Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Jul. 31, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
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 $0.0001 | |
Trading Symbol | INBX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 43,668,153 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Entity Central Index Key | 0001739614 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 192,492 | $ 273,865 |
Prepaid expenses and other current assets | 10,502 | 6,371 |
Total current assets | 203,321 | 280,493 |
Property and equipment, net | 2,832 | 2,501 |
Right-of-use asset | 3,853 | 4,717 |
Other non-current assets | 3,164 | 3,164 |
Total assets | 213,170 | 290,875 |
Current liabilities: | ||
Accounts payable | 9,700 | 8,326 |
Accrued expenses | 19,551 | 17,224 |
Deferred revenue | 119 | 166 |
Current portion of lease liability | 1,959 | 1,860 |
Total current liabilities | 31,329 | 27,576 |
Long-term debt, including final payment fee | 204,482 | 202,069 |
Non-current portion of lease liability | 2,171 | 3,173 |
Total liabilities | 237,982 | 232,818 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity (deficit) | ||
Preferred stock, $0.0001 par value; 15,000,000 shares authorized as of June 30, 2023 and December 31, 2022; no shares issued or outstanding as of June 30, 2023 and December 31, 2022. | 0 | 0 |
Common stock, $0.0001 par value; 120,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 43,667,374 and 43,564,283 issued and outstanding as of June 30, 2023 and December 31, 2022, respectively. | 4 | 4 |
Additional paid-in-capital | 443,525 | 430,426 |
Accumulated deficit | (468,341) | (372,373) |
Total stockholders’ equity (deficit) | (24,812) | 58,057 |
Total liabilities and stockholders’ equity (deficit) | 213,170 | 290,875 |
Nonrelated Party | ||
Current assets: | ||
Accounts receivable | 327 | 243 |
Related Party | ||
Current assets: | ||
Accounts receivable | $ 0 | $ 14 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
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 issued (in shares) | 0 | 0 |
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) | 43,667,374 | 43,564,283 |
Common stock, shares outstanding (in shares) | 43,667,374 | 43,564,283 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenue: | ||||
Total revenue | $ 30 | $ 711 | $ 47 | $ 1,640 |
Operating expenses: | ||||
Research and development | 34,106 | 29,906 | 71,492 | 54,801 |
General and administrative | 7,263 | 5,402 | 13,660 | 10,453 |
Total operating expenses | 41,369 | 35,308 | 85,152 | 65,254 |
Loss from operations | (41,339) | (34,597) | (85,105) | (63,614) |
Other income (expense): | ||||
Interest expense | (7,905) | (3,202) | (15,468) | (5,520) |
Interest income | 2,414 | 54 | 4,897 | 98 |
Other income (expense), net | (217) | 17 | (287) | 54 |
Total other expense | (5,708) | (3,131) | (10,858) | (5,368) |
Loss before income tax expense | (47,047) | (37,728) | (95,963) | (68,982) |
Provision for income taxes | 5 | 4 | 5 | 4 |
Net loss | $ (47,052) | $ (37,732) | $ (95,968) | $ (68,986) |
Net loss per share, basic (in dollars per share) | $ (1.08) | $ (0.97) | $ (2.20) | $ (1.77) |
Net loss per share, diluted (in dollars per share) | $ (1.08) | $ (0.97) | $ (2.20) | $ (1.77) |
Weighted-average shares of common stock outstanding, basic (in shares) | 43,642 | 39,040 | 43,609 | 39,029 |
Weighted-average shares of common stock outstanding, diluted (in shares) | 43,642 | 39,040 | 43,609 | 39,029 |
License fee revenue | ||||
Revenue: | ||||
Total revenue | $ 30 | $ 711 | $ 47 | $ 1,626 |
Grant revenue | ||||
Revenue: | ||||
Total revenue | $ 0 | $ 0 | $ 0 | $ 14 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 38,991,000 | |||
Beginning balance at Dec. 31, 2021 | $ 52,383 | $ 4 | $ 279,526 | $ (227,147) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | 5,108 | 5,108 | ||
Issuance of shares upon exercise of stock options (in shares) | 35,000 | |||
Issuance of shares upon exercise of stock options | 401 | 401 | ||
Issuance of warrants | 712 | 712 | ||
Net loss | (31,254) | (31,254) | ||
Ending balance (in shares) at Mar. 31, 2022 | 39,026,000 | |||
Ending balance at Mar. 31, 2022 | 27,350 | $ 4 | 285,747 | (258,401) |
Beginning balance (in shares) at Dec. 31, 2021 | 38,991,000 | |||
Beginning balance at Dec. 31, 2021 | 52,383 | $ 4 | 279,526 | (227,147) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net loss | (68,986) | |||
Ending balance (in shares) at Jun. 30, 2022 | 39,041,000 | |||
Ending balance at Jun. 30, 2022 | (4,922) | $ 4 | 291,207 | (296,133) |
Beginning balance (in shares) at Mar. 31, 2022 | 39,026,000 | |||
Beginning balance at Mar. 31, 2022 | 27,350 | $ 4 | 285,747 | (258,401) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | 5,296 | 5,296 | ||
Issuance of shares upon exercise of stock options (in shares) | 15,000 | |||
Issuance of shares upon exercise of stock options | 164 | 164 | ||
Net loss | (37,732) | (37,732) | ||
Ending balance (in shares) at Jun. 30, 2022 | 39,041,000 | |||
Ending balance at Jun. 30, 2022 | $ (4,922) | $ 4 | 291,207 | (296,133) |
Beginning balance (in shares) at Dec. 31, 2022 | 43,564,283 | 43,564,000 | ||
Beginning balance at Dec. 31, 2022 | $ 58,057 | $ 4 | 430,426 | (372,373) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | 5,636 | 5,636 | ||
Issuance of shares upon exercise of stock options (in shares) | 31,000 | |||
Issuance of shares upon exercise of stock options | 356 | 356 | ||
Net loss | (48,916) | (48,916) | ||
Ending balance (in shares) at Mar. 31, 2023 | 43,595,000 | |||
Ending balance at Mar. 31, 2023 | $ 15,133 | $ 4 | 436,418 | (421,289) |
Beginning balance (in shares) at Dec. 31, 2022 | 43,564,283 | 43,564,000 | ||
Beginning balance at Dec. 31, 2022 | $ 58,057 | $ 4 | 430,426 | (372,373) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of shares upon exercise of stock options (in shares) | 103,000 | |||
Net loss | $ (95,968) | |||
Ending balance (in shares) at Jun. 30, 2023 | 43,667,374 | 43,667,000 | ||
Ending balance at Jun. 30, 2023 | $ (24,812) | $ 4 | 443,525 | (468,341) |
Beginning balance (in shares) at Mar. 31, 2023 | 43,595,000 | |||
Beginning balance at Mar. 31, 2023 | 15,133 | $ 4 | 436,418 | (421,289) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | 6,253 | 6,253 | ||
Issuance of shares upon exercise of stock options (in shares) | 72,000 | |||
Issuance of shares upon exercise of stock options | 854 | 854 | ||
Net loss | $ (47,052) | (47,052) | ||
Ending balance (in shares) at Jun. 30, 2023 | 43,667,374 | 43,667,000 | ||
Ending balance at Jun. 30, 2023 | $ (24,812) | $ 4 | $ 443,525 | $ (468,341) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (95,968) | $ (68,986) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 589 | 614 |
Accretion of debt discount and non-cash interest expense | 2,413 | 1,171 |
Stock-based compensation expense | 11,889 | 10,404 |
Non-cash lease expense | 864 | 793 |
Loss on disposal of fixed assets | 2 | 6 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (84) | 130 |
Receivables from related parties | 14 | 464 |
Prepaid expenses and other current assets | (4,131) | 2,029 |
Other non-current assets | 0 | (1,317) |
Accounts payable | 792 | 216 |
Accrued expenses | 2,327 | 2,851 |
Operating lease liability | (903) | (811) |
Deferred revenue, current portion | (47) | (1,317) |
Deferred revenue, non-current portion | 0 | (110) |
Net cash used in operating activities | (82,243) | (53,863) |
Cash flows from investing activities | ||
Purchase of fixed assets | (340) | (439) |
Net cash used in investing activities | (340) | (439) |
Cash flows from financing activities | ||
Proceeds from the issuance of debt | 0 | 98,871 |
Payment of fees associated with debt | 0 | (50) |
Proceeds from the exercise of stock options | 1,210 | 565 |
Net cash provided by financing activities | 1,210 | 99,386 |
Net increase (decrease) in cash and cash equivalents | (81,373) | 45,084 |
Cash and cash equivalents at beginning of period | 273,865 | 131,301 |
Cash and cash equivalents at end of period | 192,492 | 176,385 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 12,948 | 3,975 |
Cash paid for income taxes | 5 | 4 |
Supplemental schedule of non-cash investing and financing activities | ||
Payable for purchase of fixed assets | 582 | 0 |
Fair value of warrants issued to lender in conjunction with February 2022 Amendment | $ 0 | $ 712 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2023 | |
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 biopharmaceutical 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. Basis of Presentation The accompanying unaudited condensed 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 interim report on the Form 10-Q. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these unaudited interim condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the fiscal year ended December 31, 2022, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 6, 2023. Liquidity As of June 30, 2023, the Company had an accumulated deficit of $468.3 million and cash and cash equivalents of $192.5 million. From its inception and through June 30, 2023, 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, pre-commercialization activities, 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 condensed 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, strategic transactions and other similar arrangements. 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. Use of Estimates The preparation of these unaudited condensed 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 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. Cash and Cash Equivalents Cash and cash equivalents are comprised of cash held in financial institutions including readily available checking and money market accounts and highly liquid investments in debt securities with an original maturity of three months or less. As of June 30, 2023, the Company’s investments in debt securities consisted of U.S. Treasury Bills, all of which mature in the third quarter of 2023. As of June 30, 2023, these investments were recorded at their amortized cost of $133.7 million, which was adjusted for the amortization or accretion of premiums or discounts. Concentrations of Credit Risk Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents, including investments in debt securities. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits by the Federal Deposit Insurance Corporation, or FDIC, of up to $250,000. The Company’s investment portfolio consists of investments in U.S. Treasury securities, in excess of Securities Investor Protection Corporation limits of up to $500,000 in securities. The Company’s cash management and investment policy limits investment instruments to investment-grade securities with the objective to preserve capital and to maintain liquidity until the funds can be used in operations. 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. 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 Company’s investments in debt securities consist of U.S. Treasury Bills, which are classified as Level 1 in the fair value hierarchy. Due to the short-term nature of these securities which are classified as cash equivalents, the amortized value approximates fair value and the Company does not remeasure these instruments at fair value. The Company’s outstanding debt and warrants are both classified as Level 2 in the fair value hierarchy. As of June 30, 2023 and December 31, 2022, the Company had no financial instruments measured at fair value on a recurring basis. 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. Collaborative Research, Development, and License Agreements The Company enters into collaborative agreements with partners which may include the transfer of licenses, options to license and the performance of research and development activities. The terms associated with these agreements may 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. Payments received from customers are included in deferred revenue, allocated between current and non-current on the condensed consolidated balance sheet, until all revenue recognition criteria are met. Typically, license fees, non-refundable upfront fees and funding of research activities are considered fixed, while milestone payments, including option exercise fees, are identified as variable consideration, which is constrained and excluded from the transaction price. The Company will recognize revenue for sales-based royalty if and when a subsequent sale occurs. The Company applies significant judgment when making estimates and assumptions under these agreements, including evaluating whether contractual obligations represent distinct performance obligations, including the assessment of whether options represent material rights, determining whether there are observable standalone prices and allocating transaction price to performance obligations within a contract, assessing whether any licenses are functional or symbolic, determining when performance obligations have been met, and assessing the recognition of variable consideration. 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, performance obligations consisting of a transfer of a license or the achievement of milestones are recognized at a point in time upon the transfer, while performance obligations consisting of research activities are recognized over time using an input method which is representative of the Company’s efforts to fulfill the performance obligation, based on costs incurred with third-parties or internal labor hours performed. Accrued Research and Development and Clinical Trial Costs 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 contract development and manufacturing organizations, or 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 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. 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. Accordingly, for the six months ended June 30, 2023 and June 30, 2022, there is no difference in the number of shares used to calculate basic and diluted shares outstanding. 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 JUNE 30, 2023 2022 Outstanding stock options 6,608 5,196 Warrants to purchase common stock 47 47 6,655 5,243 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 From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies. 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 condensed consolidated financial condition or results of operations upon adoption. Adoption of New Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update, or ASU, 2016-13, Financial Instruments - Credit Losses : Measurement of Credit Losses on Financial Instruments (Topic 326), which intends to improve financial reporting by requiring earlier recognition of credit losses on certain financial assets, such as held-to-maturity 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. The Company adopted ASU 2016-13 as of January 1, 2023, which did not result in a material impact on its condensed consolidated financial statements and related disclosures. |
OTHER FINANCIAL INFORMATION
OTHER FINANCIAL INFORMATION | 6 Months Ended |
Jun. 30, 2023 | |
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 AS OF JUNE 30, 2023 DECEMBER 31, 2022 Clinical trials (1) $ 6,835 $ 4,294 Clinical drug substance and product manufacturing (2) 2,362 1,171 Outside research and development services (3) 280 232 Licenses 701 493 Other 324 181 Prepaid expense and other current assets $ 10,502 $ 6,371 (1) Relates primarily to the Company’s prepayments to third-party CROs for management of clinical trials and prepayments for drug supply to be used in combination with the Company’s therapeutics. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (2) Relates primarily to the Company’s usage of third-party CDMOs for clinical and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (3) Relates to the Company’s usage of third-parties for other research and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. Property and Equipment, Net Property and equipment, net were comprised of the following (in thousands): AS OF AS OF JUNE 30, 2023 DECEMBER 31, 2022 Machinery and equipment $ 7,393 $ 7,023 Leasehold improvements 441 441 Computer software 53 53 Furniture, fixtures, and other 527 524 Construction in process 518 — Total property and equipment 8,932 8,041 Less: accumulated depreciation and amortization (6,100) (5,540) Property and equipment, net $ 2,832 $ 2,501 Depreciation and amortization expense totaled $0.3 million for each of the three months ended June 30, 2023 and June 30, 2022, and $0.6 million for each of the six months ended June 30, 2023 and June 30, 2022 and consisted of the following (in thousands): THREE MONTHS ENDED JUNE 30, SIX MONTHS ENDED 2023 2022 2023 2022 Research and development $ 242 $ 248 $ 479 $ 506 General and administrative 53 59 110 108 Total depreciation and amortization expense $ 295 $ 307 $ 589 $ 614 Accrued Expenses Accrued expenses were comprised of the following (in thousands): AS OF AS OF JUNE 30, 2023 DECEMBER 31, 2022 Clinical trials (1) $ 8,185 $ 4,527 Clinical drug substance and product manufacturing (2) 3,335 5,381 Other outside research and development (3) 1,397 1,164 Interest expense 2,230 2,124 Compensation-related 3,390 3,374 Professional fees 674 428 Other 340 226 Accrued expenses $ 19,551 $ 17,224 (1) Relates primarily to the Company’s usage of third-party CROs for management of clinical trials. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (2) Relates primarily to the Company’s usage of third-party CDMOs for clinical and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (3) Relates to the Company’s usage of third-parties for other research and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. |
DEBT
DEBT | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT 2020 Loan Agreement In July 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, or Term A. The 2020 Loan Agreement was subsequently amended in November 2020, or the November 2020 Amendment, upon which a second tranche in an aggregate principal amount of $20.0 million was funded, or Term B, and in June 2021, or the June 2021 Amendment, upon which a third tranche in an aggregate principal amount of $40.0 million was funded, or Term C. In February 2022, the Company entered into an additional amendment, or the February 2022 Amendment, to the 2020 Loan Agreement, collectively, the Amended 2020 Loan Agreement, upon which the Company received gross proceeds of $40.0 million, or Term D. The February 2022 Amendment also provided for an increase in the interest rate and for three future tranches of debt to be funded upon the achievement of certain milestones. In June 2022, the Company received additional gross proceeds of $30.0 million, or Term E, following the initiation of part 4 of the Phase 1/2 clinical trial of INBRX-105, as well as an additional $30.0 million in gross proceeds, or Term F, following the receipt of positive topline data from the Phase 1 clinical trial of INBRX-101. In October 2022, the Company entered into an amendment to the Amended 2020 Loan Agreement, or the October 2022 Amendment. The October 2022 Amendment amended the milestone terms of the last remaining tranche, Term G, under the Amended 2020 Loan Agreement to provide for the funding of $30.0 million upon the announcement of the regulatory path for INBRX-101 rather than upon the initiation of a registration-enabling clinical trial of INBRX-101. In October 2022, the Company met this milestone and drew the final tranche for additional gross proceeds of $30.0 million. The Company determined the November 2020, June 2021, February 2022, and October 2022 Amendments should be treated as modifications of the original 2020 Loan Agreement since the terms and resulting cash flows were not substantially changed upon each of the amendments. The Company will continue to amortize the existing debt discounts prior to modification through the Amended Maturity Date (as defined below). As of June 30, 2023, the Company had $200.0 million in gross principal outstanding in term loans under the Amended 2020 Loan Agreement. The outstanding term loans will mature on January 1, 2027, or the Amended Maturity Date, and bear interest at a floating per annum rate equal to the greater of (1) 8.30% or (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%. Under the Amended 2020 Loan Agreement, the repayment schedule provides for interest-only payments through February 1, 2025, followed by 23 months of principal and interest payments, unless extended by a financing event as defined in the Amended 2020 Loan Agreement. In the event of a qualifying financing event in which the Company raises at least $100.0 million in upfront licensing or partnership proceeds by February 2025, the interest-only period may be extended an additional 12 months through February 1, 2026, which would then be followed by 11 months of equal payments of principal plus interest, beginning on March 1, 2026. 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 $18.0 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. The Company’s outstanding debt balance under the Amended 2020 Loan Agreement consisted of the following as of June 30, 2023 and December 31, 2022 (in thousands). AS OF AS OF JUNE 30, 2023 DECEMBER 31, 2022 Term A $ 10,900 $ 10,900 Term B 21,800 21,800 Term C 43,600 43,600 Term D 43,600 43,600 Term E 32,700 32,700 Term F 32,700 32,700 Term G 32,700 32,700 Less: debt discount (13,518) (15,931) Long-term debt, including debt discount and final payment fee $ 204,482 $ 202,069 As of June 30, 2023, and unless extended in accordance with the terms described above, the Company’s interest-only period will continue through February 2025, with principal payments beginning in March 2025. Future principal payments and final fee payments will be made as follows (in thousands): AS OF JUNE 30, 2023 2025 $ 86,956 2026 104,348 2027 26,696 Total future minimum payments 218,000 Less: unamortized debt discount (13,518) Total debt $ 204,482 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 with a positive lien on 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 the Company to maintain a minimum cash balance of $20.0 million. As of June 30, 2023, 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 February 2022 Amendment, the Company issued 40,000 warrants to Oxford to purchase shares of the Company’s common stock at an exercise price of $45.00. Upon issuance, the warrants were classified as equity and recorded at their fair value of $0.7 million. See Note 4 for further discussion of these warrants. 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. During the three months ended June 30, 2023, interest expense was $7.9 million, $1.2 million of which related to non-cash amortization of the debt discount and accretion of the final payment. During the three months ended June 30, 2022, interest expense was $3.2 million, $0.7 million of which related to non-cash amortization of the debt discount and accretion of the final payment. During the six months ended June 30, 2023, interest expense was $15.5 million, $2.4 million of which related to non-cash amortization of the debt discount and accretion of the final payment. During the six months ended June 30, 2022, interest expense was $5.5 million, $1.2 million of which related to non-cash amortization of the debt discount and accretion of the final payment. |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | STOCKHOLDERS’ EQUITY Common Stock In September 2021, 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. 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. During each of the six months ended June 30, 2023 and June 30, 2022, the Company did not issue any shares under the Sales Agreement. Common Stock Warrants As of June 30, 2023, the following equity-classified warrants were outstanding: Expiration Date Shares of Common Stock Issuable Upon Exercise Price July 15, 2030 7,354 $ 17.00 February 18, 2032 40,000 $ 45.00 The Company’s warrants are equity-classified and carried at the instruments’ fair value upon classification into equity, with no subsequent remeasurements. |
EQUITY COMPENSATION PLAN
EQUITY COMPENSATION PLAN | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
EQUITY COMPENSATION PLAN | EQUITY COMPENSATION PLAN 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 June 30, 2023, an aggregate of 7.8 million shares of common stock were reserved for issuance under the 2017 Plan, of which 0.5 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 six months ended June 30, 2023 is as follows (in thousands, except for per share data and years): Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding as of December 31, 2022 5,305 $ 22.95 Granted 1,478 $ 23.10 Exercised (103) $ 11.74 Forfeited (72) $ 28.35 Outstanding as of June 30, 2023 6,608 $ 23.10 8.1 $ 35,768 Vested and exercisable as of June 30, 2023 2,855 $ 20.93 6.9 $ 22,466 The aggregate intrinsic value of stock options exercised during the six months ended June 30, 2023 and June 30, 2022 was $1.3 million and $1.0 million, 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 June 30, 2023, respectively. The total fair value of stock options vested during the six months ended June 30, 2023 and June 30, 2022 was $13.8 million and $16.1 million, respectively. The Company expects all outstanding stock options to vest. Stock-Based Compensation Expense 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 six months ended June 30, 2023 and June 30, 2022 were as follows: SIX MONTHS ENDED JUNE 30, 2023 2022 Risk-free interest rate 3.73 % 2.17 % Expected volatility 84.35 % 85.12 % Expected dividend yield — % — % Expected term (in years) 6.08 6.08 Weighted average fair value $ 16.97 $ 18.75 Stock-based compensation expense for stock options consisted of the following (in thousands): THREE MONTHS ENDED SIX MONTHS ENDED 2023 2022 2023 2022 Research and development $ 4,245 $ 3,540 $ 8,094 $ 7,219 General and administrative 2,008 1,756 3,795 3,185 Total stock-based compensation expense $ 6,253 $ 5,296 $ 11,889 $ 10,404 As of June 30, 2023, the Company had $64.4 million of total unrecognized stock-based compensation expense related to its stock options, which is expected to be recognized over a weighted-average period of 2.8 years. |
LICENSE AND GRANT REVENUES
LICENSE AND GRANT REVENUES | 6 Months Ended |
Jun. 30, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Abstract] | |
LICENSE AND GRANT REVENUES | LICENSE AND GRANT REVENUES The following table summarizes the total revenue recorded in the Company’s condensed consolidated statements of operations (in thousands): THREE MONTHS ENDED SIX MONTHS ENDED 2023 2022 2023 2022 License fee revenue Chiesi Farmaceutici S.p.A. $ 30 $ 98 $ 47 $ 339 Phylaxis BioScience, LLC — 413 — 1,087 2seventy bio, Inc. — 200 — 200 Total license fee revenue 30 711 47 1,626 Grant revenue — — — 14 Total revenue $ 30 $ 711 $ 47 $ 1,640 License and Collaboration Agreements 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. Additionally, the Chiesi Option Agreement provides Chiesi with a right of negotiation for INBRX-101 development and commercialization rights in the United States and Canada in the event that the Company engages in discussions with any third parties for such rights during the term of the Chiesi Option Agreement or, as applicable, the term of a definitive exclusive license agreement between Chiesi and the Company. 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 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 written scientific advice from the European Medicines Agency 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. On July 24, 2023, the Company received written scientific advice from the EMA which confirmed CT lung densitometry as the established primary regulatory endpoint to support a marketing authorization application in the European Union for the treatment of emphysema secondary to AATD. The Company provided a copy of the EMA scientific advice to Chiesi upon receipt which, as described above, fulfilled the necessary deliverables to Chiesi and triggered its 60-day option period window. If Chiesi chooses to exercise its option by September 22, 2023, pursuant to the Chiesi Option Agreement, a one-time, non-refundable option exercise payment of $12.5 million will be payable to the Company. 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 three months ended June 30, 2023 and June 30, 2022, the Company recognized $17,000 and $0.1 million in revenue related to this agreement, respectively. During the six months ended June 30, 2023 and June 30, 2022, the Company recognized $47,000 and $0.3 million in revenue related to this agreement, respectively. As of June 30, 2023 and December 31, 2022, the Company had $0.1 million of deferred revenue related to this agreement at each date, all of which is classified as current deferred revenue in each period. Phylaxis In July 2020, the Company entered into a joint venture with 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 third quarter of 2022, the Company fulfilled this performance obligation in full and recognized all remaining deferred revenue under this contract. During the three and six months ended June 30, 2023, the Company recognized no revenue related to this performance obligation following its completion in 2022. During the three months ended June 30, 2022, the Company recognized $0.4 million of revenue related to this performance obligation. During the six months ended June 30, 2022, the Company recognized $1.1 million of revenue related to this performance obligation. As of June 30, 2023 and December 31, 2022, there was no deferred revenue remaining related to the Phylaxis Agreements. 2seventy In June 2020, the Company entered into an Option and License Agreement with bluebird bio, Inc., or bluebird, pursuant to which the Company granted to bluebird exclusive worldwide rights 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. In November 2021, this agreement, or the 2020 2seventy Agreement, was also assigned to 2seventy bio, Inc., or 2seventy, 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. In June 2022, 2seventy selected a third program and paid a non-refundable upfront option fee of $0.2 million in exchange for a development license. Under each of the three programs, the Company 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. 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 re-assesses its performance obligations and transaction price accordingly. In June 2022, pursuant to the terms regarding the addition of new programs in the 2020 2seventy Agreement, the Company received a $0.2 million upfront option fee related to the selection of a third program and transferred the related know-how and development license. The Company recognized the $0.2 million of revenue at the point in time in which the program was added and the program term began. During the three and six months ended June 30, 2022, the Company recognized $0.2 million of revenue related to this agreement. During the three and six months ended June 30, 2023, the Company did not recognize any revenue related to this agreement. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Operating Leases In September 2017, the Company entered into a seven-year lease agreement 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 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 June 30, 2023 and December 31, 2022 are as follows (in thousands): AS OF AS OF JUNE 30, 2023 DECEMBER 31, 2022 Right-of-use asset $ 3,853 $ 4,717 Operating lease liability Current $ 1,959 $ 1,860 Non-current 2,171 $ 3,173 Total operating lease liability $ 4,130 $ 5,033 During each of the three months ended June 30, 2023 and June 30, 2022, the Company recognized operating lease expense of $0.8 million. During the six months ended June 30, 2023 and June 30, 2022, the Company recognized operating lease expense of $1.7 million and $1.6 million, respectively. During each of the three months ended June 30, 2023 and June 30, 2022, the Company paid $0.5 million in cash for amounts included in the measurement of the operating lease liability. During each of the six months ended June 30, 2023 and June 30, 2022, the Company paid $1.1 million in cash for amounts included in the measurement of the operating lease liability. As of June 30, 2023 and December 31, 2022, the Company’s operating lease had a remaining term of 2.0 and 2.5 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 June 30, 2023 and December 31, 2022. Future minimum rental commitments for the Company’s operating leases reconciled to the lease liability are as follows (in thousands): AS OF JUNE 30, 2023 2023 $ 1,110 2024 2,247 2025 1,137 Thereafter — Total future minimum lease payments $ 4,494 Less: imputed interest (364) Present value of operating lease liability 4,130 Less: current portion of operating lease liability (1,959) Non-current portion of operating lease liability $ 2,171 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. 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 June 30, 2023 and December 31, 2022, the non-cancellable portion of these contracts total in aggregate, excluding amounts paid or incurred at each respective date, approximately $76.5 million and $74.8 million, respectively. The non-cancellable purchase commitments relate to the purchase of raw materials and future contract manufacturing of drug supply for INBRX-101. During the six months ended June 30, 2023 and June 30, 2022, the Company incurred $1.0 million and $0.6 million, respectively, of expenses related to its non-cancellable purchase agreements. Litigation |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed 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 interim report on the Form 10-Q. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these unaudited interim condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the fiscal year ended December 31, 2022, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 6, 2023. |
Liquidity | Liquidity As of June 30, 2023, the Company had an accumulated deficit of $468.3 million and cash and cash equivalents of $192.5 million. From its inception and through June 30, 2023, 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, pre-commercialization activities, 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 condensed 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, strategic transactions and other similar arrangements. 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. |
Use of Estimates | Use of Estimates The preparation of these unaudited condensed 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 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. |
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 and highly liquid investments in debt securities with an original maturity of three months or less. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents, including investments in debt securities. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits by the Federal Deposit Insurance Corporation, or FDIC, of up to $250,000. The Company’s investment portfolio consists of investments in U.S. Treasury securities, in excess of Securities Investor Protection Corporation limits of up to $500,000 in securities. The Company’s cash management and investment policy limits investment instruments to investment-grade securities with the objective to preserve capital and to maintain liquidity until the funds can be used in operations. 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. |
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 |
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. Collaborative Research, Development, and License Agreements The Company enters into collaborative agreements with partners which may include the transfer of licenses, options to license and the performance of research and development activities. The terms associated with these agreements may 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. Payments received from customers are included in deferred revenue, allocated between current and non-current on the condensed consolidated balance sheet, until all revenue recognition criteria are met. Typically, license fees, non-refundable upfront fees and funding of research activities are considered fixed, while milestone payments, including option exercise fees, are identified as variable consideration, which is constrained and excluded from the transaction price. The Company will recognize revenue for sales-based royalty if and when a subsequent sale occurs. The Company applies significant judgment when making estimates and assumptions under these agreements, including evaluating whether contractual obligations represent distinct performance obligations, including the assessment of whether options represent material rights, determining whether there are observable standalone prices and allocating transaction price to performance obligations within a contract, assessing whether any licenses are functional or symbolic, determining when performance obligations have been met, and assessing the recognition of variable consideration. 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, performance obligations consisting of a transfer of a license or the achievement of milestones are recognized at a point in time upon the transfer, while performance obligations consisting of research activities are recognized over time using an input method which is representative of the Company’s efforts to fulfill the performance obligation, based on costs incurred with third-parties or internal labor hours performed. |
Accrued Research and Development and Clinical Trial Costs | Accrued Research and Development and Clinical Trial Costs 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 contract development and manufacturing organizations, or 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 |
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. |
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. Accordingly, for the six months ended June 30, 2023 and June 30, 2022, there is no difference in the number of shares used to calculate basic and diluted shares outstanding. |
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 Financial Accounting Standards Board, or FASB, or other standard setting bodies. 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 condensed consolidated financial condition or results of operations upon adoption. Adoption of New Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update, or ASU, 2016-13, Financial Instruments - Credit Losses : Measurement of Credit Losses on Financial Instruments (Topic 326), which intends to improve financial reporting by requiring earlier recognition of credit losses on certain financial assets, such as held-to-maturity 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. The Company adopted ASU 2016-13 as of January 1, 2023, which did not result in a material impact on its condensed consolidated financial statements and related disclosures. |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
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 JUNE 30, 2023 2022 Outstanding stock options 6,608 5,196 Warrants to purchase common stock 47 47 6,655 5,243 |
OTHER FINANCIAL INFORMATION (Ta
OTHER FINANCIAL INFORMATION (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Prepaid Expense and Other Current Assets | Prepaid expense and other current assets were comprised of the following (in thousands): AS OF AS OF JUNE 30, 2023 DECEMBER 31, 2022 Clinical trials (1) $ 6,835 $ 4,294 Clinical drug substance and product manufacturing (2) 2,362 1,171 Outside research and development services (3) 280 232 Licenses 701 493 Other 324 181 Prepaid expense and other current assets $ 10,502 $ 6,371 (1) Relates primarily to the Company’s prepayments to third-party CROs for management of clinical trials and prepayments for drug supply to be used in combination with the Company’s therapeutics. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (2) Relates primarily to the Company’s usage of third-party CDMOs for clinical and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. |
Schedule of Property and Equipment | Property and equipment, net were comprised of the following (in thousands): AS OF AS OF JUNE 30, 2023 DECEMBER 31, 2022 Machinery and equipment $ 7,393 $ 7,023 Leasehold improvements 441 441 Computer software 53 53 Furniture, fixtures, and other 527 524 Construction in process 518 — Total property and equipment 8,932 8,041 Less: accumulated depreciation and amortization (6,100) (5,540) Property and equipment, net $ 2,832 $ 2,501 Depreciation and amortization expense totaled $0.3 million for each of the three months ended June 30, 2023 and June 30, 2022, and $0.6 million for each of the six months ended June 30, 2023 and June 30, 2022 and consisted of the following (in thousands): THREE MONTHS ENDED JUNE 30, SIX MONTHS ENDED 2023 2022 2023 2022 Research and development $ 242 $ 248 $ 479 $ 506 General and administrative 53 59 110 108 Total depreciation and amortization expense $ 295 $ 307 $ 589 $ 614 |
Schedule of Accrued Expenses | Accrued expenses were comprised of the following (in thousands): AS OF AS OF JUNE 30, 2023 DECEMBER 31, 2022 Clinical trials (1) $ 8,185 $ 4,527 Clinical drug substance and product manufacturing (2) 3,335 5,381 Other outside research and development (3) 1,397 1,164 Interest expense 2,230 2,124 Compensation-related 3,390 3,374 Professional fees 674 428 Other 340 226 Accrued expenses $ 19,551 $ 17,224 (1) Relates primarily to the Company’s usage of third-party CROs for management of clinical trials. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (2) Relates primarily to the Company’s usage of third-party CDMOs for clinical and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (3) Relates to the Company’s usage of third-parties for other research and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. |
DEBT (Tables)
DEBT (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | The Company’s outstanding debt balance under the Amended 2020 Loan Agreement consisted of the following as of June 30, 2023 and December 31, 2022 (in thousands). AS OF AS OF JUNE 30, 2023 DECEMBER 31, 2022 Term A $ 10,900 $ 10,900 Term B 21,800 21,800 Term C 43,600 43,600 Term D 43,600 43,600 Term E 32,700 32,700 Term F 32,700 32,700 Term G 32,700 32,700 Less: debt discount (13,518) (15,931) Long-term debt, including debt discount and final payment fee $ 204,482 $ 202,069 |
Schedule of Maturities of Long-term Debt | Future principal payments and final fee payments will be made as follows (in thousands): AS OF JUNE 30, 2023 2025 $ 86,956 2026 104,348 2027 26,696 Total future minimum payments 218,000 Less: unamortized debt discount (13,518) Total debt $ 204,482 |
STOCKHOLDERS_ EQUITY (Tables)
STOCKHOLDERS’ EQUITY (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Schedule of Equity-classified Warrants | As of June 30, 2023, the following equity-classified warrants were outstanding: Expiration Date Shares of Common Stock Issuable Upon Exercise Price July 15, 2030 7,354 $ 17.00 February 18, 2032 40,000 $ 45.00 |
EQUITY COMPENSATION PLAN (Table
EQUITY COMPENSATION PLAN (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Options Roll Forward | A summary of the Company’s stock option activity under its 2017 Plan for the six months ended June 30, 2023 is as follows (in thousands, except for per share data and years): Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding as of December 31, 2022 5,305 $ 22.95 Granted 1,478 $ 23.10 Exercised (103) $ 11.74 Forfeited (72) $ 28.35 Outstanding as of June 30, 2023 6,608 $ 23.10 8.1 $ 35,768 Vested and exercisable as of June 30, 2023 2,855 $ 20.93 6.9 $ 22,466 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | 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 six months ended June 30, 2023 and June 30, 2022 were as follows: SIX MONTHS ENDED JUNE 30, 2023 2022 Risk-free interest rate 3.73 % 2.17 % Expected volatility 84.35 % 85.12 % Expected dividend yield — % — % Expected term (in years) 6.08 6.08 Weighted average fair value $ 16.97 $ 18.75 |
Schedule of Stock-Based Compensation Expense | Stock-based compensation expense for stock options consisted of the following (in thousands): THREE MONTHS ENDED SIX MONTHS ENDED 2023 2022 2023 2022 Research and development $ 4,245 $ 3,540 $ 8,094 $ 7,219 General and administrative 2,008 1,756 3,795 3,185 Total stock-based compensation expense $ 6,253 $ 5,296 $ 11,889 $ 10,404 |
LICENSE AND GRANT REVENUES (Tab
LICENSE AND GRANT REVENUES (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Abstract] | |
Schedule of License and Grant Revenue | The following table summarizes the total revenue recorded in the Company’s condensed consolidated statements of operations (in thousands): THREE MONTHS ENDED SIX MONTHS ENDED 2023 2022 2023 2022 License fee revenue Chiesi Farmaceutici S.p.A. $ 30 $ 98 $ 47 $ 339 Phylaxis BioScience, LLC — 413 — 1,087 2seventy bio, Inc. — 200 — 200 Total license fee revenue 30 711 47 1,626 Grant revenue — — — 14 Total revenue $ 30 $ 711 $ 47 $ 1,640 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Operating Lease, by Balance Sheet Location | The right-of-use asset and operating lease liability as of June 30, 2023 and December 31, 2022 are as follows (in thousands): AS OF AS OF JUNE 30, 2023 DECEMBER 31, 2022 Right-of-use asset $ 3,853 $ 4,717 Operating lease liability Current $ 1,959 $ 1,860 Non-current 2,171 $ 3,173 Total operating lease liability $ 4,130 $ 5,033 |
Schedule of Operating Lease Maturity | Future minimum rental commitments for the Company’s operating leases reconciled to the lease liability are as follows (in thousands): AS OF JUNE 30, 2023 2023 $ 1,110 2024 2,247 2025 1,137 Thereafter — Total future minimum lease payments $ 4,494 Less: imputed interest (364) Present value of operating lease liability 4,130 Less: current portion of operating lease liability (1,959) Non-current portion of operating lease liability $ 2,171 |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 468,341 | $ 372,373 |
Cash and cash equivalents | 192,492 | $ 273,865 |
Debt securities, amortized cost | $ 133,700 | |
Number of operating segments | segment | 1 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Potential Dilutive Securities (Details) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Antidilutive securities excluded from earnings per share computation (in shares) | 6,655 | 5,243 |
Outstanding stock options | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Antidilutive securities excluded from earnings per share computation (in shares) | 6,608 | 5,196 |
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) | 47 | 47 |
OTHER FINANCIAL INFORMATION - P
OTHER FINANCIAL INFORMATION - Prepaid Expense and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical trials | $ 6,835 | $ 4,294 |
Clinical drug substance and product manufacturing | 2,362 | 1,171 |
Outside research and development services | 280 | 232 |
Licenses | 701 | 493 |
Other | 324 | 181 |
Prepaid expense and other current assets | $ 10,502 | $ 6,371 |
OTHER FINANCIAL INFORMATION -_2
OTHER FINANCIAL INFORMATION - Property and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | $ 8,932 | $ 8,932 | $ 8,041 | ||
Less: accumulated depreciation and amortization | (6,100) | (6,100) | (5,540) | ||
Property and equipment, net | 2,832 | 2,832 | 2,501 | ||
Depreciation and amortization | 295 | $ 307 | 589 | $ 614 | |
Machinery and equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | 7,393 | 7,393 | 7,023 | ||
Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | 441 | 441 | 441 | ||
Computer software | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | 53 | 53 | 53 | ||
Furniture, fixtures, and other | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | 527 | 527 | 524 | ||
Construction in process | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | $ 518 | $ 518 | $ 0 |
OTHER FINANCIAL INFORMATION - D
OTHER FINANCIAL INFORMATION - Depreciation and Amortization Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Property, Plant and Equipment [Line Items] | ||||
Depreciation and amortization | $ 295 | $ 307 | $ 589 | $ 614 |
Research and development | ||||
Property, Plant and Equipment [Line Items] | ||||
Depreciation and amortization | 242 | 248 | 479 | 506 |
General and administrative | ||||
Property, Plant and Equipment [Line Items] | ||||
Depreciation and amortization | $ 53 | $ 59 | $ 110 | $ 108 |
OTHER FINANCIAL INFORMATION - A
OTHER FINANCIAL INFORMATION - Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical trials | $ 8,185 | $ 4,527 |
Clinical drug substance and product manufacturing | 3,335 | 5,381 |
Other outside research and development | 1,397 | 1,164 |
Interest expense | 2,230 | 2,124 |
Compensation-related | 3,390 | 3,374 |
Professional fees | 674 | 428 |
Other | 340 | 226 |
Accrued expenses | $ 19,551 | $ 17,224 |
DEBT - Narrative (Details)
DEBT - Narrative (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||
Oct. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) | Feb. 28, 2022 USD ($) tranche $ / shares shares | Jun. 30, 2021 USD ($) | Nov. 30, 2020 USD ($) | Jul. 31, 2020 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | |
Debt Instrument [Line Items] | |||||||||||
Proceeds from the issuance of debt | $ 0 | $ 98,871 | |||||||||
Reclassification of warrant liabilities to equity | $ 712 | ||||||||||
Amortization of debt discount and accretion | 2,400 | 1,200 | |||||||||
Secured Debt | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt interest expense | $ 7,900 | $ 3,200 | 15,500 | $ 5,500 | |||||||
Amortization of debt discount and accretion | 1,200 | $ 700 | |||||||||
Amended 2020 Oxford Term Loan Tranche One | Secured Debt | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from the issuance of debt | $ 10,000 | ||||||||||
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 | ||||||||||
2022 Loan Agreement | Secured Debt | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from the issuance of debt | $ 40,000 | ||||||||||
Number of additional tranches available upon contingent events | tranche | 3 | ||||||||||
Minimum cash balance | 20,000 | 20,000 | |||||||||
2022 Loan Agreement | Secured Debt | Warrants Issued Concurrently With 2022 Loan Agreement | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Warrants issued (in shares) | shares | 40 | ||||||||||
Warrant price (in dollars per share) | $ / shares | $ 45 | ||||||||||
Reclassification of warrant liabilities to equity | $ 700 | ||||||||||
Amended 2020 Oxford Term Loan February 2022 Amendment Tranche One | Secured Debt | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from the issuance of debt | $ 30,000 | ||||||||||
Amended 2020 Oxford Term Loan February 2022 Amendment Tranche Two | Secured Debt | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from the issuance of debt | $ 30,000 | ||||||||||
Amended 2020 Oxford Term Loan February 2022 Amendment Tranche Three | Secured Debt | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Term loan aggregate amount | $ 30,000 | ||||||||||
Amended 2020 Oxford Term Loan October 2022 Amendment | Secured Debt | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from the issuance of debt | $ 30,000 | ||||||||||
Amended 2020 Oxford Term Loan | Secured Debt | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Gross principal outstanding | $ 200,000 | $ 200,000 | |||||||||
Annual interest rate | 8.30% | 8.30% | |||||||||
Equal payments of principal and interest period if interest only period is extended | 23 months | ||||||||||
Upfront licensing or partnership proceeds raised | $ 100,000 | ||||||||||
Equal payments of principal period if interest only period is extended | 11 months | ||||||||||
Percentage of principal amount for final payment | 9% | 9% | |||||||||
Periodic payment terms, final payment amount | $ 18,000 | $ 18,000 | |||||||||
Amended 2020 Oxford Term Loan | Secured Debt | LIBOR | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Basis spread on variable rate | 8.19% | ||||||||||
2020 Loan Agreement | Secured Debt | Minimum | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Prepayment fee | 1% | 1% | |||||||||
2020 Loan Agreement | Secured Debt | Maximum | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Prepayment fee | 3% | 3% |
DEBT - Loan Agreement Balance (
DEBT - Loan Agreement Balance (Details) - Secured Debt - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
2022 Loan A | ||
Debt Instrument [Line Items] | ||
Debt | $ 10,900 | |
2020 Term A | ||
Debt Instrument [Line Items] | ||
Debt | $ 10,900 | |
2022 Loan B | ||
Debt Instrument [Line Items] | ||
Debt | 21,800 | |
2020 Term B | ||
Debt Instrument [Line Items] | ||
Debt | 21,800 | |
2022 Loan C | ||
Debt Instrument [Line Items] | ||
Debt | 43,600 | |
2020 Term C | ||
Debt Instrument [Line Items] | ||
Debt | 43,600 | |
2022 Loan D | ||
Debt Instrument [Line Items] | ||
Debt | 43,600 | |
2020 Term D | ||
Debt Instrument [Line Items] | ||
Debt | 43,600 | |
2022 Term Loan E | ||
Debt Instrument [Line Items] | ||
Debt | 32,700 | |
2020 Term Loan E | ||
Debt Instrument [Line Items] | ||
Debt | 32,700 | |
2022 Term Loan F | ||
Debt Instrument [Line Items] | ||
Debt | 32,700 | |
2020 Term Loan F | ||
Debt Instrument [Line Items] | ||
Debt | 32,700 | |
2022 Term Loan G | ||
Debt Instrument [Line Items] | ||
Debt | 32,700 | |
2020 Term Loan G | ||
Debt Instrument [Line Items] | ||
Debt | 32,700 | |
2022 Loan Agreement | ||
Debt Instrument [Line Items] | ||
Less: debt discount | (13,518) | |
Total debt | $ 204,482 | |
2020 Loan Agreement | ||
Debt Instrument [Line Items] | ||
Less: debt discount | (15,931) | |
Total debt | $ 202,069 |
DEBT - Future Minimum Payments
DEBT - Future Minimum Payments (Details) - 2020 and 2022 Oxford Term Loans - Secured Debt $ in Thousands | Jun. 30, 2023 USD ($) |
Debt Instrument [Line Items] | |
2025 | $ 86,956 |
2026 | 104,348 |
2027 | 26,696 |
Total future minimum payments | 218,000 |
Less: unamortized debt discount | (13,518) |
Total debt | $ 204,482 |
STOCKHOLDERS_ EQUITY - Narrativ
STOCKHOLDERS’ EQUITY - Narrative (Details) - Sales Agreement $ in Millions | 1 Months Ended |
Sep. 30, 2021 USD ($) | |
Temporary Equity [Line Items] | |
Aggregate offering price | $ 200 |
Commission percent | 3% |
STOCKHOLDERS_ EQUITY - Common S
STOCKHOLDERS’ EQUITY - Common Stock Warrants (Details) | Jun. 30, 2023 $ / shares shares |
July, 15, 2030 | |
Class of Warrant or Right [Line Items] | |
Shares of Common Stock Issuable Upon Exercise of Warrants (in shares) | shares | 7,354 |
Exercise Price per Share (in dollars per share) | $ / shares | $ 17 |
February 18, 2032 | |
Class of Warrant or Right [Line Items] | |
Shares of Common Stock Issuable Upon Exercise of Warrants (in shares) | shares | 40,000 |
Exercise Price per Share (in dollars per share) | $ / shares | $ 45 |
EQUITY COMPENSATION PLAN - Narr
EQUITY COMPENSATION PLAN - Narrative (Details) - USD ($) shares in Millions, $ in Millions | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance (in shares) | 7.8 | |
Available shares reserved for issuance (in shares) | 0.5 | |
Aggregate intrinsic value of stock options exercised | $ 1.3 | $ 1 |
Total fair value of stock options | $ 13.8 | $ 16.1 |
Employee 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 | $ 64.4 | |
Weighted-average period of recognition | 2 years 9 months 18 days | |
Employee Stock Option | Cliff Vesting | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 1 year |
EQUITY COMPENSATION PLAN - Stoc
EQUITY COMPENSATION PLAN - Stock Option Activity (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 6 Months Ended |
Jun. 30, 2023 | |
Number of Shares | |
Outstanding, beginning balance (in shares) | 5,305 |
Granted (in shares) | 1,478 |
Exercised (in shares) | (103) |
Forfeited (in shares) | (72) |
Outstanding, ending balance (in shares) | 6,608 |
Vested and exercisable (in shares) | 2,855 |
Weighted Average Exercise Price | |
Outstanding, beginning balance (in dollars per share) | $ 22.95 |
Granted (in dollars per share) | 23.10 |
Exercised (in dollars per share) | 11.74 |
Forfeited (in dollars per share) | 28.35 |
Outstanding, ending balance (in dollars per share) | 23.10 |
Vested and exercisable (in dollars per share) | $ 20.93 |
Weighted Average Remaining Contractual Term (in years) | 8 years 1 month 6 days |
Weighted Average Remaining Contractual Term, vested and exercisable | 6 years 10 months 24 days |
Aggregate Intrinsic Value | $ 35,768 |
Aggregate Intrinsic Value, vested and exercisable | $ 22,466 |
EQUITY COMPENSATION PLAN - Fair
EQUITY COMPENSATION PLAN - Fair Value of Stock Option Grants (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value (in dollars per share) | $ 16.97 | $ 18.75 |
Employee Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 3.73% | 2.17% |
Expected volatility | 84.35% | 85.12% |
Expected dividend yield | 0% | 0% |
Expected term (in years) | 6 years 29 days | 6 years 29 days |
EQUITY COMPENSATION PLAN - St_2
EQUITY COMPENSATION PLAN - Stock-based Compensation Expense (Details) - Employee Stock Option - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 6,253 | $ 5,296 | $ 11,889 | $ 10,404 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 4,245 | 3,540 | 8,094 | 7,219 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 2,008 | $ 1,756 | $ 3,795 | $ 3,185 |
LICENSE AND GRANT REVENUES - Re
LICENSE AND GRANT REVENUES - Revenue Summary (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | $ 30 | $ 711 | $ 47 | $ 1,640 |
License fee revenue from non-affiliates | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 30 | 711 | 47 | 1,626 |
License fee revenue from non-affiliates | Chiesi Farmaceutici S.p.A. | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 30 | 98 | 47 | 339 |
License fee revenue from non-affiliates | Phylaxis BioScience, LLC | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 0 | 413 | 0 | 1,087 |
License fee revenue from non-affiliates | 2seventy bio, Inc. | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 0 | 200 | 0 | 200 |
Grant revenue | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | $ 0 | $ 0 | $ 0 | $ 14 |
LICENSE AND GRANT REVENUES - Li
LICENSE AND GRANT REVENUES - License and Collaboration Agreements (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||
Jul. 24, 2023 USD ($) | Jun. 30, 2022 USD ($) program | Jul. 31, 2020 USD ($) compound performanceObligation | Jun. 30, 2020 USD ($) program performanceObligation | Aug. 31, 2019 USD ($) performanceObligation | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) program | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) program | Dec. 31, 2022 USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Deferred revenue | $ 119,000 | $ 119,000 | $ 166,000 | |||||||
Total revenue | 30,000 | $ 711,000 | 47,000 | $ 1,640,000 | ||||||
License fee revenue from non-affiliates | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Total revenue | 30,000 | 711,000 | 47,000 | 1,626,000 | ||||||
Phylaxis BioScience, LLC | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Equity interest percentage | 10% | |||||||||
Additional equity interest percentage entitled to receive | 5% | |||||||||
Chiesi Farmaceutici S.p.A. | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Nonrefundable, upfront payment | $ 10,000,000 | |||||||||
Additional payable due from agreement | 12,500,000 | |||||||||
Milestone payments receivable | $ 122,500,000 | |||||||||
Number of performance obligations | performanceObligation | 1 | |||||||||
Term of research and development services option period | 60 days | |||||||||
Deferred revenue | 100,000 | 100,000 | 100,000 | |||||||
Chiesi Farmaceutici S.p.A. | Subsequent Event | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Term of option period due from deliverables | 60 days | |||||||||
Nonrefundable, option exercise payment | $ 12,500,000 | |||||||||
Chiesi Farmaceutici S.p.A. | License fee revenue from non-affiliates | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Revenue recognized related to performance obligation | 17,000 | 100,000 | 47,000 | 300,000 | ||||||
Total revenue | 30,000 | 98,000 | 47,000 | 339,000 | ||||||
Phylaxis BioScience, LLC | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Nonrefundable, upfront payment | $ 2,500,000 | |||||||||
Additional payable due from agreement | $ 2,500,000 | |||||||||
Number of performance obligations | performanceObligation | 1 | |||||||||
Deferred revenue | 0 | 0 | $ 0 | |||||||
Additional payment receivable period | 180 days | |||||||||
Development milestone payment receivable | $ 225,000,000 | |||||||||
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 | |||||||||
Phylaxis BioScience, LLC | Payment One | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Additional payable due from agreement | $ 1,250,000 | |||||||||
Phylaxis BioScience, LLC | Payment Two | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Additional payable due from agreement | $ 1,250,000 | |||||||||
Phylaxis BioScience, LLC | License fee revenue from non-affiliates | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Revenue recognized related to performance obligation | 0 | 400,000 | 0 | 1,100,000 | ||||||
Total revenue | 0 | $ 413,000 | 0 | $ 1,087,000 | ||||||
2seventy bio, Inc. | Initial Programs | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Nonrefundable, upfront payment | $ 400,000 | |||||||||
Number of performance obligations | performanceObligation | 1 | |||||||||
Number of program related to collaborative agreement | program | 3 | 2 | 3 | 3 | ||||||
2seventy bio, Inc. | Additional Programs | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Number of program related to collaborative agreement | program | 8 | |||||||||
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. | Initial Programs, Program 3 | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Nonrefundable, upfront payment | $ 200,000 | |||||||||
2seventy bio, Inc. | 2020 Option and License Agreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Development milestone payment receivable | $ 51,500,000 | |||||||||
2seventy bio, Inc. | License fee revenue from non-affiliates | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Total revenue | 0 | $ 200,000 | 0 | $ 200,000 | ||||||
2seventy bio, Inc. | License fee revenue from non-affiliates | 2020 Option and License Agreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||||||||
Total revenue | $ 0 | $ 200,000 | $ 0 | $ 200,000 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | May 31, 2019 | Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |||||||
Lease agreement term | 7 years | ||||||
Lease extension term | 5 years | ||||||
Initial base rent per month | $ 30 | $ 100 | |||||
Annual escalations | 2% | 2% | |||||
Operating lease expense | $ 800 | $ 800 | $ 1,700 | $ 1,600 | |||
Payments included in measurement of lease liability | $ 500 | 500 | $ 1,100 | 1,100 | |||
Remaining term of operating lease | 2 years | 2 years | 2 years 6 months | ||||
Weighted-average discount rate | 8.20% | 8.20% | 8.20% | ||||
Purchase commitment, future period | 12 months | ||||||
Purchase commitment | $ 76,500 | $ 76,500 | $ 74,800 | ||||
Purchase commitment, expenses incurred | $ 1,000 | $ 600 | $ 1,000 | $ 600 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Schedule of Right-Of-Use Asset and Operating Lease Liability (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Right-of-use asset | $ 3,853 | $ 4,717 |
Operating lease liability | ||
Current | 1,959 | 1,860 |
Non-current | 2,171 | 3,173 |
Present value of operating lease liability | $ 4,130 | $ 5,033 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES - Schedule of Operating Lease Liability Maturity (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
2023 | $ 1,110 | |
2024 | 2,247 | |
2025 | 1,137 | |
Thereafter | 0 | |
Total future minimum lease payments | 4,494 | |
Less: imputed interest | (364) | |
Present value of operating lease liability | 4,130 | $ 5,033 |
Less: current portion of operating lease liability | (1,959) | (1,860) |
Non-current portion of lease liability | $ 2,171 | $ 3,173 |