Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 06, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Registrant Name | IN8BIO, INC. | |
Entity Central Index Key | 0001740279 | |
Entity Tax Identification Number | 82-5462585 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity File Number | 001-39692 | |
Entity Shell Company | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Small Business | true | |
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 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | INAB | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 44,123,949 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets | ||||
Cash | $ 13,015 | $ 10,860 | ||
Prepaid expenses and other current assets | 2,740 | $ 3,343 | ||
Non-current assets | ||||
Property and equipment, net | 3,325 | 3,514 | ||
Restricted cash | 256 | 253 | ||
Current liabilities | ||||
Accrued expenses and other current liabilities | 895 | 2,955 | ||
Short-term finance lease liability | 680 | |||
Short-term operating lease liability | 856 | |||
Long-term finance lease liability | 351 | |||
Long-term operating lease liability | 3,828 | |||
Stockholders' Equity | ||||
Total Stockholders' Equity | $ 17,526 | $ 24,937 | $ 16,788 | $ 22,732 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) | Mar. 31, 2024 $ / shares shares |
Statement of Financial Position [Abstract] | |
Preferred stock shares authorised | 10,000,000 |
Common stock, par value | $ / shares | $ 0.0001 |
Common stock, shares authorized | 490,000,000 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses: | ||
Research and development | $ 4,903 | $ 4,385 |
General and administrative | 3,742 | 3,470 |
Total operating expenses | 8,645 | 7,855 |
Interest income | 83 | 0 |
Other Income | 0 | 330 |
Loss from operations | (8,562) | (7,525) |
Net loss | $ (8,562) | $ (7,525) |
Net loss per share attributable to common stockholders - basic | $ (0.2) | $ (0.3) |
Net loss per share attributable to common stockholders - diluted | $ (0.2) | $ (0.3) |
Weighted-average number of shares used in computing net loss per common share, basic | 43,287,325 | 24,732,580 |
Weighted-average number of shares used in computing net loss per common share, diluted | 43,287,325 | 24,732,580 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] |
Shares beginning at Dec. 31, 2022 | 24,545,157 | |||
Balance beginning at Dec. 31, 2022 | $ 22,732 | $ 3 | $ 83,941 | $ (61,212) |
Stock issued during period shares new issues, amount | 722 | 722 | ||
Stock issued during period shares new issues, shares | 415,712 | |||
Issuance costs | 0 | |||
Stock-based compensation expense | 859 | 859 | ||
Net Income (Loss) | (7,525) | (7,525) | ||
Shares ending at Mar. 31, 2023 | 24,960,869 | |||
Balance ending at Mar. 31, 2023 | 16,788 | $ 3 | 85,522 | (68,737) |
Shares beginning at Dec. 31, 2023 | 43,287,325 | |||
Balance beginning at Dec. 31, 2023 | 24,937 | $ 4 | 116,152 | (91,219) |
Issuance costs | (89) | (89) | ||
Stock-based compensation expense | 1,240 | 1,240 | ||
Net Income (Loss) | (8,562) | (8,562) | ||
Shares ending at Mar. 31, 2024 | 43,287,325 | |||
Balance ending at Mar. 31, 2024 | $ 17,526 | $ 4 | $ 117,303 | $ (99,781) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating activities | ||
Net loss | $ (8,562) | $ (7,525) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 239 | 243 |
Non-cash stock-based compensation | 1,240 | 859 |
Amortization of financing lease right-of-use assets | 204 | 188 |
Amortization of operating lease right-of-use assets | 189 | 159 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 603 | 510 |
Other non-current assets | (65) | 0 |
Accounts payable | 489 | (1,035) |
Accrued expenses and other current liabilities | (2,060) | (667) |
Short-term operating lease liabilities | 37 | 25 |
Long-term operating lease liabilities | (233) | (196) |
Net cash used in operating activities | (7,919) | (7,439) |
Investing activities | ||
Purchases of property and equipment | (50) | (371) |
Construction in progress | (21) | (58) |
Net cash used in investing activities | (71) | (429) |
Financing activities | ||
Payment of issuance costs | (89) | 0 |
Proceeds from the issuance of common stock, net of issuance costs | 0 | 722 |
Principal payments on financing leases | (188) | (175) |
Net cash (used in) provided by financing activities | (277) | 547 |
Net decrease in cash and restricted cash | (8,267) | (7,321) |
Cash and restricted cash at beginning of period | 21,538 | 18,434 |
Cash and restricted cash at end of period | 13,271 | 11,113 |
Cash, end of period | 13,015 | 10,860 |
Restricted cash, end of period | 256 | 253 |
Cash and restricted cash, end of period | 13,271 | 11,113 |
Supplemental disclosure of non-cash operating, financing and investing information | ||
Initial measurement of operating lease right-of-use assets and liabilities | 714 | 0 |
Lease modification of operating lease right-of-use assets and liabilities | $ 492 | $ 0 |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Payment of issuance costs | $ 89 | $ 0 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (8,562) | $ (7,525) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
NonRule10b51ArrModifiedFlag | false |
Rule10B51ArrModifiedFlag | false |
Organization and Nature of Oper
Organization and Nature of Operations | 3 Months Ended |
Mar. 31, 2024 | |
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 candidate, INB-400, is currently in a company-sponsored Phase 2 clinical trial in which autologous, genetically modified gamma-delta T cells will be assessed in newly diagnosed glioblastoma ("GBM") patients at centers across the United States. In addition, the Company has two programs in Phase 1 clinical trials: INB-200, for the treatment of patients with newly diagnosed GBM, and INB-100, for the treatment of patients with hematologic malignancies that are undergoing hematopoietic stem cell transplantation ("HSCT"). In addition, the Company’s DeltEx platform has yielded a broad portfolio of preclinical programs, including INB-300 and INB-500, focused on addressing acute myeloid leukemia ("AML") and other solid and hematological 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 ("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. Liquidity and Going Concern To date, the Company has funded its operations primarily with proceeds from various public and private offerings of its common stock, preferred stock and warrants. The Company has incurred recurring losses and negative operating cash flows since its inception, including net losses of $ 8.6 million and $ 7.5 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, the Company had an accumulated deficit of $ 99.8 million. 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. Based on the Company’s business strategy, its existing cash of $ 13.0 million as of March 31, 2024 will only fund the Company’s projected operating expenses and capital expenditure requirements into January 2025. Accordingly, there is substantial doubt about the Company’s ability to continue to operate as a going concern for a period of 12 months from the date of issuance of these condensed financial statements. 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 equity and/or debt offerings, including through at-the-market program ("ATM") offerings and private placements of securities, and identifying strategic collaborations, licensing or other arrangements to support development of the Company’s product candidates. Through May 2, 2024, the Company sold an aggregate of 856,624 shares of its common stock under the ATM program, resulting in net proceeds of approximately $ 1.0 million after deducting underwriting discounts. In addition, the Company may receive an additional $ 14.8 million in aggregate proceeds if the holders of the Series A ordinary warrants exercise their warrants pursuant to the mandatory exercise feature, which is triggered upon the Company's public announcement of INB-100 data for the 10 currently enrolled patients, should they remain alive and evaluable, covering a period of at least 11 months of long-term follow-up for each patient, along with certain stock price and trading volume requirements. Further, if not otherwise redeemed by the Company, the Company may also receive aggregate proceeds of up to $ 17.7 million from the exercise of its outstanding Series B ordinary warrants. There is no assurance, however, that the Company will receive any additional proceeds from these warrants or 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 condensed 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 | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Significant Accounting Policies The Company’s significant accounting policies, which are disclosed in the audited financial statements for the year ended December 31, 2023 and the notes thereto, are included in the Company’s Annual Report on Form 10-K (the “Annual Report”) that was filed with the Securities and Exchange Commission ("SEC") on March 14, 2024. Since the date of that filing, there have been no material changes to the Company’s significant accounting policies. Basis of Presentation The Company has prepared the accompanying condensed financial statements in conformity with generally accepted accounting principles in the United States ("U.S. GAAP"). Un audited Interim Financial Information The condensed financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the SEC. Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these condensed financial statements, as is permitted by such rules and regulations. Accordingly, these condensed financial statements should be read in conjunction with the financial statements and notes thereto in the Company's Annual Report. The results for any interim period are not necessarily indicative of results for any future period. In the opinion of the Company’s management, all adjustments (consisting of normal and recurring adjustments) considered necessary for a fair statement of the results for the interim periods presented have been included. Use of Estimates The preparation of condensed 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 condensed 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 the related valuation allowance, stock-based compensation, the useful lives of property and equipment and the valuation of warrants. 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 and restricted 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 and amortized 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. Capitalized Software The Company capitalizes the application development phase costs of internal use software in accordance with Accounting Standards Codification (“ASC”) 350-40, Intangibles-Goodwill and Other-Internal Use Software . Capitalized costs will be amortized on a straight-line basis over the estimated useful life of the asset upon completion. Recently Issued Accounting Standards Updates The Company has evaluated all other issued and unadopted Accounting Standard Updates , and believes the adoption of these standards will not have a material impact on the condensed financial statements. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2024 | |
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): March 31, December 31, Prepaid research and development $ 1,752 $ 2,283 Prepaid insurance 449 790 Other 539 270 Prepaid expenses and other current assets $ 2,740 $ 3,343 |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 4. PROPERTY AND EQUIPMENT, NET Property and equipment, net consist of the following (in thousands): March 31, December 31, Machinery and equipment $ 427 $ 379 Furniture and fixtures 370 370 Software 126 126 Leasehold improvements 3,924 3,922 Less accumulated depreciation and amortization ( 1,522 ) ( 1,283 ) Property and equipment, net $ 3,325 $ 3,514 Depreciation and amortization expense was $ 0.2 million for the three months ended March 31, 2024 and 2023 . |
Construction in Progress
Construction in Progress | 3 Months Ended |
Mar. 31, 2024 | |
Public Utilities, Property, Plant and Equipment, Plant in Service [Abstract] | |
Construction in Progress | 5. CONSTRUCTION IN PROGRESS Construction in progress consists of the following (in thousands): March 31, December 31, Internal use software not yet in service $ 203 $ 182 Construction in progress $ 203 $ 182 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2024 | |
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): March 31, December 31, Accrued clinical trials $ 153 $ 598 Accrued compensation 480 1,673 Accrued legal 79 306 Accrued other 183 378 Accrued expenses and other current liabilities $ 895 $ 2,955 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | 7. 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. ATM Facility In November 2022, the Company filed a shelf registration statement on Form S-3 (File No. 333-268288) (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 $ 200.0 million of its common stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, of which $ 50.0 million of common stock may be issued and sold pursuant to an ATM. The Company entered into a Controlled Equity Offering SM sales agreement (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. On March 8, 2024, the Company delivered a termination notice to Truist, removing them as a sales agent under the ATM program. Such termination became effective on March 14, 2024. 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 12-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, 2023, the Company's calculated public float was less than $ 75.0 million. During the year ended December 31, 2023, the Company sold an aggregate of 7,492,580 shares of its common stock under the ATM program, resulting in net proceeds of approximately $ 14.4 million after deducting underwriting discounts. Through May 2, 2024, the Company sold an aggregate of 856,624 shares of its common stock under the ATM program, resulting in net proceeds of approximately $ 1.0 million after deducting underwriting discounts. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2024 | |
Other Liabilities Disclosure [Abstract] | |
Warrants | 8. WARRANTS In December 2023, the Company issued 574,241 pre-funded warrants, 11,823,829 Series A warrants and 11,823,829 Series B warrants. The pre-funded warrants have an exercise price of $ 0.0001 per share, are exercisable immediately and are exercisable until the pre-funded warrant is exercised in full. In lieu of making the cash payment otherwise contemplated to be made to the Company upon exercise of a pre-funded warrant in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the pre-funded warrants terms. The pre-funded warrants meet the criteria for permanent equity classification. As of March 31, 2024 , 574,241 pre-funded warrants were issued and outstanding. The Series A warrants have an exercise price of $ 1.25 per share. The Series A warrants are exercisable immediately and expire on June 13, 2025 . The Company has the option to cause the Series A warrants to be exercised at a strike price of $ 1.25 per share upon the Company’s public announcement of INB-100 clinical data for the 10 currently enrolled patients, should they remain alive and evaluable, covering a period of at least 11 months, along with certain stock price and trading volume requirements. The Series A warrants meet the criteria for permanent equity classification. As of March 31, 2024 , 11,823,829 Series A warrants were issued and outstanding. The Series B warrants have an exercise price of $ 1.50 per share. The Series B warrants are exercisable immediately and expire on December 13, 2028 . The Series B warrants allow the Company to redeem such warrants at a price of $ 0.01 per Series B warrant upon the Company’s public announcement of its INB-100 data for all enrolled patients covering a period of at least 22 months, along with certain stock price and trading volume requirements. Holders of Series B warrants may choose to exercise such warrants at a purchase price of $ 1.50 per share prior to such redemption. The Series B warrants meet the criteria for permanent equity classification. As of March 31, 2024 , 11,823,829 Series B warrants were issued and outstanding. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
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 Company's Board of Directors and the Company’s stockholders and became effective on July 29, 2021. Upon the effectiveness of the 2023 Plan (as defined below), the 2020 Plan was terminated and no further issuances were made under the 2020 Plan, although it continues to govern the terms of any equity grants that remain outstanding under the 2020 Plan. Amended and Restated 2023 Equity Incentive Plan The Amended and Restated 2023 Equity Incentive Plan (the “2023 Plan”) was approved by the Company's Board of Directors and the Company’s stockholders and became effective on June 15, 2023. The Board of Directors, or a committee thereof, is authorized to administer the 2023 Plan. The 2023 Plan provides for the grant of Incentive Stock Options ("ISO") within the meaning of Section 422 of the Internal Revenue Code ("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 the Company’s employees, directors and consultants and any Company affiliates’ employees and consultants. The number of shares initially reserved for issuance under the 2023 Plan was 7,400,000 , which automatically increases on January 1 of each year for a period of 10 years , beginning on January 1, 2024 and continuing through January 1, 2033, 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 2023 Plan is 41,000,000 shares. Pursuant to the terms of the 2023 Plan, the number of shares available under the 2023 Plan was increased by 2,164,366 shares effective January 1, 2024. As of March 31, 2024, 7,227,415 shares were available for grant pursuant to the 2023 Plan, including the increase effective January 1, 2024. 2020 Employee Stock Purchase Plan The 2020 Employee Stock Purchase Plan (the “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 by the lesser of (i) 1 % of the outstanding number of shares of common stock on the immediately preceding December 31 and (ii) 400,000 , or such lesser number of shares as determined by the Board of Directors. As of March 31, 2024 , no shares of common stock had been issued under the ESPP and 787,812 shares remained available for future issuance under the ESPP. The Company’s Board of Directors or designated committee has not set an offering period. Pursuant to the terms of the ESPP, the number of shares available under the ESPP increased by 400,000 shares, effective January 1, 2024. Stock Option Activity The following is a summary of the stock option award activity during the three months ended March 31, 2024: Number Weighted- Weighted- Aggregate Outstanding at December 31, 2023 6,695,933 $ 3.52 8.32 $ 361 Granted 1,690,675 1.24 Exercised — — Forfeited ( 50,335 ) 4.43 Outstanding at March 31, 2024 8,336,273 $ 3.05 8.49 $ 40 Exercisable at March 31, 2024 2,797,539 $ 5.04 7.45 $ 17 Options expected to vest as of March 31, 2024 5,538,734 $ 2.05 9.02 $ 23 The weighted-average grant date fair value of options granted during the three months ended March 31, 2024 and 2023 was $ 1.24 and $ 2.00 , 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 March 31, 2024 and December 31, 2023. Stock-Based Compensation Expense For the three months ended March 31, 2024 and 2023 , 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: March 31, March 31, Volatility 94.20 % - 102.54 % 91.91 % Expected life (years) 6.08 6.08 Risk-free interest rate 3.98 % - 4.16 % 3.99 % 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 condensed statements of operations for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended 2024 2023 Research and development $ 532 $ 389 General and administrative 708 470 Total stock-based compensation expense $ 1,240 $ 859 No related tax benefits from stock-based compensation expense were recognized for the three months ended March 31, 2024 and 2023. As of March 31, 2024, there was $ 7.5 million in unrecognized stock-based compensation expense, which is expected to be recognized over a weighted-average period of 2.63 years. |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2024 | |
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 the 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. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 11. 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): Three Months Ended 2024 2023 Net loss $ ( 8,562 ) $ ( 7,525 ) Net loss per share—basic and diluted $ ( 0.20 ) $ ( 0.30 ) Weighted-average number of shares used in computing net loss 43,287,325 24,732,580 The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share, as their effect is antidilutive: Three Months Ended 2024 2023 Stock options to purchase common stock 7,707,784 3,870,924 Pre-Funded Warrants 574,241 — Series A Warrants 11,823,829 — Series B Warrants 11,823,829 — Total 31,929,683 3,870,924 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | 12. 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 party 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. |
Equipment and Facility Leases
Equipment and Facility Leases | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Equipment and Facility Leases | 13. EQUIPMENT AND Facility LEASES The Company has historically entered into lease arrangements for its facilities. As of March 31, 2024, the Company had four operating leases with required future minimum payments. 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 date. 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 March 31, 2024 , the Company has 11 active leases 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 Company entered into an agreement with another equipment leasing company in the second quarter of 2023. As of March 31, 2024 , the Company has one active lease from this leasing company. The terms of the lease are three years and afterwards provide for either annual extensions or an outright purchase of the equipment. The equipment leases require three advance rental payments to be held as security deposits. The security deposits held amounted to approximately $ 0.3 million as of March 31, 2024 and December 31, 2023, and are included in other non-current assets on the condensed balance sheets. Operating Leases The Company has an operating lease for office space in Birmingham, Alabama, which was modified and expanded in March 2024 for a 60-month term ending in March 2029, with an option to extend five years, resulting in an increase to both the right of use assets and operating lease liabilities . 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 operating leases require security deposits at the inception of each lease. The security deposits amounted to approximately $ 0.3 million as of March 31, 2024 and December 31, 2023. As of March 31, 2024 and December 31, 2023, approximately $ 256,000 was included in restricted cash and $ 10,000 was included in other current assets. The following table contains a summary of the lease costs recognized and other information pertaining to the Company’s finance and operating leases for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended 2024 2023 Lease Cost Amortization of finance right-of-use assets $ 204 $ 149 Interest on finance lease liabilities 27 14 Operating lease cost 304 112 Short-term lease cost 83 105 Variable lease cost 24 — Total lease cost $ 642 $ 380 March 31, Other Lease Information Cash paid for amounts included in the measurement of lease liability – finance leases $ 27 Cash paid for amounts included in the measurement of lease liability – operating leases $ 310 Weighted-average remaining lease term – finance leases (years) 1.57 Weighted-average remaining lease term – operating leases (years) 4.36 Weighted-average discount rate – finance leases 9.5 % Weighted-average discount rate – operating leases 12.7 % The following table reconciles the undiscounted cash flows to the operating and finance lease liabilities at March 31, 2024 (in thousands): Finance Leases Operating Leases Remainder of 2024 $ 552 $ 1,051 2025 501 1,401 2026 52 1,416 2027 — 1,224 2028 — 891 Thereafter — 120 Total lease payment 1,105 6,103 Less: interest 74 1,419 Total lease liabilities 1,031 4,684 Less: short-term lease liability 680 856 Long-term lease liability $ 351 $ 3,828 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies, which are disclosed in the audited financial statements for the year ended December 31, 2023 and the notes thereto, are included in the Company’s Annual Report on Form 10-K (the “Annual Report”) that was filed with the Securities and Exchange Commission ("SEC") on March 14, 2024. Since the date of that filing, there have been no material changes to the Company’s significant accounting policies. |
Basis of Presentation | Basis of Presentation The Company has prepared the accompanying condensed financial statements in conformity with generally accepted accounting principles in the United States ("U.S. GAAP"). |
Unaudited Interim Financial Information | Un audited Interim Financial Information The condensed financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the SEC. Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these condensed financial statements, as is permitted by such rules and regulations. Accordingly, these condensed financial statements should be read in conjunction with the financial statements and notes thereto in the Company's Annual Report. The results for any interim period are not necessarily indicative of results for any future period. In the opinion of the Company’s management, all adjustments (consisting of normal and recurring adjustments) considered necessary for a fair statement of the results for the interim periods presented have been included. |
Use of Estimates | Use of Estimates The preparation of condensed 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 condensed 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 the related valuation allowance, stock-based compensation, the useful lives of property and equipment and the valuation of warrants. 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 and restricted 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 and amortized 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. |
Capitalized Software | Capitalized Software The Company capitalizes the application development phase costs of internal use software in accordance with Accounting Standards Codification (“ASC”) 350-40, Intangibles-Goodwill and Other-Internal Use Software . Capitalized costs will be amortized on a straight-line basis over the estimated useful life of the asset upon completion. |
Recently Issued Accounting Standards Updates | Recently Issued Accounting Standards Updates The Company has evaluated all other issued and unadopted Accounting Standard Updates , and believes the adoption of these standards will not have a material impact on the condensed financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Property and Equipment | 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 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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): March 31, December 31, Prepaid research and development $ 1,752 $ 2,283 Prepaid insurance 449 790 Other 539 270 Prepaid expenses and other current assets $ 2,740 $ 3,343 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Components of Property and Equipment, Net | Property and equipment, net consist of the following (in thousands): March 31, December 31, Machinery and equipment $ 427 $ 379 Furniture and fixtures 370 370 Software 126 126 Leasehold improvements 3,924 3,922 Less accumulated depreciation and amortization ( 1,522 ) ( 1,283 ) Property and equipment, net $ 3,325 $ 3,514 |
Construction in Progress (Table
Construction in Progress (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Public Utilities, Property, Plant and Equipment, Plant in Service [Abstract] | |
Schedule of construction in progress | Construction in progress consists of the following (in thousands): March 31, December 31, Internal use software not yet in service $ 203 $ 182 Construction in progress $ 203 $ 182 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following (in thousands): March 31, December 31, Accrued clinical trials $ 153 $ 598 Accrued compensation 480 1,673 Accrued legal 79 306 Accrued other 183 378 Accrued expenses and other current liabilities $ 895 $ 2,955 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Award Activity | The following is a summary of the stock option award activity during the three months ended March 31, 2024: Number Weighted- Weighted- Aggregate Outstanding at December 31, 2023 6,695,933 $ 3.52 8.32 $ 361 Granted 1,690,675 1.24 Exercised — — Forfeited ( 50,335 ) 4.43 Outstanding at March 31, 2024 8,336,273 $ 3.05 8.49 $ 40 Exercisable at March 31, 2024 2,797,539 $ 5.04 7.45 $ 17 Options expected to vest as of March 31, 2024 5,538,734 $ 2.05 9.02 $ 23 |
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: March 31, March 31, Volatility 94.20 % - 102.54 % 91.91 % Expected life (years) 6.08 6.08 Risk-free interest rate 3.98 % - 4.16 % 3.99 % Dividend rate — — |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense was recorded in the following line items in the condensed statements of operations for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended 2024 2023 Research and development $ 532 $ 389 General and administrative 708 470 Total stock-based compensation expense $ 1,240 $ 859 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of 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): Three Months Ended 2024 2023 Net loss $ ( 8,562 ) $ ( 7,525 ) Net loss per share—basic and diluted $ ( 0.20 ) $ ( 0.30 ) Weighted-average number of shares used in computing net loss 43,287,325 24,732,580 |
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: Three Months Ended 2024 2023 Stock options to purchase common stock 7,707,784 3,870,924 Pre-Funded Warrants 574,241 — Series A Warrants 11,823,829 — Series B Warrants 11,823,829 — Total 31,929,683 3,870,924 |
Equipment and Facility Leases (
Equipment and Facility Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Schedule of Lease Costs and Other Information to Company's Finance and Operating Liabilities | The following table contains a summary of the lease costs recognized and other information pertaining to the Company’s finance and operating leases for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended 2024 2023 Lease Cost Amortization of finance right-of-use assets $ 204 $ 149 Interest on finance lease liabilities 27 14 Operating lease cost 304 112 Short-term lease cost 83 105 Variable lease cost 24 — Total lease cost $ 642 $ 380 March 31, Other Lease Information Cash paid for amounts included in the measurement of lease liability – finance leases $ 27 Cash paid for amounts included in the measurement of lease liability – operating leases $ 310 Weighted-average remaining lease term – finance leases (years) 1.57 Weighted-average remaining lease term – operating leases (years) 4.36 Weighted-average discount rate – finance leases 9.5 % Weighted-average discount rate – operating leases 12.7 % |
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 finance lease liabilities at March 31, 2024 (in thousands): Finance Leases Operating Leases Remainder of 2024 $ 552 $ 1,051 2025 501 1,401 2026 52 1,416 2027 — 1,224 2028 — 891 Thereafter — 120 Total lease payment 1,105 6,103 Less: interest 74 1,419 Total lease liabilities 1,031 4,684 Less: short-term lease liability 680 856 Long-term lease liability $ 351 $ 3,828 |
Organization and Nature of Op_2
Organization and Nature of Operations - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Nov. 01, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Organization And Nature Of Operations [Line Items] | ||||
Losses from operations | $ 8,562 | $ 7,525 | ||
Cash | 13,015 | 10,860 | ||
Proceeds from the issuance of common stock | 0 | 722 | ||
Maximum [Member] | ||||
Organization And Nature Of Operations [Line Items] | ||||
Public float | $ 75,000 | |||
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 | |||
ATM [Member] | ||||
Organization And Nature Of Operations [Line Items] | ||||
Aggregate net proceeds from offering | $ 1,000 | $ 14,400 | ||
Sale of shares | 856,624 | 7,492,580 | ||
Proceeds from the issuance of common stock | $ 50,000 | |||
Series A Financing | ||||
Organization And Nature Of Operations [Line Items] | ||||
Losses from operations | $ (8,600) | $ (7,500) | ||
Accumulated deficit | 99,800 | |||
Series A Warrants [Member] | ||||
Organization And Nature Of Operations [Line Items] | ||||
Proceeds from private placement common stock, net of issuance costs | 14,800 | |||
Series B Warrants [Member] | ||||
Organization And Nature Of Operations [Line Items] | ||||
Proceeds from private placement common stock, net of issuance costs | $ 17,700 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Property and Equipment (Details) | Mar. 31, 2024 |
Furniture | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Machinery and equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 3 years |
Machinery and equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Software | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 3 years |
Prepaid Expenses And Other Cu_3
Prepaid Expenses And Other Current Assets - Schedule of Prepaid expenses and other current assets (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development | $ 1,752 | $ 2,283 |
Prepaid insurance | 449 | 790 |
Other | 539 | 270 |
Prepaid expenses and other current assets | $ 2,740 | $ 3,343 |
Property And Equipment, Net - S
Property And Equipment, Net - Schedule of Components of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Less accumulated depreciation and amortization | $ (1,522) | $ (1,283) |
Property and equipment, net | 3,325 | 3,514 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 126 | 126 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 427 | 379 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 370 | 370 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 3,924 | $ 3,922 |
Property And Equipment, Net - A
Property And Equipment, Net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization | $ 239 | $ 243 |
Construction in Progress - Sche
Construction in Progress - Schedule of Construction In Progress (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Mar. 31, 2023 |
Public Utilities, Property, Plant and Equipment, Plant in Service [Abstract] | ||
Internal use software not yet in service | $ 203 | $ 182 |
Total construction in progress | $ 203 | $ 182 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued clinical trials | $ 153 | $ 598 |
Accrued compensation | 480 | 1,673 |
Accrued legal | 79 | 306 |
Accrued other | 183 | 378 |
Accrued expenses and other current liabilities | $ 895 | $ 2,955 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Nov. 01, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Class Of Stock [Line Items] | ||||
Capital units, authorized | 500,000,000 | |||
Common stock, par value | $ 0.0001 | |||
Common stock, shares authorized | 490,000,000 | |||
Preferred stock shares authorised | 10,000,000 | |||
Proceeds from the issuance of common stock | $ 0 | $ 722 | ||
Maximum [Member] | ||||
Class Of Stock [Line Items] | ||||
Public float | $ 75,000 | |||
ATM [Member] | ||||
Class Of Stock [Line Items] | ||||
Proceeds from the issuance of common stock | 50,000 | |||
Sale of shares | 856,624 | 7,492,580 | ||
Aggregate net proceeds from offering | $ 1,000 | $ 14,400 | ||
SEC [Member] | ||||
Class Of Stock [Line Items] | ||||
Proceeds from the issuance of common stock | 200,000 | |||
SEC [Member] | Maximum [Member] | ||||
Class Of Stock [Line Items] | ||||
Public float | $ 75,000 |
Warrants - Additional Informati
Warrants - Additional Information (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Pre Funded Warrant | ||
Class of Warrant or Right [Line Items] | ||
Preferred stock warrants outstanding | 574,241 | 574,241 |
Series A Warrant | ||
Class of Warrant or Right [Line Items] | ||
Preferred stock warrants outstanding | 11,823,829 | 11,823,829 |
Exercise price per unit of warrants | $ 1.25 | $ 1.25 |
Warrants and Rights Outstanding, Maturity Date | Jun. 13, 2025 | |
Series B Warrant | ||
Class of Warrant or Right [Line Items] | ||
Preferred stock warrants outstanding | 11,823,829 | 11,823,829 |
Exercise price per unit of warrants | $ 1.5 | $ 1.5 |
Redeeem warrant exercise price | $ 0.01 | |
Warrants and Rights Outstanding, Maturity Date | Dec. 13, 2028 | |
Warrant | ||
Class of Warrant or Right [Line Items] | ||
Exercise price per unit of warrants | $ 0.0001 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | ||||
Jun. 15, 2023 | Jul. 29, 2021 | Mar. 31, 2024 | Mar. 31, 2023 | Jan. 01, 2024 | |
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||||
Weighted average grant-date fair value of options granted | $ 1.24 | $ 2 | |||
Tax benefit from stock based compensation expense | $ 0 | $ 0 | |||
Share-based payment arrangement, unrecognized stock based compensation cost | $ 7.5 | ||||
Weighted-average period over which cost not yet recognized is expected to be recognized | 2 years 7 months 17 days | ||||
Amended and Restated 2023 Equity Incentive Plan | |||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||||
Common stock reserved for future issuance | 7,400,000 | 2,164,366 | |||
Shares reserved of issuance under the plan increase duration | 10 years | ||||
Percentage of number of shares of common stock outstanding | 5% | ||||
Amended and Restated 2023 Equity Incentive Plan | January 1, 2022 | |||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||||
Common stock reserved for future issuance | 41,000,000 | ||||
2023 Equity Incentive Plan | |||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||||
Share-based payment award, number of shares available for grant | 7,227,415 | ||||
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 | 787,812 | |||
Percentage of number of shares of common stock outstanding | 1% | ||||
Maximum number of shares of common stock issuable | 400,000 |
Stock-based Compensation - Sche
Stock-based Compensation - Schedule of Stock Option Award Activities (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | ||
Options outstanding, beginning balance | 6,695,933 | |
Options granted | 1,690,675 | |
Options exercised | 0 | |
Options forfeited | (50,335) | |
Options outstanding, ending balance | 8,336,273 | 6,695,933 |
Options Exerciseable | 2,797,539 | |
Options vested or expected to vest | 5,538,734 | |
Options outstanding, weighted average exercise price, beginning balance | $ 3.52 | |
Options granted, weighted average exercise price | 1.24 | |
Options exercised, weighted average exercise price | 0 | |
Options forfeited, weighted average exercise price | 4.43 | |
Options outstanding, weighted average exercise price, ending balance | 3.05 | $ 3.52 |
Options exercisable, weighted average exercise price | 5.04 | |
Options vested or expected to vest, weighted average exercise price | $ 2.05 | |
Options outstanding, weighted average remaining contractual term | 8 years 5 months 26 days | 8 years 3 months 25 days |
Options exercisable, weighted average remaining contractual term | 7 years 5 months 12 days | |
Options vested or expected to vest, weighted average remaining contractual term | 9 years 7 days | |
Options outstanding, aggregate intrinsic value | $ 40 | $ 361 |
Options exercisable, aggregate intrinsic value | 17 | |
Options vested or expected to vest, aggregate intrinsic value | $ 23 |
Stock-based Compensation - Sc_2
Stock-based Compensation - Schedule of Estimating Fair Value of the Stock Options and Common stock Warrants Granted (Details) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Volatility | 91.91% | |
Expected life (years) | 6 years 29 days | 6 years 29 days |
Risk-free interest rate | 3.99% | |
Risk-free interest rate minimum | 3.98% | |
Risk-free interest rate maximum | 4.16% | |
Dividend rate | 0% | 0% |
Minimum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Volatility | 94.20% | |
Maximum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Volatility | 102.54% |
Stock-based Compensation - Sc_3
Stock-based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 1,240 | $ 859 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 532 | 389 |
General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 708 | $ 470 |
License Agreements - Additional
License Agreements - Additional Information (Details) - UABRF [Member] $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) shares | |
Emory License Agreement [Member] | |
License agreement description | The term of the Emory License Agreement will continue until 15 years after the first commercial sale of the licensed product, or the expiration of the relevant licensed patents, whichever is later. |
Milestone payment | $ 1.4 |
Exclusive License Agreement [Member] | |
Common stock, shares, issued | shares | 91,250 |
Royalties on cumulative net sales | $ 22.5 |
Exclusive License Agreement [Member] | Maximum | |
Milestone payment | $ 1.4 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Earnings Per Share [Abstract] | ||
Net loss | $ (8,562) | $ (7,525) |
Net loss per share - basic | $ (0.2) | $ (0.3) |
Net loss per share - diluted | $ (0.2) | $ (0.3) |
Weighted-average number of shares used in computing net loss per share - basic | 43,287,325 | 24,732,580 |
Weighted-average number of shares used in computing net loss per share - diluted | 43,287,325 | 24,732,580 |
Net Loss Per Share - Schedule_2
Net Loss Per Share - Schedule of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 31,929,683 | 3,870,924 |
Stock Options to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 7,707,784 | 3,870,924 |
Pre-Funded Warrants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 574,241 | 0 |
Series A Warrants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 11,823,829 | 0 |
Series B Warrants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share | 11,823,829 | 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Royalty term | 15 years |
Equipment and Facility Leases -
Equipment and Facility Leases - Additional Information (Details) - USD ($) | 3 Months Ended | |||
Sep. 15, 2021 | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | |
Loss Contingencies [Line Items] | ||||
Restricted cash | $ 256,000 | $ 253,000 | ||
Other assets current | 539,000 | $ 270,000 | ||
Birmingham, Alabama | ||||
Loss Contingencies [Line Items] | ||||
Security deposit | 300,000 | 300,000 | ||
Restricted cash | 256,000 | 256,000 | ||
Other assets current | $ 10,000 | 10,000 | ||
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 | 60 months | |||
Operating lease, option to extend | option to extend five years, resulting in an increase to both the right of use assets and operating lease liabilities | |||
Machinery and equipment | ||||
Loss Contingencies [Line Items] | ||||
Leaseback transaction, description | Company has 11 active leases 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 Company entered into an agreement with another equipment leasing company in the second quarter of 2023. As of March 31, 2024, the Company has one active lease from this leasing company. The terms of the lease are three years and afterwards provide for either annual extensions or an outright purchase of the equipment. | |||
Security deposit | $ 300,000 | $ 300,000 | ||
Machinery and equipment | Maximum | ||||
Loss Contingencies [Line Items] | ||||
Amount held for equipment purchases | $ 2,500,000 |
Equipment and Facility Leases_2
Equipment and Facility Leases - Schedule of Lease Costs and Other Information to Company's Finance and Operating Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Lease Cost | ||
Amortization Of finance right-of-use assets | $ 204 | $ 149 |
Interest on finance lease liabilities | 27 | 14 |
Operating lease cost | 304 | 112 |
Short-term lease cost | 83 | 105 |
Variable lease cost | 24 | 0 |
Total lease cost | 642 | $ 380 |
Cash paid for amounts included in the measurement of lease liability – finance leases | 27 | |
Cash paid for amounts included in the measurement of lease liability – operating leases | $ 310 | |
Weighted-average remaining lease term – finance leases | 1 year 6 months 25 days | |
Weighted-average remaining lease term – operating leases | 4 years 4 months 9 days | |
Weighted-average discount rate – finance leases | 9.50% | |
Weighted-average discount rate – operating leases | 12.70% |
Equipment and Facility Leases_3
Equipment and Facility Leases - Schedule of Reconciliation of Undiscounted Cash Flows to Operating and Finance Lease Liabilities (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Finance Leases: | |
Remainder of 2024 | $ 552 |
2025 | 501 |
2026 | 52 |
2027 | 0 |
2028 | 0 |
Thereafter | 0 |
Total lease payment | 1,105 |
Less: interest | 74 |
Total lease liability | 1,031 |
Short-term finance lease liability | 680 |
Long-term finance lease liability | 351 |
Operating Leases: | |
Remainder of 2024 | 1,051 |
2025 | 1,401 |
2026 | 1,416 |
2027 | 1,224 |
2028 | 891 |
Thereafter | 120 |
Total lease payment | 6,103 |
Less: interest | 1,419 |
Total lease liability | 4,684 |
Short-term operating lease liability | 856 |
Long-term operating lease liability | $ 3,828 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Details) - Atm [Member] - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |
Nov. 01, 2022 | Mar. 31, 2024 | Dec. 31, 2023 | |
Subsequent Event [Line Items] | |||
Sale of shares | 856,624 | 7,492,580 | |
Proceeds from the issuance of common stock | $ 50 |