Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 28, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | IN8BIO, INC. | ||
Entity Central Index Key | 0001740279 | ||
Entity Tax Identification Number | 82-5462585 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity File Number | 001-39692 | ||
Entity Shell Company | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Icfr Auditor Attestation Flag | false | ||
Entity Small Business | true | ||
Entity Interactive Data Current | Yes | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 350 5th Avenue | ||
Entity Address, Address Line Two | Suite 5330 | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10118 | ||
City Area Code | 646 | ||
Local Phone Number | 600-6438 | ||
Trading Symbol | INAB | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Documents Incorporated By Reference | Portions of the definitive proxy statement for the 2023 Annual Meeting of Stockholders of the Registrant, or the Proxy Statement, are incorporated by reference into Part III of this Annual Report on Form 10-K. The Proxy Statement will be filed with the Securities and Exchange Commission within 120 days of the Registrant’s fiscal year ended December 31, 2022 . | ||
Entity Public Float | $ 5.9 | ||
Entity Common Stock, Shares Outstanding | 24,938,058 | ||
Auditor Name | CohnReznick LLP | ||
Auditor Location | Tysons, Virginia | ||
Auditor Firm ID | 596 | ||
Document Transition Report | false |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash | $ 18,182,000 | $ 37,021,000 |
Prepaid expenses and other current assets | 4,052,000 | 1,959,000 |
Total Current Assets | 22,234,000 | 38,980,000 |
Non-current assets | ||
Property and equipment, net | 4,397,000 | 97,000 |
Construction in progress | 29,000 | 403,000 |
Restricted cash | 252,000 | 251,000 |
Right of use assets - financing leases | 1,691,000 | 704,000 |
Right of use assets - operating leases | 4,181,000 | 1,630,000 |
Other non-current assets | 255,000 | 158,000 |
Total Non-Current Assets | 10,805,000 | 3,243,000 |
Total Assets | 33,039,000 | 42,223,000 |
Current liabilities | ||
Accounts payable | 2,091,000 | 395,000 |
Accrued expenses and other current liabilities | 2,342,000 | 1,235,000 |
Short-term financing lease liability | 682,000 | 392,000 |
Short-term operating lease liability | 707,000 | 234,000 |
Total Current Liabilities | 5,822,000 | 2,256,000 |
Long-term financing lease liability | 811,000 | 269,000 |
Long-term operating lease liability | 3,674,000 | 1,515,000 |
Total Non-Current Liabilities | 4,485,000 | 1,784,000 |
Total Liabilities | 10,307,000 | 4,040,000 |
Stockholders' Equity | ||
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized at December 31, 2022 and 2021, respectively. No shares issued and outstanding | 0 | 0 |
Common stock, par value $0.0001 per share; 490,000,000 shares authorized at December 31, 2022 and 2021; 24,545,157 and 18,781,242 shares issued and outstanding at December 31, 2022 and 2021, respectively | 3,000 | 2,000 |
Additional paid-in capital | 83,941,000 | 70,872,000 |
Accumulated deficit | (61,212,000) | (32,691,000) |
Total Stockholders' Equity | 22,732,000 | 38,183,000 |
Total Liabilities and Stockholders' Equity | $ 33,039,000 | $ 42,223,000 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 490,000,000 | 490,000,000 |
Common Stock, Shares, Issued | 24,545,157 | 18,781,242 |
Common stock, shares, outstanding | 24,545,157 | 18,781,242 |
Preferred stock par value | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred stock shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 14,062 | $ 7,347 |
General and administrative | 14,459 | 7,306 |
Total operating expenses | 28,521 | 14,653 |
Loss from operations | (28,521) | (14,653) |
Net loss | $ (28,521) | $ (14,653) |
Net loss per share - basic | $ (1.36) | $ (1.47) |
Net loss per share - diluted | $ (1.36) | $ (1.47) |
Weighted-average number of shares used in computing net loss per common share - basic | 20,967,955 | 9,969,733 |
Weighted average number of shares used in computing net loss per share basic and diluted | 20,967,955 | 9,969,733 |
Statements of Convertible Prefe
Statements of Convertible Preferred Stock, Common Stock and Stockholders' Deficit - USD ($) $ in Thousands | Total | Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | IPO [Member] | IPO [Member] Convertible Preferred Stock [Member] | IPO [Member] Common Stock [Member] | IPO [Member] Additional Paid-in Capital [Member] |
Temporary equity shares beginning at Dec. 31, 2020 | 9,993,727 | ||||||||
Temporary equity amount beginning at Dec. 31, 2020 | $ 34,900 | ||||||||
Shares beginning at Dec. 31, 2020 | 3,764,488 | ||||||||
Balance beginning at Dec. 31, 2020 | $ (16,579) | $ 1 | $ 1,458 | $ (18,038) | |||||
Issuance of common stock, net of issuance costs, amount | $ 32,290 | $ 32,290 | |||||||
Issuance of common stock, net of issuance costs, shares | 4,000,000 | ||||||||
Temporary equity conversion of convertible preferred stock to common stock, shares | (9,993,727) | ||||||||
Temporary equity conversion of convertible preferred stock to common stock | $ (34,900) | ||||||||
Conversion of convertible preferred stock to common stock upon closing of IPO, Shares | 10,990,065 | ||||||||
Conversion of convertible preferred stock to common stock upon closing of IPO | 34,900 | $ 34,900 | $ 1 | $ 34,899 | |||||
Stock options exercises, shares | 26,689 | ||||||||
Stock options exercises | 30 | 30 | |||||||
Stock-based compensation expense | 2,195 | 2,195 | |||||||
Net loss | (14,653) | (14,653) | |||||||
Shares ending at Dec. 31, 2021 | 18,781,242 | ||||||||
Balance ending at Dec. 31, 2021 | 38,183 | $ 2 | 70,872 | (32,691) | |||||
Issuance of common stock, net of issuance costs, amount | 9,542 | $ 1 | 9,541 | ||||||
Issuance of common stock, net of issuance costs, shares | 5,706,686 | ||||||||
Conversion of convertible preferred stock to common stock upon closing of IPO | 0 | ||||||||
Stock options exercises, shares | 57,229 | ||||||||
Stock options exercises | 61 | 61 | |||||||
Stock-based compensation expense | 3,467 | 3,467 | |||||||
Net loss | (28,521) | (28,521) | |||||||
Shares ending at Dec. 31, 2022 | 24,545,157 | ||||||||
Balance ending at Dec. 31, 2022 | $ 22,732 | $ 3 | $ 83,941 | $ (61,212) |
Statements of Convertible Pre_2
Statements of Convertible Preferred Stock, Common Stock and Stockholders' Deficit (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Payments of stock issuance costs | $ 919 | |
IPO [Member] | ||
Payments of stock issuance costs | $ 7,685 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities | ||
Net loss | $ (28,521,000) | $ (14,653,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 147,000 | 89,000 |
Non- cash Stock-based compensation | 3,467,000 | 2,195,000 |
Amortization of financing lease right-of-use assets | 461,000 | 537,000 |
Amortization of operating lease right-of-use assets | 495,000 | 162,000 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (2,093,000) | (1,876,000) |
Other non-current assets | (97,000) | (159,000) |
Accounts payable | 1,510,000 | (319,000) |
Accrued expenses and other current liabilities | 924,000 | 554,000 |
Short-term operating lease liabilities | 112,000 | 158,000 |
Long-term operating lease liabilities | (526,000) | (197,000) |
Net cash used in operating activities | (24,121,000) | (13,509,000) |
Investing activities | ||
Purchases of property and equipment | (3,689,000) | 0 |
Construction in progress | (16,000) | (309,000) |
Net cash used in investing activities | (3,705,000) | (309,000) |
Financing activities | ||
Proceeds from exercise of common stock options | 61,000 | 30,000 |
Proceeds from issuance of common stock after deducting underwriting discounts. | 9,542,000 | 36,327,000 |
Principal payments on financing leases | (615,000) | (535,000) |
Repayment of loan payable | 0 | (174,000) |
Payment of deferred offering costs | 0 | (2,693,000) |
Net cash provided by financing activities | 8,988,000 | 32,955,000 |
Net (decrease) increase in cash and restricted cash | (18,838,000) | 19,137,000 |
Cash and restricted cash at beginning of period | 37,272,000 | 18,135,000 |
Cash and restricted cash at end of period | 18,434,000 | 37,272,000 |
Supplemental disclosure of non-cash operating, financing and investing information | ||
Construction in progress in accounts payable | 13,000 | 94,000 |
Property and equipment in accounts payable | 356,000 | 0 |
Transfer of construction in progress to property and equipment | 403,000 | 0 |
Conversion of preferred stock - Series A into common stock | 0 | 34,900,000 |
Right-of-use assets obtained in exchange for financing lease | 0 | 309,000 |
Right-of-use assets obtained in exchange for operating lease | 0 | 969,000 |
Initial measurement of financing lease right-of-use assets | 1,448,000 | 0 |
Initial measurement of operating lease right-of-use assets | 3,046,000 | 1,693,000 |
Initial measurement Of Lease Liabilities | 4,286,000 | 1,728,000 |
Cash, end of year | 18,182,000 | 37,021,000 |
Long-term restricted cash, end of year | 252,000 | 251,000 |
Cash and restricted cash, end of year | $ 18,434,000 | $ 37,272,000 |
Organization and Nature of Oper
Organization and Nature of Operations | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Nature of Operations | 1. ORGANIZATION AND NATURE OF OPERATIONS Organization and Business IN8bio, Inc. (the “Company”) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. The Company’s lead product candidates are currently in Phase 1 clinical trials: INB-200, for the treatment of patients with newly diagnosed glioblastoma (“GBM”), and INB-100, for the treatment of patients with hematologic malignancies that are undergoing hematopoietic stem cell transplantation (“HSCT”). In addition, the Company is currently preparing to initiate patient enrollment in the company-sponsored Phase 2 clinical trial of INB-400 in which autologous genetically modified gamma-delta T cells will be assessed in newly diagnosed GBM patients. With additional funding, the Company is expecting to submit its company-sponsored investigational new drug application and initiate its Phase 1b clinical trial of INB-410 in which allogeneic genetically modified gamma-delta T cells will be assessed in both relapsed and newly diagnosed GBM patients in late 2023. Additionally, the Company’s DeltEx platform has yielded a broad portfolio of preclinical programs, including INB-300 and INB-500, focused on addressing GBM and other solid tumor types. Incysus, Inc. (“Incysus”) was a corporation formed in the State of Delaware on November 23, 2015 and Incysus, Ltd. was incorporated in Bermuda on February 8, 2016. Incysus was the wholly owned United States subsidiary of Incysus, Ltd. On May 7, 2018, Incysus, Ltd. reincorporated in the United States in a domestication transaction (the “Domestication”) in which Incysus, Ltd. converted into a newly formed Delaware corporation, Incysus Therapeutics, Inc. (“Incysus Therapeutics”). On July 24, 2019, Incysus Therapeutics merged with Incysus. Incysus Therapeutics subsequently changed its name to IN8bio, Inc. in August 2020. Following the Domestication in May 2018 and the merging of Incysus Therapeutics and Incysus in July 2019, the Company does not have any subsidiaries to consolidate. The Company is headquartered in New York, New York. Initial Public Offering On August 3, 2021 , the Company completed its initial public offering (“IPO”) in which it issued and sold 4,000,000 shares of its common stock at a public offering price of $ 10.00 per share. The Company received net proceeds from the IPO of $ 32.3 million, after deducting underwriters’ discounts, commissions, and offering-related costs. Upon closing of the IPO, all of the Company's outstanding shares of convertible preferred stock automatically converted into 10,990,065 shares of common stock (see Note 8). Going Concern To date, the Company has funded its operations primarily with proceeds from various public and private offerings of its common and preferred stock. The Company has incurred recurring losses and negative operating cash flows since its inception, including net losses of $ 28.5 million and $ 14.7 million for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, the Company had an accumulated deficit of $ 61.2 million. On August 16, 2022, the Company completed an underwritten public offering of 5,394,737 shares of its common stock at a public offering price of $ 1.90 per share, for net proceeds of approximately $ 9.0 million, after deducting underwriting discounts, commissions and offering expenses. On August 19, 2022, the underwriter partially exercised their option to purchase an additional 268,949 shares at the public offering price of $ 1.90 per share, resulting in additional net proceeds of approximately $ 0.4 million, after deducting underwriting discounts, commissions and offering expenses, increasing the aggregate net proceeds from the offering to approximately $ 9.4 million. In November 2022, the Company filed a shelf registration statement on Form S-3 (File No. 333-268288) (the “Shelf Registration Statement”) with the Securities and Exchange Commission (“SEC”), which permits the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $ 200 million of its common stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, of which $ 50 million of common stock may be issued and sold pursuant to an at-the-market offering program (“ATM”). The Company entered into a Controlled Equity Offering SM sales agreement, or the Sales Agreement, with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”) and Truist Securities, Inc. (“Truist”) under which Cantor Fitzgerald and Truist agreed to act as sales agents to sell shares of the Company’s common stock, from time to time, through the ATM program. Under current SEC regulations, if at any time the Company's public float is less than $ 75.0 million, and for so long as the Company's public float remains less than $75.0 million, the amount the Company can raise through primary public offerings of securities in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of the Company's public float, which is referred to as the baby shelf rules. As of December 31, 2022, the Company's calculated public float was less than $ 75.0 million. During the year ended December 31, 2022, the Company sold an aggregate of 43,000 shares of common stock under the ATM, resulting in net proceeds of approximately $ 0.1 million, after deducting underwriting discounts. The Company has not yet generated product sales and as a result has experienced operating losses since inception. The Company expects to incur additional losses in the future as it advances its product candidates through clinical trials, seeks to expand its product candidate portfolio through developing additional product candidates, grows its clinical, regulatory and quality capabilities, and incurs costs associated with operating as a public company, and, based on the Company’s business strategy, its existing cash of $ 18.2 million as of December 31, 2022 will not be sufficient to fund the Company’s projected operating expenses and capital expenditure requirements beyond mid-July of 2023, which includes reserves for all necessary winddown expenses. Accordingly, there is substantial doubt about the Company’s ability to continue to operate as a going concern. To continue to fund the operations of the Company beyond this time period, management has developed plans, which primarily consist of raising additional capital through some combination of public equity offerings, including through ATM offerings, and identifying strategic collaborations, licensing or other arrangements to support development of the Company’s product candidates. There is no assurance, however, that any additional financing or any revenue-generating collaboration will be available when needed, that management of the Company will be able to obtain financing or enter into a collaboration on terms acceptable to the Company, or that any additional financing or revenue generated through third party collaborations will be sufficient to fund our operations through this time period. If additional capital is not available, the Company will have to significantly delay, scale back or discontinue research and development programs or future commercialization efforts. The actual amount of cash that the Company will need to operate is subject to many factors. The accompanying financial statements have been prepared on the basis that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). 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, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting periods presented. Such estimates and assumptions are used for, but are not limited to, the accrual of research and development expenses, deferred tax assets and liabilities and related valuation allowance, fair value of common stock and stock-based compensation, and the useful lives of property and equipment. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Actual results could differ from those estimates. Concentration of Credit Risk Financial instruments that potentially expose the Company to significant concentrations of credit risk consist primarily of cash. All of the Company’s cash is deposited in accounts with major financial institutions. Such deposits are in excess of the federally insured limits. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation and amortization of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets. Significant replacements and improvements are capitalized, while maintenance and repairs, which do not improve or extend the life of the respective assets, are charged to expense as incurred. The estimated useful lives of the Company’s respective assets are as follows: Estimated Useful Life Furniture 5 years Machinery and equipment 3 - 5 years Software 3 years Leasehold improvements The shorter of the useful life of the leasehold improvement or the remaining term of the lease Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated in accordance with the above guidelines once placed into service. Upon retirement or disposal of property and equipment, the cost and related accumulated depreciation and amortization are removed from the balance sheet and any gain or loss is reflected in the statement of operations. Impairment of Long-Lived Assets Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted cash flows expected to be generated by the asset. Impairment losses are then measured by comparing the fair value of assets to their carrying amounts. There were no impairments recorded for the years ended December 31, 2022 and 2021. Research and Development Costs Research and development costs are generally expensed as incurred and consist primarily of salaries and benefits, stock-based compensation expense, lab supplies and facility costs, as well as fees paid to nonemployees and entities that conduct certain research and development activities on the Company’s behalf and expenses incurred in connection with license agreements. Non-refundable advance payments for goods or services that will be used for rendered or future research and development activities are deferred and amortized over the period that the goods are delivered, or the related services are performed, subject to an assessment of recoverability. The Company analyzes the progress of clinical trials, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. The Company makes significant judgments and estimates in determining the accrued balance and expense in each accounting period. As actual costs become known, the Company adjusts the accrued estimates. Although the Company does not expect the estimates to be materially different from amounts actually incurred, the status and timing of services performed, the number of patients enrolled and the rate of patient enrollment may vary from the Company’s estimates and could result in the Company reporting amounts that are too high or too low in any particular period. The Company’s research and development costs are dependent, in part, upon the receipt of timely and accurate reporting from clinical research organizations and other third-party service providers. Leases Effective January 1, 2021, the Company adopted the Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU 2016-02” or “ASC 842”), using the modified retrospective method and utilized the effective date as its date of initial application, with prior periods presented in accordance with previous guidance under Accounting Standards Codification (“ASC”) 840, Leases . At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and current and non-current lease liabilities, as applicable. Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. Prospectively, the Company will adjust the right-of-use assets for straight-line rent expense and remeasure the lease liability at the net present value using the same incremental borrowing rate that was in effect as of the lease commencement or transition date. The Company elected the following practical expedients, which must be elected as a package and applied consistently to all of its leases at the transition date (including those for which the entity is a lessee or a lessor): (i) the Company did not reassess whether any expired or existing contracts are or contain leases; (ii) the Company did not reassess the lease classification for any expired or existing leases (that is, all existing leases that were classified as operating leases in accordance with ASC 840 are classified as operating leases, and all existing leases that were classified as capital leases in accordance with ASC 840 are classified as finance leases); and (iii) the Company did not reassess initial direct costs for any existing leases. For leases that existed prior to the date of initial application of ASC 842 (which were previously classified as operating leases), a lessee may elect to use either the total lease term measured at lease inception under ASC 840 or the remaining lease term as of the date of initial application of ASC 842 in determining the period for which to measure its incremental borrowing rate. In transition to ASC 842, the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rates. In accordance with ASC 842, components of a lease should be split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. Entities may elect not to separate lease and non-lease components. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all of the contract consideration to the lease component only. On the adoption date, $ 1.7 million was recognized as total lease liabilities and $ 1.7 million was recognized as total right-of-use assets on the Company’s balance sheet. Additionally, $ 0.04 million was recognized as a reduction to prepaid expenses and other current assets and $ 0.02 million was recognized as a reduction to deferred rent on the Company’s balance sheet. Fair Value of Financial Instruments The Company applies fair value accounting for all financial assets and liabilities and nonfinancial assets and liabilities that are required to be disclosed at fair value in the financial statements. Fair value is the price at which an asset could be exchanged, or a liability transferred (an exit price) in an orderly transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or inputs are not available, valuation models are applied. The Company’s financial instruments include cash and restricted cash, and accounts payable. The carrying amounts of cash, restricted cash, and accounts payable approximate fair value due to the short-term nature of these instruments. Income Taxes The Company uses the asset-and-liability method for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts and tax bases of assets and liabilities and operating loss and tax credit carryforwards. These are measured using the enacted tax rates that are expected to be in effect when the differences reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to an amount that, in the opinion of management, is more likely than not to be realized. The calculation of the income tax expense involves the use of estimates, assumptions and judgments while taking into account current tax laws and our interpretation of current and possible outcomes of future tax audits. In addition, our policy for accounting for uncertainty in income taxes requires the evaluation of tax positions taken or expected to be taken in the course of the preparation of tax returns to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet the more-likely-than-not threshold would be recorded as a tax expense in the current year. Reevaluation of tax positions considers factors such as changes in facts or circumstances, changes in or interpretations of tax law, effectively settled issues under audit or expiration of statute of limitation and new audit activity. The Company classifies interest and penalty expense related to uncertain tax positions as a component of operating expenses on the statements of operations. As of December 31, 2022, the Company had no accrued interest or penalties. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require application of significant judgment. The Company is subject to U.S. federal and various state and local jurisdictions. Due to the Company’s net operating loss carryforwards, the Company may be subject to examination by authorities for all previously filed income tax returns. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted in response to the COVID-19 pandemic. The CARES Act, among other things, permits NOL carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. In addition, the CARES Act allows NOLs incurred in 2018, 2019 and 2020 to be carried back to each of the five preceding taxable years to generate a refund of previously paid income taxes. The Company evaluated the impact of the CARES Act. At present, the Company does not expect that the NOL carryback provision or other provisions of the CARES Act has resulted or will result in a material tax benefit to the Company. Stock-Based Compensation The Company measures all stock-based awards granted to employees, nonemployees and directors based on the fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. The stock-based compensation expense is accounted for in the statements of operations based on the awards’ grant date fair values. The Company accounts for forfeitures as they occur by reversing any expense recognized for unvested awards. The Company estimates the fair value of options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to a lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. The Company uses the simplified method as allowed by the SEC Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment , to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. Before the IPO, the Company utilized significant estimates and assumptions in determining the fair value of its common stock. The Company has utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation (the “Practice Aid”), to estimate the fair value of its common stock. The common stock valuation is based on the Company’s enterprise value determined utilizing various methods including the option-pricing method (“OPM”) or a hybrid of the probability-weighted expected return method (“PWERM”) and the OPM. Each valuation methodology includes estimates and assumptions that require the Company’s judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of preferred stock, the superior rights and preferences of securities senior to the Company’s common stock at the time of, and the likelihood of, achieving a liquidity event, such as an IPO or sale. Significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date. Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process preferred stock or common stock financings as deferred offering costs until such financings are consummated. As of August 3, 2021, the date of the closing of the Company’s IPO, the Company had deferred offering costs related to the IPO of $ 4.0 million. After the closing of the IPO, these costs were recorded in stockholders’ equity (deficit) as a reduction of additional paid-in capital generated as a result of the offering. Recent Accounting Pronouncements The Company did not adopt any new accounting guidance during the year ended December 31, 2022 that had a material impact on the financial statements or disclosures. Additionally, there is no pending accounting guidance that the Company expects to have a material impact on the financial statements. |
Prepaid Expenses And Other Curr
Prepaid Expenses And Other Current Assets | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 3. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consist of the following (in thousands): December 31, December 31, Prepaid research and development $ 2,562 $ 49 Prepaid insurance 1,258 1,858 Other 232 52 Prepaid expenses and other current assets $ 4,052 $ 1,959 |
Property And Equipment, Net
Property And Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 4. PROPERTY AND EQUIPMENT, NET Property and equipment, net consist of the following (in thousands): December 31, December 31, Machinery and equipment $ 358 $ 443 Furniture and fixtures 335 — Software 126 — Leasehold improvements 3,899 — Less accumulated depreciation and amortization ( 321 ) ( 346 ) Property and equipment, net $ 4,397 $ 97 Depreciation and amortization expense was $ 0.1 million for each of the years ended December 31, 2022 and 2021. |
Construction In Progress
Construction In Progress | 12 Months Ended |
Dec. 31, 2022 | |
Public Utilities, Property, Plant and Equipment, Plant in Service [Abstract] | |
Construction in Progress | 5. CONSTRUCTION IN PROGRESS Construction in progress consist of the following (in thousands): December 31, December 31, Furniture $ 29 $ 77 Leasehold improvements — 200 Internal use software not yet in service — 126 Construction in progress $ 29 $ 403 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 6. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities consist of the following (in thousands): December 31, December 31, Accrued clinical trials $ 253 $ 196 Accrued compensation 1,460 926 Accrued legal 211 62 Accrued other 418 51 Total accrued expenses and other current liabilities $ 2,342 $ 1,235 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
DEBT | 7. DEBT In April 2020, the Company was granted a loan (the “Loan”) in an amount of $ 0.2 million, pursuant to the Paycheck Protection Program (the “PPP”) under Division A, Title I of the CARES Act, which was enacted on March 27, 2020. The Loan, which was in the form of a Note dated April 16, 2020, matured on April 16, 2022 and bore interest at a rate of 1.0 % per annum, payable monthly commencing on November 16, 2020 . Funds from the Loan could only be used for payroll costs, costs to continue group healthcare benefits, mortgage payments, rent, utilities, and interest on other debt obligations incurred before February 15, 2020. The Company used the entire Loan amount for qualifying expenses. In August 2021, the Company repaid the PPP Loan of $ 0.2 million in full. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | 8. STOCKholders' equity The Company’s authorized capital stock consists of 500,000,000 shares, all with a par value of $ 0.0001 per share, of which 490,000,000 shares are designated as common stock and 10,000,000 shares are designated as preferred stock. In August 2021, upon the closing of the IPO, all of the Company's outstanding shares of convertible preferred stock automatically converted into 10,990,065 shares of common stock. There were no shares of preferred stock outstanding as of December 31, 2022 and 2021. Equity Offerings In August 2022, the Company issued and sold 5,663,686 shares of common stock at a public offering price of $ 1.90 per share, resulting in net proceeds of $ 9.4 million, after deducting underwriting discounts, commissions and offering expenses. ATM Facilities In November 2022, the Company filed the Shelf Registration Statement with the SEC, which permits the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $ 200 million of its common stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, of which $5 0 million of common stock may be issued and sold pursuant to the ATM. The Company entered into the Sales Agreement with Cantor Fitzgerald and Truist under which Cantor Fitzgerald and Truist agreed to act as sales agents to sell shares of the Company’s common stock, from time to time, through an ATM pursuant to the effective Shelf Registration Statement. Under current SEC regulations, if at any time the Company's public float is less than $ 75.0 million, and for so long as the Company's public float remains less than $75.0 million, the amount the Company can raise through primary public offerings of securities in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of the Company's public float, which is referred to as the baby shelf rules. As of December 31, 2022, our calculated public float was less than $ 75.0 million. During the year ended December 31, 2022, the Company sold an aggregate of 43,000 shares of common stock under the ATM resulting in net proceeds of approximately $ 0.1 million, after deducting underwriting discounts. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation | 9. STOCK-BASED COMPENSATION 2018 Equity Incentive Plan On May 7, 2018, the Company established and adopted the 2018 Equity Incentive Plan (the “2018 Plan”) providing for the granting of stock awards for employees, directors and consultants to purchase shares of the Company’s common stock. Upon the effectiveness of the 2020 Plan (as defined below), the 2018 Plan was terminated and no further issuances were made under the 2018 Plan, although it continues to govern the terms of any equity grants that remain outstanding under the 2018 Plan. 2020 Equity Incentive Plan The 2020 Equity Incentive Plan (the “2020 Plan”) was approved by the Board of Directors and the Company’s stockholders and became effective on July 29, 2021. The Board of Directors, or a committee thereof, is authorized to administer the 2020 Plan. The 2020 Plan provides for the grant of incentive stock options (“ISOs”) within the meaning of Section 422 of the U.S. Internal Revenue Code of 1986, (the “IRC”) as amended, to employees, and for the grant of non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of awards to employees, directors and consultants and any affiliates’ employees and consultants. The number of shares initially reserved for issuance under the 2020 Plan was 4,200,000 , which automatically increases on January 1 of each year for a period of 10 years , beginning on January 1, 2022 and continuing through January 1, 2031, in an amount equal to 5 % of the total number of shares of common stock outstanding on the last day of the immediately preceding year, or a lesser number of shares determined by the Board of Directors no later than the last day of the immediately preceding year. The maximum number of shares of common stock that may be issued upon the exercise of ISOs under the 2020 Plan will be 13,000,000 shares. On January 1, 2022, the shares reserved for issuance was increased to 5,139,062 shares. As of December 31, 2022, 979,502 shares were available for grant pursuant to the 2020 Plan. 2020 Employee Stock Purchase Plan The 2020 Employee Stock Purchase Plan (the “2020 ESPP”) was approved by the Company’s Board of Directors and the Company’s stockholders and became effective on July 29, 2021. A total of 200,000 shares of common stock were initially reserved for issuance under this plan, which automatically increases on January 1 of each year for a period of 10 years , beginning on January 1, 2021 and continuing through January 1, 2031, by the lesser of 1 % of the total number of shares of common stock outstanding on the last day of the immediately preceding year; and 400,000 shares, except before the date of any such increase, the Board of Directors may determine that such increase will be less than the amount set forth above. On January 1, 2023, the shares reserved for issuance was increased to 633,264 shares. As of December 31, 2022, no shares of common stock had been issued under the 2020 ESPP and 200,000 shares remained available for future issuance under the 2020 ESPP. The first offering period has not yet been decided by the Company’s Board of Directors or designated committee of the Company’s Board of Directors. Stock Option Activity The following is a summary of the stock option award activity during the year ended December 31, 2022: Number Weighted- Weighted- Aggregate Outstanding at December 31, 2021 2,306,379 $ 6.51 8.99 $ 983 Granted 1,845,682 2.85 Exercised ( 57,229 ) 1.07 Forfeited ( 91,538 ) 6.47 Outstanding at December 31, 2022 4,003,294 $ 4.90 8.28 $ 860 Exercisable at December 31, 2022 1,115,004 $ 6.16 7.89 $ 195 Options expected to vest as of December 31, 2022 2,888,290 $ 4.41 8.96 $ 664 The weighted-average grant date fair value of options granted during the years ended December 31, 2022 and 2021 was $ 2.85 and $ 5.41 , respectively. The aggregate intrinsic value is calculated as the difference between the exercise price and the market price of the Company’s common stock at December 31, 2022. The aggregate intrinsic value of stock options exercised in the year ended December 31, 2022 was $ 0.1 million. Stock-Based Compensation Expense For the years ended December 31, 2022 and 2021, the Company utilized the Black-Scholes option-pricing model for estimating the fair value of the stock options. The following table presents the assumptions and the Company’s methodology for developing each of the assumptions used: December 31, December 31, Volatility 86.91 % - 89.16 % 85.67 % - 89.15 % Expected life (years) 5.27 - 6.08 5.49 - 6.68 Risk-free interest rate 1.99 % - 4.31 % 0.66 % - 1.32 % Dividend rate — — • Volatility—The Company estimates the expected volatility of its common stock at the date of grant based on the historical volatility of comparable public companies over the expected term. • Expected life—The expected term represents the period that the Company’s stock option grants are expected to be outstanding. The expected term of the options granted to employees and non-employee directors by the Company has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. Under this approach, the weighted-average expected life is presumed to be the average of the vesting term and the contractual term of the option. • Risk-free interest rate—The risk-free rate for periods within the estimated life of the stock award is based on the U.S. Treasury yield curve in effect at the time of grant. • Dividend rate—The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. Stock-based compensation expense was recorded in the following line items in the statements of operations for the years ended December 31, 2022 and 2021 (in thousands): Year Ended 2022 2021 Research and development $ 1,404 $ 1,014 General and administrative 2,063 $ 1,181 Total stock-based compensation expense $ 3,467 $ 2,195 No related tax benefits from stock-based compensation expense were recognized for the years ended December 31, 2022 and 2021. As of December 31, 2022, there was $ 8.3 million in unrecognized stock-based compensation expense, which is expected to be recognized over a weighted-average period of 2.67 years. |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2022 | |
License Agreements [Abstract] | |
License Agreements | 10. LICENSE AGREEMENTS Emory University, Children’s Healthcare of Atlanta, Inc. and UAB Research Foundation In June 2016, the Company entered into an exclusive license agreement with Emory University, Children’s Healthcare of Atlanta, Inc. and UAB Research Foundation ("UABRF"), as amended from time to time (the “Emory License Agreement”). The Emory License Agreement was amended in October 2017 and July 2020. Under the Emory License Agreement, the Company obtained an exclusive worldwide license under certain immunotherapy related patents and know-how related to gamma-delta T cells developed by Emory University, Children’s Healthcare of Atlanta, Inc. and UABRF’s affiliate, the University of Alabama at Birmingham, to develop, make, have made, use, sell, import and otherwise commercialize products that are covered by such patents or otherwise incorporate or use the licensed technology. Such exclusive license is subject to certain rights retained by these institutions and also the U.S. government. In consideration of the license granted under the Emory License Agreement, the Company paid Emory University a nominal upfront payment. In addition, the Company is required to pay Emory University development milestones totaling up to an aggregate of $ 1.4 million, low-single-digit to mid-single-digit tiered running royalties on the net sales of the licensed products, including an annual minimum royalty beginning on a specified period after the first sale of a licensed product, and a share of certain payments that the Company may receive from sublicenses. In addition, in the event no milestone payments have been paid in certain years, the Company will be required to pay an annual license maintenance fee. The Emory License Agreement also requires the Company to reimburse Emory University for the cost of the prosecution and maintenance of the licensed patents. Pursuant to the Emory License Agreement, the Company is required to use its best efforts to develop, manufacture and commercialize the licensed product and is obligated to meet certain specified deadlines in the development of the licensed products. The term of the Emory License Agreement will continue until 15 years after the first commercial sale of licensed product, or the expiration of the relevant licensed patents, whichever is later . The Company may terminate the Emory License Agreement at will at any time upon prior written notice to Emory University. Emory University has the right to terminate the Emory License Agreement if the Company materially breaches the agreement (including failure to meet diligence obligations) and fails to cure such breach within a specified cure period, if the Company becomes bankrupt or insolvent or decides to cease development and commercialization of the licensed product, or if the Company challenges the validity or enforceability of any licensed patents. Exclusive License Agreement with UABRF In March 2016, the Company entered into an exclusive license agreement with UABRF, as amended from time to time (the “UABRF License Agreement”). The Company amended the UABRF License Agreement in December 2016, January 2017, June 2017 and November 2018. Under the UABRF License Agreement, the Company obtained an exclusive worldwide license under certain immunotherapy-related patents related to the use of gamma-delta T cells, certain CAR-T cells and combination treatments for cellular therapies developed by the University of Alabama at Birmingham and owned by UABRF to develop, make, have made, use, sell, import and otherwise commercialize products that are covered by such patents. Such exclusive license is subject to certain rights retained by UABRF and also the U.S. government. In consideration of the license granted under the UABRF License Agreement, the Company paid UABRF a nominal upfront payment and issued 91,250 shares of common stock to UABRF, which were subject to certain antidilution rights. In addition, the Company is required to pay UABRF development milestones totaling up to an aggregate of $ 1.4 million, lump-sum royalties on cumulative net sales totaling up to an aggregate of $ 22.5 million, mid-single-digit running royalties on net sales of the licensed products, low-single-digit running royalties on net sales of the licensed products, and a share of certain non-royalty income that the Company may receive, including from any sublicenses. The UABRF License Agreement also requires the Company to reimburse UABRF for the cost of the prosecution and maintenance of the licensed patents. Pursuant to the UABRF License Agreement, the Company is required to use good faith reasonable commercial efforts to develop, manufacture and commercialize the licensed product. The term of the UABRF License Agreement will continue until the expiration of the licensed patents. The Company may terminate the UABRF License Agreement at will at any time upon prior written notice to UABRF. UABRF has the right to terminate the UABRF License Agreement if the Company materially breaches the agreement and fails to cure such breach within a specified cure period, if the Company fails to diligently undertake development and commercialization activities as set forth in the development and commercialization plan, if the Company underreports its payment obligations or underpays by more than a specified threshold, if the Company challenges the validity or enforceability of any licensed patents, or if the Company becomes bankrupt or insolvent. Antidilution Provision The antidilution provision required the Company to issue additional shares of common stock such that UABRF maintains a 2.5 % ownership interest in the Company until it has raised at least $ 20.0 million through one or more rounds of investment. This provision was fully satisfied as of August 2020, at which time the Company raised an aggregate of $ 36.6 million through the sale of their securities. Between March 2017 and August 2020, the Company issued UABRF an additional 151,382 shares of its common stock in satisfaction of this antidilution provision. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. INCOME TAXES For the years ended December 31, 2022 and 2021, the tax provision (benefit) consisted of (in thousands): December 31, December 31, Current provision (benefit): Federal $ — $ — State — — Total — — Deferred provision (benefit) Federal ( 5,967 ) ( 2,670 ) State 1,455 ( 1,938 ) Total ( 4,512 ) ( 4,608 ) Change in valuation allowance 4,512 4,608 Income tax provision (benefit) $ — $ — The items accounting for the difference between income taxes computed at the federal statutory rate and the Company’s effective tax rate for the years ended December 31, 2022 and 2021 were as follows: December 31, December 31, U.S. Federal statutory rate 21 % 21 % State taxes, net of federal benefit 0 % 10 % Stock-based compensation - 1 % - 2 % Other permanent differences 0 % - 1 % True up adjustments - 4 % 3 % Change in valuation allowance - 16 % - 31 % Income tax provision (benefit) 0 % 0 % Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial statement purposes and the amounts used for income tax purposes. Components of the Company’s net deferred tax assets (liabilities) balance are as follows at December 31, 2022 and 2021 (in thousands): December 31, December 31, Deferred tax assets: Stock-based compensation $ 920 $ 337 Net operating loss carryforwards and alternative minimum tax credits 9,737 6,803 Lease liabilities 1,234 791 Reserves and accruals 307 304 Intangibles and fixed assets 2,940 1,922 Total deferred tax assets 15,137 10,157 Deferred tax liabilities: ROU assets ( 1,233 ) ( 766 ) Total deferred tax liabilities ( 1,233 ) ( 766 ) Valuation allowance ( 13,903 ) ( 9,391 ) Deferred tax assets (liabilities), net $ — $ — The Tax Cuts and Jobs Act of 2017 (TCJA) amended IRC Section 174 to require capitalization of all research and developmental (“R&D”) costs incurred in tax years beginning after December 31, 2021. These costs are required to be amortized over five years if the R&D activities are performed in the United States or over 15 years if the activities were performed outside the United States. The Company capitalized approximately $ 9.8 million of R&D expenses incurred during the year ended December 31, 2022. As of December 31, 2022 , the Company had federal net operating loss carryforwards of approximately $ 36.6 million, which do not expire. As of December 31, 2022, the Company had state net operating loss carryforwards of approximately $ 25.0 million which will begin to expire in 2039. The Company has evaluated both positive and negative evidences and determined that negative evidence outweighed the positive evidence and that a full valuation allowance on its net deferred tax assets will be maintained. The net change in the valuation allowance for the year ended December 31, 2022 was an increase of $ 4.5 million. IRC Section 382 imposes limitations on the use of net operating loss carryovers when the stock ownership of one or more 5% shareholders (shareholders owning 5 % or more of the Company’s outstanding capital stock) has increased on a cumulative basis by more than 50 percentage points. Accordingly, there is a risk of an ownership change that could trigger a limitation of the use of the loss carryover. The Company has undertaken a formal IRC Section 382 study as of December 31 2022. Management concluded that the Company did not undergo an ownership change as defined under IRC Section 382(g); all the attributes disclosed in this footnote reflect the conclusion of that study. However, subsequent ownership changes may further limit the Company's ability in the future to utilize its NOLs and other tax carryforwards. In the ordinary course of business, the Company’s income tax returns are subject to examination by various taxing authorities. Such examinations may result in future tax and interest assessment by these taxing authorities. Accordingly, the Company believes that it is more likely than not that it will realize the benefits of tax positions it has taken in its tax returns or for the amount of any tax benefit that exceeds the cumulative probability threshold in accordance with FASB ASC 740. Differences between the estimated and actual amounts determined upon ultimate resolution, individually or in the aggregate, are not expected to have a material adverse effect on the Company’s financial position. The Company believes its tax positions are highly certain of being upheld upon examination. The Company is subject to the U.S. federal and state income taxes with varying statutes of limitations. Tax years from 2018 forward remain open to examination due to the carryover of net operating losses or tax credits. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 12. NET LOSS PER SHARE Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is the same as basic net loss per share for the periods presented since the effects of potentially dilutive securities are antidilutive given the net loss of the Company. Basic and diluted net loss per share is calculated as follows (in thousands except share and per share amounts): Year Ended 2022 2021 Net loss $ ( 28,521 ) $ ( 14,653 ) Net loss per share—basic and diluted $ ( 1.36 ) $ ( 1.47 ) Weighted-average number of shares used in computing net loss 20,967,955 9,969,733 The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share, as their effect is antidilutive: Year Ended 2022 2021 Stock options to purchase common stock 3,200,412 1,723,587 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | 13. COMMITMENTS AND CONTINGENCIES Intellectual Property The Company has existing commitments to the licensors of the intellectual property which the Company has licensed. These commitments are based upon certain clinical research, regulatory, financial and sales milestones being achieved. Additionally, the Company is obligated to pay a single-digit royalty on commercial sales on a global basis of licensed products under the Emory License Agreement and the UABRF License Agreement. The royalty term is the later of 15 years from first commercial sale or expiration of the last-to-expire component of the licensed intellectual property. Legal Proceedings The Company is not currently part to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred costs related to such legal proceedings. |
Facility Leases
Facility Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Facility Leases | 14. FACILITY LEASES The Company has historically entered into lease arrangements for its facilities. As of December 31, 2022, the Company had three operating leases with required future minimum payments. In applying the transition guidance under ASC 842, the Company determined the classification of these leases to be operating leases and recorded right-of-use assets and lease liabilities as of the effective dates. The Company’s leases generally do not include termination or purchase options. Finance Leases The Company entered into an agreement with an equipment leasing company in 2018, which provided up to $ 2.5 million for equipment purchases in the form of sale and leasebacks or direct leases. As of December 31, 2022, the Company had completed the sale and leaseback for four pieces of equipment and is leasing three other items directly from the leasing company. The terms of the leases are three years and afterwards provide for either annual extensions or an outright purchase of the equipment. The equipment leases require two advance rental payments to be held as security deposits. The security deposits held amounted to approximately $ 255,000 and $ 141,000 as of December 31, 2022 and 2021, respectively, and are included in other non-current assets on the balance sheets. Operating Leases The Company has an operating lease for office space in Birmingham, Alabama, for a 63-month term ending in March 2026, with an option to extend five years . Throughout the term of the lease, the Company is responsible for paying certain costs and expenses, in addition to the rent, as specified in the lease, including a proportionate share of applicable taxes, operating expenses and utilities. The Company has an operating lease for office space in New York, New York, with a term that commenced on September 15, 2021, and continues through March 2027 . Throughout the term of the lease, the Company is responsible for paying certain costs and expenses, in addition to the rent, as specified in the lease, including a proportionate share of applicable taxes, operating expenses and utilities. The Company has identified an embedded lease within the University of Louisville Manufacturing Services Agreement, as the Company has the exclusive use of, and control over, a portion of the manufacturing facility and equipment of the facility during the contractual term of the manufacturing arrangement. The commencement date of the embedded lease was August 4, 2022 and it continues through August 2028. The Company had a build-to-suit lease agreement with a third party to build out the Company's labs in Birmingham, Alabama, which was substantially completed in December 2022. The agreement had a threshold of $ 4.0 million of total costs incurred. The costs incurred and classified as property and equipment, net on the balance sheets were $ 4.1 million as of December 31, 2022. The operating leases require security deposits at the inception of each lease. The security deposits amounted to approximately $ 262,000 and $ 278,000 as of December 31, 2022 and 2021, respectively. As of December 31, 2022, approximately $ 252,000 was included in restricted cash and $ 10,000 was included in other current assets. As of December 31, 2021, approximately $ 251,000 was included in restricted cash, $ 10,000 was included in other current assets and $ 17,000 was included in other non-current assets. The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s finance and operating leases for the years ended December 31, 2022 and 2021 (in thousands): December 31, December 31, Lease Cost Amortization of finance right-of-use assets $ 461 $ 537 Interest on finance lease liabilities 53 86 Operating lease cost 731 280 Short-term lease cost — 460 Total lease cost $ 1,245 $ 1,363 December 31, Other Lease Information Cash paid for amounts included in the measurement of lease liability – finance leases $ 261 Cash paid for amounts included in the measurement of lease liability – operating leases $ 651 Weighted-average remaining lease term – finance leases 2.27 years Weighted-average remaining lease term – operating leases 4.98 years Weighted-average discount rate – finance leases 9.7 % Weighted-average discount rate – operating leases 12.1 % The following table reconciles the undiscounted cash flows to the operating and financing lease liabilities at December 31, 2022 (in thousands): Financing Leases Operating Leases 2023 $ 789 $ 1,190 2024 566 1,212 2025 302 1,224 2026 — 1,013 2027 — 768 Thereafter — 421 Total lease payment 1,657 5,828 Less: interest 164 1,447 Total lease liabilities 1,493 4,381 Less: short-term lease liability 682 707 Long-term lease liability $ 811 $ 3,674 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. SUBSEQUENT EVENTS Subsequent to December 31, 2022, the Company sold an aggregate of 392,901 shares of common stock under the ATM resulting in net proceeds of approximately $ 0.7 million, after deducting underwriting discounts. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
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, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting periods presented. Such estimates and assumptions are used for, but are not limited to, the accrual of research and development expenses, deferred tax assets and liabilities and related valuation allowance, fair value of common stock and stock-based compensation, and the useful lives of property and equipment. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially expose the Company to significant concentrations of credit risk consist primarily of cash. All of the Company’s cash is deposited in accounts with major financial institutions. Such deposits are in excess of the federally insured limits. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation and amortization of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets. Significant replacements and improvements are capitalized, while maintenance and repairs, which do not improve or extend the life of the respective assets, are charged to expense as incurred. The estimated useful lives of the Company’s respective assets are as follows: Estimated Useful Life Furniture 5 years Machinery and equipment 3 - 5 years Software 3 years Leasehold improvements The shorter of the useful life of the leasehold improvement or the remaining term of the lease Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated in accordance with the above guidelines once placed into service. Upon retirement or disposal of property and equipment, the cost and related accumulated depreciation and amortization are removed from the balance sheet and any gain or loss is reflected in the statement of operations. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted cash flows expected to be generated by the asset. Impairment losses are then measured by comparing the fair value of assets to their carrying amounts. There were no impairments recorded for the years ended December 31, 2022 and 2021. |
Research and Development Costs | Research and Development Costs Research and development costs are generally expensed as incurred and consist primarily of salaries and benefits, stock-based compensation expense, lab supplies and facility costs, as well as fees paid to nonemployees and entities that conduct certain research and development activities on the Company’s behalf and expenses incurred in connection with license agreements. Non-refundable advance payments for goods or services that will be used for rendered or future research and development activities are deferred and amortized over the period that the goods are delivered, or the related services are performed, subject to an assessment of recoverability. The Company analyzes the progress of clinical trials, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. The Company makes significant judgments and estimates in determining the accrued balance and expense in each accounting period. As actual costs become known, the Company adjusts the accrued estimates. Although the Company does not expect the estimates to be materially different from amounts actually incurred, the status and timing of services performed, the number of patients enrolled and the rate of patient enrollment may vary from the Company’s estimates and could result in the Company reporting amounts that are too high or too low in any particular period. The Company’s research and development costs are dependent, in part, upon the receipt of timely and accurate reporting from clinical research organizations and other third-party service providers. |
Leases | Leases Effective January 1, 2021, the Company adopted the Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU 2016-02” or “ASC 842”), using the modified retrospective method and utilized the effective date as its date of initial application, with prior periods presented in accordance with previous guidance under Accounting Standards Codification (“ASC”) 840, Leases . At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and current and non-current lease liabilities, as applicable. Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. Prospectively, the Company will adjust the right-of-use assets for straight-line rent expense and remeasure the lease liability at the net present value using the same incremental borrowing rate that was in effect as of the lease commencement or transition date. The Company elected the following practical expedients, which must be elected as a package and applied consistently to all of its leases at the transition date (including those for which the entity is a lessee or a lessor): (i) the Company did not reassess whether any expired or existing contracts are or contain leases; (ii) the Company did not reassess the lease classification for any expired or existing leases (that is, all existing leases that were classified as operating leases in accordance with ASC 840 are classified as operating leases, and all existing leases that were classified as capital leases in accordance with ASC 840 are classified as finance leases); and (iii) the Company did not reassess initial direct costs for any existing leases. For leases that existed prior to the date of initial application of ASC 842 (which were previously classified as operating leases), a lessee may elect to use either the total lease term measured at lease inception under ASC 840 or the remaining lease term as of the date of initial application of ASC 842 in determining the period for which to measure its incremental borrowing rate. In transition to ASC 842, the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rates. In accordance with ASC 842, components of a lease should be split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. Entities may elect not to separate lease and non-lease components. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all of the contract consideration to the lease component only. On the adoption date, $ 1.7 million was recognized as total lease liabilities and $ 1.7 million was recognized as total right-of-use assets on the Company’s balance sheet. Additionally, $ 0.04 million was recognized as a reduction to prepaid expenses and other current assets and $ 0.02 million was recognized as a reduction to deferred rent on the Company’s balance sheet. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company applies fair value accounting for all financial assets and liabilities and nonfinancial assets and liabilities that are required to be disclosed at fair value in the financial statements. Fair value is the price at which an asset could be exchanged, or a liability transferred (an exit price) in an orderly transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or inputs are not available, valuation models are applied. The Company’s financial instruments include cash and restricted cash, and accounts payable. The carrying amounts of cash, restricted cash, and accounts payable approximate fair value due to the short-term nature of these instruments. |
Income Taxes | Income Taxes The Company uses the asset-and-liability method for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts and tax bases of assets and liabilities and operating loss and tax credit carryforwards. These are measured using the enacted tax rates that are expected to be in effect when the differences reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to an amount that, in the opinion of management, is more likely than not to be realized. The calculation of the income tax expense involves the use of estimates, assumptions and judgments while taking into account current tax laws and our interpretation of current and possible outcomes of future tax audits. In addition, our policy for accounting for uncertainty in income taxes requires the evaluation of tax positions taken or expected to be taken in the course of the preparation of tax returns to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet the more-likely-than-not threshold would be recorded as a tax expense in the current year. Reevaluation of tax positions considers factors such as changes in facts or circumstances, changes in or interpretations of tax law, effectively settled issues under audit or expiration of statute of limitation and new audit activity. The Company classifies interest and penalty expense related to uncertain tax positions as a component of operating expenses on the statements of operations. As of December 31, 2022, the Company had no accrued interest or penalties. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require application of significant judgment. The Company is subject to U.S. federal and various state and local jurisdictions. Due to the Company’s net operating loss carryforwards, the Company may be subject to examination by authorities for all previously filed income tax returns. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted in response to the COVID-19 pandemic. The CARES Act, among other things, permits NOL carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. In addition, the CARES Act allows NOLs incurred in 2018, 2019 and 2020 to be carried back to each of the five preceding taxable years to generate a refund of previously paid income taxes. The Company evaluated the impact of the CARES Act. At present, the Company does not expect that the NOL carryback provision or other provisions of the CARES Act has resulted or will result in a material tax benefit to the Company. |
Stock-Based Compensation | Stock-Based Compensation The Company measures all stock-based awards granted to employees, nonemployees and directors based on the fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. The stock-based compensation expense is accounted for in the statements of operations based on the awards’ grant date fair values. The Company accounts for forfeitures as they occur by reversing any expense recognized for unvested awards. The Company estimates the fair value of options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to a lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. The Company uses the simplified method as allowed by the SEC Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment , to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. Before the IPO, the Company utilized significant estimates and assumptions in determining the fair value of its common stock. The Company has utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation (the “Practice Aid”), to estimate the fair value of its common stock. The common stock valuation is based on the Company’s enterprise value determined utilizing various methods including the option-pricing method (“OPM”) or a hybrid of the probability-weighted expected return method (“PWERM”) and the OPM. Each valuation methodology includes estimates and assumptions that require the Company’s judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of preferred stock, the superior rights and preferences of securities senior to the Company’s common stock at the time of, and the likelihood of, achieving a liquidity event, such as an IPO or sale. Significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date. |
Deferred Offering Costs | Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process preferred stock or common stock financings as deferred offering costs until such financings are consummated. As of August 3, 2021, the date of the closing of the Company’s IPO, the Company had deferred offering costs related to the IPO of $ 4.0 million. After the closing of the IPO, these costs were recorded in stockholders’ equity (deficit) as a reduction of additional paid-in capital generated as a result of the offering. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The Company did not adopt any new accounting guidance during the year ended December 31, 2022 that had a material impact on the financial statements or disclosures. Additionally, there is no pending accounting guidance that the Company expects to have a material impact on the financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment Estimated Useful Lives | The estimated useful lives of the Company’s respective assets are as follows: Estimated Useful Life Furniture 5 years Machinery and equipment 3 - 5 years Software 3 years Leasehold improvements The shorter of the useful life of the leasehold improvement or the remaining term of the lease |
Property And Equipment, Net (Ta
Property And Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Components of Property and Equipment, Net | Property and equipment, net consist of the following (in thousands): December 31, December 31, Machinery and equipment $ 358 $ 443 Furniture and fixtures 335 — Software 126 — Leasehold improvements 3,899 — Less accumulated depreciation and amortization ( 321 ) ( 346 ) Property and equipment, net $ 4,397 $ 97 |
Construction in Progress (Table
Construction in Progress (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Public Utilities, Property, Plant and Equipment, Plant in Service [Abstract] | |
Schedule of construction in progress | Construction in progress consist of the following (in thousands): December 31, December 31, Furniture $ 29 $ 77 Leasehold improvements — 200 Internal use software not yet in service — 126 Construction in progress $ 29 $ 403 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): December 31, December 31, Prepaid research and development $ 2,562 $ 49 Prepaid insurance 1,258 1,858 Other 232 52 Prepaid expenses and other current assets $ 4,052 $ 1,959 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following (in thousands): December 31, December 31, Accrued clinical trials $ 253 $ 196 Accrued compensation 1,460 926 Accrued legal 211 62 Accrued other 418 51 Total accrued expenses and other current liabilities $ 2,342 $ 1,235 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Award Activity | The following is a summary of the stock option award activity during the year ended December 31, 2022: Number Weighted- Weighted- Aggregate Outstanding at December 31, 2021 2,306,379 $ 6.51 8.99 $ 983 Granted 1,845,682 2.85 Exercised ( 57,229 ) 1.07 Forfeited ( 91,538 ) 6.47 Outstanding at December 31, 2022 4,003,294 $ 4.90 8.28 $ 860 Exercisable at December 31, 2022 1,115,004 $ 6.16 7.89 $ 195 Options expected to vest as of December 31, 2022 2,888,290 $ 4.41 8.96 $ 664 |
Schedule of Estimating Fair Value of the Stock Options and Common stock Warrants Granted | The following table presents the assumptions and the Company’s methodology for developing each of the assumptions used: December 31, December 31, Volatility 86.91 % - 89.16 % 85.67 % - 89.15 % Expected life (years) 5.27 - 6.08 5.49 - 6.68 Risk-free interest rate 1.99 % - 4.31 % 0.66 % - 1.32 % Dividend rate — — |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense was recorded in the following line items in the statements of operations for the years ended December 31, 2022 and 2021 (in thousands): Year Ended 2022 2021 Research and development $ 1,404 $ 1,014 General and administrative 2,063 $ 1,181 Total stock-based compensation expense $ 3,467 $ 2,195 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss Per Share | Basic and diluted net loss per share is calculated as follows (in thousands except share and per share amounts): Year Ended 2022 2021 Net loss $ ( 28,521 ) $ ( 14,653 ) Net loss per share—basic and diluted $ ( 1.36 ) $ ( 1.47 ) Weighted-average number of shares used in computing net loss 20,967,955 9,969,733 |
Schedule of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share, as their effect is antidilutive: Year Ended 2022 2021 Stock options to purchase common stock 3,200,412 1,723,587 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Tax Provision (Benefit) | For the years ended December 31, 2022 and 2021, the tax provision (benefit) consisted of (in thousands): December 31, December 31, Current provision (benefit): Federal $ — $ — State — — Total — — Deferred provision (benefit) Federal ( 5,967 ) ( 2,670 ) State 1,455 ( 1,938 ) Total ( 4,512 ) ( 4,608 ) Change in valuation allowance 4,512 4,608 Income tax provision (benefit) $ — $ — |
Schedule of Difference Between Income Taxes at Federal Statutory Rate and Effective Tax Rate | The items accounting for the difference between income taxes computed at the federal statutory rate and the Company’s effective tax rate for the years ended December 31, 2022 and 2021 were as follows: December 31, December 31, U.S. Federal statutory rate 21 % 21 % State taxes, net of federal benefit 0 % 10 % Stock-based compensation - 1 % - 2 % Other permanent differences 0 % - 1 % True up adjustments - 4 % 3 % Change in valuation allowance - 16 % - 31 % Income tax provision (benefit) 0 % 0 % |
Schedule of Net Deferred Tax Assets (Liabilities) | Components of the Company’s net deferred tax assets (liabilities) balance are as follows at December 31, 2022 and 2021 (in thousands): December 31, December 31, Deferred tax assets: Stock-based compensation $ 920 $ 337 Net operating loss carryforwards and alternative minimum tax credits 9,737 6,803 Lease liabilities 1,234 791 Reserves and accruals 307 304 Intangibles and fixed assets 2,940 1,922 Total deferred tax assets 15,137 10,157 Deferred tax liabilities: ROU assets ( 1,233 ) ( 766 ) Total deferred tax liabilities ( 1,233 ) ( 766 ) Valuation allowance ( 13,903 ) ( 9,391 ) Deferred tax assets (liabilities), net $ — $ — |
Facility Leases (Tables)
Facility Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Summary of Lease Costs and Other Information to Company's Finance and Operating Liabilities | The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s finance and operating leases for the years ended December 31, 2022 and 2021 (in thousands): December 31, December 31, Lease Cost Amortization of finance right-of-use assets $ 461 $ 537 Interest on finance lease liabilities 53 86 Operating lease cost 731 280 Short-term lease cost — 460 Total lease cost $ 1,245 $ 1,363 December 31, Other Lease Information Cash paid for amounts included in the measurement of lease liability – finance leases $ 261 Cash paid for amounts included in the measurement of lease liability – operating leases $ 651 Weighted-average remaining lease term – finance leases 2.27 years Weighted-average remaining lease term – operating leases 4.98 years Weighted-average discount rate – finance leases 9.7 % Weighted-average discount rate – operating leases 12.1 % |
Schedule of Reconciliation of Undiscounted Cash Flows to Operating and Financing Lease Liabilities | The following table reconciles the undiscounted cash flows to the operating and financing lease liabilities at December 31, 2022 (in thousands): Financing Leases Operating Leases 2023 $ 789 $ 1,190 2024 566 1,212 2025 302 1,224 2026 — 1,013 2027 — 768 Thereafter — 421 Total lease payment 1,657 5,828 Less: interest 164 1,447 Total lease liabilities 1,493 4,381 Less: short-term lease liability 682 707 Long-term lease liability $ 811 $ 3,674 |
Organization and Nature of Op_2
Organization and Nature of Operations - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 2 Months Ended | 12 Months Ended | ||||||
Nov. 01, 2022 | Aug. 19, 2022 | Aug. 16, 2022 | Aug. 01, 2022 | Aug. 03, 2021 | Oct. 16, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Organization And Nature Of Operations [Line Items] | ||||||||
Losses from operations | $ 28,521 | $ 14,653 | ||||||
Accumulated deficit | $ (61,212) | $ (32,691) | ||||||
Additional purchase common stock shares | 268,949 | |||||||
Aggregate of common stock shares issued | 24,545,157 | 18,781,242 | ||||||
Proceeds from the issuance of common stock | $ 9,542 | $ 36,327 | ||||||
Common stock valued | 3 | 2 | ||||||
Cash | 18,182 | 37,021 | ||||||
Maximum [Member] | ||||||||
Organization And Nature Of Operations [Line Items] | ||||||||
Public Float | $ 75,000 | |||||||
IPO [Member] | ||||||||
Organization And Nature Of Operations [Line Items] | ||||||||
Sale of stock, date | Aug. 03, 2021 | |||||||
Shares issued | 5,394,737 | |||||||
Shares issued price per share | $ 1.90 | $ 1.90 | $ 1.90 | |||||
Sale of shares | 5,663,686 | 4,000,000 | ||||||
Offering price, per share | $ 10 | |||||||
Proceeds from Issuance Initial Public Offering | $ 9,400 | $ 9,400 | ||||||
Aggregate net proceeds from offering | $ 400 | $ 9,000 | $ 32,300 | |||||
Stock options exercises, shares | 10,990,065 | 10,990,065 | ||||||
ATM [Member] | ||||||||
Organization And Nature Of Operations [Line Items] | ||||||||
Sale of shares | 43,000 | |||||||
Aggregate net proceeds from offering | $ 100 | |||||||
Aggregate of common stock shares issued | 43,000 | |||||||
Proceeds from the issuance of common stock | $ 50,000 | $ 100 | ||||||
SEC [Member] | ||||||||
Organization And Nature Of Operations [Line Items] | ||||||||
Proceeds from the issuance of common stock | 200,000 | |||||||
SEC [Member] | Maximum [Member] | ||||||||
Organization And Nature Of Operations [Line Items] | ||||||||
Public Float | $ 75,000 | |||||||
Series A Financing | ||||||||
Organization And Nature Of Operations [Line Items] | ||||||||
Losses from operations | (28,500) | $ (14,700) | ||||||
Accumulated deficit | $ 61,200 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Property and Equipment Estimated Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Software | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, Estimated useful life | 3 years |
Machinery and equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, Estimated useful life | 3 years |
Machinery and equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, Estimated useful life | 5 years |
Furniture | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, Estimated useful life | 5 years |
Leasehold Improvement | |
Property, Plant and Equipment [Line Items] | |
Useful lives of Leasehold Improvement | The shorter of the useful life of the leasehold improvement or the remaining term of the lease |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Aug. 03, 2021 | |
Significant Accounting Policies [Line Items] | |||
Restricted cash | $ 252,000 | $ 251,000 | |
Impairment of long-lived assets | 0 | 0 | |
Lease liabilities | 4,381,000 | ||
Prepaid expenses and other current assets | (2,093,000) | (1,876,000) | |
Right of use assets - operating leases | $ 4,181,000 | $ 1,630,000 | |
Dividend rate | 0% | 0% | |
IPO [Member] | |||
Significant Accounting Policies [Line Items] | |||
Deferred offering costs | $ 4,000,000 | ||
Accounting Standards Update 2016-02 | |||
Significant Accounting Policies [Line Items] | |||
Lease liabilities | $ 1,700,000 | ||
Prepaid expenses and other current assets | (40,000) | ||
Reduction to deferred rent | 20,000 | ||
Right of use assets - operating leases | $ 1,700,000 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Components of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development | $ 2,562 | $ 49 |
Prepaid insurance | 1,258 | 1,858 |
Other | 232 | 52 |
Prepaid expenses and other current assets | $ 4,052 | $ 1,959 |
Property And Equipment, Net - S
Property And Equipment, Net - Schedule of Components of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Less accumulated depreciation | $ (321) | $ (346) |
Property and equipment, net | 4,397 | 97 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 358 | 443 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 335 | 0 |
Computer Software, Intangible Asset [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 126 | 0 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 3,899 | $ 0 |
Property And Equipment, Net - A
Property And Equipment, Net - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization | $ 147 | $ 89 |
Construction In Progress - Sche
Construction In Progress - Schedule of Construction In Progress (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Public Utilities, Property, Plant and Equipment, Plant in Service [Abstract] | ||
Furniture | $ 29 | $ 77 |
Leasehold improvements | 0 | 200 |
Internal use software not yet in service | 0 | 126 |
Construction in Progress | $ 29 | $ 403 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued clinical trials | $ 253 | $ 196 |
Accrued compensation | 1,460 | 926 |
Accrued legal | 211 | 62 |
Accrued other | 418 | 51 |
Total accrued expenses and other current liabilities | $ 2,342 | $ 1,235 |
Debt - Additional Information (
Debt - Additional Information (Details) - Paycheck Protection Program [Member] - USD ($) $ in Millions | 1 Months Ended | |
Aug. 31, 2021 | Apr. 30, 2020 | |
Debt Instrument [Line Items] | ||
Loan | $ 0.2 | |
Loan maturity, date | Apr. 16, 2022 | |
Interest rate | 1% | |
Debt instrument, payment terms | monthly | |
Debt instrument, date of first required payment | Nov. 16, 2020 | |
Repayment of loan | $ 0.2 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 2 Months Ended | 12 Months Ended | ||||||
Nov. 01, 2022 | Aug. 01, 2022 | Aug. 03, 2021 | Oct. 16, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Aug. 19, 2022 | Aug. 16, 2022 | |
Class Of Stock [Line Items] | ||||||||
Common stock, shares authorized | 490,000,000 | 490,000,000 | ||||||
Capital Stock Authorized | 500,000,000 | |||||||
Undesignated Preferred stock shares, authorized | 10,000,000 | 10,000,000 | ||||||
Aggregate of common stock shares issued | 24,545,157 | 18,781,242 | ||||||
Common stock, shares, outstanding | 24,545,157 | 18,781,242 | ||||||
Preferred Stock, Shares Outstanding | 0 | 0 | ||||||
Preferred stock shares issued | 0 | 0 | ||||||
Proceeds from Issuance of Common Stock | $ 9,542 | $ 36,327 | ||||||
Common Stock, Value, Issued | $ 3 | $ 2 | ||||||
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 | ||||||
Preferred stock par value | $ 0.0001 | $ 0.0001 | ||||||
IPO [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Shares issued | 5,394,737 | |||||||
Shares issued price per share | $ 1.90 | $ 1.90 | $ 1.90 | |||||
Proceeds from Issuance Initial Public Offering | $ 9,400 | $ 9,400 | ||||||
Sale of shares | 5,663,686 | 4,000,000 | ||||||
Common stock par or stated value per share | $ 10 | |||||||
Stock options exercises, shares | 10,990,065 | 10,990,065 | ||||||
SEC [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Proceeds from Issuance of Common Stock | $ 200,000 | |||||||
ATM [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Aggregate of common stock shares issued | 43,000 | |||||||
Offering Cost | 200,000 | |||||||
Proceeds from Issuance of Common Stock | 50,000 | $ 100 | ||||||
Number of transaction in sold amount | 0 | |||||||
Sale of shares | 43,000 | |||||||
Maximum [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Public Float | $ 75,000 | |||||||
Maximum [Member] | SEC [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Public Float | $ 75,000 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Jul. 29, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Weighted average grant-date fair value of options granted | $ 2.85 | $ 5.41 | |
Aggregate intrinsic value of stock options exercised | $ 100 | ||
Tax benefit from stock based compensation expense | $ 0 | $ 0 | |
Weighted-average period over which cost not yet recognized is expected to be recognized | 2 years 8 months 1 day | ||
Restricted Stock [Member] | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Share-based payment arrangement, unrecognized stock based compensation cost | $ 8,300 | ||
2020 Equity Incentive Plan | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Common stock reserved for future issuance | 4,200,000 | ||
Shares reserved of issuance under the plan increase duration | 10 years | ||
Percentage of number of shares of common stock outstanding | 5% | ||
Maximum number of shares of common stock issuable | 13,000,000 | ||
Share-based payment award, number of shares available for grant | 979,502 | ||
2020 Equity Incentive Plan | January 1, 2022 [Member] | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Common stock reserved for future issuance | 5,139,062 | ||
2020 Employee Stock Purchase Plan | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Share-based payment award, shares issued in period | 0 | ||
Common stock reserved for future issuance | 200,000 | ||
Shares reserved of issuance under the plan increase duration | 10 years | ||
Percentage of number of shares of common stock outstanding | 1% | ||
Maximum number of shares of common stock issuable | 400,000 | ||
Share-based payment award, number of shares available for grant | 200,000 | ||
2020 Employee Stock Purchase Plan | January 1, 2023 [Member] | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Common stock reserved for future issuance | 633,264 |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock Option Award Activities (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement [Abstract] | ||
Options outstanding, beginning balance | 2,306,379 | |
Options granted | 1,845,682 | |
Options exercised | (57,229) | |
Options forfeited | (91,538) | |
Options outstanding, ending balance | 4,003,294 | 2,306,379 |
Options exercisable | 1,115,004 | |
Options vested or expected to vest | 2,888,290 | |
Options outstanding, weighted average exercise price, beginning balance | $ 6.51 | |
Options granted, weighted average exercise price | 2.85 | |
Options exercised, weighted average exercise price | 1.07 | |
Options forfeited, weighted average exercise price | 6.47 | |
Options outstanding, weighted average exercise price, ending balance | 4.90 | $ 6.51 |
Options exercisable, weighted average exercise price | 6.16 | |
Options vested or expected to vest, weighted average exercise price | $ 4.41 | |
Options outstanding, weighted average remaining contractual term | 8 years 3 months 10 days | 8 years 11 months 26 days |
Options exercisable, weighted average remaining contractual term | 7 years 10 months 20 days | |
Options vested or expected to vest, weighted average remaining contractual term | 8 years 11 months 15 days | |
Options outstanding, aggregate intrinsic value | $ 860 | $ 983 |
Options exercisable, aggregate intrinsic value | 195 | |
Options vested or expected to vest, aggregate intrinsic value | $ 664 |
Stock-based Compensation - Sche
Stock-based Compensation - Schedule of Estimating Fair Value of the Stock Options and Common stock Warrants Granted (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate minimum | 1.99% | 0.66% |
Risk-free interest rate maximum | 4.31% | 1.32% |
Dividend rate | 0% | 0% |
Minimum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Volatility | 86.91% | 85.67% |
Expected life (years) | 5 years 3 months 7 days | 5 years 5 months 26 days |
Maximum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Volatility | 89.16% | 89.15% |
Expected life (years) | 6 years 29 days | 6 years 8 months 4 days |
Stock-based Compensation - Sc_2
Stock-based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 3,467 | $ 2,195 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 1,404 | 1,014 |
General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 2,063 | $ 1,181 |
License Agreements - Additional
License Agreements - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Aug. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Aggregate of common stock shares issued | 24,545,157 | 18,781,242 | |
UABRF [Member] | |||
Equity Method Investment, Ownership Percentage | 2.50% | ||
Raise of investment | $ 20 | ||
UABRF [Member] | Antidilution Provision [Member] | |||
Aggregate of common stock shares issued | 151,382 | ||
Raise of investment | $ 36.6 | ||
Emory License Agreement [Member] | UABRF [Member] | |||
License agreement description | The term of the Emory License Agreement will continue until 15 years after the first commercial sale of licensed product, or the expiration of the relevant licensed patents, whichever is later | ||
Milestone payment | $ 1.4 | ||
Exclusive License Agreement [Member] | UABRF [Member] | |||
Aggregate of common stock shares issued | 91,250 | ||
Royalties on cumulative net sales | $ 22.5 | ||
Exclusive License Agreement [Member] | UABRF [Member] | Maximum | |||
Milestone payment | $ 1.4 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) $ in Millions | Dec. 31, 2022 USD ($) |
Income Tax Disclosure [Abstract] | |
Capitalized research and development expenses | $ 9.8 |
Federal NOL carryforwards | 36.6 |
New York State and City NOL carryforwards | 25 |
Increase in valuation allowance, net deferred tax | $ 4.5 |
Percentage of stock ownership with regards to limitations on the use of net operating loss carryovers | 5% |
Income Taxes - Schedule of Tax
Income Taxes - Schedule of Tax Provision (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Current provision (benefit): | ||
Federal | $ 0 | $ 0 |
State | 0 | 0 |
Current provision (benefit) | 0 | 0 |
Deferred provision (benefit) | ||
Federal | (5,967) | (2,670) |
State | 1,455 | (1,938) |
Deferred provision (benefit) | (4,512) | (4,608) |
Change in valuation allowance | 4,512 | 4,608 |
Income tax provision (benefit) | $ 0 | $ 0 |
Income Taxes - Schedule of Diff
Income Taxes - Schedule of Difference Between Income Taxes at Federal Statutory Rate and Effective Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
U.S Federal statutory rate | 21% | 21% |
State taxes, net of Federal Benefit | 0% | 10% |
Stock-based compensation | (1.00%) | (2.00%) |
Other permanent differences | 0% | 1% |
True up adjustments | (4.00%) | 3% |
Change in valuation allowance | (16.00%) | (31.00%) |
Income tax provision (benefit) | 0% | 0% |
Income Taxes - Schedule of Net
Income Taxes - Schedule of Net Deferred Tax Assets (Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Stock-based compensation | $ 920 | $ 337 |
Net operating loss carryforwards and alternative minimum tax credits | 9,737 | 6,803 |
Lease accounting | 1,234 | 791 |
Reserves and accruals | 307 | 304 |
Intangibles and fixed assets | 2,940 | 1,922 |
Total deferred tax assets | 15,137 | 10,157 |
Deferred tax liabilities | ||
ROU assets | (1,233) | (766) |
Total deferred tax liabilities | (1,233) | (766) |
Valuation allowance | (13,903) | (9,391) |
Deferred tax assets (liabilities), net | $ 0 | $ 0 |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Net loss | $ (28,521) | $ (14,653) |
Net loss per share - diluted | $ (1.36) | $ (1.47) |
Net loss per share - basic | $ (1.36) | $ (1.47) |
Weighted average number of shares used in computing net loss per share basic and diluted | 20,967,955 | 9,969,733 |
Weighted-average number of shares used in computing net loss per common share - basic | 20,967,955 | 9,969,733 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Options To Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 3,200,412 | 1,723,587 |
Commitments and Contingencies (
Commitments and Contingencies (Additional Information) (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Royalty term | 15 years |
Facility Leases - Additional In
Facility Leases - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Loss Contingencies [Line Items] | ||
Agreement Threshold | $ 1,245,000 | $ 1,363,000 |
Construction in progress | 29,000 | 403,000 |
Restricted cash | 252,000 | 251,000 |
Other current assets | 232,000 | 52,000 |
Other non-current assets | 255,000 | 158,000 |
Birmingham, Alabama | ||
Loss Contingencies [Line Items] | ||
Construction in progress | 4,100,000 | |
Other current assets | $ 10,000 | 10,000,000 |
Other non-current assets | 17,000 | |
New York [Member] | ||
Loss Contingencies [Line Items] | ||
Lease expiration month and year | 2027-03 | |
Office Building | Birmingham, Alabama | ||
Loss Contingencies [Line Items] | ||
Operating lease, term of contract | 63 months | |
Operating lease, option to extend | option to extend five years | |
Office and Laboratory | Birmingham, Alabama | ||
Loss Contingencies [Line Items] | ||
Operating lease, existence of option to extend | true | |
Maximum | ||
Loss Contingencies [Line Items] | ||
Agreement Threshold | $ 4,000,000 | |
Minimum | Birmingham, Alabama | ||
Loss Contingencies [Line Items] | ||
Security deposit | $ 262,000 | 278,000 |
Machinery and equipment | ||
Loss Contingencies [Line Items] | ||
Leaseback transaction, description | Company had completed the sale and leaseback for four pieces of equipment and is leasing three other items directly from the leasing company. The terms of the leases are three years and afterwards provide for either annual extensions or an outright purchase of the equipment. | |
Security deposit | $ 255,000 | $ 141,000 |
Machinery and equipment | Maximum | ||
Loss Contingencies [Line Items] | ||
Amount held for equipment purchases | $ 2,500,000 |
Facility Leases - Summary of Le
Facility Leases - Summary of Lease Costs and Other Information to Company's Finance and Operating Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Lease Cost | ||
Amortization of finance right-of-use assets | $ 461 | $ 537 |
Interest on finance lease liabilities | 53 | 86 |
Operating lease cost | 731 | 280 |
Short-term lease cost | 0 | 460 |
Total lease cost | 1,245 | $ 1,363 |
Cash paid for amounts included in the measurement of lease liability – finance leases | 261 | |
Cash paid for amounts included in the measurement of lease liability – operating leases | $ 651 | |
Weighted-average remaining lease term – finance leases | 2 years 3 months 7 days | |
Weighted-average remaining lease term – operating leases | 4 years 11 months 23 days | |
Weighted-average discount rate – finance leases | 9.70% | |
Weighted-average discount rate – operating leases | 12.10% |
Facility Leases - Schedule of R
Facility Leases - Schedule of Reconciliation of Undiscounted Cash Flows to Operating and Finance Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2023 | $ 789 | |
2024 | 566 | |
2025 | 302 | |
2026 | 0 | |
2027 | 0 | |
Thereafter | 0 | |
Total lease payment | 1,657 | |
Less: interest | 164 | |
Total lease liability | 1,493 | |
Short-term financing lease liability | 682 | $ 392 |
Long-term financing lease liability | 811 | 269 |
2023 | 1,190 | |
2024 | 1,212 | |
2025 | 1,224 | |
2026 | 1,013 | |
2027 | 768 | |
Thereafter | 421 | |
Total lease payment | 5,828 | |
Less: interest | 1,447 | |
Total lease liability | 4,381 | |
Less: short-term operating lease liability | 707 | 234 |
Long-term operating lease liability | $ 3,674 | $ 1,515 |
Schedule Of Quarterly Financial
Schedule Of Quarterly Financial Data - Schedule of Selected Quarterly Financial Data (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Prepaid research and development | $ 14,062 | $ 7,347 |
General and administrative | 14,459 | 7,306 |
Total operating expenses | 28,521 | 14,653 |
Loss from operations | (28,521) | (14,653) |
Net loss | $ (28,521) | $ (14,653) |
SUBSEQUENT EVENTS (Additional I
SUBSEQUENT EVENTS (Additional Information) (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Jan. 01, 2023 | Nov. 01, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | ||||
Proceeds from issuance of common stock after deducting underwriting discounts. | $ 9,542 | $ 36,327 | ||
ATM [Member] | ||||
Subsequent Event [Line Items] | ||||
Proceeds from issuance of common stock after deducting underwriting discounts. | $ 50,000 | $ 100 | ||
Sale of shares | 43,000 | |||
Subsequent Event [Member] | ATM [Member] | ||||
Subsequent Event [Line Items] | ||||
Proceeds from issuance of common stock after deducting underwriting discounts. | $ 700 | |||
Sale of shares | 392,901 |