Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 06, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CUE | |
Entity Registrant Name | Cue Biopharma, Inc. | |
Entity Central Index Key | 0001645460 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Interactive Data Current | Yes | |
Document Transition Report | false | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 48,643,316 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-38327 | |
Entity Tax Identification Number | 47-3324577 | |
Entity Address, Address Line One | 40 Guest Street | |
Entity Address, City or Town | Boston | |
Entity Address State or Province | MA | |
Entity Address, Postal Zip Code | 02135 | |
City Area Code | 617 | |
Local Phone Number | 949-2680 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 41,029 | $ 48,514 |
Accounts receivable | 1,400 | 1,698 |
Prepaid expenses and other current assets | 2,240 | 1,242 |
Total current assets | 44,669 | 51,454 |
Property and equipment, net | 754 | 795 |
Operating lease right-of-use | 5,573 | 6,323 |
Deposits | 2,690 | 2,690 |
Restricted cash | 151 | 151 |
Other long-term assets | 114 | 117 |
Total assets | 53,951 | 61,530 |
Current liabilities: | ||
Accounts payable | 3,919 | 3,501 |
Accrued expenses | 5,208 | 4,137 |
Research and development contract liability, current portion | 1,790 | 2,112 |
Operating lease liabilities, current | 3,210 | |
Current portion of long-term debt, net | 3,963 | 3,963 |
Total current liabilities | 18,090 | 17,081 |
Operating lease liabilities, non-current | 2,579 | |
Long-term debt, net | 3,244 | 4,202 |
Total liabilities | 23,913 | 24,445 |
Commitments and contingencies (Note 11) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding at March 31, 2024 and December 31, 2023 | 0 | 0 |
Common stock, $0.001 par value; 100,000,000 shares authorized; 48,643,316 and 47,215,116 shares issued and outstanding, at March 31, 2024 and December 31, 2023, respectively | 48 | 47 |
Additional paid in capital | 343,527 | 338,228 |
Accumulated deficit | (313,537) | (301,190) |
Total stockholders' equity | 30,038 | 37,085 |
Total liabilities and stockholders' equity | $ 53,951 | $ 61,530 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 48,643,316 | 47,215,116 |
Common stock, shares outstanding | 48,643,316 | 47,215,116 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Statement [Abstract] | ||
Collaboration revenue | $ 1,717 | $ 187 |
Operating expenses: | ||
General and administrative | 4,186 | 4,176 |
Research and development | 10,199 | 9,391 |
Total operating expenses | 14,385 | 13,567 |
Loss from operations | (12,668) | (13,380) |
Other income (expense): | ||
Interest income | 562 | 641 |
Interest expense | (241) | (370) |
Total other income (expense), net | 321 | 271 |
Net loss | (12,347) | (13,109) |
Unrealized gain from available-for-sale securities | 0 | 57 |
Comprehensive loss | $ (12,347) | $ (13,052) |
Net loss per common share, basic | $ (0.25) | $ (0.29) |
Net loss per common share, diluted | $ (0.25) | $ (0.29) |
Weighted average common shares outstanding, basic | 49,466,711 | 44,652,353 |
Weighted average common shares outstanding, diluted | 49,466,711 | 44,652,353 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | AOCI Attributable to Parent | Accumulated Deficit |
Balance at Dec. 31, 2022 | $ 65,683 | $ 43 | $ 316,192 | $ (96) | $ (250,456) |
Balance, Shares at Dec. 31, 2022 | 43,042,548 | ||||
Stock-based compensation | 1,998 | 1,998 | |||
Exercise of stock options | 388 | 388 | |||
Exercise of stock options, Shares | 135,602 | ||||
Unrealized gain from available-for-sale securities | 57 | 57 | |||
Net Income (Loss) | (13,109) | (13,109) | |||
Balance at Mar. 31, 2023 | 55,017 | $ 43 | 318,578 | $ (39) | (263,565) |
Balance, Shares at Mar. 31, 2023 | 43,178,150 | ||||
Balance at Dec. 31, 2023 | 37,085 | $ 47 | 338,228 | (301,190) | |
Balance, Shares at Dec. 31, 2023 | 47,215,116 | ||||
Issuance of common stock from ATM offering, net ofsales agent commission and fees | 3,354 | $ 1 | 3,353 | ||
Issuance of common stock from public offerings, net of underwriter discounts, Shares | 1,428,200 | ||||
Stock-based compensation | $ 1,946 | 1,946 | |||
Exercise of stock options, Shares | 0 | ||||
Net Income (Loss) | $ (12,347) | (12,347) | |||
Balance at Mar. 31, 2024 | $ 30,038 | $ 48 | $ 343,527 | $ (313,537) | |
Balance, Shares at Mar. 31, 2024 | 48,643,316 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities | ||
Net Loss | $ (12,347,000) | $ (13,109,000) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 99,000 | 177,000 |
Stock-based compensation | 1,946,000 | 1,998,000 |
Decrease in the carrying amount of right-of-use-assets | 750,000 | 703,000 |
Gain on sale of property and equipment | 0 | (2,000) |
Amortization of premium/discount on purchased securities | 0 | (149,000) |
Amortization of debt issuance costs | 9,000 | 9,000 |
Accretion of final payment on term loan | 33,000 | 33,000 |
Changes in operating assets and liabilities: | ||
Account receivable | 298,000 | (139,000) |
Prepaid expenses and other current assets | (998,000) | (1,518,000) |
Deposits | 0 | 139,000 |
Accounts payable | 418,000 | (580,000) |
Accrued expenses | 1,071,000 | (709,000) |
Research and development contract liability | (322,000) | 2,966,000 |
Operating lease liability | (741,000) | (652,000) |
Net cash used in operating activities | (9,784,000) | (10,833,000) |
Cash flows from investing activities | ||
Purchases of property and equipment | (55,000) | 0 |
Cash received from the sale of property and equipment | 0 | 2,000 |
Redemption of marketable securities | 0 | 15,000,000 |
Net cash (used in) provided by investing activities | (55,000) | 15,002,000 |
Cash flows from financing activities | ||
Proceeds from ATM offering, net of sales agent commission and fees | 3,354,000 | 0 |
Payment of term loan | (1,000,000) | 0 |
Proceeds from exercise of stock options | 0 | 388,000 |
Net cash provided by financing activities | 2,354,000 | 388,000 |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (7,485,000) | 4,557,000 |
Cash, cash equivalents, and restricted cash at beginning of period | 48,665,000 | 51,764,000 |
Cash, cash equivalents, and restricted cash at end of period | 41,180,000 | 56,321,000 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Cash paid for interest | $ 209,000 | $ 330,000 |
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 Income (Loss) | $ (12,347) | $ (13,109) |
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 Basis of Prese
Organization and Basis of Presentation | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Cue Biopharma, Inc. (the "Company") is a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells directly within the patient’s body. The Company's vision is to translate nature's signals, or "cues", into protein therapeutics by generating a new class of T cell engagers for selective modulation of disease specific T cells. The Company’s corporate office and research facilities are located in Boston, Massachusetts. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company is in the development stage and has incurred recurring losses and negative cash flows from operations since inception. As of March 31, 2024, the Company had cash and cash equivalents of $ 41.0 million . Management believes that current cash and cash equivalents on hand at March 31, 2024 are sufficient to fund operations into the first quarter of 2025; however, the future viability of the Company is dependent on its ability to raise additional capital to finance its operations and to fund research and development costs in order to seek approval for commercialization of its drug product candidates. The Company is exploring raising additional capital through a combination of equity offerings, collaborations, and other strategic alliances, and, depending on the availability and level of additional financings, and cash expenditure reduction, there is no guarantee that the Company will be successful in these mitigation efforts. The Company’s failure to raise capital as and when needed would have a negative impact on its financial condition and its ability to pursue its business strategies as this capital is necessary for the Company to perform the research and development activities required to develop and commercialize the Company’s drug product candidates in order to generate future revenue streams. Therefore, management has determined that the Company’s accumulated deficit, history of losses, negative cash flows from operations and future expected losses raise substantial doubt about the Company’s ability to continue as a going concern within one year of the issuance date of these financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements as of March 31, 2024, and for the three months ended March 31, 2024 and 2023, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”) and generally accepted accounting principles in the United States (“U.S. GAAP”) for financial information, which prescribes elimination of all significant intercompany accounts and transactions in the accounts of the Company and its wholly owned subsidiary, Cue Biopharma Securities Corp., which was incorporated in the Commonwealth of Massachusetts in December 2018. In the opinion of management, these financial statements reflect all adjustments which are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2024. Interim results for the three months ended March 31, 2024 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2024, or any future periods. Public Offerings In October 2021, the Company entered into an open market sale agreement (the “October 2021 ATM Agreement”) with Jefferies LLC ("Jefferies"), as agent, to sell shares of the Company’s common stock for aggregate gross proceeds of up to $ 80 million, from time to time, through an at-the-market equity offering program. The October 2021 ATM Agreement will terminate upon the earliest of (a) the sale of $ 80 million of shares of the Company’s common stock pursuant to the October 2021 ATM Agreement or (b) the termination of the October 2021 ATM Agreement by the Company or Jefferies. During the three months ended March 31, 2024 , the Company sold 1,428,200 shares of common stock under the October 2021 ATM Agreement for proceeds of $ 3.4 million, net of commission paid, but excluding transaction expenses. There were no sales under the October 2021 ATM Agreement during the three months ended March 31, 2023. As of March 31, 2024, the Company sold an aggregate of 9,028,573 shares of common stock under the October 2021 ATM Agreement for proceeds of $ 40.4 million, net of commission paid, but excluding transaction expenses, since its inception. Consolidation The accompanying condensed consolidated financial statements include the Company and its wholly owned subsidiary, Cue Biopharma Securities Corp. The Company has eliminated all intercompany transactions. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates include estimates related to collaboration revenue, the accounting for potential liabilities and accrued expenses, the assumptions utilized in valuing stock-based compensation issued for services, the realization of deferred tax assets, and the useful life with respect to long-lived assets and intangibles. Actual results could differ from those estimates. Cash Concentrations The Company maintains its cash balances with financial institutions in federally insured accounts and may periodically have cash balances in excess of insurance limits. The Company maintains its accounts with financial institutions with a high credit rating. The Company has not experienced any losses to date from our deposits with these financial institutions and believes that it is not exposed to any significant credit risk on cash. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents. The Company currently invests available cash in money market funds. Marketable Securities Marketable securities consist of investments with original maturities greater than ninety days and less than one year from the date of the Company's condensed consolidated balance sheets. The Company classifies all of its investments as available-for-sale securities. Accordingly, these investments are recorded at fair value, which is based on quoted market prices. Unrealized gains and losses are recognized and determined on a specific identification basis and are included in comprehensive loss. Realized gains and losses are determined on a specific identification basis and are included in other income on the condensed consolidated statements of operations and comprehensive loss. Amortization and accretion of discounts and premiums is recorded in interest income. The Company had no marketable securities as of March 31, 2024 and December 31, 2023. At March 31, 2024, the Company invested available cash in money market funds, and at March 31, 2023 the Company invested available cash in U.S. Treasury securities. Restricted Cash The Company had $ 151,000 in restricted cash deposited with a separate commercial bank to collateralize Company credit cards as of March 31, 2024 and December 31, 2023 . Property and Equipment Property and equipment is recorded at cost. Major improvements are capitalized, while maintenance and repairs are charged to expense as incurred. Gains and losses from dispositions of property and equipment are included in income and expense when realized. Amortization of leasehold improvements is provided using the straight-line method over the shorter of the lease term or the useful life of the underlying assets. Depreciation of property and equipment is provided using the straight-line method over the following estimated useful lives: Laboratory equipment 5 years Computer equipment 3 years Furniture and fixtures 3 - 8 years The Company recognizes depreciation and amortization expense in general and administrative expenses and in research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss, depending on how each category of property and equipment is utilized in the Company’s business activities. Trademark Trademark consists of the Company’s right, title and interest to the CUE BIOLOGICS Mark, and any derivative mark incorporating CUE, throughout the world, together with all associated goodwill and common law rights appurtenant thereto, including, but not limited to, any right, title and interest in any corporate name, company name, business, name, trade name, dba, domain name, or other source identifier incorporating CUE. The Company has classified the trademark as a component of other long-term assets, having a useful life of 15 years. The Company evaluates the status of this intangible asset for amortization and impairment at each quarter end and year end reporting date. The Company recorded $ 3,000 in amortization expense, on a straight-line basis, for each of the three months ended March 31, 2024 and 2023. Debt Issuance Costs Debt issuance costs are deferred and presented as a reduction to long-term debt. Debt issuance costs are amortized using the effective interest rate method over the term of the loan. Amortization of deferred debt issuance costs are included in interest expense in the condensed consolidated statements of operations and comprehensive loss. Revenue Recognition The Company recognizes collaboration revenue under certain of the Company’s license and collaboration agreements that are within the scope of Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers (“ASC 606”). The Company’s contracts with customers typically include promises related to licenses to intellectual property and research and development services. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. Accordingly, the transaction price is generally comprised of a fixed fee due at contract inception and variable consideration in the form of milestone payments due upon the achievement of specified events and tiered royalties earned when customers recognize net sales of licensed products. The Company measures the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. The Company utilizes the “expected value method” method to estimate the amount of variable consideration, to predict the amount of consideration to which it will be entitled for its one open contract. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. At the inception of each arrangement that includes development and regulatory milestone payments, the Company evaluates whether the associated event is considered probable of achievement and estimates the amount to be included in the transaction price using the expected value method. Research and Development Expenses Research and development expenses consist primarily of compensation costs, fees paid to consultants, outside service providers and organizations (including research institutes at universities), facility costs, and development and clinical trial costs with respect to the Company’s drug product candidates. Research and development expenses incurred under contracts are expensed ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different pattern of performance is more appropriate. Other research and development expenses are charged to operations as incurred. Nonrefundable advance payments are recognized as an expense as the related services are performed. The Company evaluates whether it expects the services to be rendered at each quarter end and year end reporting date. If the Company does not expect the services to be rendered, the advance payment is charged to expense. Nonrefundable advance payments for research and development services are included in prepaid and other current assets on the Company's condensed consolidated balance sheets. To the extent that a nonrefundable advance payment is for contracted services to be performed within 12 months from the reporting date, such advance is included in current assets; otherwise, such advance is included in non-current assets. The Company evaluates the status of its research and development agreements and contracts, and the carrying amount of the related assets and liabilities, at each quarter end and year end reporting date, and adjusts the carrying amounts and their classification on the Company's condensed consolidated balance sheets as appropriate. Patent Expenses The Company is the exclusive worldwide licensee of, and has patent applications pending for, numerous domestic and foreign patents. Due to the significant uncertainty associated with the successful development of one or more commercially viable drug product candidates based on the Company’s research efforts and any related patent applications, all patent costs, including patent-related legal fees, filing fees and other costs are charged to general and administrative expense as incurred. For the three months ended March 31, 2024 and March 31, 2023, patent expenses were $ 537,000 and $ 632,000 , respectively. Licensing Fees and Costs Licensing fees and costs consist primarily of costs relating to the acquisition of the Company’s license agreement with the Albert Einstein College of Medicine (“Einstein”), including related royalties, maintenance fees, milestone payments and product development costs. Licensing fees and costs are charged to research and development expense as incurred. Long-Lived Assets The Company reviews long-lived assets, consisting of property and equipment, for impairment when events or changes in circumstances indicate the carrying value of these assets may exceed their current fair values. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the assets. Assets to be disposed of are separately presented in the Company's condensed consolidated balance sheets and reported at the lower of the carrying amount or fair value less costs to sell and are no longer depreciated. The Company has not historically recorded any impairment to its long-lived assets. In the future, if events or market conditions affect the estimated fair value to the extent that a long-lived asset is impaired, the Company will adjust the carrying value of these long-lived assets in the period in which the impairment occurs. There were no disposals of property and equipment for the three months ended March 31, 2024. During the three months ended March 31, 2023, the Company sold fully depreciated lab equipment with an acquisition cost of $ 41,000 and collected cash of $ 2,000 . The Company recorded a gain on the sale of fixed assets of $ 2,000 , which is presented in other income on the condensed consolidated statements of operations and comprehensive loss. Leases The Company accounts for leases under ASC 842, Leases , which requires a lessee to record a right-of-use asset and a corresponding lease liability for most lease arrangements on the Company's condensed consolidated balance sheets. Under the standard, disclosure of key information about leasing arrangements to assist users of the financial statements with assessing the amount, timing and uncertainty of cash flows arising from leases are required. Stock-Based Compensation The Company periodically issues stock-based awards to officers, directors, employees, Scientific and Clinical Advisory Board members and consultants for services rendered. Such issuances vest and expire according to terms established at the issuance date. Stock-based payments to officers, directors, employees, Scientific and Clinical Advisory Board members and consultants, including grants of employee stock options, are recognized in the financial statements based on their grant date fair values. Stock option grants, which are generally time-vested, are measured at the grant date fair value and charged to operations on a straight-line basis over the service period, which generally approximates the vesting term. The Company also grants performance-based awards periodically to officers of the Company. The Company recognizes compensation costs related to performance awards over the requisite service period if and when the Company concludes that it is probable that the performance condition will be achieved. The fair value of stock options and restricted stock units is determined utilizing the Black-Scholes option-pricing model, which is affected by several variables, including the risk-free interest rate, the expected dividend yield, the life of the equity award, the exercise price of the stock option as compared to the fair value of the common stock on the grant date, and the estimated volatility of the common stock over the term of the equity award. The Company recognizes the fair value of stock-based compensation in general and administrative expenses and in research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss, depending on the type of services provided by the recipient of the equity award. The Company accounts for forfeitures as they occur. Comprehensive Income (Loss) Components of comprehensive income or loss, including net income or loss, are reported in the financial statements in the period in which they are recognized. Other comprehensive income or loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss) are reported net of any related tax effect to arrive at comprehensive income (loss). Comprehensive income (loss) includes net income (loss) as well as changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. The Company’s only element of other comprehensive income (loss) in periods presented was unrealized gain or loss on available-for-sale securities. Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) for the respective periods includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average number of common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares that would result from the exercise of outstanding stock options and warrants as if they had been exercised at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Basic and diluted loss per common share is the same for all periods presented because all outstanding stock options and warrants are anti-dilutive. Per ASC 260-10-45-13, shares issuable for little to no consideration should be included in the number of outstanding shares used for basic EPS. The Financial Accounting Standards Board (“FASB”) proposed that warrants or options exercisable for little to no cost (sometimes referred to as “penny warrants”) be included in the denominator of basic EPS (and therefore diluted EPS) once there were no further vesting conditions or contingencies associated with them. The Company included 1,531,440 pre-funded warrants in the denominator of basic EPS at March 31, 2024. At March 31, 2024 and 2023, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of EPS, as their effect would have been anti-dilutive. March 31, 2024 2023 Common stock warrants 9,188,406 9,188,406 Common stock options 9,270,666 7,044,599 Total 18,459,072 16,233,005 Fair Value of Financial Instruments The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active exchange-traded securities and exchange-based derivatives. Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges. Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives and commingled investment funds and are measured using present value pricing models. The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end. The Company had $ 41.0 million and $ 39.1 million in cash equivalents as of March 31, 2024 and December 31, 2023, respectively. The carrying value of financial instruments (consisting of cash, a certificate of deposit, debt, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. Recent Accounting Pronouncements In December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its condensed consolidated financial statements. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Fair Value
Fair Value | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 3. Fair Value The Company accounts for its financial assets and liabilities using fair value measurements. The authoritative accounting guidance defines fair value, establishes a framework for measuring fair value under U.S. GAAP and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The following table presents information about the Company’s assets that are measured at fair value on a recurring basis as of March 31, 2024 and December 31, 2023, and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of March 31, 2024 (in thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 41,029 $ — $ — $ 41,029 Total $ 41,029 $ — $ — $ 41,029 Fair Value Measurements as of December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 39,148 $ — $ — $ 39,148 Total $ 39,148 $ — $ — $ 39,148 As of March 31, 2024, the Company had $ 41.0 million in cash equivalents. The Company measures the cash equivalents that are invested in money market funds using Level 1 inputs for identical securities. As of December 31, 2023, the Company had $ 39.1 million in cash equivalents. During the three months ended March 31, 2024 , and the year ended December 31, 2023, there were no transfers between Level 2 and Level 3. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. Property and Equipment Property and equipment as of March 31, 2024 and December 31, 2023 consisted of the following: March 31, December 31, (in thousands) Laboratory equipment $ 4,097 $ 4,069 Furniture and fixtures 81 81 Computer equipment 169 143 Leasehold improvements 118 118 Total property and equipment 4,465 4,411 Less accumulated depreciation ( 3,711 ) ( 3,616 ) Property and equipment, net $ 754 $ 795 Depreciation expense was $ 96,000 and $ 174,000 for the three months ended March 31, 2024 and 2023, respectively. Depreciation expense for the three months ended March 31, 2024 and 2023 excludes trademark amortization expense of $ 3,000 . There were no disposals of property and equipment for the three months ended March 31, 2024. During the three months ended March 31, 2023, the Company sold fully depreciated lab equipment with an acquisition cost of $ 41,000 and collected cash of $ 2,000 . The Company recorded a gain on the sale of fixed assets of $ 2,000 , which is presented in other income on the condensed consolidated statements of operations and comprehensive loss. |
Loan with Silicon Valley Bank
Loan with Silicon Valley Bank | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
Loan with Silicon Valley Bank | 5. Loan with First Citizens Bank (formerly with Silicon Valley Bank) On February 15, 2022 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Loan Agreement”), with Silicon Valley Bank, as lender (“SVB”). The Company drew $ 10,000,000 in term loans under the Loan Agreement (the "Term Loans") on the Closing Date. The Loan Agreement was amended in April 2023. The Term Loans bear interest at a floating rate per annum equal to the greater of (A) the prime rate (as published in the money rates section of The Wall Street Journal) plus 2.25 % and (B) 5.50 %. The Term Loans were interest only from the Closing Date through June 30, 2023 , after which the Company is required to pay 30 equal monthly installments of principal. At March 31, 2024, the interest rate was 10.75 % which is based on the prime rate plus 2.25 %. The Term Loans may be prepaid in full prior to February 15, 2024 with payment of a 2.00 % prepayment premium, on or after which they may be prepaid in full with payment of a 1.00 % prepayment premium. Upon prepayment or repayment in full of the Term Loans, the Company will be required to pay a one-time final payment fee equal to 5.00 % of the original principal amount of any funded Term Loans being repaid. This one-time final payment fee is recorded to interest expense using the effective interest method over the period of the Term Loans in the condensed consolidated statements of operations and comprehensive loss. The Term Loans and related obligations under the Loan Agreement are secured by substantially all of the Company’s properties, rights and assets, except for its intellectual property which is subject to a negative pledge under the Loan Agreement. The Loan Agreement contains customary representations, warranties, events of default and covenants, including a requirement that the Company maintain in accounts of the Company at SVB unrestricted and unencumbered cash equal to the lesser of all of the Company’s cash or $ 20,000,000 . On March 10, 2023, SVB was closed and the FDIC was appointed receiver for the bank. The FDIC created a successor bridge bank, and all deposits and loans of SVB were transferred to the bridge bank under a systemic risk exception approved by the United States Department of the Treasury, the Federal Reserve and the FDIC. On March 27, 2023, First Citizens Bank & Trust Company (“First Citizens Bank”), assumed all of SVB’s deposits and certain other liabilities and acquired substantially all of SVB’s loans and certain other assets from the FDIC. First Citizens Bank continues to hold the Company’s Term Loans under the same existing terms and covenants which were in place with SVB. During the three months ended March 31, 2024 and March 31, 2023, the Company recognized interest expense related to the Term Loans of $ 199,000 and $ 330,000 , respectively. For each of the three months ended March 31, 2024 and March 31, 2023, the Company recognized $ 33,000 in interest expense related to accretion of the final payment. The following table presents the aggregate maturities of long-term debt as of March 31, 2024 (in thousands): Year 2024 $ 3,000 2025 4,000 Total $ 7,000 The following table presents long-term and current portions of debt as of March 31, 2024 (in thousands): Long-term debt $ 3,000 Accretion of final payment 272 Less: unamortized debt issuance costs ( 28 ) Long-term debt, net $ 3,244 Current portion of long-term debt $ 4,000 Less: unamortized debt issuance costs ( 37 ) Current portion of long-term debt, net $ 3,963 Debt Issuance Costs Debt issuance costs are deferred and presented as a reduction to long-term debt. Debt issuance costs are amortized using the effective interest rate method over the term of the loan. Amortization of deferred debt issuance costs are included in interest expense in the condensed consolidated statements of operations and comprehensive loss. The Company has incurred $ 142,000 in debt issuance costs related to the Loan Agreement. For each of the three months ended March 31, 2024 and March 31, 2023 , the Company recognized interest expense of $ 9,000 for amortization of debt issuance costs in the condensed consolidated statements of operations and comprehensive loss. The Company recorded $ 37,000 and $ 28,000 to short- and long-term debt issuance costs contra-liabilities as of March 31, 2024 , respectively. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consist of the following: March 31, December 31, (In thousands) 2024 2023 Employee and board compensation $ 3,106 $ 2,219 Contract research services 1,816 1,411 Professional services 207 344 Contract manufacturing services 79 163 Total $ 5,208 $ 4,137 |
Einstein License and Service Ag
Einstein License and Service Agreement | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Einstein License and Service Agreement | 7. Einstein License Agreement On January 14, 2015 , the Company entered into a license agreement (the “Einstein License”), with Albert Einstein College of Medicine (“Einstein”) for certain patent rights relating to the Company’s core technology platform for the engineering of biologics to control T cell activity, precision, immune-modulatory drug product candidates, and two supporting technologies that enable the discovery of costimulatory signaling molecules (ligands) and T-cell targeting peptides. On July 31, 2017, the Company entered into an amended and restated license agreement which modified certain obligations of the parties under the Einstein License. The Einstein License was further amended on January 13, 2024. Under the Einstein License, the Company holds an exclusive worldwide license, with the right to sublicense, import, make, have made, use, provide, offer to sell, and sell all products, processes and services that use the patents covered by the Einstein License, including certain technology received from Einstein relating thereto (the “Licensed Products”). Under the Einstein License, the Company is required to: • Pay royalties and amounts based on a certain percentage of proceeds, as defined in the Einstein License, from sales of Licensed Products and sublicense agreements. • Pay escalating annual maintenance fees, which are nonrefundable, but are creditable against the amount due to Einstein for royalties. • Make significant payments based upon the achievement of certain milestones, as defined in the Einstein License. Payments made upon achievement of milestones are nonrefundable and are not creditable against any other payment due to Einstein. At March 31, 2024 , the Company has made aggregate payments totaling $ 1.2 million since inception with respect to achievement of these milestones. • Incur minimum product development costs until the first commercial sale of the first licensed product. The Company was in compliance with its obligations under the Einstein License at March 31, 2024 and 2023. The Einstein License expires upon the expiration of the Company’s last obligation to make royalty payments to Einstein which may be due with respect to certain Licensed Products, unless terminated earlier under the provisions thereof. The Einstein License includes certain termination provisions if the Company fails to meet its obligations thereunder. Pursuant to the Einstein License, the Company issued to Einstein 671,572 shares of the Company’s common stock in connection with the consummation of the initial public offering of its common stock on December 27, 2017. The Company accounts for license fees incurred in connection with the Einstein License in accordance with ASC 730, Research and Development. Please refer to Note 10 Collaboration Revenue. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based compensation | 8. Stock-Based Compensation Stock Option Valuation For stock options requiring an assessment of value during the three months ended March 31, 2024 and 2023, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model utilizing the following assumptions: March 31, 2024 Risk-free interest rate 3.83 % - 4.28 % Expected dividend yield 0 % Expected volatility 66.27 % - 109.86 % Expected life 5.50 to 8.91 years March 31, 2023 Risk-free interest rate 3.40 % - 3.99 % Expected dividend yield 0 % Expected volatility 97.0 % - 100.4 % Expected life 5.50 to 6.25 years A summary of stock option activity for the three months ended March 31, 2024 is as follows: Number of Weighted Weighted Stock options outstanding at December 31, 2023 7,492,917 $ 8.41 6.12 Granted 1,869,500 2.02 — Exercised — — — Cancelled ( 91,751 ) 10.63 — Stock options outstanding at March 31, 2024 9,270,666 7.10 6.74 Stock options exercisable at March 31, 2024 5,085,904 $ 9.85 4.72 The Company recognized $ 1.9 million and $ 2.0 million in stock-based compensation expense during the three months ended March 31, 2024 and 2023, respectively, related to stock options activity. As of March 31, 2024, total unrecognized stock-based compensation expense was $ 10.6 million , which is expected to be recognized as an operating expense in the Company’s condensed consolidated statements of operations and comprehensive loss over the weighted average remaining period of 2.55 years . As of March 31, 2023, total unrecognized stock-based compensation expense was $ 12.8 million, which is expected to be recognized as an operating expense in the Company’s condensed consolidated statements of operations and comprehensive loss over the weighted average remaining period of 2.62 years. During the three months ended March 31, 2023, the Company granted stock options to purchase 1,321,900 shares of common stock with a weighted average grant date fair value of $ 3.20 per share. Stock-based Compensation Stock-based compensation expense for the three months ended March 31, 2024 and 2023 was included in the Company’s condensed consolidated statements of operations and comprehensive loss as follows: Three Months Ended (in thousands) 2024 2023 General and administrative $ 956 $ 888 Research and development 990 1,110 Total stock-based compensation expense $ 1,946 $ 1,998 |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2024 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | 9. Warrants On November 16, 2022, the Company issued warrants exercisable for an aggregate of 9,188,406 shares of common stock with an exercise price of $ 3.93 and a 5-year term and pre-funded warrants exercisable for an aggregate of 1,531,440 shares of common stock (“Pre-Funded Warrants”) at a nominal exercise price of $ 0.0001 per share. These November 2022 warrants remain outstanding at March 31, 2024. The November 2022 warrants were evaluated under ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging, and the Company determined that equity classification was appropriate. The Company determined equity classification for both warrants and pre-funded warrants as they do not embody an obligation for the Company to repurchase its shares and permit the holders to receive a fixed number of shares of common stock upon exercise. Per ASC 815-40-25, the Company accounts for the warrants and pre-funded warrants as equity, as the Company does not provide the holder a fixed or guaranteed return. |
Collaboration Revenue
Collaboration Revenue | 3 Months Ended |
Mar. 31, 2024 | |
Revenue from Contract with Customer [Abstract] | |
Collaboration Revenue | 10. Collaboration Revenue The Company recognizes collaboration revenue under certain of the Company’s license or collaboration agreements that are within the scope of ASC 606. The Company’s contracts with customers typically include promises related to licenses to intellectual property and research and development services. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and if, over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company’s contracts may include options to acquire additional goods and/or services. The terms of the Company’s arrangements with customers typically include the payment of one or more of the following: (i) non-refundable, up-front payment, and pass through costs related to research activities, (ii) development, regulatory and commercial milestone payments, (iii) future options and (iv) royalties on net sales of licensed products. Accordingly, the transaction price is generally comprised of a fixed fee due at contract inception and variable consideration in the form of pass through costs and milestone payments due upon the achievement of specified events and tiered royalties earned when customers recognize net sales of licensed products. The Company measures the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. The Company utilizes the “expected value method” method to estimate the amount of variable consideration, to predict the amount of consideration to which it will be entitled for its one open contract. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Milestone payments that are not within the control of the Company or the licensee, such as those dependent upon receipt of regulatory approval, are not considered to be probable of achievement until the triggering event occurs. At the end of each reporting period, the Company reevaluates the probability of achievement of each milestone and any related constraint, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, the Company recognizes revenue upon the later of: (i) when the related sales occur or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any development, regulatory or commercial milestones or royalty revenue resulting from any of its collaboration arrangements. Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception. The Company allocates the transaction price to each performance obligation identified in the contract on a relative standalone selling price basis, when applicable. However, certain components of variable consideration are allocated specifically to one or more particular performance obligations in a contact to the extent both of the following criteria are met: (i) the terms of the payment relate specifically to the efforts to satisfy the performance obligation or transfer the distinct good or service and (ii) allocating the variable amount of consideration entirely to the performance obligation or the distinct good or service is consistent with the allocation objective of the standard whereby the amount allocated depicts the amount of consideration to which the entity expects to be entitled in exchange for transferring the promised goods or services. The Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in each contract. The key assumptions utilized in determining the standalone selling price for each performance obligation may include forecasted revenues, development timelines, estimated research and development costs, discount rates, likelihood of exercise and probabilities of technical and regulatory success. Revenue is recognized based on the amount of the transaction price that is allocated to each respective performance obligation when or as the performance obligation is satisfied by transferring a promised good and/or service to the customer. For performance obligations that are satisfied over time, the Company recognizes revenue by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress which depicts the performance in transferring control of the associated goods and/or services to the customer. The Company uses input methods to measure progress toward the complete satisfaction of performance obligations satisfied over time. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. The Company measures progress toward satisfaction of the performance obligation over time as effort is expended. Collaboration Agreement with LG Chem On November 6, 2018, the Company entered into a collaboration agreement (the “LG Chem Collaboration Agreement”) with LG Chem Ltd. (“LG Chem”) related to the development of the Company’s Immuno-STATs focused in the field of oncology. Pursuant to the LG Chem Collaboration Agreement, the Company granted LG Chem an exclusive license to develop, manufacture and commercialize the Company’s lead product, CUE-101, as well as Immuno-STATs that target T cells against two additional cancer antigens, in certain Asian countries (collectively, the “LG Chem Territory”). On April 30, 2021, LG Chem’s option pursuant to the Global License and Collaboration Agreement entered into between the Company and LG Chem on December 18, 2019 and as amended on November 5, 2020 (the "Global License and Collaboration Agreement"), expired, and accordingly the Company no longer has any material obligations under the Global License and Collaboration Agreement. In June 2021, after ongoing discussions regarding the selection of the second of the two additional cancer antigens, LG Chem and the Company agreed to let the selection period expire without a second antigen being selected. The Company retains rights to develop and commercialize all assets included in the LG Chem Collaboration Agreement in the United States and in global markets outside of the LG Chem Territory. In exchange for the licenses and other rights granted to LG Chem under the LG Chem Collaboration Agreement, LG Chem made a $ 5.0 million equity investment in common stock of the Company and a $ 5.0 million nonrefundable up-front cash payment. The Company is also eligible to receive up to an additional $ 400.0 million in research, development, regulatory and sales milestones. In addition, the LG Chem Collaboration Agreement also provides that LG Chem will pay the Company tiered single-digit percentage royalties on net sales of commercialized drug product candidates in the LG Chem Territory. On May 16, 2019, LG Chem paid the Company a $ 2.5 million milestone payment for the U.S. Food and Drug Administration’s (“FDA”) acceptance of the investigational new drug application (“IND”) for the Company’s lead drug product candidate, CUE-101, pursuant to the LG Chem Collaboration Agreement. The $ 2.5 million milestone payment was recorded as a contract liability upon receipt of payment as it requires deferral of revenue recognition to a future period until the Company performs its obligations under the arrangement. Of the $ 2.5 million milestone payment, $ 0.4 million was recognized as tax withholding, shown as income tax expense on the consolidated statement of operations and comprehensive loss. On December 7, 2020, the Company earned a $ 1.3 million milestone payment on the selection of a preclinical candidate pursuant to the LG Chem Collaboration Agreement. The $ 1.3 million milestone payment was recorded as a contract liability upon receipt. Revenue related to this milestone payment was recognized by the Company pursuant to the Company’s revenue recognition policy in relation to the performance of its obligations related to the development of this preclinical candidate. Of the $ 1.25 million milestone payment, $ 0.2 million was withheld as payment of foreign tax withholding and shown as income tax expense on the consolidated statement of operations and comprehensive loss. On November 23, 2021, the Company earned a $ 3.0 million milestone payment for the selection of a clinical product candidate in partnership with LG Chem. The $ 3.0 million milestone payment was recorded as a contract liability upon receipt. Revenue related to this milestone payment was recognized by the Company pursuant to the Company’s revenue recognition policy in relation to the performance of its obligations related to the development of this preclinical candidate. Of the $ 3.0 million milestone payment, $ 0.5 million was withheld as payment of foreign tax withholding and shown as income tax expense on the condensed consolidated statements of operations and comprehensive loss. Cash was collected in relation to this milestone payment in February 2022. Aside from the $ 6.8 million in milestone payments earned to date, the Company does not believe that any variable consideration should be included in the transaction price as of March 31, 2024. Such assessment considered the application of the constraint to ensure that estimates of variable consideration would be included in the transaction price only to the extent the Company had a high degree of confidence that revenue would not be reversed in a subsequent reporting period. The Company will re-evaluate the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as other changes in circumstances occur. For the three months ended March 31, 2024 and 2023, the Company recognized revenue of $ 34,000 and $ 36,000 , respectively, related to the LG Chem Collaboration Agreement. The Company did not record short or long-term research and development liabilities on its balance sheets dated March 31, 2024 and December 31, 2023, as the performance obligation was met and completed. Research and development cost sharing provisions under the agreement expired on March 31, 2022, thereafter the Company recognized revenue on intellectual patent filing passthrough costs in the LG Chem Territory. Collaboration and Option Agreement with Ono On February 22, 2023, the Company entered into a strategic collaboration agreement (the "Ono Collaboration and Option Agreement") with Ono Pharmaceutical Co., Ltd. ("Ono") to further develop CUE-401 and provide dedicated resources and capabilities to help advance CUE-401 toward the clinic. Under the terms of the Ono Collaboration and Option Agreement, Ono paid the Company an upfront payment and agreed to fully fund all research activities related to CUE-401 through a specified option period. During this option period, the Company will be responsible for the research and development of CUE-401. Upon Ono’s exercise of its option to license CUE-401, the Company will receive an option exercise payment and be eligible for development and commercial milestone payments up to an aggregate of $ 220.0 million, as well as tiered royalties on sales. Upon any such exercise, Ono will receive worldwide rights to develop and commercialize CUE-401, with the Company retaining a 50 % co-development and co-commercialization right in the United States. The Company’s decision to elect the co-development and co-commercialization option may be made within 30 days of Ono’s option exercise to license CUE-401. The amount paid by Ono to the Company for the option exercise and future milestone payments will vary based upon the Company’s decision to exercise the co-development and co-commercialization option. Under the terms of the Ono Collaboration and Option Agreement, the Company will perform research activities related to CUE-401 through a specified option period of 24 months (the “Research Term”). During this Research Term, the Company will be responsible for the execution of scientific investigation, nonclinical, preclinical, and clinical drug research and development activities designed to progress CUE-401 toward a potential IND and regulatory approval (such activities, collectively referred to as “R&D”). Ono is responsible for the funding of R&D activities performed by the Company. Per the agreement, as consideration for the R&D activities performed by the Company, Ono (i) made a one-time, non-refundable, non-creditable upfront payment of $ 3.0 million to the Company and (ii) will reimburse the Company for all costs incurred in conducting research, including (a) pass through costs from third party contractors and (b) full time employee salaries capped at $ 2.1 million in the first 18 months of the Research Term. Subsequently, the Company and Ono agreed to increase this cap for full time employee salaries to $2.8 million. The term of the Ono Collaboration and Option Agreement extends until the expiration of the Research Term which cannot exceed a 24-month period. The Company has forecasted that it will be able to complete the R&D activities in the first 18 months of the Research Term based on the initial research and development plans it has established. The Company received the $ 3.0 million upfront payment in March 2023. Aside from the $ 3.0 million upfront payment and funding related to pass through costs, the Company does not believe that any variable consideration should be included in the transaction price as of March 31, 2024. Such assessment considered the application of the constraint to ensure that estimates of variable consideration would be included in the transaction price only to the extent the Company had a high degree of confidence that revenue would not be reversed in a subsequent reporting period. The Company will re-evaluate the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as other changes in circumstances occur. For the three months ended March 31, 2024 and 2023, the Company recognized revenue of $ 1.7 million and $ 0.2 million, respectively, related to the Ono Collaboration and Option Agreement. The Company recorded short-term research and development liabilities on its balance sheet dated March 31, 2024 of $ 1.8 million. The Company recorded short-term research and development liabilities on its balance sheet dated December 31, 2023, of $ 2.1 million. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 11. Commitments and Contingencies Einstein License Agreement In 2015, the Company entered into the Einstein License with Einstein for certain patent rights relating to the Company’s core technology platform for the engineering of biologics to control T cell activity, precision, immune-modulatory drug product candidates, and two supporting technologies that enable the discovery of costimulatory signaling molecules (ligands) and T cell targeting peptides. The Company entered into an amended and restated license agreement on July 31, 2017, as amended on October 2018, which modified certain obligations of the parties under the Einstein License. The Einstein License was further amended on January 13, 2024. For the three months ended March 31, 2024 and 2023, the Company incurred $ 25,000 and $ 44,000 , respectively, in fees payable to Einstein in relation to this license. The Company’s remaining commitments with respect to the Einstein License are based on the attainment of future milestones. The aggregate amount of milestone payments made under the Einstein License may equal up to $ 1.9 million for each Licensed Product, and up to $ 1.9 million for each new indication of a Licensed Product. Additionally, the aggregate amount of one-time milestone payments based on cumulative sales of all Licensed Products may equal up to $ 5.8 million. The Company is also party to a service agreement with Einstein to support the Company’s ongoing research and development activities. Collaboration Agreement with LG Chem See discussion of the LG Chem Collaboration Agreement in Note 10. Collaboration Agreement with Ono See discussion of the Ono Collaboration and Option Agreement in Note 10. Contingencies The Company accrues contingent liabilities to the extent that the liability is probable and estimable. There are no accruals for contingent liabilities in the Company’s condensed consolidated financial statements. The Company may be subject to various legal proceedings from time to time as part of its business. As of March 31, 2024 , the Company was not a party to any legal proceedings or threatened legal proceedings, the adverse outcome of which, individually or in the aggregate, would have a material adverse effect on its business, financial condition or results of operations. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Leases | 12. Leases On March 28, 2022, the Company entered into a License Agreement (the “License”) with MIL 40G, LLC (the “Licensor”), pursuant to which the Company leases approximately 13,000 square feet of office, research and development and laboratory space located at 40 Guest Street, Boston, Massachusetts 02135 (the “Premises”). The Company relocated its corporate headquarters to the Premises in April 2022. The Company recognized a right of use asset of $ 9.1 million and an operating lease liability of $ 9.1 million which were recorded as of the Term Commencement Date (as defined below) related to the License. The term of the License commenced on April 15, 2022 (the “Term Commencement Date”) and expires on April 14, 2026 (the “Term”). The License has a monthly rental rate of $ 200,700 for the first year of the Term, $ 208,728 for the second year of the Term, $ 217,077 for the third year of the Term and $ 225,760 for the remainder of the Term. Pursuant to the License, the Company prepaid two months of rent and a security deposit. The Licensor is obligated under the License to provide certain services to the Company, including providing certain gases, chemicals and equipment to the Premises’ laboratory space, IT support, security, office support and health and safety training. The Licensor has the right to terminate the License for Cause (as defined in the License). On May 3, 2022, the Company entered into the First Amendment to the License ("First Amendment”) with the Licensor, pursuant to which the License was expanded to include an additional room effective July 15, 2022. In consideration of the First Amendment, the security deposit was increased from $ 225,760 to $ 235,884 effective July 15, 2022. Upon execution of the First Amendment, the Company prepaid three months of rent, two of which will be held in escrow and credited against future rent payments and the other of which was applied to the first month’s rent. Effective July 15, 2022, the monthly rental rate under the First Amendment increased to $ 209,700 from $ 200,700 . During the year ended December 31, 2022, the Company recognized a right of use asset of $ 369,000 and a short and long term operating lease liability of $ 100,300 and $ 260,600 , respectively, using the weighted average discount rate of 8 %, which were recorded as of the Term Commencement Date related to the License. On May 31, 2022, the Company entered into an operating lease for additional laboratory space at 40 Guest Street, Boston, Massachusetts for the period from December 1, 2022, through December 1, 2024 (the “40G Additional Laboratory Lease”). The 40G Additional Laboratory Lease contains escalating payments during the lease period. The monthly rental rate under the 40G Additional Laboratory Lease is $ 59,152 for the first 12 months and $ 61,519 for the remainder of the term. Under the terms of this lease agreement, the Company prepaid three months of rent, two of which are held in escrow and will be credited against future rent payments and the other of which was applied to the first month’s rent. During the year ended December 31, 2022, the Company recognized a right of use asset of $ 1,307,000 and a short and long term operating lease liability of $ 712,000 , and $ 535,000 , respectively, using the weighted average discount rate of 10 %, which were recorded as of the Term Commencement Date related to the 40G Additional Laboratory Lease. On September 9, 2022, the Company terminated its lab space lease in Cambridge, Massachusetts with MIL 21E, LLC with an effective termination date of December 6, 2022. The Company performed an analysis of the accounting implications of this termination based on ASC 360 Impairments and Abandonments guidance. During the year ended December 31, 2022, the Company recorded an entry to remove the remaining lease liability and right of use asset of $ 963,000 and $ 945,000 , respectively. The difference between the carrying amounts of the right of use asset and lease liability of $ 19,000 was recorded to gain on right of use asset and included in the consolidated statement of operations and comprehensive loss. For the three months ended March 31, 2024, the Company recorded $ 0.1 million in interest expense to the lease liability. At March 31, 2024, operating lease right-of-use assets were $ 5.6 million . Corresponding operating lease liabilities were $ 5.8 million as of March 31, 2024, of which $ 3.2 million were recorded in current liabilities and $ 2.6 million were recorded in long-term liabilities on the Company’s condensed consolidated balance sheets. As of March 31, 2023 and December 31, 2023, security deposits of $ 0.6 million related to the 40G Additional Laboratory Lease were included in deposits on the Company’s consolidated balance sheets. Future minimum lease payments under these leases at March 31, 2024 are as follows: (in thousands) 2024 (remaining 9 months) 2,529 2025 2,799 2026 818 Total lease payments 6,146 Less: imputed interest ( 357 ) Present value of lease payments $ 5,789 Rent expense of $ 0.9 million was included in the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023. Other information pertaining to the Company’s operating leases for the three months ended March 31, 2024 is summarized in the table below. The weighted average remaining lease term and discount rate related to the Company's leases were as follows: March 31, December 31, Weighted average remaining lease term (years) 1.93 2.16 Weighted average discount rate 6.18 % 6.25 % |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements as of March 31, 2024, and for the three months ended March 31, 2024 and 2023, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”) and generally accepted accounting principles in the United States (“U.S. GAAP”) for financial information, which prescribes elimination of all significant intercompany accounts and transactions in the accounts of the Company and its wholly owned subsidiary, Cue Biopharma Securities Corp., which was incorporated in the Commonwealth of Massachusetts in December 2018. In the opinion of management, these financial statements reflect all adjustments which are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2024. Interim results for the three months ended March 31, 2024 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2024, or any future periods. |
Public Offerings | Public Offerings In October 2021, the Company entered into an open market sale agreement (the “October 2021 ATM Agreement”) with Jefferies LLC ("Jefferies"), as agent, to sell shares of the Company’s common stock for aggregate gross proceeds of up to $ 80 million, from time to time, through an at-the-market equity offering program. The October 2021 ATM Agreement will terminate upon the earliest of (a) the sale of $ 80 million of shares of the Company’s common stock pursuant to the October 2021 ATM Agreement or (b) the termination of the October 2021 ATM Agreement by the Company or Jefferies. During the three months ended March 31, 2024 , the Company sold 1,428,200 shares of common stock under the October 2021 ATM Agreement for proceeds of $ 3.4 million, net of commission paid, but excluding transaction expenses. There were no sales under the October 2021 ATM Agreement during the three months ended March 31, 2023. As of March 31, 2024, the Company sold an aggregate of 9,028,573 shares of common stock under the October 2021 ATM Agreement for proceeds of $ 40.4 million, net of commission paid, but excluding transaction expenses, since its inception. |
Consolidation | Consolidation The accompanying condensed consolidated financial statements include the Company and its wholly owned subsidiary, Cue Biopharma Securities Corp. The Company has eliminated all intercompany transactions. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates include estimates related to collaboration revenue, the accounting for potential liabilities and accrued expenses, the assumptions utilized in valuing stock-based compensation issued for services, the realization of deferred tax assets, and the useful life with respect to long-lived assets and intangibles. Actual results could differ from those estimates. |
Cash Concentrations | Cash Concentrations The Company maintains its cash balances with financial institutions in federally insured accounts and may periodically have cash balances in excess of insurance limits. The Company maintains its accounts with financial institutions with a high credit rating. The Company has not experienced any losses to date from our deposits with these financial institutions and believes that it is not exposed to any significant credit risk on cash. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents. The Company currently invests available cash in money market funds. |
Marketable Securities | Marketable Securities Marketable securities consist of investments with original maturities greater than ninety days and less than one year from the date of the Company's condensed consolidated balance sheets. The Company classifies all of its investments as available-for-sale securities. Accordingly, these investments are recorded at fair value, which is based on quoted market prices. Unrealized gains and losses are recognized and determined on a specific identification basis and are included in comprehensive loss. Realized gains and losses are determined on a specific identification basis and are included in other income on the condensed consolidated statements of operations and comprehensive loss. Amortization and accretion of discounts and premiums is recorded in interest income. The Company had no marketable securities as of March 31, 2024 and December 31, 2023. At March 31, 2024, the Company invested available cash in money market funds, and at March 31, 2023 the Company invested available cash in U.S. Treasury securities. |
Restricted Cash | Restricted Cash The Company had $ 151,000 in restricted cash deposited with a separate commercial bank to collateralize Company credit cards as of March 31, 2024 and December 31, 2023 . |
Property and Equipment | Property and Equipment Property and equipment is recorded at cost. Major improvements are capitalized, while maintenance and repairs are charged to expense as incurred. Gains and losses from dispositions of property and equipment are included in income and expense when realized. Amortization of leasehold improvements is provided using the straight-line method over the shorter of the lease term or the useful life of the underlying assets. Depreciation of property and equipment is provided using the straight-line method over the following estimated useful lives: Laboratory equipment 5 years Computer equipment 3 years Furniture and fixtures 3 - 8 years The Company recognizes depreciation and amortization expense in general and administrative expenses and in research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss, depending on how each category of property and equipment is utilized in the Company’s business activities. |
Trademark | Trademark Trademark consists of the Company’s right, title and interest to the CUE BIOLOGICS Mark, and any derivative mark incorporating CUE, throughout the world, together with all associated goodwill and common law rights appurtenant thereto, including, but not limited to, any right, title and interest in any corporate name, company name, business, name, trade name, dba, domain name, or other source identifier incorporating CUE. The Company has classified the trademark as a component of other long-term assets, having a useful life of 15 years. The Company evaluates the status of this intangible asset for amortization and impairment at each quarter end and year end reporting date. The Company recorded $ 3,000 in amortization expense, on a straight-line basis, for each of the three months ended March 31, 2024 and 2023. Debt Issuance Costs Debt issuance costs are deferred and presented as a reduction to long-term debt. Debt issuance costs are amortized using the effective interest rate method over the term of the loan. Amortization of deferred debt issuance costs are included in interest expense in the condensed consolidated statements of operations and comprehensive loss. |
Revenue Recognition | Revenue Recognition The Company recognizes collaboration revenue under certain of the Company’s license and collaboration agreements that are within the scope of Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers (“ASC 606”). The Company’s contracts with customers typically include promises related to licenses to intellectual property and research and development services. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. Accordingly, the transaction price is generally comprised of a fixed fee due at contract inception and variable consideration in the form of milestone payments due upon the achievement of specified events and tiered royalties earned when customers recognize net sales of licensed products. The Company measures the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. The Company utilizes the “expected value method” method to estimate the amount of variable consideration, to predict the amount of consideration to which it will be entitled for its one open contract. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. At the inception of each arrangement that includes development and regulatory milestone payments, the Company evaluates whether the associated event is considered probable of achievement and estimates the amount to be included in the transaction price using the expected value method. |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist primarily of compensation costs, fees paid to consultants, outside service providers and organizations (including research institutes at universities), facility costs, and development and clinical trial costs with respect to the Company’s drug product candidates. Research and development expenses incurred under contracts are expensed ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different pattern of performance is more appropriate. Other research and development expenses are charged to operations as incurred. Nonrefundable advance payments are recognized as an expense as the related services are performed. The Company evaluates whether it expects the services to be rendered at each quarter end and year end reporting date. If the Company does not expect the services to be rendered, the advance payment is charged to expense. Nonrefundable advance payments for research and development services are included in prepaid and other current assets on the Company's condensed consolidated balance sheets. To the extent that a nonrefundable advance payment is for contracted services to be performed within 12 months from the reporting date, such advance is included in current assets; otherwise, such advance is included in non-current assets. The Company evaluates the status of its research and development agreements and contracts, and the carrying amount of the related assets and liabilities, at each quarter end and year end reporting date, and adjusts the carrying amounts and their classification on the Company's condensed consolidated balance sheets as appropriate. |
Patent Expenses | Patent Expenses The Company is the exclusive worldwide licensee of, and has patent applications pending for, numerous domestic and foreign patents. Due to the significant uncertainty associated with the successful development of one or more commercially viable drug product candidates based on the Company’s research efforts and any related patent applications, all patent costs, including patent-related legal fees, filing fees and other costs are charged to general and administrative expense as incurred. For the three months ended March 31, 2024 and March 31, 2023, patent expenses were $ 537,000 and $ 632,000 , respectively. |
Licensing Fees and Costs | Licensing Fees and Costs Licensing fees and costs consist primarily of costs relating to the acquisition of the Company’s license agreement with the Albert Einstein College of Medicine (“Einstein”), including related royalties, maintenance fees, milestone payments and product development costs. Licensing fees and costs are charged to research and development expense as incurred. |
Long-Lived Assets | Long-Lived Assets The Company reviews long-lived assets, consisting of property and equipment, for impairment when events or changes in circumstances indicate the carrying value of these assets may exceed their current fair values. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the assets. Assets to be disposed of are separately presented in the Company's condensed consolidated balance sheets and reported at the lower of the carrying amount or fair value less costs to sell and are no longer depreciated. The Company has not historically recorded any impairment to its long-lived assets. In the future, if events or market conditions affect the estimated fair value to the extent that a long-lived asset is impaired, the Company will adjust the carrying value of these long-lived assets in the period in which the impairment occurs. There were no disposals of property and equipment for the three months ended March 31, 2024. During the three months ended March 31, 2023, the Company sold fully depreciated lab equipment with an acquisition cost of $ 41,000 and collected cash of $ 2,000 . The Company recorded a gain on the sale of fixed assets of $ 2,000 , which is presented in other income on the condensed consolidated statements of operations and comprehensive loss. |
Leases | Leases The Company accounts for leases under ASC 842, Leases , which requires a lessee to record a right-of-use asset and a corresponding lease liability for most lease arrangements on the Company's condensed consolidated balance sheets. Under the standard, disclosure of key information about leasing arrangements to assist users of the financial statements with assessing the amount, timing and uncertainty of cash flows arising from leases are required. |
Stock-Based Compensation | Stock-Based Compensation The Company periodically issues stock-based awards to officers, directors, employees, Scientific and Clinical Advisory Board members and consultants for services rendered. Such issuances vest and expire according to terms established at the issuance date. Stock-based payments to officers, directors, employees, Scientific and Clinical Advisory Board members and consultants, including grants of employee stock options, are recognized in the financial statements based on their grant date fair values. Stock option grants, which are generally time-vested, are measured at the grant date fair value and charged to operations on a straight-line basis over the service period, which generally approximates the vesting term. The Company also grants performance-based awards periodically to officers of the Company. The Company recognizes compensation costs related to performance awards over the requisite service period if and when the Company concludes that it is probable that the performance condition will be achieved. The fair value of stock options and restricted stock units is determined utilizing the Black-Scholes option-pricing model, which is affected by several variables, including the risk-free interest rate, the expected dividend yield, the life of the equity award, the exercise price of the stock option as compared to the fair value of the common stock on the grant date, and the estimated volatility of the common stock over the term of the equity award. The Company recognizes the fair value of stock-based compensation in general and administrative expenses and in research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss, depending on the type of services provided by the recipient of the equity award. The Company accounts for forfeitures as they occur. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Components of comprehensive income or loss, including net income or loss, are reported in the financial statements in the period in which they are recognized. Other comprehensive income or loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss) are reported net of any related tax effect to arrive at comprehensive income (loss). Comprehensive income (loss) includes net income (loss) as well as changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. The Company’s only element of other comprehensive income (loss) in periods presented was unrealized gain or loss on available-for-sale securities. |
Earnings (Loss) Per Share | Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) for the respective periods includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average number of common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares that would result from the exercise of outstanding stock options and warrants as if they had been exercised at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Basic and diluted loss per common share is the same for all periods presented because all outstanding stock options and warrants are anti-dilutive. Per ASC 260-10-45-13, shares issuable for little to no consideration should be included in the number of outstanding shares used for basic EPS. The Financial Accounting Standards Board (“FASB”) proposed that warrants or options exercisable for little to no cost (sometimes referred to as “penny warrants”) be included in the denominator of basic EPS (and therefore diluted EPS) once there were no further vesting conditions or contingencies associated with them. The Company included 1,531,440 pre-funded warrants in the denominator of basic EPS at March 31, 2024. At March 31, 2024 and 2023, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of EPS, as their effect would have been anti-dilutive. March 31, 2024 2023 Common stock warrants 9,188,406 9,188,406 Common stock options 9,270,666 7,044,599 Total 18,459,072 16,233,005 |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active exchange-traded securities and exchange-based derivatives. Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges. Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives and commingled investment funds and are measured using present value pricing models. The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end. The Company had $ 41.0 million and $ 39.1 million in cash equivalents as of March 31, 2024 and December 31, 2023, respectively. The carrying value of financial instruments (consisting of cash, a certificate of deposit, debt, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its condensed consolidated financial statements. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Summary of Estimated Useful Lives of Assets | Depreciation of property and equipment is provided using the straight-line method over the following estimated useful lives: Laboratory equipment 5 years Computer equipment 3 years Furniture and fixtures 3 - 8 years |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | At March 31, 2024 and 2023, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of EPS, as their effect would have been anti-dilutive. March 31, 2024 2023 Common stock warrants 9,188,406 9,188,406 Common stock options 9,270,666 7,044,599 Total 18,459,072 16,233,005 |
Fair Value (Tables)
Fair Value (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value Assets Measured on Recurring Basis | The following table presents information about the Company’s assets that are measured at fair value on a recurring basis as of March 31, 2024 and December 31, 2023, and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of March 31, 2024 (in thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 41,029 $ — $ — $ 41,029 Total $ 41,029 $ — $ — $ 41,029 Fair Value Measurements as of December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Fair Value Cash equivalents $ 39,148 $ — $ — $ 39,148 Total $ 39,148 $ — $ — $ 39,148 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment as of March 31, 2024 and December 31, 2023 consisted of the following: March 31, December 31, (in thousands) Laboratory equipment $ 4,097 $ 4,069 Furniture and fixtures 81 81 Computer equipment 169 143 Leasehold improvements 118 118 Total property and equipment 4,465 4,411 Less accumulated depreciation ( 3,711 ) ( 3,616 ) Property and equipment, net $ 754 $ 795 |
Loan with Silicon Valley Bank (
Loan with Silicon Valley Bank (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Future Principal Debt Payments on Term Loan Agreement | The following table presents the aggregate maturities of long-term debt as of March 31, 2024 (in thousands): Year 2024 $ 3,000 2025 4,000 Total $ 7,000 The following table presents long-term and current portions of debt as of March 31, 2024 (in thousands): Long-term debt $ 3,000 Accretion of final payment 272 Less: unamortized debt issuance costs ( 28 ) Long-term debt, net $ 3,244 Current portion of long-term debt $ 4,000 Less: unamortized debt issuance costs ( 37 ) Current portion of long-term debt, net $ 3,963 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Liabilities, Current [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consist of the following: March 31, December 31, (In thousands) 2024 2023 Employee and board compensation $ 3,106 $ 2,219 Contract research services 1,816 1,411 Professional services 207 344 Contract manufacturing services 79 163 Total $ 5,208 $ 4,137 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Schedule of Estimated Fair Value of Each Stock Option Award | For stock options requiring an assessment of value during the three months ended March 31, 2024 and 2023, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model utilizing the following assumptions: March 31, 2024 Risk-free interest rate 3.83 % - 4.28 % Expected dividend yield 0 % Expected volatility 66.27 % - 109.86 % Expected life 5.50 to 8.91 years March 31, 2023 Risk-free interest rate 3.40 % - 3.99 % Expected dividend yield 0 % Expected volatility 97.0 % - 100.4 % Expected life 5.50 to 6.25 years |
Summary of Stock Option Activity | A summary of stock option activity for the three months ended March 31, 2024 is as follows: Number of Weighted Weighted Stock options outstanding at December 31, 2023 7,492,917 $ 8.41 6.12 Granted 1,869,500 2.02 — Exercised — — — Cancelled ( 91,751 ) 10.63 — Stock options outstanding at March 31, 2024 9,270,666 7.10 6.74 Stock options exercisable at March 31, 2024 5,085,904 $ 9.85 4.72 |
Schedule of Stock-Based Compensation Included in Statement of Operations | Stock-based compensation expense for the three months ended March 31, 2024 and 2023 was included in the Company’s condensed consolidated statements of operations and comprehensive loss as follows: Three Months Ended (in thousands) 2024 2023 General and administrative $ 956 $ 888 Research and development 990 1,110 Total stock-based compensation expense $ 1,946 $ 1,998 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Schedule of Future Minimum Lease Payments for Operating Lease | Future minimum lease payments under these leases at March 31, 2024 are as follows: (in thousands) 2024 (remaining 9 months) 2,529 2025 2,799 2026 818 Total lease payments 6,146 Less: imputed interest ( 357 ) Present value of lease payments $ 5,789 |
Schedule of Other Information of Operating Leases | Other information pertaining to the Company’s operating leases for the three months ended March 31, 2024 is summarized in the table below. The weighted average remaining lease term and discount rate related to the Company's leases were as follows: March 31, December 31, Weighted average remaining lease term (years) 1.93 2.16 Weighted average discount rate 6.18 % 6.25 % |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) $ in Millions | Mar. 31, 2024 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash and cash equivalents, and marketable securities | $ 41 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Proceeds from ATM offering, net of sales agent commission and fees | $ 3,354,000 | $ 0 | |
Useful life of trademark | 15 years | ||
Type of Cost, Good or Service [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember | |
Cash equivalents | $ 41,000,000 | $ 39,100,000 | |
Marketable securities | $ 0 | 0 | |
Pre Funded Warrants | 1,531,440 | ||
General and Administrative Expense [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Patent expenses | $ 537,000 | $ 632,000 | |
Trademarks | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Amortization of intangible assets | 3,000 | 3,000 | |
Certificate of Deposit | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Restricted cash used to collateralize a credit card | 151,000,000 | $ 151,000,000 | |
Laboratory Equipment [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Disposals of property and equipment | 41,000 | ||
Cash collected from sale of assets | 2,000 | ||
Gain (Loss) on disposal of property and equipment | $ 2,000 | ||
Transaction Expense | Sales Agreement November 2019 | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Proceeds from sale of common stock | $ 40,400,000 | ||
Sale of common stock, number of shares | 9,028,573 | ||
Jefferies LLC [Member] | Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Proceeds from Issuance Initial Public Offering | $ 80,000,000 | ||
Jefferies LLC [Member] | Transaction Expense | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Proceeds from sale of common stock | $ 80,000,000 | ||
Jefferies LLC [Member] | Transaction Expense | Sales Agreement November 2019 | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Stock Issued During Period, Shares, New Issues | 1,428,200 | ||
Proceeds from sale of common stock | $ 3,400,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Estimated Useful Lives of Assets (Details) | Mar. 31, 2024 |
Laboratory Equipment | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 5 years |
Computer equipment | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 3 years |
Furniture and Fixtures | Minimum [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 3 years |
Furniture and Fixtures | Maximum | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 8 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 18,459,072 | 16,233,005 |
Common Stock Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 9,188,406 | 9,188,406 |
Common Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 9,270,666 | 7,044,599 |
Fair Value - Schedule of Fair V
Fair Value - Schedule of Fair Value Assets Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 41,000 | $ 39,100 |
Total | 41,000 | 39,100 |
Fair Value Measurements, Recurring Basis | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 41,029 | 39,148 |
Total | 41,029 | 39,148 |
Fair Value Measurements, Recurring Basis | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 41,029 | 39,148 |
Total | 41,029 | 39,148 |
Fair Value Measurements, Recurring Basis | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Total | 0 | 0 |
Fair Value Measurements, Recurring Basis | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Total | $ 0 | $ 0 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value Disclosures [Abstract] | ||
Cash equivalents | $ 41,000 | $ 39,100 |
Fair value assets transfers between Level 2 and Level 3 | $ 0 | $ 0 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 4,465 | $ 4,411 |
Less accumulated depreciation | (3,711) | (3,616) |
Net property and equipment | 754 | 795 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 4,097 | 4,069 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 81 | 81 |
Computer and office equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 169 | 143 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 118 | $ 118 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Property Plant And Equipment [Line Items] | ||
Depreciation expense | $ 96,000 | $ 174,000 |
Depreciation | $ 3,000 | 3,000 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Disposal of property and equipment, gross | 41,000 | |
Cash Collected from sale of fixed assets | 2,000 | |
Laboratory Equipment | Other Income | ||
Property Plant And Equipment [Line Items] | ||
Gain (Loss) on disposal of property and equipment | $ 2,000 |
Loan with Silicon Valley Bank_2
Loan with Silicon Valley Bank (Additional Information) (Details) - USD ($) | 3 Months Ended | ||||
Feb. 15, 2025 | Feb. 15, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Feb. 15, 2022 | |
Line of Credit Facility [Line Items] | |||||
Short-term debt | $ 37,000 | ||||
Other short-term debt | 28,000 | ||||
Interest expense, net | 33,000 | $ 33,000 | |||
Interest Expense relating accretion of the final payment | 199,000 | 330,000 | |||
Debt issuance costs | 142,000 | ||||
Amortization of debt issuance costs | 9,000 | $ 9,000 | |||
Cash obligation | $ 20,000,000 | ||||
Silicon Valley Bank | |||||
Line of Credit Facility [Line Items] | |||||
Final fee (percentage) | 5% | ||||
Prepayment premium rate | 1% | 2% | |||
Silicon Valley Bank | Term Loan Agreement | |||||
Line of Credit Facility [Line Items] | |||||
Short-term debt | $ 10,000,000 | ||||
Interest rate | 10.75 | ||||
Closing Date | Jun. 30, 2023 | ||||
Variable interest rate (percentage) | 2.25% | ||||
Silicon Valley Bank | Term Loan Agreement | Maximum | |||||
Line of Credit Facility [Line Items] | |||||
Variable interest rate (percentage) | 5.50% | ||||
Silicon Valley Bank | Term Loan Agreement | Minimum | |||||
Line of Credit Facility [Line Items] | |||||
Variable interest rate (percentage) | 2.25% | ||||
Silicon Valley Bank | Tranche A loan | |||||
Line of Credit Facility [Line Items] | |||||
Monthly installments | 30 months |
Loan with Silicon Valley Bank -
Loan with Silicon Valley Bank - Summary of Future Principal Debt Payments on Term Loan Agreement (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Instruments [Abstract] | ||
2024 | $ 3,000 | |
2025 | 4,000 | |
Total | 7,000 | |
Long-term debt | 3,000 | |
Accretion of final payment | 272 | |
Less: unamortized debt issuance costs | (28) | |
Long-term debt, net | 3,244 | $ 4,202 |
Current portion of long-term debt | 4,000 | |
Less: unamortized debt issuance costs | (37) | |
Current portion of long-term debt, net | $ 3,963 | $ 3,963 |
Accrued Expenses - Summary of A
Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Accrued Liabilities, Current [Abstract] | ||
Employee and board compensation | $ 3,106 | $ 2,219 |
Contract research services | 1,816 | 1,411 |
Professional services | 207 | 344 |
Contract manufacturing services | 79 | 163 |
Accrued expenses | $ 5,208 | $ 4,137 |
License Agreement Entered Date
License Agreement Entered Date (Additional Information) (Details) - Einstein License Agreement $ in Millions | 3 Months Ended | |
Jan. 14, 2015 | Mar. 31, 2024 USD ($) SupportingTechnology shares | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
License agreement entered date | Jan. 14, 2015 | |
Number of supporting technology | SupportingTechnology | 2 | |
Nonrefundable milestone payments | $ | $ 1.2 | |
Issuance of common stock from public offerings, net of underwriter discounts, Shares | shares | 671,572 |
Stock Based Compensation - Sche
Stock Based Compensation - Schedule of Estimated Fair Value of Each Stock Option Award (Details) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 3.83% | 3.40% |
Risk-free interest rate, maximum | 4.28% | 3.99% |
Expected dividend yield | 0% | 0% |
Expected volatility, minimum | 66.27% | 97% |
Expected volatility, maximum | 109.86% | 100.40% |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected life | 6 years 3 months | 8 years 10 months 28 days |
Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected life | 5 years 6 months | 5 years 6 months |
Stock Based Compensation - Summ
Stock Based Compensation - Summary of Stock Option Activity (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Net of Forfeitures [Abstract] | ||
Number of Shares, Outstanding Beginning Balance | 7,492,917 | |
Number of Shares, Granted | 1,869,500 | |
Number of Shares, Exercised | 0 | |
Number of Shares, Cancelled | (91,751) | |
Number of Shares, Outstanding Ending Balance | 9,270,666 | 7,492,917 |
Number of Shares, Exercisable | 5,085,904 | |
Weighted Average Exercise Price, Outstanding Beginning Balance | $ 8.41 | |
Weighted Average Exercise Price, Granted | 2.02 | |
Weighted Average Exercise Price, Exercised | 0 | |
Weighted Average Exercise Price, Cancelled | 10.63 | |
Weighted Average Exercise Price, Outstanding Ending Balance | 7.1 | $ 8.41 |
Weighed Average Exercise Price, Exercisable | $ 9.85 | |
Weighted Average Remaining Contractual Life (in Years) | 6 years 8 months 26 days | 6 years 1 month 13 days |
Weighted Average Remaining Contractual Life (in Years), Exercisable | 4 years 8 months 19 days |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation | $ 1,946 | $ 1,998 | |
Stock based payment options outstanding weighted average remaining term | 6 years 8 months 26 days | 6 years 1 month 13 days | |
Number of Shares, Granted | 1,869,500 | ||
Weighted Average Exercise Price, Granted | $ 2.02 | ||
weighted average grant date fair value | $ 3.2 | ||
Unrecognized stock-based compensation | $ 10,600 | $ 12,800 | |
Number of shares, granted | 1,869,500 | ||
Stock-based compensation | $ 1,946 | $ 1,998 | |
Common Stock [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock options granted purchase shares | 1,321,900 | ||
Stock Option | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation | $ 1,900 | $ 2,000 | |
Stock based payment options outstanding weighted average remaining term | 2 years 6 months 18 days | 2 years 7 months 13 days |
Stock Based Compensation - Sc_2
Stock Based Compensation - Schedule of Stock-Based Compensation Included in Statement of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | $ 1,946 | $ 1,998 |
General and Administrative Expense | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | 956 | 888 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | $ 990 | $ 1,110 |
Warrants - Additional Informati
Warrants - Additional Information (Details) - $ / shares | 3 Months Ended | ||
Nov. 16, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | |
Class Of Warrant Or Right [Line Items] | |||
Pre Funded Warrants | 1,531,440 | ||
Earnings Per Share, Basic | $ (0.25) | $ (0.29) | |
Warrant | |||
Class Of Warrant Or Right [Line Items] | |||
Common stock warrants outstanding | 9,188,406 | ||
Exercise price of common stock warrants | $ 3.93 | ||
Common stock warrants life | 5 years | ||
Pre-Funded Warrants [Member] | |||
Class Of Warrant Or Right [Line Items] | |||
Exercise price of common stock warrants | $ 0.0001 | ||
Pre Funded Warrants | 1,531,440 |
Collaboration Revenue - Additio
Collaboration Revenue - Additional Information (Details) - USD ($) | 3 Months Ended | |||||||
Nov. 23, 2021 | Dec. 07, 2020 | May 16, 2019 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Feb. 22, 2023 | Nov. 06, 2018 | |
Disaggregation Of Revenue [Line Items] | ||||||||
Collaboration revenue | $ 1,717,000 | $ 187,000 | ||||||
Short-term research and development contract liability | 1,790,000 | $ 2,112,000 | ||||||
Milestone payment associated with contract liability | $ 3,000,000 | $ 1,250,000 | $ 2,500,000 | |||||
Income tax expense | 400,000 | |||||||
Prepaid expenses and other short-term assets | 2,240,000 | 1,242,000 | ||||||
Other long-term assets | 114,000 | 117,000 | ||||||
Ono Collaboration and Option Agreement [Member] | ||||||||
Disaggregation Of Revenue [Line Items] | ||||||||
Percentage of right to development and commercialized | 50% | |||||||
Development and commercial milestone payment payable cuo biopharma | $ 220,000,000 | |||||||
One Time Up Front Payment Payable As Consideration RD Activities | 3,000,000 | |||||||
Milestone payments received | $ 3,000,000 | 3,000,000 | ||||||
First Research Term Processed Milestone Payment Under Agreement | 18 months | |||||||
Collaboration revenue | $ 1,700,000 | 200,000 | ||||||
Short-term research and development contract liability | 1,800,000 | $ 2,100,000 | ||||||
Ono Collaboration and Option Agreement [Member] | Maximum | ||||||||
Disaggregation Of Revenue [Line Items] | ||||||||
Full time employe salary payable in first research term | 2,100,000 | |||||||
Collaboration Agreement with LG Chem Life Sciences | LG Chem Life Sciences | ||||||||
Disaggregation Of Revenue [Line Items] | ||||||||
Milestone payments received | 3,000,000 | 1,300,000 | 2,500,000 | 6,800,000 | ||||
Collaboration revenue | $ 34,000 | $ 36,000 | ||||||
Equity investment nonrefundable upfront cash payment | $ 5,000,000 | |||||||
Equity investment for research collaboration agreement | 5,000,000 | |||||||
Milestone payment associated with contract liability | 3,000,000 | 1,300,000 | $ 2,500,000 | |||||
Income tax expense | $ 500,000 | $ 200,000 | ||||||
Collaboration Agreement with LG Chem Life Sciences | LG Chem Life Sciences | Maximum | ||||||||
Disaggregation Of Revenue [Line Items] | ||||||||
Additional amount receivable research development regulatory and sales milestones | $ 400,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Commitments And Contingencies [Line Items] | ||
Type of Cost, Good or Service [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember |
Albert Einstein College Of Medicine | Einstein License And Service Agreement | ||
Commitments And Contingencies [Line Items] | ||
Milestone payments for each product, process or service | $ 1,900 | |
Milestone payments for each new indication of licensed product | 1,900 | |
Aggregate amount of additional milestone payments | 5,800 | |
Einstein License | ||
Commitments And Contingencies [Line Items] | ||
Patent expenses | $ 25,000 | $ 44,000 |
Type of Cost, Good or Service [Extensible List] | us-gaap:LicenseMember |
Leases - Additional Information
Leases - Additional Information (Details) | 3 Months Ended | 12 Months Ended | ||||||
Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) | May 31, 2022 USD ($) | May 03, 2022 USD ($) | Apr. 15, 2022 USD ($) | Mar. 28, 2022 ft² | |
Lessee Lease Description [Line Items] | ||||||||
Operating lease right-of-use | $ 5,573,000 | $ 6,323,000 | ||||||
Operating lease, liability | 5,789,000 | |||||||
Total | 5,789,000 | |||||||
Rent expense | $ 900,000 | $ 900,000 | ||||||
Operating lease, weighted average discount rate | 6.18% | 6.25% | ||||||
Operating lease liability, current portion | $ 3,210,000 | 3,368,000 | ||||||
Operating lease liability, net of current portion | 2,579,000 | 3,162,000 | ||||||
Non-cash interest expense to the lease liability | 100,000 | |||||||
License Agreement | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Operating lease right-of-use | 9,100,000 | |||||||
Operating lease, liability | 9,100,000 | |||||||
Total | 9,100,000 | |||||||
Operating lease, weighted average discount rate | 8% | |||||||
Security deposit | $ 225,760 | |||||||
License monthly rental rate | 209,700 | |||||||
License monthly rental rate first year | $ 200,700 | |||||||
License monthly rental rate remainder of the term | 200,700 | 225,760 | ||||||
License monthly rental rate second year | 208,728 | |||||||
License monthly rental rate third year | $ 217,077 | |||||||
Increase in security deposit | $ 235,884 | |||||||
First Amendment | License Agreement | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Operating lease right-of-use | $ 369,000 | |||||||
Operating lease liability, current portion | 100,300 | |||||||
Operating lease liability, net of current portion | 260,600 | |||||||
40G Office and Additional Laboratory | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Security deposit | $ 600,000 | $ 600,000 | ||||||
Lab Space Lease Member | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Operating lease right-of-use | 945,000 | |||||||
Operating lease cost (in thousands) | 963,000 | |||||||
Gain on right-of-use asset termination | 19,000 | |||||||
ASU 2016-02 | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Operating lease right-of-use | 5,600,000 | |||||||
Operating lease, liability | 5,800,000 | |||||||
Total | 5,800,000 | |||||||
Operating lease liability, current portion | 3,200,000 | |||||||
Operating lease liability, net of current portion | $ 2,600,000 | |||||||
Cambridge, Massachusetts | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Office space for lease | ft² | 13,000 | |||||||
Boston, Massachusetts | Operating Lease Agreement For Additional Laboratory Space | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Operating lease right-of-use | $ 1,307,000 | |||||||
Lessee operating lease monthly rental payments for remaining term | $ 61,519 | |||||||
Lessee operating lease monthly rental payments | $ 59,152 | |||||||
Operating lease, weighted average discount rate | 10% | |||||||
Operating lease liability, current portion | $ 712,000 | |||||||
Operating lease liability, net of current portion | $ 535,000 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Lease Payments on Operating Leases (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Leases [Abstract] | |
2024 (remaining 9 months) | $ 2,529 |
2025 | 2,799 |
2026 | 818 |
Total lease payment | 6,146 |
Less: present value discount | (357) |
Total | $ 5,789 |
Leases - Schedule of Other Info
Leases - Schedule of Other Information of Operating Leases (Details) | Mar. 31, 2024 | Dec. 31, 2023 |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Weighted average discount rate | 6.18% | 6.25% |
Weighted average remaining lease term | 1 year 11 months 4 days | 2 years 1 month 28 days |
Subsequent Events (Additional I
Subsequent Events (Additional Information) (Details) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 | Nov. 16, 2022 |
Subsequent Event [Line Items] | |||
Common stock, shares issued | 48,643,316 | 47,215,116 | |
Warrant | |||
Subsequent Event [Line Items] | |||
Exercise price of common stock warrants | $ 3.93 |