Document and Entity Information
| Document and Entity Information - shares | 9 Months Ended | |
| Sep. 30, 2022 | Nov. 01, 2022 | |
| Cover [Abstract] | ||
| Document Type | 10-Q | |
| Amendment Flag | false | |
| Document Period End Date | Sep. 30, 2022 | |
| Document Fiscal Year Focus | 2022 | |
| Document Fiscal Period Focus | Q3 | |
| 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 | false | |
| Entity Emerging Growth Company | true | |
| Entity Ex Transition Period | 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, $0.0001 par value per share | |
| Security Exchange Name | NASDAQ | |
| Entity Common Stock, Shares Outstanding | 24,502,157 | |
| Document Quarterly Report | true | |
| Document Transition Report | false |
Condensed Balance Sheets
| Condensed Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
| Current assets | ||
| Cash | $ 27,647,000 | $ 37,021,000 |
| Prepaid expenses and other current assets | 2,007,000 | 1,959,000 |
| Total Current Assets | 29,654,000 | 38,980,000 |
| Non-current assets | ||
| Property and equipment, net | 350,000 | 97,000 |
| Construction In progress | 3,197,000 | 403,000 |
| Restricted Cash | 252,000 | 251,000 |
| Right of use assets - financing leases | 363,000 | 704,000 |
| Right of use assets - operating leases | 4,336,000 | 1,630,000 |
| Other non-current assets | 231,000 | 158,000 |
| Total Non-Current Assets | 8,729,000 | 3,243,000 |
| Total Assets | 38,383,000 | 42,223,000 |
| Current liabilities | ||
| Accounts payable | 1,108,000 | 395,000 |
| Accrued expenses and other current liabilities | 2,877,000 | 1,235,000 |
| Short-term financing lease liability | 276,000 | 392,000 |
| Short-term operating lease liability | 639,000 | 234,000 |
| Total Current Liabilities | 4,900,000 | 2,256,000 |
| Long-term financing lease liability | 67,000 | 269,000 |
| Long-term operating lease liability | 3,852,000 | 1,515,000 |
| Total Non-Current Liabilities | 3,919,000 | 1,784,000 |
| Total Liabilities | 8,819,000 | 4,040,000 |
| Stockholders' Equity | ||
| Common stock, par value $0.0001 per share; 490,000,000 shares authorized at September 30, 2022 and December 31, 2021; 24,502,157 and 18,781,242 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 3,000 | 2,000 |
| Additional paid-in capital | 82,975,000 | 70,872,000 |
| Accumulated deficit | (53,414,000) | (32,691,000) |
| Total Stockholders' Equity | 29,564,000 | 38,183,000 |
| Total Liabilities and Stockholders' Equity | $ 38,383,000 | $ 42,223,000 |
Condensed Balance Sheets (Paren
| Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 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 | 24,502,157 | 18,781,242 |
| Common stock, shares, outstanding | 24,502,157 | 18,781,242 |
Condensed Statements of Operati
| Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
| Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
| Operating expenses: | ||||
| Research and development | $ 4,255 | $ 1,350 | $ 10,140 | $ 4,660 |
| General and administrative | 3,144 | 2,041 | 10,583 | 4,144 |
| Total operating expenses | 7,399 | 3,391 | 20,723 | 8,804 |
| Loss from operations | (7,399) | (3,391) | (20,723) | (8,804) |
| Net loss | (7,399) | (3,391) | (20,723) | (8,804) |
| Net loss attributable to common stockholders (Note 10) | $ (7,399) | $ (3,391) | $ (20,723) | $ (8,804) |
| Net loss per share attributable to common stockholders - basic | $ (0.34) | $ (0.25) | $ (1.05) | $ (1.26) |
| Net loss per share attributable to common stockholders - diluted | $ (0.34) | $ (0.25) | $ (1.05) | $ (1.26) |
| Weighted-average number of shares used in computing net loss per common share, basic | 21,661,544 | 13,377,682 | 19,774,070 | 7,004,099 |
| Weighted-average number of shares used in computing net loss per common share, diluted | 21,661,544 | 13,377,682 | 19,774,070 | 7,004,099 |
Condensed Statements of Convert
| Condensed Statements of Convertible Preferred Stock, Common Stock and Stockholders' Deficit (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Convertible Preferred Stock | Convertible Preferred Stock Preferred Stock [Member] | IPO [Member] | IPO [Member] Common Stock [Member] | IPO [Member] Additional Paid-in Capital [Member] | IPO [Member] Convertible Preferred Stock |
| 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) | ||||||
| Stock-based compensation expense | 361 | 361 | ||||||||
| Net loss | (2,363) | (2,363) | ||||||||
| Temporary equity shares ending at Mar. 31, 2021 | 9,993,727 | |||||||||
| Temporary equity amount ending at Mar. 31, 2021 | 34,900 | |||||||||
| Shares ending at Mar. 31, 2021 | 3,764,488 | |||||||||
| Balance ending at Mar. 31, 2021 | (18,581) | $ 1 | 1,819 | (20,401) | ||||||
| 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) | ||||||
| Conversion of convertible preferred stock to common stock upon closing of IPO, Value | 34,900 | |||||||||
| Stock-based compensation expense | 1,230 | |||||||||
| Net loss | (8,804) | |||||||||
| Shares ending at Sep. 30, 2021 | 18,754,553 | |||||||||
| Balance ending at Sep. 30, 2021 | 43,038 | $ 3 | 69,877 | (26,842) | ||||||
| Temporary equity shares beginning at Mar. 31, 2021 | 9,993,727 | |||||||||
| Temporary equity amount beginning at Mar. 31, 2021 | 34,900 | |||||||||
| Shares beginning at Mar. 31, 2021 | 3,764,488 | |||||||||
| Balance beginning at Mar. 31, 2021 | (18,581) | $ 1 | 1,819 | (20,401) | ||||||
| Stock-based compensation expense | 392 | 392 | ||||||||
| Net loss | (3,050) | (3,050) | ||||||||
| Shares ending at Jun. 30, 2021 | 3,764,488 | 9,993,727 | ||||||||
| Balance ending at Jun. 30, 2021 | (21,239) | $ 1 | 2,211 | (23,451) | $ 34,900 | |||||
| Stock issued during period shares new issues, amount | $ 32,291 | $ 1 | $ 32,290 | |||||||
| Stock issued during period shares new issues, 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 | 10,990,065 | |||||||||
| Conversion of convertible preferred stock to common stock upon closing of IPO, Value | $ 34,900 | $ 1 | $ 34,899 | |||||||
| Stock-based compensation expense | 477 | 477 | ||||||||
| Net loss | (3,391) | (3,391) | ||||||||
| Shares ending at Sep. 30, 2021 | 18,754,553 | |||||||||
| Balance ending at Sep. 30, 2021 | 43,038 | $ 3 | 69,877 | (26,842) | ||||||
| Shares beginning at Dec. 31, 2021 | 18,781,242 | |||||||||
| Balance beginning at Dec. 31, 2021 | 38,183 | $ 2 | 70,872 | (32,691) | ||||||
| Conversion of convertible preferred stock to common stock, shares | 31,025 | |||||||||
| Conversion of convertible preferred stock to common stock | 33 | 33 | ||||||||
| Stock-based compensation expense | 764 | 764 | ||||||||
| Net loss | (6,145) | (6,145) | ||||||||
| Shares ending at Mar. 31, 2022 | 18,812,267 | |||||||||
| Balance ending at Mar. 31, 2022 | 32,835 | $ 2 | 71,669 | (38,836) | ||||||
| Shares beginning at Dec. 31, 2021 | 18,781,242 | |||||||||
| Balance beginning at Dec. 31, 2021 | 38,183 | $ 2 | 70,872 | (32,691) | ||||||
| Conversion of convertible preferred stock to common stock, shares | 10,990,065 | |||||||||
| Conversion of convertible preferred stock to common stock upon closing of IPO, Value | 0 | |||||||||
| Stock-based compensation expense | 2,545 | |||||||||
| Net loss | (20,723) | |||||||||
| Shares ending at Sep. 30, 2022 | 24,502,157 | |||||||||
| Balance ending at Sep. 30, 2022 | 29,564 | $ 3 | 82,975 | (53,414) | ||||||
| Shares beginning at Mar. 31, 2022 | 18,812,267 | |||||||||
| Balance beginning at Mar. 31, 2022 | 32,835 | $ 2 | 71,669 | (38,836) | ||||||
| Conversion of convertible preferred stock to common stock, shares | 26,204 | |||||||||
| Conversion of convertible preferred stock to common stock | 28 | 28 | 0 | |||||||
| Stock-based compensation expense | 884 | 884 | ||||||||
| Net loss | (7,179) | (7,179) | ||||||||
| Shares ending at Jun. 30, 2022 | 18,838,471 | |||||||||
| Balance ending at Jun. 30, 2022 | 26,568 | $ 2 | 72,581 | (46,015) | ||||||
| Stock issued during period shares new issues, amount | 9,498 | $ 1 | 9,497 | |||||||
| Stock issued during period shares new issues, shares | 5,663,686 | |||||||||
| Stock-based compensation expense | 897 | 897 | ||||||||
| Net loss | (7,399) | (7,399) | ||||||||
| Shares ending at Sep. 30, 2022 | 24,502,157 | |||||||||
| Balance ending at Sep. 30, 2022 | $ 29,564 | $ 3 | $ 82,975 | $ (53,414) |
Condensed Statements of Cash Fl
| Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
| Sep. 30, 2022 | Sep. 30, 2021 | |
| Operating activities | ||
| Net loss | $ (20,723) | $ (8,804) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation | 71 | 67 |
| Non-cash stock-based compensation | 2,545 | 1,230 |
| Amortization of financing lease right-of-use assets | 341 | 392 |
| Amortization of operating lease right-of-use assets | 340 | 95 |
| Changes in operating assets and liabilities: | ||
| Prepaid expenses and other current assets | (48) | (3,117) |
| Other current assets | (73) | (268) |
| Accounts payable | 710 | 42 |
| Accrued expenses and other current liabilities | 969 | (938) |
| Short-term operating lease liabilities | 45 | 87 |
| Long-term operating lease liabilities | (349) | (119) |
| Net cash used in operating activities | (16,172) | (11,333) |
| Investing activities | ||
| Purchases of property and equipment | (48) | 0 |
| Construction in progress | (2,394) | (153) |
| Net cash used in investing activities | (2,442) | (153) |
| Financing activities | ||
| Proceeds from initial public offering | 9,498 | 36,327 |
| Principal payments on financing leases | (318) | (390) |
| Exercise of common stock | 61 | 0 |
| Loan payable | 0 | (174) |
| Deferred offering costs paid | 0 | (1,596) |
| Net cash used in financing activities | 9,241 | 34,167 |
| Net increase in cash and restricted cash | (9,373) | 22,681 |
| Cash and restricted cash at beginning of period | 37,272 | 17,994 |
| Cash and restricted cash at end of period | 27,899 | 40,675 |
| Cash, end of period | 27,647 | 40,424 |
| Restricted cash, end of period | 252 | 251 |
| Cash and restricted cash, end of period | 27,899 | 40,675 |
| Supplemental disclosure of non-cash operating, financing and investing information | ||
| Construction in progress included in accounts payable | 676 | 30 |
| Conversion of preferred stock - Series A into common stock | 0 | 34,900 |
| Right-of-use assets obtained in exchange for financing lease | 0 | 309 |
| Right-of-use Assets Obtained In Exchange For Operating Lease | 0 | 969 |
| Initial measurement of operating lease right-of-use assets and liabilities | $ 3,046 | $ 3,483 |
Organization and Nature of Oper
| Organization and Nature of Operations | 9 Months Ended |
| Sep. 30, 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 therapies for the treatment of cancer. 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 leukemia 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-400, 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. Coronavirus Pandemic The ongoing COVID-19 pandemic, including the periods of resurgences of cases relating to the spread of various strains, has had a significant impact, both direct and indirect, on businesses and commerce, as certain worker shortages have occurred, supply chains have been disrupted, and facilities and productions have been suspended. The COVID-19 pandemic has impacted and may continue to impact the clinical sites and startup activities for the Company’s Phase 1/2 clinical trial, including third-party manufacturing and logistics providers, which have disrupted and may continue to disrupt its supply chains and the availability or cost of materials, and it has affected and may continue to affect the Company’s ability to timely initiate, enroll and complete its clinical trials, conduct regulatory activities and operate its business more generally. The ongoing pandemic may impact the timing of regulatory approval of the investigational new drug application for clinical trials, the enrollment of any clinical trials that are approved, the availability of clinical trial materials and regulatory approval and commercialization of our products. The pandemic may also continue to impact the capital markets, inflation expectations and the Company’s ability to access capital, which could negatively impact short-term and long-term liquidity. The full extent to which the pandemic may impact the Company’s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including as a result of evolving variants of COVID-19, the duration and intensity of the related effects of the pandemic and the uncertainty of the timing of the broader economic recovery to pre-pandemic levels. 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 6). Liquidity and Capital Resources 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 $ 20.7 million and $ 8.8 million for the nine months ended September 30, 2022 and 2021, respectively. As of September 30, 2022, the Company had an accumulated deficit of $ 53.4 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 $9.3 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 $ 0.5 million, after deducting underwriting discounts, commissions and offering expenses, increasing the aggregate net proceeds from the offering to approximately $ 9.8 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 to conduct research and development, and, based on the Company’s business strategy, its existing cash of $ 27.6 million as of September 30, 2022 will not be sufficient to fund the Company’s projected operating expenses and capital expenditure requirements for at least 12 months from the issuance of these condensed financial statements. 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, an at-the-market (“ATM”) equity offering program, 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 or that management of the Company will be able to obtain financing or enter into a collaboration on terms acceptable to the Company. 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 to 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 | 9 Months Ended |
| Sep. 30, 2022 | |
| 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, 2021 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 17, 2022. 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 (“US 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 US 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 US 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 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. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation 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 Computer equipment 3 years Furniture 5 years Machinery and equipment 3 - 5 years 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 are removed from the balance sheet and any gain or loss is reflected in the statement of operations. Recently Issued Accounting Standards Updates In December 2019, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2019-12, Income Taxes (Topic 740): Simplifying the Accounting of Income Taxes ("Topic 740"), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years and interim periods within those fiscal years, beginning after December 15, 2021, with early adoption permitted. The Company has evaluated this guidance and determined that it does not have a material impact to its condensed financial statements. |
Property and Equipment, Net
| Property and Equipment, Net | 9 Months Ended |
| Sep. 30, 2022 | |
| Property, Plant and Equipment [Abstract] | |
| Property and Equipment, Net | 3. PROPERTY AND EQUIPMENT, NET Property and equipment, net consists of the following (in thousands): September 30, December 31, Machinery and equipment $ 469 $ 443 Furniture and fixtures 172 — Software 126 — Less accumulated depreciation ( 417 ) ( 346 ) Property and equipment, net $ 350 $ 97 Depreciation expense was $ 33 ,000 and $ 22 ,000 for the three months ended September 30, 2022 and 2021, respectively and was $ 0.1 million for the nine months ended September 30, 2022 and 2021 . |
Construction in Progress
| Construction in Progress | 9 Months Ended |
| Sep. 30, 2022 | |
| Public Utilities, Property, Plant and Equipment, Plant in Service [Abstract] | |
| Construction in Progress | 4. CONSTRUCTION IN PROGRESS Construction in progress consists of the following (in thousands): September 30, December 31, Furniture $ 3 $ 77 Leasehold improvements 3,194 200 Internal use software not yet in service — 126 Total construction in progress $ 3,197 $ 403 |
Accrued Expenses and Other Curr
| Accrued Expenses and Other Current Liabilities | 9 Months Ended |
| Sep. 30, 2022 | |
| Payables and Accruals [Abstract] | |
| Accrued Expenses and Other Current Liabilities | 5. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities consist of the following (in thousands): September 30, December 31, Accrued clinical trials $ 414 $ 196 Accrued compensation 1,094 926 Accrued manufacturing 402 — Accrued leasehold improvements 673 — Accrued other 294 113 Total accrued expenses and other current liabilities $ 2,877 $ 1,235 |
Redeemable Convertible Preferre
| Redeemable Convertible Preferred Stock | 9 Months Ended |
| Sep. 30, 2022 | |
| Stockholders' Equity Note [Abstract] | |
| Redeemable Convertible Preferred Stock | 6. REDEEMABLE COVERTIBLE PREFERRED STOCK 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. |
Stock-based Compensation
| Stock-based Compensation | 9 Months Ended |
| Sep. 30, 2022 | |
| Share-Based Payment Arrangement [Abstract] | |
| Stock-based Compensation | . 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 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, as amended, to employees, and for the grant of nonstatutory 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 2,626,710, 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 3,565,772 shares. As of September 30, 2022, 1,656,445 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. As of December 31, 2021 , 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. On January 1, 2022, the shares reserved for issuance was increased to 387,812 shares. 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 nine months ended September 30, 2022: Number Weighted- Weighted- Aggregate Outstanding at December 31, 2021 2,306,379 $ 6.51 8.99 $ 983 Granted 1,151,200 3.67 Exercised ( 57,229 ) 1.07 Forfeited ( 73,999 ) 6.94 Outstanding at September 30, 2022 3,326,351 $ 5.60 8.68 $ 219 Exercisable at September 30, 2022 902,644 $ 6.10 7.99 $ 141 Options expected to vest as of September 30, 2022 2,423,707 $ 5.41 8.93 $ 78 The weighted-average grant date fair value of options granted during the nine months ended September 30, 2022 and 2021 was $ 3.69 and $ 5.79 , 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 September 30, 2022. The aggregate intrinsic value of stock options exercised in the nine months ended September 30, 2022 was $ 0.1 million. Stock-Based Compensation Expense For the three and nine months ended September 30, 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: September 30, September 30, Volatility 86.91 % - 89.16 % 88.78 % - 89.15 % Expected life (years) 5.27 - 6.08 5.49 - 6.27 Risk-free interest rate 1.99 % - 3.39 % 0.66 % - 0.70 % 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 and nine months ended September 30, 2022 and 2021 (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Research and development $ 365 $ 129 $ 1,015 $ 477 General and administrative 532 348 1,530 753 Total stock-based compensation expense $ 897 $ 477 $ 2,545 $ 1,230 No related tax benefits from stock-based compensation expense were recognized for the three and nine months ended September 30, 2022 and 2021. As of September 30, 2022, there was $ 8.5 million in unrecognized stock-based compensation expense, which is expected to be recognized over a weighted-average period of 2.81 years. |
License Agreements
| License Agreements | 9 Months Ended |
| Sep. 30, 2022 | |
| License Agreements [Abstract] | |
| License Agreements | . 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. 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 their common stock in satisfaction of this antidilution provision. |
Net Loss Per Share
| Net Loss Per Share | 9 Months Ended |
| Sep. 30, 2022 | |
| Earnings Per Share [Abstract] | |
| Net Loss Per Share | . 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 attributable to common stockholders is calculated as follows (in thousands, except share and per share amounts): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Net loss $ ( 7,399 ) $ ( 3,391 ) $ ( 20,723 ) $ ( 8,804 ) Net loss attributable to common stockholders $ ( 7,399 ) $ ( 3,391 ) $ ( 20,723 ) $ ( 8,804 ) Net loss per share—basic and diluted $ ( 0.34 ) $ ( 0.25 ) $ ( 1.05 ) $ ( 1.26 ) Weighted-average number of shares used in computing net loss 21,661,544 13,377,682 19,774,070 7,004,099 The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share, as Three Months Ended Nine Months Ended 2022 2021 2022 2021 Stock options to purchase common stock 3,326,351 1,905,844 3,326,351 1,905,844 |
Commitments and Contingencies
| Commitments and Contingencies | 9 Months Ended |
| Sep. 30, 2022 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments and contingencies | . 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. The royalty term is the later of 10 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. |
Facility Leases
| Facility Leases | 9 Months Ended |
| Sep. 30, 2022 | |
| Leases [Abstract] | |
| Leases | 11. Facility LEASES The Company has historically entered into lease arrangements for its facilities. As of September 30, 2022, the Company had three operating leases with required future minimum payments. In applying the transition guidance under Accounting Standards Codification (“ASC”) 842, Leases , 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 $ 1.4 million for equipment purchases in the form of sale and leasebacks or direct leases. As of September 30, 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 $ 231,000 and $ 141,000 as of September 30, 2022 and December 31, 2021 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, 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 has a build-to-suit lease agreement with a third party to build out the Company's labs in Birmingham Alabama. The agreement has a threshold of $ 4.0 million of total costs incurred. The costs incurred and classified as construction in progress on the condensed balance sheets were $ 3.2 million and $ 0.2 million as of September 30, 2022 and December 31, 2021, respectively. 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 September 30, 2022 and December 31, 2021, respectively. As of September 30, 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 three and nine months ended September 30, 2022 and 2021 (in thousands, unless otherwise noted): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Lease Cost Amortization of finance right-of-use assets $ 90 $ 141 $ 341 $ 392 Interest on finance lease liabilities 10 22 36 67 Operating lease cost 228 63 444 168 Short-term lease cost 85 118 297 367 Total lease cost $ 413 $ 344 $ 1,118 $ 994 September 30, Other Operating Lease Information Cash paid for amounts included in the measurement of lease liability – finance leases $ 390 Cash paid for amounts included in the measurement of lease liability – operating leases $ 408 Weighted-average remaining lease term – finance leases 1.25 years Weighted-average remaining lease term – operating leases 5.24 years Weighted-average discount rate – finance leases 10.2 % Weighted-average discount rate – operating leases 12.2 % The following table reconciles the undiscounted cash flows to the operating and financing lease liabilities at September 30, 2022 (in thousands): Financing Leases Operating Leases Remainder of 2022 $ 81 $ 243 2023 252 1,190 2024 30 1,212 2025 — 1,224 2026 — 1,013 Thereafter — 1,189 Total lease payment 363 6,071 Less: interest 20 1,580 Total lease liabilities 343 4,491 Less: Short-term lease liability 276 639 Long-term lease liability $ 67 $ 3,852 |
Summary of Significant Accoun_2
| Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
| Sep. 30, 2022 | |
| 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, 2021 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 17, 2022. 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 (“US 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 US 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 US 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 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. |
| Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation 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 Computer equipment 3 years Furniture 5 years Machinery and equipment 3 - 5 years 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 are removed from the balance sheet and any gain or loss is reflected in the statement of operations. |
| Recently Issued Accounting Standards Updates | Recently Issued Accounting Standards Updates In December 2019, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2019-12, Income Taxes (Topic 740): Simplifying the Accounting of Income Taxes ("Topic 740"), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years and interim periods within those fiscal years, beginning after December 15, 2021, with early adoption permitted. The Company has evaluated this guidance and determined that it does not have a material impact to its condensed financial statements. |
Summary of Significant Accoun_3
| Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
| Sep. 30, 2022 | |
| Accounting Policies [Abstract] | |
| Property and Equipment | The estimated useful lives of the Company’s respective assets are as follows: Estimated Useful Life Computer equipment 3 years Furniture 5 years Machinery and equipment 3 - 5 years |
Property and Equipment, Net (Ta
| Property and Equipment, Net (Tables) | 9 Months Ended |
| Sep. 30, 2022 | |
| Property, Plant and Equipment [Abstract] | |
| Schedule of Components of Property and Equipment, Net | Property and equipment, net consists of the following (in thousands): September 30, December 31, Machinery and equipment $ 469 $ 443 Furniture and fixtures 172 — Software 126 — Less accumulated depreciation ( 417 ) ( 346 ) Property and equipment, net $ 350 $ 97 |
Construction in Progress (Table
| Construction in Progress (Tables) | 9 Months Ended |
| Sep. 30, 2022 | |
| Public Utilities, Property, Plant and Equipment, Plant in Service [Abstract] | |
| Schedule of construction in progress | Construction in progress consists of the following (in thousands): September 30, December 31, Furniture $ 3 $ 77 Leasehold improvements 3,194 200 Internal use software not yet in service — 126 Total construction in progress $ 3,197 $ 403 |
Accrued Expenses and Other Cu_2
| Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
| Sep. 30, 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): September 30, December 31, Accrued clinical trials $ 414 $ 196 Accrued compensation 1,094 926 Accrued manufacturing 402 — Accrued leasehold improvements 673 — Accrued other 294 113 Total accrued expenses and other current liabilities $ 2,877 $ 1,235 |
Stock-based Compensation (Table
| Stock-based Compensation (Tables) | 9 Months Ended |
| Sep. 30, 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 nine months ended September 30, 2022: Number Weighted- Weighted- Aggregate Outstanding at December 31, 2021 2,306,379 $ 6.51 8.99 $ 983 Granted 1,151,200 3.67 Exercised ( 57,229 ) 1.07 Forfeited ( 73,999 ) 6.94 Outstanding at September 30, 2022 3,326,351 $ 5.60 8.68 $ 219 Exercisable at September 30, 2022 902,644 $ 6.10 7.99 $ 141 Options expected to vest as of September 30, 2022 2,423,707 $ 5.41 8.93 $ 78 |
| 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: September 30, September 30, Volatility 86.91 % - 89.16 % 88.78 % - 89.15 % Expected life (years) 5.27 - 6.08 5.49 - 6.27 Risk-free interest rate 1.99 % - 3.39 % 0.66 % - 0.70 % 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 and nine months ended September 30, 2022 and 2021 (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Research and development $ 365 $ 129 $ 1,015 $ 477 General and administrative 532 348 1,530 753 Total stock-based compensation expense $ 897 $ 477 $ 2,545 $ 1,230 |
Net Loss Per Share (Tables)
| Net Loss Per Share (Tables) | 9 Months Ended |
| Sep. 30, 2022 | |
| Earnings Per Share [Abstract] | |
| Computation of Basic and Diluted Net Loss Per Share | Basic and diluted net loss per share attributable to common stockholders is calculated as follows (in thousands, except share and per share amounts): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Net loss $ ( 7,399 ) $ ( 3,391 ) $ ( 20,723 ) $ ( 8,804 ) Net loss attributable to common stockholders $ ( 7,399 ) $ ( 3,391 ) $ ( 20,723 ) $ ( 8,804 ) Net loss per share—basic and diluted $ ( 0.34 ) $ ( 0.25 ) $ ( 1.05 ) $ ( 1.26 ) Weighted-average number of shares used in computing net loss 21,661,544 13,377,682 19,774,070 7,004,099 The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share, as Three Months Ended Nine Months Ended 2022 2021 2022 2021 Stock options to purchase common stock 3,326,351 1,905,844 3,326,351 1,905,844 |
Facility Leases (Tables)
| Facility Leases (Tables) | 9 Months Ended |
| Sep. 30, 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 three and nine months ended September 30, 2022 and 2021 (in thousands, unless otherwise noted): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Lease Cost Amortization of finance right-of-use assets $ 90 $ 141 $ 341 $ 392 Interest on finance lease liabilities 10 22 36 67 Operating lease cost 228 63 444 168 Short-term lease cost 85 118 297 367 Total lease cost $ 413 $ 344 $ 1,118 $ 994 September 30, Other Operating Lease Information Cash paid for amounts included in the measurement of lease liability – finance leases $ 390 Cash paid for amounts included in the measurement of lease liability – operating leases $ 408 Weighted-average remaining lease term – finance leases 1.25 years Weighted-average remaining lease term – operating leases 5.24 years Weighted-average discount rate – finance leases 10.2 % Weighted-average discount rate – operating leases 12.2 % |
| 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 September 30, 2022 (in thousands): Financing Leases Operating Leases Remainder of 2022 $ 81 $ 243 2023 252 1,190 2024 30 1,212 2025 — 1,224 2026 — 1,013 Thereafter — 1,189 Total lease payment 363 6,071 Less: interest 20 1,580 Total lease liabilities 343 4,491 Less: Short-term lease liability 276 639 Long-term lease liability $ 67 $ 3,852 |
Organization and Nature of Op_2
| Organization and Nature of Operations - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 2 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
| Aug. 19, 2022 | Aug. 03, 2021 | Oct. 16, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Aug. 16, 2022 | Dec. 31, 2021 | |
| Organization And Nature Of Operations [Line Items] | |||||||||
| Losses from operations | $ 7,399 | $ 3,391 | $ 20,723 | $ 8,804 | |||||
| Accumulated deficit | (53,414) | (53,414) | $ (32,691) | ||||||
| Cash | $ 27,647 | $ 40,424 | $ 27,647 | 40,424 | $ 37,021 | ||||
| Common Stock, Shares, Issued | 24,502,157 | 24,502,157 | 18,781,242 | ||||||
| Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||
| Proceeds from initial public offering | $ 9,498 | 36,327 | |||||||
| IPO [Member] | |||||||||
| Organization And Nature Of Operations [Line Items] | |||||||||
| Sale of stock, date | Aug. 03, 2021 | ||||||||
| Sale of shares | 4,000,000 | ||||||||
| Offering price, per share | $ 10 | ||||||||
| Aggregate net proceeds from offering | $ 32,300 | ||||||||
| Conversion of convertible preferred stock to common stock, shares | 10,990,065 | 10,990,065 | |||||||
| Sale of Stock, Consideration Received on Transaction | $ 32,300 | ||||||||
| Proceeds from initial public offering | $ 9,800 | ||||||||
| Shares issued | 5,394,737 | ||||||||
| Shares issued price per share | $ 1.90 | $ 1.90 | |||||||
| Additional offering costs | $ 500 | ||||||||
| Additional purchase common stock shares | 268,949 | ||||||||
| Series A Financing | |||||||||
| Organization And Nature Of Operations [Line Items] | |||||||||
| Losses from operations | $ (20,700) | $ (8,800) | |||||||
| Accumulated deficit | $ 53,400 | $ 53,400 | |||||||
Summary of Significant Accoun_4
| Summary of Significant Accounting Policies - Property and Equipment (Details) | 9 Months Ended |
| Sep. 30, 2022 | |
| Computer Equipment [Member] | |
| Property, Plant and Equipment [Line Items] | |
| Property, Plant and Equipment, Useful Life | 3 years |
| Furniture | |
| Property, Plant and Equipment [Line Items] | |
| Property, Plant and Equipment, Useful Life | 5 years |
| Equipment | Minimum | |
| Property, Plant and Equipment [Line Items] | |
| Property, Plant and Equipment, Useful Life | 3 years |
| Equipment | Maximum | |
| Property, Plant and Equipment [Line Items] | |
| Property, Plant and Equipment, Useful Life | 5 years |
Property And Equipment, Net - S
| Property And Equipment, Net - Schedule of Components of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
| Property, Plant and Equipment [Line Items] | ||
| Less accumulated depreciation | $ (417) | $ (346) |
| Property and equipment, net | 350 | 97 |
| Software [Member] | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, Plant and Equipment, Gross | 126 | 0 |
| Furniture and Fixtures [Member] | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, Plant and Equipment, Gross | 172 | 0 |
| Machinery and Equipment [Member] | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, Plant and Equipment, Gross | $ 469 | $ 443 |
Property And Equipment, Net - A
| Property And Equipment, Net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
| Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
| Property, Plant and Equipment [Abstract] | ||||
| Depreciation | $ 33 | $ 22 | $ 71 | $ 67 |
Construction in Progress - Sche
| Construction in Progress - Schedule of Construction In Progress (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
| Public Utilities, Property, Plant and Equipment, Plant in Service [Abstract] | ||
| Furniture | $ 3 | $ 77 |
| Leasehold improvements | 3,194 | 200 |
| Internal use software not yet in service | 0 | 126 |
| Construction in progress | $ 3,197 | $ 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 | Sep. 30, 2022 | Dec. 31, 2021 |
| Payables and Accruals [Abstract] | ||
| Accrued clinical trials | $ 414 | $ 196 |
| Accrued compensation | 1,094 | 926 |
| Accrued manufacturing | 402 | 0 |
| Accrued leasehold improvements | 673 | 0 |
| Accrued other | 294 | 113 |
| Total accrued expenses and other current liabilities | $ 2,877 | $ 1,235 |
Redeemable Convertible Prefer_2
| Redeemable Convertible Preferred Stock - Additional Information (Details) - shares | 9 Months Ended | |
| Aug. 03, 2021 | Sep. 30, 2022 | |
| IPO [Member] | ||
| Class Of Stock [Line Items] | ||
| Conversion of convertible preferred stock to common stock, shares | 10,990,065 | 10,990,065 |
Stock-based Compensation - Addi
| Stock-based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
| Jul. 29, 2021 | Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
| Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||||
| Weighted average grant-date fair value of options granted | $ 3.69 | $ 5.79 | |||
| Tax benefit from stock based compensation expense | $ 0 | $ 0 | $ 0 | ||
| Aggregate intrinsic value of stock options exercised | 100,000 | ||||
| Share-based payment arrangement, unrecognized stock based compensation cost | $ 8,500,000 | $ 8,500,000 | |||
| Weighted-average period over which cost not yet recognized is expected to be recognized | 2 years 9 months 21 days | ||||
| 2020 Equity Incentive Plan | |||||
| Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||||
| 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 | 1,656,445 | 1,656,445 | |||
| 2020 Equity Incentive Plan | January 1, 2022 | |||||
| Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||||
| Common stock reserved for future issuance | 3,565,772 | 3,565,772 | |||
| 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, 2022 | |||||
| Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||||
| Common stock reserved for future issuance | 387,812 | 387,812 | |||
Stock-based Compensation - Summ
| Stock-based Compensation - Summary of Stock Option Award Activities (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
| Sep. 30, 2022 | Dec. 31, 2021 | |
| Share-Based Payment Arrangement [Abstract] | ||
| Options outstanding, beginning balance | 2,306,379 | |
| Options granted | 1,151,200 | |
| Options exercised | (57,229) | |
| Options forfeited | (73,999) | |
| Options outstanding, ending balance | 3,326,351 | 2,306,379 |
| Options Exerciseable | 902,644 | |
| Options vested or expected to vest | 2,423,707 | |
| Options outstanding, weighted average exercise price, beginning balance | $ 6.51 | |
| Options granted, weighted average exercise price | 3.67 | |
| Options exercised, weighted average exercise price | 1.07 | |
| Options forfeited, weighted average exercise price | (6.94) | |
| Options outstanding, weighted average exercise price, ending balance | 5.60 | $ 6.51 |
| Options exercisable, weighted average exercise price | 6.10 | |
| Options vested or expected to vest, weighted average exercise price | $ 5.41 | |
| Options outstanding, weighted average remaining contractual term | 8 years 8 months 4 days | 8 years 11 months 26 days |
| Options exercisable, weighted average remaining contractual term | 7 years 11 months 26 days | |
| Options vested or expected to vest, weighted average remaining contractual term | 8 years 11 months 4 days | |
| Options outstanding, aggregate intrinsic value | $ 219 | $ 983 |
| Options vested or expected to vest, aggregate intrinsic value | 78 | |
| Options Exercisable, Intrinsic Value | $ 141 |
Stock-based Compensation - Sche
| Stock-based Compensation - Schedule of Estimating Fair Value of the Stock Options and Common stock Warrants Granted (Details) | 9 Months Ended | |
| Sep. 30, 2022 | Sep. 30, 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 | 3.39% | 0.70% |
| Dividend rate | 0% | 0% |
| Minimum | ||
| Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
| Volatility | 86.91% | 88.78% |
| 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 3 months 7 days |
Stock-based Compensation - Sc_2
| Stock-based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
| Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
| Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||||||
| Stock-based compensation expense | $ 897 | $ 884 | $ 764 | $ 477 | $ 392 | $ 361 | $ 2,545 | $ 1,230 |
| Research and Development | ||||||||
| Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||||||
| Stock-based compensation expense | 365 | 129 | 1,015 | 477 | ||||
| General and Administrative | ||||||||
| Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||||||
| Stock-based compensation expense | $ 532 | $ 348 | $ 1,530 | $ 753 | ||||
License Agreements - Additional
| License Agreements - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | |
| Aug. 31, 2020 | Sep. 30, 2022 | Dec. 31, 2021 | |
| Common stock, shares, issued | 24,502,157 | 18,781,242 | |
| UABRF [Member] | |||
| Equity Method Investment, Ownership Percentage | 2.50% | ||
| Raise of investment | $ 20 | ||
| UABRF [Member] | Antidilution Provision [Member] | |||
| Raise of investment | $ 36.6 | ||
| Common stock additional shares issued | 151,382 | ||
| 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 the licensed product, or the expiration of the relevant licensed patents, whichever is later. | ||
| Milestone payment | $ 1.4 | ||
| Exclusive License Agreement [Member] | UABRF [Member] | |||
| Common stock, shares, issued | 91,250 | ||
| Royalties on cumulative net sales | $ 22.5 | ||
| Exclusive License Agreement [Member] | UABRF [Member] | Maximum | |||
| Milestone payment | $ 1.4 |
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 | 3 Months Ended | 9 Months Ended | ||||||
| Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
| Earnings Per Share [Abstract] | ||||||||
| Net loss | $ (7,399) | $ (7,179) | $ (6,145) | $ (3,391) | $ (3,050) | $ (2,363) | $ (20,723) | $ (8,804) |
| Net loss attributable to common stockholders | $ (7,399) | $ (3,391) | $ (20,723) | $ (8,804) | ||||
| Weighted Average Number of Shares Outstanding, Basic | 21,661,544 | 13,377,682 | 19,774,070 | 7,004,099 | ||||
| Weighted Average Number of Shares Outstanding, Diluted | 21,661,544 | 13,377,682 | 19,774,070 | 7,004,099 | ||||
| Net loss per share - basic | $ (0.34) | $ (0.25) | $ (1.05) | $ (1.26) | ||||
| Net loss per share - diluted | $ (0.34) | $ (0.25) | $ (1.05) | $ (1.26) | ||||
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 | 3 Months Ended | 9 Months Ended | ||
| Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 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 | 3,326,351 | 1,905,844 | 3,326,351 | 1,905,844 |
Commitments and Contingencies (
| Commitments and Contingencies (Additional Information) (Details) | 9 Months Ended |
| Sep. 30, 2022 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Royalty term | 10 years |
Facility Leases - Additional In
| Facility Leases - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
| Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
| Loss Contingencies [Line Items] | |||||
| Agreement Threshold | $ 413,000 | $ 344,000 | $ 1,118,000 | $ 994,000 | |
| Restricted Cash | 252,000 | 252,000 | $ 251,000 | ||
| Other non-current assets | 231,000 | 231,000 | 158,000 | ||
| Construction in progress | 3,197,000 | 3,197,000 | 403,000 | ||
| Birmingham, Alabama | |||||
| Loss Contingencies [Line Items] | |||||
| Other Assets, Current | 10,000 | 10,000 | 10,000,000 | ||
| Other non-current assets | 17,000 | ||||
| Construction in progress | $ 3,200,000 | $ 3,200,000 | 200,000 | ||
| 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 | 63 months | |||
| Operating lease, option to extend | option to extend five years | ||||
| Maximum | |||||
| Loss Contingencies [Line Items] | |||||
| Agreement Threshold | $ 4,000,000 | ||||
| Minimum | Birmingham, Alabama | |||||
| Loss Contingencies [Line Items] | |||||
| Security deposit | $ 262,000 | $ 262,000 | 278,000 | ||
| 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 | 231,000 | $ 231,000 | $ 141,000 | ||
| Equipment | Maximum | |||||
| Loss Contingencies [Line Items] | |||||
| Amount held for equipment purchases | $ 1,400,000 | $ 1,400,000 | |||
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 | 3 Months Ended | 9 Months Ended | ||
| Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
| Lease Cost | ||||
| Amortization of finance right-of-use assets | $ 90 | $ 141 | $ 341 | $ 392 |
| Interest on finance lease liabilities | 10 | 22 | 36 | 67 |
| Operating lease cost | 228 | 63 | 444 | 168 |
| Short-term lease cost | 85 | 118 | 297 | 367 |
| Total lease cost | 413 | $ 344 | 1,118 | $ 994 |
| Cash paid for amounts included in the measurement of lease liability – finance leases | 390 | 390 | ||
| Cash paid for amounts included in the measurement of lease liability – operating leases | $ 408 | $ 408 | ||
| Weighted-average remaining lease term – finance leases | 1 year 3 months | 1 year 3 months | ||
| Weighted-average remaining lease term – operating leases | 5 years 2 months 26 days | 5 years 2 months 26 days | ||
| Weighted-average discount rate – finance leases | 10.20% | 10.20% | ||
| Weighted-average discount rate – operating leases | 12.20% | 12.20% | ||
Facility Leases - Schedule of R
| Facility Leases - Schedule of Reconciliation of Undiscounted Cash Flows to Operating and Finance Lease Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
| Leases [Abstract] | ||
| Remainder of 2022 | $ 81 | |
| 2023 | 252 | |
| 2024 | 30 | |
| 2025 | 0 | |
| 2026 | 0 | |
| Thereafter | 0 | |
| Total lease payment | 363 | |
| Less: interest | 20 | |
| Total lease liability | 343 | |
| Short-term financing lease liability | 276 | $ 392 |
| Long-term financing lease liability | 67 | 269 |
| Remainder of 2022 | 243 | |
| 2023 | 1,190 | |
| 2024 | 1,212 | |
| 2025 | 1,224 | |
| 2026 | 1,013 | |
| Thereafter | 1,189 | |
| Total lease payment | 6,071 | |
| Less: interest | 1,580 | |
| Total lease liability | 4,491 | |
| Short-term operating lease liability | 639 | 234 |
| Long-term operating lease liability | $ 3,852 | $ 1,515 |
Subsequent Event (Additional In
| Subsequent Event (Additional Information) (Details) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
| Subsequent Event [Line Items] | ||
| Common Stock, Shares, Issued | 24,502,157 | 18,781,242 |
| Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |