Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | Apr. 30, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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 $0.0001 | |
Trading Symbol | INBX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 52,401,941 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Entity Central Index Key | 0001739614 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 252,483 | $ 277,924 |
Accounts receivable | 171 | 171 |
Other receivables | 2,867 | 607 |
Prepaid expenses and other current assets | 19,017 | 16,656 |
Total current assets | 274,538 | 295,358 |
Property and equipment, net | 6,966 | 6,419 |
Operating right-of-use asset | 2,487 | 2,952 |
Other non-current assets | 4,586 | 3,164 |
Total assets | 288,577 | 307,893 |
Current liabilities: | ||
Accounts payable | 14,792 | 10,954 |
Accrued expenses | 51,329 | 43,295 |
Current portion of long-term debt, net of discount | 3,632 | 0 |
Current portion of operating lease liability | 2,117 | 2,063 |
Total current liabilities | 71,870 | 56,312 |
Long-term debt, including debt discount and final payment fee | 204,578 | 206,968 |
Non-current portion of operating lease liability | 561 | 1,110 |
Total liabilities | 277,009 | 264,390 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity | ||
Preferred stock, $0.0001 par value; 15,000,000 shares authorized as of March 31, 2024 and December 31, 2023; no shares issued or outstanding as of March 31, 2024 and December 31, 2023. | 0 | 0 |
Common stock, $0.0001 par value; 120,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 49,234,225 and 47,369,511 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively. | 5 | 5 |
Additional paid-in-capital | 704,007 | 657,232 |
Accumulated deficit | (692,444) | (613,734) |
Total stockholders’ equity | 11,568 | 43,503 |
Total liabilities and stockholders’ equity | $ 288,577 | $ 307,893 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
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) | 49,234,225 | 47,369,511 |
Common stock, shares outstanding (in shares) | 49,234,225 | 47,369,511 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenue: | ||
Total revenue | $ 0 | $ 17 |
Operating expenses: | ||
Research and development | 63,851 | 37,386 |
General and administrative | 9,974 | 6,397 |
Total operating expenses | 73,825 | 43,783 |
Loss from operations | (73,825) | (43,766) |
Other income (expense): | ||
Interest expense | (8,130) | (7,563) |
Interest income | 3,304 | 2,483 |
Other expense, net | (59) | (70) |
Total other expense | (4,885) | (5,150) |
Loss before income tax expense | (78,710) | (48,916) |
Provision for income taxes | 0 | 0 |
Net loss | $ (78,710) | $ (48,916) |
Net loss per share, basic (in dollars per share) | $ (1.44) | $ (1.12) |
Net loss per share, diluted (in dollars per share) | $ (1.44) | $ (1.12) |
Weighted-average shares of common stock and pre-funded warrants outstanding, basic (in shares) | 54,554 | 43,575 |
Weighted-average shares of common stock and pre-funded warrants outstanding, diluted (in shares) | 54,554 | 43,575 |
License fee revenue | ||
Revenue: | ||
Total revenue | $ 0 | $ 17 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2022 | 43,564,000 | |||
Beginning balance at Dec. 31, 2022 | $ 58,057 | $ 4 | $ 430,426 | $ (372,373) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | 5,636 | 5,636 | ||
Issuance of shares upon exercise of stock options (in shares) | 31,000 | |||
Issuance of shares upon exercise of stock options | 356 | 356 | ||
Net loss | (48,916) | (48,916) | ||
Ending balance (in shares) at Mar. 31, 2023 | 43,595,000 | |||
Ending balance at Mar. 31, 2023 | $ 15,133 | $ 4 | 436,418 | (421,289) |
Beginning balance (in shares) at Dec. 31, 2023 | 47,369,511 | 47,369,000 | ||
Beginning balance at Dec. 31, 2023 | $ 43,503 | $ 5 | 657,232 | (613,734) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | $ 6,397 | 6,397 | ||
Issuance of shares upon exercise of stock options (in shares) | 1,865,000 | 1,865,000 | ||
Issuance of shares upon exercise of stock options | $ 40,378 | 40,378 | ||
Net loss | $ (78,710) | (78,710) | ||
Ending balance (in shares) at Mar. 31, 2024 | 49,234,225 | 49,234,000 | ||
Ending balance at Mar. 31, 2024 | $ 11,568 | $ 5 | $ 704,007 | $ (692,444) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities | ||
Net loss | $ (78,710) | $ (48,916) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 360 | 295 |
Accretion of debt discount and non-cash interest expense | 1,242 | 1,196 |
Stock-based compensation expense | 6,397 | 5,636 |
Non-cash lease expense | 465 | 427 |
Loss on disposal of fixed assets | 0 | 2 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 0 | (61) |
Other receivables | (610) | 0 |
Receivables from related parties | 0 | 14 |
Prepaid expenses and other current assets | (2,361) | (2,848) |
Other non-current assets | (1,422) | 0 |
Accounts payable | 4,050 | 2,332 |
Accrued expenses | 8,034 | 2,442 |
Operating lease liability | (495) | (446) |
Deferred revenue, current portion | 0 | (17) |
Net cash used in operating activities | (63,050) | (39,944) |
Cash flows from investing activities | ||
Purchase of fixed assets | (1,119) | (23) |
Net cash used in investing activities | (1,119) | (23) |
Cash flows from financing activities | ||
Proceeds from the exercise of stock options | 38,728 | 356 |
Net cash provided by financing activities | 38,728 | 356 |
Net decrease in cash and cash equivalents | (25,441) | (39,611) |
Cash and cash equivalents at beginning of period | 277,924 | 273,865 |
Cash and cash equivalents at end of period | 252,483 | 234,254 |
Supplemental schedule of non-cash investing and financing activities | ||
Payable for purchase of fixed assets | 307 | 258 |
Receivable for proceeds from the exercise of stock options | $ 1,650 | $ 0 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization Inhibrx, Inc., or the Company, or Inhibrx, is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. The Company combines target biology with protein engineering, technologies, and research and development to design therapeutic candidates. The Company’s current pipeline is focused on oncology and orphan diseases. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or the SEC, related to an interim report on the Form 10-Q. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these unaudited interim condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the fiscal year ended December 31, 2023, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on February 28, 2024. Reclassification of Prior Year Presentation Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations. Merger and Spin-Off On January 22, 2024, the Company, Aventis Inc., or Parent, a wholly owned indirect subsidiary of Sanofi, and Art Acquisition Sub, Inc., or the Merger Sub, a wholly owned subsidiary of Parent, entered into an Agreement and Plan of Merger, or the Merger Agreement. Pursuant to the terms of the Merger Agreement, Parent will acquire all outstanding shares of the Company via the merger of Merger Sub with and into the Company, or Merger, with the Company surviving the Merger as a wholly owned subsidiary of Parent, and in turn each shareholder will receive (i) $30.00 per share in cash, (ii) one contingent value right per share, representing the right to receive a contingent payment of $5.00 in cash upon the achievement of a regulatory milestone, and (iii) one SEC-registered, publicly listed, share of Inhibrx Biosciences, Inc., or New Inhibrx, for every four shares of Inhibrx common stock held. In addition, in connection with the transaction, Parent will (1) assume and retire the Company’s outstanding third-party debt, (2) cause New Inhibrx to be funded with $200.0 million in cash, and (3) retain an equity interest in New Inhibrx of approximately 8%. In connection with and as a condition to the Merger, the Company and New Inhibrx entered into a Separation and Distribution Agreement, dated as of January 22, 2024, or the Separation and Distribution Agreement, pursuant to which, immediately prior to the effective time of the Merger: (i) the Company will effect a pre-closing reorganization, which will result in (x) the Company owning, assuming or retaining all assets and liabilities primarily related to INBRX-101, or the 101 Business, and (y) New Inhibrx owning, assuming or retaining all other assets and liabilities of the Company and its subsidiaries; and (ii) thereafter, the Company will distribute to its stockholders as of the record date on a pro rata basis, 92% of the issued and outstanding shares of New Inhibrx common stock, at a ratio of one share of New Inhibrx common stock for every four shares of the Company’s issued and outstanding common stock held on the record date. Following the spin-off, New Inhibrx will be a separate public company and the Company will retain 8% of the issued and outstanding shares of New Inhibrx common stock as of the effective time of the spin-off. The boards of directors of both the Company and Sanofi have unanimously approved the spin-off and the Merger. Parent will pay transaction consideration totaling approximately $2.2 billion in aggregate value. Parent will also make payments at the closing of the Merger to settle the Company’s third-party debt. Following the closing of the Merger, New Inhibrx will continue to operate under the Inhibrx name. Parent’s acquisition of the Company is subject to the completion of the New Inhibrx spin-off transaction and other customary closing conditions, including approval by the Company’s shareholders. The companies expect the transaction to close in the second quarter of 2024. The Merger Agreement contains certain termination rights for each of the Company and Parent. Upon termination of the Merger Agreement in accordance with its terms, under certain circumstances, the Company will be required to pay Parent a termination fee in an amount equal to $54.5 million, including if the Merger Agreement is terminated due to (i) the Company accepting a Superior Proposal (as defined in the Merger Agreement) or (ii) the board of directors changing its recommendation that stockholders vote to approve the Merger Agreement. This termination fee will also be payable by the Company if the Merger Agreement is terminated under certain circumstances and prior to such termination, a proposal to acquire the 101 Business or more than 50% of the Company’s stock or assets is made or publicly announced and not publicly withdrawn and the Company enters into a definitive agreement for, or completes, any transaction involving the acquisition of the 101 Business or more than 50% of its stock or assets within twelve months of such termination. The Merger Agreement also provided that Parent will be required to pay the Company a reverse termination fee of $92.1 million if the Merger is not consummated due to the failure of certain conditions to be satisfied as a result of failure to obtain antitrust clearance. The Company and Parent filed notification of the proposed Merger with the Federal Trade Commission and the Department of Justice under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, or the HSR Act. The applicable waiting period under the HSR Act expired on March 11, 2024. Liquidity As of March 31, 2024, the Company had an accumulated deficit of $692.4 million and cash and cash equivalents of $252.5 million. From its inception and through March 31, 2024, the Company has devoted substantially all of its efforts to therapeutic drug discovery and development, conducting preclinical studies and clinical trials, enabling manufacturing activities in support of its therapeutic candidates, pre-commercialization activities, organizing and staffing the Company, establishing its intellectual property portfolio and raising capital to support and expand these activities. In August 2023, the Company received gross proceeds of $200.0 million before deducting $0.4 million of offering expenses payable by the Company in a private placement transaction, or the Private Placement, with certain institutional and other accredited investors, or Purchasers, in which the Company sold and issued 3,621,314 shares of the Company’s common stock and, with respect to certain Purchasers, pre-funded warrants to purchase 6,714,636 shares of the Company’s common stock. See Note 4 for further discussion of this equity offering. The Company believes that its existing cash and cash equivalents will be sufficient to fund the Company’s operations for at least 12 months from the date these condensed consolidated financial statements are issued. The Company plans to finance its future cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses, strategic transactions and other similar arrangements. If the Company does raise additional capital through public or private equity or convertible debt offerings, the ownership interests of its existing stockholders will be diluted, and the terms of those securities may include liquidation or other preferences that adversely affect its stockholders’ rights. If the Company raises capital through additional debt financings, it may be subject to covenants limiting or restricting its ability to take specific actions, such as incurring additional debt or making certain capital expenditures. To the extent that the Company raises additional capital through strategic licensing, collaboration or other similar agreement, it may have to relinquish valuable rights to its therapeutic candidates, future revenue streams or research programs at an earlier stage of development or on less favorable terms than it would otherwise choose, or to grant licenses on terms that may not be favorable to the Company. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future. If the Company is unable to secure adequate additional funding, it will need to reevaluate its operating plan and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of its development programs, or relinquish rights to its technology on less favorable terms than it would otherwise choose. These actions could materially impact its business, financial condition, results of operations and prospects. The rules and regulations of the SEC or any other regulatory agencies may restrict the Company’s ability to conduct certain types of financing activities, or may affect the timing of and amounts it can raise by undertaking such activities. Use of Estimates The preparation of these unaudited condensed consolidated financial statements in conformity with GAAP requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expense and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. The Company’s most significant estimates relate to evaluation of whether revenue recognition criteria have been met, accounting for development work and preclinical studies and clinical trials, determining the assumptions used in measuring stock-based compensation, the incremental borrowing rate estimated in relation to the Company’s operating lease, and valuation allowances for the Company’s deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. The Company’s actual results may differ from these estimates under different assumptions or conditions. Cash and Cash Equivalents Cash and cash equivalents are comprised of cash held in financial institutions including readily available checking, overnight sweep, and money market accounts. Concentrations of Credit Risk Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits by the Federal Deposit Insurance Corporation, or FDIC, of up to $250,000. The Company’s cash management and investment policy limits investment instruments to investment-grade securities with the objective to preserve capital and to maintain liquidity until the funds can be used in operations. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial condition of the depository institutions in which those deposits are held. Fair Value Measurements The Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established by accounting guidance and prioritizes the inputs used in measuring fair value. These tiers include: • Level 1 - Quoted prices in active markets for identical assets or liabilities. • Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the level in the fair value hierarchy within which the fair value measurement in its entirety falls has been determined based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. During the three months ended March 31, 2023, the Company’s investments in debt securities consisted of U.S. Treasury Bills, which were classified as Level 1 in the fair value hierarchy. Due to the short-term nature of these securities which were classified as cash equivalents, the amortized value approximated fair value and the Company did not remeasure these instruments at fair value. As of March 31, 2024 and December 31, 2023, the Company held no investments in debt securities. The Company’s outstanding debt is classified as Level 2 in the fair value hierarchy. As of March 31, 2024 and December 31, 2023, the Company had no financial instruments measured at fair value on a recurring basis. Accrued Research and Development and Clinical Trial Costs Research and development costs are expensed as incurred based on estimates of the period in which services and efforts are expended, 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 estimates determined by reviewing cost information provided by CROs and CDMOs, other third-party vendors and internal clinical personnel, and contractual arrangements with CROs and CDMOs and the scope of work to be performed. 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 stock 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 stock equivalents 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. The weighted average number of common stock used in the basic and diluted net loss per common stock calculations includes the weighted-average pre-funded warrants outstanding during the period as they are exercisable at any time for nominal cash consideration. For purposes of the diluted net loss per share calculation, other than pre-funded warrants as discussed above, warrants for purchase of common stock and stock options are considered to be potentially dilutive securities. Accordingly, for the three months ended March 31, 2024 and March 31, 2023, 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, as weighted based on the period outstanding, are as follows (in thousands): THREE MONTHS ENDED 2024 2023 Outstanding stock options 6,042 5,785 Warrants to purchase common stock 47 47 Total 6,089 5,832 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. Recently Issued but Not Yet Adopted Accounting Pronouncements In November 2023, the FASB issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which updates reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses. The amendments are effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The amendments should be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating this ASU to determine its impact on the Company's consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvement to Income Tax Disclosures |
OTHER FINANCIAL INFORMATION
OTHER FINANCIAL INFORMATION | 3 Months Ended |
Mar. 31, 2024 | |
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 MARCH 31, 2024 DECEMBER 31, 2023 Clinical drug substance and product manufacturing (1) $ 8,510 $ 9,888 Clinical trials (2) 8,372 5,409 Licenses 1,044 728 Outside research and development services (3) 552 265 Other 539 366 Prepaid expense and other current assets $ 19,017 $ 16,656 (1) Relates primarily to the Company’s usage of third-party CDMOs for clinical and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (2) Relates primarily to the Company’s prepayments to third-party CROs for management of clinical trials and prepayments for drug supply to be used in combination with the Company’s therapeutics. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (3) Relates to the Company’s usage of third-parties for other research and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. Property and Equipment, Net Property and equipment, net were comprised of the following (in thousands): AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Machinery and equipment $ 8,519 $ 8,480 Furniture, fixtures, and other 542 540 Leasehold improvements 795 441 Computer software 53 53 Construction in process (1) 4,088 3,592 Total property and equipment 13,997 13,106 Less: accumulated depreciation and amortization (7,031) (6,687) Property and equipment, net $ 6,966 $ 6,419 (1) Consists of renovations to the Company’s office space and software not yet placed in service. Depreciation and amortization expense totaled $0.4 million and $0.3 million for the three months ended March 31, 2024 and March 31, 2023, respectively, and consisted of the following (in thousands): THREE MONTHS ENDED 2024 2023 Research and development $ 256 $ 237 General and administrative 104 58 Total depreciation and amortization expense $ 360 $ 295 Accrued Expenses Accrued expenses were comprised of the following (in thousands): AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Clinical drug substance and product manufacturing (1) $ 29,912 $ 22,805 Clinical trials (2) 14,105 9,224 Other outside research and development (3) 1,144 1,129 Interest expense 2,344 2,348 Compensation-related 2,100 6,506 Professional fees 1,318 780 Other 406 503 Accrued expenses $ 51,329 $ 43,295 (1) Relates primarily to the Company’s usage of third-party CDMOs for clinical and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (2) Relates primarily to the Company’s usage of third-party CROs for management of clinical trials. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. |
DEBT
DEBT | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT 2020 Loan Agreement In July 2020, the Company entered into a loan and security agreement, or the 2020 Loan Agreement, with Oxford Finance LLC, or Oxford. Under the original 2020 Loan Agreement and subsequent amendments between November 2020 and October 2022, or collectively, the Amended 2020 Loan Agreement, the Company received an aggregate principal amount of $200.0 million over seven tranches, or Terms A-G. The Company determined each of the amendments under the Amended 2020 Loan Agreement should be treated as modifications of the original 2020 Loan Agreement since the terms and resulting cash flows were not substantially changed upon each of the amendments. The Company has continued to amortize the existing debt discounts prior to modification through the Amended Maturity Date (as defined below). As of July 1, 2023, a LIBOR Transition Event, as defined in the Amended 2020 Loan Agreement, occurred, and pursuant to the Amended 2020 Loan Agreement, Oxford selected a LIBOR Replacement Rate, as defined in the Amended 2020 Loan Agreement, replacing the 30 day U.S. Dollar London InterBank Offered Rate with the 1-Month Chicago Mercantile Exchange term secured overnight financing rate, or 1-Month CME Term SOFR, causing an amendment to the interest rate of the Company’s outstanding loans. No other terms were changed. The Company has elected the optional expedient under ASC Topic 848-20 and therefore deemed the modification to not be substantial. As of March 31, 2024, the Company had $200.0 million in gross principal outstanding in term loans under the Amended 2020 Loan Agreement. The outstanding term loans will mature on January 1, 2027, or the Amended Maturity Date, and bear interest at a floating per annum rate equal to the greater of (1) 8.30% or (2) the sum of (i) the 1-Month CME Term SOFR on the last business day of the month that immediately precedes the month in which the interest will accrue, (ii) 0.10%, and (iii) 8.19%. Under the Amended 2020 Loan Agreement, the repayment schedule provides for interest-only payments through February 1, 2025, followed by 23 months of principal and interest payments. In the event of a qualifying financing event in which the Company raises at least $100.0 million in upfront licensing or partnership proceeds by February 2025, the interest-only period may be extended an additional 12 months through February 1, 2026, which would then be followed by 11 months of equal payments of principal plus interest, beginning on March 1, 2026. Upon the Amended Maturity Date, a final payment of 9.0% of the original principal amount will be due to Oxford. This final payment of $18.0 million is being accreted over the life of the Amended 2020 Loan Agreement using the effective interest method. The Company has the option to prepay the outstanding balance of the term loans in full prior to the Amended Maturity Date, subject to a prepayment fee ranging from 1.0% to 3.0%, depending upon the timing of the prepayment. The Company’s outstanding debt balance under the Amended 2020 Loan Agreement consisted of the following as of March 31, 2024 and December 31, 2023 (in thousands). AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Term A $ 10,900 $ 10,900 Term B 21,800 21,800 Term C 43,600 43,600 Term D 43,600 43,600 Term E 32,700 32,700 Term F 32,700 32,700 Term G 32,700 32,700 Less: debt discount (9,790) (11,032) Total debt 208,210 206,968 Less: Current portion, including debt discount (3,632) — Long-term debt, including debt discount and final payment fee $ 204,578 $ 206,968 As of March 31, 2024, and unless extended in accordance with the terms described above, the Company’s interest-only period will continue through February 2025, with principal payments beginning in March 2025. Future principal payments and final fee payments will be made as follows (in thousands): AS OF MARCH 31, 2024 2025 $ 86,956 2026 104,348 2027 26,696 Total future minimum payments 218,000 Less: unamortized debt discount (9,790) Total debt $ 208,210 The Company’s obligations under the Amended 2020 Loan Agreement are secured by a first priority security interest of substantially all of the Company’s assets with a positive lien on intellectual property. The Amended 2020 Loan Agreement includes customary events of default, including instances of a material adverse change in the Company’s operations, that may require prepayment of the outstanding term loans. Additionally, following the amendment in June 2021, the Amended 2020 Loan Agreement requires the Company to maintain a minimum cash balance of $20.0 million. As of March 31, 2024, the Company was 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 amendment in February 2022, the Company issued 40,000 warrants to Oxford to purchase shares of the Company’s common stock at an exercise price of $45.00. Upon issuance, the warrants were classified as equity and recorded at their fair value of $0.7 million. See Note 4 for further discussion of these warrants. Interest Expense Interest expense is calculated using the effective interest method and is inclusive of non-cash amortization of the debt discount and accretion of the final payment. During the three months ended March 31, 2024, interest expense was $8.1 million, $1.2 million of which related to non-cash amortization of the debt discount and accretion of the final payment. During the three months ended March 31, 2023, interest expense was $7.6 million, $1.2 million of which related to non-cash amortization of the debt discount and accretion of the final payment. |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | STOCKHOLDERS’ EQUITY Securities Purchase Agreement In August 2023, the Company entered into a Securities Purchase Agreement, as amended, or the Purchase Agreement, with the Purchasers, pursuant to which the Company sold and issued 3,621,314 shares of the Company’s common stock for $19.35 per share and, with respect to certain Purchasers, pre-funded warrants to purchase 6,714,636 shares of the Company’s common stock in the Private Placement. The purchase price of the pre-funded warrants was $19.3499 per pre-funded warrant, with an exercise price of $0.0001 per share. The Company received gross proceeds of $200.0 million from the Private Placement, before deducting $0.4 million of offering expenses payable by the Company. The pre-funded warrants are equity-classified and carried at the instruments’ fair value upon issuance. The pre-funded warrants are exercisable upon issuance pursuant to certain beneficial ownership limitations as defined in the Purchase Agreement and will expire when exercised in full. As of March 31, 2024, all pre-funded warrants were still outstanding. Warrants Issued in Connection with Amended 2020 Loan Agreement As of March 31, 2024, the following equity-classified warrants were outstanding, in addition to the pre-funded warrants discussed above: Expiration Date Shares of Common Stock Issuable Upon Exercise Price July 15, 2030 7,354 $ 17.00 February 18, 2032 40,000 $ 45.00 The Company’s warrants are equity-classified and carried at the instruments’ fair value upon classification into equity, with no subsequent remeasurements. Common Stock Reserved for Future Issuance Common stock reserved for future issuance as of March 31, 2024 and December 31, 2023 consisted of the following (in thousands): AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Options to purchase common stock issued and outstanding 4,623 6,494 Shares available for future equity grants 2,432 533 Pre-funded warrants issued and outstanding 6,715 6,715 Warrants issued and outstanding 47 47 Total common stock reserved for future issuance 13,817 13,789 |
EQUITY COMPENSATION PLAN
EQUITY COMPENSATION PLAN | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024, an aggregate of 9.7 million shares of common stock were authorized for issuance under the 2017 Plan, of which 2.4 million remained available for issuance. 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 three months ended March 31, 2024 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, 2023 6,494 $ 23.22 Exercised (1,865) $ 21.65 Forfeited (6) $ 32.97 Outstanding as of March 31, 2024 4,623 $ 23.84 7.6 $ 52,413 Vested and exercisable as of March 31, 2024 1,892 $ 22.84 6.3 $ 23,474 The aggregate intrinsic value of stock options exercised during the three months ended March 31, 2024 and March 31, 2023 was $25.5 million and $0.4 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 the fair value of common stock as of March 31, 2024, respectively. The total fair value of stock options vested during the three months ended March 31, 2024 and March 31, 2023 was $8.3 million and $7.7 million, respectively. The Company expects all outstanding stock options to vest. Stock-Based Compensation Expense The weighted-average assumptions used by the Company to estimate the fair value of stock option grants using the Black-Scholes option pricing model, as well as the resulting weighted-average fair value, for the three months ended March 31, 2023 were as follows: THREE MONTHS ENDED Risk-free interest rate 3.81 % Expected volatility 84.31 % Expected dividend yield — % Expected term (in years) 6.08 Weighted average fair value $ 17.95 The Company did not grant any stock options during the three months ended March 31, 2024. Stock-based compensation expense for stock options consisted of the following (in thousands): THREE MONTHS ENDED 2024 2023 Research and development $ 4,192 $ 3,849 General and administrative 2,205 1,787 Total stock-based compensation expense $ 6,397 $ 5,636 As of March 31, 2024, the Company had $45.2 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 2.3 years. |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
LEASES | LEASES Operating Leases In September 2017, the Company entered into a seven-year lease agreement as its sole location in La Jolla, California. The lease expires in June 2025 with an option to extend the lease an additional five years, which is not included in the right-of-use asset and lease liabilities. The lease contained an initial base rent of approximately $0.1 million per month with 2% annual escalations, plus a percentage of taxes and operating expenses incurred by the lessor in connection with the ownership and management of the property, the latter of which to be determined annually. In May 2019, the Company executed an amendment to its lease agreement to expand its facilities and began occupying this space in January 2020. The amended lease terminates coterminously with the initial lease agreement and contains an initial base rent of approximately $30,000 per month with 2% annual escalations, plus a percentage of taxes and operating expenses incurred by the lessor in connection with the ownership and management of the property, the latter of which is to be determined annually. The operating right-of-use asset and operating lease liability as of March 31, 2024 and December 31, 2023 were as follows (in thousands): AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Operating right-of-use asset $ 2,487 $ 2,952 Operating lease liability Current $ 2,117 $ 2,063 Non-current 561 $ 1,110 Total operating lease liability $ 2,678 $ 3,173 During the three months ended March 31, 2024 and March 31, 2023, the Company recognized operating lease expense of $0.8 million and $0.9 million, respectively. During each of the three months ended March 31, 2024 and March 31, 2023, the Company paid $0.6 million in cash for amounts included in the measurement of the operating lease liability. As of March 31, 2024 and December 31, 2023, the Company’s operating lease had a remaining term of 1.3 and 1.5 years, respectively. The Company discounts its lease payments using its incremental borrowing rate as of the commencement of the lease. The Company determined a weighted-average discount rate of 8.2% as of March 31, 2024 and December 31, 2023. Future minimum rental commitments for the Company’s operating leases reconciled to the operating lease liability are as follows (in thousands): AS OF MARCH 31, 2024 2024 1,690 2025 1,137 Thereafter — Total future minimum lease payments $ 2,827 Less: imputed interest (149) Present value of operating lease liability 2,678 Less: current portion of operating lease liability (2,117) Non-current portion of operating lease liability $ 561 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Litigation Other than as described below, the Company is not party to any material legal proceedings. From time to time, it may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on the Company because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained. I-Mab Litigation On March 1, 2022, I-Mab Biopharma, or I-Mab, filed a lawsuit against the Company and Brendan Eckelman, the Company’s co-founder and Chief Scientific Officer, in the United States District Court for the District of Delaware, C.A. No. 22-00276-CJB, asserting claims for misappropriation of trade secrets related to Dr. Eckelman’s service as an expert witness for Tracon Pharmaceuticals, Inc., or Tracon, in Tracon’s arbitration against I-Mab. The parties are currently engaged in expert discovery and summary judgment motions are expected to be filed in or around June 2024, with trial currently scheduled to commence in October 2024. I-Mab is seeking royalty damages and alternative damages in the form of unjust enrichment. The Company is unable to reasonably estimate possible damages or a range of possible damages in this matter given the uncertainty and therefore has not recorded a liability on its books as of March 31, 2024. Purchase Commitments The Company has several ongoing contracts with CROs for preclinical studies and clinical trials and with CDMOs for clinical supplies and manufacturing scale-up activities. While these contracts are generally cancellable, some may contain specific activities that involve one or more noncancellable commitments, including minimum purchase commitments, binding annual forecasts and capital equipment investments. Additionally, depending on the timing and reasoning of the exit, certain termination penalties may apply and can range from cost of work performed to date and up to twelve months of future committed manufacturing costs. As of March 31, 2024 and December 31, 2023, the noncancellable portion of these contracts totaled in aggregate, excluding amounts paid or incurred at each respective date, approximately $44.8 million and $62.8 million, respectively. The noncancellable purchase commitments relate to the purchase of raw materials and future contract manufacturing of drug supply for INBRX-101. Contingencies In connection with the proposed Merger, the Company engaged legal counsel under a contingent fee arrangement. Under this agreement, the Company is obligated to pay a fee of $20.0 million, contingent upon the consummation of the proposed transaction. The Company also engaged financial advisors under a contingent fee arrangement. Under this agreement, the Company is obligated to pay a fee of 2.0% of the total aggregate consideration paid in the proposed Merger, or $45.0 million. In the event the Merger is not completed, the Company does not owe any fees to its legal counsel or financial advisors under these agreements. The Company will incur these costs in full upon the consummation of the Merger, if and when it is completed, and has not incurred any portion of these fees as of March 31, 2024. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS In April 2024, pre-funded warrants to purchase 2,747,245 shares of the Company’s common stock, as issued under the Purchase Agreement, were exercised at an exercise price of $0.0001 per share. Pre-funded warrants to purchase 3,967,391 shares of the Company’s common stock remain outstanding. From April 1, 2024 through May 7, 2024, a total of 680,001 stock options under the 2017 Plan were exercised at a weighted average exercise price of $15.93. The Company received total proceeds of $10.8 million upon exercise of these stock options. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net loss | $ (78,710) | $ (48,916) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or the SEC, related to an interim report on the Form 10-Q. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these unaudited interim condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the fiscal year ended December 31, 2023, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on February 28, 2024. |
Reclassification of Prior Year Presentation | Reclassification of Prior Year Presentation |
Liquidity | Liquidity As of March 31, 2024, the Company had an accumulated deficit of $692.4 million and cash and cash equivalents of $252.5 million. From its inception and through March 31, 2024, the Company has devoted substantially all of its efforts to therapeutic drug discovery and development, conducting preclinical studies and clinical trials, enabling manufacturing activities in support of its therapeutic candidates, pre-commercialization activities, organizing and staffing the Company, establishing its intellectual property portfolio and raising capital to support and expand these activities. In August 2023, the Company received gross proceeds of $200.0 million before deducting $0.4 million of offering expenses payable by the Company in a private placement transaction, or the Private Placement, with certain institutional and other accredited investors, or Purchasers, in which the Company sold and issued 3,621,314 shares of the Company’s common stock and, with respect to certain Purchasers, pre-funded warrants to purchase 6,714,636 shares of the Company’s common stock. See Note 4 for further discussion of this equity offering. The Company believes that its existing cash and cash equivalents will be sufficient to fund the Company’s operations for at least 12 months from the date these condensed consolidated financial statements are issued. The Company plans to finance its future cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses, strategic transactions and other similar arrangements. If the Company does raise additional capital through public or private equity or convertible debt offerings, the ownership interests of its existing stockholders will be diluted, and the terms of those securities may include liquidation or other preferences that adversely affect its stockholders’ rights. If the Company raises capital through additional debt financings, it may be subject to covenants limiting or restricting its ability to take specific actions, such as incurring additional debt or making certain capital expenditures. To the extent that the Company raises additional capital through strategic licensing, collaboration or other similar agreement, it may have to relinquish valuable rights to its therapeutic candidates, future revenue streams or research programs at an earlier stage of development or on less favorable terms than it would otherwise choose, or to grant licenses on terms that may not be favorable to the Company. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future. If the Company is unable to secure adequate additional funding, it will need to reevaluate its operating plan and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of its development programs, or relinquish rights to its technology on less favorable terms than it would otherwise choose. These actions could materially impact its business, financial condition, results of operations and prospects. The rules and regulations of the SEC or any other regulatory agencies may restrict the Company’s ability to conduct certain types of financing activities, or may affect the timing of and amounts it can raise by undertaking such activities. |
Use of Estimates | Use of Estimates The preparation of these unaudited condensed consolidated financial statements in conformity with GAAP requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expense and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. The Company’s most significant estimates relate to evaluation of whether revenue recognition criteria have been met, accounting for development work and preclinical studies and clinical trials, determining the assumptions used in measuring stock-based compensation, the incremental borrowing rate estimated in relation to the Company’s operating lease, and valuation allowances for the Company’s deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. The Company’s actual results may differ from these estimates under different assumptions or conditions. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents are comprised of cash held in financial institutions including readily available checking, overnight sweep, and money market accounts. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits by the Federal Deposit Insurance Corporation, or FDIC, of up to $250,000. The Company’s cash management and investment policy limits investment instruments to investment-grade securities with the objective to preserve capital and to maintain liquidity until the funds can be used in operations. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial condition of the depository institutions in which those deposits are held. |
Fair Value Measurements | Fair Value Measurements The Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established by accounting guidance and prioritizes the inputs used in measuring fair value. These tiers include: • Level 1 - Quoted prices in active markets for identical assets or liabilities. • Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the level in the fair value hierarchy within which the fair value measurement in its entirety falls has been 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. |
Accrued Research and Development and Clinical Trial Costs | Accrued Research and Development and Clinical Trial Costs |
Income Taxes | Income Taxes |
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 stock 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 stock equivalents 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. The weighted average number of common stock used in the basic and diluted net loss per common stock calculations includes the weighted-average pre-funded warrants outstanding during the period as they are exercisable at any time for nominal cash consideration. |
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. Recently Issued but Not Yet Adopted Accounting Pronouncements In November 2023, the FASB issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which updates reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses. The amendments are effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The amendments should be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating this ASU to determine its impact on the Company's consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvement to Income Tax Disclosures |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, as weighted based on the period outstanding, are as follows (in thousands): THREE MONTHS ENDED 2024 2023 Outstanding stock options 6,042 5,785 Warrants to purchase common stock 47 47 Total 6,089 5,832 |
OTHER FINANCIAL INFORMATION (Ta
OTHER FINANCIAL INFORMATION (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Prepaid Expense and Other Current Assets | Prepaid expense and other current assets were comprised of the following (in thousands): AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Clinical drug substance and product manufacturing (1) $ 8,510 $ 9,888 Clinical trials (2) 8,372 5,409 Licenses 1,044 728 Outside research and development services (3) 552 265 Other 539 366 Prepaid expense and other current assets $ 19,017 $ 16,656 (1) Relates primarily to the Company’s usage of third-party CDMOs for clinical and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (2) Relates primarily to the Company’s prepayments to third-party CROs for management of clinical trials and prepayments for drug supply to be used in combination with the Company’s therapeutics. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. |
Schedule of Property and Equipment | Property and equipment, net were comprised of the following (in thousands): AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Machinery and equipment $ 8,519 $ 8,480 Furniture, fixtures, and other 542 540 Leasehold improvements 795 441 Computer software 53 53 Construction in process (1) 4,088 3,592 Total property and equipment 13,997 13,106 Less: accumulated depreciation and amortization (7,031) (6,687) Property and equipment, net $ 6,966 $ 6,419 (1) Consists of renovations to the Company’s office space and software not yet placed in service. Depreciation and amortization expense totaled $0.4 million and $0.3 million for the three months ended March 31, 2024 and March 31, 2023, respectively, and consisted of the following (in thousands): THREE MONTHS ENDED 2024 2023 Research and development $ 256 $ 237 General and administrative 104 58 Total depreciation and amortization expense $ 360 $ 295 |
Schedule of Accrued Expenses | Accrued expenses were comprised of the following (in thousands): AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Clinical drug substance and product manufacturing (1) $ 29,912 $ 22,805 Clinical trials (2) 14,105 9,224 Other outside research and development (3) 1,144 1,129 Interest expense 2,344 2,348 Compensation-related 2,100 6,506 Professional fees 1,318 780 Other 406 503 Accrued expenses $ 51,329 $ 43,295 (1) Relates primarily to the Company’s usage of third-party CDMOs for clinical and development efforts. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. (2) Relates primarily to the Company’s usage of third-party CROs for management of clinical trials. See “Accrued Research and Development Clinical Trial Costs” in Note 1 for further discussion of the components of research and development. |
DEBT (Tables)
DEBT (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 and December 31, 2023 (in thousands). AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Term A $ 10,900 $ 10,900 Term B 21,800 21,800 Term C 43,600 43,600 Term D 43,600 43,600 Term E 32,700 32,700 Term F 32,700 32,700 Term G 32,700 32,700 Less: debt discount (9,790) (11,032) Total debt 208,210 206,968 Less: Current portion, including debt discount (3,632) — Long-term debt, including debt discount and final payment fee $ 204,578 $ 206,968 |
Schedule of Maturities of Long-term Debt | Future principal payments and final fee payments will be made as follows (in thousands): AS OF MARCH 31, 2024 2025 $ 86,956 2026 104,348 2027 26,696 Total future minimum payments 218,000 Less: unamortized debt discount (9,790) Total debt $ 208,210 |
STOCKHOLDERS_ EQUITY (Tables)
STOCKHOLDERS’ EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Schedule of Warrants Issued | As of March 31, 2024, the following equity-classified warrants were outstanding, in addition to the pre-funded warrants discussed above: Expiration Date Shares of Common Stock Issuable Upon Exercise Price July 15, 2030 7,354 $ 17.00 February 18, 2032 40,000 $ 45.00 |
Schedule of Common Stock Reserved For Future Issuance | Common stock reserved for future issuance as of March 31, 2024 and December 31, 2023 consisted of the following (in thousands): AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Options to purchase common stock issued and outstanding 4,623 6,494 Shares available for future equity grants 2,432 533 Pre-funded warrants issued and outstanding 6,715 6,715 Warrants issued and outstanding 47 47 Total common stock reserved for future issuance 13,817 13,789 |
EQUITY COMPENSATION PLAN (Table
EQUITY COMPENSATION PLAN (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Options Activity | A summary of the Company’s stock option activity under its 2017 Plan for the three months ended March 31, 2024 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, 2023 6,494 $ 23.22 Exercised (1,865) $ 21.65 Forfeited (6) $ 32.97 Outstanding as of March 31, 2024 4,623 $ 23.84 7.6 $ 52,413 Vested and exercisable as of March 31, 2024 1,892 $ 22.84 6.3 $ 23,474 |
Schedule of Weighted-Average Assumptions Used to Estimate Fair Value | The weighted-average assumptions used by the Company to estimate the fair value of stock option grants using the Black-Scholes option pricing model, as well as the resulting weighted-average fair value, for the three months ended March 31, 2023 were as follows: THREE MONTHS ENDED Risk-free interest rate 3.81 % Expected volatility 84.31 % Expected dividend yield — % Expected term (in years) 6.08 Weighted average fair value $ 17.95 |
Schedule of Stock-Based Compensation Expense | Stock-based compensation expense for stock options consisted of the following (in thousands): THREE MONTHS ENDED 2024 2023 Research and development $ 4,192 $ 3,849 General and administrative 2,205 1,787 Total stock-based compensation expense $ 6,397 $ 5,636 |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Schedule of Operating Lease, by Balance Sheet Location | The operating right-of-use asset and operating lease liability as of March 31, 2024 and December 31, 2023 were as follows (in thousands): AS OF AS OF MARCH 31, 2024 DECEMBER 31, 2023 Operating right-of-use asset $ 2,487 $ 2,952 Operating lease liability Current $ 2,117 $ 2,063 Non-current 561 $ 1,110 Total operating lease liability $ 2,678 $ 3,173 |
Schedule of Operating Lease Maturity | Future minimum rental commitments for the Company’s operating leases reconciled to the operating lease liability are as follows (in thousands): AS OF MARCH 31, 2024 2024 1,690 2025 1,137 Thereafter — Total future minimum lease payments $ 2,827 Less: imputed interest (149) Present value of operating lease liability 2,678 Less: current portion of operating lease liability (2,117) Non-current portion of operating lease liability $ 561 |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) | 1 Months Ended | 3 Months Ended | ||
Jan. 22, 2024 USD ($) right $ / shares | Aug. 31, 2023 USD ($) $ / shares shares | Mar. 31, 2024 USD ($) segment | Dec. 31, 2023 USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Sale of stock, price per share (in dollars per share) | $ / shares | $ 30 | |||
Sale of stock, right per share, contingency | right | 1 | |||
Sale of stock, price per share, contingency (in dollars per share) | $ / shares | $ 5 | |||
Exchange ratio | 4 | |||
Payments for merger | $ 200,000,000 | |||
Ownership percentage (as a percent) | 8% | |||
Exchange ratio, pro-rate basis (as a percent) | 92% | |||
Exchange ratio, pro-rate basis, post spin-off transaction (as a percent) | 8% | |||
Consideration transferred | $ 2,200,000,000 | |||
Termination fee | $ 54,500,000 | |||
Consummation threshold (as a percent) | 50% | |||
Reverse termination fee | $ 92,100,000 | |||
Accumulated deficit | $ 692,444,000 | $ 613,734,000 | ||
Cash and cash equivalents | 252,483,000 | 277,924,000 | ||
Debt securities, amortized cost | $ 0 | $ 0 | ||
Number of operating segments | segment | 1 | |||
Private Placement | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Sale of stock, price per share (in dollars per share) | $ / shares | $ 19.35 | |||
Sale of stock, proceeds received | $ 200,000,000 | |||
Proceeds from issuance of common stock and pre-funded warrants in private placement | $ 400,000 | |||
Sale of stock, shares issued/sold (in shares) | shares | 3,621,314 | |||
Private Placement | Warrants, Pre-Funded | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock issuable upon exercise of warrants (in shares) | shares | 6,714,636 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Potential Dilutive Securities (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Antidilutive securities excluded from earnings per share computation (in shares) | 6,089 | 5,832 |
Outstanding stock options | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Antidilutive securities excluded from earnings per share computation (in shares) | 6,042 | 5,785 |
Warrants to purchase common stock | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Antidilutive securities excluded from earnings per share computation (in shares) | 47 | 47 |
OTHER FINANCIAL INFORMATION - P
OTHER FINANCIAL INFORMATION - Prepaid Expense and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical drug substance and product manufacturing | $ 8,510 | $ 9,888 |
Clinical trials | 8,372 | 5,409 |
Licenses | 1,044 | 728 |
Outside research and development services | 552 | 265 |
Other | 539 | 366 |
Prepaid expense and other current assets | $ 19,017 | $ 16,656 |
OTHER FINANCIAL INFORMATION -_2
OTHER FINANCIAL INFORMATION - Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 13,997 | $ 13,106 |
Less: accumulated depreciation and amortization | (7,031) | (6,687) |
Property and equipment, net | 6,966 | 6,419 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 8,519 | 8,480 |
Furniture, fixtures, and other | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 542 | 540 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 795 | 441 |
Computer software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 53 | 53 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 4,088 | $ 3,592 |
OTHER FINANCIAL INFORMATION - D
OTHER FINANCIAL INFORMATION - Depreciation and Amortization Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Property, Plant and Equipment [Line Items] | ||
Total depreciation and amortization expense | $ 360 | $ 295 |
Research and development | ||
Property, Plant and Equipment [Line Items] | ||
Total depreciation and amortization expense | 256 | 237 |
General and administrative | ||
Property, Plant and Equipment [Line Items] | ||
Total depreciation and amortization expense | $ 104 | $ 58 |
OTHER FINANCIAL INFORMATION - A
OTHER FINANCIAL INFORMATION - Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical drug substance and product manufacturing | $ 29,912 | $ 22,805 |
Clinical trials | 14,105 | 9,224 |
Other outside research and development | 1,144 | 1,129 |
Interest expense | 2,344 | 2,348 |
Compensation-related | 2,100 | 6,506 |
Professional fees | 1,318 | 780 |
Other | 406 | 503 |
Accrued expenses | $ 51,329 | $ 43,295 |
DEBT - Narrative (Details)
DEBT - Narrative (Details) - Secured Debt $ / shares in Units, shares in Thousands, $ in Millions | 1 Months Ended | 3 Months Ended | 24 Months Ended | |
Feb. 28, 2022 USD ($) $ / shares shares | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Oct. 31, 2022 USD ($) tranche | |
Debt Instrument [Line Items] | ||||
Debt interest expense | $ 8.1 | $ 7.6 | ||
Amortization of debt discount and accretion | 1.2 | $ 1.2 | ||
2020 Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Proceeds from the issuance of debt | $ 200 | |||
Number of tranches | tranche | 7 | |||
Total long-term debt | $ 200 | |||
Annual interest rate (as a percent) | 8.30% | |||
Equal payments of principal and interest period if interest only period is extended (in months) | 23 months | |||
Upfront licensing or partnership proceeds raised | $ 100 | |||
Equal payments of principal period if interest only period is extended (in months) | 11 months | |||
Percentage of principal amount for final payment (as a percent) | 9% | |||
Periodic payment terms, final payment amount | $ 18 | |||
Minimum cash balance | $ 20 | |||
2020 Loan Agreement | Warrants Issued Concurrently With 2022 Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Warrants issued (in shares) | shares | 40 | |||
Warrant price (in dollars per share) | $ / shares | $ 45 | |||
Reclassification of warrant liabilities to equity | $ 0.7 | |||
2020 Loan Agreement | SOFR | Debt Instrument Rate One | ||||
Debt Instrument [Line Items] | ||||
Basis spread on variable rate (as a percent) | 0.10% | |||
2020 Loan Agreement | SOFR | Debt Instrument Rate Two | ||||
Debt Instrument [Line Items] | ||||
Basis spread on variable rate (as a percent) | 8.19% | |||
2020 Loan Agreement | Minimum | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee (as a percent) | 1% | |||
2020 Loan Agreement | Maximum | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee (as a percent) | 3% |
DEBT - Outstanding Debt Balance
DEBT - Outstanding Debt Balance 2020 Loan Agreement (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Instrument [Line Items] | ||
Less: Current portion, including debt discount | $ (3,632) | $ 0 |
Long-term debt, including debt discount and final payment fee | 204,578 | 206,968 |
2020 Loan Agreement | Secured Debt | ||
Debt Instrument [Line Items] | ||
Term loan | 218,000 | |
Less: debt discount | (9,790) | (11,032) |
Total debt | 208,210 | 206,968 |
Less: Current portion, including debt discount | (3,632) | 0 |
Long-term debt, including debt discount and final payment fee | 204,578 | 206,968 |
2020 Term A | Secured Debt | ||
Debt Instrument [Line Items] | ||
Term loan | 10,900 | 10,900 |
2020 Term B | Secured Debt | ||
Debt Instrument [Line Items] | ||
Term loan | 21,800 | 21,800 |
2020 Term C | Secured Debt | ||
Debt Instrument [Line Items] | ||
Term loan | 43,600 | 43,600 |
2020 Term D | Secured Debt | ||
Debt Instrument [Line Items] | ||
Term loan | 43,600 | 43,600 |
2020 Term E | Secured Debt | ||
Debt Instrument [Line Items] | ||
Term loan | 32,700 | 32,700 |
2020 Term F | Secured Debt | ||
Debt Instrument [Line Items] | ||
Term loan | 32,700 | 32,700 |
2020 Term G | Secured Debt | ||
Debt Instrument [Line Items] | ||
Term loan | $ 32,700 | $ 32,700 |
DEBT - Future Minimum Payments
DEBT - Future Minimum Payments (Details) - 2020 Loan Agreement - Secured Debt - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Instrument [Line Items] | ||
2025 | $ 86,956 | |
2026 | 104,348 | |
2027 | 26,696 | |
Total future minimum payments | 218,000 | |
Less: unamortized debt discount | (9,790) | $ (11,032) |
Total debt | $ 208,210 | $ 206,968 |
STOCKHOLDERS_ EQUITY - Narrativ
STOCKHOLDERS’ EQUITY - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | |
Aug. 31, 2023 | Jan. 22, 2024 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Sale of stock, price per share (in dollars per share) | $ 30 | |
Private Placement | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Sale of stock, shares issued/sold (in shares) | 3,621,314 | |
Sale of stock, price per share (in dollars per share) | $ 19.35 | |
Sale of stock, proceeds received | $ 200 | |
Proceeds from issuance of common stock and pre-funded warrants in private placement | $ 0.4 | |
Private Placement | Warrants, Pre-Funded | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock issuable upon exercise of warrants (in shares) | 6,714,636 | |
Purchase price (in dollars per share) | $ 19.3499 | |
Exercise price (in dollars per share) | $ 0.0001 |
STOCKHOLDERS_ EQUITY - Warrants
STOCKHOLDERS’ EQUITY - Warrants Issued in Connection with Amended 2020 Loan Agreement (Details) | Mar. 31, 2024 $ / shares shares |
July 15, 2030 | |
Class of Warrant or Right [Line Items] | |
Shares of Common Stock Issuable Upon Exercise of Warrants (in shares) | shares | 7,354 |
Exercise Price per Share (in dollars per share) | $ / shares | $ 17 |
February 18, 2032 | |
Class of Warrant or Right [Line Items] | |
Shares of Common Stock Issuable Upon Exercise of Warrants (in shares) | shares | 40,000 |
Exercise Price per Share (in dollars per share) | $ / shares | $ 45 |
STOCKHOLDERS_ EQUITY - Common S
STOCKHOLDERS’ EQUITY - Common Stock Reserved for Future Issuance (Details) - shares shares in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance (in shares) | 13,817 | 13,789 |
Options to purchase common stock issued and outstanding | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance (in shares) | 4,623 | 6,494 |
Shares available for future equity grants | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance (in shares) | 2,432 | 533 |
Pre-funded warrants issued and outstanding | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance (in shares) | 6,715 | 6,715 |
Warrants issued and outstanding | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance (in shares) | 47 | 47 |
EQUITY COMPENSATION PLAN - Narr
EQUITY COMPENSATION PLAN - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized (in shares) | 9,700,000 | |
Number of shares authorized, currently available (in shares) | 2,400,000 | |
Aggregate intrinsic value of stock options exercised | $ 25.5 | $ 0.4 |
Total fair value of stock options | $ 8.3 | $ 7.7 |
Granted (in shares) | 0 | |
Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period (in years) | 4 years | |
Contractual term (in years) | 10 years | |
Unrecognized stock-based compensation expense | $ 45.2 | |
Weighted-average period of recognition (in years) | 2 years 3 months 18 days | |
Stock Option | Cliff Vesting | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period (in years) | 1 year |
EQUITY COMPENSATION PLAN - Stoc
EQUITY COMPENSATION PLAN - Stock Option Activity (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) $ / shares shares | |
Number of Shares | |
Outstanding, beginning balance (in shares) | shares | 6,494 |
Exercised (in shares) | shares | (1,865) |
Forfeited (in shares) | shares | (6) |
Outstanding, ending balance (in shares) | shares | 4,623 |
Vested and exercisable (in shares) | shares | 1,892 |
Weighted Average Exercise Price | |
Outstanding, beginning balance (in dollars per share) | $ / shares | $ 23.22 |
Exercised (in dollars per share) | $ / shares | 21.65 |
Forfeited (in dollars per share) | $ / shares | 32.97 |
Outstanding, ending balance (in dollars per share) | $ / shares | 23.84 |
Vested and exercisable (in dollars per share) | $ / shares | $ 22.84 |
Weighted Average Remaining Contractual Term (in years) | 7 years 7 months 6 days |
Weighted Average Remaining Contractual Term, Vested and Exercisable (in years) | 6 years 3 months 18 days |
Aggregate Intrinsic Value | $ | $ 52,413 |
Aggregate Intrinsic Value, vested and exercisable | $ | $ 23,474 |
EQUITY COMPENSATION PLAN - Fair
EQUITY COMPENSATION PLAN - Fair Value of Stock Option Grants (Details) - Stock Option | 3 Months Ended |
Mar. 31, 2023 $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Risk-free interest rate (as a percent) | 3.81% |
Expected volatility (as a percent) | 84.31% |
Expected dividend yield (as a percent) | 0% |
Expected term (in years) | 6 years 29 days |
Weighted average fair value (in dollars per share) | $ 17.95 |
EQUITY COMPENSATION PLAN - St_2
EQUITY COMPENSATION PLAN - Stock-based Compensation Expense (Details) - Stock Option - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 6,397 | $ 5,636 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 4,192 | 3,849 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 2,205 | $ 1,787 |
LEASES - Narrative (Details)
LEASES - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | ||||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | May 31, 2019 | Sep. 30, 2017 | |
Leases [Abstract] | |||||
Lease agreement term (in years) | 7 years | ||||
Lease extension term (in years) | 5 years | ||||
Initial base rent per month | $ 30 | $ 100 | |||
Annual escalations (as a percent) | 2% | 2% | |||
Operating lease expense | $ 800 | $ 900 | |||
Payments included in measurement of lease liability | $ 600 | $ 600 | |||
Remaining term of operating lease (in years) | 1 year 3 months 18 days | 1 year 6 months | |||
Weighted-average discount rate (as a percent) | 8.20% | 8.20% |
LEASES - Schedule of Right-Of-U
LEASES - Schedule of Right-Of-Use Asset and Operating Lease Liability (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Leases [Abstract] | ||
Operating right-of-use asset | $ 2,487 | $ 2,952 |
Operating lease liability | ||
Current | 2,117 | 2,063 |
Non-current | 561 | 1,110 |
Present value of operating lease liability | $ 2,678 | $ 3,173 |
LEASES - Schedule of Operating
LEASES - Schedule of Operating Lease Liability Maturity (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Leases [Abstract] | ||
2024 | $ 1,690 | |
2025 | 1,137 | |
Thereafter | 0 | |
Total future minimum lease payments | 2,827 | |
Less: imputed interest | (149) | |
Present value of operating lease liability | 2,678 | $ 3,173 |
Less: current portion of operating lease liability | (2,117) | (2,063) |
Non-current portion of operating lease liability | $ 561 | $ 1,110 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Purchase commitment, future period (in months) | 12 months | |
Purchase commitment | $ 44.8 | $ 62.8 |
Legal Merger Contingency Fee | ||
Loss Contingencies [Line Items] | ||
Contingency accrual, legal | $ 20 | |
Contingent fee arrangement, financial advisors, obligation, percentage of consideration paid in transaction (as a percent) | 2% | |
Contingent fee arrangement, financial advisors, obligation, consideration paid in transaction | $ 45 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |||
May 07, 2024 | Apr. 30, 2024 | Aug. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Subsequent Event [Line Items] | |||||
Stock options exercised (in shares) | 1,865,000 | ||||
Proceeds from the exercise of stock options | $ 38,728 | $ 356 | |||
Private Placement | |||||
Subsequent Event [Line Items] | |||||
Sale of stock, shares issued/sold (in shares) | 3,621,314 | ||||
Warrants, Pre-Funded | Private Placement | |||||
Subsequent Event [Line Items] | |||||
Exercise price (in dollars per share) | $ 0.0001 | ||||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Stock options exercised (in shares) | 680,001 | ||||
Stock options exercised (in dollars per share) | $ 15.93 | ||||
Proceeds from the exercise of stock options | $ 10,800 | ||||
Subsequent Event | Warrants, Pre-Funded | Private Placement | |||||
Subsequent Event [Line Items] | |||||
Sale of stock, shares issued/sold (in shares) | 2,747,245 | ||||
Exercise price (in dollars per share) | $ 0.0001 | ||||
Shares of common stock issuable upon exercise of warrants, outstanding (in shares) | 3,967,391 |