ 6,343 $ 2,204 Other 590 689 Prepaid expense and other current assets $ 6,933 $ 2,893 Property and Equipment, Net Property and equipment, net were comprised of the following (in thousands): AS OF DECEMBER 31, 2021 2020 Machinery and equipment $ 6,286 $ 5,652 Leasehold improvements 441 441 Furniture and fixtures 514 507 Computer software 42 — Construction in process 281 257 Total property and equipment 7,564 6,857 Less: accumulated depreciation and amortization (4,411) (3,365) Property and equipment, net $ 3,153 $ 3,492 Depreciation and amortization expense totaled $1.2 million and $1.0 million for the years ended December 31, 2021 and 2020, respectively, and consisted of the following (in thousands): YEAR ENDED DECEMBER 31, 2021 2020 Research and development $ 1,003 $ 836 General and administrative 192 183 Total depreciation and amortization expense $ 1,195 $ 1,019 Accrued Expenses Accrued expenses were comprised of the following (in thousands): AS OF DECEMBER 31, 2021 2020 Clinical research and development $ 4,496 $ 970 Other outside research and development 2,893 10,559 Compensation expense 1,322 1,165 Professional fees 261 282 Other 649 381 Accrued expenses $ 9,621 $ 13,357 |
DEBT
DEBT | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT 2020 Loan Agreement On July 15, 2020, the Company entered into a loan and security agreement, or the 2020 Loan Agreement, with Oxford Finance LLC, or Oxford, pursuant to which it received $10.0 million in gross proceeds, net of $0.1 million of debt issuance costs. On November 12, 2020, the Company entered into an amendment to the 2020 Loan Agreement, or the November 2020 Amendment, and received $20.0 million in additional gross proceeds, net of $0.02 million of debt issuance costs and $0.7 million of a one-time first amendment fee. The November 2020 Amendment provided for two additional tranches of term loans, in addition to the first $10.0 million tranche, or Term A, for an aggregate principal amount of up to $50.0 million, as follows: (a) the second tranche in an aggregate principal amount of $20.0 million, funded upon the closing of the November 2020 Amendment, or Term B, and (b) the third tranche in an aggregate principal amount of $20.0 million to fund on or before September 30, 2021, subject to the initiation of a potentially registration-enabling trial for the Company’s therapeutic candidate, INBRX-109, in unresectable or metastatic conventional chondrosarcoma, pursuant to the terms of the November 2020 Amendment, or Term C. The terms of Term A under the 2020 Loan Agreement were modified to align with Term B pursuant to the November 2020 Amendment. On June 18, 2021, the Company entered into an additional amendment to the 2020 Loan Agreement, or the June 2021 Amendment (collectively with the November 2020 Amendment, the Amended 2020 Loan Agreement). Pursuant to the June 2021 Amendment, the principal amount of the Term C Loan was increased from $20.0 million to $40.0 million. All terms of the Term C Loan align with the existing terms of the Term A and Term B Loans. Upon execution of the June 2021 Amendment and based on the initiation of a potentially registration-enabling trial in unresectable or metastatic conventional chondrosarcoma, the Company drew the Term C Loan and received $40.0 million in gross proceeds, net of $0.01 million of debt issuance costs. As of December 31, 2021 the Company has $70.0 million in gross principal outstanding in term loans under the Amended 2020 Loan Agreement. The outstanding term loans will mature on November 1, 2025, or the Amended Maturity Date, and bear interest at a floating per annum rate equal to the greater of (1) 7.96% and (2) the sum of (i) the 30 day U.S. Dollar LIBOR 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 (ii) 7.80%. The repayment schedule provides for interest-only payments until January 1, 2025. The interest-only period is followed by 11 months of equal payments of principal and interest. Upon the Amended Maturity Date, a final payment of 9.0% of the original principal amount will be due to Oxford. This final payment of $6.3 million is being accreted over the life of the Amended 2020 Loan Agreement using the effective interest method. The Company has the option to prepay the outstanding balance of the term loans in full prior to the Amended Maturity Date, subject to a prepayment fee ranging from 1.0% to 3.0%, depending upon the timing of the prepayment. All other terms of the original 2020 Loan Agreement remain outstanding. The Company’s outstanding debt balance under the Amended 2020 Loan Agreement consisted of the following (in thousands). AS OF DECEMBER 31, 2021 2020 Term A $ 10,900 $ 10,900 Term B 21,800 21,800 Term C 43,600 — Less: Debt discount (5,830) (3,456) Total debt 70,470 29,244 Less: Current portion, including debt discount — — Long-term debt, including debt discount $ 70,470 $ 29,244 Through 2024, the Company is only required to make interest payments on the outstanding principal balance, with future principal payments and final fee payments beginning in 2025, as follows (in thousands): AS OF DECEMBER 31, 2021 2021 2025 $ 76,300 Total future minimum payments 76,300 Less: unamortized debt discount (5,830) Total debt $ 70,470 In November 2020 and June 2021, the Company evaluated the amendments and determined they should be treated as modifications of the original 2020 Loan Agreement since the terms and resulting cash flow were not substantially changed in either the November 2020 Amendment or the June 2021 Amendment. The Company will continue to amortize the existing debt discounts prior to modification through the Amended Maturity Date. The Company’s obligations under the Amended 2020 Loan Agreement are secured by a first priority security interest of substantially all of the Company’s assets, other than its intellectual property. The Amended 2020 Loan Agreement includes customary events of default, including instances of a material adverse change in the Company’s operations, that may require prepayment of the outstanding term loans. Additionally, following the June 2021 Amendment, the Amended 2020 Loan Agreement requires a minimum cash balance of $20.0 million to be maintained in a collateral account. As of December 31, 2021, the Company is in compliance with all covenants under the Amended 2020 Loan Agreement and has not received any notification or indication from Oxford of an intent to declare the loan due prior to maturity. Concurrently with the debt issuance in July 2020, the Company issued to Oxford warrants to purchase shares of the Company’s capital stock equal to 1.25% of the funded amount, or $125,000. Upon issuance, the warrants were exercisable for preferred stock and were classified as liabilities pursuant to Topic ASC 480 at their fair value of $0.12 million. Upon the consummation of the Company’s IPO in August 2020, the Company remeasured the warrants and determined a fair value of approximately $0.14 million. The change in fair value was recorded as a change in fair value of warrant liabilities within other income in the Company’s consolidated statements of operations during the year ended December 31, 2020. As of December 31, 2021 and 2020, the warrants are equity-classified and are exercisable for 7,354 shares of common stock of the Company at $17.00 per share. Interest Expense Interest expense is calculated using the effective interest method and is inclusive of non-cash amortization of the debt discount and accretion of the final payment. Interest expense was approximately $5.4 million and $0.9 million for the years ended December 31, 2021 and 2020, respectively, as related to the Amended 2020 Loan Agreement. Interest expense was approximately $44,000 for the year ended December 31, 2020 as related to the Company’s previous loan and security agreement, as amended, or the 2015 Loan Agreement, with Oxford. The Company recorded no interest expense for the year ended December 31, 2021 related to the 2015 Loan Agreement since it was paid in full in March 2020. |
CONVERTIBLE PROMISSORY NOTE
CONVERTIBLE PROMISSORY NOTE | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
CONVERTIBLE PROMISSORY NOTE | CONVERTIBLE PROMISSORY NOTES In May 2019, the Company issued the 2019 Note in the aggregate principal amount of $40.0 million to Viking in a private placement transaction. The 2019 Note began to accrue interest in February 2020 at a rate of 1.5% per month. In April 2020, the Company issued the 2020 Notes in the aggregate principal amount of $15.0 million to Viking and certain other investors in a private placement transaction. Upon issuance, the 2020 Notes accrued interest at a rate of 1.0% per month. Conversion Upon IPO On August 21, 2020, the Company completed its IPO. The aggregate total balance of the 2019 Note, or $43.7 million, converted at the fixed price of $14.35 per share, resulting in the issuance of 3,046,467 shares of common stock to the holder. The aggregate total balance of the 2020 Notes, or $15.7 million, converted at a fixed price of $12.56 per share, resulting in the issuance of 1,248,136 shares of common stock to the holders. The conversion of the 2019 Note and the 2020 Notes were evaluated for contingent BCFs under ASC Topic 470-20, Debt With Conversion and Other Options . See discussion of debt discount below for evaluation upon conversion. Derivative Liabilities The terms of the 2019 Note and the 2020 Notes contained alternative conversion options to the IPO upon the consummation of certain events, each of which had its own conversion prices and terms. The Company determined certain settlement features qualified as conversion features not meeting the requirements for separate accounting as embedded derivatives, while others qualified as redemption features meeting the requirements for separate accounting which were accounted for as derivative instruments. Upon issuance of the 2019 Note and the 2020 Notes, the Company recorded derivative liabilities with corresponding debt discounts on the consolidated balance sheets at the estimated fair value of the bifurcated compound liabilities. The Company remeasured the fair value at each reporting period. Changes in the probability of each embedded redemption feature drove changes in the fair value of the derivative liabilities and had a corresponding impact on the Company’s net loss. During the second quarter of 2020, the fair value of the derivatives were determined to be zero based upon the expected conversion of the notes via an embedded conversion feature which did not meet the definition of a derivative. Upon conversion of the 2019 Note and the 2020 Notes in August 2020 upon completion of the Company’s IPO, the derivative liabilities were extinguished. No additional expense was recorded at extinguishment since the derivative liabilities had already been assessed to have zero value. During the year ended December 31, 2020, the Company recorded other income of $2.7 million related to changes in fair value of derivative liabilities in the consolidated statements of operations. Debt Discount Upon issuance of the 2019 Note and the 2020 Notes, the Company recorded debt discounts related to BCFs, as well as derivative liabilities and debt issuance costs. Prior to conversion, the debt discounts were amortized over the life of the notes. Amortization of the debt discount from inception of the 2019 Note until conversion of the 2019 Note and the 2020 Notes upon IPO was $8.7 million. At the time of conversion, the 2019 Note and the 2020 Notes had unamortized discounts of $6.9 million and $2.7 million, respectively. Upon conversion of the 2019 Note and the 2020 Notes, the Company remeasured the intrinsic value of the BCFs which resulted in a reversal of the remaining unamortized discounts associated with the BCFs, resulting in a $7.4 million impact to additional paid-in-capital. Additionally, the Company accelerated the unamortized debt discounts related to the debt issuance costs and the derivative liabilities, resulting in a $2.2 million charge to interest expense during the third quarter of 2020. |
STOCKHOLDERS_ EQUITY (DEFICIT)
STOCKHOLDERS’ EQUITY (DEFICIT) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY (DEFICIT) | STOCKHOLDERS’ EQUITY (DEFICIT) Amended and Restated Certificate of Incorporation On August 21, 2020 upon completion of the IPO, the Company’s certificate of incorporation was amended and restated to authorize 120,000,000 shares of common stock and 15,000,000 shares of preferred stock, each with a par value of $0.0001 per share. Convertible Preferred Stock In connection with the completion of the Company’s IPO in August 2020, all of the outstanding shares of convertible preferred stock were converted into 7,211,086 shares of the Company’s common stock. Prior to its conversion to common stock, the convertible preferred stock was classified as temporary, or mezzanine, equity on the accompanying consolidated balance sheets since the shares contained certain redemption features that were not solely within the control of the Company. The Company had not previously accreted the convertible preferred stock to its redemption value since the shares were not currently redeemable and redemption was not deemed to be probable. No convertible preferred stock was authorized or issued as of December 31, 2021 or December 31, 2020. Common Stock In September 2021, the Company entered into the Sales Agreement with the Sales Agent, under which it may, from time to time, sell shares of its common stock having an aggregate offering price of up to $200.0 million through the Sales Agent, or the ATM Offering. Pursuant to the Sales Agreement, the Company will pay the Sales Agent a commission for its services in acting as an agent in the sale of common stock in an amount equal to 3% of the gross sales price per share sold. As of December 31, 2021, the Company has sold 921,042 shares under the ATM Offering for net proceeds of $40.2 million, after deducting commissions of $1.2 million. In connection with the ATM Offering, the Company incurred an additional $0.5 million of expenses which were offset against the proceeds of the offering. Common Stock Warrants As discussed in Note 3, the Company issued warrants to Oxford concurrently with the 2020 Loan Agreement. Upon the consummation of the Company’s IPO in August 2020, the warrants are exercisable for 7,354 shares of common stock of the Company at $17.00 per share. As of December 31, 2021, the warrants are equity-classified and reflected in additional paid-in-capital at $0.14 million. The fair value of the warrants was determined using the Black-Scholes model on the date of reclassification. No subsequent remeasurement is required for equity-classified warrants. |
EQUITY COMPENSATION PLANS
EQUITY COMPENSATION PLANS | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
EQUITY COMPENSATION PLANS | EQUITY COMPENSATION PLANS Stock Incentive Plan The Company’s share-based compensation plan, the Amended and Restated 2017 Employee, Director and Consultant Equity Incentive Plan, or the 2017 Plan, provides for the issuance of incentive stock options, restricted and unrestricted stock awards, and other stock-based awards. As of December 31, 2021, an aggregate of 4.5 million shares of common stock were reserved for issuance under the 2017 Plan, of which 0.1 million were available. Stock Option Activity The Company recognizes compensation costs related to stock-based awards, including stock options, based on the estimated fair value of the awards on the date of grant. The Company grants options with an exercise price equal to the fair market value of the Company’s stock on the date of the option grant. The options are subject to four-year vesting with a one-year cliff and have a contractual term of 10 years. A summary of the Company’s stock option activity under its 2017 Plan for the year ended December 31, 2021 is as follows (in thousands, except for per share data and years): Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (In Years) Aggregate Intrinsic Value Outstanding as of December 31, 2020 2,525 $ 11.80 Granted 2,307 $ 32.00 Forfeited (410) $ 23.09 Exercised (358) $ 11.05 Outstanding as of December 31, 2021 4,064 $ 22.19 8.3 $ 87,303 Vested and exercisable as of December 31, 2021 1,253 $ 11.37 7.1 $ 40,468 The aggregate intrinsic value of stock options exercised during the years ended December 31, 2021 and 2020 was $7.5 million and $19,000, respectively. Aggregate intrinsic value of stock options exercised and outstanding is calculated using the fair value of common stock on the date of exercise and as of December 31, 2021, respectively. Stock-Based Compensation Expense Stock options are valued using the Black-Scholes Merton option pricing model on the date of grant. This option pricing model involves a number of estimates, including the expected lives of the stock options, the Company’s anticipated stock volatility, and interest rates. Stock-based compensation expense is recognized using the straight-line method over the vesting period. The Company recognizes forfeitures as they occur. The weighted-average assumptions used by the Company to estimate the fair value of stock option grants using the Black-Scholes option pricing model, as well as the resulting weighted-average fair value for the years ended December 31, 2021 and 2020 were as follows. YEAR ENDED DECEMBER 31, 2021 2020 Risk-free interest rate 0.71 % 0.42 % Expected volatility 93.49 % 97.72 % Expected dividend yield — % — % Expected term 6.08 6.08 Weighted average fair value $ 24.20 $ 10.82 The Company determines the assumptions used in the option pricing model in the following manner: Risk-Free Interest Rate— For the determination of the risk-free interest rates, the Company utilizes the U.S. Treasury yield curve for instruments in effect at the time of measurement with a term commensurate with the expected term assumption. Expected Volatility— Due to the Company’s limited historical stock price volatility data, the Company based its estimate of expected volatility on the estimated and expected volatilities of a guideline group of publicly traded companies. For these analyses, the Company selected companies with comparable characteristics including enterprise value, risk profiles, and with historical share price information sufficient to meet the expected life of the stock-based awards. The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of its stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Expected Dividend— The expected dividend yield is assumed to be zero since the Company has never paid dividends and does not have current plans to pay any dividends on its common stock. Expected Term— The Company estimates the expected term of its stock options granted to employees and non-employee directors using the simplified method, whereby, the expected term equals the average of the vesting term and the original contractual term of the option. The Company utilizes this method since it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. Prior to the Company’s IPO, given the absence of a public trading market for the Company’s common stock, its board of directors exercised their judgment and considered a number of objective and subjective factors to determine the best estimate of the fair value of the Company’s common stock underlying the stock options, such as: contemporaneous valuations performed by independent third-party specialists, its stage of development, including the status of its research and development efforts of its therapeutic candidates and the material risks related to its business and industry, its results of operations and financial condition, including its levels of capital resources, the prices at which its sold shares of its convertible preferred stock, the rights, preferences and privileges of its convertible preferred stock relative to those of its common stock, the conditions in the biotechnology industry and the economy in general, the stock price performance and volatility of comparable life sciences public companies, as well as recently completed mergers and acquisitions of peer companies, the likelihood of achieving a liquidity event for the holders of its common stock or convertible preferred stock, such as an IPO or a sale of the Company given prevailing market conditions, trends and developments in its industry, external market conditions affecting the life sciences and biotechnology sectors, and the lack of liquidity of its common stock, among other factors. Subsequent to the Company’s IPO, the fair value of the Company’s common stock is determined based on its closing market price on the date of the grant. The Company’s board of directors intended all options granted to be exercisable at a price per share not less than the per share fair value of its common stock underlying those options on the grant date. Stock-based compensation expense for stock options consisted of the following (in thousands): YEAR ENDED DECEMBER 31, 2021 2020 Research and development $ 11,830 $ 4,300 General and administrative 3,218 723 Total stock-based compensation expense $ 15,048 $ 5,023 |
LICENSE AND GRANT REVENUES
LICENSE AND GRANT REVENUES | 12 Months Ended |
Dec. 31, 2021 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
LICENSE AND GRANT REVENUES | LICENSE AND GRANT REVENUES The following table summarizes the total revenue recorded in the Company’s consolidated statements of operations (in thousands): YEAR ENDED DECEMBER 31, 2021 2020 License fee revenue from affiliates Elpiscience Biopharmaceuticals, Inc. $ — $ 2,000 Total license fee revenue from affiliates — 2,000 License fee revenue from non-affiliates 2seventy bio, Inc. 4,200 400 Phylaxis BioScience, LLC 2,392 1,993 Chiesi Farmaceutici S.p.A. 533 7,365 Other license revenues from non-affiliates — 1,050 Total license fee revenue from non-affiliates 7,125 10,808 Grant revenue Congressionally Directed Medical Research Program 106 80 Total grant revenue 106 80 Total revenue $ 7,231 $ 12,888 License and Collaboration Agreements Elpiscience In April 2018, the Company entered into a separate License Agreement, or the OX40 License Agreement, with Elpiscience Biopharmaceuticals, Inc., or Elpiscience, whereby the Company granted Elpiscience an exclusive license to the Company’s multivalent protein therapeutic directed to the biological target OX40, or INBRX-106. This license provides Elpiscience with the right to further advance the therapeutic candidate through clinical trials, as well as manufacture and commercialize it. It also requires the Company to provide Elpiscience with know-how and materials specific to INBRX-106, including process development and manufacturing data and information necessary to develop INBRX-106. In the OX40 License Agreement, the Company also agreed to negotiate an agreement to supply Elpiscience with INBRX-106 for its development in Mainland China, Hong Kong Macau and Taiwan. The Company is eligible to receive certain developmental and commercial milestones of up to an aggregate of $100.0 million, as well as percentage tiered royalties on future product sales with rates in the high single-digits. Due to the uncertainty in the achievement of the developmental and commercial milestones, the variable consideration associated with the future milestone payments has been fully constrained (excluded) from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. This will be re-assessed at each reporting period. In September 2020, the Company achieved a milestone under the contract for $2.0 million, which was received during September 2020. The Company recognized revenue of $2.0 million during the year ended December 31, 2020. No revenue was recognized related to this agreement during the year ended December 31, 2021. 2seventy bio, Inc. 2018 License Agreement On December 20, 2018, the Company entered into a License Agreement with bluebird bio, Inc., or bluebird, whereby the Company granted bluebird the exclusive, worldwide rights to develop, manufacture, and commercialize certain cell therapy products containing binders. In November 2021, bluebird assigned the agreement, or the 2018 2seventy Agreement, to its affiliate, 2seventy bio, Inc., or 2seventy, in connection with an internal restructuring and subsequent spin-out of 2seventy. Under this agreement, the Company is entitled to receive specified development milestone payments of up to an aggregate of $51.5 million per therapeutic, as well as percentage tiered royalties on future product sales with rates in the mid-single-digits. Due to the uncertainty in the achievement of the developmental milestones, the variable consideration associated with the future milestone payments has been fully constrained (excluded) from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. These estimates will be re-assessed at each reporting period. In July 2021, a milestone event under the 2018 2seventy Agreement was achieved and the Company recognized $2.0 million of revenue at that point in time. The Company received the associated $2.0 million payment in August 2021. During the year ended December 31, 2021, the Company recognized a total of $2.0 million in revenue related to this agreement. During the year ended December 31, 2020, the Company recognized no revenue related to this agreement. 2020 Option and License Agreement In June 2020, the Company entered into an Option and License Agreement with bluebird, pursuant to which the Company granted to bluebird exclusive worldwide development licenses to develop binders and cell therapy products containing single domain antibodies, or sdAbs, directed to specified targets, consisting of two initial programs and up to an additional 8 programs. The Company retains all rights to the specific sdAbs outside of the cell therapy field. This agreement, or the 2020 2seventy Agreement, was also assigned to 2seventy in November 2021 in connection with bluebird’s internal restructuring and subsequent spin-out of 2seventy. In June 2020, the Company received a non-refundable upfront option fee of $0.2 million in connection with each of the two initial programs, or $0.4 million in aggregate, and is entitled to an upfront option fee for each additional program, on a program-by-program basis. The Company also granted an option in which 2seventy may acquire an exclusive license with respect to all binders and cell therapy products developed under this agreement, which entitles the Company to additional fees upon exercise of the option. In connection with each program for which 2seventy exercises its option, 2seventy will be required to pay the Company a one-time, non-refundable, non-creditable fee in the low-single-digit millions for each option 2seventy chooses to exercise. The Company is also entitled to receive certain developmental milestone payments of up to an aggregate of $51.5 million per therapeutic, as well as percentage tiered royalties on future product sales with rates in the mid-single-digits. Due to the uncertainty in the achievement of the developmental milestones and future sales, the variable consideration associated with the future milestone payments has been fully constrained (excluded) from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. These estimates will be re-assessed at each reporting period. As of the effective date of the 2020 2seventy Agreement, the Company identified one performance obligation, which was the transfer of the exclusive development license to bluebird for the two initial programs. The Company determined that the option granted for an exclusive license in the future was not a material right. For the eight programs not identified upon execution of the contract, the Company evaluated the customer option for additional purchases and determined that those options for additional programs did not constitute material rights nor variable consideration. As additional programs are identified, the Company will re-assess its performance obligations and transaction price accordingly. The Company determined the total transaction price of the 2020 2seventy Agreement at execution was $0.4 million for the transfer of the two exclusive development licenses. The Company recognized $0.4 million of revenue related to this agreement at the point in time in which the exclusive development licenses were transferred to bluebird, which occurred upon execution of the agreement in June 2020. In May 2021, pursuant to the option extension terms in the 2020 2seventy Agreement, bluebird requested to extend the option term for one of the initial programs by an additional six months in exchange for an option extension fee of $0.1 million. The Company recognized the $0.1 million of revenue related to this extension in May 2021, the point in time in which the extension was granted. In October 2021, pursuant to the option exercise terms in the 2020 2seventy Agreement, the Company received a $2.1 million option exercise fee for one of the initial programs and transferred an exclusive license for the program and recognized the $2.1 million of revenue related to this option exercise at the point in time in which the exclusive license was transferred. During the years ended December 31, 2021 and 2020, the Company recognized $2.2 million and $0.4 million of revenue related to this agreement, respectively. Phylaxis Agreements In July 2020, the Company entered into a joint venture with an entity affiliated with ArrowMark Partners, Phylaxis BioScience, LLC, or Phylaxis. In connection with the joint venture, the Company entered into the following agreements: Contribution Agreement, License Agreement, Limited Liability Company Agreement, and Master Services Agreement, or collectively the Phylaxis Agreements, pursuant to which the Company licensed certain intellectual property and know-how to Phylaxis and agreed to provide services to develop certain compounds. Upon closing, the Company received a $2.5 million nonrefundable, upfront payment from Phylaxis under the Master Services Agreement, or the MSA. The Company has also received an additional $2.5 million, which was payable within 180 days from closing under the MSA, in two payments of $1.25 million each, received in October 2020 and January 2021. Upon closing, the Company received a 10% equity interest in Phylaxis as consideration for the contribution of the license of the Company’s intellectual property and know-how and is entitled to receive an additional 5% based on the achievement of certain milestones. Under the License Agreement, the Company is also entitled to specified development and commercialization milestone payments of up to an aggregate of $225.0 million and $175.0 million, respectively. The Company is also entitled to share in a percentage of the profits of Phylaxis under the Limited Liability Company Agreement. In order to determine the fair value of the equity interest in Phylaxis, the Company engaged a third-party valuation specialist. The valuation report utilized a market approach to establish the total equity value of Phylaxis using inputs not observable in the market, including the discount rate. The fair value of the equity interest was $0.5 million, which has been accounted for under the equity method. The fair value of the equity interest upon the execution of the agreements has been included in the transaction price, along with the $5.0 million of payments due pursuant to the MSA. The Company identified the transfer of the exclusive licenses for, and performance of, development services to modify the first and second compounds as one performance obligation and allocated the transaction price evenly between the two compounds. Revenue related to the performance obligation will be recognized over time as services are performed, based on the Company’s progress to satisfy the performance obligation. During the years ended December 31, 2021 and 2020, the Company recognized $2.4 million and $2.0 million of revenue related to this performance obligation, respectively. As of December 31, 2021, the Company has $1.1 million of deferred revenue related to this agreement, all of which is classified as current. As of December 31, 2020, the Company had $1.6 million and $0.6 million of current and non-current deferred revenue related to this agreement, respectively. Chiesi In May 2019, the Company entered into an Option Agreement, as amended by the First Amendment to Option Agreement, dated August 19, 2019, or the Chiesi Option Agreement, with Chiesi Farmaceutici S.p.A., or Chiesi, pursuant to which the Company granted to Chiesi an exclusive option to obtain an exclusive license to develop and commercialize INBRX-101 outside of the United States and Canada. Under the terms of the Chiesi Option Agreement, the Company received a one-time, non-refundable option initiation payment of $10.0 million in August 2019. If Chiesi chooses to exercise its option under the Chiesi Option Agreement, then Chiesi must pay the Company a one-time, non-refundable fee of $12.5 million upon the effective date of the definitive agreement granting Chiesi the exclusive license. If the option is exercised, under the license agreement, the Company may be entitled to receive specified milestone payments of up to $122.5 million, as well as royalties on future product sales. The Company has identified one performance obligation as of the effective date of the Chiesi Option Agreement, which is to perform research and development services for Chiesi during the option period, which will continue (unless the Chiesi Option Agreement is terminated earlier by the Chiesi or the Company) until 60 days following the last to occur of (i) the Company’s delivery to Chiesi of the trial phase data for the first Phase I Clinical Trial, (ii) the Company’s delivery to Chiesi of the finalized minutes from the definitive U.S. Food and Drug Administration, or FDA, scientific advice meeting conducted following completion of such Phase I Clinical Trial, and (iii) the Company’s delivery to Chiesi of the finalized minutes from the definitive parallel European Medicines Agency health technology assessment, or EMA-HTA, scientific advice meeting conducted following completion of such Phase I Clinical Trial. The Company has determined that the option to grant a license in the future is not a material right. The $10.0 million upfront payment has been allocated to the single performance obligation. Revenue is recognized over time as services are performed during the option period, based on the Company’s effort to satisfy the performance obligation relative to the total expense estimated to be incurred during the option period. During the years ended December 31, 2021 and 2020, the Company recognized $0.5 million and $7.4 million in revenue related to this agreement, respectively. As of December 31, 2021, the Company has $0.9 million and $0.1 million of current and non-current deferred revenue related to this agreement, respectively. As of December 31, 2020, the Company had $1.4 million and $0.1 million of current and non-current deferred revenue related to this agreement, respectively. Celgene In June 2012, the Company entered into a Development and Option Agreement with Celgene whereby the Company granted Celgene an option to exclusively license certain intellectual property rights relating to the Company’s CD47 checkpoint inhibitor. Upon grant of the Development and Option Agreement, Celgene made a non-refundable upfront option payment for the exclusive license. In June 2013, Celgene opted to exercise its right to license the intellectual property rights associated with the Company’s CD47 therapeutic. The Company is also eligible to receive certain developmental and commercial milestones of an aggregate of $934.1 million, assuming the achievement of all potential milestones in the agreement, as well as percentage tiered royalties based on future worldwide sales, with rates ranging between the high single-digits and low teens. The Company is obligated to pay 2% of future amounts received under the Development and Option Agreement to advisors who assisted the Company with the negotiation and other matters in connection with the Development and Option Agreement. Due to the uncertainty in the achievement of the developmental and commercial milestones, the variable consideration associated with the future milestone payments has been fully constrained (excluded) from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. This will be re-assessed at each reporting period. No revenue was recognized under this agreement during the years ended December 31, 2021 and 2020. Government Grants Grant revenue was recognized in accordance with the Company’s stated methodology discussed in Note 1. CDMRP funded through the DoD During September 2018, the Company was awarded a grant by the CDMRP funded through the DoD by the U.S. Army Medical Research Acquisition Activity in the amount of approximately $0.3 million for the continued development of multi-specific antibodies for the treatment against Acinetobacter baumannii infection by circumventing development of bacterial resistance, or the 2018 DoD grant. The work under this grant began in December 2018 and was completed in September 2020. In February 2021, the Company was awarded an additional grant from the DoD in the amount of approximately $0.3 million for the development of sdAb based therapeutics targeting SARS-CoV-2 Spike protein for the treatment of COVID-19, or the 2021 DoD grant. Work under the grant began in February 2021 and is expected to continue through February 2022. Revenue from these grants is based upon internal and subcontractor costs incurred by the Company that are specifically covered by the grants, and where applicable, an additional facilities and administrative rate that provided funding for overhead expenses. Revenue is recognized when the Company incurs these covered expenses related to the grant’s continued progression. The Company submits requests for reimbursement to the DoD for only those expenses which have been incurred by the Company in each period, resulting in reimbursement in arrears. As of December 31, 2021, $0.3 million has been recognized to date under the 2018 DoD grant, all of which has been received in cash from the DoD. As of December 31, 2021, $106,000 has been recognized to date under the 2021 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | RELATED PARTY TRANSACTIONS From time to time, the Company will enter into an agreement with a related party in the ordinary course of its business. These agreements are ratified by the Company’s Board of Directors or a committee thereof pursuant to policy. LAV Summit Limited LAV Summit Limited, or LAV SL, a limited company, is a principal shareholder owning more than 5% of the Company’s outstanding equity interest during the year ended December 31, 2021. Due to this equity ownership, LAV SL was considered a related party. LAV SL’s General Partner, Lilly Asia Ventures, or LAV, through one of its funds, holds a significant equity ownership position in Elpiscience, and the Venture Partner of LAV is the CEO, Founder, and Director at Elpiscience. Accordingly, the Company identified Elpiscience as a related party. As of December 31, 2021, LAV SL no longer holds more than 5% of the Company’s outstanding equity interest. Elpiscience In April 2018, the Company entered into the OX40 License Agreement with Elpiscience, whereby the Company granted Elpiscience an exclusive license to the Company’s multivalent protein therapeutic directed to the biological target OX40, or INBRX-106. Under this agreement, the Company is entitled to reimbursement for certain chemistry, manufacturing, and controls, or CMC, and toxicology expenses incurred for which Elpiscience has paid the Company approximately $5.2 million to date as of December 31, 2021. As of December 31, 2021, the Company has $0.2 million recorded as receivables from related parties from Elpiscience for expenses incurred which have not yet been reimbursed. Additional reimbursements of approximately $38,000 related to multi-year stability studies are expected to be recognized and paid upon completion. During the year ended December 31, 2021, the Company received no reimbursements for expenses already incurred. During the year ended December 31, 2020, the Company received reimbursements of $0.2 million for expenses already incurred. During the year ended December 31, 2021, the Company did not derecognize any expenses related to these reimbursements under the OX40 License Agreement. During the year ended December 31, 2020, the Company derecognized approximately $0.2 million of expenses related to these reimbursements under the OX40 License Agreement, respectively. In July 2020, the Company entered into an additional cost sharing agreement with Elpiscience related to the OX40 License Agreement. Under this agreement, the Company is entitled to reimbursement for certain formulation development costs. Through December 31, 2021, the Company has received $0.2 million of reimbursements for expenses already incurred under this agreement. As of December 31, 2021, the Company has approximately $0.3 million recorded as receivables from related parties from Elpiscience for expenses incurred which have not yet been reimbursed. During the year ended December 31, 2021, the Company received reimbursements of $0.2 million for expenses already incurred. During the year ended December 31, 2021, the Company did not derecognize any expenses related to this agreement. During the year ended December 31, 2020, the Company received no reimbursements. During the year ended December 31, 2020, the Company derecognized $0.3 million of expenses related to this agreement. In July 2021, the Company entered into a Sale and Purchase Agreement with Elpiscience, in which the Company sold drug substance supply to Elpiscience for approximately $37,000, for which it derecognized expenses during the year ended December 31, 2021. As of December 31, 2021, the Company has $37,000 recorded as receivables from related parties for this purchase. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES The components of income tax expense (benefit) were as follows for the years ended December 31, 2021 and 2020, respectively (in thousands): YEAR ENDED DECEMBER 31, 2021 2020 Current expense: State $ 2 $ 3 Total current expense $ 2 $ 3 The provision for the years ended December 31, 2021 and 2020 was related to California state income tax. A reconciliation of income tax expense to the amount computed by applying the statutory federal income tax rate to the loss from operations is summarized for the years ended December 31, 2021 and 2020 as follows (in thousands): YEAR ENDED DECEMBER 31, 2021 2020 Expected income tax benefit at federal statutory rate $ (17,171) $ (15,985) State income tax expense (benefit), net of federal benefit (1,006) 4,548 Permanent items (207) 2,291 R&D credits (1,912) (2,878) Unrecognized tax benefits (FIN 48) 691 707 Return to provision true-ups 165 164 Valuation allowance 19,442 11,156 Income tax expense $ 2 $ 3 Income taxes are accounted for under the asset and liability method. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax assets will not be realized. The components of net deferred income taxes were as follows (in thousands): AS OF DECEMBER 31, 2021 2020 Deferred income tax assets Net operating loss carryforward $ 43,440 $ 27,055 Research and development credits 8,539 6,465 Intangibles 3,875 4,176 Accruals 257 233 Stock compensation 1,888 409 Deferred revenue 456 806 Operating lease liabilities 1,428 1,733 Other 14 3 Gross deferred tax assets 59,897 40,880 Less: Valuation allowance (58,528) (39,087) Total deferred tax assets 1,369 1,793 Deferred income tax liabilities Fixed assets (20) (140) Operating lease right-of-use assets (1,349) (1,653) Total deferred tax liabilities (1,369) (1,793) Net deferred tax assets (liabilities) $ — $ — As of December 31, 2021, the Company had unused federal and state NOL carryforwards of approximately $198.9 million and $24.5 million, respectively. The federal NOL carryforwards may be carried forward indefinitely but are only available to offset up to 80% of pre-NOL taxable income each year. The state NOL carryforwards will begin to expire in 2038, if not utilized. As of December 31, 2021, the Company also had federal and state research tax credit carryforwards of $8.3 million and $3.9 million, respectively. The federal research tax credit carryforwards begin to expire in 2038, while the state carryforwards have no expiration. The utilization of NOL and research tax credit carryforwards to offset future taxable income may be subject to an annual limitation as a result of ownership changes that have occurred previously or may occur in the future. Under Sections 382 and 383 of the IRC, a corporation that undergoes an “ownership change” may be subject to limitations on its ability to utilize its pre-change NOLs and other tax attributes otherwise available to offset future taxable income and/or tax liability. An ownership change is defined as a cumulative change of 50% or more in the ownership positions of certain stockholders during a rolling three-year period. The Company has not completed a formal study to determine if any ownership changes within the meaning of IRC Section 382 and 383 have occurred. It is possible that the Company has already incurred ownership changes and may incur additional ownership changes in the future. If an ownership change has occurred, the Company’s ability to use its NOL or tax credit carryforwards may be restricted, which could require the Company to pay federal or state income taxes earlier than would be required if such limitations were not in effect. The Company has established a full valuation allowance against its deferred tax assets due to uncertainties that preclude it from determining that it is more likely than not that the Company will be able to generate sufficient taxable income to realize such assets. Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred over the three-year period ended December 31, 2021. Such objective evidence limits the ability to consider other subjective evidence such as the Company’s projections for future growth. Based on this evaluation, as of December 31, 2021, a valuation allowance of $58.5 million has been recorded in order to measure only the portion of the deferred tax asset that more likely than not will be realized. The amount of the deferred tax asset considered realizable, however, could be adjusted if objective negative evidence in the form of cumulative losses is no longer present and additional weight may be given to subjective evidence, such as estimates of future taxable income during carryforward periods and the Company’s projections for growth. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While the Company believes that it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcome of examinations by tax authorities in determining the adequacy of its provision for income taxes. The following table summarizes the activity related to the Company’s unrecognized tax benefits (in thousands): AS OF DECEMBER 31, 2021 2020 Beginning balance $ 2,155 $ 1,499 Increases related to current year tax positions 691 656 Ending balance $ 2,846 $ 2,155 As of December 31, 2021, the Company had gross unrecognized tax benefits of $2.8 million, none of which would affect the effective tax rate due to the existence of a full valuation allowance. The Company does not expect any significant increases or decreases to its unrecognized tax benefits within the next 12 months. The Company’s policy is to recognize the interest expense and/or penalties related to income tax matters as a component of income tax expense. The Company had no accrual for interest or penalties on its consolidated balance sheets as of December 31, 2021 or December 31, 2020, and has not recognized interest and/or penalties in its consolidated statements of operations for the years ended December 31, 2021 and 2020 as the unrecognized tax benefits relate to tax positions for which no cash tax liability has been reduced. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
LEASES | LEASES Operating Leases In September 2017, the Company entered into a seven-year lease agreement for approximately 34,000 square feet as its sole location in La Jolla, California. The lease expires in June 2025 with an option to extend the lease an additional five years. The lease contained an initial base rent of approximately $0.1 million per month with 2% annual escalations, plus a percentage of taxes and operating expenses incurred by the lessor in connection with the ownership and management of the property, the latter of which to be determined annually. In May 2019, the Company executed an amendment to its lease agreement to expand its facilities by approximately 9,000 square feet and began occupying this space in January 2020. The amended lease terminates coterminously with the initial lease agreement and contains an initial base rent of approximately $30,000 per month with 2% annual escalations, plus a percentage of taxes and operating expenses incurred by the lessor in connection with the ownership and management of the property, the latter of which is to be determined annually. The right-of-use asset and operating lease liability as of December 31, 2021 and 2020 are as follows: AS OF DECEMBER 31, 2021 2020 Right-of-use asset $ 6,338 $ 7,831 Operating lease liability Current 1,674 1,503 Non-current 5,033 6,707 Total operating lease liability $ 6,707 $ 8,210 During each of the years ended December 31, 2021 and 2020, the Company recognized operating lease expense of $3.1 million. As of December 31, 2021 and 2020, the Company’s operating lease had a remaining term of 3.5 and 4.5 years, respectively. The Company discounts its lease payments using its incremental borrowing rate as of the commencement of the lease. The Company has determined a weighted-average discount rate of 8.2% as of December 31, 2021 and 2020. Future minimum rental payments under operating leases are as follows (in thousands): AS OF DECEMBER 31, 2021 2022 2,161 2023 2,203 2024 2,247 2025 1,137 Total future minimum lease payments $ 7,748 Less: imputed interest (1,041) Present value of operating lease liability 6,707 Less: current portion of operating lease liability (1,674) Non-current portion of operating lease liability $ 5,033 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Litigation The Company is not party to any material legal proceedings. From time to time, it may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on the Company because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained. Indemnification In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. In some cases, the indemnification obligation will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. In addition, the Company has entered into indemnification agreements with its directors and certain officers that may require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. To date, no demands have been made upon the Company to provide indemnification under these agreements, and thus, there are no indemnification claims that the Company is aware of that could have a material effect on the Company’s consolidated balance sheets, consolidated statements of operations, or consolidated statements of cash flows. Purchase Commitments The Company has several ongoing contracts with CROs for preclinical studies and clinical trials and with CDMOs for clinical supplies and manufacturing scale-up activities. These contracts are generally cancellable, with notice, at the Company’s option. The Company recorded accrued expenses of approximately $7.4 million and $11.5 million in its consolidated balance sheets for expenditures incurred by CROs and CDMOs as of December 31, 2021 and December 31, 2020, respectively. While these contracts are generally cancellable, some may contain specific activities that involve one or more non-cancellable commitments, including minimum purchase commitments, binding annual forecasts, and capital equipment investments. Additionally, depending on the timing and reasoning of the exit, certain termination penalties may apply and can range from cost of work performed to date and up to twelve months of future committed manufacturing costs. As of December 31, 2021 and December 31, 2020, the non-cancellable portion of these contracts total in aggregate, excluding amounts recorded in accounts payable and accrued expenses at each respective date, was approximately $2.4 million and $7.0 million, respectively. During the years ended December 31, 2021 and 2020, the Company incurred $1.0 million and $30.2 million of expenses related to these agreements, respectively. Other Commitments |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS For the audited consolidated financial statements as of December 31, 2021, the Company evaluated subsequent events to assess the need for potential recognition or disclosure in this report. Based upon this evaluation, it was determined that no additional subsequent events required recognition or disclosure in these consolidated financial statements, other than disclosures related to those outlined below. Stock Option Issuance During January and February 2022, the Company granted stock options to purchase an aggregate of 0.8 million common shares at a weighted average exercise price of $33.84 per share to employees under the 2017 Equity Incentive Plan. The Company granted these options with an exercise price equal to the fair market value of the Company’s stock on the date of the option grant. The options are subject to four-year vesting with a one-year cliff and have a contractual term of 10 years. Amendment to the 2020 Loan Agreement with Oxford On February 18, 2022, the Company entered into an additional amendment to the 2020 Loan Agreement, or the February 2022 Amendment. The February 2022 Amendment provides for four additional tranches of term loans in an aggregate principal amount of up to $200.0 million, as follows: (a) an aggregate principal amount of $110.0 million, which includes the $70.0 million already outstanding; the incremental $40.0 million principal amount funded upon the closing of the February 2022 Amendment, or Term D, (b) an aggregate principal amount of $30.0 million, funded upon initiation of Part 4 of the INBRX-105 Phase 1 clinical trial, or Term E, (c) an aggregate principal of $30.0 million, funded upon the reception of positive topline Phase 1 data from INBRX-101 in AAT, or Term F, and (d) an aggregate principal amount of $30.0 million, funded upon the initiation of an INBRX-101 potential registration-enabling trial in AAT, or Term G. In accordance with the February 2022 Amendment, the Company paid a one-time amendment fee of $1.1 million, which is equal to the amount accreted for the final payment on the existing tranches at the time of the amendment. The terms of the three existing tranches under the Amended 2020 Loan Agreement were modified to align with the four additional tranches under the February 2022 Amendment. The outstanding term loans will mature on January 1, 2027 and bear interest at the greater of (1) 8.30% and (2) the sum of (i) the 30 day U.S. Dollar LIBOR 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 (ii) 8.19%. The repayment schedule provides for interest-only payments through February 1, 2025, with principal payments beginning on March 1, 2025. The interest-only payments may be extended by 12 months through February 2026, with principal payments beginning on March 1, 2026, if the Company raises at least $100.0 million in upfront licensing or partnership proceeds by February 2025. The interest-only period is followed by 23 months of equal payments of principal plus interest, or if the interest-only period is extended, by 11 months of equal payments of principal plus interest. Upon the maturity date of January 1, 2027, a final payment of 9.0% of the total principal amount will be due to Oxford. The Company has the option to prepay the outstanding balance of the term loan in full prior to maturity, subject to a prepayment fee ranging from 1.0% to 3.0%, depending on the timing of the prepayment. The Company granted Oxford a first priority lien against all of its assets with a positive lien on intellectual property. All other terms of the Amended 2020 Loan Agreement remain outstanding. Concurrently with the debt issuance upon the February 2022 Amendment, the Company issued to Oxford warrants to purchase 40,000 shares of the Company’s common stock at a strike price of $45.00 per share. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or the SEC, related to an annual report on the Form 10-K. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary and have been prepared in conformity with GAAP. All intercompany accounts and transactions have been eliminated in consolidation. |
Liquidity | Liquidity As of December 31, 2021, the Company had an accumulated deficit of $227.1 million and cash and cash equivalents of $131.3 million. From its inception and through December 31, 2021, the Company has devoted substantially all of its efforts to therapeutic drug discovery and development, conducting preclinical studies and clinical trials, enabling manufacturing activities in support of its therapeutic candidates, organizing and staffing the Company, establishing its intellectual property portfolio and raising capital to support and expand these activities. The Company believes that its existing cash and cash equivalents will be sufficient to fund the Company’s operations for at least 12 months from the date these consolidated financial statements are issued. The Company plans to finance its future cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements. As discussed in Note 5, the Company entered into the Open Market Sale Agreement, or the Sales Agreement, with Jefferies LLC, or the Sales Agent, under which it may, from time to time, sell shares of its common stock having an aggregate offering price of up to $200.0 million through the Sales Agent, or the ATM Offering. As of December 31, 2021, 921,042 shares have been sold pursuant to the Sales Agreement for net proceeds of $40.2 million, after deducting commissions. If the Company does raise additional capital through public or private equity or convertible debt offerings, the ownership interests of its existing stockholders will be diluted, and the terms of those securities may include liquidation or other preferences that adversely affect its stockholders’ rights. If the Company raises capital through additional debt financings, it may be subject to covenants limiting or restricting its ability to take specific actions, such as incurring additional debt or making certain capital expenditures. To the extent that the Company raises additional capital through strategic licensing, collaboration or other similar agreement, it may have to relinquish valuable rights to its therapeutic candidates, future revenue streams or research programs at an earlier stage of development or on less favorable terms than it would otherwise choose, or to grant licenses on terms that may not be favorable to the Company. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future. If the Company is unable to secure adequate additional funding, it will need to reevaluate its operating plan and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of its development programs, or relinquish rights to its technology on less favorable terms than it would otherwise choose. These actions could materially impact its business, financial condition, results of operations and prospects. |
Use of Estimates | Use of Estimates The preparation of these consolidated financial statements in conformity with GAAP requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expense and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. The Company’s most significant estimates relate to evaluation of embedded derivative instruments and beneficial conversion features, or BCFs, within its previously issued and outstanding convertible notes, whether revenue recognition criteria have been met, accounting for development work and preclinical studies and clinical trials, determining the assumptions used in measuring stock-based compensation, the incremental borrowing rate estimated in relation to the Company’s operating lease, and valuation allowances for the Company’s deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. The Company’s actual results may differ from these estimates under different assumptions or conditions. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments consist principally of accounts receivable, accounts payable, accrued expense, its long-term debt, convertible notes, warrants, and derivative instruments as applicable. The carrying amounts of financial instruments such as accounts receivable, accounts payable, accrued expense, and convertible notes approximate their related fair values due to the short-term nature of these instruments. The carrying value of the Company’s debt approximates fair value due to its interest being reflective of current market rates for debt with similar terms and conditions. The Company’s derivative instruments and warrants are carried at fair value based on unobservable market inputs. |
Cash and Cash Equivalents | Cash and Cash EquivalentsCash and cash equivalents are comprised of cash held in financial institutions including readily available checking and money market accounts. |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial condition of the depository institutions in which those deposits are held. The Company continually evaluates its accounts receivable for all outstanding third-party balances to determine the potential exposure to a concentration of credit risk. The Company’s major third-party contracting parties, some of which account for significant balances in both accounts receivable and revenue, are generally large, credit-worthy biotechnology companies and government bodies. The Company assesses the collectability of accounts receivable through a review of its current aging, as well as an analysis of its historical collection rate, general economic conditions, and credit status of these third parties. As of December 31, 2021 and 2020, all outstanding accounts receivable were deemed to be fully collectible, and therefore, no allowance for doubtful accounts was recorded. |
Dividends | Dividends As of December 31, 2021, the Company has never declared or paid any dividends on its common stock. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost less accumulated depreciation. Depreciation is provided on a straight-line basis over the estimated useful lives of the assets. The Company estimates useful lives as follows: • machinery and equipment: three • furniture and fixtures: three • computer software: four |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss is recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. If such assets are considered impaired, the amount of the impairment loss recognized is measured as the amount by which the carrying value of the asset exceeds the fair value of the asset, fair value being determined based upon future cash flows or appraised values, depending on the nature of the asset. The Company recognized no impairment losses during any of the periods presented within its consolidated financial statements. |
Leases | Leases The Company has two existing leases for its corporate headquarters in La Jolla, California. Its first lease commenced in June 2018. In May 2019, the Company signed an amendment to its lease agreement to expand the Company’s facilities, which commenced in January 2020 and is accounted for as a separate lease. The Company’s two existing leases are classified as operating leases. For the long-term operating lease of its corporate headquarters, the Company recognized a right-of-use asset and lease liability on its consolidated balance sheet. The lease liability is determined as the present value of future lease payments using an estimated incremental borrowing rate that the Company would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The right-of-use asset is based on the liability adjusted for any prepaid or deferred rent. The lease term at the commencement date is determined by considering whether renewal options and termination options are reasonably assured of exercise. Agreements are reviewed at inception to determine if they contain a lease. Leases are reviewed and classified as operating or financing leases at commencement. The Company has elected to exclude from its consolidated balance sheets recognition of leases having a term of 12 months or less (short-term leases) and has elected not to separate lease components and non-lease components for its long-term operating leases. |
Equity Method Investment | Equity Method Investment The Company uses the equity method of accounting for equity investments in companies if the investment provides the ability to exercise significant influence, but not control, over operating and financial policies of the investee. As discussed in Note 7, the Company received an equity investment in the form of a 10% equity interest as consideration in a series of agreements with Phylaxis (as defined below), which is accounted for as an equity method investment. The Company's proportionate share of the net income or loss of these companies is included as loss in equity method investment in the consolidated statement of operations. Judgment regarding the level of influence over each equity method investment includes considering key factors such as the Company’s ownership interest, representation on the board of directors, legal form of the investee (e.g. limited liability corporation), participation in policy-making decisions, and material purchase and sale transactions. During the third quarter of 2020, the Company’s equity method investment was written down to zero as a result of the allocation of the Company’s share of losses of the investee. As of December 31, 2021 and 2020, the equity method investment remains at zero. |
Derivative Liabilities | Derivative Liabilities As discussed in Note 4, the convertible promissory note, or the 2019 Note, issued in May 2019 to DRAGSA 50 LLC, an entity affiliated with Viking Global Investors LP, or Viking, and the convertible promissory notes, or the 2020 Notes, issued in April 2020 to Viking and certain other investors contained embedded features that provided multiple settlement alternatives. Certain of these settlement features provided the noteholders with a right to a fixed number of the Company’s shares upon conversion of the note. Other settlement features provided the noteholders the right or the obligation to receive cash or a variable number of shares upon the completion of a capital raising transaction, change of control, qualified IPO (as defined in the 2019 Note and the 2020 Notes), or default of the Company. The Company evaluated each settlement alternative within the 2019 Note and the 2020 Notes under the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 815-15, Embedded Derivatives and ASC Topic 815-40, Contracts in Entity’s Own Equity and determined certain of the settlement features would be accounted for as redemption features meeting the requirements for separate accounting as a single, compound derivative instrument. This single, compound derivative instrument was accounted for as a liability at its estimated fair value as of the date of issuance, and then subsequently remeasured to fair value as of each balance sheet date, with the related remeasurement adjustment being recognized as a component of change in fair value of derivative liabilities in the consolidated statements of operations. During August 2020, the Company consummated its IPO, resulting in the conversion of the 2019 Note and the 2020 Notes into shares of the Company’s common stock. As of December 31, 2021 and 2020, the derivative liabilities no longer exist. |
Warrant Liabilities | Warrant Liabilities As discussed in Note 3, in conjunction with the 2020 Loan Agreement with Oxford, the Company issued warrants for the purchase of: 1) its preferred stock if the Company remained privately-held or 2) common stock upon the successful completion of an IPO prior to December 31, 2020. Upon the issuance of the warrants in July 2020, pursuant to ASC Topic 480, the warrants were accounted for as liabilities and measured at their estimated fair value as of the date of issuance, based on the potential conversion into preferred stock. During August 2020, upon consummation of the Company’s IPO, the warrants were deemed to be issued for the purchase of common stock and |
Fair Value Measurements | Fair Value Measurements The Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established by accounting guidance and prioritizes the inputs used in measuring fair value. These tiers include: • Level 1 - Quoted prices in active markets for identical assets or liabilities. • Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the level in the fair value hierarchy within which the fair value measurement in its entirety falls has been determined based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The 2019 Note and the 2020 Notes contained embedded derivative liabilities (see Note 4). The 2020 Loan Agreement contained warrant liabilities (see Note 3). Prior to the completion of the IPO in August 2020, these were classified within Level 3 of the hierarchy, since they were valued by using inputs that were unobservable in the market. Upon the consummation of the IPO in August 2020, the derivative liabilities and warrant liabilities no longer existed. As of December 31, 2021 and 2020, the Company had no financial liabilities measured at fair value. |
Deferred Financing Costs and Other Debt-Related Costs and Deferred Offering Costs | Deferred Financing Costs and Other Debt-Related Costs Deferred financing costs are capitalized, recorded as an offset to the Company’s debt balances and amortized as interest expense over the term of the associated debt instrument using the effective interest method, pursuant to ASC Topic 835-30, Imputation of Interest . If the maturity of the debt is accelerated as a result of default or early debt repayment, the amortization would then be accelerated. Amounts paid related to debt financing activities are presented on the consolidated balance sheet as a direct deduction from the debt liability. Deferred Offering Costs The Company capitalizes costs that are directly associated with equity financings until such financings are consummated at which time such costs are recorded against the gross proceeds of the offering. Legal, accounting, and filing fees related directly to the Company’s IPO were capitalized as deferred offering costs to be offset against proceeds upon the consummation of the IPO within stockholders’ equity (deficit). In August 2020, the Company completed its IPO and offset $11.0 million of IPO costs against the proceeds. No deferred offering costs were capitalized on the Company’s consolidated balance sheets as of December 31, 2020. |
Revenue Recognition | Revenue Recognition The Company has generated revenue from its license and collaboration agreements with partners, as well as from grants from government agencies and private not-for-profit organizations. Payments received from customers are included in deferred revenue, allocated between current and non-current on the consolidated balance sheet until all revenue recognition criteria are met. In accordance with ASC Topic 606, Revenue from Contracts with Customers, or ASC Topic 606, the Company recognizes revenue when, or as, the promised goods or services are transferred to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those services. To determine revenue recognition for arrangements the Company concludes are within the scope of ASC Topic 606, the Company performs the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligation(s) in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligation(s) in the contract; and (5) recognize revenue when (or as) the performance obligation(s) are satisfied. At contract inception, the Company assesses the goods or services promised within each contract, assesses whether each promised good or service is distinct and identifies those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. Collaborative Research, Development, and License Agreements The Company enters into collaborative agreements with partners that typically include one or more of the following: (1) license fees; (2) nonrefundable up-front fees; (3) payments for reimbursement of research costs; (4) payments associated with achieving specific development, regulatory, or commercial milestones; and (5) royalties based on specified percentages of net product sales, if any. At the initiation of an agreement, the Company analyzes whether each unit of account results in a contract with a customer under ASC Topic 606 or in an arrangement with a collaborator subject to guidance under ASC Topic 808, Collaborative Arrangements , or ASC Topic 808. The Company’s licensing arrangements are typically for functional intellectual property as it exists at a point in time, being the time that the license agreement is executed. The Company typically does not have an ongoing performance obligation to support or maintain the licensed intellectual property. The Company considers a variety of factors in determining the appropriate estimates and assumptions under these arrangements, such as whether the elements are distinct performance obligations, whether there are observable stand-alone prices, and whether any licenses are functional or symbolic. The Company evaluates each performance obligation to determine if it can be satisfied and recognized as revenue at a point in time or over time. Typically, license fees, non-refundable upfront fees, and funding of research activities are considered fixed, while milestone payments are identified as variable consideration which must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. The Company estimates the amount of variable consideration using the most likely amount, as milestone payments typically only have two possible outcomes. The Company recognizes revenue for sales-based royalty promised in exchange for the license of intellectual property only when the subsequent sale occurs. In the case of an agreement which provides the partner with an option to license a therapeutic or therapeutic candidate in the future, the Company evaluates whether this option represents a material right at the inception of the agreement. If determined to be a material right, the Company will consider the option a separate performance obligation. The Company has historically concluded that the option to grant a license in the future are not material rights as they are contingent upon future events which may not occur. When an option is exercised, the Company will identify any separate performance obligations. The Company may allocate transaction price using a number of methods including estimating standalone selling price of performance obligations and using the residual approach when the standalone selling price of the license is highly variable or uncertain, and observable standalone selling prices exist for the other goods or services promised in the contract. Grant Revenue The Company has been awarded grants from the Congressionally Directed Medical Research Program, or CDMRP, funded through the DoD. With respect to revenue derived from reimbursement of direct, out-of-pocket expenses for research and development costs associated with these grants, where the Company acts as a principal with discretion to choose suppliers, bears credit risk, and performs part of the services required in the transaction, the Company records revenue for the gross amount of the reimbursement. The costs associated with these reimbursements are reflected as a component of research and development expense in the consolidated statements of operations. Since there is no transfer of control of goods or services to the granting entities, the granting entities do not meet the definition of a “customer” as defined by ASC Topic 606 and therefore, these government grants and private not-for-profit institution grants are not within the scope of ASC Topic 606. |
Research and Development and Clinical Trial Accruals | Research and Development and Clinical Trial Accruals Research and development costs are expensed as incurred and include the cost of compensation and related expenses, as well as expenses for third parties who conduct research and development on the Company’s behalf, pursuant to development and consulting agreements in place. The Company’s preclinical studies and clinical trials are performed internally, by third party contract research organizations, or CROs, and/or clinical investigators. The Company also engages with CDMOs, for clinical supplies and manufacturing scale-up activities related to its therapeutic candidates. Invoicing from these third parties may be monthly based upon services performed or based upon milestones achieved. The Company accrues these expenses based upon its assessment of the status of each clinical trial and the work completed, and upon information obtained from the CROs and CDMOs. The Company’s estimates are dependent upon the timeliness and accuracy of data provided by the CROs and CDMOs regarding the status and cost of the studies. Costs incurred related to the Company’s purchases of in-process research and development for early-stage products or products that are not commercially viable and ready for use, or have no alternative future use, are charged to expense in the period incurred. Costs incurred related to the licensing of products that have not yet received marketing approval to be marketed, or that are not commercially viable and ready for use, or have no alternative future use, are charged to expense in the period incurred. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax assets will not be realized. The Company also follows the provisions of accounting for uncertainty in income taxes which prescribes a model for the recognition and measurement of a tax position taken or expected to be taken in a tax return, and provides guidance on derecognition, classification, interest and penalties, disclosure and transition. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the same period. Diluted net loss per share is computed by dividing net loss by the weighted average number of common and common equivalent shares outstanding during the same period. The Company excludes common stock equivalents from the calculation of diluted net loss per share when the effect is anti-dilutive. For purposes of the diluted net loss per share calculation, warrants for purchase of common stock and stock options are considered to be potentially dilutive securities. Basic and diluted net loss attributable to common stockholders per share is presented in conformity with the two class method required for participating securities as the convertible preferred stock is considered a participating security. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders. Accordingly, for the years ended December 31, 2021 and 2020, there is no difference in the number of shares used to calculate basic and diluted shares outstanding. |
Fair Value of Stock-Based Awards | Fair Value of Stock-Based Awards The Company recognizes compensation costs related to stock options based on the estimated fair value of the awards on the date of grant. The Company estimates the grant date fair value, and the resulting stock-based compensation expense, using the Black-Scholes option pricing model. The grant date fair value of the stock-based awards is generally recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. The Company recognizes forfeitures as they occur. |
Other Comprehensive Income | Other Comprehensive Income The Company has no material components of other comprehensive loss and accordingly, net loss is equal to comprehensive loss in all periods presented. |
Segment Information | Segment Information The Company operates under one segment which develops biologic therapeutic candidates. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies. Unless otherwise stated, the Company believes that the impact of the recently issued accounting pronouncements that are not yet effective will not have a material impact on its consolidated financial condition or results of operations upon adoption. Adoption of New Accounting Pronouncements In January 2020, the FASB issued ASU 2020-01, Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815), - Clarifying the Interactions between Topic 321, Topic 323, and Topic 815, which addresses the accounting for the transition into and out of the equity method and provides clarification of the interaction of rules for equity securities, the equity method of accounting, and forward contracts and purchase options on certain types of securities. The amendments clarify that: (a) an entity should consider observable transactions that require it to either apply or discontinue the equity method of accounting for the purposes of applying the measurement alternative in accordance with Topic 321 immediately before applying or upon discontinuing the equity method; and (b) an entity should not consider whether, upon the settlement of the forward contract or exercise of the purchased option, individually or with existing investments, the underlying securities would be accounted for under the equity method in Topic 323 or the fair value option in accordance with the financial instruments guidance in Topic 825. The provisions of this guidance are to be applied prospectively upon their effective date. ASU 2020-01 was effective for fiscal years beginning after December 15, 2020, and interim periods within those years. Early adoption was permitted, but required simultaneous adoption of all provisions of this guidance. The Company adopted this guidance as of January 1, 2021, which did not result in a material impact on its consolidated financial statements and related disclosures. In December 2019, the FASB issued ASU 2019-12, Income Taxes : Simplifying the Accounting for Income Taxes (Topic 740), which simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. ASU 2019-12 also improves consistent application and simplification of other areas of Topic 740 by clarifying and amending existing guidance. ASU 2019-12 was effective for fiscal years beginning after December 15, 2020. The Company adopted this guidance as of January 1, 2021, which did not result in a material impact on its consolidated financial statements and related disclosures. In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options, or Subtopic 470-20 and Derivatives and Hedging—Contracts in Entity’s Own Equity, or Subtopic 815-40: Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. Specifically, ASU 2020-06 simplifies accounting for the issuance of convertible instruments by removing major separation models required under current GAAP. In addition, the ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and simplifies the diluted earnings per share, or EPS, calculation in certain areas. ASU 2020-06 will be effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, beginning in fiscal years which begin after December 15, 2020, including interim periods within those fiscal years. The Company early adopted ASU 2020-06 under a modified retrospective approach as of January 1, 2021. As a result of the adoption, there was no impact on retained earnings or other components of equity or to earnings per share in the Company’s consolidated financial statements. Accounting Standards Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses : Measurement of Credit Losses on Financial Statements (Topic 362), which intends to improve financial reporting by requiring earlier recognition of credit losses on certain financial assets, such as available-for-sale debt securities. Subsequent to the issuance of ASU 2016-13, the FASB issued several additional ASUs to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance. In November 2019, the FASB issued an amendment making this ASU effective for fiscal years beginning after December 15, 2022 for smaller reporting companies. The Company was a smaller reporting company at the determination date, and therefore the new standard will be effective for the Company on January 1, 2023. The Company is currently evaluating the potential impact that the adoption of ASU 2016-13 may have on its consolidated financial statements and related disclosures. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options , which intends to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The guidance is effective for fiscal years beginning after December 15, 2021, including interim periods therein, and early adoption is permitted. The Company is currently evaluating the potential impact that the adoption of ASU 2021-04 may have on its consolidated financial statements and related disclosures. |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Reconciliation of Notes Measured at Fair Value Using Level 3 Unobservable Inputs | Prior to the completion of the IPO in August 2020, the Company’s liabilities that were measured at fair value on a recurring basis using significant unobservable inputs (Level 3) included the derivative liabilities related to the 2019 Note and the 2020 Notes and the warrants issued with the 2020 Loan Agreement. The following table provides a reconciliation of financial instruments measured at fair value using Level 3 unobservable inputs for the year ended December 31, 2020 (in thousands): Balance as of December 31, 2019 $ 1,916 Establishment of derivative liability on the 2020 Notes 735 Establishment of warrant liabilities on the 2020 Loan Agreement 115 Change in fair value of derivative liabilities on the 2019 and 2020 Notes (2,651) Change in fair value of warrant liabilities 24 Reclassification of warrant liabilities into equity (139) Balance as of December 31, 2020 $ — |
Schedule of Potential Dilutive Securities Excluded from Diluted Loss Per Share | Potentially dilutive securities not included in the calculation of diluted net loss per share, because to do so would be anti-dilutive, are as follows (in thousands): AS OF DECEMBER 31, 2021 2020 Outstanding stock options 4,064 2,525 Warrant to purchase common stock 7 7 4,071 2,532 |
OTHER FINANCIAL INFORMATION (Ta
OTHER FINANCIAL INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Prepaid Expense and Other Current Assets | Prepaid expense and other current assets were comprised of the following (in thousands): AS OF DECEMBER 31, 2021 2020 Outside research and development services $ 6,343 $ 2,204 Other 590 689 Prepaid expense and other current assets $ 6,933 $ 2,893 |
Schedule of Property and Equipment | Property and equipment, net were comprised of the following (in thousands): AS OF DECEMBER 31, 2021 2020 Machinery and equipment $ 6,286 $ 5,652 Leasehold improvements 441 441 Furniture and fixtures 514 507 Computer software 42 — Construction in process 281 257 Total property and equipment 7,564 6,857 Less: accumulated depreciation and amortization (4,411) (3,365) Property and equipment, net $ 3,153 $ 3,492 Depreciation and amortization expense totaled $1.2 million and $1.0 million for the years ended December 31, 2021 and 2020, respectively, and consisted of the following (in thousands): YEAR ENDED DECEMBER 31, 2021 2020 Research and development $ 1,003 $ 836 General and administrative 192 183 Total depreciation and amortization expense $ 1,195 $ 1,019 |
Schedule of Accrued Expenses | Accrued Expenses Accrued expenses were comprised of the following (in thousands): AS OF DECEMBER 31, 2021 2020 Clinical research and development $ 4,496 $ 970 Other outside research and development 2,893 10,559 Compensation expense 1,322 1,165 Professional fees 261 282 Other 649 381 Accrued expenses $ 9,621 $ 13,357 |
DEBT (Tables)
DEBT (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | The Company’s outstanding debt balance under the Amended 2020 Loan Agreement consisted of the following (in thousands). AS OF DECEMBER 31, 2021 2020 Term A $ 10,900 $ 10,900 Term B 21,800 21,800 Term C 43,600 — Less: Debt discount (5,830) (3,456) Total debt 70,470 29,244 Less: Current portion, including debt discount — — Long-term debt, including debt discount $ 70,470 $ 29,244 |
Schedule of Maturities of Long-term Debt | Through 2024, the Company is only required to make interest payments on the outstanding principal balance, with future principal payments and final fee payments beginning in 2025, as follows (in thousands): AS OF DECEMBER 31, 2021 2021 2025 $ 76,300 Total future minimum payments 76,300 Less: unamortized debt discount (5,830) Total debt $ 70,470 |
EQUITY COMPENSATION PLANS (Tabl
EQUITY COMPENSATION PLANS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock Options Activity | A summary of the Company’s stock option activity under its 2017 Plan for the year ended December 31, 2021 is as follows (in thousands, except for per share data and years): Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (In Years) Aggregate Intrinsic Value Outstanding as of December 31, 2020 2,525 $ 11.80 Granted 2,307 $ 32.00 Forfeited (410) $ 23.09 Exercised (358) $ 11.05 Outstanding as of December 31, 2021 4,064 $ 22.19 8.3 $ 87,303 Vested and exercisable as of December 31, 2021 1,253 $ 11.37 7.1 $ 40,468 |
Schedule of Weighted-Average Assumptions Used to Estimate Fair Value | The weighted-average assumptions used by the Company to estimate the fair value of stock option grants using the Black-Scholes option pricing model, as well as the resulting weighted-average fair value for the years ended December 31, 2021 and 2020 were as follows. YEAR ENDED DECEMBER 31, 2021 2020 Risk-free interest rate 0.71 % 0.42 % Expected volatility 93.49 % 97.72 % Expected dividend yield — % — % Expected term 6.08 6.08 Weighted average fair value $ 24.20 $ 10.82 |
Schedule of Stock-Based Compensation Expense | Stock-based compensation expense for stock options consisted of the following (in thousands): YEAR ENDED DECEMBER 31, 2021 2020 Research and development $ 11,830 $ 4,300 General and administrative 3,218 723 Total stock-based compensation expense $ 15,048 $ 5,023 |
LICENSE AND GRANT REVENUES (Tab
LICENSE AND GRANT REVENUES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
Schedule of License and Grant Revenue | The following table summarizes the total revenue recorded in the Company’s consolidated statements of operations (in thousands): YEAR ENDED DECEMBER 31, 2021 2020 License fee revenue from affiliates Elpiscience Biopharmaceuticals, Inc. $ — $ 2,000 Total license fee revenue from affiliates — 2,000 License fee revenue from non-affiliates 2seventy bio, Inc. 4,200 400 Phylaxis BioScience, LLC 2,392 1,993 Chiesi Farmaceutici S.p.A. 533 7,365 Other license revenues from non-affiliates — 1,050 Total license fee revenue from non-affiliates 7,125 10,808 Grant revenue Congressionally Directed Medical Research Program 106 80 Total grant revenue 106 80 Total revenue $ 7,231 $ 12,888 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The components of income tax expense (benefit) were as follows for the years ended December 31, 2021 and 2020, respectively (in thousands): YEAR ENDED DECEMBER 31, 2021 2020 Current expense: State $ 2 $ 3 Total current expense $ 2 $ 3 |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of income tax expense to the amount computed by applying the statutory federal income tax rate to the loss from operations is summarized for the years ended December 31, 2021 and 2020 as follows (in thousands): YEAR ENDED DECEMBER 31, 2021 2020 Expected income tax benefit at federal statutory rate $ (17,171) $ (15,985) State income tax expense (benefit), net of federal benefit (1,006) 4,548 Permanent items (207) 2,291 R&D credits (1,912) (2,878) Unrecognized tax benefits (FIN 48) 691 707 Return to provision true-ups 165 164 Valuation allowance 19,442 11,156 Income tax expense $ 2 $ 3 |
Schedule of Deferred Tax Assets and Liabilities | The components of net deferred income taxes were as follows (in thousands): AS OF DECEMBER 31, 2021 2020 Deferred income tax assets Net operating loss carryforward $ 43,440 $ 27,055 Research and development credits 8,539 6,465 Intangibles 3,875 4,176 Accruals 257 233 Stock compensation 1,888 409 Deferred revenue 456 806 Operating lease liabilities 1,428 1,733 Other 14 3 Gross deferred tax assets 59,897 40,880 Less: Valuation allowance (58,528) (39,087) Total deferred tax assets 1,369 1,793 Deferred income tax liabilities Fixed assets (20) (140) Operating lease right-of-use assets (1,349) (1,653) Total deferred tax liabilities (1,369) (1,793) Net deferred tax assets (liabilities) $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward | The following table summarizes the activity related to the Company’s unrecognized tax benefits (in thousands): AS OF DECEMBER 31, 2021 2020 Beginning balance $ 2,155 $ 1,499 Increases related to current year tax positions 691 656 Ending balance $ 2,846 $ 2,155 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of Operating Lease, by Balance Sheet Location | The right-of-use asset and operating lease liability as of December 31, 2021 and 2020 are as follows: AS OF DECEMBER 31, 2021 2020 Right-of-use asset $ 6,338 $ 7,831 Operating lease liability Current 1,674 1,503 Non-current 5,033 6,707 Total operating lease liability $ 6,707 $ 8,210 |
Schedule of Operating Lease Maturity | Future minimum rental payments under operating leases are as follows (in thousands): AS OF DECEMBER 31, 2021 2022 2,161 2023 2,203 2024 2,247 2025 1,137 Total future minimum lease payments $ 7,748 Less: imputed interest (1,041) Present value of operating lease liability 6,707 Less: current portion of operating lease liability (1,674) Non-current portion of operating lease liability $ 5,033 |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - IPO (Details) - USD ($) $ / shares in Units, $ in Millions | Aug. 21, 2020 | Dec. 31, 2020 | Dec. 31, 2021 |
Subsidiary, Sale of Stock [Line Items] | |||
Conversion of outstanding warrants to purchase convertible preferred stock into common stock (in shares) | 7,354 | ||
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 | 120,000,000 |
Preferred stock, shares authorized (in shares) | 15,000,000 | 15,000,000 | 15,000,000 |
Common Stock | |||
Subsidiary, Sale of Stock [Line Items] | |||
Issuance of shares in conversion of convertible securities (in shares) | 7,211,086 | ||
Convertible Preferred Stock | Common Stock | |||
Subsidiary, Sale of Stock [Line Items] | |||
Issuance of shares in conversion of convertible securities (in shares) | 7,211,086 | 7,211,000 | |
2019 and 2020 Notes | Common Stock | |||
Subsidiary, Sale of Stock [Line Items] | |||
Issuance of shares in conversion of convertible securities (in shares) | 4,295,000 | ||
2019 and 2020 Notes | Convertible Debt | |||
Subsidiary, Sale of Stock [Line Items] | |||
Issuance of shares of common stock after conversion (in shares) | 4,294,603 | ||
IPO | |||
Subsidiary, Sale of Stock [Line Items] | |||
Sale of stock, shares issued (in shares) | 8,050,000 | ||
Sale of stock, price per share (in dollars per share) | $ 17 | ||
Sale of stock, proceeds received | $ 125.9 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) | Aug. 11, 2020 | May 11, 2020USD ($) | Dec. 31, 2021USD ($)leaseshares | Sep. 30, 2021USD ($) | Aug. 31, 2020USD ($) | Dec. 31, 2021USD ($)segmentleaseshares | Dec. 31, 2020USD ($) | Nov. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Jul. 31, 2020 | Apr. 30, 2020USD ($) |
Property, Plant and Equipment [Line Items] | |||||||||||
Reverse stock split ratio | 0.5753 | ||||||||||
Accumulated deficit | $ (227,147,000) | $ (227,147,000) | $ (145,379,000) | ||||||||
Cash and cash equivalents | 131,301,000 | 131,301,000 | 128,664,000 | ||||||||
Common stock offering price | $ 200,000,000 | ||||||||||
Proceeds from the Paycheck Protection Program loan | 0 | 1,875,000 | |||||||||
Deferred payment of federal payroll taxes | 100,000 | $ 100,000 | $ 400,000 | ||||||||
Payments associated with equity offering | $ 300,000 | ||||||||||
Number of operating leases held | lease | 2 | 2 | |||||||||
Costs associated with initial public offering | $ 11,000,000 | ||||||||||
Deferred offering costs | $ 1,700,000 | ||||||||||
Number of operating segments | segment | 1 | ||||||||||
Sales Agreement | |||||||||||
Property, Plant and Equipment [Line Items] | |||||||||||
Common stock shares sold (in shares) | shares | 921,042 | 921,042 | |||||||||
Sale of stock, proceeds received | $ 40,200,000 | ||||||||||
PPP Loan | Notes Payable, Other Payables | |||||||||||
Property, Plant and Equipment [Line Items] | |||||||||||
Proceeds from the Paycheck Protection Program loan | $ 1,900,000 | ||||||||||
Phylaxis BioScience, LLC | |||||||||||
Property, Plant and Equipment [Line Items] | |||||||||||
Equity interest percentage | 10.00% | ||||||||||
Equity method investment | $ 0 | $ 0 | $ 0 | $ 0 | |||||||
Affiliates | WuXi Biologics Healthcare Venture | |||||||||||
Property, Plant and Equipment [Line Items] | |||||||||||
Collaborative arrangement, term | 3 years | ||||||||||
Minimum | Machinery and equipment | |||||||||||
Property, Plant and Equipment [Line Items] | |||||||||||
Property and equipment useful life | 3 years | ||||||||||
Minimum | Furniture and fixtures | |||||||||||
Property, Plant and Equipment [Line Items] | |||||||||||
Property and equipment useful life | 3 years | ||||||||||
Minimum | Computer software | |||||||||||
Property, Plant and Equipment [Line Items] | |||||||||||
Property and equipment useful life | 4 years | ||||||||||
Maximum | Machinery and equipment | |||||||||||
Property, Plant and Equipment [Line Items] | |||||||||||
Property and equipment useful life | 5 years | ||||||||||
Maximum | Furniture and fixtures | |||||||||||
Property, Plant and Equipment [Line Items] | |||||||||||
Property and equipment useful life | 5 years | ||||||||||
Maximum | Computer software | |||||||||||
Property, Plant and Equipment [Line Items] | |||||||||||
Property and equipment useful life | 5 years |
ORGANIZATION AND SUMMARY OF S_6
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Reconciliation Measured at Fair Value Using Level 3 Inputs (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Warrant And Derivative Liabilities | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning balance | $ 1,916 |
Ending balance | 0 |
Warrants to purchase common stock | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Establishment of liabilities | 115 |
Change in fair value of liabilities | 24 |
Reclassification of liabilities into equity | (139) |
2020 Convertible Note | Derivative liabilities | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Establishment of liabilities | 735 |
2019 and 2020 Notes | Derivative liabilities | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Change in fair value of liabilities | $ (2,651) |
ORGANIZATION AND SUMMARY OF S_7
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Potential Dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Antidilutive securities excluded from earnings per share computation (in shares) | 4,071,000 | 2,532,000 |
Stock Option | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Antidilutive securities excluded from earnings per share computation (in shares) | 4,064,000 | 2,525,000 |
Warrants to purchase common stock | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Antidilutive securities excluded from earnings per share computation (in shares) | 7,000 | 7,000 |
OTHER FINANCIAL INFORMATION - P
OTHER FINANCIAL INFORMATION - Prepaid Expense and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Outside research and development services | $ 6,343 | $ 2,204 |
Other | 590 | 689 |
Prepaid expense and other current assets | $ 6,933 | $ 2,893 |
OTHER FINANCIAL INFORMATION -_2
OTHER FINANCIAL INFORMATION - Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 7,564 | $ 6,857 |
Less: accumulated depreciation and amortization | (4,411) | (3,365) |
Property and equipment, net | 3,153 | 3,492 |
Depreciation and amortization | 1,195 | 1,019 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 6,286 | 5,652 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 441 | 441 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 514 | 507 |
Computer software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 42 | 0 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 281 | $ 257 |
OTHER FINANCIAL INFORMATION - D
OTHER FINANCIAL INFORMATION - Depreciation and Amortization Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation and amortization | $ 1,195 | $ 1,019 |
Research and development | ||
Property, Plant and Equipment [Line Items] | ||
Depreciation and amortization | 1,003 | 836 |
General and administrative | ||
Property, Plant and Equipment [Line Items] | ||
Depreciation and amortization | $ 192 | $ 183 |
OTHER FINANCIAL INFORMATION - A
OTHER FINANCIAL INFORMATION - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical research and development | $ 4,496 | $ 970 |
Accrued Outside Research And Development, Other, Current | 2,893 | 10,559 |
Compensation expense | 1,322 | 1,165 |
Professional fees | 261 | 282 |
Other | 649 | 381 |
Accrued expenses | $ 9,621 | $ 13,357 |
DEBT - Narrative (Details)
DEBT - Narrative (Details) $ / shares in Units, $ in Thousands | Jun. 18, 2021USD ($) | Nov. 12, 2020USD ($)tranche | Jul. 15, 2020USD ($) | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Aug. 31, 2020USD ($) |
Debt Instrument [Line Items] | ||||||
Proceeds from the issuance of debt | $ 39,992 | $ 29,938 | ||||
Equal payments of principal and interest period if interest only period is extended | 11 months | |||||
Warrants Issued Concurrently With 2020 Loan Agreement | ||||||
Debt Instrument [Line Items] | ||||||
Common or preferred stock warrants issued as a percent of funded amount | 1.25% | |||||
Warrants issued, amount | $ 125 | |||||
Warrants Issued Concurrently With 2020 Loan Agreement | Preferred Stock | ||||||
Debt Instrument [Line Items] | ||||||
Warrants liability | 120 | |||||
2020 Oxford Term Loans Term B, Term C & Tranche 1 of Term A | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from the issuance of debt | 10,000 | |||||
2020 Loan Agreement | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Debt issuance costs | $ 100 | |||||
Total long-term debt | $ 76,300 | |||||
Debt interest expense | $ 5,400 | $ 900 | ||||
2020 Loan Agreement | Secured Debt | Minimum | ||||||
Debt Instrument [Line Items] | ||||||
Prepayment fee | 1.00% | |||||
2020 Loan Agreement | Secured Debt | Maximum | ||||||
Debt Instrument [Line Items] | ||||||
Prepayment fee | 3.00% | |||||
2020 Loan Agreement | Secured Debt | Warrants Issued Upon Consummation of IPO | ||||||
Debt Instrument [Line Items] | ||||||
Warrants liability | $ 140 | |||||
Warrants exercisable for shares of common stock (in shares) | shares | 7,354 | 7,354 | ||||
Warrant price (in dollars per share) | $ / shares | $ 17 | $ 17 | ||||
Amended 2020 Oxford Term Loan Tranche One | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from the issuance of debt | $ 20,000 | |||||
Amended 2020 Oxford Term Loan | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Debt issuance costs | 20 | |||||
One-time first amendment fee | $ 700 | |||||
Number of additional tranches | tranche | 2 | |||||
Aggregate principal amount of additional tranches | $ 50,000 | |||||
Total long-term debt | $ 70,000 | |||||
Annual interest rate | 7.96% | |||||
Percentage of principal amount for final payment | 9.00% | |||||
Periodic payment terms, final payment amount | $ 6,300 | |||||
Amended 2020 Oxford Term Loan | Secured Debt | LIBOR | ||||||
Debt Instrument [Line Items] | ||||||
Basis spread on variable rate | 7.80% | |||||
Amended 2020 Oxford Term Loan Tranche Two | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from the issuance of debt | $ 20,000 | |||||
Amended 2020 Oxford Term Loan June 2021 Amendment | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from the issuance of debt | $ 40,000 | |||||
Debt issuance costs | $ 10 | |||||
Minimum cash balance | $ 20,000 | |||||
2015 Loan Agreement | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Debt interest expense | $ 44 |
DEBT - Outstanding Debt Balance
DEBT - Outstanding Debt Balance 2020 Loan Agreement (Details) - Secured Debt - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
2020 Loan Agreement | ||
Debt Instrument [Line Items] | ||
Term loan | $ 76,300 | |
Less: Debt discount | (5,830) | $ (3,456) |
Total debt | 70,470 | 29,244 |
Less: Current portion, including debt discount | 0 | 0 |
Long-term debt, including debt discount | 70,470 | 29,244 |
Term A | ||
Debt Instrument [Line Items] | ||
Term loan | 10,900 | 10,900 |
Term B | ||
Debt Instrument [Line Items] | ||
Term loan | 21,800 | 21,800 |
Term C | ||
Debt Instrument [Line Items] | ||
Term loan | $ 43,600 | $ 0 |
DEBT - Future Minimum Payments
DEBT - Future Minimum Payments (Details) - 2020 Loan Agreement - Secured Debt - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
2025 | $ 76,300 | |
Total future minimum payments | 76,300 | |
Less: unamortized debt discount | (5,830) | $ (3,456) |
Total debt | $ 70,470 | $ 29,244 |
CONVERTIBLE PROMISSORY NOTE (De
CONVERTIBLE PROMISSORY NOTE (Details) - USD ($) | Aug. 21, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Aug. 21, 2020 | Jun. 30, 2020 | Apr. 30, 2020 | Feb. 29, 2020 | May 20, 2019 |
Debt Instrument [Line Items] | ||||||||
Other income related to changes in fair value of derivative liability | $ 0 | $ 2,651,000 | ||||||
Additional Paid-in Capital | ||||||||
Debt Instrument [Line Items] | ||||||||
Reversal of unamortized BCF | $ 7,400,000 | |||||||
Convertible Debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Derivative liability | $ 0 | |||||||
Other income related to changes in fair value of derivative liability | 2,700,000 | |||||||
Charge of amortized debt issuance costs to interest expense | 2,200,000 | |||||||
2019 Convertible Note | ||||||||
Debt Instrument [Line Items] | ||||||||
Reversal of unamortized BCF | 5,332,000 | |||||||
2019 Convertible Note | Additional Paid-in Capital | ||||||||
Debt Instrument [Line Items] | ||||||||
Reversal of unamortized BCF | 5,332,000 | |||||||
2019 Convertible Note | Convertible Debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Note aggregate principal amount | $ 40,000,000 | |||||||
Note monthly interest rate | 1.50% | |||||||
Total debt | $ 43,700,000 | $ 43,700,000 | ||||||
Conversion price (in dollars per share) | $ 14.35 | $ 14.35 | ||||||
Issuance of shares of common stock after conversion (in shares) | 3,046,467 | |||||||
Amortization of debt discount | $ 8,700,000 | |||||||
Unamortized debt discounts | $ 6,900,000 | 6,900,000 | ||||||
2020 Convertible Note | ||||||||
Debt Instrument [Line Items] | ||||||||
Reversal of unamortized BCF | 2,107,000 | |||||||
2020 Convertible Note | Additional Paid-in Capital | ||||||||
Debt Instrument [Line Items] | ||||||||
Reversal of unamortized BCF | $ 2,107,000 | |||||||
2020 Convertible Note | Convertible Debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Note aggregate principal amount | $ 15,000,000 | |||||||
Note monthly interest rate | 1.00% | |||||||
Total debt | $ 15,700,000 | $ 15,700,000 | ||||||
Conversion price (in dollars per share) | $ 12.56 | $ 12.56 | ||||||
Issuance of shares of common stock after conversion (in shares) | 1,248,136 | |||||||
Unamortized debt discounts | $ 2,700,000 | $ 2,700,000 |
STOCKHOLDERS_ EQUITY (DEFICIT)
STOCKHOLDERS’ EQUITY (DEFICIT) (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 21, 2020 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 |
Temporary Equity [Line Items] | ||||
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 | 120,000,000 | |
Preferred stock, shares authorized (in shares) | 15,000,000 | 15,000,000 | 15,000,000 | |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Common stock offering price | $ 200,000 | |||
Commission percent | 3.00% | |||
At the market offering costs | $ 500 | |||
Sales Agreement | ||||
Temporary Equity [Line Items] | ||||
Common stock shares sold (in shares) | 921,042 | |||
Sale of stock, proceeds received | $ 40,200 | |||
Commissions costs | $ 1,200 | |||
Warrants Issued Upon Consummation of IPO | 2020 Loan Agreement | Secured Debt | ||||
Temporary Equity [Line Items] | ||||
Warrants exercisable for shares of common stock (in shares) | 7,354 | 7,354 | ||
Warrant price (in dollars per share) | $ 17 | $ 17 | ||
Common Stock | ||||
Temporary Equity [Line Items] | ||||
Issuance of shares in conversion of convertible securities (in shares) | 7,211,086 | |||
Additional Paid-in Capital | ||||
Temporary Equity [Line Items] | ||||
Warrants outstanding | $ 140 |
EQUITY COMPENSATION PLANS - Nar
EQUITY COMPENSATION PLANS - Narrative (Details) - USD ($) $ in Thousands, shares in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance (in shares) | 4.5 | |
Available shares reserved for issuance (in shares) | 0.1 | |
Aggregate intrinsic value of options exercised | $ 7,500 | $ 19 |
Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years | |
Contractual term | 10 years | |
Unrecognized stock-based compensation expense | $ 47,000 | |
Weighted-average period of recognition | 3 years 14 days | |
Cliff Vesting | Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 1 year |
EQUITY COMPENSATION PLANS - Sto
EQUITY COMPENSATION PLANS - Stock Option Activity (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Number of Shares | |
Outstanding, beginning balance (in shares) | shares | 2,525 |
Granted (in shares) | shares | 2,307 |
Forfeited (in shares) | shares | (410) |
Exercised (in shares) | shares | (358) |
Outstanding, ending balance (in shares) | shares | 4,064 |
Vested and exercisable (in shares) | shares | 1,253 |
Weighted Average Exercise Price | |
Outstanding, beginning balance (in dollars per share) | $ / shares | $ 11.80 |
Granted (in dollars per share) | $ / shares | 32 |
Forfeited (in dollars per share) | $ / shares | 23.09 |
Exercised (in dollars per share) | $ / shares | 11.05 |
Outstanding, ending balance (in dollars per share) | $ / shares | 22.19 |
Vested and exercisable (in dollars per share) | $ / shares | $ 11.37 |
WEIGHTED AVERAGE REMAINING CONTRACTUAL TERM | 8 years 3 months 18 days |
WEIGHTED AVERAGE REMAINING CONTRACTUAL TERM, Vested and exercisable | 7 years 1 month 6 days |
AGGREGATE INTRINSIC VALUE Beginning value | $ | |
AGGREGATE INTRINSIC VALUE Ending value | $ | $ 87,303 |
AGGREGATE INTRINSIC VALUE, Vested and exercisable | $ | $ 40,468 |
EQUITY COMPENSATION PLANS - Fai
EQUITY COMPENSATION PLANS - Fair Value of Stock Option Grants (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value (in dollars per share) | $ 24.20 | $ 10.82 |
Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 0.71% | 0.42% |
Expected volatility | 93.49% | 97.72% |
Expected dividend yield | 0.00% | 0.00% |
Expected term | 6 years 29 days | 6 years 29 days |
EQUITY COMPENSATION PLANS - S_2
EQUITY COMPENSATION PLANS - Stock-based Compensation Expense (Details) - Stock Option - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 15,048 | $ 5,023 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 11,830 | 4,300 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 3,218 | $ 723 |
LICENSE AND GRANT REVENUES - Re
LICENSE AND GRANT REVENUES - Revenue Summary (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | $ 7,231,000 | $ 12,888,000 | ||
License fee revenue, affiliates | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 0 | 2,000,000 | ||
License fee revenue, affiliates | Elpiscience Biopharmaceuticals, Inc. | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | $ 2,000,000 | 0 | 2,000,000 | |
License fee revenue, non-affiliates | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 7,125,000 | 10,808,000 | ||
License fee revenue, non-affiliates | 2seventy bio, Inc. | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | $ 400,000 | 4,200,000 | 400,000 | |
License fee revenue, non-affiliates | Phylaxis BioScience, LLC | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 2,392,000 | 1,993,000 | ||
License fee revenue, non-affiliates | Chiesi Farmaceutici S.p.A. | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 533,000 | 7,365,000 | ||
License fee revenue, non-affiliates | Other license revenues from non-affiliates | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 0 | 1,050,000 | ||
Grant revenue | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 106,000 | 80,000 | ||
Grant revenue | Congressionally Directed Medical Research Program | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | $ 106,000 | $ 80,000 |
LICENSE AND GRANT REVENUES - Li
LICENSE AND GRANT REVENUES - License and Collaboration Agreements (Details) | 1 Months Ended | 12 Months Ended | |||||||||||||
Oct. 31, 2021USD ($) | Aug. 31, 2021USD ($) | Jul. 31, 2021USD ($) | May 31, 2021USD ($) | Sep. 30, 2020USD ($) | Jul. 31, 2020USD ($)compoundperformanceObligation | Jun. 30, 2020USD ($)performanceObligationlicenseprogram | Aug. 31, 2019USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Oct. 31, 2020USD ($) | Aug. 19, 2019performanceObligation | Dec. 20, 2018USD ($) | Apr. 30, 2018USD ($) | Jun. 30, 2013USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | $ 7,231,000 | $ 12,888,000 | |||||||||||||
Current portion of deferred revenue | 2,034,000 | 3,081,000 | |||||||||||||
Non-current portion of deferred revenue | 110,000 | 737,000 | |||||||||||||
License fee revenue, non-affiliates | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | 7,125,000 | 10,808,000 | |||||||||||||
License fee revenue, affiliates | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | 0 | 2,000,000 | |||||||||||||
Phylaxis BioScience, LLC | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Equity interest percentage | 10.00% | ||||||||||||||
Additional equity interest percentage entitled to receive | 5.00% | ||||||||||||||
Equity method investment | $ 0 | $ 0 | 0 | ||||||||||||
Phylaxis BioScience, LLC | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Development milestone payment receivable | $ 225,000,000 | ||||||||||||||
Nonrefundable, upfront payment | $ 2,500,000 | ||||||||||||||
Number of performance obligations | performanceObligation | 1 | ||||||||||||||
Additional payable due from agreement | $ 2,500,000 | $ 1,250,000 | |||||||||||||
Additional payment receivable period | 180 days | ||||||||||||||
Commercialization milestone payment receivable | 175,000,000 | ||||||||||||||
Equity method investment | 500,000 | ||||||||||||||
Payments due pursuant to agreement | $ 5,000,000 | ||||||||||||||
Number of compounds | compound | 2 | ||||||||||||||
Current portion of deferred revenue | $ 1,100,000 | 1,600,000 | |||||||||||||
Non-current portion of deferred revenue | 600,000 | ||||||||||||||
Phylaxis BioScience, LLC | License fee revenue, non-affiliates | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | 2,392,000 | 1,993,000 | |||||||||||||
Revenue recognized related to performance obligation | 2,400,000 | 2,000,000 | |||||||||||||
2seventy bio, Inc. | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Development milestone payment receivable | $ 51,500,000 | $ 51,500,000 | |||||||||||||
Exclusive development license | license | 2 | ||||||||||||||
2seventy bio, Inc. | License fee revenue, non-affiliates | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | $ 400,000 | 4,200,000 | 400,000 | ||||||||||||
2seventy bio, Inc. | Initial Programs | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Number of programs related to collaborative agreement | program | 2 | ||||||||||||||
Nonrefundable, upfront payment | $ 400,000 | ||||||||||||||
Number of performance obligations | performanceObligation | 1 | ||||||||||||||
2seventy bio, Inc. | Initial Programs, Program 1 | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Nonrefundable, upfront payment | $ 200,000 | ||||||||||||||
2seventy bio, Inc. | Initial Programs, Program 2 | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Nonrefundable, upfront payment | $ 200,000 | ||||||||||||||
2seventy bio, Inc. | Additional Programs | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Number of programs related to collaborative agreement | program | 8 | ||||||||||||||
2seventy bio, Inc. | 2018 Option and License Agreement | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Milestone payment received | $ 2,000,000 | ||||||||||||||
2seventy bio, Inc. | 2018 Option and License Agreement | License fee revenue, non-affiliates | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | $ 2,000,000 | 2,000,000 | 0 | ||||||||||||
2seventy bio, Inc. | 2020 Option And License Agreement | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Option extension fee | $ 2,100,000 | $ 100,000 | |||||||||||||
2seventy bio, Inc. | 2020 Option And License Agreement | License fee revenue, non-affiliates | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | $ 2,100,000 | $ 100,000 | 2,200,000 | 400,000 | |||||||||||
Chiesi Farmaceutici S.p.A. | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Milestone payments receivable | $ 122,500,000 | ||||||||||||||
Nonrefundable, upfront payment | 10,000,000 | ||||||||||||||
Number of performance obligations | performanceObligation | 1 | ||||||||||||||
Additional payable due from agreement | $ 12,500,000 | ||||||||||||||
Current portion of deferred revenue | 900,000 | 1,400,000 | |||||||||||||
Non-current portion of deferred revenue | 100,000 | 100,000 | |||||||||||||
Chiesi Farmaceutici S.p.A. | License fee revenue, non-affiliates | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | 533,000 | 7,365,000 | |||||||||||||
Revenue recognized related to performance obligation | 500,000 | 7,400,000 | |||||||||||||
Elpiscience Biopharmaceuticals, Inc. | License fee revenue, affiliates | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | $ 2,000,000 | $ 0 | $ 2,000,000 | ||||||||||||
Elpiscience Biopharmaceuticals, Inc. | OX40 License Agreement | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Milestone payments receivable | $ 100,000,000 | ||||||||||||||
Celgene | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Development milestone payment receivable | $ 934,100,000 | ||||||||||||||
Percentage due to advisors | 0.02 |
LICENSE AND GRANT REVENUES - Go
LICENSE AND GRANT REVENUES - Government Grants (Details) - USD ($) $ in Thousands | 11 Months Ended | 12 Months Ended | 37 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2021 | Feb. 28, 2021 | Sep. 30, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||
Total revenue | $ 7,231 | $ 12,888 | ||||
Congressionally Directed Medical Research Program, 2018 Grant | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||
Grant award | $ 300 | |||||
Congressionally Directed Medical Research Program, 2021 Grant | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||
Grant award | $ 300 | |||||
Grant revenue | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||
Total revenue | 106 | 80 | ||||
Grant revenue | Congressionally Directed Medical Research Program, 2018 Grant | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||
Total revenue | $ 300 | |||||
Grant revenue | Congressionally Directed Medical Research Program, 2021 Grant | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||
Total revenue | $ 106 | |||||
Revenue recognized, cash | $ 86 | |||||
Grant revenue | Congressionally Directed Medical Research Program | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||
Total revenue | $ 106 | $ 80 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Elpiscience Biopharmaceuticals, Inc. | Sale And Purchase Agreement | ||
Related Party Transaction [Line Items] | ||
Liabilities derecognized from agreements | $ 37,000 | |
Receivables from related parties | 37,000 | |
Elpiscience Biopharmaceuticals, Inc. | OX40 License Agreement | ||
Related Party Transaction [Line Items] | ||
Reimbursement for related party transaction expenses incurred to date | 5,200,000 | |
Receivable for expenses incurred, not yet reimbursed | 200,000 | |
Expenses expected to be reimbursed | 38,000 | |
Reimbursement expenses | 0 | $ 200,000 |
Liabilities derecognized from agreements | 0 | 200,000 |
Elpiscience Biopharmaceuticals, Inc. | OX40 License Agreement | Cost Sharing Agreement | ||
Related Party Transaction [Line Items] | ||
Reimbursement for related party transaction expenses incurred to date | 200,000 | |
Reimbursement expenses | 200,000 | |
Liabilities derecognized from agreements | $ 300,000 | |
Receivables from related parties | $ 300,000 | |
Affiliates | LAV Summit Limited | ||
Related Party Transaction [Line Items] | ||
Ownership interest, more than | 5.00% |
INCOME TAXES - Narrative (Detai
INCOME TAXES - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Tax Credit Carryforward [Line Items] | |||
Deferred tax asset valuation allowance | $ 58,528,000 | $ 39,087,000 | |
Gross unrecognized tax benefits | 2,846,000 | 2,155,000 | $ 1,499,000 |
Accrual for interest and penalties | 0 | 0 | |
Recognized interest and penalties | 0 | $ 0 | |
Federal | |||
Tax Credit Carryforward [Line Items] | |||
Net operating loss carryforwards | 198,900,000 | ||
Federal | Research Tax Credit Carryforward | |||
Tax Credit Carryforward [Line Items] | |||
Tax credit carryforward | 8,300,000 | ||
State | |||
Tax Credit Carryforward [Line Items] | |||
Net operating loss carryforwards | 24,500,000 | ||
State | Research Tax Credit Carryforward | |||
Tax Credit Carryforward [Line Items] | |||
Tax credit carryforward | $ 3,900,000 |
INCOME TAXES - Components of In
INCOME TAXES - Components of Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
State | $ 2 | $ 3 |
Provision for income taxes | $ 2 | $ 3 |
INCOME TAXES - Reconciliation o
INCOME TAXES - Reconciliation of Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Expected income tax benefit at federal statutory rate | $ (17,171) | $ (15,985) |
State income tax expense (benefit), net of federal benefit | (1,006) | 4,548 |
Permanent items | (207) | 2,291 |
R&D credits | (1,912) | (2,878) |
Unrecognized tax benefits (FIN 48) | 691 | 707 |
Return to provision true-ups | 165 | 164 |
Valuation allowance | 19,442 | 11,156 |
Provision for income taxes | $ 2 | $ 3 |
INCOME TAXES - Components of ne
INCOME TAXES - Components of net deferred income taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred income tax assets | ||
Net operating loss carryforward | $ 43,440 | $ 27,055 |
Research and development credits | 8,539 | 6,465 |
Intangibles | 3,875 | 4,176 |
Accruals | 257 | 233 |
Stock compensation | 1,888 | 409 |
Deferred revenue | 456 | 806 |
Operating lease liabilities | 1,428 | 1,733 |
Other | 14 | 3 |
Gross deferred tax assets | 59,897 | 40,880 |
Less: Valuation allowance | (58,528) | (39,087) |
Total deferred tax assets | 1,369 | 1,793 |
Deferred income tax liabilities | ||
Fixed assets | (20) | (140) |
Operating lease right-of-use assets | (1,349) | (1,653) |
Total deferred tax liabilities | (1,369) | (1,793) |
Net deferred tax assets (liabilities) | $ 0 | $ 0 |
INCOME TAXES - Unrecognized Tax
INCOME TAXES - Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Unrecognized Tax Benefits [Roll Forward] | ||
Beginning balance | $ 2,155 | $ 1,499 |
Increases related to current year tax positions | 691 | 656 |
Ending balance | $ 2,846 | $ 2,155 |
LEASES - Narrative (Details)
LEASES - Narrative (Details) ft² in Thousands, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | May 31, 2019USD ($)ft² | Sep. 30, 2017USD ($)ft² | |
Leases [Abstract] | ||||
Lease agreement term | 7 years | |||
Square footage of lease agreement (in sq feet) | ft² | 34 | |||
Lease extension term | 5 years | |||
Initial base rent per month | $ | $ 30 | $ 100 | ||
Annual escalations | 2.00% | 2.00% | ||
Square footage of lease extension agreement (in sq feet) | ft² | 9 | |||
Operating Lease, Expense | $ | $ 3,100 | $ 3,100 | ||
Remaining term of operating lease | 3 years 6 months | 4 years 6 months | ||
Weighted-average discount rate | 8.20% | 8.20% |
LEASES - Schedule of Right-Of-U
LEASES - Schedule of Right-Of-Use Asset and Operating Lease Liability (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Right-of-use asset | $ 6,338 | $ 7,831 |
Current portion of lease liability | 1,674 | 1,503 |
Non-current portion of lease liability | 5,033 | 6,707 |
Total operating lease liability | $ 6,707 | $ 8,210 |
LEASES - Schedule of Operating
LEASES - Schedule of Operating Lease Liability Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2022 | $ 2,161 | |
2023 | 2,203 | |
2024 | 2,247 | |
2025 | 1,137 | |
Total future minimum lease payments | 7,748 | |
Less: imputed interest | (1,041) | |
Total operating lease liability | 6,707 | $ 8,210 |
Less: current portion of operating lease liability | (1,674) | (1,503) |
Non-current portion of lease liability | $ 5,033 | $ 6,707 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Other Commitments [Line Items] | ||
Clinical research and development | $ 4,496 | $ 970 |
Non-cancellable portion of contract | 2,400 | 7,000 |
Expenses related to agreements | 1,000 | 30,200 |
Purchase Commitment | ||
Other Commitments [Line Items] | ||
Clinical research and development | $ 7,400 | $ 11,500 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) $ / shares in Units, $ in Thousands | Feb. 18, 2022USD ($)tranche$ / sharesshares | Nov. 12, 2020USD ($)tranche | Feb. 28, 2022$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($) |
Subsequent Event [Line Items] | |||||
Stock options granted (in shares) | shares | 2,307,000 | ||||
Award granted, weighted average exercise price (in dollars per share) | $ / shares | $ 32 | ||||
Proceeds from the issuance of debt | $ 39,992 | $ 29,938 | |||
Equal payments of principal and interest period if interest only period is extended | 11 months | ||||
Amended 2020 Oxford Term Loan | Secured Debt | |||||
Subsequent Event [Line Items] | |||||
Number of additional tranches | tranche | 2 | ||||
Aggregate principal amount of additional tranches | $ 50,000 | ||||
Term loan | $ 70,000 | ||||
One-time first amendment fee | 700 | ||||
Annual interest rate | 7.96% | ||||
Percentage of principal amount for final payment | 9.00% | ||||
Amended 2020 Oxford Term Loan | Secured Debt | LIBOR | |||||
Subsequent Event [Line Items] | |||||
Basis spread on variable rate | 7.80% | ||||
Amended 2020 Oxford Term Loan Tranche One | Secured Debt | |||||
Subsequent Event [Line Items] | |||||
Proceeds from the issuance of debt | 20,000 | ||||
Outstanding debt | $ 70,000 | ||||
Amended 2020 Oxford Term Loan Tranche Two | Secured Debt | |||||
Subsequent Event [Line Items] | |||||
Proceeds from the issuance of debt | $ 20,000 | ||||
Stock Option | |||||
Subsequent Event [Line Items] | |||||
Vesting period | 4 years | ||||
Contractual term | 10 years | ||||
Stock Option | Cliff Vesting | |||||
Subsequent Event [Line Items] | |||||
Vesting period | 1 year | ||||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Upfront partnership proceeds | $ 100,000 | ||||
Equal payments of principal and interest period | 23 months | ||||
Equal payments of principal and interest period if interest only period is extended | 11 months | ||||
Warrants issued (in shares) | shares | 40,000 | ||||
Warrant price (in dollars per share) | $ / shares | $ 45 | ||||
Subsequent Event | Amended 2020 Oxford Term Loan | Secured Debt | |||||
Subsequent Event [Line Items] | |||||
Number of additional tranches | tranche | 4 | ||||
Aggregate principal amount of additional tranches | $ 200,000 | ||||
One-time first amendment fee | $ 1,100 | ||||
Number of existing tranches | tranche | 3 | ||||
Annual interest rate | 8.30% | ||||
Percentage of principal amount for final payment | 9.00% | ||||
Subsequent Event | Amended 2020 Oxford Term Loan | Secured Debt | Minimum | |||||
Subsequent Event [Line Items] | |||||
Prepayment fee | 1.00% | ||||
Subsequent Event | Amended 2020 Oxford Term Loan | Secured Debt | Maximum | |||||
Subsequent Event [Line Items] | |||||
Prepayment fee | 3.00% | ||||
Subsequent Event | Amended 2020 Oxford Term Loan | Secured Debt | LIBOR | |||||
Subsequent Event [Line Items] | |||||
Basis spread on variable rate | 8.19% | ||||
Subsequent Event | Amended 2020 Oxford Term Loan Tranche One | Secured Debt | |||||
Subsequent Event [Line Items] | |||||
Proceeds from the issuance of debt | $ 110,000 | ||||
Term loan | 40,000 | ||||
Subsequent Event | Amended 2020 Oxford Term Loan Tranche Two | Secured Debt | |||||
Subsequent Event [Line Items] | |||||
Proceeds from the issuance of debt | 30,000 | ||||
Subsequent Event | Amended 2020 Oxford Term Loan Tranche Three | Secured Debt | |||||
Subsequent Event [Line Items] | |||||
Proceeds from the issuance of debt | 30,000 | ||||
Subsequent Event | Amended 2020 Oxford Term Loan Tranche Four | Secured Debt | |||||
Subsequent Event [Line Items] | |||||
Proceeds from the issuance of debt | $ 30,000 | ||||
Subsequent Event | Stock Option | |||||
Subsequent Event [Line Items] | |||||
Stock options granted (in shares) | shares | 800,000 | ||||
Award granted, weighted average exercise price (in dollars per share) | $ / shares | $ 33.84 | ||||
Vesting period | 4 years | ||||
Contractual term | 10 years | ||||
Subsequent Event | Stock Option | Cliff Vesting | |||||
Subsequent Event [Line Items] | |||||
Vesting period | 1 year |