Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
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 $0.0001 | |
Trading Symbol | INBX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 43,551,422 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Entity Central Index Key | 0001739614 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 146,073 | $ 131,301 |
Accounts receivable | 243 | 373 |
Receivables from related parties | 72 | 505 |
Prepaid expenses and other current assets | 7,366 | 6,933 |
Total current assets | 153,754 | 139,112 |
Property and equipment, net | 2,799 | 3,153 |
Right-of-use asset | 5,135 | 6,338 |
Other non-current assets | 3,164 | 1,847 |
Total assets | 164,852 | 150,450 |
Current liabilities: | ||
Accounts payable | 8,569 | 9,125 |
Accrued expenses | 14,605 | 9,621 |
Current portion of deferred revenue | 440 | 2,034 |
Current portion of lease liability | 1,812 | 1,674 |
Total current liabilities | 25,426 | 22,454 |
Long-term debt, including final payment fee | 170,819 | 70,470 |
Non-current portion of lease liability | 3,657 | 5,033 |
Non-current portion of deferred revenue | 0 | 110 |
Total liabilities | 199,902 | 98,067 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity (deficit) | ||
Preferred stock, $0.0001 par value; 15,000,000 shares authorized as of September 30, 2022 and December 31, 2021; no shares issued or outstanding as of September 30, 2022 and December 31, 2021. | 0 | 0 |
Common stock, $0.0001 par value; 120,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 39,087,173 and 38,991,307 issued and outstanding as of September 30, 2022 and December 31, 2021, respectively. | 4 | 4 |
Additional paid-in-capital | 296,404 | 279,526 |
Accumulated deficit | (331,458) | (227,147) |
Total stockholders’ equity (deficit) | (35,050) | 52,383 |
Total liabilities and stockholders’ equity (deficit) | $ 164,852 | $ 150,450 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
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) | 39,087,173 | 38,991,307 |
Common stock, shares outstanding (in shares) | 39,087,173 | 38,991,307 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue: | ||||
Total revenue | $ 278 | $ 2,532 | $ 1,918 | $ 4,375 |
Operating expenses: | ||||
Research and development | 24,934 | 18,485 | 79,735 | 52,825 |
General and administrative | 5,347 | 2,848 | 15,800 | 8,710 |
Total operating expenses | 30,281 | 21,333 | 95,535 | 61,535 |
Loss from operations | (30,003) | (18,801) | (93,617) | (57,160) |
Other income (expense): | ||||
Interest expense, net | (5,340) | (1,778) | (10,762) | (3,437) |
Other income (expense), net | 18 | (1) | 72 | 20 |
Total other expense | (5,322) | (1,779) | (10,690) | (3,417) |
Loss before income tax expense | (35,325) | (20,580) | (104,307) | (60,577) |
Provision for income taxes | 0 | 0 | 4 | 2 |
Net loss | $ (35,325) | $ (20,580) | $ (104,311) | $ (60,579) |
Net loss per share, basic (in dollars per share) | $ (0.90) | $ (0.54) | $ (2.67) | $ (1.60) |
Net loss per share, diluted (in dollars per share) | $ (0.90) | $ (0.54) | $ (2.67) | $ (1.60) |
Weighted-average shares of common stock outstanding, basic (in shares) | 39,071 | 37,893 | 39,043 | 37,818 |
Weighted-average shares of common stock outstanding, diluted (in shares) | 39,071 | 37,893 | 39,043 | 37,818 |
License fee revenue | ||||
Revenue: | ||||
Total revenue | $ 278 | $ 2,508 | $ 1,904 | $ 4,289 |
Grant revenue | ||||
Revenue: | ||||
Total revenue | $ 0 | $ 24 | $ 14 | $ 86 |
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, 2020 | 37,712,000 | |||
Beginning balance at Dec. 31, 2020 | $ 75,473 | $ 4 | $ 220,848 | $ (145,379) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | 3,421 | 3,421 | ||
Issuance of shares upon exercise of stock options (in shares) | 93,000 | |||
Issuance of shares upon exercise of stock options | 988 | 988 | ||
Net loss | (19,289) | (19,289) | ||
Ending balance (in shares) at Mar. 31, 2021 | 37,805,000 | |||
Ending balance at Mar. 31, 2021 | 60,593 | $ 4 | 225,257 | (164,668) |
Beginning balance (in shares) at Dec. 31, 2020 | 37,712,000 | |||
Beginning balance at Dec. 31, 2020 | 75,473 | $ 4 | 220,848 | (145,379) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net loss | (60,579) | |||
Ending balance (in shares) at Sep. 30, 2021 | 37,933,000 | |||
Ending balance at Sep. 30, 2021 | 28,200 | $ 4 | 234,154 | (205,958) |
Beginning balance (in shares) at Mar. 31, 2021 | 37,805,000 | |||
Beginning balance at Mar. 31, 2021 | 60,593 | $ 4 | 225,257 | (164,668) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | 3,951 | 3,951 | ||
Issuance of shares upon exercise of stock options (in shares) | 44,000 | |||
Issuance of shares upon exercise of stock options | 485 | 485 | ||
Net loss | (20,710) | (20,710) | ||
Ending balance (in shares) at Jun. 30, 2021 | 37,849,000 | |||
Ending balance at Jun. 30, 2021 | 44,319 | $ 4 | 229,693 | (185,378) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | 3,493 | 3,493 | ||
Issuance of shares upon exercise of stock options (in shares) | 84,000 | |||
Issuance of shares upon exercise of stock options | 968 | 968 | ||
Net loss | (20,580) | (20,580) | ||
Ending balance (in shares) at Sep. 30, 2021 | 37,933,000 | |||
Ending balance at Sep. 30, 2021 | $ 28,200 | $ 4 | 234,154 | (205,958) |
Beginning balance (in shares) at Dec. 31, 2021 | 38,991,307 | 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 | 38,991,307 | 38,991,000 | ||
Beginning balance at Dec. 31, 2021 | $ 52,383 | $ 4 | 279,526 | (227,147) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of shares upon exercise of stock options (in shares) | 96,000 | |||
Net loss | $ (104,311) | |||
Ending balance (in shares) at Sep. 30, 2022 | 39,087,173 | 39,086,000 | ||
Ending balance at Sep. 30, 2022 | $ (35,050) | $ 4 | 296,404 | (331,458) |
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) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | 4,691 | 4,691 | ||
Issuance of shares upon exercise of stock options (in shares) | 45,000 | |||
Issuance of shares upon exercise of stock options | 506 | 506 | ||
Net loss | $ (35,325) | (35,325) | ||
Ending balance (in shares) at Sep. 30, 2022 | 39,087,173 | 39,086,000 | ||
Ending balance at Sep. 30, 2022 | $ (35,050) | $ 4 | $ 296,404 | $ (331,458) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (104,311) | $ (60,579) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 923 | 888 |
Accretion of debt discount and non-cash interest expense | 2,190 | 833 |
Stock-based compensation expense | 15,095 | 10,865 |
Non-cash lease expense | 1,203 | 1,108 |
(Gain) loss on disposal of fixed assets | 18 | (9) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 130 | (38) |
Receivables from related parties | 433 | 150 |
Prepaid expenses and other current assets | (383) | (2,586) |
Other non-current assets | (1,317) | 0 |
Accounts payable | (724) | (1,232) |
Accrued expenses and other current liabilities | 4,984 | (5,053) |
Operating lease liability | (1,238) | (1,111) |
Deferred revenue, current portion | (1,594) | (312) |
Deferred revenue, non-current portion | (110) | (627) |
Net cash used in operating activities | (84,701) | (57,703) |
Cash flows from investing activities | ||
Purchase of fixed assets | (419) | (597) |
Proceeds from the sale of property and equipment | 0 | 55 |
Net cash used in investing activities | (419) | (542) |
Cash flows from financing activities | ||
Proceeds from the issuance of debt | 98,871 | 39,992 |
Payment of fees associated with debt | (50) | 0 |
Proceeds from the exercise of stock options | 1,071 | 2,441 |
Deferred offering costs paid | 0 | (148) |
Net cash provided by financing activities | 99,892 | 42,285 |
Net increase (decrease) in cash and cash equivalents | 14,772 | (15,960) |
Cash and cash equivalents at beginning of period | 131,301 | 128,664 |
Cash and cash equivalents at end of period | 146,073 | 112,704 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 7,834 | 2,001 |
Cash paid for income taxes | 4 | 2 |
Supplemental schedule of non-cash investing and financing activities | ||
Fair value of warrants issued to lender in conjunction with February 2022 Amendment | 712 | 0 |
Payable for purchase of fixed assets | 261 | 78 |
Deferred offering costs included in accounts payable and accrued expenses | $ 0 | $ 198 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2022 | |
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 a deep understanding of target biology with innovative protein engineering, proprietary discovery technologies, and an integrative approach to research and development to design highly differentiated 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 interim condensed 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 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 financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2021, which are included in the Company’s Annual Report on Form 10-K filed with the SEC. Liquidity As of September 30, 2022, the Company had an accumulated deficit of $331.5 million and cash and cash equivalents of $146.1 million. From its inception and through September 30, 2022, the Company has devoted substantially all of its efforts to therapeutic drug discovery and development, conducting preclinical studies and clinical trials, enabling manufacturing activities in support of its therapeutic candidates, organizing and staffing the Company, establishing its intellectual property portfolio and raising capital to support and expand these activities. The Company believes that its existing cash and cash equivalents will be sufficient to fund the Company’s operations for at least 12 months from the date these 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. As discussed in Note 4, the Company entered into the Open Market Sale Agreement, or the Sales Agreement, with Jefferies LLC, or the Sales Agent, under which it may, from time to time, sell shares of its common stock having an aggregate offering price of up to $200.0 million through the Sales Agent, or the ATM Offering. During the year ended December 31, 2021, the Company sold 921,042 shares pursuant to the Sales Agreement for net proceeds of $40.2 million, after deducting commissions. During the nine months ended September 30, 2022, the Company did not issue any shares under the Sales Agreement. As discussed in Note 3, the Company received $40.0 million in gross proceeds upon entering into the February 2022 Amendment to the 2020 Loan Agreement, as amended (both as defined below). Pursuant to the Amended 2020 Loan Agreement (as defined below), three additional tranches became available upon the occurrence of contingent events, for additional gross proceeds of up to $90.0 million. In June 2022, two of these tranches were drawn for additional gross proceeds of $60.0 million. If the Company does raise additional capital through public or private equity or convertible debt offerings, the ownership interests of its existing stockholders will be diluted, and the terms of those securities may include liquidation or other preferences that adversely affect its stockholders’ rights. If the Company raises capital through additional debt financings, it may be subject to covenants limiting or restricting its ability to take specific actions, such as incurring additional debt or making certain capital expenditures. To the extent that the Company raises additional capital through strategic licensing, collaboration or other similar agreement, it may have to relinquish valuable rights to its therapeutic candidates, future revenue streams or research programs at an earlier stage of development or on less favorable terms than it would otherwise choose, or to grant licenses on terms that may not be favorable to the Company. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future. If the Company is unable to secure adequate additional funding, it will need to reevaluate its operating plan and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of its development programs, or relinquish rights to its technology on less favorable terms than it would otherwise choose. These actions could materially impact its business, financial condition, results of operations and prospects. The rules and regulations of the SEC or any other regulatory agencies may restrict the Company’s ability to conduct certain types of financing activities, or may affect the timing of and amounts it can raise by undertaking such activities. Impact of COVID-19 Pandemic In response to the global COVID-19 pandemic, the Company continues to take the necessary precautions to ensure the safety of its employees and to minimize interruptions to its operations. The full impact of the COVID-19 outbreak continues to evolve as of the date of these financial statements. While the pandemic has not yet had a material effect on the Company’s financial results, the degree to which COVID-19, including new variants of the virus, may impact the Company’s financial condition, liquidity and future results of operations is uncertain. Management is actively monitoring the risks to public health and the impact of overall global business activity on its financial condition, liquidity, operations, suppliers, industry, and workforce. The U.S. federal government enacted the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which, among a number of varied provisions, aimed to ease tax burdens on companies during the COVID pandemic, permitted employers to defer the payment of the employer share of social security taxes due for the period beginning March 27, 2020 and ending December 31, 2020. Of the amounts deferred, 50% was required to be paid by December 31, 2021 and the remaining 50% is required to be paid by December 31, 2022. The Company began deferring payment of the employer share of social security taxes in April 2020 and deferred a total of $0.4 million of such taxes during the period. The Company paid $0.3 million of deferred taxes during December 2021. As of September 30, 2022, the Company has a remaining deferred payment of $0.1 million of such taxes, which are classified as accrued expenses in the Company’s condensed consolidated balance sheets. 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 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, 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. Concentrations of Credit Risk The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial condition of the depository institutions in which those deposits are held. 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. As of September 30, 2022 and December 31, 2021, the Company had no financial instruments measured at fair value on a recurring basis. Deferred Offering Costs The Company capitalizes costs that are directly associated with equity financings until such financings are consummated, at which time such costs are recorded against the gross proceeds of the offering. Legal, accounting, and filing fees related directly to the Company’s Sales Agreement are capitalized as deferred offering costs. Deferred offering costs associated with the Sales Agreement are reclassified to additional paid-in capital when the Company completes offerings under the Company’s Shelf Registration on Form S-3ASR. In November 2021, the Company completed an ATM Offering under the Sales Agreement and offset $1.7 million of offering costs against the proceeds. Financial Instruments with Characteristics of Both Liabilities and Equity The Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, or ASC 480-10, and ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock, or ASC 815-40. Under ASC 480-10, warrants are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in other expense, net in the condensed consolidated statements of operations as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or under another applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. The Company’s outstanding warrants do not meet the requirements for liability classification under ASC-480-10 or ASC-815-40. Therefore, the warrants were treated as equity at the time of issuance. Revenue Recognition The Company has generated revenue from its license and collaboration agreements with partners, as well as from grants from government agencies and private not-for-profit organizations. Payments received from customers are included in deferred revenue, allocated between current and non-current on the condensed consolidated balance sheet until all revenue recognition criteria are met. In accordance with ASC Topic 606, Revenue from Contracts with Customers, or ASC Topic 606, the Company recognizes revenue when, or as, the promised goods or services are transferred to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those services. To determine revenue recognition for arrangements the Company concludes are within the scope of ASC Topic 606, the Company performs the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligation(s) in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligation(s) in the contract; and (5) recognize revenue when (or as) the performance obligation(s) are satisfied. At contract inception, the Company assesses the goods or services promised within each contract, assesses whether each promised good or service is distinct and identifies those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. Collaborative Research, Development, and License Agreements The Company enters into collaborative agreements with partners that typically include one or more of the following: (1) license fees; (2) nonrefundable up-front fees; (3) payments for reimbursement of research costs; (4) payments associated with achieving specific development, regulatory, or commercial milestones; and (5) royalties based on specified percentages of net product sales, if any. At the initiation of an agreement, the Company analyzes whether each unit of account results in a contract with a customer under ASC Topic 606 or in an arrangement with a collaborator subject to guidance under ASC Topic 808, Collaborative Arrangements . The Company’s licensing arrangements are typically for functional intellectual property as it exists at a point in time, being the time that the license agreement is executed. The Company typically does not have an ongoing performance obligation to support or maintain the licensed intellectual property. The Company considers a variety of factors in determining the appropriate estimates and assumptions under these arrangements, such as whether the elements are distinct performance obligations, whether there are observable stand-alone prices, and whether any licenses are functional or symbolic. The Company evaluates each performance obligation to determine if it can be satisfied and recognized as revenue at a point in time or over time. Typically, license fees, non-refundable upfront fees, and funding of research activities are considered fixed, while milestone payments are identified as variable consideration which must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. The Company estimates the amount of variable consideration using the most likely amount, as milestone payments typically only have two possible outcomes. The Company recognizes revenue for sales-based royalty promised in exchange for the license of intellectual property only when the subsequent sale occurs. In the case of an agreement which provides the partner with an option to license a therapeutic or therapeutic candidate in the future, the Company evaluates whether this option represents a material right at the inception of the agreement. If determined to be a material right, the Company will consider the option a separate performance obligation. The Company has historically concluded that the option to grant a license in the future is not a material right as it is contingent upon future events which may not occur. When an option is exercised, the Company will identify any separate performance obligations. The Company may allocate transaction price using a number of methods including estimating standalone selling price of performance obligations and using the residual approach when the standalone selling price of the license is highly variable or uncertain, and observable standalone selling prices exist for the other goods or services promised in the contract. Research and Development and Clinical Trial Accruals Research and development costs are expensed as incurred and include the cost of compensation and related expenses, as well as expenses for third parties who conduct research and development on the Company’s behalf, pursuant to development and consulting agreements in place. The Company’s preclinical studies and clinical trials are performed internally, by third party contract research organizations, or CROs, and/or clinical investigators. The Company also engages with 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 nine months ended September 30, 2022 and September 30, 2021, 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 SEPTEMBER 30, 2022 2021 Outstanding stock options 5,269 3,983 Warrants to purchase common stock 47 7 5,316 3,990 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 May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options , which intends to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The Company adopted ASU 2021-04 on |
OTHER FINANCIAL INFORMATION
OTHER FINANCIAL INFORMATION | 9 Months Ended |
Sep. 30, 2022 | |
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 SEPTEMBER 30, 2022 DECEMBER 31, 2021 Outside research and development services $ 6,539 $ 6,343 Other 827 590 Prepaid expense and other current assets $ 7,366 $ 6,933 Property and Equipment, Net Property and equipment, net were comprised of the following (in thousands): AS OF AS OF SEPTEMBER 30, 2022 DECEMBER 31, 2021 Machinery and equipment $ 6,976 $ 6,286 Leasehold improvements 441 441 Computer software 53 42 Furniture and fixtures 524 514 Construction in process 65 281 Total property and equipment 8,059 7,564 Less: accumulated depreciation and amortization (5,260) (4,411) Property and equipment, net $ 2,799 $ 3,153 Depreciation and amortization expense totaled $0.3 million for each of the three months ended September 30, 2022 and September 30, 2021 and $0.9 million for each of the nine months ended September 30, 2022 and September 30, 2021, and consisted of the following (in thousands): THREE MONTHS ENDED SEPTEMBER 30, NINE MONTHS ENDED SEPTEMBER 30, 2022 2021 2022 2021 Research and development $ 251 $ 250 $ 757 $ 746 General and administrative 58 49 166 142 Total depreciation and amortization expense $ 309 $ 299 $ 923 $ 888 Accrued Expenses Accrued expenses were comprised of the following (in thousands): AS OF AS OF SEPTEMBER 30, 2022 DECEMBER 31, 2021 Clinical trials (1) $ 3,950 $ 4,496 Clinical drug substance and product manufacturing (2) 3,697 1,564 Other outside research and development 1,418 1,329 Compensation-related 2,712 1,322 Professional fees 1,011 261 Other 1,817 649 Accrued expenses $ 14,605 $ 9,621 (1) Relates primarily to the Company’s usage of third-party CROs for management of clinical trials. See Note 1 for further discussion of the components of research and development. |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT 2020 Loan Agreement On July 15, 2020, the Company entered into a loan and security agreement, or the 2020 Loan Agreement, with Oxford Finance LLC, or Oxford, pursuant to which it received $10.0 million in gross proceeds, 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, net of $1.1 million of legal and amendment fees. 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 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. One additional tranche with an aggregate principal amount of $30.0 million, or Term G, remains available to the Company, which will be funded subject to the initiation of a registrational clinical trial of INBRX-101 on or before June 30, 2023. The Company determined the November 2020, June 2021, and February 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. As of September 30, 2022, the Company had $170.0 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%. The repayment schedule provides for interest-only payments through February 1, 2025. The interest-only period is followed by 23 months of equal payments of principal and interest beginning on March 1, 2025. The interest-only period may be extended by an additional 12 months in the event the Company raises at least $100.0 million in upfront licensing or partnership proceeds by February 2025, which would then be followed by 11 months of principal repayments. 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 $15.3 million is being accreted over the life of the Amended 2020 Loan Agreement using the effective interest method. The Company has the option to prepay the outstanding balance of the term loans in full prior to the Amended Maturity Date, subject to a prepayment fee ranging from 1.0% to 3.0%, depending upon the timing of the prepayment. The Company’s outstanding debt balance under the Amended 2020 Loan Agreement consisted of the following as of September 30, 2022 and December 31, 2021 (in thousands). AS OF AS OF SEPTEMBER 30, 2022 DECEMBER 31, 2021 Term A $ 10,900 $ 10,900 Term B 21,800 21,800 Term C 43,600 43,600 Term D 43,600 — Term E 32,700 — Term F 32,700 — Less: debt discount (14,481) (5,830) Long-term debt, including debt discount and final payment fee $ 170,819 $ 70,470 As of September 30, 2022, and unless extended in accordance with the terms described above, the Company’s interest-only period will continue through January 2025, with principal payments beginning in February 2025. Future principal payments and final fee payments will be made as follows (in thousands): AS OF SEPTEMBER 30, 2022 2025 $ 73,913 2026 88,696 2027 22,691 Total future minimum payments 185,300 Less: unamortized debt discount (14,481) Total debt $ 170,819 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, the Amended 2020 Loan Agreement requires a minimum cash balance of $20.0 million to be maintained in a collateral account. As of September 30, 2022, 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. Interest expense was approximately $5.5 million and $1.8 million for the three months ended September 30, 2022 and September 30, 2021 and $11.1 million and $3.6 million for the nine months ended September 30, 2022 and September 30, 2021, respectively, all of which was related to the Amended 2020 Loan Agreement in each period. |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | STOCKHOLDERS’ EQUITY Common Stock In September 2021, the Company entered into the Sales Agreement with the Sales Agent, under which it may, from time to time, sell shares of its common stock having an aggregate offering price of up to $200.0 million through the Sales Agent, or the ATM Offering. Pursuant to the Sales Agreement, the Company will pay the Sales Agent a commission for its services in acting as an agent in the sale of common stock in an amount equal to 3% of the gross sales price per share sold. During the year ended December 31, 2021, the Company sold 921,042 shares pursuant to the Sales Agreement for net proceeds of $40.2 million, after deducting commissions. During the nine months ended September 30, 2022, the Company did not issue any shares under the Sales Agreement. Common Stock Warrants The Company has 7,354 warrants outstanding at an exercise price of $17.00 per share, which are exercisable for shares of common stock through their expiration date of July 15, 2030. As of September 30, 2022, the warrants are equity-classified and reflected in additional paid-in-capital at a fair value of $0.1 million. Upon the February 2022 Amendment, the Company issued 40,000 warrants, which are exercisable for shares of common stock of the Company at $45.00 per share. The warrants are exercisable through their expiration date of February 18, 2032. The warrants are equity-classified and reflected in additional paid-in-capital at a fair value of $0.7 million. The fair value of the warrants was determined using the Black-Scholes model on the date of issuance. No subsequent remeasurement is required for equity-classified warrants. |
EQUITY COMPENSATION PLAN
EQUITY COMPENSATION PLAN | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022, an aggregate of 6.1 million shares of common stock were reserved for issuance under the 2017 Plan, of which 0.3 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 nine months ended September 30, 2022 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, 2021 4,064 $ 22.19 Granted 1,682 $ 24.32 Exercised (96) $ 11.17 Forfeited (381) $ 30.73 Outstanding as of September 30, 2022 5,269 $ 22.45 7.9 $ 13,157 Vested and exercisable as of September 30, 2022 2,247 $ 18.26 6.5 $ 9,894 The aggregate intrinsic value of stock options exercised during the nine months ended September 30, 2022 and September 30, 2021 was $1.4 million and $3.4 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 September 30, 2022, respectively. 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 nine months ended September 30, 2022 and September 30, 2021 were as follows: NINE MONTHS ENDED SEPTEMBER 30, 2022 2021 Risk-free interest rate 2.45 % 0.67 % Expected volatility 85.23 % 93.55 % Expected dividend yield — % — % Expected term (in years) 6.08 6.08 Weighted average fair value $ 17.15 $ 24.01 Stock-based compensation expense for stock options consisted of the following (in thousands): THREE MONTHS ENDED NINE MONTHS ENDED 2022 2021 2022 2021 Research and development $ 3,545 $ 2,696 $ 10,764 $ 8,679 General and administrative 1,146 797 4,331 2,186 Total stock-based compensation expense $ 4,691 $ 3,493 $ 15,095 $ 10,865 As of September 30, 2022, the Company had $52.2 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 | 9 Months Ended |
Sep. 30, 2022 | |
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 NINE MONTHS ENDED 2022 2021 2022 2021 License fee revenue Phylaxis BioScience, LLC $ 14 $ 460 $ 1,101 $ 1,838 2seventy bio, Inc. — 2,000 200 2,100 Chiesi Farmaceutici S.p.A. 264 48 603 351 Total license fee revenue 278 2,508 1,904 4,289 Grant revenue — 24 14 86 Total revenue $ 278 $ 2,532 $ 1,918 $ 4,375 License and Collaboration Agreements Phylaxis In July 2020, the Company entered into a joint venture with an entity affiliated with ArrowMark Partners, Phylaxis BioScience, LLC, or Phylaxis. In connection with the joint venture, the Company entered into the following agreements: Contribution Agreement, License Agreement, Limited Liability Company Agreement, and Master Services Agreement, or collectively the Phylaxis Agreements, pursuant to which the Company licensed certain intellectual property and know-how to Phylaxis and agreed to provide services to develop certain compounds. Upon closing, the Company received a $2.5 million nonrefundable, upfront payment from Phylaxis under the Master Services Agreement, or 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 months ended September 30, 2022 and September 30, 2021, the Company recognized $14,000 and $0.5 million of revenue related to this performance obligation, respectively. During the nine months ended September 30, 2022 and September 30, 2021, the Company recognized $1.1 million and $1.8 million of revenue related to this performance obligation, respectively. As of September 30, 2022, there was no deferred revenue remaining related to the Phylaxis Agreements. As of December 31, 2021, there was $1.1 million of deferred revenue related to the Phylaxis Agreements, all of which was classified as current. 2seventy bio, Inc. 2018 License Agreement On December 20, 2018, the Company entered into a License Agreement with bluebird bio, Inc., or bluebird, whereby the Company granted bluebird the exclusive, worldwide rights to develop, manufacture, and commercialize certain cell therapy products containing binders. In November 2021, bluebird assigned the agreement, which we refer to as the 2018 2seventy Agreement, to its affiliate, 2seventy bio, Inc., or 2seventy, in connection with an internal restructuring and subsequent spin-out of 2seventy. Under the 2018 2seventy Agreement, the Company is entitled to receive specified development milestone payments of up to an aggregate of $51.5 million per therapeutic, as well as percentage tiered royalties on future product sales with rates in the mid-single-digits. Due to the uncertainty in the achievement of the developmental milestones, the variable consideration associated with the future milestone payments has been fully constrained (excluded) from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. These estimates will be re-assessed at each reporting period. In July 2021, a milestone event under the 2018 2seventy Agreement was achieved and the Company recognized $2.0 million of revenue at that point in time. The Company received the associated $2.0 million payment in August 2021. During each of the three and nine months ended September 30, 2021, the Company recognized a total of $2.0 million in revenue related to this agreement. During the three and nine months ended September 30, 2022, the Company recognized no revenue related to this agreement. 2020 License Agreement In June 2020, the Company entered into an Option and License Agreement with bluebird pursuant to which the Company granted to bluebird exclusive worldwide 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. This agreement, or the 2020 2seventy Agreement, was assigned to bluebird’s affiliate, 2seventy, in November 2021 in connection with bluebird’s internal restructuring and subsequent spin-out of 2seventy. In June 2020, the Company received a non-refundable upfront option fee of $0.2 million in connection with each of the two initial programs, or $0.4 million in aggregate, and is entitled to an upfront option fee for each additional program, on a program-by-program basis. 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 has 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 May 2021, pursuant to the option extension terms in the 2020 2seventy Agreement, bluebird requested to extend the option term for one of the initial programs by an additional six months in exchange for an option extension fee of $0.1 million. The Company recognized the $0.1 million of revenue related to this extension in May 2021, the point in time in which the extension was granted. In October 2021, pursuant to the option exercise terms in the 2020 2seventy Agreement, the Company received a $2.1 million option exercise fee for one of the initial programs and transferred an exclusive license for the program and recognized the $2.1 million of revenue related to this option exercise at the point in time in which the exclusive license was transferred. 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 nine months ended September 30, 2022 and September 30, 2021, the Company recognized $0.2 million and $0.1 million of revenue related to this agreement, respectively. During the three months ended September 30, 2022 and September 30, 2021, the Company recognized no revenue related to this agreement in either period. 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 the finalized minutes from the definitive parallel European Medicines Agency health technology assessment scientific advice meeting conducted following completion of such Phase I Clinical Trial. The Company has determined that the option to grant a license in the future is not a material right. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 9 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | RELATED PARTY TRANSACTIONS From time to time, the Company will enter into an agreement with a related party in the ordinary course of its business. These agreements are ratified by the Company’s Board of Directors or a committee thereof pursuant to policy. LAV Summit Limited LAV Summit Limited, or LAV SL, a limited company, is a principal shareholder which owned more than 5% of the Company’s outstanding equity interest during the year ended December 31, 2021. Due to this equity ownership, LAV SL was considered a related party. LAV SL’s General Partner, Lilly Asia Ventures, or LAV, through one of its funds, holds a significant equity ownership position in Chinese biotechnology company, Elpiscience Biopharmaceuticals, Inc., or Elpiscience, and the Venture Partner of LAV is the CEO, Founder, and Director at Elpiscience. Accordingly, the Company identified Elpiscience as a related party and all agreements entered into between the Company and Elpiscience through December 31, 2021 are deemed related party agreements. As of December 31, 2021, LAV SL no longer holds more than 5% of the Company’s outstanding equity interest. Accordingly, any future contracts entered into with LAV SL affiliates will not be considered related party transactions. Elpiscience In April 2018, the Company entered into a license agreement, or the OX40 License Agreement, with Elpiscience, whereby the Company granted Elpiscience an exclusive license to the Company’s multivalent protein therapeutic directed to the biological target OX40, or INBRX-106. Under this agreement, the Company is entitled to reimbursement for certain CMC and toxicology expenses incurred. The Company received $0.2 million in reimbursements under this agreement during the first quarter of 2022, and has received $5.3 million to date as of September 30, 2022. During the three months ended September 30, 2022, the Company derecognized $32,000 as contra-expenses, which are recorded as receivables from affiliates as of September 30, 2022. No further reimbursements remain under this contract following the receipt of this balance. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2022 | |
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 for approximately 34,000 square feet as its sole location in La Jolla, California. The lease expires in June 2025 with an option to extend the lease an additional five years. The lease contained an initial base rent of approximately $0.1 million per month with 2% annual escalations, plus a percentage of taxes and operating expenses incurred by the lessor in connection with the ownership and management of the property, the latter of which to be determined annually. In May 2019, the Company executed an amendment to its lease agreement to expand its facilities by approximately 9,000 square feet and began occupying this space in January 2020. The amended lease terminates coterminously with the initial lease agreement and contains an initial base rent of approximately $30,000 per month with 2% annual escalations, plus a percentage of taxes and operating expenses incurred by the lessor in connection with the ownership and management of the property, the latter of which is to be determined annually. The right-of-use asset and operating lease liability as of September 30, 2022 and December 31, 2021 are as follows (in thousands): AS OF AS OF SEPTEMBER 30, 2022 DECEMBER 31, 2021 Right-of-use asset $ 5,135 $ 6,338 Operating lease liability Current $ 1,812 $ 1,674 Non-current 3,657 $ 5,033 Total operating lease liability $ 5,469 $ 6,707 During the three and nine months ended September 30, 2022, the Company recognized operating lease expense of $0.9 million and $2.5 million, respectively. During the three and nine months ended September 30, 2021, the Company recognized operating lease expense of $0.8 million and $2.3 million, respectively. During the three months ended September 30, 2022 and September 30, 2021, the Company paid $0.5 million for amounts included in the measurement of the lease liability in each period. During the nine months ended September 30, 2022 and September 30, 2021, the Company paid $1.6 million for amounts included in the measurement of the lease liability in each period. As of September 30, 2022 and December 31, 2021, the Company’s operating lease had a remaining term of 2.8 and 3.5 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 September 30, 2022 and December 31, 2021. Future minimum rental commitments for the Company’s operating leases reconciled to the lease liability are as follows (in thousands): AS OF SEPTEMBER 30, 2022 2022 $ 544 2023 2,203 2024 2,247 2025 1,137 Thereafter — Total future minimum lease payments $ 6,131 Less: imputed interest (662) Present value of operating lease liability 5,469 Less: current portion of operating lease liability (1,812) Non-current portion of operating lease liability $ 3,657 Litigation |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS For the unaudited interim condensed consolidated financial statements as of September 30, 2022, the Company evaluated subsequent events to assess the need for potential recognition or disclosure in these financial statements. Based upon this evaluation, it was determined that no additional subsequent events required recognition or disclosure in these condensed consolidated financial statements, other than disclosures related to those outlined below. On October 3, 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 potential registration-enabling clinical trial of INBRX-101. On October 4, 2022, the Company met this milestone and on October 24, 2022, drew the final tranche for additional gross proceeds of $30.0 million. In October 2022, the Company sold 4,332,354 shares of its common stock pursuant to its Sales Agreement for net proceeds of $127.4 million after deducting commissions. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
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 interim condensed 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 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 financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2021, which are included in the Company’s Annual Report on Form 10-K filed with the SEC. |
Liquidity | Liquidity As of September 30, 2022, the Company had an accumulated deficit of $331.5 million and cash and cash equivalents of $146.1 million. From its inception and through September 30, 2022, the Company has devoted substantially all of its efforts to therapeutic drug discovery and development, conducting preclinical studies and clinical trials, enabling manufacturing activities in support of its therapeutic candidates, organizing and staffing the Company, establishing its intellectual property portfolio and raising capital to support and expand these activities. The Company believes that its existing cash and cash equivalents will be sufficient to fund the Company’s operations for at least 12 months from the date these 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. As discussed in Note 4, the Company entered into the Open Market Sale Agreement, or the Sales Agreement, with Jefferies LLC, or the Sales Agent, under which it may, from time to time, sell shares of its common stock having an aggregate offering price of up to $200.0 million through the Sales Agent, or the ATM Offering. During the year ended December 31, 2021, the Company sold 921,042 shares pursuant to the Sales Agreement for net proceeds of $40.2 million, after deducting commissions. During the nine months ended September 30, 2022, the Company did not issue any shares under the Sales Agreement. As discussed in Note 3, the Company received $40.0 million in gross proceeds upon entering into the February 2022 Amendment to the 2020 Loan Agreement, as amended (both as defined below). Pursuant to the Amended 2020 Loan Agreement (as defined below), three additional tranches became available upon the occurrence of contingent events, for additional gross proceeds of up to $90.0 million. In June 2022, two of these tranches were drawn for additional gross proceeds of $60.0 million. 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 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, 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. |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial condition of the depository institutions in which those deposits are held. |
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. |
Deferred Offering Costs | Deferred Offering CostsThe Company capitalizes costs that are directly associated with equity financings until such financings are consummated, at which time such costs are recorded against the gross proceeds of the offering. Legal, accounting, and filing fees related directly to the Company’s Sales Agreement are capitalized as deferred offering costs. Deferred offering costs associated with the Sales Agreement are reclassified to additional paid-in capital when the Company completes offerings under the Company’s Shelf Registration on Form S-3ASR. In November 2021, the Company completed an ATM Offering under the Sales Agreement and offset $1.7 million of offering costs against the proceeds. |
Financial Instruments with Characteristics of Both Liabilities and Equity | Financial Instruments with Characteristics of Both Liabilities and Equity The Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, or ASC 480-10, and ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock, or ASC 815-40. Under ASC 480-10, warrants are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in other expense, net in the condensed consolidated statements of operations as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or under another applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. The Company’s outstanding warrants do not meet the requirements for liability classification under ASC-480-10 or ASC-815-40. Therefore, the warrants were treated as equity at the time of issuance. |
Revenue Recognition | Revenue Recognition The Company has generated revenue from its license and collaboration agreements with partners, as well as from grants from government agencies and private not-for-profit organizations. Payments received from customers are included in deferred revenue, allocated between current and non-current on the condensed consolidated balance sheet until all revenue recognition criteria are met. In accordance with ASC Topic 606, Revenue from Contracts with Customers, or ASC Topic 606, the Company recognizes revenue when, or as, the promised goods or services are transferred to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those services. To determine revenue recognition for arrangements the Company concludes are within the scope of ASC Topic 606, the Company performs the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligation(s) in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligation(s) in the contract; and (5) recognize revenue when (or as) the performance obligation(s) are satisfied. At contract inception, the Company assesses the goods or services promised within each contract, assesses whether each promised good or service is distinct and identifies those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. Collaborative Research, Development, and License Agreements The Company enters into collaborative agreements with partners that typically include one or more of the following: (1) license fees; (2) nonrefundable up-front fees; (3) payments for reimbursement of research costs; (4) payments associated with achieving specific development, regulatory, or commercial milestones; and (5) royalties based on specified percentages of net product sales, if any. At the initiation of an agreement, the Company analyzes whether each unit of account results in a contract with a customer under ASC Topic 606 or in an arrangement with a collaborator subject to guidance under ASC Topic 808, Collaborative Arrangements . The Company’s licensing arrangements are typically for functional intellectual property as it exists at a point in time, being the time that the license agreement is executed. The Company typically does not have an ongoing performance obligation to support or maintain the licensed intellectual property. The Company considers a variety of factors in determining the appropriate estimates and assumptions under these arrangements, such as whether the elements are distinct performance obligations, whether there are observable stand-alone prices, and whether any licenses are functional or symbolic. The Company evaluates each performance obligation to determine if it can be satisfied and recognized as revenue at a point in time or over time. Typically, license fees, non-refundable upfront fees, and funding of research activities are considered fixed, while milestone payments are identified as variable consideration which must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. The Company estimates the amount of variable consideration using the most likely amount, as milestone payments typically only have two possible outcomes. The Company recognizes revenue for sales-based royalty promised in exchange for the license of intellectual property only when the subsequent sale occurs. In the case of an agreement which provides the partner with an option to license a therapeutic or therapeutic candidate in the future, the Company evaluates whether this option represents a material right at the inception of the agreement. If determined to be a material right, the Company will consider the option a separate performance obligation. The Company has historically concluded that the option to grant a license in the future is not a material right as it is contingent upon future events which may not occur. When an option is exercised, the Company will identify any separate performance obligations. |
Research and Development and Clinical Trial Accruals | Research and Development and Clinical Trial Accruals Research and development costs are expensed as incurred and include the cost of compensation and related expenses, as well as expenses for third parties who conduct research and development on the Company’s behalf, pursuant to development and consulting agreements in place. The Company’s preclinical studies and clinical trials are performed internally, by third party contract research organizations, or CROs, and/or clinical investigators. The Company also engages with 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 |
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 nine months ended September 30, 2022 and September 30, 2021, 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 May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options , which intends to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The Company adopted ASU 2021-04 on |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 SEPTEMBER 30, 2022 2021 Outstanding stock options 5,269 3,983 Warrants to purchase common stock 47 7 5,316 3,990 |
OTHER FINANCIAL INFORMATION (Ta
OTHER FINANCIAL INFORMATION (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Prepaid Expense and Other Current Assets | Prepaid expense and other current assets were comprised of the following (in thousands): AS OF AS OF SEPTEMBER 30, 2022 DECEMBER 31, 2021 Outside research and development services $ 6,539 $ 6,343 Other 827 590 Prepaid expense and other current assets $ 7,366 $ 6,933 |
Schedule of Property and Equipment | Property and equipment, net were comprised of the following (in thousands): AS OF AS OF SEPTEMBER 30, 2022 DECEMBER 31, 2021 Machinery and equipment $ 6,976 $ 6,286 Leasehold improvements 441 441 Computer software 53 42 Furniture and fixtures 524 514 Construction in process 65 281 Total property and equipment 8,059 7,564 Less: accumulated depreciation and amortization (5,260) (4,411) Property and equipment, net $ 2,799 $ 3,153 Depreciation and amortization expense totaled $0.3 million for each of the three months ended September 30, 2022 and September 30, 2021 and $0.9 million for each of the nine months ended September 30, 2022 and September 30, 2021, and consisted of the following (in thousands): THREE MONTHS ENDED SEPTEMBER 30, NINE MONTHS ENDED SEPTEMBER 30, 2022 2021 2022 2021 Research and development $ 251 $ 250 $ 757 $ 746 General and administrative 58 49 166 142 Total depreciation and amortization expense $ 309 $ 299 $ 923 $ 888 |
Schedule of Accrued Expenses | Accrued expenses were comprised of the following (in thousands): AS OF AS OF SEPTEMBER 30, 2022 DECEMBER 31, 2021 Clinical trials (1) $ 3,950 $ 4,496 Clinical drug substance and product manufacturing (2) 3,697 1,564 Other outside research and development 1,418 1,329 Compensation-related 2,712 1,322 Professional fees 1,011 261 Other 1,817 649 Accrued expenses $ 14,605 $ 9,621 (1) Relates primarily to the Company’s usage of third-party CROs for management of clinical trials. See Note 1 for further discussion of the components of research and development. |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 and December 31, 2021 (in thousands). AS OF AS OF SEPTEMBER 30, 2022 DECEMBER 31, 2021 Term A $ 10,900 $ 10,900 Term B 21,800 21,800 Term C 43,600 43,600 Term D 43,600 — Term E 32,700 — Term F 32,700 — Less: debt discount (14,481) (5,830) Long-term debt, including debt discount and final payment fee $ 170,819 $ 70,470 |
Schedule of Maturities of Long-term Debt | Future principal payments and final fee payments will be made as follows (in thousands): AS OF SEPTEMBER 30, 2022 2025 $ 73,913 2026 88,696 2027 22,691 Total future minimum payments 185,300 Less: unamortized debt discount (14,481) Total debt $ 170,819 |
EQUITY COMPENSATION PLAN (Table
EQUITY COMPENSATION PLAN (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 nine months ended September 30, 2022 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, 2021 4,064 $ 22.19 Granted 1,682 $ 24.32 Exercised (96) $ 11.17 Forfeited (381) $ 30.73 Outstanding as of September 30, 2022 5,269 $ 22.45 7.9 $ 13,157 Vested and exercisable as of September 30, 2022 2,247 $ 18.26 6.5 $ 9,894 |
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 nine months ended September 30, 2022 and September 30, 2021 were as follows: NINE MONTHS ENDED SEPTEMBER 30, 2022 2021 Risk-free interest rate 2.45 % 0.67 % Expected volatility 85.23 % 93.55 % Expected dividend yield — % — % Expected term (in years) 6.08 6.08 Weighted average fair value $ 17.15 $ 24.01 |
Schedule of Stock-Based Compensation Expense | Stock-based compensation expense for stock options consisted of the following (in thousands): THREE MONTHS ENDED NINE MONTHS ENDED 2022 2021 2022 2021 Research and development $ 3,545 $ 2,696 $ 10,764 $ 8,679 General and administrative 1,146 797 4,331 2,186 Total stock-based compensation expense $ 4,691 $ 3,493 $ 15,095 $ 10,865 |
LICENSE AND GRANT REVENUES (Tab
LICENSE AND GRANT REVENUES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 NINE MONTHS ENDED 2022 2021 2022 2021 License fee revenue Phylaxis BioScience, LLC $ 14 $ 460 $ 1,101 $ 1,838 2seventy bio, Inc. — 2,000 200 2,100 Chiesi Farmaceutici S.p.A. 264 48 603 351 Total license fee revenue 278 2,508 1,904 4,289 Grant revenue — 24 14 86 Total revenue $ 278 $ 2,532 $ 1,918 $ 4,375 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Operating Lease, by Balance Sheet Location | The right-of-use asset and operating lease liability as of September 30, 2022 and December 31, 2021 are as follows (in thousands): AS OF AS OF SEPTEMBER 30, 2022 DECEMBER 31, 2021 Right-of-use asset $ 5,135 $ 6,338 Operating lease liability Current $ 1,812 $ 1,674 Non-current 3,657 $ 5,033 Total operating lease liability $ 5,469 $ 6,707 |
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 SEPTEMBER 30, 2022 2022 $ 544 2023 2,203 2024 2,247 2025 1,137 Thereafter — Total future minimum lease payments $ 6,131 Less: imputed interest (662) Present value of operating lease liability 5,469 Less: current portion of operating lease liability (1,812) Non-current portion of operating lease liability $ 3,657 |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Feb. 18, 2022 USD ($) | Jun. 30, 2022 USD ($) tranche | Feb. 28, 2022 USD ($) tranche | Dec. 31, 2021 USD ($) shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) segment | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) shares | Nov. 30, 2021 USD ($) | Apr. 30, 2020 USD ($) | |
Property, Plant and Equipment [Line Items] | ||||||||||
Accumulated deficit | $ 227,147 | $ 331,458 | $ 227,147 | |||||||
Cash and cash equivalents | 131,301 | 146,073 | $ 131,301 | |||||||
Common stock offering price | $ 200,000 | |||||||||
Proceeds from the issuance of debt | 98,871 | $ 39,992 | ||||||||
Deferred payment of federal payroll taxes | $ 100 | $ 400 | ||||||||
Payments associated with equity offering | $ 300 | |||||||||
Deferred offering costs | $ 1,700 | |||||||||
Number of operating segments | segment | 1 | |||||||||
Amended 2022 Oxford Term Loan | Secured Debt | ||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||
Proceeds from the issuance of debt | $ 40,000 | $ 60,000 | $ 40,000 | |||||||
Number of additional tranches available upon contingent events | tranche | 3 | |||||||||
Additional gross proceeds | $ 90,000 | |||||||||
Number of additional tranches available upon contingent events, drawn from | tranche | 2 | |||||||||
Sales Agreement | ||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||
Common stock shares sold (in shares) | shares | 921,042 | 921,042 | ||||||||
Sale of stock, proceeds received | $ 40,200 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Potential Dilutive Securities (Details) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Antidilutive securities excluded from earnings per share computation (in shares) | 5,316 | 3,990 |
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) | 5,269 | 3,983 |
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 | 7 |
OTHER FINANCIAL INFORMATION - P
OTHER FINANCIAL INFORMATION - Prepaid Expense and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Outside research and development services | $ 6,539 | $ 6,343 |
Other | 827 | 590 |
Prepaid expense and other current assets | $ 7,366 | $ 6,933 |
OTHER FINANCIAL INFORMATION -_2
OTHER FINANCIAL INFORMATION - Property and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | $ 8,059 | $ 8,059 | $ 7,564 | ||
Less: accumulated depreciation and amortization | (5,260) | (5,260) | (4,411) | ||
Property and equipment, net | 2,799 | 2,799 | 3,153 | ||
Depreciation and amortization | 309 | $ 299 | 923 | $ 888 | |
Machinery and equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | 6,976 | 6,976 | 6,286 | ||
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 | 42 | ||
Furniture and fixtures | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | 524 | 524 | 514 | ||
Construction in process | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | $ 65 | $ 65 | $ 281 |
OTHER FINANCIAL INFORMATION - D
OTHER FINANCIAL INFORMATION - Depreciation and Amortization Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Property, Plant and Equipment [Line Items] | ||||
Depreciation and amortization | $ 309 | $ 299 | $ 923 | $ 888 |
Research and development | ||||
Property, Plant and Equipment [Line Items] | ||||
Depreciation and amortization | 251 | 250 | 757 | 746 |
General and administrative | ||||
Property, Plant and Equipment [Line Items] | ||||
Depreciation and amortization | $ 58 | $ 49 | $ 166 | $ 142 |
OTHER FINANCIAL INFORMATION - A
OTHER FINANCIAL INFORMATION - Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical trials | $ 3,950 | $ 4,496 |
Clinical drug substance and product manufacturing | 3,697 | 1,564 |
Other outside research and development | 1,418 | 1,329 |
Compensation-related | 2,712 | 1,322 |
Professional fees | 1,011 | 261 |
Other | 1,817 | 649 |
Accrued expenses | $ 14,605 | $ 9,621 |
DEBT - Narrative (Details)
DEBT - Narrative (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Feb. 18, 2022 USD ($) $ / shares | Jun. 18, 2021 USD ($) | Nov. 12, 2020 USD ($) | Jul. 15, 2020 USD ($) | Jun. 30, 2022 USD ($) | Feb. 28, 2022 USD ($) tranche $ / shares shares | Sep. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jun. 23, 2023 USD ($) | |
Debt Instrument [Line Items] | ||||||||||||
Proceeds from the issuance of debt | $ 98,871 | $ 39,992 | ||||||||||
Reclassification of warrant liabilities to equity | $ 712 | |||||||||||
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 | $ 60,000 | $ 40,000 | |||||||||
Legal and amendment fees | 1,100 | |||||||||||
Number of additional tranches available upon contingent events | tranche | 3 | |||||||||||
Number of additional tranches available upon contingent events, remaining | tranche | 1 | |||||||||||
Minimum cash balance | $ 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 | $ 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 | Forecast | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Term loan aggregate amount | $ 30,000 | |||||||||||
Amended 2020 Oxford Term Loan | Secured Debt | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Gross principal outstanding | $ 170,000 | $ 170,000 | ||||||||||
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 | $ 15,300 | $ 15,300 | ||||||||||
Amended 2020 Oxford Term Loan | Secured Debt | LIBOR | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Basis spread on variable rate | 8.19% | |||||||||||
Amended 2020 Oxford Term Loan | Secured Debt | Minimum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Prepayment fee | 1% | 1% | ||||||||||
Amended 2020 Oxford Term Loan | Secured Debt | Maximum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Prepayment fee | 3% | 3% | ||||||||||
2020 Loan Agreement | Secured Debt | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt interest expense | $ 5,500 | $ 1,800 | $ 11,100 | $ 3,600 |
DEBT - Loan Agreement Balance (
DEBT - Loan Agreement Balance (Details) - Secured Debt - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
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 | 0 | |
2022 Oxford Term Loan E | ||
Debt Instrument [Line Items] | ||
Debt | 32,700 | |
2020 Oxford Term Loan E | ||
Debt Instrument [Line Items] | ||
Debt | 0 | |
2022 Oxford Term Loan F | ||
Debt Instrument [Line Items] | ||
Debt | 32,700 | |
2020 Oxford Term Loan F | ||
Debt Instrument [Line Items] | ||
Debt | 0 | |
2022 Loan Agreement | ||
Debt Instrument [Line Items] | ||
Less: debt discount | (14,481) | |
Total debt | $ 170,819 | |
2020 Loan Agreement | ||
Debt Instrument [Line Items] | ||
Less: debt discount | (5,830) | |
Total debt | $ 70,470 |
DEBT - Future Minimum Payments
DEBT - Future Minimum Payments (Details) - 2020 and 2022 Oxford Term Loans - Secured Debt $ in Thousands | Sep. 30, 2022 USD ($) |
Debt Instrument [Line Items] | |
2025 | $ 73,913 |
2026 | 88,696 |
2027 | 22,691 |
Total future minimum payments | 185,300 |
Less: unamortized debt discount | (14,481) |
Total debt | $ 170,819 |
STOCKHOLDERS_ EQUITY (Details)
STOCKHOLDERS’ EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Feb. 28, 2022 | Sep. 30, 2021 | Mar. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | Feb. 18, 2022 | |
Temporary Equity [Line Items] | ||||||
Aggregate offering price | $ 200,000 | |||||
Commission percent | 3% | |||||
Reclassification of warrant liabilities to equity | $ 712 | |||||
Additional Paid-in Capital | ||||||
Temporary Equity [Line Items] | ||||||
Reclassification of warrant liabilities to equity | $ 712 | |||||
Warrants Issued Upon Consummation of IPO | 2020 Loan Agreement | Secured Debt | ||||||
Temporary Equity [Line Items] | ||||||
Warrants exercisable for shares of common stock (in shares) | 7,354 | |||||
Warrant price (in dollars per share) | $ 17 | |||||
Warrants Issued Upon Consummation of IPO | 2020 Loan Agreement | Secured Debt | Additional Paid-in Capital | ||||||
Temporary Equity [Line Items] | ||||||
Reclassification of warrant liabilities to equity | $ 100 | |||||
Warrants Issued Concurrently With 2022 Loan Agreement | Amended 2022 Oxford Term Loan | Secured Debt | ||||||
Temporary Equity [Line Items] | ||||||
Warrant price (in dollars per share) | $ 45 | $ 45 | ||||
Reclassification of warrant liabilities to equity | $ 700 | |||||
Warrants issued (in shares) | 40,000 | |||||
Warrants Issued Concurrently With 2022 Loan Agreement | Amended 2022 Oxford Term Loan | Secured Debt | Additional Paid-in Capital | ||||||
Temporary Equity [Line Items] | ||||||
Reclassification of warrant liabilities to equity | $ 700 | |||||
Sales Agreement | ||||||
Temporary Equity [Line Items] | ||||||
Common stock shares sold (in shares) | 921,042 | |||||
Sale of stock, proceeds received | $ 40,200 |
EQUITY COMPENSATION PLAN - Narr
EQUITY COMPENSATION PLAN - Narrative (Details) - USD ($) shares in Millions, $ in Millions | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance (in shares) | 6.1 | |
Available shares reserved for issuance (in shares) | 0.3 | |
Aggregate intrinsic value of stock options exercised | $ 1.4 | $ 3.4 |
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 | $ 52.2 | |
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 | 9 Months Ended |
Sep. 30, 2022 | |
Number of Shares | |
Outstanding, beginning balance (in shares) | 4,064 |
Granted (in shares) | 1,682 |
Exercised (in shares) | (96) |
Forfeited (in shares) | (381) |
Outstanding, ending balance (in shares) | 5,269 |
Vested and exercisable (in shares) | 2,247 |
Weighted Average Exercise Price | |
Outstanding, beginning balance (in dollars per share) | $ 22.19 |
Granted (in dollars per share) | 24.32 |
Exercised (in dollars per share) | 11.17 |
Forfeited (in dollars per share) | 30.73 |
Outstanding, ending balance (in dollars per share) | 22.45 |
Vested and Exercisable (in dollars per share) | $ 18.26 |
Weighted Average Remaining Contractual Term | 7 years 10 months 24 days |
Weighted Average Remaining Contractual Term, Vested and Exercisable | 6 years 6 months |
Aggregate Intrinsic Value | $ 13,157 |
Aggregate Intrinsic Value, Vested and Exercisable | $ 9,894 |
EQUITY COMPENSATION PLAN - Fair
EQUITY COMPENSATION PLAN - Fair Value of Stock Option Grants (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value (in dollars per share) | $ 17.15 | $ 24.01 |
Employee Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.45% | 0.67% |
Expected volatility | 85.23% | 93.55% |
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 | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 4,691 | $ 3,493 | $ 15,095 | $ 10,865 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 3,545 | 2,696 | 10,764 | 8,679 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 1,146 | $ 797 | $ 4,331 | $ 2,186 |
LICENSE AND GRANT REVENUES - Re
LICENSE AND GRANT REVENUES - Revenue Summary (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | $ 278 | $ 2,532 | $ 1,918 | $ 4,375 |
License fee revenue from non-affiliates | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 278 | 2,508 | 1,904 | 4,289 |
License fee revenue from non-affiliates | Phylaxis BioScience, LLC | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 14 | 460 | 1,101 | 1,838 |
License fee revenue from non-affiliates | 2seventy bio, Inc. | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 0 | 2,000 | 200 | 2,100 |
License fee revenue from non-affiliates | Chiesi Farmaceutici S.p.A. | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | 264 | 48 | 603 | 351 |
Grant revenue | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | ||||
Total revenue | $ 0 | $ 24 | $ 14 | $ 86 |
LICENSE AND GRANT REVENUES - Li
LICENSE AND GRANT REVENUES - License and Collaboration Agreements (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||||
Jun. 30, 2022 USD ($) program | Oct. 31, 2021 USD ($) | Aug. 31, 2021 USD ($) | Jul. 31, 2021 USD ($) | May 31, 2021 USD ($) | Jul. 31, 2020 USD ($) performance_obligation compound | Jun. 30, 2020 USD ($) program performance_obligation | Aug. 31, 2019 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Aug. 19, 2019 performance_obligation | Dec. 20, 2018 USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Current portion of deferred revenue | $ 440,000 | $ 440,000 | $ 2,034,000 | ||||||||||||
Total revenue | 278,000 | $ 2,532,000 | 1,918,000 | $ 4,375,000 | |||||||||||
Non-current portion of deferred revenue | 0 | 0 | 110,000 | ||||||||||||
License fee revenue from non-affiliates | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | 278,000 | 2,508,000 | 1,904,000 | 4,289,000 | |||||||||||
Phylaxis BioScience, LLC | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Equity interest percentage | 10% | ||||||||||||||
Additional equity interest percentage entitled to receive | 5% | ||||||||||||||
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 | ||||||||||||||
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 performance obligations | performance_obligation | 1 | ||||||||||||||
Number of compounds | compound | 2 | ||||||||||||||
Current portion of deferred revenue | 0 | 0 | 1,100,000 | ||||||||||||
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 | 14,000 | 500,000 | 1,100,000 | 1,800,000 | |||||||||||
Total revenue | 14,000 | 460,000 | 1,101,000 | 1,838,000 | |||||||||||
2seventy bio, Inc. | 2018 Option and License Agreement | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Development milestone payment receivable | $ 51,500,000 | ||||||||||||||
2seventy bio, Inc. | Initial Programs | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Nonrefundable, upfront payment | $ 400,000 | ||||||||||||||
Number of performance obligations | performance_obligation | 1 | ||||||||||||||
Number of programs related to collaborative agreement | program | 3 | 2 | |||||||||||||
2seventy bio, Inc. | Additional Programs | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Number of programs related to collaborative agreement | program | 8 | ||||||||||||||
2seventy bio, Inc. | 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 | ||||||||||||||
Project extension term | 6 months | ||||||||||||||
Option extension fee | $ 2,100,000 | $ 100,000 | |||||||||||||
2seventy bio, Inc. | License fee revenue from non-affiliates | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | 0 | 2,000,000 | 200,000 | 2,100,000 | |||||||||||
2seventy bio, Inc. | License fee revenue from non-affiliates | 2018 Option and License Agreement | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | $ 2,000,000 | 0 | 2,000,000 | 0 | 2,000,000 | ||||||||||
Milestone payment received | $ 2,000,000 | ||||||||||||||
2seventy bio, Inc. | License fee revenue from non-affiliates | 2020 Option and License Agreement | |||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions Line Items | |||||||||||||||
Total revenue | $ 2,100,000 | $ 100,000 | 0 | 0 | 200,000 | 100,000 | |||||||||
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 | ||||||||||||||
Number of performance obligations | performance_obligation | 1 | ||||||||||||||
Current portion of deferred revenue | 400,000 | 400,000 | 900,000 | ||||||||||||
Milestone payments receivable | $ 122,500,000 | ||||||||||||||
Term of research and development services option period | 60 days | ||||||||||||||
Non-current portion of deferred revenue | $ 100,000 | ||||||||||||||
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 | 300,000 | 0 | 600,000 | 400,000 | |||||||||||
Total revenue | $ 264,000 | $ 48,000 | $ 603,000 | $ 351,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Sep. 30, 2022 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Elpiscience | OX40 License Agreement | ||||
Related Party Transaction [Line Items] | ||||
Reimbursement expenses | $ 200 | |||
Reimbursement for related party transaction expenses incurred to date | $ 5,300 | |||
Liabilities derecognized from agreements | 32 | |||
Elpiscience | OX40 License Agreement | Cost Sharing Agreement | ||||
Related Party Transaction [Line Items] | ||||
Reimbursement expenses | $ 300 | $ 200 | ||
Reimbursement for related party transaction expenses incurred to date | $ 500 | |||
Affiliates | LAV Summit Limited | ||||
Related Party Transaction [Line Items] | ||||
Ownership interest, more than | 5% |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Narrative (Details) ft² in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 | May 31, 2019 USD ($) ft² | Sep. 30, 2017 USD ($) ft² | |
Commitments and Contingencies Disclosure [Abstract] | |||||||
Lease agreement term | 7 years | ||||||
Square footage of lease agreement (in sq feet) | ft² | 34 | ||||||
Lease extension term | 5 years | ||||||
Initial base rent per month | $ 30 | $ 100 | |||||
Annual escalations | 2% | 2% | |||||
Square footage of lease extension agreement (in sq feet) | ft² | 9 | ||||||
Operating lease expense | $ 900 | $ 800 | $ 2,500 | $ 2,300 | |||
Payments included in measurement of lease liability | $ 500 | $ 500 | $ 1,600 | $ 1,600 | |||
Remaining term of operating lease | 2 years 9 months 18 days | 2 years 9 months 18 days | 3 years 6 months | ||||
Weighted-average discount rate | 8.20% | 8.20% | 8.20% |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Schedule of Right-Of-Use Asset and Operating Lease Liability (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Right-of-use asset | $ 5,135 | $ 6,338 |
Operating lease liability | ||
Current | 1,812 | 1,674 |
Non-current | 3,657 | 5,033 |
Present value of operating lease liability | $ 5,469 | $ 6,707 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES - Schedule of Operating Lease Liability Maturity (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
2022 | $ 544 | |
2023 | 2,203 | |
2024 | 2,247 | |
2025 | 1,137 | |
Thereafter | 0 | |
Total future minimum lease payments | 6,131 | |
Less: imputed interest | (662) | |
Present value of operating lease liability | 5,469 | $ 6,707 |
Current portion of lease liability | (1,812) | (1,674) |
Non-current portion of lease liability | $ 3,657 | $ 5,033 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||
Oct. 24, 2022 | Oct. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Oct. 03, 2022 | |
Subsequent Event [Line Items] | ||||||
Proceeds from the issuance of debt | $ 98,871,000 | $ 39,992,000 | ||||
Sales Agreement | ||||||
Subsequent Event [Line Items] | ||||||
Sale of stock, proceeds received | $ 40,200,000 | |||||
Subsequent Event | Sales Agreement | ||||||
Subsequent Event [Line Items] | ||||||
Sale of stock, shares issued (in shares) | 4,332,354 | |||||
Sale of stock, proceeds received | $ 127,400,000 | |||||
Subsequent Event | Secured Debt | Amended 2020 Oxford Term Loan October 2022 Amendment | ||||||
Subsequent Event [Line Items] | ||||||
Term loan aggregate amount | $ 30,000,000 | |||||
Proceeds from the issuance of debt | $ 30,000,000 |